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Oregon Bulletin

November 1, 2011

 

Oregon Health Authority,
Public Health Division
Chapter 333

Rule Caption: Updating rules for Medical Marijuana pertaining to registration fees and adding new fee charges.

Adm. Order No.: PH 8-2011

Filed with Sec. of State: 9-30-2011

Certified to be Effective: 10-1-11

Notice Publication Date: 9-1-2011

Rules Amended: 333-008-0010, 333-008-0020, 333-008-0025, 333-008-0030, 333-008-0040, 333-008-0045, 333-008-0050, 333-008-0060, 333-008-0070, 333-008-0080, 333-008-0120

Subject: The Oregon Health Authority, Public Health Division, Oregon Medical Marijuana Program is permanently amending administrative rules in chapter 333, division 8. The 2011 Legislative Assembly adopted a Public Health budget that requires an increase in fees charged to OMMP applicants as well as an additional fee for growers to generate revenue to fund other public health programs. The new fees will be implemented beginning October 1, 2011. The current administrative rule does not require a fee for the growers in order for an applicant or grower to obtain an OMMP registry identification card. The Oregon Medical Marijuana Act (OMMA) mandates the Authority to adopt a fee structure in rules. In order to comply with the OMMA and legislative direction, the OMMP must amend its rules to increase the application fee, the replacement card fee, add a grow site fee, and also, to add definitions to clarify new terms and meanings for Authority, food stamps, grow site, and replacement registry identification card which are provisions in the rule that are not defined.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-008-0010

Definitions

For the purposes of OAR 333-008-0000 through 333-008-0120, the following definitions apply:

(1) “Act” means the Oregon Medical Marijuana Act.

(2) “Applicant” means a person applying for an Oregon Medical Marijuana registry identification card on a form prescribed by the Authority.

(3) “Attending physician” means a Doctor of Medicine (MD) or Doctor of Osteopathy (DO), licensed under ORS Chapter 677, who has primary responsibility for the care and treatment of a person diagnosed with a debilitating medical condition.

(4) “Authority” means the Oregon Health Authority.

(5) “Debilitating medical condition” means:

(a) Cancer, glaucoma, agitation due to Alzheimer’s disease, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, or treatment for these conditions;

(b) A medical condition or treatment for a medical condition that produces, for a specific patient, one or more of the following:

(A) Cachexia;

(B) Severe pain;

(C) Severe nausea;

(D) Seizures, including but not limited to seizures caused by epilepsy; or

(E) Persistent muscle spasms, including but not limited to spasms caused by multiple sclerosis; or

(c) Any other medical condition or treatment for a medical condition adopted by the Authority by rule or approved by the Authority pursuant to a petition submitted under OAR 333-008-0090.

(6) “Delivery” means the actual, constructive or attempted transfer, other than by administering or dispensing, from one person to another of a controlled substance, whether or not there is an agency relationship, but does not include transfer of marijuana from one patient to another patient if no consideration is paid for the transfer.

(7) “Designated primary caregiver” means an individual 18 years of age or older who has significant responsibility for managing the well-being of a person who has been diagnosed with a debilitating medical condition and who is designated as such on that person’s application for a registry identification card or in other written notification to the Authority. “Designated primary caregiver” does not include the person’s attending physician.

(8) “Food stamps” means the Supplemental Nutrition Assistance Program as defined and governed by ORS 411.806 through 411.845.

(9) “Grow site” means a specific location used by the grower to produce marijuana for medical use by a specific patient.

(10) “Grow site registration card” means the card issued to the patient and displayed at the grow site.

(11) “Grower” has the same meaning as “person responsible for a marijuana grow site.”

(12) “Immature plant” has the same meaning as “seedling or start.”

(13) “Marijuana” means all parts of the plant Cannabis family Moraceae, whether growing or not; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination.

(14) “Mature plant” means a marijuana plant that does not fall within the definition of a seedling or a start.

(15) “Medical use of marijuana” means the production, possession, delivery, or administration of marijuana, or paraphernalia used to administer marijuana, as necessary for the exclusive benefit of a person to mitigate the symptoms or effects of his or her debilitating medical condition.

(16) “Oregon Health Plan (OHP)” means the medical assistance program administered by the Authority under ORS Chapter 414.

(17) “OMMP” refers to the office within the Authority that administers the provisions of the OMMA, and all policies and procedures pertaining thereto, as set forth in these rules.

(18) “Parent or legal guardian” means the custodial parent or legal guardian with responsibility for health care decisions for the person under 18 years of age.

(19) “Patient” has the same meaning as “registry identification cardholder.”

(20) “Person responsible for a marijuana grow site” means a person who has been selected by a patient to produce medical marijuana for the patient, and who has been registered by the Authority for this purpose.

(21) “Primary responsibility” as that term is used in relation to an attending physician means that the physician:

(a) Provides primary health care to the patient; or

(b) Provides medical specialty care and treatment to the patient as recognized by the American Board of Medical Specialties; or

(c) Is a consultant who has been asked to examine and treat the patient by the patient’s primary care physician licensed under ORS Chapter 677, the patient’s physician assistant licensed under ORS Chapter 677, or the patient’s nurse practitioner licensed under ORS Chapter 678; and,

(d) Has reviewed a patient’s medical records at the patient’s request and has conducted a thorough physical examination of the patient, has provided or planned follow-up care, and has documented these activities in the patient’s medical record.

(22) “Production” includes the manufacture, planting, cultivation, growing or harvesting of a controlled substance.

(23) “Registry identification card” means a document issued by the Authority that identifies a person authorized to engage in the medical use of marijuana, and the person’s designated primary caregiver, if any.

(24) “Registry identification cardholder” means a person who has been diagnosed by an attending physician with a debilitating medical condition and for whom the use of medical marijuana may mitigate the symptoms or effects of the person’s debilitating medical condition, and who has been issued a registry identification card by the Authority.

(25) “Replacement registry identification card” means a new card issued in the event that a registry identification cardholder’s card, designated primary caregiver identification card, grower identification card, or grow site registration card is lost or stolen, or if a registry identification cardholder’s designation of primary caregiver, grower, or grow site has changed.

(26) “Seedling or start” means a marijuana plant that has no flowers, is less than 12 inches in height, and less than 12 inches in diameter. A seedling or start that does not meet all three criteria shall be considered a mature plant.

(27) “Supplemental Security Income (SSI)” means the monthly benefit assistance program administered by the federal government for persons who are age 65 or older, or blind, or disabled and who have limited income and financial resources.

(28) “Usable marijuana” means the dried leaves and flowers of the plant Cannabis family Moraceae and any mixture or preparation thereof, that are appropriate for medical use. “Usable marijuana” does not include the seeds, stalks and roots of the plant.

(29) “Written documentation” means a statement signed and dated by the attending physician of a person diagnosed with a debilitating medical condition or copies of the person’s relevant medical records, maintained in accordance with standard medical record practices.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 15-1998(Temp), f. & cert. ef. 12-24-98 thru 6-22-99; OHD 3-1999, f. & cert. ef. 4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0020

New Registration Application and Verification

(1) A person may apply for a registry identification card on forms prescribed by the Authority. In order for an application to be considered complete, an applicant must submit the following:

(a) An application form signed and dated by the applicant;

(b) Copies of legible and valid U.S. state or federal issued photographic identification that includes last name, first name, and date of birth from the applicant, the designated primary caregiver, and grower, as applicable. Acceptable forms of current U.S. state or federal issued photographic identification include but are not limited to:

(A) Driver’s license;

(B) State identification card;

(C) Passport; or

(D) Military identification card.

(c) Written documentation, which may consist of relevant portions of the applicant’s medical record, signed by the applicant’s attending physician within 90 days of the date of receipt by the Authority, which describes the applicant’s debilitating medical condition and states that the use of marijuana may mitigate the symptoms or effects of the applicant’s debilitating medical condition;

(d) If applicable, a completed and notarized “Declaration of Person Responsible for Minor” form for any person under 18 years of age, signed and dated by the person responsible for the minor;

(e) The name of a designated primary caregiver, if any, and one designated grower (either the patient or another person) and the location of the grow site; and

(f) An application fee and grow site registration fee, if applicable, in the form of cash, bank check, money order, or personal check.

(2) The Authority shall process an application prior to issuing registry identification cards to assure that the application is complete and information provided has been verified.

(a) The Authority shall only accept applications that are mailed or are hand-delivered.

(b) If an applicant does not provide all the information required and the application is considered incomplete, the Authority shall notify the applicant of the information that is missing, and shall allow the applicant 14 days to submit the missing information.

(c) If an applicant does not provide the information necessary to declare an application complete, or to complete the verification process within the timelines established in subsections (2)(b) and (3)(e) of this rule, the application shall be rejected as incomplete. An applicant whose application is rejected as incomplete may reapply at any time. If an applicant submits an application fee and the application is subsequently denied or rejected, the application fee may be applied toward a new application submitted within one year of the denial or rejection date.

(d) The Authority may reject an application if the application or supporting documents appear to be altered (e.g., writing is whited out). An application shall be denied in accordance with OAR 333-008-0030 if an application or supporting documents are determined to have been falsified.

(e) The Authority may verify information on each application and accompanying documentation, including:

(A) Contacting each applicant by telephone or by mail. If proof of identity is uncertain, the Authority may require a face-to-face meeting and may require the production of additional identification materials;

(B) Contacting a minor’s parent or legal guardian;

(C) Contacting the Oregon Medical Board to verify that an attending physician is licensed to practice in the state and is in good standing;

(D) Contacting the attending physician to request further documentation to support a finding that the physician is the applicant’s attending physician. The Authority shall notify the applicant of the intent to review the medical records and request the applicant’s authorization to conduct the review. Failure to authorize a review of medical records may result in the application being declared incomplete, or denial of an application. If the Authority is unable to verify that the applicant’s attending physician meets the definition under OAR 333-008-0010(3) the applicant will be allowed 30 days to submit written documentation or a new attending physician’s declaration from a physician meeting the requirements of these rules. Failure to submit the required attending physician documentation is grounds for denial under ORS 475.309 and OAR 333-008-0030;

(E) Contacting the Division of Medical Assistance Programs, Department of Human Services-Self Sufficiency, or the Social Security Administration (SSA) to verify eligibility for benefits; and

(F) Conducting a criminal records check under ORS 181.534 of any person whose name is submitted as a grower.

(3) Application fees.

(a) A non-refundable application fee of $200 is required at the time of application.

(b) If applicable as specified in OAR 333-008-0025, a non-refundable grow site registration fee of $50 is required at the time of application.

(c) An applicant who can prove he or she is an Oregon resident and can demonstrate current receipt of SSI benefits, current eligibility for OHP benefits or current receipt of food stamp benefits through the Oregon SNAP program, qualifies for a reduced non-refundable application fee.

(A) Proof of residency may be shown through provision of:

(i) A current Oregon driver’s license or Oregon issued identification card; and

(ii) A utility bill, mortgage statement, lease payment statement or lease agreement for the previous month with the applicant’s name and an Oregon physical address.

(B) An applicant demonstrating receipt of SSI benefits by providing a copy of a current monthly SSI benefit card showing dates of coverage is entitled to a reduced application fee of $20.

(C) An applicant demonstrating current eligibility for OHP benefits by providing a copy of the applicant’s current eligibility statement is entitled to a reduced application fee of $100.

(D) An applicant demonstrating receipt of current food stamp benefits, verified by enrollment in Oregon’s Food Stamp Management Information System database system and by providing current proof of his or her food stamp benefits, is entitled to a reduced application fee of $100.

(d) The Authority shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check. Upon receipt by the Authority of a notice of non-sufficient funds (NSF) or stop payment, an applicant will be allowed 14 days to submit payment in the form of a bank check or cash. Application fees paid in the form of cash must be hand-delivered. Applicants are advised not to make payments in cash through the United States mail or private delivery services. The Authority will not accept responsibility for payments of cash that are lost in the mail or stolen in transit.

(e) The Authority shall notify an applicant who submits a reduced application fee for which the applicant is not eligible and will allow the applicant 14 days from the date of notice to pay the correct application fee and submit a current valid proof of eligibility.(4) The application forms referenced in this rule may be obtained by contacting the: Oregon Medical Marijuana Program (OMMP) at PO Box 14450, Portland, OR 97293-0450 or calling 971-673-1234.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 38-2004, f. 12-22-04, cert. ef. 1-1-05; PH 17-2005, f. 11-25-05, cert. ef. 12-1-05; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 14-2010(Temp), f. & cert. ef. 7-6-10 thru 12-31-10; PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0025

Marijuana Grow Site Registration

(1) A patient must register a marijuana grow site with the Authority. The Authority will register only one grow site per patient, and will only register grow sites in Oregon.

(2) To register a marijuana grow site, an applicant or patient must submit to the Authority an application, prescribed by the Authority, that includes:

(a) The name of the grower;

(b) The date of birth of the grower;

(c) The physical address of the marijuana grow site where marijuana is to be produced;

(d) The mailing address of the grower;

(e) The registry identification card number of the patient, if known, for whom the marijuana is being produced; and

(f) A non-refundable grow site registration fee of $50 in the form of cash, bank check, money order, or personal check. If the grower is the applicant, he or she is not required to pay the grow site registration fee. The Authority shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check. Upon receipt by the Authority of a notice of non-sufficient funds (NSF) or stop payment, an applicant will be allowed 14 days to submit payment in the form of a bank check or cash. Application fees paid in the form of cash must be hand-delivered. Applicants are advised not to make payments in cash through the United States mail or private delivery services. The Authority will not accept responsibility for payments of cash that are lost in the mail or stolen in transit.

(3) The Authority shall conduct a criminal background check on the grower as authorized under ORS 475.304.

(a) A person convicted of a Class A or Class B felony under ORS 475.840 to 475.920 for the manufacture or delivery of a controlled substance in Schedule I or Schedule II, if the offense occurred on or after January 1, 2006, may not be issued a marijuana grow site registration card or produce marijuana for a registry identification cardholder for five years from the date of conviction.

(b) A person convicted more than once of a Class A or Class B felony under ORS 475.840 to 475.920 for the manufacture or delivery of a controlled substance in Schedule I or Schedule II, if the offenses occurred after January 1, 2006, may not be issued a marijuana grow site registration card or produce marijuana for a registry identification cardholder.

(c) The Authority shall notify a patient by certified mail that the grower is ineligible and the patient will be allowed the opportunity to identify another grower.

(4) The Authority shall issue a marijuana grow site registration card to a patient who has met the requirements of section (2) of this rule, unless the grower is disqualified under section (3) of this rule.

(5) A grower must display a marijuana grow site registration card for each patient for whom marijuana is being produced, at the marijuana grow site at all times.

(6) All usable marijuana, plants, seedlings and seeds, associated with the production of marijuana for a patient by a grower, are the property of the patient and must be provided to the patient upon request.

(7) All marijuana produced for a patient must be provided to the patient or designated primary caregiver when the grower ceases producing marijuana for the patient.

(8) A grower must return the grow site registration card to the patient to whom the card was issued when requested to do so by the patient or when the grower ceases producing marijuana for the patient.

(9) A patient or the designated primary caregiver of the patient may reimburse the grower for the costs of supplies and utilities associated with production of marijuana for patient. No other costs associated with the production of marijuana for the patient, including the cost of labor, may be reimbursed.

(10) A grower may produce marijuana for no more than four patients or designated primary caregivers concurrently.

Stat.Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0030

Registration Approval and Denial

(1) The Authority shall approve or deny an application within 30 days of receiving a complete application, including payment of the designated fee.

(2) If the Authority approves the application, the Authority shall issue a serially numbered registry identification card to the patient within five business days. The registry identification card shall include, but is not limited to:

(a) The patient’s name, address, and date of birth;

(b) The effective date, date of issuance, and expiration date of the registry identification card;

(c) The designated primary caregiver’s name, address, and date of birth, if applicable;

(d) The name, address, and date of birth of the grower, if applicable; and

(e) The location where the marijuana is produced.

(3) When a patient has specified a designated primary caregiver, or a grower, the Authority shall issue an OMMP registry identification card for the designated primary caregiver and the grower. The Authority shall also issue a grow site registration card to the patient. All cards shall contain the information specified in section (2) of this rule, as appropriate.

(4) The Authority may deny an application if:

(a) The applicant did not provide the information required as provided in ORS 475.309 to establish the applicant’s debilitating medical condition and to document the applicant’s consultation with an attending physician regarding the medical use of marijuana in connection with such condition;

(b) The Authority determines that the information provided was falsified;

(c) The applicant has been prohibited by a court order from obtaining a registry identification card; or

(d) An applicant has willfully violated the provisions of ORS 475.300 to 475.346 or these rules.

(5) If the Authority denies an application, the Authority shall send the applicant a denial letter within 30 days of receipt of the complete application. The time period set forth in OAR 333-008-0020 that provides an applicant an opportunity to supplement an incomplete application does not count towards the 30-day deadline for processing an application. The denial letter will be sent by certified mail to the address listed on the application form. The letter will state the reasons for denial and when the applicant may reapply.

(6) Denial of a registry identification card shall be considered a final Authority action, subject to judicial review. Only the person whose application has been denied, or, in the case of a person under the age of 18 whose application has been denied, the person’s parent or legal guardian shall have standing to contest the Authority’s action.

(7) Any person whose application has been denied may not reapply for at least six months from the date of the denial, unless so authorized by the Authority or a court of competent jurisdiction.

(8) If a patient registry identification card, a designated primary caregiver identification card, or a grower registry identification card or grow site registration card has been lost or stolen, the fee to receive a replacement card is $100. If the patient qualifies for the reduced application fee of $20, the fee to receive any of the replacement cards is $20.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; OHD 21-2001(Temp), f. & cert. ef. 10-12-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 12-2004(Temp), f. & cert. ef. 4-1-04 thru 8-2-04; Administrative correction 8-19-04; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0040

Annual Renewal

(1) A patient shall register on an annual basis to maintain active registration status by submitting a renewal application prescribed by the Authority. A renewal application shall be submitted by mail or in person at the OMMP office.

(2) Between 60 to 90 calendar days prior to expiration, the Authority shall mail to the patient’s address of record, a letter notifying the patient of the upcoming expiration date, along with a renewal application.

(3) In addition to completing the renewal application, the patient must submit, prior to the expiration of the registry identification card:

(a) Written documentation, signed by the patient’s attending physician within 90 days prior to the expiration date of the patient’s current card, reconfirming the patient’s debilitating medical condition and that the medical use of marijuana mitigates the symptoms of the patient’s debilitating medical condition; and

(b) The information and fees required in OAR 333-008-0020. A patient applying for renewal may qualify for a reduced application fee if the applicant meets the criteria set forth in OAR 333-008-0020.

(4) If the renewal information is not received by the expiration date on the registry identification card, the patient’s registry identification card and all other associated OMMP cards, if any, shall be deemed expired. The expiration date may be extended, due to personal hardship, at the discretion of the Authority. If a person fails to apply for renewal within the time period specified in this rule, that person must submit a new application.

(5) The Authority shall verify the renewal application information in the same manner as specified in OAR 333-008-0020.

(6) The Authority may reject a renewal application if the application or supporting documents appear to be altered (e.g., writing is whited out). An application shall be denied in accordance with OAR 333-008-0030 if an application or supporting documents are determined to have been falsified.

Stat. Auth.: ORS 475.309 & 475.312

Stats. Implemented: ORS 475.309 & 475.312

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0045

Interim Changes

(1) A patient shall notify the Authority within 30 calendar days of any change in the patient’s name, address, telephone number, attending physician, designated primary caregiver, grower or grow site address.

(2) A patient shall notify the designated primary caregiver and the grower of any changes in status including, but not limited to:

(a) The assignment of another individual as the designated primary caregiver for the patient;

(b) The assignment of another individual as a grower for the patient; or

(c) The end of eligibility of the patient to hold a registry identification card.

(3) If the Authority is notified by the patient that a designated primary caregiver or a grower has changed, the Authority shall notify the designated primary caregiver or the grower by mail at the address of record confirming the change in status and informing the caregiver or grower that their card is no longer valid and must be returned to the Authority within seven calendar days.

(4) A patient who has been diagnosed by an attending physician as no longer having a debilitating medical condition or whose attending physician has determined that the medical use of marijuana is contraindicated for the patient’s debilitating medical condition shall return the registry identification card and all associated OMMP cards to the Authority within 30 calendar days of notification of the diagnosis or notification of the contraindication. If, due to circumstances beyond control of the patient he or she is unable to obtain a second medical opinion about the patient’s continuing eligibility to use medical marijuana before the 30-day period has expired, the Authority may grant the patient additional time to obtain a second opinion before requiring the patient to return the registry identification card and all associated cards.

(5) Change forms may only be submitted to the Authority via mail or in person at the OMMP office.

(6) If a patient’s designated primary caregiver, grower or grow site has changed, the fee to receive a replacement card is $100. If the patient qualifies for the reduced application fee of $20, the fee to receive any replacement card is $20.

(7) If a patient is registering a new grow site at any time other than when submitting a new application or a renewal application, a grow site registration fee will not be charged.

Stat. Auth.: ORS 475.309 & 475.312

Stats. Implemented: ORS 475.309 & 475.312

Hist.: PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0050

Confidentiality

(1) The Authority shall create and maintain either paper or computer data files of patients, designated primary caregivers, growers, and grow site addresses. The data files shall include all information collected on the application forms or equivalent information from other written documentation, plus a copy of OMMP registry identification cards, effective date, date of issue, and expiration date. Except as provided in section (2) of this rule, the names and identifying information of registry identification cardholders and the name and identifying information of a pending applicant for a card, a designated primary caregiver, a grower, and a marijuana grow site location, shall be confidential and not subject to public disclosure.

(2) Names and other identifying information made confidential under section (1) of this rule may be released to:

(a) Authorized employees of the Authority as necessary to perform official duties of the Authority, including the production of any reports of aggregate (i.e., non-identifying) data or statistics;

(b) Authorized employees of state or local law enforcement agencies when they provide a specific name or address. Information will be supplied only as necessary to verify:

(A) That a person is or was a lawful possessor of a registry identification card; or

(B) That the address is or was a documented grow site, and how many people are authorized to grow at that grow site; or

(C) How many people a person was or is authorized to grow for.

(c) Other persons (such as, but not limited to, employers, lawyers, family members) upon receipt of a properly executed release of information signed by the patient, the patient’s parent or legal guardian, designated primary caregiver or grower. The release of information must specify what information the Authority is authorized to release and to whom.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0060

Monitoring and Investigations

(1) The Authority may, at any time, contact a patient, designated primary caregiver, grower, or a patient’s attending physician by telephone, mail or in person to verify the current accuracy of information included in the registration system. This authority does not extend to allowing Authority staff to routinely search the person or property of a person who possesses a registry identification card, a grow site, or to search the property of an attending physician.

(2) Notwithstanding section (1) of this rule, the Authority may, when it has reason to believe a violation of ORS 475.300 through 475.346 has occurred, either conduct an investigation to collect evidence of a violation of the Oregon Medical Marijuana Act, or arrange for this responsibility to be assumed by the proper state or local authorities. Such violations include, but are not limited to:

(a) Failure by a patient to notify the Authority of any change in the patient’s name, address, attending physician, designated primary caregiver, grower, or grow site location.

(b) Failure by a patient, designated primary caregiver, or grower to return the OMMP identity and registry identification cards to the Authority within seven calendar days of the patient’s notification of the diagnosis that the patient no longer has a debilitating medical condition.

(c) Failure by a designated primary caregiver or grower to return the OMMP identity and registry identification cards to the Authority within seven calendar days of notification by the patient that the person’s designation as primary caregiver or grower has been terminated.

(d) Submission of false information by a patient, designated primary caregiver, grower, or attending physician during the registration or registration renewal process.

(e) Conviction of a patient, designated primary caregiver, or grower of a marijuana-related offense that occurred after the date of issuance of a registry identification card.

(3) If the Authority has reason to believe that an individual, signing an application as the attending physician, does not meet the definition of attending physician under these rules, the Authority may examine the original patient medical record in the physician’s possession or a copy provided by the physician. The sole purpose of this examination is to determine whether the physician meets the definition of attending physician in OAR 333-008-0010, including whether the physician has primary responsibility for a patient as that is defined in OAR 333-008-0010, and will not include review of any clinical judgments such as adequacy of diagnosis or propriety of treatment.

(a) The Authority shall notify the patient of the intent to review the medical records pursuant to this section and request the patient’s authorization to conduct the review. An applicant’s or patient’s failure to authorize a review of his or her medical records may result in denial of an application.

(b) The Authority shall send written notification allowing the physician 10-days to provide additional information requested by the Authority.

(4) In determining whether to examine a patient’s medical record pursuant to section (3) of this rule, the Authority may consider, but is not limited to, factors such as complaints from patients or family members, complaints from health care providers, total number of applicants for whom the physician provided documentation, or number of applicants for whom the physician provided documentation during a specific time period.

(5) If the Authority records show that any one physician is the attending physician of record for more than 450 patients at any point in time, the Authority shall request, in writing, that the physician do one of the following:

(a) Provide information for each new patient over the 450 threshold, including:

(A) Documentation that the patient’s medical records have been reviewed;

(B) Patient chart notes documenting the patient was examined by the physician and the date of the examination; and

(C) Documentation showing provided or planned follow-up care;

(b) Provide a letter from a clinic at which the physician provides care requesting that the physician be exempted from section (5) of this rule, and provide documentation from the clinic that:

(A) It has clear systems for ensuring medical records are reviewed and that each patient is examined by a physician;

(B) It provides follow-up care for patients;

(C) It maintains a record system documenting the review of medical records, physician examination, and follow-up care; and

(D) It will allow on-site inspections by the Authority to confirm compliance; or

(c) Provide a written statement explaining why the physician should be released from this requirement, for example, an explanation that the physician:

(A) Has a practice that includes a disproportionately high percentage of patients with qualifying conditions;

(B) Serves as a consultant for other health care providers who refer patients requesting medical marijuana; or

(C) Has multiple practice sites and at one of the practice sites the physician clearly meets the attending physician definition.

(6) If the Authority receives a request from a physician to be exempted from the requirement in section (5) of this rule, the Authority shall provide the physician a decision, in writing, explaining whether the physician is or is not exempted from the requirement in section (5) of this rule. The Authority’s written decision shall explain the basis for the Authority’s decision.

(7) The Authority shall refer criminal complaints against a patient, designated primary caregiver, or grower; or medical practice complaints against an attending physician to the appropriate state or local authorities.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0070

Suspension and Revocation

(1) The Authority may suspend a registry identification card, and preclude a person from using a registry identification card for a period of up to six months if the Authority obtains evidence that establishes a registry identification cardholder has:

(a) Committed egregious violations of the Act, including obtaining a registry identification card by fraud;

(b) Committed multiple or continuing violations of the Act; or

(c) Been convicted of a marijuana-related offense.

(2) The Authority shall send written notice of a suspension by certified mail.

(3) The Authority shall revoke the registry identification card of a cardholder if a court has issued an order that prohibits the cardholder from participating in the medical use of marijuana or otherwise participating in the OMMP under ORS 475.300 through 475.346. The cardholder shall return the registry identification card to the Authority within seven calendar days.

(4) The cardholder shall return the registry identification card to the Authority within seven calendar days of the final order of suspension being issued. If the cardholder is a patient, the patient shall return his or her card and all other associated OMMP cards.

(5) If, during the period of suspension, a patient’s annual renewal date comes due, the patient must apply for renewal at the end of the period of suspension.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0080

Permissible Amounts of Medical Marijuana

(1) A patient or the patient’s designated primary caregiver may possess up to six mature marijuana plants, 24 ounces of usable marijuana, and a patient and the patient’s designated primary caregiver may possess a combined total of up to 18 marijuana seedlings or starts.

(2) Notwithstanding section (1) of this rule, if a patient has been convicted, on or after January 1, 2006, of a Class A or Class B felony under ORS 475.840 through 475.920 for the manufacture or delivery of a controlled substance in Schedule I or Schedule II, and the offense occurred on or after January 1, 2006, the patient or the patient’s designated primary caregiver may possess only one ounce of usable marijuana at any given time for a period of five years from the date of the conviction.

(3) A grower:

(a) May produce marijuana for and provide marijuana to a patient or that person’s designated primary caregiver as authorized under ORS 475.300 through 475.346 and these rules;

(b) May possess up to six mature plants and up to 24 ounces of usable marijuana for each patient or designated primary caregiver for whom marijuana is being produced;

(c) May possess up to 18 marijuana seedlings or starts for each patient for whom marijuana is being produced.

(4) A grower may produce marijuana for no more than four patients or designated primary caregivers concurrently.

(5) A patient, the designated primary caregiver for a patient and the grower must have, in his or her possession, his or her OMMP identity card when transporting marijuana. A patient must have, in his or her possession, his or her OMMP identity card when using marijuana in a location other than the residence of the cardholder.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

333-008-0120

System to Allow Verification of Data at All Times

(1) The Authority shall establish an interactive method to allow authorized employees of state and local law enforcement agencies to use the Oregon State Police Law Enforcement Data System (LEDS) to query an OMMP data file in order to verify at any time whether a particular patient, designated primary caregiver, grower, or grow site location is registered with the Authority.

(2) LEDS access will only allow a yes or no answer to the query and the information obtained may not be used for any other purpose other than verification.

(3) The Authority may allow the release of reports related to verification if it is without identifying data.

(4) The Authority shall have staff available by phone to verify law enforcement agency employee questions during regular business hours in case the electronic verification system is down, and in the event the system is expected to be down for more than two business days, the Authority shall ensure program staff are available by phone for verification purposes.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 – 475.346

Hist.: PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11

 

Rule Caption: WIC Vendor and Farmer Administration.

Adm. Order No.: PH 9-2011

Filed with Sec. of State: 9-30-2011

Certified to be Effective: 9-30-11

Notice Publication Date: 9-1-2011

Rules Amended: 333-054-0010, 333-054-0020, 333-054-0025, 333-054-0027, 333-054-0035, 333-054-0040, 333-054-0050, 333-054-0055, 333-054-0060, 333-054-0070

Subject: The Oregon Health Authority, Public Health Division is permanently amending administrative rules in chapter 333, division 54 as they pertain to vendors and farmers. These amendments are clarifications and adjustments to definitions, monitoring language, violation and sanction language, which reflect current program vendor and farmer administration practices. Additionally, the rules have been amended to replace references to “FSP” and the “Food Stamp Program” with the program’s new name “Supplemental Nutrition Assistance Program” or “SNAP.”

Rules Coordinator: Brittany Sande—(971) 673-1291

333-054-0010

Definitions

(1) “A50” means an authorized vendor or applicant that derives, or is expected to derive, more than 50 percent of its total annual food sales from WIC food sales. The total food sales do not include alcohol, tobacco, lottery or any other non-food item.

(2) “Abbreviated administrative review” means a hearing that is held at the request of a vendor that has been issued an application denial, civil money penalty, fine, or sanction by the Authority. Abbreviated Reviews are facilitated by the Authority staff other than the staff person that imposed the sanction. A facilitated discussion is held in order to resolve the imposition of a sanction.

(3) “Adequate participant access” means there are authorized vendors sufficient for participant need.

(4) “Annual Food Sales” means sales of all Supplemental Nutrition Assistance Program (SNAP) eligible foods intended for home preparation and consumption including meat, fish, and poultry; bread and cereal products; dairy products; fruits and vegetables. Food items such as condiments and spices, coffee, tea, cocoa, and carbonated and non-carbonated drinks may be included in food sales when offered for sale along with foods in the categories identified above. Food sales do not include sales of any items that cannot be purchased with SNAP benefits, such as hot foods or food that will be eaten in the store.

(5) “Applicant” means any person, or person with an interest in the business, making a written request for authorization to participate in the WIC Program, including vendors and farmers that reapply for authorization.

(6) “Authority” means the Oregon Health Authority.

(7) “Authorization” means the process by which the Authority assesses, selects, and enters into agreements with stores and farmers that apply or subsequently reapply to be vendors or authorized farmers allowed to transact CVVs.

(8) “Authorized food” means any supplemental foods listed on the WIC Authorized Food List, food instrument or CVV.

(9) “Authorized shopper” means the participant or any person designated by a participant who has been documented as such to act on the participant’s behalf and, in the case of an infant or child, the caretaker or the caretaker’s designee. This includes any representative posing as a participant or participant designee as authorized by the Authority.

(10) “CFR” means Code of Federal Regulations.

(11) “Change of Ownership” means a change in the ownership or control of ten percent or more of any class of stock in a corporation; a change in, addition of or removal of a partner of any partnership; a change in ownership or control of ten percent or more of the total investment commitment in partnership; or a change in the owner of a sole proprietorship.

(12) “CMP” means civil money penalty.

(13) “Cash Value Voucher” or “CVV” means a fixed-dollar check, voucher, electronic benefit transfer (EBT) card or other document which is used by a participant to obtain WIC authorized fruits and vegetables.

(14) “Compliance buy” means a single covert, on-site visit in which an Authority authorized representative poses as an authorized shopper and attempts to transact, or transacts, one or more food instruments or CVVs.

(15) “Disqualification” means cancelling the WIC program participation of a vendor or farmer, as a punitive action.

(16) “Farmer” means an individual who owns, leases, rents or sharecrops land to grow, cultivate or harvest crops on that land.

(17) “Farmer agreement” means a standard written legal contract between the farmer and the Authority that sets forth responsibilities of the parties.

(18) “FNS” means the Food and Nutrition Service of the U. S. Department of Agriculture.

(19) “Food instrument” or “FI” means a WIC Program voucher, check, coupon or other WIC approved document, which is used to obtain authorized foods.

(20) “Full administrative review” means a formal hearing that is held before an assigned administrative law judge from the state Office of Administrative Hearings. Attorneys may be present to represent both parties. Formal procedures are followed as to the presentation of evidence, examination of documentation and cross-examination of witnesses in accordance with 7 CFR § 246.18 and ORS Chapter 183.

(21) “Incentive item” means a food or non-food item offered free of charge to WIC shoppers to motivate them to shop at a particular store. Examples of incentive items include, but are not limited to, cash prizes, lottery tickets, transportation, sales/specials such as a buy-one-get one free or free additional ounces offer, and other free food or merchandise.

(22) “Inventory audit” means an examination of food invoices or other proofs of vendor purchases to determine whether a vendor has purchased sufficient quantities of authorized foods to support the vendor’s claim for reimbursement for such foods from the Authority during a specific period of time.

(23) “Investigation” means a period of review, beginning with the start of an inventory audit or the first compliance buy and closing when the audit has been completed or a sufficient number of compliance buys have been completed to provide evidence of compliance or non-compliance, not to exceed 24 months, to determine a vendor or farmer’s compliance with program rules and procedures.

(24) “Local agency” means:

(a) A public or private non profit health or human services agency that provides health services, either directly or through contract, in accordance with 7 CFR § 246.5;

(b) An Indian Health Service unit;

(c) An Indian tribe, band or group recognized by the Department of the Interior which operates a health clinic or is provided health services by an Indian Health Service unit; or

(d) An intertribal council or group that is an authorized representative of Indian tribes, bands or groups recognized by the Department of the Interior, which operates a health clinic or is provided health services by an Indian Health Service unit.

(25) “Overcharge” means intentionally or unintentionally charging the Authority more for authorized foods than the actual shelf price or the price charged to other shoppers.

(26) “Participant” means any pregnant woman, breastfeeding woman, post-partum woman, infant or child who receives authorized foods or food instruments or CVVs under the WIC Program, and the breastfed infant of any participating breastfeeding woman.

(27) “Pattern” means three or more findings of the same rule violation that occurs within a single investigation or routine monitoring(s).

(28) “Peer group” means a group of vendors considered to be in the same category by the Authority based on factors such as store type, store size and geography.

(29) “Person” means a human being, a public or private corporation, an unincorporated association, a partnership, a Limited Liability Corporation, a sole proprietor, a government or a governmental instrumentality.

(30) “Person with an interest in the business” means an officer, director, partner, or manager of the business or a shareholder with 10 percent interest or more in the business.

(31) “Price adjustment” means an adjustment made by the Authority, in accordance with the vendor/farmer agreement, to the purchase price on a food instrument or CVV, after it has been submitted by a vendor/farmer for redemption to ensure that the payment to the vendor/farmer for the food instrument or CVV complies with the Authority price limitations.

(32) “Prominently displayed” means immediately noticeable by persons entering the vendor or farmer location.

(33) “Routine monitoring” means an overt, on-site visit in which the Authority authorized representatives or federal officials identify themselves to vendor or farm personnel.

(34) “Shelf Price Survey” or “SPS” means a tool used by the Authority to collect a sample of a WIC authorized vendor’s current shelf prices.

(35) “SNAP” means the Supplemental Nutrition Assistance Program of the Food and Nutrition Services of the U.S. Department of Agriculture. This program was formerly known as the Food Stamp Program or “FSP.”

(36) “Stand Alone Pharmacy” means a pharmacy that is operated independently from or is not located in a WIC authorized grocery store. These stores are exempt from the minimum stock requirements set forth for grocery vendors.

(37) “Store Run Pharmacy” means a pharmacy that is located within a WIC authorized grocery store and is affiliated with that business entity.

(38) “Termination” means the cancellation of a vendor or farmer agreement which may or may not be linked to a disqualification.

(39) “Trafficking” means buying or selling food instruments or CVVs for cash.

(40) “U.S.C.” means United States Code.

(41) “Unauthorized food item” means foods and/or brands, and/or size not allowed on the WIC Authorized Food List. It also means foods not specified on a food instrument or CVV as eligible for purchase for that participant, with WIC benefits.

(42) “Vendor” means the current owner(s) or any person with an interest in the business, of any retail store location that is currently authorized by the Authority to participate in the WIC Program. Vendor may also refer to the authorized store location.

(43) “Vendor agreement” means a standard written legal contract between the vendor and the Authority that sets forth responsibilities of the parties.

(44) “Vendor Price List” means a comprehensive list of current authorized foods and minimum stock requirements, with current shelf prices completed by the vendor.

(45) “Violation” means an activity that is prohibited by OAR 333-054-0000 through 333-054-0070 and is classified in OAR 333-054-0050 and 333-054-0055.

(46) “WIC Authorized Food List” means the supplemental foods approved by the State of Oregon.

(47) “WIC Program” means the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) authorized by Section 17 of the Federal Child Nutrition Act of 1966, as amended, 42 U.S.C. § 1786.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: HD 7-1993, f. & cert. ef. 6-11-93; HD 31-1994, f. & cert. ef. 12-22-94; OHD 17-2001, f. 8-02-01, cert. ef. 8-15-01; OHD 22-2002, f. & cert. ef. 12-24-02; PH 19-2003(Temp), f. & cert. ef. 11-14-03 thru 5-12-04; PH 22-2003, f. 12-31-03, cert. ef. 1-5-04; PH 7-2005(Temp), f. & cert. ef. 5-2-05 thru 10-28-05; PH 16-2005, f. & cert. ef. 10-28-05; PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0020

How a Vendor Becomes WIC Authorized

(1) Only vendors authorized by the Authority may accept Oregon food instruments or CVVs in exchange for authorized foods.

(2) Application:

(a) An applicant shall submit a completed application to the Authority, which includes:

(A) An application form;

(B) A Vendor Price List;

(C) A current SNAP authorization number; and

(D) Any other documents or information required by the Authority.

(b) The Authority may limit the periods during which applications for vendor authorization will be accepted and processed. The Authority will process applications, outside of the limited application period, if it determines the applicant’s store is necessary to ensure adequate participant access in a specific geographic location.

(3) Selection Criteria: In order for the Authority to consider authorizing an applicant, the applicant shall:

(a) Demonstrate and maintain competitive pricing as determined by the Authority based on the applicant’s shelf prices and as compared to data from the peer group appropriate to the applicant’s characteristics. Such data may include redemption prices and/or shelf prices. If an applicant’s store is necessary to ensure adequate participant access, it may be exempt from this requirement;

(b) Possess a current bank account number;

(c) Not have, within the previous six years, a criminal conviction or civil judgment involving fraud or any other offense related to the applicant’s business integrity or honesty;

(d) Possess a current SNAP authorization number. Pharmacies, military commissaries, and stores that are determined by the Authority as necessary to provide adequate participant access shall be exempt from this selection requirement due to the nature of the services they provide for the WIC Program;

(e) Not have a history of serious violations with either the WIC Program or SNAP;

(f) Not be currently disqualified from participation in another state’s WIC Program. The Authority shall not authorize an applicant that has been assessed a CMP in lieu of disqualification by another state WIC Program until the period of the disqualification that would otherwise have been imposed has expired;

(g) Not be currently disqualified from participation in the SNAP. The Authority shall not authorize an applicant that has been assessed a SNAP civil money penalty in lieu of disqualification until the period of the disqualification that would otherwise have been imposed has expired unless this store has been determined necessary for participant access;

(h) Have a fixed location for each store;

(i) Stock representative items from all food categories specified on the Vendor Price List. Minimum quantities specified on the Vendor Price List shall be stocked or on order before authorization of an applicant:

(A) The Authority may grant a written exception if the applicant is able to provide documentation that appropriate stock was on order at the time of the initial on-site review and will be in the store within seven days;

(B) The Authority may grant a written exception to this requirement for cases where there is no participant need in the applicant’s area for a specific authorized food item, such as infant formula. The Authority shall determine participant need based on the local agency’s input regarding a vendor request for exception, vendor redemption data relative to the vendor’s request, and the number of infants using formula in the vendor’s store’s zip code. If a local agency notifies the vendor of a specific need for that authorized food item, the vendor will ensure that the authorized food item is available within seven days of the request;

(C) Pharmacies are exempt from this requirement; however, they shall obtain infant formula, including formula that requires a prescription, within 72 hours of an Authority or participant request.

(j) An applicant must purchase infant formula, which is to be sold to WIC shoppers, only from manufacturers, wholesalers, distributors, and retailers authorized by the Oregon WIC Program.

(k) Vendor must maintain and provide documentation of SNAP-eligible food sales throughout the contract period. According to USDA, ¦CFR 245.2, “Food sales” means sales of all foods that are eligible items under the SNAP. These foods are intended for home preparation and consumption and include:

(A) Meat, fish, and poultry;

(B) Bread and cereal products;

(C) Dairy products; and

(D) Fruits and vegetables.

(l) Food items such as condiments and spices, coffee, tea, cocoa, and carbonated and noncarbonated beverages may be included in food sales when offered for sale along with foods in the four primary categories. Food sales do not include sales of any items that are not approved for purchase with SNAP benefits, such as alcoholic beverages, hot foods, or foods that will be eaten on the store premises.

(m) Vendor must maintain and provide documentation and receipts showing source(s) of infant formula purchases.

(4) Authorization Requirements:

(a) The Authority or the local agency shall conduct a documented on-site visit prior to, or at the time of, authorization of an applicant, including evaluating the inventory and condition of authorized foods and providing the applicant with the WIC Program information prior to or at the time of authorization;

(b) The Authority shall conduct a live interactive training prior to or at the time of authorization. The Authority shall designate the date, time, and location of the training, except that the Authority shall provide the vendor with at least one alternate date on which to attend such training; and

(c) Once authorized, the vendor shall remain in compliance with the current selection criteria set forth in OAR 333-054-0020(3) for the duration of the vendor agreement. The Authority shall disqualify the vendor at any time the vendor does not meet the current selection criteria.

(5) Application Denials: the Authority shall give the applicant written notification of denial, in conformance with ORS chapter 183, as otherwise provided in these rules, the Authority may deny an applicant authorization for reasons including, but not limited to, the following:

(a) The applicant’s failure to meet the selection criteria;

(b) The applicant’s failure to meet all of the WIC rules initially or for the duration of the vendor agreement;

(c) The applicant’s store or business has been sold by its previous owner in an attempt to circumvent a WIC program sanction. In making this determination, the Authority may consider such factors as whether the applicant’s store or business was sold to a relative by blood or marriage of the previous owner(s) or sold to any person for less than its fair market value;

(d) The applicant’s history of complaints, violations and/or sanctions;

(e) The applicant’s refusal to accept training from the WIC program; or

(f) The applicant’s misrepresentation of information on the application.

(6) Subsequent to authorization, an agreement may be terminated if it is found that the vendor provided false or omitted pertinent information during the authorization process.

(7) If the Authority denies an application it may require the applicant to wait some period of time before reapplying.

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: HD 7-1993, f. & cert. ef. 6-11-93; OHD 17-2001, f. 8-02-01, cert. ef. 8-15-01; OHD 22-2002, f. & cert. ef. 12-24-02; PH 19-2003(Temp), f. & cert. ef. 11-14-03 thru 5-12-04; PH 22-2003, f. 12-31-03, cert. ef. 1-5-04; PH 7-2005(Temp), f. & cert. ef. 5-2-05 thru 10-28-05; PH 16-2005, f. & cert. ef. 10-28-05; PH 16-2006(Temp), f. 6-30-06, cert. ef. 7-1-06 thru 12-27-06; PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0025

Above 50% Vendors (A50)

(1) An applicant that is likely to derive more than 50 percent of the store’s annual food sales from WIC transactions will not be authorized except for cases of participant access hardship as determined solely by the Authority.

(2) An existing A50 will be allowed to close a current location and open at a new location as long as there is no break in service to WIC participants.

(3) Provision of incentive items. The Authority may not authorize or continue the authorization of an A50 vendor, or make payments to an A50 vendor which provides or indicates an intention to provide prohibited incentive items to customers. Evidence of such intent includes, but is not necessarily limited to, advertising the availability of prohibited incentive items.

(a) The Authority may approve any of the following incentive items to be provided by A50 vendors to customers, at the discretion of the Authority:

(A) Food, merchandise, or services obtained at no cost to the vendor, subject to documentation;

(B) Food, merchandise, or services of nominal value, i.e., having a per item cost of less than two dollars ($2), subject to documentation;

(C) Food sales and specials which involve no cost or less than two dollars ($2) in cost to the vendor for the food items involved, subject to documentation, and do not result in a charge to a WIC food instrument for foods in excess of the foods listed on the food instrument; and

(D) Minimal customary courtesies of the retail food trade, such as helping the customer to obtain an item from a shelf or from behind a counter, bagging food for the customer, and assisting the customer with loading the food into a vehicle.

(b) The following incentive items are prohibited for A50 vendors to provide to customers:

(A) Services which result in a conflict of interest or the appearance of such conflict for the A50 vendor, such as assistance with applying for WIC benefits;

(B) Lottery tickets provided to customers at no charge or below face value;

(C) Cash gifts in any amount for any reason;

(D) Anything made available in a public area as a complimentary gift which may be consumed or taken without charge;

(E) An allowable incentive item provided more than once per customer per shopping visit, regardless of the number of customers or food instruments involved, unless the incentive items had been obtained by the vendor at no cost or the total value of multiple incentive items provided during on shopping visit would not exceed the less than two dollar ($2) nominal value limit;

(F) Food, merchandise, or services of greater than nominal value provided to the customer;

(G) Food, merchandise sold to customers below cost, or services purchased by customers below fair market value;

(H) Any kind of incentive item which incurs a liability for the WIC Program; and

(I) Any kind of incentive item which violates any Federal, State, or local law or regulations.

(c) For-profit goods or services offered by the A50 vendor to WIC participants at fair market value based on comparable for-profit goods or services of other businesses are not incentive items subject to approval or prohibition, except that such goods or services must not constitute a conflict of interest or result in a liability for the WIC Program.

(4) If a currently authorized vendor is found to derive more than 50 percent of the store’s annual food sales from WIC transactions the Authority will terminate the vendor agreement unless the vendor is necessary for participant access.

Stat. Auth.: ORS 409.600

Stat. Implemented: ORS 409.600

Hist.: PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0027

How a Farmer Becomes WIC Authorized

(1) Only authorized farmers may accept CVVs from participants in exchange for eligible foods. Authorized farmers may not accept CVVs from unauthorized farmers.

(2) In order to be eligible for participation in the WIC program, a farmer applicant must:

(a) Grow, cultivate, or harvest fresh fruits or vegetables in Oregon or a bordering county in a contiguous state to sell fresh or frozen at a farmers’ market or farm stand. Farmers are exempt from the minimum WIC authorized food stocking requirements as indicated for vendor authorization under OAR 333-054-0020(3)(i);

(b) Complete the farmer application and return it to the appropriate state office to verify eligibility; and

(c) Agree to follow the terms and conditions of the farmer agreement.

(3) The Authority shall conduct an interactive training for all farmers who have never previously participated in the program prior to their commencing participation.

(4) The Authority and the WIC program are not required to authorize all applicants.

(5) Any individual who purchases all the produce they plan to sell is considered a distributor and is not allowed to participate in the WIC program as a farmer.

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0035

Farmer Agreements

(1) A farmer application/agreement must be signed by a representative who has legal authority to obligate the farmer.

(2) The farmer application/agreement must include a requirement that the farmer comply with OAR 333-054-0000 through 333-054-0070, as applicable to farmers.

(3) The farmer application/agreement will be valid up to, but not exceeding, three years.

(4) Neither the Authority nor the farmer is obligated to renew the agreement.

(5) An authorized farmer must comply with requirements contained in 7 CFR 246 and the terms and conditions of the farmer application/agreement.

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0040

Vendor and Farmer Monitoring

The Authority shall monitor vendors and farmers for compliance with applicable laws and rules, which may include on-site investigation of selected vendors.

(1) The Authority or its authorized representative must conduct compliance buys or inventory audits to collect evidence of improper vendor practices.

(2) The Authority or its authorized representative shall conduct routine monitorings and survey current WIC authorized food shelf prices of selected vendors.

(3) The Authority shall conduct covert compliance buys and/or routine monitorings of authorized farmers for compliance with the Authority rules and regulations.

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: HD 7-1993, f. & cert. ef. 6-11-93; OHD 17-2001, f. 8-2-01, cert. ef. 8-15-01; OHD 22-2002, f. & cert. ef. 12-24-02; PH 19-2003(Temp), f. & cert. ef. 11-14-03 thru 5-12-04; PH 22-2003, f. 12-31-03, cert. ef. 1-5-04; PH 16-2005, f. & cert. ef. 10-28-05; PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0050

Vendor Violation Notifications and Sanctions

(1) Prior warning:

(a) The Authority must notify a vendor in writing when an investigation reveals an initial incidence of a violation for which a pattern of incidences must be established in order to impose a sanction, before another such incidence is documented, unless the Authority determines, in its discretion, on a case-by-case basis, that notifying the vendor would compromise an investigation.

(b) Prior to imposing a sanction for a pattern of violative incidences, the Authority must either provide such notice to the vendor, or document in the vendor file the reason(s) for determining that such a notice would compromise an investigation.

(c) If notification is provided, the Authority may continue its investigation after the notice of violation is received by the vendor, or presumed to be received by the vendor consistent with the Authority’ procedures for providing such notice.

(d) All incidences of a violation occurring during the first compliance buy visit must constitute only one incidence of that violation for the purpose of establishing a pattern of incidences.

(e) A single violative incidence may only be used to establish the violations as written in OAR 333-054-0050(3)(c) and 333-054-0050(3)(d).

(2) Vendors shall receive a written “Notice of Non-compliance” for a single instance of:

(a) Failing to comply with Part 3 of the vendor’s current vendor agreement;

(b) Failing to complete and return the Vendor Price List by the deadline set by the Authority;

(c) Failing to complete and return the Shelf Price Survey (SPS) by the deadline set by the Authority;

(d) Failing to provide the authorized shopper with a receipt for foods purchased with a food instrument or CVV;

(e) Failing to ensure that within 60 days of a name change the outside sign bears the same name as that listed on the vendor agreement;

(f) Influencing an authorized shopper’s selection of authorized foods;

(g) Requesting or requiring any identification or information from the authorized shopper other than the WIC Program identification card;

(h) Selling expired authorized foods or infant formula to authorized shoppers;

(i) Failing to respond to a request issued by the Authority;

(j) Failing to accept training when required by the Authority;

(k) Using the “WIC” acronym or logos in an unauthorized manner;

(l) Failing to maintain or provide, to the Authority upon request, invoices or receipts to show source(s) of formula purchase;

(m) Retaining WIC identification or any information that identifies a shopper as a WIC participant or disclosing information regarding a client of the WIC Program to any person other than the Authority, its representatives or a federal official;

(n) Failing to comply with the terms in a final order issued by the Authority;

(o) Failing to comply with an investigation by federal or state officials;

(p) Refusing the Authority or a federal official access to food instruments or CVVs negotiated on the day of review;

(q) Failing to provide, within two business days of the Authority’s request, purchasing/receiving records to substantiate the volume and prices charged to the Authority;

(r) Failing to stock appropriate quantities of authorized foods and infant formula;

(s) Violating the nondiscrimination clause listed in the vendor agreement; and

(t) A50s only: Failing to maintain or provide, to the Authority upon request, documentation for each incentive item.

(3) Sanctions:

(a) For the following violations, the Authority shall disqualify a vendor for one year:

(A) A pattern of providing unauthorized food items in exchange for food instruments or CVVs, including charging for authorized food provided in excess of those listed on the food instrument;

(B) A pattern of failing to stock appropriate quantities of authorized foods and infant formula;

(C) A pattern of providing change when redeeming a food instrument or CVV;

(D) A pattern of allowing a refund or any other item of value in exchange for authorized foods or providing exchanges for authorized food items obtained with food instruments or CVVs, except for exchanges of an identical authorized food item when the original authorized food item is defective, spoiled, or has exceeded its “sell by,” “best if used by,” or other date limiting the sale or use of the food item. An identical authorized food item means the exact brand and size as the original authorized food item obtained and returned by the authorized shopper;

(E) A50s only: A pattern of providing WIC shoppers with incentive items or other merchandise and/or services not approved by the Authority.

(b) For the following violations, the Authority shall disqualify the vendor for three years:

(A) One incident of the sale of alcohol, an alcoholic beverage, or a tobacco product in exchange for a food instrument or CVV;

(B) Failing an Authority inventory audit;

(C) A pattern of claiming reimbursement for the sale of an amount of a specific authorized food item, which exceeds the store’s documented inventory of that authorized food item for a specific period of time;

(D) A pattern of vendor overcharges;

(E) A pattern of receiving, transacting and/or redeeming food instruments or CVVs outside of authorized channels or locations. This includes, but is not limited to use of an unauthorized vendor and/or unauthorized person, and/or redemption of food instruments or CVVs outside of an authorized store location;

(F) A pattern of charging for foods not received by the authorized shopper; and

(G) A pattern of providing credit or non-food items in exchange for food instruments or CVVs, other than those items listed in OAR 333-054-0050(3)(c) and 333-054-0050(3)(d).

(c) For the following violations, the Authority shall disqualify the vendor for six years:

(A) One incident of buying or selling a food instrument or CVV for cash (trafficking); or

(B) One incident of selling a firearm, ammunition, explosive, or controlled substance, as defined in 21 U.S.C. § 802, in exchange for a food instrument or CVV.

(d) The Authority shall permanently disqualify a vendor convicted of trafficking in food instruments or CVVs or selling firearms, ammunition, explosives, or controlled substances as defined in 21 U.S.C. § 802 in exchange for a food instrument or CVV.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: HD 7-1993, f. & cert. ef. 6-11-93; OHD 17-2001, f. 8-2-01, cert. ef. 8-15-01; OHD 22-2002, f. & cert. ef. 12-24-02; PH 19-2003(Temp), f. & cert. ef. 11-14-03 thru 5-12-04; PH 22-2003, f. 12-31-03, cert. ef. 1-5-04; PH 7-2005(Temp), f. & cert. ef. 5-2-05 thru 10-28-05; PH 16-2005, f. & cert. ef. 10-28-05; PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0055

Farmer Violations and Sanctions

(1) A farmer is in violation if a farmer fails to comply with WIC program rules and the terms and conditions of the farmer application/agreement or fails to respond to requests, implement corrective action, or comply with the terms in final orders as directed by the Authority.

(2) Farmer Sanctions:

(a) CVVs that are not stamped with the farmer’s Authority-assigned identification number will be returned to the farmer without payment;

(b) CVVs redeemed with the following violations will not be reimbursed:

(A) Accepting a CVV before the “First Day To Use” or after the “Last Day To Use;”

(B) Failing to enter the actual purchase price in the designated box;

(C) Failing to obtain the authorized shoppers signature at the time of the transaction, in the designated box, on the front of the CVV accepted for payment.

(c) The Authority may issue a written notification of non-compliance to an authorized farmer for an initial incident of:

(A) Accepting CVVs for ineligible foods;

(B) Failing to prominently display the official sign provided by the Authority, each market day when at authorized farmers’ markets or authorized farm stands;

(C) Failing to provide WIC shoppers with the full amount of product for the value of each CVV;

(D) Failing to ensure that WIC shoppers receive equitable treatment, including the availability of produce that is of the same quality and no greater price than sold to other shoppers;

(E) Failing to reimburse the Authority for CVVs that are improperly transacted;

(F) Charging sales tax on CVV purchases;

(G) Seeking restitution from WIC participants for CVVs not paid by the Authority;

(H) Giving cash back for purchases less than the value of the CVV (providing change);

(I) Accepting CVVs from an unauthorized farmer;

(J) Failing to respond to requests, implement corrective action, or comply with the terms in final orders as directed by the Authority;

(K) Using CVVs for any purpose other than to deposit or cash them at the authorized farmer’s financial institution; and

(L) Failing to cooperate with staff from the Authority, staff authorized to act on the Authority’s behalf or the Oregon Department of Agriculture in monitoring for compliance with program requirements and failing to provide information that the Authority or the Oregon Department of Agriculture may require.

(d) The Authority may disqualify a farmer for six months for an initial incident of providing credit in exchange for CVVs.

(e) The Authority may disqualify a farmer for six months, for second or subsequent incidents of:

(A) Accepting CVVs for ineligible foods;

(B) Failing to prominently display the official sign provided by the Authority, each market day when at authorized farmers’ markets or authorized farm stands;

(C) Failing to provide WIC shoppers with the full amount of product for the value of each CVV;

(D) Failing to ensure that WIC shoppers receive equitable treatment, including the availability of produce that is of the same quality and no greater price than sold to other shoppers;

(E) Charging sales tax on CVV purchases;

(F) Seeking restitution from WIC participants for CVVs not paid by the Authority;

(G) Using CVVs for any purpose other than deposit or cash at the authorized farmer’s financial institution;

(H) Charging WIC participants higher prices than other customers;

(I) Giving cash back for purchases less than the value of the CVV (providing change);

(J) Accepting CVVs from an unauthorized farmer; and

(K) Failing to respond to requests, implement corrective action, or comply with the terms in final orders as directed by the Authority.

(f) The Authority may disqualify a farmer for one year following second or subsequent incidents of:

(A) Failing to reimburse the Authority for CVVs that are improperly transacted; or

(B) Failing to cooperate with staff from the Authority or the Oregon Department of Agriculture in monitoring for compliance with program requirements and failing to provide information required to be submitted by the Authority or the Oregon Department of Agriculture.

(g) The Authority may immediately disqualify a farmer for three years for an incident of:

(A) Trafficking in CVVs (exchanging checks for cash, controlled substances, tobacco products, firearms, or alcohol) in any amount; or

(B) A USDA substantiated violation of laws regarding non-discrimination, and applicable USDA instructions.

Stat. Auth.: ORS 409.600

Stat. Implemented: ORS 409.600

Hist.: PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0060

Vendor Disqualifications

(1) A vendor may not apply for authorization during a period of disqualification from the WIC Program.

(2) The Authority shall not accept a vendor’s voluntary withdrawal from the WIC Program as an alternative to disqualification. In addition, the Authority may not use non-renewal as an alternative to disqualification.

(3) The Authority shall disqualify a vendor that does not pay, partially pays or fails to timely pay, a CMP assessed in lieu of disqualification, for the length of the disqualification corresponding to the violation for which the CMP was assessed.

(4) In order to participate in the WIC program after a vendor is disqualified, it must apply for authorization after the disqualification period has passed.

(5) The Authority shall disqualify a vendor for a period corresponding to the most serious sanction during the course of a single investigation when the Authority determines the vendor has committed multiple violations. The Authority shall include all violations in the notice of administrative action. If a sanction for a specific violation is not upheld after the hearing or appeal, the Authority may impose a sanction for any remaining violations.

(6) If the basis for disqualification of a vendor is for violation of OAR 333-054-0050(3)(d), the effective date of the disqualification is the date the vendor received notice, either actual or constructive, of the disqualification.

(7) The Authority may disqualify a vendor that has been disqualified or assessed a CMP in lieu of disqualification by another WIC state agency for a mandatory sanction.

(a) The length of the disqualification shall be for the same length of time as the disqualification by the other WIC state agency or, in the case of a CMP in lieu of disqualification assessed by the other WIC state agency, for the same length of time for which the vendor would otherwise have been disqualified. The disqualification may begin at a later date than the sanction imposed by the other WIC state agency.

(b) If the Authority determines that disqualification of a vendor would result in inadequate participant access, the Authority shall not impose a CMP in lieu of disqualification.

(8) The Authority shall disqualify a vendor who has been disqualified from the SNAP. The disqualification shall be for the same length of time as the SNAP disqualification, although it may begin at a later date than the SNAP disqualification. Such disqualification by the WIC program shall not be subject to administrative or judicial review under the WIC program.

(a) The Authority may disqualify a vendor who has been assessed a CMP in lieu of disqualification in the SNAP, as provided in 7 CFR § 278.6. The length of such disqualification shall correspond to the period for which the vendor would otherwise have been disqualified in the SNAP. The Authority shall determine if the disqualification of a vendor would result in inadequate participant access prior to disqualifying a vendor for SNAP disqualification pursuant to section (8) of this rule or for any of the violations listed in this rule. If the Authority determines that disqualification of the vendor would result in inadequate participant access, the Authority shall not disqualify or impose a CMP in lieu of disqualification. The Authority shall include participant access documentation in vendor files.

(b) The Authority shall provide the appropriate FNS office with a copy of the notice of adverse action and information on vendors it has disqualified. This information shall include the vendor’s name, address, identification number, the type of violation(s), length of the disqualification, or the length of the disqualification corresponding to the violation for which a SNAP CMP was assessed.

(9) Disqualification from the WIC Program may result in disqualification as a retailer in the SNAP. Such disqualification may not be subject to administrative or judicial review under the SNAP.

(10) Prior to disqualifying a vendor, the Authority shall determine if disqualification of the vendor would result in inadequate participant access.

(a) If the Authority determines that disqualification of the vendor would result in inadequate participant access, the Authority shall not disqualify the vendor and shall impose a CMP in lieu of disqualification.

(b) The Authority shall include documentation of its participant access determination and any supporting documentation in the vendor’s file.

(c) The Authority shall not impose a CMP in lieu of disqualification for third or subsequent sanctions, even if the disqualification results in inadequate participant access.

(d) The Authority shall not impose a CMP in lieu of disqualification for trafficking or an illegal sales conviction, even if the disqualification results in inadequate participant access.

(11) Pursuant to 7 CFR 246.12 (l)(1), the Authority shall use the following formula to calculate a CMP imposed in lieu of disqualification:

(a) Determine the vendor’s average monthly redemptions for at least the 6-month period ending with the month immediately preceding the month during which the notice of administrative action is dated;

(b) Multiply the average monthly redemptions figure by 10 percent (.10); and

(c) Multiply the product from subsection (11)(b) of this rule by the number of months for which the store would have been disqualified. This is the amount of the CMP, provided that the CMP shall not exceed $11,000 for each violation. For a violation that warrants permanent disqualification, the amount of the CMP shall be $11,000. The Authority shall impose a CMP for each violation when during the course of a single investigation the Authority determines a vendor has committed multiple violations. The total amount of CMPs imposed for violations cited as part of a single investigation shall not exceed $44,000.

(12) The Authority shall use the formula in subsection (11)(a) through (c) of this rule to calculate a CMP in lieu of disqualification for any violation under OAR 333-054-0050(3)(a). The Authority has the discretion to reduce the amount of this CMP in quarterly increments, after reviewing the following criteria:

(a) Whether the vendor had other WIC violations or complaints within the 12 months immediately proceeding the month the notice of administrative action is dated;

(b) The degree of severity of the violations and/or complaints in subsection (10)(a);

(c) If the vendor being sanctioned is part of a multi-store chain, whether there is a pattern within the corporation of violations and the seriousness of those violations; and

(d) The degree of cooperation shown by the vendor, demonstrated by the vendor’s willingness to schedule staff training and to make changes in store operations based on the Authority recommendations.

(13) The Authority shall, where appropriate, refer vendors who abuse the WIC Program to appropriate federal, state or local authorities for prosecution under applicable statutes.

(14) A vendor who commits fraud or abuse of the Program is subject to prosecution under applicable federal, state or local laws. A vendor who has embezzled, willfully misapplied, stolen or fraudulently obtained program funds, assets, or property shall be subject to a fine of not more than $25,000 or imprisonment for not more than five years or both, if the value of the funds is $100 or more. If the value is less than $100, the penalties are a fine of not more than $1,000 or imprisonment for not more than one year or both.

(15) A vendor may be subject to actions in addition to the sanctions in this rule, such as claims by the Authority of reimbursement for improperly redeemed food instruments or CVVs and penalties outlined in 7 CFR § 246.12(1)(2)(i).

(16) The Authority shall use the following criteria to determine inadequate participant access:

(a) The availability of other authorized vendors within a 15-mile radius;

(b) Accessibility to public transportation;

(c) Physical geographic barriers;

(d) Catering to a specific minority population;

(e) Local agency recommendations based upon identified participants’ needs;

(f) Unavailability of public transportation and roads; and

(g) Number of WIC participants living near the vendor.

(17) Any time the Authority uses criteria in section (16) of this rule, the Authority shall include participant access documentation in the vendor file.

(18) The Authority shall not reimburse for food instruments or CVVs submitted by a vendor for payment during a period of disqualification.

(19) A vendor is not entitled to receive any compensation for revenues lost as a result of a disqualification.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: HD 7-1993, f. & cert. ef. 6-11-93; OHD 17-2001, f. 8-2-01, cert. ef. 8-15-01; OHD 22-2002, f. & cert. ef. 12-24-02; PH 19-2003(Temp), f. & cert. ef. 11-14-03 thru 5-12-04; PH 22-2003, f. 12-31-03, cert. ef. 1-5-04; PH 7-2005(Temp), f. & cert. ef. 5-2-05 thru 10-28-05; PH 16-2005, f. & cert. ef. 10-28-05; PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

333-054-0070

Administrative Review

(1) The Authority shall provide a full administrative review in accordance with the provisions of ORS Chapter 183 for the following, as applicable:

(a) Denial of authorization based on a determination that the vendor or farmer is attempting to circumvent a sanction;

(b) Termination of an agreement for cause;

(c) Disqualification;

(d) Imposition of a fine or a CMP in lieu of disqualification; and

(e) Denial of authorization based on the vendor selection criteria for competitive price or minimum variety and quantity of authorized WIC foods.

(2) The Authority may provide a vendor with an abbreviated or full administrative review in accordance with the provisions of ORS chapter 183 for the following, as applicable:

(a) Denial of authorization based on selection criteria for business integrity or for a current FSP disqualification or CMP penalty for hardship;

(b) Denial of authorization based on an Authority selection criteria for previous history of WIC sanctions or SNAP withdrawal of authorization or disqualification;

(c) Denial of authorization based on the Authority’s limiting criteria;

(d) Termination of an agreement because of a change in ownership or location or cessation of operations;

(e) Disqualification based on a trafficking conviction;

(f) Disqualification based on the imposition of a SNAP CMP for hardship;

(g) Disqualification or CMP based on a USDA mandatory sanction from another state WIC agency; and

(h) Application of criteria used to determine whether a store is an A50.

(3) The vendor or farmer shall not be entitled to an administrative review for the following actions, as applicable:

(a) The validity or appropriateness of the Authority’s limiting or selection criteria;

(b) The validity or appropriateness of the Authority’s participant access criteria and the Authority’s participant access determinations;

(c) The Authority’s determination regarding whether an effective policy and program in effect to prevent trafficking regardless of the vendor or farmer’s awareness, approval, and/or involvement in the violation activity;

(d) Denial of authorization if the Authority vendor authorization is subject to the procurement procedures applicable to the Authority;

(e) The expiration of the agreement;

(f) Disputes regarding food instrument or CVV payments and claims;

(g) Disqualification of a vendor as a result of disqualification from the SNAP;

(h) The Authority’s determination whether to notify a vendor in writing when an investigation reveals an initial violation for which a pattern of violations must be established in order to impose a sanction;

(i) The Authority’s determination to include or exclude an infant formula manufacturer, wholesaler, distributor, or retailer from the list required;

(j) The validity or appropriateness of the Authority’s criteria used to determine whether or not a vendor is an A50 store; and

(k) The validity or appropriateness of the Authority’s prohibition of incentive items and the Authority’s denial of an A50 vendor’s request to provide an incentive item to customers.

(4) A request for a hearing must be in writing and must be received within 30 days from the date of the notice describing the proposed action.

(5) The Authority may, at its discretion, permit the vendor or farmer to continue participating in the program pending the outcome of an administrative hearing. The vendor or farmer may be required to repay funds for FIs or CVVs redeemed during the pendency of the hearing, depending on the hearing outcome.

(6) If an agreement expires during the appeal period, the Authority will accept application for renewal and delay determination until all appeals have been exhausted.

Stat. Auth.: ORS 409.600

Stats. Implemented: ORS 409.600

Hist.: HD 7-1993, f. & cert. ef. 6-11-93; OHD 17-2001, f. 8-2-01, cert. ef. 8-15-01; OHD 22-2002, f. & cert. ef. 12-24-02; PH 19-2003(Temp), f. & cert. ef. 11-14-03 thru 5-12-04; PH 22-2003, f. 12-31-03, cert. ef. 1-5-04; PH 16-2005, f. & cert. ef. 10-28-05; PH 30-2006, f. & cert. ef. 12-27-06; PH 5-2009, f. & cert. ef. 6-1-09; PH 9-2011, f. & cert. ef. 9-30-11

 

Rule Caption: Amendments of rules related to Radiation Protection Services.

Adm. Order No.: PH 10-2011

Filed with Sec. of State: 9-30-2011

Certified to be Effective: 10-1-11

Notice Publication Date: 9-1-2011

Rules Amended: 333-100-0005, 333-100-0020, 333-100-0070, 333-101-0065, 333-102-0015, 333-102-0115, 333-102-0130, 333-102-0190, 333-102-0250, 333-102-0285, 333-102-0290, 333-102-0293, 333-102-0305, 333-102-0310, 333-102-0340, 333-103-0010, 333-103-0030, 333-103-0035, 333-105-0530, 333-106-0005, 333-106-0035, 333-106-0045, 333-106-0055, 333-106-0325, 333-106-0370, 333-106-0750, 333-111-0015, 333-116-0020, 333-116-0025, 333-116-0035, 333-116-0105, 333-116-0220, 333-116-0250, 333-116-0260, 333-116-0290, 333-116-0320, 333-116-0330, 333-116-0360, 333-116-0390, 333-116-0440, 333-116-0470, 333-116-0585, 333-116-0660, 333-116-0670, 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0715, 333-116-1000, 333-119-0010, 333-119-0090, 333-119-0100, 333-120-0015, 333-120-0100, 333-120-0550, 333-120-0650, 333-120-0660, 333-120-0720, 333-120-0730, 333-120-0740

Subject: The Oregon Health Authority, Public Health Division is permanently amending Oregon Administrative Rules related to programs within the Radiation Protection Services. The radiation materials licensing program is amending rules to comply with 10 CFR Parts 1-50 to meet federal law pertaining to byproduct material management. The X-ray program is amending rules to permit operations of X-ray equipment performed by dental hygienists as outlined in ORS 680.205. The tanning program is amending rules to outline skin type definitions and the use of digital timers with tanning bed operations, remove OAR 333-119-0100(20), and create new rule definitions for skin typing.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-100-0005

Definitions

The following definitions apply to OAR chapter 333 divisions 100, 102, 103, 106, 111, 116, 118, 119, 120, 121, 122, 123, and 124. Additional definitions used only in a certain division will be found in that division.

(1) “Absorbed dose” means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

(2) “Accelerator” means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, “particle accelerator” is an equivalent term.

(3) “Accelerator-produced material” means any material made radioactive by a particle accelerator.

(4) “Act” means Oregon Revised Statutes 453.605 through 453.807.

(5) “Activity” means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq), defined as one disintegration per second, and the curie (Ci), defined as 3.7 x 1010 disintegrations per second.

(6) “Adult” means an individual 18 or more years of age.

(7) “Agreement State” means any state with which the U.S. Nuclear Regulatory Commission or the U.S. Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

(8) “Airborne radioactive material” means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.

(9) “Airborne radioactivity area” means a room, enclosure, or area in which airborne radioactive material, composed wholly or partly of licensed material, exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in Appendix B, Table I, column 3, to 10 CFR Part 20.1001 to 20.2401; or

(b) To such a degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or 12 DAC-hours.

(10) “ALARA” (acronym for “As Low As Reasonably Achievable”) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in this part as is practical consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest.

(11) “Alert” means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.

(12) “Annual” means occurring every year or within a consecutive twelve month cycle.

(13) “Annual Limit on Intake” (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the Reference Man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B, Table I, Columns 1 and 2, to 10 CFR Part 20.1001 to 20.2401.

(14) “As Low As Reasonably Achievable” see “ALARA.”

(15) “Authority” means the Oregon Health Authority.

(16) “Background radiation” means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. “Background radiation” does not include sources of radiation from radioactive or special nuclear materials regulated by the Authority.

(17) “Becquerel” (Bq) means the International System of Units (SI) unit of activity. One becquerel is equal to one disintegration or transformation per second (dps or tps).

(18) “Bioassay” means the determination of kinds, quantities or concentrations, and, in some cases, the locations, of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

(19) “Brachytherapy” means a method of radiation therapy in which sealed sources are utilized to deliver dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

(20) “Byproduct material” means:

(a) Any radioactive material, except special nuclear material, yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; and

(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction process. Underground ore bodies depleted by such solution extraction operations do not constitute “byproduct material” within this definition.

(21) “Calendar quarter” means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year must begin in January and subsequent calendar quarters must be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. No licensee or registrant may change the method observed for determining calendar quarters except at the beginning of a calendar year.

(22) “Calibration” means the determination of:

(a) The response or reading of an instrument relative to a series of known radiation values over the range of the instrument; or

(b) The strength of a source of radiation relative to a standard.

(23) “CFR” means Code of Federal Regulations.

(24) “Chelating agent” means amine polycarboxylic acids, hydroxy-carboxylic acids, gluconic acid, and polycarboxylic acids.

(25) “Class” means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. For purposes of these rules, “lung class” or “inhalation class” are equivalent terms. Materials are classified as D, W, or Y, which applies to a range of clearance half-times:

(a) For Class D, Days, of less than 10 days;

(b) For Class W, Weeks, from 10 to 100 days; and

(c) For Class Y, Years, of greater than 100 days.

(26) “Clinical laboratory” means a laboratory licensed pursuant to ORS 438.110 through 438.140.

(27) “Collective dose” means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(28) “Committed dose equivalent” (HT, 50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.

(29) “Committed effective dose equivalent” (HE, 50) is the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE, 50 = ∑WT,HT,50).

(30) “Contamination” (Radioactive) means deposition or presence of radioactive material in any place where it is not desired, and particularly in any place where its presence can be harmful. The harm may be in compromising the validity of an experiment or a procedure, or in being a source of danger to persons. Contamination may be divided into two types: Fixed and removable. Removable contamination may be transferred easily from one object to another by light rubbing or by the use of weak solvents such as water or alcohol. Removable contamination is evaluated and recorded in units of microcuries or dpm. Fixed contamination is not easily transferred from one object to another and requires mechanical or strong chemicals to remove it from its current location. Fixed contamination is evaluated and recorded in units of mR/hr.

(31) “Curie” means a unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7 x 1010 disintegrations or transformations per second (dps or tps).

(32) “Declared pregnant woman” means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

(33) “Decommission” means to remove (as a facility) safely from service and reduce residual radioactivity to a level that permits:

(a) Release of the property for unrestricted use and termination of license; or

(b) Release of the property under restricted conditions and termination of the license.

(34) “Deep dose equivalent” (Hd) which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

(35) “Depleted uranium” means source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

(36) “Derived air concentration” (DAC) means the concentration of a given radionuclide in air which, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of these rules, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in Table I, Column 3, of Appendix B to 10 CFR Part 20.1001 to 20.2401.

(37) “Derived air concentration-hour” (DAC-hour) means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

(38) “Dose” is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these rules, “radiation dose” is an equivalent term.

(39) “Dose equivalent” (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem (see “Rem”). (See OAR 333-100-0070(2) for SI equivalent sievert.)

(40) “Dose limits” means the permissible upper bounds of radiation doses established in accordance with these rules. For purposes of these rules, “limits” is an equivalent term.

(41) “Dosimetry processor” means an individual or an organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose delivered to the equipment.

(42) “Effective dose equivalent” (HE) means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (WT) applicable to each of the body organs or tissues that are irradiated (HE = WT HT).

(43) “Electronic product” means any manufactured product or device or component part of such a product or device that is capable of generating or emitting electromagnetic or sonic radiation such as, but not limited to, X-rays, ultrasonic waves, microwaves, laser light or ultraviolet light.

(44) “Embryo/fetus” means the developing human organism from conception until the time of birth.

(45) “Entrance or access point” means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed or registered radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, irrespective of their intended use.

(46) “Exclusive use” (also referred to in other regulations as “sole use” or “full load”) means the sole use of a conveyance by a single consignor and for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee.

(47) “Explosive material” means any chemical compound, mixture, or device that produces a substantial instantaneous release of gas and heat spontaneously or by contact with sparks or flame.

(48) “Exposure” means:

(a) The quotient of dQ by dm where “dQ” is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass “dm” are completely stopped in air. The SI unit of exposure is the coulomb per kilogram.

(b) Being exposed to ionizing radiation or to radioactive material.

(49) “Exposure rate” means the exposure per unit of time, such as roentgen per minute (R/min) and milliroentgen per hour (mR/hr).

(50) “External dose” means that portion of the dose equivalent received from any source of radiation outside the body.

(51) “Extremity” means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.

(52) “Eye dose equivalent” means the external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeter (300 mg/cm2).

(53) “Fixed gauge” means a measuring or controlling device that is intended to be mounted at a specific location, stationary, not to be moved, and is not portable.

(54) “Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC) licensed facilities” means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.

(55) “General license” means a license granted by rule, in contrast to an issued license, to acquire, own, possess, use, or transfer radioactive material or a device that contains radioactive material.

(56) “Generally applicable environmental radiation standards” means standards issued by the U.S. Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(57) “Gray” (Gy) means the International System of Units (SI), unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (100 rad). (See OAR 333-100-0070(2))

(58) “Hazardous waste” means those wastes designated as hazardous by U.S. Environmental Protection Agency regulations in 40 CFR Part 261.

(59) “Healing arts” means:

(a) The professional disciplines authorized by the laws of this state to use X-rays or radioactive material in the diagnosis or treatment of human or animal disease. For the purposes of this Authority they are Medical Doctors, Osteopaths, Dentists, Veterinarians, Chiropractors, and Podiatrists; or

(b) Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury or unhealthy or abnormal physical or mental condition.

(60) “Human use” means the internal or external administration of radiation or radioactive material to human beings.

(61) “Individual” means any human being.

(62) “Individual monitoring” means:

(a) The assessment of dose equivalent by the use of devices designed to be worn by an individual;

(b) The assessment of committed effective dose equivalent by bioassay (see Bioassay) or by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours; or

(c) The assessment of dose equivalent by the use of survey data.

(63) “Individual monitoring devices” means devices designed to be worn by a single individual for the assessment of dose equivalent such as film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal (“lapel”) air sampling devices.

(64) “Inhalation class” (see “Class”).

(65) “Inspection” means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Authority.

(66) “Interlock” means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

(67) “Internal dose” means that portion of the dose equivalent received from radioactive material taken into the body.

(68) “Ionizing radiation” means any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. It includes any or all of the following: Alpha particles, beta particles, electrons, positrons, gamma rays, X-rays, neutrons, high-speed electrons, high-speed protons, fission fragments and other atomic and subatomic particles; but not sound or radio waves, or visible, infrared, or ultraviolet light.

(69) “Laser” means any device which, when coupled with an appropriate laser energy source, can produce or amplify electromagnetic radiation by the process of controlled stimulated emission.

(70) “License” means a license issued by the Authority in accordance with rules adopted by the Authority.

(71) “Licensed material” means radioactive material received, possessed, used, transferred or disposed of under a general or specific license granted or issued by the Authority. For the purpose of meeting the definition of a Licensing State by the Conference of Radiation Control Program Directors, Inc. (CRCPD), Naturally Occurring and Accelerator Produced Radioactive Material (NARM) refers only to discrete sources of NARM. Diffuse sources of NARM are excluded from consideration by the CRCPD for Licensing State designation purposes.

(72) “Licensee” means any person who is licensed by the Authority in accordance with these rules and the Act.

(73) “Licensing state” means any state with rules or regulations equivalent to the Suggested State Regulations for Control of Radiation relating to, and having an effective program for, the regulatory control of NARM.

(74) “Limits” (dose limits) means the permissible upper bounds of radiation doses.

(75) “Lost or missing licensed or registered source of radiation” means licensed or registered source(s) of radiation whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

(76) “Lung class” (see “Class”).

(77) “Major processor” means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding four times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in division 118 of this chapter.

(78) “Member of the public” means an individual, except when that individual is receiving an occupational dose.

(79) “Minor” means an individual less than 18 years of age.

(80) “Monitoring” means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these rules, “radiation monitoring” and “radiation protection monitoring” are equivalent terms.

(81) “NARM” means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material.

(82) “Natural radioactivity” means radioactivity of naturally occurring nuclides.

(83) “Naturally-occurring radioactive material” (NORM) means any nuclide that is found in nature as a radioactive material (i.e., not technologically produced).

(84) “Natural thorium” means thorium with the naturally occurring distribution of thorium isotopes (essentially 100 weight percent thorium-232).

(85) “Natural uranium” means a mixture of the uranium isotopes 234, 235 and 238 (approximately 0.7 weight percent uranium- 235 and the remainder by weight essentially uranium-238), found in nature, that is neither enriched nor depleted in the isotope uranium 235.

(86) “Nonstochastic effect” means a health effect that varies with the dose and a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of these rules, “deterministic effect” is an equivalent term.

(87) “Normal form radioactive material” means radioactive material that has not been demonstrated to qualify as “special form radioactive material”. See “Special form.”

(88) “NRC” is the acronym for Nuclear Regulatory Commission.

(89) “Nuclear Regulatory Commission” (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

(90) “Package” means the packaging together with its radioactive contents as presented for transport.

(91) “Particle accelerator” means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one MeV.

(92) “Person” means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing.

(93) “Personnel monitoring equipment” means devices such as film badges, pocket dosimeters, and thermoluminescent dosimeters designed to be worn or carried by an individual for the purpose of estimating the dose received by the individual. See “Individual monitoring devices.”

(94) “Pharmacist” means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice pharmacy.

(95) “Physician” means an individual licensed by the Oregon State Board of Medical Examiners to dispense drugs in the practice of medicine.

(96) “Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

(97) “Portable gauge” means a measuring or controlling device that is intended to be portable and is not fixed to a specific location. All portable gauges require a specific license (there is no general license granted for portable generally licensed devices in the State of Oregon).

(98) “Program” means the Radiation Protection Services section of the Public Health Division of the Oregon Health Authority.

(99) “Pyrophoric liquid” means any liquid that ignites spontaneously in dry or moist air at or below 130OF (54.4OC).

(100) “Pyrophoric solid” means any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing, or which can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation, handling, or disposal hazard. Included are spontaneously combustible and water-reactive materials.

(101) “Qualified expert” means an individual, approved by the Authority, who has demonstrated, pursuant to these rules, that he/she possesses the knowledge, skills, and training to measure ionizing radiation, to evaluate radiation parameters, to evaluate safety techniques, and to advise regarding radiation protection needs. The individual must:

(a) Be certified in the appropriate field by the American Board of Radiology, the American Board of Health Physics, the American Board of Medical Physics or the American Board of Nuclear Medicine Science; or

(b) Hold a master’s or doctor’s degree in physics, biophysics, radiological physics, health physics, or medical physics and have completed one year of documented, full time training in the appropriate field and also one year of documented, full time work experience under the supervision of a qualified expert in the appropriate field. To meet this requirement, the individual must have performed the tasks required of a qualified expert during the year of work experience; or

(c) Receive approval from the Authority for specific activities.

(102) “Quality factor” (Q) means the modifying factor (listed in Tables 1004(b).1 and 1004(b).2 of 10 CFR Part 20.1004 provided at the end of this division) that is used to derive dose equivalent from absorbed dose.

(103) “Quarter” means a period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(104) “Rad” means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray). See OAR 333-100-0070(2) for SI equivalent gray.

(105) “Radiation” means:

(a) Ionizing radiation including gamma rays, X-rays, alpha and beta particles, protons, neutrons, and other atomic or nuclear particles or rays;

(b) Any electromagnetic radiation which can be generated during the operations of electronic products and which the Authority has determined to present a biological hazard to the occupational or public health and safety but does not include electromagnetic radiation which can be generated during the operation of an electronic product licensed by the Federal Communications Commission;

(c) Any sonic, ultrasonic or infrasonic waves which are emitted from an electronic product as a result of the operation of an electronic circuit in such product and which the Authority has determined to present a biological hazard to the occupational or public health and safety.

(106) “Radiation area” means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.

(107) “Radiation machine” means any device capable of producing radiation except those which produce radiation only from radioactive material.

(108) “Radiation safety officer” means:

(a) An individual who has the knowledge, responsibility, and authority to apply appropriate radiation protection rules; or

(b) The representative of licensee management, authorized by the Authority, and listed on the specific license as the radiation safety officer, who is responsible for the licensee’s radiation safety program.

(109) “Radioactive material” means any solid, liquid, or gas that emits radiation spontaneously.

(a) Radioactive material, as used in these rules, includes: byproduct material, naturally occurring radioactive material, accelerator produced material, and source material, as defined in this rule.

(b) Radioactive material, as used in these rules, does not include special nuclear material.

(110) “Radioactive waste” means radioactive material that is unwanted or is unusable, as defined in division 50 of chapter 345. No radioactive material may be disposed of in Oregon except as provided in division 50 of chapter 345.

(111) “Radioactivity” means the transformation of unstable atomic nuclei by the emission of radiation.

(112) “Reference Man” means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base. A description of the Reference Man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, “Report of the Task Group on Reference Man.”

(113) “Registrant” means any person who is registered with the Authority and is legally obligated to register with the Authority pursuant to these rules and the Act.

(114) “Registration” means the identification of any material or device emitting radiation, and the owner of such material or device must furnish information to the Authority in accordance with the rules adopted by the Authority.

(115) “Regulations of the U.S. Department of Transportation” means the regulations in 49 CFR Parts 100-189 and Parts 390-397.

(116) “Rem” means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 sievert).

(117) “Research and development” means:

(a) Theoretical analysis, exploration, or experimentation; or

(b) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

(118) “Respiratory protective equipment” means an apparatus, such as a respirator, used to reduce an individual’s intake of airborne radioactive materials.

(119) “Restricted area” means an area to which access is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. A restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(120) “Roentgen” means the special unit of exposure. One roentgen (R) equals 2.58 x 10-4 Coulombs/kilogram of air (see “Exposure” and division 120).

(121) “Sanitary sewerage” means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.

(122) “Screening” means the use of a systematic approach to obtain cursory examinations of a person or group of persons without regard to specific clinical indications.

(123) “Sealed source” means radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.

(124) “Sealed Source and Device Registry” means the national registry that contains all the registration certificates, generated by both the U.S. Nuclear Regulatory Commission and Agreement States, that summarize the radiation safety information for sealed sources and devices and describe the licensing and use conditions approved for the product.

(125) “Shallow dose equivalent” (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over an area of one square centimeter.

(126) “SI” means the abbreviation for the International System of Units.

(127) “Sievert” means the International System of Units (SI), unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem). (See OAR 333-100-0070(2).

(128) “Site boundary” means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

(129) “Source material” means:

(a) Uranium or thorium or any combination of uranium and thorium in any physical or chemical form; or

(b) Ores that contain by weight one-twentieth of one percent (0.05 percent) or more of uranium, thorium, or any combination thereof. Source material does not include special nuclear material.

(130) “Source material milling” means any activity that results in the production of byproduct material, as defined by this rule.

(131) “Source of radiation” means any radioactive material or any device or equipment emitting, or capable of producing, radiation. Source of radiation, pursuant to this rule, includes, but is not limited to, radiation facilities, radiation producing machines, radiation producing devices, radioactive material sealed and unsealed form (normal form and special form), and radioactive material uses.

(132) “Special form radioactive material” means radioactive material that satisfies the following conditions:

(a) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(b) The piece or capsule has at least one dimension not less than five millimeters (0.2 inch); and

(c) It satisfies the test requirements specified by the U.S. Nuclear Regulatory Commission. A special form encapsulation designed in accordance with the U.S. Nuclear Regulatory Commission requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, and a special form encapsulation designed in accordance with the Nuclear Regulatory Commission requirements in effect on March 31. 1996, and constructed prior to April 1, 1998, may continue to be used. Any other special form encapsulation either designed or constructed after April 1, 1998, must meet requirements of this definition applicable at the time of its design or construction.

(133) “Special nuclear material” means:

(a) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the U.S. Nuclear Regulatory Commission, pursuant to the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

(b) Any material artificially enriched by any of the foregoing but does not include source material.

(134) “Special nuclear material in quantities not sufficient to form a critical mass” means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination must not exceed one.

For example, the following quantities in combination would not exceed the limitation and are within the formula: * * (175 (grams contained U-235)/350 + (50 (grams U-233)/200 + (50 (grams Pu)/200 = 1.

(135) “Specific activity of a radionuclide” means the radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.

(136) “Stochastic effect” means health effects that occur randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects.

(137) “Supervision” as used in these rules, means the responsibility for, and control of, the application, quality, radiation safety and technical aspects of all sources of radiation possessed, used and stored through authorization granted by the Authority.

(138) “Survey” means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.

(139) “Termination” means:

(a) The end of employment with the licensee or registrant or, in the case of individuals not employed by the licensee or registrant, the end of work assignment in the licensee’s or registrant’s restricted area in a given calendar quarter, without expectation or specific scheduling of re-entry into the licensee’s or registrant’s restricted area during the remainder of that calendar quarter; or

(b) The closure of a registered or licensed facility and conclusion of licensed or registered activities, pursuant to a registration or specific license.

(140) “Test” means the process of verifying compliance with an applicable rule.

(141) “These rules,” mean all parts of the Oregon Administrative Rules promulgated under ORS 453.605 through 453.807.

(142) “Total effective dose equivalent” (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

(143) “Total organ dose equivalent” (TODE) means the sum of the deep dose equivalent (DDE) and the committed dose equivalent (CDE) to the organ receiving the highest dose as described in OAR 333-120-650(1)(d).

(144) “Transport index” means the dimensionless number (rounded up to the first decimal place) placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is the number expressing the maximum radiation level in millirem per hour at one meter from the external surface of the package.

(145) “U.S. Department of Energy” means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the Department exercises functions formerly vested in the U.S. Atomic Energy Commission, its Chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237 42 U.S.C. 5814, effective January 19, 1975) and retransferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977).

(146) “Unrefined and unprocessed ore” means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

NOTE: “Ore” refers to fuel cycle materials pursuant to 10 CFR Part 150.

(147) “Unrestricted area” means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these rules, “uncontrolled area” is an equivalent term.

(148) “Uranium — depleted, enriched” means:

(a) “Depleted uranium” means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes.

(b) “Enriched uranium” means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.

(149) “Validation certificate” means the official document issued upon payment to the Authority of the appropriate fee listed in division 103 of this chapter. The license or registration is subject and void without the annual validation certificate.

(150) “Waste” means radioactive waste.

(151) “Week” means seven consecutive days starting on Sunday.

(152) “Weighting factor” (WT) for an organ or tissue (T) means:

(a) The proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of WT are:

(A) Gonads 0.25

(B) Breast 0.15

(C) Red Bone Marrow 0.12

(D) Lung 0.12

(E) Thyroid 0.03

(F) Bone Surfaces 0.03

(G) Remainder 0.30 (see note below)

(H) Whole Body 1.00

Note: Assignment of 0.30 for the remaining organs results from a weighting factor of 0.06 for each of five “remainder” organs, excluding the skin and the lens of the eye, that receive the highest doses.

(b) For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, WT = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

(153) “Whole body” means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

(154) “Worker” means an individual engaged in work under a license or registration issued by the Authority and controlled by a licensee or registrant, but does not include the licensee or registrant.

(155) “Working level” (WL) means any combination of short-lived radon progeny in one liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy. The short-lived radon-222 progeny are: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220 the progeny are: polonium-216, lead-212, bismuth-212, and polonium-212.

(156) “Working level month” (WLM) means an exposure to one working level for 170 hours (2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.)

(157) “Year” means the period of time beginning in January used to determine compliance with the provisions of these rules. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

[ED. NOTE: Tables and Appendices referenced are available from the agency.]

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 10-1987, f. & ef. 7-28-87; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; Administrative Reformatting 12-8-97; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-100-0020

Prohibited Uses

(1) Hand-held fluoroscopic screens shall not be used unless they have been listed in the Registry of Sealed Source and Devices or accepted for certification by the U.S. Food and Drug Administration, Center for Devices and Radiological Health.

(2) Shoe-fitting fluoroscopic devices shall not be used.

(3) Sources of radiation shall not be used to expose any individual solely for training or demonstration purposes.

(4) Sources of radiation shall not be used for the purpose of screening or inspecting individuals for concealed weapons, hazardous materials, stolen property, illegal goods or contraband.

(5) No person shall intentionally apply or allow to be applied, either directly or indirectly, ionizing radiation to human beings except by, or under the supervision of, persons licensed by the State of Oregon to practice the healing arts and who are authorized to use radiation on humans. Notwithstanding this restriction, the Authority recognizes practitioners of the healing arts to be as outlined in ORS 676.110, that is:

(a) Podiatrists, Chiropractors, Dentists, Naturopath, Osteopaths, Medical Doctors, and Veterinarians;

(b) Nurse Practitioners and Physician Assistants may prescribe X-ray when doing so within the bounds of their independent rules;

(c) Dental Professionals are permitted to prescribe and review intraoral radiographs, in accordance with the Oregon Board of Dentistry administrative rules, chapter 818.

(d) No person will be allowed to use X-ray producing equipment without first meeting the requirements of OAR 333-106-0045(15) or 333-106-0055.

(6) No person shall intentionally or unintentionally expose another individual to radiation other than ionizing radiation in such a way as to adversely affect the health or safety of that individual. Notwithstanding this restriction, the use of radiation other than ionizing radiation by persons licensed by the State of Oregon to practice the healing arts and who are authorized to use radiation will be allowed.

(7) Dental units with a Kilovolt peak (kVp) of 50 and below are prohibited from being sold, leased, transferred or lent.

(a) Existing diagnostic dental X-ray systems less than 55 kVp shall not be used on minors.

(b) After October 1, 2011, registrants may not use diagnostic dental X-ray systems with a fixed, nominal kVp of less than 55.

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-100-0070

Units of Exposure and Dose

The Metric Conversion Act of 1975 (PL 94-168) urged the increasing awareness and use of the International System of Units (SI). The generally accepted regulatory values in the narrative portions of this document are followed by the SI equivalents in parentheses. Where appropriate, schedules and appendices are provided with notes concerning conversion factors. The inclusion of the SI equivalent is for informational purposes only.

(1) The unit of exposure is the coulomb per kilogram (C/kg). One roentgen is equal to 2.58x10-4 coulomb per kilogram of air.

(2) The units of radiation dose are:

(a) Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose of one joule per kilogram (100 rad);

(b) Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 Gy);

(c) Rem is the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

(d) Sievert is the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

(e) As used in these regulations, the quality factors for converting absorbed dose to dose equivalent are shown in 10 CFR 20 Part 20.1004 Table 1004(b).1.

(3) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rem per hour or sieverts per hour, as provided in (2)(c) of this rule, one rem (0.01 Sv) of neutron radiation of unknown energies may, for purposes of the regulations in this part, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from 10 CFR 20 part 20.1004 Table 1004(b).2 (at the end of this division) to convert a measured tissue dose in gray or rad to dose equivalent in sievert rem.

[ED. NOTE: Tables referenced are available from the agency.]

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-101-0065

Additional Requirements

(1) No person shall use a radiation machine unless that machine is registered with the Oregon Health Authority in accordance with OAR 333-101-0005 or is exempt from the registration under OAR 333-101-0010 or 333-101-0025.

(2) No registrant shall use a radiation machine unless a current certificate of validation has been issued for that machine.

(3) The registrant must comply with any additional requirements or conditions listed on the then current certificate of validation on which the Authority has deemed appropriate or necessary to minimize danger to public health and safety or property.

Stat. Auth.: ORS 453.605 - ORS 453.807

Stats. Implemented: ORS 453.605 - ORS 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-81-91; Renumbered from 333-101-0030; PH 12-2006, f. & cert. ef. 6-16-06; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0015

Certain Items Containing Radioactive Material

(1) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from these rules to the extent that he or she receives, possesses, uses, transfers, owns or acquires the following products:

NOTE: Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

(a) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(A) 25 millicuries (925 MBq) of tritium per timepiece;

(B) Five millicuries (185 MBq) of tritium per hand;

(C) 15 millicuries (555 MBq) of tritium per dial (when used, bezels must be considered as part of the dial);

(D) 100 microcuries (3.7 MBq) of promethium-147 per watch or 200 microcuries (7.4 MBq) of promethium-147 per any other timepiece;

(E) 20 microcuries (0.74 MBq) of promethium-147 per watch hand or 40 microcuries (1.48 MBq) of promethium-147 per other timepiece hand;

(F) 60 microcuries (2.22 MBq) of promethium-147 per watch dial or 120 microcuries (4.44 MBq) of promethium-147 per other timepiece dial (when used, bezels must be considered as part of the dial);

(G) 0.15 microcurie (5.55 kBq) of radium per timepiece;

(H) 0.03 microcurie (1.11 kBq) of radium per hand;

(I) 0.09 microcurie (3.33 kBq) of radium per dial (when used, bezels must be considered as part of the dial);

(J) The radiation dose rate from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(i) For wrist watches, 0.1 millirad (one Gy) per hour at 10 centimeters from any surface;

(ii) For pocket watches, 0.1 millirad (one Gy) per hour at one centimeter from any surface; and

(iii) For any other timepiece, 0.2 millirad (two Gy) per hour at 10 centimeters from any surface.

(K) One microcurie (37 kBq) of radium-226 per timepiece in intact timepieces manufactured prior to November 30, 2007.

(b) Precision balances containing not more than one millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part manufactured before December 17, 2007;

(c) Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before December 17, 2007;

(d) Electron tubes: Provided, that each tube does not contain more than one of the following specified quantities of radioactive material:

(A) 150 millicuries (5.55 GBq) of tritium per microwave receiver protector tube or 10 millicuries (370 MBq) of tritium per any other electron tube;

(B) One microcurie (37 kBq) of cobalt-60;

(C) Five microcuries (185 kBq) of nickel-63;

(D) 30 microcuries (1.11 MBq) of krypton-85;

(E) Five microcuries (185 kBq) of cesium-137; or

(F) 30 microcuries (1.11 MBq) of promethium-147.

(G) And provided further, that the radiation dose rate from each electron tube containing radioactive material will not exceed one millirad (10 Gy) per hour at one centimeter from any surface when measured through seven milligrams per square centimeter of absorber.

NOTE: For purposes of, subsection (1)(d) of this rule “electron tubes” include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents.

(e) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

(A) Each source contains no more than one exempt quantity set forth in 10 CFR Part 30.71 Schedule B; and

(B) Each instrument contains no more than 10 exempt quantities. For purposes of this requirement, an instrument’s source(s) may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in 10 CFR Part 30.71 Schedule B provided that the sum of such fractions must not exceed unity.

(C) For americium-241, 0.05 microcuries (1.85 kBq) is considered an exempt quantity under paragraph (1)(e)(A) of this rule.

(i) Ionization chamber smoke detectors containing not more than one microcurie (uCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.

(2) The exemptions contained in this rule must not authorize any of the following:

(a) The manufacture of any product listed;

(b) The application or removal of radioactive luminous material to or from meters and timepieces or hands and dials therefore;

(c) The installation into automobile locks of illuminators containing tritium or promethium-147 or the application of tritium to balances of precision or parts thereof;

(d) Human use, or the use in any device or article, except timepieces, which is intended to be placed on or in the human body;

(e) As applied to radioactive material exempted under section (1) of this rule, the production, packaging, repackaging or transfer of radioactive material for purposes of commercial distribution or the incorporation of radioactive material into products intended for commercial distribution.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0115

Certain Measuring, Gauging and Controlling Devices

(1) A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their business, and state or local government agencies to own, receive, acquire, possess, use or transfer in accordance with the provisions of OAR 333-103-0015 and sections (2), (3) and (4) of this rule, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.

(2) The general license in section (1) of this rule applies only to radioactive material contained in devices that have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the Authority pursuant to OAR 333-102-0200 or in accordance with the specifications contained in a specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State, that authorizes distribution of devices to persons generally licensed by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.

(3) The devices must have been received from one of the specific licensees described in section (2) of this rule or through a transfer made in accordance with subsection (4)(i) of this rule.

NOTE: Regulations under the Federal Food, Drug and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in 21 CFR 179.21.

(4) Any person who owns, receives, acquires, possesses, uses or transfers radioactive material in a device pursuant to the general license in section (1) of this rule:

(a) Must assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and must comply with all instructions and precautions provided by such labels;

(b) Must assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than six-month intervals or at such other intervals as are specified in the label; however:

(A) Devices containing only krypton need not be tested for leakage of radioactive material; and

(B) Devices containing only tritium or not more than 100 microcuries (3.7 MBq) of other beta and/or gamma emitting material or 10 microcuries (0.37 MBq) of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose.

(c) Must assure that tests required in subsection (4)(b) of this rule and other testing, installation servicing and removing from installation involving the radioactive materials, its shielding or containment, are performed:

(A) In accordance with the instructions provided by the labels; or

(B) By a person holding an applicable specific license from the Authority, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such activities.

(d) Must maintain records showing compliance with the requirements of subsections (4)(b) and (4)(c) of this rule. The records must show the results of tests. The records also must show the dates of performance of, and the names of persons performing, testing, installation servicing and removal from installation concerning the radioactive material, its shielding or containment. The licensee must retain these records as follows:

(A) Records of tests for leakage of radioactive material required by subsection (4)(b) of this rule must be maintained as required in OAR 333-100-0057.

(B) Records of tests of the on-off mechanism and indicator required by subsection (4)(b) of this rule must be maintained as required in OAR 333-100-0057.

(C) Records which are required by subsection (4)(c) of this rule must be maintained as required in OAR 333-100-0057.

(e) Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie (185 Bq) or more of removable radioactive material, the licensee must immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the Authority, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to repair such devices. The device and any radioactive material from the device may only be disposed of by transfer to a person authorized by a specific license to receive the radioactive material in the device or as otherwise approved by the Authority. A report containing a brief description of the event and the remedial action taken; and, in the case of detection of 0.005 microcurie or more removable radioactive material or failure of or damage to a source likely to result in contamination of the premises or the environs, a plan for ensuring that the premises and environs are acceptable for unrestricted use, must be submitted to the Authority within 30 days. Under these circumstances, the criteria set out in OAR 333-120-0190, as determined by the Authority, on a case-by-case basis;

(f) Must not abandon the device containing radioactive material;

(g) Except as provided in subsection (4)(i) of this rule, must transfer or dispose of the device containing radioactive material only by export as provided by subsection (4)(l) of this rule, by transfer to another general licensee as authorized in subsection (4)(i) of this rule, or by transfer to a specific licensee of the Authority, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State whose specific license authorizes the individual to receive the device; and

(A) Must furnish to the Authority, within 30 days after transfer of a device to a specific licensee or export, a report containing identification of the device by manufacturer’s name, model number, serial number, the date of transfer, and the name, address and license number of the person receiving the device;

(B) The general licensee must obtain written Authority approval before transferring the device to any other specific licensee not specifically identified in subsection (4)(g) of this rule.

(h) A holder of a specific license may transfer a device for possession and use under its own specific license without prior approval, if the holder:

(A) Verifies that the specific license authorized the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

(B) Removes, alters, covers, or clearly and unambiguously augments the existing label so that the device is labeled in compliance with OAR 333-120-0430, however the manufacturer model and serial numbers must be retained;

(C) Obtains manufacturer’s or initial transferor’s information concerning maintenance that would be applicable under the specific license (such as leak testing procedures); and

(D) Reports the transfer under OAR 333-102-0115(4)(g)(A).

(i) Must transfer the device to another general licensee only:

(A) Where the device remains in use at a particular location. In such case the transferor must give the transferee a copy of this rule and any safety documents identified in the label on the device and within 30 days of the transfer, report to the Authority the manufacturer’s (or initial transferor’s) name, model number, serial number of the device transferred, the date of transfer, the name and address of the transferee and the location of use, and the name, title and phone number of the individual who is a point of contact between the Authority and the transferee. This individual must have the knowledge and authority to take actions to ensure compliance with the appropriate rules and requirements concerning the possession and use of these devices; or

(B) Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee.

(j) Must comply with the provisions of OAR 333-120-0700 and 333-120-0710 for reporting radiation incidents, theft or loss of licensed material but shall be exempt from the other requirements of divisions 111 and 120 of this chapter;

(k) Must submit the required Authority form and receive from the Authority a validated registration certificate acknowledging the general license and verifying that all provisions of these rules have been met. The form must be submitted within 30 days after the first receipt or acquisition of such device. The general licensee must develop and maintain procedures designed to establish physical control over the device as described in this rule and designed to prevent transfer of such devices in any form, including metal scrap, to persons not authorized to receive the devices.

(l) Shall not export a device containing radioactive material except in accordance with 10 CFR Part 110.

(5) The general license in section (1) of this rule does not authorize the manufacture of devices containing radioactive material.

(6) The general license provided in section (1) of this rule is subject to the provisions of OAR 333-100-0040 through 333-100-0055, 333-102-0335, 333-103-0015 and 333-118-0050.

(7) The general licensee possessing or using devices licensed under the general license established by section (1) of this rule must report in writing to the Authority any changes in information furnished by the licensee on the required Authority form. The report must be submitted within 30 days after the effective date of such change.

(8) The licensee must appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, must ensure the day-to-day compliance with appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in this regard.

(9)(a) A device distributed or otherwise received as a generally licensed device must be registered with the Authority. Each address for a location of use, as described under subsection (9)(b) of this rule, represents a separate general licensee and requires a separate registration and fee. Devices containing more than 37 MBq (1 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90, 37 MBq (1 mCi) of cobalt-60, any quantity of americium-241, 3.7 MBq (0.1 mCi) of radium 226 or any other transuranic (i.e., element with atomic number greater than uranium (92)), based on the activity indicated on the label are required to have a specific license.

(b) In registering devices, the general licensee must furnish the following information and any other information specifically requested by the Authority:

(A) Name and mailing address of the general licensee;

(B) Information about each device. The manufacturer (or initial transferor), model number, serial number, the radioisotope and activity (as indicated on the label);

(C) Name, title, and telephone number of the responsible person designated as a representative of the general licensee under section (8) of this rule.

(D) Address or location at which the device(s) are used and/or stored. For portable devices, the address of the primary place of storage.

(E) Certification by the responsible representative of the general licensee that the information concerning the device(s) has been verified through a physical inventory and checking of label information.

(F) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.

(10) General licensees must report changes to their mailing address or the location of use (including a change in name of general licensee) to the Authority within 30 days of the effective date of the change.

(11) Generally licensed devices that are not in use for longer than two years must be transferred to an authorized recipient or disposed of as radioactive waste. Shutters must be locked in the closed position on devices that are not being used or are in storage. The testing required by subsection (4)(b) of this rule need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use.

(12) Persons generally licensed by an Agreement State with respect to devices meeting the criteria in section (9) of this rule are not subject to registration requirements if the devices are used in areas subject to NRC jurisdiction for a period less than 180 days in any calendar year. The Nuclear Regulatory Commission does not require registration information from such licensees.

(13) The general license in section (1) of this rule does not authorize the manufacture or import of devices containing radioactive material.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0130

General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing

(1) A general license is hereby granted to any physician, veterinarian, clinical laboratory, or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with sections (2), (3), (4), (5) and (6) of this rule, the following radioactive materials in prepackaged units for use in In Vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:

(a) Iodine-125 in units not exceeding ten microcuries (370 kBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals;

(b) Iodine-131, in units not exceeding ten microcuries (370 kBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals;

(c) Carbon-14, in units not exceeding ten microcuries (370 kBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals;

(d) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals;

(e) Iron-59 in units not exceeding 20 microcuries (740 kBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals;

(f) Selenium-75, in units not exceeding ten microcuries (370 kBq) each for use in in vitro clinical or laboratory tests not involving internal or external administration of byproduct material, or the radiation therefrom, to human beings or animals;

(g) Mock iodine-125 reference or calibration sources, in units not exceeding 0.05 microcuries (1.85 kBq) of iodine-129 and 0.005 microcuries (185 Bq) of americium-241 each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.

(2) A person may not receive, acquire, possess, use or transfer radioactive material under the general license granted by section (1) of this rule unless that person:

(a) Has filed the required Authority application for registration pursuant to OAR 333-101-0007 and submitted the registration fee pursuant to 333-103-0015 and received from the Authority a validated license with certification number assigned; or

(b) Has a license that authorizes the medical use of radioactive material that was issued under OAR chapter 333, division 116.

(3) A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by section (1) of this rule must comply with the following:

(a) The general licensee must not possess at any one time, at any one location of storage or use a total amount of iodine-125, iodine-131, selenium-75, cobalt-57 and/or iron-59 in excess of 200 microcuries (7.4 MBq);

(b) The general licensee must store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection;

(c) The general licensee must use the radioactive material only for the uses authorized by section (1) of this rule;

(d) The general licensee must dispose of the mock iodine-125 reference or calibration sources described in subsection (1)(g) of this rule as required by OAR 333-120-0500 and section (6);

(e) The general licensee must not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Authority, the U.S. Nuclear Regulatory Commission, any Agreement State or Licensing State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.

(4) The general licensee must not receive, acquire, possess or use radioactive material pursuant to section (1) of this rule:

(a) Except as prepackaged units that are labeled in accordance with the provisions of an applicable specific license issued by the U.S. Nuclear Regulatory Commission, any Agreement State or any Licensing State that authorizes the manufacture and distribution of iodine-125, iodine-131, carbon-14, hydrogen-3 (tritium), selenium-75, cobalt-57, iron-59 or mock iodine-125 for distribution to persons generally licensed under section (1) of this rule or its equivalent; and

(b) Unless one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(A) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation there from, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

 ________________________________

Name of Manufacturer

(B) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation there from, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.

 ________________________________

Name of Manufacturer

(5) The registrant possessing or using radioactive material granted by the general license of section (1) of this rule must report in writing to the Authority any changes in the information furnished on the required Authority form. The report must be furnished within 30 days after the date of such change.

(6) Any person using radioactive material pursuant to the general license granted by section (1) of this rule is exempt from the requirements of divisions 111 and 120 of this chapter with respect to radioactive material covered by that general license, except that such persons using mock iodine-125 described in subsection (1)(g) of this rule must comply with provisions of OAR 333-120-0500, 333-120-0700 and 333-120-0710.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0190

Application for Specific Licenses.

(1) Applications for specific licenses must be filed on a form prescribed by the Authority. Information contained in previous applications, statements or reports filed with the Authority, the US Nuclear Regulatory Commission, or an Agreement State or a Licensing State or the Atomic Energy Commission may be incorporated by reference, provided that the reference is clear and specific.

(2) The Authority may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Authority to determine whether the application should be granted or denied or whether a license should be modified or revoked.

(3) Each application must be signed by the applicant or licensee or a person duly authorized to act for and on the applicant’s or licensee’s behalf.

(4) Each applicant for a specific license is required to have a permanent in-state office with a copy of all required records available for inspection by the Authority.

(5) An application for a license filed pursuant to the rules in this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter will be considered also as an application for licenses authorizing other activities for which licenses are required by the Act, provided that the application specifies the additional activities for which licenses are requested and complies with rules of the Authority and the US Nuclear Regulatory Commission as to applications for such licenses.

(6) Each new application for a radioactive material license must be accompanied by the fee prescribed by OAR 333-103-0010. No fee will be required to accompany an application for renewal or amendment of a license, except as provided in OAR 333-103-0010.

(7) An application for a license to receive and possess radioactive material for the conduct of any activity that the Authority has determined, pursuant to Subpart A of Part 51 of 10 CFR (Environmental Protection Regulations applicable to materials licensing), will significantly affect the quality of the environment, must be filed at least nine months prior to commencement of construction of the plant or facility in which the activity will be conducted and must be accompanied by any Environmental Report required pursuant to Subpart A of 10 CFR Part 51.

(8) An application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either:

(a) Identify the source or device by manufacturer and model number as registered with the US Nuclear Regulatory Commission under 10 CFR Part 32.210 or with an Agreement State; or for a source or a device containing radium-226 or accelerator-produced radioactive material with a state under provisions comparable to 10 CFR Parts 32.210; or

(b) Contain the information identified in 10 CFR Part 32.210(c); or

(c) Sources or devices containing naturally occurring or accelerator produced radioactive material manufactured prior to November 30, 2007 that are not registered with the Nuclear Regulatory Commission or an Agreement State which the applicant is unable to provide all categories of information specified in 10 CFR Part 32.210(c) the applicant must provide:

(A) All available information identified in 10 CFR Part 32.210(c) concerning the source and if applicable the device; and

(B) Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Information must include a description of the source or device, description of radiation safety features, intended use and associated operating experience and the results of a recent leak test.

(9) As provided by OAR 333-102-0200, certain applications for specific licenses filed under this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning as follows:

NOTE: If a renewal application was submitted on or before July 27, 1990, the decommissioning information may follow the renewal application but must be submitted prior to the license being issued.

(10)(a) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in 10 CFR 30.72, “Schedule C — Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release,’’ must contain either:

(A) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed one rem effective dose equivalent or five rems to the thyroid; or

(B) An emergency plan for responding to a release of radioactive material.

(b) One or more of the following factors may be used to support an evaluation submitted under paragraph (10)(a)(A) of this rule:

(A) The radioactive material is physically separated so that only a portion could be involved in an accident;

(B) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(C) The release fraction in the respirable size range would be lower than the release fraction shown in 10 CFR Part 30.72 (Schedule C — Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release) due to the chemical or physical form of the material;

(D) The solubility of the radioactive material would reduce the dose received;

(E) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in 10 CFR Part 30.72;

(F) Operating restrictions or procedures would prevent a release fraction as large as that shown in 10 CFR Part 30.72; or

(G) Other factors appropriate for the specific facility.

(c) An emergency plan for responding to a release of radioactive material submitted under paragraph (10)(a)(B) of this rule must include the following information:

(A) Facility description. A brief description of the licensee’s facility and area near the site.

(B) Types of accidents. An identification of each type of radio-active materials accident for which protective actions may be needed.

(C) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.

(D) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

(E) Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.

(F) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

(G) Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Authority; also responsibilities for developing, maintaining, and updating the plan.

(H) Notification and coordination. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee also must commit to notify the Authority immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

NOTE: These reporting requirements do not supercede or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499 or other state or federal reporting requirements.

(I) Information to be communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to offsite response organizations and to the Authority.

(J) Training. A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training must familiarize personnel with site-specific emergency procedures. Also, the training must thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.

(K) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

(L) Exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee must invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios must not be known to most exercise participants. The licensee must critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.

(M) Hazardous chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, title III, Pub. L. 99-499, if applicable to the applicant’s activities at the proposed place of use of the byproduct material.

(N) An application from a medical facility, educational institution, or federal facility to produce Positron Emission Tomography (PET) radiopharmaceutical drugs for noncommercial transfer to licensees in its consortium authorized for medical use under 10 CFR Part 35 or division 116 of this chapter or equivalent Agreement State requirements shall include:

(i) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under 10 CFR Part 30 or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(ii) Evidence that the applicant is qualified to produce radiopharmaceutical drugs for medical use by meeting one of the criteria in 10 CFR 32.72(a)(2).

(iii) Identification of individual(s) authorized to prepare the PET radiopharmaceutical drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in OAR 333-116-0880 and 333-116-0910.

(iv) Information identified in 10 CFR Part 32.72(a)(3) on the PET radiopharmaceutical to be non-commercially transferred to members of its consortium.

(v) Each applicant for a license for byproduct material shall protect Safeguards Information against unauthorized disclosure in accordance with the requirements in 10 CFR Parts 73.21, 73.22 and 73.23 as applicable.

(d) The licensee must allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensee’s emergency plan before submitting it to the Authority. The licensee must provide any comments received within the 60 days to the Authority with the emergency plan.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0250

Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License

An application for a specific license to manufacture or distribute radioactive material for use under the general license specified in OAR 333-102-0130 or equivalent will be approved if:

(1) The applicant satisfies the general requirements specified in OAR 333-102-0200;

(2) The radioactive material is to be prepared for distribution in prepackaged units of:

(a) Carbon-14 in units not exceeding ten microcuries (370 kBq) each;

(b) Cobalt-57 in units not exceeding ten microcuries (370 kBq) each;

(c) Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each;

(d) Iodine-125 in units not exceeding ten microcuries (370 kBq) each;

(e) Mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each;

(f) Iodine-131 in units not exceeding ten microcuries (370 kBq) each;

(g) Iron-59 in units not exceeding 20 microcuries (740 kBq) each;

(h) Selenium-75 in units not exceeding ten microcuries (370 kBq) each;

(i) Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each.

(3) Each prepackaged unit bears a durable, clearly visible label:

(a) Identifying the radioactive contents as to chemical form and radionuclide and indicating that the amount of radioactivity does not exceed ten microcuries (370 kBq) of iodine-125, iodine-131, carbon-14, cobalt-57 or selenium-75; 50 microcuries (1.85 MBq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each or colbalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) and;

(b) Displaying the radiation caution symbol described in OAR 333-120-0400 and the words, CAUTION, RADIOACTIVE MATERIAL and Not for Internal or External Use in Humans or Animals.

(4) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(a) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation there from, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

____________________________

Name of manufacturer

(b) This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation there from, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.

________________________

Name of manufacturer

(5) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements in OAR 333-120-0500.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 4-2007, f. & cert. ef. 3-1-07; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0285

Manufacture, Preparation, or Transfer for Commercial Distribution of Radiopharmaceutical Drugs Containing Radioactive Material for Medical Use Under Division 116

(1) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radiopharmaceutical drugs containing radioactive material for use by persons authorized pursuant to division 116 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in OAR 333-102-0200;

(b) The applicant submits evidence that the applicant is at least one of the following:

(A) Registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a);

(B) Registered or licensed with a state agency as a drug manufacturer;

(C) Licensed as a pharmacy by a state Board of Pharmacy;

(D) Operating as a nuclear pharmacy within a federal medical institution; or

(E) A Positron Emission Tomography (PET) drug production facility registered with a state agency.

(c) The applicant submits information on the radionuclide, chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radiopharmaceutical drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and storage of the radiopharmaceutical drugs by medical use licensees; and

(d) The applicant satisfies the following labeling requirements:

(A) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radiopharmaceutical drug to be transferred for commercial distribution. The label must include the radiation symbol and the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL; the name of the radiopharmaceutical drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radiopharmaceutical drugs with a half life greater than 100 days, the time may be omitted.

(B) A label is affixed to each syringe, vial, or other container used to hold a radiopharmaceutical drug to be transferred for commercial distribution. The label must include the radiation symbol and the words CAUTION, RADIOACTIVE MATERIAL or DANGER, RADIOACTIVE MATERIAL’’ and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

(2) A licensee described by paragraphs (1)(b)(C) or (D) of this rule:

(a) May prepare radiopharmaceutical drugs for medical use, as defined in OAR 333-116-0020, provided that the radiopharmaceutical drug is prepared either by an authorized nuclear pharmacist, as specified in subsections (2)(c) and (2)(d) of this rule, or an individual under the supervision of an authorized nuclear pharmacist as specified in OAR 333-116-0100.

(b) May allow a pharmacist to work as an authorized nuclear pharmacist if:

(A) This individual qualifies as an authorized nuclear pharmacist as defined in OAR 333-116-0020;

(B) This individual meets the requirements specified in OAR 333-116-0910, 333-116-0760, 333-116-0915 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

(C) This individual is designated as an authorized nuclear pharmacist in accordance with subsection (2)(d) of this rule.

(c) The actions authorized in subsections (2)(a) and (2)(b) of this rule are permitted in spite of more restrictive language in license conditions.

(d) May designate a pharmacist (as defined in OAR 333-116-0020) as an authorized nuclear pharmacist if:

(A) The individual was a nuclear pharmacist preparing only radiopharmaceutical drugs containing accelerator-produced radioactive material; and

(B) The individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the Nuclear Regulator Commission.

(e) Shall provide to the Authority a copy of:

(A) Each individual’s certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in OAR 333-116-0910 with the written attestation signed by a preceptor as required by OAR 333-116-0680(2)(b); or

(B) The Commission or Agreement State license; or

(C) Commission master materials licensee permit; or

(D) The permit issued by a licensee or Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

(E) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and

(F) A copy of the state pharmacy licensure or registration no later than 30 days after the date that the licensee allows pursuant to paragraphs (2)(b)(A) and (2)(b)(C) of this rule, which allows the individual to work as an authorized nuclear pharmacist.

(3) A licensee shall possess and use instrumentation to measure the radioactivity of radiopharmaceutical drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radiopharmaceutical drugs prior to transfer for commercial distribution. In addition, the licensee shall:

(a) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument and make adjustments when necessary; and

(b) Check each instrument for constancy and proper operation at the beginning of each day of use.

(4) Nothing in this rule relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radiopharmaceutical drugs.

NOTE: Although the Authority does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radio pharmaceuticals containing radioactive material as a part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material, who desires to have the reagent kits approved by the Authority for use by persons licensed for medical use pursuant to OAR 333-116 or by persons authorized under a group license, or equivalent, by the U.S. Nuclear Regulatory Commission or any other Agreement State, may submit the pertinent information specified in this rule.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0290

Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use

(1) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to division 116 of this chapter for use as a calibration, transmission, or reference source, or for the uses listed in OAR 333-116-0400, 333-116-0420, 333-116-0480 and 333-116-0485 will be approved if:

(a) The applicant satisfies the general requirements in OAR 333-102-0200.

(b) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(A) The radioactive material contained, its chemical and physical form and amount;

(B) Details of design and construction of the source or device;

(C) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

(D) For devices containing radioactive material, the radiation profile of a prototype device;

(E) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

(F) Procedures and standards for calibrating sources and devices;

(G) Legend and methods for labeling sources and devices as to their radioactive content; and

(H) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device. Provided, that instructions that are too lengthy for such a label may be summarized on the label and printed in detail on a brochure that is referenced on the label.

(c) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, date of assay and a statement that the U.S. Nuclear Regulatory Commission has approved distribution of the (name of source or device) to persons licensed to use radioactive material identified in OAR 333-116-0190, 333-116-0400, or 333-116-0420, as appropriate, and to persons who hold an equivalent license issued by an Agreement State or the US Nuclear Regulatory Commission. However, labels worded in accordance with requirements that were in place on March 30, 1987 may be used until March 30, 1989.

(2) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months:

(a) The applicant must include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

(b) In determining the acceptable interval for test of leakage of radioactive material, the Authority will consider information that includes, but is not limited to:

(A) Primary containment or source capsule;

(B) Protection of primary containment;

(C) Method of sealing containment;

(D) Containment construction materials;

(E) Form of contained radioactive material;

(F) Maximum temperature withstood during prototype tests;

(G) Maximum pressure withstood during prototype tests;

(H) Maximum quantity of contained radioactive material;

(I) Radiotoxicity of contained radioactive material; and

(J) Operating experience with identical sources or devices similarly designed and constructed sources or devices.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0293

Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications

(1) An application for a specific license to manufacture industrial products or devices containing depleted uranium for use pursuant to OAR 333-102-0103 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

(a) The applicant satisfies the general requirements specified in OAR 333-102-0200;

(b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of one calendar quarter a radiation dose in excess of ten percent of the limits specified in OAR 333-120-0100; and

(c) The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

(2) In the case of an industrial product or device whose unique benefits are questionable, the Authority will approve an application for a specific license under this rule only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

(3) The Authority may deny any application for a specific license under this rule if the end use(s) of the industrial product or device cannot be reasonably foreseen.

(4) Each person licensed pursuant to section (1) of this rule must:

(a) Maintain the level of quality control required by the license in the manufacture of the industrial product or device; and in the installation of the depleted uranium into the product or device;

(b) Label or mark each unit to:

(A) Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium and the quantity of depleted uranium in each product or device; and

(B) State that the receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State.

(c) Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: Depleted Uranium.

(A) Furnish a copy of the general license contained in OAR 333-102-0103 to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in 333-102-0103; or

(B) Furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission’s or Agreement State’s regulation equivalent to OAR 333-102-0103 and a copy of the U.S. Nuclear Regulatory Commission’s or Agreement State’s certificate, or alternatively, furnish a copy of the general license contained in 333-102-0103 to each person to whom depleted uranium in a product or device is transferred for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or Agreement State under requirements substantially the same as those in 333-102-0103.

(d) Report to the Authority all transfers of industrial products or devices to persons for use under the general license in OAR 333-102-0103. Such report must identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Authority and the general licensee, the type and model number of device transferred and the quantity of depleted uranium contained in the product or device. The report must be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons granted a general license by OAR 333-102-0103 during the reporting period, the report must so indicate.

(e) Report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in section 40.25 of 10 CFR Part 40.

(A) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to OAR 333-102-0115 for use under a general license in that state’s regulations equivalent to 333-102-0103.

(B) Such report must identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Authority and the general licensee, the type and model number of the device transferred and the quantity of depleted uranium contained in the product or device. The report must be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person.

(C) If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information must be reported to the U.S. Nuclear Regulatory Commission.

(f) If no transfers have been made to general licensees within a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State Agency upon the request of that Agency.

(g) Keep records showing the name, address and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in OAR 333-102-0101(4) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records must be maintained until inspection by the Authority and must show the date of each transfer, the quantity of depleted uranium in each product or device transferred and compliance with the report requirements of section (9) of this rule.

(h) Licensees required to submit emergency plans by OAR 333-102-0190(10) must follow the emergency plan approved by the Commission. The licensee may change the plan without Commission approval if the changes do not decrease the effectiveness of the plan. The licensee must furnish the change to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555 and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease the effectiveness of the approved emergency plan may not be implemented without application to and prior approval by the Authority.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0305

Specific Terms and Conditions of Licenses

(1) Each license issued pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120, 121 and 124 of this chapter are subject to all the provisions of the Act, now or hereafter in effect, and to all rules, regulations and orders of the Authority.

(2) No license issued or granted pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120 and 121 of this chapter nor any right may be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Authority, after securing full information, shall find that the transfer is in accordance with the provisions of the Act, and shall give its consent in writing.

(3) Each person licensed by the Authority pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120 and 121 of this chapter must confine the use and possession of the radioactive material to the locations and purposes authorized in the license. Except as otherwise provided in the license, a license issued pursuant to the rules in this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter shall carry with it the right to receive, acquire, own, and possess radioactive material. Preparation for shipment and transport of radioactive material must be in accordance with the provisions of division 118 of this chapter.

(4) Each license issued pursuant to the rules in this division and divisions 105, 113, 115, 116, 117, and 121 of this chapter shall be deemed to contain the provisions set forth in section 183b.-d., inclusive, of the Atomic Energy Act of 1954, as amended, whether or not these provisions are expressly set forth in the license.

(5) The Authority may incorporate, in any license issued pursuant to the rules in this division and divisions 103, 105, 113, 115, 116, 117, 120 and 121 of this chapter, at the time of issuance, or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the licensee’s receipt, possession, use and transfer of radioactive material as it deems appropriate or necessary in order to:

(a) Promote the common defense and security;

(b) Protect health or to minimize danger to life or property;

(c) Protect restricted data; and

(d) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be necessary or appropriate to effectuate the purposes of the Act and regulations thereunder.

(6) Licensees required to submit emergency plans by OAR 333-102-0190(10) must follow the emergency plan approved by the Authority. The licensee may change the approved plan without Authority approval only if the changes do not decrease the effectiveness of the plan. The licensee must furnish the change to the Authority and to affected offsite response organizations within six months after the change is made. Proposed changes that decrease, or potentially decrease, the effectiveness of the approved emergency plan may not be implemented without prior application to and prior approval by the Authority.

(7) Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82 generators must test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85, respectively, in accordance with OAR 333-116-0330. The licensee must record the results of each test and retain each record for three years after the record is made.

(8)(a) Each general licensee subject to the registration requirement in OAR 333-101-0007 and each specific licensee must notify the Authority in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (Bankruptcy) of the United States Code by or against:

(A) The licensee;

(B) An entity (as that term is defined in 11 U.S.C. 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or

(C) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of the licensee.

(b) This notification must indicate:

(A) The bankruptcy court in which the petition for bankruptcy was filed; and

(B) The date of the filing of the petition.

(9) Sealed sources or detector cells containing licensed material must not be opened or sources removed from source holders or detector cells by the licensee.

(10) No licensee may acquire licensed radioactive material in a sealed source or in a device that contains a sealed source unless the source or device has been registered with the U.S. Nuclear Regulatory Commission under 10 CFR 32.210 or with an Agreement State.

(11) Any sealed source fabricated by a licensee must be registered, inspected, and tested for construction defects, leakage, and contamination prior to any use or transfer as a sealed source in accordance with requirements in 10 CFR 32.210.

(12) Each licensee must conduct a physical inventory at intervals not to exceed six months to account for all radioactive material received and possessed by licensee. Inventories must include the types and quantities of radioactive material, location of materials, date of receipt, and the date of the inventory; and for sealed sources, the inventory must include the types and quantities of sealed sources, sealed source manufacturer, model number, serial number, date of receipt, condition of sealed sources, and the date of the inventory. Records of the inventories required by section (12) of this rule must be kept until inspection by the Authority.

(13) Each licensee must transport radioactive material or deliver radioactive material to a carrier for transport in accordance with the provisions of Parts 170 through 189 of Title 49, Code of Federal Regulations and in accordance with division 118 of this chapter, “Transportation of Radioactive Material.”

(14) Each licensee possessing a device licensed pursuant to OAR 333-103-0010(2)(h) must perform an inspection of all devices at intervals not to exceed six months. Inspections must include condition of labeling and posting of each radiation device, and corrective actions taken if any; condition of shutter operation, if applicable, of each device, and corrective actions taken if any; and location of each device. Records of the inspections required by section (14) of this rule must be kept until inspection by the Authority.

(15) No licensee may open or remove radioactive material from sealed sources or detector cells containing licensed radiation sources.

(16) No person may repair, modify, dismantle, or effect any change in licensed devices or radiation sources, nor modify nor alter labels affixed to licensed devices by the manufacturer

(17) Installation, initial radiation survey, relocation, removal from service, maintenance, and repair of fixed gauging devices containing radioactive sealed sources, and installation, replacement, and disposal of sealed sources must be performed only by persons specifically authorized by the Authority, the U.S. Nuclear Regulatory Commission, or another Agreement state to perform such services. Records of all surveys must be maintained for inspection by the Radiation Protection Services section.

(18) If the licensee has previously determined that monitoring for internal exposure pursuant to OAR 333-120-0130, 333-120-0210, or 333-120-0320 is required, the data and results of this evaluation must be placed in the worker’s exposure records and included the worker’s Oregon Form Z report.

(19) Testing for leakage or contamination of sealed sources must be in accordance with requirements in OAR 333-120-0460. In the absence of a certificate from a transferor indicating that a test has been made within six months prior to the transfer, a sealed source or detector cell received from another person must not be put into use until tested.

(20) Detector cells must be used only in conjunction with a properly operating temperature control mechanism that prevents foil temperatures from exceeding manufacturer’s specifications. Exhaust from detector cells must be vented to keep exposures to personnel and the public as low as reasonably achievable pursuant to OAR 333-120-0180.

(21) Licensees who possess sealed sources used for testing at field sites must possess at such locations transport documents, a current copy of the specific radioactive materials license, specific license validation certificates, the current leak test certificate, and the licensee’s operating and emergency procedures. Licensed materials stored in an unrestricted area must be secured from unauthorized removal from the place of storage in accordance with provisions of OAR 333-120-0250 and 333-120-0260.

(22) Any specific licensee is authorized to receive, possess, use, transfer, and import up to 999 kilograms of uranium contained as shielding for specific licensed radioactive material authorized by license.

(23) A licensee may store, pursuant to OAR 333-120-0500, radioactive waste for decay in storage before disposal in accordance with OAR 333-116-0290.

(24) Licensed materials in an unrestricted area and not in storage must be tended under the constant surveillance and immediate control of the licensee.

(25) Except as otherwise specified in a radioactive materials license, the licensee must have available and follow the instructions contained in the manufacturer’s instruction manual for the chromatography device.

(26) In lieu of using the conventional radiation caution colors (magenta or purple on yellow background) as provided in OAR 333-120-0400(2), the licensee is hereby authorized to label detector cells and cell baths, containing licensed radioactive material and used in gas chromatography devices, with conspicuously etched or stamped radiation caution symbols without a color requirement.

(27) If a radiography licensee plans to use, during normal industrial radiographic operations subject to division 105 of this chapter, two or more exposure devices at one jobsite, the licensee must require at least one Radiographer or Radiographer Instructor authorized user for each exposure device, and the total number of authorized personnel (radiographers and assistant radiographers) at the temporary jobsite must not be less than n+1 where n=the number of cameras.

(28) Security requirements for portable devices containing licensed radioactive materials. Each portable device containing licensed radioactive materials must be secured using a minimum of two independent physical controls that form two separate tangible barriers to prevent unauthorized removal or use, whenever the portable device is not under the direct control and constant surveillance of the licensee.

(29) Authorization under OAR 333-102-0190(10)(c)(N) to produce Positron Emission Tomography (PET) radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable FDA, other federal, and state requirements governing radiopharmaceutical drugs.

(30) Each licensee authorized under OAR 333-102-0190(10)(c)(N) to produce PET radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium shall:

(a) Satisfy the labeling requirements in OAR 333-102-0285(1)(d) for each PET radiopharmaceutical drug transport radiation shield and each syringe, vial, or other container used to hold a PET radiopharmaceutical drug intended for noncommercial distribution to members of its consortium.

(b) Possess and use instrumentation to measure the radioactivity of the PET radiopharmaceutical drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in OAR 333-102-0285(3).

(31) A licensee that is a pharmacy authorized under OAR 333-102-0190(10)(c)(N) to produce PET radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium shall require that any individual that prepares PET radiopharmaceutical drugs shall be:

(a) An authorized nuclear pharmacist who meets the requirements in OAR 333-116-0910; or

(b) An individual under the supervision of an authorized nuclear pharmacist as specified in OAR 333-116-0100.

(32) A pharmacy, authorized under OAR 333-102-0190(10)(c)(N) to produce PET radiopharmaceutical drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of OAR 333-116-0910.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0310

Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas

(1)(a) Except as provided in subsection (1)(b) of this rule, each specific license must expire at the end of the day on the expiration date stated in the license unless the licensee has filed an application for renewal under OAR 333-102-0315 before the expiration date stated in the existing license (or, for those licenses subject to subsection (1)(b) of this rule, before the deemed expiration date in that section). If an application for renewal has been filed before the expiration date stated in the existing license (or, for those licenses subject to subsection (2)(a) of this rule, before the deemed expiration date in that section), the existing license expires at the end of the day on which the Authority makes a final determination to deny the renewal application or, if the determination states an expiration date, the expiration date stated in the determination.

(b) Each specific license that has an expiration date after July 1, 1995, and is not one of the licenses described in subsection (1)(c) of this rule, shall be deemed to have an expiration date that is five years after the expiration date stated in the current license.

(c) The following specific licenses are not subject to, or otherwise affected by, the provisions of subsection (1)(b) of this rule:

(A) Specific licenses for which, on February 15, 1996, an evaluation or an emergency plan is required in accordance with OAR 333-102-0190(10);

(B) Specific licenses whose holders are subject to the financial assurance requirements specified in OAR 333-102-0200(6), and on February 15, 1996, the holders either:

(i) Have not submitted a decommissioning funding plan or certification of financial assurance for decommissioning; or

(ii) Have not received written notice that the decommissioning funding plan or certification of financial assurance for decommissioning is acceptable;

(C) Specific licenses whose holders are listed in the SDMP List published in NUREG 1444, Supplement 1 (November 1995);

(D) Specific licenses who need an environmental assessment or environmental impact statement pursuant to Subpart A of Part 51 and OAR 333-102-0200(5);

(E) Specific licenses whose holders have not had at least one Authority inspection of licensed activities before February 15, 1996;

(F) Specific licenses whose holders, as the result of the most recent Authority inspection of licensed activities conducted before February 15, 1996, have been:

(i) Cited for a serious health and safety noncompliance;

(ii) Subject to an Order issued by the Authority; or

(iii) Subject to a Confirmatory Action Letter issued by the Authority.

(G) Specific licenses with expiration dates before July 1, 1995, for which the holders have submitted applications for renewal under OAR 333-102-0315.

(2) Each specific license revoked by the Authority expires at the end of the day on the date of the Commission’s final determination to revoke the license, or on the expiration date stated in the determination, or as otherwise provided by Authority Order.

(3) Each specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material or source material until the Authority notifies the licensee in writing that the license is terminated. During this time, the licensee must:

(a) Limit actions involving material to those related to decommissioning; and

(b) Continue to control entry to restricted areas until they are suitable for release in accordance with Authority requirements.

(4) Within 60 days of the occurrence of any of the following, consistent with the administrative directions in OAR 333-100-0045, each licensee must provide notification to the Authority in writing of such occurrence, and either begin decommissioning its site, or any separate building or outdoor area that contains residual radioactivity so that the building or outdoor area is suitable for release in accordance with Authority requirements, or submit within 12 months of notification a decommissioning plan, if required by subsection (7)(a) of this rule, and begin decommissioning upon approval of that plan if:

(a) The license has expired pursuant to sections (1) or (2) of this rule; or

(b) The licensee has decided to permanently cease principal activities, as defined in OAR 333-102-0203, at the entire site or in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Authority requirements; or

(c) No principal activities under the license have been conducted for a period of 24 months; or

(d) No principal activities have been conducted for a period of 24 months in any separate building or outdoor area that contains residual radioactivity such that the building or outdoor area is unsuitable for release in accordance with Authority requirements.

(5) Coincident with the notification required by section (4) of this rule, the licensee must maintain in effect all decommissioning financial assurances established by the licensee pursuant to OAR 333-102-0200(6) in conjunction with a license issuance or renewal or as required by this rule. The amount of the financial assurance must be increased, or may be decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to paragraph (7)(d)(E) of this rule.

(a) Any licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan must do so when this rule becomes effective November 24, 1995.

(b) Following approval of the decommissioning plan, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site with the approval of the Authority.

(6) The Authority may grant a request to extend the time periods established in section (4) of this rule if the Authority determines that this relief is not detrimental to the public health and safety and is otherwise in the public interest. The request must be submitted no later than 30 days before notification pursuant to section (4) of this rule. The schedule for decommissioning set forth in section (4) of this rule may not commence until the Authority has made a determination on the request.

(7)(a) A decommissioning plan must be submitted if required by license condition or if the procedures and activities necessary to carry out decommissioning of the site or separate building or outdoor area have not been previously approved by the Authority and these procedures could increase potential health and safety impacts to workers or to the public, such as in any of the following cases:

(A) Procedures would involve techniques not applied routinely during cleanup or maintenance operations;

(B) Workers would be entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;

(C) Procedures could result in significantly greater airborne concentrations of radioactive material or source material than are present during operation; or

(D) Procedures could result in significantly greater releases of radioactive material or source material to the environment than those associated with operation.

(b) The Authority may approve an alternate schedule for submittal of a decommissioning plan required pursuant to section (4) of this rule if the Authority determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to the public health and safety and is otherwise in the public interest.

(c) Procedures such as those listed in subsection (7)(a) of this rule with potential health and safety impacts may not be carried out prior to approval of the decommissioning plan.

(d) The proposed decommissioning plan for the site or separate building or outdoor area must include:

(A) A description of the conditions of the site or separate building or outdoor area sufficient to evaluate the acceptability of the plan;

(B) A description of planned decommissioning activities;

(C) A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;

(D) A description of the planned final radiation survey; and

(E) An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning.

(F) For decommissioning plans calling for completion of decommissioning later than 24 months after plan approval, the plan must include a justification for the delay based on the criteria in section (9) of this rule.

(e) The proposed decommissioning plan will be approved by the Authority if the information therein demonstrates that the decommissioning will be completed as soon as practicable and that the health and safety of workers and the public will be adequately protected.

(8)(a) Except as provided in section (9) of this rule, licensees must complete decommissioning of the site or separate building or outdoor area as soon as practicable but no later than 24 months following the initiation of decommissioning.

(b) Except as provided in section (9) of this rule, when decommissioning involves the entire site, the licensee must request license termination as soon as practicable but no later than 24 months following the initiation of decommissioning.

(9) The Authority may approve a request for an alternative schedule for completion of decommissioning of the site or separate building or outdoor area, and license termination if appropriate, if the Authority determines that the alternative is warranted by consideration of the following:

(a) Whether it is technically feasible to complete decommissioning within the allotted 24-month period;

(b) Whether sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted 24-month period;

(c) Whether a significant volume reduction in wastes requiring disposal will be achieved by allowing short-lived radionuclides to decay;

(d) Whether a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and

(e) Other site-specific factors which the Authority may consider appropriate on a case-by-case basis, such as the regulatory requirements of other government agencies, lawsuits, ground-water treatment activities, monitored natural ground-water restoration, actions that could result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.

(10) As the final step in decommissioning, the licensee must:

(a) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed NRC Form 314 or equivalent information; and

(b) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR Part 20, Subpart E. The licensee must, as appropriate:

(A) Report levels of gamma radiation in units of millisieverts (microroentgen) per hour at one meter from surfaces, and report levels of radioactivity, including alpha and beta, in units of megabecquerels (disintegrations per minute or microcuries) per 100 square centimeters — removable and fixed — for surfaces, megabecquerels (microcuries) per milliliter for water, and becquerels (picocuries) per gram for solids such as soils or concrete; and

(B) Specify the survey instrument(s) used and certify that each instrument is properly calibrated and tested.

(11) Specific licenses, including expired licenses, will be terminated by written notice to the licensee when the Authority determines that:

(a) Radioactive material or source material has been properly disposed;

(b) Reasonable effort has been made to eliminate residual radioactive contamination, if present; and

(c)(A) A radiation survey has been performed that demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR Part 20, Subpart E; or

(B) Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning in 10 CFR Part 20, Subpart E.

(d) The licensee has kept records of receipt, transfer, and disposal of radioactive material or source material, pursuant to OAR 333-100-0055 that meet the following criteria:

(A) The licensee must retain each record of receipt of radioactive material or source material as long as the material is possessed and for three years following transfer or disposal of the material.

(B) The licensee who transferred the material must retain each record of transfer for three years after each transfer unless a specific requirement in another part of the rules in this chapter dictates otherwise.

(C) The licensee who disposed of the material must retain each record of disposal of byproduct material until the Authority terminates each license that authorizes disposal of the material.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-102-0340

Reciprocal Recognition of Licenses

(1) Subject to these rules, any person who holds a specific license from the U.S. Nuclear Regulatory Commission, an Agreement State, or a licensing state, and issued by the Authority having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of 180 days in any calendar year, provided that:

(a) The licensing document does not limit the activity authorized by such document to specified installations or locations;

(b) The out-of-state licensee has notified the Authority using the Notification of Entry to Perform Activities Under Oregon Reciprocity Application form at least three days prior to engaging in such activity and has paid the applicable registration fee pursuant to OAR 333-103-0030. Such notification shall indicate the location, period and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the three-day period would impose an undue hardship on the out-of-state licensee, the licensee may, upon application to the Authority, obtain permission to proceed sooner. The Authority may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license granted by subsection (1)(a) of this rule;

(c) The out-of-state licensee complies with all applicable rules of the Authority and with all the terms and conditions of the licensing document, except any such terms and conditions that may be inconsistent with applicable rules of the Authority or laws of the State of Oregon;

(d) The out-of-state licensee supplies such other information as the Authority may request; and

(e) The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in subsection (1)(a) of this rule except by transfer to a person:

(A) Specifically licensed by the Authority or by the U.S. Nuclear Regulatory Commission to receive such material; or

(B) Exempt from the requirements for a license for such material under OAR 333-102-0010(2).

(2) Notwithstanding the provisions of section (1) of this rule, any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission, pursuant to 10 CFR 31.6 or equivalent regulations of an Agreement State, authorizing the holder of the license to manufacture, transfer, install or service a device described in OAR 333-102-0115(1) within the State of Oregon is hereby granted a general license to install, transfer, demonstrate or service such a device in this state provided that:

(a) Such person shall register the general license pursuant to OAR 333-101-0007;

(b) File a report with the Authority within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred and the quantity and type of radioactive material contained in the device;

(c) Ensure that the device has been manufactured, labeled, installed and serviced in accordance with applicable provisions of the specific license issued to such person by the U.S. Nuclear Regulatory Commission or an Agreement State;

(d) Ensure that any labels required to be affixed to the device under rules of the licensing authority also include the statement “Removal of this label is prohibited”; and

(e) The holder of the specific license shall furnish to each general licensee to whom such device is transferred, or on whose premises such a device is installed, a copy of the general license contained in OAR 333-102-0115 or in equivalent rules of the Authority having jurisdiction over the manufacture and distribution of the device.

(3) The Authority may withdraw, limit or qualify its acceptance of any specific license or equivalent licensing document issued by the U.S. Nuclear Regulatory Commission or an Agreement State, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property. The Authority may deny the licensee to perform activities under Oregon reciprocity.

(4) The out-of-state licensee shall at all times during work at any work location within the state have available the pertinent licensing document, the applicable sections of the State of Oregon radiation regulations, a complete source inventory, pertinent U.S. Department of Transportation documentation, leak test records, instrument calibration records, personnel training records, and necessary documentation required by applicable special requirements of these regulations.

(5) While working in Oregon, the out-of-state licensee shall notify the Authority (in writing, indicating date and court) immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (bankruptcy) of the United States code by or against:

(a) The licensee;

(b) An entity (as that term is defined in II U.S.C 101(14)) controlling the licensee or listing the license or licensee as property of the estate; or

(c) An affiliate (as that term is defined in II U.S.C. 101(2)) of the license.

(6) If multiple work crews or persons work concurrently at more than one work location under a general license granted pursuant to this rule, each day worked at each location shall count toward the limit of 180 days in a calendar year.

(7) Each general licensee granted authorization to conduct activities within the State of Oregon pursuant to this rule, based upon an acceptable licensing document, will receive acknowledgment from the Authority. This acknowledgment shall be kept at the site of use.

(8) Each general licensee granted authorization to conduct activities within the State of Oregon pursuant to this rule based upon an acceptable licensing document is subject to the reciprocity fee and may be inspected by the Authority. The fee for the general license granting reciprocity shall:

(a) Be charged as provided by division 103 of this chapter; and

(b) Shall not be charged more often than once during each calendar year.

(9) Each general licensee operating within the state under reciprocity in areas of exclusive federal jurisdiction shall comply with the applicable provisions of 10 CFR 150.20.

Stat. Auth.: ORS 453.635, 453.665

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-103-0010

Annual Fee for Specific Licenses

(1)(a) Each specific license listed in section (2) of this rule, as defined in OAR 333-102-0203, shall be licensed pursuant to sections (2), (3), (4), (5), and (6) of this rule by a specific license fee.

(b) Upon written request and approval by the Authority, fees for new licenses or additional sources may be prorated on a quarterly basis for the current fiscal year.

(2) Each specific license type appearing in the following fee schedule shall be licensed separately with a specific license fee as indicated:

(a) Analytical/Leak Test/Fixed X-ray Fluorescence, $552(F);

(b) Basic License, $976(F);

(c) Brachytherapy, $2,204(F);

(d) Broad Scope A, $3,000(F);

(e) Broad Scope B, $2,204(F);

(f) Broad Scope C, $1,096(F);

(g) Distribution, $1,096 (F);

(h) Fixed Gauge, $276(S);

(i) High, medium and low doserate brachytherapy, $2,756(S);

(j) Imaging and Localization, $1,096(F);

(k) In Vitro Laboratory, $364(F);

(l) Industrial Radiography:

(A) Fixed Facility, $3,000(F);

(B) Field Use, $3,000(F);

(m) Instrument Calibration, $828(S);

(n) Investigational New Drug, $1,652(F);

(o) Irradiator Self-Shielded, $1,096(S);

(p) Manufacturing/Compounding, $2,936(F);

(q) Mobile Nuclear Medicine, $2,936(F);

(r) NORM (no processing), $736(F);

(s) Nuclear Pharmacy, $3,000(F);

(t) Other Measuring Device, $160(S). Six sources or more, for attenuation purposes, may apply for a basic license;

(u) Portable Gauge:

(A) X-ray Fluorescence, $552(S);

(B) All other portable gauges, $736(S);

(v) Radiopharmaceutical Therapy, $1,652(F);

(w) RAM/NOS Facility, $3,000(F);

(x) Research & Development, $1,652(F);

(y) Sealed Sources for Diagnosis, $552(S);

(z) Source Material, $3,000(F);

(aa) Special Nuclear Material (sealed), $1,096(S);

(bb) Special Nuclear Material (unsealed), $2,756(F);

(cc) Teletherapy (external beam), $3,000(S);

(dd) Unique, $No Fee;

(ee) Uptake and Dilution, $736(F);

(ff) Use of Xenon Gas, $736(F);

(gg) Waste Packaging, $3,000(F);

(hh) Well Logging, $1,652(S);

NOTE: (F) means facility; (S) means source.

(3) Each specific license validation fee shall be due and payable:

(a) Each specific license validation fee shall be due and payable based on the following fee schedule.

(A) Validation fees for licenses expiring July through September are due by October 1 each year.

(B) Validation fees for licenses expiring October through December are due by January 1 each year.

(C) Validation fees for licenses expiring January through March are due by April 1 each year; and,

(D) Validation fees for licenses expiring April through June are due by July 1 each year.

(b) For each specific license source of radiation listed in section (2) of this rule for which application pursuant to OAR 333-102-0190 for an Oregon Radioactive Materials License has been made;

(c) For each additional specific license source of radiation in an amendment to an existing Oregon Radioactive Materials License pursuant to OAR 333-102-0320.

(4) A license for each specific license issued pursuant to section (3) of this rule shall be provided by the Authority. The certificate of validation for the current fiscal year shall be retained by the licensee and attached to the license pursuant to requirements in OAR 333-111-0005.

(5) The specific license fee that validates specific sealed sources also validates possession of one additional sealed source during source exchange (one new source and one spent source) for a period not to exceed 30 calendar days.

(6) Sealed sources manufactured and distributed as reference sources that do not exceed 100 times the quantity in 30.71 Schedule B of 10 CFR Part 30 are exempt from specific license fees and validation if used pursuant to a specific license listed in section (2) of this rule. The license validation fee for reference sources that exceed 100 times the quantity in 30.71 Schedule B of 10 CFR Part 30 or reference sources authorized alone without additional licensed radioactive material shall be $976, pursuant to subsection (2)(b) of this rule.

Stat. Auth.: ORS 453.757

Stats. Implemented: ORS 453.757

Hist.: HD 4-1985, f. & ef. 3-20-85; HD 13-1988, f. 6-7-88, cert. ef. 7-1-88; HD 1-1991, f. & cert. ef. 1-8-91; HD 15-1991, f. & cert. ef. 10-1-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 2-1995(Temp), f. & cert. ef. 7-11-95; HD 4-1995, f. & cert. ef. 9-8-95; HD 3-1996, f. & cert. ef. 8-9-96; PH 11-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-103-0030

Reciprocal Recognition Fee

(1) Any radiation machine or radioactive material source brought into the state for use under reciprocity must pay a fee equal to 100 percent of the appropriate license or registration validation fee, listed in OAR 333-103-0005 or 333-103-0010, not to exceed $3,000 in a year.

(2) Reciprocal fees shall be due and payable prior to entry into the state.

(3) An acknowledgment of fee payment, such as a certificate of validation, will be provided by the Authority. The acknowledgment of fee payment must be retained by the licensee or registrant and attached to the license or registration.

(4) Reciprocal fees shall not be transferred or refunded.

(5) Reciprocal fees shall expire 12 months from the issue date.

(6) Any use of radioactive material in Oregon pursuant to OAR 333-102-0340 exceeding 30 consecutive days or 180 calendar days shall require an application for an Oregon specific radioactive materials license pursuant to OAR 333-102-0190.

Stat. Auth.: ORS 453.757

Stats. Implemented: ORS 453.757

Hist.: HD 15-1991, f. & cert. ef. 10-1-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 2-1995(Temp), f. & cert. ef. 7-11-95; HD 4-1995, f. & cert. ef. 9-8-95; PH 11-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-103-0035

Fees For Radiological Analyses

(1) An individual, agency, or company that requests that the Authority Radiation Laboratory perform radiological analyses on samples must pay a fee to the Authority in accordance with the schedule in section (2) of this rule. The responsible individual submitting the sample(s) must first obtain a request form from the Authority. This form contains the fee schedule and the types of radiological analyses offered. That individual must then submit the completed form along with the sample and the appropriate fee to the Authority. The Authority will send the results by return mail in accordance with the estimated time as per section (3) of this rule.

(2) Fee Schedule:

(a) Gamma Isotopic:

(A) Liquid — $248

(B) Solid — $284

(b) Low-level Iodine-131 — $212;

(C) Tritium (H-3) — $92.

(3) The analyses results will be available in approximately five working days for Gamma Isotopic analyses.

NOTE: If the Authority cannot complete the analyses according to the schedule in section (3) of this rule, the Authority will notify the customer as soon as possible.

(4) A $100 surcharge shall be added to the fee for a one-day completion schedule for a Gamma Isotopic analysis.

Stat. Auth.: ORS 453.757

Stats. Implemented: ORS 453.757

Hist.: HD 15-1991, f. & cert. ef. 10-1-91; HD 15-1994, f. & cert. ef. 5-6-94; HD 2-1995(Temp), f. & cert. ef. 7-11-95; HD 4-1995, f. & cert. ef. 9-8-95; PH 11-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 20-2010, f. & cert. ef. 9-1-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

333-105-0530

Training