Unknown. Interim rule and request for comments
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/register/2003/02/26/03-4526A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2003-02-26.xml --- 68 38 Wednesday, February 26, 2003 Contents Agency Agency for Healthcare Research and Quality NOTICES Meetings: Health Care Policy and Research Special Emphasis Panel, 8906-8907 03-4531 Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Food Safety and Inspection Service See Forest Service See Natural Resources Conservation Service American American Battle Monuments Commission RULES Freedom of Information Act; implementation, 8825-8829 03-4080 Animal Animal and Plant Health Inspection Service RULES Plant-related quarantine, domestic:
Mexican fruit fly, 8817-8820 03-4526 Commerce Commerce Department See National Oceanic and Atmospheric Administration See National Telecommunications and Information Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 8876-8877 03-4559 Comptroller Comptroller of the Currency NOTICES National banks: Preemption determinations— National City Bank, N.A., et al.; nonapplication of Georgia Fair Lending Act, 8959-8964 03-4507 Consumer Consumer Product Safety Commission NOTICES Meetings;
Sunshine Act, 8878 03-4658 Defense Defense Department RULES Freedom of Information Act; implementation, 8825 03-4442 Wildfire Suppression Aircraft Transfer Act of 1996; implementation, 8822-8824 03-4443 Education Education Department NOTICES Grants and cooperative agreements; availability, etc.: Special education and rehabilitative services— Experimental and Innovative Training Program, 8969-8973 03-4549 03-4550 Migrant and Seasonal Farmworkers Program; individuals with disabilities, 8878-8879 03-4548 Employment Employment and Training Administration NOTICES Alien temporary employment labor certification process:
Agriculture and logging; adverse effect wage rates, meal charges, and maximum travel subsistence reimbursement, 8929-8930 03-4500 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Meetings: Environmental Management Site-Specific Advisory Board— Oak Ridge Reservation, TN, 8879-8880 03-4530 Natural gas exportation and importation: Berkshire Gas Co. et al., 8880-8881 03-4529 EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States:
California, 8830-8841 03-4376 03-4378 03-4381 03-4383 Kansas, 8845-8847 03-4626 Virginia; correction, 8841-8845 03-4520 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Polymers, low-risk, 8847-8856 03-4384 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: California, 03-4377 8868-8871 03-4382 03-4514 Kansas, 8871 03-4627 NOTICES Agency information collection activities; proposals, submissions, and approvals, 8887-8892 03-4523 03-4524 Confidential business information and data transfer, 8892-8895 03-4249 03-4250 03-4251 Meetings:
Ozone Transport Commission, 8895 03-4519 Pesticide, food, and feed additive petitions: Syngenta Crop Protection, Inc., 8896-8900 03-4386 Pesticides; experimental use permits, etc.: Valent BioSciences Corp., 8900-8901 03-4525 Toxic and hazardous substances control: Endocrine Disruptor Screening Program; chemical selection approach for initial list, 8901-8902 03-4385 Interagency Testing Committee report— Receipt and comment request, 8975-8988 03-4522 Water pollution; discharge of pollutants (NPDES):
Colorado; Federal facility small municipal separate storm sewer systems; storm water discharges; general permit, 8902-8903 03-4521 FAA Federal Aviation Administration PROPOSED RULES Airworthiness directives: Bell, 8862-8864 03-4480 Schweizer Aircraft Corp., 8865-8868 03-4479 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation filings: Consumers Energy Co. et al., 8885-8886 03-4562 Pacific Gas & Electric Co. et al., 8886-8887 03-4561 *Applications, hearings, determinations, etc.:* CenterPoint Energy Gas Transmission Co., 8881 03-4472 Great Lakes Gas Transmission L.P., 8881-8882 03-4467 Honeoye Storage Corp., 8882 03-4469 Iroquois Gas Transmission System, L.P., 8882-8883 03-4471 Kern River Gas Transmission Co., 8883 03-4466 MIGC, Inc., 8883 03-4468 Natural Gas Pipeline Co. of America, 8883-8884 03-4470 PG&E Gas Transmission, Northwest Corp., 03-4463 8884 03-4465 Portland Natural Gas Transmission System, 8884-8885 03-4464 Texas Eastern Transmission, LP, 8885 03-4473 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 8903 03-4558 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies:
Formations, acquisitions, and mergers, 8903-8904 03-4390 FTC Federal Trade Commission NOTICES Meetings: Technologies for protecting personal information, consumer and business experience; workshops, 8904-8906 03-4502 Financial Financial Management Service See Fiscal Service Fiscal Fiscal Service NOTICES Privacy Act: Systems of records, 8964-8965 03-4457 Fish Fish and Wildlife Service NOTICES Boundary establishment, descriptions, etc.: Kodiak National Wildlife Refuge, AK, 8922-8923 03-4527 Food Food and Drug Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 8907-8908 03-4493 Biological product licenses:
Delmont Laboratories, Inc.; revocation hearing, 8908-8910 03-4491 Meetings: Phenoxy Herbicides and Contaminants Possible Long-Term Health Effects Special Studies Advisory Committee, 8910 03-4492 Food Food Safety and Inspection Service PROPOSED RULES Meat, poultry, and egg products inspection services; fee changes, 8858-8860 03-4393 Forest Forest Service NOTICES Environmental statements; availability, etc.: Payette National Forest, ID, 8874 03-4482 Environmental statements; notice of intent:
Caribou-Targhee National Forest, ID, 8874-8875 03-4486 Malheur National Forest, OR; correction, 8967 C3-2836 Meetings: Opal Creek Scenic Recreation Area Advisory Council, 8875 03-4488 Resource Advisory Committees— Glenn/Colusa County, 8875-8876 03-4462 GAO General Accounting Office NOTICES Reports and guidance documents; availability, etc.: Joint Financial Management Improvement Program; Federal Financial Management System Requirements, 8906 03-4528 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Food and Drug Administration Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 8910-8920 03-4447 03-4448 Privacy Act:
Computer matching programs, 8920-8922 03-4445 03-4446 Immigration Immigration and Naturalization Service RULES Emergency Federal law enforcement assistance: State and local law enforcement officers authorized to enforce immigration law during mass influx of aliens; training abbreviation or waiver, 8820-8822 03-4441 NOTICES Immigration: Nonimmigrants registration and monitoring; ports-of-entry designated for departure of aliens subject to special registration Correction, 8967-8968 C3-4130 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Reclamation Bureau IRS Internal Revenue Service PROPOSED RULES Income taxes:
Controlled foreign partnerships; filing requirements, cross-reference; hearing cancellation, 8868 03-4545 Outbound liquidations to foreign corporations; anti-abuse rule; hearing cancellation, 8868 03-4544 NOTICES Agency information collection activities; proposals, submissions, and approvals, 8965-8966 03-4547 Meetings: Taxpayer Advocacy Panels, 8966 03-4414 International International Trade Commission NOTICES Import investigations: Screen printing machines, vision alignment devices, and component parts, 8924-8925 03-4458 Stainless steel plate from— Various countries, 8925-8926 03-4459 Steel wire garment hangers from— China, 8926 03-4460 Justice Justice Department See Immigration and Naturalization Service NOTICES Environmental statements; availability, etc.:
Community Oriented Policing Services— Methamphetamine/Drug Hot Spots Program, 8926-8927 03-4543 Pollution control; consent judgments: Certus, Inc., 8927 03-4541 Hammond, Danny, 8927 03-4542 Labor Labor Department See Employment and Training Administration NOTICES International Labor Affairs Bureau: Chile; labor rights and laws governing exploitative child labor, 8928 03-4499 Land Land Management Bureau NOTICES Environmental statements; availability, etc.: Coos County, OR; natural gas pipeline, 8923 03-4496 Protraction diagram plat filings:
Montana, 8923 03-4485 Legal Legal Services Corporation RULES Legal assistance eligibility; maximum income guidelines Correction, 8856-8857 03-4429 NASA National Aeronautics and Space Administration NOTICES Inventions, Government-owned; availability for licensing, 03-4430 8930-8931 03-4431 03-4432 03-4433 03-4434 03-4435 03-4436 Meetings: Advisory Council Space Science Advisory Committee, 03-4437 8932 03-4438 National Credit National Credit Union Administration PROPOSED RULES Credit unions:
Involuntary liquidation regulation— Swap agreements; treatment as qualified financial contracts in liquidation or conservatorship, 8860-8862 03-4444 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management: Magnuson-Stevens Act provisions— Domestic fisheries; exempted fishing permit applications, 8871-8873 03-4439 03-4440 National Science National Science Foundation NOTICES Agency information collection activities; proposals, submissions, and approvals, 8932-8935 03-4452 03-4453 03-4454 National Telecommunications National Telecommunications and Information Administration NOTICES Electronic Signatures in Global and National Commerce Act:
Exceptions review, 8877 03-4501 NRCS Natural Resources Conservation Service NOTICES Field office technical guides; changes: Michigan, 8876 03-4451 Tennessee, 8876 03-4450 Nuclear Nuclear Regulatory Commission NOTICES *Applications, hearings, determinations, etc.:* BWX Technologies, Inc., 8935-8936 03-4535 Framatome Advanced Nuclear Power, Inc., 8936-8939 03-4533 03-4534 Global Nuclear Fuel-Americas, LLC, 8940-8941 03-4536 Power Resources, Inc., 8941-8942 03-4538 Westinghouse Electric Co., LLC, 8942-8944 03-4537 Postal Postal Service NOTICES Meetings;
Sunshine Act, 8944 03-4692 Public Public Debt Bureau See Fiscal Service Reclamation Reclamation Bureau NOTICES Environmental statements; notice of intent: Humboldt Project Conveyance, NV, 8924 03-4456 Research Research and Special Programs Administration NOTICES Hazardous materials: Applications; exemptions, renewals, etc., 8956-8958 03-4556 03-4557 SEC Securities and Exchange Commission NOTICES Investment Company Act of 1940: Exemption applications— Eaton Vance Variable Trust et al., 8944-8951 03-4503 Order applications— Lincoln National Life Insurance Co. et al., 8951-8955 03-4506 Self-regulatory organizations; proposed rule changes:
Chicago Stock Exchange, Inc., 8955-8956 03-4505 Philadelphia Stock Exchange, Inc., 8956 03-4504 Transportation Transportation Department See Federal Aviation Administration See Research and Special Programs Administration See Transportation Statistics Bureau Transportation Transportation Statistics Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 8958-8959 03-4554 03-4555 Treasury Treasury Department See Comptroller of the Currency See Fiscal Service See Internal Revenue Service Separate Parts In This Issue Part II Education Department, 8969-8973 03-4549 03-4550 Part III Environmental Protection Agency, 8975-8988 03-4522 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 68 38 Wednesday, February 26, 2003 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. 02-129-2] Mexican Fruit Fly; Treatments AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments. SUMMARY: We are amending the Mexican fruit fly regulations to allow the use of irradiation as a treatment for fruits listed as regulated articles. This action will provide an additional option for qualifying those regulated articles for movement from regulated areas. DATES: This interim rule was effective February 20, 2003. We will consider all comments that we receive on or before April 28, 2003. ADDRESSES: You may submit comments by postal mail/commercial delivery or by e-mail.
If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 02-129-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 02-129-2. If you use e-mail, address your comment to *regulations@aphis.usda.gov.* Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 02-129-2” on the subject line.
You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call
(202)690-2817 before coming. APHIS documents published in the **Federal Register** , and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at *http://www.aphis.usda.gov/ppd/rad/webrepor.html.* FOR FURTHER INFORMATION CONTACT: Mr. Stephen A. Knight, Senior Staff Officer, PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1236;
(301)734-8247. SUPPLEMENTARY INFORMATION: The Mexican fruit fly *(Anastrepha ludens)* is a destructive pest of citrus and many other types of fruit. The short life cycle of the Mexican fruit fly allows rapid development of serious outbreaks that can cause severe economic losses in commercial citrus-producing areas. The Mexican fruit fly regulations, contained in 7 CFR 301.64 through 301.64-10 (referred to below as the regulations), were established to prevent the spread of the Mexican fruit fly to noninfested areas of the United States. The regulations impose restrictions on the interstate movement of regulated articles from the regulated areas. We are amending the Mexican fruit fly regulations to include irradiation as a treatment for those fruits that are listed as regulated articles in § 301.64-2(a) of the regulations. Without irradiation, the only treatments for fruit made available by the regulations have been cold treatment, fumigation, or high-temperature forced air, and those treatments have been made available for only some of the fruits listed as regulated articles. The addition of irradiation provides a treatment option for use on those regulated articles for which treatments have been available, as well as for those regulated articles for which no treatments have been listed in the regulations. To accommodate the inclusion of irradiation as an authorized treatment under the Mexican fruit fly regulations, we are amending § 301.64-10, “Treatments,” by adding the irradiation provisions as a new paragraph (g). The provisions we are adding to the Mexican fruit fly regulations for the use of irradiation as a treatment are, for all practical purposes, the same as those provided in § 301.78-10(c) of “Subpart-Mediterranean Fruit Fly” (7 CFR 301.78 through 318.78-10), which provides for the use of irradiation as a treatment for nuts, berries, fruits, and vegetables grown in areas quarantined because of the Mediterranean fruit fly *(Ceratitis capitata)* . The irradiation provisions we have added to the Mexican fruit fly regulations differ from those of § 301.78-10(c) in only two substantive respects:
(1)The pest ( *A. ludens* rather than *C. capitata* ) and commodities for which irradiation is an approved treatment and
(2)the prescribed irradiation dose rate. These two differences are discussed below. With respect to the first difference cited above-the commodities for which irradiation is an authorized treatment-the irradiation provisions we are adding to the Mexican fruit fly regulations will provide for the use of irradiation to treat several commodities that are listed as regulated articles in the Mexican fruit fly regulations that are not also listed as regulated articles under the Mediterranean fruit fly regulations. Those additional commodities are as follows: Cherimoya ( *Annona cherimola* ) Custard apple ( *Annona reticulata* ) Mamey ( *Mammea americana* ) Sapota, Sapodilla ( *Sapotaceae* ) Sargentia, yellow chapote ( *Sargentia greggii* ) Spanish plum, purple mombin or Ciruela ( *Spondias spp.* ) As noted in APHIS' policy statement regarding the application of irradiation to phytosanitary problems (published in the **Federal Register** on May 15, 1996, 61 FR 24433-24439, Docket No. 95-088-1), the U.S. Department of Agriculture's (USDA's) Agricultural Research Service
(ARS)conducted exhaustive research to determine commodity-generic irradiation dose rates that will provide an acceptable level of quarantine security with regard to certain pests. Given that a commodity-generic dose rate has been established for Mexican fruit fly, we believe that it is appropriate to provide the prescribed irradiation treatment as an option for growers of any of the fruits listed as regulated articles in § 301.64-2(a) who wish to obtain certification for the interstate movement of their commodities on the basis of treatment. The second difference cited above pertains to the prescribed irradiation dose rate. The commodity-generic dose rate established by ARS for Mexican fruit fly is 150 Gray (15 krad), so we have established 150 Gray as the prescribed dose rate in the Mexican fruit fly regulations, rather than the 225 Gray (22.5 krad) prescribed in § 301.78-10(c) of the Mediterranean fruit fly regulations. The remaining provisions of § 301.78-10(c) of the Mediterranean fruit fly regulations— *i.e.* , those provisions regarding approved facilities, treatment monitoring, packaging, dosimetry systems, certification based on treatment, recordkeeping, requests for approval and inspection of facilities, denial and withdrawal of approval, and the USDA's non-responsibility for loss or damage resulting from treatment—have been carried over to § 301.64-10(g) of the Mexican fruit fly regulations and serve the same purpose as in § 301.78-10(c). Emergency Action This rulemaking is necessary on an emergency basis to provide an additional option for qualifying regulated articles for movement from regulated areas. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the **Federal Register** . We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the **Federal Register** . The document will include a discussion of any comments we receive and any amendments we are making to the rule. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866. This rule amends the Mexican fruit fly regulations by allowing the use of irradiation as a treatment for fruits listed as regulated articles. This action will provide an additional option for qualifying those regulated articles for movement from regulated areas. This emergency situation makes timely compliance with section 604 of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) impracticable. We are currently assessing the potential economic effects of this action on small entities. Based on that assessment, we will either certify that the rule will not have a significant economic impact on a substantial number of small entities or publish a final regulatory flexibility analysis. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. ( *See* 7 CFR part 3015, subpart V.) Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule:
(1)Preempts all State and local laws and regulations that are inconsistent with this rule;
(2)has no retroactive effect; and
(3)does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), the information collection and recordkeeping requirements included in this interim rule have been submitted for emergency approval to the Office of Management and Budget (OMB). OMB has assigned control number 0579-0215 to the information collection and recordkeeping requirements. We plan to request continuation of that approval for 3 years. Please send written comments on the 3-year approval request to the following addresses:
(1)Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and
(2)Docket No. 02-129-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 02-129-2 and send your comments within 60 days of publication of this rule. This interim rule allows for the use of irradiation as a treatment for those fruits that are listed as regulated articles in § 301.64-2(a) of the regulations. This action provides an additional option for qualifying regulated articles for movement from regulated areas. Any person engaged in the business of growing, handling, or moving regulated articles may enter into a compliance agreement to facilitate the movement of regulated articles under § 301.64-6. The compliance agreement is a written agreement between a person engaged in those previously mentioned activities and Plant Protection and Quarantine, wherein the person agrees to comply with the provisions set forth in § 301.64-6. We are soliciting comments from the public (as well as affected agencies) concerning our information collection and recordkeeping requirements. These comments will help us:
(1)Evaluate whether the information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2)Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; *e.g.* , permitting electronic submission of responses). *Estimate of burden:* Public reporting burden for this collection of information is estimated to average .6399 hours per response. *Respondents:* Growers and State plant regulatory officials. *Estimated annual number of respondents:* 722. *Estimated annual number of responses per respondent:* 1. *Estimated annual number of responses:* 722. *Estimated total annual burden on respondents:* 462 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at
(301)734-7477. Government Paperwork Elimination Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this interim rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at
(301)734-7477. List of Subjects in 7 CFR Part 301 Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, we are amending 7 CFR part 301 as follows: PART 301—DOMESTIC QUARANTINE NOTICES 1. The authority citation for part 301 continues to read as follows: Authority: 7 U.S.C. 7711, 7712, 7714, 7731, 7735, 7751, 7752, 7753, 7754, and 7760; 7 CFR 2.22, 2.80, and 371.3. Section 301.75-15 also issued under Sec. 204, Title II, Pub. L. 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 also issued under Sec. 203, Title II, Pub. L. 106-224, 114 Stat. 400 (7 U.S.C. 1421 note). 2. In § 301.64-10, a new paragraph
(g)is added to read as follows: § 301.64-10 Treatments.
(g)*Approved irradiation treatment.* Irradiation, carried out in accordance with the provisions of this paragraph, is approved as a treatment for any fruit listed as a regulated article in § 301.64-2(a).
(1)*Approved facility.* The irradiation treatment facility and treatment protocol must be approved by the Animal and Plant Health Inspection Service. In order to be approved, a facility must:
(i)Be capable of administering a minimum absorbed ionizing radiation dose of 150 Gray (15 krad) to the fruit; 8 8 The maximum absorbed ionizing radiation dose and the irradiation of food are regulated by the Food and Drug Administration under 21 CFR part 179.
(ii)Be constructed so as to provide physically separate locations for treated and untreated fruit, except that fruit traveling by conveyor directly into the irradiation chamber may pass through an area that would otherwise be separated. The locations must be separated by a permanent physical barrier such as a wall or chain link fence 6 or more feet high to prevent transfer of cartons;
(iii)Complete a compliance agreement with the Animal and Plant Health Inspection Service as provided in § 301.64-6; and
(iv)Be certified by Plant Protection and Quarantine for initial use and annually for subsequent use. Recertification is required in the event that an increase or decrease in radioisotope or a major modification to equipment that affects the delivered dose. Recertification may be required in cases where a significant variance in dose delivery is indicated.
(2)*Treatment monitoring.* Treatment must be carried out under the monitoring of an inspector. This monitoring must include inspection of treatment records and unannounced inspection visits to the facility by an inspector. Facilities that carry out continual irradiation operations must notify an inspector at least 24 hours before the date of operations. Facilities that carry out periodic irradiation operations must notify an inspector of scheduled operations at least 24 hours before scheduled operations. 9 9 Inspectors are assigned to local offices of the Animal and Plant Health Inspection Service, which are listed in telephone directories.
(3)*Packaging.* Fruits and vegetables that are treated within a quarantined area must be packaged in the following manner:
(i)The cartons must have no openings that will allow the entry of fruit flies and must be sealed with seals that will visually indicate if the cartons have been opened. They may be constructed of any material that prevents the entry of fruit flies and prevents oviposition by fruit flies into the fruit in the carton. 10 10 If there is a question as to the adequacy of a carton, send a request for approval of the carton, together with a sample carton, to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Oxford Plant Protection Center, 901 Hillsboro St., Oxford, NC 27565.
(ii)The pallet-load of cartons must be wrapped before it leaves the irradiation facility in one of the following ways:
(A)With polyethylene sheet wrap;
(B)With net wrapping; or
(C)With strapping so that each carton on an outside row of the pallet load is constrained by a metal or plastic strap.
(iii)Packaging must be labeled with treatment lot numbers, packing and treatment facility identification and location, and dates of packing and treatment.
(4)*Dosage.* The fruits and vegetables must receive a minimum absorbed ionizing radiation dose of 150 Gray (15 krad). 11 11 See footnote 8.
(5)*Dosimetry systems.*
(i)Dosimetry mapping must indicate the dose needed to ensure the fruit will receive the minimum dose prescribed.
(ii)Absorbed dose must be measured using an accurate dosimetry system that ensures that the absorbed dose meets or exceeds 150 Gray (15 krad).
(iii)When designing the facility's dosimetry system and procedures for its operation, the facility operator must address guidance and principles from American Society for Testing and Materials
(ASTM)standards. 12 12 Designation ISO/ASTM 51261-2002(E), “Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing,” American Society for Testing and Materials, *Annual Book of ASTM Standards.*
(6)*Records.* Records or invoices for each treated lot must be made available for inspection by an inspector during normal business hours (8 a.m. to 4:30 p.m., Monday through Friday, except holidays). An irradiation processor must maintain records as specified in this section for a period of time that exceeds the shelf life of the irradiated food product by 1 year, and must make these records available for inspection by an inspector. These records must include the lot identification, scheduled process, evidence of compliance with the scheduled process, ionizing energy source, source calibration, dosimetry, dose distribution in the product, and the date of irradiation.
(7)*Request for approval and inspection of facility.* Persons requesting approval of an irradiation treatment facility and treatment protocol must submit the request for approval in writing to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Oxford Plant Protection Center, 901 Hillsboro St., Oxford, NC 27565. Before the Administrator determines whether an irradiation facility is eligible for approval, an inspector will make a personal inspection of the facility to determine whether it complies with the standards of paragraph (g)(1) of this section.
(8)*Denial and withdrawal of approval.*
(i)The Administrator will withdraw the approval of any irradiation treatment facility when the irradiation processor requests in writing the withdrawal of approval.
(ii)The Administrator will deny or withdraw approval of an irradiation treatment facility when any provision of this section is not met. Before withdrawing or denying approval, the Administrator will inform the irradiation processor in writing of the reasons for the proposed action and provide the irradiation processor with an opportunity to respond. The Administrator will give the irradiation processor an opportunity for a hearing regarding any dispute of a material fact, in accordance with rules of practice that will be adopted for the proceeding. However, the Administrator will suspend approval pending final determination in the proceeding, if he or she determines that suspension is necessary to prevent the spread of any dangerous insect infestation. The suspension will be effective upon oral or written notification, whichever is earlier, to the irradiation processor. In the event of oral notification, written confirmation will be given to the irradiation processor within 10 days of the oral notification. The suspension will continue in effect pending completion of the proceeding and any judicial review of the proceeding.
(9)*Department not responsible for damage.* This treatment is approved to assure quarantine security against Mediterranean fruit fly. From the literature available, the fruits authorized for treatment under this section are believed tolerant to the treatment; however, the facility operator and shipper are responsible for determination of tolerance. The Department of Agriculture and its inspectors assume no responsibility for any loss or damage resulting from any treatment prescribed or supervised. Additionally, the Nuclear Regulatory Commission is responsible for ensuring that irradiation facilities are constructed and operated in a safe manner. Further, the Food and Drug Administration is responsible for ensuring that irradiated foods are safe and wholesome for human consumption. (Approved by the Office of Management and Budget under control number 0579-0215.) Done in Washington, DC, this 20th day of February 2003. Bobby R. Acord, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 03-4526 Filed 2-25-03; 8:45 am]
Connectionstraces to 8
9 references not yet in our index
- 7 CFR 301
- 7 CFR 301.64
- 7 CFR 301.78
- 7 CFR 3015
- 7 CFR 2.22
- Pub. L. 106-113
- Pub. L. 106-224
- 114 Stat. 400
- 21 CFR 179
Citation graph
cites case law
Unknown
Interim rule and request for comments
Cite7 CFR 301
Cite7 CFR 301.64
Cite7 CFR 301.78
Cite7 CFR 3015
Cites 17 · showing 12Cited by 0 across 0 sources