Unknown. Notice of availability of policy statement
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/register/2007/03/29/07-1536A 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-2007-03-29.xml --- 72 60 Thursday, March 29, 2007 Contents Agricultural Agricultural Marketing Service RULES Cranberries grown in Massachusetts, et al., 14651-14654 E7-5791 Potatoes (Irish) grown in Colorado, 14654-14657 E7-5817 Spearmint oil produced in Far West, 14657-14662 E7-5811 PROPOSED RULES Avocados grown in Florida, 14709 E7-5788 Nectarines and peaches grown in California, 14710-14712 E7-5789 NOTICES Agency information collection activities; proposals, submissions, and approvals, 14767 E7-5793 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Forest Service See Rural Business-Cooperative Service See Rural Utilities Service Animal Animal and Plant Health Inspection Service RULES Plant pests:
Regulated genetically engineered plant materials; low-level presence; policy statement, 14649-14651 07-1536 NOTICES Agency information collection activities; proposals, submissions, and approvals, 14767-14769 E7-5780 E7-5781 Army Army Department NOTICES Environmental statements; availability, etc.: Fort Bliss, TX and NM; land and airspace use; correction, 14864 C7-1432 Patent licenses; non-exclusive, exclusive, or partially exclusive: Multiple pass Faraday rotation amplifier; correction, 14864 C7-1276 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Census Census Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 14777-14778 E7-5726 Commerce Commerce Department See Census Bureau See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-5722 E7-5723 14776-14777 E7-5724 E7-5727 CITA Committee for the Implementation of Textile Agreements NOTICES Textile and apparel categories:
Dominican Republic-Central America Free Trade Agreement; commercial availability— 2-way stretch woven fabrics; correction, 14779 07-1555 Commodity Commodity Futures Trading Commission PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 Comptroller Comptroller of the Currency PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 Defense Defense Department See Army Department See Defense Logistics Agency NOTICES Meetings;
Sunshine Act, 14779-14781 07-1559 07-1561 Defense Defense Logistics Agency NOTICES Environmental statements; availability, etc.: Privatization of packaged petroleum, oils and lubricants and certain chemicals, 14781 07-1531 Drug Drug Enforcement Administration NOTICES *Applications, hearings, determinations, etc.:* Roche Diagnostics Operations, Inc., 14832 E7-5777 Election Election Assistance Commission NOTICES Meetings; Sunshine Act, 14781 07-1576 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Electricity export and import authorizations, permits, etc.:
CMS Energy Resource Management Co., 14781-14782 E7-5785 DTE Energy Trading, Inc., 14782-14783 E7-5782 EPA Environmental Protection Agency RULES Air programs: Fuels and fuel additives— East St. Louis; reformulated gasoline program extension; withdrawn, 14681 E7-5808 Air quality implementation plans; approval and promulgation; various States: Indiana, 14678-14681 E7-5655 Toxic substances: Significant new uses— 2-Thiazolidinone, etc., 14681-14708 E7-5797 PROPOSED RULES Air pollutants, hazardous; national emission standards:
Risk and technology review (Phase II, Group 2), 14734-14750 E7-5805 Air quality implementation plans; approval and promulgation; various States: Indiana, 14728-14729 E7-5654 Ohio, 14729-14734 E7-5809 NOTICES Air pollution control: Citizens suits; proposed settlements— Sierra Club, 14801-14803 E7-5799 Committees; establishment, renewal, termination, etc.: Science Advisory Board, 14804-14805 E7-5810 Meetings: Commodity-grade mercury; non-Federal supplies management; stakeholder panel process, 14805-14807 E7-5813 Reports and guidance documents; availability, etc.:
Great Lakes and New England Regions; combined sewer overflow; potential impacts of climate change; screening, 14803-14804 E7-5803 Great Lakes Region; publicly-owned treatment works; water quality-based effluent limits implementation costs; potential impacts of climate change; screening, 14807-14808 E7-5798 Toxic and hazardous substances control: Integrated Risk Information System— Nitrobenzene; toxicological review, 14808-14810 E7-5801 Executive Executive Office of the President See Presidential Documents FAA Federal Aviation Administration RULES Airworthiness directives:
Raytheon Correction, 14864 C7-1106 Practice and procedure: Civil penalty actions; technical amendment, 14668-14669 07-1524 PROPOSED RULES Airworthiness directives: Airbus, 14715-14718 E7-5666 Boeing, 14719-14721 E7-5667 Bombardier, 14721-14724 E7-5668 Rolls-Royce Corp., 14724-14727 E7-5775 FDIC Federal Deposit Insurance Corporation PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 Federal Election Federal Election Commission RULES Compliance procedures:
Administrative fines challenges; best efforts, 14662-14668 E7-5730 Federal Energy Federal Energy Regulatory Commission NOTICES Complaints filed: Tesoro Refining and Marketing Co., et al., 14789 E7-5761 Dockets: Unassigned gas docket numbers, 14789 E7-5772 Electric rate and corporate regulation combined filings, 14790-14791 E7-5773 Environmental statements; availability, etc.: Santee Cooper Hydroelectric Project, E7-5697 14791-14792 E7-5768 Hydroelectric applications, 14792-14801 E7-5698 E7-5767 E7-5771 Meetings:
Wholesale power markets competition; conference, 14801 E7-5755 *Applications, hearings, determinations, etc.:* Alliance Pipeline, L.P., 14783 E7-5701 Brookfield Asset Management, Inc., et al., 14783 E7-5759 CenterPoint Energy Gas Transmission Co., 14783-14784 E7-5704 Colorado Interstate Gas Co., 14784 E7-5756 Columbia Gas Transmission Corp., 14784-14785 E7-5757 Duke Energy Carolinas, LLC, E7-5769 14785-14786 E7-5770 Duke Energy Shared Services, Inc., et al., 14786 E7-5700 Entergy Nuclear Palisades, LLC, 14786 E7-5760 EXCO Resources, Inc., et al., 14786-14787 E7-5693 Northern Natural Gas Co., 14787 E7-5703 Northwest Pipeline Corp., 14787 E7-5694 Paiute Pipeline Co., 14788 E7-5692 SemGas Storage, L.L.C., 14788-14789 E7-5758 Williston Basin Interstate Pipeline Co., 14789 E7-5702 Federal Railroad Federal Railroad Administration NOTICES Exemption petitions, etc.:
Royal Gorge Route Railroad, 14849 E7-5746 Wallowa Union Railroad, 14849-14850 E7-5747 Railroad safety: Locomotive horns use at highway-rail grade crossings; sounding requirements; nationwide significant risk threshold adjustment, 14850 E7-5617 Traffic control systems; discontinuance or modification: Union Pacific Railroad Co., 14850-14851 E7-5745 Federal Reserve Federal Reserve System PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 NOTICES Banks and bank holding companies:
Formations, acquisitions, and mergers, 14810 E7-5794 Permissible nonbanking activities, 14810 E7-5795 FTC Federal Trade Commission PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 NOTICES Agency information collection activities; proposals, submissions, and approvals, 14810-14814 E7-5818 E7-5819 Privacy Act; systems of records, 14814-14815 E7-5821 Federal Transit Federal Transit Administration NOTICES Reports and guidance documents; availability, etc.:
Elderly Individuals and Individuals with Disabilities, Job Access and Reverse Commute, and New Freedom Programs; final circulars, 14851-14861 E7-5734 Fish Fish and Wildlife Service RULES Endangered and threatened species: Findings on petitions, etc.— Grizzly bears; Yellowstone distinct population segment, 14866-14938 07-1474 PROPOSED RULES Endangered and threatened species: Findings on petitions, etc.— Siskiyou Mountains salamander and Scott Bar salamander, 14750-14759 E7-5774 Gray wolf; comment extension, 14760-14761 E7-5744 Food Food and Drug Administration RULES Human drugs:
Laxative products (OTC)— Psyllium ingredients in granular dosage forms, 14669-14674 E7-5740 NOTICES Biological products: Patent extension; regulatory review period determinations— RETEVASE, 14818-14819 E7-5736 Human drugs: Patent extension; regulatory review period determinations— VAPRISOL, 14819-14820 E7-5737 Meetings: Feed contaminants; animal and human health; ranking method, 14820-14821 E7-5820 Women's Health Information Sharing Network; workshop, 14822 07-1546 Forest Forest Service NOTICES Environmental statements; notice of intent:
Sawtooth National Forest, ID, 14769-14770 07-1533 Health Health and Human Services Department See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Meetings: American Health Information Community, 07-1539 14815-14816 07-1540 07-1541 07-1542 National Toxicology Program: Toxicological study nominations; comment request; clarification, 14816-14818 E7-5831 Homeland Homeland Security Department See National Communications System See U.S.
Citizenship and Immigration Services Housing Housing and Urban Development Department PROPOSED RULES Public and indian housing: Indian Housing Block Grant Program; annual performance report due date extension, 15002-15003 E7-5738 NOTICES Agency information collection activities; proposals, submissions, and approvals, 14827-14828 E7-5731 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau IRS Internal Revenue Service RULES Income taxes: Corporate reorganizations; additional distributions guidance Correction, 14678 E7-5603 Simplified service cost method and simplified production method, 14675-14678 E7-5732 NOTICES Inflation adjustment factor and reference prices:
Renewable electricity production and refined coal production credit, 14862-14863 E7-5733 International International Trade Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 14778-14779 E7-5725 North American Free Trade Agreement (NAFTA); binational panel reviews: Oil country tubular goods from— Mexico, 14779 E7-5742 International International Trade Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 14830 E7-5822 Justice Justice Department See Drug Enforcement Administration NOTICES Pollution control; consent judgments:
Charles E. Carlson, et al., 14830-14831 07-1527 Hayes Lemmerz International, Inc., et al., 14831 07-1526 PPL Montana, LLC, et al., 14831-14832 07-1528 Labor Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Environmental statements; notice of intent: South Gillette Area, WY; public scoping meetings, 14828-14830 07-1566 National Communications National Communications System NOTICES Meetings: National Security Telecommunications Advisory Committee; canceled, 14827 E7-5830 National Credit National Credit Union Administration PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:
Arts and the Humanities, President's Committee, 14834 E7-5653 Humanities Panel, 14834-14835 E7-5786 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 14822 E7-5832 Meetings: National Heart, Lung, and Blood Institute, 07-1548 14822-14823 07-1550 National Human Genome Research Institute, 14823 07-1547 National Institute of Allergy and Infectious Diseases, 14823 07-1553 National Library of Medicine, 14823-14824 07-1551 Scientific Review Center, 07-1549 14824-14825 07-1552 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management:
Alaska; fisheries of Exclusive Economic Zone— North Pacific groundfish, 14764-14766 E7-5826 Western Pacific fisheries— Bigeye and yellowfin tuna, 14761-14764 E7-5825 Nuclear Nuclear Regulatory Commission PROPOSED RULES Rulemaking petitions: Project on Government Oversight and Union of Concerned Scientists, 14713-14715 07-1543 Occupational Occupational Safety and Health Administration PROPOSED RULES Construction safety and health standards: Excavation standard; regulatory review, 14727-14728 E7-5609 NOTICES Agency information collection activities; proposals, submissions, and approvals, 14832-14833 E7-5779 Personnel Personnel Management Office NOTICES Excepted service; positions placed or revoked, 14835-14837 E7-5778 Presidential Presidential Documents PROCLAMATIONS *Special observances:* Education and Sharing Day, U.S.A.
(Proc. 8116), 15005-15008 07-1587 Rural Rural Business-Cooperative Service PROPOSED RULES Rural Business Investment Program; administrative provisions, 14712-14713 07-1530 RUS Rural Utilities Service PROPOSED RULES Rural Business Investment Program; administrative provisions, 14712-14713 07-1530 NOTICES Grants and cooperative agreements; availability, etc.: Household Water Well System Grant Program, 14770-14776 E7-5751 SEC Securities and Exchange Commission PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 NOTICES Self-regulatory organizations; proposed rule changes:
Chicago Board Options Exchange, Inc., 14837-14839 E7-5815 Fixed Income Clearing Corp., 14839-14841 E7-5752 National Association of Securities Dealers, Inc., 14841-14842 E7-5814 New York Stock Exchange LLC, 14842-14844 E7-5816 Options Clearing Corp., 14844-14845 E7-5753 Social Social Security Administration RULES Freedom of Information Act; implementation: Technical correction, 14669 E7-5494 NOTICES Agency information collection activities; proposals, submissions, and approvals, 14845-14847 E7-5728 Meetings:
Ticket to Work and Work Incentives Advisory Panel, 14847-14848 E7-5729 State State Department NOTICES Committees; establishment, renewal, termination, etc.: International Economic Policy Advisory Committee, 14848 E7-5806 Meetings: Democracy Promotion Advisory Committee, 14848 E7-5807 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 14825-14827 E7-5796 Surface Surface Transportation Board NOTICES Railroad services abandonment:
CSX Transportation, Inc., 14861-14862 E7-5472 TVA Tennessee Valley Authority NOTICES Meetings; Sunshine Act, 14849 07-1569 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Thrift Thrift Supervision Office PROPOSED RULES Privacy of consumer financial information; model privacy form, 14940-15000 07-1476 Transportation Transportation Department See Federal Aviation Administration See Federal Railroad Administration See Federal Transit Administration See Surface Transportation Board Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service See Thrift Supervision Office MISSING FOR:
U.S. Citizenship and Immigration Services U.S. Citizenship and Immigration Services NOTICES Agency information collection activities; proposals, submissions, and approvals, 14827 E7-5783 Veterans Veterans Affairs Department NOTICES Meetings: CARES Business Plan Studies Advisory Committee, 14863 07-1529 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 14866-14938 07-1474 Part III Commodity Futures Trading Commission; Federal Deposit Insurance Corporation;
Federal Reserve System; Federal Trade Commission; National Credit Union Administration; Securities and Exchange Commission; Treasury Department, Comptroller of the Currency; Treasury Department, Thrift Supervision Office, 14940-15000 07-1476 Part IV Housing and Urban Development Department, 15002-15003 E7-5738 Part V Executive Office of the President, Presidential Documents, 15005-15008 07-1587 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. 72 60 Thursday, March 29, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 340 [Docket No. APHIS-2006-0167] APHIS Policy on Responding to the Low-Level Presence of Regulated Genetically Engineered Plant Materials AGENCY:
Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability of policy statement. SUMMARY: This notice describes the Animal and Plant Health Inspection Service's (APHIS) policy for responding to low-levels of regulated genetically engineered plant materials which may occur in commercial seeds or grain. This notice is intended to provide clarification for the public and developers of genetically engineered plants on APHIS' response to such situations. The policy statement does not confer any rights upon or create any rights for any person and does not operate to bind APHIS or the public, nor does it address how other Federal agencies might respond to such situations.
ADDRESSES: Copies of the policy statement are available on the Internet at *http://www.aphis.usda.gov/biotechnology/current_initiatives.shtml* . Copies may also be obtained by contacting Dr. John Turner, Director, Policy Division, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1238;
(301)734-8365. FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, Policy Division, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1238;
(301)734-8365. SUPPLEMENTARY INFORMATION: Background APHIS works to protect America's agriculture and environment using a science-based regulatory framework that allows for the safe development and use of genetically engineered
(GE)plants. Under the authority of the Plant Protection Act 1 (PPA), APHIS regulates the introduction (importation, interstate movement, and field release) of GE organisms in order to prevent direct or indirect risks to plant health and the environment. 1 The Plant Protection Act is found at 7 U.S.C. 7701 *et seq.* APHIS' biotechnology regulations are found at 7 CFR part 340. Genetic engineering is a method used to introduce new traits into plants by moving genes from one or more organism(s) into a second organism. GE plants that can tolerate herbicides, resist insects or viruses, or enhance nutrition and provide other health or environmental benefits are examples of crops currently being grown and tested. Plant breeding may occasionally result in low-level mixing of genes and gene products from unintended plant sources. This is true for both conventionally bred plants as well as biotechnology-derived plants. These occurrences can result from natural processes such as the movement of seeds or pollen, or human-mediated processes associated with field testing, plant breeding, or seed production. The mixing of low levels of GE plant materials may result in unauthorized introductions of regulated materials in, for example, commercial seeds and grain. The potential for these occurrences may increase with the expansion of GE crop research, development, and use. This document is intended to describe how APHIS protects agriculture and the environment by responding to situations involving a low-level mixing with commercial seeds and grains of genes and gene products from GE plants subject to regulation by APHIS under 7 CFR part 340. Overview of the APHIS Regulatory System for GE Plants A developer wishing to introduce a new GE plant must obtain APHIS' authorization before proceeding. Depending on the nature of the GE plant, the developer files either a notification or a permit application with APHIS. With either process, the developer must adhere to APHIS regulations and requirements to ensure, through appropriate measures, confinement of the regulated material. An applicant must submit required information on the movement, importation, or field release, which APHIS scientists review to determine whether to authorize the applicant's request. To ensure compliance with the permit or notification conditions, APHIS performs targeted inspections and audits of field tests using the relative risk of each type of trial to determine the frequency and number of inspections performed. For example, for sites where developers are cultivating GE plants engineered to produce pharmaceutical and industrial proteins, APHIS generally inspects seven times throughout field testing, including before, during, and after the field trial. APHIS also maintains oversight of the movement of regulated plants to and from field trial locations. Regulated plants must be transported according to the regulations and as described in the permit. The methods of transport are subject to verification by inspectors at the receiving facility. This permitting and notification system is designed to restrict introductions of GE plants and plant materials as long as they are regulated by the Agency. Permits are generally more restrictive than notifications and are used for any type of GE plant that may pose an elevated risk to plant health or the environment or for which APHIS has less regulatory experience and familiarity, such as plants engineered to produce pharmaceutical or industrial compounds. In addition to detailed information on the biological properties of the GE plant, the permit applicant also must provide detailed descriptions of how field tests will be performed, including specific measures for ensuring confinement and reducing any potential risk that may be associated with the GE plant. Using this information, APHIS scientists create a set of permit conditions that applicants must meet when conducting approved field trials or transporting the GE plants. Most GE plants qualify for, and are field tested under, the notification process. The notification process is used only for plants and traits with which APHIS has a great deal of regulatory experience and familiarity and that do not pose an elevated risk for plant health or the environment. To qualify for the notification process, a plant or trait must meet six safety-related eligibility criteria that center on the plant's potential to pose a risk to plant health or the environment. To ensure confinement, the developer must perform the field test in a way that meets performance standards that are specified in APHIS' regulations. 2 If a GE plant does not meet the criteria for notification, the applicant must follow the permitting process. 2 Performance standards are found at 7 CFR 340.3(c). After a GE plant has been field-tested extensively and the developer can show that the GE plant does not pose a plant pest risk, the developer may file a petition for deregulation. The developer must submit extensive information about the plant's biology and field test results. After conducting an environmental assessment
(EA)or an environmental impact statement
(EIS)and seeking public comment, APHIS may approve a petition for deregulation if it reaches the conclusion that the GE plant does not pose a plant pest risk. 3 Alternatively, an extension process can be used in cases where the GE plant is similar to a previously deregulated plant. The extension process, which was established in 1997 and has been used numerous times since, is based on the premise that a GE plant that is similar to a previously deregulated plant with respect to plant genotype and the expressed protein(s) is also similar in terms of any potential risk. Based on a thorough review of information in the extension request, which includes data showing similarity, APHIS may conclude that the new GE plant, like the previously deregulated GE plant, does not pose a plant pest risk and therefore will no longer be regulated. 4 3 Deregulation requirements are found at 7 CFR 340.6. 4 Regulatory authority to conduct extension requests is found at 7 CFR 340.6(e). APHIS' Future Biotechnology Regulations APHIS continually evaluates its policies and regulations and makes changes as necessary as the complexity and scope of biotechnology continue to grow. One of the key changes has been the strengthening of the requirements for the field testing of certain GE plants. As announced in a notice in the **Federal Register** on January 23, 2004 (Docket No. 03-031-2; 69 FR 3271-3272) and in a January 2004 USDA press release, 5 APHIS is preparing a draft EIS to evaluate the current regulatory system and analyze several possible changes in order to keep pace with science and to more fully utilize the authority provided by the PPA. APHIS will solicit public comments on the possible changes analyzed in the draft EIS. In any event, APHIS will continue to regulate each GE plant in a manner that is proportionate to the risks associated with that GE plant. 5 USDA Press Release, “USDA Announces First Steps to Update Biotechnology Regulations,” January 22, 2004. Interagency Coordination on Low Level Presence APHIS works in concert with the U.S. Department of Health and Human Services' Food and Drug Administration
(FDA)and the U.S. Environmental Protection Agency
(EPA)to provide regulatory oversight of the development of GE organisms, consistent with the Coordinated Framework for Regulation of Biotechnology 6 , adopted in 1986. The Coordinated Framework is a comprehensive Federal regulatory policy for ensuring the safety of biotechnology research and products. APHIS is responsible for protecting agriculture and the environment. FDA has primary responsibility for ensuring the safety of food (including food for animals). EPA regulates pesticides to ensure they can be used without unreasonable adverse effects on the environment, and to ensure public safety from the use of pesticides, including the residue of pesticides on food and animal feed. 6 Coordinated Framework for Regulation of Biotechnology, 51 FR 23302, June 26, 1986. The biological conditions of plant breeding, whether with conventional or GE plants, are such that there is a potential for low levels of genes and gene products to occasionally move beyond confined research sites into commercial seeds and grain that enter commerce. Recognizing this fact, the Federal Government, in an August 2002 notice in the **Federal Register** , 7 proposed measures aimed at strengthening the controls for preventing low levels of regulated materials from GE plants from entering commerce until appropriate safety standards have been met. The proposed actions to be taken by the three agencies were based on three fundamental principles: 7 Proposed Federal Actions To Update Field Test Requirements for Biotechnology Derived Plants and To Establish Early Food Safety Assessments for New Proteins Produced by Such Plants, 67 FR 50578, August 2, 2002. • The level of confinement for a field test must be consistent with the level of risk associated with the introduced protein or trait; • Field test confinement measures must be rigorous to restrict the low-level occurrence in commerce for those traits or proteins that present an unacceptable or unknown risk; and • Regardless of risk, field test requirements should minimize out-crossing and commingling of seed. Since the 2002 notice, FDA issued guidance for industry on early food safety assessments of new nonpesticidal proteins produced by new plant varieties intended for food use, 8 and EPA clarified its guidance for field testing of plant-incorporated protectants (pesticides intended to be produced and used in a living plant). 9 APHIS strengthened its field testing requirements for plants producing pharmaceutical or industrial compounds to ensure that regulated material from these plants is not found, even at low levels, in commerce. In addition, as discussed above, APHIS has initiated a process to amend its biotechnology regulations under 7 CFR part 340. As part of that process, the Agency will consider establishing new criteria to determine whether low levels of regulated materials would be acceptable in commercial seeds and grain based on risks to plant health, public health and the environment. 8 FDA issued its guidance in June 2006, which can be found at *http://www.cfsan.fda.gov/~dms/bioprgu2.html#ftn7* . 9 EPA released its draft guidance on September 29, 2006, which can be found at *http://www.epa.gov/fedrgstr/EPA-PEST/2006/September/Day-29/p16072.htm* . Through practical experience, APHIS has developed a policy based on current regulations for responding to the low-level presence of regulated materials in commercial seeds and grain. This policy provides the foundation for Agency actions in these cases. For purposes of transparency, this policy is set forth below for the public. APHIS Policy on Responding to the Low-Level Presence of Regulated GE Plant Materials APHIS requirements for both permits and notifications minimize the likelihood that regulated GE plant materials will occur in commercial seeds and grain. APHIS' policy is to respond to occurrences of regulated materials in commercial seeds and grain with remedial action that is appropriate to the level of risk and warranted by the facts in each case. In every such case, APHIS will initiate an inquiry to determine the circumstances surrounding the release, evaluate the risk attendant to the release, and determine what regulatory actions, including remedial and enforcement actions, are required. If APHIS determines that action is not necessary to mitigate low-level presence of a regulated material in commerce to protect plant health or the environment, this determination does not preclude enforcement action against a company or individual for violation of APHIS regulations. APHIS will investigate and take appropriate enforcement action whenever regulated materials are detected in commerce. APHIS coordinates closely with EPA and FDA on investigations, risk evaluations, and the determination of what remediation measures, if any, will be necessary. This cooperation is crucial and helps to ensure that there are no unresolved safety issues. Any regulatory action taken by APHIS will not preclude FDA or EPA from pursuing action under their own authorities, as necessary, to ensure the safety of food as well as to protect human health and the environment from the sale, distribution, or use of any pesticide. APHIS has authority under the PPA to take or order remedial measures which include the authority to hold, seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of regulated materials if it is determined that such measures are necessary to prevent the dissemination of a plant pest within or throughout the United States. 10 Any remedial action taken would be determined on a case-by-case basis. Key considerations include the extent of the occurrence, the nature of the regulated material, as well as any potential risks to plant health or the environment. In any case where APHIS determines that an incident involving a GE plant would result in the introduction or dissemination of material that could pose a threat to plant health or the environment, remediation measures will be required. It is important to note that, due to the strict requirements that APHIS has developed in recent years for GE plants that pose elevated risks, such occurrences would be unlikely. 10 See 7 U.S.C. 7714; 7 CFR 340.0(b). There are two principal situations in which APHIS may determine that action under the PPA was not necessary. Even though remedial measures would not generally be applied in these two situations, applicants field testing these types of plants must be authorized through either notifications or permits and must follow all APHIS requirements. The first situation would be when the regulated material is derived from plants that meet all of the criteria to qualify for APHIS' notification process. The six eligibility requirements are: 11 11 The specific criteria for GE crops planted under notification are found at 7 CFR 340.3. • The plant must not be listed on the Federal Noxious Weed list or be considered a weed in the area of proposed release. • The introduced genetic material must be stably integrated, which means the introduced DNA must remain inside the living cell and replicate only with the plant DNA. • The function of the introduced genetic material is known, and its presence in the regulated article does not result in a plant disease. • The introduced genetic material does not cause the production of an infectious entity, produce substances that are known to be, or are likely to be, toxic to nontarget organisms, or produce products intended for pharmaceutical or industrial use. • The introduced genetic sequences derived from plant viruses do not pose a significant risk of creating a new plant virus. • The plant has not been modified to contain certain genetic material derived from animal or human pathogens. In addition, plants containing coding sequences whose products are known agents of diseases in humans or nontarget animals are not eligible. The majority of GE plants field tested under APHIS regulations qualify for the notification process because they present minimal risk to plant health and the environment. Many of the plants that have been engineered for common traits such as pest resistance, herbicide tolerance, male sterility, and improved product quality such as delayed fruit ripening meet the criteria for notification. APHIS has extensive experience with these types of plants and has overseen thousands of field tests involving them. The second situation in which APHIS may not take remedial action is if the GE plant is similar to another GE plant that has already been deregulated by APHIS with respect to both plant genotype and any novel protein(s) expressed. APHIS will carefully assess the GE plant material, including the plant genotype, the introduced genes, and any proteins produced. When these are sufficiently similar to those of a previously deregulated plant, APHIS is able to conclude confidently that, like the previously deregulated plant, the new GE plant poses no significant safety risk to plant health or the environment, and thus, remedial action may not be necessary. Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. Done in Washington, DC, this 26th day of March 2007. Bruce Knight, Under Secretary for Marketing and Regulatory Programs. [FR Doc. 07-1536 Filed 3-27-07; 2:00 pm]
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8 references not yet in our index
- 7 CFR 340
- 7 CFR 340.3(c)
- 7 CFR 340.6
- 7 CFR 340.6(e)
- 7 CFR 340.0(b)
- 7 CFR 340.3
- 7 USC 7701-7772
- 7 CFR 2.22
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Notice of availability of policy statement
Cite7 CFR 340
Cite7 CFR 340.3(c)
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