07-3474. Introduction of Organisms and Products Altered or Produced Through Genetic Engineering

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability of draft environmental impact statement and request for comments.

SUMMARY:

We are evaluating our regulatory program to determine whether we should revise our regulations regarding the importation, interstate movement, and environmental release of genetically engineered organisms. We are seeking public comment on the draft environmental impact statement (DEIS) we have prepared relative to the regulatory revisions we are considering. The DEIS evaluates the alternatives we have identified in terms of their potential effects on the human environment compared to the effects of our current regulatory program. We believe our ongoing evaluation of these alternatives would benefit from the submission of additional views and data from the public, and we are especially interested in receiving comments on the subset of DEIS alternatives described in this notice.

DATES:

We will consider all comments that we receive on or before September 17, 2007.

ADDRESSES:

You may submit comments addressing the draft environmental impact statement by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0112 to submit or view public comments and to view supporting and related materials, including the DEIS, that are available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0112, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0112.

Issues in the DEIS are organized using 10 numbered issue areas developed through the scoping process. When possible, please relate each point in your comment to one of these 10 issue areas.

Public Meetings: APHIS intends to hold public meetings to encourage additional public comment on the DEIS. The locations and dates of the public meetings will be announced on the APHIS Web site (http://www.aphis.usda.gov/​brs/​brs_​meetings.html) and in a future Federal Register notice.

Reading Room: You may read any comments that we receive on this notice and the DEIS 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 [phone] before coming.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Dr. Michael Wach, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone].

SUPPLEMENTARY INFORMATION:

Background

Under the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.), the Secretary of Agriculture may prohibit or restrict the importation, entry, or movement in interstate commerce of any plant, plant product, biological control organism, noxious weed, article, or means of conveyance, if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or the dissemination of a plant pest or noxious weed into the United States. The Secretary's authority under the PPA has been delegated to the Administrator of the Animal and Plant Health Inspection Service (APHIS).

Under that authority, APHIS administers regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests” (referred to below as the regulations). The regulations govern the introduction (importation, interstate movement, or release into the environment) of any organism or product altered or produced through genetic engineering that is a plant pest or that there is reason to believe may be a plant pest, or any product that contains such an organism that is unclassified and/or whose classification is unknown. The regulations refer to such genetically engineered organisms as “regulated articles.”

Current APHIS Regulations

Current APHIS regulations for genetically engineered organisms are based on authority in the PPA to regulate the introduction of organisms that are plant pests or for which there is reason to believe may be plant pests. Applicants must submit required information for review by APHIS scientists who evaluate the potential risks posed by the introduction and the procedures that the applicant will use to minimize those risks. Depending on the nature of the genetically engineered organism, an applicant applies for either a permit or a notification. APHIS authorizes introductions after considering the organism, the nature of the genetic engineering, and the ways in which the genetically engineered organism is likely to interact with the environment.

A notification is a more streamlined authorization process that is used only for plants with traits considered to be low risk. To qualify for a notification, the genetically engineered plant must meet strict eligibility requirements to ensure that it poses a minimal plant pest risk. The genetically engineered plant must also be grown under conditions designed to meet performance standards ensuring confinement of the regulated material. The remaining organisms—including plants that are genetically engineered to produce pharmaceutical or industrial compounds—are subject to the permitting process.

The permit process is designed to ensure the safe introduction of any genetically engineered organism over which APHIS has authority. All required information submitted in a permit application is reviewed by APHIS scientists. Permits will prescribe confinement conditions and standard operating procedures tailored on a case-by-case basis to maintain confinement of the genetically engineered organism throughout the course of the introduction. APHIS requires that all plants genetically engineered to produce pharmaceutical or industrial compounds be grown under extremely strict management protocols. These plants are required to be grown in a way that maintains confinement of the plant to the release area, with additional precautions taken to prevent the escape of pollen, seeds, or plant parts from the field test site.

After a genetically engineered organism has been field tested extensively and the developer demonstrates that the organism does not pose a plant pest risk, the developer may request the deregulation of the organism by filing a petition for a “determination of nonregulated status.” After the applicant submits the required data and it has been carefully evaluated, APHIS prepares an environmental assessment or, if warranted, an environmental impact statement (EIS) to analyze the potential impacts the plant may have on the human environment and seeks public comment. APHIS approves a petition only when it reaches the conclusion that the genetically engineered organism does not pose a plant pest risk. Once APHIS has deregulated an organism, it may be freely moved and planted without the requirement of permits or other regulatory oversight by APHIS. Deregulated status may be extended to genetically engineered organisms which APHIS determines are similar to previously deregulated organisms. Conversely, given new information, APHIS may determine that a previously deregulated genetically engineered organism poses a plant pest risk and should, therefore, be brought back under Agency oversight.

The Draft Environmental Impact Statement

APHIS is evaluating its regulatory program to determine if there is a need to revise its regulations in light of our current knowledge and experience and advances in science and technology. It is important that any regulations we may develop effectively carry out the purposes of the PPA, ensure environmental protection, provide regulatory processes that are transparent to stakeholders and the public, efficiently use Agency resources, minimize regulatory burdens, adhere to the principles of E.O. 12866, and are consistent with our international agreements, such as the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures.

We have prepared a draft EIS (DEIS) evaluating all of the regulatory alternatives we are currently considering for a future proposed rule to revise our biotechnology regulations. A copy of the DEIS may be obtained through the Federal eRulemaking Portal as described under ADDRESSES above. When commenting on the DEIS, please identify which of the 10 issue areas identified in the DEIS each point in your comment addresses.

While we invite comments on all alternatives in the DEIS, this notice identifies specific areas where we are particularly interested in further public input and data that will assist us in evaluating and refining these regulatory alternatives. We are requesting data on specific topics for some of the alternatives listed below, and we also welcome comments on how each alternative would affect areas such as the overall effectiveness of our biotechnology program, its operational efficiency, industry compliance, and other issues that would be associated with the development, adoption, and implementation of an alternative.

The DEIS alternatives highlighted in this notice are discussed in depth in the DEIS, and readers should refer to that document in preparing comments in response to this notice. The issues from the DEIS for which we are especially seeking additional public comment are listed below, with some notes on the particular types of data or views we believe would be most helpful.

DEIS Issue 1 and 5—Scope of the Program

Given the rapid advances in biotechnology, the present scope of the regulations may not be of sufficient breadth to cover the full range of genetically engineered organisms and the full range of potential agricultural and environmental risks posed by these organisms, including risks to public health. Historically, the Agency has relied exclusively on its authority to protect against plant pests as the basis for regulating genetically engineered organisms. This authority, which is found in the PPA, was derived from the Federal Plant Pest Act and the Plant Quarantine Act. The PPA, however, consolidated and redefined the Agency's plant health authorities. The PPA authorizes the regulation of noxious weeds—defined as any plant or plant product that can directly or indirectly injure or cause damage to crops (including nursery stock or plant products), livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment—and biological control organisms—defined as any enemy, antagonist, or competitor used to control a plant pest or noxious weed. Regulatory alternatives are now being considered with due regard for the revised plant health authorities of the PPA and in light of the many advances in biotechnology.

Based on our evaluation of several alternatives in the DEIS, APHIS has made a preliminary determination that regulatory oversight should be enhanced by expanding the scope of regulations to utilize the range of authorities in the PPA, not just the plant pest provision, to include the authority over noxious weeds and biological control organisms. The noxious weed provision would allow oversight of genetically engineered plants by expanding the scope of what is regulated and by allowing a broader consideration of potential risks, including risks to public health. This would allow APHIS to consider what is known about the potential hazards of the introduced proteins and other substances to humans or animals, if inadvertently consumed or released. This information could, in turn, be used to develop appropriate regulatory safeguards in connection with introductions of genetically engineered organisms.

APHIS has also made a preliminary determination that it would be beneficial to regulate nonviable plant material originating from field tests when there is reason to believe, based on scientific review, that such debris might be harmful to the environment if it were allowed to remain. Such an approach would allow the Agency to maintain regulatory control if nonviable material poses a hazard (e.g., potential food contamination).

APHIS is interested in receiving comment on these preliminary determinations and the other alternatives discussed in the DEIS. In particular, APHIS requests comment on whether APHIS should broaden the scope of its regulations to reflect its authority over noxious weeds and biological control organisms. If APHIS does propose to broaden its regulatory scope to include consideration of noxious weed risk, how should oversight and evaluation of genetically engineered plants differ from what is done under the current plant pest risk-oriented regulations? If APHIS does propose to establish regulations regarding genetically engineered biological control organisms, on what risks should the regulations be focused? Should APHIS tailor the scope of such regulations to focus on specific risks? If so, how?

DEIS Issue 2—Transparent, Risk Based Permit System

APHIS has always used a risk-based approach in regulating genetically engineered organisms. The Agency has concluded that there is public interest in biotechnology regulation and how APHIS regulates various types of organisms based on to risk and Agency familiarity with a given organism. In addition, there is a trend toward more highly varied organisms and the regulatory process may need greater flexibility and rigor to more appropriately regulate the increasing variety of organisms. Accordingly, the Agency is considering revising the regulations to make the Agency's use of risk-based categories—where genetically engineered organisms are classified according to risk and familiarity so that oversight and confinement vary by category—more refined, more explicit and more transparent to the industry and the public. Redefined risk categories, we believe, can provide added flexibility, improving the Agency's ability to regulate diverse organisms and new types of traits, and provide better clarity to the regulated community and to the public, which may in turn promote greater confidence in the regulatory system.

Accordingly, APHIS' has made a preliminary determination to adopt an expanded tiered permitting system based on potential environmental risk and Agency familiarity with the organism. A detailed example of such a system is described in this DEIS. The goals of such a tiered system would be to increase transparency with respect to how the Agency regulates various types of genetically engineered organisms and to increase regulatory flexibility such that the Agency could move genetically engineered organisms among the tiers as new information becomes available. For well characterized low-risk genetically engineered organisms, APHIS would continue to use a process similar to the current notification process found in 7 CFR 340.3; however, the term notification would no longer be used. Such a process would become the lowest risk “permit.” This change would, we believe, increase transparency and avoid any potential confusion about the status of these organisms as regulated articles.

APHIS is interested in receiving comment on this alternative, and, in particular, requests comment on the criteria that should be used to establish risk-based categories. What characteristics of genetically engineered plants should be considered in establishing such categories? How many categories should there be? Which types or species of plants should be assigned to which categories? What specific regulatory requirements or restrictions would be appropriate for each such category and why would they be appropriate?

DEIS Issue 3—Nonregulated Status

Once an article has been deregulated, APHIS does not place any restrictions or requirements on its use. Restrictions have not been deemed necessary because BRS risk assessments have concluded that the genetically engineered plants APHIS has deregulated pose no plant pest risk. APHIS recognizes, however, that future development and commercialization of plants with less familiar traits may pose new challenges for the Agency because even a thorough and comprehensive assessment may not resolve all unknowns regarding an article proposed for deregulation. These unresolved issues may justify continued scrutiny and data collection or use restrictions, but be of such a minor nature and minimal risk or concern that allowing planting of the article without a permit would be appropriate. APHIS is exploring the concept of a system that could give increased flexibility for handling special cases involving less familiar traits by creating provisions that allow for imposition of conditions for unconfined release. This could facilitate commercialization, while requiring appropriate restrictions or monitoring.

APHIS has made a preliminary determination to propose a new feature for its regulatory system whereby the Agency would retain oversight in specific cases as appropriate. We envision, of course, that the vast majority of organisms would be fully deregulated and that this determination would be identical to deregulation under our current regulations. The new system could include processes and criteria to allow release and use, with some restrictions, for special cases where there were minor risks that could be mitigated with conditions to ensure safe commercial use.

We are therefore interested in receiving comments on how to manage genetically engineered organisms that present only minor unresolved risks that can be mitigated effectively, and on what factors should be considered in establishing appropriate mitigations. APHIS is also considering the use of new terminology to describe both deregulation as it currently exists and the more limited deregulation where some oversight would be retained. One possibility is to use the term “approval” to indicate that specific genetically engineered organisms are “unconditionally approved.” This would be synonymous with full deregulation under our current regulations. Other genetically engineered organisms could be “approved with conditions” but would remain subject to continuing regulatory oversight in some respects. Alternatively, APHIS could retain the term “deregulation” and use “deregulation in part” or another term to refer to situations where genetically engineered organisms remain subject to regulatory oversight in some respects. We are interested in receiving comment on this potential change in terminology.

DEIS Issue 4—Oversight of Pharmaceuticals and Industrial Substances

Genetic engineering technology has advanced to the point where organisms can be developed that produce novel proteins and other substances with biological activity or industrial utility. Because the gene products made by such pharmaceutical and industrial compound producing plants may pose hazards not associated with proteins and other substances commonly found in the food supply, it is particularly important to ensure effective confinement measures for these plants. At the same time, however, the confinement measures prescribed for plants producing pharmaceutical and industrial compounds would be based on risk, not on the type of plant alone.

The Agency has considered various alternatives with respect to the regulation of genetically engineered plants producing pharmaceutical compounds, including whether food crops should be used and whether they should be allowable for open air introductions. We have made a preliminary determination that under stringent conditions and with rigorous oversight, including due consideration of substantive food safety issues, food crops can be safely used for production of these compounds.

In connection with this preliminary determination, the Agency seeks input on the need for and development of new or additional regulatory mechanisms to ensure that genetically engineered organisms producing pharmaceutical or industrial compounds are subject to requirements and oversight commensurate with the potential risks. We are also interested in comments regarding the biological characteristics that the Agency should consider in imposing safeguards. What should be done to ensure that such crops are commercialized under appropriate safeguards?

DEIS Issue 6—Commercialization Under Multi-Year Permits

For organisms that might be commercialized but that do not meet the criteria for deregulation, APHIS is considering whether a new type of permitting system would be more appropriate in terms of efficiency and effectiveness than the current system. In addition, there is much public and State interest in these types of plantings and a new mechanism may increase transparency and allow for greater State involvement.

Based on considerations more fully described in the DEIS, APHIS has made a preliminary determination to create a multi-year permit for genetically engineered organisms, with stringent oversight, in cases where developers are not interested or would not qualify for deregulation but plan to produce under permit. This would cover situations where producers are able to commercialize with relatively small plantings (e.g., industrial and pharmaceutical plants). Regulatory rigor would remain high to protect the environment, but efficiency and transparency would increase. The State partnership would be strengthened under this new system. The system would rely on multiyear permits and intensive reviews of standard operating procedures (SOPs), as well as audits and inspections. Though the new system under consideration could be used for pharmaceutical and industrial plants, the Agency might also find it appropriate for other types of genetically engineered plants.

We are seeking comments on such a system and are particularly interested in comments regarding new or additional regulatory mechanisms to ensure that genetically engineered organisms produced under multi-year permits would be subject to effective requirements and oversight commensurate with the potential risks.

DEIS Issue 7—Low Levels of Biotechnology-Derived Genes and Gene Products Occurring in Commerce That Have Not Gone Through All Applicable Regulatory Reviews

As with traditional plant breeding, large scale annual field testing of genetically engineered plants that have not completed all applicable reviews may result in materials from these trials occasionally being detected at low levels in commercial commodities and seeds. Current regulations do not expressly allow for such occurrences, though experience continues to show that such occurrences can occur. In a notice published in the Federal Register on August 2, 2002 (67 FR 50577-50580), by the Office of Science and Technology Policy, APHIS committed to conducting a risk-based regulatory program that minimizes the occurrence of these materials but includes safety criteria under which these materials would be allowed at low levels in commercial commodities and seeds. On March 29, 2007, APHIS published a policy statement in the Federal Register (72 FR 14649-14651, Docket No. APHIS-2006-0167) to clarify how it currently handles cases of low-level presence of regulated materials in commodities and seeds.

Based on our evaluation and assessment of alternatives in the DEIS, APHIS has made a preliminary determination to establish in regulations criteria under which the occurrence of regulated articles would be allowable, that is, considered not actionable by APHIS. The occasional detection of regulated material in commercial crops as seeds can occur as a result of field tests conducted under confinement conditions appropriate for notifications. This is due to cross-pollination and also commingling from shared equipment and facilities. In addition, such incidents will inevitably result from the importation of seeds and commodities from countries where such material has been fully approved but has not completed all U.S. reviews. In the majority of cases, this low-level occurrence of regulated articles will be of minimal risk, and this fact should be accounted for in any regulatory scheme since oversight should be commensurate with risk.

APHIS is interested in receiving comment on this alternative, but in particular, requests comment on whether APHIS should establish a new regulatory approach to address such incidents of low-level presence of genetically engineered plant material. If low-level presence incidents occur, what criteria should the Agency use to determine whether remedial action will be required, and to determine the nature and scope of any such remedial action?

DEIS Issue 8—Importation of Genetically Engineered Commodities Not Intended for Propagation

APHIS anticipates an increasing number of requests to import regulated genetically engineered organisms that are not intended for propagation, such as organisms that are intended for direct use as food, feed, or for processing. The current system of permits and notifications was not designed to handle such requests on a case-by-case basis. However, in anticipation of this increase, APHIS' goal is to design an efficient system that protects U.S. agriculture and human health without erecting unnecessary trade barriers. To that end, the Agency has evaluated several different alternatives.

Based on considerations more fully described in the DEIS, APHIS has made a preliminary determination to have a new regulatory mechanism to allow for imports of commodities for nonpropagative use, that is, for food, feed, or processing, in cases where these commodities might not have been deregulated in the United States. With this approach, we could establish criteria to ensure safety and allow for additional environmental review when appropriate. Allowing such imports without prior deregulation would not obviate the need to comply with requirements at other agencies, such as FDA and EPA.

APHIS is interested in receiving comment on this alternative and, more specifically, comments as to the commodity characteristics and other data that APHIS should consider when determining the appropriate safeguards for commodities coming in for processing or to be used directly as food or feed.

DEIS Issue 9—Interstate Movement of Well-Studied, Low Risk Organisms

Currently, genetically engineered Arabidopsis spp. and a few other organisms are exempt from interstate movement restrictions under 7 CFR 340.2 because they are well understood and extensively used in research. Based on considerations more fully described in the DEIS, APHIS is considering whether to expand the current exemption from interstate movement restrictions to other well-studied, low-risk, genetically engineered research organisms. Such a change would create a consistent, risk based approach to organisms with similar risk profiles.

Are there other genetically engineered organisms that should also be exempt from regulation in the same or similar manner as genetically engineered Arabidopsis spp.? Which organisms, if any, should be considered for such an exemption? Should the quantity of seeds or plant material being moved be considered in any exemption? In connection with such an exemption, should there continue to be some limited regulatory oversight, and what should be the nature and scope of such oversight?

As noted above, we are interested in receiving comments on all of the issues presented in the DEIS and particularly on the issues and alternatives outlined above.

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 12th day of July 2007.

Bruce Knight,

Under Secretary for Marketing and Regulatory Programs.