E9-905. Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule; reopening of comment period.

SUMMARY:

We are reopening the comment period for our proposed rule that would revise our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This action will allow interested persons additional time to prepare and submit comments.

DATES:

We will consider all comments that we receive on or before March 17, 2009.

ADDRESSES:

You may submit comments by any of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2008-0023 to submit or view comments and to view supporting and related materials available electronically.
• Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS-2008-0023, 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-2008-0023.
• Public Forum: Written and oral comment will be accepted at a public forum held during the comment period. See Public Forums below.

Reading Room: 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 [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:

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

SUPPLEMENTARY INFORMATION:

On October 9, 2008, we published in the Federal Register (73 FR 60007-60048, Docket No. APHIS-2008-0023) a proposal ^[1] to revise our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms. The proposed revisions would bring the regulations into alignment with provisions of the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) and update the regulations in response to advances in genetic science and technology and our accumulated experience in implementing the current regulations.

By the time the public comment period closed on November 24, 2008, we had received over 15,000 comments, including requests for APHIS to extend the public comment period. We are currently evaluating all the comments, and it is apparent that additional time for public comment is warranted and that it would be particularly helpful to receive additional comments on a variety of specific issues that have been raised thus far on the proposed rule.

Therefore, we are reopening the comment period on Docket No. APHIS-2008-0023 for an additional 60 days. We will also consider all comments received between November 25, 2008 (the date following the close of the original comment period), and the date of this notice. This action will allow interested persons additional time to prepare and submit comments. While all aspects of the proposal may be addressed by the public, we are particularly seeking additional comments on the issues listed below. In some cases commenters identified concerns about these issues, but did not provide specific suggestions as to how the proposed rule could be modified to address these concerns. By reopening the comment period, we hope to elicit more specific information and detailed suggestions regarding these issues.

Issue 1: Scope of the regulation and which GE organisms should be regulated. Section 340.0 of the proposed rule lists a number of criteria or factors to consider to identify those GE organisms which would be subject to the regulations. The proposal stated that in many cases a person could correctly apply the criteria to determine whether a specific GE organism is subject to the regulations, and stated that consultation with APHIS would be available in cases where it was not readily apparent whether or not a GE organism is regulated. Some commenters questioned whether the proposed scope could be interpreted with reasonable certainty. Some commenters thought the scope was effectively too broad and would regulate too many harmless GE organisms, while others thought it was too narrow and would exempt GE organisms that should be regulated. Some commenters stated that all GE plants should be subject to the regulations. We welcome additional comments on these subjects, including suggestions on what the criteria should be for determining the scope and applicability of the regulations and suggestions on which specific GE organisms should be included or excluded from the regulations based upon the potential risks consistent with the authorities provided in the PPA.

Issue 2: Incorporation of the Plant Protection Act noxious weed provisions. The proposed rule included APHIS evaluating certain GE organisms as a noxious weed risk pursuant to the PPA definition of “noxious weed” including consideration of noxious weed attributes in the scope of the regulation and in the decision making standards proposed in the regulations. Some comments suggested that this aspect of the proposal overestimates the likelihood that the use of GE techniques will create a noxious weed, whereas other comments suggested that the proposal did not pay enough attention to noxious weed attributes. Other comments broadly discussed the utility of the noxious weed authority of the PPA and how APHIS should apply it in these regulations. We welcome additional comments on how APHIS should include and apply the PPA's noxious weed provisions in the regulations in order to provide an appropriate level of protection based upon the potential risks consistent with the authorities provided in the PPA.

Issue 3: Elimination of notification procedure and revision of the permit procedure. The proposed rule would eliminate the notification procedure for authorizing importations, interstate movements, and releases into the environment, and instead use the permitting procedure for these activities. The proposal provided categories that APHIS would use for environmental release permits. Commenters raised many questions about the consequences of eliminating notifications. They also raised questions about the clarity of the requirements associated with the proposed permit categories. Some commenters expressed concern that the proposal would remove from the regulations firm timeframes for APHIS administrative action on applications, and that the proposed generalized timeframes were much longer than the timeframes under the current notification procedure. Several commenters saw this proposed change as detrimental to planning activities, especially for conducting field tests. Some commenters raised concerns that the proposed changes would substantially increase the data collection and recordkeeping burden on all applicants and responsible persons, whereas the current recordkeeping requirements for notifications are less than the requirements for permits. We welcome additional comments on these issues, including specific suggestions on how the regulations could achieve the necessary level of protection against the introduction and dissemination of plant pests or noxious weeds while minimizing any additional compliance burden for applicants or delay in processing applications.

Issue 4: Environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds. In the proposal, the categories for environmental release permits would be an initial administrative sorting done by APHIS prior to a full evaluation and determination of appropriate permit conditions for that particular permit. Most of the comments focused on the four categories APHIS proposed for GE plants. The two primary factors APHIS identified as most relevant to define its initial sorting system for environmental release permits were (1) the ability of the unmodified recipient plant species to persist in the wild and (2) the potential of the engineered trait to cause harm, injury, or damage, as described in the definitions of plant pest and noxious weed. The categories in the proposal were not based on intended use of the GE plant, but rather its properties. Many commenters, however, stated that they wanted APHIS to act on the intended use of the GE plant and ban all environmental releases of GE plants that are intended to produce compounds to be used in pharmaceutical or industrial uses, especially if that plant species is also used for the production of food or feed. We are seeking further comment on whether or how an intended use to produce pharmaceutical or industrial compounds contributes to an increase in plant pest or noxious weed risks. We welcome additional comments on all these issues, including specific suggestions on how the regulations could best provide the appropriate level of protection based upon the potential risks consistent with the authorities provided in the PPA.

Public Forums

In order to provide additional opportunities for the public to comment on the proposed rule, APHIS held public forums on the proposal in Davis, CA, on October 28, 2008; in Kansas City, MO, on October 30, 2008; and Riverdale, MD, on November 13, 2008. APHIS intends to hold one additional public forum on the proposed rule during the extended public comment period. The time and place of the public forum will be announced in the Federal Register.

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 13th day of January 2009.

Cindy J. Smith,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the proposed rule, supporting documents, and any comments we have received, go to http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2008-0023.