[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 2907-2909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-905]



Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2008-0023]
RIN 0579-AC31

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 (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

[[Page 2908]]

FOR FURTHER INFORMATION CONTACT: Biotechnology Regulatory Services, 
APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-

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.

    \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.

    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 
    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

[[Page 2909]]

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.
 [FR Doc. E9-905 Filed 1-15-09; 8:45 am]