[Federal Register: January 16, 2009 (Volume 74, Number =
11)]
[Proposed Rules] =20
[Page 2907-2909]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja09-39] =20
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 340
[Docket No. APHIS-2008-0023]
RIN 0579-AC31
=20
Importation, Interstate Movement, and Release Into the=20
Environment of Certain Genetically Engineered Organisms
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule; reopening of comment period.
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SUMMARY: We are reopening the comment period for our proposed rule that=20
would revise our regulations regarding the importation, interstate=20
movement, and environmental release of certain genetically engineered=20
organisms. This action will allow interested persons additional time to=20
prepare and submit comments.
DATES: We will consider all comments that we receive on or before March=20
17, 2009.
ADDRESSES: You may submit comments by any of the following methods:
Federal eRulemaking Portal: Go to http://frwebga=
te.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3Dlin=
klog&to=3Dhttp://www.regulations.gov/fdmspublic/component/main?main=3D=
DocketDetail%26d=3DAPHIS-2008-0023 to submit or view comments and=20
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of=20
your comment to Docket No. APHIS-2008-0023, Regulatory Analysis and=20
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,=20
Riverdale, MD 20737-1238. Please state that your comment refers to=20
Docket No. APHIS-2008-0023.
Public Forum: Written and oral comment will be accepted at=20
a public forum held during the comment period. See Public Forums below.
Reading Room: You may read any comments that we receive on this=20
docket in our reading room. The reading room is located in room 1141 of=20
the USDA South Building, 14th Street and Independence Avenue, SW.,=20
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,=20
Monday through Friday, except holidays. To be sure someone is there to=20
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its=20
programs is available on the Internet at http://frw=
ebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3D=
linklog&to=3Dhttp://www.aphis.usda.gov.
[[Page 2908]]
FOR FURTHER INFORMATION CONTACT: Biotechnology Regulatory Services,=20
APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-
5710.
SUPPLEMENTARY INFORMATION: On October 9, 2008, we published in the=20
Federal Register (73 FR 60007-60048, Docket No. APHIS-2008-0023) a=20
proposal \1\ to revise our regulations regarding the importation,=20
interstate movement, and environmental release of certain genetically=20
engineered (GE) organisms. The proposed revisions would bring the=20
regulations into alignment with provisions of the Plant Protection Act=20
(PPA, 7 U.S.C. 7701 et seq.) and update the regulations in response to=20
advances in genetic science and technology and our accumulated=20
experience in implementing the current regulations.
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\1\ To view the proposed rule, supporting documents, and any=20
comments we have received, go to http://frwebga=
te.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3Dlin=
klog&to=3Dhttp://www.regulations.gov/fdmspublic/component/main?main=3D=
DocketDetail%26d=3DAPHIS-2008-0023.
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--
By the time the public comment period closed on November 24, 2008,=20
we had received over 15,000 comments, including requests for APHIS to=20
extend the public comment period. We are currently evaluating all the=20
comments, and it is apparent that additional time for public comment is=20
warranted and that it would be particularly helpful to receive=20
additional comments on a variety of specific issues that have been=20
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=20
received between November 25, 2008 (the date following the close of the=20
original comment period), and the date of this notice. This action will=20
allow interested persons additional time to prepare and submit=20
comments. While all aspects of the proposal may be addressed by the=20
public, we are particularly seeking additional comments on the issues=20
listed below. In some cases commenters identified concerns about these=20
issues, but did not provide specific suggestions as to how the proposed=20
rule could be modified to address these concerns. By reopening the=20
comment period, we hope to elicit more specific information and=20
detailed suggestions regarding these issues.
Issue 1: Scope of the regulation and which GE organisms should be=20
regulated. Section 340.0 of the proposed rule lists a number of=20
criteria or factors to consider to identify those GE organisms which=20
would be subject to the regulations. The proposal stated that in many=20
cases a person could correctly apply the criteria to determine whether=20
a specific GE organism is subject to the regulations, and stated that=20
consultation with APHIS would be available in cases where it was not=20
readily apparent whether or not a GE organism is regulated. Some=20
commenters questioned whether the proposed scope could be interpreted=20
with reasonable certainty. Some commenters thought the scope was=20
effectively too broad and would regulate too many harmless GE=20
organisms, while others thought it was too narrow and would exempt GE=20
organisms that should be regulated. Some commenters stated that all GE=20
plants should be subject to the regulations. We welcome additional=20
comments on these subjects, including suggestions on what the criteria=20
should be for determining the scope and applicability of the=20
regulations and suggestions on which specific GE organisms should be=20
included or excluded from the regulations based upon the potential=20
risks consistent with the authorities provided in the PPA.
Issue 2: Incorporation of the Plant Protection Act noxious weed=20
provisions. The proposed rule included APHIS evaluating certain GE=20
organisms as a noxious weed risk pursuant to the PPA definition of=20
``noxious weed'' including consideration of noxious weed attributes in=20
the scope of the regulation and in the decision making standards=20
proposed in the regulations. Some comments suggested that this aspect=20
of the proposal overestimates the likelihood that the use of GE=20
techniques will create a noxious weed, whereas other comments suggested=20
that the proposal did not pay enough attention to noxious weed=20
attributes. Other comments broadly discussed the utility of the noxious=20
weed authority of the PPA and how APHIS should apply it in these=20
regulations. We welcome additional comments on how APHIS should include=20
and apply the PPA's noxious weed provisions in the regulations in order=20
to provide an appropriate level of protection based upon the potential=20
risks consistent with the authorities provided in the PPA.
Issue 3: Elimination of notification procedure and revision of the=20
permit procedure. The proposed rule would eliminate the notification=20
procedure for authorizing importations, interstate movements, and=20
releases into the environment, and instead use the permitting procedure=20
for these activities. The proposal provided categories that APHIS would=20
use for environmental release permits. Commenters raised many questions=20
about the consequences of eliminating notifications. They also raised=20
questions about the clarity of the requirements associated with the=20
proposed permit categories. Some commenters expressed concern that the=20
proposal would remove from the regulations firm timeframes for APHIS=20
administrative action on applications, and that the proposed=20
generalized timeframes were much longer than the timeframes under the=20
current notification procedure. Several commenters saw this proposed=20
change as detrimental to planning activities, especially for conducting=20
field tests. Some commenters raised concerns that the proposed changes=20
would substantially increase the data collection and recordkeeping=20
burden on all applicants and responsible persons, whereas the current=20
recordkeeping requirements for notifications are less than the=20
requirements for permits. We welcome additional comments on these=20
issues, including specific suggestions on how the regulations could=20
achieve the necessary level of protection against the introduction and=20
dissemination of plant pests or noxious weeds while minimizing any=20
additional compliance burden for applicants or delay in processing=20
applications.
Issue 4: Environmental release permit categories and regulation of=20
GE crops that produce pharmaceutical and industrial compounds. In the=20
proposal, the categories for environmental release permits would be an=20
initial administrative sorting done by APHIS prior to a full evaluation=20
and determination of appropriate permit conditions for that particular=20
permit. Most of the comments focused on the four categories APHIS=20
proposed for GE plants. The two primary factors APHIS identified as=20
most relevant to define its initial sorting system for environmental=20
release permits were (1) the ability of the unmodified recipient plant=20
species to persist in the wild and (2) the potential of the engineered=20
trait to cause harm, injury, or damage, as described in the definitions=20
of plant pest and noxious weed. The categories in the proposal were not=20
based on intended use of the GE plant, but rather its properties. Many=20
commenters, however, stated that they wanted APHIS to act on the=20
intended use of the GE plant and ban all environmental releases of GE=20
plants that are intended to produce compounds to be used in=20
pharmaceutical or industrial uses, especially if that plant species is=20
also used for the production of food or feed. We are seeking further=20
comment on whether or how an intended use to produce pharmaceutical or=20
industrial compounds contributes to an increase in plant pest or=20
noxious weed risks. We
[[Page 2909]]
welcome additional comments on all these issues, including specific=20
suggestions on how the regulations could best provide the appropriate=20
level of protection based upon the potential risks consistent with the=20
authorities provided in the PPA.
Public Forums
In order to provide additional opportunities for the public to=20
comment on the proposed rule, APHIS held public forums on the proposal=20
in Davis, CA, on October 28, 2008; in Kansas City, MO, on October 30,=20
2008; and Riverdale, MD, on November 13, 2008. APHIS intends to hold=20
one additional public forum on the proposed rule during the extended=20
public comment period. The time and place of the public forum will be=20
announced in the Federal Register.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7=20
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]
BILLING CODE 3410-34-P