[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Proposed Rules]
[Pages 11598-11599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-04463]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 /
Proposed Rules
[[Page 11598]]
DEPARTMENT OF AGRICULTURE
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; withdrawal.
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SUMMARY: We are withdrawing a proposed rule that would have amended the
regulations regarding the introduction (importation, interstate
movement, and environmental release (field testing)) of certain
genetically engineered organisms. We are doing this in light of the
experience we have gained over the past 28 years, continuing advances
in biotechnology, and comments we received on the rule. We will begin a
fresh stakeholder engagement aimed at exploring alternative policy
approaches. This engagement will begin with a series of webinars that
will provide the stakeholder community an opportunity to provide
initial feedback. Information on these webinars will be announced in
the coming month.
DATES: Effective March 4, 2015, the proposed rule published on October
9, 2008 (73 FR 60008), is withdrawn.
FOR FURTHER INFORMATION CONTACT: Mrs. Chessa Huff-Woodard,
Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146,
Riverdale, MD 20737-1236; (301) 8513943.
SUPPLEMENTARY INFORMATION:
Background
On October 9, 2008, the Animal and Plant Health Inspection Service
(APHIS) published in the Federal Register a proposal \1\ (73 FR 60008-
60048, Docket No. APHIS-2008-0023) to amend the regulations regarding
the introduction (importation, interstate movement, and environmental
release (field testing)) of certain genetically engineered (GE)
organisms in response to advancements in biotechnology and APHIS'
accumulated experience in implementing the current regulations. The
proposed revisions were extensive and included significant changes to
the scope of the regulations and the mechanics of APHIS' regulatory
oversight. These changes included aligning the regulations with
provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.) and
eliminating the current notification and permitting procedures and
developing a multiple-category permitting system in its place.
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\1\ To view the proposed rule, supporting documents, and
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0023.
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APHIS sought public comment on the proposal from October 9, 2008,
to June 29, 2009. We received over 88,300 comments by the close of the
comment period. These were received in 5,580 submissions that included
unique comments, form letters, and signatories to petitions. We
thoroughly reviewed each comment we received. Comments were from a
variety of stakeholders, including advocacy groups; State, Tribal, and
foreign governments; university researchers; farmers, businesses, trade
associations and other regulated entities; and private citizens. We
wish to thank the commenters for sharing their knowledge and views on
this important subject.
Many commenters indicated that the proposed scope and many of the
provisions of the rule were unclear. With regard to the scope of the
proposed changes, some commenters asserted that APHIS regulations
needed to be more rigorous and far-reaching, while others believed that
the proposed regulations were overly restrictive. Other commenters
indicated that they were not clear as to what would and would not be
regulated, and raised concerns regarding what future criteria might be
used to determine what organisms would fall under APHIS regulatory
jurisdiction. Concerns regarding oversight of crops that produce
pharmaceutical and industrial compounds and increased regulatory burden
are just a few examples of the complex issues raised by commenters.
Many commenters also expressed opposition to genetic engineering in
general and expressed concerns with a wide range of issues, many of
which were outside the scope of the proposed rule. For example,
commenters stated that APHIS should consider non-safety based risks,
such as economic and social impacts, including impacts on the
marketability of non-GE products. Other commenters requested that APHIS
regulations include provisions related to the labeling of GE products
and raised concerns regarding health effects of GE products and
increased pesticide use.
Based on the experience we have gained over the past 28 years,
continuing advances in biotechnology, and the scope of comments
received on the proposed rule, we have decided to withdraw it and to
begin a fresh stakeholder engagement aimed at exploring alternative
policy approaches. Because of rules limiting ex parte \2\
communications with respect to active rulemakings, publication of the
2008 proposed rule has constrained our ability to talk about
alternatives with stakeholders. Withdrawing the proposed rule will lift
this constraint and provide for a more timely and transparent dialogue.
Once it is withdrawn, the nature of our conversations with stakeholders
can change, allowing APHIS to discuss regulatory issues in ways that
were not possible while the proposal was in formal rulemaking. Our
intention is to utilize an open and robust policy dialogue to drive the
development of a forward-looking rule that will provide a foundation
for our future regulatory activities.
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\2\ Ex parte rules are designed to prevent unequal access or the
perception of favoritism during the active rulemaking period
occurring after a new rule is proposed.
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Therefore, we are withdrawing the October 9, 2008, proposed rule.
As we explore a full range of policy alternatives, we will consider the
comments we received on the proposed rule, as well as new scientific
knowledge whenever it is available, and continue to seek the active and
open input of stakeholders. In the coming months, we will engage
stakeholders on biotechnology regulation alternatives to ensure the
safe environmental release (field testing), interstate movement, and
importation of certain GE organisms
[[Page 11599]]
regulated under 7 CFR part 340. Plans for that engagement are underway
and will begin with a series of webinars that will provide the
stakeholder community an opportunity to provide initial feedback.
Information on these webinars will be announced in the coming month and
will be available on the APHIS Web site.\3\ For those interested in
additional information in advance of the webinars, this will be one of
many topics at an upcoming U.S. Department of Agriculture workshop \4\
on coexistence that is being held on March 12-13, 2015, and will be
made widely available via webcast.
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\3\ Information on upcoming webinars will be available at http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology/!ut/p/a1/04_Sj9CPykssy0xPLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V2dDDz93HwCzL29jAyMTIEKIvEo8DYlTr-zu6OHibmPgYGBiYWRgaeLk4eLuaWvgYGnGXH6DXAARwNC-sP1o_AqAfkArACfE8EK8LihIDc0NMIg0xMA5AbGNw!!/?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fsa_biotechnology%2Fsa_news%2Fct_news.
\4\ Call-in and Webcast information is available at the
agricultural coexistence workshop Web page at: http://www.aphis.usda.gov/wps/portal/aphis/newsroom/stakeholder-info/!ut/p/a1/nVFNU4MwEP0tHjxmEkgk4Ug7foBKD9W25MJskyixFChEx_57gem1aN3bzr739u1bLPEGywq-7Ds4W1dQDr0MchYL36fEj8ULFyQi8zBZxCtC6E0PyHoAOVMRGfnJ4sH3Zj3_fhnekjhd3T2LJ04fZwFeY4mlqlzjCpxBU9guV3XlTOXy0m5baIlowbar;XpIMctvWny8f52HcOdqao
S23ablBolNU4CxljRocaBYp6iCnOkdAAiAPVEBiujQcnxxOWfrl4dDyhkPATYCKUrPfAz
y5JAry88KjkD3-yH4eDjPq0h3y_Hd78M-5m_7oX9Ih2b2mKZHb1A2VTHxo!/
?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_about_aphis%2F
sa_stakeholders%2Fct_coexistence_meeting. A notice announcing the
workshop was published on February 3, 2015 (80 FR 5729-5731, Docket
No. APHIS-2013-0047).
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
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CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 27th day of February 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-04463 Filed 3-3-15; 8:45 am]
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