[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9, 2008 (73 FR 60008), is withdrawn.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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