Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms, 11598-11599 [2015-04463]

Download as PDF 11598 Proposed Rules Federal Register Vol. 80, No. 42 Wednesday, March 4, 2015 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. 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 Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; withdrawal. AGENCY: 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 DATES: Effective March 4, 2015, the proposed rule published on October 9, 2008 (73 FR 60008), is withdrawn.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: asabaliauskas on DSK5VPTVN1PROD with PROPOSALS SUMMARY: Background On October 9, 2008, the Animal and Plant Health Inspection Service (APHIS) published in the Federal Register a VerDate Sep<11>2014 17:17 Mar 03, 2015 Jkt 235001 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. 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. 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 1 To view the proposed rule, supporting documents, and comments we received, go to https://www.regulations.gov/#!docketDetail; D=APHIS-2008-0023. 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. PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\04MRP1.SGM 04MRP1 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Proposed Rules 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. 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 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] BILLING CODE 3410–34–P DEPARTMENT OF ENERGY 10 CFR Part 429 [Docket No. EERE–2013–BT–NOC–0005] Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Open Meeting and Webinar Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of open meeting and webinar. AGENCY: This document announces a meeting of the Appliance Standards and asabaliauskas on DSK5VPTVN1PROD with PROPOSALS SUMMARY: 3 Information on upcoming webinars will be available at https://www.aphis.usda.gov/wps/portal/ aphis/ourfocus/biotechnology/!ut/p/a1/04_Sj9CPy kssy0xPLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V 2dDDz93HwCzL29jAyMTIEKIvEo8DYlTr-zu6OH ibmPgYGBiYWRgaeLk4eLuaWvgYGnGXH6DX AARwNC-sP1o_AqAfkArACfE8EK8LihIDc0NMIg0x MA5AbGNw!!/?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: https://www.aphis.usda.gov/wps/portal/aphis/ newsroom/stakeholder-info/!ut/p/a1/nVFNU4Mw EP0tHjxmEkgk4Ug7foBKD9W25MJskyixFChEx_ 57gem1aN3bzr739u1bLPEGywq-7Ds4W1dQ Dr0MchYL36fEj8ULFyQi8zBZxCtC6E0PyHoAOV MRGfnJ4sH3Zj3_fhnekjhd3T2LJ04fZwFeY4ml qlzjCpxBU9guV3XlTOXy0m5baIlowbar; XpIMctvWny8f52HcOdqaoS23ablBolNU4CxljRoc aBYp6iCnOkdAAiAPVEBiujQcnxxOWfrl4dDyhk PATYCKUrPfAzy5JAry88KjkD3-yH4eDjPq0h3y_ Hd78M–5m_7oX9Ih2b2mKZHb1A2VTHxo!/?1dmy &urile=wcm%3apath%3a%2Faphis_content_ library%2Fsa_about_aphis%2Fsa_stakeholders %2Fct_coexistence_meeting. A notice announcing the workshop was published on February 3, 2015 (80 FR 5729–5731, Docket No. APHIS–2013–0047). VerDate Sep<11>2014 17:17 Mar 03, 2015 Jkt 235001 Rulemaking Federal Advisory Committee (ASRAC). DATES: The meeting will be held on Thursday, March 19, 2015 from 9 a.m. to 1 p.m. ADDRESSES: U.S. Department of Energy, Forrestal Building, Room 8E–089, 1000 Independence Avenue SW., Washington, DC 20585. For individuals that wish to attend by webinar, please register at—https:// attendee.gotowebinar.com/register/ 9166475973377623554. After registering you will receive an email with the appropriate link to join the meeting and the necessary call-in information. FOR FURTHER INFORMATION CONTACT: John Cymbalsky, ASRAC Designated Federal Officer, U.S. Department of Energy (DOE), Office of Energy Efficiency and Renewable Energy, 950 L’Enfant Plaza SW., Washington, DC, 20024. Email: asrac@ee.doe.gov. SUPPLEMENTARY INFORMATION: The Federal Advisory Committee Act, Public Law 92–463, 86 Stat. 770, requires that agencies publish notice of an advisory committee meeting in the Federal Register. Purpose of Meeting: To provide advice and recommendations to the Energy Department on the development of standards and test procedures for residential appliances and commercial equipment. Tentative Agenda: (Subject to change; final agenda will be posted at https:// www.appliancestandards.energy.gov): • Discussion of formation of working groups to negotiate proposed rules for commercial and industrial fans and miscellaneous refrigeration products. • Discussion of other topics where ASRAC can assist the Appliance and Equipment Standards Program • Discussion of public engagement under DOE’s retrospective regulatory review plan Public Participation: Members of the public are welcome to observe the business of the meeting and, if time allows, may make oral statements during the specified period for public comment. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, email asrac@ ee.doe.gov. In the email, please indicate your name, organization (if appropriate), citizenship, and contact information. Please note that foreign nationals participating in the public meeting are subject to advance security screening procedures which require advance notice prior to attendance at the public meeting. If a foreign national wishes to participate in the public meeting, please inform DOE as soon as possible by contacting Ms. Regina Washington at PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 11599 (202) 586–1214 or by email: Regina.Washington@ee.doe.gov so that the necessary procedures can be completed. Anyone attending the meeting will be required to present a government photo identification, such as a passport, driver’s license, or government identification. Due to the required security screening upon entry, individuals attending should arrive early to allow for the extra time needed. Due to the REAL ID Act implemented by the Department of Homeland Security (DHS) recent changes regarding ID requirements for individuals wishing to enter Federal buildings from specific states and U.S. territories. Driver’s licenses from the following states or territory will not be accepted for building entry and one of the alternate forms of ID listed below will be required. DHS has determined that regular driver’s licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, Louisiana, New York, American Samoa, Maine, Oklahoma, Arizona, Massachusetts, Washington, and Minnesota. Acceptable alternate forms of PhotoID include: U. S. Passport or Passport Card; An Enhanced Driver’s License or Enhanced ID-Card issued by the states of Minnesota, New York or Washington (Enhanced licenses issued by these states are clearly marked Enhanced or Enhanced Driver’s License); A military ID or other Federal government issued Photo-ID card. Members of the public will be heard in the order in which they sign up for the Public Comment Period. Time allotted per speaker will depend on the number of individuals who wish to speak but will not exceed five minutes. Reasonable provision will be made to include the scheduled oral statements on the agenda. The co-chairs of the Committee will make every effort to hear the views of all interested parties and to facilitate the orderly conduct of business. Participation in the meeting is not a prerequisite for submission of written comments. ASRAC invites written comments from all interested parties. Any comments submitted must identify the ASRAC, and provide docket number EERE–2013–BT–NOC–0005. Comments may be submitted using any of the following methods: 1. Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments. 2. Email: ASRAC@ee.doe.gov. Include docket number EERE–2013–BT–NOC– 0005 in the subject line of the message. E:\FR\FM\04MRP1.SGM 04MRP1

Agencies

[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Proposed Rules]
[Pages 11598-11599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04463]


========================================================================
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.

========================================================================


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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, supporting documents, and 
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2008-0023.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ Information on upcoming webinars will be available at https://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: https://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 
---------------------------------------------------------------------------
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]
BILLING CODE 3410-34-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.