80 FR 11598 - Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 80, Issue 42 (March 4, 2015)
Animal and Plant Health Inspection Service
Federal Register Volume 80, Issue 42 (March 4, 2015)
| Page Range | 11598-11599 | |
| FR Document | 2015-04463 |
[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)] [Proposed Rules] [Pages 11598-11599] From the Federal Register Online [www.thefederalregister.org] [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 DATES: Effective March 4, 2015, the proposed rule published on October 9, 2008 (73 FR 60008), is withdrawn.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 http://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 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 --------------------------------------------------------------------------- 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
![11598
Proposed Rules Federal Register
Vol. 80, No. 42
Wednesday, March 4, 2015
This section of the FEDERAL REGISTER proposal 1 (73 FR 60008–60048, Docket burden are just a few examples of the
contains notices to the public of the proposed No. APHIS–2008–0023) to amend the complex issues raised by commenters.
issuance of rules and regulations. The regulations regarding the introduction Many commenters also expressed
purpose of these notices is to give interested (importation, interstate movement, and opposition to genetic engineering in
persons an opportunity to participate in the environmental release (field testing)) of general and expressed concerns with a
rule making prior to the adoption of the final wide range of issues, many of which
certain genetically engineered (GE)
rules.
organisms in response to advancements were outside the scope of the proposed
in biotechnology and APHIS’ rule. For example, commenters stated
DEPARTMENT OF AGRICULTURE accumulated experience in that APHIS should consider non-safety
implementing the current regulations. based risks, such as economic and social
Animal and Plant Health Inspection The proposed revisions were extensive impacts, including impacts on the
Service and included significant changes to the marketability of non-GE products. Other
scope of the regulations and the commenters requested that APHIS
7 CFR Part 340 mechanics of APHIS’ regulatory regulations include provisions related to
oversight. These changes included the labeling of GE products and raised
[Docket No. APHIS–2008–0023] aligning the regulations with provisions concerns regarding health effects of GE
of the Plant Protection Act (7 U.S.C. products and increased pesticide use.
RIN 0579–AC31 7701 et seq.) and eliminating the current Based on the experience we have
notification and permitting procedures gained over the past 28 years,
Importation, Interstate Movement, and and developing a multiple-category continuing advances in biotechnology,
Release Into the Environment of permitting system in its place. and the scope of comments received on
Certain Genetically Engineered APHIS sought public comment on the the proposed rule, we have decided to
Organisms proposal from October 9, 2008, to June withdraw it and to begin a fresh
29, 2009. We received over 88,300 stakeholder engagement aimed at
AGENCY: Animal and Plant Health comments by the close of the comment exploring alternative policy approaches.
Inspection Service, USDA. period. These were received in 5,580 Because of rules limiting ex parte 2
ACTION: Proposed rule; withdrawal. submissions that included unique communications with respect to active
comments, form letters, and signatories rulemakings, publication of the 2008
SUMMARY: We are withdrawing a to petitions. We thoroughly reviewed proposed rule has constrained our
proposed rule that would have amended each comment we received. Comments ability to talk about alternatives with
the regulations regarding the were from a variety of stakeholders, stakeholders. Withdrawing the proposed
introduction (importation, interstate including advocacy groups; State, rule will lift this constraint and provide
movement, and environmental release Tribal, and foreign governments; for a more timely and transparent
(field testing)) of certain genetically university researchers; farmers, dialogue. Once it is withdrawn, the
engineered organisms. We are doing this businesses, trade associations and other nature of our conversations with
in light of the experience we have regulated entities; and private citizens. stakeholders can change, allowing
gained over the past 28 years, We wish to thank the commenters for APHIS to discuss regulatory issues in
continuing advances in biotechnology, sharing their knowledge and views on ways that were not possible while the
and comments we received on the rule. this important subject. proposal was in formal rulemaking. Our
We will begin a fresh stakeholder Many commenters indicated that the intention is to utilize an open and
engagement aimed at exploring proposed scope and many of the robust policy dialogue to drive the
alternative policy approaches. This provisions of the rule were unclear. development of a forward-looking rule
engagement will begin with a series of With regard to the scope of the proposed that will provide a foundation for our
webinars that will provide the changes, some commenters asserted that future regulatory activities.
stakeholder community an opportunity APHIS regulations needed to be more Therefore, we are withdrawing the
to provide initial feedback. Information rigorous and far-reaching, while others October 9, 2008, proposed rule. As we
on these webinars will be announced in believed that the proposed regulations explore a full range of policy
the coming month. were overly restrictive. Other alternatives, we will consider the
DATES: Effective March 4, 2015, the commenters indicated that they were comments we received on the proposed
proposed rule published on October 9, not clear as to what would and would rule, as well as new scientific
2008 (73 FR 60008), is withdrawn. not be regulated, and raised concerns knowledge whenever it is available, and
FOR FURTHER INFORMATION CONTACT: Mrs. regarding what future criteria might be continue to seek the active and open
Chessa Huff-Woodard, Biotechnology used to determine what organisms input of stakeholders. In the coming
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Regulatory Services, APHIS, 4700 River would fall under APHIS regulatory months, we will engage stakeholders on
Road Unit 146, Riverdale, MD 20737– jurisdiction. Concerns regarding biotechnology regulation alternatives to
1236; (301) 8513943. oversight of crops that produce ensure the safe environmental release
SUPPLEMENTARY INFORMATION: pharmaceutical and industrial (field testing), interstate movement, and
compounds and increased regulatory importation of certain GE organisms
Background
1 To view the proposed rule, supporting 2 Ex parte rules are designed to prevent unequal
On October 9, 2008, the Animal and
documents, and comments we received, go to access or the perception of favoritism during the
Plant Health Inspection Service (APHIS) http://www.regulations.gov/#!docketDetail; active rulemaking period occurring after a new rule
published in the Federal Register a D=APHIS-2008-0023. is proposed.
VerDate Sep<11>2014 17:17 Mar 03, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\04MRP1.SGM 04MRP1](https://thefederalregister.org/doc/80_FR_11640/page/1.svg)
![Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Proposed Rules 11599
regulated under 7 CFR part 340. Plans Rulemaking Federal Advisory (202) 586–1214 or by email:
for that engagement are underway and Committee (ASRAC). Regina.Washington@ee.doe.gov so that
will begin with a series of webinars that DATES: The meeting will be held on the necessary procedures can be
will provide the stakeholder community Thursday, March 19, 2015 from 9 a.m. completed. Anyone attending the
an opportunity to provide initial to 1 p.m. meeting will be required to present a
feedback. Information on these webinars ADDRESSES: U.S. Department of Energy, government photo identification, such
will be announced in the coming month Forrestal Building, Room 8E–089, 1000 as a passport, driver’s license, or
and will be available on the APHIS Web Independence Avenue SW., government identification. Due to the
site.3 For those interested in additional Washington, DC 20585. For individuals required security screening upon entry,
information in advance of the webinars, that wish to attend by webinar, please individuals attending should arrive
this will be one of many topics at an register at—https:// early to allow for the extra time needed.
upcoming U.S. Department of attendee.gotowebinar.com/register/ Due to the REAL ID Act implemented
Agriculture workshop 4 on coexistence 9166475973377623554. After registering by the Department of Homeland
that is being held on March 12–13, you will receive an email with the Security (DHS) recent changes regarding
2015, and will be made widely available appropriate link to join the meeting and ID requirements for individuals wishing
via webcast. the necessary call-in information. to enter Federal buildings from specific
Authority: 7 U.S.C. 7701–7772 and 7781– FOR FURTHER INFORMATION CONTACT: John
states and U.S. territories. Driver’s
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
Cymbalsky, ASRAC Designated Federal licenses from the following states or
371.3. territory will not be accepted for
Officer, U.S. Department of Energy
Done in Washington, DC, this 27th day of (DOE), Office of Energy Efficiency and building entry and one of the alternate
February 2015. Renewable Energy, 950 L’Enfant Plaza forms of ID listed below will be
Kevin Shea, SW., Washington, DC, 20024. Email: required.
Administrator, Animal and Plant Health asrac@ee.doe.gov. DHS has determined that regular
Inspection Service. driver’s licenses (and ID cards) from the
SUPPLEMENTARY INFORMATION: The
[FR Doc. 2015–04463 Filed 3–3–15; 8:45 am] following jurisdictions are not
Federal Advisory Committee Act, Public
BILLING CODE 3410–34–P acceptable for entry into DOE facilities:
Law 92–463, 86 Stat. 770, requires that
Alaska, Louisiana, New York, American
agencies publish notice of an advisory
Samoa, Maine, Oklahoma, Arizona,
committee meeting in the Federal
DEPARTMENT OF ENERGY Massachusetts, Washington, and
Register.
Purpose of Meeting: To provide Minnesota.
10 CFR Part 429 advice and recommendations to the Acceptable alternate forms of Photo-
Energy Department on the development ID include: U. S. Passport or Passport
[Docket No. EERE–2013–BT–NOC–0005]
of standards and test procedures for Card; An Enhanced Driver’s License or
Appliance Standards and Rulemaking residential appliances and commercial Enhanced ID-Card issued by the states
Federal Advisory Committee: Notice of equipment. of Minnesota, New York or Washington
Open Meeting and Webinar Tentative Agenda: (Subject to change; (Enhanced licenses issued by these
final agenda will be posted at http:// states are clearly marked Enhanced or
AGENCY: Office of Energy Efficiency and Enhanced Driver’s License); A military
Renewable Energy, Department of www.appliancestandards.energy.gov):
• Discussion of formation of working ID or other Federal government issued
Energy. Photo-ID card.
groups to negotiate proposed rules for
ACTION: Notice of open meeting and Members of the public will be heard
commercial and industrial fans and
webinar. miscellaneous refrigeration products. in the order in which they sign up for
SUMMARY: This document announces a • Discussion of other topics where the Public Comment Period. Time
ASRAC can assist the Appliance and allotted per speaker will depend on the
meeting of the Appliance Standards and
Equipment Standards Program number of individuals who wish to
3 Information on upcoming webinars will be • Discussion of public engagement speak but will not exceed five minutes.
available at http://www.aphis.usda.gov/wps/portal/ under DOE’s retrospective regulatory Reasonable provision will be made to
aphis/ourfocus/biotechnology/!ut/p/a1/04_Sj9CPy review plan include the scheduled oral statements
kssy0xPLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V Public Participation: Members of the on the agenda. The co-chairs of the
2dDDz93HwCzL29jAyMTIEKIvEo8DYlTr-zu6OH
ibmPgYGBiYWRgaeLk4eLuaWvgYGnGXH6DX public are welcome to observe the Committee will make every effort to
AARwNC-sP1o_AqAfkArACfE8EK8LihIDc0NMIg0x business of the meeting and, if time hear the views of all interested parties
MA5AbGNw!!/?1dmy&urile=wcm%3apath%3a allows, may make oral statements and to facilitate the orderly conduct of
%2Faphis_content_library%2Fsa_our_focus%2Fsa_ during the specified period for public business.
biotechnology%2Fsa_news%2Fct_news.
4 Call-in and Webcast information is available at comment. To attend the meeting and/or Participation in the meeting is not a
the agricultural coexistence workshop Web page at: to make oral statements regarding any of prerequisite for submission of written
http://www.aphis.usda.gov/wps/portal/aphis/ the items on the agenda, email asrac@ comments. ASRAC invites written
newsroom/stakeholder-info/!ut/p/a1/nVFNU4Mw ee.doe.gov. In the email, please indicate comments from all interested parties.
EP0tHjxmEkgk4Ug7foBKD9W25MJskyixFChEx_ Any comments submitted must identify
57gem1aN3bzr739u1bLPEGywq-7Ds4W1dQ
your name, organization (if appropriate),
citizenship, and contact information. the ASRAC, and provide docket number
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Dr0MchYL36fEj8ULFyQi8zBZxCtC6E0PyHoAOV
MRGfnJ4sH3Zj3_fhnekjhd3T2LJ04fZwFeY4ml Please note that foreign nationals EERE–2013–BT–NOC–0005. Comments
qlzjCpxBU9guV3XlTOXy0m5baIlowbar; participating in the public meeting are may be submitted using any of the
XpIMctvWny8f52HcOdqaoS23ablBolNU4CxljRoc following methods:
aBYp6iCnOkdAAiAPVEBiujQcnxxOWfrl4dDyhk
subject to advance security screening
PATYCKUrPfAzy5JAry88KjkD3-yH4eDjPq0h3y_ procedures which require advance 1. Federal eRulemaking Portal:
Hd78M–5m_7oX9Ih2b2mKZHb1A2VTHxo!/?1dmy notice prior to attendance at the public www.regulations.gov. Follow the
&urile=wcm%3apath%3a%2Faphis_content_ meeting. If a foreign national wishes to instructions for submitting comments.
library%2Fsa_about_aphis%2Fsa_stakeholders
%2Fct_coexistence_meeting. A notice announcing
participate in the public meeting, please 2. Email: ASRAC@ee.doe.gov. Include
the workshop was published on February 3, 2015 inform DOE as soon as possible by docket number EERE–2013–BT–NOC–
(80 FR 5729–5731, Docket No. APHIS–2013–0047). contacting Ms. Regina Washington at 0005 in the subject line of the message.
VerDate Sep<11>2014 17:17 Mar 03, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\FR\FM\04MRP1.SGM 04MRP1](https://thefederalregister.org/doc/80_FR_11640/page/2.svg)
Document Created: 2018-02-21 09:31:38
Document Modified: 2018-02-21 09:31:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule; withdrawal. | |
| Dates | Effective March 4, 2015, the proposed rule published on October 9, 2008 (73 FR 60008), is withdrawn. | |
| Contact | Mrs. Chessa Huff-Woodard, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1236; (301) 8513943. | |
| FR Citation | 80 FR 11598 | |
| RIN Number | 0579-AC31 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR