82_FR_51796 82 FR 51582 - Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms

82 FR 51582 - Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 214 (November 7, 2017)

Page Range51582-51583
FR Document2017-24202

We are withdrawing a proposed rule that would have revised our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. We are taking this action after considering the comments we received following the publication of the proposed rule.

Federal Register, Volume 82 Issue 214 (Tuesday, November 7, 2017)
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Proposed Rules]
[Pages 51582-51583]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24202]


========================================================================
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. 82, No. 214 / Tuesday, November 7, 2017 / 
Proposed Rules

[[Page 51582]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2015-0057]
RIN 0579-AE15


Importation, Interstate Movement, and Environmental Release 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 revised our 
regulations regarding the importation, interstate movement, and 
environmental release of certain genetically engineered organisms. We 
are taking this action after considering the comments we received 
following the publication of the proposed rule.

DATES: We are withdrawing the proposed rule published January 19, 2017 
(82 FR 7008) as of November 7, 2017.

FOR FURTHER INFORMATION CONTACT: Mr. Sidney Abel, Assistant Deputy 
Administrator, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1238; (301) 851-3896.

SUPPLEMENTARY INFORMATION: On January 19, 2017, we published in the 
Federal Register (82 FR 7008-7039, Docket No. APHIS-2015-0057) a 
proposal \1\ to amend the regulations in 7 CFR part 340 regarding the 
importation, interstate movement, and environmental release of certain 
genetically engineered (GE) organisms.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0057.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 120 days ending 
May 19, 2017. We extended the deadline for comments until June 19, 
2017, in a document published in the Federal Register on February 10, 
2017 (Docket No. APHIS-2015-0057, 82 FR 10312-10313). We received 203 
comments by that date. They were from GE developers, growers of GE 
crops, GE industry and agricultural trade associations, universities 
and academic researchers, organic producers and trade associations, 
consumer safety and environmental advocacy groups, a Federal agency, 
and private citizens.
    Many commenters objected to the scope of the proposed rule. Some 
thought that our criteria for designating GE organisms as regulated 
organisms were too expansive, potentially resulting in our regulating a 
wider range of GE organisms than necessary and thereby increasing, 
rather than reducing, the regulatory burden for the biotechnology 
industry. Other commenters, however, thought that certain exemptions 
and exclusions contained in the proposed rule would effectively narrow 
the scope of our regulatory authority over GE organisms and increase 
the risk of the unintended presence of GE crops in organic and other 
non-GE crops.
    The January 2017 proposed rule represented a major change from our 
existing ``regulate first/analyze later'' approach to one that entailed 
assessing new GE organisms to determine if they posed plant pest or 
noxious weed risks and then regulating only organisms that did present 
risks. Some commenters expressed concern that the proposed risk 
assessment process could prove lengthy, cumbersome, and confusing, 
thereby hindering innovation and preventing GE products from getting to 
market in a timely manner. Though we did provide exclusions that would 
have allowed GE organisms with certain plant/trait combinations to 
bypass the risk assessment process, these commenters viewed the 
exclusions as too narrow. Other commenters, however, took the opposite 
view. These commenters objected to our proposed exemption from the risk 
assessment process of products having plant/trait combinations 
corresponding to specific organisms that had been granted nonregulated 
status based on previous risk assessments. A number of these commenters 
also thought the proposed process as a whole would be insufficiently 
rigorous, with some objecting specifically to our proposal to no longer 
require the submission of field test data as part of the assessment 
process.
    Another issue that drew many comments was our proposal to 
incorporate our noxious weed authority into the biotechnology 
regulations in part 340. Noting that noxious weeds are also regulated 
under the Plant Protection and Quarantine regulations in 7 CFR part 
360, commenters expressed concern that this proposal could result in 
the creation of two parallel but inconsistent regulatory systems and 
thus more regulatory uncertainty.
    Finally, many commenters expressed opposition to genetic 
engineering in general, as well as concerns about a wide range of 
issues, many of which were outside the scope of the proposed rule. For 
example, commenters stated that the Animal and Plant Health Inspection 
Service (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 scope of comments received on the January 2017 
proposed rule, we have decided to withdraw the rule and to begin a 
fresh stakeholder engagement aimed at exploring alternative policy 
approaches. Because of rules limiting ex parte communications with 
respect to active rulemakings, publication of the 2017 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 open and robust policy dialogue.
    Therefore, we are withdrawing the January 19, 2017, proposed rule 
referenced above. 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, and continue to seek the active and open 
input of stakeholders.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.


[[Page 51583]]


    Done in Washington, DC, this 1st day of November 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-24202 Filed 11-6-17; 8:45 am]
BILLING CODE 3410-34-P



                                                  51582

                                                  Proposed Rules                                                                                                Federal Register
                                                                                                                                                                Vol. 82, No. 214

                                                                                                                                                                Tuesday, November 7, 2017



                                                  This section of the FEDERAL REGISTER                    document published in the Federal                     no longer require the submission of field
                                                  contains notices to the public of the proposed          Register on February 10, 2017 (Docket                 test data as part of the assessment
                                                  issuance of rules and regulations. The                  No. APHIS–2015–0057, 82 FR 10312–                     process.
                                                  purpose of these notices is to give interested          10313). We received 203 comments by
                                                  persons an opportunity to participate in the                                                                     Another issue that drew many
                                                                                                          that date. They were from GE                          comments was our proposal to
                                                  rule making prior to the adoption of the final
                                                  rules.
                                                                                                          developers, growers of GE crops, GE                   incorporate our noxious weed authority
                                                                                                          industry and agricultural trade                       into the biotechnology regulations in
                                                                                                          associations, universities and academic               part 340. Noting that noxious weeds are
                                                  DEPARTMENT OF AGRICULTURE                               researchers, organic producers and trade              also regulated under the Plant
                                                                                                          associations, consumer safety and                     Protection and Quarantine regulations
                                                  Animal and Plant Health Inspection                      environmental advocacy groups, a                      in 7 CFR part 360, commenters
                                                  Service                                                 Federal agency, and private citizens.                 expressed concern that this proposal
                                                                                                             Many commenters objected to the                    could result in the creation of two
                                                  7 CFR Part 340                                          scope of the proposed rule. Some                      parallel but inconsistent regulatory
                                                  [Docket No. APHIS–2015–0057]
                                                                                                          thought that our criteria for designating             systems and thus more regulatory
                                                                                                          GE organisms as regulated organisms
                                                  RIN 0579–AE15
                                                                                                                                                                uncertainty.
                                                                                                          were too expansive, potentially
                                                                                                          resulting in our regulating a wider range                Finally, many commenters expressed
                                                  Importation, Interstate Movement, and                   of GE organisms than necessary and                    opposition to genetic engineering in
                                                  Environmental Release of Certain                        thereby increasing, rather than reducing,             general, as well as concerns about a
                                                  Genetically Engineered Organisms                        the regulatory burden for the                         wide range of issues, many of which
                                                  AGENCY:  Animal and Plant Health                        biotechnology industry. Other                         were outside the scope of the proposed
                                                  Inspection Service, USDA.                               commenters, however, thought that                     rule. For example, commenters stated
                                                                                                          certain exemptions and exclusions                     that the Animal and Plant Health
                                                  ACTION: Proposed rule; withdrawal.
                                                                                                          contained in the proposed rule would                  Inspection Service (APHIS) should
                                                  SUMMARY:   We are withdrawing a                         effectively narrow the scope of our                   consider non-safety-based risks, such as
                                                  proposed rule that would have revised                   regulatory authority over GE organisms                economic and social impacts, including
                                                  our regulations regarding the                           and increase the risk of the unintended               impacts on the marketability of non-GE
                                                  importation, interstate movement, and                   presence of GE crops in organic and                   products. Other commenters requested
                                                  environmental release of certain                        other non-GE crops.                                   that APHIS regulations include
                                                  genetically engineered organisms. We                       The January 2017 proposed rule                     provisions related to the labeling of GE
                                                  are taking this action after considering                represented a major change from our                   products and raised concerns regarding
                                                  the comments we received following the                  existing ‘‘regulate first/analyze later’’             health effects of GE products and
                                                  publication of the proposed rule.                       approach to one that entailed assessing               increased pesticide use.
                                                  DATES: We are withdrawing the                           new GE organisms to determine if they                    Based on the scope of comments
                                                  proposed rule published January 19,                     posed plant pest or noxious weed risks                received on the January 2017 proposed
                                                  2017 (82 FR 7008) as of November 7,                     and then regulating only organisms that               rule, we have decided to withdraw the
                                                  2017.                                                   did present risks. Some commenters                    rule and to begin a fresh stakeholder
                                                                                                          expressed concern that the proposed                   engagement aimed at exploring
                                                  FOR FURTHER INFORMATION CONTACT:     Mr.                risk assessment process could prove
                                                  Sidney Abel, Assistant Deputy                                                                                 alternative policy approaches. Because
                                                                                                          lengthy, cumbersome, and confusing,                   of rules limiting ex parte
                                                  Administrator, Biotechnology                            thereby hindering innovation and
                                                  Regulatory Services, APHIS, 4700 River                                                                        communications with respect to active
                                                                                                          preventing GE products from getting to                rulemakings, publication of the 2017
                                                  Road Unit 147, Riverdale, MD 20737–                     market in a timely manner. Though we
                                                  1238; (301) 851–3896.                                                                                         proposed rule has constrained our
                                                                                                          did provide exclusions that would have                ability to talk about alternatives with
                                                  SUPPLEMENTARY INFORMATION: On                           allowed GE organisms with certain
                                                  January 19, 2017, we published in the                                                                         stakeholders. Withdrawing the proposed
                                                                                                          plant/trait combinations to bypass the                rule will lift this constraint and provide
                                                  Federal Register (82 FR 7008–7039,                      risk assessment process, these
                                                  Docket No. APHIS–2015–0057) a                                                                                 for a more open and robust policy
                                                                                                          commenters viewed the exclusions as                   dialogue.
                                                  proposal 1 to amend the regulations in 7                too narrow. Other commenters,
                                                  CFR part 340 regarding the importation,                 however, took the opposite view. These                   Therefore, we are withdrawing the
                                                  interstate movement, and environmental                  commenters objected to our proposed                   January 19, 2017, proposed rule
                                                  release of certain genetically engineered               exemption from the risk assessment                    referenced above. As we explore a full
                                                  (GE) organisms.                                         process of products having plant/trait                range of policy alternatives, we will
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                                                    We solicited comments concerning                      combinations corresponding to specific                consider the comments we received on
                                                  our proposal for 120 days ending May                    organisms that had been granted                       the proposed rule, as well as new
                                                  19, 2017. We extended the deadline for                  nonregulated status based on previous                 scientific knowledge, and continue to
                                                  comments until June 19, 2017, in a                      risk assessments. A number of these                   seek the active and open input of
                                                                                                          commenters also thought the proposed                  stakeholders.
                                                    1 To view the proposed rule, supporting

                                                  documents, and the comments we received, go to
                                                                                                          process as a whole would be                             Authority: 7 U.S.C. 7701–7772 and 7781–
                                                  http://www.regulations.gov/#!docketDetail;D=            insufficiently rigorous, with some                    7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
                                                  APHIS-2015-0057.                                        objecting specifically to our proposal to             371.3.



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                                                                       Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Proposed Rules                                                     51583

                                                   Done in Washington, DC, this 1st day of                30, West Building Ground Floor, Room                          We will post all comments we
                                                  November 2017.                                          W12–140, 1200 New Jersey Avenue SE.,                        receive, without change, to http://
                                                  Michael C. Gregoire,                                    Washington, DC 20590.                                       www.regulations.gov, including any
                                                  Acting Administrator, Animal and Plant                    • Hand Delivery: Deliver to Mail                          personal information you provide. We
                                                  Health Inspection Service.                              address above between 9 a.m. and 5                          will also post a report summarizing each
                                                  [FR Doc. 2017–24202 Filed 11–6–17; 8:45 am]             p.m., Monday through Friday, except                         substantive verbal contact we receive
                                                  BILLING CODE 3410–34–P                                  Federal holidays.                                           about this NPRM.
                                                                                                            For service information identified in
                                                                                                          this NPRM, contact Piper Aircraft, Inc.,                    Discussion
                                                  DEPARTMENT OF TRANSPORTATION                            2926 Piper Drive, Vero Beach, Florida                         We received two reports of significant
                                                                                                          32960; telephone: (772) 567–4361;                           corrosion found on the main wing spars
                                                  Federal Aviation Administration                         Internet: www.piper.com. You may                            on certain Piper Aircraft, Inc. Models
                                                                                                          review this referenced service                              PA–28–140, PA–28–150, PA–28–160,
                                                  14 CFR Part 39                                          information at the FAA, Policy and                          PA–28–180, PA–28–235, PA–32–260,
                                                                                                          Innovation Division, 901 Locust, Kansas                     and PA–32–300 airplanes. The
                                                  [Docket No. FAA–2017–1059; Product                      City, Missouri 64106. For information                       corrosion was found during
                                                  Identifier 2017–CE–035–AD]                              on the availability of this material at the                 maintenance in an area that is not easily
                                                  RIN 2120–AA64                                           FAA, call (816) 329–4148.                                   accessible for inspection. This
                                                                                                          Examining the AD Docket                                     condition, if not detected and corrected,
                                                  Airworthiness Directives; Piper                                                                                     could cause the main wing spar to fail.
                                                  Aircraft, Inc. Airplanes                                   You may examine the AD docket on                         This failure could result in loss of
                                                                                                          the Internet at http://                                     control.
                                                  AGENCY: Federal Aviation                                www.regulations.gov by searching for
                                                  Administration (FAA), DOT.                              and locating Docket No. FAA–2017–                           Related Service Information Under
                                                  ACTION: Notice of proposed rulemaking                   1059 or in person at the Docket                             1 CFR Part 51
                                                  (NPRM).                                                 Management Facility between 9 a.m.                             We reviewed Piper Aircraft, Inc.
                                                                                                          and 5 p.m., Monday through Friday,                          Service Bulletin No. 1304, dated August
                                                  SUMMARY:   We propose to adopt a new                    except Federal holidays. The AD docket
                                                  airworthiness directive (AD) for certain                                                                            23, 2017. The service bulletin describes
                                                                                                          contains this NPRM, the regulatory                          procedures for installing an inspection
                                                  Piper Aircraft, Inc. Models PA–28–140,                  evaluation, any comments received, and
                                                  PA–28–150, PA–28–160, PA–28–180,                                                                                    access panel in the lower wing skin near
                                                                                                          other information. The street address for                   the left and the right main wing spars,
                                                  PA–28–235, PA–32–260, and PA–32–                        the Docket Office (phone: 800–647–
                                                  300 airplanes. This proposed AD was                                                                                 if not already there, inspect for
                                                                                                          5527) is in the ADDRESSES section.                          corrosion, and, if corrosion is found,
                                                  prompted by reports of corrosion found                  Comments will be available in the AD
                                                  in an area of the main wing spar not                                                                                taking all necessary corrective actions.
                                                                                                          docket shortly after receipt.                               This service information is reasonably
                                                  easily accessible for inspection. This                  FOR FURTHER INFORMATION CONTACT: Dan
                                                  proposed AD would require installing                                                                                available because the interested parties
                                                                                                          McCully, Aerospace Engineer, FAA,                           have access to it through their normal
                                                  an inspection access panel in the lower                 Atlanta ACO Branch, 1701 Columbia
                                                  wing skin near the left and the right                                                                               course of business or by the means
                                                                                                          Avenue, College Park, Georgia 30337;                        identified in the ADDRESSES section.
                                                  main wing spars if not already there,                   telephone: (404) 474–5548; fax: (404)
                                                  inspecting the left and the right main                  474–5606; email: william.mccully@faa.                       FAA’s Determination
                                                  wing spars for corrosion, and taking all                gov.
                                                  necessary corrective actions. We are                                                                                  We are proposing this AD because we
                                                  proposing this AD to address the unsafe                 SUPPLEMENTARY INFORMATION:                                  evaluated all the relevant information
                                                  condition on these products.                                                                                        and determined the unsafe condition
                                                                                                          Comments Invited                                            described previously is likely to exist or
                                                  DATES: We must receive comments on                                                                                  develop in other products of the same
                                                                                                            We invite you to send any written
                                                  this proposed AD by December 22,                        relevant data, views, or arguments about                    type design.
                                                  2017.                                                   this proposal. Send your comments to
                                                                                                                                                                      Proposed AD Requirements
                                                  ADDRESSES:  You may send comments,                      an address listed under the ADDRESSES
                                                  using the procedures found in 14 CFR                    section. Include ‘‘Docket No. FAA–                            This proposed AD would require
                                                  11.43 and 11.45, by any of the following                2017–1059; Product Identifier 2017–CE–                      accomplishing the actions specified in
                                                  methods:                                                035–AD’’ at the beginning of your                           the service information described
                                                                                                          comments. We specifically invite                            previously.
                                                    • Federal eRulemaking Portal: Go to                   comments on the overall regulatory,                         Costs of Compliance
                                                  http://www.regulations.gov. Follow the                  economic, environmental, and energy
                                                  instructions for submitting comments.                   aspects of this NPRM. We will consider                         We estimate that this proposed AD
                                                    • Fax: 202–493–2251.                                  all comments received by the closing                        affects 11,476 airplanes of U.S. registry.
                                                    • Mail: U.S. Department of                            date and may amend this NPRM                                   We estimate the following costs to
                                                  Transportation, Docket Operations, M–                   because of those comments.                                  comply with this proposed AD:
nshattuck on DSK9F9SC42PROD with PROPOSALS




                                                                                                                        ESTIMATED COSTS
                                                                                                                                                                                          Cost per     Cost on U.S.
                                                                   Action                                  Labor cost                                   Parts cost                        product       operators

                                                  Main wing spar inspection ..............   2 work-hours × $85 per hour =              Not Applicable ................................         $170     $1,950,920
                                                                                               $170 to inspect both wings.




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Document Created: 2018-10-25 10:26:01
Document Modified: 2018-10-25 10:26:01
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule; withdrawal.
DatesWe are withdrawing the proposed rule published January 19, 2017 (82 FR 7008) as of November 7, 2017.
ContactMr. Sidney Abel, Assistant Deputy Administrator, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1238; (301) 851-3896.
FR Citation82 FR 51582 
RIN Number0579-AE15

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