[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Proposed Rules]
[Pages 51582-51583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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