Westhoff Vertriebsgesellschaft mbH; Availability of Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, and Preliminary Finding of No Significant Impact for Determination of Nonregulated Status of Petunias Genetically Engineered for Flower Color
| Citation | 85 FR 60755 |
| Published date | 28 September 2020 |
| Record Number | 2020-21357 |
| Section | Notices |
| Court | Animal And Plant Health Inspection Service |
60755
Federal Register / Vol. 85, No. 188 / Monday, September 28, 2020 / Notices
1
To view the final rule, go to http://
www.regulations.gov/#!docketDetail;D=APHIS-
2018-0034.
2
On March 6, 2012, APHIS published in the
Federal Register (77 FR 13258–13260, Docket No.
APHIS–2011–0129) a notice describing our public
review process for soliciting public comments and
information when considering petitions for
determinations of nonregulated status for GE
organisms. To view the notice, go to http://
www.regulations.gov/#!docketDetail;D=APHIS-
2011-0129.
3
To view the notice, its supporting document,
and the comments we received, go to http://
www.regulations.gov/#!docketDetail;D=APHIS-
2019-0037.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2019–0037]
Westhoff Vertriebsgesellschaft mbH;
Availability of Preliminary Plant Pest
Risk Assessment, Draft Environmental
Assessment, and Preliminary Finding
of No Significant Impact for
Determination of Nonregulated Status
of Petunias Genetically Engineered for
Flower Color
AGENCY
: Animal and Plant Health
Inspection Service, USDA.
ACTION
: Notice.
SUMMARY
: We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a
preliminary plant pest risk assessment,
draft environmental assessment, and
preliminary finding of no significant
impact regarding a request from
Westhoff Vertriebsgesellschaft mbH
seeking a determination of nonregulated
status of petunias containing the A1
gene from maize (A1–DFR Petunias),
which have been genetically engineered
to add a new color (orange) and
brilliance to the flowers. We are making
these documents available for public
review and comment.
DATES
: We will consider all comments
that we receive on or before October 28,
2020.
ADDRESSES
: You may submit comments
by either of the following methods:
•Federal eRulemaking Portal: Go to
http://www.regulations.gov/
#!docketDetail;D=APHIS-2019-0037.
•Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2019–0037, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
The preliminary plant pest risk
assessment, draft environmental
assessment, and any comments we
receive on this docket may be viewed at
http://www.regulations.gov/
#!docketDetail;D=APHIS-2019-0037 or
in our reading room, which is located in
Room 1620 of the USDA South
Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal
reading room hours are 8 a.m. to 4:30
p.m., Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
The petition is also available on the
APHIS website at: https://
www.aphis.usda.gov/aphis/ourfocus/
biotechnology/permits-notifications-
petitions/petitions/petition-status under
APHIS petition 19–099–01p.
FOR FURTHER INFORMATION CONTACT
: Ms.
Cynthia Eck, Team Lead,
Communications Group, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 146, Riverdale, MD 20737–
1236; (301) 851–3892; cynthia.a.eck@
usda.gov.
SUPPLEMENTARY INFORMATION
: Under the
authority of the plant pest provisions of
the Plant Protection Act (7 U.S.C. 7701
et seq.), the regulations in 7 CFR part
340, ‘‘Introduction of Organisms and
Products Altered or Produced Through
Genetic Engineering Which Are Plant
Pests or Which There Is Reason to
Believe Are Plant Pests,’’ regulate,
among other things, the introduction
(importation, interstate movement, or
release into the environment) of
organisms and products altered or
produced through genetic engineering
that are plant pests or that there is
reason to believe are plant pests. Such
genetically engineered (GE) organisms
and products are considered ‘‘regulated
articles.’’
Pursuant to the terms set forth in a
final rule published in the Federal
Register on May 17, 2020 (85 FR 29790–
29838, Docket No. APHIS–2018–0034),
1
any person may submit a petition to the
Animal and Plant Health Inspection
Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
APHIS received a petition (APHIS
Petition Number 19–099–01p) from
Westhoff Vertriebsgesellschaft mbH
(Westhoff) seeking a determination of
nonregulated status for petunias
containing the A1 gene from maize (A1–
DFR Petunias), which have been
genetically engineered to add a new
color (orange) and brilliance to the
flowers. The Westhoff petition stated
that the plants with the new flower
color and brilliance are unlikely to pose
a plant pest risk and, therefore, should
not be considered a regulated article
under APHIS’ regulations in part 340.
According to our process
2
for
soliciting public comment when
considering petitions for determination
of nonregulated status of GE organisms,
APHIS accepts written comments
regarding a petition once APHIS deems
it complete. On July 25, 2019, we
published in the Federal Register (84
FR 35849–35850, Docket No. APHIS–
2019–0037) a notice
3
regarding the
availability of the Westhoff petition for
public comment. APHIS solicited
comments on the petition for 60 days
ending September 23, 2019, in order to
help identify potential environmental
and interrelated economic issues and
impacts that APHIS may determine
should be considered in our evaluation
of the petition.
Nine comments were received. Seven
were supportive of the petition, while
two were opposed but did not discuss
the petition itself. APHIS evaluated the
issues raised during the initial comment
period and, where appropriate,
provided a discussion of these issues in
our draft environmental assessment
(EA).
After public comments are received
on a completed petition, APHIS
evaluates those comments and then
provides a second opportunity for
public involvement in our decision-
making process.
According to our public review
process (see footnote 2), the second
opportunity for public involvement
follows one of two approaches, as
described below.
If APHIS decides, based on its review
of the petition and its evaluation and
analysis of comments received during
the 60-day public comment period on
the petition, that the petition involves a
GE organism that raises no substantive
new issues, APHIS will follow
Approach 1 for public involvement.
Under Approach 1, APHIS announces in
the Federal Register the availability of
APHIS’ preliminary regulatory
determination along with its draft EA,
preliminary finding of no significant
impact (FONSI), and its preliminary
plant pest risk assessment (PPRA) for a
30-day public review period. APHIS
will evaluate any information received
related to the petition and its supporting
documents during the 30-day public
review period.
Under Approach 2, if APHIS decides,
based on its review of the petition and
its evaluation and analysis of comments
received during the 60-day public
comment period on the petition, that the
petition involves a GE organism that
raises substantive new issues, APHIS
first solicits written comments from the
public on a draft EA and preliminary
PPRA for a 30-day comment period
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60756
Federal Register / Vol. 85, No. 188 / Monday, September 28, 2020 / Notices
through the publication of a Federal
Register notice. Then, after reviewing
and evaluating the comments on the
draft EA and preliminary PPRA and
other information, APHIS will revise the
preliminary PPRA as necessary. It will
then prepare a final EA, and based on
the final EA, a National Environmental
Policy Act (NEPA) decision document
(either a FONSI or a notice of intent to
prepare an environmental impact
statement).
For this petition, we will be following
Approach 1.
As part of our decision-making
process regarding a GE organism’s
regulatory status, APHIS prepares a
PPRA to assess the plant pest risk of the
article. APHIS also prepares the
appropriate environmental
documentation—either an EA or an
environmental impact statement—in
accordance with NEPA. This will
provide the Agency and the public with
a review and analysis of any potential
environmental impacts that may result
if the petition request is approved.
APHIS concludes in its preliminary
PPRA that A1–DFR Petunias, which as
stated above have been genetically
engineered for the new color orange and
brilliance are unlikely to pose a plant
pest risk. In section 403 of the Plant
Protection Act, ‘‘plant pest’’ is defined
as any living stage of any of the
following that can directly or indirectly
injure, cause damage to, or cause
disease in any plant or plant product: A
protozoan, a nonhuman animal, a
parasitic plant, a bacterium, a fungus, a
virus or viroid, an infectious agent or
other pathogen, or any article similar to
or allied with any of the foregoing.
APHIS has also prepared a draft EA in
which we present two alternatives based
on our analysis of data Westhoff
submitted, a review of other scientific
data, field tests conducted under
APHIS’ oversight, and comments
received on the petition (see footnote 3).
APHIS is considering the following
alternatives: (1) Take no action, i.e.,
APHIS would not change the regulatory
status of A1–DFR Petunias, or (2) make
a determination of nonregulated status
for A1–DFR Petunias.
The draft EA was prepared in
accordance with (1) NEPA, as amended
(42 U.S.C. 4321 et seq.), (2) regulations
of the Council on Environmental
Quality for implementing the
procedural provisions of NEPA (40 CFR
parts 1500–1508), (3) USDA regulations
implementing NEPA (7 CFR part 1b),
and (4) APHIS’ NEPA Implementing
Procedures (7 CFR part 372).
Based on APHIS’ analysis of field and
laboratory data submitted by Westhoff,
references provided in the petition,
peer-reviewed publications, information
analyzed in the draft EA, the
preliminary PPRA, comments provided
by the public on the petition, and
discussion of issues in the draft EA,
APHIS has determined that petunias
designated as event A1–DFR are
unlikely to pose a plant pest risk.
We are making available for a 30-day
review period our preliminary
determination, draft EA, preliminary
FONSI, and our PPRA. The preliminary
determination, draft EA, preliminary
FONSI, and PPRA are available as
indicated under
ADDRESSES
and
FOR
FURTHER INFORMATION CONTACT
above.
Copies of these documents may also be
obtained from the person listed under
FOR FURTHER INFORMATION CONTACT
.
After the 30-day review period closes,
APHIS will review and evaluate any
information received during the 30-day
review period.
(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 16th day of
September 2020.
Mark Davidson,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2020–21357 Filed 9–25–20; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2017–0069]
International Trade Data System:
Timeline for Enforcing APHIS Core
Message Set Flags in the Automated
Commercial Environment
AGENCY
: Animal and Plant Health
Inspection Service, USDA.
ACTION
: Notice.
SUMMARY
: The Animal and Plant Health
Inspection Service (APHIS) is
announcing a delay in the full
implementation of the APHIS Core
Message Set in the Automated
Commercial Environment/International
Trade Data System (ACE/ITDS) for the
electronic submission of data required
by APHIS Animal Care, Biotechnology
Regulatory Services, Plant Protection
and Quarantine, and Veterinary
Services. APHIS intended to begin
applying Harmonized Tariff Schedule
flags, which would alert filers who
opted to submit electronically using
ACE whether APHIS import data is or
may be required, on August 3, 2020.
Due to the COVID–19 pandemic, APHIS
is delaying implementation until
January 25, 2021. Full implementation
of the message set will bring APHIS into
compliance with the mandates of the
Security and Accountability For Every
Port Act of 2006 and Executive Order
13659. The information collected will
enhance APHIS’ ability to make data-
driven policy decisions, improve risk
analysis/assessments, and enhance
ability to respond to changing pest/
disease conditions.
DATES
: APHIS will begin full
implementation of the APHIS Core
Message Set on January 25, 2021.
FOR FURTHER INFORMATION CONTACT
: Mr.
Richard Leshin, APHIS Liaison for
Automated Commercial Environment,
International Trade Data System,
Management and Program Analyst,
Quarantine Policy, Analysis and
Support, PPQ, APHIS, 4700 River Road
Unit 60, Riverdale, MD 20737; (301)
851–2085; Richard.Leshin@usda.gov.
SUPPLEMENTARY INFORMATION
:
Background
The National Customs Automation
Program (NCAP) was established in
Subtitle B of Title VI-Customs
Modernization, in the North American
Free Trade Agreement Implementation
Act (Pub. L. 103–182, 107 Stat. 2057,
2170, December 8, 1993; see 19 U.S.C.
1411). Through NCAP, the initial thrust
of customs modernization was on trade
compliance and the development of the
Automated Commercial Environment
(ACE), the planned successor to the
Automated Commercial System. ACE is
an automated and electronic system for
commercial trade processing intended
to streamline business processes,
facilitate growth in trade, ensure cargo
security, and foster participation in
global commerce, while ensuring
compliance with U.S. laws and
regulations and reducing costs for U.S.
Customs and Border Protection (CBP)
and all of its communities of interest.
The ability to meet these objectives
depends on successfully modernizing
CBP’s business functions and the
information technology that supports
those functions.
The International Trade Data System
(ITDS) is authorized by section 405 of
the Security and Accountability For
Every Port Act of 2006 (SAFE Port Act,
Pub. L. 109–347). The purpose of ITDS,
as defined by section 405 of the SAFE
Port Act, is to eliminate redundant
information filing requirements,
efficiently regulate the flow of
commerce, and effectively enforce laws
and regulations relating to international
trade, by establishing a single portal
system, operated by CBP, for the
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