83 FR 37459 - Texas A&M AgriLife Research; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Cotton Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 148 (August 1, 2018)

Page Range		37459-37460
FR Document		2018-16389

We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment a draft plant pest risk assessment (PPRA) and draft environmental assessment (EA) for cotton designated as event TAM66274, which has been genetically engineered for ultra-low gossypol levels in the cottonseed. We are making the draft PPRA and draft EA available for public review and comment.

Federal Register, Volume 83 Issue 148 (Wednesday, August 1, 2018)

[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Notices]
[Pages 37459-37460]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16389]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / 
Notices

[[Page 37459]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2017-0097]


Texas A&M AgriLife Research; Availability of a Draft Plant Pest 
Risk Assessment and Draft Environmental Assessment for Cotton 
Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is making available for public comment a draft plant 
pest risk assessment (PPRA) and draft environmental assessment (EA) for 
cotton designated as event TAM66274, which has been genetically 
engineered for ultra-low gossypol levels in the cottonseed. We are 
making the draft PPRA and draft EA available for public review and 
comment.

DATES: We will consider all comments that we receive on or before 
August 31, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0097.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0097, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-
0097 or in our reading room, which is located in room 1141 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: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under 
APHIS petition 17-292-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, email: john.t.turner@aphis.usda.gov. To obtain copies 
of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
cynthia.a.eck@aphis.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.''
    The regulations in Sec.  340.6(a) provide that 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 
17-292-01p) from Texas A&M AgriLife Research of College Station, TX 
(Texas A&M), seeking a determination of nonregulated status of cotton 
(Gossypium hirsutum) designated as event TAM66274, which has been 
genetically engineered for ultra-low gossypol levels in the cottonseed. 
The Texas A&M petition states that information collected during field 
trials and laboratory analyses indicates that TAM66274 cotton is not 
likely to be a plant pest and therefore should not be a regulated 
article under APHIS' regulations in 7 CFR part 340.
    According to our process \1\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in the Federal 
Register on December 5, 2017 (82 FR 57426-57427, Docket No. APHIS-2017-
0097), APHIS announced the availability of the Texas A&M petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on February 5, 2018, 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. 
APHIS received 47 comments on the petition. Of those, 44 were 
supportive, two opposed, and one was not related to the petition. APHIS 
has evaluated the issues raised during the comment period and, where 
appropriate, has provided a discussion of these issues in our draft 
environmental assessment (EA).
---------------------------------------------------------------------------

    \1\ 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.
    \2\ To view the notice, the petition, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2017-0097.
---------------------------------------------------------------------------

    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), 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

[[Page 37460]]

impact (FONSI), and its draft 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.
    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 will follow Approach 
2. Under Approach 2, APHIS first solicits written comments from the 
public on a draft EA and draft PPRA for a 30-day comment period through 
the publication of a Federal Register notice. Then, after reviewing and 
evaluating the comments on the draft EA and draft PPRA and other 
information, APHIS will revise the PPRA as necessary and 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 are 
using Approach 2.
    As part of our decisionmaking 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, to 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 has prepared a draft PPRA and has concluded that cotton 
designated as event TAM66274, which has been genetically engineered for 
ultra-low gossypol levels in the cottonseed, is 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 submitted by Texas A&M, a 
review of other scientific data, field tests conducted under APHIS 
oversight, and comments received on the petition. APHIS is considering 
the following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of cotton designated as event TAM66274, or 
(2) make a determination of nonregulated status of cotton designated as 
event TAM66274.
    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) U.S. Department of Agriculture 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372).
    In accordance with our process for soliciting public input when 
considering petitions for determinations of nonregulated status for GE 
organisms, we are publishing this notice to inform the public that 
APHIS will accept written comments on our draft EA and our draft PPRA 
regarding the petition for a determination of nonregulated status from 
interested or affected persons for a period of 30 days from the date of 
this notice. Copies of the draft EA and the draft PPRA, as well as the 
previously published petition, are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the 30-day comment period closes, APHIS will review and 
evaluate any information received during the comment period and any 
other relevant information. After reviewing and evaluating the comments 
on the draft EA and the draft PPRA and other information, APHIS will 
revise the PPRA as necessary and prepare a final EA. Based on the final 
EA, APHIS will prepare a NEPA decision document (either a FONSI or a 
notice of intent to prepare an environmental impact statement). If a 
FONSI is reached, APHIS will furnish a response to the petitioner, 
either approving or denying the petition. APHIS will also publish a 
notice in the Federal Register announcing the regulatory status of the 
GE organism and the availability of APHIS' final EA, PPRA, FONSI, and 
our regulatory determination.

    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 26th day of July 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-16389 Filed 7-31-18; 8:45 am]
 BILLING CODE 3410-34-P

37459

Notices Federal Register
Vol. 83, No. 148

Wednesday, August 1, 2018

This section of the FEDERAL REGISTER Washington, DC. Normal reading room According to our process 1 for
contains documents other than rules or hours are 8 a.m. to 4:30 p.m., Monday soliciting public comment when
proposed rules that are applicable to the through Friday, except holidays. To be considering petitions for determinations
public. Notices of hearings and investigations, sure someone is there to help you, of nonregulated status of GE organisms,
committee meetings, agency decisions and please call (202) 799–7039 before APHIS accepts written comments
rulings, delegations of authority, filing of
coming. regarding a petition once APHIS deems
petitions and applications and agency
statements of organization and functions are
The petition is also available on the it complete. In a notice 2 published in
examples of documents appearing in this APHIS website at: http:// the Federal Register on December 5,
section. www.aphis.usda.gov/biotechnology/ 2017 (82 FR 57426–57427, Docket No.
petitions_table_pending.shtml under APHIS–2017–0097), APHIS announced
APHIS petition 17–292–01p. the availability of the Texas A&M
DEPARTMENT OF AGRICULTURE FOR FURTHER INFORMATION CONTACT: Dr. petition for public comment. APHIS
John Turner, Director, Environmental solicited comments on the petition for
Animal and Plant Health Inspection Risk Analysis Programs, Biotechnology 60 days ending on February 5, 2018, in
Service Regulatory Services, APHIS, 4700 River order to help identify potential
[Docket No. APHIS–2017–0097] Road, Unit 147, Riverdale, MD 20737– environmental and interrelated
1236; (301) 851–3954, email: economic issues and impacts that
Texas A&M AgriLife Research; john.t.turner@aphis.usda.gov. To obtain APHIS may determine should be
Availability of a Draft Plant Pest Risk copies of the petition, contact Ms. Cindy considered in our evaluation of the
Assessment and Draft Environmental Eck at (301) 851–3892, email: petition. APHIS received 47 comments
Assessment for Cotton Genetically cynthia.a.eck@aphis.usda.gov. on the petition. Of those, 44 were
Engineered for Ultra-low Gossypol SUPPLEMENTARY INFORMATION: Under the supportive, two opposed, and one was
Levels in the Cottonseed authority of the plant pest provisions of not related to the petition. APHIS has
the Plant Protection Act (7 U.S.C. 7701 evaluated the issues raised during the
AGENCY: Animal and Plant Health et seq.), the regulations in 7 CFR part comment period and, where
Inspection Service, USDA. 340, ‘‘Introduction of Organisms and appropriate, has provided a discussion
ACTION: Notice. Products Altered or Produced Through of these issues in our draft
Genetic Engineering Which Are Plant environmental assessment (EA).
SUMMARY: We are advising the public After public comments are received
Pests or Which There Is Reason to
that the Animal and Plant Health on a completed petition, APHIS
Believe Are Plant Pests,’’ regulate,
Inspection Service is making available evaluates those comments and then
among other things, the introduction
for public comment a draft plant pest provides a second opportunity for
(importation, interstate movement, or
risk assessment (PPRA) and draft public involvement in our
release into the environment) of
environmental assessment (EA) for decisionmaking process. According to
organisms and products altered or
cotton designated as event TAM66274, our public review process (see footnote
produced through genetic engineering
which has been genetically engineered 1), the second opportunity for public
that are plant pests or that there is
for ultra-low gossypol levels in the involvement follows one of two
reason to believe are plant pests. Such
cottonseed. We are making the draft approaches, as described below.
genetically engineered (GE) organisms If APHIS decides, based on its review
PPRA and draft EA available for public
and products are considered ‘‘regulated of the petition and its evaluation and
review and comment.
articles.’’ analysis of comments received during
DATES: We will consider all comments The regulations in § 340.6(a) provide
that we receive on or before August 31, the 60-day public comment period on
that any person may submit a petition the petition, that the petition involves a
2018. to the Animal and Plant Health GE organism that raises no substantive
ADDRESSES: You may submit comments Inspection Service (APHIS) seeking a new issues, APHIS will follow
by either of the following methods: determination that an article should not Approach 1 for public involvement.
• Federal eRulemaking Portal: Go to be regulated under 7 CFR part 340. Under Approach 1, APHIS announces in
http://www.regulations.gov/#!docket APHIS received a petition (APHIS the Federal Register the availability of
Detail;D=APHIS-2017-0097. Petition Number 17–292–01p) from APHIS’ preliminary regulatory
• Postal Mail/Commercial Delivery: Texas A&M AgriLife Research of College determination along with its draft EA,
Send your comment to Docket No. Station, TX (Texas A&M), seeking a preliminary finding of no significant
APHIS–2017–0097, Regulatory Analysis determination of nonregulated status of
and Development, PPD, APHIS, Station cotton (Gossypium hirsutum) designated 1 On March 6, 2012, APHIS published in the
3A–03.8, 4700 River Road Unit 118, as event TAM66274, which has been Federal Register (77 FR 13258–13260, Docket No.
Riverdale, MD 20737–1238. genetically engineered for ultra-low APHIS–2011–0129) a notice describing our public
Supporting documents and any gossypol levels in the cottonseed. The review process for soliciting public comments and
sradovich on DSK3GMQ082PROD with NOTICES

information when considering petitions for
comments we receive on this docket Texas A&M petition states that determinations of nonregulated status for GE
may be viewed at http:// information collected during field trials organisms. To view the notice, go to http://
www.regulations.gov/#!docket and laboratory analyses indicates that www.regulations.gov/#!docketDetail;D=APHIS-
Detail;D=APHIS-2017-0097 or in our TAM66274 cotton is not likely to be a 2011-0129.
2 To view the notice, the petition, and the
reading room, which is located in room plant pest and therefore should not be comments we received, go to http://
1141 of the USDA South Building, 14th a regulated article under APHIS’ www.regulations.gov/#!docketDetail;D=APHIS-
Street and Independence Avenue SW, regulations in 7 CFR part 340. 2017-0097.

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37460 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices

impact (FONSI), and its draft plant pest regulatory status of cotton designated as DEPARTMENT OF AGRICULTURE
risk assessment (PPRA) for a 30-day event TAM66274, or (2) make a
public review period. APHIS will determination of nonregulated status of Forest Service
evaluate any information received cotton designated as event TAM66274.
related to the petition and its supporting Idaho (Boise, Caribou-Targhee,
The draft EA was prepared in Salmon-Challis, and Sawtooth National
documents during the 30-day public
accordance with (1) NEPA, as amended Forests and Curlew National
review period.
If APHIS decides, based on its review (42 U.S.C. 4321 et seq.), (2) regulations Grassland); Nevada (Humboldt-
of the petition and its evaluation and of the Council on Environmental Toiyabe National Forest); Utah (Ashley,
analysis of comments received during Quality for implementing the Dixie, Fishlake, Manti-La Sal, and
the 60-day public comment period on procedural provisions of NEPA (40 CFR Uinta-Wasatch-Cache National
the petition, that the petition involves a parts 1500–1508), (3) U.S. Department Forests); Wyoming (Bridger-Teton
GE organism that raises substantive new of Agriculture regulations implementing National Forest); and Wyoming/
issues, APHIS will follow Approach 2. NEPA (7 CFR part 1b), and (4) APHIS’ Colorado (Medicine Bow-Routt
Under Approach 2, APHIS first solicits NEPA Implementing Procedures (7 CFR National Forest and Thunder Basin
written comments from the public on a part 372). National Grassland); Amendments to
draft EA and draft PPRA for a 30-day Land Management Plans for Greater
In accordance with our process for
comment period through the Sage-Grouse Conservation
soliciting public input when
publication of a Federal Register notice.
considering petitions for determinations AGENCY: Forest Service, USDA.
Then, after reviewing and evaluating the
of nonregulated status for GE organisms, ACTION: Notice to extend the public
comments on the draft EA and draft
PPRA and other information, APHIS we are publishing this notice to inform scoping period for supplemental notice
will revise the PPRA as necessary and the public that APHIS will accept of intent to prepare an environmental
prepare a final EA and, based on the written comments on our draft EA and impact statement; notice of updated
final EA, a National Environmental our draft PPRA regarding the petition information concerning the Forest
Policy Act (NEPA) decision document for a determination of nonregulated Service greater sage-grouse land and
(either a FONSI or a notice of intent to status from interested or affected resource management plan
prepare an environmental impact persons for a period of 30 days from the amendments; correction.
statement). For this petition, we are date of this notice. Copies of the draft
SUMMARY: The USDA Forest Service is
using Approach 2. EA and the draft PPRA, as well as the
As part of our decisionmaking process issuing this notice to advise the public
previously published petition, are
regarding a GE organism’s regulatory of a 14-day extension to the public
available as indicated under ADDRESSES scoping period on the supplemental
status, APHIS prepares a PPRA to assess and FOR FURTHER INFORMATION CONTACT
the plant pest risk of the article. APHIS notice of intent to prepare an
above. environmental impact statement for the
also prepares the appropriate
environmental documentation—either After the 30-day comment period amendments to land management plans
an EA or an environmental impact closes, APHIS will review and evaluate for greater sage-grouse conservation.
statement—in accordance with NEPA, any information received during the DATES: Comments concerning the scope
to provide the Agency and the public comment period and any other relevant of the analysis must be received by
with a review and analysis of any information. After reviewing and August 15, 2018.
potential environmental impacts that evaluating the comments on the draft ADDRESSES: Send written comments to
may result if the petition request is EA and the draft PPRA and other Sage-grouse Amendment Comment,
approved. information, APHIS will revise the USDA Forest Service Intermountain
APHIS has prepared a draft PPRA and PPRA as necessary and prepare a final Region, Federal Building, 324 25th
has concluded that cotton designated as EA. Based on the final EA, APHIS will Street, Ogden, UT 84401.
event TAM66274, which has been prepare a NEPA decision document Comments may also be sent via email
genetically engineered for ultra-low (either a FONSI or a notice of intent to to, comments-intermtn-regional-office@
gossypol levels in the cottonseed, is prepare an environmental impact fs.fed.us, or via facsimile to 801–625–
unlikely to pose a plant pest risk. In statement). If a FONSI is reached, 5277.
section 403 of the Plant Protection Act, APHIS will furnish a response to the FOR FURTHER INFORMATION CONTACT: John
‘‘plant pest’’ is defined as any living petitioner, either approving or denying Shivik at 801–625–5667 or email
stage of any of the following that can
the petition. APHIS will also publish a johnashivik@fs.fed.us. Individuals who
directly or indirectly injure, cause
notice in the Federal Register use telecommunication devices for the
damage to, or cause disease in any plant
announcing the regulatory status of the deaf (TDD) may call the Federal
or plant product: A protozoan, a
GE organism and the availability of Information Relay Service (FIRS) at 1–
nonhuman animal, a parasitic plant, a
APHIS’ final EA, PPRA, FONSI, and our 800–877–8339 between 8 a.m. and 8
bacterium, a fungus, a virus or viroid, an
regulatory determination. p.m., Eastern Time, Monday through
infectious agent or other pathogen, or
Friday.
any article similar to or allied with any Authority: 7 U.S.C. 7701–7772 and 7781–
of the foregoing. 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and SUPPLEMENTARY INFORMATION: The
APHIS has also prepared a draft EA in 371.3. original corrected notice of intent for
which we present two alternatives based public comment on the greater sage-
sradovich on DSK3GMQ082PROD with NOTICES

Done in Washington, DC, this 26th day of
on our analysis of data submitted by July 2018.
grouse plan amendments was published
Texas A&M, a review of other scientific in the Federal Register on July 2, 2018
data, field tests conducted under APHIS Kevin Shea, (83 FR 30909). The original notice of
oversight, and comments received on Administrator, Animal and Plant Health intent provided a 30 day comment
the petition. APHIS is considering the Inspection Service. period, which may be insufficient for
following alternatives: (1) Take no [FR Doc. 2018–16389 Filed 7–31–18; 8:45 am] comment preparation from all interested
action, i.e., APHIS would not change the BILLING CODE 3410–34–P parties. As such, the comment period

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Document Created: 2018-08-01 01:23:16
Document Modified: 2018-08-01 01:23:16

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		Notices
Action		Notice.
Dates		We will consider all comments that we receive on or before August 31, 2018.
Contact		Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation		83 FR 37459

83 FR 37459 - Texas A&M AgriLife Research; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Cotton Genetically Engineered for Ultra-low Gossypol Levels in the Cottonseed

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 83, Issue 148 (August 1, 2018)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service