83 FR 26410 - Bayer CropScience LP; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Cotton Genetically Engineered For Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 83, Issue 110 (June 7, 2018)
Animal and Plant Health Inspection Service
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26410-26412 | |
| FR Document | 2018-12187 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Notices] [Pages 26410-26412] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12187] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0073] Bayer CropScience LP; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Cotton Genetically Engineered For Resistance to HPPD- Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- [[Page 26411]] SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary determination regarding a request from Bayer CropScience LP seeking a determination of nonregulated status for cotton designated as event GHB811, which has been genetically engineered for dual resistance to HPPD-inhibitor herbicides (e.g., isoxaflutole) and the herbicide glyphosate. We are also making available for public review and comment our preliminary plant pest risk assessment, draft environmental assessment, and preliminary finding of no significant impact for the preliminary determination of nonregulated status. DATES: We will consider all comments that we receive on or before July 9, 2018. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0073, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737- 1238. The draft environmental assessment, preliminary regulatory determination, preliminary finding of no significant impact, preliminary plant pest risk assessment, and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0073 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. Supporting documents for this petition are also available on the APHIS website at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 17-138-01p. 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: [email protected]. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]. 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 17-138-01p) from Bayer CropScience LP (Bayer) of Research Triangle Park, NC, seeking a determination of nonregulated status of cotton (Gossypium spp.) designated as event GHB811, which has been genetically engineered for dual resistance to HPPD-inhibitor herbicides (e.g., isoxaflutole) and the herbicide glyphosate. The Bayer petition states that information collected during field trials and laboratory analyses indicates that GHB811 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 October 27, 2017 (82 FR 49782-49783, Docket No. APHIS-2017- 0073), APHIS announced the availability of the Bayer petition for public comment. APHIS solicited comments on the petition for 60 days ending on December 26, 2017, 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 eight comments on the petition. One submission was in favor of the GHB811 cotton determination. Seven of the comments expressed a general disapproval of the planting and use of GE crops. Of the seven comments in opposition, two submissions contained attached comments by organizations. 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- 2017-0073. --------------------------------------------------------------------------- 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 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. For this petition, we are using Approach 1. Had APHIS decided, 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 would follow Approach 2. Under Approach 2, APHIS first solicits written comments from the public on a draft EA and preliminary 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 preliminary PPRA and other information, APHIS would revise the preliminary 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). [[Page 26412]] 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 preliminary PPRA and has concluded that cotton designated as event GHB811, which has been genetically engineered for dual herbicides resistance, 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 Bayer, 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 GHB811, or (2) make a determination of nonregulated status of cotton designated as event GHB811. 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 our draft EA and other pertinent scientific data, APHIS has prepared a preliminary FONSI with regard to the preferred alternative identified in the draft EA. Based on APHIS' analysis of field and laboratory data submitted by Bayer, 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 cotton designated as event GHB811 is unlikely to pose a plant pest risk. We have therefore reached a decision to make a preliminary determination of nonregulated status of cotton designated as event GHB811, whereby cotton designated as event GHB811 would no longer be subject to our regulations governing the introduction of certain GE organisms. We are making available for a 30-day review period APHIS' preliminary regulatory determination of cotton designated as event GHB811, along with our preliminary PPRA, draft EA, and preliminary FONSI for the preliminary determination of nonregulated status. The draft EA, preliminary FONSI, preliminary PPRA, and our preliminary determination for cotton designated as event GHB811, as well as the Bayer petition and the comments received on the petition, 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. If, after evaluating the information received, APHIS determines that we have not received substantive new information that would warrant APHIS altering our preliminary regulatory determination or preliminary FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, APHIS will notify the public through an announcement on our website of our final regulatory determination. If, however, APHIS determines that we have received substantive new information that would warrant APHIS altering our preliminary regulatory determination or preliminary FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, then APHIS will conduct the additional analysis and prepare an amended EA, a new FONSI, and/or a revised PPRA, which would be made available for public review in a subsequent notice in the Federal Register, similar to an Approach 2 petition. APHIS will also notify the petitioner. 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 1st day of June 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2018-12187 Filed 6-6-18; 8:45 am] BILLING CODE 3410-34-P
![26410
Notices Federal Register
Vol. 83, No. 110
Thursday, June 7, 2018
This section of the FEDERAL REGISTER Within part 94, § 94.9 contains species or products susceptible to these
contains documents other than rules or requirements governing the importation diseases.
proposed rules that are applicable to the of pork and pork products from regions On February 20, 2018, we published
public. Notices of hearings and investigations, where CSF exists. Section 94.10 in the Federal Register (83 FR 7138,
committee meetings, agency decisions and contains importation requirements for Docket No. APHIS–2017–0098) a
rulings, delegations of authority, filing of
swine from regions where CSF is notice 1 in which we announced the
petitions and applications and agency
statements of organization and functions are considered to exist. Section 94.12 availability for review and comment of
examples of documents appearing in this contains requirements governing the our evaluation of the CSF and SVD
section. importation of pork or pork products status of Japan. We solicited comments
from regions where SVD exists. Section on the notice for 30 days ending on
94.14 prohibits the importation of March 22, 2018. We received no
DEPARTMENT OF AGRICULTURE domestic swine which are moved from comments on our evaluation.
or transit any region in which SVD is Therefore, based on the findings of
Animal and Plant Health Inspection known to exist. our evaluation and the absence of
Service In accordance with §§ 94.9(a)(1) and comments that would lead us to
94.10(a)(1), the Animal and Plant Health reconsider those findings, we are
[Docket No. APHIS–2017–0098] Inspection Service (APHIS) maintains a announcing our determination to add
web-based list of regions which the Japan to the list of regions declared free
Notice of a Determination Regarding of CSF and the list of regions declared
the Classical Swine Fever and Swine Agency considers free of CSF. Sections
94.9(a)(2) and 94.10(a)(2) state that free of SVD. These lists are available on
Vesicular Disease Status of Japan the APHIS website at https://
APHIS will add a region to this list after
AGENCY: Animal and Plant Health it conducts an evaluation of the region www.aphis.usda.gov/aphis/ourfocus/
Inspection Service, USDA. and finds that CSF is not present. animalhealth/animal-and-animal-
product-import-information/ct_animal_
ACTION: Notice. Similarly, in accordance with disease_status.
§ 94.12(a)(1), APHIS maintains a web-
SUMMARY: We are advising the public of based list of regions which the Agency Authority: 7 U.S.C. 450, 7701–7772, 7781–
our determination that Japan is free of 7786, and 8301–8317; 21 U.S.C. 136 and
considers free of SVD. Paragraph (a)(2)
classical swine fever (CSF) and swine 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
of this section states that APHIS will 371.4.
vesicular disease (SVD). Based on an add a region to this list after it conducts
evaluation of the CSF and SVD status of an evaluation of the region and finds Done in Washington, DC, this 1st day of
Japan, which we made available to the June 2018.
that SVD is not present.
public for review and comment through Kevin Shea,
The regulations in § 92.2 contain
a previous notice, the Administrator has Administrator, Animal and Plant Health
requirements for requesting the
determined that CSF and SVD are not Inspection Service.
recognition of the animal health status
present in Japan and that live swine, [FR Doc. 2018–12186 Filed 6–6–18; 8:45 am]
of a region (as well as for the approval
pork, and pork products may safely be BILLING CODE 3410–34–P
of the export of a particular type of
imported into the United States from
animal or animal product to the United
Japan subject to conditions in the
States from a foreign region). If, after
regulations. DEPARTMENT OF AGRICULTURE
review and evaluation of the
DATES: This change in Japan’s CSF and information submitted in support of the Animal and Plant Health Inspection
SVD status will be recognized on July 9, request, APHIS believes the request can Service
2018. be safely granted, APHIS will make its
FOR FURTHER INFORMATION CONTACT: Dr. evaluation available for public comment [Docket No. APHIS–2017–0073]
Kelly Rhodes, Senior Staff Veterinarian, through a document published in the
Bayer CropScience LP; Availability of
Regionalization Evaluation Services, Federal Register. Following the close of
a Preliminary Plant Pest Risk
National Import Export Services, VS, the comment period, APHIS will review
Assessment, Draft Environmental
APHIS, USDA, 4700 River Road Unit 38, all comments received and will make a
Assessment, Preliminary Finding of No
Riverdale, MD 20737–1231; email: final determination regarding the
Significant Impact, and Preliminary
Kelly.Rhodes@aphis.usda.gov; (301) request that will be detailed in another
Determination of Nonregulated Status
851–3315. document published in the Federal
for Cotton Genetically Engineered For
SUPPLEMENTARY INFORMATION: Register.
Resistance to HPPD-Inhibitor
The regulations in 9 CFR part 94 In accordance with that process, Japan Herbicides (e.g., Isoxaflutole) and
(referred to below as the regulations) requested that APHIS evaluate the CSF Glyphosate
govern the importation of certain and SVD disease status of the country.
sradovich on DSK3GMQ082PROD with NOTICES
animals and animal products into the Based on our evaluation, we determined AGENCY: Animal and Plant Health
United States in order to prevent the that Japan is free of both CSF and SVD Inspection Service, USDA.
introduction of various animal diseases, and that the surveillance, prevention, ACTION: Notice.
including classical swine fever (CSF) and control measures implemented by
and swine vesicular disease (SVD). Japan are sufficient to minimize the 1 To view the notice and the supporting
These are dangerous and communicable likelihood of introducing CSF and SVD documents, go to https://www.regulations.gov/
diseases of swine. into the United States via imports of docket?D=APHIS20170098.
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![26412 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
As part of our decisionmaking process preliminary determination of COMMISSION ON CIVIL RIGHTS
regarding a GE organism’s regulatory nonregulated status of cotton designated
status, APHIS prepares a PPRA to assess as event GHB811, whereby cotton Notice of Public Meeting of the Idaho
the plant pest risk of the article. APHIS designated as event GHB811 would no Advisory Committee
also prepares the appropriate longer be subject to our regulations
AGENCY: U.S. Commission on Civil
environmental documentation—either governing the introduction of certain GE
Rights.
an EA or an environmental impact organisms.
We are making available for a 30-day ACTION: Announcement of meeting.
statement—in accordance with NEPA,
to provide the Agency and the public review period APHIS’ preliminary SUMMARY: Notice is hereby given,
with a review and analysis of any regulatory determination of cotton pursuant to the provisions of the rules
potential environmental impacts that designated as event GHB811, along with and regulations of the U.S. Commission
may result if the petition request is our preliminary PPRA, draft EA, and on Civil Rights (Commission) and the
approved. preliminary FONSI for the preliminary Federal Advisory Committee Act
APHIS has prepared a preliminary determination of nonregulated status. (FACA) that a meeting of the Idaho
PPRA and has concluded that cotton The draft EA, preliminary FONSI, Advisory Committee (Committee) to the
designated as event GHB811, which has preliminary PPRA, and our preliminary Commission will be held at 1:00 p.m.
been genetically engineered for dual determination for cotton designated as (Mountain Time) Wednesday, June 20,
herbicides resistance, is unlikely to pose event GHB811, as well as the Bayer 2018, for the purpose of discussing
a plant pest risk. In section 403 of the petition and the comments received on potential civil rights topics of study.
Plant Protection Act, ‘‘plant pest’’ is the petition, are available as indicated
DATES: The meeting will be held on
defined as any living stage of any of the under ADDRESSES and FOR FURTHER
following that can directly or indirectly Wednesday, June 20, 2018, at 1:00 p.m.
INFORMATION CONTACT above. Copies of
injure, cause damage to, or cause MT.
these documents may also be obtained Public Call Information:
disease in any plant or plant product: A from the person listed under FOR Dial: 877–675–4751.
protozoan, a nonhuman animal, a FURTHER INFORMATION CONTACT. Conference ID: 5522721.
parasitic plant, a bacterium, a fungus, a After the 30-day review period closes,
FOR FURTHER INFORMATION CONTACT:
virus or viroid, an infectious agent or APHIS will review and evaluate any
other pathogen, or any article similar to Angelica Trevino at atrevino@usccr.gov
information received during the 30-day
or allied with any of the foregoing. or (213) 894–3437.
review period. If, after evaluating the
APHIS has also prepared a draft EA in SUPPLEMENTARY INFORMATION: This
information received, APHIS determines
which we present two alternatives based that we have not received substantive meeting is available to the public
on our analysis of data submitted by new information that would warrant through the following toll-free call-in
Bayer, a review of other scientific data, APHIS altering our preliminary number: 877–675–4751, conference ID
field tests conducted under APHIS regulatory determination or preliminary number: 5522721. Any interested
oversight, and comments received on FONSI, substantially changing the member of the public may call this
the petition. APHIS is considering the proposed action identified in the draft number and listen to the meeting.
following alternatives: (1) Take no EA, or substantially changing the Callers can expect to incur charges for
action, i.e., APHIS would not change the analysis of impacts in the draft EA, calls they initiate over wireless lines,
regulatory status of cotton designated as APHIS will notify the public through an and the Commission will not refund any
event GHB811, or (2) make a announcement on our website of our incurred charges. Callers will incur no
determination of nonregulated status of final regulatory determination. If, charge for calls they initiate over land-
cotton designated as event GHB811. however, APHIS determines that we line connections to the toll-free
The draft EA was prepared in have received substantive new telephone number. Persons with hearing
accordance with (1) NEPA, as amended information that would warrant APHIS impairments may also follow the
(42 U.S.C. 4321 et seq.), (2) regulations altering our preliminary regulatory proceedings by first calling the Federal
of the Council on Environmental determination or preliminary FONSI, Relay Service at 1–800–877–8339 and
Quality for implementing the substantially changing the proposed providing the Service with the
procedural provisions of NEPA (40 CFR action identified in the draft EA, or conference call number and conference
parts 1500–1508), (3) USDA regulations substantially changing the analysis of ID number.
implementing NEPA (7 CFR part 1b), Members of the public are entitled to
impacts in the draft EA, then APHIS
and (4) APHIS’ NEPA Implementing make comments during the open period
will conduct the additional analysis and
Procedures (7 CFR part 372). Based on at the end of the meeting. Members of
prepare an amended EA, a new FONSI,
our draft EA and other pertinent the public may also submit written
and/or a revised PPRA, which would be
scientific data, APHIS has prepared a comments; the comments must be
made available for public review in a
preliminary FONSI with regard to the received in the Regional Programs Unit
subsequent notice in the Federal
preferred alternative identified in the within 30 days following the meeting.
Register, similar to an Approach 2
draft EA. Written comments may be mailed to the
Based on APHIS’ analysis of field and petition. APHIS will also notify the
Western Regional Office, U.S.
laboratory data submitted by Bayer, petitioner.
Commission on Civil Rights, 300 North
references provided in the petition, Authority: 7 U.S.C. 7701–7772 and 7781– Los Angeles Street, Suite 2010, Los
peer-reviewed publications, information 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and Angeles, CA 90012. They may be faxed
analyzed in the draft EA, the 371.3.
sradovich on DSK3GMQ082PROD with NOTICES
to the Commission at (213) 894–0508, or
preliminary PPRA, comments provided Done in Washington, DC, this 1st day of emailed Angelica Trevino at atrevino@
by the public on the petition, and June 2018. usccr.gov. Persons who desire
discussion of issues in the draft EA, Kevin Shea, additional information may contact the
APHIS has determined that cotton Administrator, Animal and Plant Health Regional Programs Unit at (213) 894–
designated as event GHB811 is unlikely Inspection Service. 3437.
to pose a plant pest risk. We have [FR Doc. 2018–12187 Filed 6–6–18; 8:45 am] Records and documents discussed
therefore reached a decision to make a BILLING CODE 3410–34–P during the meeting will be available for
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Document Created: 2018-06-07 00:50:52
Document Modified: 2018-06-07 00:50:52
| 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 July 9, 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 26410 |
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