80 FR 60613 - Availability of an Environmental Assessment and Finding of No Significant Impact for Field Use of Vaccines Against Avian Influenza H5 Virus Strains

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 194 (October 7, 2015)

Page Range		60613-60614
FR Document		2015-25445

We are advising the public that an environmental assessment has been prepared by the Animal and Plant Health Inspection Service relative to the use of one or more veterinary biological products as a treatment for and as an aid in the reduction of highly pathogenic avian influenza (HPAI) incidence caused by strains such as Eurasian H5 viruses of clade 2.3.4.4 lineage. Any biological products would become part of the measures to reduce the incidence of HPAI in the nation's commercial poultry flocks. Based on the environmental assessment, we have concluded that the use of vaccines as described in the environmental assessment will not have a significant impact on the human environment. We are making this environmental assessment and finding of no significant impact available to the public for review and comment.

Federal Register, Volume 80 Issue 194 (Wednesday, October 7, 2015)

[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60613-60614]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25445]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0062]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Use of Vaccines Against Avian Influenza H5 
Virus Strains

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: We are advising the public that an environmental assessment 
has been prepared by the Animal and Plant Health Inspection Service 
relative to the use of one or more veterinary biological products as a 
treatment for and as an aid in the reduction of highly pathogenic avian 
influenza (HPAI) incidence caused by strains such as Eurasian H5 
viruses of clade 2.3.4.4 lineage. Any biological products would become 
part of the measures to reduce the incidence of HPAI in the nation's 
commercial poultry flocks. Based on the environmental assessment, we 
have concluded that the use of vaccines as described in the 
environmental assessment will not have a significant impact on the 
human environment. We are making this environmental assessment and 
finding of no significant impact available to the public for review and 
comment.

DATES: We will consider all comments that we receive on or before 
November 6, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0062.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0062, 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-2015-
0062 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.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support 
Section, Center for Veterinary Biologics, Policy, Evaluation, and 
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; (301) 851-3426, fax (301) 734-4314.

SUPPLEMENTARY INFORMATION: Under the Virus-Serum-Toxin Act (21 U.S.C. 
151 et seq.), the Animal and Plant Health Inspection Service (APHIS) is 
authorized to promulgate regulations designed to ensure that veterinary 
biological products are pure, safe, potent, and efficacious. Veterinary 
biological products include viruses, serums, toxins, and analogous 
products of natural or synthetic origin, such as vaccines, antitoxins, 
or the immunizing components of microorganisms intended for the 
diagnosis, treatment, or prevention of diseases in domestic animals.
    APHIS issues licenses to qualified establishments that produce 
veterinary biological products and issues permits to importers of such 
products. APHIS also enforces requirements concerning production, 
packaging, labeling, and shipping of these products and sets standards 
for the testing of these products. Regulations concerning veterinary 
biological products are contained in 9 CFR parts 101 to 124.
    Veterinary biological products meeting the requirements of the 
regulations may be considered for addition to the U.S. National 
Veterinary Stockpile (NVS). The NVS is the nation's repository of 
vaccines and other

[[Page 60614]]

critical veterinary supplies and equipment. It exists to augment State 
and local resources in responding to high-consequence livestock 
diseases that could potentially devastate U.S. agriculture, seriously 
affect the economy, and threaten public health. NVS vaccines would be 
used in APHIS programs or under department control or supervision. The 
addition of vaccines to the stockpile would not preclude private 
development and use of other poultry vaccines meeting the requirements 
of the Virus-Serum-Toxin Act.
    The arrival in December 2014 of Eurasian H5 strains of highly 
pathogenic avian influenza (HPAI) and their subsequent dissemination in 
North America caused a catastrophic outbreak in both domestic poultry 
and avian wildlife. It is thought that wild, migratory waterfowl 
carried an H5 virus into North America, which generated reassortants 
(genetic variants resulting from crosses among AI strains) that spilled 
over into the domestic poultry population. The H5 viruses are likely to 
persist within the endemic wild, migratory waterfowl population, which 
is the primary reservoir of the virus. This viral reservoir will 
continue to pose a significant threat to U.S. poultry and avian 
collections.
    Two poultry production sectors, commercial meat turkeys and laying 
chickens, were heavily impacted by these H5 viruses, resulting in the 
loss or destruction of over 48 million birds between December 2014 and 
June 2015. Response by regulatory agencies combined with migration of 
wild waterfowl and the natural disinfectant action of the summer heat 
temporarily halted new disease outbreaks. The return of potentially 
infected migratory waterfowl in autumn, however, may precipitate a new 
round of outbreaks on an expanded national scale.
    Therefore, we are advising the public that we have prepared an 
environmental assessment (EA) entitled ``For Field Use of Avian 
Influenza Vaccines Against Avian Influenza H5 Virus Strains (August 
2015)'' to analyze the potential use of one or more veterinary 
biological products as a treatment for and as an aid in the reduction 
of HPAI incidence caused by H5 strain viruses. We are publishing this 
notice to inform the public that we will accept written comments 
regarding the EA from interested or affected persons for a period of 30 
days from the date of this notice. Based on an individual vaccine's 
risk analysis and the findings in this EA, APHIS would authorize 
deployment (including shipment, field testing, addition to the NVS, and 
use in commercial poultry production) of safe, well-characterized 
biological products upon making a finding of no significant impact 
(FONSI).
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. If APHIS receives substantive comments that were not 
previously considered, the Agency would consider issuing a supplement 
to the EA and FONSI. Because timeliness is essential, it is imperative 
that APHIS authorize shipment and field use of safe, well-characterized 
vaccines as soon as possible, and possibly prior to the close of the 
comment period of this notice.
    Possible Field Use Locations: Where Federal and State authorities 
agree on use.
    The EA has been prepared in accordance with: (1) The National 
Environmental Policy Act of 1969 (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).

    Authority: 21 U.S.C. 151-159.

    Done in Washington, DC, this 1st day of October 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-25445 Filed 10-6-15; 8:45 am]
 BILLING CODE 3410-34-P

Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices 60613

during preenforcement review of an agency If an issue exhaustion question arises in DATES: We will consider all comments
rule. The list should be understood as a litigation, litigants should be given an that we receive on or before November
checklist of potentially relevant factors, not opportunity to demonstrate that some 6, 2015.
a fixed doctrinal formula, and as inapplicable participant adequately raised the issue
where a statute directs otherwise. during the rulemaking or that circumstances ADDRESSES: You may submit comments
Specifically, the list includes consideration exist to justify not requiring issue exhaustion. by either of the following methods:
of whether: And if a court declines to apply issue • Federal eRulemaking Portal: Go to
• The issue was raised by a participant in exhaustion principles to preclude review of http://www.regulations.gov/
the rulemaking other than the litigant.23 new issues, the agency should be given an #!docketDetail;D=APHIS-2015-0062.
• The issue was addressed by the agency opportunity to respond to new objections on • Postal Mail/Commercial Delivery:
on its own initiative in the rulemaking.24 the merits.30 Where application of the issue Send your comment to Docket No.
• The agency failed to address an issue exhaustion doctrine forecloses judicial
that was so fundamental to the rulemaking
APHIS–2015–0062, Regulatory Analysis
review, the Administrative Procedure Act, 5 and Development, PPD, APHIS, Station
proceeding or to the rule’s basis and purpose U.S.C. 553(e), can provide a procedural
that the agency had an affirmative mechanism for the public to raise new issues
3A–03.8, 4700 River Road Unit 118,
responsibility to address it.25 that were not presented to the agency during Riverdale, MD 20737–1238.
• The issue involves an objection that the a rulemaking proceeding: The right to Supporting documents and any
rule violates the U.S. Constitution.26 petition agencies for amendment or repeal of comments we receive on this docket
• It would have been futile to raise the rules. may be viewed at http://
issue during the rulemaking proceeding www.regulations.gov/
because the agency clearly indicated that it [FR Doc. 2015–25570 Filed 10–6–15; 8:45 am]
would not entertain comments on or BILLING CODE 6110–1–P
#!docketDetail;D=APHIS-2015-0062 or
objections regarding that issue.27 in our reading room, which is located in
• The issue could not reasonably be room 1141 of the USDA South Building,
expected to have been raised during the 14th Street and Independence Avenue
rulemaking proceeding because of the DEPARTMENT OF AGRICULTURE SW., Washington, DC. Normal reading
procedures used by the agency.28 room hours are 8 a.m. to 4:30 p.m.,
• The basis for the objection did not exist Animal and Plant Health Inspection
Monday through Friday, except
at a time when rulemaking participants could Service
raise it in a timely comment.29
holidays. To be sure someone is there to
[Docket No. APHIS–2015–0062] help you, please call (202) 799–7039
23 See Portland Gen. Elec. Co. v. Bonneville Power
before coming.
Admin., 501 F.3d 1009, 1024 (9th Cir. 2007) (‘‘In Availability of an Environmental FOR FURTHER INFORMATION CONTACT: Dr.
general, we will not invoke the waiver rule in our Assessment and Finding of No Donna Malloy, Operational Support
review of a notice-and-comment proceeding if an Significant Impact for Field Use of
agency has had an opportunity to consider the Section, Center for Veterinary Biologics,
issue. This is true even if the issue was considered
Vaccines Against Avian Influenza H5 Policy, Evaluation, and Licensing, VS,
sua sponte by the agency or was raised by someone Virus Strains APHIS, 4700 River Road Unit 148,
other than the petitioning party.’’). Riverdale, MD 20737–1231; (301) 851–
24 Id. AGENCY: Animal and Plant Health
25 See NRDC v. EPA, 755 F.3d 1010, 1023 (D.C. Inspection Service, USDA. 3426, fax (301) 734–4314.
Cir. 2014) (‘‘EPA retains a duty to examine key ACTION: Notice of availability and SUPPLEMENTARY INFORMATION: Under the
assumptions as part of its affirmative burden of Virus-Serum-Toxin Act (21 U.S.C. 151
promulgating and explaining a nonarbitrary, non- request for comments.
capricious rule . . .’’) (internal quotation marks
et seq.), the Animal and Plant Health
omitted). This factor may include issues arising SUMMARY: We are advising the public Inspection Service (APHIS) is
under the applicable substantive statute or the APA. that an environmental assessment has authorized to promulgate regulations
26 Cf., Noel Canning v. NLRB, 705 F.3d 490, 497
been prepared by the Animal and Plant designed to ensure that veterinary
(D.C. Cir. 2013), aff’d NLRB v. Noel Canning, 134
S. Ct. 2550 (2014) (invoking ‘‘extraordinary Health Inspection Service relative to the biological products are pure, safe,
circumstances’’ exception in statutory provision use of one or more veterinary biological potent, and efficacious. Veterinary
requiring issue exhaustion to address constitutional products as a treatment for and as an aid biological products include viruses,
issue not raised with the NLRB because the issue in the reduction of highly pathogenic serums, toxins, and analogous products
went to the very power of the agency to act and
implicated fundamental separation of powers avian influenza (HPAI) incidence of natural or synthetic origin, such as
concerns). It is worth emphasizing that regardless caused by strains such as Eurasian H5 vaccines, antitoxins, or the immunizing
of whether the issue exhaustion doctrine would viruses of clade 2.3.4.4 lineage. Any components of microorganisms
apply, participants in a rulemaking should raise
constitutional issues during the rulemaking biological products would become part intended for the diagnosis, treatment, or
proceeding to give the agency an opportunity to of the measures to reduce the incidence prevention of diseases in domestic
adjust its rule to eliminate the constitutional of HPAI in the nation’s commercial animals.
objection or at least to explain in the administrative poultry flocks. Based on the APHIS issues licenses to qualified
record why its rule does not raise constitutional
concerns. environmental assessment, we have establishments that produce veterinary
27 See Comite De Apoyo A Los Trabajadores concluded that the use of vaccines as biological products and issues permits
Agricolas v. Solis, No. 09–240, 2010 WL 3431761, described in the environmental to importers of such products. APHIS
at *18 (E.D. Pa. Aug. 31, 2010); cf. WATCH v. FCC, assessment will not have a significant also enforces requirements concerning
712 F.2d 677, 682 (D.C. Cir. 1983) (remarking that production, packaging, labeling, and
‘‘[a] reviewing court . . . may in some cases impact on the human environment. We
consider arguments that it would have been futile are making this environmental shipping of these products and sets
to raise before the agency,’’ but cautioning that assessment and finding of no significant standards for the testing of these
‘‘[f]utility should not lightly be presumed’’). products. Regulations concerning
asabaliauskas on DSK5VPTVN1PROD with NOTICES

28 See Alaska Survival v. Surface Transp. Bd., 705
impact available to the public for review
and comment. veterinary biological products are
F.3d 1073 (9th Cir. 2013) (declining to apply issue
exhaustion because the agency’s procedures were contained in 9 CFR parts 101 to 124.
informal and ‘‘never provided direct notice of or 30 Courts have a variety of options for soliciting Veterinary biological products
requested public comment’’ on challenged issue). the agency’s views that should vary depending on meeting the requirements of the
29 Cf. CSX Transp., Inc., v. Surface Transp. Bd., the circumstances. These options include regulations may be considered for
584 F.3d 1076, 1079–81 (D.C. Cir. 2009) (declining permitting the agency to brief the issue or
to apply issue exhaustion to a litigant’s argument supplement the administrative record, or ordering
addition to the U.S. National Veterinary
that the final rule was not a logical outgrowth of a remand for the limited purpose of soliciting the Stockpile (NVS). The NVS is the
the noticed rule). agency’s views. nation’s repository of vaccines and other

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Document Created: 2015-12-15 08:49:21
Document Modified: 2015-12-15 08:49:21

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 of availability and request for comments.
Dates		We will consider all comments that we receive on or before November 6, 2015.
Contact		Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737- 1231; (301) 851-3426, fax (301) 734-4314.
FR Citation		80 FR 60613

80 FR 60613 - Availability of an Environmental Assessment and Finding of No Significant Impact for Field Use of Vaccines Against Avian Influenza H5 Virus Strains

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 194 (October 7, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service