[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Proposed Rules]
[Pages 33567-33570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13152]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 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.
 
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 

  Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / 
Proposed Rules  

[[Page 33567]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 2

[Docket No. APHIS-2020-0101]
RIN 0579-AC69


Handling of Animals; Contingency Plans

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Animal and Plant Health Inspection Service issued a final 
rule on December 31, 2012, to establish regulations under which 
research facilities and dealers, exhibitors, intermediate handlers, and 
carriers must meet certain requirements for contingency planning and 
training of personnel. Implementation of the final rule was stayed on 
July 31, 2013, so that the agency could conduct additional review to 
further consider the impact of contingency plan requirements on 
regulated entities. Since that time, we have conducted such a review, 
and the 2021 Congressional Appropriations Act has required us to 
propose to lift the stay. We are therefore proposing to lift the stay 
and make minor revisions to the requirements in order to update 
compliance dates and clarify intent. The lifting of the stay and 
proposed revisions would better ensure that entities responsible for 
animals regulated under the Animal Welfare Act are prepared to 
safeguard the health and welfare of such animals in the event of 
possible emergencies or disasters.

DATES: We will consider all comments that we receive on or before 
August 24, 2021.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2020-0101 in the Search field.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0101, 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 www.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT: Dr. Elizabeth Theodorson, DVM, MPH, 
Assistant Deputy Administrator, Animal Care, APHIS, 4700 River Road 
Unit 86, Riverdale, MD 20737; (970) 494-7473.

SUPPLEMENTARY INFORMATION:

Background

    Under the Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.), the 
Secretary of Agriculture is authorized to promulgate standards and 
other requirements governing the humane handling, care, treatment, and 
transportation of certain animals by dealers, research facilities, 
exhibitors, carriers, and intermediate handlers. The Secretary has 
delegated authority for administering the AWA to the Administrator of 
the U.S. Department of Agriculture's (USDA's) Animal and Plant Health 
Inspection Service (APHIS). Within APHIS, the responsibility for 
administering the AWA has been delegated to the Deputy Administrator 
for APHIS' Animal Care program (AC). Regulations and standards 
established under the AWA are contained in 9 CFR parts 1, 2, and 3 
(referred to below as the regulations).
    Following the events experienced during the 2005 hurricane season, 
AC concluded that entities responsible for animals covered by the AWA 
could better safeguard the health and welfare of their animals by 
developing contingency plans for possible emergencies or disasters 
(situations which could reasonably be anticipated and expected to be 
detrimental to the good health and well-being of the animals in the 
regulated entity's possession). Consequently, on December 31, 2012, 
APHIS published in the Federal Register (77 FR 76815-76824, Docket No. 
APHIS-2006-0159) a final rule \1\ establishing regulations under which 
research facilities and dealers, exhibitors, intermediate handlers, and 
carriers of animals regulated under the AWA must meet certain 
requirements for developing contingency plans and training personnel in 
their role and responsibilities related to the contingency plan.
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    \1\ To view the final rule, go to https://www.regulations.gov/document/APHIS-2006-0159-0209.
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    After learning that a number of small entities considered the 
requirements of these regulations excessive for their specific cases, 
and determining there to be validity to such a claim, on July 31, 2013, 
we published in the Federal Register (78 FR 46255, Docket No. APHIS-
2006-0159) a stay \2\ of the regulations to reexamine any unique 
circumstances and costs that may vary by the type and size of 
businesses affected by the final rule.
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    \2\ To view the stay of the regulations, go to https://www.regulations.gov/document/APHIS-2006-0159-0214.
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    Since that time, APHIS has issued de minimis exemptions to animal 
licensure. On June 4, 2018, we published in the Federal Register (83 FR 
25549-25555, Docket No. APHIS-2014-0059) a final rule \3\ that exempted 
from licensing dealers with four or fewer breeding female pet animals, 
small exotic or small wild mammals (such as hedgehogs, degus, spiny 
mice, prairie dogs, flying squirrels, jerboas, domesticated ferrets, 
chinchillas, and gerbils), and/or domesticated farm-type animals (such 
as cows, goats, pigs, sheep, llamas, and alpacas), and added an 
exemption from licensing for exhibitors who maintained eight or fewer 
pet animals, small exotic or small wild mammals, and/or domesticated 
farm-type animals for exhibition.
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    \3\ To view the final rule, go to https://www.regulations.gov/document/APHIS-2014-0059-0032.
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    Following issuance of the 2018 final rule, APHIS notified 525 
licensees operating small businesses that they may be newly eligible 
for exemption from requirements under the amended regulations. As of 
December 2020, 259 licensees have canceled their licenses, and we 
anticipate that this number will increase on a rolling basis as 
licenses meet their expiration dates. APHIS believes that these 
broadened exemptions address the concerns that led to the stay, and 
that contingency

[[Page 33568]]

planning requirements remain an important safeguard for the health and 
welfare of animals regulated under the AWA.
    Additionally, on December 27, 2020, the 2021 Congressional 
Appropriations Act (Pub. L. 116-260) required APHIS to propose to lift 
the stay on the final rule establishing requirements for contingency 
plans within 180 days of issuance of that Act. Consistent with our own 
evaluation, as well as the terms of the Act, we are issuing this 
proposed rule to lift the stay.
    We are also proposing to make minor changes to the contingency plan 
regulations. These changes include updating the compliance dates by 
which regulated entities must create their contingency plans to 180 
days after the effective date of a final rule following this proposed 
rule; modifying the dates regarding when regulated entities must 
provide training to personnel to 60 days after the contingency plan 
being put in place; removing an extraneous reference to additional 
requirements for marine mammals to minimize confusion; and removing the 
requirement that facilities as well as dealers, exhibitors, 
intermediate handlers, and carriers document their personnel's 
participation in requisite trainings.
    Finally, to increase the ease of and decrease the time burden 
associated with contingency planning, AC has created an optional form 
that entities may use to develop and document a contingency plan. The 
form would be available on the APHIS AC website, in the USDA Forms 
library on the USDA website, or upon request by email to 
[email protected] or by mail to USDA/APHIS/AC, 2150 Centre Ave., 
Building B, Mailstop 3W11, Fort Collins, CO 80526-8117. We are 
proposing to add a reference to this form in the regulations.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget. Details on the estimated costs of 
this proposed rule can be found in the rule's economic analysis.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides an initial regulatory flexibility analysis that examines 
the potential economic effects of this rule on small entities, as 
required by the Regulatory Flexibility Act. The economic analysis is 
summarized below. Copies of the full analysis are available by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT or 
on the Regulations.gov website (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic impact on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kinds of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    While it is difficult to quantify the benefits of contingency 
planning, they are numerous. First, contingency planning can prevent 
loss of animal life and any resulting undisposed carcasses that pose a 
threat to public health. Second, loss of valuable research resources 
and income can be mitigated with contingency planning. Third, having a 
contingency plan can reduce the time of recovery from disasters and 
thus provide cost savings to the affected businesses and organizations 
and allow for business continuity. Finally, required contingency 
planning will reassure the general public that facilities have measures 
in place to ensure the welfare of the animals in times of catastrophic 
and common emergencies.
    APHIS' AC program will be providing a fillable form that can be 
used to develop and document the contingency plan; however, entities 
that have contingency plans in place may use those. For example, we 
believe that Public Health Service-funded research facilities and 
Association of Zoos and Aquariums zoos and aquariums have already 
developed contingency plans; they would not need to adopt the template. 
The template is intended to aid entities currently without a written 
contingency plan, and we estimate it will take 1-2 hours per entity to 
complete the plan, which includes the time to collect and document the 
required information. We anticipate that the use of this form will 
improve compliance and expedite the time for annual review by regulated 
entities of the plan. APHIS also estimates it will take up to 1 hour to 
train employees on the operations of the plan, which consists of 
familiarizing employees with their roles and responsibilities as 
outlined in the plan. APHIS invites comments on the time it may take to 
develop and implement contingency plans for the proposed rule and to 
provide the employee training required by the proposed rule. The Agency 
invites suggestions for guidance or other information that would help 
regulated facilities achieve compliance at minimum costs.
    We estimated lower and upper range estimates of costs for licensees 
and registrants to develop contingency plans in the first year. As 
noted above, we assume an average of 1 to 2 hours is required to 
prepare and implement a contingency plan using the form and 1 hour for 
employee training in the first year. We multiplied this time by the 
average industry-specific wage rate of the entities. Our estimate of 
the total one-time cost to develop the contingency plans across all 
affected entity categories ranges from about $185,000 to about $370,000 
and $185,000 for employee training, as well as possible capital costs, 
which will differ from entity to entity and which we accordingly are 
not able to estimate in aggregate. These estimates may be high, given 
our inclusion of entities that may currently have comparable 
contingency plans and already provide employee training, but for which 
we lack verifying information. We request specific public comment on 
our estimates.
    The 1 to 2 hours that we assume would be required to develop a 
contingency plan includes the time needed to identify resources for the 
plan's preparation and documentation. The 1-hour training estimate for 
all current and new employees considers the time it would take an 
employee to become familiar with their roles and responsibilities as 
outlined in the plan. The costs included in this analysis reflect 
training for the first year only. Contingency planning also requires 
recordkeeping, ensuring that the contingency plans are kept current, 
and employee training. The type of training and type of contingency 
plan required may differ depending on the type of organization or 
business, as well as its location and the location's climate history.

[[Page 33569]]

Executive Order 12372
    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)
Executive Order 12988
    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. It is not intended to have retroactive effect. 
The Act does not provide administrative procedures which must be 
exhausted prior to a judicial challenge to the provisions of this rule.
National Environmental Policy Act
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with 
contingency planning, we have prepared an environmental assessment. The 
environmental assessment was 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).
    The environmental assessment may be viewed on the Regulations.gov 
website or in our reading room. (A link to Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this proposed rule.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.
Executive Order 13175
    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' Executive Order 13175 requires Federal agencies 
to consult and coordinate with Tribes on a government-to-government 
basis on policies that have Tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes.
    Based on the foregoing, the USDA's Office of Tribal Relations (OTR) 
has assessed the impact of this rule on Indian Tribes and determined 
that consultation is not required at this time. If consultation is 
requested, OTR will work with APHIS to ensure quality consultation is 
provided.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Written comments and recommendations for the proposed information 
collection should be sent within 60 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. Please send a copy of your 
comments to: (1) Docket No. APHIS-2020-0101, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, Room 
404-W, 14th Street and Independence Avenue SW, Washington, DC 20250. A 
comment to OMB is best assured of having its full effect if OMB 
receives it within 30 days of publication of this proposed rule.
    The proposed rule would amend the current regulations and would 
require all licensees and registrants, which include research 
facilities, dealers, exhibitors, intermediate handlers, and carriers, 
to develop, document, and maintain contingency plans for the handling 
of animals during all emergencies or disasters.
    We are soliciting comments from the public (as well as affected 
agencies) concerning the new proposed optional APHIS form for creating 
and documenting them, as well as our proposed information collection 
and recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public burden for this collection of 
information is estimated to average 1.75 hours per response.
    Respondents: Dealers, exhibitors, research facilities, carriers, 
and intermediate handlers.
    Estimated annual number of respondents: 8,795.
    Estimated annual number of responses per respondent: 2.
    Estimated annual number of responses: 17,590.
    Estimated total annual burden on respondents: 30,783 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    A copy of the information collection may be viewed on the 
Regulations.gov website or in our reading room. (A link to 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) A copy may also be obtained from Mr. Joseph 
Moxey, APHIS' Paperwork Reduction Act Coordinator, at (301) 851-2483. 
APHIS will respond to any ICR-related comments in the final rule. All 
comments will also become a matter of public record.
E-Government Act Compliance
    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mr. Joseph 
Moxey, APHIS' Paperwork Reduction Act Coordinator, at (301) 851-2483.

List of Subjects in 9 CFR Part 2

    Animal welfare, Pets, Reporting and recordkeeping requirements, 
Research.

    Accordingly, we propose to amend 9 CFR part 2 as follows:

PART 2--REGULATIONS

0
1. The authority citation for part 2 continues to read as follows:


[[Page 33570]]


    Authority:  7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.

0
2. Amend Sec.  2.38:
0
a. By lifting the stay on paragraph (l);
0
b. In paragraph (l)(2):
0
i. In the first sentence by removing the date ``July 29, 2013'' and 
adding ``[DATE 180 DAYS AFTER EFFECTIVE DATE OF FINAL RULE]'' in its 
place;
0
ii. In the next to last sentence by removing the words ``and training 
records''; and
0
ii. By revising the last sentence; and
0
c. By revising paragraph (l)(3).
    The revisions read as follows:


Sec.  2.38  Miscellaneous.

* * * * *
    (l) * * *
    (2) * * * The APHIS Contingency Plan form may be used to keep and 
maintain the information required by paragraph (l)(1) of this section 
and this paragraph (l)(2).
    (3) The facility must provide training for its personnel regarding 
their roles and responsibilities as outlined in the plan. For current 
registrants, training of facility personnel must be completed within 60 
days of the research facility putting their plan in place; for research 
facilities registered after [DATE 180 DAYS AFTER EFFECTIVE DATE OF 
FINAL RULE] training of facility personnel must be completed within 60 
days of the facility putting its contingency plan in place. To fulfill 
this training requirement, employees hired 30 days or more before the 
contingency plan is put in place must be trained by the date the 
facility puts its contingency plan in place. For employees hired less 
than 30 days before that date or after that date, training must be 
conducted within 30 days of their start date. Any changes to the plan 
as a result of the annual review must be communicated to employees 
through training which must be conducted within 30 days of making the 
changes.
0
3. Amend Sec.  2.134:
0
a. By lifting the stay on the section;
0
b. In paragraph (b):
0
i. In the first sentence by removing the date ``July 29, 2013'' and 
adding ``[DATE 180 DAYS AFTER EFFECTIVE DATE OF FINAL RULE]'' in its 
place;
0
ii. In the fifth sentence by removing the words ``and training 
records''; and
0
iii. By revising the last sentence; and
0
c. By revising paragraph (c).
    The revisions read as follows:


Sec.  2.134   Contingency planning.

* * * * *
    (b) * * * The APHIS Contingency Plan form may be used to keep and 
maintain the information required by Sec.  2.38(l)(1) and (2).
    (c) Dealers, exhibitors, intermediate handlers, and carriers must 
provide training for their personnel regarding their roles and 
responsibilities as outlined in the plan. For current licensees and 
registrants, training of dealer, exhibitor, intermediate handler, and 
carrier personnel must be completed within 60 days of the licensee and 
registrant putting their contingency plan in place; for new dealers, 
exhibitors, intermediate handlers, or carriers licensed or registered 
after [DATE 180 DAYS AFTER EFFECTIVE DATE OF FINAL RULE], training of 
personnel must be completed within 60 days of the dealer, exhibitor, 
intermediate handler, or carrier putting their contingency plan in 
place. To fulfill this requirement, employees hired 30 days or more 
before the contingency plan is put in place must be trained by the date 
the licensee or registrant puts their contingency plan in place. For 
employees hired less than 30 days before that date or after that date, 
training must be conducted within 30 days of their start date. Any 
changes to the plan as a result of the annual review must be 
communicated to employees through training which must be conducted 
within 30 days of making the changes.

    Done in Washington, DC, this 16th day of June 2021.
Mae Wu,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2021-13152 Filed 6-24-21; 8:45 am]
BILLING CODE 3410-34-P