Proposed Rule2021-13152
Handling of Animals; Contingency Plans
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 25, 2021
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 120 (Friday, June 25, 2021)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13152]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
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.
========================================================================
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.
-----------------------------------------------------------------------
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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2020-0101 in the Search field.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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.
---------------------------------------------------------------------------
\1\ To view the final rule, go to <a href="https://www.regulations.gov/document/APHIS-2006-0159-0209">https://www.regulations.gov/document/APHIS-2006-0159-0209</a>.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ To view the stay of the regulations, go to <a href="https://www.regulations.gov/document/APHIS-2006-0159-0214">https://www.regulations.gov/document/APHIS-2006-0159-0214</a>.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ To view the final rule, go to <a href="https://www.regulations.gov/document/APHIS-2014-0059-0032">https://www.regulations.gov/document/APHIS-2014-0059-0032</a>.
---------------------------------------------------------------------------
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
<a href="/cdn-cgi/l/email-protection#45242b2c2824292624372005303621246b222a33"><span class="__cf_email__" data-cfemail="e687888f8b878a85879483a693958287c8818990">[email protected]</span></a> 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 <a href="http://Regulations.gov">Regulations.gov</a> website (see ADDRESSES above for instructions
for accessing <a href="http://Regulations.gov">Regulations.gov</a>).
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 <a href="http://Regulations.gov">Regulations.gov</a>
website or in our reading room. (A link to <a href="http://Regulations.gov">Regulations.gov</a> 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
<a href="http://Regulations.gov">Regulations.gov</a> website or in our reading room. (A link to
<a href="http://Regulations.gov">Regulations.gov</a> 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 25, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.