Handling of Animals; Contingency Plans, 76815-76824 [2012-31422]
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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations
Done in Washington, DC, this 20th day of
December, 2012.
Rebecca Blue,
Deputy Under Secretary for Marketing and
Regulatory Programs.
[FR Doc. 2012–31417 Filed 12–28–12; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 2 and 3
[Docket No. APHIS–2006–0159]
RIN 0579–AC69
Handling of Animals; Contingency
Plans
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
We are amending the Animal
Welfare Act regulations to add
requirements for contingency planning
and training of personnel by research
facilities and by dealers, exhibitors,
intermediate handlers, and carriers. We
are taking this action because we believe
all licensees and registrants should
develop a contingency plan for all
animals regulated under the Animal
Welfare Act in an effort to better prepare
for potential disasters. This action will
heighten the awareness of licensees and
registrants regarding their
responsibilities and help ensure a
timely and appropriate response should
an emergency or disaster occur.
DATES: Effective Date: January 30, 2013.
FOR FURTHER INFORMATION CONTACT: Dr.
Jeanie Lin, Eastern Region Emergency
Programs Manager, Animal Care,
APHIS, 920 Main Campus Drive,
Raleigh NC 27606; (919) 855–7100.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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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. Regulations established under
the AWA are contained in the Code of
Federal Regulations (CFR) in 9 CFR
parts 1 and 2, and 9 CFR part 3 contains
standards for the humane handling,
care, treatment, and transportation of
animals covered by the AWA. Currently,
part 3 consists of subparts A through E,
which contain specific standards for
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dogs and cats, guinea pigs and hamsters,
rabbits, nonhuman primates, and
marine mammals, respectively, and
subpart F, which sets forth general
standards for warmblooded animals not
otherwise specified.
The only requirement for contingency
planning by licensees and registrants in
the regulations has been in § 3.101(b),
which covers water and power supply
requirements at facilities housing
marine mammals. Specifically, this
section requires such facilities to submit
written contingency plans to the Deputy
Administrator of Animal Care (AC)
regarding emergency sources of water
and electric power should primary
sources fail. Among other things, the
plans must include evacuation plans in
the event of a disaster and a description
of backup systems and/or arrangements
for relocating marine mammals
requiring artificially cooled or heated
water.
Following the events experienced
during the 2005 hurricane season, a
Federal document, ‘‘The Federal
Response to Katrina: Lessons Learned,’’
which can be found on the Internet at
https://georgewbushwhitehouse.archives.gov/reports/
katrina-lessons-learned/, was published
that highlighted the need for planning to
minimize the impact of disasters. AC’s
experience indicates that, although
contingency planning would benefit the
health and welfare of animals covered
by the AWA, at least some entities
responsible for regulated animals have
not undertaken such planning. We
believe all licensees and registrants
should be required to develop a
contingency plan for all animals
regulated under the AWA in an effort to
better prepare for potential disasters.
Therefore, on October 23, 2008, we
published in the Federal Register (73
FR 63085–63090, Docket No. APHIS–
2006–0159) a proposal 1 to amend the
AWA regulations to add requirements
for contingency planning and training of
personnel by research facilities and by
dealers, exhibitors, intermediate
handlers, and carriers.
We solicited comments concerning
our proposal for 60 days ending on
December 22, 2008. On December 19,
2008, we published a notice in the
Federal Register (73 FR 77554) that
extended the comment period an
additional 60 days until February 20,
2009. We received 997 comments by
that date. They were from private
citizens, breeders, dealers, animal
welfare organizations, research
1 To view the proposed rule and the comments
we received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2006-0159.
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facilities, Government agencies,
pharmaceutical companies, universities
and colleges, research associations,
exhibitors, carriers, kennels, and
medical associations. Fifty commenters
supported the rule as it was proposed.
The issues raised by the remaining
commenters are discussed below by
topic.
Many commenters had comments or
questions that were not germane to the
proposed rule, such as asking the
Animal and Plant Health Inspection
Service (APHIS) to end the trade of
exotic animals. We are not addressing
those comments in this final rule
because they are outside of its scope.
Objections to Mandating Contingency
Plans
Many commenters objected to APHIS
mandating contingency plans. One
commenter stated that, since no plan
can be 100 percent successful, it does
not make sense to mandate plans. One
commenter stated that the AWA has
language prohibiting prescribing
methods of research and that the
proposed rule violates this by
prescribing emergency planning
methods.
As stated in the proposed rule, the
events experienced during the 2005
hurricane season highlighted the need
for planning to minimize the impact of
disasters on the health and welfare of all
animals covered by the AWA. The
intent of the proposed rule was to
safeguard the health and welfare of
animals in emergency situations. We
understand that contingency plans may
not be 100 percent successful. However,
we do not agree that plans should not
be mandated because, to promote
animal welfare, entities should be able
to demonstrate a reasonable effort to
address emergency situations. The rule
does not prescribe emergency planning
methods. In addition, we do not
consider a contingency plan to be a
research method.
One commenter suggested that
instead of mandated plans, APHIS
should provide guidance materials,
training videos, or classes, as it would
be cheaper for both APHIS and the
regulated entities.
APHIS plans to provide guidance
materials, which may include videos
and classes. However, this does not
replace a need for contingency plans as
contingency plans are more adaptable to
the unique circumstances of each
licensee and registrant and will
determine what training is needed. In
addition, as facilities have widely
varying needs, allowing licensees and
registrants to determine and implement
their own unique training allows
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flexibility and will potentially keep
training costs down. We have prepared
guidance materials that are being made
available concurrently with this final
rule on our Web site 2 and will provide
additional guidance to licensees and
registrants for drafting appropriate
contingency plans upon request.
Several commenters stated that they
already had contingency plans in place
or followed other accreditation
standards (e.g., Association of Zoos and
Aquariums standards), which they
stated were sufficient to address the
contingency plan components we
proposed to require. Some of these
commenters asked that they be exempt
from the requirements of the rule
because they already had plans in place
or that APHIS work with other
organizations that have accreditation
standards to draft a standard document
so that the regulations are not
redundant. One commenter stated that
APHIS should have done a better job of
talking to facilities that already have
contingency plans in place.
We recognize that many AWA
licensees and registrants may already
have contingency plans in place.
Although many of these plans may be
sufficient to satisfy the new contingency
plan requirements in this final rule,
exemption is not practical as those
nongovernmental accreditation
standards are not mandatory, nor are
they linked by regulatory processes to
the AWA. However, before developing
the proposed rule, we gathered
information on regulated entities that
currently have contingency plans in
place. This information was used as a
basis for the proposed criteria for
developing contingency plans.
Submission of Contingency Plans
Many commenters asked how APHIS
will review the contingency plans, and
in particular whether we will require
submission of contingency plans to
APHIS. Many commenters objected to
submitting contingency plans because
they were concerned that the plans
would be subject to the Freedom of
Information Act (FOIA) and that
disclosure of contingency plans would
put at risk the safety and security of
facilities, employees, and animals by
giving animal rights extremists
important information. Many other
commenters supported submitting
contingency plans to APHIS or other
agencies or making them available to the
public or making relevant portions of
plans available to local services
identified by facilities as potentially
2 https://www.aphis.usda.gov/animal_welfare/
awa_contingency_plan.shtml.
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important to the execution of their
contingency plan. One commenter
suggested posting contingency plans
online while another suggested
electronic submission. Several
commenters stated that licenses should
be revoked or not renewed if
contingency plans are not submitted to
APHIS or that plans that have been
modified due to personnel changes or
updates should be submitted to APHIS.
We do not intend to require
submission of contingency plans. As
stated in the analysis of significant
alternatives to the rule in the proposed
rule, there are over 10,000 licensees and
registrants and requiring each of them to
submit plans to APHIS for review would
take an enormous amount of resources
for the Agency to process, review, and
store. Therefore, we proposed that each
research facility, dealer, exhibitor,
intermediate handler, or carrier will be
required to review their contingency
plan on at least an annual basis. We
would expect that each licensee and
registrant would maintain
documentation of their annual reviews,
including documenting any
amendments or changes made to their
plan since the previous year’s review,
such as changes made as a result of
recently predicted, but historically
unforeseen, circumstances (e.g., weather
extremes). We are making this
clarification in § 2.38(l)(2) and
§ 2.134(b). We are also clarifying that
APHIS will have the opportunity to
review annual review documentation
and training records, as well as
contingency plans, as a part of our
routine inspection process. It is the
regulated facility’s decision whether or
not to share its plan with outside
entities. The AWA does not require
licensees and registrants to disclose
documentation to outside entities.
However, if a contingency plan details
coordination with other government
entities, an inspector may check for
evidence supporting this coordination.
Expertise
Several commenters stated that there
is no evidence that APHIS has more
expertise in contingency planning than
other organizations, such as
universities. One commenter stated that
APHIS should consult with other
agencies such as the Federal Emergency
Management Agency (FEMA) in the
development of requirements for
contingency plans or in the
implementation of contingency plans.
APHIS already has the technical
expertise to ensure that regulated
entities protect the health and wellbeing of animals in accordance with the
AWA. Further, in 2008, APHIS
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launched an Animal Care Emergency
Programs unit, which is a full-time unit
dedicated to collaborating with other
organizations to support the safety and
well-being of animals during
emergencies and disasters. As required
by the AWA, APHIS consults and
cooperates with other Federal agencies
concerned with the welfare of animals
used for research, experimentation, or
exhibition. APHIS also routinely works
closely with FEMA and other
organizations on animal welfare issues
prior to and during disasters and
emergencies.
Several commenters stated that the
facility and not the Government should
decide what should be in contingency
plans.
As stated in the proposed rule,
because we recognize that individual
circumstances for regulated entities may
be different, it is difficult to go into
specific detail as to what elements must
be included in all contingency plans.
Therefore, we have not sought to
develop a one-size-fits-all plan but have
instead provided a framework of four
criteria, in § 2.38(l)(1) for research
facilities and § 2.134 for dealers,
exhibitors, intermediate handlers, and
carriers, that we believe are the
minimum criteria necessary to ensure a
successful contingency plan. We have
largely left to the discretion of each
regulated entity how best to develop
contingency plans that:
• Identify common emergencies such
as electrical outages, faulty HVAC
systems, fires, animal escapes, and
natural disasters the facility is most
likely to experience.
• Outline specific tasks required to be
carried out in response to the identified
emergencies including, but not limited
to, specific animal evacuation plans or
shelter-in-place plans and provisions for
providing backup sources of food and
water as well as sanitation, ventilation,
bedding, veterinary care, etc.
• Identify a chain of command and
who (by name or by position title) will
be responsible for fulfilling these tasks.
• Address how response and recovery
will be handled in terms of materials,
resources, and training needed.
We believe that fulfilling these criteria
is essential to the success of a
contingency plan. In addition, we
believe that these criteria provide an
adequate degree of flexibility to allow
all regulated entities to comply with the
provisions of this final rule. These
criteria are essential because they form
a framework of what potential events to
address, who has responsibility, and
how to mitigate the potential events.
These criteria form the basis of FEMA’s
‘‘Ready Business’’ campaign, which
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provides information to businesses on
how to plan for emergencies. We have
modified that information to address
animal welfare concerns.
Specific Criteria
One commenter stated that the
contingency plan should identify and
evaluate the location of the facility and
the probable specific emergency
situations that location is likely to
experience. The commenter further
stated that any facility-specific
vulnerability should be identified and
addressed. One commenter stated that
facility grounds should be in areas not
prone to flooding or earthquakes and
that it is preferable to provide onsite
care during an emergency.
One of the proposed criteria for
development of contingency plans is
that the plan identify situations, such as
emergencies and natural disasters, that
a regulated entity is most likely to
experience that would trigger the need
for the measures identified in a
contingency plan to be put into action.
We expect that, if a facility-specific
vulnerability would impact the humane
handling and care of AWA-regulated
animals during an emergency, the
vulnerability would be addressed
within the regulated entity’s
contingency plan. While we agree that
ideally a regulated entity would not be
located in an area prone to flooding or
earthquakes, we realize that is not
always feasible to ensure. As stated in
the proposed rule, such disasters, if
likely to be encountered by a particular
regulated entity, would be expected to
be addressed in that regulated entity’s
contingency plan.
Several commenters stated that
euthanasia should be considered a
viable option in the event of a disaster.
Several commenters stated that marine
mammals should be microchipped to
facilitate recovery in the event they are
released into the wild. One commenter
stated that all tasks necessary for
ensuring the welfare of animals should
be itemized and the time required for
each task estimated. Several
commenters recommended providing
criteria for development of contingency
plans by animal group or by species
and, for marine mammals, criteria by
geographic location. Several
commenters stated that agreements with
alternative facilities for evacuation
should be part of the contingency plan.
Since each regulated entity has
different needs, we have largely left to
the discretion of each regulated entity
how best to fulfill the criteria of this
final rule. Details about elements to
include in a contingency plan, such as
whether to use microchip identification
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methods or euthanasia or whether to
itemize and time tasks, are to be decided
upon by the regulated entity. In
addition, as long as a regulated entity
addresses each of the elements required
for contingency plans, it may divide its
plan according to criteria such as animal
group, species, or geographic location.
While we encourage regulated entities
to explore cost-efficient options such as
entering into mutual aid agreements
with nearby similar entities, we are not
requiring them to do so, as long as their
contingency plans are adequate to
protect the animals’ welfare.
As noted previously, the only
contingency planning currently required
for licensees and registrants are those
requirements in § 3.101(b) which cover
water and power supply requirements
for facilities housing marine mammals.
One commenter suggested that the
requirements in § 3.101(b) be revised to
require that contingency plans
submitted for marine mammals include
the proposed criteria for contingency
plans included in § 2.134.
The regulations added in this final
rule in § 2.134 for developing
contingency plans apply to all dealers,
exhibitors, intermediate handlers, and
carriers, including those that handle
marine mammals. We are amending
§ 3.101(b) in this final rule to make it
clear that facilities housing marine
mammals must comply with the
contingency planning requirements in
§ 2.134.
Transportation
Several commenters stated that
carriers and intermediate handlers
should not have to develop contingency
plans because it would be costly for
them, because the number of animals
lost or harmed in transit is miniscule, or
because they have limited resources to
respond to emergency situations. Given
this, several commenters expressed
concern that, if forced to comply with
the proposed rule, carriers may not want
to do business with research facilities.
We believe that all research facilities,
dealers, exhibitors, intermediate
handlers, and carriers should be
required to develop a contingency plan
for all animals regulated under the
AWA. Although there may be costs
associated with developing contingency
plans, we expect such costs to be
reasonable given that we have largely
left it up to the discretion of regulated
entities to determine the best way to
fulfill the contingency plan criteria
provided in this final rule for their own
unique circumstances (i.e., size, type of
entity, location, etc.). Therefore, we do
not expect that developing contingency
plans will cause a significant financial
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76817
burden on carriers and intermediate
handlers. At a minimum, we would
expect that carriers, intermediate
handlers, and traveling exhibitors
would have provisions in place to
respond to weather-related problems
and animal escapes, as well as other
problems, such as mechanical failures,
most likely to be experienced during
transit. We do not necessarily expect
carriers and intermediate handlers to
have backup sources of food and water
on hand when traveling, but we would
expect that their contingency plan
would document how and where to get
them if needed. In addition, we are
clarifying in § 2.134(b) that all traveling
entities must carry a copy of their
contingency plan with them at all times
and make it available for inspection
while in travel status. Having a copy of
their contingency plan on hand will
allow regulated entities to refer directly
to their plan in the event of an
emergency while traveling. We believe
this will result in preventing the loss or
harm of regulated animals.
Several commenters stated that
facilities should have backup carriers if
their plans require evacuation. Also, the
commenters stated that carriers should
include in their plans which facility to
service first in the event that a major
disaster happens and multiple facilities
are impacted.
While we do not require regulated
entities to employ backup carriers, if a
regulated entity’s contingency plan
includes a backup carrier, we expect
that the regulated entity will ensure that
the carrier is compliant with the
elements of the contingency plan. In
addition, we believe that carriers should
coordinate with the facilities they serve.
Because we realize that some dealers,
exhibitors, intermediate handlers, and
carriers do not have stationary facilities,
we are making a change to the
requirements in § 2.134(a)(1) by
removing the word ‘‘facility’’ and
replacing it with the more inclusive
words ‘‘licensees and registrants.’’ In
addition, we are adding ‘‘mechanical
breakdowns’’ to the list of likely
emergencies that may be addressed in a
contingency plan.
Several commenters stated that
licensees who travel with animals
should be required to submit
contingency plans both for at home and
on the road. Several commenters stated
that travel as part of contingency plans
for dangerous animals or for marine
mammals should be prohibited unless
necessary for the welfare of the animals
because of the risks to public safety and
animal welfare, particularly in
emergency situations. One commenter
asked how animals that cannot be
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evacuated will be cared for and stated
that there needs to be a requirement for
securing a facility in the event animals
cannot be evacuated. One commenter
stated that the contingency plan must
document how and by whom animals
would be moved and what efforts will
be made to ensure the relocation of
animals is done in the most humane or
least stressful manner possible.
The intent of the proposed rule was
to safeguard the welfare of animals in
emergency situations. There is no
requirement to travel with animals
unless it is part of a facility’s
contingency plan. As stated in the
proposed rule, the contingency plan
would have to provide detailed
instructions for evacuation or shelter-inplace. Therefore, if a contingency plan
includes provisions for evacuation, we
expect that the plan will also include
details on how and by whom the
animals would be moved in a way that
would be as humane as possible given
the disaster circumstances a facility may
be facing.
One commenter asked whether an
outside carrier’s equipment, if called
upon, would have to comply with AWA
requirements.
Regulated entities are expected to
ensure that their routine and back-up
carriers are compliant with all AWA
requirements.
Disasters
Several commenters stated that
detailed evacuation or shelter-in-place
plans may be possible for emergencies,
but are impractical for natural disasters
because regulated entities rarely have
advance notice of disasters and because
there are so many variations in facilities
and disasters that it does not make sense
to have a one-size-fits-all plan. The
commenters further stated that the rule
should acknowledge this and allow for
a ‘‘best efforts’’ approach when making
contingency plans for unpredictable
natural disasters. Several commenters
expressed concern that the proposal
seemed to require that all potential
disasters be addressed no matter how
likely they are to occur. However, one
commenter stated that all potential
disasters that might occur should be
addressed in the contingency plan.
We recognize that it is not practical to
prescribe detailed contingency plans for
all situations. Therefore, we have not
sought to develop a one-size-fits-all
plan, but have largely left to the
discretion of each regulated entity how
best to fulfill the criteria described in
the proposed rule. This rule intends to
set the minimum criteria necessary to
ensure a successful contingency plan.
We believe this provides an adequate
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degree of flexibility to allow all
regulated entities to comply with the
provisions of the rule. As stated in the
proposal, we would require that
regulated entities address those
emergencies and disasters most likely to
occur, rather than requiring them to
address all possible disasters and
emergencies regardless of likelihood.
We encourage regulated entities to
consider all scales of emergencies, but
recognize that highly localized events
such as power disruptions and road
closures (e.g., from a vehicular accident)
are most likely. APHIS encourages the
regulated communities to address these
more routine events in their
contingency plans, and to work with
their local emergency management
organization. APHIS understands that
disaster and emergency events may be
unpredictable and that it is impossible
for every possible event to be addressed
in a contingency plan.
One commenter stated that the
contingency planning requirements are
inconsistent with Homeland Security
Presidential Directive 8: National
Preparedness (HSPD–8) because terms
used in the rule, such as ‘‘major
disaster’’ and ‘‘emergency,’’ are not
consistent with those used in the
directive.
HSPD–8 establishes policy for dealing
with terrorist attacks, major disasters,
and other events of national scope.
Section 2(e) of the directive states that
the terms ‘‘major disaster’’ and
‘‘emergency’’ are defined in section 102
of the Robert T. Stafford Disaster Relief
and Emergency Assistance Act. Under
that Act, ‘‘emergency’’ is defined as any
occasion or instance, as determined by
the President, where Federal assistance
is needed to save lives, protect property
and public health and safety, or to
lessen or avert a catastrophe. A ‘‘major
disaster’’ is defined as any natural
catastrophe, as determined by the
President, which causes damage of
sufficient severity and magnitude to
warrant major disaster assistance in
order to supplement the efforts and
available resources of States, local
governments, and disaster relief
organizations in alleviating the damage,
loss, hardship, or suffering caused by
the catastrophe. The Stafford Act is
largely a framework for Federal
assistance to State and local
governments for disaster relief, and
these terms require Presidential
involvement. The scope of this rule is
broader, and thus we use the terms
‘‘disaster’’ and ‘‘emergency’’ in more
general terms. This rule considers
‘‘disaster’’ and ‘‘emergency’’ to mean
those events which disrupt the ability of
a licensee or registrant to continue with
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normal business routine and which are
expected to be detrimental to the good
health and well-being of the animals in
the licensee’s or registrant’s care. A core
concept of emergency management is
that emergencies are managed at the
most local level possible. The National
Incident Management System,
December 2008, supports this in stating
that ‘‘incidents typically begin and end
locally, and are managed on a daily
basis at the lowest possible
geographical, organizational, and
jurisdictional level.’’ The document is
available from the FEMA Web site at
https://www.fema.gov/pdf/emergency/
nims/NIMS_core.pdf. While
emergencies and disasters may be
Statewide or even national in scope, we
expect that most often they will be
events that do not generally involve
disaster declarations and that remain
localized, such as power outages,
facility fires, or ice storms.
One commenter stated that
contingency plans should be integrated
into the overall hazard response plan for
facilities.
Although we do not require regulated
entities to integrate animal contingency
plans into their business continuity
plans, we encourage them to do so.
APHIS believes that having a business
continuity plan supports animal health
and welfare as well as overall good
business practices.
Backups
The proposed requirements in
§§ 2.38(l)(1)(ii) and 2.134(a)(2) stated
that regulated entities must include in
their contingency plans provisions for
providing backup sources of food and
water as well as sanitation, ventilation,
bedding, veterinary care, etc. Several
commenters recommended that we
remove the words ‘‘backup sources of’’
from this provision and insert the words
‘‘as described in the contingency plan’’
after the phrase ‘‘as well as sanitation,
ventilation, bedding, veterinary care,
etc.’’ These commenters stated that it
may not be possible to maintain all of
the veterinary care provisions listed in
§ 2.33(b) during a disaster.
While it may not be possible to
provide the same level of veterinary care
during an emergency or disaster as
during normal business operations,
APHIS believes that the veterinary care
requirements in § 2.33(b) are the
minimum requirements necessary to
ensure the health and welfare of
regulated animals. As with the
contingency plan criteria, these
veterinary care requirements are general
rather than specific to allow regulated
entities the discretion to determine how
best to fulfill the requirements based on
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their own unique situations. In addition,
as backup veterinary care is an element
that must be addressed within the
contingency plan, APHIS will be able to
assess the adequacy of the backup
veterinary care as it assesses the
adequacy of veterinary care overall
during routine inspections.
Review and Enforcement
Several commenters expressed
concern regarding APHIS’ ability to
provide adequate inspection and review
of plans, stating that the review of plans
would present an excessive burden to
APHIS. One commenter suggested that
APHIS could reduce the inspection
burden by reviewing a random sampling
of plans. Two commenters suggested
that, at a minimum, APHIS should
review the contingency plans of
facilities with dangerous animals such
as elephants, nonhuman primates, or
large carnivores. One commenter asked
who APHIS would pay to obtain the
extra staff to enforce the rule. One
commenter suggested that licensing fees
be increased to fund additional
inspectors or that APHIS stop issuing
licenses until numbers of facilities drop
to a manageable level.
We do not believe that our review of
contingency plans would present an
excessive burden on APHIS. As noted
above, we would review contingency
plans as a part of the routine inspection
process, similar to the process for our
review of dog exercise and nonhuman
primate environment enhancement
plans. We believe in this way we will
be able to provide adequate review of
the contingency plans for all regulated
entities. We do not anticipate that
additional APHIS staff will need to be
hired as a result of this rule. Neither do
we anticipate needing to contract out to
other organizations to obtain additional
staff.
Many commenters were concerned
that there were not enough specifics
about what would make a contingency
plan acceptable and that facilities could
be cited for failing to include certain
items in their plans or for not following
their plans exactly. Several commenters
suggested punishments for facilities that
either do not submit their plans or
whose plans are inadequate. One
commenter asked whether the judgment
of noncompliance will be affected by
whether animals were harmed in any
way.
We have issued a guidance document
along with this final rule that will assist
licensees and registrants in determining
what elements to include in their
contingency plans. The guidance
document is intended only to provide
suggestions for how regulated entities
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may satisfy the criteria in the
regulations rather than to prescribe
specific measures that must be
undertaken or equipment that must be
purchased. For example, a regulated
entity has multiple options to mitigate
the potential failure of an HVAC system
besides purchasing a backup generator,
some of which are no-cost solutions.
These no-cost solutions might include
the use of a borrowed generator,
opening windows, using existing fans,
and/or moving the animals to a cooler
location. Any of these actions could be
considered adequate ways of responding
to the potential failure of an HVAC
system and could therefore be included
in a contingency plan as long as the
action listed is actually feasible. For
instance, if a regulated entity’s
contingency plan calls for opening
windows, but the facility’s windows are
incapable of opening, opening windows
would not be a valid mitigation
measure. We wish to emphasize that
compliance with this final rule will be
achieved through the development of an
appropriate contingency plan and the
training of facility personnel with
respect to that plan. Nothing in this rule
should be construed as requiring
affected entities to make capital
expenditures—for example, purchasing
backup generators or making structural
changes to a facility—in order to comply
with the rule. As we do currently when
enforcing the regulations, APHIS will
assess the adequacy of a regulated
entity’s contingency plan using the
Animal Welfare Act and Animal
Welfare Regulations. This may be
demonstrated by the plan itself, training
records, the presence of materials and
resources mentioned in the plan, or a
documented history of responses to
similar situations. An adequate
contingency plan is one in which the
minimum criteria considered necessary
for a successful contingency plan have
been addressed. Enforcement action
may be taken on a case-by-case basis.
One commenter asked if missing the
training deadline by a few days would
result in noncompliance with the
training requirements in the regulations
regarding the contingency plan.
All noncompliant items, including
failure to train employees on the
components of the contingency plan,
found during inspection would be
documented on the inspection report
and may be subject to enforcement
action on a case-by-case basis.
Enforcement actions may include
issuance of official warnings, civil
monetary penalties, license suspension,
or license revocation. Licensees and
registrants are expected to comply with
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all requirements of the regulations and
standards, including training deadlines.
Several commenters asked who would
be determining the adequacy of plans
and what training they would have.
APHIS inspectors will review and
determine the adequacy of contingency
plans. We will provide training to the
inspection personnel on evaluating
contingency plans pursuant to the
criteria set forth in this rule.
One commenter asked on what basis
regulated entities would be expected to
determine what natural disasters they
may face and whether and how this
determination will be evaluated by
inspectors.
In the proposed rule we provided
links to the U.S. Geological Survey
‘‘Hazards’’ Web site and the Weather
Channel ‘‘WeatherREADY’’ Web site.
These Web sites are good resources for
determining the natural disasters
facilities are most likely to encounter in
their location. We would largely leave it
up to the regulated entity to determine
which natural disasters they may face.
However, if it is apparent the regulated
entity is likely to encounter a disaster
that the contingency plan does not
address (e.g., a facility in Florida that
has experienced hurricanes in the past),
APHIS inspectors will notify the entity
and give the entity time to add
provisions for responding to the disaster
in the contingency plan. We anticipate
that inspectors, who are typically
stationed in the local area surrounding
the facility, will be able to provide
further guidance on potential natural
disasters.
One commenter stated that the rule
should be revised to include language
relieving a regulated facility of
responsibility if a higher emergency
response authority steps in.
We expect that most emergencies will
be of a local nature, such as facility fires
or water main breaks. For emergencies
or disasters of a larger scale, APHIS will
consider the roles of jurisdictional
emergency response authorities with
respect to contingency plan
implementation. It is not the intent of
the rule to interfere with local, State, or
Federal jurisdictional emergency
response activities.
Training
As stated in the proposed rule,
training of personnel could be
developed and offered by the research
facility, dealer, exhibitor, intermediate
handler, or carrier or provided by an
outside entity. Several commenters
stated that training requirements should
be identified, including how facilities
will document training. One commenter
stated that a checklist should be
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implemented with staff signing off that
they have read the standard operating
procedures and completed training.
Two commenters stated that there
should be requirements for training and
availability of backup personnel or for
ensuring intermediate personnel
replacement and training. Several
commenters stated that trial runs of the
contingency plan must be carried out.
As stated previously, because we
recognize that individual circumstances
for regulated entities may be different, it
is difficult to go into specific detail as
to what elements must be included in
all contingency plans. Therefore, we do
not believe it appropriate to provide
technical and tactical requirements,
such as protocols for personnel
replacement and training, in the
regulations. We anticipate that
inspectors may confirm that
contingency plan training is delivered
in a similar manner to their current
process for confirming that other
required training has been delivered
(e.g., for husbandry practices and
veterinary care protocols). Such
confirmation may include reviewing
training documentation maintained by
the regulated entity or asking involved
employees questions about facility
practices. While we have not
specifically mandated trial runs of
contingency plans, training may include
trial runs in order to prepare licensees
and registrants adequately in the event
of a disaster or emergency.
One commenter stated that both
position title and name of employees
who play a part in implementing the
contingency plan should be included in
the contingency plan.
As stated in the proposed rule,
regulated entities would need to
identify a chain of command and who
(by name or position title) will be
responsible for fulfilling required tasks.
We would leave it up to the regulated
entity whether to include both position
title and name or whether to include
one or the other.
Several commenters stated that
training should only apply to
individuals who have a role to play
within the contingency plan.
We believe the decision of which
individuals should be trained is a
decision best left up to the discretion of
the regulated entity. However, we
would expect all personnel who may be
involved in or impacted by an
emergency or disaster to be trained at an
appropriate level.
Dates
In the proposed rule, we proposed to
require that contingency plans be in
place 180 days after the effective date of
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this final rule. In addition, we proposed
that training of personnel would have to
take place within 60 days following the
adoption of a contingency plan by the
research facility, dealer, exhibitor,
intermediate handler, or carrier.
Employees hired within 30 days or less
after adoption of the contingency plan
would have to be trained in that 60-day
period while employees hired more
than 30 days after adoption of the
contingency plan would have to be
trained within 30 days of their start
date.
Several commenters asked that we
further push back the effective date of
the regulations to allow time to finalize
contingency plans. One commenter
stated that it was unclear whether the
adoption date mentioned in the
proposed rule is the date the rule is
adopted or the date plans must be in
place and that, if it is the former, the
rule needs to be revised since this
would require training to be completed
before the contingency plan, which will
guide the training, is in place. The
commenter further stated that the 180day period for having plans in place
should begin at the later of either the
effective date of the final rule or the date
of issuance of guidance documents by
APHIS. Two commenters asked whether
the 180-day timeframe for having
contingency plans in place includes
procuring all necessary materials and
resources for implementing the
contingency plan. The commenters
stated that if such is the case, it is too
short of a timeframe to gather materials
and resources that are not currently
available within a facility.
As stated in the proposed rule, the
adoption date is the date the
contingency plan must be in place. For
current licensees and registrants, this
date is 180 days after the effective date
of this final rule. For future licensees
and registrants, we expect the licensee
or registrant to have a contingency plan
in place prior to conducting regulated
activities. We are making changes to
paragraphs (l)(2) and (l)(3) in § 2.38 and
paragraphs (b) and (c) in § 2.134(b) in
order to make it clearer that the
adoption date is the date the
contingency plans must be finalized.
Training of personnel must take place
within 60 days after the adoption date.
We believe 180 days is a sufficient
length of time to ensure that
contingency plans are in place and to
procure any necessary materials and
resources for implementing contingency
plans.
Several commenters stated that the
30-day training requirement for newly
hired personnel is unnecessary and not
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in keeping with the lack of specificity
for the rest of the plan.
We believe that it is important to
ensure that employees of a regulated
entity are familiar with the regulated
entity’s contingency plan. Therefore, it
is appropriate to require that training
occur within 30 days.
Guidance
One commenter stated that guidance
documents for developing contingency
plans should be developed by a lead
organization with expertise in
collaboration with outside
organizations. One commenter stated
that guidance documents should not be
developed by entities outside of APHIS
but that stakeholders/licensees should
have input. Several commenters
objected to guidance documents or other
means for providing criteria outside of
the regulations at all. Several
commenters stated that the guidance
document should be made available via
the Internet, and released with the final
rule.
APHIS has expertise in collaborating
with outside organizations and is also
responsible for enforcing the AWA.
Therefore, it is appropriate for us to take
the lead role in developing guidance
documents to support contingency
planning. As stated previously, we are
providing a guidance document with
this final rule. During the comment
period for the proposed rule, we asked
for public comment, including comment
from stakeholders and licensees, on
what elements should be included in
the guidance document. To reiterate,
APHIS will assess the adequacy of a
regulated entity’s contingency plan
using the Animal Welfare Act and
Animal Welfare Regulations. The
guidance document provides
suggestions for how regulated entities
may satisfy the criteria in the
regulations.
One commenter said that USDA
should provide guidance on how
contingency plans might address
elements unique to each facility. One
commenter suggested that APHIS create
a Web site with more information that
includes guidelines, checklists, and
templates. Several commenters supplied
examples of contingency plans, links to
contingency plans, or resources for
drafting contingency plans.
We are issuing a guidance document
that may assist regulated entities in
addressing the circumstances unique to
their location or facility. We also
reviewed the information provided by
the commenters and will make a list of
helpful resources available on our Web
site (see footnote 2). The guidance
document is intended to be only a tool
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when considering how a facility might
meet the regulatory requirements, and
does not provide a new set of criteria.
Economic and Paperwork Concerns
Many commenters stated that the
proposed rule will cause a serious
financial impact, especially on small
businesses, which make up the majority
of those affected. Several commenters
stated that a cost-benefit study has not
been conducted and asked that APHIS
withdraw the rule until one has been
conducted or until APHIS has evaluated
whether the rule is truly necessary.
A preliminary regulatory impact
analysis was conducted for the
proposed rule and a final regulatory
impact analysis has been conducted for
this rule. A summary of the final
regulatory impact analysis appears in
this document under the heading
‘‘Executive Orders 12866 and 13563 and
Regulatory Flexibility Act.’’ The full
analysis may be viewed on the
Regulations.gov Web site (see footnote
1) or obtained by contacting the person
listed under FOR FURTHER INFORMATION
CONTACT. One of the components of the
preliminary regulatory impact analysis
is a cost-benefit analysis. APHIS has
estimated that about 5 hours, on
average, will be required by a facility to
develop a contingency plan, using
guides provided and recommended by
APHIS. Depending on the size and type
of regulated entity and its
circumstances, this cost, in terms of the
time needed to develop a contingency
plan, will vary; some facilities will
require less than 5 hours to develop
their plans and other entities will
require more time. APHIS estimates that
it will take 4 to 6 hours to develop and
document a contingency plan. We note
that many large regulated entities, in
particular, already have contingency
plans. In addition to the costs associated
with the development of a contingency
plan, there may also be certain
expenditures necessitated by the
regulated entity’s plan itself. As an
example, a particular regulated entity’s
plan may call for a backup generator to
supply electricity in case of a power
outage. We expect such costs to total
within a reasonable range given that we
have largely left it up to the discretion
of facilities to determine the best way to
fulfill the contingency plan criteria
provided in the proposed rule for their
own unique circumstances (i.e., size,
type of entity, location, etc.). The costs
of developing a plan and related
equipment purchases should be viewed
in terms of the benefits of reduced risk
of harm to the animals under a regulated
entity’s care when there is an emergency
or disaster. A reasonably scaled
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contingency plan that has identified
potential emergencies and natural
disasters therefore contributes to a
regulated entity’s long-term operational
strength and financial security. To the
extent to which the animals held by a
licensee or registrant represent a capital
asset or business investment, we do not
believe it is unreasonable to expect that
entities will have already put in place
measures to ensure the continued wellbeing of those animals. Thus, the actual
amount of new costs incurred by
regulated entities due solely to the
identification of a need during the
development of a contingency plan
should not be significant.
One commenter stated that the rule
does not comply with the Regulatory
Flexibility Act because it shifts the
burden of investigating what would be
required for a contingency plan to
businesses. One commenter expressed
concern that the Small Business
Administration was not consulted when
developing the proposed rule.
The Regulatory Flexibility Act
requires that Federal agencies endeavor
to fit regulatory and informational
requirements to the scale of the
businesses, organizations, and
governmental jurisdictions subject to
regulation. To achieve this principle,
agencies are required to solicit and
consider flexible regulatory proposals
and to explain the rationale for their
actions to assure that such proposals are
given serious consideration. APHIS
recognizes that each regulated entity is
the best judge of the particular measures
that should be included in its
contingency plan. APHIS is minimizing
the burden of the rule for small entities
by allowing each one to determine for
itself how best to meet the requirements
in accordance with the general criteria
and guidance documents. APHIS also
consulted with the Small Business
Administration in the preparation of the
proposed rule and this final rule.
One commenter stated that since the
rule is significant and an Initial
Regulatory Flexibility Analysis was
prepared that APHIS is required to
publish a compliance guide which will
help regulated industries comply with
the regulation.
The guidance document that we are
making available concurrently with this
rule will assist licensees and registrants
in complying with the regulation. Any
additional compliance guides will be
posted on the APHIS Web site (see
footnote 2) and made available to the
public to further assist small entities in
complying with this rule.
Two commenters asked whether they
would have to build additional
alternative facilities, or, if not, what
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76821
shelter would be acceptable on a
temporary basis, and whether USDA is
ready to help shoulder some of the costs
until a facility can be repaired. One
commenter expressed concern that they
would need to purchase disaster
insurance.
We do not intend to require the
building of alternative facilities. While
the costs for development and execution
of the plan are expected to be borne by
the regulated entity, they will be
determined based on the emergencies
and potential natural disasters most
likely to be experienced by the regulated
entity. As stated previously, we expect
that these costs will be reasonable. The
purpose of a contingency plan is to help
ensure that licensees and registrants are
able to respond in a timely and
appropriate manner should an
emergency or disaster occur. Disaster
insurance is not required by this rule,
and promoting the purchase of disaster
insurance is not an objective of this rule.
Three commenters expressed concern
that the number of animals lost during
Hurricane Katrina as stated in the
economic analysis of the proposed rule
is greater than the total number of
regulated animals in Louisiana.
In the preliminary regulatory impact
analysis, APHIS may have inadvertently
implied that the number of animals
covered under the Animal Welfare Act
that were harmed or killed as a result of
Hurricane Katrina was comparable to
the 50,000 pets that reportedly were
negatively impacted by the disaster.
This is incorrect. There is a difference
in scale between the number of animals
for which pet owners are responsible
versus the number of animals for which
research facilities and other licensed
and registered facilities are responsible.
Therefore, AWA licensees and
registrants caring for large numbers of
animals who did not have contingency
plans in place likely found it difficult to
evacuate or otherwise ensure the
animals’ safety during Hurricane
Katrina. Our intent in the proposed rule
was to illustrate this fact rather than to
compare the number of regulated
animals negatively impacted to the
number of pets that were negatively
impacted. We have reexamined the
available data and we present our
findings in the full final regulatory
flexibility analysis, which can be
viewed on the Regulations.gov Web site
(see the address listed in footnote 1).
One commenter suggested that a
tiered contingency plan system be
implemented to accommodate small
businesses.
As a practical matter, one would
expect that the smaller the business, the
smaller the scale of the contingency
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plan that the business would be
expected to prepare, just as a large
entity with numerous animals would
require a larger scale, more complex
contingency plan. Because we recognize
that individual circumstances may be
different between research facilities,
dealers, exhibitors, carriers, and
intermediate handlers, we have
provided general contingency plan
criteria and largely left it up to the
discretion of regulated facilities to
determine how best to fulfill the criteria.
Because the response to each criterion
will be appropriate to the size of each
individual entity, it is reasonable to
describe the contingency plan system
provided for by this rule as tiered.
Several commenters expressed
concern regarding the costs of and time
for drafting a contingency plan. One
commenter stated that the rule may be
imposing redundant paperwork
requirements because of similar
requirements at the State and local
levels.
Many regulated facilities are currently
required to have contingency plans by
other organizations (e.g., accrediting
institutions, State and local regulators).
Many of these plans will meet the
proposed contingency plan
requirements, and paperwork
redundancies for entities with such
plans should be minimal. Those
regulated facilities that do not already
have plans in place may incur an
additional burden to develop
contingency plans. However, we believe
that having an established contingency
plan promotes animal welfare and will
aid in business continuity, therefore
reducing the burden on facilities and
regulated animals in the event of a
natural disaster or emergency.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule as a final
rule, with the changes discussed in this
document.
Executive Orders 12866 and 13563 and
Regulatory Flexibility Act
This proposed rule has been
determined to be significant/
economically significant for the
purposes of Executive Order 12866 and,
therefore, has been reviewed by the
Office of Management and Budget.
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,
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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 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 on the Regulations.gov Web
site (see footnote 1 in this document for
a link to Regulations.gov) or by
contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
Preparedness for emergencies and
disasters can reduce the harm to
animals and their loss of life. The
devastating impact of the 2005
hurricane season underscores the need
for contingency planning for all animals
covered under the Animal Welfare Act.
Currently, only facilities that house
marine mammals are required under 9
CFR 3.101 to develop contingency
plans. The final rule requires that all of
the more than 10,000 licensees and
registrants develop and document
contingency plans for all other animals
covered under the Act. In addition,
training to carry out contingency plans
will be required of a regulated entity’s
employees. The majority of
establishments that will be affected by
this rule are small, based on industry
estimates obtained from the Economic
Census and the Census of Agriculture.
The full final regulatory flexibility
analysis identifies breeders, wholesale
dealers, licensed and registered
exhibitors, registered research facilities,
and registered transport carriers and
handlers as those entities most likely to
be impacted by the requirement for the
development of contingency plans.
While no economic data are available on
business size for the specific entities, we
may assume the majority of the
potentially impacted establishments are
small, based on the industry estimates
obtained from the Economic Census and
the Census of Agriculture.
The final rule will impose certain
costs to develop and document the
contingency plans and provide
employee training, but these costs are
not expected to be excessive. The cost
of training personnel will vary
depending on the type and size of
business. However, many organizations
offer training courses on general disaster
planning specific to the type of animals
at the particular facility or operation.
FEMA offers free training, while some
organizations offer courses with prices
ranging from $50 to $300. These courses
cover the development and
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implementation of contingency plans. In
addition, many of the larger facilities, in
particular, already have contingency
plans in place. APHIS recognizes that
each entity is the best judge of the
particular measures that should be
included in its contingency plan, and
will provide general criteria and
guidance documents to minimize
compliance costs. Each entity will
determine for itself how best to meet the
rule’s requirements.
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 7 CFR part
3015, subpart V.)
Executive Order 12988
This final 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.
Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), the information collection or
recordkeeping requirements included in
this rule have been approved by the
Office of Management and Budget
(OMB) under OMB control number
0579–0352.
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 rule, please contact Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 851–2908.
List of Subjects
9 CFR Part 2
Animal welfare, Pets, Reporting and
recordkeeping requirements, Research.
9 CFR Part 3
Animal welfare, Marine mammals,
Pets, Reporting and recordkeeping
requirements, Research, Transportation.
Accordingly, we are amending 9 CFR
chapter I, subchapter A, as follows:
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PART 2—REGULATIONS
1. The authority citation for part 2
continues to read as follows:
■
Authority: 7 U.S.C. 2131–2159; 7 CFR
2.22, 2.80, and 371.7.
2. Section 2.38 is amended by adding
new paragraphs (i)(4) and (l) to read as
follows:
■
§ 2.38
Miscellaneous.
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*
*
*
*
*
(i) * * *
(4) The other person or premises must
either be directly included in the
research facility’s contingency plan
required under paragraph (l) of this
section or must develop its own
contingency plan in accordance with
paragraph (l) of this section.
*
*
*
*
*
(l) Contingency planning. (1) Research
facilities must develop, document, and
follow an appropriate plan to provide
for the humane handling, treatment,
transportation, housing, and care of
their animals in the event of an
emergency or disaster (one which could
reasonably be anticipated and expected
to be detrimental to the good health and
well-being of the animals in their
possession). Such contingency plans
must:
(i) Identify situations the facility
might experience that would trigger the
need for the measures identified in a
contingency plan to be put into action
including, but not limited to,
emergencies such as electrical outages,
faulty HVAC systems, fires, and animal
escapes, as well as natural disasters the
facility is most likely to experience.
(ii) Outline specific tasks required to
be carried out in response to the
identified emergencies or disasters
including, but not limited to, detailed
animal evacuation instructions or
shelter-in-place instructions and
provisions for providing backup sources
of food and water as well as sanitation,
ventilation, bedding, veterinary care,
etc.;
(iii) Identify a chain of command and
who (by name or by position title) will
be responsible for fulfilling these tasks;
and
(iv) Address how response and
recovery will be handled in terms of
materials, resources, and training
needed.
(2) For current registrants, the
contingency plan must be in place by
July 29, 2013. For research facilities
registered after this date, the
contingency plan must be in place prior
to conducting regulated activities. The
plan must be reviewed by the research
facility on at least an annual basis to
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ensure that it adequately addresses the
criteria listed in paragraph (l)(1) of this
section. Each registrant must maintain
documentation of their annual reviews,
including documenting any
amendments or changes made to their
plan since the previous year’s review,
such as changes made as a result of
recently predicted, but historically
unforeseen, circumstances (e.g., weather
extremes). Contingency plans, as well as
all annual review documentation and
training records, must be made available
to APHIS and any funding Federal
agency representatives upon request.
Facilities maintaining or otherwise
handling marine mammals in captivity
must also comply with the requirements
of § 3.101(b) of this subchapter.
(3) The facility must provide and
document participation in and
successful completion of training for its
personnel regarding their roles and
responsibilities as outlined in the plan.
For current registrants, training of
facility personnel must be completed by
September 27, 2013; for research
facilities registered after July 29, 2013,
training of facility personnel must be
completed within 60 days of the facility
putting its contingency plan in place.
Employees hired 30 days or more before
the contingency plan is put in place
must also be trained by that date. 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.
■ 3. Section 2.102 is amended by adding
new paragraphs (a)(4) and (b)(3) to read
as follows:
§ 2.102
Holding facility.
(a) * * *
(4) The other person or premises must
either be directly included in the
dealer’s or exhibitor’s contingency plan
required under § 2.134 or must develop
its own contingency plan in accordance
with § 2.134.
(b) * * *
(3) The other person or premises must
either be directly included in the
intermediate handler’s contingency plan
required under § 2.134 or must develop
its own contingency plan in accordance
with § 2.134.
■ 4. A new section § 2.134 is added to
read as follows:
§ 2.134
Contingency planning.
(a) Dealers, exhibitors, intermediate
handlers, and carriers must develop,
document, and follow an appropriate
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76823
plan to provide for the humane
handling, treatment, transportation,
housing, and care of their animals in the
event of an emergency or disaster (one
which could reasonably be anticipated
and expected to be detrimental to the
good health and well-being of the
animals in their possession). Such
contingency plans must:
(1) Identify situations the licensee or
registrant might experience that would
trigger the need for the measures
identified in a contingency plan to be
put into action including, but not
limited to, emergencies such as
electrical outages, faulty HVAC systems,
fires, mechanical breakdowns, and
animal escapes, as well as natural
disasters most likely to be experienced;
(2) Outline specific tasks required to
be carried out in response to the
identified emergencies or disasters
including, but not limited to, detailed
animal evacuation instructions or
shelter-in-place instructions and
provisions for providing backup sources
of food and water as well as sanitation,
ventilation, bedding, veterinary care,
etc.;
(3) Identify a chain of command and
who (by name or by position title) will
be responsible for fulfilling these tasks;
and
(4) Address how response and
recovery will be handled in terms of
materials, resources, and training
needed.
(b) For current licensees and
registrants, the contingency plan must
be in place by July 29, 2013. For new
dealers, exhibitors, intermediate
handlers, and carriers licensed or
registered after this date, the
contingency plan must be in place prior
to conducting regulated activities. The
plan must be reviewed by the dealer,
exhibitor, intermediate handler, or
carrier on at least an annual basis to
ensure that it adequately addresses the
criteria listed in paragraph (a) of this
section. Each licensee and registrant
must maintain documentation of their
annual reviews, including documenting
any amendments or changes made to
their plan since the previous year’s
review, such as changes made as a result
of recently predicted, but historically
unforeseen, circumstances (e.g., weather
extremes). Contingency plans, as well as
all annual review documentation and
training records, must be made available
to APHIS upon request. Traveling
entities must carry a copy of their
contingency plan with them at all times
and make it available for APHIS
inspection while in travel status.
Dealers, exhibitors, intermediate
handlers, and carriers maintaining or
otherwise handling marine mammals in
E:\FR\FM\31DER1.SGM
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Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations
captivity must also comply with the
requirements of § 3.101(b) of this
subchapter.
(c) Dealers, exhibitors, intermediate
handlers, and carriers must provide and
document participation in and
successful completion of training for
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 by
September 27, 2013. For new dealers,
exhibitors, intermediate handlers, or
carriers licensed or registered after July
29, 2013, training of personnel must be
completed within 60 days of the dealer,
exhibitor, intermediate handler, or
carrier putting their contingency plan in
place. Employees hired 30 days or more
before their contingency plan is put in
place must also be trained by that date.
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.
PART 3—STANDARDS
5. The authority citation for part 3
continues to read as follows:
■
Authority: 7 U.S.C. 2131–2159; 7 CFR
2.22, 2.80, and 371.7.
6. In § 3.101, paragraph (b) is amended
by adding a new sentence at the end of
the paragraph to read as follows:
■
§ 3.101
Facilities, general.
*
*
*
*
*
(b) * * * Facilities handling marine
mammals must also comply with the
requirements of § 2.134 of this
subchapter.
*
*
*
*
*
Done in Washington, DC, this 20th day of
December 2012.
Rebecca Blue,
Deputy Under Secretary for Marketing and
Regulatory Programs.
[FR Doc. 2012–31422 Filed 12–28–12; 8:45 am]
ebenthall on DSK5TPTVN1PROD with
BILLING CODE 3410–34–P
VerDate Mar<15>2010
01:38 Dec 29, 2012
Jkt 229001
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. FSIS–2012–0039]
RIN 0583–AD05
Uniform Compliance Date for Food
Labeling Regulations
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is establishing
January 1, 2016, as the uniform
compliance date for new meat and
poultry product labeling regulations that
are issued between January 1, 2013, and
December 31, 2014. FSIS periodically
announces uniform compliance dates
for new meat and poultry product
labeling regulations to minimize the
economic impact of label changes.
DATES: This rule is effective December
31, 2012. Comments on this final rule
must be received on or before January
30, 2013.
ADDRESSES: FSIS invites interested
persons to submit relevant comments on
this proposed rule. Comments may be
submitted by either of the following
methods:
• Federal eRulemaking Portal: This
Web site provides the ability to type
short comments directly into the
comment field on this Web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov/. Follow
the online instructions at that site for
submitting comments.
• Mail, including CD–ROMs: Send to
Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, OPPD,
Patriots Plaza 3, 1400 Independence
Avenue SW., Mailstop 3782, 8–163A,
Washington, DC 20250–3700.
• Hand- or courier-delivered items:
Send to Docket Clerk, U.S. Department
of Agriculture (USDA), FSIS, OPPD,
Patriots Plaza 3, 355 E. Street SW., 8–
163A, Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2012–0039. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov/.
Docket: For access to background
documents or comments received, go to
the FSIS Docket Room at the address
listed above between 8 a.m. and 4:30
p.m., Monday through Friday.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Rosalyn Murphy-Jenkins, Director,
Labeling and Program Delivery Division,
Office of Policy and Program
Development, Food Safety and
Inspection Service, U.S. Department of
Agriculture, Telephone: 301–504–0879.
SUPPLEMENTARY INFORMATION:
Background
FSIS periodically issues regulations
that require changes in the labeling of
meat and poultry food products. Many
meat and poultry establishments also
produce non-meat and non-poultry food
products that are subject to the
jurisdiction of the Food and Drug
Administration (FDA). FDA also
periodically issues regulations that
require changes in the labeling of
products under its jurisdiction.
On December 14, 2004, FSIS issued a
final rule that established January 1,
2008, as the uniform compliance date
for new meat and poultry labeling
regulations issued between January 1,
2005, and December 31, 2006. The 2004
final rule also provided that the Agency
would set uniform compliance dates for
new labeling regulations in 2-year
increments and periodically issue final
rules announcing those dates.
Consistent with that final rule, the
Agency has published three final rules
establishing the uniform compliance
dates of January 1, 2010, January 1,
2012, and January 1, 2014 (72 FR 9651,
73 FR 75564, and 75 FR 71344).
The Final Rule
This final rule establishes January 1,
2016, as the uniform compliance date
for new meat and poultry product
labeling regulations that are issued
between January 1, 2013 and December
31, 2014, and is consistent with the
previous final rules that established
uniform compliance dates. In addition,
FSIS’ approach for establishing uniform
compliance dates for new food labeling
regulations is consistent with FDA’s
approach. FDA is also planning to
publish a final rule establishing a new
compliance date.
Two-year increments enhance the
industry’s ability to make orderly
adjustments to new labeling
requirements without unduly exposing
consumers to outdated labels. With this
approach, the meat and poultry industry
is able to plan for use of label
inventories and to develop new labeling
materials that meet the requirements of
all labeling regulations made within the
two year period, thereby minimizing the
economic impact of labeling changes.
This compliance approach also serves
consumers’ interests because the cost of
multiple short-term label revisions that
E:\FR\FM\31DER1.SGM
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Agencies
[Federal Register Volume 77, Number 250 (Monday, December 31, 2012)]
[Rules and Regulations]
[Pages 76815-76824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31422]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 2 and 3
[Docket No. APHIS-2006-0159]
RIN 0579-AC69
Handling of Animals; Contingency Plans
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the Animal Welfare Act regulations to add
requirements for contingency planning and training of personnel by
research facilities and by dealers, exhibitors, intermediate handlers,
and carriers. We are taking this action because we believe all
licensees and registrants should develop a contingency plan for all
animals regulated under the Animal Welfare Act in an effort to better
prepare for potential disasters. This action will heighten the
awareness of licensees and registrants regarding their responsibilities
and help ensure a timely and appropriate response should an emergency
or disaster occur.
DATES: Effective Date: January 30, 2013.
FOR FURTHER INFORMATION CONTACT: Dr. Jeanie Lin, Eastern Region
Emergency Programs Manager, Animal Care, APHIS, 920 Main Campus Drive,
Raleigh NC 27606; (919) 855-7100.
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. Regulations
established under the AWA are contained in the Code of Federal
Regulations (CFR) in 9 CFR parts 1 and 2, and 9 CFR part 3 contains
standards for the humane handling, care, treatment, and transportation
of animals covered by the AWA. Currently, part 3 consists of subparts A
through E, which contain specific standards for dogs and cats, guinea
pigs and hamsters, rabbits, nonhuman primates, and marine mammals,
respectively, and subpart F, which sets forth general standards for
warmblooded animals not otherwise specified.
The only requirement for contingency planning by licensees and
registrants in the regulations has been in Sec. 3.101(b), which covers
water and power supply requirements at facilities housing marine
mammals. Specifically, this section requires such facilities to submit
written contingency plans to the Deputy Administrator of Animal Care
(AC) regarding emergency sources of water and electric power should
primary sources fail. Among other things, the plans must include
evacuation plans in the event of a disaster and a description of backup
systems and/or arrangements for relocating marine mammals requiring
artificially cooled or heated water.
Following the events experienced during the 2005 hurricane season,
a Federal document, ``The Federal Response to Katrina: Lessons
Learned,'' which can be found on the Internet at https://georgewbush-whitehouse.archives.gov/reports/katrina-lessons-learned/, was published
that highlighted the need for planning to minimize the impact of
disasters. AC's experience indicates that, although contingency
planning would benefit the health and welfare of animals covered by the
AWA, at least some entities responsible for regulated animals have not
undertaken such planning. We believe all licensees and registrants
should be required to develop a contingency plan for all animals
regulated under the AWA in an effort to better prepare for potential
disasters. Therefore, on October 23, 2008, we published in the Federal
Register (73 FR 63085-63090, Docket No. APHIS-2006-0159) a proposal \1\
to amend the AWA regulations to add requirements for contingency
planning and training of personnel by research facilities and by
dealers, exhibitors, intermediate handlers, and carriers.
---------------------------------------------------------------------------
\1\ To view the proposed rule and the comments we received, go
to https://www.regulations.gov/#!docketDetail;D=APHIS-2006-0159.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 60 days ending on
December 22, 2008. On December 19, 2008, we published a notice in the
Federal Register (73 FR 77554) that extended the comment period an
additional 60 days until February 20, 2009. We received 997 comments by
that date. They were from private citizens, breeders, dealers, animal
welfare organizations, research facilities, Government agencies,
pharmaceutical companies, universities and colleges, research
associations, exhibitors, carriers, kennels, and medical associations.
Fifty commenters supported the rule as it was proposed. The issues
raised by the remaining commenters are discussed below by topic.
Many commenters had comments or questions that were not germane to
the proposed rule, such as asking the Animal and Plant Health
Inspection Service (APHIS) to end the trade of exotic animals. We are
not addressing those comments in this final rule because they are
outside of its scope.
Objections to Mandating Contingency Plans
Many commenters objected to APHIS mandating contingency plans. One
commenter stated that, since no plan can be 100 percent successful, it
does not make sense to mandate plans. One commenter stated that the AWA
has language prohibiting prescribing methods of research and that the
proposed rule violates this by prescribing emergency planning methods.
As stated in the proposed rule, the events experienced during the
2005 hurricane season highlighted the need for planning to minimize the
impact of disasters on the health and welfare of all animals covered by
the AWA. The intent of the proposed rule was to safeguard the health
and welfare of animals in emergency situations. We understand that
contingency plans may not be 100 percent successful. However, we do not
agree that plans should not be mandated because, to promote animal
welfare, entities should be able to demonstrate a reasonable effort to
address emergency situations. The rule does not prescribe emergency
planning methods. In addition, we do not consider a contingency plan to
be a research method.
One commenter suggested that instead of mandated plans, APHIS
should provide guidance materials, training videos, or classes, as it
would be cheaper for both APHIS and the regulated entities.
APHIS plans to provide guidance materials, which may include videos
and classes. However, this does not replace a need for contingency
plans as contingency plans are more adaptable to the unique
circumstances of each licensee and registrant and will determine what
training is needed. In addition, as facilities have widely varying
needs, allowing licensees and registrants to determine and implement
their own unique training allows
[[Page 76816]]
flexibility and will potentially keep training costs down. We have
prepared guidance materials that are being made available concurrently
with this final rule on our Web site \2\ and will provide additional
guidance to licensees and registrants for drafting appropriate
contingency plans upon request.
---------------------------------------------------------------------------
\2\ https://www.aphis.usda.gov/animal_welfare/awa_contingency_plan.shtml.
---------------------------------------------------------------------------
Several commenters stated that they already had contingency plans
in place or followed other accreditation standards (e.g., Association
of Zoos and Aquariums standards), which they stated were sufficient to
address the contingency plan components we proposed to require. Some of
these commenters asked that they be exempt from the requirements of the
rule because they already had plans in place or that APHIS work with
other organizations that have accreditation standards to draft a
standard document so that the regulations are not redundant. One
commenter stated that APHIS should have done a better job of talking to
facilities that already have contingency plans in place.
We recognize that many AWA licensees and registrants may already
have contingency plans in place. Although many of these plans may be
sufficient to satisfy the new contingency plan requirements in this
final rule, exemption is not practical as those nongovernmental
accreditation standards are not mandatory, nor are they linked by
regulatory processes to the AWA. However, before developing the
proposed rule, we gathered information on regulated entities that
currently have contingency plans in place. This information was used as
a basis for the proposed criteria for developing contingency plans.
Submission of Contingency Plans
Many commenters asked how APHIS will review the contingency plans,
and in particular whether we will require submission of contingency
plans to APHIS. Many commenters objected to submitting contingency
plans because they were concerned that the plans would be subject to
the Freedom of Information Act (FOIA) and that disclosure of
contingency plans would put at risk the safety and security of
facilities, employees, and animals by giving animal rights extremists
important information. Many other commenters supported submitting
contingency plans to APHIS or other agencies or making them available
to the public or making relevant portions of plans available to local
services identified by facilities as potentially important to the
execution of their contingency plan. One commenter suggested posting
contingency plans online while another suggested electronic submission.
Several commenters stated that licenses should be revoked or not
renewed if contingency plans are not submitted to APHIS or that plans
that have been modified due to personnel changes or updates should be
submitted to APHIS.
We do not intend to require submission of contingency plans. As
stated in the analysis of significant alternatives to the rule in the
proposed rule, there are over 10,000 licensees and registrants and
requiring each of them to submit plans to APHIS for review would take
an enormous amount of resources for the Agency to process, review, and
store. Therefore, we proposed that each research facility, dealer,
exhibitor, intermediate handler, or carrier will be required to review
their contingency plan on at least an annual basis. We would expect
that each licensee and registrant would maintain documentation of their
annual reviews, including documenting any amendments or changes made to
their plan since the previous year's review, such as changes made as a
result of recently predicted, but historically unforeseen,
circumstances (e.g., weather extremes). We are making this
clarification in Sec. 2.38(l)(2) and Sec. 2.134(b). We are also
clarifying that APHIS will have the opportunity to review annual review
documentation and training records, as well as contingency plans, as a
part of our routine inspection process. It is the regulated facility's
decision whether or not to share its plan with outside entities. The
AWA does not require licensees and registrants to disclose
documentation to outside entities. However, if a contingency plan
details coordination with other government entities, an inspector may
check for evidence supporting this coordination.
Expertise
Several commenters stated that there is no evidence that APHIS has
more expertise in contingency planning than other organizations, such
as universities. One commenter stated that APHIS should consult with
other agencies such as the Federal Emergency Management Agency (FEMA)
in the development of requirements for contingency plans or in the
implementation of contingency plans.
APHIS already has the technical expertise to ensure that regulated
entities protect the health and well-being of animals in accordance
with the AWA. Further, in 2008, APHIS launched an Animal Care Emergency
Programs unit, which is a full-time unit dedicated to collaborating
with other organizations to support the safety and well-being of
animals during emergencies and disasters. As required by the AWA, APHIS
consults and cooperates with other Federal agencies concerned with the
welfare of animals used for research, experimentation, or exhibition.
APHIS also routinely works closely with FEMA and other organizations on
animal welfare issues prior to and during disasters and emergencies.
Several commenters stated that the facility and not the Government
should decide what should be in contingency plans.
As stated in the proposed rule, because we recognize that
individual circumstances for regulated entities may be different, it is
difficult to go into specific detail as to what elements must be
included in all contingency plans. Therefore, we have not sought to
develop a one-size-fits-all plan but have instead provided a framework
of four criteria, in Sec. 2.38(l)(1) for research facilities and Sec.
2.134 for dealers, exhibitors, intermediate handlers, and carriers,
that we believe are the minimum criteria necessary to ensure a
successful contingency plan. We have largely left to the discretion of
each regulated entity how best to develop contingency plans that:
Identify common emergencies such as electrical outages,
faulty HVAC systems, fires, animal escapes, and natural disasters the
facility is most likely to experience.
Outline specific tasks required to be carried out in
response to the identified emergencies including, but not limited to,
specific animal evacuation plans or shelter-in-place plans and
provisions for providing backup sources of food and water as well as
sanitation, ventilation, bedding, veterinary care, etc.
Identify a chain of command and who (by name or by
position title) will be responsible for fulfilling these tasks.
Address how response and recovery will be handled in terms
of materials, resources, and training needed.
We believe that fulfilling these criteria is essential to the
success of a contingency plan. In addition, we believe that these
criteria provide an adequate degree of flexibility to allow all
regulated entities to comply with the provisions of this final rule.
These criteria are essential because they form a framework of what
potential events to address, who has responsibility, and how to
mitigate the potential events. These criteria form the basis of FEMA's
``Ready Business'' campaign, which
[[Page 76817]]
provides information to businesses on how to plan for emergencies. We
have modified that information to address animal welfare concerns.
Specific Criteria
One commenter stated that the contingency plan should identify and
evaluate the location of the facility and the probable specific
emergency situations that location is likely to experience. The
commenter further stated that any facility-specific vulnerability
should be identified and addressed. One commenter stated that facility
grounds should be in areas not prone to flooding or earthquakes and
that it is preferable to provide onsite care during an emergency.
One of the proposed criteria for development of contingency plans
is that the plan identify situations, such as emergencies and natural
disasters, that a regulated entity is most likely to experience that
would trigger the need for the measures identified in a contingency
plan to be put into action. We expect that, if a facility-specific
vulnerability would impact the humane handling and care of AWA-
regulated animals during an emergency, the vulnerability would be
addressed within the regulated entity's contingency plan. While we
agree that ideally a regulated entity would not be located in an area
prone to flooding or earthquakes, we realize that is not always
feasible to ensure. As stated in the proposed rule, such disasters, if
likely to be encountered by a particular regulated entity, would be
expected to be addressed in that regulated entity's contingency plan.
Several commenters stated that euthanasia should be considered a
viable option in the event of a disaster. Several commenters stated
that marine mammals should be microchipped to facilitate recovery in
the event they are released into the wild. One commenter stated that
all tasks necessary for ensuring the welfare of animals should be
itemized and the time required for each task estimated. Several
commenters recommended providing criteria for development of
contingency plans by animal group or by species and, for marine
mammals, criteria by geographic location. Several commenters stated
that agreements with alternative facilities for evacuation should be
part of the contingency plan.
Since each regulated entity has different needs, we have largely
left to the discretion of each regulated entity how best to fulfill the
criteria of this final rule. Details about elements to include in a
contingency plan, such as whether to use microchip identification
methods or euthanasia or whether to itemize and time tasks, are to be
decided upon by the regulated entity. In addition, as long as a
regulated entity addresses each of the elements required for
contingency plans, it may divide its plan according to criteria such as
animal group, species, or geographic location. While we encourage
regulated entities to explore cost-efficient options such as entering
into mutual aid agreements with nearby similar entities, we are not
requiring them to do so, as long as their contingency plans are
adequate to protect the animals' welfare.
As noted previously, the only contingency planning currently
required for licensees and registrants are those requirements in Sec.
3.101(b) which cover water and power supply requirements for facilities
housing marine mammals. One commenter suggested that the requirements
in Sec. 3.101(b) be revised to require that contingency plans
submitted for marine mammals include the proposed criteria for
contingency plans included in Sec. 2.134.
The regulations added in this final rule in Sec. 2.134 for
developing contingency plans apply to all dealers, exhibitors,
intermediate handlers, and carriers, including those that handle marine
mammals. We are amending Sec. 3.101(b) in this final rule to make it
clear that facilities housing marine mammals must comply with the
contingency planning requirements in Sec. 2.134.
Transportation
Several commenters stated that carriers and intermediate handlers
should not have to develop contingency plans because it would be costly
for them, because the number of animals lost or harmed in transit is
miniscule, or because they have limited resources to respond to
emergency situations. Given this, several commenters expressed concern
that, if forced to comply with the proposed rule, carriers may not want
to do business with research facilities.
We believe that all research facilities, dealers, exhibitors,
intermediate handlers, and carriers should be required to develop a
contingency plan for all animals regulated under the AWA. Although
there may be costs associated with developing contingency plans, we
expect such costs to be reasonable given that we have largely left it
up to the discretion of regulated entities to determine the best way to
fulfill the contingency plan criteria provided in this final rule for
their own unique circumstances (i.e., size, type of entity, location,
etc.). Therefore, we do not expect that developing contingency plans
will cause a significant financial burden on carriers and intermediate
handlers. At a minimum, we would expect that carriers, intermediate
handlers, and traveling exhibitors would have provisions in place to
respond to weather-related problems and animal escapes, as well as
other problems, such as mechanical failures, most likely to be
experienced during transit. We do not necessarily expect carriers and
intermediate handlers to have backup sources of food and water on hand
when traveling, but we would expect that their contingency plan would
document how and where to get them if needed. In addition, we are
clarifying in Sec. 2.134(b) that all traveling entities must carry a
copy of their contingency plan with them at all times and make it
available for inspection while in travel status. Having a copy of their
contingency plan on hand will allow regulated entities to refer
directly to their plan in the event of an emergency while traveling. We
believe this will result in preventing the loss or harm of regulated
animals.
Several commenters stated that facilities should have backup
carriers if their plans require evacuation. Also, the commenters stated
that carriers should include in their plans which facility to service
first in the event that a major disaster happens and multiple
facilities are impacted.
While we do not require regulated entities to employ backup
carriers, if a regulated entity's contingency plan includes a backup
carrier, we expect that the regulated entity will ensure that the
carrier is compliant with the elements of the contingency plan. In
addition, we believe that carriers should coordinate with the
facilities they serve.
Because we realize that some dealers, exhibitors, intermediate
handlers, and carriers do not have stationary facilities, we are making
a change to the requirements in Sec. 2.134(a)(1) by removing the word
``facility'' and replacing it with the more inclusive words ``licensees
and registrants.'' In addition, we are adding ``mechanical breakdowns''
to the list of likely emergencies that may be addressed in a
contingency plan.
Several commenters stated that licensees who travel with animals
should be required to submit contingency plans both for at home and on
the road. Several commenters stated that travel as part of contingency
plans for dangerous animals or for marine mammals should be prohibited
unless necessary for the welfare of the animals because of the risks to
public safety and animal welfare, particularly in emergency situations.
One commenter asked how animals that cannot be
[[Page 76818]]
evacuated will be cared for and stated that there needs to be a
requirement for securing a facility in the event animals cannot be
evacuated. One commenter stated that the contingency plan must document
how and by whom animals would be moved and what efforts will be made to
ensure the relocation of animals is done in the most humane or least
stressful manner possible.
The intent of the proposed rule was to safeguard the welfare of
animals in emergency situations. There is no requirement to travel with
animals unless it is part of a facility's contingency plan. As stated
in the proposed rule, the contingency plan would have to provide
detailed instructions for evacuation or shelter-in-place. Therefore, if
a contingency plan includes provisions for evacuation, we expect that
the plan will also include details on how and by whom the animals would
be moved in a way that would be as humane as possible given the
disaster circumstances a facility may be facing.
One commenter asked whether an outside carrier's equipment, if
called upon, would have to comply with AWA requirements.
Regulated entities are expected to ensure that their routine and
back-up carriers are compliant with all AWA requirements.
Disasters
Several commenters stated that detailed evacuation or shelter-in-
place plans may be possible for emergencies, but are impractical for
natural disasters because regulated entities rarely have advance notice
of disasters and because there are so many variations in facilities and
disasters that it does not make sense to have a one-size-fits-all plan.
The commenters further stated that the rule should acknowledge this and
allow for a ``best efforts'' approach when making contingency plans for
unpredictable natural disasters. Several commenters expressed concern
that the proposal seemed to require that all potential disasters be
addressed no matter how likely they are to occur. However, one
commenter stated that all potential disasters that might occur should
be addressed in the contingency plan.
We recognize that it is not practical to prescribe detailed
contingency plans for all situations. Therefore, we have not sought to
develop a one-size-fits-all plan, but have largely left to the
discretion of each regulated entity how best to fulfill the criteria
described in the proposed rule. This rule intends to set the minimum
criteria necessary to ensure a successful contingency plan. We believe
this provides an adequate degree of flexibility to allow all regulated
entities to comply with the provisions of the rule. As stated in the
proposal, we would require that regulated entities address those
emergencies and disasters most likely to occur, rather than requiring
them to address all possible disasters and emergencies regardless of
likelihood. We encourage regulated entities to consider all scales of
emergencies, but recognize that highly localized events such as power
disruptions and road closures (e.g., from a vehicular accident) are
most likely. APHIS encourages the regulated communities to address
these more routine events in their contingency plans, and to work with
their local emergency management organization. APHIS understands that
disaster and emergency events may be unpredictable and that it is
impossible for every possible event to be addressed in a contingency
plan.
One commenter stated that the contingency planning requirements are
inconsistent with Homeland Security Presidential Directive 8: National
Preparedness (HSPD-8) because terms used in the rule, such as ``major
disaster'' and ``emergency,'' are not consistent with those used in the
directive.
HSPD-8 establishes policy for dealing with terrorist attacks, major
disasters, and other events of national scope. Section 2(e) of the
directive states that the terms ``major disaster'' and ``emergency''
are defined in section 102 of the Robert T. Stafford Disaster Relief
and Emergency Assistance Act. Under that Act, ``emergency'' is defined
as any occasion or instance, as determined by the President, where
Federal assistance is needed to save lives, protect property and public
health and safety, or to lessen or avert a catastrophe. A ``major
disaster'' is defined as any natural catastrophe, as determined by the
President, which causes damage of sufficient severity and magnitude to
warrant major disaster assistance in order to supplement the efforts
and available resources of States, local governments, and disaster
relief organizations in alleviating the damage, loss, hardship, or
suffering caused by the catastrophe. The Stafford Act is largely a
framework for Federal assistance to State and local governments for
disaster relief, and these terms require Presidential involvement. The
scope of this rule is broader, and thus we use the terms ``disaster''
and ``emergency'' in more general terms. This rule considers
``disaster'' and ``emergency'' to mean those events which disrupt the
ability of a licensee or registrant to continue with normal business
routine and which are expected to be detrimental to the good health and
well-being of the animals in the licensee's or registrant's care. A
core concept of emergency management is that emergencies are managed at
the most local level possible. The National Incident Management System,
December 2008, supports this in stating that ``incidents typically
begin and end locally, and are managed on a daily basis at the lowest
possible geographical, organizational, and jurisdictional level.'' The
document is available from the FEMA Web site at https://www.fema.gov/pdf/emergency/nims/NIMS_core.pdf. While emergencies and disasters may
be Statewide or even national in scope, we expect that most often they
will be events that do not generally involve disaster declarations and
that remain localized, such as power outages, facility fires, or ice
storms.
One commenter stated that contingency plans should be integrated
into the overall hazard response plan for facilities.
Although we do not require regulated entities to integrate animal
contingency plans into their business continuity plans, we encourage
them to do so. APHIS believes that having a business continuity plan
supports animal health and welfare as well as overall good business
practices.
Backups
The proposed requirements in Sec. Sec. 2.38(l)(1)(ii) and
2.134(a)(2) stated that regulated entities must include in their
contingency plans provisions for providing backup sources of food and
water as well as sanitation, ventilation, bedding, veterinary care,
etc. Several commenters recommended that we remove the words ``backup
sources of'' from this provision and insert the words ``as described in
the contingency plan'' after the phrase ``as well as sanitation,
ventilation, bedding, veterinary care, etc.'' These commenters stated
that it may not be possible to maintain all of the veterinary care
provisions listed in Sec. 2.33(b) during a disaster.
While it may not be possible to provide the same level of
veterinary care during an emergency or disaster as during normal
business operations, APHIS believes that the veterinary care
requirements in Sec. 2.33(b) are the minimum requirements necessary to
ensure the health and welfare of regulated animals. As with the
contingency plan criteria, these veterinary care requirements are
general rather than specific to allow regulated entities the discretion
to determine how best to fulfill the requirements based on
[[Page 76819]]
their own unique situations. In addition, as backup veterinary care is
an element that must be addressed within the contingency plan, APHIS
will be able to assess the adequacy of the backup veterinary care as it
assesses the adequacy of veterinary care overall during routine
inspections.
Review and Enforcement
Several commenters expressed concern regarding APHIS' ability to
provide adequate inspection and review of plans, stating that the
review of plans would present an excessive burden to APHIS. One
commenter suggested that APHIS could reduce the inspection burden by
reviewing a random sampling of plans. Two commenters suggested that, at
a minimum, APHIS should review the contingency plans of facilities with
dangerous animals such as elephants, nonhuman primates, or large
carnivores. One commenter asked who APHIS would pay to obtain the extra
staff to enforce the rule. One commenter suggested that licensing fees
be increased to fund additional inspectors or that APHIS stop issuing
licenses until numbers of facilities drop to a manageable level.
We do not believe that our review of contingency plans would
present an excessive burden on APHIS. As noted above, we would review
contingency plans as a part of the routine inspection process, similar
to the process for our review of dog exercise and nonhuman primate
environment enhancement plans. We believe in this way we will be able
to provide adequate review of the contingency plans for all regulated
entities. We do not anticipate that additional APHIS staff will need to
be hired as a result of this rule. Neither do we anticipate needing to
contract out to other organizations to obtain additional staff.
Many commenters were concerned that there were not enough specifics
about what would make a contingency plan acceptable and that facilities
could be cited for failing to include certain items in their plans or
for not following their plans exactly. Several commenters suggested
punishments for facilities that either do not submit their plans or
whose plans are inadequate. One commenter asked whether the judgment of
noncompliance will be affected by whether animals were harmed in any
way.
We have issued a guidance document along with this final rule that
will assist licensees and registrants in determining what elements to
include in their contingency plans. The guidance document is intended
only to provide suggestions for how regulated entities may satisfy the
criteria in the regulations rather than to prescribe specific measures
that must be undertaken or equipment that must be purchased. For
example, a regulated entity has multiple options to mitigate the
potential failure of an HVAC system besides purchasing a backup
generator, some of which are no-cost solutions. These no-cost solutions
might include the use of a borrowed generator, opening windows, using
existing fans, and/or moving the animals to a cooler location. Any of
these actions could be considered adequate ways of responding to the
potential failure of an HVAC system and could therefore be included in
a contingency plan as long as the action listed is actually feasible.
For instance, if a regulated entity's contingency plan calls for
opening windows, but the facility's windows are incapable of opening,
opening windows would not be a valid mitigation measure. We wish to
emphasize that compliance with this final rule will be achieved through
the development of an appropriate contingency plan and the training of
facility personnel with respect to that plan. Nothing in this rule
should be construed as requiring affected entities to make capital
expenditures--for example, purchasing backup generators or making
structural changes to a facility--in order to comply with the rule. As
we do currently when enforcing the regulations, APHIS will assess the
adequacy of a regulated entity's contingency plan using the Animal
Welfare Act and Animal Welfare Regulations. This may be demonstrated by
the plan itself, training records, the presence of materials and
resources mentioned in the plan, or a documented history of responses
to similar situations. An adequate contingency plan is one in which the
minimum criteria considered necessary for a successful contingency plan
have been addressed. Enforcement action may be taken on a case-by-case
basis.
One commenter asked if missing the training deadline by a few days
would result in noncompliance with the training requirements in the
regulations regarding the contingency plan.
All noncompliant items, including failure to train employees on the
components of the contingency plan, found during inspection would be
documented on the inspection report and may be subject to enforcement
action on a case-by-case basis. Enforcement actions may include
issuance of official warnings, civil monetary penalties, license
suspension, or license revocation. Licensees and registrants are
expected to comply with all requirements of the regulations and
standards, including training deadlines.
Several commenters asked who would be determining the adequacy of
plans and what training they would have.
APHIS inspectors will review and determine the adequacy of
contingency plans. We will provide training to the inspection personnel
on evaluating contingency plans pursuant to the criteria set forth in
this rule.
One commenter asked on what basis regulated entities would be
expected to determine what natural disasters they may face and whether
and how this determination will be evaluated by inspectors.
In the proposed rule we provided links to the U.S. Geological
Survey ``Hazards'' Web site and the Weather Channel ``WeatherREADY''
Web site. These Web sites are good resources for determining the
natural disasters facilities are most likely to encounter in their
location. We would largely leave it up to the regulated entity to
determine which natural disasters they may face. However, if it is
apparent the regulated entity is likely to encounter a disaster that
the contingency plan does not address (e.g., a facility in Florida that
has experienced hurricanes in the past), APHIS inspectors will notify
the entity and give the entity time to add provisions for responding to
the disaster in the contingency plan. We anticipate that inspectors,
who are typically stationed in the local area surrounding the facility,
will be able to provide further guidance on potential natural
disasters.
One commenter stated that the rule should be revised to include
language relieving a regulated facility of responsibility if a higher
emergency response authority steps in.
We expect that most emergencies will be of a local nature, such as
facility fires or water main breaks. For emergencies or disasters of a
larger scale, APHIS will consider the roles of jurisdictional emergency
response authorities with respect to contingency plan implementation.
It is not the intent of the rule to interfere with local, State, or
Federal jurisdictional emergency response activities.
Training
As stated in the proposed rule, training of personnel could be
developed and offered by the research facility, dealer, exhibitor,
intermediate handler, or carrier or provided by an outside entity.
Several commenters stated that training requirements should be
identified, including how facilities will document training. One
commenter stated that a checklist should be
[[Page 76820]]
implemented with staff signing off that they have read the standard
operating procedures and completed training. Two commenters stated that
there should be requirements for training and availability of backup
personnel or for ensuring intermediate personnel replacement and
training. Several commenters stated that trial runs of the contingency
plan must be carried out.
As stated previously, because we recognize that individual
circumstances for regulated entities may be different, it is difficult
to go into specific detail as to what elements must be included in all
contingency plans. Therefore, we do not believe it appropriate to
provide technical and tactical requirements, such as protocols for
personnel replacement and training, in the regulations. We anticipate
that inspectors may confirm that contingency plan training is delivered
in a similar manner to their current process for confirming that other
required training has been delivered (e.g., for husbandry practices and
veterinary care protocols). Such confirmation may include reviewing
training documentation maintained by the regulated entity or asking
involved employees questions about facility practices. While we have
not specifically mandated trial runs of contingency plans, training may
include trial runs in order to prepare licensees and registrants
adequately in the event of a disaster or emergency.
One commenter stated that both position title and name of employees
who play a part in implementing the contingency plan should be included
in the contingency plan.
As stated in the proposed rule, regulated entities would need to
identify a chain of command and who (by name or position title) will be
responsible for fulfilling required tasks. We would leave it up to the
regulated entity whether to include both position title and name or
whether to include one or the other.
Several commenters stated that training should only apply to
individuals who have a role to play within the contingency plan.
We believe the decision of which individuals should be trained is a
decision best left up to the discretion of the regulated entity.
However, we would expect all personnel who may be involved in or
impacted by an emergency or disaster to be trained at an appropriate
level.
Dates
In the proposed rule, we proposed to require that contingency plans
be in place 180 days after the effective date of this final rule. In
addition, we proposed that training of personnel would have to take
place within 60 days following the adoption of a contingency plan by
the research facility, dealer, exhibitor, intermediate handler, or
carrier. Employees hired within 30 days or less after adoption of the
contingency plan would have to be trained in that 60-day period while
employees hired more than 30 days after adoption of the contingency
plan would have to be trained within 30 days of their start date.
Several commenters asked that we further push back the effective
date of the regulations to allow time to finalize contingency plans.
One commenter stated that it was unclear whether the adoption date
mentioned in the proposed rule is the date the rule is adopted or the
date plans must be in place and that, if it is the former, the rule
needs to be revised since this would require training to be completed
before the contingency plan, which will guide the training, is in
place. The commenter further stated that the 180-day period for having
plans in place should begin at the later of either the effective date
of the final rule or the date of issuance of guidance documents by
APHIS. Two commenters asked whether the 180-day timeframe for having
contingency plans in place includes procuring all necessary materials
and resources for implementing the contingency plan. The commenters
stated that if such is the case, it is too short of a timeframe to
gather materials and resources that are not currently available within
a facility.
As stated in the proposed rule, the adoption date is the date the
contingency plan must be in place. For current licensees and
registrants, this date is 180 days after the effective date of this
final rule. For future licensees and registrants, we expect the
licensee or registrant to have a contingency plan in place prior to
conducting regulated activities. We are making changes to paragraphs
(l)(2) and (l)(3) in Sec. 2.38 and paragraphs (b) and (c) in Sec.
2.134(b) in order to make it clearer that the adoption date is the date
the contingency plans must be finalized. Training of personnel must
take place within 60 days after the adoption date. We believe 180 days
is a sufficient length of time to ensure that contingency plans are in
place and to procure any necessary materials and resources for
implementing contingency plans.
Several commenters stated that the 30-day training requirement for
newly hired personnel is unnecessary and not in keeping with the lack
of specificity for the rest of the plan.
We believe that it is important to ensure that employees of a
regulated entity are familiar with the regulated entity's contingency
plan. Therefore, it is appropriate to require that training occur
within 30 days.
Guidance
One commenter stated that guidance documents for developing
contingency plans should be developed by a lead organization with
expertise in collaboration with outside organizations. One commenter
stated that guidance documents should not be developed by entities
outside of APHIS but that stakeholders/licensees should have input.
Several commenters objected to guidance documents or other means for
providing criteria outside of the regulations at all. Several
commenters stated that the guidance document should be made available
via the Internet, and released with the final rule.
APHIS has expertise in collaborating with outside organizations and
is also responsible for enforcing the AWA. Therefore, it is appropriate
for us to take the lead role in developing guidance documents to
support contingency planning. As stated previously, we are providing a
guidance document with this final rule. During the comment period for
the proposed rule, we asked for public comment, including comment from
stakeholders and licensees, on what elements should be included in the
guidance document. To reiterate, APHIS will assess the adequacy of a
regulated entity's contingency plan using the Animal Welfare Act and
Animal Welfare Regulations. The guidance document provides suggestions
for how regulated entities may satisfy the criteria in the regulations.
One commenter said that USDA should provide guidance on how
contingency plans might address elements unique to each facility. One
commenter suggested that APHIS create a Web site with more information
that includes guidelines, checklists, and templates. Several commenters
supplied examples of contingency plans, links to contingency plans, or
resources for drafting contingency plans.
We are issuing a guidance document that may assist regulated
entities in addressing the circumstances unique to their location or
facility. We also reviewed the information provided by the commenters
and will make a list of helpful resources available on our Web site
(see footnote 2). The guidance document is intended to be only a tool
[[Page 76821]]
when considering how a facility might meet the regulatory requirements,
and does not provide a new set of criteria.
Economic and Paperwork Concerns
Many commenters stated that the proposed rule will cause a serious
financial impact, especially on small businesses, which make up the
majority of those affected. Several commenters stated that a cost-
benefit study has not been conducted and asked that APHIS withdraw the
rule until one has been conducted or until APHIS has evaluated whether
the rule is truly necessary.
A preliminary regulatory impact analysis was conducted for the
proposed rule and a final regulatory impact analysis has been conducted
for this rule. A summary of the final regulatory impact analysis
appears in this document under the heading ``Executive Orders 12866 and
13563 and Regulatory Flexibility Act.'' The full analysis may be viewed
on the Regulations.gov Web site (see footnote 1) or obtained by
contacting the person listed under FOR FURTHER INFORMATION CONTACT. One
of the components of the preliminary regulatory impact analysis is a
cost-benefit analysis. APHIS has estimated that about 5 hours, on
average, will be required by a facility to develop a contingency plan,
using guides provided and recommended by APHIS. Depending on the size
and type of regulated entity and its circumstances, this cost, in terms
of the time needed to develop a contingency plan, will vary; some
facilities will require less than 5 hours to develop their plans and
other entities will require more time. APHIS estimates that it will
take 4 to 6 hours to develop and document a contingency plan. We note
that many large regulated entities, in particular, already have
contingency plans. In addition to the costs associated with the
development of a contingency plan, there may also be certain
expenditures necessitated by the regulated entity's plan itself. As an
example, a particular regulated entity's plan may call for a backup
generator to supply electricity in case of a power outage. We expect
such costs to total within a reasonable range given that we have
largely left it up to the discretion of facilities to determine the
best way to fulfill the contingency plan criteria provided in the
proposed rule for their own unique circumstances (i.e., size, type of
entity, location, etc.). The costs of developing a plan and related
equipment purchases should be viewed in terms of the benefits of
reduced risk of harm to the animals under a regulated entity's care
when there is an emergency or disaster. A reasonably scaled contingency
plan that has identified potential emergencies and natural disasters
therefore contributes to a regulated entity's long-term operational
strength and financial security. To the extent to which the animals
held by a licensee or registrant represent a capital asset or business
investment, we do not believe it is unreasonable to expect that
entities will have already put in place measures to ensure the
continued well-being of those animals. Thus, the actual amount of new
costs incurred by regulated entities due solely to the identification
of a need during the development of a contingency plan should not be
significant.
One commenter stated that the rule does not comply with the
Regulatory Flexibility Act because it shifts the burden of
investigating what would be required for a contingency plan to
businesses. One commenter expressed concern that the Small Business
Administration was not consulted when developing the proposed rule.
The Regulatory Flexibility Act requires that Federal agencies
endeavor to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration. APHIS recognizes that each regulated entity is
the best judge of the particular measures that should be included in
its contingency plan. APHIS is minimizing the burden of the rule for
small entities by allowing each one to determine for itself how best to
meet the requirements in accordance with the general criteria and
guidance documents. APHIS also consulted with the Small Business
Administration in the preparation of the proposed rule and this final
rule.
One commenter stated that since the rule is significant and an
Initial Regulatory Flexibility Analysis was prepared that APHIS is
required to publish a compliance guide which will help regulated
industries comply with the regulation.
The guidance document that we are making available concurrently
with this rule will assist licensees and registrants in complying with
the regulation. Any additional compliance guides will be posted on the
APHIS Web site (see footnote 2) and made available to the public to
further assist small entities in complying with this rule.
Two commenters asked whether they would have to build additional
alternative facilities, or, if not, what shelter would be acceptable on
a temporary basis, and whether USDA is ready to help shoulder some of
the costs until a facility can be repaired. One commenter expressed
concern that they would need to purchase disaster insurance.
We do not intend to require the building of alternative facilities.
While the costs for development and execution of the plan are expected
to be borne by the regulated entity, they will be determined based on
the emergencies and potential natural disasters most likely to be
experienced by the regulated entity. As stated previously, we expect
that these costs will be reasonable. The purpose of a contingency plan
is to help ensure that licensees and registrants are able to respond in
a timely and appropriate manner should an emergency or disaster occur.
Disaster insurance is not required by this rule, and promoting the
purchase of disaster insurance is not an objective of this rule.
Three commenters expressed concern that the number of animals lost
during Hurricane Katrina as stated in the economic analysis of the
proposed rule is greater than the total number of regulated animals in
Louisiana.
In the preliminary regulatory impact analysis, APHIS may have
inadvertently implied that the number of animals covered under the
Animal Welfare Act that were harmed or killed as a result of Hurricane
Katrina was comparable to the 50,000 pets that reportedly were
negatively impacted by the disaster. This is incorrect. There is a
difference in scale between the number of animals for which pet owners
are responsible versus the number of animals for which research
facilities and other licensed and registered facilities are
responsible. Therefore, AWA licensees and registrants caring for large
numbers of animals who did not have contingency plans in place likely
found it difficult to evacuate or otherwise ensure the animals' safety
during Hurricane Katrina. Our intent in the proposed rule was to
illustrate this fact rather than to compare the number of regulated
animals negatively impacted to the number of pets that were negatively
impacted. We have reexamined the available data and we present our
findings in the full final regulatory flexibility analysis, which can
be viewed on the Regulations.gov Web site (see the address listed in
footnote 1).
One commenter suggested that a tiered contingency plan system be
implemented to accommodate small businesses.
As a practical matter, one would expect that the smaller the
business, the smaller the scale of the contingency
[[Page 76822]]
plan that the business would be expected to prepare, just as a large
entity with numerous animals would require a larger scale, more complex
contingency plan. Because we recognize that individual circumstances
may be different between research facilities, dealers, exhibitors,
carriers, and intermediate handlers, we have provided general
contingency plan criteria and largely left it up to the discretion of
regulated facilities to determine how best to fulfill the criteria.
Because the response to each criterion will be appropriate to the size
of each individual entity, it is reasonable to describe the contingency
plan system provided for by this rule as tiered.
Several commenters expressed concern regarding the costs of and
time for drafting a contingency plan. One commenter stated that the
rule may be imposing redundant paperwork requirements because of
similar requirements at the State and local levels.
Many regulated facilities are currently required to have
contingency plans by other organizations (e.g., accrediting
institutions, State and local regulators). Many of these plans will
meet the proposed contingency plan requirements, and paperwork
redundancies for entities with such plans should be minimal. Those
regulated facilities that do not already have plans in place may incur
an additional burden to develop contingency plans. However, we believe
that having an established contingency plan promotes animal welfare and
will aid in business continuity, therefore reducing the burden on
facilities and regulated animals in the event of a natural disaster or
emergency.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
This proposed rule has been determined to be significant/
economically significant for the purposes of Executive Order 12866 and,
therefore, has been reviewed by the Office of Management and Budget.
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 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
on the Regulations.gov Web site (see footnote 1 in this document for a
link to Regulations.gov) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
Preparedness for emergencies and disasters can reduce the harm to
animals and their loss of life. The devastating impact of the 2005
hurricane season underscores the need for contingency planning for all
animals covered under the Animal Welfare Act. Currently, only
facilities that house marine mammals are required under 9 CFR 3.101 to
develop contingency plans. The final rule requires that all of the more
than 10,000 licensees and registrants develop and document contingency
plans for all other animals covered under the Act. In addition,
training to carry out contingency plans will be required of a regulated
entity's employees. The majority of establishments that will be
affected by this rule are small, based on industry estimates obtained
from the Economic Census and the Census of Agriculture.
The full final regulatory flexibility analysis identifies breeders,
wholesale dealers, licensed and registered exhibitors, registered
research facilities, and registered transport carriers and handlers as
those entities most likely to be impacted by the requirement for the
development of contingency plans. While no economic data are available
on business size for the specific entities, we may assume the majority
of the potentially impacted establishments are small, based on the
industry estimates obtained from the Economic Census and the Census of
Agriculture.
The final rule will impose certain costs to develop and document
the contingency plans and provide employee training, but these costs
are not expected to be excessive. The cost of training personnel will
vary depending on the type and size of business. However, many
organizations offer training courses on general disaster planning
specific to the type of animals at the particular facility or
operation. FEMA offers free training, while some organizations offer
courses with prices ranging from $50 to $300. These courses cover the
development and implementation of contingency plans. In addition, many
of the larger facilities, in particular, already have contingency plans
in place. APHIS recognizes that each entity is the best judge of the
particular measures that should be included in its contingency plan,
and will provide general criteria and guidance documents to minimize
compliance costs. Each entity will determine for itself how best to
meet the rule's requirements.
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 7 CFR part 3015, subpart V.)
Executive Order 12988
This final 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.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0352.
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 rule, please contact Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at (301) 851-2908.
List of Subjects
9 CFR Part 2
Animal welfare, Pets, Reporting and recordkeeping requirements,
Research.
9 CFR Part 3
Animal welfare, Marine mammals, Pets, Reporting and recordkeeping
requirements, Research, Transportation.
Accordingly, we are amending 9 CFR chapter I, subchapter A, as
follows:
[[Page 76823]]
PART 2--REGULATIONS
0
1. The authority citation for part 2 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
0
2. Section 2.38 is amended by adding new paragraphs (i)(4) and (l) to
read as follows:
Sec. 2.38 Miscellaneous.
* * * * *
(i) * * *
(4) The other person or premises must either be directly included
in the research facility's contingency plan required under paragraph
(l) of this section or must develop its own contingency plan in
accordance with paragraph (l) of this section.
* * * * *
(l) Contingency planning. (1) Research facilities must develop,
document, and follow an appropriate plan to provide for the humane
handling, treatment, transportation, housing, and care of their animals
in the event of an emergency or disaster (one which could reasonably be
anticipated and expected to be detrimental to the good health and well-
being of the animals in their possession). Such contingency plans must:
(i) Identify situations the facility might experience that would
trigger the need for the measures identified in a contingency plan to
be put into action including, but not limited to, emergencies such as
electrical outages, faulty HVAC systems, fires, and animal escapes, as
well as natural disasters the facility is most likely to experience.
(ii) Outline specific tasks required to be carried out in response
to the identified emergencies or disasters including, but not limited
to, detailed animal evacuation instructions or shelter-in-place
instructions and provisions for providing backup sources of food and
water as well as sanitation, ventilation, bedding, veterinary care,
etc.;
(iii) Identify a chain of command and who (by name or by position
title) will be responsible for fulfilling these tasks; and
(iv) Address how response and recovery will be handled in terms of
materials, resources, and training needed.
(2) For current registrants, the contingency plan must be in place
by July 29, 2013. For research facilities registered after this date,
the contingency plan must be in place prior to conducting regulated
activities. The plan must be reviewed by the research facility on at
least an annual basis to ensure that it adequately addresses the
criteria listed in paragraph (l)(1) of this section. Each registrant
must maintain documentation of their annual reviews, including
documenting any amendments or changes made to their plan since the
previous year's review, such as changes made as a result of recently
predicted, but historically unforeseen, circumstances (e.g., weather
extremes). Contingency plans, as well as all annual review
documentation and training records, must be made available to APHIS and
any funding Federal agency representatives upon request. Facilities
maintaining or otherwise handling marine mammals in captivity must also
comply with the requirements of Sec. 3.101(b) of this subchapter.
(3) The facility must provide and document participation in and
successful completion of training for its personnel regarding their
roles and responsibilities as outlined in the plan. For current
registrants, training of facility personnel must be completed by
September 27, 2013; for research facilities registered after July 29,
2013, training of facility personnel must be completed within 60 days
of the facility putting its contingency plan in place. Employees hired
30 days or more before the contingency plan is put in place must also
be trained by that date. 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. Section 2.102 is amended by adding new paragraphs (a)(4) and (b)(3)
to read as follows:
Sec. 2.102 Holding facility.
(a) * * *
(4) The other person or premises must either be directly included
in the dealer's or exhibitor's contingency plan required under Sec.
2.134 or must develop its own contingency plan in accordance with Sec.
2.134.
(b) * * *
(3) The other person or premises must either be directly included
in the intermediate handler's contingency plan required under Sec.
2.134 or must develop its own contingency plan in accordance with Sec.
2.134.
0
4. A new section Sec. 2.134 is added to read as follows:
Sec. 2.134 Contingency planning.
(a) Dealers, exhibitors, intermediate handlers, and carriers must
develop, document, and follow an appropriate plan to provide for the
humane handling, treatment, transportation, housing, and care of their
animals in the event of an emergency or disaster (one which could
reasonably be anticipated and expected to be detrimental to the good
health and well-being of the animals in their possession). Such
contingency plans must:
(1) Identify situations the licensee or registrant might experience
that would trigger the need for the measures identified in a
contingency plan to be put into action including, but not limited to,
emergencies such as electrical outages, faulty HVAC systems, fires,
mechanical breakdowns, and animal escapes, as well as natural disasters
most likely to be experienced;
(2) Outline specific tasks required to be carried out in response
to the identified emergencies or disasters including, but not limited
to, detailed animal evacuation instructions or shelter-in-place
instructions and provisions for providing backup sources of food and
water as well as sanitation, ventilation, bedding, veterinary care,
etc.;
(3) Identify a chain of command and who (by name or by position
title) will be responsible for fulfilling these tasks; and
(4) Address how response and recovery will be handled in terms of
materials, resources, and training needed.
(b) For current licensees and registrants, the contingency plan
must be in place by July 29, 2013. For new dealers, exhibitors,
intermediate handlers, and carriers licensed or registered after this
date, the contingency plan must be in place prior to conducting
regulated activities. The plan must be reviewed by the dealer,
exhibitor, intermediate handler, or carrier on at least an annual basis
to ensure that it adequately addresses the criteria listed in paragraph
(a) of this section. Each licensee and registrant must maintain
documentation of their annual reviews, including documenting any
amendments or changes made to their plan since the previous year's
review, such as changes made as a result of recently predicted, but
historically unforeseen, circumstances (e.g., weather extremes).
Contingency plans, as well as all annual review documentation and
training records, must be made available to APHIS upon request.
Traveling entities must carry a copy of their contingency plan with
them at all times and make it available for APHIS inspection while in
travel status. Dealers, exhibitors, intermediate handlers, and carriers
maintaining or otherwise handling marine mammals in
[[Page 76824]]
captivity must also comply with the requirements of Sec. 3.101(b) of
this subchapter.
(c) Dealers, exhibitors, intermediate handlers, and carriers must
provide and document participation in and successful completion of
training for 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 by September 27, 2013. For new dealers, exhibitors,
intermediate handlers, or carriers licensed or registered after July
29, 2013, training of personnel must be completed within 60 days of the
dealer, exhibitor, intermediate handler, or carrier putting their
contingency plan in place. Employees hired 30 days or more before their
contingency plan is put in place must also be trained by that date. 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.
PART 3--STANDARDS
0
5. The authority citation for part 3 continues to read as follows:
Authority: 7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
0
6. In Sec. 3.101, paragraph (b) is amended by adding a new sentence at
the end of the paragraph to read as follows:
Sec. 3.101 Facilities, general.
* * * * *
(b) * * * Facilities handling marine mammals must also comply with
the requirements of Sec. 2.134 of this subchapter.
* * * * *
Done in Washington, DC, this 20th day of December 2012.
Rebecca Blue,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2012-31422 Filed 12-28-12; 8:45 am]
BILLING CODE 3410-34-P