Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 76815 

1To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2006-0159. 

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 

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 § 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 

http://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 

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 


ebenthall on DSK5TPTVN1PROD with 
76816 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 

2http://www.aphis.usda.gov/animal_welfare/ 

awa_contingency_plan.shtml. 

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 

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 

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 


ebenthall on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 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 § 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 

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 


ebenthall on DSK5TPTVN1PROD with 
76818 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 

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 

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 

http://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 


ebenthall on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 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 


ebenthall on DSK5TPTVN1PROD with 
76820 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 

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 § 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 

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 


ebenthall on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 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 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 

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 


ebenthall on DSK5TPTVN1PROD with 
76822 Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 

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: 


ebenthall on DSK5TPTVN1PROD with 
Federal Register / Vol. 77, No. 250 / Monday, December 31, 2012 / Rules and Regulations 76823 

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. 

* * * * * 

(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 § 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 

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 


ebenthall on DSK5TPTVN1PROD with 
76824 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] 

BILLING CODE 3410–34–P 

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 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: 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 http://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 http:// 

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. 

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 


ebenthall on DSK5TPTVN1PROD with