**Regulatory Impact Analysis and Final Regulatory Flexibility Analysis** 

**Final Rule**
**Contingency Plans for the Handling of Animals Docket No. APHIS**  **- 2006**  **- 0159**  **RIN 0579 -**  **AC69**

**U.S. Department of Agriculture Animal and Plant Inspection**  **Service**

**January 2012**2

Contingency Plan s for the Handling of Animals Introduction The Animal Welfare Act (AWA) was signed into law in 1966 and has been amended four times (1970, 1976, 1985, and 1990). The original intention of the Act was to regulate the care and use of animals in the laboratory . Over the years, it has evolved into the only

Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and use b y dealers. There are other laws, policies, and guidelines that may

include additional species coverage or specifications for animal care and use. However, the Animal Welfare Act is the minimum acceptable standard that regulates animal care and use in the United States

. The Act regulates the treatment of live or dead dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, and an y
warm - blooded animal s that are used or are intended for use in research, teaching, testing, experimentation, for exhibition purposes, or as pets. Businesses and organi zations that buy and/or sell warm

- blooded animals, exhibit them to the public, transport animals commerciall y , or use animals in experiment s or as teaching tools must be licensed or registered b y the United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA APHIS). Businesses or organizations that grow, buy , or sell animals for food and fiber, and those that use fish and other cold

- blooded animals are exempt , as are facilities that use rats , mice, or birds that are bred for use in research

. While the Animal Welfare Act mandates contingency plans for marine mammals, there are no contingency

plan requirements for other animals covered under the Act. Under 9 CFR § 3.101(b), facilities housing marine mammals must provide reliabl e and3

adequate sources of water and electric power. In addition, the facilities are required to submit contingency

plans regarding emergency sources of water and electric power for approval to the Deputy Administrator of Animal Care, APHIS. Contingency pl ans must incorporate evacuation procedures in the event of a disaster and a description of backup sy stems or arrangements for relocating marine mammals requiring artificially cooled or heated water. The World Health Organization categorize s disasters as ei ther natural or manmade. Natural disasters are the result of natural phenomena and account for 80 percent of all disaster s around the world (Sen and Chander 2003). Manmade disasters on the other hand occur as a result of man’s intervention or non

- interve ntion

. Lack of preparedness can leave businesses and organizations and the animals in their care vulnerable , as was the case in the southern United States in 2005

. The hurricane season’s devastating impact that year underscore s the need for contingency pl anning for the handling of all animals , particularl y those regulated by APHIS and protected under the Animal Welfare Act. While there are no estimates of how man y animals in research facilities or other licensed and registered establishments were harmed o r died because of Hurricane Katrina , we expect that th is natural disaster was devastating for these regulated animals. AWA licensees and registrants caring for large numbers of animals who did not have contingency

plan s in place likely found it difficult to evacuate or otherwise ensure the animals’ safety. In one instance, after facility personnel were evacuated , authorities were not notified for 10 day s that animals had been abandoned. B y that time , approximately4

90 percent of the animals either had die d or needed to be humanel y euthanized

. 1 This
was one of man y tragic outcome s that could have been pr evented or mitigated if the facility had had a contingency

plan in place. Other natural disasters have also had devastating impact s on regulated businesses or organizations and on th e animals in their care

. In the wake of Tropical Storm Allison , in 2001 , 4,700 research animals , valued at $7.4 million, died

. Animal

- based research at the facility was delayed for approximately 18 months , at a cost of $105 mil lion (LAMA Disaster Preparedness Resource)

. Since this incident, the facility has implemented contingency

planning to avoid a repeat of such loss es . In 200 7 , Animal Care reported that over one million animals , including dogs, cats, guinea pigs, nonhuman primates, hamsters, and rabbits , were used b y registered research facilities. 2 This large number of animals used b y research facilities underscores the importance of contingency plans to protect these animals and mitigate impact s of natural and manmade di sasters. In accordance with requirement s of the Office of Management and Budget for significant rulemaking, the economic anal ys is provides a cost

- benefit anal ysis, as required b y 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 anal ys is also examines

1 Dr. Jodie Kulpa

- Eddy , USDA APHIS, Animal Care. 2 http://www.aphis.usda.gov/publications/animal_we lfare/content/printable_version/2007_AC_Report.pdf5

the potential economic effects of this rule on small entities, as required b y the Regulatory Flexibility

Act. Final Rule and Contingency Plan Components The final rule will amend the current regulations and require all licensees and registrants, which include research facilities, dealers, exhibitors, intermediate handlers, and carrier s , to develop and document contingency plans for the handling of animals during emergencies. The contingency plans should identify

common emergencies , such as electrical outages, faulty HVAC s ys tems, fires, and animal escapes, as well as natural disasters the regulated entity is most likely to experience. Because c ontingency

planning is already

a requirement for marine mammal facilities , there is a wealth of information available from various Federal and State agencies and private organizations that addre ss es animal disaster planning. In addition, since Hurricane Katrina there has been heightened awareness of the need to plan for disaster s . A s a result, many Federal, State, and private organizations have developed guidelines for handling animals during em ergencies. A list of resources that may aid in the development and implementation of contingency plans is presented in t able 1
. In addition, APHI S will provide a guidance document to assist regulated entities in complying with this rule. Because the regul ated entities are in various industry classification categories, it is difficult to develop a standard contingency plan. However, key

elements of the plan should be disaster mitigation, preparedness, response , and recovery (FEMA 2008 ). Organizations and b usiness es can identify F ederal and S tate agencies that are associated with specific disaster mitigation. Mitigation includes any activities that prevent an6

emergency , reduce the chances of an emergency , or reduce the damaging effects of unavoidable emerge ncies. Preparedness includes plans and preparations made to save lives and to assist in response and recovery

. Response refers to actions taken to save lives and prevent further property damage during an emergency situation. Recovery includes actions taken to return to a normal or safer situation following an emergency

. Emergencies may

require secondary sources of water and food, backup s ys tems in the event of power outages or faulty HVAC systems, means of evacuation in the event of fire or floods, and p rocedures for recapturing animals that escape. Items that may be considered and incorporated into a contingency plan are shown in table 2 , categorized by cost. L isted actions and purchases for disaster preparedness are grouped into those requiring no fin ancial expenditures (but that do demand time), ones expected to cost less than $500, and others that are more expensive

.7

**Table 1 : List of Available Sources on Disaster Planning and Management**  **Books and Articles** Dorn, C. Richard. “Veterinary Service and Animal Care Emergency Operations Plans.” Journal of American Veterinary Medical Association . 1 Oct. 1993. Heath, Sebastian E. Animal Management in Disasters . St. Louis: Mosby, Inc., 1999. Russell, Ray L. “Business Aspects of Disaster Plannin g and Recovery.” Journal of American Veterinary Medical Association . 1 Oct. 1993. Vogelweid, C. M. “Developing Emergency Management Plans for University Laboratory Animal Programs and Facilities.” Contemporary Topics of Laboratory Animal Science. Sept . 1998. **Example Checklists** ARENA/ OLAW: Institutional Animal Care & Use Committee Guidebook ; 2 nd edition, 2002 (Excerpt ~ Emergency Preparedness

- Section B.6)

- pages 71

- 81 <http://grants.nih.gov/grants/olaw/guidebook_excerpt.doc> Federal Emergenc y Management Agency (FEMA). “Animal Disaster Plan Worksheet for Planners and Emergency Managers.” 21 Mar. 2006. <http://www.fema.gov/emergency/managers/dispws> **Useful Websites** American Veterinary Medical Association (AVMA). Disaster Preparedness Response Guide

. April 2009

. http://www.avma.org/disaster/ FEMA Independent Study Program. Animals in Disaster. Module A (IS

- 10) and Module B (IS

- 11). May 2007
. http://training.fema.gov/EMIWeb/IS/IS11a.asp Humane Society of the United States. “Disaster P lanning.” Disaster Services, 201 0. http://www.humanesociety.org/search/search.jsp?query=disaster+planning Information Resources for Institutional Animal Care and Use Committees. “Disaster Planning.” AWIC Resource S eries No. 7. 28 June 2001. (Published by USDA

- ARS, APHIS, NAL, Tim Allen M.S., ed.) <http://www.nal.usda.gov/awic/pubs/IACUC/iacuc.htm> Louisiana State University Emergency Animal Shelter. Disaster Response Manual . 2006. Complied by Susan K. Mikot a DVM <http://lsuemergencyanimalshelter.org/index.htm> National Institutes of Health. Office of Extramural Research. Office of Laboratory Animal Welfare. Disaster Planning and Response Resources. 22 March 2006. <http://grants.nih.gov/grants/olaw/disa ster_planning.htm>
University of California. Division of Agriculture and Natural Resources. Veterinary Medicine Extension. DANR Guide to Disaster Preparedness . 1999. http://www.vetmed.ucdavis.edu/vetext/DANR/DANRGuide2_02

- 03Intro.pdf8

**Table 2**  **: Costs to Develop a Disaster Protection and Business Continuity Plan**  **No Cost** Meet with your insurance provider to review current coverage. Create procedures to quickly evacuate or shelter

- in

- place. Practice the plans. Talk to your people about the co mp any’s disaster plan. T wo - way communication is essential, before, during, and after a disaster. Create an emergency contact list . I nclude employee emergency contact information. Know what type of emergencies might affect your com pany both internally an d externally. Decide in advance what you will do if your building in unusable. Create a list of critical business contractors and others whom you will use in an emergency

. Create an inventory list of equipment , including computer hardware, software and peripherals, for insurance purposes. Talk to utility service providers about potential alternatives and identify back

- up options. Promote family and individual preparedness among your co

- workers. Include emergency preparedness information in staff meeti ng discussion s, in newsletters, on company I ntranet, periodic employee emails and other internal communication tools. **Under $500** Buy a fire extinguisher and smoke alarm. Decide which emergency supplies the company can feasibly provide, if any, and talk to your co
- wo rkers about what supplies individuals might want to keep in a personal and portable science kit. Set up a telephone call tree, password

- protected page on the company W ebsite, an email alert or a call

- in voice recording to communicate with emp loyees in an emergency. Provide first aid and CPR training to key co

- workers. Use and keep up

- to
- date computer and anti

- virus software and firewalls. Attach equipment and cabinets to walls or other stable equipment. Place heavy or breakable objects on low shelves. Elevate valuable inventory and electric machinery off the floor in case of flooding. If applicable, make sure your building’s HVAC system is working properly and well

- maintained

. Back

- up your records and critical data. Keep a copy offsite. **More than $500** Consider additional insurance such as for business interruption, flood or earthquake. Purchase, install and pre

- wire a generator to the buildings essential electrical circuits. Provide for other utility alternatives and back

- up options

. Install automatic sprinkler systems, fire hoses and fire

- resistant doors and walls

. Make sure your building meet standards and codes. Consider a professional engineer to evaluate the wind, fire or seismic resistance of your building. Consider a security professional to evaluate and/or create your disaster preparedness and business continuity plan. Update your building’s HVAC system to secure outdoor air intakes and increase filter efficiency. Send safety and key emergency response employees for trainin g and relevant conferences

. Provide employees with first aid and CPR training.
Source: FEMA W ebsite http://www.ready. gov/sites/default/files/documents/files/cost.pdf9 As shown in table 1 , there are a number of sources available that provide useful info rmation for the development of contingency plans. T he APHIS W ebsite provides links to animal disaster planning and training and is linked to the Federal Emergency Management Agency , FEMA. FEMA provides two trainin g modules on disaster planning. The first (IS

- 10 Animals in Disaster, Module A: Awareness and Preparedness) includes sections on ty

pical hazards, how these affect animals , and what can be done by owners to reduce the impact of disasters. Itis intended to help animal owners, care providers and i ndustries to better understand emergency management. The second **(** IS

- 11 Animals in Disaster, Module B: Community Planning**)** is intended to guide emergency management officials and animal owners, care providers, and industries in preparing community

disaster plans. Both training modules provide online courses that may be downloaded and printed for ease of use

. Another source of information is the American Veterinary

Medical Association , which provides a disaster preparedness and response guide that is avail able online

. Presented b elow are some suggested general steps that should be taken b y regulated entities in the formation and implementation of contingency plans.

I. Evaluat ion of facility contingency planning needs
a. Id entify

possible disasters (extent and ty pe) b. Id entify

agencies and organizations associated with specific disaster mitigation c. Assess building structures d. Map the area and post the map II. Develop ment of the emergency plan

—c ontinuous planning and employee training/drills10 a. Form a response team

— e merge ncy

organization (direction and control) b. Prioritize response activities c. Id entify

and list resources i. Supplies ii. Assistance d. Communication resources e. Animal identification and tracking f. Transportation (caging, equipment) services g. Alternate facility

location h. Documentation and vital record keeping/preservation III. Response and recovery a. Cautionary

check of the surroundings b. F amiliarization with insurance policy and sources of financial assistance c. Repair costs d. E valuation of response actions e. Re
- evaluation of m itigation me asures Specific Considerations While principal components and steps involved in developing a contingency plan , as identified in the outline above, are common for all regulated entities , exhibitors and zoos, research facilities and veterinary businesses, p rivate dealers and carriers , all have different areas of focus

. T he emphasis should be on prevent ing harm and loss of li fe for human s and animal s and minimiz ing other impact s of disasters. Presented below are a few key elements that specific t ypes of busi nesses or organizations may consider. Exhibitors/Zoos

. A component of contingency plans for these facilities may be transport options. Z oos house large animals that require special transport equipment. Food and water requirements if an evacuation should be required are critical in disaster planning. Because the majority of zoo animals are exotic and many can cause harm to humans if not confined , spec ial consideration should be given to securing these animals11

an d training employees to handle them in the c ase of a disaster

. D isaster training can complement the training already required for handlers of exotic animals. Research Facilities

. Research facilities comprise 10 percent of licensees and registrants and are largely composed of university and pharmac eutical facilities

. The y have proven in the past to be extremely vulnerable during disasters

. H arm to animals from disasters can cause enormous losses in terms of research time and funding. R esearch facilities should have a good communication sy stem in place to ensure animals are cared for in the event of evacuation and during the recovery period

. S pecial attention also should be given to mitigating the impact of more common emergencies , such as HVAC failures and power failures. Carriers/Dealers (Private Businesses)

. In addition to a comp re he nsive evacuation plan for the animals , carriers and deale r s should have up

- to
- date record s on the animals to help maintain the animal s’ health and safety during the recovery phase. Expected Benefits and Costs of th e Rule A d isaster not only results in economic losses, but can also present public health and environmental challenge s . Contingency planning can alleviate the impact of catastrophic and common disasters and prevent often tragic outcomes

. Although not yet mandatory , m an y of the over 10,000 licensees and registrants, particularl y zoos and ones involved in research and conservation activities , have al ready developed and implemented contingency planning as evidenced by the facilities ’ W ebsites Inaddition,

m any communities have coordinated efforts and emergency operation plans with S tate and Federal agencies to handle animals during both cat astrophic and common emergencies.12 While it is difficult to quantify the benefits of contingency p lanning, the y are
nume rous . First, contingency planning can prevent loss of animal life and the resulting undisposed carcasses that can pose a threat to public health

. Second, loss of valuable research resources and income can be mitigated with contingency planning

. Third , h aving a contingency

plan can reduce the time of recovery from disasters and thus provide cost savings to the affected businesses and organizations and allow for business continuity

. Finall y , requir ed contingency planning will reassure the general public that facilities have measures in place to ensure the welfare of the animals in times of catastrophic and common emergencies

. The costs of developing a contingency plan are expected to vary by the ty pe and size of business. B usinesses dealing with larger and more exotic animals are likely to require more detailed contingency planning. B usinesses dealing with fewer and smaller
non - exotic animals may re quire less time to document and develop the ir plans . These smaller entities may

be able to adopt some of the practices in t able 2 for which the cost is minimal

. O verall , the economic impact of the final rule on businesses is not expected to be significant , particularly since many

of the licensees and registrants already have contingency

plans in place

. APHI S estimates that it will take between 4 and 6 hours to develop and document a contingency plan. This estimate is based on the time required to identi fy resources for the plan’s preparation and documentation

. C ontingency planning also requires record keeping, ensuring that the contingency plans are kept current, and employee trainin g. The cost of these activities is also expected to vary by ty pe and s ize of business, and the ty

pe of animals

. O rganizations offer training courses on general disaster planning specific to the ty pe of animals. FEMA offers free training , while13

organizations such as the United Animals Nation, the American Red Cross and the American Humane Society offer courses that cost from $ 50 to $ 300
. These courses cover the development and implementation of contingency plans. The type of training required may be specific to the ty

pe of organization or business. Capital costs associate d with developing a contingency plan will depend on the size and ty

pe of regulated entity

. As noted, w e expect that man y entities, especially zoos and research facilities, already have plans in place and as a result have emergency equipment on hand, such as generators in case of power failures . These facilities are not likely to incur additional equipment costs. Equipment costs for those entities that do not currentl y have contingency plans will vary relativ e to the size of the regulated entity and the number of animals cared for. An alternative to the final rule would be to require that all licensees and registrants submit the contingency plans that they develop to APHI S for review, as is already required of marine mammal facilities. As there are over 1 0,000 licensees and registrants, APHIS believes that this alternative would be unduly costl y and time prohibitive. Rather, APHI S will have access upon request to the contingency plan of any affected regulated entity , but will not require the submission of contingency pl ans for Agency review. Final Regulatory Flexibility Anal ys is In accordance w ith § 604 of the Regulatory Flexibility

A ct of 1980 (Public Law 96

- 354), this anal ys is considers the expected economic impact of the final rule on small businesses, small organizations, and small governm ental jurisdictions.14

Need for and Objective of the Rule APHI S is takin g action to improve the care of animals during and following catastrophic disasters and other emergencies , such as electric al failures , HVAC sy ste m failures, and animal escapes . Impacts of recent disasters in the United States have been devastating and the outcome for animals often has been tragic

. Although the well

- being of many animals is protected in various way s under the Animal Welfare Act , co ntingency planning is currentl y only required f or marine mammals

. The final rule will help ensure the welfare of other animals regulated under the AWA by requiring that research facilities, dealers, exhibitors, inte rmediate handlers, and carriers develop , document , and update contingency

plan s that may include evacuation, relocation, recapture, and back

- up sy stems. In addition, the employees of all licens ees and registrants will be required to be familiar with the contingency plan s v ia emplo ye r - based train ing. Finally , while APHI S will not require the submission of the contingency plan s , the plans are to be available for review b y APHIS upon request. Summary of Significant Issues Raised by Public Comment Many commenters stated that the proposed rule wil l cause a serious financial impact, especiall y 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 APHI S withdraw the rule until one has been conducte d or until APHI S has evaluated whether the rule is truly

necessary . A preliminary

regulatory impact anal ys is was conducted for the proposed rule and this document c ontains the final regulatory impact analy sis. APHIS has estimated that15

about 5 hours, on average, will be required by a regulated entity to develop a contingency plan, using guides provided by the Agency . Depending on the size and t yp e of regulated entity and its circumstances, this cost will vary . We note that many of the larger facilities, 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 plan itself. As an example, a plan may call for a back

- up generator to supply

electricity

in case of a power outage. We expect such costs to total within a reasonable range ; each regulated entity will determine the best way to fulfill the contingency

plan criteria based on its unique circumstances (i.e., size, ty pe of regulated 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 reas onabl y - scaled contingency

plan that has identified potential emergencies and natural disasters contributes to a regulated entity's long

- term operational strength and financial security. 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 Re gulatory

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 have been given serious16

consideration. APHIS recognizes that each regulated entity is the best judge of the particu lar measures that should be included in its contingency plan. In providing general criteria and guidance documents, APHI S is minimizing the burden of the rule for small entities by

allowing each one to determine for itself how best to meet the requirement s in accordance with the general criteria and guidance documents. APHI S 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 Init ial Regulatory Flexibility

Anal ys is was prepared that APHIS is required to publish a compliance guide which will help regulated industries comply with the regulation. Compliance guides will be made available by APHI S to the public. Two commenters asked whe ther they would have to build additional alternative facilities and if 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 inte nd to require the building of alternative facilities. While the costs for development and execution of the plan are expected to be borne b y the regulated entity , the y will be determined based on the emergencies and potential natural disasters most likely to be experienced by the regulated entity . 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.17 Three commenters expressed concern that the number of animals lost during Hurricane Katrina as stated in the economic anal ysis of the proposed rule is great er than the total number of regulated animals in Louisiana. In the preliminary

regulatory

impact anal ys is, APHI S may have inadvertently implied that the number of animals covered under the Animal Welfare Act that were harmed or killed as a result of Hurric ane Katrina was comparable to the 50,000 pets that reportedl y were negatively impacted by

the disaster

. The total number of animals used in research in Louisiana in fiscal year 200 5 was approximately 12,446
. 3 O ther animals regulated under the AWA include those in the care of breeders (Class A licensees) , dealers (Class B licensees) , and exhibitors (Class C licensees )

. While estimates of the total population of regulated animals harmed or killed by Hurricane Katrina are not available, it is not likely

that those figures would exceed 50,000. As stated previously , 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 facil ities 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 negativel y impacted. One commenter suggested that a tiered contingency plan sy stem be implement ed to accommodate small businesses.

3 http://www.aphis.usda.gov/publications/animal_welfare/content/printable_version/2007_AC_Report.pdf18 As a practical matter, one would expect that the smaller the business, the smaller the scale of the contingency plan that the business would be expected to prepare, just as a large entity with numerous animals would req uire 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 largel y 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 contingen cy

plan sy stem provided for by the final rule as appropriate for each facility

. Several commenters expressed concern regarding the cost and time required to draft a contingency

plan. One commenter stated that the rule may be imposing redundant paperwork r equirements because of similar requirements at the State and local levels. Many regulated facilities are currentl y required to have contingency plans by other organizations (e.g., accrediting institutions, State and local regulators). Many of these plans will meet th is rul e ’s r equirements, and paperwork redundancies should be minimal. Those regulated facilities that do not already have plans in place will incur costs in develop ing their contingency plans. However, having a contingency plan will help ensure the welfare of animals cared for b y a regulated entity . At the same time, contingency

plans will help regulated facilities to mitigate their financial losses due to emergencies or natural disasters and allow them to more quickly resume normal operation s, while meeting the animal welfare objective.19

Description and Estimate of the Number of Small Entities Affected The final rule may

affect research facilities, dealers, exhibitors, intermediate handlers, and carriers that fall into nine categories of the North American Industry Classification System (NAI CS)

. For the purpose of this analy sis and following Small Business Administration (SBA) guidelines, the potentially affected entities are classified within the following industries: All Other Animal Produ ction (NAICS 112990) ; Pet and Pet Supplies Stores (NAICS 453910) ; 4 Schedule F reight Transport (NAICS 48112); General Freight Trucking, L ocal (NAI CS 484110); General Freight Trucking, Long

Distance, Truckload (NAI CS 484121); General Freight Trucking, Long

- D istance, Less than Truckload (NAICS 484122); Research and Development in Phy sical Engineerin g and L ife Sciences (NAICS 5417 10); Vet erinary Services (NAICS 541940); Zoos and Botanical Gardens (NAICS 712130); Nature Park and Other Similar Institutions (NAI CS 712190) ; Environment C onservation and Wildlif e Organizations (NAICS 813312); and Pe t Care Services (NAICS 812910). Establishments in the industry category of All Other Animal Production (NAI CS 112990) are considered small by SBA standards if annual sales are not more than $0.75 million . According to the 200 7 Census of Agriculture, 97 percent of farming businesses are considered small

. 5 Establishments in the category Research and Development in Phy sical Engineering and L ife Sciences (NAI CS 54171 2 ) are cons idered small if they employ not more than 500 employees . According to the 2007 Economic Census, o f the 11,974 establishments 10,551 operated the entire year. 82 percent of tho se businesses that

4 Businesses are included in this category if they deal in exotic pets such as primates. 5 This percent age is for all farming businesses in the United States including businesses classified within NAICS 112990.20

operated the entire ye ar meet this criterion . Establishments i n the category Schedule d Freight Air Transport ation (NAICS 48 1 112) are cons idered small if they employ not
more than 1,500 employees . According to the Economic Census, there were 489 establishments in 2007 of which 441 operated the entire year. Of the esta blishments that operated the entire ye ar, 96 percent had less than 1 ,000 employees so we can assume that the majority

are small by SBA standards. Entities within the following categories are considered small b y SBA standards if annual sales are not more th an $25.5 million: General Freight Trucking, L ocal (NAI CS 484110); General Freight Trucking, Long

Distance, Truckload (NAI CS 484121); and General Freight Trucking, Long

- Distance, Less than Truckload (NAICS 484122). In terms of General Freight Trucking, Local (NAICS 484110), there were 27,682 establishments in 2007 of which 21,353 operated the entire year. Of the businesses th at operated the entire year, 99 percent had annual sales of $10 million or less and therefore we can assume the majority are small by

S BA standards. Establishments in the category General Freight Trucking, Long

- Distance, Truckload (NAICS 484121) totaled 30,759 in 2007. Of this total, 24,567 ope rated the entire year and 94 percent ha d revenue of $10 million or less so we can assume that i n this industry category , the majority

are small by

SBA standards . For e stablishments in the General Freight Trucking, Long
- Distance, Less than Truckload (NAICS 484122) category , according to the Economic Census , there were 8,010 in 2007 of which 7,044 ope rated the entire year. Of entities that operated the entire ye ar, 1,013 or 14 percent had sales over $10 million and we can assume the majority are small by

SBA size standards. Establishments in the Pet and Pet Supplies Stores (NAICS 453910) are considere d small if their annual sales are not more than $19.0 million. Of the 7,501 establishments21

that operated the entire year, six had annual sales ranging from $ 10 to $25 million , and one had annual sales greater than $25 million. Given this information and ba sed on the SBA size standards, we can assume the majority of the entities in this industry category are small. Except for businesses within the industry category Environment Conservation and Wildlife Organizations (NAICS 813312) , establishments in the oth er industry categories named above are considered small if their annual sales are not more than $7 million. Of the 28,400 establishments in the category Vet erinary Services (NAI CS 541940), 26,155 operated the entire ye ar. Of the entities that operated the entire year, 240 had annual sales greater than $5 million. We can assume that the majority are small by SBA standards. In terms of Nature Park and Other Similar Institutions (NAICS 7 121 90), there were 701 establishments of which 615 operated the entire ye ar and 98 percent had annual sales less than $5 million. This is below the $7 million threshold and we can assume the majority

are small by

SBA standards. According to the 2007 Economic Census, Zoos and Botanical Gardens (NAICS 712130) totaled 569. Of th is total , 499 operated the entire ye ar and 79 percent had annual sales less than $5 million. Therefore, we can assume that the majority of entities in this industry category are small by

SBA standards. Pet Care Services (NAI CS 812910) are also considered s mall by SBA standards if annual sales are less than $7 million. In 2007, there were 11,353 establishments of which 9,338 operated the entire year and 99.8 percent had annual sales less than $5 million. W e can assume the majority of businesses in this cate gory are considered small b y SBA standards. Environment Conservation and Wildlife Organizations (NAICS 813312) business are considered small by SBA standards if annual sales do not exceed $14 million. Of the 6,276 establishments in 2007, 5,75122

operated the entire year and of those that operated the entire ye ar 98 percent had annual
s ales less than $10 million. The majority of entities in this industry category are assumed small by SBA standards. There are approximately

10,351 licensees and registrants that fall under the various industry

classifications : 4,975 Class A licensees (breeders), 1,109 Class B licensees (wholesale dealers), 2,660 licensed and registered exhibitors, 1,123 registered research facilities, and 484 registered transport carriers and handlers. Breeders comprise 48 percent of the entities , followed by exhibitors at 25 percent, and dealers and research facilities make up about 11 percent each. While no economic data are available on business size for the specific entities, we may assume the majority

of the establishments are small, based on the industry estimates obtained from the Economic Census and the Census of Agriculture. B ased on information available to APHI S, it is e xpected that man y licensees and

r egistrants will incur costs in develop ing and document ing contingency plan s . This cost will vary by the size and ty

pe of entity . As shown in t able 2 , the cost of developing a contingency

plan may range from little to no financial outlay to hundreds of dollars. Overall, we do not anticipate a significant economic impact on the affected entities

. One of the major benefits of contingency planning is the mitigation of loss of animal s in a disaster, which can have devastating economic impact s . In addition, contingency planning can mitigate the suffering that animals may undergo while awaiting rescue and thereby more fully

ensure the welfare of the animals. Another benefit is improved public safety ; in the event that dangerous animals escape, contingency planning will provide for expeditiou s re capture of these animals, thus lessening the risk of harm to human s .23

Description and Estimate of Compliance Requirement s The final rule is expected to result in increase d compliance cost s of developing and documenting c ontingency plan s , and training of employees to carry out the plans. It is estimated that approximately f our to six (or an average of f ive ) hours will be required to develop the contingency plans

. 6 T raining costs will vary depending on the ty

pe and size of the business

. APHI S will provi de guid ance docum ents to assist the licensees and registrant s in developing the i r plans , alleviat ing the compliance burden. Significant Alternatives to the Rule Based on our review of available information, APHI S does not expect th is rule to have signi ficant economic impact s on the regulated small entities overall . In the absence of significant impact s , we have not identified significant alternatives that could minimize such impacts. Summary P reparedness for emergencies and disasters can reduce the harm to animals and their loss of life

. The devastating impact of the 2005 hurricane season underscore s the need for contingency

planning for all animals covered under the Animal Welfare Act. Currently , onl y facilities that house marine mammals are required under 9 CFR § 3.101 to develop contingency

plans. The final rule will require that all 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. T he majority of establishments that will be affected b y this rule are small ,

6 This estimate is based on the time required to utilize available resources such as FEMA’s Website to develop and document contingency plans.24

based on industry

estimates obtained from the Economic Census and the Census of Agricultur e . T he final rule will impose certain cost s 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 t ype and size of business. Many of the larger facilities, in par ticular, already have contingency plans in place

. APHI S 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 complian ce costs. Each entity will determine for itself how best to meet the rule’s requirements.25

References Animals in Research, 200 7 , http://www. aphis.usda.gov/publications/animal_welfare/content/printable_version/2007_ AC_Report.pdf Census of Agriculture, 200 7 , http://www.nass.usda.gov/Census_of_Agriculture/index.asp Econo mic Census, 2007 , http://www.census.gov/econ/census07/ FEMA, 2008, http://www.fema.gov/business/guide/index.shtm LAMA Disaster Preparedness Res ource, www.lama

- online.org Sen, A. and M. Chander, Disaster Management in India: the Case of Livestock and Poultry .” Review of Science and Technology 22(3), 915

- 930 Small Business Administration. A Guide for Governmen t Agencies How to Comply with the Regulatory Flexibility Act. http://archive.sba.gov/advo/laws/rfaguide.pdf Small Business Administration. Small Business Standard Match to North American Industr y Classification System http://www.sba.gov/content/small

- business

- size

standards