Vol. 78 Friday, No. 32 February 15, 2013

Part VI

Department of Health and Human Services

42 CFR Part 71 Control of Communicable Disease; Foreign—Requirements for Importers of Nonhuman Primates (NHP); Final Rule

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DEPARTMENT OF HEALTH AND C. What is the history of this rulemaking? B. What is the legal authority for this HUMAN SERVICES II. Summary of the Proposed Rule rulemaking? Requirements Section 361 of the Public Health 42 CFR Part 71 III. Comment Summary and Responses A. General Opposition and Support Service Act (PHSA) (42 U.S.C. 264) [Docket No. HHS/CDC–2011–0001] B. Public Comments Regarding Purpose authorizes the Secretary of the RIN 0920–AA23 and Scope Department of Health and Human C. Public Comments Regarding Definitions Services (HHS) to make and enforce Control of Communicable Disease; D. Public Comments Regarding Prohibition regulations as may be necessary to Foreign—Requirements for Importers on Importing NHPs prevent the introduction, transmission, of Nonhuman Primates (NHP) E. Public Comments Regarding Authorized or spread of communicable diseases Points of Entry from foreign countries into the United AGENCY: Centers for Disease Control and F. Public Comments Regarding Importer States or from one State or possession to Prevention (CDC), Department of Health Licensing Requirements another. Section 361 of the PHSA also and Human Services (HHS). G. Public Comments Regarding provides that, as the Secretary deems ACTION: Final rule. Recordkeeping, Reporting, and necessary, such regulations may provide Notification Requirements for inspection and destruction of SUMMARY: The Centers for Disease H. Public Comments Regarding Worker Control and Prevention (CDC), located animals or articles found to be infected Protection Requirements or contaminated as a source of within the Department of Health and I. Public Comments Regarding Equipment, Human Services (HHS), is amending Transfer/Transport, and Handling dangerous infection. Section 361 of the regulations for the importation of live J. Public Comments Regarding Quarantine PHSA serves as the primary legal nonhuman primates (NHPs) by Facility Requirements authority for 42 CFR 71.53, regarding extending existing requirements for the K. Public Comments Regarding the importation of NHPs. importation of Macaca fascicularis Requirements for Veterinarians and Section 368 of the PHSA (42 U.S.C. (cynomolgus), Chlorocebus aethiops Veterinary Pathologists 271) sets forth penalties for violations of (African green), and Macaca mulatta L. Public Comments Regarding Zoo-to-Zoo any regulations prescribed under (rhesus) monkeys to all NHPs with the and Laboratory-to-Laboratory Transfers; section 361 of the PHSA. Under section exception of the filovirus testing Animal Acts 368(a) of the PHSA, any person who requirement. Filovirus testing will only M. Public Comments Regarding NHP violates a regulation prescribed under be required for Old World NHPs in Products section 361 of the PHSA may be N. Public Comments Regarding Appeals quarantine that have illness consistent punished by a fine up to $1,000 or by O. Public Comments Regarding HHS/CDC with filovirus infection or that die for imprisonment for up to 1 year, or both Monitoring and Enforcement [42 U.S.C. 271(a)]. These penalties are any reason other than trauma during P. Miscellaneous Comments quarantine. HHS/CDC is also finalizing strengthened under the sentencing IV. Alternatives Considered classification provisions of 18 U.S.C. a provision to reduce the frequency at V. Regulatory Analyses sections 3559 and 3571, which provide which importers of cynomolgus, African A. Economic Analysis green, and rhesus monkeys are required B. Paperwork Reduction Act Analysis for more strict penalties for criminal to renew their special permits (from C. Federalism Impact violations that would otherwise be every 180 days to every 2 years). HHS/ D. Environmental Impact classified as Class A misdemeanors. CDC is incorporating existing guidelines E. Unfunded Mandates Reform Act Individuals may be punished by a fine into the regulations and adding new F. Plain Language Act of 2010 of up to $100,000 per violation not provisions to address the following: VI. References resulting in the death of an individual, or up to $250,000 per violation resulting NHPs imported as part of an animal act; I. Background NHPs imported or transferred by in the death of an individual [18 U.S.C. zoological societies; the transfer of A. What is the risk to human health 3559, 3571(b)]. Organizations may be NHPs from approved laboratories; and from NHPs? fined up to $200,000 per violation not non-live imported NHP products. resulting in the death of an individual Finally, HHS/CDC is also requiring that NHPs, particularly those recently and $500,000 per violation resulting in all NHPs be imported only through captured in the wild, may harbor agents the death of an individual [18 U.S.C. ports of entry where a HHS/CDC infectious to humans. Although such 3559, 3571(c)]. These penalties are quarantine station is located. infectious agents, if present, are usually criminal in nature and would thus be DATES: This final rule is effective April detectable in the NHP’s blood, they also imposed by a court, not administratively 16, 2013. may be detected in secreted bodily by HHS or HHS/CDC. fluids such as urine, feces, or saliva. FOR FURTHER INFORMATION CONTACT: Due to the nature of the job, persons C. What is the history of this Ashley A. Marrone, J.D., Division of working in temporary and long-term rulemaking? Global Migration and Quarantine, holding facilities and those involved in To address the risk NHPs pose to Centers for Disease Control and transporting NHPs (e.g., cargo handlers humans, since October 10, 1975, HHS/ Prevention, 1600 Clifton Road NE., and inspectors) are especially at risk for CDC has prohibited the importation of Mailstop E–03, Atlanta, Georgia 30333, infection. NHPs are a potential source of NHPs except for scientific, educational, telephone, 404–498–1600. pathogens and communicable or or exhibition purposes (42 CFR 71.53). SUPPLEMENTARY INFORMATION: This final zoonotic disease that may be fatal to NHP importers have been required to rule is organized as follows: humans, including filoviruses, hepatitis, register with HHS/CDC, renew this Table of Contents herpes B virus, tuberculosis (TB), and registration every 2 years, and hold parasitic infections (National Research NHPs in quarantine for a minimum of I. Background A. What is the risk to human health from Council, 2003). Quarantine 31 days following entry into the United NHPs? requirements for imported NHPs are States. Importers also must maintain B. What is the legal authority for this designed to reduce this communicable records on imported NHPs; immediately rulemaking? disease risk. report illness suspected of being

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communicable to humans; and make 2% of imported NHPs and the risk for standard for conducting those activities. their facilities, vehicles, equipment, and TB infection posed to caretakers (HHS/ The Agency endeavored to allow business records used in the CDC, 1993). These published regulated entities flexibility in choosing importation of NHPs available to HHS/ requirements included provisions for how to meet the standard’s goals and CDC during operating business days and recordkeeping to track and trace NHPs objectives. hours, and at other ‘‘necessary and and for use of personal protective To extend the public health benefits reasonable times,’’ to enable HHS/CDC equipment (PPE) by NHP handlers to of the special permit requirements to ascertain compliance with the prevent transmission of TB (HHS/CDC, regarding identifying filovirus regulations in this section. 1993). Since publishing the guidelines infections, HHS/CDC proposed Additional requirements for importers in the MMWR, HHS/CDC has required a extending filovirus testing to include all of NHPs have been developed and minimum of three negative tuberculin Old World NHPs in quarantine that implemented in response to specific skin tests (TSTs) administered at 2-week have illness consistent with filovirus public health threats, including interim intervals, on each imported NHP before infection or that die for any reason other guidelines for handling NHPs during approving release of any NHPs from than trauma during quarantine. This transit and quarantine (HHS/CDC quarantine. requirement was proposed because Old Update: Ebola-Related, 1990) issued On February 12, 2013, HHS/CDC World NHPs are susceptible to filovirus following a 1990 incident involving published a final rule at 78 FR 9828 infection and they originate from areas identification of Ebola virus (Reston establishing a user fee for filovirus of the world where filoviruses have strain) among NHPs imported from the testing of all nonhuman primates that caused fatal disease in NHPs. Philippines. As a result of this incident, die during the HHS/CDC-required 31- Consequently, surveillance for filovirus HHS/CDC concluded that cynomolgus, day quarantine period for any reason infection would include not just the African green, and rhesus monkeys were other than trauma. This provision was species covered under the special capable of being an animal host or initially designated in the NPRM at permit requirements, but all newly vector of filovirus which may pose a § 71.53(j). Because HHS/CDC had imported Old World primates threat to human health. On April 20, already published its proposal for a (unpublished data, HHS/CDC; 1990, HHS/CDC published a notice in filovirus user fee, we did not solicit or Formenty, et al., 1999; Rollin, et al., the Federal Register requiring a special receive additional comment on this 1999, Rouquet, et al., 2005; Leroy, et al., permit for importing cynomolgus, proposal through this current 2004). African green, and rhesus monkeys (55 rulemaking. Through today’s final rule, Also in keeping with the special FR 15210, April 20, 1990), with we are renumbering the filovirus user permit requirements, HHS/CDC enhanced requirements for the granting fee provision as § 71.53(v). HHS/CDC is proposed under paragraph (h) to require of a special permit to import these making this non-substantive change to that NHP importers develop a written species, including submitting a plan to increase the functionality and ease of policy for ensuring that imported NHPs HHS/CDC every 180 days describing use of these regulations. and their offspring would be used and specific isolation, quarantine, and distributed only for the permitted II. Summary of the Proposed Rule disease control measures and detailing purposes defined in the regulation. Requirements measures to be carried out at every step HHS/CDC proposed requiring importers of the chain of custody, from In the January 5, 2011, NPRM, HHS/ to keep written certifications that would embarkation at the country of origin, CDC proposed to continue, in § 71.53(d), follow the NHP for life and demonstrate through delivery of the NHPs and the the long-standing general prohibition on the continued use of the NHPs and any completion of the required quarantine importing NHPs, and to reflect, in offspring only for permitted purposes. period. Importers also were required to § 71.53(e), its authority to require The intended purpose of this describe and implement testing disposal of prohibited or excluded requirement was to ensure that NHPs procedures for all quarantined NHPs to NHPs. HHS/CDC also proposed a list of are not diverted into the pet trade, rule out the possibility of filovirus definitions specific to modern subsequently placing individuals at risk infection. importation principles and practices for of contracting zoonotic diseases that Over time, HHS/CDC revised NHPs, including adding new definitions NHPs may carry. components of the special permit and revising existing ones, to add clarity Under proposed paragraph (h) requirement in response to surveillance to the provisions regulating the importers would be required to findings and the development of importation of NHPs. maintain these records in an organized improved laboratory tests. HHS/CDC Additionally, HHS/CDC proposed to manner, and in a central location, which informed covered importers of these expand the isolation, quarantine, and is at or in close proximity to the NHP changes by letter in 1991 (Roper, 1991). worker protection requirements; and to facility, to allow HHS/CDC to inspect The special permit notice required expand the registration process the records during regular business filovirus antigen-capture testing on described in the special permit hours or within one hour of HHS/CDC specimens from any NHP that died requirements for cynomolgus, African site visits. Proposed § 71.53(g)(1) would during quarantine for reasons other than green, and rhesus monkeys to all require any importer to establish, trauma, and filovirus antibody testing of importations of NHPs. HHS/CDC implement, and maintain a serum sample taken at the end of intended that the proposed changes documentation and standard operating quarantine before a cohort is released would simplify importer registration procedures (SOPs) associated with the from quarantine on any NHPs that procedures and provide an enhanced importation of NHPs. HHS/CDC’s recover from illness consistent with a measure of worker and NHP safety proposal included performance-based possible filovirus infection during against known and emerging zoonotic requirements for worker education quarantine (Tipple, 1996). diseases. concerning risks, exposure notification On July 30, 1993, HHS/CDC HHS/CDC intended to achieve its and reporting, PPE, development of published guidelines in the Morbidity regulatory objectives through a SOPs, TB and other diagnostic testing, and Mortality Weekly Report (MMWR) performance-based standard focusing on post-exposure procedures, and other for TB testing requirements for NHPs, desired characteristics of the regulated requirements for the development and following the recognition of TB in up to activities, rather than a prescriptive implementation of a plan sufficient, as

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determined by HHS/CDC, for protecting the United States to those ports of entry NHP products such as carcasses, workers from the risks associated with where HHS/CDC quarantine stations are trophies, blood, and other biological handling NHPs. located, except in limited circumstances samples were proposed under § 71.53(t). The proposed rule contained approved in advance by HHS/CDC. In III. Comment Summary and Responses quarantine provisions, including a 31- § 71.53(k), HHS/CDC proposed that an day period of quarantine at a U.S. importer establish, implement, A. General Opposition and Support quarantine facility, with possible maintain, and adhere to SOPs for HHS/CDC received public comments extensions of quarantine if the NHPs ground vehicles to ensure the safe from 23 individuals and entities to the showed infection with certain transport of NHPs to quarantine January 5, 2011, NPRM. One commenter communicable diseases, if the importer facilities, and ensure that pre- opposed the rule in its entirety, or HHS/CDC suspected that an NHP was quarantined NHPs posed no risk to asserting that all imports of NHPs infected with certain communicable human health. Under proposed should be banned, irrespective of the diseases, or if the importer or HHS/CDC § 71.53(m), an importer would have to purpose for which the NHP was determined that there was a need for notify HHS/CDC of certain events listed imported. However, if such imports additional diagnostic testing. in the paragraph within the designated were permitted, this commenter said we Additionally, HHS/CDC proposed to time period. For example, proposed should require a physical inspection of eliminate the 31-day quarantine § 71.53(m)(6) would require an importer the importer’s premise, the importer’s requirement and associated restrictions to report to HHS/CDC within 48 hours fingerprints and picture identification, for transfers of NHPs into the United any positive or suspicious TST results, and posting of the importer’s States between Association of Zoos and necropsy findings, or laboratory results. application forms on the web for public Aquariums (AZA)-accredited zoos. In addition to the NHP health-reporting HHS/CDC proposed a similar quarantine requirements in § 71.53(m), HHS/CDC inspection. HHS/CDC response. HHS/CDC is exception for transfers of NHPs from proposed 19 general reporting and obligated to regulate animal imports to laboratories accredited by the recordkeeping requirements in best protect public health and is Association for Assessment and § 71.53(n), with which the importer satisfied that this final rule achieves this Accreditation of Laboratory Animal would have to comply. Care International (AAALAC) or its Paragraph (g) Registration or Renewal goal. Further, HHS/CDC maintains a equivalent, if the laboratory has a of Importers requires all animal acts to very efficient and effective registration foreign-based and a U.S.-based facility comply with requirements in § 71.53(h) and oversight program for the and the NHP is part of an ongoing through (n). HHS/CDC proposed importation of NHPs and the protection research project. The proposed additional requirements for animal acts of public health, which includes a procedures and standards contained in entering and re-entering the United thorough review of all records and § 71.53(l) were based on procedures and States under proposed § 71.53(o). Under unannounced inspection of the standards of the National Research proposed paragraph (o)(1) of the animal premises in which the NHPs are kept Council (NRC), HHS/CDC biosafety act provision, a foreign-based importer during quarantine. We do not believe guidelines, current knowledge of would have to provide additional the addition of fingerprinting or picture infectious agent transmission routes, information and documentation to help identification is necessary or would and experience gained from identify the individual NHP and to improve oversight. Further, an investigating filovirus infection describe the conditions under which the importer’s application contains outbreaks (HHS/CDC, 1996; HHS/CDC, NHPs are housed in the United States, proprietary information and therefore 1989). and maintain documentation signed by would not be appropriate for public Other quarantine requirements a licensed veterinarian attesting to the display. proposed in § 71.53(l) addressed routine results of physical examinations for Several commenters expressed veterinary medical care and screening NHPs. Under proposed paragraph (o)(2) support for portions of the proposed for zoonotic diseases of NHPs in of that provision, the importer of a U.S.- rule. Eight commenters approved of quarantine, management of illnesses based animal act would meet additional extending the import requirements for and deaths of unknown etiology, written specified requirements when the special permit NHP importers to all protocols for the evaluation and animals re-enter the United States. importers, and four supported extending diagnostic testing of suspect cases of For those NHPs entering the United the period for permit renewal from 6 zoonotic disease in NHPs, and improved States under the zoo-to-zoo and months to 2 years. Four commenters surveillance and testing procedures in laboratory-to-laboratory transfers also supported easing the quarantine NHP quarantine and research facility exception, proposed § 71.53(p) and (q) restrictions for zoo-to-zoo transfers of settings. The proposed requirements for set requirements for the recipient zoo or NHPs between zoos accredited by the SOPs and equipment for crating, caging, laboratory within the United States, AZA or an equivalent organization, and and transporting NHPs in § 71.53(j) including registration, submission of laboratory-to-laboratory transfers where outlined the requirements that the veterinary medical records that the importer can document that the importer must meet, either directly or document an NHP’s current and past animals are part of a research project by contractual or other arrangement, to health history, accreditation standards, following Institutional Animal Care and ensure safe handling of NHPs during and equivalency standards for zoos and Use Committee (IACUC)-approved transportation. The proposed aquariums. HHS/CDC also proposed protocols. One commenter supported procedures included preventing requirements for brokers in the United the proposal to import shipments of contamination of other articles and States handling in-transit shipments of NHPs only through ports of entry with cargo during transportation; providing NHPs that have a layover or are HHS/CDC quarantine stations, and physical separation of crates from other detained or delayed at a U.S. airport. another supported the animal act cargo; and ensuring decontamination of Finally, HHS/CDC proposed new provisions. aircraft, ships, vehicles, and related procedures for revocation and HHS/CDC Response. HHS/CDC has equipment following NHP transport. In reinstatement of an importer’s reviewed and considered all details of addition, in § 71.53(f), HHS/CDC registration [§ 71.53(s)] as well as these comments and will discuss each proposed to restrict entry of NHPs into requirements for importing untreated in turn.

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B. Public Comments Regarding Purpose HHS/CDC Response. HHS/CDC does Any untreated NHP product poses a and Scope not have the authority to require USDA risk to human health, irrespective of to issue a license to an individual or whether the product is a trophy from a One commenter said that we should entity. A ‘‘sanctuary’’ would fall under ‘‘personal sport-hunt’’ or from broaden the purpose provision in the definition of ‘‘person,’’ which means commercial or other activity, and would § 71.53(a) to include not only preventing such entities fall under § 71.53(b) and require the importer to obtain a permit the transmission of communicable the general prohibition in § 71.53 (d) from HHS/CDC before bringing the disease and pathogens from imported against receiving, maintaining, or product into the United States. To NHPs to humans, but also preventing distributing an NHP for other than a import any NHP product, an importer the importation of diseases and permitted purpose. For clarity, we have must render the product noninfectious pathogens themselves. revised the definition of ‘‘person’’ in under a HHS/CDC approved method, or HHS/CDC Response. NHPs are only § 71.53(c) to explicitly include not-for- obtain a permit in advance from the one of the imports that HHS/CDC profit organizations, such as sanctuaries. Director of HHS/CDC.1 regulates to prevent the introduction of Finally, we note that in keeping with Other commenters addressed the communicable disease. Specifically, the current practices, any ‘‘person’’ may definitions in § 71.53(c). Two argued importation of pathogens is regulated submit an application to HHS/CDC to that we should change the definition of under 42 CFR 71.54, Etiological agents, become a registered importer, including ‘‘zoonotic disease’’ because the hosts, and vectors. Further, the HHS/ a sanctuary. proposed definition was inconsistent CDC Director has broad general with the background information in the authority under 42 CFR 71.32(b) to take C. Public Comments Regarding NPRM and with the medical dictionary measures with regard to any carrier, Definitions definition of the term. Instead, these article, or thing that may be One commenter supported the commenters suggested we define the contaminated with a communicable definition of ‘‘education and scientific term as ‘‘any infectious agent or disease. Therefore, HHS/CDC does not purposes,’’ saying that they had communicable disease that is able to be believe it necessary to broaden the experienced problems with importers transmitted from animals, both wild and purpose and scope of this section. abusing the concept and endeavoring to domestic, to humans.’’ This same commenter said we should bring NHPs into the United States by Another commenter suggested broaden the scope provision in claiming the animals were purchased revising four proposed definitions. First, § 71.53(b) to include post-importation for a thesis. This commenter said that the commenter recommended revising recipients of NHPs and the offspring of the proposed definition would ‘‘prevent ‘‘broker’’ by adding ‘‘of NHP from these NHPs, arguing that the proposal such an abuse.’’ However, this another country, or as an intermediary placed ‘‘an unreasonable indirect commenter also noted that our proposed between such an’’ immediately enforcement burden on registered definition of ‘‘trophy’’ was broader than following ‘‘official agent of an exporter’’ importers’’ by requiring them to the same definition of this term in 50 and before ‘‘exporter and an importer of question their customers’ intended use CFR 23.74(b). Whereas the U.S. Fish and NHPs.’’ Second, the commenter of the importer’s products. The Wildlife Service (USFWS) defines a recommended a new definition of commenter recommended requiring trophy as ‘‘items taken as a result of ‘‘cohort’’ as ‘‘a shipment or shipments of prospective recipients of post- sport-hunting,’’ the commenter asserted NHP that shared a confined space or importation NHPs and their offspring to that HHS/CDC’s proposed definition close proximity (within 5 feet) during register with HHS/CDC, and maintain included any such items ‘‘purchased import into the United States and/or records regarding the use, distribution, abroad that are display items,’’ and transit to the importer quarantine and disposition of these animals. noted that under the Convention on facility.’’ Third, for clarity and HHS/CDC Response. Under § 71.53, International Trade in Endangered specificity, this commenter said we HHS/CDC regulates the initial Species (CITES), only an item resulting should consider changing the term ‘‘in importation of NHPs into the United from a ‘‘personal sport-hunt’’ would be transit’’ to ‘‘in international transit’’ or States. To be approved to register as an a trophy. ‘‘in international transit within the importer, an importer must agree to only HHS/CDC Response. Regarding the U.S.’’ Asserting that the definition for distribute NHPs for a permitted comment on CITES requirements for ‘‘offspring’’ lacked documentation purpose. The requirement that an any product defined by that agency as criteria, the commenter suggested the importer retain records of distribution a ‘‘sports-hunted trophy,’’ we note that fourth change of specifying minimum allows HHS/CDC to monitor this today’s final rule provisions do not verification documentation in the agreement to ensure importers are negate other federal requirements. definition. HHS/CDC Response. To clarify many adhering to the distribution restrictions. However, we note, too, that our mandate of the terms used in § 71.53, HHS/CDC Therefore, HHS/CDC believes that the to protect public health is different from has adopted most of the above current practice of holding the initial the CITES program objective and commenter’s suggestions. We did not importer responsible for the transfer of requires targeting a broader class of change the term ‘‘in transit’’ because we an NHP for a permitted purpose is imported NHP products. However, CDC believe the definition adequately sufficient to protect the public’s health agrees that our proposed definition of specifies and clarifies HHS/CDC’s and will remain in place. ‘‘trophy’’ may cause confusion among intent. the regulated communities; therefore, Finally, a commenter suggested A fifth commenter suggested adding a we have introduced a new definition for requiring that ‘‘sanctuaries’’ obtain a definition of ‘‘unusually high product that includes sports-hunted U.S. Department of Agriculture (USDA) morbidity,’’ which the commenter trophies. Under this final rule, a license, HHS/CDC registration, or both, argued was inadequately defined in the ‘‘product’’ is defined as ‘‘skulls, skins, if the sanctuary is to receive or possess proposed documentation requirements previously imported NHPs. The bodies, blood, tissues, or other biological samples from a nonhuman commenter asserted that such entities 1 http://www.HHS/CDC.gov/animalimportation/ ‘‘must agree not otherwise (to) dispose primate, including trophies, mounts, lawsregulations/nonhuman-primates/nprm/ (of) or distribute said primates.’’ rugs, or other display items.’’ questions-answers-importers.html.

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in §§ 71.53(i) and 71.53(l). This same registration from HHS/CDC before and Mexico.’’ Such an exception, commenter said that in the notification importing these animals. asserted the commenters, ran contrary to requirements in § 71.53(m), ‘‘the HHS/CDC notes that since we our stated purpose for the port-of-entry definition of ‘severe’ illness in this established quarantine restrictions for requirement. These commenters said section is ambiguous.’’ NHPs in 1975, the number of HHS/CDC- further that including shipments coming HHS/CDC Response. Regarding the registered NHP importers went from 140 from U.S. border countries in the comment on defining ‘‘unusually high (according to a 1989 review) to 27 in paragraph (f) requirement was logical, morbidity,’’ we note that HHS/CDC did 1999 (Roberts, 2008), and the mortality would have little economic impact not propose use of the term in the rates for NHPs imported under a special given the few importers who ship NHPs regulatory text and therefore we do not permit during shipment and quarantine across those borders, and would believe that it is necessary to define it. went from 20 percent to less than 1 maintain public health and safety at the Regarding the comment on notification percent (Roberts, 2008; DeMarcus, 1999) cost of a small inconvenience to requirements in § 71.53 (m), HHS/CDC and has remained there (ILAR, 2006). importers. has removed ‘‘severe illness’’ from this These data indicate the efficacy of our HHS/CDC Response. HHS/CDC notes provision in the final rule to alleviate certification process for NHP importers. that there is no exception in the final any ambiguity. Further, allowing NHP imports for rule from the port-of-entry requirement specific and limited purposes under for over-the-road (OTR) shipments of D. Public Comments Regarding HHS/CDC authorization is consistent NHPs coming from Canada or Mexico. A Prohibition on Importing NHPs with the Executive Order 13656 section person importing NHPs from those Two commenters said we should 1 directive of protecting public health countries either must bring the animals expand the general prohibition on with the ‘‘least burdensome tools for through ports of entry with a HHS/CDC importing NHPs in § 71.53(d). One achieving regulatory ends.’’ quarantine station, or obtain prior argued that expanding the prohibition Agency approval for bringing the E. Public Comments Regarding would relieve the burdensome shipment through an alternate U.S. port Authorized Points of Entry requirements imposed on importers. of entry. Further, HHS/CDC maintains This commenter suggested adding a Comments were received regarding public health safety through direct provision to prohibit persons from the proposal in § 71.53(f) to require oversight of the importation, because a receiving ‘‘post-importation NHPs’’ importation of live NHPs into the candidate for registration certification or unless the recipient was registered with United States only through ports of renewal must allow HHS/CDC to HHS/CDC under § 71.53, and a entry with a HHS/CDC quarantine inspect records, facilities, transport provision like paragraph (d)(2) for station, unless the importer received vehicles, and equipment during importers, but instead addressed ‘‘post- advance written approval from HHS/ operating days and hours, and at other importation’’ recipients of NHPs. CDC for some other port of entry. One necessary and reasonable times. (See HHS/CDC Response. As noted above, commenter asked that the preamble to § 71.53(b)(1) and (g)(2)(i).) under § 71.53, HHS/CDC regulates the the final rule discuss requirements in 50 initial importation of NHPs into the CFR part 14 for NHP importers to obtain F. Public Comments Regarding Importer United States. To be approved to from USFWS a port-exception permit Licensing Requirements register as an importer, an importer before a shipment entered the United Commenters addressed the must agree to only distribute NHPs for States at Detroit, Dulles, El Paso, application and permit renewal a permitted purpose. The requirement Minneapolis, San Diego, or San Juan. proposals in § 71.53(g). Two that an importer retain records of This commenter also noted that there commenters opposed eliminating the distribution allows HHS/CDC to are no USFWS staff at the port of entry 180-day registration renewal monitor this agreement to ensure in Philadelphia. requirement for special permit holders. importers are adhering to the HHS/CDC Response. HHS/CDC is Presenting several examples of alleged distribution restrictions. Therefore, the adopting the proposal that, absent prior noncompliance and Animal Welfare Act current practice of holding the initial approval, a shipment of live NHPs into violations by ‘‘top NHP importation importer responsible for the initial the United States must come through companies in the United States,’’ one transfer of an NHP for a permitted ports of entry with a HHS/CDC commenter argued that reducing purpose will remain in place. quarantine station. In response to the government oversight of companies One commenter suggested that we comment on USFWS’s requirements ‘‘with documented histories of should expressly prohibit the under 50 CFR part 14, in promulgating noncompliance’’ would pose a serious importation of wild and feral NHPs this final rule, HHS/CDC does not threat to public health. Further, argued because these animals represent serious intend to supersede—and believes that the commenter, there was no evidence risks to public health and animal these requirements are not inconsistent in the record that the species subject to welfare. with—any applicable USFWS or USDA special permit requirements HHS/CDC Response. In § 71.53(d) of regulation nor any applicable state (cynomolgus, African green, and rhesus the final rule, HHS/CDC retains the regulation. An importer must have a monkeys) present less of a threat to general prohibition on the importation CITES permit to bring NHPs into the human health than they did when we of live NHPs except for certain limited United States, and an importer in first established the requirements in purposes. No matter its origin, there can violation of otherwise applicable 1990. The same commenter asserted we be no question of an NHP coming into regulations is prohibited from importing failed to make the case that moving to the United States without prior HHS/ NHPs. We will continue working with a 2-year renewal period would be in the CDC review and issuance of a federal partners at ports of entry to best interest of public health. registration certificate, regardless of ensure that the administrative burden HHS/CDC Response. HHS/CDC is whether the animal is caught in the wild on partner agencies is not unreasonable. adopting the proposal to extend the time or raised in captivity, because live NHPs Another commenter opposed what for special permit renewal from every present the same potential for infectious they viewed as an exception for NHP 180 days to every 2 years. We believe disease outbreaks. Under § 71.53(g), shipments entering the United States at that the concern about the reduction in each NHP importer must obtain ‘‘certain border crossing[s] from Canada government oversight is misplaced,

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because registration is only part of the § 71.53(h)(2) to require that importers retention period similar to existing oversight of importers. Importers must collect or create records of the intended USDA requirements (i.e., 3 years after continue to notify HHS/CDC of all purpose for imported NHPs and disposition). Two commenters asserted shipments and we will continue to maintain records regarding each that the retention period under perform regular site visits, including the distribution of imported primates; and paragraph (h) should be at least for the review of importer SOPs. clarify in § 71.53(h)(3) how an importer life of the animal, plus a post-mortem Indeed, there is constant must authenticate electronic records, if period to investigate disease outbreaks communication between HHS/CDC and HHS/CDC would permit such records. or rules violations. One commenter importers. Further, extending the HHS/CDC Response. Each HHS/CDC- agreed that the retention period for renewal period is consistent with the registered NHP importer is subjected to § 71.53(h) documentation should be for directive in Executive Order 13653 periodic, mandatory site visits. During the life of the NHP. section 1 that we apply the least these site visits, HHS/CDC staff assesses HHS/CDC Response. HHS/CDC agrees burdensome tools for achieving compliance with recordkeeping with commenters’ concern that there regulatory ends. requirements. Importers are also should be a specified period for which An individual commenter suggested required to provide HHS/CDC staff with an importer must keep the written changes to three of the proposed an intended-use statement for each NHP certifications required under paragraphs in (g)(1). The first suggestion that was distributed following HHS/ § 71.53(h)(1), and has revised the final was to change paragraph (g)(1)(ii) to CDC quarantine. Failure to comply with rule to specify the period of record state that an applicant must submit a these recordkeeping requirements may retention as 3 years after distribution or completed statement of the intended result in suspension or forfeiture of an transfer of the animal. In § 71.53(h)(2) of permitted purpose for which an NHP is importer’s HHS/CDC registration. HHS/ the final rule, HHS/CDC also clarifies its imported and must name any ‘‘intended CDC also agrees that there should be a intention for importers to maintain prospective post-importation requirement for time-dating of records regarding each distribution of recipients.’’ The second was to remove electronic records in a manner that primates for the required 3-year period, the requirement in proposed (g)(1)(iii) cannot be altered, and for back-up including information identifying each for applicants to submit ‘‘a copy of all’’ copies of such records. We have revised animal in a shipment. We believe these SOPs. The final suggestion was to add § 71.53(h)(3) accordingly. retention periods are sufficient for in proposed (g)(1)(iv) a requirement for One commenter expressed general protecting public health and tracking applicants to submit ‘‘copies of all support for the proposed reporting NHPs after their release from Federal, State, or local registrations.’’ requirements and asked that we notify quarantine, and that it is overly HHS/CDC Response. HHS/CDC does USFWS if we receive disease reports burdensome to require record retention not believe it is reasonable to require from importers that might raise for the life of an NHP and a period after importers to submit ‘‘prospective’’ concerns about its wildlife inspections. death, as some commenters suggested. recipients of NHPs. HHS/CDC routinely HHS/CDC Response. With regard to Another commenter asked whether audits importer records to verify that the commenter’s request that USFWS importers must document the intended distribution is for permitted purposes. ‘‘receive disease reports from importers purpose for the life of the NHP, what the As part of this oversight, HHS/CDC will that might raise concerns about its effects would be if there were continue to require importers to submit wildlife inspections,’’ HHS/CDC subsequent movements of the NHP copies of all SOPs. However, in routinely informs USFWS of ongoing within the United States, and whether response to the commenter’s third potentially life-threatening disease paragraph (h) applied to offspring of suggestion, the final rule will require a outbreaks occurring among USFWS- imported NHPs. copy of all federal, state, or local licensed facilities. HHS/CDC Response. HHS/CDC has registrations, licenses, and/or permits. The same commenter strongly revised § 71.53(h) to state expressly that Another commenter said that HHS/ recommended that HHS/CDC require an importer must develop and CDC should require applicants for an tattoos or microchip numbers for NHPs document compliance with a written importer license or license renewal to to better identify animals involved in a policy for use and distribution of NHPs submit the documentation required transfer or transaction. and their offspring. Paragraph (h)(1) also under § 71.53(i) for worker protection HHS/CDC Response. Paragraph makes clear that it is the importer’s and § 71.53(l) quarantine facilities as (l)(3)(i) of this final rule requires obligation to collect a signed record of part of the permit application process. importers to ensure that all NHPs are the intended purpose for which NHPs HHS/CDC Response. We have added identified individually with a unique are imported from the customer, and to clarifying language to the title and number or alphanumeric code take reasonable steps to ensure that its throughout § 71.53(g) of the final rule to permanently applied to the NHP. customers will use NHPs in accordance make it clear that the same However, consistent with our intent to with Part 71. These records must be documentation is needed to apply for set performance-based requirements, the retained for three years after registration or renewing a registration rule does not require one specific distribution. The original importer is certificate for importing NHPs. identification yet allows the importer to not responsible for documenting select a ‘‘tattoo, microchip, or other subsequent movements of the NHP G. Public Comments Regarding permanent identifier.’’ This requirement beyond the initial transfer. Again, this is Recordkeeping, Reporting, and ensures that NHPs may be identified in a codification of the accepted current Notification Requirements any transfer or transaction. practice that importers only distribute Several commenters discussed The January 2011 NPRM specifically NHPs for scientific, educational, or various proposed recordkeeping, solicited public comment on how long exhibition purposes as defined in this reporting, and notification requirements records should be maintained by the final rule. in § 71.53(h), (i), (k), (m), and (n). importer, e.g., for the expected life of One commenter requested An individual suggested that we the NHP. One commenter said that, as clarification on proposed required change paragraph § 71.53(h) to require written, § 71.53(h) failed to indicate certifications under paragraph (h)(5), that importers develop and document how long an importer must maintain and asked how HHS/CDC would compliance with a written policy; revise documentation, and suggested a monitor, track, and record these

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certifications; how often the importer Other commenters addressed the transfers mirror the requirements for should provide us with certifications; proposed health reporting requirements laboratory-to-laboratory transfers in and how subsequent movement of NHPs in § 71.53(m). One commenter proposed § 71.53(q)(2)(i) and (ii). and their offspring would affect the questioned the proposal in paragraph HHS/CDC Response. HHS/CDC agrees certifications. Another commenter said (m)(4) that an importer must notify that notification requirements should be they were uncertain whether the sellers HHS/CDC if the mortality of an NHP the same for laboratory-to-laboratory needed to verify the authority of the cohort exceeds 5 percent. The transfers as for zoo-to-zoo transfers and person who certifies use of primates at commenter said this threshold could has edited the text of the final rule the purchasing institution, and said they preclude the earliest detection of accordingly. were against imposing a requirement on outbreaks or identification of H. Public Comments Regarding Worker the seller other than maintaining associations between cases, and argued Protection Requirements certification from the consignee. that we should establish an evidence- HHS/CDC Response. Regarding the based, risk-averse threshold through Commenters addressed the training, comment on how we would receive and epidemiological analysis and other notification, and SOP requirements in track certifications under proposed available data. proposed § 71.53(i). One commenter § 71.53(h)(5) (not adopted under the Regarding the proposal in paragraph said HHS/CDC should specify a final rule), we note that the intent of the (m)(7) that an importer notify HHS/CDC maximum interval between training final requirements under paragraph (h) within 48 hours if an NHP exhibits signs sessions. Two commenters said we is for the importer to retain the records, of TB, four commenters asserted the should require employee training on not to send them to HHS/CDC. HHS/ reporting period should be 24 hours. post-exposure procedures when the CDC will review certifications in person These commenters said that because TB employee is hired and at least annually and regularly through an audit process is extremely communicable and highly thereafter. One commenter suggested yet does not expect importers to certify dangerous to humans, it was that worker training include the authority of the signatory beyond ‘‘nonsensical’’ to have a reporting contingency plans to prevent exposure normal due diligence. An example of period that is double that for reporting to NHPs during transit. due diligence would be for the importer other zoological diseases. The HHS/CDC Response. HHS/CDC agrees to include a statement of authority on commenter said that although paragraph with the comment that worker training the certification form. (m) stated proposed notification requirements should specify when Two commenters commented on the requirements for six events, the failure workers should receive initial training proposed requirement in § 71.53(i)(3) on to define what would constitute a and the maximum acceptable interval notification to HHS/CDC of a worker’s ‘‘severe’’ illness made the provision between trainings. NHP workers should exposure to a zoonotic illness. The ambiguous, and difficult to either receive initial training when they are commenters said we should change this comply with or enforce. hired or before receiving a shipment of provision to make it consistent with HHS/CDC Response. In § 71.53(m)(2), NHPs, and refresher training at least other, similar reporting requirements. the final rule requires notifying the annually. However, because each Specifically, said the commenters, the Agency of any morbidity or mortality of facility varies in size and importation provision should read, ‘‘An importer animals in quarantine, rather than of frequency, we have decided to evaluate must immediately contact HHS/CDC by ‘‘severe illness or death’’ as proposed. training frequency upon review of telephone, SMS text, or email, as Similarly, § 71.53(m)(4) of the final rule importer application and SOPs, in specified in the importer’s standard removes the 5 percent threshold for keeping performance based standard of operating procedures, to report any notifying HHS/CDC of morbidity or review. This policy of review also instance of a worker exposed to a mortality in a shipment between addresses another commenter’s concern zoonotic illness and must include embarkation from the county of origin for refresher training on post-exposure instructions for contacting HHS/CDC in through release from quarantine in the procedures. As stated in § 71.53(i)(4)(i), its worker protection plan.’’ For the United States. Instead, as with worker protection plan training must same reason, the commenters suggested paragraph (m)(2), the rule requires include how to avoid and respond to revising the sentence on notification in notification of any morbidity or disease exposures associated with § 71.53(i)(9) to read as follows: ‘‘The mortality during the period described. NHPs. Plans for refresher and importer must promptly notify HHS/ As to the comment that we set an contingency training should also be CDC by telephone, SMS text, or email as evidenced-based threshold for reporting included in these SOPs. specified in the importer’s standard mortality, we noted previously that the One commenter fully supported the operating procedures if such illness mortality rates for special permit proposed plans for importers, and occurs.’’ process NHPs during shipment and especially noted his or her appreciation These same commenters suggested quarantine has been less than 1 percent of the worker PPE requirements for revising § 71.53(k)(5) to permit notifying over the last 5 years (Roberts, 2008; employees who handle live NHPs, HHS/CDC of the arrival of an NHP DeMarcus, 1999). Therefore, requiring which the commenter said, would shipment by SMS text or email as notification of any morbidity or benefit USFWS inspectors. This specified in the importer’s SOPs. They mortality sets a conservative, evidence- commenter added a request that we also requested that HHS/CDC should based reporting standard. Further, we notify the USFWS-Office of Law permit written notice by email in have set a more conservative 24-hour Enforcement of our concerns with their notification requirements before requirement in § 71.53(m)(7) for inspectors who might be responsible for authorizing the import of NHPs in notifying the Agency of positive or inspecting a shipment of wildlife later § 71.53(n)(2). suspicious TST results as most found to be a source of TB exposure. HHS/CDC Response. HHS/CDC agrees protective of human health. All HHS/CDC Response. We will with the commenters and has revised notification periods in § 71.53(m) are continue to work with and the text of the final rule to expressly now 24 hours. communicate with our federal partners permit notifying the Agency by These commenters also suggested that whose employees may be exposed to telephone, text message, or email of notification requirements in proposed NHPs while inspecting animal worker exposure to a zoonotic illness. § 71.53(p)(2)(i) and (ii) for zoo-to-zoo shipments to ensure awareness of any

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health concerns, including the potential Similarly, the commenter described as adopted the commenter suggestion to for exposure to TB. We note that ‘‘unrealistic’’ our proposal in paragraph state expressly that importers must USFWS inspectors, as with all (j)(8) that during NHP transport, ensure SOPs for both the removal from individuals, should be wearing recirculated air in the NHP transport vehicles and proper disposal appropriate eye and respiratory compartment must be HEPA-filtered, of biohazardous waste following a protection when handling or within five given that neither planes nor shipment of live NHPs. feet of the live NHP shipments. commercial OTR trucks commonly are An individual said we should Another commenter asked why we equipped with such air-filter systems for consider requiring at least two transport recommended hepatitis B vaccine rather cargo. Regarding our proposal in workers for over-the-road (OTR) NHP than hepatitis A vaccine, asserting that paragraph (j)(9) concerning cargo shipments, written contingency plans, animals frequently arrive in quarantine loading of NHP shipments, this and signage on the transport vehicle with naturally occurring positive titers individual said importers have little warning the public to call a designated of hepatitis A, and that hepatitis A is a control over aircraft loading procedures, number before entering a vehicle disease commonly found throughout the and cannot enforce loading transporting live NHPs. The commenter world, including the United States. requirements. The individual suggested suggested further that we require OTR HHS/CDC Response. In the NPRM, we work with the International Air shippers to register with HHS/CDC and CDC did not recommend specific Transport Association (IATA). For undergo training specific to transport vaccines as part of the worker protection paragraph (j)(11), the commenter workers. Another commenter suggested plan. HHS/CDC recommends that all suggested beginning the provision with, having OTR transporters register with workers who are at high risk of exposure ‘‘For each importation itinerary,’’ HHS/CDC. This same commenter also to NHPs be current on routine arguing that without this language, we suggested GPS-equipped vehicles that vaccinations, in accordance with good would require monitoring and meet ‘‘certain minimum standards,’’ and public health practice and as reflected certification during each shipment. with operators possessing ‘‘all in the Advisory Committee on Finally, regarding paragraphs (j)(13) and applicable licenses/permits to operate as Immunization Practices 2 (k)(3), this individual suggested we a commercial transporter.’’ HHS/CDC Response. In response to recommendations. expressly require the removal of potentially contaminated material from the comment that we require two I. Public Comments Regarding ground transport vehicles ‘‘upon arrival transport workers per OTR transport Equipment, Transfer/Transport, and at the quarantine facility,’’ and the shipment of NHPs, and that these Handling appropriate disposal of biohazardous transport workers and vehicles be subject to certain additional Commenters discussed the proposed waste. requirements, we note that HHS/CDC requirements in § 71.53(j) and § 71.53(k) HHS/CDC Response. HHS/CDC has not traditionally regulated transport for NHP equipment, processing, recognizes that while the importer may not have control over how a plane is workers, but rather NHP importers. transport, and identification. An loaded at the port of destination, Accordingly, we believe that continuing individual commenter made several importer SOPs should include to regulate NHP importers, rather than comments concerning these proposed information for training of airport cargo placing new requirements on transport provisions. The commenter described as handlers regarding the importance of workers is the best way to protect public ‘‘unrealistic’’ the proposed requirement loading NHPs into aircraft to assure that health. However, we agree with the in paragraph (j)(5) that only an importer no contamination of other cargo occurs commenter that importers should plan or an authorized representative could and that any issues with the shipment for contingencies in OTR transport, and receive a shipment of NHPs. For be easily determined and corrected. have revised § 71.53(i)(4)(i) to clarify airplanes, said the commenter, a plane Further, we have revised the that worker protection plans should will not wait if there is no one present requirement proposed in paragraph address procedures for responding to who has authority to take receipt of the (j)(8) (codified in the final rule as emergencies during transport. shipment under this requirement. paragraph (j)(7)) to give importers the J. Public Comments Regarding Instead, said the commenter, HHS/CDC option of either ensuring an adequate Quarantine Facility Requirements should require a contingency plan to ventilation system is in place, with address Agency concerns. HEPA filtration for airflow circulating Commenters addressed the proposed HHS/CDC Response. HHS/CDC made between NHPs and passengers traveling provisions on quarantine requirements a number of changes to the final rule in with a shipment of live NHPs, or in § 71.53(l) for importers not otherwise response to comments on the proposed providing NHP transport workers with exempted under this provision (i.e., standard operating requirements and respiratory PPE if there is not an authorized zoo-to-zoo and lab-to-lab equipment standards for crating, caging, adequate ventilation system. The transfers). and transporting live NHPs. We have Agency believes this change makes the Two commenters commented on the deleted proposed paragraph (j)(4), and provision less prescriptive while proposed air-handling system renumbered proposed paragraphs (j)(5) offering adequate protection against requirements in § 71.53(l)(2)(v) and (vi) through (j)(13) as (j)(4) through (j)(12) in transmitting zoonotic diseases from that would mandate a separate system the final rule. Paragraph (j)(4) of the NHPs to humans traveling on the same for each quarantine room, which would final rule requires an importer to conveyance. remain under negative pressure relative establish an emergency contingency We have also revised proposed to the common hallway or anterooms. plan in the unlikely event that the paragraph (j)(11) (paragraph (j)(10) of One commenter said the requirement importer or its representative is unable the final rule) to make clear that before needed further explanation, given that to meet the conveyance transporting an beginning operations, or ‘‘for each inhibiting air mixture between rooms NHP shipment. This change makes clear import,’’ importers must establish and could be accomplished with separate HHS/CDC’s intent that importers should document the communicable disease- exhaust equipment for each room or a anticipate and plan for contingencies. prevention SOPs to be carried out dedicated exhaust system that pools throughout the chain of custody. In final adjacent rooms. The commenter noted 2 http://www.HHS/CDC.gov/vaccines/recs/acip. rule paragraph (j)(12), HHS/CDC has that exhaust systems are on emergency

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generator power and supply-side air to poorly performing test in many NHPs,’’ reactions for animals in import quarantine rooms is often provided with that the current requirements for quarantine as positive or negative. The a common HVAC (heating, ventilation, multiple testing at 2-week intervals is commenter asserted that that the TB test and air conditioning) system. Regarding ‘‘physiologically demanding’’ on the itself is imperfect, and that ‘‘any range the airflow indicator, the other animals, and that there is an inherent of abnormal display may be seen on an commenter asked whether it would risk to animals and humans each time individual that is truly infected.’’ suffice to confirm negative pressure in an NHP must be immobilized for such HHS/CDC Response. HHS/CDC does the wards and no air circulation out of testing. The same commenter argued not accept the assertions that there are the ward, if the importer mounted a alternatively for ‘‘currently available currently TB tests more appropriate pressure monitor in the wall indicating confirmatory tests, which can be than the required MOT, but believes negative pressure in the ward compared utilized in conjunction with skin that a more improved test may be to the exterior. testing, minimizing repeat developed in the future. The currently HHS/CDC Response. HHS/CDC agrees immobilization procedures.’’ approved test for the diagnosis of TB in with the commenter’s concerns above Another commenter said that there is NHPs is the TST performed using MOT, and has edited the text of the final rule a diagnostic TB test other than the 0.1cc injected intradermally in the to better explain the intent of the intradermal TST and HHS/CDC’s failure palpebrum and observed at 24, 48, and provision. to recognize the alternative test has 72 hours (ILAR, 1980). Other TB tests One commenter asked whether under hampered sales. The commenter have been evaluated but it has been proposed § 71.53(l)(3)(iii), HHS/CDC asserted that the alternative test permits noted that ‘‘no single screening test will should permit veterinary discretion use of the same blood sample drawn meet all the requirements for within a quarantine room to use nets or during a health examination and surveillance and diagnosis of TB in gloves to recapture a small NHP rather provides results in minutes rather than nonhuman primates. Instead, the use of than anesthetizing or tranquilizing the days. This commenter said that TST several tests in combination can animal ‘‘before handling.’’ The measured only cell-mediated immunity, increase the overall sensitivity and commenter said that the proposed text which might be suppressed in a latent specificity of screening and surveillance would preclude the use of these infection, and that combining TST with programs and likely represents the alternative capture methods—even measures of humoral immune response future of TB testing in nonhuman where experienced personnel would be would increase diagnostic power and primates’’ (Lerche, 2008). HHS/CDC will involved in the recapture—and the size, could reduce the possibility of failing to continue to require the TST until an species, or clinical soundness of the detect latent infection during improved testing procedure is animal would warrant a non-chemical quarantine. This commenter further developed. Until then, if test results are restraint. asserted that there was no proof of TST positive, the importer may elect a HHS/CDC Response. To address the working in all NHP species, that there battery of tests to confirm the TST comment that HHS/CDC should permit is no requirement to test new finding, and in consultation with HHS/ the use of methods other than production batches of TST on primates, CDC, may choose either to treat or anesthesia or tranquilizer before and that imposing the same testing euthanize the animals. Further, handling a live NHP, we have revised requirements on all NHPs is an concerning grading scales for animals § 71.53(l)(3)(iii) to allow handling where approach based on tradition, not with ‘‘questionable’’ responses, HHS/ an animal is ‘‘otherwise restrained.’’ scientific merit. Another commenter CDC appreciates that many NHP Because anesthetizing or tranquilizing a also objected to maintaining the TST, importers consider any MOT reaction as live animal before handling is most saying that given the poor reliability of positive. Again, our regulations are protective of human health and safety, TST results in NHPs, we should influenced by the ILAR guidelines those are the preferred methods under strengthen the proposed requirements to (ILAR, 1980), which do allow subjecting the regulation. However, we recognize reflect the best available science and NHPs to further testing in a ‘‘suspect’’ that using an alternative restraint practices for test methods and regimens. case of TB. HHS/CDC believes that it is method may be appropriate where the Yet another commenter recommended permissible for an importer to interpret restraint is part of the facility’s SOPs ‘‘replacing the (proposed) tuberculin the TST according to the importer’s and is the last resort for obtaining quick testing procedures.’’ The commenter approved standard operating procedure capture and veterinary handling of a also said that rather than rely solely on and to do further diagnostic testing for live NHP. ‘‘poorly-performing screening tests in NHPs with a suspect TB reaction as There were several observations and quarantine,’’ HHS/CDC should require defined by the SOP. suggestions from commenters ‘‘currently available confirmatory tests A commenter noted that paragraph concerning the proposed necropsy and and then rigorous, ongoing bio-security (l)(3) should spell out steps for diagnostic testing requirements under and surveillance once in the managed removing samples from the quarantine § 71.53(l), with most commenters zoo collection.’’ Noting the proposed ward to perform laboratory analyses. addressing TB testing and procedures. requirement for including in the SOPs a HHS/CDC Response. In response to One commenter recommended grading scale interpretation of TSTs for the commenter’s observation that there replacing the proposed TB testing NHPs in quarantine, this commenter was no language in the proposed rule procedures. Another commenter said suggested removing this requirement describing procedures for removing that current TB testing methods used in from § 71.53(l)(3)(ix), and instead, samples from the quarantine ward, NHP screening are inadequate, and that grading reactive animals in import HHS/CDC has added a requirement in the proposed changes to these methods quarantine either as negative or positive. § 71.53(l)(3)(iv) for importers to describe ‘‘do not go far enough’’ to protect public The commenter asserted that although procedures for handling and and NHP health and welfare. And quarantine facilities might use such a transporting such samples. another commenter suggested we scale during import quarantine, many Three commenters noted that reconsider the decision to rely on TB ‘‘do not recognize ‘questionable’ proposed § 71.53(l)(3)(viii)(B) would skin testing using the mammalian old responses,’’ and prefer to err ‘‘on the require antibody testing for animals tuberculin (MOT) method. The side of caution.’’ Similarly, another surviving quarantine and displaying commenter said that skin testing is ‘‘a commenter said it preferred to grade signs suggestive of a filovirus infection,

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but that paragraph (l)(6)(viii) of the requested to clarify that an importer made to § 71.53(i) and (l) based upon provision would require performing must not request a release of an NHP these comments. filovirus testing using the antigen- from quarantine if the animal is ‘‘visibly A commenter asserted that the rule capture enzyme-linked immunosorbent ill.’’ should include as minimum assay (ELISA) method on the liver of Referencing proposed paragraphs requirements for veterinarians: A any animal that dies or is euthanized for § 71.53(i)(5), (j)(6), (j)(12) and (13), current veterinary license, USDA reasons other than trauma. The (k)(3), and (l)(2); a commenter said we accreditation, and experience with commenters suggested we modify should clarify acceptable procedures for NHPs. Another commenter also stated § 71.53(l)(6)(viii) to require antigen- disinfecting, autoclaving, or disposing that HHS/CDC should define ‘‘qualified capture testing of liver tissue only from of animal wastes, bedding, and uneaten veterinarian’’ similar to USDA. animals that died or were euthanized food. The commenter also said we HHS/CDC response. HHS/CDC agrees and exhibited potential signs of a should clarify disinfection requirements that these would be the ideal minimal filovirus infection. for vehicles. This same commenter said requirements for a licensed veterinarian HHS/CDC Response. In accordance that when dealing with imports of large working with NHPs. In response, we with the intent of the provision, HHS/ species or large numbers of primates, have added a definition for licensed CDC has clarified the proposed language the cost of disposing of bedding and veterinarian to the text of the regulation in § 71.53(l)(6)(viii) to specify that medical wastes could be prohibitive for to clarify that these individuals must antigen-capture testing is required for zoos, and autoclaving could be have experience working with NHPs. NHPs that die or are euthanized for any impractical or impossible. A commenter asked why HHS/CDC HHS/CDC Response. Regarding the other reason than trauma or adverse would require a veterinary pathologist commenter’s request that HHS/CDC environmental conditions. to have a state license, which would A commenter asked whether an clarify acceptable procedures for preclude other qualified professionals exemption from a BSL3 type quarantine disinfecting animal wastes, bedding, from conducting procedures such as still would require adhering to proposed and uneaten food, we note that all paragraphs § 71.53(i), (j) and (k). The methods that meet the performance- necropsy. The commenter said that commenter suggested worker protection, based standard will be considered. One because veterinary pathologists do not crating, and transport at a BSL1 or BSL2 example for handling of animal waste, ‘‘practice,’’ most do not obtain or for NHPs with well-documented bedding, and uneaten food other than maintain state licenses. The commenter medical histories prior to import. Also, autoclaving or disposal by a biohazard also suggested that we require the this commenter and another asked HHS/ company would be to put the waste into performance of necropsies by a board- CDC to clarify the apparent the sanitary sewer system. Also, trucks certified veterinary pathologist or a inconsistency between proposed can be cleaned of gross debris to be state-licensed veterinarian. § 71.53(l)(6)(ii), requiring performance properly disposed of and then sprayed HHS/CDC response. HHS/CDC agrees of a necropsy under biosafety level or fogged with a tuberculocidal, that requiring a veterinary pathologist to (BSL)3 containment, and virucidal, or bactericidal disinfectant for perform necropsy is not always § 71.53(l)(6)(iv), requiring necropsy an adequate contact time and then necessary and may be too limiting to an under BSL3 or BSL2 containment. cleaned. NHP import facility, but that just any HHS/CDC Response. To address state-licensed veterinarian may not be commenter requests for clarification K. Public Comments Regarding familiar with the public health risk regarding the appropriate biosafety level Requirements for Veterinarians and associated with performing necropsies procedures for necropsy requirements Veterinary Pathologists on imported NHPs. We have removed under § 71.53(l)(6), we deleted the The January 2011 NPRM specifically ‘‘state-licensed veterinary pathologist’’ reference to BSL3 in paragraph (l)(6)(ii). asked for feedback on what factors from § 71.53(l)(6)(ii) and edited the We revised paragraph (l)(6)(iv) to should be taken into consideration in language to reflect a requirement for the require BSL3 or BSL2+ precautions for the determination of whether a performance of necropsies by a necropsies only. However, HHS/CDC veterinarian is sufficiently veterinary pathologist or a state-licensed acknowledges that all NHPs pose a ‘‘experienced’’ in the care of NHPs and veterinarian with knowledge and potential risk to human health and what constitutes a ‘‘qualified’’ experience with the disease risks should therefore be handled while laboratory. A few commenters discussed associated with performing these wearing recommended PPE, as dictated the requirements for veterinarians and necropsies. Additionally, the veterinary in the approved SOPs. BSL2+ is a veterinary pathologists. One commenter pathologist or licensed veterinarian hybrid level of precautions that requires said that in requiring quarantine must be familiar with the precautions at least the use of a BSL2 facility with facilities to have access to a qualified and level of containment that should be BSL3 containment equipment and veterinarian, proposed § 71.53(i) and (l) used to perform these necropsies. should specify that such personnel be practices. (HHS/CDC and NIH, 2007). L. Public Comments Regarding Zoo-to- An individual commented that we on duty and on site during business Zoo and Laboratory-to-Laboratory should modify or delete proposed hours; and that there be appropriate Transfers; Animal Acts § 71.53(l)(3)(vii)(C) that would prohibit veterinary coverage for evenings, an importer from releasing an animal weekends, and holidays. This Some commenters addressed the from quarantine if the importer knows commenter said further that the proposed requirements for zoo-to-zoo or has reason to suspect the NHP has a requirements should specify a number and laboratory-to-laboratory transfers in zoonotic exposure or infection. The of available and qualified veterinarians § 71.53(l)(1), which would exempt these commenter said we should not consider commensurate with the number of entities from the quarantine facility zoonotic agents such as herpes B virus NHPs. requirements in this provision provided in the same category as TB, yellow HHS/CDC Response. While HHS/CDC that the transfer complied with fever, or filovirus. may agree that these are good proposed § 71.53(p)(2) and § 71.53(q)(2). HHS/CDC Response. HHS/CDC has requirements for a facility, these do not After stating their strong support for also revised paragraph help to define qualifications of a paragraph (p)(2), one commenter § 71.53(l)(3)(viii)(C) as the commenter veterinarian. Thus, no changes were recommended following proposed risk-

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reduction procedures irrespective of wearing recommended PPE, as dictated requirements.’’ More specifically, the whether quarantine is required. in the approved SOPs. commenter said the proposed change HHS/CDC Response. Regarding the One commenter said it was unclear would result in risks to public health recommendation for a defined disease why there was inconsistency in the and animal health and welfare, and risk assessment for NHPs imported by standards for documentation of negative would create the potential for abuse. AZA-accredited zoos, HHS/CDC does TB tests for animal acts, zoo-to-zoo Another commenter also opposed easing not believe further risk reduction transfers, and laboratory-to-laboratory quarantine requirements for laboratory- procedures are necessary, because a zoo transfers. The commenter suggested that to-laboratory transfers of NHPs. Citing must conform to AZA standards as a the standard for all three should be the published papers to support the condition of being excepted from higher one, which is the laboratory-to- proposition that neither new shipments otherwise applicable quarantine laboratory transfer standard. Two nor established colonies of NHPs are requirements. commenters suggested that we have the immune from infectious diseases, the In response to the commenter’s same standard for medical records and commenter said we should not request that we clarify HHS/CDC criteria certificates for zoo-to-zoo and eliminate quarantine requirements for for determining that a zoo outside the laboratory-to-laboratory transfers from any reason. United States is ‘‘AZA equivalent,’’ outside the United States. HHS/CDC Response. Regarding the HHS/CDC Response. HHS/CDC HHS/CDC will consider a facility as differing TB standards for zoo-to-zoo, disagrees with these commenters and meeting this standard if it is accredited laboratory-to-laboratory, and animal emphasizes that such transfers will not by an organization that has standards acts, HHS/CDC believes the commenter be without oversight. For laboratory-to- comparable to those in the AZA may have misinterpreted the proposed laboratory transfers of NHPs, importers Accreditation Standards and Related provisions. Neither the proposed must have protocols approved by the Policies.3 These standards include language nor final rule language IACUC, a self-regulating entity required performance-based procedures specifies a more stringent standard for under U.S. law for institutions using addressing appropriate veterinary care, one group. However, each group will be laboratory animals for research and quarantine and necropsy, and public expected to present documentation of instruction. Further, the importer must exposure to animals. This approach regular TB testing and good health. demonstrate that the animals are part of allows individual institutions to decide One commenter recommended that long-term, established studies with on the best procedures within their NHPs imported through AZA-accredited specific study protocols. Sending institutional capabilities to reach the zoos go through a defined risk laboratories must submit records desired results. assessment and decision analysis before showing TB testing, number of NHPs, Another commenter requested that we importation and release from current health certificates, clarify the § 71.53(p)(2) proposed quarantine. This commenter also asked documentation of the research project, exemption from the 31-day quarantine what criteria HHS/CDC would use to and travel itineraries. provision in § 71.53(l)(1) for zoo-to-zoo determine that a zoo outside the United transfers. The commenter stated that One commenter said that because States was an AZA-equivalent zoo. NHPs in zoos and in many professional importers involved in zoo-to-zoo HHS/CDC Response. Although we are animal acts live in uncontrolled transfers of NHPs still would have to easing some of the quarantine environments where interaction with comply with proposed §§ 71.53(i) requirements for zoo-to-zoo and humans may be unlimited, imported (worker protection and PPE), 71.53(j) laboratory-to-laboratory transfers, these (SOPs for NHP crating, caging, and entities still will be regulated and NHPs in zoo populations and animal transport), and 71.53(k) (ground required to follow risk-reduction acts leaving and then returning to the transport requirements). The same procedures. Further, as explained in the United States should have no special commenter asserted that as written, regulatory analyses section for this rule, import exemptions. This commenter these subsections indicate that if an importers transferring NHPs between suggested maintaining the 31-day NHP with a known medical history qualifying zoos and qualifying quarantine requirements for both were the subject of a zoo-to-zoo transfer, laboratories already are regulated by categories of NHPs. Two commenters the animal still would be handled under USDA, may be bound by the Public both agreed we should maintain the BSL3 protocols until its arrival at a U.S. Health Service (PHS) policy for humane quarantine period for zoo-to-zoo zoo, where it then would be exempt treatment of laboratory animals, and transfers. from any type of quarantine. The must meet guidelines for animal care HHS/CDC Response. HHS/CDC agrees commenter said there appeared to be an and occupational health and safety from with the comment that transfers of NHP inconsistency. accrediting organizations. For zoos, that from facilities outside the United States HHS/CDC Response. HHS/CDC means providing a quarantine facility should be subject to the same medical clarifies the intent of the regulation by for animals new to the collection. records and health certificate emphasizing that qualified zoos and Considering all these factors, we believe requirements—irrespective of whether labs under paragraphs (p) and (q) are not that our registration, records, and the transfer is between qualified zoos or exempt from the worker protection, oversight requirements; the laboratories. Although these groups will ground transportation, or SOP requirements of accrediting not be required to undergo the 31-day requirements under this regulation. organizations; and oversight by other quarantine, these importers still are Further, the only BSL2+ or BSL3 federal entities provides health and subject to registration with the Agency requirements in this regulation are for safety assurance equivalent to what the before bringing animals into the United necropsies. However, HHS/CDC 31-day quarantine period provides for States. The final rule will also hold acknowledges that all NHPs pose a other importers. importers of U.S.-based animal acts to potential risk to human health and One commenter opposed § 71.53(p)(2) the same requirements for entry as should therefore be handled while and § 71.53(q)(2) provisions permitting foreign-based animal acts; all such NHP transfers between laboratories NHPs will be subject to a quarantine 3 http://www.aza.org/uploadedFiles/ without subjecting the animals to period regardless of where the animals Accreditation/Accreditation%20Standards.pdf. ‘‘certain testing and quarantine are based.

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M. Public Comments Regarding NHP preparations of slides and blocks from HHS/CDC Director is unambiguous and Products formalin-fixed tissue. The commenter provides sufficient procedural One commenter said we should better described slides and blocks as subject to safeguards against erroneous permit define ‘‘the scope, requirements or disinfecting in the form of serial denials. exposure to extractive solvents (e.g., duration’’ of the permit process to help O. Public Comments Regarding HHS/ alcohol) and heat during tissue importers of NHP blood and tissue CDC Monitoring and Enforcement processing and block preparation. It said samples ensure that shipments of such An individual commenter stated that products would not be degraded or that penetration of thin slices of tissue used on slides permits excellent our proposal said little about facility destroyed and lose their scientific value. penetration of solvents, and that the inspection, importer compliance, The commenter questioned the preparation of paraffin-embedded number of personnel, program funding, necessity for further permit blocks and slides provides a physical and enforcement actions. The requirements given that importers of barrier that minimizes potential commenter questioned how we would these products already must obtain a exposure. The commenter said that ensure consistent monitoring and CITES permit. these materials are for scientific enforcement. Another commenter HHS/CDC Response. Under § 71.53(t), purposes, that knowledgeable people referenced what it called ‘‘obvious Nonhuman primate products, importers handle the materials in laboratories disincentives’’ for reporting are required to obtain a permit from equipped for handling potentially noncompliance by overseas suppliers HHS/CDC prior to shipment of these infectious samples from humans or and shippers, and the apparent lack of products. However, this final rule does animals, and that the value of permits a mechanism for HHS/CDC to assess not change the current and longstanding for such materials is questionable. The compliance before an NHP shipment practice of obtaining such a permit. commenter said that should HHS/CDC arrives in the United States. Calling the HHS/CDC recognizes the need for require importers of blood and tissue proposed procedures in § 71.53(j) timely shipment of such products and samples to obtain a permit, that it must ‘‘inadequate,’’ and given what the will expedite all requested permits to define and structure the process to commenter said was the failure of NHP ensure that no products are degraded or avoid delays that may adversely affect breeding farms outside the United States destroyed. the scientific quality of samples. to match our health and welfare Two commenters made remarks on HHS/CDC Response. As noted earlier, standards, this commenter said we proposed requirements for permits for although some importers of NHP should ‘‘directly monitor’’ NHP overseas importing NHP products, including products are subject to the CITES operations. This commenter suggested blood and biological samples. One program, HHS/CDC’s mandate is to that the Agency take a direct, active role commenter asked us to indicate that a protect public health, and any untreated in risk management, by follow the HHS/CDC permit covers NHP products NHP product poses a risk to human approach the United Kingdom now not intended for commercial use. health. However, items which may be employs. In the alternative, said the HHS/CDC Response. In response, a compromised by rendering them commenter, we could prohibit NHP HHS/CDC permit is required and will noninfectious may still enter the United imports altogether. cover any NHP product (personal or States if accompanied by a HHS/CDC- HHS/CDC Response. HHS/CDC does commercial) unless it has been rendered issued permit. Under § 71.53(t)(1) of the not have the authority to regulate noninfectious, as defined in the final final rule, we lay out the conditions for foreign NHP facilities. However, text of the regulation. importing noninfectious products into enforcement of the regulations for U.S. A commenter asked us also to clarify the United States. In § 71.53(t)(2) of the facilities will remain as it is currently, that although a product importer may final rule, we clarify that it may be and the same penalties apply for not need a HHS/CDC permit for some permissible to import infectious blood violations. For compliance and products, there may be other non-HHS/ and tissue samples for bona fide inspections, HHS/CDC will continue to CDC permits required for import. scientific, educational, and exhibition make unannounced visits for U.S.-based Asserting that proposed § 71.53(t) would purposes under conditions set out in importers, as these importers must make cover blood and tissue samples from that provision. Timely requests for records, facilities, vehicles, and NHPs, another commenter noted that importing these products are processed equipment available for HHS/CDC importing these materials already expeditiously. As the final rule makes inspection during operating business requires holding a CITES permit, which clear in § 71.53(t)(1), an NHP product days and hours, and at other necessary HHS/CDC may use to track these importer may use formalin fixation or and reasonable times. importers and materials. any method approved by HHS/CDC to Another commenter asked whether HHS/CDC Response. At present, HHS/ render products noninfectious. inspection of NHP importers would CDC does not have the resources to include importers of blood and tissue track permits issued by other federal N. Public Comments Regarding Appeals samples, and asked what criteria we agencies. Furthermore, such outside Regarding the appeals process in would use for such inspections. permits are reviewed and issued for proposed § 71.53(u), four commenters HHS/CDC Response. Because of the purposes other than to protect public asserted that the proposed time for extensive resources that would be health. appeal was too short, the process was required for such inspections, the The commenter also noted that the undefined, and a rationale for so short Agency will not perform site visits but requirement to render biological a period was absent. Commenters will rely on HHS/CDC quarantine samples noninfectious could destroy suggested expanding appeals to 5 days. station inspections of incoming their scientific value. This commenter HHS/CDC Response. HHS/CDC agrees shipments for compliance with these further asked whether formalin-treated that importers who are denied a permit requirements. NHP tissues and slides containing such should have more time to appeal the Another commenter also suggested we tissue would require a permit for denial. Therefore, § 71.53(u)(2) extends add ‘‘employee health and safety importation. The same commenter said the time for appeal from 2 to 5 days. records’’ and ‘‘animal health records’’ to it was important to distinguish between Regarding the process itself, we believe the list of things an importer must make formalin-fixed tissue and histological that an appeal of a permit denial to the available for HHS/CDC inspection.

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HHS/CDC Response. HHS/CDC agrees although one objective of this rule is to positive feedback from the public with this comment and has inserted the reduce the compliance burden on during the comment period for the suggested language into paragraph special permit species importers; the NPRM. Compliance with provisions of (b)(1). principal goals of this rulemaking are to the 180-day special permit has been Regarding a change in the special extend special permit species excellent. Any potential for permit-renewal period from every 180 requirements to all NHP imports, to misinterpretation of the provisions is days to every two years, one commenter improve Agency oversight through a identified during the at-least biannual said this change would ‘‘vastly reduc[e] general requirement that NHP review of the importer’s standard regulatory oversight of importers’’ shipments enter the United States operating procedures and annual site without evidence that the health risk through ports of entry with a HHS/CDC visits. posed by these importers has changed. quarantine facility, and to codify This commenter further asserted that we existing guidelines. We have extended The NHP import industry has provided no justification for changing the registration renewal period for changed vastly during the 22 years since the renewal period other than easing the special permit species importers not just the 180-day special permit final rule $84/year burden on the regulated to reduce the burden on the regulated was promulgated. Before the community, and that such a goal alone community, as the commenter asserts, requirements of the special permit were is insufficient ‘‘to justify the serious but because the reduction and introduced, there were hundreds of threat to the public posed by relaxing continuing low morbidity and mortality NHP importers and high levels of NHP standards for importation of these rates for these species in transit and mortality during import. Many of these species of NHPs.’’ quarantine demonstrate that a 2-year operations were poorly equipped and HHS/CDC Response. HHS/CDC renewal period would be sufficiently quickly dropped out of the industry in believes that the commenter’s concern protective of public health. response to the special permit about the reduction in government Concerning the change in timeframe regulation and other HHS/CDC- oversight is misplaced. We did not for renewal of importer licenses, HHS/ mandated provisions concerning propose a reduction in oversight, but in CDC would like to emphasize that we tuberculosis. Currently there are only 24 administrative burden. Importers must have incorporated all provisions of the NHP importers registered with CDC: 11 continue to notify HHS/CDC of all old 180-day permit requirement into the commercial importers; 7 zoos; 4 shipments and the Agency will continue new regulation and have strengthened national primate research centers; 1 to perform regular site visits, including these requirements by requiring university; 1 private research facility. the review of importer standard filovirus testing on all Old World This number has decreased from 27 operating procedures. Indeed, there is Monkeys. All currently registered registered importers in 2004. There are constant communication between HHS/ importers of the three special-permit now only 8 importers who routinely CDC and importers. Extending the species (cynomolgus and rhesus import NHP covered by the special renewal period for special permit macaques, and African green monkeys) species will not result in less oversight, have been importing these animals since permit. and is consistent with the directive in the special permit first went into effect The number of NHPs imported Executive Order 13653 section 1 that we in 1990. There have been no legal annually has decreased dramatically apply the least burdensome tools for challenges to any of the provisions of over the last several years, as shown in achieving regulatory ends. Further, the special permit. We received only the Figure 1 below.

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Factors for this decrease include taxpayer resources (i.e., staff time) to arrive in the United States, which difficulties encountered in international review and approve renewal includes providing detailed information transportation of NHPs (fewer airlines applications, when there is no current on the animals; the in transit itinerary; allow transport each year), as well as evidence to suggest that such a equipment used in transport, housing decreased demand. frequency of scrutiny contributes and decontamination procedures; and When an importer requests renewal of appreciably to protecting public health. other performance-based procedures to the special permit, the importer submits As stated above, regulations should reduce the risk of exposing the public to an email, and CDC re-authorizes the impose the smallest reasonable burden health hazards presented by NHPs. special permit, provided there have on the regulated entities in order to Further, the same penalties apply to been no changes in the importer’s accomplish the purpose of the brokers as to other entities subject to standard operating procedures and no regulations; we are acting in the spirit these regulations. of that principle by reducing the burden uncorrected procedural violations. In P. Miscellaneous Comments the last 8 years of program oversight, on the NHP importers because there is there has never been an instance where no evidence that requiring them to Asserting that proposed reporting of a special permit has not been renewed renew their special permits every 180 NHP illnesses and deaths upon arrival promptly. Any deficiencies on the part days is necessary to accomplish the and in quarantine would reveal ‘‘only a of the importer are: Noted during purpose of the regulations. fraction’’ of morbidity and mortality for quarantine station oversight when the It is our opinion based on extensive these animals, a commenter asked that shipment reaches the United States; experience that the 180-day special we provide an analysis of such cases self-reported during quarantine by the permit final rule was promulgated from the recent past before continuing importer; picked up on biannual review during a much different phase of the with this rulemaking. The commenter of the importer’s registration import industry. Changes in the said we should report on the precise application; or identified during routine industry since then lead us to believe nature of illnesses and deaths, and site visits. All special permit NHP firmly that it has no appreciable benefits include laboratory and post-mortem importers are visited annually. public health benefits over a two-year results. According to one comment, HHS/CDC’s rulemaking is in keeping timeframe. such an analysis would ensure that the with Executive Order 13563, Improving An individual asked how we will public appreciated and understood any Regulation and Regulatory Review, monitor compliance and apply penalties risks and benefits of the changes we which states that regulations must for brokers given there were no apparent proposed. ‘‘identify and use the best, most requirements for them to register with HHS/CDC Response. HHS/CDC innovative and least burdensome tools HHS/CDC under § 71.53(r). disagrees with this comment. All for achieving regulatory ends. [The HHS/CDC Response. Although there morbidity and mortality in a shipment regulations] must take into account is no requirement for brokers to register of NHPs upon arrival and during the 31- benefits and costs, both quantitative and with the Agency, under § 71.53(r), day quarantine period is reported to qualitative.’’ Renewing the special brokers must notify HHS/CDC of in (and recorded by) HHS/CDC. Illness permits every 180 days expends transit shipments before the shipments reports and necropsy reports are

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reviewed before any NHPs are released and the NHP is part of an ongoing quarantine, other operations, personnel from the required quarantine. research project. training, and worker health programs Additionally, veterinary medical prior to importation of NHPs; although V. Regulatory Analyses records are reviewed during the regular, the rule does not add new terms or unannounced site visits. A. Executive Orders 12866 and 13563 requirements. The regulation also One commenter recommended that in HHS/CDC has examined the impacts allows stakeholders to exercise their the final rule preamble or the rule itself, of the proposed rule under Executive own good judgment in implementing we discuss whether the rule would Order 12866, Regulatory Planning and the regulatory guidelines through apply retroactively to NHPs imported Review (58 FR 51735, October 4, 1993) performance-based standards, rather before issuance of the final rule. The and Executive Order 13563, Improving than dictating prescriptive compliance. agency expressed particular interest in Regulation and Regulatory Review, (76 The rule impact will be unification of rule provisions addressing an importer’s FR 3821, January 21, 2011). Both existing rules and codification ability to maintain, sell, resell, or Executive Orders direct agencies to professional guidance. The rule will otherwise distribute imported NHPs or evaluate any rule prior to promulgation create qualitative costs and benefits for the offspring of imported NHPs. to determine the regulatory impact in all NHP importation stakeholders and HHS/CDC Response. Regarding the the United State public as explained question of retroactive applicability, terms of costs and benefits to United States populations and businesses. below. HHS/CDC notes that the new rule does Benefits. There are benefits to the rule Further, together, the two Executive not apply to animals or the offspring of that accrue to: (1) The public in the form Orders set the following bars: quantify animals imported into the country of protecting public health; (2) business costs and benefits where the new before 1975. For decades, there have stakeholders in the form of investment regulation creates a change in current been prohibitions on importing NHPs protection and a reduction in time practice; define qualitative costs and except for scientific, exhibition, or needed to be spent on regulatory benefits; choose approaches that educational purposes; or for using the compliance leading to a benefit of maximize benefits; support regulations offspring of imported NHPs for reasons avoided costs; (3) the NHP workforce; that protect public health and safety; other than scientific, exhibition, or and (4) the scientific community. educational purposes. The revised rule and minimize the impact of regulation. Public health benefits: continues these prohibitions. HHS/CDC has analyzed the rule as • Reduction in risk of transmission of required by these Executive Orders and IV. Alternatives Considered a variety of zoonotic infections has determined that it is consistent with including filoviruses, TB, herpes B Executive Order 13563 recommends the principles set forth in the Executive virus, and parasites. that the regulatory impact analysis Orders and the Regulatory Flexibility • Entry through quarantine stations consider all feasible alternatives to Act, as amended by the Small Business where qualified personnel examine the current practice and the rule as Regulatory Enforcement Fairness Act NHP to ascertain any potential exposure proposed. The main impact of the rule (SBREFA) and that the rule will not to the public through direct contact or is to unify existing regulations and create enough change in current practice contaminated cargo. codify and professional guidance to have a measurable, quantifiable • Certifying the health of NHPs in regarding infection control and worker impact. animal acts will reduce the risk of safety procedures to prevent This rule is not being treated as a spectators coming in contact with ill transmitting pathogens from NHPs to significant regulatory action as defined animals. humans. As explained in II. Summary of by Executive Order 12866. As such, it Business stakeholders benefits the Proposed Rule Requirements, HHS/ has not been reviewed by the Office of (reduction in time spent on regulatory CDC proposed a number of changes in Management and Budget. This compliance, or avoided costs, and the NPRM that would achieve its regulatory action is not a major rule investment protection): regulatory objectives through under the Congressional Review Act. In • Investment protection—Certifying performance-based standards rather our screening analysis under the the health of NHP will reduce the than promulgating prescriptive Regulatory Flexibility Act, HHS/CDC potential transmission of disease standards for importers. HHS/CDC also concludes that the rule will not between NHP and reduce the costs to endeavored to allow regulated entities have a significant economic impact on the business of caring for other ill flexibility in choosing how to meet the a substantial number of small entities. animals, or in the worst case, stop the standards. We have provided flexibility HHS/CDC has determined that the loss of investment through death. regarding recordkeeping requirements, main impact of the rule will be to unify • Regulatory reduction (avoided standard operating procedures, and existing regulations and codify cost)—The registration renewal time for worker protection requirements. professional guidance regarding all NHPs will now be 2 years. HHS/CDC reviewed the 31-day infection control and worker safety Previously, importers of cynomolgus, quarantine requirement and associated procedures to prevent transmitting African green, and rhesus monkeys were restrictions for transfers of NHPs into pathogens from NHPs to humans. All required to renew their special permit the United States between Association stakeholders involved in the registration every 180 days, or two times of Zoos and Aquariums (AZA)- importation and maintenance of NHPs a year. According to HHS/CDC records, accredited zoos and proposed to will now be subject to the same set of special-permit holders are about a third eliminate that requirement. Similarly, rules and guidelines. This rule of all NHP importers (20 of a total of 60). HHS/CDC proposed a quarantine combines a disparate set of professional This is a four-fold reduction in exception for transfers of NHPs from recommendations and rules that were paperwork for registration renewal for laboratories accredited by the published or established in various about a third of all NHP importers. Association for Assessment and formats between 1975 and 1993 (see C. • Regulatory reduction (avoided Accreditation of Laboratory Animal What is the History of this cost)—More specific definitions and Care International (AAALAC) or its Rulemaking?). This rule clarifies uniform application of rules and equivalent, if the laboratory has a definitions of terms and requirements standards will make it much easier for foreign-based and a U.S.-based facility for developing plans and SOPs for businesses to reliably forecast the time

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they need to spend complying with little additional cost impact to the D. Environmental Impact regulation. importer. • In the absence of an applicable Regulatory reduction (avoided Cost-Benefit comparison. Benefits and categorical exclusion, the Director, cost)—The rule eradicates the 31-day avoided costs as enumerated in the HHS/CDC, has determined that quarantine period for animals being benefits section appear to outweigh the provisions amending 42 CFR 71.53 will transferred between zoos and additional transportation cost of not have a significant impact on the laboratories when the facilities have additional travel for one or two human environment. been approved by professional importers each year that will need to organizations (AZA for zoos and enter through points with quarantine E. Unfunded Mandates Reform Act AAALAC for laboratories). CDC station. The Unfunded Mandates Reform Act professionals indicate that there are B. Paperwork Reduction Act Analysis at 2 U.S.C. 1532 requires that agencies between three and five such transfers a prepare an assessment of anticipated HHS/CDC has determined that this year. Professional opinion and costs and benefits before developing any rule contains data collection and record discussion with zoos and laboratories rule that may result in expenditure by keeping requirements that are subject to indicates that this would result in State, local, or tribal governments, in the review by the Office of Management and avoided costs of about $500 to $1,800 aggregate, or by the private sector of Budget (OMB) under the Paperwork per transfer, depending on the facility $100 million or more (adjusted for Reduction Act of 1995 (PRA) (44 U.S.C. costs for quarantine. inflation) in any given year. This rule is Scientific benefits: 3501–3420). HHS/CDC already has • approval from OMB for the collection of not expected to result in any one-year Obstacles to the movement of expenditure that would exceed this highly endangered NHPs will be registration information from importers and record keeping requirements under amount, therefore HHS/CDC has not removed to protect the species. prepared a table of quantified costs and • Controlled entry of NHPs for long- OMB Control No. 0920–0134: Foreign benefits. term research will be allowed when the Quarantine Regulations (expiration date research can only be performed in July 31, 2015). F. Plain Language Act of 2010 In addition, HHS/CDC has approval United States laboratories. Under Public Law 111–274 (October from OMB under OMB Control No. NHP workers benefits: 13, 2010), executive Departments and • The regulation now defines the 0920–0263: Requirements for a Special Agencies are required to use plain types of personal protective gear that Permit to Import Cynomolgus, African language in documents that explain to workers must wear in order to protect Green, or Rhesus Monkeys into the the public how to comply with a the worker from the potential United States (expiration date June 30, requirement the Federal Government transmission of infectious agents. 2014) to collect data from importers administers or enforces. HHS/CDC has • Guidelines for regular TB testing who wish to apply for a special permit attempted to use plain language in have been established to ensure that to import non-human primates. workers are tested and diagnosed in a promulgating this rule consistent with timely manner. C. Federalism Impact the Federal Plain Writing Act • Guidelines are now established for Under Executive Order 13132, if the guidelines. access to medical care in the event of rule would limit or preempt State VI. References zoonotic-human illness transmission to authorities, then a Federalism analysis ensure that workers are tested and is required. The agency must consult National Research Council. ‘‘Occupational Health and Safety in the Care and Use of diagnosed in a timely manner. with State and local officials to Nonhuman Primates.’’ Institute for Costs. The current regulation is determine whether the rule would have Laboratory Animal Research, Division of primarily definitional and changes very a substantial direct effect on State or Earth and Life Studies, National little actual current practice. The only local governments, as well as whether it Research Council, The National part of the new regulation that will would either preempt State law or Academies Press 2003, Washington, DC. create an additional cost will be the impose a substantial direct cost of HHS/CDC (Centers for Disease Control and requirement that all NHPs being compliance. Prevention). 1990. Update: Ebola-Related imported enter the country through a In accordance with section 361(e) of Filovirus Infection in Nonhuman Primates and Interim Guidelines for port of entry or airport with a the PHSA [42 U.S.C. 264(e)], nothing in Handling Nonhuman Primates during quarantine station. At the current time this rule would supersede any Transit and Quarantine. Morbidity and the majority of, as much as 95% provisions of State or local law except Mortality Weekly Report (MMWR). according to CDC subject matter experts, to the extent that such a provision 39(2):22–24, 29–30. of NHPs enter the country at ports with conflicts with this rule. For example, HHS/CDC (Centers for Disease Control and quarantine stations because they arrive the rule would not prevent a State from Prevention). 1990. Update: Filovirus on airlines that frequent those ports of taking stronger measures to deal with Infection in Animal Handlers. Morbidity entry. The remaining NHPs that are infected or possibly infected NHPs or to and Mortality Weekly Report (MMWR). 39(13):221. transported into the United States come cover additional species. Further, our 55 FR 15210, April 20, 1990, Requirements in by truck across smaller border rule will not supersede state for a Special Permit to Import crossings between Mexico and the requirements not in conflict with the Cynomolgus, African Green, or rhesus United States or Canada and the United federal rule’s provisions. However, in Monkeys into the United States. States. Professionals in CDC’s accordance with section 361(e) of the Roper, W.L. Dear interested party (letter). Quarantine Branch estimate that this PHSA, any state or local law that would October 10, 1991. Available upon amounts to approximately one shipment permit any activity prohibited under request: (404) 639–1600. per year, or less than 5% of all NHP this rule would conflict with this rule Tipple, M.A. Dear interested party (letter). and, therefore, would be superseded. March 5, 1996. Available upon request: imported to the United States. HHS/ (404) 639–1600. CDC also notes that arrangements can be The rule would not have a substantial HHS/CDC (Centers for Disease Control and made in advance for alternative ports of direct effect on State or local Prevention). 1993. Tuberculosis in entry if the importers contact HHS/CDC. governments or impose a substantial Imported Nonhuman Primates—United Thus, HHS/CDC believes there is very direct cost of compliance on them. States, June 1990–May 1993. Morbidity

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and Mortality Weekly Report (MMWR). PART 71—FOREIGN QUARANTINE MOT means mammalian old 42(39):572–576. tuberculin, a biological product used as Formenty, P., et al. Ebola Virus Outbreak ■ 1. The authority citation for 42 CFR a diagnostic tool in the evaluation for among Wild Chimpanzees Living in a part 71 continues to read as follows: mycobacterial (TB and related bacteria) Rain Forest of Cote d’Ivoire. J. Infect. Dis. 1999; 179(Suppl 1):S120–126. Authority: Sec. 311 of the Public Health infections. Rollin PE, et al. Ebola (Subtype Reston) Virus Service (PHS) Act, as amended (42 U.S.C. NIOSH means the National Institute among Quarantined Nonhuman Primates 243), secs. 361–369, PHS Act, as amended for Occupational Safety and Health, Recently Imported from the Philippines (42 U.S.C. 264–272). Centers for Disease Control and to the United States. J Infect Dis., 1999; ■ 2. Revise § 71.53 to read as follows: Prevention, U.S. Department of Health 179(Suppl 1):S108–14. and Human Services. Rouquet P, et al. Wild Animal Mortality § 71.53 Requirements for importers of PPE means personal protective Monitoring and Human Ebola Outbreaks, nonhuman primates. equipment, such as gloves, respirators, Gabon and Republic of Congo 2001– (a) Purpose. The purpose of this and other devices used in preventing 2003. Emerg Infect Dis., 2005; 11:283–90. section is to prevent the transmission of the spread of communicable diseases. Leroy EM, Telfer P, Kumulungui B, et al. SOPs means standard operating Serological Survey of Ebola Virus communicable disease from nonhuman Infection in Central African Nonhuman primates (NHPs) imported into the procedures. Primates. J Infect Dis., 2004; 190:1895–9. United States, or their offspring, to TB means tuberculosis. HHS/CDC (Centers for Disease Control and humans. The regulations in this section TST means tuberculin skin test. Prevention). 1996. Ebola-Reston Virus are in addition to other regulations USDA means United States Infection among Quarantined Nonhuman promulgated by the Secretary to prevent Department of Agriculture. (2) For purposes of this section, the Primates—Texas, 1996. Morbidity and the introduction, transmission, and Mortality Weekly Report (MMWR). terms listed below shall have the spread of communicable diseases under 45(15):314–316. following meanings: 42 CFR part 71, subpart A and 42 CFR HHS/CDC (Centers for Disease Control and Animal act means any use of NHPs, part 70. Prevention). 1989. Ebola Virus Infection including offspring, for entertainment in (b) Scope. This section applies to any in Imported Primates—Virginia. which the NHPs are trained to perform Morbidity and Mortality Weekly Report person importing a live NHP into the some behavior or action and are part of (MMWR). 38(48):831–832, 837–838. United States, including existing a routinely scheduled show, Roberts, J.A., Andrews, A. Nonhuman importers, any person applying to performance, or exhibition, open to the Primate Quarantine: Its Evolution and become a registered importer, and any general public. Practice. 2008. Institute for Laboratory person importing NHP products. Animal Research (ILAR) Journal. 49(2). Breeding colony means a facility DeMarcus, T.A., Tipple, A., Ostrowski, S.R. (1) Importers must make their where NHPs, including offspring, are US Policy for Disease Control among facilities, vehicles, equipment, and maintained for reproductive purposes. imported nonhuman primates. 1999. J business records, including employee Broker means a person or organization Infect Dis. 179:S281–S82. health records and animal health within the United States that acts as an Institute for Laboratory Animal Research records, used in the importation of official agent of an exporter of NHPs (ILAR. 2006 Citing Mullan R.J. NHPs, available to HHS/CDC for from another country, or as an Nonhuman Primate Importation and inspection during operating business Quarantine: United States. Presentation intermediary between such an exporter days and hours, and at other necessary and an importer of NHPs. at Annual Meeting of the Association of and reasonable times, to enable HHS/ Primate Veterinarians, Park City, Utah, Cohort means a group of NHPs October 12–14. CDC to ascertain compliance with the imported together into the United Lerche NW., Yee JL, Capuano SV, Flynn JL. regulations in this section. States. New approaches to tuberculosis (2) Nothing in this section supersedes Director means the Director of the surveillance in nonhuman primates. or preempts enforcement of emergency Centers for Disease Control and ILAR J. 2008;49(2):170–8. response requirements imposed by Prevention, U.S. Department of Health ILAR Subcommittee on Care and Use, statutes or other regulations. and Human Services, or an authorized Committee on Nonhuman Primates. (c) Acronyms, initialisms, and representative. Laboratory Animal Management: definitions. Educational purpose means the use of Nonhuman Primates. ILAR News (1) For the purposes of this section: XXIII:2–3:28–29; National Academy NHPs, including offspring, in the Press 1980; Washington, DC. AAALAC means the Association for teaching of a defined educational Centers for Disease Control and Prevention Assessment and Accreditation of program at the university level or and National Institutes of Health. Laboratory Animal Care International. equivalent. Biosafety in Microbiological and AZA means the Association of Zoos Exhibition purposes means the use of Biomedical Laboratories. U.S. and Aquariums. NHPs, including offspring, as part of a Department of Health and Human CITES means the Convention on public display open to the general Services, Fifth Edition, 2007; U.S. International Trade in Endangered public during routinely scheduled hours Government Printing Office, Species. in a facility that meets or exceeds AZA Washington, DC, March 31, 2008. ELISA means enzyme-linked accreditation standards. List of Subjects in 42 CFR Part 71 immunosorbent assay, a type of Importer means any person importing, laboratory test that measures antibodies or attempting to import, a live NHP into Airports, Animals, Communicable or detects antigens for specific the United States, including an diseases, Harbors, Imports, Pesticides pathogens. applicant to become a registered and pests, Public health, Quarantine, HHS/CDC means U.S. Department of importer. Within the meaning of this Reporting and recordkeeping Health and Human Services, Centers for section, ‘‘importer’’ includes any person requirements. Disease Control and Prevention, or an maintaining a facility or institution For the reasons discussed in the authorized representative acting on its housing NHPs during quarantine. preamble, the Centers for Disease behalf. Within the meaning of this section, Control and Prevention amends 42 CFR IACUC means Institutional Animal ‘‘importer’’ also includes the agent of part 71 as follows: Care and Use Committee. any animal act, laboratory, or zoo that

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is subject to or carries out Quarantine means the practice of (iii) It is maintained, sold, resold, or responsibilities in accordance with the isolating live NHPs for at least 31 days distributed for other than permitted regulations in this section. after arrival in a U.S. quarantine facility purpose; In transit means NHPs located within where the NHPs are observed for (iv) It is imported by a person who is the United States that are not intended evidence of infection with not a registered importer; or for import, whether scheduled or not, as communicable disease, and where (v) It is otherwise deemed to part of the movement of those NHPs measures are in place to prevent constitute a public health threat by the between a foreign country of departure transmission of infection to humans or Director. and foreign country of final destination. NHPs within the cohort. (2) For any NHP arriving in the Lab or laboratory means a facility in Quarantine facility means a facility United States through an unauthorized the United States accredited by used by a registered importer of NHPs location, for other than the permitted AAALAC or licensed by USDA, for the purpose of quarantining purposes, or by a person who is not a conducting research using NHPs, having imported NHPs. registered importer, the person foreign based facilities, and intending to Quarantine room means a room in a attempting to import that NHP, must, as transfer or transferring one or more registered import facility for housing approved by the Director and at the NHPs that were originally part of an imported NHPs during the quarantine person’s own expense, do one of the institutionally approved, ongoing period. following: protocol, from its foreign-based facility Scientific purposes means the use of (i) Export or arrange for destruction of into its United States facility for NHPs including offspring for research the NHP, or purposes related to that specific following a defined protocol and other (ii) Donate the NHP for a scientific, research project. standards for research projects as educational, or exhibition purpose after Licensed veterinarian means a person normally conducted at the university quarantine at a HHS/CDC-registered who has graduated from a veterinary level. facility. (3) If the person attempting to import school accredited by the American Zoo means: a NHP fails to dispose of the NHP by Veterinary Medical Association’s (1) Within the United States, an AZA- one of the options described in Council on Education, or has a accredited and professionally paragraph (e)(2) of this section, the certificate issued by the American maintained park, garden, or other place Director will dispose of the NHP at the Veterinary Medical Association’s in which animals are kept for public person’s expense. Education Commission for Foreign exhibition and viewing; or Veterinary Graduates, or has received (4) Pending disposal of any prohibited (2) Outside of the United States, a or excluded NHPs, the NHP will be equivalent formal education as professionally maintained park, garden, determined by the HHS/CDC; and has detained at the person’s expense at a or other place in which animals are kept location approved by the Director. received training and/or experience in for public exhibition and viewing that the care and management of nonhuman (f) Authorized ports of entry for live meets or exceeds the accrediting NHPs. (1) An importer may import live primates. standards of the AZA. Medical consultant means an NHPs into the United States only Zoonotic disease means any through a port of entry where a HHS/ occupational health physician, infectious agent or communicable physician’s assistant, or registered CDC quarantine station is located. The disease that is capable of being list of current HHS/CDC quarantine nurse, who is knowledgeable about the transmitted from animals (both wild and risks to human health associated with stations can be found at http:// domestic) to humans. www.HHS/CDC.gov/quarantine/ NHPs. (d) General prohibition on importing Nonhuman primate or NHP means all QuarantineStations.html. nonhuman primates. (1) A person may nonhuman members of the Order (2) In the event that the importer is not import live NHPs into the United Primates. unable to provide for entry at a port NHP product or Product means skulls, States unless the person is registered where a HHS/CDC quarantine station is skins, bodies, blood, tissues, or other with HHS/CDC as a NHP importer in located, the importer may only import biological samples from a nonhuman accordance with this section. live NHPs into the United States primate, including trophies, mounts, (2) A person may only import live through another port of entry if the rugs, or other display items. NHPs into the United States for: Director provides advance written Offspring means the direct offspring (i) Permitted purposes, as defined approval. of any live NHPs imported into the under paragraph (c)(2) of this section; or (3) If prior written approval is not United States and the descendants of (ii) Use in breeding colonies, provided obtained from the Director, the importer any such offspring. that all offspring will be used only as and excluded NHPs will be subject to Old World Nonhuman Primate means replacement breeding stock or for the provisions of paragraph (e) of this all nonhuman primates endemic to Asia permitted purposes. section. or Africa. (3) A person may not accept, (g) Registration or renewal of Pathogen means any organism or maintain, sell, resell, or otherwise importers. Before importing any live substance capable of causing a distribute imported NHPs (including NHP into the United States, including communicable disease. their offspring) for use as pets, as a those that are part of an animal act or Permitted purpose means the use of hobby, or as an avocation with those involved in zoo-to-zoo or NHPs for scientific, educational, or occasional display to the general public. laboratory-to-laboratory transfers, an exhibition purposes as defined in this (e) Disposal of prohibited or excluded importer must register with and receive section. NHPs. (1) HHS/CDC may seize, written approval from the Director. Person means any individual or examine, isolate, quarantine, export, (1) To register, or to renew a partnership, firm, company, treat, or destroy any NHP if: registration certificate, as an importer, a corporation, association, organization, (i) It is imported through a location person must submit the following including a not-for-profit organization, other than an authorized port of entry; documents to HHS/CDC: such as a sanctuary, or other legal (ii) It is imported for other than (i) A completed registration/ entity. permitted purposes; application form;

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(ii) A completed statement of intent that is at or in close proximity to the infection among workers whose duties that describes the number and types of NHP facility to allow HHS/CDC to easily may result in exposure to NHPs and: NHPs intended for import during the inspect the records during HHS/CDC (A) SOPs that include requirements registration period, the intended site visits during regular business hours for preventing workplace infection from permitted purposes for which the NHPs or within one hour of such visits. If potentially contaminated needles or will be imported; records are maintained electronically, other sharp instruments and that, at a (iii) Written SOPs that include all they must be time-dated in a manner minimum, prohibit workers from elements required in paragraphs (h) than cannot be altered, and redundant recapping used needles by hand; through (n) of this section; back-up copies must be made in a removing needles by hand; or otherwise (iv) A copy of all federal, state, or manner that protects against loss. bending, breaking, or manipulating used local registrations, licenses, and/or (4) Before distributing or transferring needles by hand. permits; and an imported NHP, an importer must: (B) SOPs requiring that used (v) A signed, self-certification stating (i) Communicate to the recipients of disposable syringes and needles, scalpel that the importer is in compliance with NHPs, in writing, the restrictions and blades, and other sharp items be placed the regulations contained in this section definitions of permitted purposes; and in puncture-resistant containers kept as and agrees to continue to comply with (ii) Obtain written certifications from close to the work site as practical and the regulations in this section. the intended recipient that the NHPs disinfected and/or disposed of as (2) Upon receiving the documentation will be used and distributed only for hazardous waste. required by this section, the Director permitted purposes. (C) SOPs requiring that removable, will review the application and either (i) Worker protection plan and disposable PPE be autoclaved, grant or deny the application for personal protective Equipment. (1) In incinerated, or otherwise disposed of as registration as an importer. Applications addition to complying with the biohazardous waste. Nondisposable that are denied may be appealed under requirements of this section, an clothing worn in the quarantine facility paragraph (u) of this section. importer must comply with all relevant must be disinfected on site before (i) Before issuing a registration, the federal and state requirements relating laundering. Director may inspect any business to occupational health and safety. (D) An infection-prevention program record, facility, vehicle, or equipment to (2) Importers must have a written that requires NHP handlers to cleanse be used in importing NHPs. worker protection plan for anyone all bites, scratches, and/or mucosal (ii) Unless revoked in accordance whose duties may result in exposure to surfaces or abraded skin exposed to with paragraph (t) of this section, a NHPs, including procedures for blood or body fluids immediately and registration certificate issued under this appropriate response measures in the thoroughly. section is effective for two years event of an emergency. An importer (E) Infection-prevention procedures beginning from the date HHS/CDC must adhere to the plan and SOPs and that require workers to immediately issues the registration certificate. must ensure that each worker covered flush their eyes with water for at least (iii) An importer must apply to HHS/ under the plan also adheres to it and all CDC for renewal of the registration 15 minutes following an exposure of pertinent SOPs. blood or body fluids to the eye. certificate not less than 30 days and not (3) An importer must contact HHS/ (vii) Post-exposure procedures that more than 60 days before the existing CDC immediately by telephone, text, or provide potentially exposed workers registration expires. email, as specified in the importer’s with direct and rapid access to a (3) All importers must comply with SOP, to report any instance of a worker medical consultant including: the requirements of paragraphs (h) exposed to a zoonotic illness and must (A) Procedures ensuring that exposed through (n) of this section. include instructions for contacting workers have direct and immediate (h) Documentation. An importer must HHS/CDC in its worker protection plan. develop, and document compliance (4) A worker protection plan must access to a medical consultant who has with, a written policy that states include the following: been previously identified in the SOPs imported NHPs, including their (i) Procedures to protect and train to HHS/CDC. offspring, will only be used and transport workers in how to avoid and (B) For potential exposures to herpes distributed for permitted purposes. respond to zoonotic disease exposures B virus, post-exposure procedures that (1) An importer must collect or create associated with NHPs, including require the routing of diagnostic a record of the intended purpose of procedures for appropriate responses in specimens to the National B Virus importation for each imported NHP and the event of a vehicle crash or other Resource Center located at Georgia State the purpose must comply with one of emergency during transport; University in Atlanta, Georgia, or the permitted purposes. An importer (ii) Hazard evaluation and worker another location as specified by HHS/ must retain written certifications communication procedures that adhere CDC. demonstrating that the NHPs and their to those in paragraph (i)(5) of this (viii) Procedures for documenting the offspring will continue to be used for section; frequency of worker training, including permitted purposes for three years after (iii) PPE requirements that adhere to for those working in the quarantine the distribution or transfer of the NHP. those in paragraph (i)(6) of this section; facility. (2) An importer must retain records (iv) TB-control requirements that (5) As part of the worker protection regarding each distribution of imported adhere to those in paragraph (i)(7) of plan described in this paragraph (i), an NHPs. Each record must include the this section; importer must establish, implement, identity of any recipients, the number (v) If applicable, SOPs that adhere to and maintain hazard evaluation and and identity of each NHP in each requirements relating to macaques as worker communication procedures that shipment or sale, and the dates of each described in paragraph (i)(8) of this include the following: shipment or sale, for three years after section; (i) A description of the known the distribution or transfer of the NHP. (vi) An infection-prevention program, zoonotic disease and injury hazards (3) An importer must maintain these including infection-prevention methods associated with handling NHPs; records in an organized manner, either requiring, at a minimum, PPE and (ii) The need for PPE when handling electronically or in a central location workplace practices for preventing NHPs and training in proper use of PPE,

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including re-training and reinforcement (ii) Prompt and direct access to a could scratch or otherwise injure of appropriate use; medical consultant who is capable of workers or NHPs. (iii) Procedures for monitoring performing the evaluation and (2) Glass items must not be used for workers for signs of zoonotic illness, maintaining records for such tests; feeding or watering NHPs during including procedures that ensure (iii) If an NHP is found to have transport. reporting to HHS/CDC by telephone, laboratory-confirmed TB, any worker (3) NHPs must only be removed from text, or email within 24 hours of the who had previously entered any room crates in an approved quarantine facility occurrence of illness in any worker where a confirmed NHP has been under the supervision of a licensed suspected of having a zoonotic disease; housed must promptly undergo a post- veterinarian. and exposure TB evaluation and (4) NHPs must not be removed from (iv) Procedures for disinfection of (A) If that test is negative, the worker crates during transport. garments, supplies, equipment, and must undergo another TB evaluation 3 (5) Upon arrival into the United waste. months later; and States, only an importer or an (6) As part of the worker protection (B) If either test is reactive, the worker plan described in this paragraph (i), an authorized representative may receive must be referred for medical evaluation; the NHPs from a conveyance (e.g., importer must identify the PPE required and for each task or working area. airplane, ship). The importer must (C) The HHS/CDC must be establish an emergency contingency Additionally, in this part of the worker immediately notified of the results of protection plan, an importer must plan in the unlikely event they are the medical evaluation by telephone, unable to meet the shipment. ensure the following: text, or email as specified in the (6) All reusable items must be (i) Any required PPE must be importer’s SOPs. decontaminated between uses. available to workers when needed; (iv) Compliance with exposure- (ii) Workers in direct contact with control planning elements under 29 CFR (7) At all times during transport, NHPs must wear the following: 1910.1030 for workers who will have crates containing NHPs must be (A) Gloves of sufficient thickness to parenteral and other contact with blood separated by a physical barrier from reduce the risk of cuts, scratches, and or other potentially infectious material workers, other individuals, and all other punctures; from NHPs and compliance with the animals and cargo, or by a spatial barrier (B) At a minimum, disposable NIOSH- respiratory protection requirements in greater than 5 feet, that prevents approved N95 respirators, in 29 CFR 1910.134. contamination of cargo or individuals compliance with OSHA 29 CFR (8) For importation of macaques, an with bodily fluids, feces, or soiled § 1910.134, which requires a respiratory importer must develop, implement and bedding. protection program; adhere to a written PPE program to (8) At all times during transport, (C) Face shields or eye protection; and prevent herpes B virus transmission. individuals traveling with the shipment (D) Outer protective clothing when The program must be based on a must be protected from shared air of opening crates, removing foreign thorough hazard assessment of all work NHPs to prevent the transmission of materials from crates, feeding NHPs, procedures, potential routes of exposure zoonotic diseases. Airflow must be removing dead NHPs, or handling (e.g., bites, scratches, or mucosal unidirectional from NHP transport bedding materials. exposures), and potential adverse health workers to NHPs or, if any air is (iii) Workers handling crates or pallets outcomes. recirculated to the NHP transport containing NHPs must wear the workers, it must be HEPA-filtered. If a following: (9) An importer must keep records of all serious febrile illnesses (fever greater ventilation system is not in place, all (A) Elbow-length, reinforced leather NHP transport workers must wear gloves or equivalent gloves that prevent than 101.3 degrees Fahrenheit [38.5 degrees Celsius] for more than 48 hours) respiratory protection. penetration of splinters, other crating (9) If traveling by plane, crates materials, or debris; in workers having exposure to NHPs in transit or in quarantine. The record containing NHPs should be loaded in (B) Outer protective clothing; the cargo hold last and removed first, (C) Waterproof shoes or boots; must be kept by the importer as part of must be placed on plastic that prevents (D) NIOSH-approved respiratory the worker’s administrative records. The spillage onto the deck of the plane, and protection that is compliant with OSHA importer must promptly notify HHS/ must be placed on pallets or double regulations at 29 CFR 1910.134, and; CDC by telephone, text, or email if such crated to ensure separation from other (E) Face shields or eye protection. an illness occurs. An importer must (iv) Workers whose faces may come ensure that the medical consultant cargo. within 5 feet of an NHP must wear providing care is informed that the (10) Workers, as well as NHPs, must disposable NIOSH-approved N95 patient works with and/or has been be protected from communicable respirators and either face shields or eye exposed to NHPs. disease exposures at any facility used en protection to protect against aerosol or (j) SOP requirements and equipment route, including transportation holding droplet transmission of pathogens; standards for crating, caging, and facilities. An importer must maintain a (v) Workers must remove disposable transporting live nonhuman primates. description of any transportation PPE and discard as a biohazard; and Equipment standards for crating, caging, holding facilities and document the (vi) Workers must not drink, eat, or and transporting live NHPs must be in communicable disease prevention smoke while physically handling NHPs accordance with USDA Animal Welfare measures taken to protect workers at or cages, crates, or other materials from regulation standards (9 CFR parts 1, 2, facilities used en route. such NHPs. and 3) and International Air Transport (11) For each import, documentation (7) For TB protection, an importer Association standards, and an importer must be made of the communicable must ensure the following: must establish, implement, maintain, disease-prevention procedures to be (i) Workers in a facility housing NHPs and adhere to SOPs that ensure the carried out in every step of the chain of must have a baseline evaluation for TB following requirements are met: custody, from the time of embarkation prior to working with NHPs and an (1) Any crate used to transport NHPs of the NHPs at the country of origin evaluation at least annually; must be free of sharp projections that until arrival at the quarantine facility.

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(12) Procedures to ensure that aircraft, is infected with, or has been exposed to, whenever possible and that any ship, vehicles, and related equipment a zoonotic disease, or if an importer or individual NHP is anesthetized, are decontaminated following transport. HHS/CDC finds a need for additional tranquilized, or otherwise restrained (13) Used PPE, bedding, and other diagnostic testing. before handling. potentially contaminated material must (i) For any quarantine facility (iv) A description of handling and be removed from the ground transport established or maintained under this transporting samples. For any procedure vehicle upon arrival at the quarantine section, an importer must establish, involving the use of a syringe, a facility and disposed of as biohazardous implement, maintain, and adhere to separate, disposable needle and syringe waste. SOPs that meet the following physical must be used, including a sterile needle (k) Ground transport vehicles. An security requirements: and syringe for withdrawing medication importer must establish, implement, (A) The facility must be locked and from any multi-dose vials (e.g., maintain, and adhere to SOPs for secure, with access limited to ketamine). ground transport vehicles transporting authorized, trained, and knowledgeable (v) Before any contaminated item is NHPs that meet the following personnel. removed from a quarantine facility, an requirements. (B) An importer must limit access to importer must ensure that all NHP (1) Ground transport vehicles must NHP quarantine areas to authorized waste, bedding, uneaten food, or other have a separate cargo compartment with personnel who are responsible for the possibly contaminated items are separate heating, ventilation, and air- transport, study, care, or treatment of disinfected, autoclaved, or double- conditioning systems. the NHPs. bagged for disposal as biomedical waste (2) The interior surfaces of ground (ii) An importer must keep the by a licensed facility. transport vehicle cargo compartments number of workers involved in the care, (vi) All cages, feeding bottles, reusable must be of smooth construction, easy to transport, and inspection of NHPs to the items, and other contaminated items clean and disinfect. minimum necessary to perform these must be disinfected between uses and (3) Used PPE, bedding, and other functions. before disposal. potentially contaminated material must (iii) The facility must be designed and (vii) Any equipment used for infusion be removed from the ground transport operated in such a manner as to allow of NHPs must be autoclaved or vehicle upon arrival at the quarantine for adequate disinfecting. incinerated, as appropriate. facility and disposed of as biohazardous (iv) The facility must have adequate (viii) During the quarantine period, an waste by a licensed facility. equipment and space for discarding and importer must monitor NHPs for signs (4) Ground transport vehicle cargo disinfecting all equipment, clothing, of any zoonotic illness, including signs compartments must be large enough to and caging. consistent with yellow fever, allow safe stowage of NHP crates in a (v) Each heating ventilation and air- monkeypox, or filovirus disease. manner that allows ready access to each conditioning unit in the quarantine (A) If any NHP appears ill during NHP during transit without unloading facility must be designed so that there quarantine, an importer must monitor any crates. is no mixing of air among quarantine that NHP for signs of zoonotic illness, (5) After transport of the NHP rooms and each quarantine room must including filovirus disease, and ensure shipment from the port of entry to the remain under negative air pressure in appropriate treatment. quarantine facility, the importer must relationship to the common hallway or (B) If an Old World NHP displays notify HHS/CDC in writing, text anteroom(s) adjacent to the quarantine signs suggestive of filovirus infection message, or email as specified within room. (e.g., diarrhea with melena or frank the SOP, within 48 hours of the time the (vi) Each quarantine room must have blood, bleeding from external orifices or shipment arrived at the quarantine air flow indicators (pressure gauges or petechiae, or suffusive hemorrhage), and facility. visual flow indicators) that are affixed survives, an importer must collect (6) As part of the notification of outside the quarantine room that serum samples on day 31 of quarantine arrival in paragraph (k)(5) of this indicate the direction of airflow into or and test these samples for antibodies to section, an importer must inform HHS/ out of quarantine rooms and adjoining filovirus while the entire cohort remains CDC whether suspected or confirmed common hallways and anterooms. in quarantine. An importer must test the transmission or spread of communicable (3) An importer must establish, serum for immunoglobulin G (IgG) disease occurred during transport, implement, maintain, and adhere to antibodies to filovirus by using an including notification of NHPs that SOPs for handling, monitoring, and ELISA methodology, or other method died, became ill, or were injured during testing NHPs in quarantine that meet the approved by HHS/CDC. transport, or malfunctions associated following requirements: (C) An importer must not knowingly with disease-mitigation procedures or (i) An importer must ensure that all request a release from HHS/CDC of any equipment. NHPs are identified individually with a ill NHP from quarantine under (l) Quarantine facilities. (1) The unique number or alphanumeric code paragraph (l)(4) of this section. requirements of this paragraph (l) permanently applied to the NHP by (ix) For each NHP in a quarantine relating to quarantine facilities do not tattoo, microchip, or other permanent facility, an importer must administer at apply to laboratory-to-laboratory identifier before importation or after the least three TSTs on the eyelid using old transfers or zoo-to-zoo transfers that are 31-day quarantine. Tattoos, microchips, mammalian tuberculin (MOT), with at in compliance with paragraphs (p)(2) or other permanent identifiers must not least 2 weeks between tests, before the and (q)(2) of this section, respectively. be applied during the quarantine period. NHP is released from import quarantine. (2) An importer must maintain a (ii) Health certificates, shipping TSTs must be read and recorded at 24, quarantine facility for holding a cohort documents, and NHP health records 48, and 72 hours, and a grading scale for during the required quarantine period. must include the number or code interpretation of these tests must be NHPs must be quarantined for 31 days required in paragraph (l)(3)(i) of this listed in an SOP for TB testing. after arrival at the importer’s quarantine section, as well as the age, sex, and (A) An importer must ensure that any facility. HHS/CDC may extend the species of the NHP. cohort with positive or suspicious TST quarantine period if an importer or (iii) An importer must ensure NHPs reaction remains in quarantine and HHS/CDC finds or suspects that an NHP are confined in a squeeze-back cage receives at least five additional TSTs

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(each administered at least two weeks additional measures to rule out the morbidity or mortality of NHPs in apart) following removal of the last spread of suspected zoonotic disease quarantine facilities, or following a zoo- affected NHP. before releasing a shipment from to-zoo or laboratory-to-laboratory (B) The validity of TB test results may quarantine, including examination, transfer. be compromised if during quarantine an additional diagnostic procedures, (3) For any morbidity or mortality NHP contracts a viral illness, including treatment, detention, isolation, seizure, from time of embarkation from country measles; is treated with steroids; or is or destruction of exposed animals. of origin to release from HHS/CDC immunized. An importer must (6) An importer must establish, quarantine, an importer must report the document such occurrence(s) and hold implement, and adhere to SOPs for safe circumstances to HHS/CDC promptly, the NHPs until they have recovered handling and necropsy of any NHP that including the cause of death for each from the illness or are no longer on dies in quarantine. The SOPs must NHP. treatment, and for a recommended time ensure the following: (4) Upon completion of the quarantine after recovery (to be determined in (i) The carcass of the NHP must be period and before an importer releases consultation with HHS/CDC, depending placed in a waterproof double-bag and any NHP, cohort, or mixed cohort from on the illness or treatment in question) properly stored for necropsy, specimen quarantine, the importer must ensure before TB tests are performed. collection, autoclaving and/or that the quarantine facility’s licensed (C) An importer must retain records of incineration, and disposal; veterinarian notifies HHS/CDC in all TSTs performed during the lifetime (ii) A necropsy must be performed by writing of the health status of the of each NHP at the facility housing the a veterinary pathologist or state-licensed shipment. NHP until the NHP is transferred to veterinarian. Each necropsy report must (5) An importer must notify HHS/CDC another facility. These records must address all major organ systems and within 24 hours if any NHP tests accompany the NHP during moves to incorporate clinical history and positive for filovirus virus antigen or other facilities. laboratory findings; antibody. (x) An importer must ensure that (iii) Necropsy and appropriate (6) An importer must report to HHS/ different cohorts of NHPs are laboratory testing of the NHP must CDC within 24 hours, any positive or quarantined in separate quarantine document the cause of death and/or rule suspicious TST results, necropsy rooms. out zoonotic illness; findings, or laboratory results. Any (A) If mixing of cohorts should occur, (iv) Necropsy must be performed report required under this section must an importer must treat the mixed cohort under biosafety level 3 (BSL3) or include a copy or summary of the as a single cohort. enhanced biosafety level 2 ‘‘plus’’ individual NHP’s health records. (B) All NHPs within that mixed (BSL2+) to protect against exposure to (n) Recordkeeping and reporting cohort must remain in quarantine until highly infectious agents; requirements for importing NHPs. (1) (v) Any samples of tissues, blood, each NHP in that mixed cohort has Before authorizing the import of any serum, and/or transudates (bodily fluid) completed the minimum 31-day NHPs, an importer must be in collected during necropsy must be quarantine period. compliance with all applicable elements (C) Quarantined NHPs must be retained until the NHP shipment has of the importer’s SOPs. housed in such a manner that they do been released from quarantine by HHS/ (2) At least seven days before not expose non-quarantined NHPs to CDC, in case other testing is required by importing a shipment of NHPs, an non-filtered air and other potentially HHS/CDC; importer must notify HHS/CDC in infectious materials, including soiled (vi) Fresh and formalin-fixed tissue writing or by email of the impending bedding, caging, and other potentially specimens, including tracheobronchial shipment and provide the following contaminated items. lymph node, liver, lung, and spleen, (4) Before releasing a NHP from regardless of necropsy findings, must be information: quarantine, an importer must obtain collected for laboratory examination; (i) The importer’s name and address; written permission from HHS/CDC. (vii) Any granulomatous lesions (ii) Number and species of NHPs HHS/CDC may permit the release of a found in any NHP at necropsy, being imported; cohort from quarantine when all the regardless of whether TB in the NHP (iii) Description of crates; following conditions have been met: was previously suspected, must be (iv) Means of individually identifying (i) The 31-day quarantine period, submitted to a laboratory for laboratory NHPs; including any required extension of examination for acid-fast bacilli and for (v) Origin of NHPs, including the quarantine, has been completed. mycobacterial culture; and country, the exporter, and the exporter’s (ii) HHS/CDC has confirmed receipt of (viii) In the event that an Old World address; written notification of the health status NHP dies or is euthanized for any (vi) Use of NHPs under paragraph (h) of the NHPs in the shipment from the reason other than trauma or unexpected of this section; quarantine facility’s licensed adverse environmental conditions (vii) Specific itinerary with names, veterinarian as required by paragraph during quarantine, liver tissue for dates, flights, times, airports, sea ports, (m)(4) of this section. filovirus antigen by using the antigen- and responsible parties to contact at (iii) HHS/CDC confirms that the capture ELISA method must be every step of travel, including all importer has addressed and resolved to submitted to a qualified laboratory for ground transportation; HHS/CDC’s satisfaction any NHP or testing. The laboratory should provide (viii) Port of entry; worker communicable disease issues documentation of test validation and (ix) If arriving by flight, the name of that were reported to HHS/CDC during records of ongoing quality assurance. the airline and its flight number; shipment. (m) Health reporting requirements for (x) If arriving by vehicle, the name of (5) If HHS/CDC notifies an importer of nonhuman primates. (1) An importer the vehicle’s owner and its license plate any evidence that NHPs have been must notify HHS/CDC of the events number; exposed to a zoonotic disease, the listed in this paragraph (m) by (xi) If arriving by ship, the name of importer must, at the importer’s telephone, text, or email. the ship and its vessel number; expense, implement or cooperate in the (2) An importer must notify HHS/CDC (xii) Name and address of the HHS/CDC’s implementation of within 24 hours of the occurrence of any destination quarantine facility;

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(xiii) Name, address, and contact (B) At least once a year, TB testing (iv) A specific itinerary with names, information for shipper, if other than with MOT and interpreted as stated in dates, flights, times, airports, seaports, the importer; paragraph (l)(3)(ix) of this section; and responsible parties to contact at (xiv) If applicable, name, address, and (C) NHPs with positive TST results every step of travel, including all contact information for broker in the must be evaluated for potential ground transportation. United States; antituberculosis chemotherapy in (3) Persons importing live NHPs that (xv) Name, address, and contact consultation with HHS/CDC. are transferred from one zoo to another, information for the person(s) (D) If the NHP is a chimpanzee, who are not able to meet the responsible for off-loading NHPs in the serology and antigen testing for hepatitis requirements listed in paragraphs United States; B, serology for hepatitis C, and any (p)(2)(i) and (ii) of this section, must (xvi) Name, address, and contact additional titers must be performed as comply with all the elements in information for any party responsible indicated by clinical history or exam. A paragraphs (g), (h), (i), (j), (k), (l), (m), for ground transportation from port of chimpanzee found serologically positive and (n) of this section. entry to quarantine facility; for hepatitis B and/or hepatitis C is (q) Laboratory-to-laboratory transfers. (xvii) Expected quarantine facility, if ineligible for entry or re-entry into the (1) A laboratory transferring NHPs on an different from the importer; United States, unless confirmatory established research protocol from its (xviii) Master air waybill number for evidence signed by a licensed foreign-based facility to its U.S.-based shipment; veterinarian shows that there is no laboratory must comply with all the hepatitis B or hepatitis C virus present elements listed in paragraphs (g), (h), (i), (xix) CITES permit number and in the NHP. (j), (k), and (n) of this section; and expiration date. (vii) SOPs for transporting the NHPs paragraphs (m)(1), (m)(2), (m)(5), and (o) Animal acts. (1) All animal acts internationally, including the shipping (m)(6) of this section. must be registered with HHS/CDC under crates or enclosures, the type of (2) If a lab is receiving one or more paragraph (g) of this section. In addition conveyance, and measures to minimize NHPs for purposes related to an ongoing to the requirements in paragraph (g) of human exposure to the NHPs. research project from another this section, which incorporates the (viii) A copy of a negative TST established research facility outside the requirements in paragraphs (h) through conducted within the past 12 months, or United States, the recipient facility (m), an importer must provide: medical documentation that the must, before the transfer, submit the (i) A description of the animal act that individual is free of clinically active TB, following to HHS/CDC for approval: includes each NHP. for each trainer and/or handler. (i) A copy of each NHP’s veterinary (ii) Brochures, advertising materials, (ix) A copy of each SOP for medical records, including regular and/or documentation of recent or responding to suspected zoonotic testing for TB from the previous lab for planned animal act performances. diseases. HHS/CDC’s approval. The medical (iii) A current list of all NHPs in the (x) If macaques are in the animal act, record should include a positive animal act, indicating each NHP’s name, an SOP for responding to potential identification of the NHP, such as a species, sex, age, distinguishing herpes B-virus exposures. tattoo, microchip, or photograph. physical description, and unique (p) Zoo-to-zoo transfers. (1) Persons (ii) A copy of a current health identifier such as a tattoo, microchip, or who will only be importing live NHPs certificate(s), including documentation other permanent identifier. into the United States through transfer of a negative TST, signed by a state- (iv) Prior to entry or re-entry into the from one zoo to another must comply licensed veterinarian within 14 days of United States, specific itinerary with with all the elements listed in the transfer stating that the NHP(s) names, dates, flights, times, airports, sea paragraphs (g), (h), (n), (i)(1) through (5), appear healthy and are free from ports, and responsible parties to contact (i)(6)(i), (i)(6)(v), (i)(6)(vi), (i)(7) through communicable diseases; and at every step of travel, including all (9); (j)(1), (j)(2), (j)(5), (j)(10) through (iii) Documentation of the ongoing ground transportation. (12); (k)(5) and (k)(6); and (m)(1), (m)(2), IACUC-approved research project and (v) A description, diagram, and (m)(5), and (m)(6) of this section. the reason the NHP needs to be photographs of the facilities where the (2) If a zoo is importing one or more transported to the U.S. laboratory importer houses the NHPs in the animal NHPs into the United States from facility. act in the United States, including another zoo, the recipient zoo must, (iv) A specific itinerary with names, illustrations of the primate caging and/ before the transfer, submit the following dates, flights, times, airports, seaports, or enclosures; the relationship of these information for approval by HHS/CDC: and responsible parties to contact at cages or enclosures to other structures (i) A copy of each NHP’s veterinary every step of travel, including all on the property and adjoining medical records, including regular ground transportation. properties; whether the primate testing for TB from the previous zoo for (3) Persons importing live NHPs that facilities are open to the air or fully HHS/CDC’s approval. The medical are transferred from one lab to another, enclosed; and the physical security record should include a positive who are not able to meet the measures of the facility. identification of the NHP, such as a requirements listed in paragraphs (vi) Documentation signed by a tattoo, microchip, or photograph. (q)(2)(i), (ii), and (iii) of this section, licensed veterinarian describing the (ii) A copy of a current health must comply with all the elements in physical exam performed on each NHP certificate, including documentation of paragraphs (g), (h), (i), (j), (k), (l), (m), in the animal act. Such examinations a negative TB test, signed by a state and (n) of this section. must be performed at least once a year. licensed veterinarian within 14 days of (r) In transit shipments of NHPs. (1) The physical exam must include the the transfer stating that the NHP(s) Before arrival into the United States, following: appear healthy and are free from brokers of in transit shipments must (A) Routine complete blood counts, communicable diseases; and notify HHS/CDC of all scheduled in clinical chemistries, fecal exams, and (iii) Documentation which verifies transit shipments of NHPs not intended any additional testing indicated by the that the recipient zoo is registered in for import into the United States and physical exam. accordance with this section, and provide the following information:

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(i) Number and species of NHPs in the the notice of revocation, and the and issue a decision that shall constitute shipment; response, and make a decision in final agency action. (ii) Origin of NHPs, including the writing based on the written record. (ii) The product may only be imported country, the exporter, and the exporter’s (4) As soon as practicable after for bona fide scientific, educational, or address; completing the written record review, exhibition purposes. (iii) Name and full address of the final the Director will issue a decision in (iii) A permit will only be issued if destination quarantine facility in the writing that shall constitute final agency the product will be received by a facility importing country; action. The Director will serve the (iv) Means of individually identifying equipped to handle potentially importer with a copy of the written infectious NHP materials. NHPs, if required by the importing decision. country; (iv) The product must comply with (5) The Director may reinstate a any other applicable federal (v) A specific itinerary while in the revoked registration after inspecting the United States including names, dates, requirements, including those relating importer’s facility, examining its to packaging, shipping, and transport of flights, times, airports, seaports, and records, conferring with the importer, responsible parties to contact at every potentially infectious, biohazardous and receiving information and step of travel within the United States, substances as well as those for select assurance from the importer of including all ground transportation; agents pursuant to 42 CFR part 73, 7 (vi) Description of crates; compliance with the requirements of CFR part 331, and 9 CFR part 121. this section. (vii) SOPs describing procedures to (u) Appeal of denial for a permit to (t) Nonhuman primate products. (1) protect and train transport workers from import. If the HHS/CDC denies your NHP products may be imported without exposure to communicable disease request for a permit under this section, obtaining a permit under this section if while handling NHPs; you may appeal that denial to the HHS/ accompanied by documentation (viii) SOPs describing procedures to CDC Director. prevent contamination of other articles demonstrating that the products have (1) You must submit your appeal in and cargo during transit, including been rendered noninfectious using one writing to the HHS/CDC Director, physical separation of crates from other of the following methods: stating the reasons for the appeal and cargo; (i) Boiling in water for an appropriate (ix) SOPs describing procedures to time so as to ensure that any matter demonstrating that there is a genuine decontaminate aircraft, ships, vehicles, other than bone, horns, hooves, claws, and substantial issue of fact in dispute. and related equipment following antlers, or teeth is removed; or (2) You must submit the appeal transport; and (ii) Gamma irradiation at a dose of at within 5 business days after you receive (x) Proposed use, if any, of in transit least 20 kilo Gray at room temperature the denial. holding facilities and steps to be taken (20° C or higher); or (3) HHS/CDC will issue a written to protect workers, as well as NHPs, (iii) Soaking, with agitation, in a 4% response to the appeal, which shall from communicable disease exposure at (w/v) solution of washing soda (sodium constitute final Agency action. each facility to be used en route. carbonate, Na2CO3) maintained at pH (v) Filovirus testing fee. (1) Non- (2) While located in the United States, 11.5 or above for at least 48 hours; or human primate importers shall be in transit shipments must be housed (iv) Soaking, with agitation, in a charged a fee for filovirus testing of non- and cared for in a manner consistent formic acid solution (100 kg salt [NaCl] human primate liver samples submitted with requirements for NHPs intended and 12 kg formic acid per 1,000 liters to the Centers for Disease Control and for import into the United States as water) maintained at below pH 3.0 for Prevention (CDC). specified in paragraphs (j) and (k) of this at least 48 hours; wetting and dressing (2) The fee shall be based on the cost section. agents may be added; of reagents and other materials (s) Revocation and reinstatement of (v) In the case of raw hides, salting for necessary to perform the testing; the use an importer’s registration. (1) If the at least 28 days with sea salt containing of the laboratory testing facility; Director determines that an importer has 2% washing soda (sodium carbonate, irradiation for inactivation of the failed to comply with any applicable Na2CO3); sample; personnel costs associated with provisions of this section, including the (vi) Formalin fixation; or importer’s SOPs, the Director may performance of the laboratory tests; and (vii) Another method approved by administrative costs for test planning, revoke the importer’s registration. HHS/CDC. (2) HHS/CDC will send the importer review of assay results, and (viii) Fully taxidermied products are a notice of revocation stating the dissemination of test results. considered rendered noninfectious, and grounds upon which the proposed (3) An up-to-date fee schedule is revocation is based. so do not require a permit from the available from the Division of Global (i) If the importer wishes to contest Director. Migration & Quarantine, Centers for the revocation, the importer must file a (2) NHP products that have not been Disease Control and Prevention, 1600 written response to the notice within 20 rendered noninfectious are considered Clifton Road, Atlanta, Georgia 30333. calendar days after receiving the notice. to pose a potential human health risk Any changes in the fee schedule will be (A) As part of the response, an and may only be imported under the published in the Federal Register. importer may request that the Director following circumstances: (4) The fee must be paid in U.S. review the written record. (i) The product must be accompanied dollars at the time that the importer (B) If an importer fails to file a by a permit issued by the Director. submits the specimens to HHS/CDC for response within 20 calendar days, all of Requests for permits should be testing. the grounds listed in the proposed accompanied by an explanation of the revocation will be deemed admitted, in product’s intended use and a Dated: February 6, 2013. which case the notice shall constitute description of how the product will be Kathleen Sebelius, final agency action. handled to ensure that it does not pose Secretary, Department of Health and Human (ii) [Reserved] a zoonotic disease threat to humans. Services. (3) If an importer’s response is timely, The Director will review the request for [FR Doc. 2013–03064 Filed 2–14–13; 8:45 am] the Director will review the registration, a permit, and accompanying materials, BILLING CODE 4163–18–P

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