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Department of Health and Human Services 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 VerDate Mar<15>2010 19:42 Feb 14, 2013 Jkt 229001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\15FER5.SGM 15FER5 TKELLEY on DSK3SPTVN1PROD with RULES5 11522 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 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 VerDate Mar<15>2010 19:42 Feb 14, 2013 Jkt 229001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\15FER5.SGM 15FER5 TKELLEY on DSK3SPTVN1PROD with RULES5 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 11523 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
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