Reporting Illness and Screening Test Results in Nonhuman Primates Imported under 42 CFR § 71.53

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Date: January 20, 2023

Subject

CDC policy statement: Reporting illness and screening test results in nonhuman primates imported under 42 CFR § 71.53

The Centers for Disease Control and Prevention’s (CDC) Division of Global Migration Health (DGMH), among other activities, administers regulations governing the importation of nonhuman primates (NHPs) into the United States.

Authority

Under the authority of section 361 of the Public Health Service Act (42 U.S.C. § 264), the Secretary of Health and Human Services is authorized to make and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States and from one U.S. state or territory into any other U.S. state or territory. Federal quarantine regulations (42 CFR § 71.53) restrict the importation of NHPs into the United States. Under these regulations, importers of NHPs must register with CDC, implement infection control measures, and report specific health events to CDC during quarantine. They may only import and distribute NHPs for bona fide scientific, educational, or exhibition purposes, as defined in the regulations.

Policy statement

This policy statement provides clarification of the regulatory requirements for reporting nonhuman primate (NHP) illness and elective screening test results during the CDC-mandated quarantine period.  Under 42 CFR § 71.53, importers of NHPs must monitor NHPs for signs of zoonotic illness, ensure appropriate testing and treatment, and report specific health events to CDC during quarantine.

NHP Illness

Any zoonotic illness of potential public health importance in a NHP must be reported to CDC within 24 hours. When illness occurs during the CDC-mandated quarantine period, the entire shipment will not be released from quarantine until diseases of potential public health importance have been ruled out and an entry to that effect is made in the record. Importers must not knowingly request a quarantine release from CDC of any ill NHP.

Reportable signs of zoonotic illness in NHPs during quarantine include, but are not limited to:

  • Diarrhea (with or without the presence of blood) suspected or confirmed to be due to infectious/zoonotic etiology
  • Coughing
  • Unexplained weight loss
  • Palpable abdominal mass
  • Abscessed tissue
  • Hemorrhage
  • Rash
  • Jaundice
  • Anemia
  • Splenomegaly
  • Fever

Screening Tests

Other than tuberculosis, CDC does not currently require screening tests to be performed in apparently healthy NHPs during the CDC-mandated quarantine period. If importers choose to screen apparently healthy animals for zoonotic infections in addition to tuberculosis during the quarantine period, positive results must be reported to CDC within 24 hours. This includes, but is not limited to:

  • Positive fecal/rectal bacterial cultures (e.g., Shigella, Salmonella, Yersinia, Campylobacter)
  • Positive Plasmodium screening tests (e.g., PCR, blood smears) [1]
  • Diagnostic evidence of zoonotic gastrointestinal parasites
  • Serological evidence of infection with zoonotic viruses (e.g., filoviruses, retroviruses, B virus)

When CDC receives notification of positive screening test results, additional measures to prevent the spread of zoonotic disease may be required before releasing a shipment from quarantine, including examination, additional diagnostic procedures, extended quarantine, and treatment.

CDC-registered NHP importers should provide notification of illness and positive screening tests in writing to CDC by emailing NHPImporters@cdc.gov. Please direct any questions regarding this policy statement to NHPImporters@cdc.gov.

[1] See Treatment of Plasmodium infection in nonhuman primates (NHPs) imported under 42 CFR § 71.53 for clarification on CDC requirements for asymptomatic NHPs having positive Plasmodium screening test during the CDC-mandated quarantine period.

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