Division of Agricultural Select Agents and Toxins (DASAT) Policy Statement: Personal Quarantine Policy for Specified Veterinary Services (VS) Select Agents

Date: December 3, 2021

Subject: Division of Agricultural Select Agents and Toxins (DASAT) Policy Statement: Personal Quarantine Policy for Specified Veterinary Services (VS) Select Agents

Authority:

DASAT regulates the possession, use, and transfer of biological agents listed in 7 C.F.R. Part 331 and 9 C.F.R. Part 121 that have the potential to pose a severe threat to animal or plant health or animal or plant products (select agents and toxins).

An individual or entity required to register under 9 C.F.R. Part 121 must develop and implement a written biosafety plan that is commensurate with the risk of the select agent, given its intended use (9 C.F.R. § 121.12(a)).  The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent (9 C.F.R. § 121.12(a)).  The referenced biosafety and containment procedures must be sufficient to contain the select agent (e.g., physical structure and features of the entity, and operational and procedural safeguards) (9 C.F.R. § 121.12(b)).

Policy Statement:

It is DASAT policy that the biosafety plan for certain VS select agents listed in 9 C.F.R. § 121.3(b), specifically, African swine fever virus, classical swine fever virus, foot-and-mouth disease virus, highly pathogenic avian influenza virus, rinderpest virus,[a] and virulent Newcastle disease virus include a personal quarantine policy.¹

A personal quarantine policy is designed to restrict personnel from having direct or indirect contact (e.g., a visit to a county fair, a visit to a hog farming operation, or a visit to a free range poultry farm) with susceptible species for a specified time period, known as the quarantine time period.  The quarantine time period should commence after having performed work-related duties with, or in proximity to, the VS select agents mentioned in this policy statement and must be adhered to until the last possible contact by personnel.  The definition of “in proximity to” includes personnel that have entered a room or suite that is approved for work and/or storage for a VS select agent mentioned in this policy except in the following circumstances:

1. BSL4/ABSL4 approved rooms/suites, unless there has been an exposure, or potential exposure to one of the VS select agents mentioned in this policy statement;
2. approved storage only rooms when the VS select agents mentioned in this policy statement remain intact and untouched; or
3. personnel having contact with susceptible species at their entity.

This policy statement does not apply to diagnostic laboratories and other entities that meet the exemption requirements in 9 C.F.R. § 121.5(a) or (b).

Personal quarantines are a component of risk mitigation to protect agriculture from African swine fever virus, classical swine fever virus, foot-and-mouth disease virus, highly pathogenic avian influenza virus, rinderpest virus, and/or virulent Newcastle disease virus.  These VS select agents do not exist outside of laboratories in the United States (i.e., are foreign animal disease agents), are highly contagious, and the most economically damaging VS select agents that impact their respective industries, animal by-products, and trade.   Most animals in the United States are not vaccinated against these agents and are very susceptible to infection from them. If one of these highly infectious agents is introduced into a modern agricultural system, it can rapidly move from one farm to another via the infected animals and/or fomites.­­­­­­­­­

The existence of a personal quarantine policy in the biosafety plan is just one of multiple factors that DASAT will consider in evaluating the adequacy of the biosafety and containment procedures for the aforementioned VS select agents.

It is DASAT policy that a personal quarantine policy for African swine fever virus, classical swine fever virus, foot-and-mouth disease virus, highly pathogenic avian influenza virus, rinderpest virus, and/or virulent Newcastle disease virus adhere to the following conditions:

1. Personnel entering a room or suite approved for work with and/or storage for the VS select agents listed in this policy statement must sign a personal quarantine policy prior to entering;
2. A record of the personal quarantine policy is maintained for a minimum of three years from the date of signing pursuant to the regulations (9 C.F.R. § 121.17(a), (c)) or the duration of the active project necessitating the personal quarantine policy, if that time period exceeds three years;
3. No susceptible species are to be kept at the personal residence of an employee who has signed a personal quarantine policy;
4. The personal quarantine policy be adhered to until the last possible contact by personnel;
5. The personal quarantine policy applies to personnel who perform in vitro and/or in vivo work as well as personnel who come in contact with biological materials (e.g., tissues, cultures, or cells) that have been in contact with a VS select agent mentioned in this policy statement; and
6. The personal quarantine policy contains, at minimum, the quarantine periods stated in Table 1.

[a] Rinderpest virus was declared eradicated in 2011.

Table 1.  Minimum Quarantine Periods

* Cloven-hoofed animals refer to domestic and wild mammalian species that have a hoof split into two toes for weight bearing.  Examples include cattle, buffalo, sheep, goats, pigs, deer, and antelope.

References:

¹See Biosafety in Microbiological and Biomedical Laboratories, 6th Ed., June 2020, Potential Enhancements for BSL-3 and ABSL-3 Facilities for Conducting Work with Pathogens Affecting Agricultural Animals, 427-429.

² See Food & Agriculture Organization of The United Nations, Preparation of African Swine Fever   Contingency Plans, Chapter 2, 2009.

³See The Center for Food Safety Security and Public Health, Iowa State University, Fast Fact Disease Summary, 4/2008.

⁴See World Animal Health Organization (OIE), Technical Disease Card.

⁵See Foreign Animal Diseases, The United States Animal Health Association, 2008, 7th Edition.

⁶See Tiwariexternal icon, A., Patnayakexternal icon, D., Chanderexternal icon, Y., Parsadexternal icon, M., Goyalexternal icon, S. 2006. Survival of Two Avian Respiratory Viruses on Porous and Nonporous Surfaces.  Avian Dis. 50, No. 2:284-287.

⁷See World Animal Health Organization (OIE), Checklist on the Practical Application of Compartmentalisation for Avian Influenza and Newcastle Disease.

⁸See Food & Agriculture Organization of The United Nations, Manual on the Preparation of Rinderpest Contingency Plans, Chapter 2.

⁹See The Center for Food Safety Security and Public Health, Iowa State University, Prevention Practices For Rinderpest.