PHS Policy (Public Health Service Policy on Humane Care and Use of Laboratory Animals)

PHS Policy — formally the Public Health Service Policy on Humane Care and Use of Laboratory Animals — is the binding policy administered by NIH’s Office of Laboratory Animal Welfare (OLAW) that governs any live vertebrate animal used in Public Health Service (PHS)-supported research, research training, or testing, including NIH-funded work. It derives its statutory authority from the Health Research Extension Act of 1985 (Pub. L. 99-158, 42 U.S.C. § 289d), and its central operative requirement is that no PHS-supported animal activity may begin until the institution has an Animal Welfare Assurance on file and accepted by OLAW.

What the Assurance requirement actually requires

PHS Policy Section IV.A.1 states that no PHS-conducted or PHS-supported activity involving animals may proceed until the performing institution has provided a written Assurance, acceptable to PHS, setting out how it will comply with the Policy. The Assurance is submitted to OLAW and must be signed by the institution’s Institutional Official; OLAW evaluates it to determine whether the institution’s proposed animal care and use program is adequate, and may approve, disapprove, or negotiate changes with the institution before accepting it. Once accepted, the Assurance is the institution-wide compliance document — it is not filed per grant or per protocol. Section IV.B further requires the institution’s Institutional Animal Care and Use Committee (IACUC) to act as OLAW’s agent for oversight: conducting semiannual program reviews and facility inspections, and reviewing and approving individual animal-use protocols, with reports going to the Institutional Official. PHS Policy also requires institutions to base their animal care and use program on the Guide for the Care and Use of Laboratory Animals (National Research Council, 8th edition) and to comply with the applicable USDA Animal Welfare Regulations (9 CFR Subchapter A) as an “absolute requirement” of the Policy itself — folding AWA compliance in as a floor, not an alternative. Source: olaw.nih.gov/policies-laws/phs-policy.htm.

Distinct from the Animal Welfare Act

PHS Policy and the Animal Welfare Act (AWA) are two separate legal instruments that happen to overlap heavily in practice, not the same rule under two names:

• Legal basis and reach. The AWA (7 U.S.C. §§ 2131–2159) is a general federal statute enforced by USDA/APHIS through inspection, applying to covered facilities regardless of funding source. PHS Policy is a funding-conditioned policy: it binds an institution only because, and for as long as, that institution accepts PHS/NIH support for animal activities. An institution with no PHS funding at all is not reached by PHS Policy, even if it is still reached by the AWA.
• Species coverage. The AWA’s statutory definition of “animal” (7 U.S.C. § 2132(g)) excludes purpose-bred rats of the genus Rattus, purpose-bred mice of the genus Mus, and purpose-bred birds. PHS Policy has no such exclusion — it reaches any live vertebrate animal used in PHS-supported work, which is why a PHS-funded study using purpose-bred laboratory mice still requires IACUC protocol review and falls under an institution’s Assurance, even though those same mice sit outside AWA coverage. See Research Animal for the full comparison of what each framework does and doesn’t reach.
• Enforcement. AWA noncompliance is a USDA/APHIS enforcement matter (inspection citations, license/registration action, civil penalties). PHS Policy noncompliance is an OLAW/NIH funding matter — OLAW can require corrective action, and in serious or unresolved cases can restrict, suspend, or terminate PHS funding to the institution, up to and including revoking the institution’s Assurance.

Distinct from AAALAC accreditation

PHS Policy compliance is sometimes conflated with AAALAC accreditation because both lean on the same reference standard, but they are not interchangeable:

• PHS Policy / OLAW Assurance is mandatory for any institution using PHS/NIH funding for animal work, and is a precondition of that funding — it is not optional and has no accrediting body; OLAW itself reviews and accepts the Assurance.
• AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation is a voluntary, private, peer-reviewed program that many PHS-funded institutions pursue on top of their Assurance, using the same Guide for the Care and Use of Laboratory Animals as its primary accreditation standard. AAALAC accreditation is widely viewed favorably by OLAW and can streamline aspects of program review, but it does not substitute for filing and maintaining an OLAW-accepted Animal Welfare Assurance — an AAALAC-accredited institution receiving PHS funding must still hold its own Assurance.

How this fits with the 3Rs and protocol review

PHS Policy’s IACUC-review requirement is where the 3Rs principle (Replacement, Reduction, Refinement) becomes an operative compliance step rather than an abstract ethical commitment: investigators submitting a protocol under an institution’s PHS Assurance must describe the species and approximate number of animals to be used, justify that number, and describe their consideration of alternatives to procedures likely to cause pain or distress. The IACUC cannot approve the protocol without this analysis.

Examples

• A university submitting its first NIH R01 application involving purpose-bred mice must have an OLAW-accepted Animal Welfare Assurance in place, and IACUC approval of the specific protocol, before any award funds may be used for the animal work — even though those mice are excluded from AWA coverage.
• A contract research organization that is AAALAC-accredited but has never received PHS/NIH funding is not bound by PHS Policy at all; if it later accepts an NIH subaward involving animals, it (or the awardee institution extending coverage to it) must obtain an Assurance before that work can proceed, regardless of its AAALAC status.

Counter-example

A privately funded biotech company running preclinical animal studies entirely on internal or venture funding, with no PHS or NIH support anywhere in the project, is not subject to PHS Policy — it has no Assurance obligation to OLAW. It may still be subject to the AWA (if it uses AWA-covered species) and may still choose to pursue AAALAC accreditation voluntarily, but neither of those substitutes for or triggers a PHS Assurance requirement in the absence of PHS funding.

Related terms

• Animal Welfare Act (AWA) — the separate USDA-enforced statute PHS Policy is often paired with.
• IACUC (Institutional Animal Care and Use Committee) — the committee that carries out PHS Policy’s protocol- and program-review functions at the institutional level.
• Research Animal — how PHS Policy’s vertebrate-animal scope compares with the AWA’s narrower definition, and where the 3Rs framework is discussed in full.
• Guide for the Care and Use of Laboratory Animals — the reference standard PHS Policy requires institutions to base their program on.

For the broader compliance landscape this sits within, see the Research Integrity & Compliance pillar.