USDA Covered Species

What makes a species “covered” under the AWA

The Animal Welfare Act (AWA, 7 U.S.C. §2131 et seq.) is the primary US federal law setting minimum standards for the humane care, handling, and treatment of certain animals used in research, teaching, testing, and exhibition. It is enforced by the USDA’s Animal and Plant Health Inspection Service (APHIS), which registers covered research facilities, sets housing and care standards in the Animal Welfare Regulations (9 CFR Parts 1-3), and conducts inspections.

Whether APHIS oversight applies to a given research animal depends entirely on whether that species falls within the AWA’s statutory definition of “animal,” codified at 9 CFR 1.1:

“Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet.”

That single sentence is what makes a species “covered” for AWA purposes — and it is immediately followed, in the same regulatory definition, by a set of explicit exclusions that matter more in practice than the inclusion list.

The exclusions: rats, mice, and birds bred for research

The same 9 CFR 1.1 definition explicitly excludes from “animal”:

• Rats of the genus Rattus bred for use in research
• Mice of the genus Mus bred for use in research
• Birds bred for use in research
• Cold-blooded species (fish, amphibians, reptiles) and invertebrates
• Horses not used for research, and most farm animals used or intended for food, fiber, or production-efficiency research

These exclusions are not an oversight or a loophole created by USDA rulemaking alone — Congress wrote the rat, mouse, and research-bred-bird exclusion directly into the statute via the Farm Security and Rural Investment Act of 2002, which amended the AWA’s definition of “animal.” USDA’s implementing regulation followed in a 2004 final rule (69 FR 31513), which also narrowed a broader pre-existing bird exclusion so that only birds specifically bred for research are excluded (birds acquired from the wild, or bred for other purposes, remain covered).

The practical effect is significant: purpose-bred rats and mice are estimated to make up the large majority of animals used in US biomedical and behavioral research. Because they are excluded from the AWA’s definition of “animal,” a facility using only purpose-bred rats, mice, and research-bred birds has no AWA-driven obligation to register with APHIS, file USDA Form 7023 annual reports, or undergo 9 CFR Part 3 facility inspections for that work — regardless of how large the colony is.

The coverage gap this creates — and why it usually isn’t a compliance gap

This is one of the most commonly misunderstood points in US animal-research compliance: the AWA’s rat/mouse/bird exclusion does not mean that work is unregulated. It means the AWA specifically is not the applicable framework for those species. Two other mechanisms typically fill the gap:

• PHS Policy (the Public Health Service Policy on Humane Care and Use of Laboratory Animals) applies to all live vertebrate animals used in PHS-funded research — including NIH, CDC, FDA, and other Public Health Service agency grants — with no genus-level exclusion for rats, mice, or birds. Any institution receiving PHS funding for animal research must hold an Animal Welfare Assurance with OLAW and maintain IACUC review of that work, following the same Guide for the Care and Use of Laboratory Animals standards the AWA references for covered species.
• Institutional policy and voluntary accreditation (chiefly AAALAC International) commonly extend IACUC review and Guide-based care standards to all vertebrate species an institution uses, regardless of AWA coverage or funding source, as a condition of accreditation or institutional assurance.

So in practice: a purpose-bred mouse colony funded by an NIH grant is excluded from AWA/APHIS oversight but fully subject to PHS Policy, OLAW assurance, and IACUC review. The same colony, if funded entirely by industry or foundation money with no PHS nexus and at an institution without a broader institutional assurance or AAALAC accreditation, could genuinely fall outside both frameworks for that specific work — which is why many research institutions choose to hold an institution-wide Assurance covering all vertebrate species regardless of funding source, closing the gap voluntarily rather than relying on funding-source-by-funding-source coverage.

Covered vs. non-covered species: quick reference

Species / category	AWA-covered (APHIS/9 CFR)?	PHS Policy-covered (if PHS-funded)?
Dogs, cats, non-human primates, guinea pigs, hamsters, rabbits	Yes	Yes
Purpose-bred rats (Rattus) and mice (Mus)	No — statutory exclusion	Yes
Birds bred for research	No — statutory exclusion	Yes
Wild-caught birds, or birds bred for non-research purposes	Yes	Yes
Farm animals (livestock/poultry) used or intended for food, fiber, or production research	No — statutory exclusion	Typically covered by the Ag Guide and institutional/IACUC policy rather than PHS Policy or the AWA
Cold-blooded and invertebrate species (fish, amphibians, reptiles, Drosophila, C. elegans)	No	No — PHS Policy is also limited to vertebrates

Why this distinction matters for research administration

Confusing “not AWA-covered” with “not regulated” is a common and consequential error. For research administrators and IACUC staff, the practical checklist is:

1. Identify the species and confirm whether it meets the AWA’s 9 CFR 1.1 definition of “animal” — if it’s a purpose-bred rat, mouse, or research-bred bird, AWA/APHIS obligations (registration, Form 7023, inspection) do not apply on that basis.
2. Check the funding source: any PHS funding (most commonly NIH) brings the work under PHS Policy regardless of AWA status, requiring OLAW assurance and IACUC review.
3. Check institutional policy and accreditation status: AAALAC-accredited institutions, and many institutions with a broad Animal Welfare Assurance, extend IACUC/Guide-based review to all vertebrate species as a matter of institutional commitment, independent of species-specific federal triggers.
4. For agricultural or production-oriented animal research specifically, consult the Ag Guide (Guide for the Care and Use of Agricultural Animals in Research and Teaching), which is the field-standard reference many IACUCs apply even where neither the AWA nor PHS Policy strictly requires it.

The bottom line: “USDA covered species” is a narrower category than “animals used in regulated research.” Verifying AWA coverage answers only one of several questions a protocol needs answered before an IACUC can determine which standards actually apply.