TIPS TO AVOID REPORTING ERRORS

You may be required to provide explanations for certain entries in your Annual Report. You must attach these to your Annual Report. This 

sheet provides useful guidance on attachments related to Column “E” explanations.

General Tips: For teaching activities involving veterinary students 

or veterinary technology students: — DO NOT report the use of laboratory rats

and mice (genera Rattus and Mus) bred for use +

in research, reptiles, or fish or other animals

which are exempt from the regulation under

the Animal Welfare Act (AWA).

— DO NOT include animal patients participating

in clinical trials in the context of medical care

under a veterinary client relationship.

— DO NOT include any birds in your 

Annual Report.

DO remember that reporting may be 

retrospective or prospective. Retrospective 

reporting involves collecting data on individual 

animals to put each study animal into the most 

appropriate category based on clinical signs of 

pain and distress. While more labor intensive, 

this method generally produces more accurate 

reporting. Prospective reporting means that all 

animals used for a particular activity may be 

categorized in the highest applicable pain 

category. This method is less labor intensive 

but may result in over-reporting.

— DO NOT include client-owned or shelter 

animals at spay-neuter clinics that are used 

only in the context of a veterinary client 

patient relationship.

— DO NOT include animals on working farms

used for teaching husbandry procedures at the 

farm location.

— DO NOT include animals used in a field study 

as defined under the AWA regulations. A field 

study is defined as “a study conducted on 

free-living wild animals in their natural habitat. 

However, this term excludes any study that 

involves an invasive procedure, harms, or 

materially alters the behavior of an animal 

under study.” The IACUC makes the 

determination for the research facility of 

whether an activity meets this definition.

— DO NOT report animals that a facility holds 

outside the United States, or Territories or 

Commonwealths of the United States.

Useful guidance for Column E categories 

is available in chapter 7 of the Animal 

Welfare Inspection Guide in sections

7.5.3 (Annual Report) and 7.2.4.1

(Painful/Distressful Procedures).

Help is also available via the Annual 

Report hotline at (970) 494-7477 or 

by email AnimalCare@usda.gov.

The Animal Welfare Inspection Guide 

can be found on our website at 

https://www.aphis.usda.gov/ani

mal_welfare/downloads/AnimalCare-Inspection-Guide.pdf

If you have listed any animals in Column E, you will be required to submit an

attachment with an explanation of the procedure.

Explain any procedures causing more than slight or momentarypain

or distress.

ATTACHMENTS TO EXPLAIN COLUMN “E” ENTRIES

The reasons pain and distress could not be relieved should be science-based 

and described clearly in plain terms. You may wish to briefly describe 

procedures that limit pain or distress in Column E animals for context.

If pain or distress could not be relieved due to regulatory requirements, 

list the agency, the code of Federal Regulations (CFR) title number

and the specific section number (e.g., APHIS, 9 CFR 113.102). If the 

requirement is in accordance with a guidance document, such as an 

agency notice or harmonization guideline, please provide sufficient 

information to identify the cited document.

Make sure the number of animals in the attached explanations matches 

the numbers reported in Column E for items 4-13. If they differ, you will 

receive a letter requesting clarification.

Please provide all explanations in Freedom of Information Act (FOIA)

-ready form or call FOIA at: (301) 851-4102. Please see the attached

form and information included in this packet.

When submitting online, you will be able to upload attachments in the

system.

The explanation should be brief, explained in plain terms, and focus on what 

the animal experienced (for example: seizures, neurologic signs, inappetence, 

lethargy, gastrointestinal distress, etc.). DO NOT include any protocols, 

IACUC or Meeting notes.

QUESTIONS ON SPECIFIC SITUATIONS?

DO NOT REPORT NONREGULATED ANIMALS

TIPS ON ANNUAL REPORT ATTACHMENTS

(COLUMN “E” EXPLANATIONS)

Tips for Attachments of Column E Explanations

1. The Annual Report is posted on the USDA website.

Therefore, because protocols, proprietary information,

personally identifiable information, and other confidential

information is not required as a part of your Annual Report,

you are highly encouraged to use form 7023B found within

this packet to address the regulatory requirements of the

Animal Welfare Act. 

2. Explanations should be clear, brief descriptions of what the

animals experienced, such as lethargy, inappetence,

gastrointestinal disturbances, seizures, neurologic signs,

etc. 

3. Use of bullet point format is acceptable

4. It is recommended that a statement be included that the

IACUC approved this Column E activity, although citing the

protocol number is not recommended.

5. Please indicate if husbandry methods, humane end points,

or other methods are used to minimize the pain or distress

that animals experience. 

6. Ensure that the same common name and/or species name

is listed in your explanation and on form 7023.
WHAT TO REPORT WHAT NOT TO REPORT

Exceptions TO REPORT on the Annual Report should be 

noted as IACUC-approved on the report and include:

+ Exceptions approved by the IACUC under 9 C.F.R. § 2.38(k) 

that are not provided for under the AWA regulations and 

standards, such as:

+ Removal of resting platforms from cat enclosures

+ Extension of interval for cleaning/sanitization of enclosures

+ Keeping animals in 24 hour dark cycle

+ Keeping animals in temperatures outside range described 

in the AWA standards for the relevant species

+ Exceptions approved by Animal Care, such as:

+ Approval for use of an animal in more than one major operative

procedure from which it is allowed to recover on more than one

protocol (9 C.F.R. § 2.31(d)(1)(x)(C))

+ Exception to the health certificate requirements (9 C.F.R. §

2.38(h)(2))

+ Temporary tethering of dogs used as the primary enclosure

Exceptions that should NOT be reported on the Annual 

Report include:

— Exceptions approved by the IACUC that are provided for under 

the AWA regulations and standards, such as:

– Approval for use of an animal in more than one major operative 

procedure from which it is allowed to recover on one protocol (9 

C.F.R. § 2.31(d)(1)(x)(A))

– Short term withholding of food and water from animals (9 C.F.R.

§ 2.38(f)(2)(ii))

– Exemption of an individual non-human primate from some or all 

of the environmental enhancement plan (9 C.F.R. § 3.81(e)(2))

– Any deviation from the methods of euthanasia as defined in the 

AWA regulations which were justified for scientific reasons, in 

writing, by the investigator (9 C.F.R. § 2.3 l(d)(1)(xi))

— Exceptions approved by a veterinarian as part of the provision 

of veterinary care, such as:

– Animal is fasted for surgery conducted for husbandry reasons

– Any major operative procedures for medical or colony

management purposes (9 C.F.R. § 2.31(d)(1)(x)(B))

– Animals housed in an enclosure that does not meet space 

requirements for medical reasons while recovering from 

husbandry or veterinary care related surgery

– An animal that develops vomiting/diarrhea (not study-related) 

and veterinarian prescribes IV fluids and severely restricts food 

and water intake by mouth for several days

Ensure that attachments include a brief description of the exception, species 

(use common names), and the number of animals affected for the reporting year 

only (October 1, 2020 through September 30, 2021).

Review the information below on “What to Report” and “What Not to Report”. If

you have any Exceptions to report, follow the guidance in this checklist.

EXCEPTION ATTACHMENTS

» Exceptions or exemptions to a particular AWA regulation or standard that are 

approved by the IACUC must be for scientific reasons and justified in writing.

» If a regulation or standard also provides specific parameters for an exception or 

exemption, those parameters must be followed.

Check your numbers! If the numbers of animals listed in an Exception exceed the 

totals used in research for that species, you will receive a letter requesting

clarification.

Please provide all Exceptions in FOIA-ready form or call FOIA at: (301) 851-4102. 

More information is included in this packet.

You may be required to provide explanations along with your Annual Report. You must attach these to your Annual Report. This sheet 

provides useful guidance on attachments related to Exceptions.

Useful guidance for Column E categories 

is available in chapter 7 of the Animal 

Welfare Inspection Guide in sections

7.5.3 (Annual Report) and 7.2.4.1

(Painful/Distressful Procedures).

Help is also available via the Annual 

Report hotline at (970) 494-7477 or 

by email at AnimalCare@usda.gov

QUESTIONS ON SPECIFIC SITUATIONS?

TIPS ON ANNUAL REPORT ATTACHMENTS

(EXCEPTIONS)

(9 C.F.R. § 3.6(c)(4))

Tips for Attachments of Column E Exceptions

• The exceptions should be a brief summary that is 

readily understood by a lay person. 

• Use of bullet point format is acceptable

• Basic information to include for the exception should 

be the same common name and/or species name as 

documented on form 7023, number of animals 

affected, what the exception is, and why the 

exception was required.

• It is recommended that a statement be included that 

the IACUC approved this exception, although citing 

the protocol number is not recommended.