An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM 800.215 

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants 

 

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Guidelines Regarding the Revision to Animal and Plant Health 

Inspection Service (APHIS) Implementing Procedures for the National 

Environmental Policy Act (NEPA)

I. PURPOSE

This memorandum provides guidance to licensees, permittees, and applicants regarding 

the revision to APHIS’ implementing procedures for the NEPA of 1969, as it relates to 

the licensure of veterinary biologicals, specifically viable, replicating, recombinant, 

biotechnology-derived vaccines. The memorandum is not applicable to diagnostic, 

inactivated, allergenic, or antibody products. 

II. BACKGROUND

NEPA requires federal agencies specify which actions entail preparation of an 

environmental impact statement (EIS), preparation of an environmental assessment 

(EA), or are categorically excluded (title 40, Code of Federal Regulations (CFR), part 

1507.3(b)). In 1995, APHIS set out its implementing procedures for NEPA 

(7 CFR 372). Since then, the Center for Veterinary Biologics (CVB) sought NEPA 

compliance for all field safety trials of experimental vaccines that met testing 

requirements and are approaching licensure. In so doing, the CVB evaluated numerous 

live recombinant vaccines for potential significant impact on animals, humans, or the 

physical environment. Many of these vaccines used similar or even identical vectors 

that differ only in the insertion of genetic sequence coding for another pathogen’s 

immunogen. 

To establish the safety of these vaccines, the CVB often sought input from subject 

matter experts to determine whether to consider alternative actions or any mitigations, 

and whether an EA or EIS would be required. In all cases thus far, it was determined 

that EAs were sufficient to evaluate risk, and the CVB issued a finding of no significant 

impact (FONSI). To maintain compliance with NEPA, APHIS announced pending field 

safety trials through publication in the Federal Register to notify the public and provide 

an opportunity to comment on the proposed action. Following publication in the 

Federal Register, APHIS did not reverse any of the FONSIs as a result of public 

comments or concerns not previously addressed and resolved by the CVB. 

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250 for
VETERINARY SERVICES MEMORANDUM NO. 800.215

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 An Equal Opportunity Provider and Employer

On May 24, 2018, APHIS amended the 1995 regulations that set out implementing 

procedures for NEPA, with publication of a Final Rule in the Federal Register. The 

amendments include revision of the categories of actions for which an EIS or an EA might be 

completed, and expansion of the list of potential actions APHIS might grant a categorical 

exclusion from additional environmental evaluation and documentation. These changes 

reflect the new activities, advances, and data accumulated since 1995. By establishing more 

appropriate use of categorical exclusions, APHIS can remove the need to prepare timeconsuming, costly, redundant, and unnecessary NEPA documents, and move vaccines to 

market in a more timely manner.

III. POLICY [or GUIDELINES]

A. NEPA considerations

1. Risk assessment for viable, replicating biotechnology-derived vaccines at the

CVB will continue to include examination of genotypic and phenotypic stability 

in cell culture and target animals, zoonotic potential, changes in tissue tropism, 

shed/spread capabilities, effect of overdosage, recombination potential and 

consequences, and survivability in the environment and in target and non-target 

animals.

2. The biologics firm will submit the appropriate information in its Risk Analysis 

(RA), consisting of Summary Information Format and Risk Assessment

documents. The CVB will conduct a risk review of proposed field trials and 

assess potential effects of the live vaccine on animal safety, public health, and 

the physical environment, consulting with subject matter experts as needed, to 

determine if an EA or EIS is required. The CVB will summarize its conclusions 

regarding whether to categorically exclude a proposed action in a record of 

environmental consideration. If the CVB cannot categorically exclude a 

proposed field safety trial from public notification in the Federal Register, the 

firm will submit an RA with confidential business information redacted. The 

CVB will send the redacted document along with the EA or EIS prepared by the 

CVB and a Notice announcing pending field trials for Federal Register 

publication.

3. Alternately, if the CVB applies a categorical exclusion based on review of the 

RA, the CVB will not submit documents for further agency and departmental 

review, and will not publish a Notice in the Federal Register. In these cases, 

sufficiently similar vaccines have previously been through the Federal Register 

process, comment period, and FONSI determination with satisfactory results. 

Categorical exclusions will be applicable to well-characterized, safe vectors or 

recombinant vaccines that, through prior experience and monitoring, have no 

significant impact on animals, humans, or the physical environment. Curtailing 

the preparation, submission, and review of further documents will provide 
VETERINARY SERVICES MEMORANDUM NO. 800.215

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 An Equal Opportunity Provider and Employer

benefit to APHIS, the public, and biologics manufacturers by saving time and 

resources to bring qualified vaccines to market.

4. When an exception for a categorically excluded action occurs, i.e., a condition 

that suggests a normally excluded action has the potential for a significant 

adverse effect on the environment (7 CFR 372.5), the CVB will determine if that 

circumstance requires further analysis in an EA or EIS. The CVB expects new 

types of live biotechnology-derived vaccines will go through the Federal 

Register process. Even a vector that might otherwise qualify for a categorical 

exclusion may have an exceptional circumstance requiring further assessment. If 

a risk assessment indicates uncertainty regarding vaccine safety or potentially 

hazardous use, an EA or EIS will be prepared for publication. Scientifically 

controversial vaccines may go through the Federal Register process more than 

once if concerns remain.

B. Circumstances under which categorical exclusions may apply

1. Previous data for the same or sufficiently similar vector(s), as determined by the

CVB, has led to licensure of more than one product, following Federal Register 

publication, comment period, and satisfactory field safety trial; and

2. The same biologics firm that previously licensed vaccines using the same or 

sufficiently similar vector(s) is submitting a new recombinant produced by using 

the same or a sufficiently similar manufacturing process, as determined by the

CVB.

a. The new vectored vaccine does not have to be of the same product type, e.g. 

only an influenza vaccine; but changes in species, route of administration, or 

other conditions may be considered an exception that requires the Federal 

Register process be completed. Vaccines using the same vector given across 

multiple species, with demonstrated safety data in the target species, would be 

eligible for consideration for categorical exclusion by the CVB.

b. Different firms using a similar vector may not receive a categorical exclusion 

solely on the basis of exclusions granted to another manufacturer. However, 

following satisfactory technology transfer from the manufacturer that has 

categorical excluded vaccines, as determined by the CVB, another firm using 

the same or similar vector(s) may apply for a categorical exclusion.

IV. IMPLEMENTATION/APPLICABILITY

This policy applies to all viable, recombinant, biotechnology-derived vaccines and is

effective 30 days from the date of this memorandum.