# Viruses, Serums, Toxins, and Analogous Products; Animal Rabies Vaccines

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-24781

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** October 6, 1994

## Text

DEPARTMENT OF AGRICULTURE
9 CFR Part 102

[Docket No. 91-064-1]

Viruses, Serums, Toxins, and Analogous Products; Animal Rabies
Vaccines

agency: Animal and Plant Health Inspection Service, USDA.

action: Request for data.

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summary: This document announces that the Animal and Plant Health
Inspection Service is requesting additional information to determine
whether the regulations under the Virus-Serum-Toxin Act should be
amended to require that rabies vaccines be distributed and used only by
or under the direct supervision of licensed veterinarians.
The Animal and Plant Health Inspection Service has received
requests from the National Association of State Public Health
Veterinarians to consider proposing such a restriction.

dates: Consideration will be given only to comments received on or
before January 4, 1995.

addresses: Please send an original and three copies of your comments to
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804,
Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please
state that your comments refer to Docket No. 91-064-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and
4:30 p.m., Monday through Friday, except holidays. Persons wishing to
inspect comments are requested to call ahead on (202) 690-2817 to
facilitate entry into the comment reading room.

for further information contact: Dr. Robert B. Miller, Chief Staff
Veterinarian, Veterinary Biologics, BBEP, APHIS, USDA, room 838,
Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-
5863.

supplementary information: The regulations concerning veterinary
biological products in 9 CFR 102.5(e) provide that:

[W]here the Administrator determines that the protection of
domestic animals or the public health, interest, or safety, or both
necessitates restrictions on the use of a product, the product shall
be subject to such additional restrictions as are prescribed on the
license. Such restrictions may include, but are not limited to,
limits on distribution of the product or provisions that the
biological product is restricted to use by veterinarians, or under
the supervision of veterinarians, or both.

The Animal and Plant Health Inspection Service (APHIS) has received
requests from the National Association of State Public Health
Veterinarians (NASPHV) to consider proposing a Federal restriction that
animal rabies vaccines be distributed and used only by or under the
direct supervision of a licensed veterinarian. The NASPHV believes that
a uniform national restriction would result in: (1) proper handling of
animal rabies vaccines to help ensure potency and (2) improved
documentation of animal rabies vaccinations.
APHIS has attempted to identify specific issues that need to be
addressed prior to proposing such restrictions on animal rabies
vaccines. The Agency is seeking data and information on these issues
for consideration before it decides whether or not to proceed with such
a proposal.
In 1979, APHIS published a notice of proposed action (44 FR 54737-
54738, September 21, 1979) to restrict animal rabies vaccines to
distribution and use by or under the direction of a licensed
veterinarian. APHIS received 150 comments in response to that notice of
proposed action. Sixty-six commenters supported the proposed action
without change. Seventy-two commenters were opposed to the proposed
action. At that time, there was a lack of agreement concerning the need
and justification for a Federal restriction. The prevailing opinion of
those opposed to a Federal restriction was that there was a need for
flexibility to meet local needs, especially in rural areas.
Based on the comments received in 1979, the restriction that animal
rabies vaccine be distributed and used by or under the direction of a
veterinarian was not imposed on a nationwide basis. Rather, APHIS
determined that the decision concerning control of distribution and use
of animal rabies vaccines should be made by each State based on what
would work best for a particular State. Thus the current restriction
reads in relevant part that animal rabies vaccines are restricted ``to
authorized recipients designated by proper State officials under such
additional conditions as those authorities may require'' (see 44 FR
18411, March 21, 1980).
At least 34 States currently restrict or have pending legislation
to restrict the distribution and use of animal rabies vaccines. Some
sixteen States do not restrict the distribution and use of animal
rabies vaccines.
The National Association of State Public Health Veterinarians
(NASPHV), the American Veterinary Medical Association (AVMA), and other
organizations including State public health agencies have expressed
concern regarding rabies control programs in various States. They
requested in 1989 that APHIS consider the promulgation of a Federal
restriction on the distribution and use of animal rabies vaccines on a
nationwide basis to protect the health and safety of animals and the
public.
The groups that took an active role in studying the various
problems associated with the control of rabies were the NASPHV
Compendium Committee, the National Centers for Disease Control and
Prevention, the AVMA, State and local veterinary medical associations,
veterinary medical schools, veterinary practitioners, and numerous
State public health agencies.
The NASPHV evaluated the progress of rabies control programs in the
United States. As a result of its study, NASPHV requested that the
Federal Government consider strengthening current restrictions aimed
toward controlling rabies nationwide.
In response to the request from the NASPHV to amend the Federal
restriction on animal rabies vaccines to require that they be
distributed and used only by or under the direct supervision of a
licensed veterinarians, APHIS requested that the NASPHV address four
issues raised by the comments to the 1979 notice of proposed action
concerning restrictions on animal rabies vaccines. Four main points
were cited by commenters opposing the 1979 proposed restriction that
rabies vaccines be distributed and used only by or under the direction
of a veterinarian: (1) There were inadequate veterinary services in
remote rural areas of the United States; (2) a veterinary monopoly on
rabies vaccine would raise the cost of vaccination to unaffordable
amounts (especially for individuals with many animals), resulting in
fewer animals being vaccinated; (3) traveling to and from a veterinary
clinic during business hours (especially for individuals with many
animals) could be very inconvenient and impractical; and (4) APHIS has
no information whether misuse of rabies vaccines by nonveterinarians is
a problem.
In response to the questions which were raised, NASPHV made the
following replies. The local needs of rural areas within the United
States have changed since 1979, and the lack of adequate veterinary
services in rural States is no longer a problem. The veterinary
profession stands ready to accommodate owners of multiple pets. NASPHV
also indicated that in many cases, the cost of a rabies vaccination
from a veterinarian had not kept up with the rising consumer price
index. In addition, the Association stated that the inconvenience of
traveling to and from a veterinary clinic during business hours for
rabies vaccinations was no different than the inconvenience of pet
ownership in general, and that improper vaccination by nonveterinarians
was worse than no vaccination at all because such vaccination gave a
false sense of security.
The NASPHV argued that proper handling of animal rabies vaccines,
including cold storage, physical examination of the animal receiving
vaccine to ensure the health status of the animal, proper timing and
route of administration according to label instructions, and knowledge
of rabies control were essential for effective rabies vaccination.
The NASPHV further argued that in a mobile society such as the
United States, it was unfair and unsafe for the public to rely on so
many different State rabies laws and regulations to protect the public.
The restriction of rabies vaccines at the Federal level would reduce
confusion, unnecessary revaccination, and the necessity for human post-
exposure treatment. Further, as endemic reservoirs of wildlife rabies
continue to spread and put more areas of the United States at risk, the
standardization of rabies control becomes more important. The
Association concluded that the need for proper administration and
improved documentation of animal rabies vaccinations are the most
important issues concerning national rabies prevention in man and
animals.
A case arose in 1986, in which a rabies vaccine manufacturer needed
to follow documentation of rabies vaccinations in order to trace
recipients of its vaccine after a change had been made in the
instructions for administration. Since the particular manufacturer's
vaccine was sold to and administered by veterinarians or State
authorized recipients, in large part, the appropriate records were
available for the tracking and revaccination of thousands of animals.
Public health officials have expressed concern regarding the
uncertainties of vaccine administration and certification when animals
are vaccinated by nonveterinarians or without adequate veterinary
supervision. There is reason to believe that some distributors, in
States without restrictions on vaccine sale or administration, are
distributing rabies vaccines to unauthorized individuals in other
States that currently have such restrictions. This practice destroys
the effectiveness of State programs designed to monitor and verify
vaccine sale and administration in such States and is contrary to their
law. Such practice also creates significant safety concerns since any
failure associated with vaccine administration and documentation
increases the risk of rabies exposure to both animals and man.
Dogs and cats that have properly documented rabies vaccinations and
that are involved in bite cases involving a human being are isolated
and observed for 10 days at a veterinary quarantine facility to confirm
the absence of rabies. When the vaccination record of a dog or cat that
has bitten someone cannot be verified, the animal may be euthanized to
determine if rabies virus is present in brain tissue. In these cases,
the individual who has been bitten and the physician are placed in the
position of weighing the risks and costs of post-exposure prophylactic
treatment against the odds of having been exposed to rabies. Because
the verification of animal rabies vaccination is important in decisions
relating to both animals and man, the Association argued that the issue
of proper documentation of vaccination is a major concern. The fact
that 618 cases of rabies among domestic animals in the United States
(including 155 dogs and 189 cats) were reported to the Centers for
Disease Control and Prevention in 1991 makes an informed choice
important. Because of questions concerning proper vaccine handling,
storage, administration, documentation of vaccination and
revaccination, and recordkeeping, many State public health departments
disregard rabies vaccination claims by owners and only rely on
documentation from a veterinarian as proof of vaccination.
After reviewing NASPHV's request to amend the Federal restriction
on the distribution and use of animal rabies vaccines, APHIS has
determined that it needs additional information to determine the
appropriate course of action with respect to this matter. Before
proceeding with a proposal to amend the Federal restriction on animal
rabies vaccines, the Agency must determine whether such an amendment
would in fact be beneficial, whether rabies control programs and rabies
vaccination could not be better managed by the States and local
jurisdictions, and whether the benefit of Federal control would
outweigh the cost of such a program.
It could be argued that the anticipated benefits from amending the
Federal restriction on animal rabies vaccines to require that they be
distributed and used only by or under the direct supervision of a
licensed veterinarian would be: (1) more uniform regulation of the
distribution and administration of animal rabies vaccines, (2) improved
documentation of animal rabies vaccinations to enable public health
officials to make an informed choice concerning the therapy for animal
bite victims; (3) facilitation of the recall of any unsatisfactory
serials of rabies vaccines, and (4) assurance of the identification of
animals receiving vaccines determined not to meet requirements for
stability or potency.
Currently, it is reported that 98.4 percent of the 25,000,000 doses
of animal rabies vaccine that are distributed in the United States each
year are sold directly to veterinarians. It is not known, however, how
many of these doses are redistributed through catalogs and over the
counter for administration by nonveterinarians.
An estimated 9,000 human beings are treated annually in the United
States for potential exposure to rabid dogs and cats. Post-exposure
human rabies prophylaxis costs an estimated $1,000 per patient. In
1989, the Centers for Disease Control and Prevention recommended that
the most effective methods for reducing human exposure to rabies are
education of the public to avoid unfamiliar, especially wild animals,
and vaccination of pet dogs and cats.

Request for Comments

Since receiving the request from the NASPHV to amend the Federal
restrictions on animal rabies vaccines, APHIS has attempted to identify
specific issues (enumerated below) that need to be addressed before the
Agency can proceed with a notice of proposed rulemaking. Some of these
issues raise questions and identify competing interests that are
difficult to resolve. For example, a Federal restriction that animal
rabies vaccines only be distributed to veterinarians and administered
by or under the direct supervision of a licensed veterinarian could
have the benefit of ensuring proper administration and could also
enable public health officials to certify that a rabies vaccine was
properly administered. An unintended effect of such a restriction,
however, could be a reduction in the number of animals vaccinated with
a corresponding reduction in the effectiveness of rabies prevention by
making it more expensive or impractical to vaccinate multiple animals
in single households, animals in kennels, farm animals, or animals in
metropolitan animal shelters--animals which are often vaccinated by
nonveterinarians. With regard to the issue of proper vaccine
administration, a 1989 study showed that only 5% of rabid cats and 14%
of rabid dogs reported that year had been vaccinated against rabies,
suggesting that rabies incidence in dogs and cats is related more to
the failure to vaccinate than the failure of vaccination. After
considering the various factors involved in rabies control, APHIS
believes that any amended Federal restriction that the Agency may
promulgate should encourage the vaccination of pets while providing the
greatest benefit/cost value. Towards this end, the Agency seeks input
on alternative approaches to the control of animal rabies vaccines. The
experience of States that have enacted their own State restrictions is
sought on these issues.
Public comment is requested to assist APHIS in its evaluation of
the benefits and costs of a Federal restriction providing that animal
rabies vaccines be distributed and used only by or under the direct
supervision of a licensed veterinarian.
In order to obtain a better understanding of the benefits versus
the costs of such a Federal restriction, specific comments,
projections, or data are requested on the following issues:
1. The rate of vaccine misuse and failure when vaccine is
administered by nonveterinarians versus veterinarians;
2. the projected cost versus benefits (e.g. decreased incidence of
animal rabies, better recordkeeping, or fewer human rabies prophylaxes
being sought) of a regulatory requirement that animal rabies vaccines
be distributed and used only by or under the direct supervision of a
licensed veterinarian, based on the experience of States that have
passed such legislation;
3. the number of persons seeking post-exposure rabies prophylaxis
in situations in which a current animal vaccination could not be
confirmed by a veterinarian;
4. information indicating that 98.4 percent of the 25,000,000 doses
of animal rabies vaccines that are distributed in the United States
each year are sold directly to licensed veterinarians only;
5. the number of doses, if any, of animal rabies vaccine that are
distributed or sold to nonveterinarians for administration by
nonveterinarians that are not under the supervision of a veterinarian;
6. the impact of a Federal restriction concerning the distribution
and use of animal rabies vaccines by or under the direct supervision of
a licensed veterinarian on metropolitan animal shelters and other
organizations that currently vaccinate their own animals;
7. the availability of low-cost rabies clinics nationwide and
particularly in rural areas to accommodate those individuals who
currently vaccinate their own animals because of cost;
8. the effect, if any, of such a Federal rabies restriction on
animal rabies vaccines on the number of animals that are vaccinated
based on the experience of States that have passed such restrictions;
and
9. the impact, if any, on the number of companion animals versus
farm animals that are vaccinated, of such a Federal restriction on
animal rabies vaccines; and
10. less restrictive, alternative approaches to animal rabies
control such as a Federal requirement that distribution of animal
rabies vaccines be restricted to licensed veterinarians only; or that
distribution and use of animal rabies vaccines be by or under the
direction of a licensed veterinarian only, or other options.
Factual data supported by verifiable sources (published reports in
peer-reviewed journals, university-sponsored studies, objective
scientific data, etc.) will be given greater weight by the Agency than
anecdotal information in arriving at its decision whether or not to
proceed with a proposed rulemaking. Any projections provided to APHIS
should indicate data sources and the assumptions made in reaching
whatever conclusions obtained.
For those questions for which data are not available, APHIS also
requests comments on the most cost-effective means to obtain such data.

References

Many of the factual statements in this notice are based on the
following references:
1. Eng, T.R., D.B. Fishbein, and the National Study Group on
Rabies, J. Amer. Vet. Med. Assoc. 197: 201-209, (1990).
2. Reid-Sanden. J.B. Dobbins, J.S. Smith, and D.B. Fishbein, J.
Amer. Vet. Med. Assoc. 197: 1571-1583, (1990).

Public Participation

Interested parties are invited to submit comments on these and
other pertinent issues related to the need for a Federal restriction
that animal rabies vaccines be distributed and used only by or under
the direct supervision of a licensed veterinarian. Written comments
should be submitted within the 90-day comment period specified in this
notice under the section entitled ``DATES'' to the person listed under
the section entitled ``ADDRESSES''. All comments received on or before
the close of the comment period will be considered in determining the
appropriate course of action.

Authority: 21 U.S.C. 151-159; 7 CFR 2.17, 2.51, and 371.2(d).

Done in Washington, DC, this 3rd day of October 1994.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-24781 Filed 10-5-94; 8:45am]
BILLING CODE 3410-34-M

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-24781. Public record. Not legal advice.