[Federal Register Volume 59, Number 193 (Thursday, October 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24781]


[[Page Unknown]]

[Federal Register: October 6, 1994]


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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