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

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]

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