80 FR 26819 - Viruses, Serums, Toxins, and Analogous Products; Exemptions From Preparation Pursuant to an Unsuspended and Unrevoked License

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 90 (May 11, 2015)

We are amending the Virus-Serum-Toxin Act regulations to require that veterinary biologics prepared under the veterinary practitioner exemption must be prepared at the same facility the veterinarian utilizes in conducting the day-to-day activities associated with his or her practice. This exemption applies to veterinary biologics prepared by a veterinary practitioner solely for administration to animals in the course of a State-licensed professional practice of veterinary medicine under a veterinarian- client-patient relationship. This rule is necessary to ensure that veterinary biologics are not prepared in unlicensed establishments in violation of the Virus-Serum-Toxin Act and to clarify the regulations regarding the preparation of product by a veterinary practitioner under a veterinarian-client-patient relationship.

[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Rules and Regulations]
[Pages 26819-26822]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11311]



========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

========================================================================


Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Rules and 
Regulations

[[Page 26819]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 107

[Docket No. APHIS-2011-0048]
RIN 0579-AD66


Viruses, Serums, Toxins, and Analogous Products; Exemptions From 
Preparation Pursuant to an Unsuspended and Unrevoked License

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the Virus-Serum-Toxin Act regulations to 
require that veterinary biologics prepared under the veterinary 
practitioner exemption must be prepared at the same facility the 
veterinarian utilizes in conducting the day-to-day activities 
associated with his or her practice. This exemption applies to 
veterinary biologics prepared by a veterinary practitioner solely for 
administration to animals in the course of a State-licensed 
professional practice of veterinary medicine under a veterinarian-
client-patient relationship. This rule is necessary to ensure that 
veterinary biologics are not prepared in unlicensed establishments in 
violation of the Virus-Serum-Toxin Act and to clarify the regulations 
regarding the preparation of product by a veterinary practitioner under 
a veterinarian-client-patient relationship.

DATES: Effective July 10, 2015.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Operational Support 
Section, Center for Veterinary Biologics, Policy, Evaluation, and 
Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-
1231; phone (301) 851-3426, fax (301) 734-4314.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in Title 9, Code of Federal Regulations (9 CFR), 
parts 101-118 (referred to below as the regulations) contain provisions 
implementing the Virus-Serum-Toxin Act (the Act), as amended (21 U.S.C. 
151-159). These regulations are administered by the Animal and Plant 
Health Inspection Service (APHIS) of the U.S. Department of Agriculture 
(USDA). The Act prohibits the preparation, sale, and shipment of 
veterinary biological products in or from the United States unless such 
products have been prepared under and in compliance with USDA 
regulations at an establishment holding an unsuspended and unrevoked 
license issued by USDA.
    In part 102 of the regulations, Sec. Sec.  102.1 and 102.2 require 
that each establishment and every person preparing biological products 
subject to the Act must hold an unexpired, unsuspended, and unrevoked 
U.S. Veterinary Biologics Establishment License issued by the 
Administrator and a U.S. Veterinary Biological Product License for each 
product prepared in such establishment. Part 107 of the regulations 
contains exemptions from the requirement for preparation pursuant to 
unsuspended and unrevoked establishment and product licenses. One of 
those exemptions, found in Sec.  107.1(a)(1), allows for product to be 
prepared by a veterinary practitioner solely for administration to 
animals in the course of his or her State-licensed professional 
practice of veterinary medicine under a veterinarian-client-patient 
relationship. The regulations in Sec.  107.1(a)(1) also set forth the 
criteria that must be satisfied in order to establish the existence of 
a veterinarian-client-patient relationship.
    On July 18, 2012, we published in the Federal Register (77 FR 
42195-42197, Docket No. APHIS-2011-0048) a proposal \1\ to amend the 
regulations to require that veterinary biologics prepared under the 
veterinary practitioner exemption be prepared at the same facility the 
veterinarian utilizes in conducting the day-to-day activities 
associated with his or her practice. The proposal was intended to 
ensure that veterinary biologics are not prepared in unlicensed 
establishments in violation of the Virus-Serum-Toxin Act and to clarify 
the regulations regarding the preparation of product by a veterinary 
practitioner under a veterinarian-client-patient relationship.
---------------------------------------------------------------------------

    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0048.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days ending 
September 17, 2012. We reopened and extended the deadline for comments 
until November 16, 2012, in a document published in the Federal 
Register on September 20, 2012 (77 FR 58323, Docket No. APHIS-2011-
0048). We received 55 comments by that date. They were from 
veterinarians and veterinary associations, several State universities, 
pork producers' associations, trade organizations, veterinary biologics 
companies, private laboratories, aquaculture companies, officials from 
the State of Iowa, and individuals. These comments are discussed below 
by topic.
    Some commenters not only supported the proposal but recommended 
that we speed the implementation process along.
    We are finalizing this rule as expeditiously as possible. Given the 
number of comments we received on the proposed rule and the substantive 
nature of most of them, however, we determined that we needed to 
carefully review and evaluate those comments before implementing any 
regulatory changes.
    Several organizations and a number of veterinary practitioners 
raised concerns about what they termed the ``forced relocation'' of 
preparation sites for veterinary biologics to the same facility in 
which the veterinarian conducts day-to-day activities connected with 
his or her practice. Commenters stated that a veterinary practice is an 
environment poorly suited to the aseptic conditions required for 
biologics production and that personnel working in these facilities are 
trained in animal care rather than in specialized laboratory work. 
Several commenters recommended that APHIS revise the rule to require 
that, regardless of the location of the production facility, 
veterinarians that use the facility must document regular involvement 
in the management of the facility, provide such documentation on 
request, and allow regular on-site inspections, presumably by APHIS.

[[Page 26820]]

    APHIS disagrees with the commenters' recommendation. As noted in 
the preamble to the July 2012 proposed rule, the intent of the 
veterinary practitioner exemption in Sec.  107.1(a)(1) is to allow a 
practitioner to prepare exempt biological products at a location not 
licensed under the Act, where the practitioner operates a veterinary 
practice, and to transport such products away from that facility when 
necessary for administration to an animal or animals under a 
veterinarian-client-patient relationship without violating the Act. The 
intention behind the proposed rule was to clarify the relationship 
between the veterinary practitioner and the facility where exempt 
veterinary biological product is prepared. No provision in the Act or 
the regulations allows an unlicensed commercial laboratory, acting as 
the agent for the practitioner, to prepare, produce, sell, and ship the 
veterinary biological product under the exemption in Sec.  107.1(a)(1). 
Such an arrangement would violate the Act. Nothing in this rule or in 
the Act, however, prevents veterinarians from working with 
establishments with a license to produce autogenous products, i.e., 
limited use biologics.
    Commenters expressed concern about how this rule would affect 
practitioners who have offices in multiple locations in which there are 
multiple practitioners. It was stated that changes within the swine 
industry have led many veterinarians to practice in this manner. 
According to the commenters, this rule would potentially require that a 
``brick and mortar'' location for vaccine production would have to be 
the same as the physical location of the veterinarian. In the 
commenters' view, such a requirement could prove problematic for a 
multi-location veterinary practice in which there may only be one 
location suitable for the preparation of exempt veterinary biological 
product. Commenters questioned how we would address the issue of 
multiple locations managed by the same veterinarian or practice even 
though the prescribing veterinarian may not routinely work out of the 
office where the exempt biological product is prepared.
    APHIS acknowledges that it has become a common occurrence in the 
swine industry for swine practitioners to work in multi-veterinarian, 
multi-location corporate practices. Nothing in this rule, however, 
prohibits a veterinarian from producing an exempt biological product in 
any of the locations routinely used in his or her day-to-day practice, 
provided that the other conditions in Sec.  107.1 are met.
    Noting that Sec.  107.1(a)(2) of the proposed rule stated that a 
biological product may be prepared by a veterinary assistant under the 
veterinarian's ``direct supervision,'' some commenters, while generally 
supportive of the rule, requested that we clarify how we define that 
term.
    APHIS interprets ``direct supervision'' to mean that the licensed 
veterinarian is readily available on the premises where the product is 
being prepared and has the responsibility for its preparation by the 
assistant working under his or her direction.
    Some commenters suggested that the emphasis of the rule should be 
redirected away from location of the exempt facilities and toward the 
quality and management of the facilities where the products are 
prepared. It was stated that the rule focuses too much on location and 
not enough on animal health.
    As noted above, the purpose of this rule is to clarify who may 
prepare exempted biological products and where those exempted products 
may be prepared under the regulations. Requirements pertaining to the 
quality and management of veterinary biologics establishments are 
already addressed in 9 CFR part 108.
    Some commenters maintained that unlicensed laboratories should be 
allowed to prepare and ship exempt veterinary biological products on 
behalf of veterinary practitioners, that the rule may hinder innovative 
practices, and that the relationship between the veterinarian and the 
facility should be legal rather than location-based. The commenters 
expressed concern that the rule will restrict veterinarians' access to 
certain customized vaccines that are prepared in specialized settings 
and thus prevent practitioners from responding rapidly to mutating 
viruses. Several commenters cited the case of an Iowa manufacturer, 
which they viewed as an innovative company with expertise in new 
technologies that enabled it to prepare vaccines quickly and 
effectively. The commenters stated that that company's activities may 
be restricted under this rule.
    The purpose of this rule is to clarify the relationship between the 
veterinary practitioner and the facility where exempt veterinary 
biological products are prepared. We do not intend to hinder innovation 
and the development of valuable new technologies, nor do we anticipate 
that this rule will have such an effect. Any manufacturing 
establishment wishing to provide its technology and expertise to 
veterinarians has several licensing options that will allow it to 
market its product. To cite one example, in 2012, APHIS published 
guidelines for obtaining a conditional veterinary biologics license 
using production platform technology. These guidelines, which describe 
the policies and procedures regarding the licensure of product 
platforms based on recombinant technology, can be viewed at http://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_213.pdf.
    Some commenters expressed concerns about how this rule may affect 
minor species, in particular, the aquaculture industry. It was stated 
that the language contained in the proposed rule was too restrictive, 
as it was based on an erroneous assumption of a homogenous type of 
veterinary practice involving mainly major species where there is only 
in-patient or on-the-farm care. Veterinary practitioners in the 
aquaculture industry routinely prepare autogenous vaccines, which may 
be isolated from a particular school of fish. A commenter stated that 
for minor species and minor indications, it is not cost-effective to 
have separate facilities for the preparation of existing exempt 
vaccines and autogenous vaccines. The commenter recommended that, for 
minor species applications, we add a provision to the final rule 
allowing the production of exempt biological products in a veterinary 
establishment that has either full or autogenous licensure to produce 
biologics, provided that the practitioner can demonstrate temporal and 
sanitary separation between exempt and non-exempt products.
    We do not agree that adding such a provision to the regulations is 
necessary. This rule does not affect the preparation of exempt 
veterinary biological product for minor species, such as farmed fish; 
it merely clarifies where such products can be prepared. Veterinarians 
who service minor species will continue to have the options currently 
available to them of preparing an exempt product or working with a 
licensed establishment to produce an autogenous vaccine.
    The July 2012 proposed rule included some additional changes to 
Sec.  107.1. Specifically, we proposed to replace the term 
``establishments'' with ``facilities'' in the introductory text and in 
paragraph (a)(1). One commenter favored retaining the original 
terminology. The commenter stated that ``facilities'' is too narrow a 
term and that, conversely, ``establishments'' correctly reflects many 
of the types of operations that licensed veterinarians are associated 
with (ambulatory, zoos,

[[Page 26821]]

aquarium, fish culture facilities, feedlots, etc.).
    We do not agree with this comment. The reason for the proposed 
change in terminology was to distinguish between manufacturers that 
produce licensed biological products in licensed establishments and 
those that produce exempt veterinary biological products under the 
conditions described in Sec.  107.1. The introductory text of Sec.  
107.1 contains a reference to establishment licenses. Elsewhere in the 
regulations, including Sec.  107.2, only production sites that are not 
exempt from licensing requirements are referred to as establishments. 
Drawing a clear distinction between establishments, where vaccines are 
prepared in accordance with our licensing requirements, and facilities, 
where exempt products are produced, helps to clarify the regulations 
and eliminate possible confusion.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, without 
change.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
on the Regulations.gov Web site (see footnote 1 in this document for a 
link to Regulations.gov) or by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT.
    This final rule amends the regulations in Sec.  107.1 to clarify 
that the preparation of biological products pursuant to the exemption 
in paragraph (a)(1) of that section must take place at the same 
facility that the veterinarian preparing the product utilizes in 
conducting the day-to-day activities associated with his/her State-
licensed professional practice of veterinary medicine.
    The exemption applies to veterinary biologics prepared by a 
veterinary practitioner solely for administration to animals in the 
course of a State-licensed professional practice of veterinary medicine 
under a veterinarian-client-patient relationship. No provision in the 
Act or the regulations allows a veterinary practitioner to take 
advantage of the licensing exemption while at the same time consigning 
the actual preparation of the product to a commercial laboratory or 
other manufacturing establishment which would then exchange or deliver 
the product to a third party.
    The Regulatory Flexibility Act requires agencies to consider 
whether a rule will have a significant economic impact on a substantial 
number of small entities.
    Some commenters on the July 2012 proposed rule expressed concerns 
that the rule would adversely affect how veterinary practitioners 
conduct day-to-day activities connected with their practices, prevent 
veterinarians from working with commercial labs or manufacturing 
facilities in preparing vaccines, and hinder the development of 
innovative practices.
    For the most part, there should be little or no effect on 
veterinary practitioners. Veterinary practitioners who are in 
compliance with the regulations do not need to alter the way they 
conduct their veterinarian-client-patient relationships. This final 
rule will not change the nature of the exemption, the number of 
veterinary practitioners eligible to take advantage of the exemption, 
or the criteria that must be satisfied in order to establish the 
existence of a veterinarian-client-patient relationship. Also, this 
final rule will not add any additional reporting or recordkeeping 
burden.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. It is not intended to have retroactive effect. 
This rule will not preempt any State or local laws, regulations, or 
policies where they are necessary to address local disease conditions 
or eradication programs. However, where safety, efficacy, purity, and 
potency of biological products are concerned, it is the Agency's intent 
to occupy the field. This includes, but is not limited to, the 
regulation of labeling. Under the Act, Congress clearly intended that 
there be national uniformity in the regulation of these products. There 
are no administrative proceedings which must be exhausted prior to a 
judicial challenge to the regulations under this rule.

Paperwork Reduction Act

    This final rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 107

    Animal biologics, Reporting and recordkeeping requirements.

    Accordingly, we are amending 9 CFR part 107 as follows:

PART 107--EXEMPTIONS FROM PREPARATION PURSUANT TO AN UNSUSPENDED 
AND UNREVOKED LICENSE

0
1. The authority citation for part 107 continues to read as follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.


0
2. Section 107.1 is amended as follows:
0
a. In the introductory text of the section and in paragraph (a)(1), 
introductory text, by removing the word ``establishments'' both times 
it appears and adding the word ``facilities'' in its place; and
0
b. By redesignating paragraph (a)(2) as paragraph (a)(3) and adding a 
new paragraph (a)(2).
    The addition reads as follows:


Sec.  107.1  Veterinary practitioners and animal owners.

* * * * *
    (a) * * *
    (2) All steps in the preparation of product being prepared under 
the exemption in paragraph (a)(1) of this section must be performed at 
the facilities that the veterinarian utilizes for the day-to-day 
activities associated with the treatment of animals in the course of 
his/her State-licensed professional practice of veterinary medicine. A 
veterinary assistant employed by the veterinary practitioner and 
working at the veterinary practice's facility under the veterinarian's 
direct supervision may perform the steps in the preparation of product. 
Such preparation may not be consigned to any other party or sub-
contracted to a commercial laboratory/manufacturing facility.
* * * * *


[[Page 26822]]


    Done in Washington, DC, this 6th day of May 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-11311 Filed 5-8-15; 8:45 am]
 BILLING CODE 3410-34-P