[Federal Register Volume 61, Number 197 (Wednesday, October 9, 1996)]
[Rules and Regulations]
[Pages 52871-52875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25931]



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  Federal Register / Vol. 61, No. 197 / Wednesday, October 9, 1996 / 
Rules and Regulations  

[[Page 52871]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 102, 104, 105, and 116

[Docket No. 93-072-2]


Viruses, Serums, Toxins, and Analogous Products; Licenses, 
Inspections, Records, and Reports

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the regulations under the Virus-Serum-Toxin 
Act to clarify certain provisions concerning licenses, inspections, 
records, and reports. The effect of the rule is to ensure that 
licensees are aware of the fact that licenses are issued on the 
condition that the licensee permit inspection of establishments, 
products, and records, and that a licensee must have at least one 
product license in order to maintain a valid establishment license. 
Failure to permit inspection will make the license subject to 
suspension or revocation. We are also amending the regulations to 
specify the types of records and reports that must be available for 
inspection including records describing product development and 
preparation and market suspensions and recalls. Finally, we are 
amending the regulations to require that APHIS receive notification 
immediately if there are indications which raise questions regarding 
purity, safety, potency, or efficacy of a product, or if it appears 
there may be a problem regarding the preparation, testing, or 
distribution of a product. The rule is necessary to clarify and 
simplify certain provisions of the regulations and to describe required 
records with greater specificity.

EFFECTIVE DATE: November 8, 1996.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy 
Director, Veterinary Biologics, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737 1237; 301-734-8245.

SUPPLEMENTARY INFORMATION:

Background

    The Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151-159, hereinafter 
the Act), as amended, is intended to ensure that veterinary biological 
products shipped in or from the United States are not worthless, 
contaminated, dangerous, or harmful. To achieve that purpose, the Act 
requires that such products be prepared in compliance with USDA 
regulations at an establishment holding an unsuspended and unrevoked 
USDA establishment license. No products may be imported into the United 
States without a permit issued by the Administrator. Provisions 
regarding veterinary biological product licenses, license suspensions, 
and inspections appear in the regulations at 9 CFR parts 102, 105, and 
116.
    On March 6, 1995, we published in the Federal Register (60 FR 
12159-12162, Docket No. 93-072-1) a proposal to amend parts 102, 104, 
105, and 116. We proposed to amend the regulations to clarify that 
licenses are issued on the condition that the licensee permit 
inspection of establishments, products, and records, and that a 
licensee must have at least one product license in order to maintain a 
valid establishment license. Failure to permit inspection will make the 
license subject to suspension or revocation. We also proposed to amend 
the regulations to broaden the scope of records and reports to include 
records describing product development and preparation, market 
suspensions, and recalls, which must be available for inspection. 
Finally, we proposed to amend the regulations to require that APHIS be 
notified immediately if there are indications which raise questions 
regarding purity, safety, potency, or efficacy of products, or if a 
biological product appears to be unsatisfactory or is found to have 
been prepared, tested, or distributed in violation of the Act and 
regulations. The rule is necessary to clarify and simplify certain 
provisions of the regulations.
    We solicited comments concerning our proposal for 60 days ending 
May 5, 1995. We received nine comments by that date. They were from 
biologics producers, a biologics consultant, and a national trade 
association. We carefully considered all of the comments we received. 
They are discussed below.
    One commenter expressed general approval of the rule as proposed. 
The commenter, however, requested definitions of ``raw data,'' ``data 
collection,'' ``method for changing raw data,'' and ``manufacturing 
records'' under proposed Sec. 105.1 and ``unsatisfactory'' and 
``immediately'' under proposed Sec. 116.5(b).
    In response to this comment, APHIS notes that the terms ``raw 
data,'' ``data collection,'' ``methods for changing raw data,'' and 
``manufacturing records'' were not included in the proposed rule. 
Therefore, APHIS believes that it would be inappropriate for the agency 
to define these terms. APHIS believes that the use of the phrase ``to 
be unsatisfactory'' is redundant with the phrase ``to have been 
prepared, tested, or distributed in violation of the VSTA and 
regulations'' which appears in the same sentence and has therefore 
deleted it from the regulations to improve clarity and avoid confusion 
as to its meaning when used in this context. Similarly, APHIS is 
removing the reference to violation of the Act or regulations and 
changing the language regarding preparation, testing, and distribution 
to more accurately reflect the intent of paragraph (b) of Sec. 116.5. 
The term ``immediately'' is self-explanatory in that notification 
should occur without delay at the time a question regarding product 
purity, safety, potency, or efficacy is raised. Therefore, APHIS is not 
adding definitions of these terms in response to this comment.
    One commenter requested that the rule for license termination after 
5 years of inactivity be withdrawn and replaced with a provision for 
recertification of the master seed to save the expense of relicensure. 
The commenter explained that there are situations in which a vaccine 
for which there has been no need suddenly comes into demand because of 
a disease condition. The example presented was an erysipelothrix 
vaccine in turkeys, the need for which is apparently resurfacing after 
a lapse of 10 years. Other examples of resurfacing vaccines were given, 
including variant chicken pox in the midwest and California, and 
Newcastle Disease Bronchitis Vaccine B1 Type B1 Strain. The 
commenter indicated that the latter vaccine has not been made for

[[Page 52872]]

17 years, but now has a significant international market.
    In response to this commenter, the current regulation provides for 
the producer to show intent to resume production within 6 months of 
notification or have the product license or permit terminated. APHIS 
proposed to amend the regulation to provide the opportunity for the 
producer to resume production within 6 months of notification or 
``within a mutually agreeable period'' should the producer have 
evidence that the vaccine might be needed in the near future. The 
proposed amendment allows the licensee to present a case to support a 
mutually agreeable period of longer than 6 months before production is 
resumed, if desired. If production is not resumed, the product license 
would be terminated without prejudice and could be reissued at a later 
date if master seed and master stocks are maintained and a market 
develops for the product. The original Outline of Production and 
licensing data could be resubmitted to support such applications and 
should only require updating to meet new licensing requirements not 
addressed when the product was originally licensed. The license 
applicant should consult with APHIS for guidance prior to applying for 
reissuance of such licenses. APHIS does not believe that a product 
license should be maintained when no product is produced or no 
establishment is maintained to support continuation of licensure. No 
change to the regulations is made in response to this comment.
    One commenter felt that the language in Sec. 116.1 lacked 
specificity. Another commenter stated that the types of records 
required for product development and manufacture should be specified. 
In response to these commenters, APHIS notes that the proposed 
amendment to Sec. 116.1 adds permittees under the regulations and 
specifies the types of records that are to be maintained at the 
permittees place of business. No change to the regulations is made in 
response to these commenters.
    Eight commenters raised concerns about the lack of clear criteria 
in the proposal for the reporting of production data and consumer 
complaints. One of the commenters raised the issue of how the firms' 
submissions of consumer reports will be handled under the Freedom of 
Information Act (FOIA). Another commenter indicated that many consumer 
reports may deal with problems related to consumer misuse that is 
beyond the control of the manufacturer. Consumer reports relevant to 
this regulation would only be those where there is a valid product-
related complaint. The commenter also inquired into how complaints will 
be resolved by the agency and what the relationship was between 
consumer reports and the agency's proposed post-licensing monitoring 
program. One commenter stated that records related to consumer reports 
are already available for inspection at licensed establishments and 
questioned whether the submission of additional reports was necessary. 
Finally, several commenters suggested that the additional reporting 
requirements would increase the level of paperwork required of both 
APHIS and the manufacturer. These commenters expressed general concerns 
about the need to reduce paperwork submissions in order to reduce 
agency burden and to facilitate agency review of and response to 
license applications.
    In response to these comments, APHIS believes that its intent with 
regard to reporting of certain consumer complaint reports was 
misunderstood. The proposed rule was not intended to require the 
implementation of a comprehensive postlicensing monitoring program but 
was only intended to ensure that licensees inform APHIS when it appears 
that a licensed product that has been released for marketing is 
involved in an unusually high number of consumer complaints or appears 
or has been found to be in violation of the Act or regulations. 
Informing APHIS under such situations provides an early warning of 
possible emerging product-related problems and ensures prompt action if 
there is a problem. Open communication between licensees and APHIS is 
essential for accurate responses to consumer inquiries and a rapid 
resolution of such situations. In response to the comment regarding 
access to consumer complaints under FOIA, all confidential business 
information would be protected. APHIS is currently working on 
regulations regarding FOIA requests related to the monitoring of 
products.
    Based on the comments, APHIS is revising proposed Sec. 116.5 
concerning the submission of consumer reports with a more general 
statement to clarify our intent that APHIS be notified when there are 
indications which raise questions regarding the purity, safety, 
potency, or efficacy of a product, or if it appears that there may be a 
problem regarding the preparation, testing, or distribution of a 
product.
    Some examples of when APHIS should be informed include when there 
are product-related data, information, or reports to show that a serial 
is contaminated, that use of a product is associated with a high 
incidence of adverse reactions, or that a product is associated with 
the failure to protect against disease. It would be necessary to 
provide available information describing circumstances surrounding 
these situations such as contributory factors and plausible options to 
help resolve the problem. Other examples of such circumstances when 
notification would be warranted are when consumer reports suggest that 
the use of a product may pose a risk to the public health, interest, or 
safety.
    APHIS is removing the reference to consumer reports from paragraph 
(b) of Sec. 116.5 of the proposed rule by removing the phrase 
``consumer reports concerning the use of products'' and substituting 
the phrase ``there are indications which.'' This revision is intended 
to remove concerns about the reporting of all claims, including those 
which might be considered frivolous or invalid. The reference to 
``immediately report'' has also been revised to read ``immediately 
notify APHIS concerning'' to provide greater flexibility in the manner 
in which information is provided to APHIS including telephone, E-mail, 
facsimile, or letter rather than by ``report'' which suggests a more 
formal communication. We have included in the regulations for 
convenience purposes the addresses and phone numbers for these 
alternative methods of notification. These changes should make it clear 
that this rule codifies current program practice and does not result in 
a net increase of the paperwork burden imposed on the manufacturer and 
the agency.
    One commenter objected to use of the term, ``When requested by the 
Administrator,'' in Sec. 116.5, paragraph (a). The same commenter 
believed that APHIS should define the rationale for submission more 
specifically. Another commenter objected to the use of terms, 
``complete information'' and ``including but not limited to'' for being 
ambiguous.
    In response to these comments, APHIS notes that these terms are 
currently used in the regulations in part 116 without further 
definition. In addition, APHIS believes that the rationale of proposed 
Sec. 116.5, paragraph (a), is not intended to be significantly 
different from that of current Secs. 116.1 and 116.5. These regulations 
were last amended in 1974 (39 FR 16853-16873, Docket No. 74-10880, May 
10, 1974). Current Sec. 116.1 reads in relevant part as follows:

    Each licensee * * * shall maintain detailed records of 
information necessary to give a complete accounting of the 
activities within each establishment. Such activities shall include, 
but shall not be limited to the items enumerated in this part.

[[Page 52873]]

    (a) Records shall be made concurrently with the performance of 
successive steps in the preparation of a biological product. Such 
records shall include the date and where critical, the time that 
each essential step was taken, the identity and quantity of 
ingredients added or removed at each step, and any loss or gain from 
start to finish in such preparation.

    Current Sec. 116.5 reads in relevant part as follows:

    When required by the Administrator, reports containing accurate 
information of production activities in each establishment * * * 
shall be prepared and forwarded to APHIS. Records necessary to make 
such reports shall be maintained in each establishment.

    The proposed amendment to Sec. 116.5, paragraph (a), merely 
specifies in greater detail the type of information that should be 
maintained or submitted to APHIS. As a commenter stated previously, 
licensed establishments already make available records of consumer 
reports for inspection. Therefore, much, if not all, of this 
information should already be available or should already have been 
made available to APHIS. No change to the regulations is made in 
response to these comments.
    Based on the rationale set forth in the proposed rule and in this 
document, we are adopting the provisions of the proposal as a final 
rule, with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    The rule amends the regulations in 9 CFR parts 102, 104, 105, and 
116 to clarify existing provisions concerning licenses, inspections, 
records, and reports. Licenses are issued on condition that the 
licensee permit inspection of establishments, products, and records. 
The rule provides that the failure to permit such inspection will make 
the license subject to suspension or revocation. In order to hold a 
valid establishment license, licensees are required to have at least 
one unexpired, unsuspended, and unrevoked product license. Otherwise, 
the establishment license will be invalid. We are also making 
amendments concerning the content of records and reports and the 
availability of their inspection.
    The rule will make clear and unambiguous certain regulatory 
provisions. No new requirements are added in the rule. Therefore, no 
adverse economic impact is anticipated to result from the rule.
    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 would not preempt any State or local laws, regulations, or 
policies, unless they present an irreconcilable conflict with this 
rule. There are no administrative procedures which must be exhausted 
prior to a judicial challenge to the provisions of this rule.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB), and there are no new requirements. The assigned OMB 
control number is 0579-0013.

Regulatory Reform

    This action is part of the President's Regulatory Reform 
Initiative, which, among other things, directs agencies to remove 
obsolete and unnecessary regulations and to find less burdensome ways 
to achieve regulatory goals.

List of Subjects

9 CFR Part 102

    Animal biologics, Reporting and recordkeeping requirements.

9 CFR Part 104

    Animal biologics, Imports, Reporting and recordkeeping 
requirements, Transportation.

9 CFR Part 105

    Animal biologics.

9 CFR Part 116

    Animal biologics, Reporting and recordkeeping requirements.

    Accordingly, 9 CFR parts 102, 104, 105, and 116 are amended as 
follows:

PART 102--LICENSES FOR BIOLOGICAL PRODUCTS

    1. The authority citation for part 102 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    2. In Sec. 102.2, the text is designated as paragraph (a) and a new 
paragraph (b) is added to read as follows:


Sec. 102.2   Licenses required.

* * * * *
    (b) An applicant who applies for an establishment license must also 
apply for at least one product license. An establishment license will 
not be issued without a license authorizing the production of a 
biological product in the establishment.
    3. In Sec. 102.4, paragraph (f) is revised, paragraph (g) is 
redesignated as paragraph (h), and new paragraph (g) is added to read 
as follows:


Sec. 102.4   U.S. Veterinary Biologics Establishment License.

* * * * *
    (f) When a licensee no longer holds at least one unexpired, 
unsuspended, or unrevoked product license authorizing the preparation 
of a biological product, or is in the process of obtaining a product 
license, the establishment license shall no longer be valid and shall 
be returned to the Administrator. In the case where an establishment 
license expires or is suspended or revoked, any product license 
authorizing preparation of a product at such establishment shall be 
invalid indefinitely or for as long as the suspension is in effect.
    (g) Any license issued under this part to establishments in which 
biological products are prepared shall be issued on condition that the 
licensee permit the inspection of such establishments, products, 
product preparation, and all relevant records as provided in part 115 
of this subchapter. Failure to permit inspection may result in the 
license being suspended or revoked.
* * * * *

PART 104--PERMITS FOR BIOLOGICAL PRODUCTS

    4. The authority citation for part 104 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    5. In Sec. 104.6, paragraph (b), the words ``Veterinary Services'' 
are removed and the words ``Animal and Plant Health Inspection 
Service'' are added in their place.
    6. In part 105, the heading for the part is revised to read as 
follows:

[[Page 52874]]

PART 105--SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL 
LICENSES OR PERMITS

    7. The authority citation for part 105 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    8. In Sec. 105.1, paragraphs (a)(4) and (a)(5) are redesignated 
paragraphs (a)(5) and (a)(6), new paragraph (a)(4) is added, and 
redesignated paragraph (a)(5) is revised to read as follows:


Sec. 105.1   Suspension or revocation.

* * * * *
    (a) * * *
    (4) The licensee, permittee, or the foreign manufacturer has failed 
to maintain and make available for inspection records in connection 
with the development and preparation of product, has failed to provide 
complete and accurate information when requested, or has failed to 
provide complete and accurate information in the Outline of Production 
or in reports and records;
    (5) The licensee or permittee has violated or failed to comply with 
any provision of the Virus-Serum-Toxin Act or the regulations in this 
subchapter;
* * * * *
    9. Section 105.4 is revised to read as follows:


Sec. 105.4   Termination of licenses and permits for inactivity.

    (a) If a biological product has not been prepared by a licensee, or 
imported by a permittee for a period of 5 years or more, the 
Administrator may require the licensee to show intent to resume 
production, or the permittee to show intent to resume importation, 
within 6 months of notification. If the licensee does not resume 
preparation, or the permittee does not resume importation, within 6 
months of notification, or within a mutually agreeable period, the 
product license, or permit, may be terminated by the Administrator.
    (b) When a license or permit is terminated, the licensee or 
permittee shall continue to be subject to the applicable records 
provisions of Sec. 116.8.
    10. In part 116, the heading for the part is revised to read as 
follows:

PART 116--RECORDS AND REPORTS

    11. The authority citation for part 116 continues to read as 
follows:

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).

    12. In Sec. 116.1, paragraphs (a), (b), and (c) are redesignated as 
paragraphs (a)(1), (a)(2), and (a)(3), respectively; redesignated 
paragraph (a)(1) is revised; the introductory paragraph is designated 
as paragraph (a) and is revised; and new paragraphs (b) and (c) are 
added to read as follows:


Sec. 116.1   Applicability and general considerations.

    (a) Each licensee, permittee, and foreign manufacturer of 
biological products imported into the United States shall maintain, at 
the licensed or foreign establishment in which the products are 
prepared, detailed records of information necessary to give a complete 
accounting of all the activities within each establishment. Such 
records shall include, but shall not be limited to, the items 
enumerated in this part.
    (1) Records shall be made concurrently with the performance of 
successive steps in the development and preparation of biological 
products, including new products under development. Such records shall 
include the date and where critical, the time that each essential step 
was taken, the identity and quantity of ingredients added or removed at 
each step, and any gain or loss of product from the beginning to the 
end of product preparation.
* * * * *
    (b) In the case of imported products, each permittee shall maintain 
at the permittee's place of business detailed and accurate records that 
are relevant to each imported product and that include, but are not 
limited to, importation documents, sampling records, test summaries, 
shipping records, and inventory and disposition records as required in 
Sec. 116.2.
    (c) When authorized by the Administrator, the licensee, permittee, 
or foreign manufacturer may maintain and retain records required under 
this part at an alternative location. Such authorization shall be 
confirmed by the filing of an addendum to the plot plan legend. The 
addendum shall list the location of the records and the condition of 
their storage and shall permit the inspection of the records by APHIS 
inspectors, or foreign inspectors acting on behalf of APHIS.

(Approved by the Office of Management and Budget under control 
number 0579-0013)


Secs. 116.2, 116.3, 116.4, and 116.6   [Amended]

    13. At the end of Secs. 116.2, 116.3, 116.4, and 116.6, the 
reference to OMB control number ``0579-0059'' is removed and the number 
``0579-0013'' is added in its place.
    14. Section 116.5 is revised to read as follows:


Sec. 116.5   Reports.

    (a) When required by the Administrator, reports containing accurate 
and complete information concerning biological products, including but 
not limited to, product development and preparation, and market 
suspensions and recalls, shall be prepared and submitted to the Animal 
and Plant Health Inspection Service by the licensee, permittee, or 
foreign manufacturer (whose products are being imported or offered for 
importation). Unless otherwise authorized by the Administrator, records 
necessary to make such reports shall be maintained in each 
establishment.
    (b) If, at any time, there are indications which raise questions 
regarding purity, safety, potency, or efficacy of a product, or if it 
appears that there may be a problem regarding preparation, testing, or 
distribution of a product, the licensee, permittee, or foreign 
manufacturer shall immediately notify Veterinary Biologics Field 
Operations, APHIS, 223 South Walnut Avenue, Ames, Iowa 50010, 
concerning the circumstances and the action taken, if any. Notification 
may be either by mail, electronic mail, facsimile, or telephone. If by 
electronic mail, [email protected]. If by facsimile, Area Code (515) 
232-7120. If by telephone, Area Code (515) 232-5785.

(Approved by the Office of Management and Budget under control 
number 0579-0013)

    15. In Sec. 116.7, the second sentence is revised to read as 
follows:


Sec. 116.7   Test records.

    * * * Summaries of such tests shall be prepared from such records 
and submitted to the Animal and Plant Health Inspection Service using 
APHIS Form 2008 or an acceptable equivalent form prior to release of 
the serial or subserial. * * *
* * * * *
    16. Section 116.8 is revised to read as follows:


Sec. 116.8 Completion and retention of records.

    All records (other than disposition records) required by this part 
shall be completed by the licensee, permittee, or foreign manufacturer 
before any portion of a serial of any product may be marketed in the 
United States or exported. All records shall be retained at the 
licensed or foreign establishment or permittee's place of business for 
a period of two years after the expiration date of a product, or for 
such longer period as may be required by the Administrator.


[[Page 52875]]


(Approved by the Office of Management and Budget under control 
number 0579-0013)

    Done in Washington, DC, this 4th day of October 1996.
A. Strating,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-25931 Filed 10-8-96; 8:45 am]
BILLING CODE 3410-34-P