[Federal Register Volume 72, Number 68 (Tuesday, April 10, 2007)]
[Rules and Regulations]
[Pages 17795-17798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6700]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 105 and 115

[Docket No. 02-107-2]
RIN 0579-AC29


Viruses, Serums, Toxins, and Analogous Products; Suspension, 
Revocation, or Termination of Biological Licenses or Permits; 
Inspections

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the Virus-Serum-Toxin Act regulations to 
specify the actions to be taken by veterinary biologics licensees and 
permittees upon receipt of notice from the Animal and Plant Health 
Inspection Service (APHIS) to stop the preparation, distribution, sale, 
barter, exchange, shipment, or importation of any worthless, 
contaminated, dangerous, harmful, or unsatisfactory veterinary 
biological product. After receiving notice from APHIS, licensees and 
permittees must notify each wholesaler, dealer, jobber, consignee, or 
other recipient known to have any such product in their possession to 
stop the preparation, distribution, sale, barter, exchange, shipment, 
or importation of such product. In addition, licensees and permittees 
must provide a complete accounting of the remaining inventory of 
affected serials or subserials of such product in the current 
possession of known wholesalers, dealers, jobbers, consignees, or other 
known recipients and provide written documentation concerning the 
required notification(s) as directed by the Administrator of APHIS. 
These changes are necessary in order to clarify the regulations, 
provide for the most expeditious means of disseminating stop 
distribution and sale notices, and to mitigate the risk that any 
worthless, contaminated, dangerous, harmful, or unsatisfactory 
veterinary biological product may cause harm to animals, the public 
health, or to the environment.

DATES: Effective Date: May 10, 2007.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief of 
Operational Support, Center for Veterinary Biologics, Licensing and 
Policy Development, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 
20737-1231, (301) 734-8245.

SUPPLEMENTARY INFORMATION:

[[Page 17796]]

Background

    Parts 105 and 115 of the Virus-Serum-Toxin Act regulations (9 CFR 
parts 105 and 115, referred to below as the regulations) provide, 
respectively, for the suspension, revocation, or termination of 
biological licenses or permits and for the inspection of veterinary 
biologics establishments and veterinary biological products. These 
regulations also contain provisions that address the actions to be 
taken by the manufacturer or importer, and any jobbers, wholesalers, 
dealers, or other persons known to have veterinary biologics in their 
possession, upon their receipt of notice from the Animal and Plant 
Health Inspection Service (APHIS) to stop the preparation, 
distribution, sale, barter, exchange, shipment, or importation of 
worthless, contaminated, dangerous, harmful, or unsatisfactory 
veterinary biological product.
    Section 105.3 of the regulations provides, in relevant part, that 
APHIS may notify a licensee or permittee to stop the preparation, sale, 
barter, exchange, shipment, or importation of any veterinary biological 
product if at any time it appears that such product may be dangerous in 
the treatment of domestic animals or unsatisfactory according to 
applicable Standard Requirements.
    Similarly, Sec.  115.2 provides, in relevant part, that if as a 
result of any inspection it appears that any veterinary biological 
product is worthless, contaminated, dangerous, or harmful, the 
Secretary will give notice of that finding to the manufacturer or 
importer and to any jobbers, wholesalers, dealers, or other persons 
known to have any of such product in their possession. After receiving 
such notice, no person may sell, barter, or exchange any such product 
in any place under the jurisdiction of the United States or ship or 
deliver for shipment any such product in or from any State, Territory, 
or the District of Columbia.
    Typically, before stop distribution and sale notifications provided 
for by Sec. Sec.  105.3 and 115.2 can be given, APHIS must obtain from 
the licensees and permittees (manufacturers or importers) the names and 
addresses of the wholesalers, dealers, jobbers, consignees, or other 
persons known to have any of such unsatisfactory product in their 
possession. Any delay in obtaining the names and addresses of persons 
in possession of biological products subject to a stop distribution and 
sale notification increases the risk that such product may cause harm 
to animals, the public health, or to the environment. We believe that 
it is prudent to use the most expeditious means available to notify 
wholesalers, dealers, jobbers, foreign consignees, or other persons 
concerning the stop distribution and sale action.
    On April 9, 2003, we published in the Federal Register (68 FR 
17327-17330, Docket No. 02-107-1) a proposal to amend the regulations 
to require veterinary biologics licensees and permittees (instead of 
APHIS) to: (1) Notify wholesalers, dealers, jobbers, or other persons 
concerning APHIS-directed stop distribution and sale notifications 
pertaining to worthless, contaminated, dangerous, harmful, or 
unsatisfactory veterinary biological product; (2) account for any 
remaining quantity of such product in the current possession of persons 
involved in the distribution or sale of said product; and (3) to 
provide written documentation concerning the required notifications as 
directed by the Administrator of APHIS.
    We solicited comments concerning our proposal for 60 days ending 
June 9, 2003. We received one comment by that date, from a trade 
association representing veterinary biologics manufacturers. We 
carefully considered this comment before we reached a decision 
concerning our proposal. The comment is discussed below.
    The commenter stated that the proposed rule could be subject to 
multiple interpretations and would require licensees and permittees to 
be accountable for activities beyond their ability to control, and 
requested clarification regarding the proposed provisions that would 
require licensees and permittees to account for the quantity for each 
serial or subserial of unsatisfactory product at each location in the 
distribution channel (i.e., the provisions of proposed Sec. Sec.  
105.3(c)(3) and 115.2(b)(3)). The commenter inquired as to whether this 
meant accounting only for the quantity of product shipped from the 
manufacturer directly to primary (presumably, known) distributors 
(wholesalers, etc.) or, in addition, accounting for product shipped 
from primary distributors to secondary and/or tertiary recipients who 
may not be known to the manufacturer or importer.
    In proposed Sec. Sec.  105.3(c)(2) and 115.2(b)(2), we specified 
that stop sale notifications should be issued to all wholesalers, 
jobbers, dealers, foreign consignees, or other persons known to have 
the product in their possession. However, we agree that the wording of 
proposed Sec. Sec.  105.3(c)(3) and 115.2(b)(3) could be interpreted as 
requiring licensees and permittees to account for product in the 
possession of persons that are not known to the manufacturer or 
importer. To clarify those provisions, we have amended Sec. Sec.  
105.3(c)(3) and 115.2(b)(3) in this final rule to refer to accounting 
for the quantity of product at each location known to the manufacturer 
or importer. As amended, Sec. Sec.  105.3(c)(3) and 115.2(b)(3) now 
read: ``Account for the remaining quantity of each serial(s) or 
subserial(s) of any such veterinary biological product at each location 
in the distribution channel known to the manufacturer or importer.''
    The commenter also inquired as to the meaning of ``immediately'' as 
used in Sec. Sec.  105.3(c)(2) and 115.2(b)(2) of the proposed rule, 
and identified several situations where ``rapid notification'' may not 
be in the best interest of the consumer or manufacturer.
    The purpose of the typical stop distribution and sale action is to 
mitigate the possibility that any worthless, dangerous, harmful, or 
unsatisfactory veterinary biological product may cause harm to animals, 
the public health, or to the environment. We realize that a hasty 
decision may not be in the best interest of the health of animals or 
the manufacturer, and would exercise great caution before issuing a 
stop distribution and sale notification. However, we believe that stop 
distribution and sale notifications should be carried out as 
expeditiously as possible once the determination has been made that 
suspension of distribution and sale of the product is the best means to 
limit harm to animals, the public health, or the environment. To 
clarify the meaning of ``immediately,'' we have amended Sec. Sec.  
105.3(c)(2) and 115.2(b)(2) in this final rule to read as follows: 
``Immediately, but no later than 2 days, send stop distribution and 
sale notifications to any wholesalers, jobbers, dealers, foreign 
consignees, or other persons known to have any such veterinary 
biological product in their possession, which instruct them to stop 
preparation, distribution, sale, barter, exchange, shipment, or 
importation of any such veterinary biological product. All such 
notifications shall be documented in writing by the licensee or 
permittee.''
    The commenter agreed with the estimate of burden in the proposed 
rule's Paperwork Reduction Act section of 1.7666 hours per response for 
respondents affected by stop distribution and sale notifications, 
provided that such notifications are only applicable to ``parties that 
are a single business transaction away from the licensee or permittee'' 
(i.e., known to the manufacturer or importer). However, the commenter 
opined that

[[Page 17797]]

1.7666 hours per response may be an underestimate for firms that market 
directly to veterinarians, or if such notifications must ``include all 
participants in each distribution chain,'' (i.e., known and unknown 
participants).
    Regarding the commenter's concern that notification must include 
all participants in each distribution chain, APHIS has amended 
Sec. Sec.  105.3(c)(3) and 115.2(b)(3) in this final rule to specify 
that licensees and permittees are only required to notify wholesalers, 
jobbers, dealers, foreign consignees, or other persons known to be in 
possession of product subject to the stop distribution and sale action. 
In addition, APHIS believes that available technological tools such as 
electronic mail, facsimile, and the telephone help lower the burden of 
notification in all cases, including for those who market directly to 
veterinarians. Given these facts, APHIS believes that the estimated 
burden of 1.7666 hours per response stated in the proposed rule is not 
unreasonable.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This 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.
    We are amending Sec. Sec.  105.3 and 115.2 of our regulations under 
the Virus-Serum-Toxin Act concerning actions that veterinary biologics 
licensees and permittees must take after receiving notice from APHIS to 
stop distribution and sale of a serial(s) or subserial(s) of veterinary 
biological product that is found to be unsatisfactory according to 
applicable standard requirements, or if it appears that such product is 
worthless, contaminated, dangerous, or harmful. Licensees and 
permittees are required to notify wholesalers, jobbers, dealers, 
foreign consignees, or other persons known to be in possession of such 
product immediately, but no later than 2 days after being contacted by 
APHIS, to stop further distribution and sale of such serial(s) or 
subserial(s) pending further instructions. This final rule also 
requires veterinary biologics licensees and permittees to document, in 
writing, their communications with wholesalers, jobbers, dealers, 
foreign consignees, or other persons concerning such stop distribution 
and sale notifications; determine the remaining inventory of such 
product in the current possession of such wholesalers, jobbers, 
dealers, consignees, or other persons; and, as directed by the 
Administrator, submit reports of all such notifications to APHIS.
    The primary effect of this rule will be to provide for the most 
expeditious means of disseminating information concerning stop 
distribution and sale notices pertaining to veterinary biological 
product found unsatisfactory according to applicable standard 
requirements, and to mitigate the risk that such unsatisfactory 
veterinary biological product may cause harm to animals, the public 
health, or the environment. The rule also clarifies the regulations 
with regard to whom licensees and permittees should contact concerning 
stop distribution and sale notification, and what information APHIS may 
require to be reported concerning such notification.
    There are approximately 125 veterinary biologics establishments, 
including permittees, that may be affected by this rule. According to 
the standards of the Small Business Administration, most veterinary 
biologics establishments would be classified as small entities.
    It is anticipated that no undue recordkeeping burden will be added 
to licensees and permittees since Sec. Sec.  116.2 and 116.5 of the 
regulations currently require the maintenance of detailed disposition 
records and the submission of reports concerning each biological 
product that is prepared and/or shipped. We further anticipate that the 
only economic effects that may result from this amendment to the 
regulations would be related to the costs incurred by licensees and 
permittees in connection with the notification process itself. This 
final rule does not specify the means by which licensees and permittees 
are required to give notification, only that notification be given 
immediately, but no later than 2 days of receipt of the stop 
distribution and sale notification from APHIS. We expect that licensees 
and permittees would use electronic mail, telephone, and facsimile to 
notify wholesalers, jobbers, dealers, consignees, or other persons 
known to be in possession of the product. These methods are 
inexpensive, so the actual costs of transmitting notifications required 
by this amendment would be minimal. The amendment will benefit 
manufacturers of veterinary biologics by clarifying the actions they 
must take should they receive notification from APHIS concerning a 
serial(s) or subserial(s) of biological product found to be 
unsatisfactory according to applicable standard requirements.
    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, unless they present an irreconcilable conflict with this 
rule. The Virus-Serum-Toxin Act does not provide 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) under OMB control number 0579-0318.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects

9 CFR Part 105

    Animal biologics, Exports, Imports, Labeling, Packaging and 
containers, Reporting and recordkeeping requirements.

9 CFR Part 115

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


0
Accordingly, we are amending 9 CFR parts 105 and 115 as follows:

[[Page 17798]]

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

0
1. 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 371.4.


0
2. Section 105.3 is amended by adding a new paragraph (c) and an OMB 
control number citation to read as follows:


Sec.  105.3  Notices re: worthless, contaminated, dangerous, or harmful 
biological products.

* * * * *
    (c) When notified to stop distribution and sale of a serial or 
subserial of a veterinary biological product under the provisions of 
paragraph (a) or (b) of this section, veterinary biologics licensees or 
permittees shall:
    (1) Stop the preparation, distribution, sale, barter, exchange, 
shipment, or importation of the affected serial(s) or subserial(s) of 
any veterinary biological product pending further instructions from 
APHIS.
    (2) Immediately, but no later than 2 days, send stop distribution 
and sale notifications to any wholesalers, jobbers, dealers, foreign 
consignees, or other persons known to have any such veterinary 
biological product in their possession, which instruct them to stop the 
preparation, distribution, sale, barter, exchange, shipment, or 
importation of any such veterinary biological product. All 
notifications shall be documented in writing by the licensee or 
permittee.
    (3) Account for the remaining quantity of each serial(s) or 
subserial(s) of any such veterinary biological product at each location 
in the distribution channel known to the manufacturer (licensee) or 
importer (permittee).
    (4) When required by the Administrator, submit complete and 
accurate reports of all notifications concerning stop distribution and 
sale actions to the Animal and Plant Health Inspection Service pursuant 
to Sec.  116.5 of this subchapter.

(Approved by the Office of Management and Budget under control 
number 0579-0318.)

PART 115--INSPECTIONS

0
3. The authority citation for part 115 continues to read as follows:

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


0
4. Section 115.2 is revised to read as follows:


Sec.  115.2  Inspections of biological products.

    (a) Any biological product, the container of which bears a United 
States veterinary license number or a United States veterinary permit 
number or other mark required by these regulations, may be inspected at 
any time or place. If, as a result of such inspection, it appears that 
any such product is worthless, contaminated, dangerous, or harmful, the 
Secretary shall give notice to stop distribution and sale to the 
manufacturer (licensee) or importer (permittee) and may proceed against 
such product pursuant to the provisions of part 118 of this subchapter.
    (b) When notified to stop distribution and sale of a serial or 
subserial of a veterinary biological product by the Secretary, 
veterinary biologics licensees or permittees shall:
    (1) Stop the preparation, distribution, sale, barter, exchange, 
shipment, or importation of the affected serial(s) or subserial(s) of 
any such veterinary biological product pending further instructions 
from APHIS.
    (2) Immediately, but no later than 2 days, send stop distribution 
and sale notifications to any jobbers, wholesalers, dealers, foreign 
consignees, or other persons known to have any such veterinary 
biological product in their possession, which instruct them to stop the 
preparation, distribution, sale, barter, exchange, shipment, or 
importation of any such veterinary biological product. All 
notifications shall be documented in writing by the licensee or 
permittee.
    (3) Account for the remaining quantity of each serial(s) or 
subserial(s) of any such veterinary biological product at each location 
in the distribution channel known to the manufacturer (licensee) or 
importer (permittee).
    (4) When required by the Administrator, submit complete and 
accurate reports of all notifications concerning stop distribution and 
sale actions to the Animal and Plant Health Inspection Service pursuant 
to Sec.  116.5 of this subchapter.
    (c) Unless and until the Secretary shall otherwise direct, no 
persons so notified shall thereafter sell, barter, or exchange any such 
product in any place under the jurisdiction of the United States or 
ship or deliver for shipment any such product in or from any State, 
Territory, or the District of Columbia. However, failure to receive 
such notice shall not excuse any person from compliance with the Virus-
Serum-Toxin Act. (Approved by the Office of Management and Budget under 
control number 0579-0318).

    Done in Washington, DC, this 4th day of April 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-6700 Filed 4-9-07; 8:45 am]
BILLING CODE 3410-34-P