[Federal Register Volume 68, Number 68 (Wednesday, April 9, 2003)]
[Proposed Rules]
[Pages 17327-17330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8599]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 105 and 115

[Docket No. 02-107-1]


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: Proposed rule.

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SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act 
regulations to specify the actions that would have to be taken by 
veterinary biologics licensees and permittees 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 any worthless, contaminated, dangerous, harmful, or 
unsatisfactory veterinary biological product. After receiving notice 
from APHIS to stop the preparation, distribution, sale, barter, 
exchange, shipment, or importation of any worthless, contaminated, 
dangerous, harmful, or unsatisfactory veterinary biological product, 
licensees and permittees would be required to notify wholesalers, 
dealers, jobbers, or other persons known to have veterinary biological 
products in their possession to stop the preparation, distribution, 
sale, barter, exchange, shipment, or importation of any worthless, 
contaminated, dangerous, harmful, or unsatisfactory veterinary 
biological product. In addition, licensees and permittees would be 
required to submit a complete accounting of the inventory of affected 
serials or subserials of biological products in the current possession 
of each person involved in the distribution or sale of the product, and 
provide written documentation concerning the required notifications as 
directed by the Administrator of APHIS. These proposed changes are 
necessary in order to clarify the regulations, provide for the most 
expeditious means of notification, and to prevent 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: We will consider all comments that we receive on or before June 
9, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 02-107-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 02-107-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
02-107-1'' on the subject line.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related

[[Page 17328]]

information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

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:

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 veterinary biologics licensees, permittees, 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 found to be 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 the 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 the 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 action increases the risk that such product may cause harm to 
animals, the public health, or to the environment. APHIS believes that 
it is prudent to use the most expeditious means available to notify 
wholesalers, dealers, jobbers, consignees, or other persons concerning 
the stop distribution and sale action. Therefore, this proposed rule 
would amend Sec. Sec.  105.3 and 115.2 to specify actions that 
veterinary biologics licensees and permittees would have to take when 
APHIS issues a stop distribution and sale notice concerning a 
veterinary biological product.
    Specifically, APHIS is proposing to amend the regulations to 
provide that APHIS would contact veterinary biologics licensees and 
permittees concerning stop distribution and sale actions against any 
worthless, contaminated, dangerous, harmful, or unsatisfactory 
veterinary biological product. After being contacted by APHIS, 
veterinary biologics licensees or permittees would be required to 
immediately provide stop distribution and sale notification to 
wholesalers, jobbers, dealers, consignees or other persons in their 
respective distribution systems known to be in possession of such 
product. APHIS believes that having licensees or permittees provide 
stop distribution and sale notification to wholesalers, jobbers, 
dealers, consignees, or other persons in their respective distribution 
systems known to be in possession of any worthless, contaminated, 
dangerous, harmful, or unsatisfactory veterinary biological product is 
the most expeditious means of notification. Licensees and permittees 
have information readily available to them concerning the products that 
have been shipped to wholesalers, jobbers, dealers, consignees, or 
other persons in their respective distribution systems.
    In addition, veterinary biologics licensees and permittees also 
would be required to document, in writing, all communications with 
wholesalers, dealers, jobbers, consignees, or other persons concerning 
the stop distribution and sale action; obtain a complete accounting of 
the inventory of such product in the possession of such wholesalers, 
jobbers, dealers, and other persons; and, as directed by the 
Administrator, submit records of all actions taken to ensure compliance 
with the stop distribution and sale notification.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    APHIS issues stop distribution and sale actions if information is 
received indicating that a serial or subserial of a licensed veterinary 
biological product is worthless, contaminated, dangerous, harmful, or 
unsatisfactory. Such information may come from inspection findings, an 
investigation, an adverse event report, or tests conducted by the 
Center for Veterinary Biologics Laboratory or by the licensee or 
permittee. Stop distribution and sale actions may be necessary to 
prevent risk to the health of animals, to the public health or well-
being, or to the environment. Currently, the regulations in Sec. Sec.  
105.3 and 115.2 provide that APHIS may issue a notice requiring 
veterinary biologics licensees and permittees to stop distribution and 
sale if a product is found to be unsatisfactory according to applicable 
standard requirements or if it appears that such product is worthless, 
contaminated, dangerous, or harmful.
    APHIS is proposing to amend the regulations to provide that APHIS 
would contact veterinary biologics licensees and permittees concerning 
stop distribution and sale actions against any worthless, contaminated, 
dangerous, harmful, or unsatisfactory veterinary biological product. 
After being contacted by APHIS, veterinary biologics licensees or 
permittees would be required to immediately provide stop distribution 
and sale notification to wholesalers, jobbers, dealers, consignees, or 
other persons in their respective distribution systems known to be in 
possession of such product. APHIS believes that having licensees or 
permittees provide stop distribution and sale notification to 
wholesalers, jobbers, dealers, consignees, or other persons in their 
respective distribution systems known to be in possession of any 
worthless, contaminated, dangerous, harmful, or unsatisfactory 
veterinary biological product is the most expeditious means of 
notification. Licensees and permittees have information readily 
available to them

[[Page 17329]]

concerning which wholesalers, jobbers, dealers, consignees, or other 
persons in their respective distribution systems are known to be in 
possession of products.
    In addition, veterinary biologics licensees and permittees also 
would be required to document, in writing, all communications with 
wholesalers, dealers, jobbers, consignees, or other persons concerning 
the stop distribution and sale action; obtain a complete accounting of 
the inventory of such product in the possession of such wholesalers, 
jobbers, dealers, and other persons; and, as directed by the 
Administrator, submit records of all actions taken to ensure compliance 
with the stop distribution and sale notification.
    The effect of this action would be to clarify the regulations, 
provide for the most expeditious means of notification, and to prevent 
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.
    This proposed rule would affect all veterinary biologics licensees 
and permittees. Currently, there are approximately 135 veterinary 
biological establishments, including permittees. According to the 
standards of the Small Business Administration, most veterinary 
biological establishments would be classified as small entities.
    Section 116.2 of the regulations currently requires licensees and 
permittees to maintain records of the quantity and location of each 
biological product that is prepared, that is in storage, and that is in 
distribution channels. In addition, each licensee, distributor, and 
permittee must maintain detailed disposition records showing the sale, 
shipment, or other disposition of any biological products that they 
have handled. Given these existing recordkeeping requirements, APHIS 
believes that the proposed requirement that licensees and permittees 
submit to APHIS a complete accounting of the inventory of an affected 
serial or subserial of a biological product in the current possession 
of each person involved in the distribution or sale of the product 
should not impose any undue recordkeeping burden. APHIS also believes 
that the current requirement for the maintenance of detailed 
disposition records would enable licensees and permittees to notify 
persons in their distribution system concerning stop distribution and 
sale notifications issued by APHIS without having to incur any undue 
recordkeeping burden.
    APHIS anticipates that the only economic effects that would be 
associated with this proposed rule would be related to the costs 
incurred by licensees and permittees in connection with the 
notification process itself. This proposed rule does not specify the 
means by which licensees and permittees are required to give 
notification, only that the notification be made by them immediately 
upon receipt of the stop distribution and sale notification from APHIS. 
APHIS expects that most licensees and permittees would use electronic 
mail or facsimile to notify wholesalers, jobbers, dealers, consignees, 
or other persons in their respective distribution systems known to be 
in possession of any biological product for which APHIS has issued a 
stop distribution and sale action. Both of these methods are 
inexpensive, so the actual transmittal costs associated with the 
proposed notification requirement would be minimal.
    Licensees and permittees could retain electronic mail return 
receipts or facsimile confirmation sheets to address the proposed 
requirement for documentation that notifications have been made, both 
of which can be produced automatically by the sender's electronic mail 
system or facsimile machine. There would be some personnel costs 
associated with producing and addressing the notification document that 
would have to be sent out, but the existing requirement for the 
maintenance of detailed disposition records discussed in the previous 
paragraph should serve to minimize, to the extent possible, the time 
spent engaging in those activities.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program is listed in the category 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 proposed 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. 
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 section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 02-107-1. 
Please send a copy of your comments to: (1) Docket No. 02-107-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    In this document, we are proposing to amend the regulations in 
Sec. Sec.  105.3 and 115.2 to specify actions that veterinary biologics 
licensees and or permittees would have to take when APHIS issues a stop 
distribution and sale notice concerning a veterinary biological 
product. This process would entail the use of two new information 
collection activities.
    First, after being contacted by APHIS, veterinary biologics 
licensees or permittees would be required to immediately provide stop 
distribution and sale notification to wholesalers, jobbers, dealers, 
consignees, or other persons in their respective distribution systems 
known to be in possession of such product.
    Second, veterinary biologics licensees and permittees would have to 
obtain a complete accounting of the inventory of such product in the 
possession of such wholesalers, jobbers, dealers, and other persons in 
their distribution system.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the

[[Page 17330]]

validity of the methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 1.7666 hours per response.
    Respondents: Licensees and permittees and wholesalers, dealers, 
jobbers, consignees, or other persons in their distribution system.
    Estimated annual number of respondents: 55.
    Estimated annual number of responses per respondent: 1.0909.
    Estimated annual number of responses: 60.
    Estimated total annual burden on respondents: 106 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this proposed 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.

    Accordingly, we propose to amend 9 CFR parts 105 and 115 as 
follows:

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

    1. The authority citation for part 105 would continue to read as 
follows:

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

    2. Section 105.3 would be amended by adding a new paragraph (c) to 
read as set forth below:


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 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 quantity of each serial(s) or subserial(s) of 
any veterinary biological product at each location in the distribution 
channel.
    (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.

PART 115--INSPECTIONS

    3. The authority citation for part 115 would continue to read as 
follows:

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

    4. Section 115.2 would be 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 or importer 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 veterinary biological product pending further instructions from 
APHIS.
    (2) Immediately 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 quantity of each serial(s) or subserial(s) of 
any veterinary biological product at each location in the distribution 
channel.
    (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.

    Done in Washington, DC, this 2nd day of April, 2003.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-8599 Filed 4-8-03; 8:45 am]
BILLING CODE 3410-34-P