[Federal Register: April 9, 2003 (Volume 68, Number 68)]
[Proposed Rules]
[Page 17327-17330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap03-24]
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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 regulations@aphis.usda.gov. 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