[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Notices]
[Page 10033-10035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe08-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0094]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Channels of Trade Policy for Commodities With Residues
of Pesticide Chemicals, for Which Tolerances Have Been Revoked,
Suspended, or Modified by the Environmental Protection Agency Pursuant
to Dietary Risk Considerations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's guidance for industry entitled ``Channels of Trade
Policy for Commodities With Residues of Pesticide Chemicals, for Which
Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency Pursuant to Dietary Risk
Considerations.''
DATES: Submit written or electronic comments on the collection of
information by April 25, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Channels of Trade Policy for Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have Been Revoked, Suspended, or
Modified by the Environmental Protection Agency Pursuant to Dietary
Risk Considerations (OMB Control Number 0910-0562)--Extension
The Food Quality Protection Act of 1996 (FQPA), which amended the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (the act), established a new
safety standard for pesticide residues in food, with an emphasis on
protecting the health of infants and children. The Environmental
Protection Agency (EPA) is responsible for regulating the use of
pesticides (under FIFRA) and for establishing tolerances or exemptions
from the requirement for tolerances for residues of pesticide chemicals
in food commodities (under the act). EPA, in accordance with the FQPA,
is in the process of reassessing the pesticide
[[Page 10034]]
tolerances and exemptions which were in effect when the FQPA was signed
into law. When EPA determines that a pesticide's tolerance level does
not meet the safety standard under section 408 of the act (21 U.S.C.
346a), the registration for the pesticide may be canceled under FIFRA
for all or certain uses. In addition, the tolerances for that pesticide
may be lowered or revoked for the corresponding food commodities. Under
section 408(l)(2) of the act, when the registration for a pesticide is
canceled or modified due to, in whole or in part, dietary risks to
humans posed by residues of that pesticide chemical on food, the
effective date for the revocation of such tolerance (or exemption in
some cases) must be no later than 180 days after the date such
cancellation becomes effective or 180 days after the date on which the
use of the canceled pesticide becomes unlawful under the terms of the
cancellation, whichever is later.
When EPA takes such actions, food derived from a commodity that was
lawfully treated with the pesticide may not have cleared the channels
of trade by the time the revocation or new tolerance level takes
effect. The food could be found by FDA, the agency that is responsible
for monitoring pesticide residue levels and enforcing the pesticide
tolerances in most foods (the U.S. Department of Agriculture (USDA) has
responsibility for monitoring residue levels and enforcing pesticide
tolerances in egg products and most meat and poultry products), to
contain a residue of that pesticide that does not comply with the
revoked or lowered tolerance. FDA would normally deem such food to be
in violation of the law by virtue of it bearing an illegal pesticide
residue. The food would be subject to FDA enforcement action as an
``adulterated'' food. However, the channels of trade provision of the
act (section 408(l)(5) of the act) addresses the circumstances under
which a food is not unsafe solely due to the presence of a residue from
a pesticide chemical for which the tolerance has been revoked,
suspended, or modified by EPA. The channels of trade provision states
that food containing a residue of such a pesticide shall not be deemed
``adulterated'' by virtue of the residue, if the residue is within the
former tolerance, and the responsible party can demonstrate to FDA's
satisfaction that the residue is present as the result of an
application of the pesticide at a time and in a manner which were
lawful under FIFRA.
In the Federal Register of May 18, 2005 (70 FR 28544), FDA
announced the availability of a guidance document entitled, ``Channels
of Trade Policy for Commodities With Residues of Pesticide Chemicals,
for Which Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency Pursuant to Dietary Risk
Considerations.'' The guidance represents the agency's current thinking
on its planned enforcement approach to the channels of trade provision
of the act and how that provision relates to FDA-regulated products
with residues of pesticide chemicals for which tolerances have been
revoked, suspended, or modified by EPA under dietary risk
considerations. The guidance can be found at http://www.cfsan.fda.gov/
guidance.html. FDA anticipates that food bearing lawfully applied
residues of pesticide chemicals that are the subject of future EPA
action to revoke, suspend, or modify their tolerances, will remain in
the channels of trade after the applicable tolerance is revoked,
suspended, or modified. If FDA encounters food bearing a residue of a
pesticide chemical for which the tolerance has been revoked, suspended,
or modified, it intends to address the situation in accordance with
provisions of the guidance. In general, FDA anticipates that the party
responsible for food found to contain pesticide chemical residues
(within the former tolerance) after the tolerance for the pesticide
chemical has been revoked, suspended, or modified will be able to
demonstrate that such food was handled, e.g., packed or processed,
during the acceptable timeframes cited in the guidance by providing
appropriate documentation to the agency as discussed in the guidance
document. FDA is not suggesting that firms maintain an inflexible set
of documents where anything less or different would likely be
considered unacceptable. Rather, the agency is leaving it to each
firm's discretion to maintain appropriate documentation to demonstrate
that the food was so handled during the acceptable timeframes.
Examples of documentation which FDA anticipates will serve this
purpose consist of documentation associated with packing codes, batch
records, and inventory records. These are types of documents that many
food processors routinely generate as part of their basic food-
production operations.
FDA is requesting the extension of OMB approval for the information
collection provisions in the guidance.
Description of Respondents: The likely respondents to this
collection of information are firms in the produce and food-processing
industries that handle food products that may contain residues of
pesticide chemicals after the tolerances for the pesticide chemicals
have been revoked, suspended, or modified.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
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Submission of documentation 1 1 1 3 3
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA expects the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA in the next 3 years to
significantly decrease, as EPA concludes its review activity. Thus, the
above estimates for respondents and numbers of responses in table 1 of
this document are based on the submissions that the agency has received
in the past 3 years and the expectation that the number of submissions
will significantly decrease in the next 3 years. However, to avoid
counting this burden as zero, FDA has estimated the burden at one
respondent making one submission a year for a total of one annual
submission.
The hours per response values were estimated as follows: First, we
assumed that the information requested in this guidance is readily
available to the submitter. We expect that the submitter will need to
gather information from appropriate persons in the submitter's company
and to prepare this information for submission to FDA. The submitter
will almost always merely need to copy existing documentation. We
believe that this effort should take no longer than 3 hours per
submission.
[[Page 10035]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
Activity Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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Develop documentation process 1 1 1 16 16
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual recordkeeping burden, FDA
estimated that at least 90 percent of firms maintain documentation,
such as packing codes, batch records, and inventory records, as part of
their basic food production or import operations. Therefore, the
recordkeeping burden was calculated as the time required for the 10
percent of firms that may not be currently maintaining this
documentation to develop and maintain documentation, such as batch
records and inventory records. In previous information collection
requests, this recordkeeping burden was estimated to be 16 hours.
Although FDA estimates that only 1 out of 10 firms will not be
currently maintaining the necessary documentation, to avoid counting
the recordkeeping burden for the one submission per year as zero, FDA
has retained its prior estimate of 16 hours for the recordkeeping
burden.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: February 15, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3415 Filed 2-22-08; 8:45 am]
BILLING CODE 4160-01-S