[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31944-31946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12819]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0084]
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of Pesticide Chemicals, for Which Tolerances Have Been Revoked,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 or we) 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 invites comments on 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Tolerances Have Been Revoked, Suspended, or Modified by the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 either electronic or written comments on the collection
of information by August 4, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [email protected].
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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
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.
[[Page 31945]]
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, which amended the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (the FD&C 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 FD&C Act). EPA may, for various reasons, e.g., as part of a
systematic review or in response to new information concerning the
safety of a specific pesticide, reassess whether a tolerance for a
pesticide residue continues to meet the safety standard in section 408
of the FD&C Act (21 U.S.C. 346a). When EPA determines that a
pesticide's tolerance level does not meet that safety standard, 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 FD&C 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 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. We 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
FD&C 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 (section 408(l)(5) of the FD&C Act)
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), we 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 FDA's current thinking on its
planned enforcement approach to the channels of trade provision of the
FD&C 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 pursuant to dietary risk considerations.
The guidance can be found at the following link: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetalsNaturalToxinsPesticides/ucm077918.htm. We
anticipate 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 we
encounter food bearing a residue of a pesticide chemical for which the
tolerance has been revoked, suspended, or modified, we intend to
address the situation in accordance with provisions of the guidance. In
general, we anticipate 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 FDA as discussed
in the guidance document. We are not suggesting that firms maintain an
inflexible set of documents where anything less or different would
likely be considered unacceptable. Rather, we are 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 we anticipate 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. Accordingly, under the PRA, we are 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.
We estimate the annual burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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.
[[Page 31946]]
We expect the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA pursuant to dietary risk
considerations in the next 3 years to remain at a low level, as there
have been no changes to the safety standard for pesticide residues in
food since 1996. Thus, we expect the number of submissions we will
receive pursuant to the guidance document will also remain at a low
level. However, to avoid counting this burden as zero, we have
estimated the burden at one respondent making one submission a year for
a total of one annual submission.
We based our estimate of the hours per response on the assumption
that the information requested in the 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.
Table 2--Estimated Annual Recordkeeping Burden\1\
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Number of
Activity Number of records per Total annual Average burden Total hours
recordkeepers recordkeeping records per record
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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, we
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 per
record. We have retained our prior estimate of 16 hours per record for
the recordkeeping burden. As shown in Table 1 of this document, we
estimate that one respondent will make one submission per year.
Although we estimate that only 1 out of 10 firms will not be currently
maintaining the necessary documentation, to avoid counting the
recordkeeping burden for the 1 submission per year as 1/10 of a
recordkeeper, we estimate that 1 recordkeeper will take 16 hours to
develop and maintain documentation recommended by the guidance.
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12819 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P