[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49778-49780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0084]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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Tolerances Have Been Revoked, Suspended, or Modified by the 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 22, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0562. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 49779]]

collection of information to OMB for review and clearance.

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Chemicals, for Which Tolerances Have Been Revoked, Suspended, or 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.
    In the Federal Register of June 3, 2014 (79 FR 31944), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the annual burden of this collection of information as 
follows:

[[Page 49780]]



                                                     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.

    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, 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: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19957 Filed 8-21-14; 8:45 am]
BILLING CODE 4164-01-P