[Federal Register Volume 73, Number 37 (Monday, February 25, 2008)]
[Notices]
[Pages 10033-10035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3415]


=======================================================================
-----------------------------------------------------------------------

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of Pesticide Chemicals, for Which Tolerances Have Been Revoked, 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.

-----------------------------------------------------------------------

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Tolerances Have Been Revoked, Suspended, or Modified by the 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                       Activity                            Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of documentation                                             1                     1                  1                  3                  3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                       Activity                           Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop documentation process                                           1                     1                  1                 16                 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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