[Federal Register Volume 68, Number 208 (Tuesday, October 28, 2003)]
[Notices]
[Pages 61444-61446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0263]


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Tolerances Have Been Revoked, Suspended, or Modified by the 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

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 
November 28, 2003.

[[Page 61445]]


ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed 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Chemicals for Which Tolerances Have Been Revoked, Suspended, or 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

    Under the pesticide tolerance reassessment process that the 
Environmental Protection Agency (EPA) was mandated to carry out under 
the Food Quality Protection Act of 1996 (FQPA), EPA is expected to 
revoke, suspend, or modify tolerances for the pesticide chemicals on 
various food commodities. Section 408(l)(5) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 346a) includes a provision, 
referred to as the ``channels of trade provision,'' that addresses the 
circumstances under which a food will not be deemed unsafe solely due 
to the presence of a residue from a pesticide chemical whose tolerance 
has been revoked, suspended, or modified by EPA.
    In general, FDA anticipates that the party responsible for food 
found to contain the previously mentioned 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 draft guidance by 
providing appropriate documentation to the agency as discussed in the 
draft 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.
    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 July 23, 2003 (68 FR 43535), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. One comment was received that did not pertain to 
this information collection.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                        No. of Responses per       Total Annual
  No. of Respondents         Respondent             Responses         Hours per Response        Total Hours
----------------------------------------------------------------------------------------------------------------
652                              1                    652                     3                  1,956
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA does not know which pesticide chemicals will have their 
tolerances revoked, suspended, or modified in the future. Instead of 
calculating the paperwork burden for any one pesticide, FDA calculated 
the cost for an ``average''' pesticide by looking at test results for 
417 pesticide chemicals on domestic products and 450 pesticide 
chemicals on imported products. FDA then used the average percent of 
samples found with residues as a substitute for the rate of residues 
found from a specific pesticide chemical.
    The estimated annual reporting burden was determined using the 
average percent of samples found with residues for all pesticides for 
domestic and imported products. Using 1999 pesticide monitoring data, 
domestic products were tested for residues of 417 pesticide chemicals. 
On average, 1.02 percent of samples tested positive for a given 
pesticide chemical. For 450 pesticides tested for residues on imported 
products, on average 2.40 percent of samples contained a given 
pesticide chemical residue. This rate of positive findings for product 
samples was applied to the number of potentially affected 
establishments, 3,730 importers and 23,201 domestic businesses, giving 
an expected number of 326 potentially-affected businesses per 
revocation, suspension, or modification of a tolerance. FDA expects 
this number to be an overestimate of the number of affected businesses 
for two reasons. First, the positive residue test may be below the new 
tolerance. Second, tolerances may not be altered for all products. If 
the tolerance was altered for only vegetables but not fruit, then the 
number of affected establishments would be smaller. We assume two 
pesticide tolerances are altered per year, resulting in 652 businesses 
reporting per year. To date, tolerances have been revoked for two 
pesticide chemicals. However, FDA expects the total number of pesticide 
tolerances that are revoked, suspended, or modified by EPA to increase.

[[Page 61446]]



                                                   Table 2.--Estimated Annual Recordkeeping Burden \1\
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                                           Annual Frequency of                                                                                 Capital
          No. of Recordkeepers                Recordkeeping         Total Annual Records    Hours per Recordkeeper        Total Hours           Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
65                                                             1                       65                       16                    1,042      $32,571
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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 currently be maintaining this 
documentation to develop and maintain documentation, such as batch 
records and inventory records. For firms that do not maintain 
documentation, such as batch records and inventory records, as part of 
their normal manufacturing operations, it was estimated that with $500 
or less, the necessary software and hardcopy filing systems could be 
obtained to implement a system.

    Dated: October 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27120 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S