[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Notices]
[Page 61444-61446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc03-62]
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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Tolerances Have Been Revoked, Suspended, or Modified by the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Chemicals for Which Tolerances Have Been Revoked, Suspended, or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\
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No. of Responses per Total Annual
No. of Respondents Respondent Responses Hours per Response Total Hours
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652 1 652 3 1,956
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\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
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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