0562 SS Part A 2014

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for Which Tolerances Have Been Revoked, Suspended, or Modified by the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 No. 0910-0562
SUPPORTING STATEMENT
Terms of Clearance: None.
A.

Justification

1.

Circumstances Making the Collection of Information Necessary

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 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 the 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 (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 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
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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 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
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Chemic
alContaminantsMetalsNaturalToxinsPesticides/ucm077918.htm.
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 of the voluntary information collection
provisions contained in the guidance 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.”
2.

Purpose and Use of the Information Collection

Information will be collected by field personnel during the course of or in follow-up inspections,
investigations, or sample collections. The information collected is used to determine whether or not
commodities found to contain pesticide residues after the tolerances for the same pesticides in those
particular commodities have been revoked, suspended, or modified are in compliance with the
channels of trade provision of the FD&C Act.
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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.
3.

Use of Improved Information Technology and Burden Reduction

The guidance does not specifically recommend the use of automated, electronic, mechanical, or
other technological techniques or other forms of information technology for use by firms.
Companies are free to use whatever forms of information technology that may best assist them in
retaining the appropriate records and making them available to regulatory officials.
The agency estimates that about twenty-five percent (25%) of the records will be maintained
electronically in the next three years.
4.

Efforts to Identify Duplication and Use of Similar Information

No duplication of information collection is likely because the information need only be collected
once should a potential violation be identified (i.e., a sample is found to contain an apparent illegal
pesticide chemical residue).
5.

Impact on Small Businesses or Other Small Entities

FDA estimates that ten percent (10%) of respondents are small businesses. Should a potentially
violative sample be identified, providing the appropriate documentation to the agency is no more
burdensome for small businesses than for large. There is no known way to minimize the burden on
a small business wishing to demonstrate that the food was handled, e.g., packed or processed,
during the acceptable timeframes cited in the guidance. FDA aids small businesses in complying
with its requirements through the agency’s Regional Small Business Representatives and through
the scientific and administrative staffs within the agency. FDA has provided a Small Business
Guide on the agency’s website at http://www.fda.gov/oc/industry/.
6.

Consequences of Collecting the Information Less Frequently

Data collection occurs occasionally. If the collection is not conducted or is conducted less
frequently, FDA will not be fulfilling its statutorily-mandated duty (sec. 408(1)(5) of the FD&C
Act) to provide firms whose food product(s) are found to contain apparently illegal pesticide
residues an opportunity to demonstrate compliance of the products(s) with the channels of trade
provision.
7.

Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The recommended information collection contained in the guidance generally does not involve:
more than quarterly submission of information to the agency, written responses to the agency in less
than 30 days, submission of more than an original and 2 copies, retention of records for more than
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three years, or the use of statistical methods. However, a firm’s submission of appropriate
documentation to the agency may contain trade secret and commercial confidential information.
This information is protected by FDA as set out below in the response to question 10. In addition, if
for some reason, samples are collected from a firm on a more-than-quarterly basis and these
samples are found to be potentially violative, the firm may wish to report information demonstrating
compliance of such commodities with the channels of trade provision. This would result in a firm
reporting on more than a quarterly basis. Also, chemical pesticide residues may remain in
processed e.g., frozen, food commodities indefinitely. Processed foods are expected to remain in
the channels of trade for up to four years after harvesting. Firms dealing with processed e.g.,
frozen, foods may be asked to make a showing up to four years after the harvesting of the crop.
8.

Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency

In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of June 3, 2014 (79 FR 31944). No comments were received.
9.

Explanation of Any Payment or Gift to Respondents

FDA does not provide any payment or gifts to respondents.
10.

Assurance of Confidentiality Provided to Respondents

Firms whose food product(s) are found to contain apparently illegal pesticide residues may provide
records to FDA to demonstrate compliance of the products(s) with the channels of trade provision
of the FD&C Act. Any records that the agency may copy or take possession of in such event would
be protected from disclosure under the Freedom of Information Act (FOIA) under sections 552(a)
and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations (21 CFR part 20).
11.

Justification for Sensitive Questions

This information collection does not involve any questions that are of a personally sensitive nature.
12.

Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate

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.

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We estimate the burden of this collection of information as follows:
Activity

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of
Total Annual Average Burden
Respondents Responses per
Responses
per Response
Respondent
1
1
1
3

Total Hours

Submission of
3
documentation
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 three 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 average burden per record on the assumption 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.
Table 2.—Estimated Annual Recordkeeping Burden1

1

Activity

No. of
Recordkeepers

No. of Records
per
Recordkeeping

Total Annual
Records

Average
Burden per
Record

Total
Hours

Develop documentation
process

1

1

1

16

16

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 ninety percent
(90%) 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 ten percent (10%) 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 one 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 1/10 of a recordkeeper, we estimate that one recordkeeper will take
16 hours to develop and maintain documentation recommended by the guidance.

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12 b. Annualized Cost Burden Estimate
Gathering the information requested in the guidance and providing it to the agency may be done by
an administrative support employee familiar with batch records and inventory records. We estimate
that the hourly wage for the employee would be $22.62 per hour (corresponding to that of a Federal
government employee at the GS-8, step 1 rate for the Washington-Baltimore locality pay area for
the year 2014). Based on that, and on the total of the burden hours calculated above (16 + 3 = 19),
the annual cost to respondents is $429.78 (19 burden hours x $22.62 per hour). To account for
overhead, this cost is increased by 100 percent, making the total estimated annualized cost to the
respondents $859.56 ($429.78 x 2).
13.

Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There are no capital, start-up, operating, or maintenance costs associated with this collection.
14.

Annualized Cost to Federal Government

This information will be collected in response to potentially-violative samples of commodities
found to contain pesticide residues that do not comply with the pesticide tolerances. Firms
responsible for such samples generally submit, or have an opportunity to submit, information in
their defense to the agency. The recommendations contained in the guidance clarify what
information to submit. We estimate that our review of the submitted information would take five
hours. We estimate the hourly cost for review and evaluation to be $43.09 per hour, the GS13/Step-1 rate for the Washington-Baltimore locality pay area for the year 2014. To account for
overhead, this cost is increased by 100 percent, making the total cost $86.18 per hour. Thus, in the
event of a review, we estimate the cost to the Federal government for the review of the submitted
information would be $430.90 ($86.18/hour x 5 hours).
15.

Explanation for Program Changes or Adjustments

The burden estimate remains unchanged.
16.

Plans for Tabulation and Publication and Project Time Schedule

The agency has no plans for publication of information from this information collection.
17.

Reason(s) Display of OMB Expiration Date is Inappropriate

There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18.

Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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