0562 ss 2017 Extension

United States Food and Drug Administration
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for Which Tolerances Have Been Revoked, Suspended, or Modified by the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 Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports agency guidance. 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 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 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.
FDA’s 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” 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
/ChemicalContaminantsMetalsNaturalToxinsPesticides/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.
We therefore request OMB approval of the information collection provisions found in the
guidance document and discussed in this supporting statement.
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,

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suspended, or modified are in compliance with the channels of trade provision of the
FD&C Act.
Description of Respondents: Respondents are typically from the private sector (e.g., forprofit businesses) engaged 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. FDA estimates that about 100% of the records will be maintained
electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that 10% of respondents are small businesses who will use electronic
means to fulfill the agency’s requirement. However, because of the potential risks to
public health, there are no exemptions or exceptions from obligations of respondents
under the applicable laws associated with the information collection discussed 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 discussed in the guidance is consistent with Section 408(l)(5) of the FD&C
Act.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Special circumstances in the collection of information may occur when 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 discussed below in
Question 10. In addition, if for some reason samples are collected from a firm on a morethan-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

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commodities) indefinitely. Processed foods are expected to remain in the channels of trade
for up to four years after harvesting. Firms dealing with processed 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 May 25, 2017 (82 FR 24133). One comment was posted to the
docket but did not address any of the four information collection topics solicited in our
notice so it is not discussed here.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gifts to respondents to the information collection.
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
We estimate the burden of this collection of information as follows:
Table 1 – Estimated Annual Reporting Burden1
Activity

Submission of
documentation

No. of
No. of
Respondents Responses per
Respondent
1
1

Total Annual
Responses
1

Average
Burden per
Response
3

Total
Hours
3

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

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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 base 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 1 – Estimated Annual Recordkeeping Burden1
Activity

Develop
documentation process

No. of
No. of
Recordkeepers Records per
Recordkeeper
1
1

Total Annual
Records
1

Average
Burden per
Record
16

Total
Hours
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, we estimated that at least 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 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 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 1/10 of a recordkeeper, we estimate that 1 recordkeeper will take
16 hours to develop and maintain documentation recommended by the guidance.
12b. 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 $23.85 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 2017). Based on that, and on the total
of the burden hours calculated above (16 + 3 = 19), the annual cost to respondents is
$453.15 (19 burden hours x $23.85 per hour). To account for overhead, this cost is
increased by 100 percent, making the total estimated annualized cost to the respondents
$906.30 ($453.15 x 2).

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Activity
Gathering information and
providing to FDA

Total Burden
Hours
19

Hourly Wage
Rate
$47.70

Total Respondent
Costs
$906.30

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this collection.
14. Annualized Cost to the 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 $45.42 per hour, the GS-13/Step-1 rate for the Washington-Baltimore
locality pay area for the year 2017. To account for overhead, this cost is increased by
100 percent, making the total cost $90.84 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 $454.20 ($90.84/hour x 5 hours).
15. Explanation for Program Changes or Adjustments
The burden estimate has not changed from our previous estimate.
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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