Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48095 

Dated: October 3, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22288 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0094] 

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Tolerances Have Been Revoked, 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 

Pursuant to Dietary Risk 

Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by November 

15, 2017. 

ADDRESSES: 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: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0562. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

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Tolerances Have Been Revoked, 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 

Pursuant to Dietary Risk 

Considerations 

OMB Control Number 0910–0562— 

Extension 

The Food Quality Protection Act of 

1996, 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 that 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. 

We 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 

that were lawful under FIFRA. 

In the Federal Register of May 18, 

2005 (70 FR 28544), we 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 FDA’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 under 

dietary risk considerations. The 

guidance can be found at the following 

link: https://www.fda.gov/Food/ 

GuidanceRegulation/ 

GuidanceDocuments

RegulatoryInformation/ 

ChemicalContaminantsMetalsNatural

ToxinsPesticides/ucm077918.htm. We 

anticipate 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 we 

encounter food bearing a residue of a 

pesticide chemical for which the 

tolerance has been revoked, suspended, 

or modified, we intend to address the 

situation in accordance with provisions 

of the guidance. In general, we 

anticipate that the party responsible for 

food found to contain pesticide 


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48096 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

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 FDA as 

discussed in the guidance document. 

We are not suggesting that firms 

maintain an inflexible set of documents 

where anything less or different would 

likely be considered unacceptable. 

Rather, we are 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 that we 

anticipate 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. 

Accordingly, under the PRA, we are 

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. 

In the Federal Register of May 25, 

2017 (82 FR 24133), we published a 60- 

day notice requesting public comment 

on the proposed extension of this 

collection of information. One comment 

was posted to the docket but did not 

address any of the four information 

collection topics solicited in our notice 

and so it is not discussed here. 

We therefore estimate the burden of 

this collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Submission of documentation .............................................. 1 1 1 3 3 

1There 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 under 

dietary risk considerations in the next 3 

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 under 

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 hours per 

response on the assumption that the 

information requested in the 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 BURDEN 1

Activity Number of 

recordkeepers 

Number of 

records 

per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Develop documentation process ......................................... 1 1 1 16 16 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In determining the estimated annual 

recordkeeping burden, we believe 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 per 

record. We retain our prior estimate of 

16 hours per record for the 

recordkeeping burden. As shown in 

table 1 of this document, we estimate 

that one respondent will make one 

submission per year. Although we 

estimate that only 1 out of 10 firms will 

not be currently maintaining the 

necessary documentation, to avoid 

counting the recordkeeping burden for 

the 1 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. 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22285 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2017–N–4951] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 


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