Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices 1247

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1309]

Final Guidance for Industry: Channels

of Trade Policy for Commodities With

Methyl Parathion Residues; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a final guidance for

industry entitled ‘‘Channels of Trade

Policy for Commodities with Methyl

Parathion Residues.’’ This guidance

presents FDA’s policy for implementing

the channels of trade provision for the

pesticide chemical methyl parathion in

section 408(l)(5) of the Federal Food,

Drug, and Cosmetic Act (the act) as

amended by the Food Quality Protection

Act (FQPA) of 1996. The final guidance

is intended to assist firms in

understanding FDA’s planned approach

to the enforcement of this provision of

the FQPA with regard to residues of

methyl parathion in food.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the final guidance to the

Office of Plant and Dairy Foods and

Beverages (HFS–305), Center for Food

Safety and Applied Nutrition, Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the final

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Michael E. Kashtock, Center for Food

Safety and Applied Nutrition (HFS–

305), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5321, FAX 202–205–4422, email: mkashtoc@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of June 2, 2000 (65 FR 35376),

FDA announced the availability of a

draft version of this guidance for

industry entitled ‘‘Channels of Trade

Policy for Commodities with Methyl

Parathion Residues.’’ The agency has

finalized that draft guidance after

considering the five comments that were

received on the draft version.

In response to a suggestion in a

comment, FDA is specifying in this final

guidance, the method it intends to use

to test for methyl parathion residues in

foods. In response to comments asking

for additional time and stating that firms

need additional time to prepare to make

showings, FDA is providing responsible

parties with an additional 6 months, i.e.,

until July 1, 2001, to prepare, e.g., by

compiling records, to make a showing to

FDA to demonstrate that a processed

food is within the scope of FDA’s

exercise of its enforcement discretion

set forth in this guidance.

Several comments addressed the

approach FDA stated it intended to

follow if it were to find residues of

methyl parathion in multiple ingredient

foods for which all ingredients are

subject to the current Environmental

Protection Agency (EPA) methyl

parathion tolerance revocation action,

e.g., an apple-pear juice. The comments

stated that the approach taken in the

draft is not consistent with current FDA

policy in a related situation regarding

pesticide residues in multiple

ingredient foods. Under existing FDA

policy, if FDA finds a pesticide residue

in a multiple ingredient food, e.g.,

mixed vegetables, in which there is a

tolerance for the pesticide in some, but

not all of the ingredients, FDA does not

ask the responsible firm to demonstrate

that the residue is not present in any of

the ingredients for which there is no

tolerance.

In response to these comments, FDA

is revising its planned approach in this

final guidance. If FDA finds a residue of

methyl parathion in such a multiple

ingredient food, e.g., apple-pear juice, to

be within the scope of FDA’s exercise of

enforcement discretion, the responsible

party should demonstrate that at least

one of the food’s ingredients could bear

the methyl parathion residue as a result

of a lawful application or use of this

pesticide chemical. However, if the

responsible party makes that showing,

FDA does not intend to ask the

responsible party to provide additional

documentation showing that other

ingredients in the food were not the

source of the residue of methyl

parathion.

FDA has also added additional

examples in the final guidance on the

approach it intends to follow if it finds

methyl parathion residues in multiple

ingredient foods in which some

ingredients are subject to the current

EPA methyl parathion tolerance

revocation action and other ingredients

are subject to tolerances that remain in

effect or are not subject to a tolerance at

all.

A comment asked if FDA considered

whether methyl parathion could persist

in the soil and transfer into crops grown

after legal application of this pesticide

was terminated by EPA. FDA has

worked closely with EPA in developing

this guidance, and EPA has given no

indication to FDA that residues of

methyl parathion persist in the

environment such that a food could

contain residues of methyl parathion

resulting from the application of this

pesticide to a previously grown crop.

Thus, FDA intends to assume that any

residue of methyl parathion found on a

food results from application of the

pesticide to the crop used to produce

the analyzed food.

In response to a request in a comment,

FDA, in the final guidance, has

provided an example of a situation

whereby FDA could come to possess

information indicating that there is a

reasonable possibility that a residue,

that is within the former tolerance,

resulted from application of the

pesticide to the crop after December 31,

1999, which would constitute an

unlawful use of methyl parathion.

Finally, in response to comments

expressing concern that food retailers

would reject food rather than accept the

potential burden of making a showing as

the ‘‘responsible party,’’ the agency

advises that under its compliance

program for pesticide residues in

domestic foods (FDA monitors pesticide

residues in both raw agricultural

commodities and processed foods in

interstate commerce under this

program), samples for routine

monitoring purposes are generally not

collected at the retail level. The program

directs that growers or packing sheds

are the preferred sites for sampling

fruits and vegetables. Thus, FDA does

not expect that in the normal course of

business, retailers will be in the role of

the ‘‘responsible party’’ under this

policy.

This final guidance is being issued as

a level 1 guidance, consistent with

FDA’s policy for good guidance

practices as set out in the Federal

Register of September 19, 2000 (65 FR

56468). This guidance represents the

agency’s current thinking on the

channels of trade provision and how

this provision relates to FDA-regulated

products with methyl parathion

residues. It does not create or confer any

rights for or on any person and does not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statutes

and regulations.

1248 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Notices

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the final

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The final

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.cfsan.fda.gov.

Dated: December 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–368 Filed 1–4–01; 8:45 am]

BILLING CODE 4160–01–F