[Federal Register Volume 65, Number 107 (Friday, June 2, 2000)]
[Notices]
[Pages 35376-35379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13813]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1309]


Draft Guidance for Industry: Channels of Trade Policy for 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 proposed guidance document entitled ``Guidance for 
Industry: Channels of Trade Policy for Commodities With Methyl 
Parathion Residues'' (the proposed guidance). The proposed guidance 
presents FDA's policy for implementing the channels of trade provision 
for the pesticide chemical methyl parathion in of the Federal Food, 
Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality 
Protection Act (FQPA) of 1996. The proposed 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 concerning this guidance and the 
information collection by August 1, 2000.

ADDRESSES: Submit written comments concerning the proposed guidance and 
the collection of information provisions to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit written requests for single copies of 
the proposed guidance entitled ``Guidance for Industry: Channels of 
Trade Policy for Commodities With Methyl Parathion Residues'' to Donna 
L. Myers, Center for Food Safety and Applied Nutrition (HFS-306), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-
4681. Send one self-adhesive address label to assist that office in 
processing your request. Comments and requests for copies should be 
identified with the docket number found in brackets in the heading of 
this document. A copy of the proposed 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.


FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4681, FAX 202-205-4422, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On August 3, 1996, the FQPA was signed into law. This law, which 
amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and the FFDCA, established a new safety standard for pesticide residues 
in food, with an emphasis on protecting the health of infants and 
children. In accordance with the FQPA, the Environmental Protection 
Agency (EPA), the agency responsible for regulating the use of 
pesticides (under FIFRA) and establishing tolerances for residues of 
pesticide chemicals in food commodities (under the FFDCA), is in the 
process of reassessing the pesticide tolerances and exemptions that 
were in effect when the law was signed. When the determination is made 
that a pesticide's tolerance level does not meet the safety standard 
set forth by the FQPA, the registration for the pesticide may be 
canceled 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 FFDCA (21 U.S.C. 
346a(l)(2)), when the registration for a pesticide is canceled or 
modified due in whole or in part to 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 meat, poultry, and

[[Page 35377]]

certain egg 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 FQPA address 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 FFDCA) states the following:
    PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF 
PESTICIDE.--Not withstanding any other provision of this Act, if a 
tolerance or exemption for a pesticide chemical residue in or on a food 
has been revoked, suspended, or modified under this section, an article 
of that food shall not be deemed unsafe solely because of the presence 
of such pesticide chemical residue in or on such food if it is shown to 
the satisfaction of the Secretary that--
      (A) the residue is present as the result of an application or use 
of a pesticide at a time and in a manner that was lawful under the 
Federal Insecticide, Fungicide, and Rodenticide Act; and
      (B) the residue does not exceed a level that was authorized at 
the time of that application or use to be present on the food under the 
tolerance, exemption, food additive regulation, or other sanction then 
in effect under this Act; unless, in the case of any tolerance or 
exemption revoked, suspended, or modified under this subsection or 
subsection (d) or (e), the Administrator has issued a determination 
that consumption of the legally treated food during the period of its 
likely availability in commerce will pose an unreasonable dietary risk.
    As part of the tolerance reassessment process mandated by the FQPA, 
in a cancellation order published in the Federal Register of October 
27, 1999 (64 FR 57877), EPA cancelled, effective on the same date, 
several registered food uses for the pesticide methyl parathion (Ref. 
1). These canceled food uses are as follows: Apples, artichokes, beets 
(greens alone), beets (with or without tops), broccoli, brussels 
sprouts, carrots, cauliflower, celery, cherries, collards, grapes, 
kale, lentils, kohlrabi, lettuce, mustard greens, nectarines, peaches, 
pears, plums (fresh prunes), rutabagas (with or without tops), rutabaga 
tops, spinach, succulent beans and peas, tomatoes, turnips (with or 
without tops), turnips greens, vegetables leafy Brassica (cole), and 
vetch.
    Under the terms of the cancellation, the application of the 
pesticide on the crops specified became unlawful after December 31, 
1999. This action was precipitated by EPA's determination that the 
dietary risks from exposure to methyl parathion exceeded the safety 
standard under the FFDCA. Consistent with section 408(l)(2) of the 
FFDCA, EPA is proposing in this issue of the Federal Register to revoke 
the pesticide tolerances for methyl parathion corresponding to the 
canceled food uses.
    FDA anticipates that some foods bearing methyl parathion residues 
resulting from lawful application of this pesticide will remain in the 
channels of trade after the revocation of the applicable tolerance for 
methyl parathion (Refs. 2 through 4). If FDA encounters such a food 
bearing a residue of methyl parathion, it intends to address the 
situation in accordance with this proposed guidance. FDA has developed 
this proposed guidance to set forth its policy for how FDA plans to 
approach its enforcement of the channels of trade provision with 
respect to the pesticide chemical methyl parathion.
    With this document, FDA is announcing the availability of the 
proposed guidance. The proposed guidance represents FDA's current 
thinking on its planned enforcement approach to the channels of trade 
provision and how such 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. The 
proposed guidance is being distributed for comment purposes, in 
accordance with FDA's policy for Level 1 Good Guidance Practices 
documents as set out in the Federal Register of February 27, 1997 (62 
FR 8961).

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Suggested Documentation for Demonstrating Compliance With 
the Channels of Trade Provision
    Description: Under the pesticide tolerance reassessment process 
that EPA was mandated to carry out under the FQPA, EPA has proposed to 
revoke the tolerances for the pesticide chemical methyl parathion on 
several food commodities. The FQPA includes a provision in section 
408(l)(5) of the FFDCA, referred to as the ``channels of trade 
provision,'' that addresses the circumstances under which a food is not 
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 methyl parathion residues (within the former 
tolerance) after the tolerance for the pesticide chemical has been 
revoked, will be able to demonstrate that such food was packed or 
processed on or prior to December 31, 2000, by providing appropriate 
documentation to the agency as discussed in the proposed guidance. FDA 
is not suggesting that firms maintain a certain set list 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 packed or processed.
    Examples of documentation which FDA anticipates will serve this 
purpose may be divided into two categories: (1) Documentation 
associated with packing codes, batch records, and inventory records, 
and (2) other types of

[[Page 35378]]

documentation. The first category includes the types of documents that 
many food processors routinely generate as part of their basic food-
production operations. The second category may include documentation 
that processors generate for the express purpose of compiling 
information that may satisfy the showing required in the channels of 
trade provision, such as copies of product specification requirements 
(requesting that the supplier not provide commodities treated with 
methyl parathion to the processor), written acknowledgement from the 
supplier that it intends to comply with the above request, and records 
demonstrating that the processor carried out an auditing program (e.g., 
spot checks) to verify that incoming commodities did not contain 
residues of methyl parathion.
    Description of Respondents: The likely respondents to this 
collection of information are firms in the produce and food-processing 
industries who handle food products that may contain residues of methyl 
parathion after the tolerances for this pesticide chemical have been 
revoked.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden \1\
------------------------------------------------------------------------
                      Annual
     No. of       Frequency per   Total Annual    Hours per      Total
   Respondents       Response      Responses      Response       Hours
------------------------------------------------------------------------
67                1              67             3             201
------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.


           Table 2.--Estimated Annual Recordkeeping Burden \1\
------------------------------------------------------------------------
                  Annual Frequency     Total
     No. of              per          Annual       Hours per      Total
  Recordkeepers     Recordkeeping     Records    Recordkeeper     Hours
------------------------------------------------------------------------
333               1                 333         20              6,660
------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    Estimates for the annual reporting burden were determined by using 
the maximum number of samples collected throughout a year that FDA 
believes may be found to contain methyl parathion residues. Because all 
residues are expected to have dissipated from nonfrozen foods by the 
time FDA intends to question firms about when a food product was packed 
or processed (i.e., after December 31, 2000), FDA included only frozen 
food in its estimate (i.e., processors of foods stored under 
refrigerated and ambient conditions were excluded) (Ref. 2). Although 
residues within the former tolerance resulting from legal application 
of methyl parathion are not expected to be found in nonfrozen foods 
after December 31, 2000, under the channels of trade provision, firms 
will have an opportunity to make a showing that any such food was 
packed or processed on or before this date.
    Considering the variation in and effects of food handling, 
particularly with regard to the time between pesticide application and 
freezing, FDA estimated that potentially half of all frozen food 
products sampled may contain methyl parathion residues, and therefore, 
the responsible party, under the approach set forth in this guidance, 
would be subject to the reporting requirement since it would be the 
burden of the responsible party to demonstrate that food found to 
contain methyl parathion residues within the former tolerance was 
packed or processed on or before December 31, 2000.
    When determining the annual recordkeeping burden, importers and 
domestic processors of frozen food commodities affected by the 
revocation of the pesticide chemical methyl parathion were considered. 
FDA estimated that most firms (at least 90 percent) maintain (or 
maintain access to) Category I documentation (packing codes, batch 
records, inventory records, etc.) as part of their basic food 
production and/or import operations. It was presumed that the 10 
percent of firms which do not maintain such documentation would likely 
begin maintaining (or maintaining access to) Category II documentation 
(other types of documentation, such as certification from the supplier 
that products do not contain methyl parathion) rather than instituting 
a system to begin maintaining Category I documentation. This being the 
case, a portion of the recordkeeping burden was calculated as the time 
required for the 10 percent of firms not currently maintaining Category 
I documentation, to develop and maintain (or maintain access to) 
Category II documentation.
    As discussed in detail in the guidance, some firms (i.e., frozen 
juice manufacturers) may decide to maintain Category II documentation 
in addition to Category I documentation, as part of the showing under 
the channels of trade provision. FDA estimated that firms fitting this 
description represent approximately one third of the frozen fruit, 
vegetable, and juice-processing industry. Therefore, a portion of the 
annual recordkeeping burden estimate was calculated based upon the time 
required for these firms to develop and maintain Category II 
documentation.
    Because all residues are expected to have dissipated from nonfrozen 
foods by the time FDA intends to ask for a showing under section 
408(l)(5) of the FFDCA (i.e., after December 31, 2000), FDA used the 
number of frozen food processors when determining the annual 
recordkeeping burden. As with the annual reporting burden estimate, 
although nonfrozen food processors are entitled to make a showing under 
the channels of trade provision, they were excluded from this estimate 
because based upon residue dissipation estimates provided by EPA (Ref. 
2), methyl parathion residues within the former tolerance resulting 
from legal application are not expected to be found in nonfrozen 
commodities after December 31, 2000.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the proposed guidance by August 1, 
2000. 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 
proposed guidance may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday. An electronic version of this draft 
guidance is available on the Internet at http://www.fda.gov/.

IV. References

    The following references have been placed on display at the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Cancellation Order from the Environmental Protection Agency 
Canceling the Registration for Methyl Parathion Effective October 
27, 1999 (www.epa.gov/fedrgstr/EPA-PEST/1999/October/Day-27/p27800.htm), Federal Register (64 FR 57877), October 27, 1999.
    2. Environmental Protection Agency, Residue Dissipation Chart, 
Draft Estimates of Methyl Parathion Dissipation Rates in Commodities 
Under Various Storage Conditions, 1999.
    3. American Frozen Food Institute, Letter to FDA Estimating the 
Amount of Time Frozen Fruits and Vegetables Are Likely to Remain in 
Commerce Prior to Being

[[Page 35379]]

Purchased by the Consumer (i.e., How Long They Are Likely to Remain 
in the Channels of Trade), October 26, 1999.
    4. National Food Processors Association, Letter to FDA 
Estimating the Amount of Time Processed Foods Are Likely to Remain 
in the Channels of Trade, August 23, 1999.

    Dated: May 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-13813 Filed 6-1-00; 8:45 am]
BILLING CODE 4160-01-F