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Imidacloprid - Proposed Pesticide Tolerances on Cottonseed and Cotton Gin Byproducts 11/95

[Federal Register: December 6, 1995 (Volume 60, Number 234)]
[Proposed Rules]
[Page 62364-62366]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 3F4169 and FAP 3H5655/P628; FRL-4971-7] RIN 2070-AC18
Imidacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish permanent tolerances for residues of
the insecticide (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) (also known as imidacloprid) and it metabolites in
or on cottonseed and cotton gin byproducts, to revoke the existing feed
additive tolerance for imidacloprid on cotton meal, and to establish a
maximum residue limit for imidacloprid on cottonseed meal. Bayer Corp.
(formerly Miles, Inc.) submitted petitions pursuant to the Federal
Food, Drug Cosmetic Act (FFDCA) requesting these regulations to
establish certain maximum permissible levels for residues of the
insecticide.

DATES: Comments, identified by the document control number, [PP 3F4169
and FAP 3H5655/P628], must be received on or before January 5, 1996.

ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted
as a comment concerning this document may be claimed confidential by
marking any part or all of that information as "Confidential Business
Information" (CBI). Information so marked will not be disclosed except
in accordance with procedures set fourth 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice. All Written comments will be
available for public inspection in Rm. 1132 at the addressed given
above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
    Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be accepted
on disks in WordPerfect in 5.1 file format or ASCII format. All comments and
data in electronic form must be identified by the docket number [PP 3F4169 and
FAP 3H5655/P628]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic comments on this proposed rule may be
filed online at many Federal Depository Libraries. Additional information on
electronic submissions can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 207, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6386; e-mail:
                edwards.dennis@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Pursuant to petitions from Miles, Inc., EPA issued final rules
establishing pesticide tolerances under section 408 of the Federal
Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a, for residues of
the insecticide (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on the raw agricultural commodities apples at
0.5 part per million (ppm), potatoes at 0.3 ppm, and cottonseed at 6.0
ppm. Based on a feed additive petition (FAP) 3H5655 from Miles, Inc.,
EPA established food or feed additive regulations under FFDCA section
409, 21 U.S.C. 348, for the combined residues of imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety, all expressed as
imidacloprid, on apple pomace (wet or dried) at 3 ppm, on potato chips
at 0.4 ppm, on potato waste at 0.9 ppm, and on cottonseed meal at 9.0
ppm. The tolerances for cottonseed and cottonseed meal were established
as time-limited tolerances and are due to expire on November 30, 1996
(see the Federal Register of November 30, 1994 (59 FR 61278)).

    The reason the cottonseed and cottonseed meal tolerances were
established as 2-year time-limited tolerances was to enable Bayer to
complete additional cotton residue trials and present a final report.
On June 2, 1994, the Agency issued a guidance document on crop residue
trials. Among other things, this document provided guidance on the
number and location of domestic crop field trials for establishment of
pesticide residue trials. Based on this guidance document, the Agency
determined that additional residue trials were needed and residue data
on gin trash were required to fully support the cotton tolerances.
    On March 31, 1995, Bayer submitted the additional residue studies.
A request was also submitted to establish a tolerance for cotton gin
byproducts. These data have been reviewed and determined to be adequate
to support both the proposed cotton gin byproducts tolerance and the
removal of the expiration date for the cottonseed and cottonseed meal
tolerances.
    EPA, however, has determined a section 409 feed additive tolerance
is no longer necessary to prevent cottonseed meal from being deemed
adulterated, and, therfore, EPA is preparing to revoke the cottonseed
meal tolerance. Addtionally, EPA is proposing to establish a maximum
residue limit for imidacloprid residues in cottonseed meal to simipifly
enforcement.

II. Statutory Background

    The FFDCA, 21 U.S.C. 301 et seq., authorizes the establishment by
regulation of maximum permissible levels of pesticides in foods. Such
regulations are commonly referred to as "tolerances." Without such a
tolerance or an exemption from the requirement of a tolerance, a food
containing a pesticide residue is "adulterated" under section 402 of
the FFDCA and may not be legally moved in interstate commerce. 21
U.S.C. 331, 342. EPA was authorized to establish pesticide tolerances
under Reorganization Plan No. 3 of 1970. 5 U.S.C. App. at 1343 (1988).
Monitoring and enforcement of pesticide tolerances are carried out by
the U.S. Food and Drug Administration (FDA) and the U.S. Department of
Agriculture (USDA).
    The FFDCA has separate provisions for tolerances for pesticide
residues on raw agricultural commodities and for residues on processed
food. For pesticide residues in or on raw commodities, EPA establishes
tolerances, or exemptions from tolerances when appropriate, under
section 408 of the act. 21 U.S.C. 346a. EPA regulates pesticide
residues in processed foods under section 409 which pertains to "food
additives." 21 U.S.C. 348. Maximum residue regulations established
under section 409 are commonly referred to as food additive tolerances.
Section 409 food additive tolerances are needed, however, only for
certain pesticide residues in processed food. Under section 402(a)(2)
of the FFDCA, a pesticide residue in processed food will not render the
food adulterated if the residue results from application of the
pesticide to a raw commodity consistent with a section 408 tolerance
and the residue in the processed food when "ready to eat" has been
removed to the extent possible by good manufacturing processes and is
below the tolerance set under section 408. This exemption in section
402(a)(2) is commonly referred to as the "flow-through" provision
because it allows the section 408 raw food tolerance to flow through to
the processed food form.

III. Proposed Removal of Expiration Date from Cottonseed Tolerance
and Establishment of Cotton Gin Byproduct Tolerance

    The scientific data submitted in the petition and other relevant
material have been evaluated regarding the Miles' request to remove the
expiration date from the cottonseed tolerance and to establish a
tolerance for cotton gin byproducts. The toxicological data considered
in support of the tolerance include:
    1. A three-generation rat reproduction study with a no-observed-
effect level (NOEL) of 100 ppm (8 mg/kg/bwt); rat and rabbit teratology
studies were negative at doses up to 30 mg/kg/ bwt and 24 mg/kg/bwt,
respectively.
    2. A 2-year rat feeding/carcinogenicity study that was negative for
carcinogenic effects under the conditions of the study and had a NOEL
of 100 ppm (5.7 mg/kg/bwt in male and 7.6 mg/kg/bwt female) for
noncarcinogenic effects that included decreased body weight gain in
females at 300 ppm and increased thyroid lesions in males at 300 ppm
and females at 900 ppm.
    3. A 1-year dog feeding study with a NOEL of 1,250 ppm (41/mg/kg/bwt).
    4. A 2-year mouse carcinogenicity study that was negative for
carcinogenic effects under conditions of the study and that had a NOEL
of 1,000 ppm (208/mg/kg/day).
    There is no cancer risk associated with exposure to this chemical.
Imidacloprid has been classified under "Group E" (no evidence of
carcinogenicity for humans) under EPA's cancer Assessment Guidelines by
the Office of Pesticide Programs (OPP) Reference Dose (RFD) Committee.
    The reference dose (RfD), based on the 2-year rat feeding/
carcinogenic study with a NOEL of 5.7 mg/kg/bwt and 100-fold
uncertainty factor, is calculated to be 0.057 mg/kg/bwt. The
theoretical maximum residue contribution (TMRC) from published uses is
0.008088 mg/kg/day. This represents 14% of the RfD for the overall U.S.
population. For exposure of the most highly exposured subgroup in the
population, children (ages 1 to 6 years), the TMRC is 0.016735 mg/kg/day. This
is equal to 30% of RfD. The proposed cotton gin byproduct tolerance will not
increase the TMRC. Dietary exposure from the existing uses and proposed
uses will not exceed the reference dose for any subpopulation
(including infants and children) based on the information available
from EPA's Dietary Risk Evaluation System.
    The nature of the residue in plants and livestock is adequately
understood. The residues of concern are imidacloprid and its
metabolites that contain the 6-chloropyridinyl moiety, all calculated
as imidacloprid. The analytical methods are common moiety methods for
imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety using permanganate oxidation, silyl derivatization, and
capillary GC-MS selective ion monitoring. Adequate geographically
representative magnitude of the residue crop field trial data for
imidacloprid on cotton indicate that residues of total imidacloprid
will not exceed the proposed tolerances when the formulation is used as
directed. Based on the results of the imidacloprid bovine and poultry
feeding studies, finite imidacloprid residues will occur in meat, milk,
poultry, and eggs from feeding of imidacloprid-treated feed items, or
their processed feed items, when the formulations are used as directed.
Appropriate secondary tolerances are established.
    There are currently no actions pending against the continued
registration of this chemical.
    This pesticide is considered useful for the purposes for which the
tolerances are sought. Based on the information and data considered,
the Agency has determined that the tolerances established by amending
40 CFR part 180 would protect the public health. Therefore, it is
proposed that the tolerances be established as set forth below.

IV. Proposed Revocation of the Feed Additive Tolerance for
Cottonseed Meal

    In June 1995 (60 FR 31300, June 14, 1995), EPA issued a revised
policy concerning when section 409 food and feed additive tolerances
were needed to prevent the adulteration of foods and animal feeds.
Under EPA's revised policy, a section 409 tolerance is necessary for
pesticide residues in processed food when it is likely that the level
of some residues of the pesticide will exceed the section 408 tolerance
level in "ready to eat" processed food. Of particular relevance to
the imidacloprid feed additive tolerance is EPA's decision to interpret
the term "ready to eat" processed food as food ready for consumption
"as is" without further preparation. For foods that are found to be
not "ready to eat," EPA takes into account the dilution of residues
that occurs in preparing a "ready to eat" food.
    EPA has determined that cottonseed meal is not a "ready to eat"
animal feed. EPA has found no evidence that cottonseed meal is fed to
livestock as a stand-alone feedstock. Rather, cottonseed meal is used
as an ingredient in animal feeds. As such, cottonseed meal can
constitute up to 50 percent of an animal feed.
    The section 408 tolerance for imadicloprid on cottonseed is 6 parts
per million (ppm). The highest residue found in crop field trials for
imidacloprid on cotton was 5.2 ppm. A processing study showed that in
producing cottonseed meal residues concentrated 50 percent (a
concentration factor of 1.5X). Thus, given this information, it is
likely that imadicloprid residues of 7.8 ppm (1.5 X 5.2) could occur in
cottonseed meal. However, to project what residues are likely in
"ready to eat" animal feed containing cottonseed meal the 7.8 ppm
level must be divided by 2 to allow for dilution occurring when
cottonseed meal is added to other ingredients in the preparation of
animal feed. Once this dilution is taken into account, the likely
residue of imidacloprid in animal feed would not be expected to exceed
3.9 ppm. Since this is below the section 408 tolerance level, animal
feed containing such residue levels would not be adulterated, and no
section 409 tolerance is needed. Accordingly, EPA proposes to revoke
the section 409 feed additive tolerance for imidacloprid in cottonseed
meal.

V. Proposed Establishment of a Maximum Residue Level of
Imidacloprid Residues in Cottonseed Meal

    In the June 1995 policy announcement, EPA noted that it generally
would establish maximum residue levels (MRLs) under FFDCA section 701
for not-ready-to-eat foods where such foods could contain residues
exceeding the section 408 tolerance. EPA's rationale was that such MRLs
are important to the efficient enforcement of the FFDCA. It is far less
resource intensive for FDA and USDA, which are the Federal agencies
which regulate pesticide residue levels in foods, to monitor residue
levels in the bulk commodities used in preparing ready-to-eat foods
than in the myriad of ready-to-eat foods manufactured from such
commodities.
    MRLs will enforce the statutory requirements that, where no food
additive tolerance has been established, pesticide residues in
processed food resulting from application of the pesticide to the
precursor raw commodity render the food adulterated unless the
pesticide was used in conformity with the applicable section 408
tolerance and the pesticide residue has been removed to the extent
possible in good manufacturing practice. 21 U.S.C. 342(a)(2)(C). Thus,
MRLs will reflect the maximum residue in processed food consistent with
a legal level of residues being present on the precursor raw commodity
and the use of good manufacturing practices. Processed foods not in
compliance with an applicable MRL will be deemed adulterated under
section 402 of the act.
    EPA will compute the MRL by multiplying the maximum residue found
in the raw commodity in field trials by the concentration factor
determined in processing studies using good manufacturing practices. As
noted, the maximum residue from the imidacloprid field trials is 5.2
ppm and the concentration factor for processing is 1.5X. Multiplying
5.2 ppm by 1.5 yields a product of 7.8 ppm. EPA believes it is
appropriate to round 7.8 ppm up to 8 ppm and proposes 8 ppm as the MRL
for imidacloprid residues in cottonseed meal. For purposes of
enforcement of the MRL, the same analytical method used for enforcement
of the section 408 tolerances should be used.
    EPA is proposing to place this MRL in existing part 186 of title 40
of the Code of Federal Regulations rather than creating a new part of
title 40. Currently, 40 CFR part 186 contains section 409 feed additive
tolerances organized by pesticide. EPA believes it will be clearer to
the regulated community and to enforcement personnel if all regulations
pertaining to residue levels of a pesticide in animal feeds are located
in the same part of the Code of Federal Regulations. Because EPA is
proposing to expand the type of regulation that would be included in
part 186, EPA proposes modifying the title of part 186 to "Pesticides
in Animal Feeds" to reflect that change.

VI. Public Participation

    Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication of
this document in the Federal Register that the portion of this rulemaking
proposal concerning establishment, amendment, or revocation of tolerances
under section 408 be referred to an Advisory Committee in accordance with
section 408(e) of FFDCA.
    Interested persons are invited to submit written comments on the
proposed regulations. Comments must bear a notation indicating the
document control number, [PP 3F4169 and FAP 35655/P628]. All written
comments filed in response to this petition will be available in the
Public Response and Program Resources Branch, at the address given
above from 8 a.m. to 4:30 p.m., Monday through Friday, except legal
holidays.

VII. Administrative Matters

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is "significant"
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
"significant" as those actions likely to lead to a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities (also known as
"economically significant"); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not "significant" and is therefore not subject to
OMB review.
    Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950). EPA has treated
regulations simular to the establishment of tolerances as also not
having a significant economic impact on substantial number of small
entities. Therefore, the proposed MRL is not expected to have such
impact.

List of Subjects in 40 CFR Parts 180 and 186

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Feed additives, Pesticides and pests,
Reporting and recordkeeping requirements.

    Dated: November 9, 1995.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR parts 180 and 186 be amended
as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as
follows:

    Authority: 21 U.S.C. 346a and 371.

    b. In Sec. 180.472, by amending paragraph (a) by adding and
alphabetically inserting the following new entries and by removing
paragraph (b) and designating it as reserved, to read as follows:

Sec. 180.472   1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine; tolerances for residues.

    (a) *  *  *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Cotton, gin byproducts.....................................       4
Cottonseed.................................................       6

                                * * * * *
------------------------------------------------------------------------

    (b) [Reserved]
* * * * *

PART 186--[AMENDED]

    2. In part 186:
    a. By revising the title of part 186 to read as follows:

Part 186--Pesticides in Animal Feed

    b. The authority citation for part 186 is revised to read as follows:

    Authority: 21 U.S.C. 342, 348, and 701.

    c. In Sec. 186.900, by revising paragraph (b), to read as follows:

Sec. 186.900   1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolinimine.

* * * * *
    (b) A maximum residue level regulation is established for residues
of the insecticide 1-[(6-choro-3-pryidinyl)methyl]-N-nitro-2-
imidazolidinimine in or on the following feed resulting from
application of the insecticide to cotton:

------------------------------------------------------------------------
                                                              Parts per
                            Food                               million
------------------------------------------------------------------------

Cottonseed meal............................................       8

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

This regulation reflects the maximum level of residues in cottonseed
meal consistent with use of 1-[(6-chloro-3-pyridinyl) methyl]-N-nitro-
2-imidazolidinimine on cotton in conformity with Sec. 180.472 of this
chapter and with the use of good manufacturing practices.
* * * * *