[Federal Register Volume 59, Number 94 (Tuesday, May 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12102]
[[Page Unknown]]
[Federal Register: May 17, 1994]
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DEPARTMENT OF THE TREASURY
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4349/P582; FRL-4865-5]
RIN No. 2070-AC18
Pesticide Tolerance for Amitraz
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish a time-limited tolerance
for residues of the insecticide/miticide amitraz (N'-[2,4-
dimethylphenyl]-N-[[(2,4-dimethylphenyl)-imino]methyl]-N-
methylmethanimidamide) and its metabolites N-(2,4-dimethylphenyl)-N-
methyl formamide and N-(2,4-dimethylphenyl)-N-methylmethanimidamide
(both calculated as the parent) in or on dried hops at 75 ppm, with an
expiration date of 2 years after the beginning date of a final rule.
Nor-Am Chemical Co. submitted a petition to EPA to establish the
maximum permissible levels of residues of the insecticide/miticide in
or on the commodity.
DATES: Comments, identified by the document control number [PP 4E4349/
P582], must be received on or before June 16, 1994.
ADDRESSES: Comments may be submitted to: Public Docket and Freedom of
Information Section, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person,
bring comments to: Rm. 1128, 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
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 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. 1128 at
the address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), 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.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of December 13, 1991 (56 FR 65080), which announced
that Nor-Am Chemical Co., Little Falls Centre One, 2711 Centerville
Rd., Wilmington, DE, 19808, had submitted a food additive petition (FAP
2H5618) to EPA requesting that the Administrator, pursuant to sections
408(d) and 409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), 348, establish a tolerance for the insecticide/miticide
amitraz (N'[2,4-dimethylphenyl]-N-[[(2,4-dimethylphenyl)imino]methyl]-
N-methyl-methanimidamide) and its metabolites N-(2,4-dimethylphenyl)-N-
methyl formamide and N-(2,4-dimethylphenyl)-N-methylmethanimidamide
(both calculated as the parent compound) in or on imported dried hops
at 75 ppm. There were no comments received in response to the initial
notice of filing.
Prior to this proposal, EPA had not proposed to establish a
tolerance for amitraz on hops because dried hops have been considered a
processed food requiring a section 409 tolerance and EPA was concerned
that a section 409 tolerance for amitraz might be prohibited by section
409's Delaney anti-cancer clause. Recently, EPA reclassified dried hops
as a raw agricultural commodity. Tolerances for raw agricultural
commodities are set under section 408 of the FFDCA, which contains no
Delaney clause.
EPA has been considering for some time whether dried hops are
properly classified as a processed food. The FFDCA defines a RAC as
``food in its raw or natural state, including all fruits that are
washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing,'' 21 U.S.C. 321 (r). Elsewhere the FFDCA lists
canning, cooking, freezing, dehydration, and milling as examples of
processing activities for RACs (21 U.S.C. 342(a)(2)).
Hops are a unique commodity, used almost exclusively as a flavoring
agent for beer. Harvested in a fresh form (green hops), they are
immediately dried in kilns. This on-farm drying is necessary to prevent
spoilage and always occurs prior to the shipment of the dried hops to
beer manufacturers. While the drying of hops is, in the most general
sense, a form of dehydration, both EPA and FDA have traditionally
treated many forms of dried or partially dried food as RACs, e.g.,
peanuts and grains. Both domestic and international hops growers have
asserted that dried hops should be considered a RAC because the drying
process takes place immediately upon harvest, before the hops leave the
farm or enter commerce, i.e., ``prior to marketing.''
Congress indicated in its most recent appropriations bill for EPA
that it believes that EPA's treatment of dried hops as a processed food
was a misinterpretation of the statute. That bill, Public Law 103-124,
which was signed by President Clinton on October 28, 1993, prohibits
EPA from using funds for any regulatory activity under FFDCA or FIFRA
resulting from the classification of hops as a processed food. In the
Congressional report that accompanied the bill, the Appropriations
Committee explained that this limitation on spending was directed at
barring EPA from acting on what Congress believes is an erroneous
interpretation of the term RAC as it applies to dried hops, S. Rep.
103-137, 103d Cong., 1st Sess. 121 (1993). In consideration of these
factors, EPA revised its guidelines to change the classification of
dried hops from a processed commodity to a RAC.
The data submitted in the petition and all other relevant material
have been evaluated. The toxicology data considered in support of the
tolerance include:
1. A 2-year rat feeding/carcinogenicity study which was negative
for carcinogenic effects under the conditions of the study and which
had a NOEL of 50 ppm (2.5 mg/kg/bwt) for noncarcinogenic effects.
2. A three-generation rat reproduction study with a NOEL of 15 ppm
(1.5 mg/kg/bwt); rat and rabbit teratology studies which were negative
at doses up to 12 mg/kg/bwt and 25 mg/kg/bwt, respectively.
3. A 2-year mouse carcinogenicity study which demonstrated an
increase in the incidence of hepatocellular tumors in female mice.
4. A 2-year dog feeding study with a NOEL of 0.25 mg/kg/bwt which
demonstrated increased blood glucose and slight hypothermia after
dosing at the 1.0 mg/kg/bwt dose. The reference dose (RfD), based on
the 2-year dog feeding study with a NOEL of 0.25 mg/kg/bwt and a 100-
fold uncertainty factor, is calculated to be 0.0025 mg/kg of body
weight/day.
The 2-year mouse carcinogenicity study which showed an increase in
the incidence of hepatocellular tumors in female mice was referred to
the Agency's Carcinogen Assessment Group (CAG) for evaluation. CAG
(1986) concluded that amitraz should be classified as a possible human
carcinogen, Group C. This classification is based on the Agency's
``Guidelines for Carcinogen Risk Assessment'' published in the Federal
Register of September 24, 1986 (51 FR 33992). In its evaluation, CAG
considered the following information:
1. The positive carcinogenic effects were found in only one
species, the mouse.
2. Tumors were discovered mostly in animals at the scheduled
terminal sacrifice.
3. The rat was negative for carcinogenic effects at doses as high
as 200 ppm.
4. There is no positive epidemiological carcinogenicity data for
amitraz.
On February 12, 1986, the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) completed a
review of the data base for the Group C classification of amitraz. The
SAP concluded that the weight-of-the-evidence was inadequate to clearly
categorize amitraz. Amitraz has also been determined to be negative in
the gene mutation, host-mediated, and dominant-lethal test systems.
Studies such as the Ames bacterial test, a mouse lymphoma assay, and an
unscheduled DNA synthesis in human embryonic cells have been conducted
with amitraz, also with negative results. For these reasons, the SAP
disagreed with the Agency classification and recommended that amitraz
be classified as a Group D carcinogen (not classifiable as to human
carcinogenicity).
Despite the SAP's recommendation, the Agency continued to regulate
amitraz as a Group C carcinogen, without quantification of the risk. In
late 1990, however, the Agency decided to reexamine the weight-of-the-
evidence regarding the carcinogenic potential of amitraz. The ``C''
classification was reaffirmed, but quantification of potential human
cancer risk, using a low-dose extrapolation model (Q*1), was
recommended. This decision was based on the fact that amitraz was
associated with the induction of multisite benign and malignant tumors
in different strains of male and female mice. Some of these tumors
(hepatocellular tumors) are considered relatively uncommon in female
B6C3F1 mice.
The Agency prepared a dietary risk assessment for amitraz in
support of the cotton tolerances recently established (58 FR 14314;
Mar. 17, 1993). The resulting dietary risk was calculated to be 2.5 X
10-6 (for the cottonseed/eggs/poultry use, plus pears, cattle,
swine and honey/beeswax). New assessments, using more accurate usage
information for cotton, pears, swine, and the honey (beehive) use, have
since lowered the overall risk to 1.7 X 10-6. The addition of the
use on hops will add 1.2 X 10-6 to this risk, assuming exposure
over a lifetime of 70 years. However, as this is a 2-year tolerance,
the actual risk is much lower.
The tolerance established would be for 2 years, with an expiration
date of 2 years after the beginning date of a final rule. The Agency
expects additional residue data to be submitted, as well as further
information on usage and sales of amitraz overseas, which may enable
EPA to refine and reevaluate the risk at the end of the 2-year period.
At this time, no residue data has been submitted for the U.S., and
there are no U.S. registrations for the use of amitraz on hops. The
Agency will not consider any applications for registration of amitraz
to be used on hops in the U.S., nor will EPA consider any special local
needs registrations (FIFRA section 24c) for amitraz.
The anticipated residue contribution (ARC) for this chemical from
published tolerances utilizes 1.4% of the RfD. The proposed tolerance
will contribute 0.000025 mg/kg/bwt/day to the human diet utilizing an
additional 1% of the RfD. This results in a total utilization of 2.4%
of the RfD.
The OPP Reference Dose Committee (RfD) recently reviewed the
toxicity data base for amitraz. In doing so, the Committee indicated
that based on evidence of some developmental toxicity at relatively low
dose levels in the rabbit developmental toxicity study, an acute
dietary risk assessment was appropriate. A Margin of Exposure (MOE) for
females aged 13 and above (the population subgroup of concern for
developmental toxicity) was calculated by comparing the NOEL of 5.0 mg/
kg bwt/day from the rabbit study to the calculated high-end exposure of
0.05 mg/kg bwt/day. The calculated MOE in this case is exactly 100;
generally, the Agency is not concerned unless the MOE is less than 100.
The analysis assumes uniform distribution of amitraz in the commodity
supply and that residues are present at tolerance level for the
published uses in addition to hops. The Agency considers this to be
extremely unlikely.
The nature of the residue in plants and livestock is adequately
understood. The analytical method is a common moiety method which
converts amitraz and its two metabolites to 2,4-dimethylaniline.
Determination of the residues is by gas chromatography using 63Ni
electron detection. There are currently no actions pending against
continued registration of this chemical.
Based on the above information considered by the Agency, the
tolerance established by amending 40 CFR part 180 would protect the
public health. Therefore, it is proposed that the tolerance be
established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under 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 this
rulemaking proposal be referred to an Advisory Committee in accordance
with FFDCA section 408(e).
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 4E4349/P582]. All written comments filed
in response to this petition will be available in the Public Docket and
Freedom of Information Section, at the address given above from 8 a.m.
to 4 p.m., Monday through Friday, except legal holidays.
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Recording and
recordkeeping requirements.
Dated: May 9, 1994.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 Code of
Federal Regulations be amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.287, by amending the table therein by adding and
alphabetically inserting the raw agricultural commodity dried hops, to
read as follows:
Sec. 180.287 Amitraz; tolerances for residues.
* * * * *
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Parts per
Commodity million
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*****
Hops, dried\1\............................................. 75
*****
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\1\Tolerance expires (date 2 years after beginning date of final rule).
[FR Doc. 94-12102 Filed 5-13-94; 2:31 pm]
BILLING CODE 6560-50-F
