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Amitraz (Mitac) Pesticide Tolerances—Final Rule 3/93

40 CFR Part 180

[OPP-300270A; FRL-4189-3]

Date="03/17/93"
Citation="58 FR 14314"
Group="environ"
Type="RULE"
Department="ENVIRONMENTAL PROTECTION AGENCY"
Agency="ENVIRONMENTAL PROTECTION AGENCY (EPA)"
Subject="Pesticide Tolerances for Amitraz"
<headER>
ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 9F3730/R1183; FRL-4573-3]

RIN 2070-AB78

Pesticide Tolerances for Amitraz

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.
ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP 9F3730/R1183; FRL-4573-3]

RIN 2070-AB78

Pesticide Tolerances for Amitraz

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

------------------------------------------------------------
SUMMARY: This rule establishes tolerances for the combined residues
of the insecticide/miticide amitraz and its metabolites in cottonseed,
eggs, and poultry. The regulation to establish a maximum permissible
level for residues of amitraz was requested in a petition submitted
by the Nor-Am Chemical Co.

EFFECTIVE DATE: This
regulation becomes effective March 17,
1993.

ADDRESSES: Written objections, identified by the document control
number, [PP 9F3730/R1183], may be submitted to: Hearing Clerk
(A-110), Environmental Protection Agency, rm. 3708, 401 M St.,
SW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards,
Jr., Product Manager (PM) 19, Registration Division (H7505C),
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 May 19, 1989 (54 FR 21664), which announced
that Nor-Am Chemical Co., Wilmington, DE 19803, had submitted
pesticide petition (PP) 9F3730 to EPA proposing to amend 40
CFR part 180 by establishing permanent tolerances under section
408 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a,
for the 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 cottonseed at 1.0
part per million (ppm) and in eggs at 0.01 ppm, poultry fat and meat at 0.01
ppm, and poultry meat-byproducts at 0.05 ppm when present as a result of
application to cotton.

   No requests for referral to an advisory committee were received
in response to the notice of filing. The toxicological data
considered in support of these tolerances include the following
toxicity studies:
   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 oncogenicity study which demonstrated an
increase in the incidence of hepatocellular tumors in female
mice, and 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. 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 oncogenicity 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 gave consideration to 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 oncogenic 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 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 class C carcinogen, without quantification
of the risk. However, in late 1990, 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 honey/beeswax tolerance recently established
(57 FR 53566, Nov. 12, 1992). The resulting dietary risk was
calculated to be 3.0 X 10-6 (for the honey/beeswax use, plus
pears, cattle, and swine). The Agency also noted that the basic
registrant, Nor-Am, had submitted a label amendment to increase
the preslaughter interval on swine from 1 to 3 days. This label
amendment has been accepted by the Agency, and results in a
smaller residue contribution from the use of amitraz on swine.
This has lowered the dietary risk for the established uses from
3.0 X 10-6 to 2.2 X 10-6. The Agency believes that the addition
of 0.3 X 10-6 from the use on cotton will still keep the overall
risk (2.5 X 10-6) within the negligible risk range.
   The calculated reference dose (RfD) for humans is 0.0025
mg/kg/bwt/day. This is based on a 2-year dog feeding study with
a NOEL of 0.25 mg/kg/bwt and a 100-fold uncertainty factor.
The anticipated residue contribution (ARC) for this chemical
utilizes 1.75 percent of the RfD (also revised due to the change
in the preslaughter interval for swine discussed above). The
proposed tolerances will contribute 0.000007 mg/kg/bwt/day to
the human diet utilizing an additional 0.28 percent of the RfD.
This results in a total utilization of 2.03 percent of the RfD.
The nature of the residue in plants and livestock is adequately
understood.
   The analytical method is gas chromatography using electron
detection. There are currently no actions pending against continued
registration of this chemical.
   Based on the above information the Agency concludes that
the establishment of the tolerances will protect the public
health. Therefore, the tolerances are established as set forth
below.
   Any person adversely affected by this regulation may, within
30 days after publication of this document in the Federal Register,
file written objections with the Hearing Clerk, at theaddress
given above. 40 CFR 178.20 The objections submitted must specify
the provisions of the regulation deemed objectionable and the
grounds for the objections. 40 CFR 178.25. Each objection must
be accompanied by the fee prescribed by 40 CFR 180.33(i). If
a hearing is requested, the objections must include a statement
of the factual issue(s) on which a hearing is requested, the
requestor's contentions on each such issue, and a summary of
any evidence relied upon by the objector. 40 CFR 178.27. A request
for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor
would, if established, taking into account uncontested claims
or facts to the contrary; and resolution of the factual issue(s)
in the manner sought by the requestor would be adequate to justify
the action requested. 40 CFR 178.32.
   The Office of Management and Budget has exempted this rule
from the requirements of section 3 of Executive Order 12291.
   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

Administrative practice
and procedures, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements

Dated: March 5, 1993.

Douglas D. Campt,
Director, Office of Pesticide Programs.
   Therefore, 40 CFR part 180 is 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. Section 180.287 is amended in the table therein by adding
and alphabetically inserting the following commodities, to read
as follows:

180.287   Amitraz; tolerances for residues.

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

               *              *              *              *              *
Cottonseed.....................................................          1.0
Eggs...........................................................         0.01

               *              *              *              *              *
Poultry fat/meat...............................................         0.01
Poultry meat byproducts........................................         0.05

               *              *              *              *              *
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[FR Doc. 93-6146 Filed 3-16-93; 8:45 am]
BILLING CODE 6560-50-F