[Federal Register Volume 59, Number 220 (Wednesday, November 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28141]
[[Page Unknown]]
[Federal Register: November 16, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 6F3372 and FAP 6H5497/R2085; FRL-4917-8]
RIN 2070-AB78
Pesticide Tolerances and Feed Additive Regulations for
Triflumizole
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for the combined residues of
the fungicide triflumizole and its metabolites in or on various
agricultural commodities. Uniroyal Chemical Co. petitioned for these
maximum permissible levels for residues of the fungicide.
EFFECTIVE DATE: October 31, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 6F3372 and FAP 6H5497/R2085], may be
submitted to: Hearing Clerk (1900), Environmental Protection Agency,
Rm. M3708, 401 M St., SW., Washington DC 20460. A copy of any
objections and hearing requests filed with the Hearing Clerk should be
identified by the document control number and submitted 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 a copy of the
objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail: Leonard S. Cole, Jr., Acting
Product Manager (PM) 21, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 227, CM
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6900.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of March 19, 1986 (51 FR 9514), which announced that
Uniroyal Chemical Co. (Uniroyal), 74 Amity Rd., Bethany, CT 06542-3402,
had submitted pesticide petition (PP) 6F3372 proposing to amend 40 CFR
part 180 by establishing tolerances for the combined residues of the
fungicide triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole and its
aniline-containing metabolites 4-chloro-2-trifluoromethylaniline, N-4-
chloro-2-trifluoromethylaniline and N-(4-chloro-2-
trifluoromethylphenyl)-propoxyacetamide, in or on the following
commodities: apples at 0.1 part per million (ppm); cattle, fat, meat,
and meat byproducts (mbyp) at 0.05 ppm; grapes at 0.3 ppm; hogs, fat,
meat, and mbyp at 0.05 ppm; milk at 0.05 ppm; pears at 0.1 ppm; and
poultry, eggs, fat, meat, and mbyp at 0.05 ppm. Uniroyal also submitted
feed additive petition (FAP) 6H5497 proposing to amend 21 CFR part 193
(redesignated in the Federal Register of June 29, 1988 (53 FR 24666),
as 40 CFR part 186) by establishing a regulation permitting the
combined residues of the fungicide described above in or on the
following commodities: apples, dried at 3.0 ppm; apple pomace, dry at
1.0 ppm; apple pomace, wet at 3.0 ppm; grape juice at 1.0 ppm; grape
pomace, dry at 1.0 ppm; grape pomace, wet at 4.0 ppm; raisins at 1.0
ppm; and raisin waste at 2.0 ppm.
Uniroyal amended these petitions, as announced in the Federal
Registers of October 5, 1988 (53 FR 39131), March 10, 1993 (58 FR
13262), and October 21, 1993 (58 FR 54350). These amendments changed
the tolerances to the following: apples at 0.5 ppm; grapes at 2.5 ppm;
pears at 0.5 ppm; meat of cattle, goats, hogs, horses, poultry, and
sheep at 0.05 ppm; milk, eggs, and poultry fat at 0.05 ppm; meat
byproducts of poultry at 0.1 ppm; meat by-products and fat of cattle,
goats, hogs, horses, and sheep at 0.5 ppm; apple pomace at 2.0 ppm;
grape pomace at 15.0 ppm; and raisin waste at 10.0 ppm. Uniroyal also
changed the chemical expression for the fungicide to combined residues
of the fungicide triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole, the
metabolite 4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate (in raw
agricultural commodities of animal origin only), and other metabolites
containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as
the parent compound.
No comments were received in response to any of the above Federal
Register notices.
The scientific data submitted in the petition and other relevant
material have been evaluated. By way of public reminder, this notice
also reiterates the registrant's responsibility, under section 6(a)(2)
of FIFRA, to submit additional factual information regarding adverse
effects on the environment and to human health by the pesticide. The
toxicological data considered in support of the tolerances include:
1. A 2-year rat feeding chronic toxicity/carcinogenicity study
(negative for carcinogenicity) with a no-observable-effect level (NOEL)
for liver effects [lowest dose tested was 100 ppm (4.1 mg/kg/day)].
2. A 2-year mouse feeding/carcinogenicity study (negative for
carcinogenicity) with a systemic NOEL of 100 ppm (16.2 mg/kg/day for
males, 21.7 mg/kg/day for females) and an LEL of 400 ppm (67.4 mg/kg/
day for males, 88.1 mg/kg/day for females).
3. A 3-month feeding study in rats with a NOEL of 200 ppm (10 mg/
kg/day) and a lowest-effect-level (LEL) of 2,000 ppm (100 mg/kg/day).
4. A 3-month feeding study with mice with a NOEL of 200 ppm (30 mg/
kg/day) and an LEL of 2,000 ppm (300 mg/kg/day).
5. A 30-day feeding study with rats with a NOEL of 200 ppm (10 mg/
kg/day) and an LEL of 2,000 ppm (100 mg/kg/day).
6. A 30-day feeding study with mice with a NOEL of 200 ppm (30 mg/
kg/day and an LEL of 2,000 ppm (300 mg/kg/day).
7. A 1-year feeding study with beagle dogs with a NOEL of 300 ppm
(10.0 mg/kg/day for males, 10.7 mg/kg/day for females) and an LEL of
1,000 ppm (34.1 mg/kg/day for males, 35.2 mg/kg/day for females).
8. Three developmental toxicity studies in rats (considered
together) with a maternal NOEL of 10 mg/kg/day and maternal LEL of 35
mg/kg/ day. The developmental toxicity NOEL was 10 mg/kg/day, and the
developmental toxicity LEL was 10 mg/kg/day.
9. Two developmental toxicity studies in rabbits (considered
together) with a maternal NOEL of 50 mg/kg/day and a maternal LEL of
100 mg/kg/day. The developmental toxicity NOEL was 50 mg/kg/day and the
developmental toxicity LEL was 100 mg/kg/day.
10. Two three-generation reproduction studies in rats (when
considered together) with a reproductive toxicity NOEL of 30 ppm (1.5
mg/kg/day) and a reproductive toxicity LEL of 70 ppm (3.5 mg/kg/day).
Triflumizole is considered a reproductive toxicant.
11. Triflumizole was negative for mutagenicity in the mitotic gene
conversion test, rec assay test, in vitro mouse micronucleus test,
reverse mutation in Salmonella and E. coli test and unscheduled DNA
synthesis test.
The Office of Pesticide Programs' Health Effects Division
Carcinogenicity Peer Review Committee has classified triflumizole in
Group E (evidence of non-carcinogenicity for humans). 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). The Agency has chosen to use the reference dose calculations
based upon chronic toxicity effects to estimate human dietary risk from
triflumizole residues since carcinogenicity is not a concern with this
chemical. Additionally, an estimate of human dietary risk for acute
effects was determined using a reference dose based upon the NOEL taken
from three developmental toxicity studies in the rat considered
together.
The reference dose (RfD) for chronic effects was established at
0.015 mg/kg body weight/day, based on the NOEL of 1.5 mg/kg/day for the
three-generation reproductive toxicity study in rats and an uncertainty
factor of 100. The Theoretical Maximum Residue Contribution (TMRC) is
estimated at 0.002221 mg/kg bodyweight/day and utilizes 14.8 percent of
the RfD for the general population of the 48 States. The percentages of
the RfD for the most highly exposed subgroups, nonnursing infants (less
than 1 year old) and children (1 to 6 years old), are 61.2% and 41.2%,
respectively. The TMRC was calculated based on the assumption that
triflumizole occurs at the maximum legal limit in all of the dietary
commodities for which tolerances are proposed. Even with this probable
large overestimate of exposure/risk, the TMRC is well below the RfD for
the population as a whole and for each of the 22 subgroups considered.
Thus, there does not appear to be any dietary concern due to chronic
effects.
The acute exposure analysis evaluates individual food consumption
and estimates the distribution of single day exposures through the diet
for the U.S. population and certain subgroups. The analysis assumes
uniform distribution of triflumizole in the commodity supply. Since the
toxicological effect to which high end exposure is being compared in
this analysis is developmental toxicity, the population group of
interest is females aged 13 years and above. This subgroup most closely
approximates women of child bearing age. The Margin of Exposure (MOE)
is a measure of how closely the high end exposure comes to the NOEL and
is calculated as the ratio of the NOEL to the exposure. The Agency is
not generally concerned about MOEs of 100 or above when the
toxicological endpoint to which the exposure is compared is taken from
an animal study. In this acute exposure analysis, the calculated
exposure of those individuals most highly exposed (0.02 mg/kg bwt/day)
was compared to the NOEL of 10 mg/kg bwt/day to get an MOE of at least
500. This means that those individuals most highly exposed to
triflumizole through these proposed uses would receive at most 1/500th
of the dose that represents the NOEL in animals for developmental
toxicity. Less than 1% of the population of females 13 years and over
would be exposed to triflumizole at levels of 0.02 mg/kg bwt/day or
greater. Based on the risk estimates arrived at in this analysis, it
appears that acute dietary risk from the proposed uses of triflumizole
is not of concern.
The nature of the residue in plants and animals is adequately
understood, and adequate analytical methods are available for
enforcement purposes. The enforcement methodology has been submitted to
the Food and Drug Administration for publication in the Pesticide
Analytical Manual, Vol. II (PAM II). Because of the long lead time for
publication of the method in PAM II, the analytical methodology is
being made available in the interim to anyone interested in pesticide
enforcement when requested from: Calvin Furlow, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232.
The pesticide is considered useful for the purpose 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 parts 180 and 186 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 to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. 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 such issues, 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 genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
Under Executive Order 12866 (58 FR 51735, Oct. 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).
List of Subjects in 40 CFR Part 180 and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Feed additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: October 31, 1994.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, chapter I of the title 40 of the Code of Federal
Regulations is 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. By adding new Sec. 180.476, to read as follows:
Sec. 180.476 Triflumizole; tolerances for residues.
(a) Tolerances are established for the combined residues of the
fungicide triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole, and its
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety,
calculated as the parent compound, in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apples..................................................... 0.5
Grapes..................................................... 2.5
Pears...................................................... 0.5
------------------------------------------------------------------------
(b) Tolerances are established for the combined residues of the
fungicide triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole, the
metabolite 4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate, and
other metabolites containing the 4-chloro-2-trifluoromethylaniline
moiety, calculated as the parent compound, in or on the following raw
agricultural commodities of animal origin:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.5
Cattle, meat 0.05
Cattle, mbyp............................................... 0.5
Eggs....................................................... 0.05
Goats, fat................................................. 0.5
Goats, meat................................................ 0.05
Goats, mbyp................................................ 0.5
Hogs, fat.................................................. 0.5
Hogs, meat................................................. 0.05
Hogs, mbyp................................................. 0.5
Horses, fat................................................ 0.5
Horses, meat............................................... 0.05
Horses, mbyp............................................... 0.5
Milk....................................................... 0.05
Poultry, fat............................................... 0.05
Poultry, meat.............................................. 0.05
Poultry, mbyp.............................................. 0.1
Sheep, fat................................................. 0.5
Sheep, meat................................................ 0.05
Sheep, mbyp................................................ 0.5
------------------------------------------------------------------------
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. By revising Sec. 186.5850, to read as follows:
Sec. 186.5850 Triflumizole.
Tolerances are established for the combined residues of the
fungicide triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole, and its
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety,
calculated as the parent compound, in or on the following processed
feed commodities when present therein as a result of application to
growing crops:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple pomace............................................... 2.0
Grape pomace............................................... 15.0
Raisin waste............................................... 10.0
------------------------------------------------------------------------
[FR Doc. 94-28141 Filed 11-15-94; 8:45 am]
BILLING CODE 6560-50-F
