[Federal Register Volume 60, Number 153 (Wednesday, August 9, 1995)]
[Rules and Regulations]
[Pages 40500-40503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19530]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0F3876/R2155; FRL-4967-8]
RIN 2070-AB78
Myclobutanil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for the combined residues of
the fungicide myclobutanil and a metabolite in or on the raw
agricultural commodities almond nutmeat at 0.1 part per million (ppm)
and almond hulls at 2.0 ppm, and increases the tolerances established
for milk to 0.2 ppm and meat to 0.1 ppm, meat byproducts (except liver)
to 0.2 ppm and liver to 1.0 ppm for cattle, goats, hogs, horses, and
sheep. Rohm & Haas Co. requested in a petition submitted pursuant to
the Federal Food, Drug and Cosmetic Act (FFDCA) the regulation to
establish a maximum permissible level for residues of myclobutanil on
almond nuts and almond hulls. EPA initiated the increased tolerances
for milk, meat, meat byproducts, and liver based on the additional
residues in or on almond nuts and almond hulls.
EFFECTIVE DATE: This regulation became effective on July 27, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 0F3876/R2155], may be submitted to:
Hearing
[[Page 40501]]
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. 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. 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 Resource
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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number,
[PP 0F3876/R2155]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this 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: Connie B. Welch, 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; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of January 16, 1991 (56 FR 1631), which announced that
the Rohm & Haas Co., Independence Mall West, Philadelphia, PA 19105,
had submitted pesticide petition (PP) 0F3876 to EPA requesting that the
Administrator, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish tolerances for
the combined residues of the fungicide myclobutanil, [alpha-butyl-
alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile], and both
the free and bound forms of its metabolite, alpha-(3-hydroxybutyl)-
alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile, in or on the
raw agricultural commodities almond nuts at 0.1 ppm and almond hulls at
2.0 ppm.
There were no comments received in response to the notice of filing
of the petition.
The data submitted in support of the petition and other relevant
material have been evaluated. The pesticide is considered useful for
the purpose for which the tolerances are sought. The toxicological data
considered in support of the tolerances include the following:
1. A 1-year dog feeding study using doses of 0, 10, 100, 400, and
1,600 ppm (equivalent to doses of 0, 0.34, 3.09, 14.28, and 54.22
milligrams/kilogram (mg/kg) body weight (bwt)/day in males and 0, 0.40,
3.83, 15.68, and 58.20 mg/kg bwt/day in females). The no-observed-
effect (NOEL) is 100 ppm (3.09 mg/kg/day for males and 3.83 mg/kg/day
for females) based upon hepatocellular hypertrophy, increases in liver
weights, ``ballooned'' hepatocytes, and increases in alkaline
phosphatase, SGPT and GGT, and possible slight hematological effects.
The lowest-observed-effect level (LOEL) is 400 ppm (14.28 mg/kg/day for
males and 15.68 mg/kg/day for females).
2. A 2-year chronic feeding/carcinogenicity study in rats using
dietary concentrations of 0, 50, 200, and 800 ppm (equivalent to doses
of 0, 2.49, 9.84 and 39.21 mg/kg bwt/day in males and 0, 3.23, 12.86,
and 52.34 mg/kg bwt/day in females). The NOEL for chronic effects other
than carcinogenicity is 2.49 mg/kg/day, and the LOEL is 9.84 mg/kg/day
based on testicular atrophy in males. No other significant effects were
observed in either sex at the stated dose levels over a 2-year period.
In addition, no carcinogenic effects were observed in either sex at any
of the dose levels tested. Based on the toxicological findings, the
maximum tolerated dose (MTD) selected for testing (based on the 90-day
feeding study) was not high enough to fully characterize the compound's
carcinogenic potential.
The study was repeated at dose levels of 0 and 2,500 ppm (125 mg/
kg/day) in the diet, which approaches the MTD, in order to characterize
the carcinogenic potential. At 2,500 ppm, the observed effects
included: decreases in absolute and relative testes weights, increases
in the incidences of centrilobular to midzonal hepatocellular
enlargement and vacuolation in the liver of both sexes, increases in
bilateral aspermatogenesis in the testes, increases in the incidence of
hypospermia and cellular debris in the epididymides, and increased
incidence of arteritis/periarteritis in the testes. In this study, a
NOEL could not be established because there were effects at the only
dose level tested. Myclobutanil was not oncogenic when tested under the
conditions of the study.
3. A 2-year carcinogenicity study in mice using dietary
concentrations of 0, 20, 100, and 500 ppm (equivalent to 0, 2.7, 13.7,
and 70.2 mg/kg/day in males and 0, 3.2, 16.5 and, 85.2 mg/kg/day in
females). The NOEL for chronic effects other than carcinogenicity was
20 ppm (2.7 mg/kg/day in males and 3.2 mg/kg/day in females). The LOEL
was 100 ppm (13.7 mg/kg/day in males and 16.5 mg/kg/day in females)
based on a slight increase in liver mixed-function oxidase (MFO).
Microscopic changes in the liver were evident in both sexes at 500 ppm
(70.2 mg/kg/day in males and 85.2 mg/kg/day in females). There were no
carcinogenic effects in either sex at any dose level tested. The
highest selected dose was satisfactory for evaluating carcinogenic
potential in male mice, but was lower than the MTD in females.
The above study was reevaluated since the increase in the MFO at 3
months in females was not considered to be significant enough to
establish an LOEL. The LOEL was raised to 500 ppm (70.2 mg/kg/day for
males and 85.2 mg/kg/day for females) based on increases in MFO in both
sexes, increases in SGPT values in females and in absolute and relative
liver weights in both sexes at 3 months, increased incidences and
severity of centrilobular hepatocytic hypertrophy, Kupffer cell
pigmentation, periportal punctate vacuolation and individual
hepatocellular necrosis in males, and increased incidences of focal
hepatocellular alteration and multifocal hepatocellular vacuolation in
both sexes. The NOEL has been raised to 100 ppm (13.7 mg/kg/day for
males and 16.5 mg/kg/day for females).
An 18-month study was conducted with female mice using a dose level
of 2,000 ppm, which approaches the MTD, to evaluate the carcinogenic
potential in female mice. In this study, a NOEL could not be
established because there were effects at the only dose level tested.
These effects included: decreases in body weight and body weight gain,
increases in liver weights, hepatocellular hypertrophy, hepatocellular
vacuolation, necrosis of single hypertrophied hepatocytes, yellow-brown
pigment in the Kupffer cells and cytoplasmic eosinophilia and
hypertrophy of the cells of the zona
[[Page 40502]]
fasciculata area of the adrenal cortex. Myclobutanil was not oncogenic
when tested under the conditions of the study.
4. A rabbit developmental toxicity study at dosages of 0, 20, 60,
and 200 mg/kg/day administered by oral gavage. The LOEL for maternal
toxicity was 200 mg/kg/day, and the maternal toxicity NOEL was 60 mg/
kg/day based on reduced body weight and body weight gain during the
dosing period, clinical signs of toxicity, and possibly abortions. THE
LOEL for developmental toxicity is 200 mg/kg/day and NOEL for
developmental toxicity is 60 mg/kg/day based on increases in
resorptions, decreases in litter size, and a decrease in the viability
index.
5. A developmental toxicity study on rats treated with dosages of
0, 31.26, 93.77, 312.58 and 468.87 mg/kg/day. The maternal toxicity
LOEL was 312.6 mg/kg/day and maternal toxicity NOEL was 93.8 mg/kg/day
based on clinical signs of toxicity. The developmental toxicity LOEL
was 312.6 mg/kg/day and the developmental toxicity NOEL was 93.8 mg/kg/
day based on increased incidences of 14th rudimentary and 7th cervical
ribs.
6. A two-generation rat reproduction study with dosage rates of 0,
50, 200, and 1,000 ppm (equivalent to 0, 2.5, 10 and 50 mg/kg/day). The
parental (systemic) toxicity LOEL was 200 ppm (10 mg/kg/day) and the
parental (systemic) toxicity NOEL was 50 ppm (2.5 mg/kg/day) based on
hepatocellular hypertrophy and increases in liver weights. The
reproductive toxicity LOEL was 1,000 ppm (50 mg/kg/day) and
reproductive toxicity NOEL was 200 ppm (10 mg/kg/day) based on an
increased incidence in the number of stillborns and atrophy of the
testes and prostate. The developmental toxicity LOEL was 1,000 ppm (50
mg/kg/day) and the developmental toxicity NOEL was 200 ppm (10 mg/kg/
day) based on a decrease in pup body weight gain during lactation.
7. A reverse mutation assay (Ames), point mutation in CHO/HGPRT
cells, in vitro and in vivo (mouse) cytogenetic assays, unscheduled DNA
synthesis and a dominant-lethal study in rats, all of which were
negative for mutagenic effects.
The Reference Dose (RfD) based on the 2-year rat chronic feeding
study (NOEL of 2.49 mg/kg bwt/day) and using a hundredfold uncertainty
factor, is calculated to be 0.025 mg/kg bwt/day. The theoretical
maximum residue contribution (TMRC) from previously established
tolerances and tolerances established here is 0.004153 mg/kg bwt/day
for the general population and utilizes 16% of the RfD. The percentage
of the RfD for the most highly exposed subgroup, nonnursing infants
(less than 1 year old), is 98%. The TMRC was calculated based on the
assumption that myclobutanil 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 below
the RfD for the population as a whole and for each of the 22 subgroups
considered. Dietary risk from exposure to myclobutanil on almond nuts
and hulls, including increases in the meat and milk tolerances because
almond hulls are a feed item, contributes 7% of the RfD for the U.S.
population and 40% of the RfD for the nonnursing infants less than l-
year old. Considering that the risk estimates are based on tolerance
levels, the actual risk is probably lower.
The nature of the residues is adequately understood and adequate
analytical methods, gas liquid chromatography using nitrogen/phosphorus
and electron-capture detectors, are available for enforcement. Prior to
its publication in the Pesticide Analytical Manual, Vol. II, the
enforcement methodology is being made available in the interim to
anyone who is interested in pesticide enforcement when requested from:
Calvin Furlow, Public Response and Program Resource 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. 1130A, CM #2, 1921 Jefferson
Davis Hwy, Arlington, VA 22202, (703)-305-5937.
There are currently no actions pending against the continued
registration of this chemical. 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 part 180 will protect the
public health. Therefore, the tolerances are established as set forth
below. 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 these pesticides.
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).
A record has been established for this rulemaking under docket
number [PP 0F3876/R2155] (including any objections and hearing requests
submitted electronically as described below). A public version of this
record, including printed, paper versions of electronic comments, which
does not include any information claimed as CBI, is available for
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Rm. 1132 of the Public
Response and Program Resource Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
Written objections and hearing requests, identified by the document
control number [PP 0F3876/R2155], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at: opp-
[email protected]. A copy of electronic objections and hearing
requests filed with the Hearing Clerk must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept
[[Page 40503]]
in paper form. Accordingly, EPA will transfer any objection and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official rulemaking
record which will also include all objections and hearing requests
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 27, 1995.
Stephen L. Johnson,
Director, Registration Division, 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. In Sec. 180.443, by amending paragraphs (a), (b), and (c) by
revising the tables therein, to read as follows:
Sec. 180.443 Myclobutanil; tolerances for residues,
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
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Almond hulls............................................... 2.0
Almond nutmeat............................................. 0.1
Apples..................................................... 0.5
Cherries (sweet and sour).................................. 5.0
Cotton seed................................................ 0.02
Grapes..................................................... 1.0
Stone fruits (except cherries)............................. 2.0
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(b) * * *
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Parts per
Commodity million
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Milk....................................................... 0.2
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(c) * * *
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Parts per
Commodity million
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Cattle, fat................................................ 0.05
Cattle, liver.............................................. 1.0
Cattle, meat............................................... 0.1
Cattle, mbyp (except liver)................................ 0.2
Eggs....................................................... 0.02
Goats, fat................................................. 0.05
Goats, liver............................................... 1.0
Goats, meat................................................ 0.1
Goats, mbyp (except liver)................................. 0.2
Hogs, fat.................................................. 0.05
Hogs, liver 1.0
Hogs, meat................................................. 0.1
Hogs, mbyp (except liver).................................. 0.2
Horses, fat................................................ 0.05
Horses, liver.............................................. 1.0
Horses, meat............................................... 0.1
Horses, mbyp (except liver)................................ 0.2
Poultry, fat............................................... 0.02
Poultry, meat.............................................. 0.02
Poultry, mbyp.............................................. 0.02
Sheep, fat................................................. 0.05
Sheep, liver............................................... 1.0
Sheep, meat................................................ 0.1
Sheep, mbyp (except liver)................................. 0.2
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[FR Doc. 95-19530 Filed 8-8-95; 8:45 am]
BILLING CODE 6560-50-F