[Federal Register Volume 60, Number 85 (Wednesday, May 3, 1995)]
[Rules and Regulations]
[Pages 21736-21739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10861]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[PP 2F4116 and FAP 2H5644/R2124; FRL-4949-3]
RIN 2070-AB78
Myclobutanil; Pesticide Tolerances and Food Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes permanent tolerances for the combined
residues of the fungicide myclobutanil and a metabolite in or on the
raw agricultural commodities stone fruits (except cherries) at 2.0
parts per million (ppm) and cherries at 5.0 ppm and establishes a food
additive regulation for the combined residues in or on the processed
food commodity dried plums at 8.0 ppm. The Rohm & Haas Co. requested
establishment of these tolerances and food additive regulation.
EFFECTIVE DATE: This regulation became effective on March 30, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 2F4116 and FAP 2H5644/R2124], 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.
A copy of objections and requests for hearings filed with the
Hearing Clerk may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies of
objections and requests for hearings must be submitted as an ASCII file
avoiding the use of special characters and any form of encryption.
Copies of objections and requests for hearings will also be accepted on
disks in WordPerfect in 5.1 file format or ASCII file format. All
copies of objections and requests for hearings in electronic form must
be identified by the docket number [PP 2F4116 and FAP 2H5644/R2124]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and requests for hearings 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:
welch.connie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal
Register of December 30, 1992 (57 FR 62333), which announced that the
Rohm & Haas Co., Independence Mall West, Philadelphia, PA 19105, had
submitted pesticide petition (PP) 2F4116 proposing to amend 40 CFR
180.443 by establishing permanent tolerances for the residues of the
fungicide myclobutanil, [alpha-butyl-alpha-(3-hydroxybutyl)-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 stone fruits group (except
cherries) at 2.0 ppm and cherries at 5.0 ppm and food additive petition
(FAP) 2H5644 proposing to amend 40 CFR 185.4350 by establishing a
tolerance for the combined residues of myclobutanil and its metabolite
in or on the food additive commodity dried plums at 8.0 ppm. Rohm &
Haas Co. also requested that previous petitions submitted for stone
fruits (PP 9F3811, PP 1F3954, and FAP 1H5608) be combined in these
petitions.
Time-limited tolerances were established for myclobutanil in or on
the raw agricultural commodities nectarines and peaches at 2.0 ppm and
cherries (sweet and sour) at 4.0 ppm with an expiration date of October
1, 1994, in response to PP 9F3811 in a document in the Federal Register
of February 5, 1992 (57 FR 4368). These tolerances were extended to
April 1, 1995, on September 30, 1994.
There were no comments received in response to the notices of
filing of any of the petitions. The data submitted in support of the
petitions and other relevant material have been evaluated. The
pesticide is considered useful for the purpose for which the tolerances
are sought. The toxicological data [[Page 21737]] 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 level (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 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 0.002319 mg/kg bwt/day for the general
population and utilizes 9% of the RfD. 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 58% and 25%, respectively.
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 well below the RfD for the
population as a whole and for each of the 22 subgroups considered.
Thus, the dietary risk from exposure to myclobutanil appears to be
minimal for the use on stone fruits.
The nature of the residues is adequately understood and adequate
[[Page 21738]] analytical methods, gas liquid chromatography using
nitrogen/phosphorus and electron capture detectors, are available for
enforcement. Prior to their 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 Information Branch, Field
Operations Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Rm 1128C, 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 185 will protect the public health. Therefore, the
tolerances are established as set forth below. By way of public
reminder, this document 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 2F4116 and FAP 2H5644/R2124] (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 Room
1132 of the Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
Written objections and requests for hearings, identified by the
document control number [PP 2F4116 and FAP 2H5644/R2124], 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 requests for hearings can be
sent directly to EPA at:
opp-Docket@epamail.epa.gov
A copy of electronic objections and requests for hearings 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 in paper form. Accordingly,
EPA will transfer any copies of objections and requests for hearings
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 comments 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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 30, 1995.
Stephen L. Johnson,
Director, Registration Division, 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. In Sec. 180.443(a), by revising the table therein, to read as
follows:
Sec. 180.443 Myclobutanil; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
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Apples..................................................... 0.5
Cherries (sweet and sour).................................. 5.0
Grapes..................................................... 1.0
Stone fruits (except cherries)............................. 2.0
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[[Page 21739]] * * * * *
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. In section 185.4350, by revising the table therein, to read as
follows:
Sec. 185.4350 Myclobutanil.
* * * * *
------------------------------------------------------------------------
Parts per
Commodity million
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Plums, dried............................................... 8.0
Raisins.................................................... 10.0
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[FR Doc. 95-10861 Filed 5-2-95; 8:45 am]
BILLING CODE 6560-50-F
