[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  
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    (b) *  *  *

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Milk.......................................................          0.2
                                                                        
------------------------------------------------------------------------

    (c) *  *  *

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