[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Rules and Regulations]
[Pages 4093-4095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1501]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1F3991/R2102; FRL-4931-1]
RIN 2070-AB78
Pesticide Tolerances for Triclopyr
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for residues of the
herbicide triclopyr [(3,5,6-trichloro-2-pyridinyl)oxyacetic acid) and
its metabolites 3,5,6-trichloro-2-pyridinol and 2-methoxy-3,5,6-
trichloropyridine in or on the raw agricultural commodities (RACs) rice
grain at 0.3 part per million (ppm) and rice straw at 10.0 ppm, and for
triclopyr in poultry meat, poultry fat, and meat byproducts (except
kidney) at 0.1 ppm, and eggs at 0.05 ppm. DowElanco requested this
regulation that establishes the maximum permissible level for residues
of the herbicide in or on the commodities.
EFFECTIVE DATE: This regulation becomes effective January 20, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 1F3991/R2102], 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
request 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 copy of objections and hearing
request 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 36277M, Pittsburgh,
PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail: Robert J. Taylor, Product
Manager (PM) 25, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 245, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703) 305-6800.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of December 13, 1991 (56 FR 65080), which announced
that DowElanco, 9330 Zionsville Rd., [[Page 4094]] Indianapolis, IN
46268, had submitted pesticide petition (PP) 1F3991 to EPA proposing
that 40 CFR 180.417 be amended by establishing a regulation to permit
the combined residues of the herbicide triclopyr [(3,5,6-trichloro-2-
pyridinyl)oxyacetic acid] and its metabolites 3,5,6-trichloro-2-
pyridinol and 2-methoxy-3,5,6-trichloropyridine in or on the raw
agricultural commodities (RACs) rice grain at 0.3 part per million
(ppm) and rice straw at 8.0 ppm, and for triclopyr in poultry meat,
poultry fat, and meat byproducts (except kidney) at 0.1 ppm, and eggs
at 0.05 ppm.
The petitioner subsequently amended the petition, notice of which
appeared in the Federal Register of October 21, 1993 (58 FR 54357), by
submitting a new Section F proposing to establish a tolerance for the
residues of the herbicide triclopyr [(3,5,6-trichloro-2-
pyridinyl)oxyacetic acid) and its metabolites 3,5,6-trichloro-2-
pyridinol and 2-methoxy-3,5,6-trichloropyridine in or on the raw
agricultural commodities (RACs) rice grain at 0.3 part per million
(ppm) and rice straw at 10.0 ppm, and for triclopyr in poultry meat,
poultry fat, and meat byproducts (except kidney) at 0.1 ppm, and eggs
at 0.05 ppm.
There were no comments or requests for referral to an advisory
committee received in response to the notices of filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed below were considered in
support of this tolerance.
1. An acute toxicology study placing technical-grade triclopyr in
toxicity Category I.
2. A 22-month carcinogenicity study with mice fed dosages of 0,
7.1, 35.7, and 178.5 mg/kg/day with no carcinogenic effects observed
under the conditions of the study. The systemic NOEL is 35.7 mg/kg/day
based on decreased body weight gain observed in both sexes at the 178.5
mg/kg/day dose.
3. A 2-year chronic toxicity/carcinogenicity study in rats fed
dosages of 0, 3, 12, and 36 mg/kg/day with no carcinogenic effects
observed under the conditions of the study at levels up to and
including 36 mg/kg/day (HDT) and a systemic NOEL of 12 mg/kg/day based
on a significant increase in hemoglobin, hematocrit and erythrocyte
values, and a significant increase in absolute and relative kidney
weights observed at the 36 mg/kg/day dose level in male rats.
4. A 6-month feeding study in dogs fed dosages of 0.1, 0.5, and 2.5
mg/kg/day with a NOEL of 0.5 mg/kg/day based on significant reductions
in PSP excretion rate, absolute and relative kidney weight, and a
significant increase in SGOT at 2.5 mg/kg/day.
5. A 1-year feeding study in dogs fed dosages of 0, 0.5, 2.5, and
5.0 mg/kg/day with a NOEL of 0.5 mg/kg/day (LDT) based on significant
increases in serum urea nitrogen and creatinine at 2.5 mg/kg/day.
6. A developmental toxicity study in rats fed dosage levels of 0,
50, 100, and 200 mg/kg/day (HDT), with a maternal toxicity NOEL of less
than 50 mg/kg/day and a developmental toxicity NOEL of 200 mg/kg/day
(HDT).
7. A developmental toxicity study in rabbits fed dosage levels of
0, 10, and 25 mg/kg/day with no developmental effects noted at 25 mg/
kg/day (HDT), and a maternal toxicity NOEL of 10 mg/kg/day based on
decreases in weight gain observed at 25 mg/kg/day (HDT).
8. A three-generation reproduction study in rats fed dosages of 0,
3, 10, and 30 mg/kg/day (HDT) showed no reproductive effects up to the
highest dose tested. The systemic NOEL is equal to or greater than 30
mg/kg/day.
9. Mutagenicity data included gene mutation assays with E. coli and
S. typhimurium (negative); DNA damage assays with B. subtillis
(negative); an unscheduled DNA synthesis with rat hepatocytes
(negative) and a chromosomal aberration test in Chinese hamster cells
(negative).
Based on the NOEL of 0.5 mg/kg bwt/day in the 1-year dog feeding
study, and using a hundredfold uncertainty factor, the RfD acceptable
daily intake (ADI) for triclopyr is calculated to be 0.005 mg/kg bwt/
day. The theoretical maximum residue contrbution (TMRC) is 0.000356 mg/
kg bwt/day for existing tolerances for the overall U.S. population. The
current action will increase the TMRC by 0.000127 mg/kg bwt/day (2.54
percent of the ADI). These tolerances and previously established
tolerances utilize a total of 7 percent of the ADI for the overall U.S.
population. For U.S. subgroup populations, nonnursing infants and
children aged 1 to 6, the current action and previously established
tolerances utilize, respectively, a total of 26 percent and 16 percent
of the ADI, assuming that residue levels are at the established
tolerances and that 100 percent of the crop is treated.
There are no desirable data lacking.
This pesticide is useful for the purposes for which the tolerances
are sought. The nature of the residues is adequately understood for the
purposes of establishing these tolerances. Adequate analytical
methodology, high-pressure liquid chromotography, is available for
enforcement purposes. Because of the long lead time from establishing
this tolerance to publication, the enforcement methodology is being
made available in the interim to anyone interested in pesticide
enforcement when requested by mail from: Calvin Furlow, Public Response
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. 1130A,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
There are currently no actions pending against the registration of
this chemical. Based on the data and information submitted above, the
Agency has determined that the establishment of tolerances by amending
40 CFR part 180 will protect the public health. Therefore, EPA is
establishing the tolerances as described below.
Any person adversely affected by this regulation may, within 30
days after the date of publication in the Federal Register, file
written objections with the Hearing Clerk, Environmental Protection
Agency, 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 each 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, 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 issue(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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
[[Page 4095]] the order defies a ``signficant regulatory action'' as an
action that is likely to result in 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 referred to as ``economically
significant''); (2) creating serious inconsistancy 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 the rights and obligations of recipients
thereof; 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 the 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: January 9, 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. 180.417 by amending paragraph (b) by revising the table
therein, to read as follows:
Sec. 180.417 Triclopyr; tolerances for residues.
* * * * *
(b) * * *
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Parts per
Commodity million
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Eggs....................................................... 0.05
Meat, fat, and meat byproducts (except liver and kidney) of
cattle, goats, hogs, horses, and sheep.................... 0.05
Meat, fat, and meat byproducts (except kidney) of poultry.. 0.1
Milk....................................................... 0.01
Liver and kidney of cattle, goats, hogs, horses, and sheep. 0.5
Rice, grain................................................ 0.3
Rice, straw................................................ 10.0
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[FR Doc. 95-1501 Filed 1-19-95; 8:45 am]
BILLING CODE 6560-50-F
