[Federal Register Volume 59, Number 53 (Friday, March 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6393]
[[Page Unknown]]
[Federal Register: March 18, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6F3344/R2043; FRL-4761-4]
RIN No. 2070-AB78
Pesticide Tolerance for N,N-Diallyl Dichloroacetamide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a time-limited tolerance for
residues of N,N-diallyl dichloroacetamide (CAS Reg. No. 37764-253) when
used as an inert ingredient (safener) in pesticide formulations applied
to corn fields before the corn plants emerge from the soil with a
maximum use level of 1.0 pound of this safener per acre per year in or
on corn, fodder at 0.05 part per million (ppm), corn, forage at 0.05
ppm and corn, grain at 0.05 ppm. A request to establish a maximum
permissible level for residues of the inert ingredient in or on the
commodity was requested by the Zeneca Ag Products. This time-limited
tolerance expires December 31, 1998.
EFFECTIVE DATE: This regulation becomes effective March 18, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 6F3344/R2043], 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 copy of 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: Connie Welch, Registration
Support Branch, Registration Division (7505W), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Westfield Building North, 6th Floor, 2800 Crystal
Drive, Arlington, VA 22202, (703)-308-8320.
SUPPLEMENTARY INFORMATION:
I. Background
EPA is charged with administration of section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346. Section 408
authorizes EPA to establish tolerance levels and exemptions from the
requirements of a tolerance for residues of pesticide chemicals in or
on raw agricultural commodities.
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 162.3(c), and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting and spreading agents;
propellants in aerosol dispensers; and emulsifiers. The term ``inert''
is not intended to imply nontoxicity; the ingredient may or may not be
chemically active.
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of Arpil 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. Where it can be determined that the inert
ingredient will present minimal or no risk, the Agency generally does
not need some or all of the listed studies to rule on the proposed
tolerance or exemption from the requirement of a tolerance for an inert
ingredient. The Agency has evaluated data pertaining to all of the
listed studies in developing this proposed rule.
In those cases where the toxicity of an inert ingredient is such
that exposure to the inert ingredient must be restricted to assure that
the use of the inert ingredient in a pesticide formulation is not
injurious to the public health, EPA will propose to establish a
tolerance for residues of the inert ingredient on raw agricultural
commodities.
II. Provisions of Rule
Zeneca Ag Products, 1800 Concord Pike, P.O. Box 751, Wilmington, DE
19897, submitted pesticide petition (PP) 6F3344 proposing to amend 40
CFR 180.1026 by establishing a regulation to permit residues of N,N-
diallyl dichloroacetamide when used as an inert ingredient (safener) in
formulations applied to corn fields before the corn plants emerge from
the soil with a maximum use level of 1.0 pound of this safener per acre
per year in or on corn, fodder at 0.05 ppm, corn, forage at 0.05 ppm
and corn, grain at 0.05 ppm. EPA issued a notice, published in the
Federal Register of November 24, 1993 (58 FR 62123), announcing receipt
of this petition. No comments were received in response to the notice
of filing. A safener is a herbicidal antidote that protects desirous
crops while allowing the herbicide to act on the intended weed targets.
This safener will be used with the active ingredient acetochlor.
The data submitted in the petitions and other relevant material
have been evaluated. This inert ingredient is considered useful for the
purpose for which the tolerance is sought. The toxicological,
ecological, and environmental fate data considered in support of the
proposed tolerance include:
1. An acute rat oral toxicity study with an acute oral LD50 of
2,055 milligrams (mg)/kilogram (kg).
2. An acute rabbit dermal toxicity study with an acute dermal
LD50 of > 5,000 mg/kg.
3. A rabbit eye irritation study in which N,N-diallyl
dichloroacetamide is determined not to be an eye irritant.
4. An acute rat inhalation toxicity study with a 4-hour inhalation
LC50 of > 5.6 mg/L.
5. A rabbit primary dermal irritation study indicating that
dichlormid is a mild dermal irritant.
6. A 90-day rat oral toxicity study with a no-observed-effect level
(NOEL) of 200 parts per million (ppm) or 10 mg/kg/day.
7. A 90-day dog oral toxicity study with a NOEL of 5 mg/kg/day or
200 ppm.
8. A rat developmental effects study with a NOEL for maternal
toxicity of 40 mg/kg/day and developmental toxicity of 40 mg/kg/day.
9. A 14-week rat inhalation study with a NOEL of 2 mg/m3.
10. Mutagenicity studies including in vivo/in vitro unscheduled DNA
synthesis in rat hepatocytes, Mammalian Cells in Culture Cytogenetic
Assay in human lymphocytes, in vivo Micronucleus Assay in Mice,
Salmonella typhimurium/mammalian plate incorporation (Ames) assay with
and without metabolic activation were negative.
11. An acute mallard duck oral toxicity study with an LD50 of
> 5,620 mg/kg.
12. An acute bobwhite quail oral toxicity study with an LD50
of 1,545 mg/kg.
13. A bobwhite quail dietary toxicity (LC50) study with an
LC50 of > 5,200 ppm.
14. A 96-hour rainbow trout static acute toxicity study with an
LC50 of 103 mg/liter (L).
15. A 48-hour daphnia magna static toxicity study with an EC50
of 161 mg/L.
16. Environmental fate studies including hydrolysis,
photodegradation in water and on soil, aerobic soil metabolism,
mobility (batch equilibrium) studies.
A reference dose (RfD) has not been established for this chemical.
However, a Provisional Acceptable Daily Intake (PADI) has been
established at 0.005 mg/kg/day based on the 90-day dog oral toxicity
study NOEL of 5 mg/kg/day. The theoretical worst-case maximum residue
contribution (TMRC) from the proposed tolerance is estimated to be
0.000017 mg/kg/bwt (bodyweight)/day for the overall U.S. population,
representing 0.3% of the PADI for dichlormid. The TMRC for the most
highly exposed subgroup, non-nursing infants less than 1 year, is
0.000049 mg/kg/bwt/day, or approximately 1% of the PADI.
This tolerance is being established as a time-limited tolerance
because the Agency does not have data from two chronic feeding/
oncogenicity studies which are part of the toxicology data typically
required to be submitted in support of a tolerance request. These
studies will be required to be submitted to the Agency by January 31,
1998. In addition, product chemistry data to fulfill Guidelines Nos.
61, 62, 63-2 through 63-6, 63-8, and 63-13 must be submitted within 6
months of the date of this notice. When the Agency receives these
chronic feeding/oncogenicity studies it will reassess the tolerance.
However, based upon the data considered in support of the tolerance and
the low degree of dietary exposure, the Agency does not believe that
this time-limited tolerance poses significant risks.
The Agency believes that this use will not result in residues in
processed food requiring additional food additive regulations because
of the low residues in the raw agricultural commodities, the structural
similarity to acetochlor, and the rapid metabolism of the safener in
plants. However, the Agency is requiring that a processing study on the
safener be submitted by March 31, 1996, to confirm that food additive
regulations are not needed.
This tolerance will expire December 31, 1998. Residues not in
excess of these tolerances will not be considered actionable if a
pesticide containing this inert ingredient is legally applied during
the term of a conditional registration under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) as amended and in accordance
with the acceptable labeling under a conditional registration. This
tolerance will be revoked if any data indicate such revocation is
necessary to protect the public health.
An analytical method for determination of the nature of the
residue, gas-liquid chromatography using an electron-capture detector,
has been reviewed by the Agency, and upon successful completion of an
Agency method validation, will be made available in the Pesticide
Analytical Manual, Vol. II (PAM II), for enforcement purposes. In the
interim, the method will be available at the address given below. By
mail: Calvin Furlow, Public Response and Program Resources Branch,
Field Operations Division (H7506C), 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.
Based upon the above information considered by the Agency, the
tolerance established by amending 40 CFR part 180 would protect the
public health. Therefore, the tolerance is 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 and/or request a hearing 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 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),
the order defines a ``significant 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 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 the rights and obligations or 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, Recording and
recordkeeping requirements.
Dated: March 11, 1994.
Douglas D. Campt,
Director, 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. By adding new Sec. 180.469, to read as follows:
Sec. 180.469 N,N-Diallyl dichloroacetamide; tolerances for residues.
Time-limited tolerances, to expire December 31, 1998, are
established for residues of N,N-diallyl dichloroacetamide (CAS Reg. No.
37764-25-3) when used as an inert ingredient (safener) in pesticide
formulations applied to corn fields before the corn plants emerge from
the soil with a maximum use level of 1.0 pound of this safener per acre
per year in or on the following raw agricultural commodities:
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Parts per
Commodity million
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Corn, forage (field)....................................... 0.05
Corn, fodder (field)....................................... 0.05
Corn, grain (field)........................................ 0.05
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[FR Doc. 94-6393 Filed 3-17-94; 8:45 am]
BILLING CODE 6560-50-F
