[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Rules and Regulations]
[Pages 49790-49793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24006]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4174/R2175; FRL-4979-5]
RIN 2070-AB78
Chlorethoxyfos; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for residues of the
insecticide phosphorothioic acid, 0,0-diethyl 0-(1,2,2,2-
tetrachloroethyl) ester (proposed common name, ``chlorethoxyfos''), in
or on the raw agricultural commodities of field, pop, and sweet corn at
0.01 part per million (ppm). E.I. Du Pont de Nemours & Co. submitted a
petition for the regulation to establish these maximum permissible
levels for residues of the insecticide pursuant to the Federal Food,
Drug and Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation became effective on September 18, 1995.
[[Page 49791]]
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 3F4174/R2175], 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.
A copy of objections and hearing requests 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
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
3F4174/R2175]. 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: Dennis H. Edwards, Product
Manager (PM-19) Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 207, CM #2, 1921
Jefferson Davis Highway, Arlington, VA 22202, (703)-305-6386; e-mail:
edwards.dennis@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 21, 1993
(58 FR 54353), EPA issued the initial filing of a pesticide petition,
PP 3F4174, from Du Pont, Agricultural Products, Walker's Mill, Barley
Mill Plaza, P.O. Box 80038, Wilmington, DE 19880-0038, proposing to
amend 40 CFR part 180 by establishing a regulation to permit residues
of chlorethoxyfos in or on corn; sweet corn separate from field corn
(corn, field, forage) at 0.01 ppm; corn, field, fodder at 0.01 ppm;
corn, field, silage at 0.01 ppm; corn, pop, forage at 0.01 ppm; corn,
pop, fodder at 0.01 ppm; corn, grain at 0.01 ppm; corn, sweet (kernels,
cob with husk removed) at 0.01 ppm; corn, sweet, forage at 0.01 ppm;
and corn, sweet, fodder at 0.01 ppm. Subsequently, EPA issued a notice
of amended filing, published in the Federal Register of August 17, 1995
(60 FR 42885), which announced that E.I. Du Pont de Nemours & Co., had
submitted the amended pesticide petition (PP 3F4174) 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 residues of the insecticide phosphorothioic acid, 0,0-diethyl 0-
(1,2,2,2-tetrachloroethyl) ester (``chlorethoxyfos''), in or on the raw
agricultural commodity corn [corn grain--field, pop; corn forage--
field, sweet; corn fodder (stover)--field, pop, sweet; and, sweet
corn--kernel and cob with husk removed] at 0.01 ppm.
There were no comments or requests for referral to an advisory
committee received in response to the notices of filing. All relevant
materials have been evaluated. The toxicology data considered in
support of the tolerance include:
1. A 2-year chronic feeding/carcinogenicity study in the rat with a
no-observed-effect level (NOEL) of 0.154 milligram (mg)/kilogram (kg)/
day (d) for males and 0.416 mg/kg/d for females (4 ppm) for
cholinesterase inhibition (ChE); and a NOEL of 0.311 mg/kg/d for males
and 0.416 mg/kg/d for females (8 ppm) for systemic effects.
2. An 18-month chronic feeding/carcinogenicity study in the mouse
with a NOEL of 3.25 mg/kg/d for males and 4.63 mg/kg/d for females (25
ppm) and no treatment-related increases in neoplasms.
3. A 2-year chronic feeding study in the dog with a NOEL of 0.063
mg/kg/d for males and 0.065 mg/kg/d for females (2 ppm) for ChE, and a
NOEL of 0.616 mg/kg/d for males and 0.591 mg/kg/d for females (20 ppm)
for systemic effects.
4. A two-generation rat reproduction study with a parental NOEL of
0.296 mg/kg/d for males and 0.357 mg/kg/d for females (4 ppm), and a
reproductive NOEL of 0.607 mg/kg/d for males and 0.776 mg/kg/d for
females (8 ppm).
5. A developmental toxicity study in the rat with a maternal NOEL
of 0.25 mg/kg/d, and a developmental NOEL of 0.25 mg/kg/d.
6. A developmental toxicity study in the rabbit with a maternal
NOEL of 0.76 mg/kg/d, and a developmental NOEL of 1.38 mg/kg/d with no
evidence of teratogenicity.
Chlorethoxyfos has been classified under ``Group D'' (not
classifiable as to human carcinogenicity) by EPA's OPP/HED's Reference
Dose (RFD)/Peer Review Committee.
The reference dose (RfD), based upon the combined subchronic and
chronic toxicity studies in dogs with an overall NOEL of 0.061 mg/kg/d
for males and 0.062 mg/kg/d for females (based on cholinesterase
inhibition) (2 ppm), and an uncertainty factor (UF) of 100, was
calculated to be 0.0006 mg/kg/d. The theoretical maximum residue
contribution (TMRC) using proposed permanent tolerances for the
proposed commodities is 0.000006 mg/kg/d for the overall U.S.
population and 0.000015 mg/kg/d for children (1 to 6 years old). This
represents 1.0% and 2.4% of the RfD, respectively. This is a worst-case
estimate of dietary exposure with all residues at tolerance level and
100 percent of the commodities assumed to be treated with
chlorethoxyfos. Dietary exposure from the proposed use will not exceed
the reference dose for any subpopulation (including infants and
children) based on the information available from EPA's Dietary Risk
Evaluation System.
The nature of the chlorethoxyfos residue in plants and animals is
adequately understood. The plant metabolite of chlorethoxyfos,
trichloroacetic acid (TCA), is not of toxicological concern at the
level found, and therefore will not require the establishment of
tolerances. Residues of chlorethoxyfos and its oxygen analog are not
expected to be detectable (less than 0.01 ppm, limit of quantitation
for each) in corn grain, corn forage and stover as a result of the
proposed use (by soil application). Residues of TCA are not expected to
be detectable (less than 0.01 ppm) in corn grain, and no greater than
0.04 ppm in corn forage and stover. Metabolites of chlorethoxyfos in
the goat via an orally administered route include carbon dioxide,
serine, glycine, and lactose, with insignificant levels of undegraded
parent and its oxygen analog. For the proposed use on corn, no
tolerances are required for residues in animal commodities.
The submitted analytical methodology is adequate for enforcement
purposes at the proposed 0.01-ppm tolerance level. The proposed
enforcement methodology is a gas chromatography electron capture (GC/
EC) method which has undergone
[[Page 49792]]
successful independent laboratory and EPA method validation.
There are adequate geographically representative crop field trial
data to show that residues of chlorethoxyfos will not exceed the
proposed tolerance on corn commodities at 0.01 ppm when used as
directed.
The Agency is concurrently issuing a 3-year conditional
registration for chlorethoxyfos use on corn. Additional toxicology and
exposure studies are being conducted by the registrant, DuPont. These
data are needed to more accurately refine the Agency's risk assessment
for chlorethoxyfos.
There are presently no actions pending against the registration of
this chemical.
This pesticide is considered useful for the purposes for which the
tolerance is sought and capable of achieving the intended physical or
technical effect. 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 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 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 issue(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 3F4174/R2175] (including 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 hearing requests, identified by the document
control number [PP 3F4174/R2175], 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-Docket@epamail.epa.gov
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 in paper form. Accordingly,
EPA will transfer any objections 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: September 15, 1995.
Peter Caulkins,
Acting 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. 180.486 to read as follows:
Sec. 180.486 Phosphorothioic acid, 0,0-diethyl 0-(1,2,2,2-
tetrachloroethyl) ester; tolerances for residues.
Tolerances are established permitting the residue of the
insecticide phosphorothioic acid, 0,0-diethyl 0-(1,2,2,2-
tetrachloroethyl) ester in or on the following raw agricultural
commodities:
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Parts per
Commodity million
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Corn, field, grain......................................... 0.01
Corn, field, forage........................................ 0.01
Corn, field, stover (fodder)............................... 0.01
Corn, pop, grain........................................... 0.01
Corn, pop, stover (fodder)................................. 0.01
Corn, sweet (K + CWHR)..................................... 0.01
[[Page 49793]]
Corn, sweet, forage........................................ 0.01
Corn, sweet,, stover (fodder).............................. 0.01
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[FR Doc. 95-24006 Filed 9-26-95; 8:45 am]
BILLING CODE 6560-50-F
