[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: [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 
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: 
[email protected].

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-D[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 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:

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