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quizalofop-p-ethyl (Assure, Super) Proposed Tolerance 7/95

Date: Tue, 18 Jul 1995 15:45:17 -0400
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To: Multiple recipients of list <epa-pest@unixmail.rtpnc.epa.gov> Subject: Quizalofop-P Ethyl Ester; Pesticide Tolerance X-Comment: U.S. EPA FEDERAL REGISTER PESTICIDE documents Status: O
X-Status:
[Federal Register: July 18, 1995 (Volume 60, Number 137)] [Proposed Rules]
[Page 36768-36770]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov] 
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0F3834/P621; FRL-4964-6]
Quizalofop-P Ethyl Ester; Pesticide Tolerance 
AGENCY: Environmental Protection Agency (EPA). 
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for the residues of the herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6- chloroquinoxalin-2-yl)oxy)phenoxyl])-propanoate], and its acid metabolite quizalofop-p [R-(2-[4-((6-chloroquinoxalin-2- yl)oxy)phenoxy]) propanoic acid], and the S enantiomers of both the ester and the acid, all expressed as quizalofop-p-ethyl ester, in or on the raw agricultural commodity lentils at 0.05 part per million (ppm). The regulation was requested by the E.I. du Pont de Nemours & Co., Inc., and establishes the maximum permissible level for residues of the herbicide in or on lentils.
DATES: Comments, identified by the document control number [PP 0F3834/ P621], must be received on or before August 17, 1995. 
ADDRESSES: By mail, submit written comments 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 comments to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as Confidental Business Information'' (CBI). Information so marked will not be diclosed except in accordance withm procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. All written comments will be avialable for public notice. All written comments will be avialable for public inspection in Rm. 1132 at the address given above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number [PP 0F3834/P621]. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic comments on this proposed 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, Robert J. Taylor, Product Manager (PM-25), Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 241, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6027; e-mail: taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of February 22, 1990 (55 FR 6311), which announced that the E.I. du Pont de Nemours & Co., Inc., Walkers Mill Bldg., Barley Mill Plaza, Wilmington, DE 19880, had submitted pesticide petition (PP) 1F3951 to EPA proposing that under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), 40 CFR 180.441 be amended by establishing a regulation to permit the combined residues of the herbicide quizalofop ethyl (ethyl-(2-[4-(6-chloroquinoxalin-2yl- oxy)phenoxy] propanoate)), its metabolite 2-[4-(6-chloroquinoxalin-2- yloxy)phenoxy] propanoic acid, and conjugates, all 
[[Page 36769]]
expressed as quizalofop ethyl, in or on lentils, dry beans, and dry peas at 0.05 ppm.
There were no comments or requests for referral to an advisory committee received in response to the notice of filing. 
The petitioner subsequently amended the petition and proposed to establish a tolerance for residues of the herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy])- propanoate] and its acid metabolite quizalop-p-[R-(2-[4-((6- chloroquinoxalin-2-yl)oxy)phenoxy]) propanoic acid], and the S enantiomers of both the ester and acid, all expressed as quizalofop-p ethyl ester, in or on the raw agricultural commodity lentils at 0.05 ppm.
The petitioner withdrew the proposals for dry beans and dry peas at 0.05 ppm. Because it has been longer than 5 years since the original proposal, the tolerance of 0.05 ppm for lentils is being proposed for 30 days to allow for public comment.
The data submitted in the petition and other relevant material have been evaluated. The toxicology data listed below considered in support of this tolerance.
1. Several acute toxicology studies placing technical-grade quizalofop ethyl in toxicity Category III. 
2. An 18-month carcinogenicity study with CD-1 mice fed dosages of 0, 0.2, 1.5, 12, and 48 mg/kg/day with no carcinogenic effects observed under the conditions of the study at levels up to and including 12 mg/ kg/day and a marginal increase in the incidence of hepatocellular tumors at 48 mg/kg/day HDT (highest dose tested), which exceeded the maximum tolerated dose (MTD).
3. A 2-year chronic toxicity/carcinogenicity study in rats fed dosages of 0, 0.9, 3.7, and 15.5 mg/kg/day for males and 0, 1.1, 4.6, and 18.6 mg/kg/day for females, with no carcinogenic effects observed under the conditions of the study at levels up to and including 18.6 g/ kg/day (HDT) and a systemic NOEL of 0.9 mg/kg/day based on altered red cell parameters and slight/minimal centrilobular enlargement of the liver at 3.7 mg/kg/day.
4. A 1-year feeding study in dogs fed dosages of 0., 0.625, 2.5, and 10 mg/kg/day with NOEL of 10 mg/kg/day (HDT). 
5. A developmental toxicity study in rats fed dosage levels of 0, 30, 100, and 300 mg/kg/day (HDT), with a maternal toxicity NOEL of 30 mg/kg/day and a developmental toxicity NOEL of greater than 300 mg/kg/ day (HDT).
6. A developmental toxicity study in rabbits fed dosage levels of 0, 7, 20, and 60 mg/kg/day with no developmental effects noted at 60 mg/kg/day (HDT), and a maternal toxicity NOEL of 20 mg/kg/day based on decreases in food consumption and body weight gain at 60 mg/kg/day (HDT).
7. A two-generation reproduction study in rats fed dosages of 1, 1.25, 5, and 20 mg/kg/day with a reproductive (developmental) NOEL of 1.25 mg/kg/day based on an increase in liver weight and increase in the incidence of eosinophillic changes in the liver at 5.0 mg/kg/day and a parental NOEL of 5.0 mg/kg/day based on decreased body weight and premating weight gain in males at 20 mg/kg/day (HDT). 
8. Mutagenicity data included gene mutation assays with E. coli and S. typhimurium (negative); DNA damage assays with B. subtillis (negative) and a chromosomal aberration test in Chinese hamster cells (negative).
The Carcinogenicity Peer Review Committed (CPRC) of HED has evaluated the rat and mouse cancer studies on quizalofop along with other relevant short- term toxicity studies, mutagencity studies, and structure-activity relationships. The CPRC concluded, after three meetings and an evaluation by the OPP Science Advisory Panel, that the classification should be a category D (not classifiable as to human cancer potential). No new cancer studies were required. 
The Category D classification is based on an approximate doubling in the incidence of male mice liver tumors between controls and the high dose. This finding was not considered strong enough to warrant the finding of a Category C (possible human carcinogen) since the increase was of marginal statistical significance, occurred at a high dose which exceeded the predicted MTD, and occurred in a study in which the concurrent control for liver tumors was somewhat low as compared to the historical controls, while the high dose control group was at the upper end of previous historical control groups. 
Based on the NOEL of 0.9 mg/kg/bwt/day in the 2-year rat feeding study, and using a hundredfold uncertainty factor, the reference dose (RfD) for quazalofop ethyl is calculated to be 0.009 mg/kg/bwt/day. The theoretical maximum residue contribution (TMRC) is 0.000218 mg/kg/bwt/ day for existing tolerances for the overall U.S. population. The current action will increase the TMRC by less than 0.000001 mg/kg/bwt/ day. These tolerances and previously established tolerances utilize a total of 2.4 % of the RfD for the overall U.S. populations, with all exposure coming from published uses. For U.S. subgroup populations, nonnursing infants and children aged 1 to 6 years, the current action and previously established tolerances utilize, respectively a total of 10.2 percent and 5.76 percent of the RfD, with all exposure coming from previously established tolerances, assuming that residue levels are at the established tolerances and that 100 percent of the crop is tested. 
The nature of the residue is adequately understood, and an adequate analytical methodology (high-pressure liquid chromatography using either ultraviolet or fluorescence detection) is available for enforcement purposes in Vol. II of the Food and Drug Administration Pesticide Analytical Method (PAM II, Method I). There are currently no actions pending against the registration of this chemical. No secondary residues are expected to occur in meat, milk, poultry, or eggs from this use.
Based on the information cited above, the Agency has determined that when used in accordance with good agricultural practice, this ingredient is useful and that the tolerance establised by amending 40 CFR part 180 will protect the public health. It is proposed, therefore, that the tolerance be established as set forth below. 
Any person who has registered or submitted an application for registration a pesticide, under the Fedral Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, which contains any of the ingredients listed herein, may request within 30 days after publication of this document in the Federal Register that this rulemaking proposal be referred to an Advisory Committee in accordance with section 408(e) of the Federal Food, Drug, and Cosmetic Act. 
Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the document control number [PP 0F3834/P621]. All written comments filed in response to this petition will be available in the Public Response and Program Resources Branch, at the address given above from 8 a.m. to 4:30 p.m., Monday through Friday, except legal holidays. 
A record has been established for this rulemaking under docket number [PP 0F3834/P621] (including comments and data 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 
[[Page 36770]]
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.
Electronic comments can be sent directly to EPA at: opp-Docket@epamail.epa.gov
Electronic comments 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 all comments 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 comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document.
The Office of Management and Budget has exempted this rule from the requirements of Executive Order 12866. 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 food additive regulations or raising tolerance levels or food additive regulations 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
Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. 
Dated: June 28, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs. 
Therefore, it is proposed that 40 CFR part 180 be amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.441, by revising paragraph (c), to read as follows: 
Sec. 180.441 Quizalofop ethyl; tolerances for residues. 
*	*	*	*	*
(c) Tolerances are established for the combined residues of the herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6- chloroquinoxalin-2-yl)oxy)phenoxyl)-propanoate], and its acid metabolite quizalofop-p [R-(2-(4((6-chloroquinoxalin-2-yl)oxy)phenoxy]) propanoic acid], and the S enatiomers of both the ester and the acid, all expressed as quizalofop-p-ethyl ester, in or on the following raw agricultural commodities:
------------------------------------------------------------------------ 
Parts per
Commodity	million
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Cottonseed.................................................	0.05
Lentils....................................................	0.05
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[FR Doc. 95-17129 Filed 7-17-95; 8:45 am] BILLING CODE 6560-50-F