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pheromones Proposed Tolerance Exemption 11/93

Arthropod Pheromones; Tolerance Exemption 



AGENCY: Environmental Protection Agency (EPA). 



ACTION: Proposed rule. 

.

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SUMMARY: This document proposes that an exemption from the requirement 

of a tolerance be established for residues of arthropod pheromones 

resulting from the use of these substances in solid matrix dispensers 

with an annual application limitation of 150 grams active ingredient 

per acre (gm ai/acre) for pest control in or on all raw agricultural 

commodities (RAC). This regulation is proposed by EPA at its 

own initiative. 



DATES: Comments identified by the docket number [OPP-300314] 

must be received on or before January 7, 1994. 



ADDRESSES: Submit written comments by mail to: Public Response 

and Program Resources Branch, Field Operations Division (7506C), 

Office of Pesticide Programs, U.S. Environmental Protection 

Agency, 401 M St., SW., Washington, DC 20460. In person, bring 

comments to: Public Docket, Rm. 1132, Crystal Mall #2, 1921 

Jefferson Davis Highway, 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 ``Confidential 

Business Information'' (CBI). Information so marked will not 

be disclosed except in accordance with 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 will be included in the public docket 

by EPA without prior notice. The public docket is available 

for public inspection in Rm. 1128 at the above address, from 

8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 



FOR FURTHER INFORMATION CONTACT: By mail: Phil Hutton, Product 

Manager (PM-18), Registration Division (7505C) Office of Pesticide 

Programs, Environmental Protection Agency, 401 M St., SW., Washington, 

DC 20460. Office location and telephone number: Rm. 213, CM 

#2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703) 

305-7690. 



SUPPLEMENTARY INFORMATION: EPA proposes to amend 40 CFR part 

180 by establishing an exemption from the requirement of a tolerance 

for all arthropod pheromones used in solid matrix dispensers 

at rates less than or equal to 150 grams active ingredient (ai)/acre/year. 



   A pheromone is defined by EPA as a compound produced by an 

arthropod that modifies the behavior of other individuals of 

the same species (40 CFR 152.25(b)(1)). EPA has examined the 

data related to human health submitted for the approximately 

30 arthropod pheromones registered to date as biochemical pesticides 

as well as available published toxicology studies on this class 

of compounds. The mammalian toxicology for these registered 

arthropod pheromones indicates no acute toxicity for the oral 

route of exposure (toxicity category IV = nontoxic). The compounds 

tested were shown not to be mutagens via the Ames Salmonella 

test. 

   Since registration of approximately 30 arthropod pheromones 

as active ingredients, the Agency has received no additional 

factual information regarding unreasonable adverse effects on 

human health or the environment relating to use of these pesticides. 

In addition the Agency is unaware of any adverse health or environmental 

effects resulting from pheromones when used in traps. 

   To date the Agency has not requested residue analyses for 

these compounds due to their low mammalian toxicity and use 

rates, which are generally below the 20 gm ai/acre limit triggering 

food residue analysis (40 CFR 158.690(b)). In addition, the 

low probability of redeposition of the pesticide onto the plant 

after volatilization would predict that food or feed residues 

are not detectable at these use rates. There is published information 

for residue analysis of pheromones applied at 129 to 141 gm 

ai/acre which reported that residues were not detectable in 

harvested fruit using techniques with a detection limit of 2 

to 5 parts per billion (Refs. 1 and 2). The Agency therefore 

believes that an upper limit of 150 grams ai/acre/year for pheromones 

in dispensers should result in no detectable residues in or 

on foods or feed. Broadcast methods of application are not included 

in this exemption because the Agency does not have sufficient 

information on the levels of exposure from pheromones which 

are broadcast. 

   EPA has determined that, when used in accordance with good 

agricultural practices, a tolerance is not necessary to protect 

the public health due to low toxicity and negligible to non-

existent food residues expected from the use of these volatile 

pheromones in solid matrices. Solid matrix dispensers, as defined 

in this notice, include, but are not limited to: Rubber septa 

dispensers, trilaminate sheets, tapes, tags, wafers, macrocapillary 

devices, such as long tubes or fibers, twist ties, or protected 

ropes which are placed by hand in the field and are of such 

size and construction that they are readily recognized. Formulations 

not included in this exemption are: Liquid flowables, microcapsules, 

microcapillary straws; granular powder, flakes, or confetti 

formulations which are sprayed or broadcast over the crop area; 

and cigarette filters or unprotected ropes which generally contain 

the active ingredient on the outer surface of the unit. These 

smaller sized formulations are not exempt because they may be 

of a size and shape readily consumed by birds and other wildlife. 

A generic exemption for this low-risk, low-exposure group of 

substances will facilitate the use of semiochemicals as alternatives 

to conventional synthetic pesticides. Therefore, EPA proposes 

that an exemption from the requirement of a tolerance be established 

as set forth below. 

   Any person who has registered or submitted an application 

for registration of a pesticide under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) as amended, which contains 

any of the ingredients listed herein, may request within 30 

days after the 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 (FFDCA). 

   Interested persons are invited to submit written comments 

on the proposed regulation. Comments must bear a notation indicating 

the document control number, [OPP-300314]. All written comments 

filed in response to this petition will be available in the 

Public Response and Program Resources Branch at the above address 

from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays. 

   The Office of Management and Budget has exempted this notice 

from the requirement of review pursuant to 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 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). 



References 



   (1) Spittler, T. D.; Leichtweis, H. C.; Dennehy, T. J. (1988) 

Biorational Control of Crop Pests by Mating Disruption: Residue 

Analyses of Z-9-Dodecen-1-yl Acetate and Z-11-Tetradecen-1-yl 

Acetate in Grapes. In: Biotechnology for Crop Protection, P. 

Hedin, J. J. Menn and R. Hollingworth (eds), ACS Symposium Series, 

379:430-436. 

   (2) Spittler, T. D.; Leichtweis, H. C.; Kirsch, P. (1992) 

Exposure, Fate and Potential Residues in Food of Applied Lepidopteran 

Pheromones. In: Insect Pheromones and Other Behaviour-Modifying 

Chemicals: Application and Regulation, R. L. Ridgway, M. Inscoe 

and H. Arn (eds), BCPC Monograph No. 51, pp. 93-108. 



List of Subjects in 40 CFR Part 180



   Environmental protection, Administrative practice and procedure, 

Agricultural commodities, Pesticides and pests, Reporting and 

recordkeeping requirements.



   Dated: November 17, 1993.



Stephen L. Johnson,

Acting Director, Registration Division, Office of Pesticide 

Programs. 

   Therefore, it is proposed that 40 CFR part 180 be 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 . 180.1124 to subpart D to read as follows: 



 180.1124   Arthropod pheromones; exemption from the requirement 

of a tolerance. 



   Arthropod pheromones, as described in 152.25(b) of this chapter, 

when used in solid matrix dispensers are exempt from the requirement 

of a tolerance in or on all raw agricultural commodities when 

applied to growing crops only at a rate not to exceed 150 grams 

active ingredient/acre/year in accordance with good agricultural 

practices.



[FR Doc. 93-29829 Filed 12-7-93; 8:45 am]