[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5723]


[[Page Unknown]]

[Federal Register: March 11, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180, 185, and 186

[PP 4F3103 and FAP 3H5654/P579; FRL-4763-5]
RIN 2070-AC18

 

Pesticide Tolerances for Methoprene

AGENCY: Environmental Protection Agency (EPA)

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish tolerances for residues of 
the insecticide methoprene in or on various agricultural commodities. 
Zoecon Corp., A Sandoz Co., requested this proposed regulation to 
establish the maximum permissible levels of methoprene in or on the 
commodities. This document also proposes to delete certain obsolete 
food additive tolerances for methoprene.

DATES: Comments, identified by the document control number, [PP 4F3103 
and FAP 3H5654/P579] must be received on or before April 11, 1994.

ADDRESSES: By mail, submit written comments to: Public Document and 
Freedom of Information Section, Field Operations Division (7506C), 
Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460. In 
person, bring comments to: Rm.211, CM #2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, (703)-305-5412.
    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 may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1128C 
at the address given below, from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Phillip O. Hutton, Product 
Manager (PM) 18, Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460, (703)-305-
7690.

SUPPLEMENTARY INFORMATION: The Agency is proposing to delete an 
expired, temporary food additive tolerance of 10 parts per million 
(ppm) for residues of the insecticide methoprene (isopropyl (E,E)-11-
methoxy-3,7,11- trimethyl-2,4-dodecadienoate) in or on raisins, wheat 
flour, macaroni (wheat), rice cereal, rye cereal, barley cereal, wheat 
cereal, corn cereal, corn meal, grits, hominy, oat cereal, spices, dry 
dog food, dried apples, dried apricots, dried peaches, and dried prunes 
resulting from applications of methoprene in accordance with the 
provisions of an experimental use permit that expired September 21, 
1986. The tolerance was established under section 409 of the Federal, 
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, and appears in chapter I 
of title 40 of the Code of Federal Regulations (40 CFR 185.4150(b)). 
This temporary tolerance was established with issuance of an 
experimental use permit (EUP) and expired on September 21, 1986. The 
tolerance is obsolete, and EPA is proposing to remove it.
    EPA issued a notice in the Federal Register of August 1, 1984 (49 
FR 149), which announced that Zoecon Corp., 975 California Ave., Palo 
Alto, CA, 94304, had submitted pesticide petition (PP) 4F3103 to EPA 
proposing to establish tolerances under section 408 of the Federal, 
Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, for the insecticide 
methoprene in or on the following commodities: barley at 10.0 ppm, 
buckwheat at 10.0 ppm, corn (all types) at 10.0 ppm, eggs at 2.0 ppm, 
fat of cattle, goats, hogs, horses and sheep at 3.0 ppm, meat and meat 
by-products of cattle, goats, hogs, horses, and sheep at 2.0 ppm, milk 
at 2.0 ppm, millet at 10.0 ppm, milo (sorghum) at 10.0 ppm, oats at 
10.0 ppm, poultry at 2.0 ppm, rice at 10.0 ppm, rye at 10.0 ppm, 
sunflower at 10.0 ppm, and wheat at 10.0 ppm.
    Subsequently, the Agency requested that Zoecon amend the petition 
by proposing tolerances as follows: cereal grains Group XV (except 
popcorn and sweet corn) at 5.0 ppm; eggs at 0.1 ppm; fat of cattle, 
goats, hogs, horses, poultry, and sheep at 1.0 ppm; meat and meat by-
products of cattle, goats, hogs, horses, poultry, and sheep at 0.1 ppm; 
and milk at 0.1 ppm. Sandoz Crop Protection Corp. acquired Zoecon Corp. 
and amended the petition as follows: a tolerance of 5 ppm for cereal 
grains Group XV (except popcorn and sweet corn); the tolerance for eggs 
reduced to 0.1 ppm; the tolerance for fat of cattle, goats, hogs, 
horses, and sheep reduced to 1.0 ppm; a tolerance for poultry fat of 
1.0 ppm added; the tolerance for meat and meat by-products of cattle, 
goats, hogs, horses, and sheep reduced to 0.1 ppm; a tolerance for meat 
and meat by-products of poultry at 0.1 ppm added; and the tolerance for 
milk reduced to 0.1 ppm.
    EPA issued a notice in the Federal Register of July 20, 1988 (53 FR 
27391), announcing that Sandoz Crop Protection Corp. had submitted 
these tolerance requests to amend PP 4F3103. In addition, the Agency 
requested that Zoecon submit a food additive petition for the proposed 
tolerances of 25 ppm in or on rice hulls and 10.0 ppm for cereal grain 
milled fractions (except flour and ricehulls). Zoecon submitted a food 
additive petition requesting tolerances of 10.0 ppm for cereal grain 
milled fractions (except flour and rice hulls) and 25 ppm in or on rice 
hulls. The Agency designated this petition as food additive petition 
(FAP) 3H5654.
    Because tolerances for meat and meat by-products of cattle, goats, 
hogs, horses, and sheep are currently established at 0.1 ppm, new 
tolerances for these commodities are not necessary. There were no 
comments received in response to the notices of filing.
    The data submitted in support of the petitions and other relevant 
material have been evaluated. The toxicological data considered in 
support of the tolerances include the following:
    1. An 18-month mouse feeding/carcinogenicity study using doses of 
0, 250, 1,000, and 2,500 ppm (equivalent to doses of 0, 37.5, 150, and 
375 milligrams/kilogram (mg/kg) of body weight (bwt)/day). The systemic 
no-observed-effect level (NOEL) is 250 ppm (37.5 mg/kg/day) based on 
liver pigmentation, and the systemic lowest-effect-level (LEL) is 1,000 
ppm (150 mg/kg/day). There was no evidence of carcinogenicity at any 
dose levels tested.
    2. A 2-year rat feeding/carcinogenicity study using dietary 
concentration of 0, 250, 100, and 5,000 ppm (equivalent to doses of 0, 
12.5, 50, and 125 mg/kg bwt/day). The systemic NOEL is 1000 ppm (50 mg/
kg/day) based on liver pathology observed. There was no evidence of 
carcinogenicity at any dose levels tested.
    3. A three-generation mouse reproduction study with a NOEL of 2,500 
ppm (125 mg/kg/day) for both reproductive and systemic effects.
    4. A rabbit developmental toxicity study was negative for 
developmental effects at all dose levels up to 2,000 mg/kg/day, the 
highest dose tested. The NOEL for maternal toxicity and developmental 
toxicity was 200 mg/kg/day, and the LEL for both maternal toxicity and 
developmental toxicity was 2,000 mg/kg/day.
    5. A mouse developmental toxicity study was negative for 
developmental effects at all dose levels up to 600 mg/kg/day, the 
highest dose tested. The NOEL for developmental toxicity was 600 mg/kg/
day.
    Methoprene was not carcinogenic in either the mouse or rat chronic/
carcinogenic feeding studies. In the mouse study, the only effect noted 
was a dark brown granular pigment in the cytoplasm of liver parenchymal 
cells. This effect was pronounced at the 2,500 ppm level, still obvious 
at the 1,000 ppm level, but was absent at the 250 ppm level. The effect 
thus seemed dose related and linked to the administration of the 
chemical. The tumor incidence in mice was not increased in this study.
    The main toxicological effect seen in the rat chronic/carcinogenic 
feeding study was liver pathology which consisted of slight portal 
lymphocytic infiltration, slight to very slight bile duct 
proliferation, and vacuolized hepatocytes. These findings were not 
consistent and dose related. No increased occurrence of tumors was 
observed in rats fed methoprene.
    EPA concludes that methoprene did not induce cancer in rats or mice 
and that no significant carcinogenic risk is posed by these tolerances.
    The reference dose (RfD), based on the 18-month mouse chronic 
feeding/carcinogenicity study (NOEL of 37.5 mg/kg bwt/day), and using a 
hundredfold uncertainty factor, is calculated to be 0.4 mg/kg bwt/day. 
The theoretical maximum residue contribution (TMRC) for the general 
population from previously established tolerances and tolerances 
established here is 0.016198 mg/kg bwt/day and utilizes 4% of the RfD. 
The subgroup most highly exposed, nonnursing infants less than one year 
old, has a TMRC from published and proposed uses of 0.045043 mg/kg bwt/
day, or 11.3% of the RfD.
    The nature of the residue is adequately understood, and adequate 
analytical methods for the enforcement of methoprene residues in milk, 
meat, and animal fat have been published in the Pesticide Analytical 
Manual, Vol. II.
    The modifications raise tolerance levels for milk, eggs, and fat of 
cattle, goats, hogs, horses, poultry, and sheep and for meat byproducts 
of poultry. The modifications lower the tolerance level for poultry 
meat. The tolerance level of 0.1 ppm for meat and meat byproducts of 
cattle, goats, hogs, horses, and sheep remains unchanged.
    The pesticide is considered useful for the purposes for which the 
tolerances are sought and capable of achieving the intended physical or 
technical effect. Based on the information and data considered, the 
Agency concludes that the establishment of the tolerances will protect 
the public health, and use of the pesticide in accordance with the 
terms of the proposed food additive regulation would be safe. 
Therefore, the tolerances and food/feed additive regulations are 
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 publication 
of this document in the Federal Register that the portion of this 
rulemaking proposal for tolerances for raw agricultural commodities 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 regulations. Comments must bear a notation indicating the 
document control number, [PP 4F3103 and FAP 3H5654/P579]. All written 
comments filed in response to this petition will be available in the 
Public Docket and Freedom of Information Section, at the address give 
above, from 8 a.m. to 4 p.m., Monday through Friday, except legal 
holidays.
    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).
    Because EPA proposes to reduce the tolerance for residues of 
methoprene on poultry meat from 0.5 ppm to 0.1 ppm, an economic impact 
assessment of the proposed reduction on business is needed to comply 
with the requirements of the Regulatory Flexibility Act and Executive 
Order 12866. The economic analysis concluded that there would be no 
impact expected on businesses or other entities of any size by reducing 
the poultry meat tolerance from 0.5 ppm to 0.1 ppm and that this 
proposed rule is not a significant rule according to Executive Order 
12866.

List of Subjects in 40 CFR Parts 180, 185, and 186

    Environmental protection, Administrative practice and procedures, 
Agriculture commodities, Food additives, Feed additives, Pesticides and 
pests, Reporting and recordkeeping requirements.

Dated: March 3, 1994.

Stephanie R. Irene,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that chapter I of title 40 of the Code of 
Federal Regulations be amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    b. By revising Sec. 180.359, to read as follows:


Sec. 180.359   Methoprene; tolerances for residues.

    Tolerance are established for residues of the insect growth 
regulator methoprene (isopropyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-
dodecadienoate) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Barley.....................................................          5.0
Buckwheat..................................................          5.0
Cattle, fat................................................          1.0
Cattle, meat...............................................          0.1
Cattle, meat byproducts....................................          0.1
Corn (except popcorn and sweetcorn)........................          5.0
Eggs.......................................................          0.1
Goats, fat.................................................          1.0
Goats, meat................................................          0.1
Goats, meat byproducts.....................................          0.1
Hogs, fat..................................................          1.0
Hogs, meat.................................................          0.1
Hogs, meat byproducts......................................          0.1
Horses, fat................................................          1.0
Horses, meat...............................................          0.1
Horses, meat byproducts....................................          0.1
Milk.......................................................          0.1
Millet.....................................................          5.0
Mushrooms..................................................          1.0
Oats.......................................................          5.0
Peanuts....................................................          2.0
Peanut hulls...............................................         40.0
Poultry, fat...............................................          1.0
Poultry, meat..............................................          0.1
Poultry, meat byproducts...................................          0.1
Rice.......................................................          5.0
Rye........................................................          5.0
Sheep, fat.................................................          1.0
Sheep, meat................................................          0.1
Sheep, meat byproducts.....................................          0.1
Sorghum (milo).............................................          5.0
Wheat......................................................          5.0
------------------------------------------------------------------------


PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

    b. In Sec. 185.4150, by revising paragraph (b), to read as follows:


Sec. 185.4150   Methoprene.

*        *        *        *        *
    (b) A tolerance of 10 parts per million is established for residues 
of isopropyl ((E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate) in 
or on the food additive commodity cereal grain milled fractions (except 
flour and rice hulls).

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

    b. In Sec. 186.4150, by adding new paragraph (d), to read as 
follows:


Sec. 186.4150   Methoprene.

*        *        *        *        *
    (d) Tolerances are established for residues of the insect growth 
regulator methoprene (isopropyl (E,E)-11-methoxy -3,7,11-trimethyl-2,4-
dodecadienoate) in or on the following feed additive commodities:

------------------------------------------------------------------------
                                                              Parts per 
                            Feed                               million  
------------------------------------------------------------------------
Cereal grain milled fractions (except flour and rice hulls)           10
Rice hulls.................................................           25
------------------------------------------------------------------------


[FR Doc. 94-5723 Filed 3-10-94; 8:45 am]
BILLING CODE 6560-50-F