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Ethyl Methylphenylglycidate - Pesticide Petition Filing 12/00

ENVIRONMENTAL PROTECTION AGENCY

[PF-981; FRL-6751-9]

Notice of Filing Pesticide Petitions to Establish Tolerances for
Certain Pesticide Chemicals in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.

DATES:  Comments, identified by docket control number PF-981, must be
received on or before January 19, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-981 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Bipin C. Gandhi,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-8380; e-mail address:
gandhi.bipin@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number PF-981. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is

[[Page 79835]]

available for inspection in the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The PIRIB telephone number is (703)
305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-981 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-981. Electronic comments may
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. What Action is the Agency Taking?

    EPA has received pesticide petitions as follows proposing the
establishment and/or amendment of regulations for residues of certain
pesticide chemicals in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that these petitions contain data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data support granting of these petitions. Additional
data may be needed before EPA rules on the petitions.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: December 8, 2000.
James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner summary of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioner and represents the view of
the petitioner. EPA is publishing the petitioner's summaries verbatim
without editing it in any way. The petitioner's summaries announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemicals
residues or an explanation of why no such method is needed.

Firmenich Incorporated

3. PP 6E4759

    EPA has received a pesticide petition (6E4759), to amend 40 CFR
part 180, to establish an exemption from the requirement of a tolerance
for ethyl methylphenylglycidate when used as an inert ingredient in the
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest under 40 CFR 180.1001(c) and applied to
animals under 40 CFR 180.1001 (e). EPA has determined that the petition
contains data or information regarding the elements set forth in
section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
support granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

    Since the petition is for an exemption from the requirement of a
tolerance, an analytical method is not required.

B. Toxicological Profile

    As a part of the EPA policy statement on inert ingredients
published in the

[[Page 79838]]

Federal Register of April 22, 1987 (52 FR 13305) (FRL -3190-1), the
Agency set forth a list of studies which can generally be used to
evaluate the risks posed by the presence of an inert ingredient in a
pesticide formulation. However, where it can be determined without that
data that the inert ingredient will present minimal or no risk, the
Agency generally does not require some or all of the listed studies to
rule on the proposed tolerance or exemption from the requirement of a
tolerance for an inert ingredient.
    The date that Firmenich believes supports establishing an exemption
from tolerance is summarized below. More detailed information has been
provided to the Agency.
    Ethyl methylphenylglycidate has been used in foodstuffs as a
flavoring agent since the 1930's and is approved by the FDA as GRAS (21
CFR 182.60) and by the Council of Europe as in the list of substances
granted "A status"-- may be used in foodstuffs (COE No. 6002). It is
recognized by the flavor and extract manufacturer's association as GRAS
(GRAS 3 (2444)).
    1. Acute toxicity. The LD50 of ethyl
methylphenylglycidate has been determined to be 5.47 g/kg for the rat,
5.6 mL/kg for the mouse, and 4.05 g/kg for the guinea pig.
    Due to the very low water solubility of ethyl methylphenylglycidate
and the octanol/water coefficient (estimated Kow 3.0), acute aquatic
toxicity testing is thereby precluded.
    2. Genotoxicty. An Ames tests with S-9 fractions from Aroclor-
pretreated rats at doses up to 3.6 mg/plate with and without S-9 gave
no adverse effect. Similarly, an Ames test, with strains TA98, TA 100,
TA1535, TA1537 and TA97, also gave no adverse effects. A Drosophila
melagaster and micronucleus test on mouse bone marrow appeared weakly
mutagenic in the Drosophila only.
    A chinese hamster ovary (CHO) cell study with ethyl
methylphenylglycidate treated 8-12 hours without rat S-9 and 2 hours
with S-9, gave positive sister chromatid exchange effects without S-9
over the full range of doses tested, 16 - 160 g/mL, and no
effect with S-9 over the whole range. Similarly, there were significant
increases in chromosome aberrations over the range 50-500 g/mL
with and without S-9.
    3. Reproductive and developmental toxicity. Toxicity and
teratogenicity of ethyl methylphenylglycidate was evaluated in chickens
with mortality and structural & functional defects being evaluated. The
teratogenicity NOEC was 25 mg/egg and the LD50 was 8.16 mg/
egg.
    A mouse carcinogenicity and mutagenesis study was conducted in 15/
sex/dose male and female mice by intraperitoneal injection 3X per weeks
for 8 weeks at the maximum tolerance dose (MTD) and 0.20X MTD of ethyl
methylphenylglycidate. There were 10 deaths at 0.45 g/kg and 4 deaths
at 2.15 g/kg. Similarly, an intraperitonile ethyl methylphenylglycidate
study with male and female mice showed no effects at the highest dose
treated, 1,856 mg/kg.
    4. Subchronic toxicity. In a 16-week rat study with male and female
Osborne-Mendel rats at 10,000 parts per million (ppm) ethyl
methylphenylglycidate weight changes, reproductive effects, growth
retardation in males, and marked testicular atrophy was observed. In a
1-year study with male and female Osborne-Mendel rats, no effects were
observed at 2,500 ppm of ethyl methylphenylglycidate on growth,
haematology or macroscopic/microscopic tissue examination. In a second
study, ethyl methylphenylglycidate, was fed to male and female rats for
15 weeks at 0.0, 0.02, 0.1, and 0.5% in the diet. No effect was
observed on the growth rate, food consumption, or water consumption of
the animals. The only effect attributable to the test substance were
increased organ weight changes in the animals fed at the 0.5% level.
The no observed adverse effect level was 0.1% ethyl
methylphenylglycidate, corresponding to 150 and 60 mg/kg/day
respectively at the beginning and end of the study.
    5. Chronic toxicity. In a rat study, male and female rats were fed
for 1.5 to 2 years at 0.1% and 0.5% ethyl methylphenylglycidate in
their diet. No effects were observed at the 0.1% level. At 0.5% in the
diet, neurotoxic effects, body weight (bwt) changes, pareses of the
rear extremities with histological degeneration of the ischia nerve,
and growth inhibition were observed. In a second study with 48 Wistar
rats/sex at 0, 0.02, 0.1, and 0.5 EMPG in the diet for 2 years, no
effects were observed at 0.1% (EMPG intake of approximately 35 mg/kg/
day ethyl methylphenylglycidate for the males and 60 mg/kg/day ethyl
methylphenylglycidate for the females). At 0.5%, weight changes, liver,
micropathology in other organs, significant decrease in body weight in
females, increased incidents of histopathology changes in lymph nodes,
pancreas, adrenal glands, and liver were noted. No differences in
mortality, hematology, serum chemistry, renal function, organ weights,
or motor coordination were observed at any dose.
    6. Endocrine disruption. Ethyl methylphenylglycidate is not
structurally similar to any substances know to be an endocrine
disrupter.

C. Aggregate Exposure

    Consistent with section 408(c)(2)(B) of FFDCA, Firmenich
Incorporated believes that, based on this submission, the Agency has
sufficient information to assess the hazards of ethyl
methylphenylglycidate and make a determination on aggregate exposure,
consistent with section 408(b)(2) for tolerance exemption for the
residues of ethyl methylphenylglycidate on growing crops, RACs after
harvest, and animals.
    Dietary exposure. For the purpose of assessing the potential
dietary exposure under these exemptions, Firmenich Incorporated
considers that ethyl methylphenylglycidate could be present in all raw
and processed agricultural commodities.
    1. Food. Ethyl methylphenylglycidate is a GRAS substance 21 CFR
182.60 and is included by the Council of Europe in the list of
substances granted"A status"--may be used in foodstuffs (COE No.
6002). The flavors and extract manufacturer's association states:
Generally recognized as safe as a flavor ingredient--GRAS 3, (2444).
The Joint Expert Committee on food additives has established an ADI of
0.5 mg/kg (1984). Therefore, no concerns for risk associated with any
potential exposure scenarios are reasonably foreseeable.
    2. Drinking water. Due to the low water solubility (estimated 87
mg/L by ECOSAR), only very low drinking water exposure is expected and
would not contribute significantly to the ADI. Therefore, no concerns
for risk associated with any potential exposure scenarios are
reasonably foreseeable.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider "available information" concerning the
cumulative effects of particular chemical's residues and "other
substances that have a common mechanism of toxicity". Ethyl
methylphenylglycidate has been in public use since the 1930's and the
lack of observed toxicity after acute and chronic exposure would
suggest that a cumulative risk assessment is therefore not necessary.

E. Safety Determination

    1. U.S. population. Ethyl methylphenylglycidate has been granted
self-affirmed GRAS status in the United States, is approved for food
use in Europe, and by the WHO Joint Expert Committee on food additives,
with an

[[Page 79839]]

ADI of 0.5 mg/kg. Based on this material's low-risk profile, there is
reasonable certainty that no harm to the U. S. population will result
from aggregate exposure to ethyl methylphenylglycidate.
    2. Infants and children. FFDCA section 408 provides that EPA shall
apply a ten-fold MOE for infants and children in the case of threshold
effects to account for prenatal and postnatal toxicity and the
completeness of the data base unless EPA concludes that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA's risk assessment either directly
through the MOE analysis or through using uncertainty (safety) factors
in calculating a dose level that pose no appreciable risk to humans.
    Due to the extensive available toxicological data base including
chronic toxicity studies and the expected low toxicity of this
compound, Firmenich Incorporated does not believe a safety factor
analysis is necessary in assessing the risk of these compounds. For the
same reasons, Firmenich believes the additional safety factor is
unnecessary.

F. International Tolerances

    There are no known international tolerances for ethyl methyl-
phenylglycidate

[FR Doc. 00-32152 Filed 12-19-00; 8:45 am]
BILLING CODE 6560-50-S