Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: August 7, 2002 (Volume 67, Number 152)]
[Notices]
[Page 51260-51262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au02-85]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0166; FRL-7190-4]
 
Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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

DATES: Comments, identified by docket ID number OPP-2002-0166, must be 
received on or before September 6, 2002.

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 ID 
number OPP-2002-0166 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8373; e-mail address: 
treva.alston@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 ID number OPP-2002-0166. 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 available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, 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 ID number OPP-2002-0166 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 Highway, 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 ID number OPP-2002-0166. 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

[[Page 51261]]

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 
ID 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 a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains 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 the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: July 25, 2002.
Peter Caukins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

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

Akzo Nobel Surface Chemistry LLC

PP 7E4807

     EPA has received a pesticide petition PP 7E4807 from Akzo Nobel 
Surface Chemistry LLC, 300 South Riverside Plaza, Chicago, IL 60606, 
proposing, pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. To 
establish an exemption from the requirement of a tolerance for [2-
ethylhexyl glucopyranoside]
to be applied to growing crops only. 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

    1. Plant metabolism. The plant metabolism of 2-ethylhexyl 
glucopyranoside has not been investigated. However, due to the 
structural similarity, the metabolic pathway for 2-ethylhexyl 
glucopyranoside is expected to be similar to that of other alkyl 
glucosides which have been previously granted an exemption from the 
requirement of a tolerance, and also of those alkyl glucosides of 
similar structure that appear on EPA's current List 4B Inert Ingredient 
List.
    2. Analytical method. The inert ingredient, impurities and oligomer 
distribution can be analyzed using high temperature gas chromatography 
with cold on column injection after derivatization with silylating 
reagents. Low levels of the inert ingredient can be detected by HPLC.
    3. Magnitude of residues. Given the current extensive and 
widespread use of structurally similar nonionic surfactants in 
herbicide formulations, the added use of 2-ethylhexyl glucopyranoside 
will not significantly contribute to the total use-volume of these 
materials. The expected concentration of 2ethylhexyl glucopyranoside 
when used in an herbicide formulation will be much lower than the 
concentration of any co-formulated pesticide active ingredient. 
Therefore, the comparable application rate, on a grams/acre basis will 
be significantly lower than that of any co-formulated active 
ingredient. It is then reasonable to assume that any potential residues 
resulting from the use of 2-ethylhexyl glucopyranoside in a pesticide 
formulation would be insignificant.

B. Toxicological Profile

    1. Acute toxicity. The results of acute toxicity testing for 2-
ethylhexyl glucopyranoside are as follows: Acute oral LD₅₀ 
(rat) >2.0 gram/kilogram (g/kg); Acute dermal LD₅₀ (rat) 
>2.38 g/kg; moderate to severe eye irritant (rabbit); non-irritating to 
skin (rabbit); not a skin sensitizer (guinea pig).
    2. Genotoxicty. 2-Ethylhexyl glucoside was negative in the Ames 
test, and did not induce chromosomal aberrations in human lymphocytes 
cultured in vivo.
    3. Reproductive and developmental toxicity. Although the final 
report has not yet been issued, the preliminary results from a one-
generation reproduction toxicity study with 2-ethylhexyl glucoside 
administered in male and female Wistar rats are available. The results 
indicate gavage treatment of male and female Wistar rats with 2-
ethylhexyl glucoside at dose levels of 15, 150 or 750 milligram/
kilogram (mg/kg) body weight/day during one generation, revealed 
parental toxicity in animals receiving 750 mg/kg b.w./day. Reproductive 
parameters and development of the pups were not affected up to 750 mg/
kg b.w./day.
     Parental toxicity consisted of affected mortality, clinical signs, 
body weights, and food consumption for animals treated at 750 mg/kg 
body weight/day.
     Based on the results in this one-generation study, the definitive 
parental no observed adverse effect level (NOAEL) was established as 
being 150 mg/kg body weight/day. The definitive reproductive and 
developmental NOAEL was established as being 750 mg/kg body weight/day.
    4. Subchronic toxicity. A 28-day oral toxicity study in the rat was 
conducted

[[Page 51262]]

on 2-ethylhexyl glucopyranoside. The results were that in the rat, 750 
mg/kg/day represents the no-observed-toxic effect level (NOTEL) and 150 
mg/kg/day represents the no-observed effect level (NOEL).
    5. Chronic toxicity. Based on the NOTEL and NOEL results of the 28-
day study conducted on 2-ethylhexyl glucopyranoside, there are no 
chronic health concerns.
    6. Animal metabolism. Animal metabolism studies have not been 
conducted on 2-ethylhexyl glucopyranoside. However, structurally 
similar radiolabeled alkyl glucopyranosides were studied after oral 
administration to mice. The results indicate that the glycosidic bond 
was rapidly hydrolyzed in the intestine and liver to sugars and the 
parent alcohol. The sugars and alcohols then entered the pathways of 
lipid and carbohydrate metabolism.
    7. Metabolite toxicology. The metabolites of 2-ethylhexyl 
glucopyranoside are expected to be the cleavage products at the 
glycosidic bond, 2-ethylhexanol and glucose. The toxicity of these two 
metabolites is well known.
    8. Endocrine disruption. No evidence of endocrine disruption was 
observed in any of the studies conducted on 2-ethylhexyl 
glucopyranoside, nor are there any known reports of any estrogenic and 
adverse effects to human population as a result of the use of 2-
ethyhexyl glucopyranoside.

C. Aggregate Exposure

    1. Dietary exposure. Based on the metabolism study that indicates 
alkyl glucopyranosides are readily metabolized in the liver and 
intestine to glucose and the alcohol, exposure to 2-ethylhexyl 
glucopyranoside should not pose a dietary risk under any foreseeable 
circumstances to the U.S. population including infants and children.
    i. Food. Exposures to 2-ethylhexyl glucopyranoside due to ingestion 
of food is not expected to occur.
    ii. Drinking water. Exposures to 2-ethylhexyl glucopyranoside due 
to ingestion of water is not expected to occur.
    2. Non-dietary exposure. Structurally similar alkyl 
glucopyranosides are currently being used in a number of institutional 
and household cleaning applications. These current uses are expected to 
result in significantly higher exposures than exposure due to the 
insignificant residue levels resulting from the use under the proposed 
exemption from the requirement of a tolerance applied to growing crops 
only.

D. Cumulative Effects.

     From the results of the tests conducted on 2-ethylhexyl 
glucopyranoside, no evidence of any specific target organ toxicity has 
been produced. Therefore, there is no evidence of a common mechanism of 
toxicity with any other substance, and there is no reason to expect 
that the use of 2-ethyhexyl glucopyranoside will contribute to any 
cumulative toxicity resulting from exposures to other substances having 
a common mechanism of toxicity.

E. Safety Determination

    1. U.S. population. The results of the acute, genotoxic, subacute 
and developmental toxicity studies conducted on 2-ethylhexyl 
glucopyranoside indicate a relatively low order of toxicity. 
Structurally similar alkyl glucopyranosides currently exempted from the 
requirement of a tolerance, also appear on EPA's List 4B Inert List. 
Therefore, due to the low order of toxicity of 2-ethylhexyl 
glucopyranoside and the lack of known adverse human health effects 
associated with this class of chemicals, the exemption from the 
requirement of a tolerance on growing crops only is not expected to 
result in any new, or adverse effects to human health or the 
environment.
    2. Infants and children. Exposure to 2-ethylhexyl glucopyranosides 
to infants and children is not expected to occur. The substance will be 
used as an inert ingredient at low levels on growing crops only, and 
any residual levels are expected to be insignificant and consistent 
with structurally similar alkyl glucopyranosides currently exempted 
from the requirement of a tolerance.

F. International Tolerances

     No codex maximum residue levels have been established for 2-
ethyhexyl glucopyranoside.

[FR Doc. 02-19805 Filed 8-6-02; 8:45 am]
BILLING CODE 6560-50-S
Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

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