[Federal Register Volume 67, Number 171 (Wednesday, September 4, 2002)]
[Notices]
[Pages 56560-56562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22235]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT20020167; FRL71906]


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 control number OPPT20020167, must 
be received on or before October 4, 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 OPPT20020167 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Adam Heyward, Regulatory 
Management Branch II, Antimicrobials Division (7510C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 3086422; e-
mail address: [email protected].

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 OPPT20020167. 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

[[Page 56561]]

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) 3055805.

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 OPPT20020167 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) 3055805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], 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 OPPT20020167. 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 
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.

    August 22, 2002.
Frank Sanders,
Director, Antimicrobials 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 Enviro Systems Inc. and represents the view of 
Enviro Systems Inc. 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.

Enviro Systems, Inc.

PP 1F6346

     EPA has received a pesticide petition (1F6346) from Enviro 
Systems, Inc., 2055 Gateway Place, Suite 220, San Jose, CA 95110 
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 P-
chloro-m-xylenol (PCMX). PCMX an aqueous solution, is to be used on 
food processing equipment, utensils and other food-contact articles, 
beverage containers including milk bottles or containers and/or 
equipment. In addition, this solution may be used on food-contact 
surfaces in public eating places. 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. Analytical method. See EcoTru[reg] Residue study, July 26, 2001.
    2. Magnitude of residues. See EcoTru[reg] Residue study, July 26, 
2001. .41 mg. per square centimeter.

B. Toxicological Profile

    1. Acute toxicity. Studies indicate at concentration of 0.2% of 
PCMX that EcoTru[reg] is assigned a Toxicity Category IV on dermal, 
ocular, oral, and inhalation.

[[Page 56562]]

    2. Genotoxicity. The salmonella mutagenesis study indicated no 
mutagenesis.
    3. Reproductive and developmental toxicity. Studies submitted 
indicate at much greater concentration levels, no reproductive or 
developmental toxicity.
    4. Subchronic toxicity. EcoTru[reg] has only a 0.2% concentration 
of the active ingredient PCMX. In a study conducted by the North 
American Contact Dermatitis Group, incidents of skin sensitization 
among 1,752 dermatitis patients exposed to 1% chloroxylenol was only 13 
reactors, less than 1%. The concentration of PCMX in the registered 
product EcoTru[reg] is substantially less demonstrating that exposure 
would be minimal.
    5. Chronic toxicity. EcoTru[reg] has only a 0.2% concentration of 
the active ingredient PCMX. In a study conducted by the North American 
Contact Dermatitis Group, incidents of skin sensitization among 1,752 
dermatitis patients exposed to 1% chloroxylenol was only 13 reactors, 
less than 1%. The concentration of PCMX in the registered product 
EcoTru[reg] is substantially less demonstrating that exposure would be 
minimal.
    6. Metabolite toxicology. The material is excreted as glucuronate 
or sulfate conjugate; these are not toxic. Since the pharmaco-kinetic 
studies have shown complete excretion of radioactive PCMX at 24 hours, 
there is little chance of accumulation in the body from either topical 
or oral administration. PCMX is rapidly metabolized with a half-life in 
dogs and rats of approximately 1 hour. It is completely excreted in the 
urine. These studies were in dosages far in excess of the concentration 
level of PCMX in EcoTru[reg].
    7. Endocrine disruption. Acute toxicology studies showed no 
endocrine disruption. The compound chloroxylenol does not have estrogen 
or steroid-like activity.

C. Aggregate Exposure

    1. Dietary exposure. PCMX, especially at the low concentration 
level as in EcoTru[reg], is not persistent nor mobile or volatile. The 
product is in liquid form directed at hard surfaces and because of the 
characteristics of the molecule, there is no evidence of dietary 
exposure. Past studies demonstrate no evidence of chronic and/or acute 
risk of aggregate exposure for the general population, infants or 
children.
    i. Food. As indicated above, with the toxicology studies 
demonstrating no dermal, ocular, oral or inhalation irritation and the 
residue level is trivial, there should be insignificant aggregate 
exposure to food.
    ii. Drinking water. The chemical has not been detected in ground or 
surface water nor would it likely pass through primary or secondary 
drinking water treatment into finished water. Registrant is unaware of 
any states conducting water-monitoring programs for this chemical.
    2. Other exposures. Other non-pesticidal uses of PCMX have been in 
soaps, cosmetics, toiletries, and such pharmaceutical products as 
athlete's foot cream, acne cream, and surgical scrub products. These 
products have much higher concentration levels of PCMX than EcoTru. 
[See FDA docket 75NO183, 1986].

D. Cumulative Effects

     PCMX increases the permeability of cell membranes. The activity at 
the cell membrane leads to death of the microbe. The microgram amounts 
of PCMX in EcoTru[reg] are trivial in comparison to the amounts used in 
the studies. Most of the studies used from 1-3% concentration of PCMX 
whereas EcoTru[reg] has a 0.2% concentration of the chemical, thereby 
even reducing the likelihood of cumulative effects. There is no 
evidence of harmful effects of such low concentrations of PCMX over 
time.

E. Safety Determination

    1. U.S. population. As set forth above, there is no evidence of 
harmful effects on the U.S. population. PCMX has been in products for 
decades in the United States amid as much larger concentrations than 
with EcoTru[reg] without reports of harm.
    2. Infants and children. The studies have indicated that no harmful 
effects on infants and children would occur with such low 
concentrations of PCMX, whether ingested or applied topically. See 
Safety Evaluation of PCMX, by Walter L Guess, Ph.D. in FDA docket 
No.750183 1986.
 [FR Doc. 02-22235 Filed 9302; 8:45 am]
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