[Federal Register Volume 67, Number 181 (Wednesday, September 18, 2002)]
[Notices]
[Pages 58799-58802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23748]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0201; FRL-7194-5]


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.

-----------------------------------------------------------------------

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-2002-0201, must be 
received on or before October 18, 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-2002-0201 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin 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: [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

[[Page 58800]]

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-2002-0201. 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-2002-0201 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: [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 OPP-2002-0201. 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.

    Dated: September 11, 2002.
Peter Caulkins,
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. The summary may have been edited by EPA if the terminology 
used was unclear, the summary contained extraneous material, or the 
summary intentionally made the reader conclude that the findings 
reflected EPA's position and not the position of the petitioner. 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.

[[Page 58801]]

Hamphire Chemical Corporation

2E6491

    EPA has received a pesticide petition (2E6491) from Hampshire 
Chemical Corporation, 2 East Spit Brook Road, Nashua, NH 03060 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 to amend an existing exemption from the 
requirement of a tolerance for N-acyl sarcosines and sodium N-acyl 
sarcosinates when used at levels not to exceed 10% as inert ingredients 
(surfactants) in pesticide formulations. 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 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Analytical method. Hamphire Chemical Corporation is requesting 
an exemption from the requirement of a tolerance without any numerical 
limitation; therefore, an analytical method is not required for 
enforcement purposes for N-acyl sarcosines and sodium N-acyl 
sarcosinates.
    2. Magnitude of residues. Based upon the proposed use as an inert 
ingredient in glyphosate formulations, dietary (food) exposure to N-
acyl sarcosines and/or sodium N-acyl sarcosinates would not be expected 
to exceed the theoretical maximum residue concentration (TMRC) of 
glyphosate to the U.S. population of 0.03 milligrams/kilogram/day (mg/
kg/day). Dietary exposure to N-acyl sarcosines and/or sodium N-acyl 
sarcosinates at or below these levels would not result in any increases 
in the normal sarcosine blood serum concentrations found in humans.

B. Toxicological Profile

    1. Acute toxicity. Acute oral toxicity of sodium N-lauroyl 
sarcosinate was evaluated in male rats. Ten groups of 10 rats per dose 
received a bolus dose of between 250 mg/kg and 2,500 mg/kg N-lauroyl 
sarcosinate in an aqueous solution. The lethal dose (LD50) 
was approximately 2,175 mg/kg.
    2. Genotoxicty. An original study examining the mutagenicity of 
various cosmetic ingredients reported that N-lauroyl sarcosine is not 
mutagenic in the Ames assay.
    3. Reproductive and developmental toxicity. Reproductive and 
developmental effects are not expected to occur through the use of N-
acyl sarcosines as inert ingredients in pesticide formulations. These 
substances have a long history of human exposure, they have been used 
extensively in a variety of consumer products, and no such adverse 
effects have been reported. Potential reproductive toxicity was 
evaluated in the chronic oral exposure study, and the authors report no 
effects on fertility between treated and control rat groups.
    4. Subchronic toxicity. A 2-year study of the oral toxicity of 
sodium N-lauroyl sarcosinate was conducted on rats. An interim 
sacrifice 3 months into the study provides toxicity data to support 
characterization of subchronic toxicity. At the 3-month interval, there 
were no significant differences in pathology, fertility, mortality, 
hematology, or weights between experimental animals in any group and 
control animals. The absence of adverse effects at any dose level up to 
90 days supports a no observed adverse effect level (NOAEL) of 1,000 
mg/kg day. Subchronic dermal toxicity studies have not been performed 
on N-acyl sarcosinates, though three studies were conducted to evaluate 
N-acyl sarcosinates for potential skin irritation and sensitization. N-
lauroyl sarcosinate was tested for irritation on rabbits and 
sensitization on guinea pigs, and N-myristoyl sarcosinate was evaluated 
for potential irritation on rabbits. Rabbits were treated daily over a 
14-day period with sodium N-lauroyl sarcosinate powder or a 20% w/v 
solution of sodium N-lauroyl sarcosinate. No evidence of dermal 
toxicity was observed. Guinea pigs were treated by intradermal 
injection of 0.01% aqueous solution of sodium N-lauroyl sarsosinate 
every other day for a total of 10 injections, followed by 3 weeks of no 
treatment before receiving a challenge injection. No reactions were 
observed at any time in these animals and no evidence of toxicity was 
observed from the injection. A formulation containing 30% sodium N-
myristoyl sarcosinate in aqueous solution was applied topically to 
abraded skin of rabbits. Very slight to well-defined erythemia and 
slight to very slight edema were observed, resulting in a mean dermal 
irritation score of 1.7. The minimal mean score required for 
classification of material as a skin irritant is 5.0; therefore, sodium 
N-myristoyl sarcosinate is not a primary skin irritant. Overt dermal 
toxicity was not observed in any of these studies.
    5. Chronic toxicity. A 2-year study of the oral toxicity of sodium 
N-lauroyl sarcosinate was conducted on rats. The dose levels were: 100 
mg/kg for 6 months, followed by 4,000 mg/kg for the remaining 18 
months, and other dose levels throughout the study were: 400 or 1,000 
mg/kg/day. After 2 years, a slight but significant pathology was 
observed in animals that received 1,000 mg/kg throughout the study and 
4,000 for the last 18 months of the study. The pathology observed was 
hyperplasia of the stratified epithelium with excess keratin formation 
of the cardiac mucosa of the stomach.
    6. Animal metabolism. N-acyl sarcosines and sodium N-acyl 
sarcosinates form a large class of chemical compunds where the acyl 
group is derived from fatty acids such as lauric, oleic and stearic 
acid and/or derived from the combined fatty acids of coconut oil. N-
acyl sarcosine and sodium N-acyl sarcosinates are metabolized by humans 
to sarcosine and the corresponding fatty acids. Sarcosine is ubiquitous 
in biological materials and is present in such foods as egg yolks, 
turkey, ham, vegetables, legumes, etc. Sarcosine is reported to be 
formed from dietary intake of choline and from the metabolism of 
methione and is rapidly degraded to glycine, which, in addition to its 
importance as a constituent of protein, plays a significant role in 
various physiological processes as a prime metabolic source of 
components of living cells such as glutathione, creatine, purines and 
serine. The concentration of sarcosine in blood serum of normal human 
subjects is reported to be 1.59 + 1.08 micromoles per liter.
    7. Endocrine disruption. There are no reports of any estrogenic or 
other adverse effects on the endocrine system in humans as a result of 
the use of N-acyl sarcosines and/or sodium N-acyl sarconates.

C. Aggregate Exposure

    1. Dietary exposure--food. Based upon the ubiquitous presence of 
sarcosine in human tissue and the fact that N-acyl sarcosines are 
readily metabolized to the N-acyl sarcosines and their salts, Hamphire 
Chemical Corporation believes that exposure to this chemical will not 
pose a dietary risk under any forseable circumstances to the U.S. 
population, including infants and children. This conclusion is based on 
the inconsequential increases in dietary exposure resulting from its 
use as an inert ingredient in glufosinate ammonium, 2,4-D, atrazine and 
dicamba.
    2. Dietary exposure--drinking water. Taking into account the 
proposed use in glufosinate ammonium, 2,4-D, atrazine, and dicamba 
formulations, Hamphire Chemical Corporation has concluded with 
reasonable certainty that residues of N-acyl sarcosines and/or the 
sodium N-acyl sarcosinates in drinking water

[[Page 58802]]

would be negligible, and that no harm will result from aggregate 
exposure to N-acyl sarcosines and/or the sodium N-acyl sarcosinates.

D. Cumulative Effects

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' EPA does not have, at this time, 
available data to determine whether N-acyl sarcosines and sodium N-acyl 
sarcosinates have a common mechanism of toxicity with other substances 
or how to include this pesticide in a cumulative risk assessment. 
Unlike other pesticides for which EPA has followed a cumulative risk 
approach based on a common mechanism of toxicity, N-acyl sarcosines and 
sodium N-acyl sarcosinates do not share common toxic metabolites with 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that N-acyl sarcosines and sodium N-acyl 
sarcocinates have a common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Based on the worst case assumption regarding 
the dietary risks resulting from exposure to N-acyl sarcosines and its 
salts when used at levels not to exceed 10% of pesticide formulations, 
residues of N-acyl sarcosines and their sodium salts would not be 
considered to be toxicologically significant. Based on the extensive 
use of N-acyl sarsocines and their sodium salts in various consumer 
products such as toothpastes, soaps, medicated skin cleaners and 
medicated shampoos; its physico-chemical properties; the fact that some 
of these chemicals have been approved for food use applications, and 
the review of its use, Hamphire Chemical Corporation does not believe 
that a potential for hazard exists when N-acyl sarcosines and their 
sodium salts are used in accordance with good agricultural practice.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects in calculating a dose level that 
accounts for prenatal and postnatal toxicity and the completeness of 
the data base unless EPA determines that a different margin of safety 
will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through the use 
of margin of exposure analysis or through using uncertainty factors 
(safety) in calculating a dose level that poses no appreciable risk to 
humans. Due to the ubiquitous nature of sarcosine in human tissue and 
food, a safety factor analysis in assessing the risk of N-acyl 
sarcosines and sodium N-acyl sarcosinates was not used. For the same 
reason, application of the additional safety factor for infants and 
children would not be appropriate.

F. International Tolerances

    No Codex maximum residue levels have been established for N-acyl 
sarcosines and/or sodium N-acyl sarcosinates.
[FR Doc. 02-23748 Filed 9-17-02; 8:45 am]
BILLING CODE 6560-50-S