[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Notices]
[Pages 57450-57453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28634]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1051; FRL-6808-6]


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 PF-1051, must be 
received on or before December 17, 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-1051 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, 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: [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.

[[Page 57451]]

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'' ``Regulation 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-1051. 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 control number PF-1051 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 control number PF-1051. 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 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: November 2, 2001.

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 information, or the 
summary unintentionally 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.

C. P. Hall Company

PP 1E6257

    EPA has received a pesticide petition (1E6257) from The C.P. Hall 
Company, 311 S. Wacker, Suite 4700, Chicago, IL

[[Page 57452]]

 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 N,N-
dimethyloctanamide, CAS Reg. No. 1118-92-9 and N,N-dimethyldecanamide, 
CAS Reg. No. 14433-76-2, when used as an inert ingredient as an 
emulsifier, soluvent and cosoluvent in pesticide formulations applied 
only to growing crops at less than 15% of the total formulation by 
weight. 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

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

B. Toxicological Profile

    1. Acute toxicity--i. Daphnia magna. The acute toxicity of daphnia 
magna was conducted for 48 hours with results as follows: 24-hour 
LC50 (lethal concentration) estimated to be >4.0 milligram/
liter (mg/L) (95% C.I. (confidence interval) could not be determined). 
48--hour LC50 = 7.7 mg/L (95% C.I. = 6.2 and 10 mg/L). 24-
hour NOEC (no observed effect concentration) = 4.0 mg/L, 48-hour NOEC = 
4.0 mg/L, 48-hour Dose Response Slope was 6.0.
    ii. Rainbow trout. The acute toxicity to rainbow trout was 
determined in a static 96-hour test according to OECD (Organization for 
Economic Cooperation and Development) guideline 203. In this test, 5 
groups of 10 fish were exposed to nominal concentrations of 5.00, 8.89, 
15.8, 28.1 and 50.0 mg/L. During test duration the test concentration 
in the mean were higher than 80% of nominal values. The test revealed 
the following results: LC50 = 21.1 mg test substance/l, LLC 
(lowest lethal concentration)= 28.1 test substance/l, LT (lethal 
threshold) = 21.2 mg/L, NOLEC (no observed lethal effect concentration 
= 15.8 mg/L, LOEC (lowest observed effect concentration) = 8.89 mg/L, 
effect threshold (geometric mean of LOEC and NOEC)= 6.67 mg and NOEC = 
5.00 mg/L.
    iii. Bobwhite quail. The acute oral toxicity to the Bobwhite Quail 
was conducted. LD50 (lethal dose) = 1,600 mg/kg (95% 
confidence level)= 1,600-3,200 milligram/kilogram (mg/kg), lowest 
lethal dose = 1,600 mg/kg, LT = 1,130 mg/kg, highest dose without 
lethal effects = 800 mg/kg, LOEC = 800 mg/kg, threshold for effects = 
570 mg/kg, NOEC = 400 mg/kg.
    iv. Rat dermal. An acute dermal toxicity study was conducted on the 
male rat with a result of approximately 2,000 mg/kg and the female rat 
with a result of 400-200 mg/kg using method OECD guideline 402. The 
test substance was of moderate toxicity to female rats and of low 
toxicity to male rats following acute dermal application.
    v. Rat inhalation. An acute inhalation study was performed using 
OECD guideline 403 on the male and female rat with a result of > 3,551 
mg/m3 air; aerosol, exposition of 4 hours. The results of 
this study show that the respirable test article aerosol had a 
relatively low acute inhalative toxic effect on the rat. The acute 
potential hazard of the respiratory tract is attributed to the potency 
of the test substance aerosol as a mucosa irritant.
    vi. Corrosivity. The corrosivity potential of the compound was 
evaluated in general compliance with the conditions specified by the 
Department of Transportation Hazardous Materials Regulation. No 
evidence of corrosion (necrosis) was found. The test material is not 
classified as a corrosive by dermal application, as defined by the 
Department of Transportation Hazardous Material Regulation.
    vii. Guinea pig sensitization. The potential of the test substance 
as a 5% w/v formulation in 80% ethanol/20% distilled water, to produce 
delayed contact hypersensitivity in guinea pigs was evaluated. 
Following primary challenge, there were no grades of one produced in 
the test or control animals. The incidence and severity of these 
responses in the test group were essentially comparable to those 
produced by the naive control group indicating that sensitization had 
not been induced.
    viii. Minnow. The acute toxicity of the compound to the fathead 
minnow was assessed. The results of the 4-day static fish toxicity 
study: 96-hour LC50 (95% C.I.) 19 mg/L, (10 to 32 mg/L). The 
slope of the 96-hour dose response line was 9.2. The 32 mg/L 
concentrations resulted in 100% mortality within 24 hours.
    ix. Eye irritation. Acute eye irritation was evaluated. Although 
the eye study was not allowed to progress to a point where formal 
classification could be applied, the eye irritation which resulted from 
exposure to this test material strongly suggests classification in 
Toxicity Category I.
    x. Rat-oral. The acute oral LD50 value was estimated to 
be 1.77 g/kg in male and female Sprague-Dawley rats, which is Toxicity 
Category III.
    xi. Skin irritation-rabbit. Due to the suspected irritation 
potential of this test material, a single animal was initiated on this 
primary skin irritation study. Due to the effects exhibited in this 
single animal, this study was ultimately terminated without testing in 
additional animals. Critical changes noted in the coloration and/or 
texture of the skin included necrosis, slight fissures, coriaceousness 
(leather-like), and light and dark brown discoloration. Evidence of 
corrosion was also found.
    2. Genotoxicity. The Salmonella/microsome test for point mutagenic 
effects in doses of up to 5,000 g per plate. Evidence of 
mutagenic activity was not seen. No biologically relevant increase in 
the mutant count in comparison with the negative controls, was 
observed. The compound was evaluated for mutagenic effects at the HGPRT 
locus in V79 cell cultures. There was no significant dose-related or 
reproducible increase in mutant frequency above that of the negative 
controls. Based on results, the test substance, is considered to be 
nonmutagenic in the V79-HGPRT Forward Mutation Assay, both with and 
without metabolic activation. The clastogenic potential of the compound 
was evaluated in a chromosome aberration test in vitro. Based on this 
test, the compound is not considered to be clastogenic for mammalian 
cells with and without metabolic activation in vitro. The compound was 
evaluated for genotoxicity in the In Vitro Rat Primary Hepatocyte 
Unscheduled DNA Synthesis (UDS) Assay. Based on the results, the test 
article was evaluated as inactive in the In Vitro Rat Primary 
Hepatocyte UDS Assay.
    3. Reproductive and developmental toxicity-- i. In pregnant 
Chinchilla rabbits, at 100 mg/kg body weight/day, reduced food 
consumption and body weight gain were noted during the dosing period. 
No effects on the dams were ascertained at 100 or 300 mg/kg of body 
weight/day. The fetal parameters were not affected up to and including 
the highest dose level of 1,000 mg/kg body weight/day. The maternal 
NOAEL 300 mg/kg and the developmental NOAEL is 1,000 mg/kg body weight/
day. The test substance did not reveal any teratogenic potential up to 
and including the highest dose level of 1,000 mg/kg body weight/day.
    ii. An embryo toxicity study including teratogenicity was performed 
on the rat.

[[Page 57453]]

Based on the results, the maternal NOAEL is 50 mg/kg body weight/day 
and the developmental NOAEL is 150 mg/kg body weight/day. This study 
did not reveal any teratogenic potential up to and including the 
highest dose level of 450 mg/kg body weight /day.
    4. Subchronic toxicity-- i. Rat inhalation. An orientation study 
for subacute inhalation toxicity was conducted with an aerosol of the 
test substance on the Wister rat. 111.2 mg of the test substance air 
was tolerated without specific effects occurring with regard to all 
parameters determined.
    ii. Rat oral. The test substance was administrated in feed to 10 
male and 10 female Wister rats for 13 weeks at 0, 400, 2,000, and 
10,000 ppm. Clinical chemistry, gross pathological and histological 
examination revealed no evidence of test article-related liver lesions 
up to and including 2,000 ppm. Increased plasma cholesterol values 
following 10,000 ppm indicate slightly impaired fat metabolism in the 
liver. This finding was not correlated histopathologically. There were 
no unusual findings among the clinical parameters measured at the end 
of the recovery period.
    iii. Dog. In a subacute toxicity study group of two male and two 
female beagle dogs treated with the test substance, there was no 
difference exhibited between the control group and the treatment group 
either in the hematological parameters or in the clinical chemistry.

C. Other Information

    1. The toxicity of green algae was conducted using OECD guideline 
method 201. The results show the Selenastrum capricornutum growth rate 
(72 h) EC50 (effective concentration) =16.06 mg/L. The 95% 
confidence limits: 7.95-32.45 mg/L. The effect threshold was 2.40 mg/L. 
The toxicity of bacteria was conducted using OECD guideline 209 with 
results of: EC50 = 212 mg/L.
    2. A Tier I seed germination, seedling emergence, and vegetative 
vigor phytotoxicity study was conducted.
    The results from the analysis of the substance Tier I germination 
test for lettuce and radishes indicated that a significant difference 
did exist. No germination was present for the lettuce in treatment (100 
ppm). Radish had a low germination of 26% for 100 ppm treatment, a 
detrimental effect greater than 25% compared to the control. The 
emergence test indicated a significant difference for lettuce in the 
substance at 113 ppm treatment, showing a detrimental effect greater 
than 25% compared to the control. Radish in the emergence test 
indicated no significant difference between treatments. The vegetative 
vigor test indicated the dicot species lettuce and radish had no 
significant effects from the exposure to the test compound 113 ppm 
treatment level.

D. Aggregate Exposure

    1. Dietary exposure. For the purpose of assessing the potential 
dietary exposure, the C.P. Hall Company considers that the compound 
could be present in all raw and processed agricultural commodities.
    i. Food. Both constituents are neither permitted nor prohibited in 
food, animal feeding stuffs, medicines or cosmetics under European 
directives. The material is listed in the ``comprehensive list'' of 
pesticide product inert ingredients and categories in ``List 3'' 
(inerts of unknown toxicity). No concerns for risk associated with any 
potential exposure scenarios are reasonably foreseeable given the 
available data.
    ii. Drinking water. The lack of observed toxicity would indicate 
that the presence of trace amounts of the compound in drinking water 
would pose no appreciable risk to humans. The test substance is 
relatively insoluble in water (0.17% in water at 25  deg.C) and is not 
expected to create any drinking water toxicity. The rate of hydrolysis 
and its degradation pattern in aqueous buffer solutions showed that the 
compound was hydrolyzed to negligible extent at pH 5, 7, and 9 at 25 
deg.C within 30 days. The adsorption and desorption of the compound was 
determined in four soils. Based on the study the compound is of low or 
medium to low mobility in the soils used in this study. The direct 
photolysis of the compound showed that it was stable against direct 
photolysis at pH 5.0 during illumination at 25  deg.C for 30 days. The 
half-life was much greater than 30 days. A study was conducted to 
determine the rate of photolysis and degradation. During illumination 
on soil thin layer plates the material was degraded and mineralized. No 
specific photodegradation product with more than 4.2% of the applied 
radioactivity was found.

E. 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 the chemicals residues. This compound has been 
used in European pesticides for a number of decades without any signs 
of acute or chronic exposure toxicity.

F. Safety Determination

    1. U.S. population. Since the material may be used in a European 
formulation of a pesticide and no toxicological effects have been 
shown, no risks are anticipated for the U.S. population.
    2. Infants and children. Due to the extensive available 
toxicological data base and the expected low toxicity of this compound, 
C.P. Hall Company does not believe a safety factor analysis is 
necessary in assessing the risk of this compound.

G. International Tolerances

    To C. P. Hall's knowledge no international tolerances exist for 
this compound.

[FR Doc. 01-28634 Filed 11-14-01; 8:45 am]
BILLING CODE 6560-50-S