[Federal Register Volume 67, Number 75 (Thursday, April 18, 2002)]
[Notices]
[Pages 19180-19184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9500]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1081; FRL-6831-2]


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-1081, must be 
received on or before May 20, 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 
control number PF-1081 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Fungicide 
Branch, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9354; 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 19181]]

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'' 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-1081. 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-1081 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-1081. 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: April 2, 2002
Robert A. Forrest
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 Safe Materials, Inc. and represents the views 
of Safe Materials, 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.

Safe Materials, Inc.

PP 2F6362

    EPA has received a pesticide petition (2F6362) from Safe Materials, 
Inc., P.O. Box 1065, Valdosta, GA 31603-1065 proposing, pursuant to 
section 408(d) of FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to 
establish an exemption from the requirement of a tolerance, in or on 
the raw agricultural commodity cotton seed. EPA has determined that

[[Page 19182]]

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 Federal Register of July 7, 1995 (60 FR 
35396) (FRL-4957-9), announced the reclassification of a number of 
inert ingredients from List 3 to List 4B (minimal risk). EPA included 
alpha- sec-alkyl(C11-15)-omega-hydroxypoly(oxyethylene) 
among those substances on List 4B indicating:
      ``On behalf of the Office of Pesticide Programs, these 
substances were reviewed by the Structure Activity Team of EPA's Office 
of Pollution Prevention and Toxics, with each judged to be of low 
concern for potential human health, and/or environmental effects.''
      ``These inert ingredients were evaluated by the Office of 
Pesticide Program's inert review group, and determined to be of minimal 
risk.''
      ``A list of these inert ingredients proposed for 
reclassification was provided to EPA's Office of Water and to the FDA's 
Center for Food Safety and Applied Nutrition for comment; no adverse 
comments were received.''
     Additionally, EPA has already exempted from the requirements of a 
tolerance under 40 CFR 180.1001(c) the residues of alpha-sec-
alkyl(C11-15)-omega-hydroxypoly(oxyethylene) for use in 
pesticide formulations applied to growing crops, or to raw agricultural 
commodities after harvest.
    The addition of alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene) to the list of substances considered exempt 
from the requirement of a tolerance when used as an active ingredient, 
would merely acknowledge the fact, that this product is safe to humans 
and the environment.
    As alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene), contains as an integral part of it's 
composition the atomic elements, carbon, hydrogen, and oxygen, it is 
not expected to be degraded into any metabolites of toxicological 
concern. This nonionic surfactant would be expected to biodegrade 
ultimately and completely into carbon dioxide and water.
    The metabolism of 4-n-nonylphenol (4-NP), a metabolite of alpha-
sec-alkyl(C11-15)-omega-hydroxypoly(oxyethylene), has been 
investigated. The metabolism was examined in cell cultures of wheat, 
according to a standard method. Four major radioactively labeled 
fractions, were detected and isolated. They were shown to be 4-
(hydroxy)- and 4-(dihydroxy) nonylphenols, which were glucosylated at 
the phenolic OH-group and further glucosylated, glucuronidated, and 
acylated with acetic acid or malonic acid. These results confirm and 
extend the findings of a trial investigating p-tert-octyphenol in 
barley plants. Hexaethoxylated p-tert-octylphenol was also reduced to 
monohydroxylated and glycosylated metabolites. It is proposed that, 
alpha-sec-alkyl(C11-15)-omega-hydroxypoly(oxyethylene), 
would also be metabolized in the same manner.
    2. Analytical method. Alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene), and its metabolites, can be extracted from 
crop matrices by blending with methylene chloride. After blending, the 
extract is filtered, volume reduced, excess solvent is evaporated using 
nitrogen. The organic residue is then analyzed by using a high 
performance liquid chromotography (HPLC) equipped with a ultraviolet 
(UV) detector.
    3. Magnitude of residues. EPA has already exempted from the 
requirements of a tolerance under 40 CFR 180.1001(c) the residues of 
alpha-sec-alkyl(C11-15)-omega-hydroxypoly(oxyethylene), when 
used as an inert ingredient in pesticide formulations that may be 
applied to growing crops, or raw agricultural commodities after 
harvest. As Safe Materials, Inc. is requesting an exemption from the 
requirement of a tolerance, the magnitude of residues in cotton seed 
was not quantified.

B. Toxicological Profile

    1. Acute toxicity. The acute rat oral LD50 was 2,910 
milligrams/kilogram (mg/kg) male and 971 mg/kg female. The acute rat 
dermal LD50 was 2,730 mg/kg male and <3,000 mg/kg for 
female. The 4-hour rat inhalation LC50 was 1.06 milligrams 
per liter (mg/L) for both male and female. Alpha-sec-
alkyl(C11-15)-omega-hydroxypoly(oxyethylene), was slightly 
irritating to rabbit skin and caused corneal involvement. Based on 
these results, alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene) would be classified as EPA Category III, for 
inhalation toxicity and dermal toxicity, EPA Category IV, for oral 
toxicity and dermal irritation, and EPA Category I, for eye irritation. 
Alpha-sec-alkyl(C11-15)-omega-hydroxypoly(oxyethylene), was 
not a sensitizer to the skin.
    2. Genotoxicty. The Ames test for mutagenicity of nonoxynol-9, a 
structurally similar product, was negative.
    3. Reproductive and developmental toxicity. The broad range of 
structurally similar products, which are presently approved for use in 
pesticide formulations, and adjuvants have not been reported to cause 
reproductive or developmental toxicity. In a 3-month study with rats, 
dietary administration of alkyl-omega-hydroxypoly(oxyethylene) (100% 
C11-15) at dose levels of 62.5, 125, 250 or 500 mg/kg/day 
resulted in statistically significant decreases in mean body weight 
gain, in both males and females at doses above 125 mg/kg/day. Females 
exhibited significant decreases in mean food consumption. Treatment had 
no effect on survival, clinical signs, organ weights, and weight gain. 
A no observed adverse effect level (NOAEL) of 62.5 mg/kg and a lowest 
observed adverse effect level (LOAEL) of 125 mg/kg was established.
    In a 3-month study with rats, dietary administration at 82, 154 and 
354 mg/kg/day caused no adverse effects on survival, clinical signs, 
organ weights, hematology, or gross and histopathology at any dose 
level. Based upon decrease in body weight gain, a NOAEL of 154 mg/kg/
day and a LOAEL of 354 mg/kg/day was established.
    A two-generation rat reproductive study to determine reproductive 
toxicity of octylphenol, a structurally similar product was conducted. 
Five groups of rats were administered octylphenol at dose levels of 0, 
0.2, 20, 200, and 2,000 parts per million (ppm). Effects were observed 
only at 2,000 ppm, including decreased body weights in adults, and 
during the latter portion of lactation in offspring and minor body 
weight-related delays in acquisition of vaginal opening and preputial 
separation. No effects on reproductive parameters, testes, prostate, or 
ovary weights or morphology, on sperm counts, motility, morphology or 
production, or on estrous cyclicity were observed. The NOAELs for 
systemic and postnatal toxicity were 200 ppm and at or above 2,000 ppm 
for reproductive toxicity.
    4. Subchronic toxicity. Para-nonylphenol is used to produce 
nonylphenol ethoxylates (a class of nonionic surfactants), a subgroup 
of alkylphenol ethoxylates to which alkyl-omega-
hydroxypoly(oxyethylene) (100% C11-15) belongs. The primary 
biodegradation of alkylphenol ethoxylates is the hydrolytic removal of 
ethoxylate groups. This step is relatively rapid, and results in the 
intermediate nonylphenol. Thus, it is widely

[[Page 19183]]

accepted that tests with para-nonylphenol represent the alkylphenol 
ethoxylates.
     In a 90-day rat feeding study, para-nonylphenol was administered 
to four groups of rats at dietary concentrations of 0, 15, 50, and 150, 
mg/kg/day. There were 25 rats/sex/group in the control and high dose 
groups and 15 rats/sex/group in the low and mid-dose groups. Ten of the 
25 rats/sex in the control and high-dose groups were designated as 
recovery animals and were maintained on control diets for 4 weeks after 
completion of the 90-day exposure period to assess the reversibility of 
any effects which might be observed. In-life effects, were limited to 
small decreases in body weight and food consumption in the 150 mg/kg 
dose group. Post-mortem measurements at week 14 indicated a dose-
related kidney weight increase in males and a decrease in renal haline 
globules/droplets in males from the high dose group. The kidney weights 
showed complete recovery following the 4-week post-dosing recovery 
period. Due to the small magnitude of the changes, (i.e., all weights 
were within or near laboratory historical control values), and the lack 
of correlating clinical or histopathological changes, the kidney weight 
alterations were not considered toxicologically significant. The 
biological significance of reduced hyaline in the kidneys of male rats 
from the high dose group is uncertain. Renal tubular hyaline is 
associated with the rat-specific protein, alpha-2u-globulin, and 
therefore, this finding was not considered toxicologically relevant to 
humans. No other effects attributable to para-nonylphenol were 
observed. Based upon the minor findings for the high dose group, the 
NOAEL in this study is considered to be 50 mg/kg/day and the LOAEL is 
150 mg/kg/day.
    5. Chronic toxicity. No long-term chronic toxicity studies are 
available for alkylphenol ethoxylates to which alkyl-omega-
hydroxypoly(oxyethylene) (100% C11-15) belongs, but an 
unpublished 2-year feeding study in rats and an 18-month dermal study 
in mice using primary alcohol ethoxylates are available. There were no 
treatment related effects.
     Additionally, in its notice of July 7, 1995 (60 FR 35396) (FRL-
4957-9) which moved alkyl-omega- hydroxypoly(oxyethylene) (100% 
C11-15) from List 3 to List 4B (minimal risk), EPA stated:
      ``On behalf of the Office of Pesticide Programs, these 
substances were reviewed by the Structure Activity Team of the EPA's 
Office of Pollution Prevention and Toxics with each judged to be of low 
concern for potential human health and/or environmental effects.''
      ``These inert ingredients were evaluated by the Office of 
Pesticide Program's Inert Review Group and determined to be of minimal 
risk.''
      ``A list of these inert ingredients proposed for 
reclassification was provided to EPA's Office of Water and to the FDA's 
Center for Food Safety and Applied Nutrition for comment; no adverse 
comments were received.''
     Safe Materials, Inc. believes, alkyl-omega-
hydroxypoly(oxyethylene) (100% C11-15), should be classified 
as a ``Not Likely'' carcinogen based upon lack of carcinogenicity in 
rats and mice. As alkyl-omega-hydroxypoly(oxyethylene) (100% 
C11--15) has been federally approved for use in pesticide 
formulations applied to growing crops, or to raw agricultural 
commodities after harvest, this particular minute, additional use 
should be of little concern to the welfare of the U.S. population.
    6. Animal metabolism. The absorption, distribution, metabolism and 
excretion of alkyl-omega-hydroxypoly(oxyethylene) (100% 
C11-15) is well understood in mammals. Pharmacokinetic data 
indicate rapid metabolism and excretion of alkylphenols, which is 
consistent with the low toxicity of nonylphenol. Current research 
confirms, that single doses of nonylphenol (5 or 200 mg/kg) are rapidly 
excreted, and that nonylphenol does not accumulate in the tissues of 
rats. It has also been proven that the liver and kidney of female rats 
were able to clear nonoxynol labeled with 14C in the 
ethylene oxide chain within 48 hours. Similarly, it has been shown that 
structurally related alkylphenol, octylphenol, was rapidly excreted 
(half-life of approximately 5 hours) by first-pass hepatic metabolism 
via glucuronide conjugation. Octylphenol toxicokinetics after repeated 
administration was investigated, in male Wistar rats receiving daily 
gavage administrations of 50 or 200 mg octylphenol/kg body weight for 
14 consecutive days. Profiles of octylphenol blood concentration vs 
time determined on day 1 and day 14 were similar, indicating that 
repeated oral gavage administration did not lead to increased blood 
concentrations. Only doses which saturated the metabolic capacity of 
the liver, (<200 mg/kg/day for 14-days), resulted in measurable 
concentrations of octylphenol in the tissues (primarily the fat). 
Another group of rats received octylphenol via drinking water saturated 
with octylphenol (8 ppm) over a period of 28-days. Octylphenol was not 
detected in any blood sample from animals treated via drinking water.
    7. Endocrine disruption. A two-generation rat reproductive study to 
determine reproductive toxicity of octylphenol, a structurally similar 
product, was conducted. Five groups of rats were administered 
octylphenol at dose levels of 0, 0.2, 20, 200, and 2,000 ppm. No 
effects in reproductive parameters, testes, prostate, or ovary weights 
or morphology, on sperm counts, motility, morphology, production, or on 
estrous cyclicity were observed. No estrogen-like effects were evident.
     In a 90-day rat feeding study, para-nonylphenol (primary breakdown 
product) was administered to four groups of rats at dietary 
concentrations of 0, 15, 50, and 150 milligram/kilogram/day (mg/kg/
day). There were 25 rats/sex/group in the control and high dose groups 
and 15 rats/sex/group in the low and mid dose groups. Ten of the 25 
rats/sex in the control and high dose groups were designated as 
recovery animals and were maintained on control diets for 4 weeks after 
completion of the 90-day exposure period to assess the reversibility of 
any effects which might be observed. Estrous cyclicity was monitored 
using vaginal cytology during week 8 of the study, and sperm count, 
motility and morphology were evaluated at termination. No changes were 
observed for estrous cycling, sperm evaluations, or effects on 
endocrine organs. Para-nonylphenol, therefore, did not manifest any 
estrogen-like activity as measured in these parameters at dietary 
concentrations as high as 150 mg/kg/day. Safe Materials, Inc., 
therefore, does not expect alkyl-omega-hydroxypoly(oxyethylene) (100% 
C11-15) to exhibit any estrogen-like activity.

C. Aggregate Exposure

    1. Dietary exposure. Alkyl-omega-hydroxypoly(oxyethylene) (100% 
C11-15), is proposed as a nematicide and fungicide for use 
on cotton. EPA has exempted from the requirements of a tolerance under 
40 CFR 180.1001(c) the residues of alpha-sec-alkyl(C11-15)-
omega-hydroxypoly(oxyethylene) when used as an inert ingredient in 
pesticide formulations, that may be applied to growing crops or raw 
agricultural commodities after harvest. 21 CFR 173.315 permits use as a 
surface active agent for washing sugar beets prior to the slicing 
operation at a level not to exceed 3 ppm. 21 CFR 178.3400, allows use 
as an emulsifier and/or surface active agent in the manufacture of 
articles or components of articles

[[Page 19184]]

intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging or holding food. 21 CFR 181.30 permits 
the use in the manufacture of paper and paperboard products for use in 
food packaging.
     The Federal Register, of July 7, 1995 (60 FR 35396), announced the 
reclassification of a number of inert ingredients from List 3 to List 
4B (minimal risk). EPA included alpha-sec-alkyl(C11-15)-
omega-hydroxypoly(oxyethylene) among those substances on List 4B 
indicating:
       ``On behalf of the Office of Pesticide Programs, these 
substances were reviewed by the Structure Activity Team of EPA's Office 
of Pollution Prevention and Toxics, with each judged to be of low 
concern for potential human health and/or environmental effects.''
       ``These inert ingredients were evaluated by the Office 
of Pesticide Program's Inert Review Group and determined to be of 
minimal risk.''
       ``A list of these inert ingredients proposed for 
reclassification was provided to EPA's Office of Water and to the FDA's 
Center for Food Safety and Applied Nutrition for comment; no adverse 
comments were received.''
     i. Food. As 61 companies currently have 135 different pesticide 
products approved by the EPA containing alpha-sec-
alkyl(C11-15)-omega-hydroxypoly(oxyethylene) at varying 
concentrations approved for various use sites including food crops, we 
believe that the approval of this petition, adding the use of cotton 
would pose minimal additional risk to the U.S. population.
     The addition of alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene) to the list of substances considered exempt, 
from the requirement of a tolerance when used as an active ingredient 
would merely acknowledge the fact that this product is safe to humans 
and the environment.
    The addition of the expanded use on cotton is not expected to 
significantly increase the dietary exposure to this compound.
    ii. Drinking water. The product has been shown to readily 
biodegrade and, therefore, is not likely to be present in potable water 
supplies. The standard wastewater treatment systems as they exist in 
the United States are able to treat surfactants effectively, and there 
is no evidence of accumulation of nonylphenol, or other structurally 
similar products in the aquatic environments.
     A risk assessment of nonylphenol and its ethoxylates (a 
degradation product of the proposed chemical, in U.S. river water and 
sediment was conducted. A survey of those river reaches most likely to 
contain nonylphenol and its ethoxylate residues was conducted based on 
a random sample of a subset of EPA River Reach File defined by certain 
selection criteria. Applying enhanced analytical techniques, little or 
no nonylphenol or nonylphenoethoxylate was found in river water at most 
locations: median 0.00008 milligrams per liter (mg/L), 95th percentile 
0.00027 mg/L.
     A study of nonylphenol polyethoxy carboxylate (NPEC) metabolites 
of nonionic surfactants in U.S. paper mill effluents, municipal sewage 
treatment plant effluents and river waters reported similar findings. 
Paper mill effluents typically contained less than 100 g/L 
NPECs and NPEC concentrations in effluents from sewage treatment plants 
ranged from 140 to 270 micrograms/Liter (g/L). Based upon 
animal metabolism studies, these low level concentrations in drinking 
water would be rapidly excreted by humans.
    2. Non-dietary exposure. Alkyl-omega-hydroxypoly(oxyethylene) (100% 
C11-15) and structurally, similar surfactants are widely 
used in various industry, institutional, and household applications. 
U.S. production exceeded 500 million pounds in 1990. Industrial uses 
(55% of total volume) included manufacture of plastics, textiles, paper 
and agricultural chemical products. Institutional applications (30% of 
total volume) include vehicle cleaning, commercial laundry products, 
and hard surface cleaners. Personal care products, contraceptives, 
cosmetics, and household laundry products account for the majority of 
household applications (15% of total volume).
     Given the wide spread use of this group of compounds, the 
additional exposure resulting from granting this petition is not 
expected to significantly alter the risk profile.

D. Cumulative Effects

    There is a wide range of structurally similar compounds that are 
used in many products to which the U.S. population is exposed. Safe 
Materials, Inc. is unaware of any cumulative effects occurring from 
such uses. Further, the use of the product that is subject to the 
tolerance exemption petition is not likely to significantly increase 
daily exposure to this class of compounds. Therefore, a cumulative risk 
assessment was not done for this chemical.

E. Safety Determination

    1. U.S. population. In the Federal Register of July 7, 1995 (60 FR 
35396), which moved alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene) from List 3 to List 4B (minimal risk) EPA 
stated:
      ``On behalf of the Office of Pesticide Programs, these 
substances were reviewed by the Structure Activity Team of EPA's Office 
of Pollution Prevention and Toxics, with each judged to be of low 
concern for potential human health and/or environmental effects.''
      ``These inert ingredients were evaluated by the Office of 
Pesticide Program's Inert Review Group and determined to be of minimal 
risk.''
      ``A list of these inert ingredients proposed for 
reclassification, was provided to EPA's Office of Water and to the 
FDA's Center for Food Safety and Applied Nutrition for comment; no 
adverse comments were received.''
     Expansion of the uses of the product to cotton as an active 
ingredient, is not likely to significantly increase the U.S. 
population's exposure to the product and related compounds. Therefore, 
there is reasonable certainty that no harm to the U.S. population will 
result from the use described.
    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 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 risk assessments, 
either directly through the use of margin of exposure (MOE) analysis, 
or through using uncertainty (safety) factors in calculating a dose 
level that poses no appreciable risk to humans. There is no available 
data to indicate any additional sensitivity of infants and children to 
this product, or to other similar products, which have been in use for 
many years and for numerous uses. There are no data that suggest that 
there is a basis to require an additional margin of safety to be 
applied.

F. International Tolerances

     There are no Codex Alimentarius Commission maximum residue levels 
established for residues of alpha-sec-alkyl(C11-15)-omega-
hydroxypoly(oxyethylene).
[FR Doc. 02-9500 Filed 4-17-02; 8:45 am]
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