[Federal Register Volume 66, Number 222 (Friday, November 16, 2001)]
[Rules and Regulations]
[Pages 57671-57679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28734]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301191; FRL-6810-2]
RIN 2070-AB78


Linear alkyl C12-16 propoxyamine ethoxylate; Exemption 
from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of poly[oxy(methyl-1,2-ethanediyl)], 
-[2-bis(2-hydroxyethyl)amino]propyl]--hydroxy,-ether 
with -hydro--hydroxypoly(oxy-1,2-ethanediyl) (1:2), 
mono-C12-16 alkyl ethers (hereinafter ``linear alkyl 
C12-16 propoxyamine ethoxylate'') when used as an inert 
ingredient (surfactant) when applied to growing crops, or to raw 
agricultural commodities after harvest. Huntsman Corporation submitted 
a petition to EPA under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA) 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of linear alkyl C12-16 propoxyamine ethoxylate.

DATES: This regulation is effective November 16, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301191, 
must be received by EPA on or before January 15, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301191 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; and 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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301191. The official record 
consists of the documents specifically referenced in this action, 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 Hwy., 
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.

II. Background and Statutory Findings

    In the Federal Register of August 14, 1998 (63 FR 43708) (FRL-6019-
8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170) announcing the filing 
of a pesticide petition (PP 5E4487) by Huntsman Petrochemical 
Corporation, 3040 Post Oak Blvd., Houston, TX 77056. This notice 
included a summary of the petition prepared by the petitioner. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.1001(c) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of

[[Page 57672]]

[poly[oxy(methyl-1,2-ethanediyl)], -[2-bis(2-
hydroxyethyl)amino]propyl]--hydroxy,-ether with -
hydro--hydroxypoly(oxy-1,2-ethanediyl) (1:2), mono-
C12-16 alkyl ethers (CAS Reg. No. 176022-82-5).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by linear 
alkyl C12-16 propoxyamine ethoxylate were evaluated by two 
methods: A process known as structure activity relationship (SAR) 
assessment and review and evaluation of submitted data.

A. SAR Assessment

    Linear alkyl C12-16 propoxyamine ethoxylate is an inert 
ingredient. To the best of the Agency's knowledge, linear alkyl 
C12-16 propoxyamine ethoxylate has no active ingredient 
properties; therefore, the complete 40 CFR part 158 data base has not 
been required. For linear alkyl C12-16 propoxyamine 
ethoxylate, toxicity was assessed, in part, by the SAR process. In this 
process, the chemical's structural similarity to other chemicals (for 
which data are available) is used to determine toxicity. For human 
health, this process, can be used to assess absorption and metabolism, 
mutagenicity, carcinogenicity, developmental and reproductive effects, 
neurotoxicity, systemic effects, immunotoxicity, and sensitization and 
irritation. This is a qualitative assessment using terms such as good, 
not likely, poor, moderate, or high.
    For linear alkyl C12-16 propoxyamine ethoxylate the SAR 
assessment determined that the chemical was not structurally related to 
any known carcinogens or developmental/reproductive toxicants. The 
following human exposures were examined as part of the analysis: 
inhalation, dermal, exposures to the eyes, and drinking water. There 
were concerns for irritation to eyes, skin, lungs, and mucous 
membranes. Overall, the level of concern for human health was 
characterized as low to moderate. Absorption was rated as poor through 
the skin, good through the lungs, and moderate through the 
gastrointestinal tract.

B. Review of Submitted Data

    1. Acute oral toxicity - rat. Lethal Dose (LD50) for 
combined sexes is from 1,154 to 1,993 milligrams/kilograms (mg/kg). 
Clinical effects observed in both sexes included decreased activity, 
poor grooming, abnormal stance and gait, diarrhea, dyspnea, 
chromodacryorrhea, decreased muscle tone, lacrimation, and prostration. 
(Toxicity Category III).
    2. Acute dermal toxicity - rabbit. The observed lethal dose for 
males and females is greater than 2,000 mg/kg. Clinical signs of 
toxicity included abnormal gait, abnormal stance, unspecified alopecia, 
decreased muscle tone, salivation, decreased activity, and poor 
grooming. (Toxicity Category III).
    3. Primary eye irritation - rabbit. It was determined that the test 
substance was a severe but reversible ocular irritant. (Toxicity 
Category II).
    4. Primary dermal irritation - rabbit. Several dermal irritations 
characterized by severe erythema and edema, necrosis, fissuring, and 
sloughing of the epidermis was observed. (Toxicity Category II).
    5. Dermal sensitization - guinea pig. It was observed that the test 
substance was a dermal sensitizer.
    6. Subchronic oral toxicity feeding - rats. The no observable 
adverse effect level (NOAEL) is 1,000 ppm in males (equivalent to 58.9 
mg/kg/day) and 500 ppm (equivalent to 35.4 mg/kg/day) in females. The 
lowest observable adverse effect level (LOAEL) is 3,000 ppm (equivalent 
to 173.6 mg/kg/day) in males and 1,000 ppm (equivalent to 68.9 mg/kg/
day) in females based on decreased body weight gain.
    7. 90-Day feeding capsule - dog. The NOAEL is 10 mg/kg/day. The 
LOAEL is 30 mg/kg/day based on clinical signs of toxicity in females 
and decreased body weight gain in males.
    8. Oral developmental toxicity - rats. The test material was 
administered by gavage to pregnant rats on gestation days 6 through 15. 
The maternal NOAEL is 25 mg/kg/day. The maternal LOAEL is 75 mg/kg/day, 
based on clinical signs of toxicity and reductions in body weight, body 
weight gains, and food consumption. The developmental NOAEL is 75 mg/
kg/day. The developmental LOAEL is 150 mg/kg/day, based on decreased 
fetal weights and increases in incidences of skeletal variation related 
to decreased ossification.
    9. In vitro mammalian cytogenetics - chromosome aberrations in 
human lymphocytes. There were no statistically significant increases in 
chromosome abberations at any dose level with or without metabolic 
activation. No mutagenic concerns were demonstrated.
    10. Salmonella typhimurium and Escherichia coli mammalian 
activation reverse gene mutation assay. There were

[[Page 57673]]

no statistically significant differences in the number of revertant 
colonies in any tester strain at any dose level or condition. No 
mutagenic concerns were demonstrated.

C. Toxicological Endpoints

    1. Acute dietary toxicity. For an acute dietary risk assessment, 
the Agency selected a developmental NOAEL of 75 mg/kg/day from the 
developmental toxicity study in the rat. The LOAEL is 150 mg/kg/day.
    2. Short-term dermal toxicity. For a short-term dermal risk 
assessment, the Agency selected a developmental NOAEL of 75 mg/kg/day 
from the developmental toxicity study in the rat. The LOAEL is 150 mg/
kg/day.
    3. Intermediate- and long-term dermal toxicity. For intermediate- 
and long-term dermal risk assessment, the Agency selected a NOAEL of 10 
mg/kg/day from a 90-day toxicity study in dogs (capsules). The LOAEL is 
30 mg/kg/day.
    4. Short-term inhalation. For a short-term inhalation risk 
assessment, the Agency selected a NOAEL of 75 mg/kg/day from the 
developmental study in the rat. The LOAEL is 150 mg/kg/day.
    5. Intermediate- and long-term inhalation. For an intermediate- and 
long-term inhalation risk assessment, the Agency selected a NOAEL of 10 
mg/kg/day from a 90-day toxicity study in the dog (capsules). The LOAEL 
is 30 mg/kg/day.
    6. Chronic dietary toxicity. For a chronic dietary risk assessment, 
the Agency selected a NOAEL of 10 mg/kg/day from the 90-day dog 
(capsule) study. The LOAEL is 30 mg/kg/day.
    7. No dermal studies or dermal absorption data were submitted. 
However, the SAR analysis rated absorption through the skin as poor. 
Therefore, a dermal absorption factor of 10% will be used.
    8. No inhalation studies were submitted. However, the SAR 
assessment rated absorption through the lungs as good. Therefore, an 
inhalation absorption factor of 100% will be used.

D. Conclusions

    The SAR assessment rated linear alkyl C12-16 
propoxyamine ethoxylate as a low to moderate toxicity chemical. Linear 
alkyl C12-16 propoxyamine ethoxylate is a surfactant, that 
is, a chemical used to modify the nature of a surface, such as reducing 
the surface tension of water. Surfactants can be used as wetting 
agents, detergents, penetrants, and emulsifiers. However, it is 
believed that the low to moderate rating is indicative of the known 
properties of a surfactant, not necessarily of the toxicological 
effects unique to linear alkyl C12-16 propoxyamine 
ethoxylate. By their very nature, surfactants are often corrosive and 
irritating. The effects displayed in the reviewed studies (decreased 
body weight gain, and possibly even the salivation) were probably due 
to the corrosion/irritation factor and not to other mechanisms of 
toxicity. The findings of the SAR assessment did not conflict with the 
data reviews.
    Based on the SAR assessment, and review and evaluation of the 
submitted data, the Agency concludes that linear alkyl 
C12-16 propoxyamine ethoxylate is a low/moderate toxicity 
chemical with the demonstrated effects consistent with the 
characteristics of a surfactant. No other effects of concern were 
noted. No additional toxicity data are required.

E. Population Adjusted Doses

    1. Safety factors. The Agency will use the NOAELs and LOAELs in 
Unit IV.C. to assess the risks of using linear alkyl C12-16 
propoxyamine ethoxylate to the general population and certain subgroups 
of the general population. However, the Agency first modifies these 
values numerically downward by dividing the NOAEL by two or more safety 
factors. The safety (uncertainty) factors used are: A 10-fold factor to 
account for intraspecies variability (the differences in how the test 
animals reacted to the test substance) and a 10-fold factor to account 
for interspecies variation (the use of animal studies to predict human 
risk).
    2. Acute dietary toxicity. The Agency divided the NOAEL by 100 (10X 
interspecies extrapolation, 10X intraspecies variation) to calculate 
the acute Population Adjusted Dose (aPAD). The aPAD is the quantity of 
a substance which if consumed in a single day is not expected to pose 
significant risk of adverse health effects. For linear alkyl 
C12-16 propoxyamine ethoxylate the aPAD is equal to 0.75 mg/
kg/day.
    3. Chronic dietary toxicity. The Agency divided the NOAEL of 10 mg/
kg/day by 300 (10X interspecies extrapolation, 10X intraspecies 
variation, and 3X for extrapolating a NOAEL from a subchronic study for 
a chronic scenario) to calculate the chronic Population Adjusted Dose 
(cPAD). The cPAD is the quantity of a substance which if absorbed on a 
daily basis over a lifetime is not expected to pose significant risk of 
adverse health effects. For linear alkyl C12-16 propoxyamine 
ethoxylate the cPAD is equal to 0.03 mg/kg/day.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from groundwater or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.

A. Dietary Exposure

    1. Food. No tolerances have been established for linear alkyl 
C12-16 propoxyamine ethoxylate. Huntsman Corporation has 
requested a tolerance exemption for the use of linear alkyl 
C12-16 propoxyamine ethoxylate as a surfactant only in 
glyphosate formulations. Glyphosate is one of the most widely used 
pesticide chemicals; it is used on a multitude of food crops. There are 
over 140 glyphosate tolerances which include major food crops, such as 
wheat, soybeans, and corn, as well as other widely-consumed foods such 
as potatoes, peanuts, and all bulb, cucurbit, fruiting, and leafy 
vegetables. Thus, a pesticide formulation containing glyphosate as the 
active ingredient and linear alkyl C12-16 propoxyamine 
ethoxylate as an inert ingredient, a surfactant, has the potential for 
being used on this multitude of food crops.
    There are no field trial data or monitoring data available for 
residues of linear alkyl C12-16 propoxyamine ethoxylate, 
which is the Agency's traditional source of exposure data for 
conducting a quantitative dietary risk assessment. The Agency has 
estimated residue levels for linear alkyl C12-16 
propoxyamine ethoxylate using a ratio of linear alkyl C12-16 
propoxyamine ethoxylate to glyphosate in the

[[Page 57674]]

formulated product. Thus, the glyphosate tolerance level residues were 
adjusted using this ratio to estimate linear alkyl C12-16 
propoxyamine ethoxylate residues. It should be noted that the 
glyphosate tolerance level residues are considered to be conservative 
exposure estimates which assume that 100% of the crops having 
glyphosate tolerances receive an application of glyphosate and that all 
residue levels are at the maximum legally permissible level. It is 
unlikely that either or both of these assumptions would actually occur, 
thus leading to the conservative nature of the exposure estimates. 
Using a ratio to adjust the glyphosate tolerance level residues to 
linear alkyl C12-16 propoxyamine ethoxylate residue levels 
is a reasonable approach for this assessment for the following reasons:
    Many of the uses of glyphosate are pre-emergent (i.e., take place 
prior to planting or emergence of the crop) and typically result in 
non-detectable residues of glyphosate in the harvested commodities. 
Although data indicate that linear alkyl C12-16 propoxyamine 
ethoxylate is longer-lived in the environment than glyphosate, residues 
of linear alkyl C12-16 propoxyamine ethoxylate resulting 
from pre-emergent uses are also expected to be non-detectable since 
unlike glyphosate, linear alkyl C12-16 propoxyamine 
ethoxylate is not expected to be systemic (i.e., not able to 
translocate through the plant to the crop commodity). The non-systemic 
nature of the surfactant, that is, its inability to translocate in and 
of itself offers a wide margin of protection.
    Some uses of glyphosate are post-emergent (i.e., made after the 
crops emerge). Most of these applications are for the purpose of 
desiccation of the crops to aid harvest. These have fairly short 
preharvest intervals (PHIs), which is the mandated wait period, usually 
given in number of days, from application of the pesticide to harvest. 
A short PHI means that there may be insufficient time for the applied 
chemicals to metabolize/degrade and therefore can still be present in 
significant quantities at the time of harvest. The glyphosate 
tolerances that result from these short PHIs, once adjusted by the 
ratio methodology to be linear alkyl C12-16 propoxyamine 
ethoxylate residue levels are not likely to significantly underestimate 
dietary (food) exposure to linear alkyl C12-16 propoxyamine 
ethoxylate.
    The methodology by which these residue levels were estimated (ratio 
in formulation, conservative assumptions of 100% crop treated and 
maximum legally permissible residue levels) should not underestimate 
residue levels of linear alkyl C12-16 propoxyamine 
ethoxylate since: (a) For pre-emergent applications linear alkyl 
C12-16 propoxyamine ethoxylate is not expected to 
translocate through the plant to the crop commodity, and thus, as 
explained, should result in non-detectable residues; and (b) for post-
emergent uses given the lack of time for metabolism/degradation to 
occur for either glyphosate or linear alkyl C12-16 
propoxyamine ethoxylate, the persistence of linear alkyl 
C12-16 propoxyamine ethoxylate is not a significant factor 
and the estimated residue levels should not underestimate food exposure 
to linear alkyl C12-16 propoxyamine ethoxylate.
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single event exposure. The Agency has conducted Tier 1 acute food 
exposure assessments for linear alkyl C12-16 propoxyamine 
ethoxylate using the Dietary Exposure Evaluation Model 
(DEEM). This model incorporates consumption data generated in 
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-
1992. For this acute food risk assessment, the entire distribution of 
single day food consumption events is combined with a single residue 
level (deterministic analysis) to obtain a distribution of exposure in 
mg/kg/day. For a Tier 1 analysis, the Agency generally considers 
exposure at the 95th percentile to be representative of high end 
exposure. The Agency's level of concern is for exposures greater than 
100% of the aPAD. For the population subgroup of concern, females 13-50 
years, at the 95th percentile, the dietary exposure is 2% of the aPAD.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. For 
chronic food risk assessments, the 3-day average consumption for each 
subpopulation is combined with residues in commodities to determine 
average exposure in mg/kg/day. In performing the chronic dietary risk 
assessment, the Agency's level of concern is for exposures greater than 
100% cPAD. The population groups with the highest percentages are 
children (1-6 years old) (54%), all infants (< 1 year) (51%), children 
(7-12 years old) (36%), total U.S. population (25%), and females (13-50 
years) (19%).
    2. Drinking water exposure. Given the limited environmental fate 
information, qualitatively linear alkyl C12-16 propoxyamine 
ethoxylate can be described as a chemical that is moderately persistent 
to persistent based on complete minerization (metabolism to carbon 
dioxide, water and basic minerals), has intermediate mobility 
(estimated Koc ranging from 630 to 6,300) with respect to 
runoff in water and eroding soil/sediment, and is possibly a compound 
which has significant potential to bioconcentrate based on an estimated 
partition coefficient between water and octanol (Kow).
    The Agency lacks sufficient monitoring exposure data to complete 
comprehensive dietary exposure analysis and risk assessment for linear 
alkyl C12-16 propoxyamine ethoxylate. Because the Agency 
does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the characteristics of linear alkyl 
C12-16 propoxyamine ethoxylate.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a % PAD. Instead drinking water 
levels of comparison (DWLOCs) are calculated and used as a point of 
comparison against the model estimates of a pesticide's concentration 
in water. DWLOCs are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food, and from residential uses.
    In lieu of submitted environmental fate studies on linear alkyl 
C12-16 propoxyamine ethoxylate, the water modeling inputs 
were estimated based on available fate and transformation data. The 
assumption ranged from no sorption to soil and no degradation to some 
sorption and some degradation. Considering the number of crops on

[[Page 57675]]

which glyphosate is used, a percent crop area adjustment was not used. 
To model Tier 1 surface water concentrations, the Agency uses the FQPA 
Index Reservoir Screening Tool (FIRST) to calculate the concentrations 
used in the drinking water assessment. It represents a small drinking 
water reservoir surrounded by a run-off prone watershed. FIRST 
estimates expected concentrations from a few basic chemical parameters 
and pesticide label application information. It is a Tier 1 model which 
uses a chemical's soil/water partition coefficient and degradation 
half-life values to estimate runoff from an agricultural field into a 
drinking water reservoir. FIRST considers reductions in dissolved 
pesticide concentration due to adsorption of pesticide to soil or 
sediment, incorporation, degradation in soil before wash off to a water 
body, direct deposition of spray drift into the water body, and 
degradation of the pesticide within the water body.
    Using FIRST, the estimated acute concentrations for surface water 
ranged from 43 to 185 g/L. The estimated chronic 
concentrations from surface water ranged from 6 to 133 g/L. 
Both ranges include an estimate with the assumption that the chemical 
is stable to biotic and abiotic processes and infinitely mobile. 
Reasonable high-end estimates of exposure based on a metabolism half-
life in soil and water of 110 days and a partition coefficient of 630 
mL/g O.C. (organic carbon) are 13 g/L for a yearly average 
concentration and 92 g/L for a peak concentration.
    SCI-GROW (Screening Concentration in Ground Water) estimates 
``worst case'' groundwater concentrations of pesticides considering the 
maximum allowable use rate in an area where the groundwater is 
exceptionally vulnerable to contamination. The model uses existing 
environmental fate properties of the chemical being examined, the 
application rate from the label, and the existing body of data from 
Agency-required small-scale prospective and two large-scale prospective 
groundwater monitoring studies for all pesticides. It should be noted 
that SCI-GROW is biased in the sense that negative data were ignored, 
i.e., studies where the pesticide was not detected in groundwater were 
not included in the data set. Thus, it is not expected that SCI-GROW 
estimates would be exceeded.
    With most groundwater sources there are no known predictable 
seasonal or longer term trends in concentration of pesticide 
contaminants. Therefore, only one concentration is estimated which 
should be used for both acute and chronic scenarios. Using SCI-GROW, 
for groundwater for both acute and chronic effects, the estimated 
concentration of 0.3 g/L is based on a metabolism half-life in 
soil and water of 110 days and a partition coefficient of 630 mL/g O.C.
    3. From non-occupational exposure. The term ``residential 
exposure'' is used in this document to refer to non-occupational, non-
dietary exposure. Linear alkyl C12-16 propoxyamine 
ethoxylate will be used in glyphosate formulations, which can be used 
in and around the home (e.g., lawn, garden, and ornamental uses). Since 
this is a residential assessment, and given the nature and non-
repetitiveness of the exposure only a short-term (1-7days) assessment 
was performed. The level of concern for residential exposures is a 
margin of exposure (MOE) of less than 100. A dermal absorption factor 
of 10% (based on the SAR assessment which rated absorption as poor 
through the skin) was used. Exposure estimates were generated using the 
Standard Operating Procedures (SOPs) for Residential Exposure 
Assessments, which are standardized methodologies for estimating 
exposures using information such as percent in the formulation. All 
MOEs for residential uses are greater than 100.
    4. Safety factor for infants and children. In assessing the 
potential for additional sensitivity of infants and children to 
residues of linear alkyl C12-16 propoxyamine ethoxylate, EPA 
considered data from a developmental toxicity study in the rat and the 
SAR assessment. The SAR assessment did not indicate a concern for 
developmental or reproductive effects. This assessment which was made 
on surrogate data, is supported by a rat developmental toxicity study 
conducted with linear alkyl C12-16 propoxyamine ethoxylate. 
A developmental toxicity study is designed to evaluate adverse effects 
on the developing organism resulting from maternal pesticide exposure 
gestation. The Agency's review and evaluation of the submitted 
developmental toxicity study indicated that there was no increase in 
susceptibility. The maternal NOAEL is 25 mg/kg/day. The developmental 
NOAEL is 75 mg/kg/day. Thus, the mother would be impacted before the 
developing fetus.
    FFDCA section 408 provides that EPA shall apply an additional 10-
fold 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 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 use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. When a quantitative risk assessment is performed for inert 
ingredients which have no active ingredient uses, the Agency reviews 
all of the available and reliable data. For linear alkyl 
C12-16 propoxyamine ethoxylate, a surfactant that is 
characterized as having low to moderate toxicity, the Agency believes 
that the following support the use of the standard uncertainty factor: 
The SAR assessment does not indicate any concerns for developmental or 
reproductive effects; and EPA's review and evaluation of the rat 
developmental toxicity study indicates that there is no increase in 
susceptibility.
    For assessing exposure, estimates were estimated based on data that 
reasonably accounts for potential exposures. Thus, based on the above 
rationales, EPA concludes that the 10X safety factor should be removed.
    5. Aggregate risks and determination of safety--i. In general. To 
estimate total aggregate exposure to a pesticide from food, drinking 
water, and residential uses, the Agency calculates DWLOCs which are 
used as a point of comparison against the model estimates of a 
chemical's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a chemical's concentration in drinking water in light of 
total aggregate exposure to a pesticide chemical in food and 
residential uses. In calculating a DWLOC, the Agency determines how 
much of the acceptable exposure (i.e., the PAD) is available for 
exposure through drinking water (e.g., allowable chronic water exposure 
(mg/kg/day) = cPAD - (average food + residential exposure)). This 
allowable exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk

[[Page 57676]]

assessment performed. For linear alkyl C12-16 propoxyamine 
ethoxylate, these are acute, short-term, and chronic.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, the Agency concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which reliable data are available) 
would not result in unacceptable levels of aggregate human health risk 
at this time.
    ii. Acute risk. As previously discussed in the unit for acute 
dietary exposure, the acute dietary exposure from food to linear alkyl 
C12-16 propoxyamine ethoxylate will occupy 2% of the aPAD 
for the populations subgroup females 13-50 years. In addition, there is 
potential for acute dietary exposure to linear alkyl C12-16 
propoxyamine ethoxylate in drinking water. The Agency calculated a 
DWLOC of 22,000 g/L which is significantly greater than the 
0.3 g/L estimated for groundwater and 92 /L estimated 
for surface water. Thus, EPA does not expect the acute aggregate 
exposure to exceed 100% of the aPAD.
    iii. Chronic risk. As previously discussed in the unit for chronic 
dietary exposure, the chronic dietary exposure from food to linear 
alkyl C12-16 propoxyamine ethoxylate will occupy 54% of the 
cPAD for children (1-6 years old), 51% of the cPAD for all infants (< 1 
year), 36% of the cPAD for children (7-12 years old), 25% of the cPAD 
for the total U.S. population, and 19% of the cPAD for females (13-50 
years) (19%). There are no residential uses for linear alkyl 
C12-16 propoxyamine ethoxylate that result in chronic 
residential exposure to linear alkyl C12-16 propoxyamine 
ethoxylate. There is a potential for chronic dietary exposure to linear 
alkyl C12-16 propoxyamine ethoxylate in drinking water. The 
Agency calculated DWLOCs of 790 g/L for adults and 140 
g/L for children. Both are greater than the 0.3 g/L 
estimated ground water and the 13 g/L estimated for surface 
water. Thus, EPA does not expect the chronic aggregate exposure to 
exceed 100% of the aPAD.
    iv. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). As previously 
discussed, in the non-occupational exposure unit, there is the 
potential for residential exposure to linear alkyl C12-16 
propoxyamine ethoxylate. The Agency calculated a DWLOC of 24,000 
g/L for homeowner adult applicators. An adult post-application 
exposure estimate would be less, thus resulting in a larger DWLOC. The 
Agency calculated a DWLOC of 7,300 g/L for post-application 
exposure for a child. Both are greater than the estimates for surface 
and groundwater concentrations. Thus, EPA does not expect the short-
term aggregate exposure to exceed its level of concern.

VI. 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 linear alkyl C12-16 propoxyamine ethoxylate has 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, linear alkyl C12-16 propoxyamine 
ethoxylate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that linear alkyl C12-16 propoxyamine 
ethoxylate has a common mechanism of toxicity with other substances. 
For information regarding EPA's efforts to determine which chemicals 
have a common mechanism of toxicity and to evaluate the cumulative 
effects of such chemicals, see the final rule for Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1999).

VII. Determination of Safety for U.S. Population, Infants and 
Children

    Based on the SAR assessment as well as the quantitative and 
qualitative risk assessments conducted using the available data, EPA 
concluded that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to [poly[oxy(methyl-1,2-ethanediyl)], -[2-bis(2-
hydroxyethyl)amino]propyl]--hydroxy,-ether with -
hydro--hydroxypoly(oxy-1,2-ethanediyl) (1:2), mono-
C12-16 alkyl ethers residues. Critical factors supporting 
this finding include: Linear alkyl C12-16 propoxyamine 
ethoxylate is of low/moderate toxicity. Moreover, the effects displayed 
in the reviewed studies (decreased body weight gain, and possibly even 
the salivation) were probably due to the corrosion/irritation factor 
common to surfactants such as linear alkyl C12-16 
propoxyamine ethoxylate and not to other mechanisms of toxicity 
generally considered to be of greater concern. The Agency is requiring 
a limitation on the use of linear alkyl C12-16 propoxyamine 
ethoxylate, ``not to exceed 15% in the formulated product.'' This 
limitation should be sufficiently protective for the corrosive effects 
common to surfactants. Further, in performing the dietary assessment 
the Agency took into account that linear alkyl C12-16 
propoxyamine ethoxylate is to be used in glyphosate products, a 
pesticide product registered for use on most commonly-consumed foods. 
Accordingly, the risk assessment assumes that linear alkyl 
C12-16 propoxyamine ethoxylate will be present in most 
commonly-consumed foods. Finally, the residue levels used in performing 
the food assessment were very conservative (health protective). The 
conservative assumptions (ratio in formulation, 100% of crop treated 
and maximum legally permissible residue levels) especially when 
considered with the non-systemic nature of linear alkyl 
C12-16 propoxyamine ethoxylate, and the short PHIs for 
glyphosate products are considered to produce estimates that do not 
underestimate food exposure and are likely to substantially 
overestimate exposure.
    Because linear alkyl C12-16 propoxyamine ethoxylate is 
unlikely to pose a dietary risk under reasonably foreseeable 
circumstances, EPA finds that exempting poly[oxy(methyl-1,2-
ethanediyl)], -[2-bis(2-hydroxyethyl)amino]propyl]--
hydroxy,-ether with -hydro--hydroxypoly(oxy-1,2-
ethanediyl) (1:2), mono-C12-16 alkyl ethers from the 
requirement of a tolerance will be safe.

VIII. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect....'' EPA has been working with interested 
stakeholders to develop a screening and testing program as well as a 
priority setting scheme. As the Agency proceeds with implementation of 
this program, further testing of products containing linear alkyl 
C12-16 propoxyamine ethoxylate for endocrine effects may be 
required.

[[Page 57677]]

B. Analytical Method

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Exemptions

    There are no existing exemptions for linear alkyl C12-16 
propoxyamine ethoxylate.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
linear alkyl C12-16 propoxyamine ethoxylate nor have any 
CODEX Maximum Residue Levels (MRLs) been established for any food crops 
at this time.

IX. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of linear alkyl C12-16 propoxyamine ethoxylate. 
Accordingly, EPA finds that exempting [poly[oxy(methyl-1,2-
ethanediyl)], -[2-bis(2-hydroxyethyl)amino]propyl]--
hydroxy,-ether with -hydro--hydroxypoly(oxy-1,2-
ethanediyl) (1:2), mono-C12-16 alkyl ethers from the 
requirement of a tolerance will be safe.

X. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301191 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before January 
15, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301191, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XI. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive

[[Page 57678]]

Order 13211, Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the exemption in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

XII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: November 5, 2001.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. In Sec. 180.1001, the table in paragraph (c) is amended by 
adding alphabetically the following inert ingredient to read as 
follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (c) *  *  *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
        *        *        *        *        *        *          *
[Poly[oxy(methyl-1,2-             Not to exceed 15%   Surfactant
 ethanediyl)], -[2-       in the formulated
 bis(2-                            product; only for
 hydroxyethyl)amino]propyl]-       use with
 -hydroxy,-ether with    glyphosate
 -hydro--
 hydroxypoly(oxy-1,2-ethanediyl)
 (1:2), mono-C12-16 alkyl
 ethers, (CAS Reg. No. 176022-82-
 5)
        *        *        *        *        *        *          *
------------------------------------------------------------------------


[[Page 57679]]

* * * * *
[FR Doc. 01-28734 Filed 11-15-01; 8:45 am]
BILLING CODE 6560-50-S