
[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Rules and Regulations]               
[Page 74628-74634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de10-9]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0095; FRL-8851-6]

 
Tristyrylphenol Ethoxylates; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of poly (oxy-1,2-ethanediyl), [alpha]-
[tris(1-phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 99734-09-
5), here in referred to as tristyrylphenol ethoxylate, when used as an 
inert ingredient post-harvest as a surfactant under 40 CFR 180.910 with 
a maximum of 15 percent by

[[Page 74629]]

weight in pesticide formulations. Ag-Chem Consulting, on behalf of LG 
Life Science, submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), requesting the establishment of an exemption 
from the requirement of a tolerance. This regulation eliminates the 
need to establish a maximum permissible level for residues of 
tristyrylphenol ethoxylate.

DATES: This regulation is effective December 1, 2010. Objections and 
requests for hearings must be received on or before January 31, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0095. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Karen Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer 
potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0095 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 31, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2008-0095, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of June 23, 2010 (75 FR 35801) (FRL-8831-
3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 0E7701) by Ag-
Chem Consulting, 12208 Quinque Lane, Clifton, VA 21024, on behalf of LG 
Life Science, 910 Sylvan Ave., Englewood Cliffs, NJ 07632. The petition 
requested that 40 CFR 180.910 be amended by establishing an exemption 
from the requirement of a tolerance for residues of tristyrylphenol 
ethoxylate (CAS Reg. No. 99734-09-5) when used as an inert ingredient 
as a surfactant with a maximum of 10 percent by weight in pesticide 
formulations applied to food areas and food contact surfaces in food 
service and food handling establishments. That notice referenced a 
summary of the petition prepared by Ag-Chem Consulting, the petitioner, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the exemption requested by limiting tristyrylphenol ethoxylate 
(CAS Reg. No. 99734-09-5) to a maximum of 15 percent by weight in 
pesticide formulations. This limitation is based on the Agency's risk 
assessment which can be found at http://www.regulations.gov in document 
``PC Code: 800900; Decision Document for Pesticide Petition 0E7701; 
poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-phenylethyl)phenyl]-[omega]-
hydroxy-, (CAS Reg. No. 99734-09-5) for use post-harvest under 40 CFR 
180.910 as an inert ingredient as a surfactant with a maximum of 15 
percent by weight in pesticide formulations'' in docket ID number EPA-
HQ-OPP-2008-0095.
    It should be noted that there are other tolerance exemptions under 
40 CFR 180.920 and 40 CFR 180.1288 that apply to this tristyrylphenol 
ethoxylate compound (CAS Reg. No. 99734-09-5),

[[Page 74630]]

as well as, other closely related tristyrylphenol ethoxylate chemicals. 
The Agency believes that these existing exemptions could be 
consolidated at a later date by establishing a pre- and post-harvest 
exemption under 40 CFR 180.910 for these tristyrylphenol ethoxylate 
compounds since these chemicals share a common chemical structure and 
are members of the same chemical class.

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. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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 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.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for tristyrylphenol ethoxylate 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 
tristyrylphenol ethoxylate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the adverse effects caused by the tristyrylphenol ethoxylates as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are 
discussed in the final rule published in the Federal Register of March 
25, 2009 (74 FR 12621) (FRL-8404-7). As stated in that document, the 
available toxicity database for the tristyrylphenol ethoxylates 
consists of studies on some of the tristyrylphenol ethoxylate 
chemicals, such as CAS Reg. Nos. 90093-37-1 and 119432-41-6), and 
guideline studies on an analog chemical (CAS Reg. No. 105362-40-1). The 
studies on the tristyrylphenol ethoxylate chemicals and analog 
chemicals were considered appropriate to evaluate the toxicity of the 
tristyrylphenol ethoxylates because these chemicals share a common 
chemical structure and are members of the same chemical class. The 
tristyrylphenol ethoxylates and analog chemicals share a close 
structural similarity and same functional groups with the only 
difference being in the associated counterions. Therefore, the toxicity 
of these chemicals is expected to be similar. The Agency has determined 
that these data are appropriate and adequate to characterize the 
toxicity of the tristyrylphenol ethoxylates.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints used for human risk 
assessment is discussed in Unit IV of the final rule published in the 
Federal Register of March 25, 2009 (74 FR 12621) (FRL-8404-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tristyrylphenol ethoxylate, EPA considered exposure under 
the proposed exemption from the requirement of a tolerance as well as 
the other existing exemptions from tolerance for other closely related 
tristyrylphenol ethoxylate chemicals. EPA assessed dietary exposures 
from

[[Page 74631]]

tristyrylphenol ethoxylate in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of tristyrylphenol ethoxylate were seen in the toxicity 
databases. Therefore, an acute dietary risk assessment for 
tristyrylphenol ethoxylate is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the United 
States Department of Agriculture (USDA) [1994-1996 and 1998] Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, no residue data were submitted for tristyrylphenol 
ethoxylate. In the absence of specific residue data, EPA has developed 
an approach which uses surrogate information to derive upper bound 
exposure estimates for the subject inert ingredient. Upper bound 
exposure estimates are based on the highest tolerance for a given 
commodity from a list of high-use insecticides, herbicides, and 
fungicides. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S. 
Piper, 2/25/09) and can be found at http://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest of tolerances 
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentration of active ingredient in agricultural products is 
generally at least 50 percent of the product and often can be much 
higher. Further, pesticide products rarely have a single inert 
ingredient; rather there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient. In the case of tristyrylphenol ethoxylate, EPA 
made a specific adjustment to the dietary exposure assessment to 
account for the use limitations of the amount of tristyrylphenol 
ethoxylate that may be in formulations (no more than 15 percent by 
weight in pesticide) and assumed that tristyrylphenol ethoxylate is 
present at the maximum limitations rather than at equal quantities with 
the active ingredient. In addition, in a previous risk assessment 
(2009) which can be found at http://www.regulations.gov in docket ID 
number EPA-HQ-OPP-2009-0095, the Agency concluded that residues 
following post harvest application to citrus crops would not be likely 
to exceed three times the residue attained following pre-harvest 
application. Therefore, the Agency applied a correction factor of 3x to 
the citrus crop group to account for the potentially higher residues 
from post-harvest treatment of this use.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100 percent of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient. In summary, 
EPA chose a very conservative method for estimating what level of inert 
residue could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data shows that tolerance level residues are typically one 
to two orders of magnitude higher than actual residues in food when 
distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    iii. Cancer. Considering the lack of mutagenicity, the lack of 
target organ toxicity in subchronic studies and known mode of action 
for the target organ toxicity, and the SAR predictions, the Agency 
concluded that carcinogenicity concerns are unlikely for the 
tristyrylphenol ethoxylate. Therefore, a cancer dietary exposure 
assessment was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for tristyrylphenol ethoxylate. Tolerance level 
residues and/or 100 percent CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for tristyrylphenol 
ethoxylate, a conservative drinking water concentration value of 100 
ppb based on screening level modeling was used to assess the 
contribution to drinking water for the chronic dietary risk assessments 
for parent compound. These values were directly entered into the 
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Tristyrylphenol ethoxylate may be used as an inert ingredient in 
pesticide products that are registered for specific uses that may 
result in both outdoor and indoor residential exposures. In addition, 
tristyrylphenol ethoxylate may be used as an inert ingredient in 
pesticide formulations that are used in and around the home. Although 
dermal and inhalation exposures are possible from residential use of 
pesticide products containing this inert ingredient, negligible 
inhalation and dermal absorption is expected based on the molecular 
weight and the physicochemical properties of the compound. A screening 
level residential exposure and risk assessment was completed for 
products containing tristyrylphenol ethoxylate as an inert ingredient. 
The Agency conducted an assessment to represent worst-case residential 
exposure by assessing post

[[Page 74632]]

application exposures and risks from tristyrylphenol ethoxylate in 
pesticide formulations (Outdoor Scenarios) and tristyrylphenol 
ethoxylate in disinfectant-type uses (Indoor Scenarios). Further 
details of this residential exposure and risk analysis can be found in 
the document (D364751) in docket ID number EPA-HQ-OPP-2008-0710.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 has not found tristyrylphenol ethoxylate to share a common 
mechanism of toxicity with any other substances, and tristyrylphenol 
ethoxylate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that tristyrylphenol ethoxylate does not have 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 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor. EPA has determined that reliable data show the safety of 
infants and children would be adequately protected if the FQPA SF were 
reduced to 1X. That decision is based on the following findings:
    2. EPA has sufficient data to assess the toxicity of the 
tristyrylphenol ethoxylates. The data presented in the assessment on 
the tristyrylphenol ethoxylates are adequate to characterize the 
expected behavior of the subject chemical. The primary toxicity appears 
to be to the kidney and thyroid in rats and liver in dogs. Because the 
kidney effects are the most sensitive endpoint, protective measures for 
kidney toxicity will be protective of any other long term effects. 
Further, EPA concluded that there is no need for the additional FQPA 
safety factor for use of subchronic toxicity for long term exposure 
assessment. The critical effect seen in the subchronic study 
(intratubular mineralization in the kidney) is believed to occur as a 
result of precipitation of a chemical based on its physicochemical 
properties. Precipitation of a chemical based on its physiochemical 
properties is a function primarily of dose level rather than duration 
of dosing. Thus, once the threshold for precipitation of the chemical 
is established (as it was in the subchronic dog study), this threshold 
level would be considered protective of any short or long term 
exposure. Therefore, the additional safety factor for the lack of long 
term studies is not warranted.
    3. EPA concluded that there is no evidence of increased 
susceptibility to infants and children. The developmental toxicity 
study in which rats were administered (CAS Reg. No. 119432-41-6) 
resulted in a NOAEL of 300 mg/kg/day for maternal toxicity (based on 
reduced body weights and increase in liver weights and loose feces seen 
at the LOAEL of 1,000 mg/kg/day) and a NOAEL of 300 mg/kg/day for 
developmental toxicity based on increased skeletal variations 
(increased incidence of all unossified proximal phalanges of the hind 
limb seen at the LOAEL of 1,000 mg/kg/day). Fetal effects were seen 
only at the limit dose and in the presence of maternal toxicity.
    4. No rabbit developmental study or reproductive toxicity studies 
are available for these chemicals, however, the developmental toxicity 
study in rats indicates no robust developmental toxicity at the limit 
dose and none of the reproductive parameters were affected in the rat 
developmental study at the limit dose of 1,000 mg/kg/day. This endpoint 
in the developmental study is considered conservative since the 
incidence of skeletal variations seen at 1,000 mg/kg/day was marginal.
    5. There is no indication in the database that the tristyrylphenol 
ethoxylates are neurotoxic chemicals and there is no evidence of 
increased susceptibility. Therefore, there is no need for a 
developmental neurotoxicity study or the acute neurotoxicity and 90-day 
neurotoxicity studies.
    6. No treatment related effects were observed on the thymus or 
spleen at very high doses, indicating a lack of immunotoxic effects. 
Therefore, a functional immunotoxicity test is not required at this 
time and no additional uncertainty factor is required because of the 
lack of a immunotoxicity study.
    7. There are no residual uncertainties identified in the exposure 
databases. In the absence of actual exposure data on tristyrylphenol 
ethoxylates, a highly conservative dietary exposure assessment would 
not underestimate the risk to infants and children. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by the tristyrylphenol 
ethoxylates. Based on overall weight of evidence, the FQPA factor of 
10X was reduced to 1X.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
tristyrylphenol ethoxylate is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for chronic exposure and the use limitations of not more than 15 
percent by weight in pesticide formulations, the chronic dietary 
exposure from food and water to tristyrylphenol ethoxylate is 13.5 
percent of the cPAD for the U.S. population and 43.6 percent of the 
cPAD for children 1 to 2 years old, the most highly exposed population 
subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into 
account

[[Page 74633]]

short-term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Tristyrylphenol 
ethoxylate is used as an inert ingredient in pesticide products that 
are currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to tristyrylphenol ethoxylate. Using 
the exposure assumptions described in this document, EPA has concluded 
that the combined short-term aggregated food, water, and residential 
exposures result in aggregate MOEs of 91 for both adult males and 
females respectively. Adult residential exposure combines high end 
dermal and inhalation handler exposure from indoor hand wiping with a 
high end post application dermal exposure from contact with treated 
lawns. The models assume high end application rates, and high end 
exposures representing worst case scenarios, as well as, assuming that 
the inert ingredients are used on all commodities and that 100 percent 
of crops are treated and that residues will be present for every 
consumed commodity (including meat, milk, poultry, and eggs) that is 
included in the Dietary Exposure Evaluation Model (DEEM\TM\). 
Considering the extremely conservative nature of this screening level 
model the Agency concluded that this MOE is not of a concern. EPA has 
concluded that the combined short-term aggregated food, water, and 
residential exposures result in an aggregate MOE of 207 for children. 
Children's residential exposure includes total exposures associated 
with contact with treated lawns (dermal and hand-to-mouth exposures). 
As the level of concern is for MOEs that are lower than 100, these MOEs 
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Intermediate-term aggregate exposure takes into account 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). 
Tristyrylphenol ethoxylate is currently registered for uses that could 
result in intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with intermediate-term residential exposures to 
tristyrylphenol ethoxylate. Using the exposure assumptions described in 
this document, EPA has concluded that the combined intermediate-term 
aggregated food, water, and residential exposures result in aggregate 
MOE of 869 for adult males and a MOE of 898 for adult females. Adult 
residential exposure includes high end post application dermal exposure 
from contact with treated lawns. EPA has concluded the combined 
intermediate-term aggregated food, water, and residential exposures 
result in an aggregate MOE of 218 for children. Children's residential 
exposure includes total exposures associated with contact with treated 
lawns (dermal and hand-to-mouth exposures). As the level of concern is 
for MOEs that are lower than 100, this MOE is not of concern.
    5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to the 
tristyrylphenol ethoxylate.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to tristyrylphenol ethoxylate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residue of 
tristyrylphenol ethoxylate in or on any food commodities. EPA is 
establishing a limitation on the amount of tristyrylphenol ethoxylate 
that may be used in pesticide formulations. That limitation will be 
enforced through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq. EPA will not register any pesticide for sale or distribution 
that contains greater than 15 percent of tristyrylphenol ethoxylate by 
weight in food use pesticide formulations.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for tristyrylphenol ethoxylate.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for poly(oxy-1,2-ethanediyl), [alpha]-
[tris(1-phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 99734-09-
5), when used post-harvest as an inert ingredient as a surfactant with 
a maximum of 15 percent by weight in pesticide formulations.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of FFDCA 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 final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) 
or Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes,

[[Page 74634]]

nor does this action alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of FFDCA. As such, the Agency has 
determined that this action will not have a substantial direct effect 
on States or tribal governments, on the relationship between the 
national government and the States or tribal governments, or on the 
distribution of power and responsibilities among the various levels of 
government or between the Federal Government and Indian tribes. Thus, 
the Agency has determined that Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 9, 2000) do not apply to this final rule. In 
addition, this final rule does not impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 18, 2010.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.910, add alphabetically the following inert ingredient 
to the table to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
      Inert ingredients              Limits                 Uses
------------------------------------------------------------------------

                              * * * * * * *
Poly(oxy-1,2-ethanediyl),     For use in post-      Surfactants.
 [alpha]-[tris(1-              harvest
 phenylethyl)phenyl]-[omega]-  applications; Not
 hydroxy-, (CAS Reg. No.       to exceed 15% by
 99734-09-5).                  weight in pesticide
                               formulations.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-29992 Filed 11-30-10; 8:45 am]
BILLING CODE 6560-50-P

