Document ID: EPA-HQ-OPP-2008-0890-0003
Agency: epa
Document Type: Rule
Title: Time-Limited Exemption from the Requirement of a Tolerance: Alpha-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega-hydroxypoly(oxyethylene)
Posted Date: 2010-05-17T04:00Z

[Federal Register: May 17, 2010 (Volume 75, Number 94)]
[Rules and Regulations]
[Page 27443-27452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my10-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0890; FRL-8824-3]

 [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene); Time-Limited Exemption from the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited exemption from the
requirement of a tolerance for residues of [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) when used as
an inert ingredient at levels not to exceed 7% in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest. The Joint Inerts Task Force, Cluster Support Team Number
5 requested an exemption for the requirement of a tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA). The exemption from the
requirement of a tolerance expires on May 17, 2012. This regulation
eliminates the need to establish a maximum permissible level for
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene).

DATES: This regulation is effective May 17, 2010. Objections and
requests for hearings must be received on or before July 16, 2010, 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-2008-0890. 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

[[Page 27444]]

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: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; e-mail address: leifer.kerry@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 cite at http://
www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://
www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2008-0890 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 July
16, 2010. 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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0890, 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. Background

    In the Federal Register of March 25, 2009 (74 FR 12856) (FRL-8399-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7466) by the Joint Inerts Task Force, Cluster Support Team 5, c/o
CropLife America, 1156 15th Street, NW., Suite 400, Washington, DC
20005. The petition requested that 40 CFR 180.910 be amended by
establishing an exemption from the requirement of a tolerance for
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of
ethylene oxide: if a blend of products is used, the average range
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 1-14 or 30-70
(herein referred to in this document as octylphenol ethoxylate or OPE)
when used as an inert ingredient in pesticide formulations applied to
growing crops and raw agricultural commodities after harvest. That
notice referenced a summary of the petition prepared by the Joint
Inerts Task Force, Cluster Support Teams 5, the petitioner, which is
available to the public in the docket, http://www.regulations.gov.
There were no comments received in response to the notice of filing.
These tolerances expire on May 17, 2012.
    Based upon review of the data supporting the petition, EPA has
determined that the 40 CFR 180.910 exemption from the requirement of a
tolerance for octylphenol ethoxylate should be time-limited for a
period of two years and include a use limitation of not to exceed 7% by
weight of the pesticide formulation. This limitation is discussed
further in Units IV.C. and V.C. and is based on the Agency's risk
assessment which can be found at http://www.regulations.gov in the
document ``Alkylphenol Ethoxylates (APEs - JITF CST 5 Inert
Ingredients). Revised Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2008-0890.
    This petition was submitted in response to a final rule that was
published in the Federal Register of August 9, 2006 (71 FR 45415) (FRL-
8084-1) in which the Agency revoked, under section 408(e)(1) of FFDCA,
the existing exemptions from the requirement of a tolerance for
residues of certain inert ingredients because of insufficient data to
make the determination of safety required by section 408(b)(2) of
FFDCA. The expiration date for the tolerance exemptions subject to
revocation was August 9, 2008, which was later extended to August 9,
2009, in the Federal Register of August 4, 2008 (73

[[Page 27445]]

FR 45317) (FRL-8373-6) to allow for data to be submitted to support the
establishment of tolerance exemptions for those inert ingredients prior
to the effective date of the tolerance exemption revocation. The
effective date of the revocation for [alpha]-[p-(1,1,3,3-
tetramethylbutyl)phenyl]-[omega]-hydroxypoly(oxyethylene) was
subsequently extended on August 7, 2009 (74 FR 39543) (FRL-8431-8),
October 9, 2009 (74 FR 52148) (FRL-8794-1), and February 9, 2010 (75 FR
6314) (FRL-8812-3). The current effective date of the revocation is May
9, 2010.

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(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 octylphenol ethoxylate
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
octkylphenol ethoxylate follows.

A. Toxicological Profile

     EPA has evaluated the available toxicity data and considered its
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.
    Octylphenol ethoxylate has low to moderate acute oral and dermal
toxicity, is a mild to moderate skin irritant, and an eye irritant.
Based on the analysis of the studies in the open literature, there is
both positive and negative evidence that octylphenol ethoxylate is
mutagenic in bacteria (Salmonella typhimurium) and mammalian (Chinese
hamster ovary, mouse lymphoma) cells. In the Harmonized Guideline
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test in rats with octylphenol
ethoxylate, there was no evidence of increased susceptibility.
Additionally, there was no evidence of neurotoxicity, developmental
toxicity, or reproductive toxicity in that same study. The Agency has
identified octylphenol as a potential metabolite/degradate of concern.
The Agency considered available toxicity data on octylphenol as well as
toxicity data on the structurally related nonylphenol when assessing
the hazard for this potential metabolite/degradate. The major effects
seen in the octylphenol/nonylphenol databases are consistent with
potential disturbances in estrogenic activity, but a complete mode of
action analysis has not been conducted. These effects are the most
sensitive endpoints for both substances and were considered the key
findings for regulatory purposes. The Agency has used available data on
the nonylphenol and octylphenol, which specifically look at these
effects, to establish toxicity endpoints for both octylphenol
ethoxylate and degradates of concern. The Agency considers the toxicity
database to be sufficient to address potential hazards, and the Agency
is regulating on the most sensitive endpoints seen in the database;
effects which are well characterized with clear no-observed-adverse-
effect levels (NOAEL).
     Specific information on the studies received and the nature of the
toxic effects caused by octylphenol ethoxylate as well as the NOAEL and
the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov in document
``Alkylphenol Ethoxylates (APEs - JITF CST 5 Inert Ingredients).
Revised Human Health Risk Assessment to Support Proposed Exemption from
the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations,'' pp. 9-20 in docket ID number EPA-HQ-OPP-2008-
0890.

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 (LOC) 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 (UF/SF) are used in conjunction
with the POD to calculate a safe exposure level - generally referred to
as a population-adjusted dose (PAD (a = acute, c = chronic)) or a
reference dose (RfD), and a safe margin of exposure (MOE) or level of
concern. 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 for octylphenol ethoxylate
used for human risk assessment is shown in the Table of this unit.

[[Page 27446]]

Table -- Summary of Toxicological Doses and Endpoints for Octylphenol Ethoxylates and its Metabolites (Including
                                  Octylphenol) for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 15.6 milligrams/ Acute RfD = 0.156 mg/kg/  Initiation and
 (Females 13-50 years of age)........   kilograms/day (mg/kg/    day                      maintenance of
                                        day) UFA = 10x          aPAD = 0.156 mg/kg/day.   pregnancy in rats
                                       UFH = 10x..............                            (octylphenol)
                                       Food Quality Protection                           LOAEL = 31.3 mg/kg/day
                                        Act Safety Factor                                 based on on increased
                                        (FQPA SF) = 1x.                                   % post-implantation
                                                                                          loss following
                                                                                          exposure of dams
                                                                                          during gestation days
                                                                                          0-8.
----------------------------------------------------------------------------------------------------------------
Acute dietary                              An endpoint attributable to a single exposure was not seen in the
(General population including infants          database; therefore a point of departure was not selected.
 and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 10 mg/kg/day UFA  Chronic RfD = 0.1 mg/kg/ 2-Generation
(All populations)....................   = 10x                    day                      reproduction study in
                                       UFH = 10x..............  cPAD = 0.1 mg/kg/day...   rats (octylphenol)
                                       FQPA SF = 1x...........                           LOAEL = 50 mg/kg/day
                                                                                          based on significant
                                                                                          increases in pituitary
                                                                                          weight ([uarr]12%,
                                                                                          males), decreases in
                                                                                          ovary weight
                                                                                          ([darr]18%) in F0
                                                                                          animals; timing of
                                                                                          vaginal opening
                                                                                          significantly
                                                                                          accelerated in F1
                                                                                          females; decreases in
                                                                                          the numbers of
                                                                                          implants and live F2
                                                                                          pups born
----------------------------------------------------------------------------------------------------------------
Incidental oral and inhalation (short- NOAEL= 150 mg/kg/day     Residential LOC for MOE  Harmonized Guideline
 term (1 to 30 days) and intermediate-  UFA = 10x                = 1,000.                 870.3650 combined
 term (1 to 6 months)                  UFH = 10x..............  Occupational LOC for      repeated dose toxicity
                                       FQPA SF = 10x..........   MOE = 100.               study with the
                                                                                          reproduction/
                                                                                          developmental toxicity
                                                                                          screening test in rats
                                                                                          (octylphenol
                                                                                          ethoxylate)
                                                                                         LOAEL = 300 mg/kg/day
                                                                                          based on clinical
                                                                                          signs (pushing head
                                                                                          through bedding after
                                                                                          dosing), decreased
                                                                                          body-weight gain in
                                                                                          both sexes during the
                                                                                          premating period,
                                                                                          decreased thymus
                                                                                          weight in females,
                                                                                          increased liver weight
                                                                                          in males, and
                                                                                          increased incidence of
                                                                                          centrilobular
                                                                                          hepatocyte hypertrophy
                                                                                          in males.
----------------------------------------------------------------------------------------------------------------
Dermal short-term                      Oral study NOAEL = 150   Residential LOC for MOE  Harmonized Guideline
(1 to 30 days) and intermediate-term    mg/kg/day (dermal        = 1,000                  870.3650 combined
 (1 to 6 months).                       absorption rate =       Occupational LOC for      repeated dose toxicity
                                        1%Dermal equivalent      MOE = 100.               study with the
                                        dose = 10,000 mg/kg/                              reproduction/
                                        day                                               developmental toxicity
                                       UFA = 10x..............                            screening test in rats
                                       UFH = 10x..............                            (octylphenol
                                       FQPA SF = 10x = UFDB...                            ethoxylate)
                                                                                         LOAEL = 300 mg/kg/day
                                                                                          based on clinical
                                                                                          signs (pushing head
                                                                                          through bedding after
                                                                                          dosing), decreased
                                                                                          body-weight gain in
                                                                                          both sexes during the
                                                                                          premating period,
                                                                                          decreased thymus
                                                                                          weight in females,
                                                                                          increased liver weight
                                                                                          in males, and
                                                                                          increased incidence of
                                                                                          centrilobular
                                                                                          hepatocyte hypertrophy
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Cancer                                     Classification: Not classified; no alerts identified in structure-
(Oral, dermal, inhalation)...........     activity database (DEREK Version 11) with respect to carcinogenicity;
                                            potential mutagenicity concern identified in open literature for
                                        octylphenol ethoxylate and metabolite. Based on a weight of the evidence
                                          consideration of the available data, the Agency believes that cancer
                                                               risks would be negligible.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFDB = to account for the absence of data or other data deficiency.

C. Exposure Assessment

    Very limited information is available for octylphenol ethoxylate
with respect to plant and animal metabolism/degradation. There is
extensive information in the literature on environmental degradation,
and some information on bacterial and mammalian metabolism, all of
which indicate similar degradation of the octylphenol ethoxylate
compounds. The ethoxylate moiety is degraded by sequential removal of
the ethoxylate groups, eventually degrading to octylphenol. There are
studies in the literature that suggest that plants have the ability to
take up octylphenol ethoxylate residues from treated soil.

[[Page 27447]]

While the Agency does not expect that the use of octylphenol ethoxylate
as an inert ingredient in pesticide formulations would result solely in
exposure to octylphenol, there are no available data on the exact
nature of octylphenol ethoxylate residues in food and drinking water
resulting from the use of octylphenol ethoxylate as an inert
ingredient. Therefore, the Agency has concluded that the residues of
concern in food and drinking water are the octylphenol ethoxylate
compounds, their partially de-ethoxylated degradation products, as well
as the degradation product octylphenol, and has conservatively assumed
that in the case of food and drinking water exposures all exposure will
be in the form of exposure to octylphenol, the potential metabolite/
degradate of greatest toxicological concern.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to octylphenol ethoxylate, EPA considered exposure from the
petitioned-for exemption from the requirement of a tolerance. EPA
assessed dietary exposures from octylphenol ethoxylate in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 exposure. Such effects were identified
for octylphenol ethoxylate. A hazard endpoint for acute exposure to
octylphenol ethoxylate was identified only for females ages 13-49; no
hazard endpoints for acute exposure were identified for any other
population group. In estimating acute dietary exposure, 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).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII.
    As to residue levels in food, in the absence of specific residue
data, both the acute and chronic dietary exposure assessments are
conducted using 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 can be found at http://
www.regulations.gov in the document ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts'' 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
concentrations of active ingredient in agricultural products are
generally at least 50% 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 relative to that of the active
ingredient. EPA made a specific adjustment to the dietary exposure
assessment to account for the use limitations of the amount of the
surfactant octylphenol ethoxylate that may be in formulations (no more
than 7%) and assumed that octylphenol ethoxylate is at the maximum
limitation rather than at equal quantities with the active ingredient.
This remains a very conservative assumption because surfactants are
generally used at levels far below these percentages. For example, EPA
examined several of the pesticide products associated with the
tolerance/commodity combination which are the driver of the risk
assessment and found that these products did not contain surfactants at
levels greater than 2.25% and that none of the surfactants was
octylphenol ethoxylate.
    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% 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
ingredient residue could be on food, and 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. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural alerts suggestive of carcinogenicity. No structural alerts
for carcinogenicity were identified. Based on a weight of the evidence
consideration of the available data, the Agency believes that cancer
risks would be negligible. Therefore, a cancer dietary exposure
assessment is not necessary to assess cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for octylphenol ethoxylate. Tolerance level residues
and/or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for octylphenol ethoxylate. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of octylphenol ethoxylate. Further information

[[Page 27448]]

regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    A screening level drinking water analysis, based on the Pesticide
Root Zone Model / Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of octylphenol ethoxylate. Modeling runs on four surrogate
inert ingredients using a range of physical chemical properties that
would bracket those of octylphenol ethoxylate were conducted. Modeled
acute drinking water values ranged from 0.001 parts per billion (ppb)
to 41 ppb. Modeled chronic drinking water values ranged from 0.0002 ppb
to 19 ppb. Further details of this drinking water analysis can be found
at http://www.regulations.gov in the document ``Alkylphenol Ethoxylates
(APEs - JITF CST 5 Inert Ingredients). Revised Human Health Risk
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations,''
p. 22 and Appendix C in docket ID number EPA-HQ-OPP-2008-0890.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for octylphenol 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 acute and chronic
dietary risk assessments for the parent compounds and for the
metabolites of concern. These values, which are 10 to 1,000 times
greater than the highest levels of these substance seen in numerous
surface and ground water monitoring studies, were directly entered into
the acute and chronic dietary exposure models.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Octylphenol
ethoxylate may be used as an inert ingredient in pesticide products
that are registered for specific uses that may result in residential
exposures. A screening level residential exposure and risk assessment
was completed for pesticide products containing octylphenol ethoxylate
as an inert ingredient. In this assessment, representative scenarios,
based on end-use product application methods and labeled application
rates, were selected. For each of the use scenarios, the Agency
assessed residential handler (applicator) inhalation and dermal
exposure for use scenarios with high exposure potential (i.e., exposure
scenarios with high-end unit exposure values) to serve as a screening
assessment for all potential residential pesticides containing
octylphenol ethoxylate. Similarly, residential postapplication dermal
and oral exposure assessments were also performed utilizing high-end
exposure scenarios. In the case of octylphenol ethoxylate, non-dietary
exposures are to octylphenol ethoxylate only as there is no appreciable
metabolism or degradation of octylphenol ethoxylate in any of the
representative residential use scenarios. Further details of this
residential exposure and risk analysis can be found at http://
www.regulations.gov in the document ``JITF Inert Ingredients.
Residential and Occupational Exposure Assessment Algorithms and
Assumptions Appendix for the Human Health Risk Assessments to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2008-0710.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
    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 octylphenol ethoxylate to share a common
mechanism of toxicity with any other substances, and octylphenol
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 octylphenol 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 website 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 pre-natal
and post-natal 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
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.
    2. Pre-natal and post-natal sensitivity. In the case of octylphenol
ethoxylate, there was no increased susceptibility to the offspring of
rats following pre-natal and post-natal exposure in the Harmonized
Guideline 870.3650 combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test. The offspring
effects (decreased body weight in male and female offspring) occurred
at 300 mg/kg/day in the presence of maternal toxicity, which was
manifested as clinical signs, decreased body-weight gain, increased
liver weight and liver hypertrophy in males, and decreased thymus
weight in females at 300 mg/kg/day. However, a study referenced in the
petition (Hazelden and Wilson, 1986) suggests more severe developmental
effects (supernumerary rib) following gestational exposure via the diet
during gestation days 6-17. The Harmonized Guideline 870.3650 study did
not include a skeletal examination of the offspring. Since the
Harmonized Guideline 870.3650 study with octylphenol ethoxylate did not
assess its impact on the estrogen system, it cannot be used alone to
properly assess the most sensitive endpoint. However, selecting the POD
from the Harmonized Guideline 870.3650 study, which is based on a NOAEL
of 150 mg/kg/day and decreased body-weight gain in both sexes during
the premating period, decreased thymus weight in females, and increased
liver weight and liver hypertrophy in males at the LOAEL of 300 mg/kg/
day, and retaining the FQPA SF of 10X is comparable to using the POD
from the reproduction studies on the most toxicologically potent
compound (nonylphenol) that assessed estrogenic activity (endpoint:
Accelerated vaginal opening; POD: 10 mg/kg/day). The endpoint
(accelerated vaginal opening) and point of departure (10 mg/kg/day) are
considered health protective of effects not assessed in the Harmonized
Guideline 870.3650 studies on the octylphenol ethoxylate.

[[Page 27449]]

    For the octylphenol metabolite, the 2-generation reproduction study
in rats showed a delay in the acquisition of preputial separation in
both the F1 and F2 pups, and the timing of
vaginal opening was accelerated in a study in prepubertal female rats.
For the related nonylphenol, two of the multigeneration reproduction
studies in rats and two studies in prepubertal female rats showed
acceleration in the acquisition of vaginal patency. A delay in
preputial separation was observed in male rats in a pubertal onset
assay. The combined toxicology databases currently available on
octylphenol and nonylphenol identify accelerated vaginal opening as the
most consistent and sensitive endpoint, and a clear NOAEL of 10 mg/kg/
day has been demonstrated.
    In a developmental toxicity study with octylphenol ethoxylate,
developmental toxicity was demonstrated, as evidenced by the increased
incidence of supernumerary ribs following exposure to the dams during
gestation days 6-17. However, the low pregnancy rate among all groups
(56%-70%) in this study makes interpretation of the results difficult.
Additionally, the Harmonized Guideline 870.3650 study did not include a
skeletal examination of the offspring. A developmental toxicity study
was identified in the octylphenol database, and a clear NOAEL of 15.6
mg/kg/day (post-implantation loss) was established. The POD for
octylphenol was selected from this study for the acute dietary (females
13+) exposure. This study is considered appropriate and health
protective of effects observed in the developmental toxicity study with
octylphenol ethoxylate.
    Since the rat reproduction studies on the most toxicologically
potent compound (nonylphenol) identified a clear NOAEL of 10 mg/kg/day
for the most sensitive endpoint (accelerated vaginal opening), and the
selected POD of 10 mg/kg/day (NOAEL for accelerated vaginal opening)
for the dietary risk assessment is protective of offspring effects,
there are no residual concerns.
    3. Conclusion. EPA has determined that the FQPA SF can be reduced
to 1X for the octylphenol metabolite upon which the dietary assessment
is based. This decision is based on the following findings:
    i. The most sensitive endpoint from the most toxicologically potent
compound (nonylphenol) was selected for risk assessment and is
considered health protective. The database for nonylphenol is
protective of octylphenol, which has a limited database. There are
several studies on nonylphenol (two multigeneration reproduction
studies, pubertal onset assays, uterotrophic assays), which demonstrate
acceleration of vaginal opening in the rat. Accelerated vaginal opening
is the most consistent and sensitive endpoint identified. Clear NOAELs
for this endpoint have been identified following exposure to
nonylphenol.
    ii. While endpoints were not selected from the Harmonized Guideline
870.3650 study in rats following pre-natal and post-natal exposure to
octylphenol ethoxylate based on concerns that the study did not look
for impacts on the estrogen system, the Agency does note that no
increased susceptibility was demonstrated in the offspring in the
Harmonized Guideline 870.3650 study in rats following pre-natal and
post-natal exposure to octylphenol ethoxylate.
    iii. Although a developmental toxicity study was identified in the
open literature for octylphenol ethoxylate with a developmental NOAEL
of 70/mg/kg/day, a developmental study on octylphenol demonstrated an
increase in post-implantation loss following exposure to the dams from
gestation day 0-8. A clear NOAEL of 15.6 mg/kg/day was established for
the offspring effects. Since the POD selected from that study for acute
dietary exposure to the octylphenol metabolite is 15.6 mg/kg/day, this
value is considered health protective of offspring effects that might
be found following octylphenol ethoxylate exposure.
    iv. There is a 2-generation reproduction study in rats on
octylphenol that demonstrates no adverse effects on reproductive
function.
    v. Although the available mammalian toxicity database does not
include any chronic toxicity data, there is one 2-generation
reproduction study on octylphenol and several multigeneration
reproduction studies on the most toxicologically potent compound in the
risk assessment, nonylphenol, in which test animals were dosed for
extended periods of time and across generations.
    vi. No evidence of neurotoxicity was demonstrated in the database
for octylphenol ethoxylate, octylphenol, or nonylphenol and thus there
is no need for a developmental neurotoxicity study or additional UFs to
account for neurotoxicity.
    vii. The exposure assessments used in this risk assessment are
considered to be highly conservative. In the absence of substantial
information on environmental degradation, the Agency has conducted an
assessment which assumes that 100% of octylphenol ethoxylate is
degradated to the more toxic degradate, octylphenol. Further, the
assessment assumed residues of octylphenol will be present in all foods
consumed at levels consistent with the highest established pesticide
tolerance, and in drinking water at a high-end estimated level of 100
ppb. The Agency anticipates that this assessment will signifcantly
overestimate risk.
    EPA has determined that the FQPA safety factor should be retained
(10X) for octylphenol ethoxylate, the compound upon which the
residential assessment is based. This decision is based on the
following findings:
    a. Although endpoints from the Harmonized Guideline 870.3650 study
in rats following pre-natal and post-natal exposure to the octylphenol
ethoxylate were selected for the residential and occupational exposure
risk assessments, there are concerns that the study did not look for
the most sensitive endpoints for the estrogen system.
    b. The Agency does note that no increased susceptibility was
demonstrated in the offspring in the Harmonized Guideline 870.3650
study in rats following pre-natal and post-natal exposure to
octylphenol ethoxylate.

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
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Short-term, intermediate-term, 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. Using the exposure assumptions discussed in this
unit for acute exposure, including the limitation of use of octylphenol
ethoxylate to not more than 7% of the pesticide product, the acute
dietary exposure from food and water to octylphenol ethoxylate willl
occupy 37% of the aPAD for females 13 to 49 years old, the only
population group for which an acute toxicity endpoint was established.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, including the limitation of use of
octylphenol ethoxylate to not more than 7% of the pesticide product,
EPA has concluded that chronic exposure to octylphenol ethoxylate from
food and water will utilize 90% of the cPAD for children 1-2 years old
the population group

[[Page 27450]]

receiving the greatest exposure. Based on the explanation in Unit
IV.C.3., regarding residential use patterns, chronic residential
exposure to residues of octylphenol is not expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Short-term
and intermediate-term aggregate risk assessments for octylphenol
ethoxylate combine high end residential short-term or intermediate-term
exposures with average food and drinking water exposures, and compare
this total to a short-term or intermediate-term POD.
    The POD for the dietary risk assessment is 10 mg/kg/day and the LOC
when examining the MOE is 100 for octylphenol ethoxylate. The POD for
the residential risk assessment is 150 mg/kg/day and the LOC is 1,000
for octylphenol ethoxylate. For the purpose of aggregating risks from
dietary and residential exposure, the Agency is using the Aggregate
Risk Index (ARI) approach for aggregate risk assessment. This approach
allows for combining exposures which must be compared to different
NOAELs and different LOCs. Potential risks of concerns are identified
by an ARI of less than 1. Short-term and intermediate-term aggregate
risks for octylphenol ethoxylate are not of concern (values ranging
from 1.0 to 4.3 for children and adults, respectively).
    4. Aggregate cancer risk for U.S. population. The Agency has
carefully considered the weight of the evidence with respect to
carcinogenicity for both the parent compounds and for the degradate.
There were no structral alerts for carcinogenicity amd there were
equivocal mutagenicity findings in the literature studies. Based on a
weight of the evidence consideration of the available data, the Agency
believes that cancer risks would be negligible. However, due to the
equivocal findings in the mutagenicity data base, the Agency is asking
for confirmatory data.
    5. 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 octylphenol 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 residues of
octylphenol ethoxylate in or on any food commodities. EPA is
establishing a limitation on the amount of octylphenol ethoxylate that
may be used in pesticide formulations applied to growing crops and raw
agricultural commodities. 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 such pesticide for sale or distribution that
contains greater than 7% of octylphenol ethoxylate by weight in the
pesticide formulation.

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 octylphenol ethoxylate.

C. Revisions to Petitioned-For Exemption from the Requirement of a
Tolerance

    EPA is revising the petitioned-for octylphenol ethoxylate exemption
from the requirement of a tolerance under 40 CFR 180.910 by including a
limitation of ``not to exceed 7% of the pesticide formulation.'' As
discussed in Unit IV.C., this limitation will ensure that there are no
aggregate risks of concern. Additionally, EPA is also revising the
octylphenol ethoxylate exemption from the requirement of a tolerance
under 40 CFR 180.910 to include a 2-year time limitation. The exemption
from the requirement of a tolerance for octylphenol ethoxylate will
expire on May 17, 2012. This two-year time limitation is being
established for two purposes:
    1. To provide time for the development and submission of
confirmatory toxicity data to address the equivocal results in the
available genotoxicity studies conducted on octylphenol ethoxylate; and
    2. To provide additional time, should the initial testing not
confirm EPA's conclusion regarding the lack of a cancer concern, for
registrants to attain EPA approval of registration amendments for
reformulation of their pesticide products to remove octylphenol
ethoxylate and to replace existing products with reformulated products.
    EPA believes that its cancer conclusion can be confirmed by
negative results in either in vitro or in vivo mutagenicity studies.
EPA is recommending that supporters of the octylphenol ethoxylate
tolerance exemption perform the following studies for confirmatory
purposes:
    A new Ames assay (Harmonized Guideline 870.5100 -- Bacterial
reverse mutation test) and a mouse lymphoma assay (Harmonized Guideline
870.5300 -- In vitro mammalian cell gene mutation test).
    A bone marrow assay (Harmonized Guideline 870.5395 -- Mammalian
erythrocyte micronucleus test).
     Since in vivo mutagenicity studies such as the bone marrow assay
are generally regarded as more definitive than in vitro studies, and a
negative result in the bone marrow test may outweigh whatever results
are found in the Ames test and mouse lymphoma assay, supporters of the
octylphenol ethoxylate tolerance exemption may opt to conduct the
mammalian erythrocyte micronucleus test in lieu of the two in vitro
mutagenicity studies. If these data do not confirm EPA's cancer
conclusion, then EPA will need two-year cancer bioassays in the mouse
and rat (Harmonized Guideline 870.4200 -- Carcinogenicity (mouse) and
Harmonized Guideline 870.4300 -- combined Chronic Toxicity/
Carcinogenicity (rat)) to make a safety finding in support of this
tolerance exemption.
    In conducting confirmatory testing, supporters of the octylphenol
ethoxylate tolerance exemption should keep the following information in
mind. EPA believes that the minimum time period for registrants to
obtain approval of reformulated products and to replace existing
products is 15 months. Thus, EPA plans to alert the registrant
community no later than February 17, 2011 whether confirmatory data has
been received and demonstrates that EPA's cancer conclusion was
correct. If submitted data do confirm EPA's conclusion, EPA will notify
registrants that it intends to remove the expiration date from the
tolerance exemption prior to expiration of the exemption. If the

[[Page 27451]]

submitted data do not confirm the conclusion, EPA will inform
registrants that they should assume that the tolerance exemption will
expire on May 17, 2012 and that they should take all appropriate steps
to insure that they do not release for shipment product that may result
in food containing residues inconsistent with the dictates of the
FFDCA. EPA does not intend to extend the expiration date for the
exemption if it is determined that two-year cancer bioassays are needed
to evaluate potential cancer risk. Additionally, if no confirmatory
data are submitted by November 17, 2010. EPA will not have time to make
a decision on any confirmatory data by February 17, 2011 and thus, at
that time, EPA will inform registrants that they should assume that the
tolerance exemption will expire on May 17, 2012 and that they should
take all appropriate steps as indicated above.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance for
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) when used as an inert ingredient at levels not
to exceed 7% in pesticide formulations applied to growing crops and raw
agricultural commodities after harvest under 40 CFR 180.910 is
established with an expiration date of May 17, 2012.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 tolerance 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, 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) (Public Law 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: May 10, 2010.
Lois Rossi,
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. Section 180.910 is amended by adding alphabetically the following
entry in the table of inert ingredients 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
------------------------------------------------------------------------
                                * ..................
[alpha]-[p-(1,1,3,3-              Not to exceed 7%    Surfactants,
 tetramethylbutyl)phenyl]-         of pesticide        related adjuvants
 [omega]-                          formulation.        of surfactants
 hydroxypoly(oxyethylene)          Expires May 17,
 produced by the condensation of   2012.
 1 mole of p-(1,1,3,3-
 tetramethylbutyl)phenol with a
 range of 1-14 or 30-70 moles of
 ethylene oxide: If a blend of
 products is used, the average
 range number of moles of
 ethylene oxide reacted to
 produce any product that is a
 component of the blend shall be
 in the range of 1-14 or 30-70
 (CAS Reg. Nos. 9036-19-5, 9002-
 93-1).
                                * * * * *
------------------------------------------------------------------------

[[Page 27452]]

* * * * *

[FR Doc. 2010-11686 Filed 5-14-10; 8:45 am]
BILLING CODE 6560-50-S