Document ID: EPA-HQ-OPP-2008-0892-0003
Agency: epa
Document Type: Rule
Title: Time-Limited Exemption from the Requirement of a Tolerance: Alpha-(p-Nonylphenol)-Omega-hydroxypoly(oxyethylene) Sulfate and Phosphate Esters
Posted Date: 2010-05-17T04:00Z

[Federal Register: May 17, 2010 (Volume 75, Number 94)]
[Rules and Regulations]
[Page 27434-27443]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17my10-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0892; FRL-8826-3]

[alpha]-(p-Nonylphenol)-[omega]-hydroxypoly(oxyethylene) Sulfate
and Phosphate Esters; 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-nonylphenol)-
[omega]-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium, potassium, sodium, and zinc salts when
used as inert ingredients at levels not to exceed 7% in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest, and animals. The Joint Inerts Task Force, Cluster
Support Team Number 9 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-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium, potassium, sodium, and zinc salts).

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-2008-0892. All documents in the
docket are listed in the docket index

[[Page 27435]]

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: 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 OPPTS harmonized test guidelines
referenced in this document electronically, please go to http://
www.epa.gov/oppts 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-2008-0892 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-2008-0892, 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
8E7478) by the Joint Inerts Task Force, Cluster Support Team 9, c/o
CropLife America, 1156 15th Street, NW., Suite 400, Washington, DC
20005. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be
amended by establishing exemptions from the requirement of a tolerance
for residues of of [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters ;
the nonyl group is a propylene trimer isomer and the poly(oxyethylene)
content averages 4-14 or 30 moles for CAS Reg. Nos. 51811-79-1, 59139-
23-0, 67922-57-0, 68412-53-3, 68553-97-9, 68954-84-7, 99821-14-4,
152143-22-1, 51609-41-7, 37340-60-6, 106151-63-7, 68584-47-4, 52503-15-
8, 68458-49-1 and [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts the nonyl group is propylene trimer
isomer and the poly(oxyethylene) content averages 4 moles for CAS Reg
Nos. 9014-90-8, 9051-57-4, 9081-17-8, 68649-55-8, 68891-33-8 (herein
referred to in this document as nonylphenol ethoxylate phosphate and
sulfate derivatives or NPEPSDs) when used as inert ingredients 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 Team
9, 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 and 40 CFR 180.930 exemptions from
the requirement of a tolerance for NPEPSDs 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 ``Nonylphenol Ethoxylates

[[Page 27436]]

and Their Phosphate and Sulfate Derivatives (NPEs - JITF CST 9 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-
2008-0892. 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 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-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, potassium, sodium, and zinc salts of the phosphate esters
and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene) sulfate,
ammonium, calcium, magnesium, potassium, sodium, and zinc salts 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
andhydrocarbons; 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 NPEPDs including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with NPEPDs 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.
    NPEPSDs have low to moderate acute oral and dermal toxicity, are
mild to moderate skin irritants, and eye irritants. Based on the
analysis of the studies in the open literature, there is both positive
and negative evidence that NPEPSDs are mutagenic in bacteria
(Salmonella typhimurium). In Harmonized Guideline 870.3650 combined
repeated dose toxicity studies with the reproduction/developmental
toxicity screening test in rats with NPEPSDs, there was no evidence of
increased susceptibility. Additionally, there was no evidence of
neurotoxicity, developmental toxicity, or reproductive toxicity in
those same studies. The Agency has identified nonylphenol as a
potential metabolite/degradate of concern. The Agency considered
available toxicity data on nonylphenol as well as toxicity data on the
structurally related octylphenol 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 NPEPSDs 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 NPEPSDs 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 ``Nonylphenol
Ethoxylates and Their Phosphate and Sulfate Derivatives (NPEs -- JITF
CST 9 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. 11-22 in
docket ID number EPA-HQ-OPP-2008-0892.

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

[[Page 27437]]

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) or level of
concern (LOC). 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 NPEPSDs used for human
risk assessment is shown in the Table of this unit.

  Table -- Summary of Toxicological Doses and Endpoints for NPEPSDs and its Metabolites (including Nonylphenol)
                                        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 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
                                                                                         3-Generation
                                                                                          reproduction study in
                                                                                          rats (nonylphenol)
                                                                                          LOAEL=30 mg/kg/day
                                                                                          based on acceleration
                                                                                          of vaginal opening by
                                                                                          by [ap]2 days and
                                                                                          [ap]6 days in F1, F2,
                                                                                          and F3 generations
                                                                                          following dietary
                                                                                          exposure at 30 and 100
                                                                                          mg/kg/day respectively
                                                                                          (NOAEL [ap]9 mg/kg/
                                                                                          day)
----------------------------------------------------------------------------------------------------------------
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
                                                                                          (NPEPSD)
                                                                                         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.
----------------------------------------------------------------------------------------------------------------

[[Page 27438]]

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..............                            (NPEPSD)
                                       FQPA SF = 10x = UFDB...                           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 NPEPSDs
                                         and metabolite. Based on a weight 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). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF =
  Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    Very limited information is available for NPEPSDs 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 NPEPSD compounds. The ethoxylate moiety is degraded
by sequential removal of the ethoxylate groups, eventually degrading to
nonylphenol. There are studies in the literature that suggest that
plants have the ability to take up nonylphenol ethoxylate residues from
treated soil. While the Agency does not expect that the use of NPEPSDs
as inert ingredients 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 NPEPSDs as inert ingredients. Therefore, the
Agency has concluded that the residues of concern in food and drinking
water are the NPEPSD compounds, their partially de-ethoxylated
degradation products, as well as the degradation product nonylphenol,
and has conservatively assumed that in the case of food and drinking
water exposures all exposure will be in the form of exposure to
nonylphenol, the potential metabolite/degradate of greatest
toxicological concern.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to NPEPSDs, EPA considered exposure from the petitioned-for
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from NPEPSDs 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 NPEPSDs. A hazard endpoint for acute exposure to NPEPSDs 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 percent of the product and often can be much
higher. Further, pesticide

[[Page 27439]]

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 NPEPSD
that may be in formulations (no more than 7%) and assumed that NPEPSDs
are 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 were NPEPSDs.
    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
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 to NPEPSDs 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 for NPEPSDs. 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% CT 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
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 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 ``Nonylphenol Ethoxylates and Their
Phosphate and Sulfate Derivatives (NPEs -- JITF CST 9 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.'' at pp. 23-25 and Appendix C in
docket ID number EPA-HQ-OPP-2008-0892.
    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 1000 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). NPEPSDs may be used
as inert ingredients 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 NPEPSDs as inert ingredients. 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 NPEPSDs. Similarly, residential
postapplication dermal and oral exposure assessments were also
performed utilizing high-end exposure scenarios. In the case of
NPEPSDs, non-dietary exposures are to NPEPSDs only as there is no
appreciable metabolism or degradation of NPEPSDs 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.

[[Page 27440]]

    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 NPEPSDs to share a common mechanism of toxicity
with any other substances, and NPEPSDs does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that NPEPSDs do 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 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.
    2. Prenatal and postnatal sensitivity. In the case of NPEPSDs,
there was no increased susceptibility to the offspring of rats
following pre-natal and post-natal exposure in either Harmonized
Guideline 870.3650 combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test. In the Harmonized
Guideline 870.3650 study with the nonylphenol ethoxylate phosphate
ester, decrease in pup viability was observed at the limit dose,
whereas parental toxicity was observed at a lower dose, as evidenced by
the decrease in body-weight gain and food consumption during premating
and signs of discomfort (pushing head through bedding) at 300 mg/kg/
day. In the Harmonized Guideline 870.3650 study on the nonylphenol
ethoxylate sulfate, decreased pup viability (decreased number of live
pups/litter at birth, increased number of dead pups and litters with
dead pups), and decreased pup body weight/body-weight gain were
observed at the limit dose where parental toxicity manifested as
mortality, clinical signs (soft feces, signs of discomfort), decreased
body weight gain, liver toxicity, and lesions in the forestomach (both
sexes) and decreased body temperature and locomotor activity,
hematologic effects, and kidney lesions in females. Since the
Harmonized Guideline 870.3650 studies with NPEPSDs did not assess their
impact on the estrogen system, they cannot be used alone to properly
assess the most sensitive endpoint. However, selecting the POD from the
Harmonized Guideline 870.3650 study on nonylphenol ethoxylate phosphate
which is based on a NOAEL of 100 mg/kg/day and decreased body-weight
gain in both sexes during the premating period 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 NPEPSDs For the nonylphenol
metabolite, two of the multigeneration reproduction studies in rats and
two studies in prepubertal female rats showed accereration in the
acquisition of vaginal patency. A delay in preputial separation was
observed in male rats in a pubertal onset assay.
    Although no developmental toxicity studies were identified in the
toxicology database for nonylphenol,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
nonylphenol was selected from this study for the acute dietary (females
13+) exposure. This study is considered appropriate and health
protective in light of the fact that octylphenol and nonylphenol differ
by only one methylene unit.
    3. Conclusion. EPA has determined that the FQPA safety factor can
be reduced to 1X for the nonylphenol 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. 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. Although no developmental toxicity studies were identified in
the open literature for nonylphenol, a developmental study on the
structurally-related substance, 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 nonylphenol exposure.
    iii. There are several multigeneration reproduction studies in rats
on nonylphenol that demonstrates no adverse effects on reproductive
function.
    iv. Although the available mammalian toxicity database does not
include any chronic toxicity data, there are 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.
    v. No evidence of neurotoxicity was demonstrated in the database
for NPEPSDs, octylphenol, or nonylphenol and thus there is no need for
a developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
    vi. 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 NPEPSDs is degradated to the more
toxic degradate, nonylphenol. Further, the assessment assumed residues
of nonylphenol 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 significantly overestimate risk.
    EPA has determined that the FQPA safety factor should be retained
(10X)

[[Page 27441]]

for NPEPSDs, 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- endpost-natal exposure to NPEPSDs were selected for the
residential and occupational risk assessments, there are concerns that
the study did not look for the most sensitive endpoints for the
estrogen system; and (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- and post-natal exposure
to NPEPSDs.

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. Using the exposure assumptions discussed in this
unit for acute exposure, including the limitation of use of NPEPSDs to
not more than 7% of the pesticide product, the acute dietary exposure
from food and water to NPEPSDs 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 NPEPSDs
to not more than 7% of the pesticide product, EPA has concluded that
chronic exposure to NPEPSDs from food and water will utilize 90% of the
cPAD for children 1-2 years old the population group 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 NPEPSDs combine
high end residential short- or intermediate-term exposures with average
food and drinking water exposures, and compare this total to a short-
or intermediate-term PoD.
    The point of departure for the dietary risk assessment is 10 mg/kg/
day and the the Level of Concern (LOC) when examining the margin of
exposure is 100 for NPEPSDs. The point of departure for the residential
risk assessment is 150 mg/kg/day and the LOC is 1000 for NPEPSDs. For
the purpose of aggregating risks from dietary and residential exposure,
the Agency is using the Aggregate Risk Index 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- and
intermediate-term aggregate risks for NPEPSDs are not of concern
(values ranging from 1.0 to 4.3 for children and adults, respectively).
    4. The Agency has carefully considered the weight of the evidence
with respect to carcinogenicity for both NPEPSDs and for nonylphenol.
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

    The Agency is not aware of any country requiring a tolerance for
octylphenol ethoxylate nor have any CODEX Maximum Residue Levels been
established for any food crops at this time.

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 two-year time limitation. The exemption from the requirement
of a tolerance for NPEPSDs 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 NPEPSDs; 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
NPEPSDs 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 NPEPSDs tolerance exemption
perform the following studies for confirmatory purposes:
    A new Ames assay (Harmonized Test 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
NPEPSDs tolerance exemption may opt to conduct the mammalian
erythrocyte micronucleus test in lieu of the two in

[[Page 27442]]

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 NPEPSD
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 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 in this Unit.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance for
residues of [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, potassium, sodium, and
zinc salts of the phosphate esters; the nonyl group is a propylene
trimer isomer and the poly(oxyethylene) content averages 4-14 or 30
moles and [alpha]-(p-nonylphenol)-[omega]-hydroxypoly(oxyethylene)
sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc
salts the nonyl group is propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles when used as inert
ingredients at levels not to exceed 7% in pesticide formulations
applied to growing crops and raw agricultural commodities after harvest
under 40 CFR 180.910 and to applied to animals under 40 CFR 180.930 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
entries 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.

* * * * *

[[Page 27443]]

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-(p-nonylphenol)-[omega]-  Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene)          of pesticide        related adjuvants
 mixture of dihydrogen phosphate   formulation.        of surfactants
 and monohydrogen phosphate        Expires May 17,
 esters and the corresponding      2012.
 ammonium, calcium, magnesium,
 potassium, sodium, and zinc
 salts of the phosphate esters;
 the nonyl group is a propylene
 trimer isomer and the
 poly(oxyethylene) content
 averages 4-14 or 30 moles (CAS
 Reg. Nos. 51811-79-1, 59139-23-
 0, 67922-57-0, 68412-53-3,
 68553-97-9, 68954-84-7, 99821-
 14-4, 152143-22-1, 51609-41-7,
 37340-60-6, 106151-63-7, 68584-
 47-4, 52503-15-8, 68458-49-1).
                                * * * * *
[alpha]-(p-nonylphenol)-[omega]-  Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene)          of pesticide        related adjuvants
 sulfate, ammonium, calcium,       formulation.        of surfactants
 magnesium, potassium, sodium,     Expires May 17,
 and zinc salts the nonyl group    2012.
 is propylene trimer isomer and
 the poly(oxyethylene) content
 averages 4 moles (CAS Reg Nos.
 9014-90-8, 9051-57-4, 9081-17-
 8, 68649-55-8, 68891-33-8).
                                * * * * *
------------------------------------------------------------------------

* * * * *
0
3. Section 180.930 is amended by adding alphabetically the following
entries in the table of inert ingredients to read as follows:

Sec. 180.930  Inert ingredients applied to animals; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-(p-nonylphenol)-[omega]-  Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene)          of pesticide        related adjuvants
 mixture of dihydrogen phosphate   formulation.        of surfactants
 and monohydrogen phosphate        Expires May 17,
 esters and the corresponding      2012.
 ammonium, calcium, magnesium,
 potassium, sodium, and zinc
 salts of the phosphate esters;
 the nonyl group is a propylene
 trimer isomer and the
 poly(oxyethylene) content
 averages 4-14 or 30 moles (CAS
 Reg. Nos. 51811-79-1, 59139-23-
 0, 67922-57-0, 68412-53-3,
 68553-97-9, 68954-84-7, 99821-
 14-4, 152143-22-1, 51609-41-7,
 37340-60-6, 106151-63-7, 68584-
 47-4, 52503-15-8, 68458-49-1).
                                * * * * *
[alpha]-(p-nonylphenol)-[omega]-  Not to exceed 7%    Surfactants,
 hydroxypoly(oxyethylene)          of pesticide        related adjuvants
 sulfate, ammonium, calcium,       formulation.        of surfactants
 magnesium, potassium, sodium,     Expires May 17,
 and zinc salts the nonyl group    2012.
 is propylene trimer isomer and
 the poly(oxyethylene) content
 averages 4 moles (CAS Reg Nos.
 9014-90-8, 9051-57-4, 9081-17-
 8, 68649-55-8, 68891-33-8).
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-11687 Filed 5-14-10; 8:45 am]
BILLING CODE 6560-50-S