[alpha]-(p-Nonylphenol)-[omega]-hydroxypoly(oxyethylene) Sulfate and Phosphate Esters; Time-Limited Exemption from the Requirement of a Tolerance, 27434-27443 [2010-11687]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 94 (Monday, May 17, 2010)]
[Rules and Regulations]
[Pages 27434-27443]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11687]


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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.

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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 https://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 https://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 https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines 
referenced in this document electronically, please go to https://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: https://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, 
https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://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
------------------------------------------------------------------------
                                * * * *