[alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]- hydroxypoly(oxyethylene); Time-Limited Exemption from the Requirement of a Tolerance, 27443-27452 [2010-11686]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 94 (Monday, May 17, 2010)]
[Rules and Regulations]
[Pages 27443-27452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11686]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective May 17, 2010. Objections and 
requests for hearings must be received on or before July 16, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0890. All documents in the 
docket are listed in the docket index available at 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

[[Page 27444]]

the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at 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 harmonized test guidelines 
referenced in this document electronically, please go to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2008-0890 in the subject line on the first page of 
your submission. All objections and requests for a hearing must be in 
writing, and must be received by the Hearing Clerk on or before July 
16, 2010. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0890, by one of the following methods:
     Federal eRulemaking Portal: 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 
8E7466) by the Joint Inerts Task Force, Cluster Support Team 5, c/o 
CropLife America, 1156 15th Street, NW., Suite 400, Washington, DC 
20005. The petition requested that 40 CFR 180.910 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of [alpha]-[p-(1,1,3,3-tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of 
ethylene oxide: if a blend of products is used, the average range 
number of moles of ethylene oxide reacted to produce any product that 
is a component of the blend shall be in the range of 1-14 or 30-70 
(herein referred to in this document as octylphenol ethoxylate or OPE) 
when used as an inert ingredient in pesticide formulations applied to 
growing crops and raw agricultural commodities after harvest. That 
notice referenced a summary of the petition prepared by the Joint 
Inerts Task Force, Cluster Support Teams 5, the petitioner, which is 
available to the public in the docket, 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 exemption from the requirement of a 
tolerance for octylphenol ethoxylate should be time-limited for a 
period of two years and include a use limitation of not to exceed 7% by 
weight of the pesticide formulation. This limitation is discussed 
further in Units IV.C. and V.C. and is based on the Agency's risk 
assessment which can be found at https://www.regulations.gov in the 
document ``Alkylphenol Ethoxylates (APEs - JITF CST 5 Inert 
Ingredients). Revised Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2008-0890.
    This petition was submitted in response to a final rule that was 
published in the Federal Register of August 9, 2006 (71 FR 45415) (FRL-
8084-1) in which the Agency revoked, under section 408(e)(1) of FFDCA, 
the existing exemptions from the requirement of a tolerance for 
residues of certain inert ingredients because of insufficient data to 
make the determination of safety required by section 408(b)(2) of 
FFDCA. The expiration date for the tolerance exemptions subject to 
revocation was August 9, 2008, which was later extended to August 9, 
2009, in the Federal Register of August 4, 2008 (73

[[Page 27445]]

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

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for octylphenol ethoxylate 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
octkylphenol ethoxylate follows.

A. Toxicological Profile

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

B. Toxicological Points of Departure/Levels of Concern

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

[[Page 27446]]



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

C. Exposure Assessment

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

[[Page 27447]]

While the Agency does not expect that the use of octylphenol ethoxylate 
as an inert ingredient in pesticide formulations would result solely in 
exposure to octylphenol, there are no available data on the exact 
nature of octylphenol ethoxylate residues in food and drinking water 
resulting from the use of octylphenol ethoxylate as an inert 
ingredient. Therefore, the Agency has concluded that the residues of 
concern in food and drinking water are the octylphenol ethoxylate 
compounds, their partially de-ethoxylated degradation products, as well 
as the degradation product octylphenol, and has conservatively assumed 
that in the case of food and drinking water exposures all exposure will 
be in the form of exposure to octylphenol, the potential metabolite/
degradate of greatest toxicological concern.
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to octylphenol ethoxylate, EPA considered exposure from the 
petitioned-for exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from octylphenol ethoxylate in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for octylphenol ethoxylate. A hazard endpoint for acute exposure to 
octylphenol ethoxylate was identified only for females ages 13-49; no 
hazard endpoints for acute exposure were identified for any other 
population group. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII.
    As to residue levels in food, in the absence of specific residue 
data, both the acute and chronic dietary exposure assessments are 
conducted using surrogate information to derive upper bound exposure 
estimates for the subject inert ingredient. Upper bound exposure 
estimates are based on the highest tolerance for a given commodity from 
a list of high-use insecticides, herbicides, and fungicides. A complete 
description of the general approach taken to assess inert ingredient 
risks in the absence of residue data can be found at 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% of the product and often can be much higher. 
Further, pesticide products rarely have a single inert ingredient; 
rather there is generally a combination of different inert ingredients 
used which additionally reduces the concentration of any single inert 
ingredient in the pesticide product relative to that of the active 
ingredient. EPA made a specific adjustment to the dietary exposure 
assessment to account for the use limitations of the amount of the 
surfactant octylphenol ethoxylate that may be in formulations (no more 
than 7%) and assumed that octylphenol ethoxylate is at the maximum 
limitation rather than at equal quantities with the active ingredient. 
This remains a very conservative assumption because surfactants are 
generally used at levels far below these percentages. For example, EPA 
examined several of the pesticide products associated with the 
tolerance/commodity combination which are the driver of the risk 
assessment and found that these products did not contain surfactants at 
levels greater than 2.25% and that none of the surfactants was 
octylphenol ethoxylate.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100% of all foods are treated with the inert 
ingredient at the rate and manner necessary to produce the highest 
residue legally possible for an active ingredient. In summary, EPA 
chose a very conservative method for estimating what level of inert 
ingredient residue could be on food, and then used this methodology to 
choose the highest possible residue that could be found on food and 
assumed that all food contained this residue. No consideration was 
given to potential degradation between harvest and consumption even 
though monitoring data shows that tolerance level residues are 
typically one to two orders of magnitude higher than actual residues in 
food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural alerts suggestive of carcinogenicity. No structural alerts 
for carcinogenicity were identified. Based on a weight of the evidence 
consideration of the available data, the Agency believes that cancer 
risks would be negligible. Therefore, a cancer dietary exposure 
assessment is not necessary to assess cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for octylphenol ethoxylate. Tolerance level residues 
and/or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for octylphenol ethoxylate. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of octylphenol ethoxylate. Further information

[[Page 27448]]

regarding EPA drinking water models used in pesticide exposure 
assessment can be found at 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 parts per billion (ppb) 
to 41 ppb. Modeled chronic drinking water values ranged from 0.0002 ppb 
to 19 ppb. Further details of this drinking water analysis can be found 
at https://www.regulations.gov in the document ``Alkylphenol Ethoxylates 
(APEs - JITF CST 5 Inert Ingredients). Revised Human Health Risk 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations,'' 
p. 22 and Appendix C in docket ID number EPA-HQ-OPP-2008-0890.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for octylphenol ethoxylate, a conservative drinking water 
concentration value of 100 ppb based on screening level modeling was 
used to assess the contribution to drinking water for acute and chronic 
dietary risk assessments for the parent compounds and for the 
metabolites of concern. These values, which are 10 to 1,000 times 
greater than the highest levels of these substance seen in numerous 
surface and ground water monitoring studies, were directly entered into 
the acute and chronic dietary exposure models.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Octylphenol 
ethoxylate may be used as an inert ingredient in pesticide products 
that are registered for specific uses that may result in residential 
exposures. A screening level residential exposure and risk assessment 
was completed for pesticide products containing octylphenol ethoxylate 
as an inert ingredient. In this assessment, representative scenarios, 
based on end-use product application methods and labeled application 
rates, were selected. For each of the use scenarios, the Agency 
assessed residential handler (applicator) inhalation and dermal 
exposure for use scenarios with high exposure potential (i.e., exposure 
scenarios with high-end unit exposure values) to serve as a screening 
assessment for all potential residential pesticides containing 
octylphenol ethoxylate. Similarly, residential postapplication dermal 
and oral exposure assessments were also performed utilizing high-end 
exposure scenarios. In the case of octylphenol ethoxylate, non-dietary 
exposures are to octylphenol ethoxylate only as there is no appreciable 
metabolism or degradation of octylphenol ethoxylate in any of the 
representative residential use scenarios. Further details of this 
residential exposure and risk analysis can be found at 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.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found octylphenol ethoxylate to share a common 
mechanism of toxicity with any other substances, and octylphenol 
ethoxylate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that octylphenol ethoxylate does not have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at 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 pre-natal 
and post-natal toxicity and the completeness of the database on 
toxicity and exposure unless EPA determines based on reliable data that 
a different margin of safety will be safe for infants and children. 
This additional margin of safety is commonly referred to as the FQPA 
SF. In applying this provision, EPA either retains the default value of 
10X, or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Pre-natal and post-natal sensitivity. In the case of octylphenol 
ethoxylate, there was no increased susceptibility to the offspring of 
rats following pre-natal and post-natal exposure in the Harmonized 
Guideline 870.3650 combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test. The offspring 
effects (decreased body weight in male and female offspring) occurred 
at 300 mg/kg/day in the presence of maternal toxicity, which was 
manifested as clinical signs, decreased body-weight gain, increased 
liver weight and liver hypertrophy in males, and decreased thymus 
weight in females at 300 mg/kg/day. However, a study referenced in the 
petition (Hazelden and Wilson, 1986) suggests more severe developmental 
effects (supernumerary rib) following gestational exposure via the diet 
during gestation days 6-17. The Harmonized Guideline 870.3650 study did 
not include a skeletal examination of the offspring. Since the 
Harmonized Guideline 870.3650 study with octylphenol ethoxylate did not 
assess its impact on the estrogen system, it cannot be used alone to 
properly assess the most sensitive endpoint. However, selecting the POD 
from the Harmonized Guideline 870.3650 study, which is based on a NOAEL 
of 150 mg/kg/day and decreased body-weight gain in both sexes during 
the premating period, decreased thymus weight in females, and increased 
liver weight and liver hypertrophy in males at the LOAEL of 300 mg/kg/
day, and retaining the FQPA SF of 10X is comparable to using the POD 
from the reproduction studies on the most toxicologically potent 
compound (nonylphenol) that assessed estrogenic activity (endpoint: 
Accelerated vaginal opening; POD: 10 mg/kg/day). The endpoint 
(accelerated vaginal opening) and point of departure (10 mg/kg/day) are 
considered health protective of effects not assessed in the Harmonized 
Guideline 870.3650 studies on the octylphenol ethoxylate.

[[Page 27449]]

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

E. Aggregate Risks and Determination of Safety

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

[[Page 27450]]

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

V. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

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

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

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

[[Page 27451]]

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

VI. Conclusion

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

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. Section 180.910 is amended by adding alphabetically the following 
entry in the table of inert ingredients to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * ..................
[alpha]-[p-(1,1,3,3-              Not to exceed 7%    Surfactants,
 tetramethylbutyl)phenyl]-         of pesticide        related adjuvants
 [omega]-                          formulation.        of surfactants
 hydroxypoly(oxyethylene)          Expires May 17,
 produced by the condensation of   2012.
 1 mole of p-(1,1,3,3-
 tetramethylbutyl)phenol with a
 range of 1-14 or 30-70 moles of
 ethylene oxide: If a blend of
 products is use