Document ID: EPA-HQ-OPP-2009-0131-0007
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of Tolerance: Alkyl Alcohol Alkoxylate Phosphate Derivatives
Posted Date: 2010-08-20T04:00Z

[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Rules and Regulations]               
[Page 51382-51388]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au10-6]                         

[[Page 51382]]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0131; FRL-8836-5]

 
Alkyl Alcohol Alkoxylate Phosphate Derivatives; Exemption from 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of alkyl alcohol alkoxylate phosphate 
derivatives (AAAPD) when used under 40 CFR part 910 as an inert 
ingredient--surfactant and related adjuvants of surfactants for pre- 
and post-harvest uses and application to animals in pesticide 
formulations under 40 CFR part 930, limited to a maximum of 30% by 
weight in end-use products. The Joint Inerts Task Force (JITF), Cluster 
Support Team Number 2 (CST 2) submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment 
of an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of AAAPDs.

DATES: This regulation is effective August 20, 2010. Objections and 
requests for hearings must be received on or before October 19, 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-2009-0131. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Lisa Austin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7894; e-mail address: austin.lisa@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR cite at http://
www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines 
referenced in this document electronically, please go to http://
www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2009-0131 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 October 
19, 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-2009-0131, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of February 4, 2010 (75 FR 5793) (FRL-8807-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 9E7628) by the 
Joint Inerts Task Force, Cluster Support Team 2 (CST 2), 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 an exemption from the requirement of a tolerance for 
residues of AAAPDs when used as an inert ingredient surfactant and 
related adjuvants of surfactants in pesticide formulations applied to 
growing crops, raw agricultural commodities and food-producing animals 
limited to a maximum of 30% by weight in end-use

[[Page 51383]]

products for the [alpha]-alkyl (minimum C6 linear or 
branched, saturated and or unsaturated)-[omega]-hydroxypolyoxyethylene 
polymer with or without polyoxypropylene, mixture of di- and 
monohydrogen phosphate esters and the corresponding ammonium, calcium, 
magnesium, monoethanolamine, potassium, sodium and zinc salts of the 
phosphate esters; minimum oxyethylene content averages 2 moles; minimum 
oxypropylene content is 0 moles, including: Poly(oxy-1 ,2-ethanediyl), 
[alpha]-tridecyl- [omega] -hydroxy-, phosphate (9046-01-9); Poly(oxy-1 
,2-ethanediyl), [alpha]-dodecyl-[omega]-hydroxy-, phosphate (39464-66-
9); Poly(oxy-1 ,2-ethanediyl), [alpha]-hexadecyl-[omega]-hydroxy-, 
phosphate (50643-20-4); Poly(oxy-1 ,2-ethanediyl), [alpha]-decyl-
[omega]-hydroxy-, phosphate (52019-36-0); Poly(oxy-1 ,2-ethanediyl), 
[alpha]-hydro-[omega]-hydroxy-, mono-C12-15-alkyl ethers, 
phosphates (68071-35-2); Polyphosphoric acids, esters with polyethylene 
glycol decyl ether (68458-48-0); Poly(oxy-1 ,2-ethanediyl), [alpha]-
hydro-[omega]-hydroxy-, mono-C10-14-alkyl ethers, phosphates 
(68585-36-4); Poly(oxy-1,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-, 
mono-C12-15-branched alkyl ethers, phosphates (68815-11-2); 
Poly(oxy-1 ,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-, mono-
C10-12-alkyl ethers, phosphates (68908-64-5); Poly(oxy-1 ,2- 
ethanediyl), [alpha]-hydro-[omega]-hydroxy-, mono-C12-14-
aIkyl ethers, phosphates (68511-37-5); Poly(oxy-1 ,2-ethanediyl), 
[alpha]-hydro-[omega]-hydroxy-, mono-C8-10-alkyl ethers, 
phosphates (68130-47-2); Poly(oxy-1 ,2-ethanediyl), [alpha]-dodecyl-
[omega]-hydroxy-, phosphate, sodium salt (42612-52-2); Poly(oxy-1 ,2-
ethanediyl), [alpha]-dodecyl-[omega]-hydroxy-, phosphate, potassium 
salt (58318-92-6); Poly(oxy-1 ,2-ethanediyl), [alpha]-hexadecyl-
[omega]-hydroxy-, phosphate, potassium salt (60267-55-2); Poly(oxy-1 
,2-ethanediyl), [alpha]-decyl- [omega] hydroxy-, phosphate, potassium 
salt (68070-99-5); Poly(oxy-1,2-ethanediyl), [alpha]-tridecyl-[omega]-
hydroxy-, phosphate, potassium salt (68186-36-7); Poly(oxy1,2-
ethanediyl), [alpha]-decyl-[omega]-hydroxy-, phosphate, sodium salt 
(68186-37-8); Poly(oxy-1,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-, 
mono-C12-15-alkyl ethers, phosphates, sodium salts (68610-
65-1); Poly(oxy-1 ,2-ethanediyl), [alpha]-isodecyl- [omega]-hydroxy-, 
phosphate, potassium salt (68071-17-0); (branched C10) 
Poly(oxy-1,2-ethanediyl), [alpha]-phosphono-[omega]-[(2- 
propylheptyl)oxy]-, potassium salt (1:2) (936100-29-7); (branched 
C10) Poly(oxy-1,2-ethanediyl), [alpha]-phosphono-[omega]-
[(2-propylheptyl)oxy]-, sodium salt (1:2) (936100-30-0); Poly(oxy-1,2- 
ethanediyl), [alpha]-isotridecyl-[omega]-hydroxy-, phosphate (73038-25-
2); Poly(oxy-1 ,2- ethanediyl), [alpha]-hydro-[omega]-hydroxy-, mono-
C11-14-isoalkyl ethers, C13-rich, phosphates 
(78330-24-2); Poly(oxy-1 ,2-ethanediyl),[alpha]-hydro-[omega]-hydroxy-, 
mono(C10-rich C9-11-isoalkyl) ethers, phosphates 
(154518-39-5); Poly(oxy-1 ,2-ethanediyl), [alpha]-hydro-[omega]-
hydroxy-, mono-C12-14-sec-alkyl ethers, phosphates (317833-
96-8); Poly(oxy-1 ,2-ethanediyl), [alpha]-isodecyl-[omega]-hydroxy-, 
phosphate (108818-88-8); Poly(oxy-1, 2- ethanediyl), [alpha]-phosphono-
[omega]-[(2- propylheptyl)oxy] (873662-29-4); Poly(oxy-1, 2-
ethanediyl), [alpha]-dodecyl-[omega]-hydroxy-, phosphate, 
monoethanolamine salt (61837-79-4); Poly(oxy-1 ,2-ethanediyl), [alpha]-
tridecyl-[omega]-hydroxy-, phosphate monoethanolamine salt (68311-02-
4); Poly(oxy-1,2- ethanediyl), [alpha]-decyl-[omega]-hydroxy-, 
phosphate, monoethanolamine salt (68425-73-0); Oxirane, methyl-, 
polymer with oxirane, phosphate (37280-82-3); Oxirane, methyl-, polymer 
with oxirane, mono-C10-16-alkyl ethers, phosphates (68649-
29-6); Oxirane, methyl-, polymer with oxirane, phosphate, potassium 
salt (67711-84-6); and Oxirane, methyl-, polymer with oxirane, mono-
C10-16-alkyl ethers, phosphates, potassium salt (68891-13-
4). That notice referenced a summary of the petition prepared by The 
Joint Inerts Task Force (JITF), Cluster Support Team Number 2 (CST 2), 
the petitioner, which is available in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for AAAPDs including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with AAAPDs follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the

[[Page 51384]]

sensitivities of major identifiable subgroups of consumers, including 
infants and children. Specific information on the studies received and 
the nature of the adverse effects caused by AAAPDs as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this 
unit.
    The AAAPDs are not acutely toxic by the oral and dermal routes of 
exposure under normal use conditions; however, concentrated materials 
are generally moderate to severe eye and skin irritants and may be skin 
sensitizers. Following subchronic exposure to rats, gastrointestinal 
irritation (increased incidences of hyperplasia, submucosal edema, and 
ulceration) was observed, but no specific target organ toxicity or 
neurotoxicity was seen. No neurotoxicological effects were detected in 
a functional observational battery or a motor activity assessment. No 
reproductive effects were noted in the database. There was a 
qualitative increase in susceptibility to pups seen in a rat 
developmental/reproductive toxicity screening study; however, effects 
were seen only in one study and were in the presence of maternal 
toxicity. Further, a clear NOAEL was established for the developmental 
effects and this NOAEL is significantly higher than the toxicological 
points of departure selected for risk assessment. There are no 
carcinogenicity concerns based on structure activity modeling. Points 
of departure for chronic dietary, incidental oral, inhalation, and 
dermal exposure were selected from a 2-generation reproduction and 
fertility effects study in rats. The endpoint was decreased absolute 
and relative liver weights and increased incidence in the number of 
animals with minimal hepatocyte necrosis in males.
    Sufficient data were provided on the chemical identity of the 
AAAPDs; however, limited data are available on the metabolism and 
environmental degradation of these compounds. The Agency relied 
collectively on information provided on the representative chemical 
structures, the submitted physicochemical data, structure activity 
relationship (SAR) information, as well as information on other 
surfactants and chemicals of similar size and functionality to 
determine the residues of concern for the AAAPDs. The Agency has 
concluded that since metabolites and environmental degradates are not 
likely to be more toxic than the parent compounds, a risk assessment 
based on the parent compounds is not likely to underestimate risk.
    Specific information on the studies received and the nature of the 
adverse effects caused by the AAAPSDs as well as the NOAEL and the 
LOAEL from the toxicity studies can be found at http://
www.regulations.gov in the document ``Alkyl Alcohol Alkoxylate 
Phosphate and Sulfate Derivatives (AAAPDs and AAASDs-JITF CST 2 Inert 
Ingredients). Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide,'' pp. 11-17 in docket ID number EPA-HQ-OPP-
2009-0131.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction 
with the POD to calculate a safe exposure level - generally referred to 
as a population-adjusted dose (PAD) or a reference dose (RfD) - and a 
safe margin of exposure (MOE). For non-threshold risks, the Agency 
assumes that any amount of exposure will lead to some degree of risk. 
Thus, the Agency estimates risk in terms of the probability of an 
occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for AAADPs used for human 
risk assessment is discussed in Unit IV. of the final rule published in 
the Federal Register of July 29, 2009 (74 FR 37571) (FRL-8424-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to AAAPDs, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from AAAPDs in food as follows:
    i. Acute and chronic exposure. In conducting the acute and chronic 
dietary exposure assessments, EPA used food consumption information 
from the United States Department of Agriculture (USDA) 1994-1996 and 
1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, no residue data were submitted 
for the AAAPDs. In the absence of specific residue data EPA has 
developed an approach which uses surrogate information to derive upper 
bound exposure estimates for the subject inert ingredients. 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 dietary exposure and risk 
assessment can be found at http://www.regulations.gov in ``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 products rarely have a single inert 
ingredient; rather there is generally a combination of different inert 
ingredients used which additionally reduces the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient. In the case of AAAPDs, EPA made a specific 
adjustment to the dietary exposure assessment to account for the use 
limitations of the amount of AAAPDs that may be in formulations (to no 
more than 30% and assumed that the AAAPDs are present at the maximum 
limitation rather than at equal quantities with the active ingredient. 
This remains

[[Page 51385]]

a very conservative assumption because surfactants are generally used 
at levels far below this percentage. 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 AAAPDs.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100 percent of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient. In summary, 
EPA chose a very conservative method for estimating what level of inert 
residue could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data shows that tolerance level residues are typically one 
to two orders of magnitude higher than actual residues in food when 
distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    ii. 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. The Agency has not identified any 
concerns for carcinogenicity relating to the inerts AAAPDs. Therefore a 
cancer dietary exposure assessment is not necessary to assess cancer 
risk.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for AAAPDs. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for AAAPDs, a 
conservative drinking water concentration value of 100 parts per 
billion (ppb) based on screening level modeling was used to assess the 
contribution to drinking water for the chronic dietary risk assessments 
for parent compound. These values were directly entered into the 
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    AAAPDs are used as inert ingredients in pesticide products that are 
registered for specific uses that could result in indoor residential 
exposures and may have uses as inert ingredients in pesticide products 
that may result in outdoor residential exposures.
    A screening level residential exposure and risk assessment was 
completed for products containing AAAPDs 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 AAAPDs. Similarly, residential 
postapplication dermal and oral exposure assessments were also 
performed utilizing high-end exposure scenarios. Further details of 
this residential exposure and risk analysis can be found at http://
www.regulations.gov in 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.
    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 AAAPDs to share a common mechanism of toxicity 
with any other substances, and AAAPDs do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that AAAPDs do not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database 
consists of Harmonized Test Guideline OPPTS 870.3650 (combined repeated 
dose toxicity study with the reproduction/developmental toxicity 
screening test) studies in rats conducted with representative AAAPDs, 
as well as a 2-generation rat reproduction toxicity (Harmonized Test 
Guideline OPPTS 870.3800) study and a rat developmental toxicity study 
conducted with a representative AAASD.
    In one Harmonized Test Guideline OPPTS 870.3650 study conducted 
with a representative AAAPD, no increased susceptibility to the 
offspring of rats following prenatal and postnatal

[[Page 51386]]

exposure was observed. In a second Harmonized Test Guideline OPPTS 
870.3650 study conducted with another representative AAAPD, there was 
evidence of increased qualitative susceptibility as indicated by the 
increased number of stillborn pups and pups dying within lactation day 
(LD) 4/5 and clinical observations (coldness to the touch, discolored 
heads, and a lack of nesting behavior) at 800 milligrams/kilogram/day 
(mg/kg/day) where lesions in the forestomach and thymus atrophy was 
observed in the parental animals. However, this qualitative 
susceptibility seen in the Harmonized Test Guideline OPPTS 870.3650 
study does not indicate a heightened risk for infants and children 
because a clear NOAEL (200 mg/kg/day) was established for developmental 
effects and an additional margin of safety is provided since the point 
of departure selected from the 2-generation rat reproduction study for 
chronic exposure is 87 mg/kg/day.
    In a rat developmental study with AAASD, no maternal or 
developmental toxicity was observed at the limit dose. In the 2-
generation reproduction study with AAASD, the only significant effects 
observed were liver effects characterized by dose-related decrease in 
absolute and relative liver weight and an increased incidence in the 
number of animals with `minimal'' hepatocyte necrosis in males. No 
treatment-related effects were observed on reproduction or in the 
offspring.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for AAAPDs is considered adequate for 
assessing the risks to infants and children (the available studies are 
described in Unit IV.D.2.).
    ii. There is no indication that AAAPDs are neurotoxic chemicals and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. Although increased qualitative susceptibility was demonstrated 
in the offspring in a reproductive/developmental screening test portion 
of an Harmonized Test Guideline OPPTS 870.3650 study with another 
AAAPD, the Agency did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment of the AAAPDs.
    iv. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. The food exposure assessments are considered 
to be highly conservative as they are based on the use of the highest 
tolerance level from the surrogate pesticides for every food and 100 
PCT is assumed for all crops. EPA also made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to AAAPDs in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by AAAPDs.

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.
    In conducting this aggregate risk assessment, the Agency has 
incorporated the petitioner's requested use limitations of AAAPDs as 
inert ingredients in pesticide product formulations into its exposure 
assessment. Specifically the petition includes a use limitation of 
AAAPDs at not more than 30% by weight in pesticide formulations.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
AAAPDs are not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
AAAPDs from food and water will utilize 43% of the cPAD for children 1-
2 yrs old, the population group receiving the greatest exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    AAAPDs are currently used as an inert ingredient in pesticide 
products that are registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to AAAPDs.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 130 and 140, for 
adult males and females respectively, for a combined high-end dermal 
and inhalation handler exposure with a high-end postapplication dermal 
exposure and an aggregate MOE of 110 for children for a combined turf 
dermal exposure with hand-to-mouth exposure. Because EPA's level of 
concern for AAAPDs is a MOE of 100 or below, these MOEs are not of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    AAAPDs are currently used as an inert ingredient in pesticide 
products that are registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to AAAPDs.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 270 and 280, for adult males and females 
respectively, for a combined high-end dermal and inhalation handler 
exposure with a high-end postapplication dermal exposure and an MOE of 
110 for children for a combined high-end dermal exposure with hand-to-
mouth exposure. Because EPA's level of concern for AAAPDs are a MOE of 
100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack 
ofstructural alerts for carcinogenicity, AAAPDs are not expected to 
pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to AAAPDs residues.

[[Page 51387]]

V. Other Considerations

A. Analytical Enforcement Methodology

     EPA is establishing a limitation on the amount of AAAPDs that may 
be used in pesticide formulations. That limitation will be enforced 
through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. EPA will not register any pesticide for sale or distribution that 
contains greater than 30% of AAAPDs by weight in the end-use pesticide 
formulation.

B. International Residue Limits

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

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 and 40 CFR 180.930 for AAAPDs when 
used as an inert ingredient (surfactants, related adjuvants of 
surfactants) in pesticide formulations applied to raw agricultural 
commodities, growing crops, and animals.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the 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: August 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. In Sec.  180.910, the table is amended by adding alphabetically the 
following 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]-alkyl (minimum C6 linear  Not to exceed 30%   Surfactants,
 or branched, saturated and or     of pesticide        related adjuvants
 unsaturated)-[omega]-             formulation         of surfactants
 hydroxypolyoxyethylene polymer
 with or without
 polyoxypropylene, mixture of di-
  and monohydrogen phosphate
 esters and the corresponding
 ammonium, calcium, magnesium,
 monoethanolamine, potassium,
 sodium and zinc salts of the
 phosphate esters; minimum
 oxyethylene content averages 2
 moles; minimum oxypropylene
 content is 0 moles (CAS Reg.
 Nos. 9046-01-9, 39464-66-9,
 50643-20-4, 52019-36-0, 68071-
 35-2, 68458-48-0, 68585-36-4,
 68815-11-2, 68908-64-5, 68511-
 37-5, 68130-47-2, 42612-52-2,
 58318-92-6, 60267-55-2, 68070-
 99-5, 68186-36-7, 68186-37-8,
 68610-65-1, 68071-17-0, 936100-
 29-7, 936100-30-0, 73038-25-2,
 78330-24-2, 154518-39-5, 317833-
 96-8, 108818-88-8, 873662-29-4,
 61837-79-4, 68311-02-4, 68425-
 73-0, 37280-82-3, 68649-29-6,
 67711-84-6, 68891-13-4.

[[Page 51388]]

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

* * * * *

0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-alkyl (minimum C6 linear  Not to exceed 30%   Surfactants,
 or branched, saturated and or     of pesticide        related adjuvants
 unsaturated)-[omega]-             formulation         of surfactants
 hydroxypolyoxyethylene polymer
 with or without
 polyoxypropylene, mixture of di-
  and monohydrogen phosphate
 esters and the corresponding
 ammonium, calcium, magnesium,
 monoethanolamine, potassium,
 sodium and zinc salts of the
 phosphate esters; minimum
 oxyethylene content averages 2
 moles; minimum oxypropylene
 content is 0 moles (CAS Reg.
 Nos. 9046-01-9, 39464-66-9,
 50643-20-4, 52019-36-0, 68071-
 35-2, 68458-48-0, 68585-36-4,
 68815-11-2, 68908-64-5, 68511-
 37-5, 68130-47-2, 42612-52-2,
 58318-92-6, 60267-55-2, 68070-
 99-5, 68186-36-7, 68186-37-8,
 68610-65-1, 68071-17-0, 936100-
 29-7, 936100-30-0, 73038-25-2,
 78330-24-2, 154518-39-5, 317833-
 96-8, 108818-88-8, 873662-29-4,
 61837-79-4, 68311-02-4, 68425-
 73-0, 37280-82-3, 68649-29-6,
 67711-84-6, 68891-13-4.
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-20708 Filed 8-19-10; 8:45 am]
BILLING CODE 6560-50-S