Document ID: EPA-HQ-OPP-2009-0131-0003
Agency: epa
Document Type: Rule
Title: Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives; Exemption From the Requirement of a Tolerance
Posted Date: 2009-07-29T04:00Z

[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]               
[Page 37571-37578]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy09-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0131; FRL-8424-6]

 
Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives; 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of alkyl alcohol alkoxylate phosphate 
derivatives when used as inert ingredients in growing crops under 40 
CFR 180.920 and for residues of alkyl alcohol alkoxylate sulfate 
derivatives when used as inert ingredients in pesticide formulations 
applied to growing crops, raw agricultural commodities after harvest, 
and animals under 40 CFR 180.910 and 40 CFR 180.930. 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 an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of alkyl alcohol alkoxylate phosphate and sulfate 
derivatives.

DATES: This regulation is effective July 29, 2009. Objections and 
requests for hearings must be received on or before September 28, 2009, 
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: 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 those 
engaged in the following activities:
     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 to 
provide 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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. 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 requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before September 28, 2009.
    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 this copy, 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. Background

    In the Federal Register of April 15, 2009 (74 FR 17487) (FRL-8409-
7), 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 
9E7533) by JITF, CST 2, c/o CropLife America, 1156 15\th\ St., NW., 
Suite 400, Washington, DC 20005, The petition requested that 40 CFR 
180.910, 40 CFR 180.920, and 40 CFR 180.930 be amended by establishing 
exemptions from the

[[Page 37572]]

requirement of a tolerance for residues of various alkyl alcohol 
alkoxylate phosphate and sulfate derivatives when used as inert 
ingredients in pesticide formulations applied to raw agricultural 
commodities, growing crops, and animals. The petition specifically 
requested the establishment of an exemption from the requirement of a 
tolerance under 40 CFR 180.920 for residues of [alpha]-alkyl (minimum 
C6 linear, branched, saturated and/or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer with or without polyoxypropylene, 
mixture of di- and monohydrogen phosphateesters and the corresponding 
ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and 
zinc salts of the phosphate esters; minimum oxyethylene content is 2 
moles; minimum oxypropylene content is 0 moles (Chemical Abstract 
Service Registry numbers (CAS 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); and the establishment of an exemption from 
the requirement of a tolerance under 40 CFR 180.910 and 40 CFR 180.930 
for residues of [alpha]-alkyl(C6-C15)-[omega]-
hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, 
potassium, sodium, and zinc salts, poly(oxyethylene) content averages 
2-4 moles (CAS Nos. 9004-82-4, 68585-34-2, 68891-38-3, 9004-84-6, 
13150-00-0, 26183-44-8, 68611-55-2, 68511-39-7, 3088-31-1, 9004-82-4, 
25446-78-0, 32612-48-9, 50602-06-7, 62755-21-9, 68424-50-0, 73665-22-
2). For ease of reading, the alkyl alcohol alkoxylate phosphate and 
sulfate derivatives are referred to throughout this document as AAAPDs 
and AAASDs respectively, and collectively as AAAPSDs. That notice 
referenced a summary of the petition prepared by JITF, CST 2, the 
petitioner which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    This petition, which also included a limitation of the 
concentration of alkyl alcohol alkoxylate phosphate and sulfate 
derivatives to not exceed 30% by weight of the pesticide formulation, 
was submitted in response to a final rule of August 9, 2006 (71 FR 
45415) (FRL-8084-1) in which the Agency revoked, under FFDCA section 
408(e)(1) 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 FFDCA section 
408(b)(2). The expiration date for the tolerance exemptions subject to 
revocation was August 9, 2008, which was later extended to August 9, 
2009, by a document published in the Federal Register issue of August 
4, 2008 (73 FR 45312) (FRL-8372-7) to allow for data to be submitted to 
support the establishment of tolerance exemptions for these inert 
ingredients prior to the effective date of the tolerance exemption 
revocation.

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. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide chemical residues. First, EPA 
determines the toxicity of pesticide chemicals. Second, EPA examines 
exposure to the pesticide chemical through food, drinking water, and 
through other exposures that occur as a result of the pesticide 
chemical use in residential settings.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 the petitioned-for exemption 
from the requirement of a tolerance for residues of AAAPSDs when used 
as inert ingredients in pesticide formulations applied to growing 
crops, raw agricultural commodities and food-producing animals. EPA's 
assessment of exposures and risks associated with establishing 
tolerances 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.
    The AAAPSDs 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 no-observed-adverse-effect-level (NOAEL) was

[[Page 37573]]

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 
AAAPSDs; 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 AAAPSDs. 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 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in 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, pages 11-17 in docket ID number EPA-HQ-
OPP-2009-0131.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that 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 AAAPSDs used for human 
risk assessment is shown in Table 1 of this unit.

       Table 1.--Summary of Toxicological Doses and Endpoints for AAAPSDs 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                             No appropriate endpoint was identified for acute dietary assessment
 (all populations)...................
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 87 millgrams/     Chronic RfD = 0.87 mg/   Reproduction/fertility
(all populations)....................   kilograms/day (mg/kg/    kg/day                   effects in male rats
                                        day)                    cPAD = 0.87 mg/kg/day..   (Master Record
                                       UFA = 10x..............                            Identification number
                                       UFH = 10x..............                            (MRID) 47060903))
                                       FQPA SF = 1x...........                           LOAEL = 223 mg/kg/day
                                                                                          based on a dose-
                                                                                          related decrease in
                                                                                          absolute and relative
                                                                                          liver weight and an
                                                                                          increased incidence in
                                                                                          the number of animals
                                                                                          with ``minimal''
                                                                                          hepatocyte necrosis in
                                                                                          males in the high-dose
                                                                                          group compared to
                                                                                          control group
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term             NOAEL= 87 mg/kg/day      LOC for MOE = 100......  Reproduction/fertility
(1 to 30 days) and intermediate-term   UFA = 10x..............                            effects in male rats
 (1 to 6 months).                      UFH = 10x..............                            (MRID 47060903)
                                       FQPA SF = 1x...........                           LOAEL = 223 mg/kg/day
                                                                                          based on a dose-
                                                                                          related decrease in
                                                                                          absolute and relative
                                                                                          liver weight and an
                                                                                          increased incidence in
                                                                                          the number of animals
                                                                                          with ``minimal''
                                                                                          hepatocyte necrosis in
                                                                                          males in the high-dose
                                                                                          group compared to
                                                                                          control group
----------------------------------------------------------------------------------------------------------------

[[Page 37574]]

Dermal and inhalation                  Oral study NOAEL = 87    LOC for MOE = 100        Reproduction/fertility
(all durations)......................   mg/kg/day (dermal                                 effects in male rats
                                        absorption rate = 5%                              (MRID 47060903)
                                        (inhalation absorption                           LOAEL = 223 mg/kg/day
                                        rate = 100%)                                      based on a dose-
                                       UFA = 10x..............                            related decrease in
                                       UFH = 10x..............                            absolute and relative
                                       FQPA SF = 1x...........                            liver weight and an
                                                                                          increased incidence in
                                                                                          the number of animals
                                                                                          with ``minimal''
                                                                                          hepatocyte necrosis in
                                                                                          males in the high-dose
                                                                                          group compared to
                                                                                          control group.
----------------------------------------------------------------------------------------------------------------
Cancer                                    Classification: No animal toxicity data available for an assessment;
(oral, dermal, inhalation)...........      based on SAR analysis, AAAPSDs are not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a =
  acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to AAAPSDs, EPA considered exposure under the petitioned-for 
exemptions from the requirement of a tolerance. EPA assessed dietary 
exposures from AAAPSDs 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 AAAPSDs. 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 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 in comparison with the active 
ingredient. In the case of AAAPSDs, EPA made a specific adjustment to 
the dietary exposure assessment to account for the use limitations of 
the amount of AAAPSDs that may be in formulations (no more than 30%) 
and assumed that the AAAPSDs are at the maximum limitations rather than 
at equal quantities with the active ingredient. This remains a very 
conservative assumption because surfactants are generally used at 
levels far below these percentages. For example, EPA examined several 
of the pesticide products associated with the tolerance/commodity 
combination which are the driver of the risk assessment and found that 
these products did not contain surfactants at levels greater than 2.25% 
and that none of the surfactants were AAAPSDs.
    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 sum, EPA chose a 
very conservative method for estimating what level of inert 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.
    ii. Cancer. The Agency used a qualitative SAR database, DEREK11, to 
determine if there were structural alerts for potential carcinogenicity 
of a

[[Page 37575]]

representative AAAPSD. No structural alerts for carcinogenicity were 
identified and the AAAPSDs are not expected to be carcinogenic. 
Therefore a quantitative cancer exposure assessment is not necessary to 
assess cancer risk.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue or PCT information in 
the dietary assessment for AAAPSDs. Tolerance level residues 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 AAAPSDs in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of AAAPSDs. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
http://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) was 
performed to calculate the estimated drinking water concentrations 
(EDWCs) of AAAPSDs. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of the AAAPSDs were conducted. Modeled acute drinking water values 
ranged from 0.001 parts per billion (ppb) to 41 ppb. Modeled chronic 
drinking water values ranged from 0.0002 ppb to 19 ppb. Further details 
of this drinking water analysis can be found at http://
www.regulations.gov in document Alkyl Amine Polyalkoxylates (JITF CST 4 
Inert Ingredients). Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations, pages 18 and 70-72 in docket ID 
number EPA-HQ-OPP-2008-0738.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for AAAPSDs, a conservative drinking water concentration 
value of 100 ppb based on screening level modeling was used to assess 
the contribution to drinking water for both the acute and chronic 
dietary risk assessments. 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., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). AAAPSDs 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 AAAPSDs 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 AAAPSDs. 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 AAAPSDs to share a common mechanism of toxicity 
with any other substances, and AAAPSDs do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that AAAPSDs do not have a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA 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 OPPTS Harmonized Guideline 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 (OPPTS Harmonized Guideline 
870.3800) study and a rat developmental toxicity study conducted with a 
representative AAASD.
    In an OPPTS Harmonized Guideline 870.3650 study conducted with a 
representative AAAPD, no increased susceptibility to the offspring of 
rats following prenatal and postnatal exposure was observed. In a 
second OPPTS Harmonized Guideline 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 mg/kg/day where lesions in the forestomach and thymus 
atrophy was observed in the parental animals. However, this qualitative 
susceptibility seen in the OPPTS Harmonized Guideline 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

[[Page 37576]]

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.
    There are no residual uncertainties identified in the exposure 
databases. The food exposure assessments are considered to be 
conservative. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children.
    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 AAAPSDs is considered adequate for 
assessing the risks to infants and children (the available studies are 
described in Unit IV.D.2.).
    ii. No susceptibility was demonstrated in the offspring in the 
reproductive/developmental screening test portion of an OPPTS 
Harmonized Guideline 870.3650 study with one AAAPD following prenatal 
and postnatal exposure at 800 mg/kg/day.
    iii. Although increased qualitative susceptibility was demonstrated 
in the offspring in a reproductive/developmental screening test portion 
of an OPPTS Harmonized Guideline 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 AAAPSDs.
    iv. There is no indication that AAAPSDs are neurotoxic chemicals 
and thus there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    v. 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 AAAPSDs 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 AAAPSDs.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    In conducting this aggregate risk assessment, the Agency has 
incorporated the petitioner's requested use limitations of AAAPSDs as 
inert ingredients in pesticide product formulations into its exposure 
assessment. Specifically the petition includes a use limitation of 
AAAPSDs at not more than 30% by weight in pesticide formulations.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effects attributable to a single exposure to 
the AAAPSDs were seen in the toxicity databases, therefore, AAAPSDs are 
not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for chronic exposure, and the use limitations of not more than 30% by 
weight in pesticide formulations, the chronic dietary exposure from 
food and water to AAAPSDs is 13% of the cPAD for the U.S. population 
and 43% of the cPAD for children 1-2 yrs old, the most highly exposed 
population subgroup.
    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).
    AAAPSDs are used as inert ingredients in pesticide products that 
are currently 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 AAAPSDs.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated 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.
    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).
    AAAPSDs are used as inert ingredients in pesticide products that 
are currently 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 AAAPSDs.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded the combined 
intermediate-term food, water, and residential exposures aggregated 
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.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
structural alerts for carcinogenicity, AAAPSDs 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 residues of AAAPSDs.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes 
since the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

[[Page 37577]]

B. International Residue Limits

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

VI. Conclusion

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of AAAPDs when used as inert ingredients in 
pesticide formulations applied to growing crops only under 40 CFR 
180.920 and residues of AAASDs when used as inert ingredients in raw 
agricultural commodities, growing crops, and animals under 40 CFR 
180.910, 40 CFR 180.920, and 40 CFR 180.930.

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: July 20, 2009.
G. Jeffrey Herndon,
Acting 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(C6-C15)-[omega]-    Not to exceed 30%   Surfactants,
 hydroxypoly(oxyethylene)sulfate   of pesticide        related adjuvants
 , and its ammonium, calcium,      formulation.        of surfactants
 magnesium, potassium, sodium,
 and zinc salts,
 poly(oxyethylene) content
 averages 2-4 moles (CAS Reg.
 Nos. 3088-31-1, 9004-82-4, 9004-
 84-6, 13150-00-0, 25446-78-0,
 26183-44-8, 32612-48-9, 50602-
 06-7, 62755-21-9, 68424-50-0,
 68511-39-7, 68585-34-2, 68611-
 55-2, 68891-38-3, 73665-22-2).
                                * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

[[Page 37578]]

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
[alpha]-Alkyl (minimum C6         Not to exceed 30%   Surfactants,
 linear, branched, saturated and/  of pesticide        related adjuvants
 or 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 is 2 moles;
 minimum oxypropylene content is
 0 moles (CAS Reg. Nos. 9046-01-
 9, 37280-82-3, 39464-66-9,
 42612-52-2, 50643-20-4, 52019-
 36-0, 58318-92-6, 60267-55-2,
 61837-79-4, 67711-84-6, 68070-
 99-5, 68071-35-2, 68071-17-0,
 68130-47-2, 68186-37-8, 68186-
 36-7, 68311-02-4, 68425-73-0,
 68458-48-0, 68511-37-5, 68610-
 65-1, 68585-36-4, 68649-29-6,
 68815-11-2, 68908-64-5, 68891-
 13-4, 73038-25-2, 78330-24-2,
 108818-88-8, 154518-39-5,
 317833-96-8, 873662-29-4,
 936100-29-7, 936100-30-0).
                                * * * * *
------------------------------------------------------------------------

0
4. 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(C6-C15)-[omega]-    Not to exceed 30%   Surfactants,
 hydroxypoly(oxyethylene)sulfate   of pesticide        related adjuvants
 , and its ammonium, calcium,      formulation.        of surfactants
 magnesium, potassium, sodium,
 and zinc salts,
 poly(oxyethylene) content
 averages 2-4 moles (CAS Reg.
 Nos. 3088-31-1, 9004-82-4, 9004-
 84-6, 13150-00-0, 25446-78-0,
 26183-44-8, 32612-48-9, 50602-
 06-7, 62755-21-9, 68424-50-0,
 68511-39-7, 68585-34-2, 68611-
 55-2, 68891-38-3, 73665-22-2).
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-18033 Filed 7-28-09; 8:45 am]

BILLING CODE 6560-50-S