[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37598-37605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17957]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0665; FRL-8421-7]


Sodium monoalkyl and dialkyl (C6-C16) 
phenoxybenzenedisulfonates and related acids; Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Sodium monoalkyl and dialkyl 
(C6-C16) phenoxybenzenedisulfonates and related 
acids, often known as the ``alkyldiphenyl oxide sulfnates'', herein 
referred to in this document as ADPOS, when used as inert ingredients 
at a maximum of 20% by weight in pesticide formulations for pre-harvest 
and post-harvest use under 40 CFR 180.910, as well as for application 
to animals under 40 CFR 180.930. Dow AgroSciences, LLC, 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 ADPOS.

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-2008-0665. 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: [email protected].

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 part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

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-2008-0665 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-2008-0665, 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.

[[Page 37599]]

II. Background

    In the Federal Register of October 8, 2008 (73 FR 58962) (FRL-8383-
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 
8E7372) by Dow AgroSciences, LLC, 9330 Zionsville Rd., Indianapolis, IN 
46268. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be 
amended by establishing exemptions from the requirement of a tolerance 
for residues of the inert ingredient ADPOS at a maximum of 20% by 
weight in pesticide formulations. That notice referenced a summary of 
the petition prepared by Dow AgroSciences, LLC, the petitioner, which 
is available to the public in the docket, http://www.regulations.gov.
    The Agency received only one comment in response to the notice of 
filing. One comment was received from a private citizen who opposed the 
authorization to sell any pesticide that leaves a residue on food. The 
Agency understands the commenter's concerns and recognizes that some 
individuals believe that no residue of pesticides should be allowed. 
However, under the existing legal framework provided by section 408 of 
the Federal Food, Drug and Cosmetic Act (FFDCA), EPA is authorized to 
establish pesticide tolerances or exemptions where persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute.
    This petition was submitted in response to a final rule of August 
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under 
section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
the existing exemptions from the requirement of a tolerance for 
residues of certain inert ingredients because of insufficient data to 
make the determination of safety required by 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 (73 FR 
45312) 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 residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
exemption from the requirement of a tolerance for residues of ADPOS 
when used as inert ingredients at a maximum of 20% by weight in 
pesticide formulations for pre-harvest and post-harvest use, as well as 
for application to 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 available mammalian toxicology database includes acute, 
subchronic repeat dose oral, reproductive/developmental screening 
tests, chronic rat and dog studies and mutagenicity data for four 
representative compounds of the C6 to C16 ADPOS 
group. The Agency concluded that the four surrogate chemicals (CAS Reg. 
Nos. 147732-60-3, 39354-74-0, 119345-04-9 (alternate CAS Reg. No. 
28519-02-0), and 70191-76-3) are representative of all the chemicals in 
the ADPOS cluster. Additionally, the Agency concluded that the 
currently available toxicity dataset is adequate to apply to the ADPOS 
inerts and to characterize these surfactants. Further, the Agency noted 
that there was sufficient bracketing of the range of molecular weights 
expected from the inerts in this grouping.
     The ADPOS inerts are not acutely toxic by the oral, dermal, and 
inhalation routes of exposure, and are moderately irritating to the 
skin and eyes. Respiratory irritation is possible with mists. The ADPOS 
inerts, like all surfactants, are surface-active materials that can 
damage the structural integrity of cellular membranes at high dose 
levels. Thus, surfactants are often corrosive and irritating in 
concentrated solutions, as indicated by the acute toxicity studies for 
these inert materials. It is possible that some of the observed 
toxicity seen in the repeated studies, such as diarrhea, 
gastrointestinal tract effects or decreased body weight gain, can be 
attributed to the corrosive and irritating nature of these surfactants. 
The liver and possibly kidney appear to be the primary target organs. 
Following subchronic exposures to ADPOS inerts, the most sensitive 
effects include increased liver enzymes (alanine and aspartate 
aminotransferase), increased prothrombin time and soft/decreased feces 
in males and significant decreases in body weight gain in both sexes 
after 47-54 days of dosing at doses between 28 and 92 mg/kg/day. In 
comparison, in most of the other studies, no effects were observed in 
the range of 100 to 500

[[Page 37600]]

mg/kg/day, even following chronic exposures. There is some evidence of 
neurotoxicity in a 28-day rat study, including high-stepping gait, 
ataxia and salivation; however, these effects are seen at the highest 
dose tested (HDT). The Agency considered these effects to be the result 
of a high dose rather than a neurotoxic condition. No quantitative or 
qualitative increased susceptibility was demonstrated in the offspring 
in the two reproductive/developmental toxicity studies in rats 
following in utero and postnatal exposure. In one OPPTS Harmonized 
Guideline 870.3650 study there were no developmental effects at the HDT 
in the presence of maternal toxicity such as increased liver enzymes 
and prothrombin time. In a second OPPTS Harmonized Guideline 870.3650 
study with test substance (CAS Reg. No. 147732-60-3) the developmental 
effects were manifested as statistically significantly decrease in body 
weight and clinical signs at 1,000 mg/kg which was in the presence 
severe maternal toxicity which manifested as mortality, clinical signs, 
and decrease in body weight were observed.
     There is no evidence that the ADPOS inerts are mutagenic, but 
there is some evidence of potential clastogenicity for a C6 
inert formulation. In vitro data for genotoxicity are available for the 
range of alkyl chains of the lower (C6) and upper 
(C16) compounds in this group. The Ames tests were negative 
for the C6 and C16 inerts. The C16 
analogue was negative in the CHO/HGPRT forward mutation assay. In 
chromosomal aberration tests that evaluate clastogenicity, 
C6 (CAS Reg. No. 147732-60-3) was clastogenic in human 
lymphocytes in the absence of metabolic activation (S9), but was 
negative in rat lymphocytes. The registrants attributed this positive 
response to peroxide as an unwanted constituent, and no longer use 
peroxide in the ADPOS process. C16 was negative in both 
human and rat lymphocytes, although the human lymphocyte study was not 
acceptable. In vivo, there was no evidence of a cytogenetic response in 
rat bone marrow cells for C16 (CAS Reg. No. 70191-76-3) in 
an unacceptable study that lacked positive controls, which limits the 
confidence of this finding. Based on these studies and the overall 
weight of the evidence, the Agency concluded that the ADPOS inerts are 
not likely to be mutagenic. There is no evidence of carcinogenicity in 
the chronic/carcinogenicity rat study at does up to 500 mg/kg/day. In 
addition, no tumors were observed in the two year toxicity study in 
dogs. Based on the negative response for carcinogenicity in the 
carcinogenicity study in rats and two year dog study, negative response 
for mutagenicity, lack of any alerts in model predictions, and SAR 
analysis, the Agency concluded that the ADPOS inerts are not likely to 
be carcinogenic.
    Specific information on the studies received and the nature of the 
adverse effects caused by ADPOS as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Alkyl Diphenyl Oxide Sulfonates (JITF 
CST 18 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 9-15 in docket ID 
number EPA-HQ-OPP-2008-0665.

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 ADPOS used for human 
health risk assessment is shown in the Table of this unit.

     Table --Summary of Toxicological Doses and Endpoints for ADPOS for Use in Human Health Risk Assessment
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                                        Point of Departure and
          Exposure Scenerio               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assesment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          NOAEL=115 milligrams/    Acute RfD=1.15 mg/kg/    28-day oral toxicity
(General Population, including          kilograms/day (mg/kg/    day                      study- rats (CAS No.
 Infants and Children).                 day) UFA=10x            aPAD=1.15 mg/kg/day....   70191-76-3)
                                       UFH=10x................                           LOAEL= 367 mg/kg/day,
                                       FQPA SF=1x.............                            based on Post-dosing
                                                                                          salivation (day 1 post-
                                                                                          dose in 3/5 male and 2/
                                                                                          5 female rats; 2-28
                                                                                          all rats.)
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[[Page 37601]]

 
Chronic Dietary                        NOAEL=28 mg/kg/day       Chronic RfD=0.28 mg/kg/  Reproductive/
(all populations)....................   UFA=10x                  day                      developmental- rat(CAS
                                       UFH=10x................  cPAD=0.28 mg/kg/day....   No. 70191-76-3)
                                       FQPA SF=1x.............                           LOAEL= 92 mg/kg/day,
                                                                                          based on increasted
                                                                                          ALT and AST in
                                                                                          females, increased
                                                                                          prothrombin time and
                                                                                          soft/decrease feces in
                                                                                          males and significant
                                                                                          decreased feces in
                                                                                          males and significant
                                                                                          decreased in body
                                                                                          weight gain in both
                                                                                          sexes after 47-54 days
                                                                                          of dosing.
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Short-Term                             NOAEL=115 mg/kg/day      Residential/             28-day oral toxicity
(1-30 days Incidental Oral/Dermal/      UFA=10x                  Occupational LOC for     study- rats(CAS No.
 Inhalation).                          UFH=10x................   MOE=100                  70191-76-3)
                                       FQPA SF=1x.............                           LOAEL= 367 mg/kg/day,
                                                                                          based on ost-dosing
                                                                                          salvation (day 1 post-
                                                                                          dose in 3/5 male and 2/
                                                                                          5 female rats; days 2-
                                                                                          28 all rats).
----------------------------------------------------------------------------------------------------------------
Intermediate and Long-Term (1-6        NOAEL=28 mg/kg/day       Residential/             Reproductive/
 months/>6months                        UFA=10x                  Occupational LOC for     developmental- rat(CAS
Incidental Oral/Dermal/Inhalation....  UFH=10x................   MOE= 100                 No. 70191-76-3)
                                       FQPA SF=1x.............                           LOAEL= 92 mg/kg/day,
                                                                                          based on increasted
                                                                                          ALT and AST in
                                                                                          females, increased
                                                                                          prothrombin time and
                                                                                          soft/decreased feces
                                                                                          in males and
                                                                                          significant decreased
                                                                                          feces in males and
                                                                                          significant decreased
                                                                                          in body weight gain in
                                                                                          both sexes after 47-54
                                                                                          days of dosing.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Classification: no
                                        edivence of
                                        carcinogenicity in
                                        available studies
----------------------------------------------------------------------------------------------------------------
1The LOAEL of 367 mg/kg/day was used from MRID 46989217 and NOAEL of 115 mg/kg/day was used from MRID 46989216
  due to artifact of dose selection. Point of Departure (POD) = A data point or an estimated point that is
  derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk
  associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level.
  LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to
  human (interspecies). UFH = potential variation in sensitivity among members of the human population
  (intraspecies). PAD = population adjusted dose (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ADPOS, EPA considered exposure under the petitioned-for 
exemptions from the requirement of a tolerance. EPA assessed dietary 
exposures from ADPOS 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 ADPOS inert ingredients. 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 general 
approach taken to assess inert ingredient risks in the absence of 
residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov 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 is 
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 ADPOS, EPA made a specific 
adjustment to the dietary exposure assessment to account for the use 
limitations of the amount of ADPOS that

[[Page 37602]]

may be in formulations (no more than 20% by weight) and assumed that 
the ADPOS are present 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 
this percentage.
    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. There is no evidence of 
carcinogenicity in the chronic/carcinogenicity study in rats at doe up 
to 500 mg/kg/day. In addition, no tumors were observed in the two year 
toxicity study in dogs. Based on the negative response of the 
carcinogenicity study in rats and two year dog study, negative response 
for mutagenicity, lack of any alerts in model predictions, and SAR 
analysis, the Agency concluded that the ADPOS inerts are not likely to 
be carcinogenic. Since the Agency has not identified any concerns for 
carcinogenicity relating to the ADPOS inerts, a cancer dietary exposure 
assessment was not performed.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for ADPOS. Tolerance level residues and/or 
100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for ADPOS in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of ADPOS. 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 ADPOS. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of the ADPOS 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 Diphenyl Oxide Sulfonates (JITF CST 18 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 16 and 71-73 in docket ID 
number EPA-HQ-OPP-2008-0665.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for ADPOS, 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). ADPOS may be used in 
inert ingredients in pesticide products that are registered for 
specific uses that may result in both indoor and outdoor residential 
exposures. A screening level residential exposure and risk assessment 
was completed for products containing ADPOS as inert ingredients. In 
this assessment, representative scenarios, based on end-use product 
application methods and labeled application rates, were selected.The 
ADPOS inerts are not added to any insecticidal products intended for 
pet use and are not likely to be used in personal care products. The 
Agency conducted an assessment to represent worst-case residential 
exposure by assessing ADPOS in pesticide formulations (outdoor 
scenarios) and ADPOS in disinfectant type uses (indoor scenarios). 
Based on information contained in the petition, the ADPOS inerts can be 
present in consumer cleaning products. Therefore, the Agency assessed 
the disinfectant-type products containing ADPOS using several anti-
microbial scenarios to represent worst-case residential handler 
exposure. Standard methodologies based on the Agency's Residential SOPs 
were used to assess residential post application exposure to hard 
surfance cleaners.
    Further details of this residential exposure and risk analysis can 
be found at http://www.regulations.gov in ``Alkyl Diphenyl Oxide 
Sulfonates (JITF CST 18 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 20-28 and 94-110 in docket ID number EPA-HQ-OPP-2008-0665.
    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 ADPOS to share a common mechanism of toxicity 
with any other substances, and ADPOS do not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that ADPOS

[[Page 37603]]

do not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The toxicity database 
consists of two rat reproductive/developmental screening studies. There 
was no increased susceptibility to the offspring of rats following in 
utero or postnatal exposure in the two reproductive/developmental 
toxicity screening tests, In one study, there were no adverse effects 
to offspring, while decreased pup body weight and clinical signs were 
noted in the presence of maternal/parental toxicity at the limit dose 
of 1,000 mg/kg/day in a second study.
    There are no neurotoxicity studies available for the ADPOS, 
however, there is some evidence of neurotoxicity in a subchronic rat 
study at 367 mg inert/kg/day (1,000 mg product/kg/day), including high-
stepping gait, ataxia and salivation. However, since the effects noted 
occurred at doses significantly higher than the current points of 
departure for risk assessment, additional neurotoxicity data is not 
required.
    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 ADPOS is considered adequate for 
assessing the risks to infants and children (the available studies are 
described in Unit iv.D.2.
    ii. There is some evidence of neurotoxicity in a 28-day rat study, 
including high-stepping gait, ataxia and salivation; however, these 
effects are seen at the HDT. Since these effects occurred at dose 
levels significantly higher than the current points of departure used 
for regulation, the Agency determined that the points of departure 
selected for this risk assessment are protective of any neurotoxicity 
effects. Therefore, additional neurotoxicity data and other toxicity 
data are not required.
    iii. No quantitative or qualitative increased susceptibility was 
demonstrated in the offspring in the two reproductive/developmental 
toxicity studies in rats following in utero and postnatal exposure.
    iv. The Agency has concluded that an additional UF for 
extrapolation from subchronic toxicity study to a chronic exposure 
scenario would not be needed since toxicity is not expected to increase 
with a longer duration of exposure for the ADPOS inerts. This is 
because for the most sensitive endpoint, prothrombin time (PT), the 
clotting factor proteins evaluated by the PT test have short plasma 
half-lives, ranging from 4 hours for factor VII to a maximum of 96 
hours for fibrinogen. The clotting factors are being continually 
synthesized by the liver and by 47 days of exposure would have reached 
steady state and further exposure is not expected to result in any 
further increase in prothrombin time. Therefore, the Agency concluded 
that the 10X interspecies and 10X intraspecies UF would be adequately 
protective.
    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 ADPOS in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by ADPOS.

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 ADPOS as 
inert ingredients in pesticide product formulations into its exposure 
assessment. Specifically, the petition includes a use limitation of 
ADPOS at not more than 20% 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. Using the exposure assumptions discussed in this unit 
for acute exposure, and the use limitations of not more than 20% by 
weight in pesticide formulations, the acute dietary exposure from food 
and water to ADPOS at the 95th percentile for food and drinking water 
is 20% of the aPAD for the U.S. population and 55% of the aPAD for 
children 1-2 yrs old, the population group receiving the greatest 
exposure.
    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 20% by 
weight in pesticide formulations, the chronic dietary exposure from 
food and water to ADPOS is 28% of the cPAD for the U.S. population and 
90% 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).
     ADPOS inerts 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 ADPOS. Using the exposure 
assumptions described in this

[[Page 37604]]

unit, EPA has concluded the combined short-term food, water, and 
residential exposures aggregated result in aggregate MOEs of 490 and 
530, for adult males and females respectively, for a combined high end 
dermal and inhalation handler exposure with a high end post application 
dermal exposure and an aggregate MOE of 380 for children for a combined 
dermal exposure with hand-to-mouth exposure. As the level of concern is 
for MOEs that are lower than 100, 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).
    ADPOS inerts 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 ADPOS.
    Using the exposure assumptions described in this unit, EPA has 
concluded the combined intermediate-term food, water, and residential 
exposures aggregated result in aggregate MOEs of 320 and 400, for adult 
males and females respectively, and an aggregate MOE of 100 for 
children. As the level of concern is for MOEs that are lower than 100, 
these MOEs are not of concern.
     5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to the ADPOS 
inerts.
    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 ADPOS.

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.

B. International Residue Limits

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

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of sodium monoalkyl and dialkyl 
(C6-C16) phenoxybenzenedisulfonates and related 
acids, when used as inert ingredients at a maximum of 20% by weight in 
pesticide formulations applied to crops pre-harvest and post-harvest, 
or to animals.

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 21, 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.

* * * * *

[[Page 37605]]



------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Sodium monoalkyl and dialkyl (C6- Not to exceed 20%   Surfactants,
 C16) phenoxy                      in pesticide        related adjuvants
 benzenedisulfonates and related   formulations        of surfactants
 acids (CAS Reg. Nos. 147732-59-
 0, 147732-60-3, 169662-22-0,
 70191-75-2, 36445-71-3, 39354-
 74-0, 70146-13-3, 119345-03-8,
 149119-20-0, 149119-19-7,
 119345-04-9, 28519-02-0, 25167-
 32-2, 30260-73-2, 65143-89-7,
 70191-76-3)
                                * * * * *
------------------------------------------------------------------------

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
------------------------------------------------------------------------
                                * * * * *
Sodium monoalkyl and dialkyl (C6- Not to exceed 20%   Surfactants,
 C16) phenoxy                      in pesticide        related adjuvants
 benzenedisulfonates and related   formulations        of surfactants
 acids (CAS Reg. Nos. 147732-59-
 0, 147732-60-3, 169662-22-0,
 70191-75-2, 36445-71-3, 39354-
 74-0, 70146-13-3, 119345-03-8,
 149119-20-0, 149119-19-7,
 119345-04-9, 28519-02-0, 25167-
 32-2, 30260-73-2, 65143-89-7,
 70191-76-3)
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------


[FR Doc. E9-17957 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S