
[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]               
[Page 38962-38970]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au09-21]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0099; FRL-8428-6]

 
Sodium Alkyl Naphthalenesulfonate; 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 alkyl naphthalenesulfonate, 
herein referred to in this document as SANS, when used as an inert 
ingredient at a maximum of 30% by weight in pesticide formulations for 
pre-harvest and post-harvest uses, as well as, for application to 
animals. The Joint Inerts Task Force (JITF), Cluster Support Team 
Number 10, 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 SANS.

DATES: This regulation is effective August 5, 2009. Objections and 
requests for hearings must be received on or before October 5, 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-2009-0099. All documents in the 
docket are listed in the docket index

[[Page 38963]]

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 part 180 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.gpo/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-2009-0099 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 October 5, 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-2009-0099, 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 
9E7524) by The Joint Inerts Task Force (JITF), Cluster Support Team 10 
(CST 10), c/o CropLife America, 1156 15th Street, NW., Suite 400, 
Washington, DC 20005. The petition requested that 40 CFR 180.910 and 40 
CFR 180.930 be amended by establishing exemptions from the requirement 
of a tolerance for residues of the inert ingredient sodium alkyl 
naphthalenesulfonate (SANS). That notice referenced a summary of the 
petition prepared by JITF (CST 10), 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.
    Based upon review of the data supporting the petition, EPA has 
modified the exemptions requested by adding a use limitation of not 
more than 30% by weight in pesticide formulations applied pre-and post-
harvest and in pesticide formulations applied to animals. This 
limitation is based on the Agency's risk assessment which can be found 
at http://www.regulations.gov in document Sodium Alkyl 
Naphthalenesulfonate (SANS) - JITF CST 10 Inert Ingredients). Human 
Health Risk Assessment to Support Proposed Exemption from the 
Requirement of a Tolerance When Used as Inert Ingredients in Pesticide 
Formulations in docket ID number EPA-HQ-OPP-2009-0099.
    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 section 408(b)(2) of 
FFDCA. The expiration date for the tolerance exemptions subject to 
revocation was August 9, 2008, which was later extended to August 9, 
2009 by a final rule published in the Federal Register 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.

[[Page 38964]]

 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 SANS, 
when used as an inert ingredient in pesticide formulations for pre-
harvest and post-harvest uses, as well as for application to animals 
provided that the concentration of the SANS inerts is limited to no 
more than 30% by weight in pesticide formulations. 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 representative test compounds for the SANS cluster group 
include (1) an aqueous mixture containing 80% 3-butyl-naphthalene- 1 
sulfonate (CAS Reg. No. 25638-17-9) and 20% sodium di-3, 6-dibutyl 
naphthalene-1-sulfonate (CAS Reg. No. 25417-20-3); (2) a complex 
mixture from a boiling distillate from petroleum catalytic reformer 
fractionator residue that includes C9-rich C8-
C10-alkyl-sodium naphthalenesulfonate (CAS Reg. No. 908356-
16-1); and (3) naphthalenesulfonic acid, sodium salt, isopropylate (CAS 
Reg. No. 68442-09-1), which is a mixture containing sodium diisopropyl 
and triisopropyl-2-naphthalenesulfonates in a 40:60 ratio, with 6% of 
mono-isopropyl-2-naphthalenesulfonates. The existing toxicology 
database for the SANS inerts consists of an OPPTS Harmonized Guideline 
870.3650 (combined repeated dose toxicity study with the reproduction/
developmental toxicity screening studies in rats) on each of the 
representative SANS, and several publicly-available studies on acute 
toxicity. These data are adequate to apply to the SANS inerts when used 
as inert ingredients in pesticide formulations and to characterize the 
potential toxic effects of these surfactants.
    The sodium alkyl naphthalenesulfonates have low acute oral and 
inhalation toxicity but are irritating to the skin and eye. No 
mutagenicity data are available. The OPPTS Harmonized Guideline 
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening tests on three representative 
surfactants demonstrate local irritation effects on the forestomach/
stomach, reduced body-weight gain during mating (males), and/or 
decrease in thymus weight and thymus atrophy and microscopic lesions in 
the kidney (females) in the parental animals. No evidence of 
neurotoxicity was observed in any of the studies.
    There was evidence of increased susceptibility to the offspring of 
rats following prenatal or postnatal exposure to naphthalenesulfonic 
acid, sodium salt, isopropylate. Increased post-implantation and 
postnatal losses and reduced pup body weights were observed at 120 and 
288 milligrams/kilograms/day (mg/kg/day), whereas maternal toxicity was 
observed only at 288 mg/kg/day, as evidenced by mortality, and increase 
in liver enzymes and creatinine, increased kidney weight, and 
histopathological lesions in the kidney (tubular cell necrosis), 
stomach (inflammatory submucosal infiltrates and mucosal ulceration) 
and liver (hepatic fatty change). Based on the fact that there is a 
clear NOAEL for the pup effects, the point of departure is based on 
this endpoint (increased post-implantation and postnatal losses and 
reduced pup weight) and is protective of the effects seen in the study, 
and because of the highly conservative inputs used in both the hazard 
and exposure assessments, there is no residual concern for this 
finding.
    No evidence of increased susceptibility was observed following 
prenatal or postnatal exposure to the other representative inerts. 
Following exposure to an aqueous mixture containing 3-butyl-
naphthalene-1 sulfonate and sodium di-3, 6-dibutyl naphthalene-1-
sulfonate, parental toxicity manifested as microscopic forestomach 
lesions, and developmental toxicity manifested as decreased pup body 
weight ([darr]7-8%). No other developmental effects or reproductive 
effects were observed, and there was no evidence of neurotoxicity in 
the adult animal. Following exposure to a complex mixture from a 
boiling distillate from petroleum catalytic reformer fractionator 
residue that includes C9-rich C8-C10-
alkyl-sodium naphthalenesulfonate, parental toxicity manifested as 
decreased body-weight gain during premating (males), decreased testes 
weight, increased incidence of hematopoiesis in the liver (females), 
and an increased incidence of erosion in the glandular stomach (both 
sexes) at the limit dose. No developmental or reproductive effects were 
observed, and there was no

[[Page 38965]]

evidence of neurotoxicity in the adult animal at the limit dose.
    The SANS metabolism and elimination are contingent on both the 
nature of the alkyl groups and the nature and extent of naphthalene 
ring substituents. The Agency's August 1998 ``Toxicological Review of 
Naphthalene (CAS Reg. No. 91-20-3)'' states that the in vivo and in 
vitro metabolism of the parent unsubstituted naphthalene has been 
studied extensively in mammalian systems. Without a functional group 
for conjugation, it is expected that the majority of absorbed 
unsubstituted naphthalene is eliminated and will proceed through 
microsome cytochrome P-450 oxygenases to 1- and 2-napthols.
    However, in the case of the CST 10 SANS surfactants, in addition to 
microsome cytochrome P-450 oxygenases, the 1- or 2-sulfonic acid sodium 
salt moieties on the naphthalene ring may provide a handle by which 
these compounds can be readily conjugated and eliminated.
    There is no evidence that the SANS inerts are carcinogenic. The 
Agency used a qualitative structure activity relationship (SAR) 
database, DEREK Version 11, to determine if there were structural 
alerts. No structural alerts were identified. In addition, there was 
little concern that any of the postulated metabolites would have 
greater toxicity than the parent compounds.
    Specific information on the studies received and the nature of the 
adverse effects caused by the SANS, 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 Sodium Alkyl Naphthalenesulfonate 
(SANS) - JITF CST 10 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 9-13 and 46-
53 in docket ID number EPA-HQ-OPP-2009-0099.

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 SANS used for human 
health risk assessment is shown in the following Table 1.

     Table 1.--Summary of Toxicological Doses and Endpoints for SANS for Use in Human Health Risk Assessment
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                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)            No appropriate endpoints identified for acute dietary assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 50 mg/kg/day     Chronic RfD = 0.5 mg/kg/ OPPTS Harmonized
                                       UFA = 10x..............   day                      Guideline 870.3650
                                       UFH = 10x..............  cPAD = 0.5 mg/kg/day...  Combined Repeated Dose
                                       FQPA SF = 1x...........                            Toxicity Study with
                                                                                          the Reproduction/
                                                                                          Developmental Toxicity
                                                                                          Screen in Rats
                                                                                         LOAEL = 120 mg/kg/day,
                                                                                          based on increased
                                                                                          postnatal loss,
                                                                                          reduced viability,
                                                                                          decreased birth index
----------------------------------------------------------------------------------------------------------------
Incidental Oral, (Short- and           NOAEL = 50 mg/kg/day     Residential LOC for MOE  OPPTS Harmonized
 Intermediate-Term), Dermal and        UFA = 10x..............   = 100                    Guideline 870.3650
 Inhalation (Short, Intermediate-,     UFH = 10x..............                           Combined Repeated Dose
 and Long-term)                        FQPA SF = 1x...........                            Toxicity Study with
                                        (5% dermal absorption;                            the Reproduction/
                                        inhalation hazard                                 Developmental Toxicity
                                        assumed to be                                     Screen in Rats
                                        equivalent to oral                               LOAEL = 120 mg/kg/day,
                                        hazard).                                          based on increased
                                                                                          postnatal loss,
                                                                                          reduced viability,
                                                                                          decreased birth index.
----------------------------------------------------------------------------------------------------------------

[[Page 38966]]


Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                            Based on SAR analysis, SANS are not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 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

    Very limited information is available for the sodium alkyl 
naphthalenesulfonates (SANS) with respect to plant and animal 
metabolism or environmental degradation. The Agency relied collectively 
on information provided on the representative chemical structures, the 
submitted physicochemical data, structure-activity relationship 
information, as well as information on other surfactants and chemicals 
of similar size and functionality to determine the residues of concern 
for these inert ingredients. Based on SAR analysis the SANS inerts are 
unlikely to degrade in the environment to compounds that are more toxic 
than the parent compounds; therefore, the parent compounds SANS are the 
residues of concern.
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to SANS, EPA considered exposure under the petitioned-for 
exemptions from the requirement of a tolerance. EPA assessed dietary 
exposures from SANS in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of SANS was seen in the toxicity databases. Therefore, an 
acute dietary risk assessment for SANS is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the U.S. 
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 SANS. 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 ingredient. Upper bound exposure estimates are based on 
the highest tolerance for a given commodity from a list of high-use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data 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 SANS, EPA made a specific 
adjustment to the dietary exposure assessment to account for the use 
limitations of the amount of SANS that may be in formulations (no more 
than 30% by weight in pesticide formulations) and assumed that the SANS 
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.
    iii. Cancer. The Agency used a qualitative structure activity 
relationship (SAR) database, DEREK11, to determine if there were 
structural

[[Page 38967]]

alerts suggestive of carcinogenicity. No structural alerts for 
carcinogenicity were identified. SANS are not expected to be 
carcinogenic. Therefore, a cancer dietary exposure assessment is not 
necessary to assess cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for SANS. Tolerance level residues and/or 100% CT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for SANS in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of SANS. Further information regarding EPA drinking 
water models used in the 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 SANS. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of SANS 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 
the document Sodium Alkyl Naphthalenesulfonate (SANS) - JITF CST 10 
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 14-15 and 56-58 in docket 
ID number EPA-HQ-OPP-2009-0099.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for SANS, a conservative drinking water concentration value 
of 100 ppb based on screening level modeling was used to assess the 
contribution to drinking water for chronic dietary risk assessments for 
the parent compounds and for the metabolites of concern. 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). SANS may be used as 
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 SANS as inert ingredients. In 
this assessment, representative scenarios based on end-use product 
application methods and labeled application rates were selected. The 
SANS may be used as inert ingredients in pesticide formulations that 
are used in and around the home. Additionally, uses are possible in 
household cleaning products. For each of the use scenarios, the Agency 
assessed residential handler (applicator) inhalation and dermal 
exposure for indoor and outdoor 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 SANS. Similarly, residential post application dermal and 
oral exposure assessments were also performed utilizing high end indoor 
and outdoor exposure scenarios. Further details of this residential 
exposure and risk analysis can be found at http://www.regulations.gov 
in the memorandum entitled 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 (D364751, 5/7/09, Lloyd/LaMay 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 the SANS to share a common mechanism of toxicity 
with any other substances, and the SANS do not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that the SANS 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 representative test 
compounds for the SANS cluster group includes:
    i. An aqueous mixture containing 80% 3-butyl-naphthalene-1 
sulfonate (CAS Reg. No. 25638-17-9) and 20% sodium di-3, 6-dibutyl 
naphthalene-1-sulfonate (CAS Reg. No. 25417-20-3);
    ii. A complex mixture from a boiling distillate from petroleum 
catalytic reformer fractionator residue that includes C9-
rich C8-C10-alkyl-sodium naphthalenesulfonate 
(CAS Reg. No. 908356-16-1); and
    iii. Naphthalenesulfonic acid, sodium salt, isopropylate (CAS Reg. 
No. 68442-09-1), which is a mixture containing sodium diisopropyl and 
triisopropyl-2-naphthalenesulfonates in a 40:60 ratio, with 6% of mono-
isopropyl-2-naphthalenesulfonates. The existing toxicology database for 
the SANS inerts consists of an OPPTS Harmonized Guideline 870.3650 
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening studies in rats on each of the 
representative SANS.
    In the case of the SANS inerts, there was no increased 
susceptibility to the offspring of rats following prenatal and 
postnatal exposure in two of the three OPPTS Harmonized Guideline 
870.3650 studies. There were no developmental effects at any dose level 
up to the limit dose following exposure to (CAS Reg. No. 908356-16-1). 
In that study, maternal toxicity was manifested as mortality, an 
increase in liver enzymes and creatinine, increased kidney weight, and 
histopathological lesions in the kidney (tubular cell necrosis), 
stomach (inflammatory submucosal infiltrates

[[Page 38968]]

and mucosal ulceration), and liver (hepatic fatty change) at 1,000 mg/
kg/day. Following exposure to (CAS Reg. No. 25638-17-9) and (CAS Reg. 
No. 25417-20-3), developmental toxicity (decreased pup body weight; 
[darr]7-8%) was observed at the same dose level where maternal/paternal 
toxicity was observed, as evidenced by microscopic lesions in the 
stomach at 540 mg/kg/day.
    Developmental toxicity was observed following exposure to (CAS Reg. 
No. 68442-09-1) at a dose level where no significant effects were 
observed in the parental animals. Offspring effects included increases 
in post-implantation loss and postnatal loss and lower pup body weights 
at dose levels of 120 and 288 mg/kg/day. Parental toxicity was observed 
at 288 mg/kg/day, as evidenced by mortality, increased kidney weight 
and histopathological lesions in the kidney (tubular cell necrosis), 
stomach (inflammatory submucosal infiltrates and mucosal ulceration), 
and liver (hepatic fatty change), and increase in liver enzymes and 
creatinine in females. Based on the fact that there is a clear NOAEL 
(50 mg/kg/day), the point of departure is based on this endpoint 
(increased postnatal loss, decreased pup viability, reduced birth 
index) and is protective of the effects seen in the study, and because 
of the highly conservative inputs used in both the hazard and exposure 
assessments, there is no residual concern for this finding.
    3. Conclusion. EPA has determined that reliable data show that 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 SANS is considered adequate for 
assessing the risks to infants and children (the available studies are 
described in unit IV.D.2.). The Agency noted changes in thymus weight 
and thymus atrophy. However, these were determined to be non-specific 
changes not indicative of immunotoxicity. In addition, no blood 
parameters were affected. Furthermore, these compounds do not belong to 
a class of chemicals that would be expected to be immunotoxic. 
Therefore, the Agency does not believe that an additional uncertainty 
factor (UFdb) for database uncertainties needs to be applied. In 
addition, this effect was not observed in the pups.
    ii. No increased susceptibility of the offspring or reproductive 
toxicity was demonstrated in the OPPTS Harmonized Guideline 870.3650 
reproductive/developmental toxicity studies in rats following prenatal 
and postnatal exposure to two of the three representative compounds 
(540 and 1,000 mg/kg/day). Increased susceptibility was demonstrated in 
the rat offspring following prenatal and postnatal exposure to one of 
the three representative compounds. Decreased pup body weight, 
increased pup mortality, and a lower viability index were observed (120 
and 288 mg/kg/day) at a dose level where no parental toxicity was 
observed. A clear NOAEL was established for these effects, and the 
point of departure is based on this endpoint. Reproductive toxicity was 
observed following exposure to one of the representative inerts (120 
and 288 mg/kg/day), as evidenced by the reduction in birth index. A 
clear NOAEL was established for this effect and the point of departure 
for risk assessment is significantly below the NOAEL for this effect. 
The selected point of departure for the dietary, dermal and inhalation 
risk assessments is protective of these offspring effects, thus there 
are no residual concerns.
    iii. There is no indication that SANS are neurotoxic chemicals and 
thus there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iv. While there is no chronic toxicity data, the Agency has 
concluded that an additional uncertainty factor is not needed for the 
use of a subchronic study for a chronic exposure assessment because the 
adverse effects observed in the available toxicity studies are 
attributable to the irritant nature of surfactants and would not be 
expected to increase in severity from subchronic to chronic exposure 
scenarios. Based on the lack of progression of severity of effects with 
time, along with the considerable similarities of effects across the 
species tested, the observation that the vast majority of the effects 
observed are related to local irritation and corrosive effects, and the 
highly conservative nature of the exposure assessment, EPA concludes 
that an additional UF for extrapolation from subchronic toxicity study 
to a chronic exposure scenario is not needed.
    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% 
crop treated is assumed for all crops. EPA also made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to SANS 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 
SANS.

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.
    1. Acute risk.There was no hazard attributable to a single exposure 
seen in the toxicity database for SANS. Therefore, the SANS 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 SANS is 23% of the cPAD for the U.S. population and 
75% of the cPAD for children 1 to 2 years 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).
    SANS 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 SANS. Using the exposure 
assumptions described in this unit, EPA has concluded that the combined 
short-term food, water, and residential exposures aggregated result in 
aggregate MOEs of

[[Page 38969]]

120 for both adult males and females, respectively. Adult residential 
exposure combines high end dermal and inhalation handler exposure with 
a high end post application dermal exposure. EPA has concluded that the 
combined short-term aggregated food, water, and residential exposures 
result in an aggregate MOE of 120 for children. Children's residential 
exposure combines dermal and hand-to-mouth exposures. 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).
    SANS 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 SANS. Using the 
exposure assumptions described in this unit, EPA has concluded that the 
combined intermediate-term aggregated food, water, and residential 
exposures result in aggregate MOEs of 520 for both adult males and 
females, respectively. Adult residential exposure includes high end 
post application dermal exposures. EPA has concluded that the combined 
intermediate-term aggregated food, water, and residential exposures 
result in an aggregate MOE of 130 for children. Children's residential 
exposure combines dermal and hand-to-mouth exposures. 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 SANS.
    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 SANS.

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 
SANS 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 alkyl naphthalenesulfonates when 
used as inert ingredients applied to crops pre-harvest and post-
harvest, and to animals at a maximum of 30% by weight in pesticide 
formulations.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of 
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 exemptions 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 29, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

[[Page 38970]]

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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Sodium alkyl                      Limited to no more  Surfactants,
 naphthalenesulfonates (CAS Reg.   than 30% by         related adjuvants
 Nos. 68909-83-1, 68909-84-2,      weight in           of surfactants
 68909-82-0, 27213-90-7, 26264-    pesticide end-use
 58-4, 27178-87-6, 111163-74-7,    products.
 908356-16-1, 25417-20-3, 25638-
 17-9, 145578-88-7, 1322-93-6,
 1323-19-9, 7403-47-6, 68442-09-
 1, 127646-44-0, 908356-18-3).
                              * * * * * * *
------------------------------------------------------------------------


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
------------------------------------------------------------------------
                              * * * * * * *
Sodium alkyl                      Limited to no more  Surfactants,
 naphthalenesulfonates (CAS Reg.   than 30% by         related adjuvants
 Nos. 68909-83-1, 68909-84-2,      weight in           of surfactants
 68909-82-0, 27213-90-7, 26264-    pesticide end-use
 58-4, 27178-87-6, 111163-74-7,    products.
 908356-16-1, 25417-20-3, 25638-
 17-9, 145578-88-7, 1322-93-6,
 1323-19-9, 7403-47-6, 68442-09-
 1, 127646-44-0, 908356-18-3).
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. E9-18702 Filed 8-4-09; 8:45 am]

BILLING CODE 6560-50-S
