
[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Rules and Regulations]
[Pages 68686-68692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27406]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0951; FRL-9361-3]


Xylenesulfonic Acid, Sodium Salt; 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 xylenesulfonic acid, sodium salt (also 
known as sodium xylene sulfonate) (CAS Reg. No. 1300-72-7) when used as 
an inert ingredient in antimicrobial pesticide formulations applied to 
food-contact surfaces in public eating places, diary processing 
equipment, and food processing equipment and utensils at 500 parts per 
million (ppm) utensils. The firm Exponent on behalf of Ecolab Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting establishment of an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of sodium xylene 
sulfonate.

DATES: This regulation is effective November 16, 2012. Objections and 
requests for hearings must be received on or before January 15, 2013, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0951, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5533; email address: dow.mark@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2011-0951 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 15, 2013. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0951, by one of the following methods:

[[Page 68687]]

     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 1E7936) by Exponent 
on behalf of Ecolab Inc. (370 N. Wabasha Street, St. Paul, MN 55102). 
The petition requested that 40 CFR 180.940(a) be amended by an 
exemption from the requirement of a tolerance for residues of xylene 
sulfonic acid, sodium salt (also known as sodium xylene sulfonate; CAS 
no. 1300-72-7) when used as an inert ingredient as an antimicrobial 
agent in pesticide formulations applied to ``food contact surfaces in 
public eating places, dairy processing equipment, and food processing 
equipment and utensils'' at a maximum of 500 ppm. That notice 
referenced a summary of the petition prepared by Exponent on behalf of 
Ecolab Inc. (370 N. Wabasha Street, St. Paul, MN 55102), the 
petitioner, which is available in the docket, http://www.regulations.gov. Sodium xylene sulfonate is currently approved for 
use in pesticide formulations applied to growing crops and animals 
under the existing exemptions from the requirement of a tolerance given 
at 40 CFR 180.920 and 40 CFR 180.930. Sodium xylene sulfonate is 
currently approved as an inert ingredient under 40 CFR 180.940(c) for 
use in food contact surface sanitizing solutions applied to food 
processing equipment and utensils at an end-use concentration not to 
exceed 62 ppm. The current petition seeks to expand the existing use of 
sodium xylene sulfonate to include use on food contact surfaces in 
public eating places, dairy processing equipment, and food processing 
equipment and utensils. Hence, the petition requests the establishment 
of an exemption covering this new use in 40 CFR 180.940(a). There were 
no comments received in response to the notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by sodium xylene sulfonate as well as the 
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in 
this unit.
    Sodium xylene sulfonate has low acute toxicity by the oral, dermal 
and inhalation route of exposure. Sodium xylene sulfonate is a slight 
skin and mild eye irritant. Based upon information regarding sodium 
toluene sulfonate, sodium xylene sulfonate is negative for dermal 
sensitization. Several subchronic studies via the oral route of 
exposure are available in the database. In two 14-day toxicity studies 
in mice and rats, no significant treatment related toxicity was 
observed at doses up to 4% in the diet (approximately 4,000 milligrams/
kilogram/day (mg/kg/day)) in mice. In rats, there were some mortalities 
which were not observed in a dose-related manner and losses of body 
weight that were probably due to palatability of the test article. In a 
repeat toxicity study in rats, mortality was not observed at doses up 
to 4% in the diet. A 90-day subchronic toxicity study was conducted in 
Wistar rats with doses of sodium xylene sulfonate up to 5% in

[[Page 68688]]

the diet. A decreased in relative spleen weight of females, along with 
some clinical chemistry and hematology changes were observed at the 
highest dose (3,454 mg/kg/day). In a separate 90-day toxicity study in 
rats and mice, no treatment related effects were observed in mice and 
rats given sodium xylene sulfonate in the diet at 2% (approximately 
2,439 and 2,467 mg/kg/day in mice and rats, respectively). Dermal 
toxicity studies for 17 days and 90 days duration were conducted in 
mice and rats. No systemic toxicity was observed in mice and rats 
exposed dermally to sodium xylene sulfonate at doses up to 1,620 and 
500 mg/kg/day in mice and rats, respectively. The results of a 2-year 
dermal toxicity study showed no evidence of skin neoplasms or any other 
neoplasms at doses up to 727 and 240 mg/kg/day in mice and rats, 
respectively. Additionally, 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.
    Sodium xylene sulfonate was tested for its mutagenic potential in 
various in vivo and in vitro genotoxicity assays. It gave a negative 
response in a mouse lymphoma assay, the Ames assay, Sister Chromatid 
Exchange assay, (positive at cytotoxic concentrations only), a 
Chromosome Aberration Test and three mouse micronucleus assays. 
Therefore, sodium xylene sulfonate is not likely to be mutagenic.
    There are no reproductive toxicity studies for sodium xylene 
sulfonate. However, the Organisation for Economic Co-operation and 
Development (OECD) Screening Information Dataset (SIDS) Assessment 
included reviews of a 91-day oral rat feeding study with sodium cumene 
sulfonate, a 90-day feeding study with sodium xylene sulfonate (mice 
and rats), and the 2-year dermal studies with sodium xylene sulfonate 
(mice and rats) which included examination of the reproductive organs 
of both sexes. There was no evidence from these studies to suggest that 
sodium xylene sulfonate would have an adverse effect on reproductive 
organs by either the oral or dermal route. No developmental toxicity 
studies in rats and rabbits are available in the sodium xylene 
sulfonate database. However, a developmental study with the rat is 
available for a surrogate chemical, calcium xylene sulfonate. In this 
study the NOAEL for maternal and fetal toxicity was the highest dose 
tested; 3,000 mg/kg/day which correspond to 936 mg/kg bw/day. Based on 
the calcium xylene sulfonate OECD Guideline study, there is no evidence 
to consider these materials as being developmental toxicants. There is 
no evidence in the sodium xylene sulfonate database that sodium xylene 
sulfonate is an immunotoxin.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No endpoint of concern following a single dose was identified in 
the available database. The Agency identified a NOAEL of 763 mg/kg bw/
day for systemic toxicity, which was selected from an oral subchronic 
study. Effects observed in this study were a decrease in spleen weight 
in females along with some clinical chemistry and hematology changes at 
the LOAEL of 3,454 mg/kg bw/day. No adverse effects were reported in 
males. This study was used for chronic dietary exposure assessment. An 
uncertainty factor of 100X is applied (10X for interspecies 
extrapolation and 10X for intraspecies variability). Based on the 
physicochemical data and lack of systemic toxicity in the available 
dermal toxicity studies, EPA concluded that there is no need to conduct 
quantitative dermal risk exposure assessment. For several reasons, no 
additional uncertainty factor is necessary for the use of subchronic 
study data for chronic exposure assessment. First there was a wide dose 
spread between the toxic effects seen at the LOAEL of 3,454 mg/kg/day 
and the NOAEL of 763 mg/kg/day. Second, the changes observed in 
clinical chemistry and hematological parameters were small in magnitude 
and no effects on organs were observed in the study. Therefore, the 
changes observed were not considered toxicologically significant. 
Finally, the NOAEL in a separate 90-day study in rats was 2,467 mg/kg/
day indicating the lower NOAEL value in the selected study is an 
artifact of dose selection. Therefore, EPA concluded that there is no 
need to add an additional uncertainty factor for use of short-term 
study for long-term exposure assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sodium xylene sulfonate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance (40 CFR 
180.940(a)) and as an inert ingredient used in pesticide formulations 
applied to growing crops and animals under the existing exemptions from 
the requirement of a tolerance given at 40 CFR 180.920 and 40 CFR 
180.930. EPA assessed dietary exposures from sodium xylene sulfonate in 
food as follows:
    In the absence of actual dietary exposure data resulting from this 
proposed use the EPA has utilized a conservative, health-protective 
method of estimating dietary intake that is based upon conservative 
assumptions related to the amount of residues that can be transferred 
to foods as a result of the proposed use of sodium xylene sulfonates in 
food contact sanitizing pesticide products. This same methodology has 
been utilized by EPA in estimating dietary exposures to antimicrobial 
pesticides used in food-handling settings. The Agency believes the 
assumptions used to estimate chronic dietary exposures lead to an 
extremely conservative assessment of chronic dietary risk due to a 
series of compounded conservatisms as described in the unit. First, 
when a surface is treated with a disinfectant, a quantity of the 
disinfectant remains on the surface (Residual Solution). In the absence 
of any other data, EPA has used an estimated worst-case concentration 
of 1 mg of solution per square centimeter (cm\2\) of treated surface 
area for this quantity. Second, the conservatism of this methodology is 
compounded by EPA's decision to assume a worst case scenario that all 
food that an individual consumes will

[[Page 68689]]

come into contact with 4,000 cm \2\ of sanitized non-porous food-
contact surfaces. This contact area represents all the surface area 
from silverware, china, and glass used by a person who regularly eats 
three meals per day at an institutional or public facility. The surface 
area of counter tops that comes in contact with food is expected to be 
smaller than the surface area for food utensils. As a conservative 
estimate, EPA assumed that 2,000 cm \2\ of treated counter top surface 
area, comes into contact with an individual's food per day. Third, EPA 
assumes that 100% of the material present on food contact surfaces will 
migrate to food. A complete description of the approach used to assess 
dietary exposures resulting from food contact sanitizing solution uses 
of sodium xylene sulfonates can be found at http://www.regulations.gov 
in document Decision Document for Petition Number 1E7936, pp. 16 of 30 
in docket ID number EPA-HQ-OPP-2011-0951.
    In conducting the acute and chronic dietary exposure assessments 
for sodium xylene sulfonate, 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 are available for sodium 
xylene sulfonate. 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 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 concentration of active ingredient in 
agricultural products is generally at least 50% of the product and 
often can be much higher. Further, pesticide products rarely have a 
single inert ingredient; rather there is generally a combination of 
different inert ingredients used which additionally reduces the 
concentration of any single inert ingredient in the pesticide product 
in relation to that of the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity.
    Finally, a third compounding conservatism is EPA's assumption that 
all foods contain the inert ingredient at the highest tolerance level. 
In other words, EPA assumed 100% of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient.
    In summary, EPA chose a very conservative method for estimating 
what level of inert 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 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.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for sodium xylene 
sulfonate, a conservative drinking water concentration value of 100 
parts per billion (ppb) based on screening level modeling was used to 
assess the contribution to drinking water for the chronic dietary risk 
assessments for sodium xylene sulfonate. These values were directly 
entered into the dietary exposure model. Further details of this 
drinking water analysis can be found at http://www.regulations.gov in 
document ``Decision Document for Petition Number 1E7936'', pp. 16 of 30 
in docket ID number EPA-HQ-OPP-2011-0951.
    The proposed use of sodium xylene sulfonate will not result in its 
presence in surface water or ground water and therefore not contribute 
to dietary exposure.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Sodium xylene sulfonate is not used as an inert ingredient in 
pesticide products that are registered for specific uses that may 
result in either indoor and outdoor residential exposures. However, 
sodium xylene sulfonate is used as a component of personal care 
products. The OECD SIDS Assessment estimated highest human exposures 
resulting from personal care product use. The exposure estimates ranged 
from 0.02-0.14 mg/kg/day for shampoos and hair conditioners to 0.11-
0.17 mg/kg/day for liquid face and hand soaps. Exposure estimates for 
cleaning product use and residuals on clothing range from 0.01-0.08 mg/
kg/day. All exposure evaluations included conservative (protective) 
input assumptions (e.g., all modeled human exposures are conservative 
due to the use of a default assumption of 100% absorption). However, 
the physicochemical data and available toxicological data suggest that 
dermal absorption is likely to be minimal. Based on the lack of concern 
for dermal toxicity and the low estimates of residential exposure, a 
quantitative residential risk assessment was not performed.
    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

[[Page 68690]]

substances that have a common mechanism of toxicity.''
    EPA has not found sodium xylene sulfonate to share a common 
mechanism of toxicity with any other substances, and sodium xylene 
sulfonate does not appear to produce a toxic metabolite produced by 
other substances. However, there are other chemicals belonging to the 
xylene sulfonate class of chemicals that may have a similar toxicity 
profile but these chemicals will be used as an alternative to sodium 
xylene sulfonate. Therefore, a cumulative risk assessment was not 
performed. Furthermore, the cPAD for pesticidal uses occupies only 7% 
of the cPAD for the general population and any potential increase in 
exposure to this class of chemicals will still be below any levels of 
concern. For the purposes of this tolerance action, therefore, EPA has 
assumed that sodium xylene sulfonate does not have a common mechanism 
of toxicity with other substances. For information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site 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. There are no reproductive 
toxicity studies reported for sodium xylene sulfonate. However, no 
effects on reproductive organs were observed at very high doses in 
number of studies such as a 91-day oral rat feeding study with sodium 
cumene sulfonate, the 90-day feeding study with sodium xylene 
sulfonate, and the 2-year dermal studies with sodium xylene sulfonate. 
Based on the above evidence, EPA concluded that sodium xylene sulfonate 
is not likely to be reproductive toxicant. This conclusion is in 
agreement with the OECD conclusion that there is no evidence to suggest 
that sodium xylene sulfonate would have an adverse effect on 
reproductive organs.
    In a developmental toxicity study in rats with calcium xylene 
sulfonate, no maternal or developmental effects were observed at doses 
of 3,000 mg/kg/day (equal to 936 mg/kg/day corrected for purity of test 
material).
    There is no evidence of prenatal or postnatal sensitivity as a 
result of exposure to sodium xylene sulfonate.
    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. Available studies included several 90-day toxicity studies via 
oral and dermal routes, chronic studies, mutagenicity battery, a 
developmental study in rats and metabolism studies. These studies 
provide an adequate characterization of sodium xylene sulfonate 
toxicity.
    ii. There is no indication that sodium xylene sulfonate is a 
neurotoxic chemical and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. No reproductive toxicity study or developmental toxicity study 
are available for sodium xylene sulfonate. However, the concern for 
increased susceptibility of infants and children exposure to sodium 
xylene sulfonate are low because no effects on reproductive parameters 
were observed in various oral toxicity studies and the developmental 
toxicity in rats for a surrogate chemical show lack of systemic 
toxicity at doses up to 936 mg/kg/day (mentioned under pre and post 
natal susceptibility).
    iv. No evidence of immunotoxicity was observed in the database 
except slightly decreased in spleen weight was observed at the LOAEL of 
3,454 mg/kg bw/day. There are no concerns for immunotoxicity and an 
immunotoxicity study is not required because the slight decreased in 
spleen weights were observed at high doses without any evidence of 
histopathological findings.
    v. No additional uncertainty factor is needed for the use of 
subchronic study data for chronic exposure assessment. The rational for 
this decision is provided in Unit IV.B.
    vi. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to sodium xylene sulfonate 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 sodium xylene sulfonate.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. EPA determines whether acute and 
chronic dietary pesticide exposures are safe by comparing aggregate 
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For 
linear cancer risks, EPA calculates the lifetime probability of 
acquiring cancer given the estimated aggregate exposure. Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
sodium xylene sulfonate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sodium xylene sulfonate from food and water including those uses for 
which tolerance exemptions under 40 CFR (180. 910, and 40 CFR 180.930 
exist) will utilize 7% of the cPAD for the U.S. population and 26% of 
the cPAD for children 1-2 years old, the population subgroup receiving 
the greatest exposure. There are no residential uses for sodium xylene 
sulfonate.
    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). A short-term 
adverse effect was identified; however, sodium xylene sulfonate is not 
currently used as an inert ingredient in pesticide products that are 
registered for any use patterns that would result in short-term 
residential exposure. Short-term risk is assessed based on short-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective

[[Page 68691]]

cPAD (which is at least as protective as the POD used to assess short-
term risk), no further assessment of short-term risk is necessary, and 
EPA relies on the chronic dietary risk assessment for evaluating short-
term risk for sodium xylene sulfonate.
    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). An intermediate-term adverse effect was identified; however, 
sodium xylene sulfonate is not currently used as an inert ingredient in 
pesticide products that are registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for sodium xylene sulfonate.
    5. Aggregate cancer risk for U.S. population. Based upon no 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies via the dermal route of exposure, negative response for 
mutagenicity in a battery of genotoxicity tests, and lack of any 
structural alerts for carcinogenicity, sodium xylene sulfonate is not 
expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to sodium xylene sulfonate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
xylene sulfonic acid, sodium salt in or on any food commodities. EPA is 
establishing a limitation on the amount of xylene sulfonic acid, sodium 
salt that may be used in pesticide formulations. That limitation will 
be enforced through the pesticide registration process under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 
136 et seq. EPA will not register any pesticide for sale or 
distribution for which the final end use concentration of xylene 
sulfonic acid, sodium salt in antimicrobial, food contact surface 
sanitizing solutions would exceed 500 ppm.

B. International Residue Limits

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

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for xylenesulfonic acid, sodium 
salt (CAS Reg. No. 1300-72-7) when used as an inert ingredient in 
antimicrobial formulations in pesticide formulations applied to food 
contact surfaces in public eating places, dairy processing equipment, 
and food processing equipment and utensils at a maximum of 500 parts 
per million of final solution. Additionally the exemption from the 
requirement of a tolerance for xylenesulfonic acid under 40 CFR 
180.940(c), can be removed as the establishment of a broader exemption 
from the requirement of a tolerance for xylenesulfonic acid under 
180.940(a) obviates the need for 40 CFR 180.940(c) tolerance exemption.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (Pub. L. 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).

[[Page 68692]]

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: November 1, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.940 is amended by adding the entry ``Xylenesulfonic 
acid, sodium salt'' to the table in paragraph (a) and removing the 
entry for ``Xylenesulfonic acid'' in the table in paragraph (c) to read 
as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

    (a) * * *

----------------------------------------------------------------------------------------------------------------
            Pesticide chemical                   CAS Reg. No.                           Limits
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Xylenesulfonic acid, sodium salt.........                1300-72-7   When ready for use, the end-use
                                                                      concentration is not to exceed 500 ppm.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-27406 Filed 11-15-12; 8:45 am]
BILLING CODE 6560-50-P


