68686 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 

■ 3. In appendix C to part 4022, Rate Set 

230, as set forth below, is added to the 

table. 

Appendix C to Part 4022—Lump Sum 

Interest Rates For Private-Sector 

Payments 

* * * * * 

Rate set 

For plans with a 

valuation date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

230 12–1–12 1–1–13 0.75 4.00 4.00 4.00 7 8 

Issued in Washington, DC, on this 7th day 

of November 2012. 

Laricke Blanchard, 

Deputy Director for Policy, Pension Benefit 

Guaranty Corporation. 

[FR Doc. 2012–27753 Filed 11–15–12; 8:45 am] 

BILLING CODE 7709–01–P 

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. 

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/textidx?&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: 


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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 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-observedadverse-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 


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68688 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 

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 foodhandling 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 (cm2) 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 


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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 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 nonoccupational, 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 


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68690 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 

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 


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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 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 intermediateterm 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). 


emcdonald on DSK7TPTVN1PROD with RULES
68692 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 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: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1029; FRL–9368–2] 

1,4-Dimethylnaphthalene; Amendment 

to an Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing exemption from the 

requirement of a tolerance for residues 

of the plant growth regulator, 1,4- 

dimethylnaphthalene (1,4-DMN) by 

expanding the current exemption to 

include all sprouting root and tuber 

vegetables (EPA Crop Group 01) and all 

bulb vegetables (EPA Crop Group 03). 

On behalf of D-I-1-4, Inc., a division of 

1,4Group, Inc., Technology Sciences 

Group, Inc. (TSG) submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

that EPA amend the existing exemption 

from the requirement of a tolerance for 

1,4-DMN. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 1,4- 

DMN under the FFDCA. 

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–2011–1029, 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: 

Colin G. Walsh, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0298; email address: walsh.

colin@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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–2011–1029 in the subject line on 


emcdonald on DSK7TPTVN1PROD with RULES