C10, 47125-47130 [2019-19397]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Rules and Regulations]
[Pages 47125-47130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19397]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0070; FRL-9998-57]


C10-C16 Alkylbenzene Sulfonates; 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 C10-C16 branched 
and linear alkylbenzene sulfonates, including benzenesulfonic acid, 
dodecyl (CAS Reg, No. 27176-87-0) and benzenesulfonic acid, dodecyl-, 
sodium salt (CAS Reg. No. 25155-30-0), when used as an active or inert 
ingredient in antimicrobial pesticide formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
and food-processing equipment and utensils at a maximum concentration 
not to exceed 700 parts per million (ppm). Exponent, Inc., 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.

DATES: This regulation is effective September 9, 2019. Objections and 
requests for hearings must be received on or before November 8, 2019 
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-2018-0070, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 308-6411; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.

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 Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2018-0070 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 
August 4, 2019. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2018-0070, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

[[Page 47126]]

II. Summary of Petitioned-For Exemption

    In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 7F8626) by Exponent, Inc., 1150 Connecticut Avenue NW, 
Suite 1100, Washington, DC 20036 on behalf of Ecolab, Inc., 1 Ecolab 
Place, St. Paul, MN 55102. The petition requested that 40 CFR 
180.940(a) be amended by establishing an exemption from the requirement 
of a tolerance for residues of C10-C16 branched 
and linear alkylbenzene sulfonates when used as an active ingredient in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment, and utensils at a maximum end use concentration 
not to exceed 700 ppm. That document referenced a summary of the 
petition prepared by Exponent, Inc., on behalf of Ecolab, Inc., the 
registrant/petitioner, which is available in the docket, https://www.regulations.gov. Comments were submitted to the docket in response 
to the notice of filing, one of which was relevant to this rulemaking. 
The Agency's response is located in Unit IV.B. below.

III. 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 exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which 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 . . 
. .''
    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 C10-C16 
alkylbenzene sulfonates including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with C10-C16 alkylbenzene sulfonates 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Alkylbenzene sulfonates (ABS) are compounds that consist of a 
sulfonated aromatic ring with an alkyl chain of varying lengths; 
C10-C16 refers to the number of carbons in the 
alkyl chain. These compounds may exist in either branched or linear 
form, depending upon where the aromatic ring is attached to the chain 
of carbons; the linear form is more common. The most common linear 
alkylbenzene sulfonate compounds used in pesticide formulations are (1) 
benzenesulfonic acid, dodecyl (CAS Reg. No. 27176-87-0) and (2) 
benzenesulfonic acid, dodecyl-, sodium salt (CAS Reg. No. 25155-30-0), 
both of which are currently approved for use as active and inert 
ingredients in registered pesticide products. Due to the similarity of 
production methods, product mixtures, and commercial use sites, as well 
as the similar or identical physical, chemical, and toxicological 
properties of ABS compounds, EPA's dietary risk assessment covers all 
registered ABS compounds, including both branched and linear forms and 
those compounds of chain lengths C10-C16; the 
toxicity data indicate that the toxicological profile is the same for 
the branched and linear form and that the length of the carbon alkyl 
chain does not change the toxicity of the ABS compound.
    There are several repeat-dose oral toxicity studies performed with 
linear alkybenzene sulfonates, ranging from a 28-day study in monkeys 
to 9-month studies conducted with rats and mice. There are also repeat-
dose dermal (guinea pigs, rabbits, and rats) and inhalation studies 
(dogs and monkeys). Collectively, these animal data suggest that the 
liver, kidney, and caecum (for oral studies) are the major target 
organs for toxicity. The liver and kidney effects were dose- and 
duration-related in that mild effects (organ weight changes and serum 
enzyme/clinical chemistry changes indicative of mild organ effects) 
were seen at lower doses but increased in severity with both dose and 
time.
    Several developmental toxicity studies via the oral and dermal 
routes have been performed with ABS in rats, mice and rabbits; there 
were also several subcutaneous injection developmental studies reported 
in mice. Some developmental effects (including some terata) were 
observed at high doses at which maternal toxicity was also observed; 
however, the available information does not suggest any qualitative or 
quantitative susceptibility differences between pups and pregnant 
animals. In reproduction toxicity tests, no reproductive toxicity was 
observed at doses up to and including 250 mg/kg/day.
    Although data are limited, there is no evidence for carcinogenicity 
of ABS. ABS is also negative in results of mutagenicity testing.
    Specific information on the studies received and the nature of the 
adverse effects caused by ABS as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document ``Draft Risk Assessment for 
Alkylbenzene Sulfonates (ABS) to Support Registration Review, and 
Petition for a Tolerance Exemption'' in docket ID number EPA-HQ-OPP-
2018-0070.

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 dose 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

[[Page 47127]]

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 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm. A 
summary of the toxicological endpoints for ABS used for human risk 
assessment is shown in Table 1. The NOAEL of 50 mg/kg/day was chosen 
based on the result of multiple animal studies including the three co-
critical studies listed in Table 1.

  Table 1--Summary of Toxicological Doses and Endpoints and Points of Departure for ABS for Use in Human Health
                                                 Risk Assessment
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                                     Dose used in risk     Special FQPA SF,
        Exposure scenario             assessment, UF          target MOE        Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)
                                  ------------------------------------------------------------------------------
                                     No endpoint was selected. No effects are attributable to a single dose in
                                                                   animal studies.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)
Systemic/Reproductive Oral NOAEL   UF = 100x...........  FQPA SF = 1x.......  6-month Oral Toxicity--Rat.
 = 50 mg/kg/day.
                                   Chronic RfD = 0.5 mg/ cPAD = cRfD/FQPA SF  NOAEL = 40 mg/kg/day (0.07%) and.
                                    kg/day.               = 0.5 mg/kg/day.
                                                                              LOAEL = 114 mg/kg/day (0.2%) based
                                                                               on increased caecum weight and
                                                                               slight kidney damage in a 6-month
                                                                               rat dietary study (Yoneyama et
                                                                               al. 1972 Ann. Rep. Tokyo Metrop.
                                                                               Res. Lab. Public Health 24:409-
                                                                               440).
                                                                              Developmental Toxicity--Rat
                                                                               Systemic/Reproductive.
                                                                              NOAEL = 50 mg/kg/day and LOAEL =
                                                                               250 mg/kg/day based on decreased
                                                                               Day 21 female pup body weight
                                                                               (MRID 43498416-Bueler, E. et al.
                                                                               1971. Tox Appl. Pharmacol. 18:83-
                                                                               91).
                                                                              9-month Drinking Water Study.
                                                                              NOAEL = 85 mg/kg/day and LOAEL =
                                                                               145 mg/kg/day from 9 month
                                                                               drinking water rat study based on
                                                                               decreased body weight gain, and
                                                                               serum/biochemical and enzymatic
                                                                               changes in the liver and kidney.
                                                                               (Yoneyama et al. 1976 Ann. Rep.
                                                                               Tokyo Metrop. Res. Lab. Public
                                                                               Health 27(2): 105-112).
Short-Term Incidental Oral (1-30   Oral NOAEL = 50 mg/   Residential LOC for  6-month Oral Toxicity--Rat.
 days).                             kg/day.               MOE = 100.          NOAEL = 40 mg/kg/day (0.07%) and
                                                                              LOAEL = 114 mg/kg/day (0.2%) based
                                                                               on increased caecum weight and
                                                                               slight kidney damage in a 6-month
                                                                               rat dietary study (Yoneyama et
                                                                               al. 1972 Ann. Rep. Tokyo Metrop.
                                                                               Res. Lab. Public Health 24:409-
                                                                               440).
Short-, Intermediate and Long-     UF = 100x             Residential LOC for
 Term Inhalation (1 to 30 days, 1-                        MOE = 100.
 6 months, >6 months).
                                                         Occupational LOC     Developmental Toxicity--Rat
                                                          for MOE = 100.       Systemic/Reproductive.
                                                                              NOAEL = 50 mg/kg/day and LOAEL =
                                                                               250 mg/kg/day based on decreased
                                                                               Day 21 female pup body weight
                                                                               (Buehler, E. et al. 1971. Tox
                                                                               Appl. Pharmacol. 18:83-91).
                                                                              9-month Drinking Water Study.
                                                                              NOAEL = 85 mg/kg/day and LOAEL =
                                                                               145 mg/kg/day from 9 month
                                                                               drinking water rat study based on
                                                                               decreased body weight gain, and
                                                                               serum/biochemical and enzymatic
                                                                               changes in the liver and kidney.
                                                                               (Yoneyama et al. 1976 Ann. Rep.
                                                                               Tokyo Metrop. Res. Lab. Public
                                                                               Health 27(2): 105-112).
                                  ------------------------------------------------------------------------------
Dermal...........................                          No dermal endpoint identified.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)    No evidence of carcinogenicity in reported published literature studies in
                                                                        rats
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. UF = Uncertainty Factor (comprised of 10x for extrapolation
  from animal to human (interspecies) and 10x for potential variation in sensitivity among members of the human
  population (intraspecies). cRfD = Chronic Reference Dose.
cPAD = Chronic Population Adjusted Dose. NOAEL = No Observable Adverse Effect Level.
LOAEL = Lowest Observable Adverse Effect Level. MOE = Margin of Exposure. LOC = Level of Concern.


[[Page 47128]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ABS, EPA considered all dietary exposure from registered 
pesticide uses as well as the petitioned-for exemption. Exposure of 
food to products containing ABS compounds may occur from various 
registered product use sites including: (1) Indirect food contact from 
residential food preparation areas, (2) indirect food contact from 
commercial food preparation areas such as public eating places, dairy-
processing equipment, and food-processing equipment and utensils 
(residues in or on food permitted by 40 CFR 180.940(a)), (3) direct 
food uses as fruit and vegetable washes (residues in or on food 
permitted by 21 CFR 173.315 and 173.405), and (4) inert ingredients 
used in pesticide formulations as a surfactant, emulsifier, or related 
adjuvants of surfactants in products applied to growing agricultural 
crops and raw agricultural commodities after harvest (residues in or on 
food permitted by 40 CFR 180.910) and to animals (residues in or on 
food permitted by 40 CFR 180.930). EPA assessed dietary exposures from 
ABS in food as follows:
    i. Acute exposure. An acute dietary risk assessment for ABS has not 
been conducted because no adverse effects could be attributed to a 
single administered oral dose.
    ii. Chronic exposure. In developing the chronic dietary risk 
assessment, EPA considered estimates from four models used to evaluate 
risk from the various pathways of exposure to residues of ABS: the 
Commercial Tier 1A model for dietary exposure from use of ABS in 
commercial settings, including the proposed use of ABS at a limit of 
700 ppm; the Indirect Dietary Residential Exposure Assessment Model 
(IDREAM) for dietary exposures from residential uses; Dietary Exposure 
Evaluation Model (DEEM) for direct applications to food via fruit and 
vegetables washes; and the inert Dietary Exposure Evaluation Model 
(iDEEM) to account for the inert uses of branched and linear 
alkylbenzene sulfonates in agricultural formulations. Each model run of 
these exposure scenarios resulted in risk levels below the Agency's 
levels of concern. For purposes of the chronic dietary assessment, the 
Agency considered the likelihood of co-occurrence of exposures from 
these various use patterns. EPA determined that it was appropriate to 
aggregate exposure from use of ABS in commercial food preparation areas 
and as an inert in pesticide formulations applied to raw agricultural 
commodities or animals due to potential co-occurrence. The Agency 
concluded that it was unlikely that an individual food commodity would 
come into contact with and retain residues from both residential and 
commercial areas and thus, utilized the exposures from use in 
commercial settings, which were higher than residues from residential 
settings. In addition, EPA concluded that residues from fruit and 
vegetable washes were likely to be washed away and should not be 
included in the co-occurrence dietary assessment. Finally, the Agency 
included exposures from inert uses of ABS in the dietary assessment 
based on the likelihood that crops treated with pesticide formulations 
containing ABS as an inert may not be washed prior to picking up 
residues from use of ABS in commercial food preparation places.
    For more specific information on the dietary exposure assessment 
for ABS can be found in the document ``Draft Risk Assessment for 
Alkylbenzene Sulfonates (ABS) to Support Registration Review and 
Petition for a Tolerance Exemption,'' available in docket ID number 
EPA-HQ-2018-0070 at https://www.regulations.gov.
    iii. Cancer. No evidence of carcinogenicity is reported published 
literature studies in rats. Therefore, a cancer dietary exposure 
assessment was not performed.
    2. Dietary exposure from drinking water. Exposure to ABS compounds 
in drinking water may occur from use in registered pesticide 
formulations containing ABS as inert ingredient. A conservative 
drinking water concentration value of 100 ppb based on screening-level 
modeling was used to assess the contribution to drinking water for the 
chronic dietary risk assessments for ABS compounds. This was directly 
entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables). 
Residential (non-dietary) exposure may occur as follows:
     Residential handlers: There is a potential for short-term 
and intermediate-term residential handler inhalation exposure from use 
of products containing ABS compounds as sanitizers in or on food-
contact surfaces and as turf and garden products.
     Post-application exposures: There is a potential for post-
application exposures from products containing ABS compounds used on 
indoor surfaces, carpets, food-contact surfaces, lawns and turf, and 
materials preservatives. The durations and routes of exposure that were 
evaluated include short-term inhalation exposure and short-term 
incidental oral exposure to children.
     Co-occurring exposures: For purposes of the aggregate risk 
assessment, EPA aggregated residential handler inhalation exposure from 
mopping and trigger-pump spray applications and used hand-to-mouth 
exposure from the turf use for post-application exposures to children, 
as it was the highest exposure use pattern.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found ABS to share a common mechanism of toxicity with 
any other substances, and ABS does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that ABS 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 
chemical, see EPA's website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (10X) tenfold 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 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA SF 
value based on the use of traditional uncertainty factors (UFs) and/or 
FQPA SFs, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased

[[Page 47129]]

sensitivity to infants and children due to pre- and post-natal exposure 
to ABS. The data submitted to the Agency, as well as those from 
published literature, demonstrate no increased susceptibility in rats, 
rabbits, or mice to in utero and/or early postnatal exposure to ABS. In 
the prenatal developmental toxicity studies in rats, rabbits, and mice 
and in the 2-generations reproduction study in rats, developmental 
effects in the fetuses or neonates occurred at or above doses that 
caused maternal or parental toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA SF to 1x. 
That decision is based on the following findings:
    i. The toxicity database for ABS is complete.
    ii. There is no indication that ABS is a neurotoxic chemical and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. Although there is evidence of developmental toxicity in some 
studies, there is no evidence of increased susceptibility. Moreover, 
the NOAELs and LOAELs are well-defined, and the endpoints selected for 
regulatory purposes are protective of those effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The screening-level dietary assessment and the residential 
exposure assessment are conservative and not likely to underestimate 
exposures.

E. Aggregate Risks and Determination of Safety

    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, 
ABS is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for co-occurring dietary chronic exposure, EPA has concluded that 
chronic exposure to ABS from food and water will be 23% of the cPAD for 
the highest exposed subpopulation (children 1 to 2) and 8.8% of the 
cPAD for adults. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
ABS is not expected.
    3. Short-term risk. Short-term aggregate risks were assessed for 
children and adults that could be exposed to ABS and concluded that the 
combined food, water and residential non-dietary exposures result in 
aggregate short term MOEs of 670 at 5% inert and 250 at 25% inert for 
adults, and 310 for children (1 to 2 years old). EPA's level of concern 
for ABS is an MOE of 100 or below; therefore, ABS is not expected to 
pose a short-term risk.
    4. Intermediate-term risk. An intermediate-term (1 to 6 months) 
aggregate assessment was performed for adults that could be exposed to 
ABS. Since possible intermediate term inhalation exposures are similar 
to the short-term and the PODs are the same, the aggregate intermediate 
term MOEs are 670 at 5% inert and 250 at 25% inert which exceed the 
target MOE of 100.
    5. Aggregate cancer risk for U.S. population. Based on a lack of 
evidence of carcinogenicity for ABS in the database, ABS is not 
expected to pose a cancer risk to humans.
    6. Determination of safety. Based on its risk assessments, EPA 
concludes that there is a reasonable certainty of no harm that will 
result to the general population, or to infants and children, from 
aggregate exposure to ABS residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method for food is not needed. Food contact 
sanitizers are typically regulated by the State health departments to 
ensure that the food industry is using products in compliance with the 
regulations in 40 CFR 180.940. The end-use solution that is applied to 
the food contact surface is analyzed; the food items that may come into 
contact with treated surface are not analyzed. An analytical method is 
available to analyze the use dilution that is applied to food contact 
surfaces. Alkylbenzene sulfonates are a class of anionic surfactants. 
An ``Anionic Content by Surfactant Electrode Method'' is used to 
determine the concentration or percent of anionic surfactant in the use 
solution. The method may be requested from Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 
20755-5350; telephone no: (410) 305-2905; email address: 
[email protected].

B. Response to Comments

    EPA received a comment expressing concern for the use of pesticides 
on food that will end up in water. No supporting information was 
provided; therefore, it is unclear whether the issue raised is related 
to the safety of consumers of food containing residues of ABS or to the 
environmental effects of pesticides in water. Nonetheless, EPA notes 
that section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
authorizes EPA to set tolerances for residues of pesticide chemicals 
when it determines that the tolerance meets the safety standard imposed 
by that statute. After considering the available data, including the 
potential for ABS residues to end up in drinking water, EPA has made 
that determination for the ABS tolerances established by this final 
rule.

V. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for residues of alkylbenzene 
sulfonates in branched and linear form of chain lengths C10-
C16, when used as an inert or an active ingredient in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public-eating places, dairy-processing equipment, and food-
processing equipment and utensils at a maximum end-use concentration 
not to exceed 700 ppm. As written, this exemption covers all ABS 
compounds of branched or linear form with the appropriate chain length; 
however, the Agency is expressly clarifying that this exemption also 
includes the two substances that are already registered and for which 
tolerance exemptions have already been established--benzenesulfonic 
acid, dodecyl and benzenesulfonic acid, dodecyl-, sodium salt. As this 
new exemption supersedes the more limited exemptions already 
established for those two substances, EPA is removing those exemptions 
from Sec.  180.940(b) and (c) as no longer necessary.

VI. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 action has been exempted from review 
under Executive Order 12866, this action 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), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82

[[Page 47130]]

FR 9339, February 3, 2017). This action 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 exemption 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: August 29, 2019.
Anita Pease,
Director, Antimicrobials 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. In Sec.  180.940:
0
a. Add alphabetically to the table in paragraph (a) the entry 
``Alkylbenzene sulfonates (branched and linear) of chain lengths C10-
C16, including benzenesulfonic acid, dodecyl and benzenesulfonic acid, 
dodecyl-, sodium salt''.
0
b. Remove from the table in paragraph (b) the entry for 
``Benzenesulfonic acid, dodecyl-''.
0
c. Remove from the table in paragraph (c) the entries for 
``Benzenesulfonic acid, dodecyl-'' and ``Benzenesulfonic acid, dodecyl-
, sodium salt''.
    The addition reads 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
------------------------------------------------------------------------
 
                              * * * * * * *
Alkylbenzene sulfonates (branched       27176-87-0  When ready for use,
 and linear) of chain lengths C10-      25155-30-0   the end-use
 C16, including benzenesulfonic                      concentration is
 acid, dodecyl and benzenesulfonic                   not to exceed 700
 acid, dodecyl-, sodium salt.                        ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2019-19397 Filed 9-6-19; 8:45 am]
 BILLING CODE 6560-50-P