[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 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), 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 http://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
http://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: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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, http://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 http://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 http://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
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Acute dietary (All populations)
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No endpoint was selected. No effects are attributable to a single dose in
animal studies.
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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).
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Dermal........................... No dermal endpoint identified.
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Cancer (oral, dermal, inhalation) No evidence of carcinogenicity in reported published literature studies in
rats
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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 http://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 http://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