80 FR 50207 - Methane Sulfonic Acid; Exemption from the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 160 (August 19, 2015)

This regulation establishes an exemption from the requirement of a tolerance for residues of methane sulfonic acid (CAS Reg. No.75- 75-2) when used as an inert ingredient (acidifying agent) in pesticide formulations applied to animals at a maximum concentration not to exceed 3% by weight and when used as an 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 concentration not to exceed 5,000 parts per million (ppm). Lewis & Harrison, on behalf of BASF Corporation, 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 methane sulfonic acid.

[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Rules and Regulations]
[Pages 50207-50212]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20252]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0633; FRL-9931-07]


Methane Sulfonic Acid; 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 methane sulfonic acid (CAS Reg. No.75-
75-2) when used as an inert ingredient (acidifying agent) in pesticide 
formulations applied to animals at a maximum concentration not to 
exceed 3% by weight and when used as an 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 concentration not to exceed 
5,000 parts per million (ppm). Lewis & Harrison, on behalf of BASF 
Corporation, 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 methane sulfonic 
acid.

DATES: This regulation is effective August 19, 2015. Objections and 
requests for hearings must be received on or before October 19, 2015], 
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-2014-0633, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; 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).
     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://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-2014-0633 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 
October 19, 2015. 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-2014-0633, 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.

II. Petition for Exemption

    In the Federal Register of March 4, 2015 (80 FR 11613) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition inert ingredient 
(PP IN-10720) by Lewis & Harrison, 122 C Street NW., Suite 505, 
Washington, DC 20001 on behalf of BASF Corporation, 100 Park Avenue, 
Florham Park, NJ 07932. The petition requested that 40 CFR 180.930 and 
40 CFR 180.940(a) be amended by establishing an exemption from the 
requirement of a tolerance for residues of methane sulfonic acid (CAS 
Reg. No.75-75-2) when used as an inert ingredient (acidifying agent) in 
pesticide formulations applied to animals at a

[[Page 50208]]

maximum concentration not to exceed 3% by weight and when used as an 
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 
concentration not to exceed 5,000 ppm. That document referenced a 
summary of the petition prepared by Lewis & Harrison on behalf of BASF 
Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. 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 methane sulfonic acid including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with methane sulfonic acid 
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 methane sulfonic acid 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 on pp. 7-11 of the document titled, 
``Methane sulfonic acid: Decision Document for Requested Exemption from 
the Requirements of a Tolerance for a Food Use Inert Ingredient'' in 
docket ID number EPA-HQ-OPP-2014-0633.
    Methane sulfonic acid has moderate acute oral toxicity to rats and 
moderate acute dermal toxicity to rabbits. Methane sulfonic acid is 
corrosive to mouse skin, extremely corrosive to the eye, but showed no 
evidence of dermal sensitization. Following repeated nose-only 
inhalation exposures in rats to low concentrations, clear evidence of 
portal-of-entry effects, such as histopathological lesions in the nasal 
turbinates were observed however there was no evidence of systemic 
toxicity at dose levels up to 0.74 milligram/Liter (mg/L) in a 7-day 
study and 0.24 mg/L in a 28-day study, the highest doses tested in both 
studies. In a 7-day repeat dose oral feeding study in rats, no systemic 
toxicity was observed at doses up to 1,805 milligrams/kilograms/day 
(mg/kg/day). No effects were seen for parental toxicity, offspring/
developmental toxicity or reproductive performance in a combined 
reproductive/developmental toxicity screening test at doses up to 1,000 
mg/kg/day. In one developmental toxicity study in rats, no parental 
systemic or developmental toxicity was observed at doses up to 400 mg/
kg/day. Available prenatal developmental toxicity data showed some 
evidence of slight maternal toxicity but no developmental effects. 
Methane sulfonic acid was not mutagenic and did not induce chromosomal 
aberrations. There are no metabolism, chronic toxicity or 
carcinogenicity studies available on methane sulfonic acid. However, 
based on the lack of systemic toxicity at 1,000 mg/kg/day and above in 
a combined reproductive/developmental screening study and 7-day dietary 
study, and the lack of mutagenicity concern, there are low concerns for 
cancer.

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 the NOAEL and the LOAEL are identified. 
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

[[Page 50209]]

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.
    The oral toxicity NOAEL is taken from the developmental toxicity 
study with female Sprague-Dawley rats where the NOAEL was identified as 
400 mg/kg/day. This dose is used for the dietary exposure assessment.
    The inhalation toxicity NOAEL was taken from the repeat-dose 
inhalation study discussed earlier. There were no treatment related 
macroscopic findings in the treated animals. Microscopic findings 
believed attributable to the test material included mucosal necrosis, 
suppurative inflammation and/or nasal exudate in males and females in 
the 0.23 and 0.74 mg/L groups. Since this is a localized effect, it was 
not considered as systemic toxicity, and the NOAEL was determined to be 
0.74 mg/L (~191 mg/kg/day).
    The dermal toxicity NOAEL is selected from an oral developmental 
toxicity study with the assumption of 100% dermal absorption. Based on 
the results of this study, the dermal toxicity NOAEL was 400 mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methane sulfonic acid, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from methane sulfonic acid in food as follows: Based 
upon the requested use patterns, humans may be exposed to methane 
sulfonic acid. Dietary exposure may occur as a result of residues 
transferred from treated food contact areas, including food/dairy 
processing equipment or systems.
    Additional dietary exposure may occur from consuming meat and dairy 
products from treated dairy cattle, sheep or goats. The Agency used the 
dietary exposure model to assess possible residues from treated 
animals.
    Food. To assess oral exposure from food handling surfaces, the 
Agency utilized the Food and Drug Administration (FDA) Food Contact 
Surface Sanitizing Solution Dietary Exposure Assessment Model (FDA/
CFSAN OPA: Chemistry Guidance--Sanitizing Solution version 1.1; January 
1993; Office of Premarket Approval now Office of Food Additive Safety). 
To assess dietary exposures from ``clean in place'' of food processing 
equipment the Agency utilized assessment techniques described in EPA, 
2006 (Reregistration Eligibility Decision Document for Alkyl Dimethyl 
Benzyl Ammonium Chloride (ADBAC) U.S. EPA Document EPA 739-R-06-009 
August 2006). The Agency used the dietary exposure model to assess 
possible residues from treated animals.
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-
FCID)\TM\, Version 3.16, EPA used food consumption information from the 
U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, What we eat in America, (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008. As to residue levels in 
food, no residue data were submitted for methane sulfonic acid. In the 
absence of specific residue data, EPA has developed an approach which 
uses surrogate information to derive upper bound exposure estimates for 
the subject inert ingredient. Upper bound exposure estimates are based 
on the highest tolerance for a given commodity from a list of high-use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738. In the 
case of methane sulfonic acid, EPA made specific adjustments to the 
dietary exposure assessment to account for the use limitations of 
methane sulfonic acid as an inert ingredient in pesticide formulations 
applied to animals (i.e., livestock used for food) only and at a 
maximum concentration of 3.0% by weight.
    2. Dietary exposure from drinking water. Based upon the requested 
use patterns and the restrictions on maximum end-use concentrations, 
the Agency believes methane sulfonic acid is not likely to be present 
in drinking water. A quantitative assessment is not necessary.
    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).
    Dermal and inhalation exposures may occur as a result of the use of 
sanitizing solutions which contain methane sulfonic acid. Such uses 
include mopping floors or wiping/sponging food contact surfaces i.e., 
counter tops. According to Antimicrobials Division, Office of Pesticide 
Programs Standard Operating Procedures, the Agency conducted 
conservative assessments of dermal and inhalation exposures for typical 
residential use patterns.
    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 methane sulfonic acid to share a common mechanism 
of toxicity with any other substances, and methane sulfonic acid does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that methane sulfonic acid 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 Food Quality 
Protection Act Safety Factor (FQPA 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 was no evidence of 
increased sensitivity to infants and children due to pre- and post-
natal exposure to methane sulfonic acid. No treatment-related effects 
were observed on maternal toxicity and offspring/

[[Page 50210]]

developmental toxicity at doses up to the limit dose of 1,000 mg/kg/day 
in a combined reproductive/developmental toxicity study with rats.
    In one developmental toxicity study in rats, there were no 
treatment related effects observed in the maternal animals or in the 
fetuses at doses up to 400 mg/kg/day (the highest dose tested). In 
another developmental toxicity study in rats no maternal or 
developmental toxicity was observed at dose levels up to 300 mg/kg/day; 
the highest dose tested.
    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. The toxicity database for methane sulfonic acid is complete for 
FQPA assessment. The available studies include two developmental 
toxicity studies in rats, a combined rat reproductive/developmental 
toxicity, two repeated dose inhalation toxicity studies in rats, and 
several mutagenicity studies.
    ii. No treatment related effects were observed in the Functional 
Observation Battery and motor activity in a combined reproductive/
developmental toxicity with rats at doses up to 1,000 mg/kg/day. Based 
on the results of this study it is concluded that methane sulfonic acid 
is not a neurotoxic chemical and there is no need for a developmental 
neurotoxicity study or additional uncertainty factors (UFs) to account 
for neurotoxicity.
    iii. There is no evidence that methane sulfonic acid results in 
increased susceptibility in in utero rats (as discussed above).
    iv. There is no immunotoxicity study available in the database, 
however, there was no systemic toxicity observed at the limit dose in a 
combined reproductive/developmental toxicity study. Therefore, there is 
no need for an immunotoxicity study or additional UFs to account for 
the lack of an immunotoxicity study.
    v. There are no residual uncertainties identified in the exposure 
databases.
    These assessments will not underestimate the exposure and risks 
posed by methane sulfonic acid.

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, 
methane sulfonic acid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit (and at http://www.regulations.gov on pp. 7-11 of the document 
titled, ``Methane sulfonic acid: Decision Document for Requested 
Exemption from the Requirements of a Tolerance for a Food Use Inert 
Ingredient'' in docket ID number EPA-HQ-OPP-2014-0633.) For chronic 
exposure, EPA has concluded that chronic exposure to methane sulfonic 
acid from food and water will utilize 0.2% of the chronic population 
adjusted reference dose (cPAD) for the U.S. population and 0.7% of the 
cPAD for children 1-2 years of age, the most highly exposed population 
group.
    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).
    Methane sulfonic acid maybe used as an inert ingredient in 
pesticide products that are registered for any use that could result in 
short-term residential exposure. It is possible that methane sulfonic 
acid could be used in such products and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with potential short-term exposures to methane sulfonic acid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined food, water and 
residential exposures result in aggregate short term MOEs of 1680 for 
adults and 300 for children (1-2 years old). EPA's level of concern for 
methane sulfonic acid is a MOE of 100 or below; therefore these MOEs 
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). No intermediate-term exposure are expected from the use of 
methane sulfonic acid as an inert ingredient, therefore, there are no 
intermediate-term risk concerns.
    5. Aggregate cancer risk for U.S. population. Aggregate cancer risk 
was not estimated because the Agency has not identified any concerns 
for cancer risk due to exposure to methane sulfonic acid.
    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 methane sulfonic acid 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 
methane sulfonic acid in or on any food commodities. EPA is 
establishing a limitation on the amount of methane sulfonic acid that 
may be used in pesticide formulations applied to animals and in food-
contact surface antimicrobial applications. Those limitations 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 formulation for use on animals 
for sale or distribution that contains greater than 3% by weight of 
methane sulfonic acid or any food-contact surface antimicrobial 
formulations for sale or distribution that contains greater than 5,000 
ppm of methane sulfonic acid.

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 methane sulfonic acid.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.930 and 40 CFR 180.940(a) for methane 
sulfonic acid (CAS Reg. No. 75-75-2) when used as an inert ingredient 
(acidifying agent) in pesticide formulations applied to animals at a 
maximum concentration not to exceed 3% by weight and when used as an 
inert ingredient in antimicrobial pesticide formulations

[[Page 50211]]

applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils at a 
concentration not to exceed 5,000 ppm.

VII. Statutory and Executive Order Reviews

    This action 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 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). 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 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 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).

VIII. 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 6, 2015.
Susan Lewis,
Director, Registration Division, Office 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.  180.930 add alphabetically the inert ingredient ``Methane 
sulfonic acid'' to the table to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Methane sulfonic acid (CAS Reg.   Not to exceed 3.0%  Acidifying agent.
 No. 75-75-2).                     by weight in
                                   pesticide
                                   formulation.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.940 add alphabetically the inert ingredient ``Methane 
sulfonic acid'' to the table in paragraph (a) to read as follows:


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

* * * * *
    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical         CAS reg. No.            Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Methane sulfonic acid..........         75-75-2  When ready for use, the
                                                  end use concentration
                                                  is not to exceed 5,000
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 50212]]

* * * * *
[FR Doc. 2015-20252 Filed 8-18-15; 8:45 am]
BILLING CODE 6560-50-P