Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Rules and Regulations 50207 

of Colorado for the 2008 ozone, 2008 

lead, and 2010 NO2 NAAQS were 

received on December 31, 2012, July 26, 

2012, and March 7, 2013, respectively. 

The State’s Infrastructure SIP is 

approved with respect to the 2008 

ozone, 2008 lead, and 2010 NO2

NAAQS with respect to section 

(110)(a)(1) and the following elements of 

section (110)(a)(2): (A), (C) with respect 

to minor NSR and PSD requirements, 

(D)(i)(II) elements 3 and 4, (D)(ii), (E), 

(F), (G), (H), (J), (K), (L), and (M); (B) for 

the 2008 Pb and 2008 ozone NAAQS 

and conditional approval of (B) for the 

2010 NO2 NAAQS; and D(i)(I) elements 

1 and 2 for the 2008 Pb and 2010 NO2

NAAQS. 

[FR Doc. 2015–20377 Filed 8–18–15; 8:45 am] 

BILLING CODE 6560–50–P 

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, dairyprocessing equipment, and foodprocessing 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: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&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 


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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, dairyprocessing equipment, and foodprocessing 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-observedadverse-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 noseonly inhalation exposures in rats to low 

concentrations, clear evidence of portalof-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 


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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 nonoccupational, 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 treatmentrelated effects were observed on 

maternal toxicity and offspring/


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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 


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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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.930 add alphabetically the 

inert ingredient ‘‘Methane sulfonic 

acid’’ to the table to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Methane sulfonic acid (CAS Reg. No. 75–75– 

2).

Not to exceed 3.0% by weight in pesticide formulation.Acidifying agent. 

* * * * * * * 

■ 3. In § 180.940 add alphabetically the 

inert ingredient ‘‘Methane sulfonic 

acid’’ to the table in paragraph (a) to 

read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS reg. No. Limits 

*******

Methane sulfonic acid ................................................... 75–75–2 When ready for use, the end use concentration is not to exceed 5,000 

ppm. 

* * * * * * * 


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50212 Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Rules and Regulations 

* * * * * 

[FR Doc. 2015–20252 Filed 8–18–15; 8:45 am] 

BILLING CODE 6560–50–P 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Parts 1837 and 1852 

RIN 2700–AE01 and 2700–AE09 

NASA Federal Acquisition Regulation 

Supplement; Correction 

AGENCY: National Aeronautics and 

Space Administration. 

ACTION: Correcting amendments. 

SUMMARY: The National Aeronautics and 

Space Administration (NASA) 

published a final rule in the Federal 

Register on Thursday, March 12, 2015 

(80 FR 12935), as part of the NASA 

Federal Acquisition Regulation 

Supplement (NFS) regulatory review. 

That final rule became effective on April 

13, 2015, however the date of effectivity 

for the affected clauses was 

inadvertently omitted. This document 

corrects the final rule by adding the 

missing clause dates and makes other 

minor editorial changes. 

DATES: Effective: August 19, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Manuel Quinones, NASA, Office of 

Procurement, Contract and Grant Policy 

Division, via email at 

manuel.quinones@nasa.gov, or 

telephone (202) 358–2143. 

SUPPLEMENTARY INFORMATION: 

I. Background 

NASA published a final rule in the 

Federal Register on March 12, 2015, 

which became effective April 13, 2015. 

This rule is part of the NASA FAR 

Supplement regulatory review. As 

published, the rule contains errors due 

to inadvertent omission of affected 

clause dates and other errors that need 

to be corrected. Specifically, clause date 

of ‘‘APR 2015’’ is to be added to NFS 

1852.215–77, 1852.219–11, 1852.219– 

18, 1852.219–75, 252.219–77, 1852.219– 

79, 1852.223–71, 1852.223–73, 

1852.227–11, 1852.227–14, 1852.227– 

70, 1852.227–71, 1852.227–72, 

1852.227–84, 1852.227–85, 1852.227– 

86, and 1852.227–88. NASA is not 

altering the text of these NFS clauses, 

but merely adding the missing clause 

dates. Additionally, NFS clause 

prescription at 1809.206–71 was 

correctly removed. However, the 

corresponding clause at 1852.209–70 

should also have been removed and 

reserved at amendatory instruction no. 

66 on page 12945 (80 FR 12945). 

List of Subject in 48 CFR Parts 1837 and 

1852 

Government procurement. 

Manuel Quinones, 

Federal Register Liaison. 

Accordingly, 48 CFR part 1852 is 

amended as follows: 

PART 1852—SOLICITATION 

PROVISIONS AND CONTRACT 

CLAUSES 

■ 1. The authority citation for part 1852 

continues to read as follows: 

Authority: 51 U.S.C. 20113(a) and 48 CFR 

chapter 1. 

1852.215–77, 1852.219–11, 1852.219–18, 

1852.219–75, 252.219–77, 1852.219–79, 

1852.223–71, 1852.223–73, 1852.227–70, 

1852.227–71, 1852.227–72, 1852.227–84, 

1852.227–85, 1852.227–86, and 1852.227–88 

[Amended] 

■ 2. Amend sections 1852.215–77, 

1852.219–11, 1852.219–18, 1852.219– 

75, 252.219–77, 1852.219–79, 1852.223– 

71, 1852.223–73, 1852.227–70, 

1852.227–71, 1852.227–72, 1852.227– 

84, 1852.227–85, 1852.227–86, and 

1852.227–88 by removing ‘‘MONTH/

YEAR’’ and adding ‘‘APR 2015’’ in its 

place. 

1852.209–70 [Removed and Reserved] 

■ 3. Remove and reserve section 

1852.209–70. 

■ 4. Amend section 1852.216–88: 

■ a. By removing clause date of ‘‘JAN 

1997’’ and adding ‘‘APR 2015’’ in its 

place. 

■ b. By revising the second sentence in 

paragraph (a)(1). The revision reads as 

follows: 

1852.216–88 Performance incentive. 

* * * * * 

(a) * * * 

(1) * * * The performance incentive 

becomes effective when the item is put 

into service. * * * 

* * * * * 

1852.223–76 [Amended] 

■ 5. Amend section 1852.223–76 by 

removing ‘‘http://fastweb.inel.gov/’’ and 

adding ‘‘https://fastweb.inel.gov/’’ in its 

place. 

1852.227–11 and 1852.227–14 [Amended] 

■ 6. Amend in sections 1852.227–11 

and 1852.227–14 by removing ‘‘DATE’’ 

and adding ‘‘APR 2015’’ in its place. 

[FR Doc. 2015–20418 Filed 8–18–15; 8:45 am] 

BILLING CODE 7510–13–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 660 

[Docket No. 140904754–5188–02] 

RIN 0648–BF27 

Magnuson-Stevens Act Provisions; 

Fisheries Off West Coast States; 

Pacific Coast Groundfish Fishery; 

2015–2016 Biennial Specifications and 

Management Measures; Inseason 

Adjustments 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule; inseason adjustments 

to biennial groundfish management 

measures. 

SUMMARY: This final rule announces 

inseason changes to management 

measures in the Pacific Coast groundfish 

fisheries. This action, which is 

authorized by the Pacific Coast 

Groundfish Fishery Management Plan 

(PCGFMP), is intended to protect 

overfished and depleted stocks while 

allowing fisheries to access more 

abundant groundfish stocks. 

DATES: This final rule is effective August 

14, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Gretchen Hanshew, phone: 206–526– 

6147, fax: 206–526–6736, or email: 

gretchen.hanshew@noaa.gov. 

SUPPLEMENTARY INFORMATION: 

Electronic Access 

This rule is accessible via the Internet 

at the Office of the Federal Register Web 

site at https://www.federalregister.gov. 

Background information and documents 

are available at the Pacific Fishery 

Management Council’s Web site at 

http://www.pcouncil.org/. Copies of the 

final environmental impact statement 

(FEIS) for the Groundfish Specifications 

and Management Measures for 2015– 

2016 and Biennial Periods Thereafter 

are available from Donald McIsaac, 

Executive Director, Pacific Fishery 

Management Council (Council), 7700 

NE Ambassador Place, Portland, OR 

97220, phone: 503–820–2280. 

Background 

The PCGFMP and its implementing 

regulations at title 50 in the Code of 

Federal Regulations (CFR), part 660, 

subparts C through G, regulate fishing 

for over 90 species of groundfish off the 

coasts of Washington, Oregon, and 

California. Groundfish specifications 


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