Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78727 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: December 6, 2013. 

Susan Hedman, 

Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. In § 52.770 the table in paragraph 

(c) is amended by adding a new entry 

in ‘‘Article 8. Volatile Organic 

Compound Rules’’ for ‘‘Rule 17. 

Industrial Solvent Cleaning Operations’’ 

in numerical order to read as follows: 

§ 52.770 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED INDIANA REGULATIONS

Indiana citation Subject Indiana 

effective date EPA approval date Notes 

*******

Article 8. Volatile Organic Compound Rules 

*******

Rule 17. Industrial Solvent Cleaning Operations 

8–17–1 ......... Applicability ..................................... 1/2/2010 2/24/2010, 75 FR 8246 ...................

8–17–2 ......... Exemptions ..................................... 5/3/2012 12/27/2013, [INSERT PAGE NUMBER WHERE THE DOCUMENT 

BEGINS].

8–17–3 ......... ‘‘Composite partial vapor pressure’’ 

defined.

1/2/2010 2/24/2010, 75 FR 8246 ...................

8–17–4 ......... VOC emissions control requirements.5/3/2012 12/27/2013, [INSERT PAGE NUMBER WHERE THE DOCUMENT 

BEGINS].

8–17–5 ......... Compliance dates ........................... 1/2/2010 2/24/2010, 75 FR 8246 ...................

8–17–6 ......... Compliance test methods ............... 1/2/2010 2/24/2010, 75 FR 8246 ...................

8–17–7 ......... Monitoring and recordkeeping ........ 5/3/2012 12/27/2013, [INSERT PAGE NUMBER WHERE THE DOCUMENT 

BEGINS].

8–17–8 ......... Reporting requirements for monitoring and recordkeeping information.1/2/2010 2/24/2010, 75 FR 8246 ...................

8–17–9 ......... Requirements on compliance certification.1/2/2010 2/24/2010, 75 FR 8246 ...................

8–17–10 ....... Recordkeeping requirements for 

exempt sources.

1/2/2010 2/24/2010, 75 FR 8246 ...................

* * * * * * * 

[FR Doc. 2013–30543 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0286; FRL–9904–30] 

Copper Sulfate Pentahydrate; 

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 copper sulfate 

pentahydrate when applied to all food 

contact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment at a maximum 

level in the end use concentration of 80 

parts per million (ppm). Toxcel on 

behalf of OhSo Clean, Inc., submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of copper 

sulfate pentahydrate. 

DATES: This regulation is effective 

December 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 2014, 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–2013–0286, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution 

Ave., NW., Washington, DC 20460– 

0001. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 


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78728 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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://

ecfr.gpoaccess.gov/cgi/t/text/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–2013–0286 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 February 25, 2014. 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– 

2013–0286, 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 July 19, 

2013 (78 FR 43115) (FRL–9392–9), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

2E8116) by Toxcel, P.O. Box 363, 7140 

Heritage Village Plaza, Gainesville, VA 

20156, on behalf of OhSo Clean, Inc., 

315 Pacific Ave., San Francisco, CA 

94111. The petition requested that 40 

CFR 180.940 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of copper sulfate pentahydrate 

(Chemical Abstracts Service Registry 

Number (CAS Reg. No.) 7758–99–8) 

when used as an inert ingredient 

(emulsion stabilizer) in antimicrobial 

pesticide formulations (food contact 

surface sanitizing solutions) not to 

exceed 80 ppm. That document 

referenced a summary of the petition 

prepared by Toxcel LLC., 7140 Heritage 

Village Plaza, Gainesville, VA 20155, 

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 non-toxicity; 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. 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 


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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78729 

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 copper sulfate 

pentahydrate including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with copper sulfate 

pentahydrate 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 copper sulfate pentahydrate, as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies, are discussed in the 

final rule published in the Federal 

Register of August 11, 2006 (71 FR 

46106) (FRL–8085–3). 

Copper is ubiquitous in nature and is 

a necessary nutritional element for both 

animals (including humans) and plants. 

Copper is found naturally in the food 

we eat including fruits, vegetables, 

meats, and seafood. It is found in the 

water we drink, the air we breathe and 

in our bodies themselves. Some of the 

environmental copper is due to direct 

modification of the environment by 

humans such as mining and smelting of 

the natural ore. It is one of the elements 

found essential to life. The National 

Academy of Science establishes 

recommended daily allowances (RDAs) 

of vitamins and minerals for the diet. 

The RDA for copper ranges from 

approximately 400 micrograms per day 

(mg/d) in young children to 900 mg/d in 

adults. Additionally, over the counter 

dietary supplements containing copper 

at level ranging from 0.33 milligram 

(mg) to 3 mg are available for 

individuals with low levels of copper. 

The copper ion is present in the adult 

human body with nearly two-thirds of 

the body copper content located in the 

skeleton and muscle. The liver is the 

primary organ for the maintenance of 

plasma copper concentrations. 

The 2006 Reregistration Eligibility 

Decision for copper compounds 

reviewed and summarized all toxicity 

studies submitted for copper and has 

determined that the toxicological 

database is sufficient to assess the 

hazard from pesticides containing 

copper. Copper generally has moderate 

to low acute toxicity based on acute 

oral, dermal, and inhalation studies in 

animals. However, copper sulfate 

pentahydrate specifically has a been 

classified as moderate for acute oral 

toxicity, low for acute dermal toxicity 

and dermal irritation, and high for 

primary eye irritation. All effects 

resulting from acute exposure to coppercontaining pesticides are due to acute 

body responses to minimize excessive 

absorption or exposure to copper. 

Current available data in animals do not 

show any evidence of upper limit 

toxicity level that warrant determining 

acute toxicity endpoints. 

Based on available data summarized 

in the 2006 Reregistration Eligibility 

Decision for Coppers, there is no 

evidence of any dietary, oral, and 

dermal or inhalation adverse effects 

warranting quantitative assessment of 

sub-chronic or chronic risk. Available 

short-term feeding studies with rats and 

mice indicate decreased food and water 

intake with increasing oral 

concentrations of copper. Irritation of 

the stomach was seen at higher copper 

concentrations. Longer-term feeding 

studies indicate decreased feed intake 

with reductions in body weight gains, 

and increased copper concentration of 

the liver. Available reproductive and 

developmental studies by the oral route 

of exposure generally indicate that the 

main concern in animals for 

reproductive and teratogenic effects of 

copper has usually been associated with 

the deficiency rather than the excess of 

copper. 

Oral ingestion of excessive amounts of 

the copper ion from pesticidal uses 

including the proposed use is unlikely. 

Copper compounds are irritating to the 

gastric mucosa. Ingestion of large 

amounts of copper results in prompt 

emesis. This protective reflex reduces 

the amount of copper ion available for 

absorption into the human body. 

Additionally, at high levels humans are 

also sensitive to the taste of copper. 

Because of this organoleptic property, 

oral ingestion would also serve to limit 

high doses. 

Only a small percentage of ingested 

copper is absorbed, and most of the 

absorbed copper is excreted. The human 

body appears to have efficient 

mechanisms in place to regulate total 

body copper. The copper ion occurs 

naturally in food and the metabolism of 

copper is well understood. 

Finally, sulfate has little toxic effect 

and is routinely used in medicine as a 

cathartic when combined with 

magnesium or sodium; the only adverse 

manifestations from this use being 

dehydration if water intake is 

concurrently limited. 

B. Toxicological Points of Departure/

Levels of Concern 

No endpoints of toxicological concern 

were identified for risk assessment 

purposes for copper sulfate 

pentahydrate. Copper sulfate 

pentahydrate readily hydrolyzes into 

the copper cation and the sulfate anion. 

Copper is a required essential 

nutritional element for both plants and 

animals. Indeed, current available data 

and literature studies indicate that there 

is a greater risk from the deficiency of 

copper intake than from excess intake. 

Copper also occurs naturally in a 

number of food items including fruits, 

meats, seafood, and vegetables. In 

humans, as part of the utilization of 

copper as an essential nutrient, there is 

an effective homeostatic mechanism 

that is involved in the dietary intake of 

copper and that protects humans from 

excess body copper. Given that copper 

is ubiquitous, is an essential nutrient, 

and is routinely consumed as part of the 

daily diet, exposure to copper as a result 

of the use of copper sulfate 

pentahydrate as a pesticide chemical 

would not be of toxicological concern. 

Further, the sulfate anion is also 

ubiquitous; it is the substrate in a 

number of normal human biosynthetic 

reactions. Following ingestion, sulfate is 

poorly absorbed via the gastrointestinal 

tract and is excreted in the urine. Other 

than a slight laxative effect at extremely 

high doses, sulfate has no known 

adverse toxic effects. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to copper sulfate 

pentahydrate, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from copper 

sulfate pentahydrate in food as follows: 

The main source of copper for infants, 

children, and adults, regardless of age, 

is the diet. Copper is typically present 

in mineral rich foods like chocolate, 

fruits (peaches and raisins), grains 

(wheat and rye), nuts (peanuts and 

pecans), and vegetables (potatoes and 

legumes (beans and peas)) in levels that 

range from 0.3 to 3.9 ppm. It is not 

likely that the approval of this petition 


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78730 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

would significantly increase exposure 

over that of the existing levels of copper. 

2. Dietary exposure from drinking 

water. Copper is a natural element 

found in the earth’s crust. As a result, 

most of the world’s surface water and 

ground water that is used for drinking 

purposes contains copper. The actual 

amount varies from region to region, 

depending on how much is present in 

the earth, but in almost all cases the 

amount of copper in water is extremely 

low. Naturally occurring copper in 

drinking water is safe for human 

consumption, even in rare instances 

where it is at levels high enough to 

impart a metallic taste to the water. 

Residues of copper in drinking water are 

regulated under the Safe Drinking Water 

Act. A Maximum Contaminant Level 

Goal of 1.3 ppm has been set by the 

Agency for copper. According to the 

National Research Council’s Committee 

on Copper in Drinking Water, this level 

is ‘‘set at a concentration at which no 

known or expected adverse health 

effects occur and for which there is an 

adequate margin of safety.’’ The Agency 

believes that this level of protection 

would not cause any potential health 

problems, i.e., stomach and intestinal 

distress, liver and kidney damage, and 

anemia. It is not likely that the approval 

of this petition would significantly 

increase exposure over that of the 

existing levels of copper. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., carpets; hard surface disinfection 

on walls, floors, and tables; swimming 

pools; and textiles (clothing and 

diapers)). 

Residential (oral, dermal, and 

inhalation) exposure to copper sulfate 

pentahydrate from its use as an inert 

ingredient in food-contact surface 

sanitizing solutions for public eating 

places, dairy processing equipment, and 

food-processing equipment and utensils 

is possible. However, since there are no 

toxicological effects of concern 

identified in the available database, it is 

not necessary to conduct a quantitative 

assessment of residential (nonoccupational) exposures. 

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 copper sulfate pentahydrate to 

share a common mechanism of toxicity 

with any other substances, and copper 

sulfate pentahydrate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that copper sulfate 

pentahydrate 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 

FFDCA, as amended by the Food 

Quality Protection Act (FQPA), directs 

the Agency to use an additional 10X 

safety factor (SF), to account for 

potential pre- and postnatal toxicity and 

completeness of the data with respect to 

exposure and toxicity to infants and 

children. FQPA authorizes the Agency 

to modify the 10X FQPA SF only if 

reliable data demonstrate that the 

resulting level of exposure would be 

safe for infants and children. Since 

copper is an essential trace element, 

with copper deficiency more common 

in humans than toxicity from the excess, 

a quantitative assessment using safety 

factors was not conducted for potential 

human health exposure to copper 

sulfate pentahydrate. For the same 

reason the 10X FQPA SF was not 

retained. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration the 

information discussed on copper sulfate 

pentahydrate, EPA has determined that 

there is a reasonable certainty that no 

harm to any population subgroup, 

including infants and children, will 

result from aggregate exposure to copper 

sulfate pentahydrate under reasonable 

foreseeable circumstances. Therefore, 

the establishment of an exemption from 

tolerance under 40 CFR 180.940(a) for 

residues of copper sulfate pentahydrate 

when used as an inert ingredient in 

pesticide formulations applied to foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils at a 

limit of 80 ppm is safe under FFDCA 

section 408. 

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 copper sulfate 

pentahydrate in or on any food 

commodities. EPA is establishing a 

limitation on the amount of copper 

sulfate pentahydrate that may be used in 

pesticide formulations. 

The limitation is enforced through the 

pesticide registration process under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136 

et seq.). EPA will not register any 

pesticide for sale or distribution that 

contains greater than 80 ppm of copper 

sulfate pentahydrate in the pesticide 

formulation. 

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 copper sulfate 

pentahydrate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for copper 

sulfate pentahydrate (CAS Reg. No. 

7758–99–8) when used in antimicrobial 

pesticide formulations applied to all 

food contact surfaces in public eating 

places, dairy-processing equipment, and 

food-processing equipment and utensils 

at a maximum level in the end use 

concentration of 80 ppm. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78731 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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 of 1995 

(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: December 20, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.940, alphabetically add the 

following inert ingredient 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 

*******

Copper sulfate pentahydrate ........................................ 7758–99–8 When ready for use, the end-use concentration is not to exceed 80 

ppm 

*******

* * * * * 

[FR Doc. 2013–31101 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0420; FRL–9903–92] 

Indoxacarb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of indoxacarb in 

or on multiple commodities and 

removes previously established 

commodities that will be superseded by 

tolerances established in this action, 

which are identified and discussed later 

in this document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 2014, 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–2012–0420, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 


tkelley on DSK3SPTVN1PROD with RULES