65824 Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations 

TABLE 4 TO § 87.23—TIER 8 NOX STANDARDS FOR NEW SUBSONIC TURBOFAN OR TURBOJET ENGINES WITH RATED

OUTPUT ABOVE 26.7 KN—Continued 

If the rated pressure ratio is— and the rated output (in kN) is— The NOX emission standard (in g/kN rated output) is— 

rPR ≥ 104.7 ....................................................... all ....................................................... 32 + 1.6·rPR 

[FR Doc. C1–2012–13828 Filed 10–30–12; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0131; FRL–9362–4] 

Calcium Gluconate; 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 calcium 

gluconate when used as an inert 

ingredient (sequestrant) in pesticide 

formulations applied to growing crops. 

ISK Biosciences 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 calcium 

gluconate. 

DATES: This regulation is effective 

October 31, 2012. Objections and 

requests for hearings must be received 

on or before December 31, 2012, 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–2012–0131, 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: 

Roger Chesser, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8516; email address: 

chesser.roger@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/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–2012–0131 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 December 31, 2012. 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 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 nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2012–0131, 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 

Confidential Business Information (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.htm. 

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 May 2, 2012 

(77 FR 25957) (FRL–9346–1), EPA 

issued a notice pursuant to FFDCA 

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

the filing of a pesticide petition (PP 

1E7900) by ISK Biosciences 

Corporation, 7470 Auburn Road, Suite 

A, Concord, OH 44077. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of calcium gluconate (CAS Reg. 

No. 299–28–5) when used as an inert 

ingredient (sequestrant) in pesticide 

formulations applied to growing crops. 

That notice referenced a summary of the 

petition prepared by ISK Biosciences 

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. 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations 65825 

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 calcium 

gluconate including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with calcium 

gluconate 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 calcium gluconate as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

Calcium gluconate has been evaluated 

by the Joint Food and Agriculture 

Organization/World Health 

Organization (FAO/WHO) Expert 

Committee on Food Additives (JECFA) 

which determined that calcium 

gluconate was of very low toxicity and 

allocated an acceptable daily intake 

(ADI) of ‘‘not specified’’. The JECFA 

evaluation of calcium gluconate was 

part of a group—gluconic acid and its 

inorganic salts, that were assessed 

together based on the fact that the 

calcium, magnesium, potassium, and 

sodium salts of gluconic acid are freely 

ionizable and that it was appropriate to 

allocate ADIs on the basis of data on 

their corresponding anion (gluconic 

acid) as calcium gluconate dissociates 

under normal physiologic conditions 

into gluconic acid. ADI ‘‘not specified’’ 

is used to refer to a food substance of 

very low toxicity, which, on the basis of 

available data (chemical, biochemical, 

toxicological, and other) and the total 

dietary intake of the substance arising 

from its use at the levels necessary to 

achieve the desired effect and from its 

acceptable background levels in food, 

does not, in the opinion of the 

Committee, represent a hazard to health. 

For that reason, and for reasons stated 

in individual evaluations, the 

establishment of an ADI expressed in 

numerical form is not necessary. 

Calcium gluconate was added to the 

CODEX General Standard for Food 

Additives (GSFA) in 1999. 

Toxicological studies considered by 

JECFA in their evaluation of gluconic 

acid and its inorganic salts included 

acute oral toxicity studies in the rat, 

mouse, rabbit and hamster with LD50

values ranging from >2,000 milligrams/ 

kilogram (mg/kg) to 7,850 mg/kg. 

Gluconic acid and its inorganic salts 

have been tested in in vitro assays 

(bacterial reverse mutation assays) 

which demonstrated that gluconic acid 

was not mutagenic with or without 

metabolic activation. 

In various subchronic, chronic, 

reproductive and developmental studies 

evaluated using gluconic acid and its 

inorganic salts by JECFA, no observable 

adverse effects were noted at or above 

limit dose levels (i.e., > 1,000 mg/kg/ 

day). (JECFA 1999). 

B. Toxicological Points of Departure/ 

Levels of Concern 

As discussed above, there was no 

hazard identified in repeat dose toxicity 

and reproductive/developmental studies 

with gluconic acid and its inorganic 

salts at the limit dose of 1,000 mg/kg/ 

day to either parental animals or their 

offspring. Thus, due to its low potential 

hazard and lack of a hazard endpoint, 

the Agency has determined that a 

quantitative risk assessment using safety 

factors applied to a point of departure 

protective of an identified hazard 

endpoint is not appropriate for calcium 

gluconate. 

Calcium gluconate was not mutagenic 

in an in vitro chromosome aberration 

test, bacterial gene mutation test. In 

addition, the available in vitro and in 

vivo mutagenicity data with glucuronic 

acid and its inorganic salts were 

negative. Based on the available 

information from the mutation studies, 

it is not anticipated to be carcinogenic. 

C. Exposure Assessment 

No hazard endpoint of concern for 

calcium gluconate was identified for the 

acute and chronic dietary assessment 

(food and drinking water), or for the 

short, intermediate, and long term 

residential assessments (via all exposure 

routes); therefore, acute and chronic 

dietary and short-, intermediate-, and 

long-term residential exposure 

assessments were not performed. 

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65826 Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations 

D. 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.’’ 

While the toxicity of calcium 

gluconate is expected to be similar to 

the other inorganic salts of gluconic acid 

as well as gluconic acid itself, there are 

no toxicological endpoints of concern 

identified for any of these substances. 

Therefore a cumulative risk assessment 

was not performed. 

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. 

E. Safety Factor for Infants and Children 

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. 

The toxicity database for calcium 

gluconate identified no hazard endpoint 

of concern for calcium gluconate and 

there is no residual uncertainty 

regarding prenatal and/or postnatal 

toxicity. No acute or subchronic 

neurotoxicity studies are available, but 

there were no clinical signs of 

neurotoxicity or any systemic toxicity 

observed in the available database at 

doses up to 1,000 mg/kg/day. No 

developmental or reproductive effects 

were seen in the available studies at 

doses up to and including 1,000 mg/kg/ 

day. 

Based on this information, there is no 

concern, at this time, for increased 

sensitivity to infants and children to 

calcium gluconate when used as an 

inert ingredient in pesticide 

formulations applied to growing crops 

and a safety factor analysis has not been 

used to assess risk. For the same reason, 

EPA has determined that an additional 

safety factor is not needed to protect the 

safety of infants and children. 

F. Aggregate Risks and Determination of 

Safety 

Given the lack of concern for hazard 

posed by calcium gluconate, EPA 

concludes that there are no dietary or 

aggregate dietary/non-dietary risks of 

concern as a result of exposure to 

calcium gluconate in food and water, or 

from residential exposure. Residues of 

concern are not anticipated for dietary 

exposure (food and drinking water) or 

for residential exposure from the use of 

calcium gluconate as an inert ingredient 

in pesticide products. As discussed in 

this unit, EPA expects aggregate 

exposure to calcium gluconate to pose 

no appreciable dietary risk given that 

the data show a lack of any systemic 

toxicity or adverse developmental/ 

reproductive effects at doses up to 1,000 

mg/kg/day. 

Taking into consideration all available 

information on calcium gluconate, 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 calcium gluconate under 

reasonable foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.920 for residues of calcium 

gluconate (CAS Reg. No. 299–28–5) 

when used as an inert ingredient in 

pesticide formulations applied to 

growing crops, 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 establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

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 calcium 

gluconate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for calcium 

gluconate (CAS Reg. No. 299–28–5) 

when used as an inert ingredient 

(sequestrant) in pesticide formulations 

applied to growing crops. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under FFDCA section 408(d) 

in response to a petition submitted to 

the Agency. The Office of Management 

and Budget (OMB) has exempted these 

types of actions from review under 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993). Because 

this final rule has been exempted from 

review under Executive Order 12866, 

this final rule 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 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 exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), do not apply. 

This 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 

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Federal Register / Vol. 77, No. 211 / Wednesday, October 31, 2012 / Rules and Regulations 65827 

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: October 15, 2012. 

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 § 180.920, the table is amended 

by adding alphabetically the following 

entry immediately before the entry for 

‘‘Camphor (CAS Reg. No. 76–22–2).’’ 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*****

Calcium gluconate (CAS 

Reg. No. 299– 

28–5).

............ Sequestrant. 

*****

* * * * * 

[FR Doc. 2012–26523 Filed 10–30–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0225; FRL–9360–9] 

Trifloxystrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of trifloxystrobin 

in or on almond hulls; and Vegetable, 

root, except sugarbeet, subgroup 1B, 

except radish. Bayer CropScience 

requested amendments to these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 31, 2012. Objections and 

requests for hearings must be received 

on or before December 31, 2012, 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–2012–0225, 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: 

Dominic Schuler, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–0260; email address: 

schuler.dominic@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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/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–2012–0225 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 December 31, 2012. 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 

mstockstill on DSK4VPTVN1PROD with RULES