11340 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

converted into a nursing home; clarifies 

the provisions for multiple and separate 

occupancy for nursing homes; enhances 

door locking provisions based on 

clinical need or specialized security 

measures; recognizes the use of aerosolbased alcohol hand rub dispensers; and 

clarifies latching provisions for certain 

doors that open into/onto corridors. In 

the proposed rule, we noted that we 

were not aware of any significant 

changes from the 2006 edition to the 

2009 edition. The commenter 

acknowledged that the differences 

between the two editions are 

insignificant. Because none of the 

applicable updates to the 2009 edition 

of NFPA 101 require costly or 

significant changes to the facilities 

governed by this rule, we make no 

changes based on this comment. 

This final rule amends § 51.200 as 

proposed without changes, and 

incorporates by reference NFPA 101, in 

accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditure by state, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

year. This final rule will have no such 

effect on state, local, and tribal 

governments, or on the private sector. 

Paperwork Reduction Act of 1995 

This document contains no new 

collections of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3521). 

Executive Order 12866 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Executive Order classifies a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB) unless OMB waives such review, 

as any regulatory action that is likely to 

result in a rule that may: (1) Have an 

annual effect on the economy of $100 

million or more or adversely affect in a 

material way the economy, a sector of 

the economy, productivity, competition, 

jobs, the environment, public health or 

safety, or state, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

VA has examined the economic, 

interagency, budgetary, legal, and policy 

implications of this final rule and has 

concluded that it does not constitute a 

significant regulatory action under the 

Executive Order. 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this regulatory amendment will not 

have a significant economic impact on 

a substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. This 

rulemaking will affect veterans and 

State Homes. The State Homes that will 

be subject to this rulemaking are state 

government entities under the control of 

state governments. All State Homes are 

owned, operated and managed by state 

governments except for a small number 

that are operated by entities under 

contract with state governments. These 

contractors are not small entities. 

Therefore, pursuant to 5 U.S.C. 605(b), 

this amendment is exempt from the 

initial and final regulatory flexibility 

analysis requirements of sections 603 

and 604. 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance numbers and titles for the 

programs affected by this document are 

64.005, Grants to States for Construction 

of State Home Facilities; 64.007, Blind 

Rehabilitation Centers; 64.008, Veterans 

Domiciliary Care; 64.009, Veterans 

Medical Care Benefits; 64.010, Veterans 

Nursing Home Care; 64.011, Veterans 

Dental Care; 64.012, Veterans 

Prescription Service; 64.013, Veterans 

Prosthetic Appliances; 64.014, Veterans 

State Domiciliary Care; 64.015, Veterans 

State Nursing Home Care; 64.016, 

Veterans State Hospital Care; 64.018, 

Sharing Specialized Medical Resources; 

64.019, Veterans Rehabilitation Alcohol 

and Drug Dependence; 64.022, Veterans 

Home Based Primary Care; and 64.026, 

Veterans State Adult Day Health Care. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. John 

R. Gingrich, Chief of Staff, Department 

of Veterans Affairs, approved this 

document on February 8, 2011, for 

publication. 

List of Subjects in 38 CFR Part 51 

Administrative practice and 

procedure, Claims, Day care, Dental 

health, Government contracts, Grant 

programs—health, Grant programs— 

veterans, Health care, Health facilities, 

Health professions, Health records, 

Incorporation by reference, Mental 

health programs, Nursing homes, 

Reporting and recordkeeping 

requirements, Travel and transportation 

expenses, Veterans. 

Dated: February 23, 2011. 

Robert C. McFetridge, 

Director, Regulations Policy and 

Management, Department of Veterans Affairs. 

For the reasons stated above, VA 

amends 38 CFR part 51 as follows: 

PART 51—PER DIEM FOR NURSING 

HOME CARE OF VETERANS IN STATE 

HOMES 

■ 1. The authority citation for part 51 

continues to read as follows: 

Authority: 38 U.S.C. 101, 501, 1710, 1741– 

1743, 1745. 

■ 2. Amend § 51.200, by removing the 

phrase ‘‘NFPA 101, Life Safety Code 

(2006 edition)’’ each place it appears 

and adding, in its place, ‘‘NFPA 101, 

Life Safety Code (2009 edition)’’. 

[FR Doc. 2011–4430 Filed 3–1–11; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0996; FRL–8859–5] 

Potassium Hypochlorite; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

the exemption from the requirement of 

a tolerance for residues of Potassium 

hypochlorite. Enviro Tech Chemical 

Services, Inc. submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting that 

Potassium hypochlorite in end-use 

products be eligible for the exemption 

from the requirement of a tolerance. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11341 

DATES: This regulation is effective 

March 2, 2011. Objections and requests 

for hearings must be received on or 

before May 2, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0996. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Wanda Henson, Antimicrobials Division 

(7510P), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–6345; e-mail 

address: henson.wanda@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 a dairy cattle milk 

producer, food manufacturer, or 

beverage manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Dairy Cattle Milk Production 

(NAICS code 11212). 

• Food manufacturing (NAICS code 

311). 

• Beverage Manufacturing (NAICS 

code 31212). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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.gpoaccess.gov/ecfr. 

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–2009–0996 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 May 2, 2011. 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 that does not 

contain 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0996, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Exemption 

In the Federal Register of Wednesday, 

January 12, 2011 (76 FR 2110) (FRL– 

8860–9), EPA issued a notice pursuant 

to section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 0F7767) 

by Enviro Tech Chemical Services, Inc, 

Modesto, CA 95358. The petition 

requested that 40 CFR part 180 be 

amended to establish an exemption 

from the requirement of a tolerance for 

potassium hypochlorite in or on apple; 

artichoke; asparagus; brussel sprouts; 

carrot; cauliflower; celery; cherry; 

cabbage; lettuce; fruits, citrus; 

cucumber; onion, green; melon; peach; 

nectarine; plum; pear; pepper, bell; 

potato; radish; fruit, stone; and tomato. 

That notice referenced a summary of the 

petition prepared by Enviro Tech 

Chemical Services, Inc., the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which requires 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue . * * *’’ 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

section 408(c)(2)(B) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

WReier-Aviles on DSKGBLS3C1PROD with RULES

11342 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for Potassium 

hypochlorite, including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with potassium hypochlorite 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by potassium hypochlorite is available 

in the docket, http:// 

www.regulations.gov. 

The Agency conducted an in-depth 

review of the similarities between 

potassium hypochlorite and the existing 

registered active ingredients, sodium 

hypochlorite and calcium hypochlorite. 

Based upon this review, the Agency 

determined that the data available to 

support the registrations of these active 

ingredients are also applicable to 

potassium hypochlorite. No additional 

generic or product-specific acute, 

chronic or subchronic toxicological 

studies were required to be submitted in 

support of this application. All 

toxicology data were bridged from 

studies on sodium and calcium 

hypochlorite based on their chemical 

similarity. 

Potassium hypochlorite is corrosive 

and can cause severe damage to the eyes 

and skin. Potassium hypochlorite has 

been assigned a Toxicity Category I, 

indicating the highest degree of toxicity 

for these acute effects. In the presence 

of oxygen, however, these compounds 

react easily with organic matter and 

convert readily into potassium chloride 

due to their simple chemical nature and 

structure. Exemptions from the 

requirement of a tolerance have been 

established for sodium and calcium 

hypochlorite used both as food contact 

surface sanitizers (40 CFR 180.940) and 

as antimicrobials used on raw 

agricultural commodities (40 CFR 

180.1054 and 180.1235). Widely used in 

disinfecting water supplies for nearly a 

century, the hypochlorite class of 

chemicals has proven safe and practical 

to use provided that necessary 

precautions are taken by the user to 

prevent the eye and skin irritation 

which are inherent to all strong 

oxidizing agents. All documents related 

to this case can be found at http:// 

www.regulations.gov in the document 

‘‘Antimicrobial Pesticide Products; 

Registration Applications’’ page 16110 

in docket ID number EPA–HQ–OPP– 

2009–0996. 

B. Toxicological Points of Departure/ 

Levels of Concern for Potassium 

Hypochlorite 

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 no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect in 

a lifetime. For more information on the 

general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to potassium hypochlorite, 

EPA considered exposure under the 

petitioned-for exemption. EPA assessed 

dietary exposures from potassium 

hypochlorite in food as follows: 

Residues of potassium hypochlorite 

may remain on certain food crops as a 

result of their disinfectant uses. 

However, these residues pose no dietary 

risks of concern to human health based 

on data bridged from sodium 

hypochlorite. Therefore, a dietary risk 

assessment for potential exposures to 

residues in food is unwarranted. 

2. Dietary exposure from drinking 

water. Residues of potassium 

hypochlorite that may remain in 

drinking water as a result of the use of 

this chemical are not expected to pose 

dietary risks of concern to human health 

based on data bridged from sodium 

hypochlorite. 

3. Non-dietary exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., textiles 

(clothing and diapers), carpets, 

swimming pools, and hard surface 

disinfection on walls, floors, tables). 

Potassium hypochlorite is currently 

registered for the following residential 

non-dietary sites: Swimming pools, spa 

and hot tubs, hard, non-porous and 

porous surfaces, and laundry. 

Although residential exposure to 

mixer/loader/applicators is likely from 

the proposed uses of potassium 

hypochlorite, a quantitative risk 

assessment is not required because 

adverse systemic effects attributable to 

the dermal and inhalation routes of 

exposure to potassium hypochlorite are 

not expected based on toxicity data 

bridged from sodium hypochlorite. 

Label precautionary statements and 

the requirement that applicators wear 

certain personal protective equipment 

(goggles or face shield and rubber 

gloves) are sufficient to protect users 

from the localized, irritation effects of 

exposure to potassium hypochlorite. In 

addition, the label states that users of 

swimming pools may not enter treated 

water until the residual chlorine is 

measured to be between 1 ppm and 3 

ppm in order to prevent acute irritation 

effects. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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 potassium 

hypochlorite to share a common 

mechanism of toxicity with any other 

substances, and potassium hypochlorite 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that Potassium hypochlorite 

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 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 11343 

chemical, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

Because potassium hypochlorite was 

of very low systemic toxicity, EPA did 

not use a safety factor analysis for 

assessing risk. For similar reasons, the 

additional safety factor for the 

protection of infants and children is not 

necessary. 

E. Aggregate Risks and Determination of 

Safety 

Based on the toxicity profile and 

exposure scenarios for potassium 

hypochlorite, EPA believes that the risks 

from dietary exposures to this pesticide 

would be minimal and without 

consequence to human health. Although 

residential use of potassium 

hypochlorite poses potential risks for 

acute eye and skin injury, it is not 

appropriate to aggregate the exposure 

related to these surface irritation effects 

with systemic exposure from dietary 

ingestion. In any event, the Agency 

believes that these acute risks will be 

sufficiently mitigated by precautionary 

labeling requiring protection of eyes and 

skin while using this pesticide. 

Based on the toxicological and 

exposure data discussed in this 

preamble, EPA concludes that 

potassium hypochlorite will not pose a 

risk under reasonably foreseeable 

circumstances. Accordingly, EPA finds 

that there is a reasonable certainty of no 

harm will result to the general 

population, or to infants and children, 

from aggregate exposure to potassium 

hypochlorite residues. 

IV. 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 U.N. 

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 

potassium hypochlorite. 

V. Conclusion 

Therefore, an exemption is 

established for residues of potassium 

hypochlorite. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Pub. L. 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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, Potassium hypochlorite. 

Dated: February 23, 2011. 

Joan Harrigan Farrelly, 

Director, Antimicrobials 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. Section 180.1300 is added to 

subpart D to read as follows: 

§ 180.1300 Potassium hypochlorite; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

WReier-Aviles on DSKGBLS3C1PROD with RULES

11344 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations 

of potassium hypochlorite in or on all 

commodities. 

[FR Doc. 2011–4534 Filed 3–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0823; FRL–8864–9] 

Difenoconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

difenoconazole in or on mango and wax 

jambu. Syngenta Crop Protection, 

Incorporated requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 2, 2011. Objections and requests 

for hearings must be received on or 

before May 2, 2011, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0823. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tony Kish, Registration Division, Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 308– 

9443; e-mail address: 

kish.tony@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://www.gpoaccess.gov/ecfr. 

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–2009–0823 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 May 2, 2011. 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 that does not 

contain 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0823, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7573) by 

Syngenta Crop Protection, Inc., P. O. 

Box 18300, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.475 

be amended by establishing tolerances 

for residues of the fungicide, 

difenoconazole, [1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H–1,2,4-triazole], 

in or on mango at 0.09 parts per 

million(ppm) and waxapple at 1.5 ppm. 

That notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, Inc., the registrant, which is 

available in the docket, http:// 

www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance for mango, fruit 

from 0.09 ppm to 0.07 ppm to reflect the 

Agency’s recommended tolerance level. 

Additionally, EPA corrected commodity 

definitions from ‘‘mango, fruit’’ to 

‘‘mango’’ and ‘‘waxapple’’ to ‘‘wax jambu’’ 

to reflect prescribed terminology. The 

reasons for these changes are explained 

in Unit IV.D. 

WReier-Aviles on DSKGBLS3C1PROD with RULES