Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Rules and Regulations 11965 

underlying rules is discussed in section 

VII of the rule titled, ‘‘Limitation of 

Approval of Prevention of Significant 

Deterioration Provisions Concerning 

Greenhouse Gas Emitting-Sources in 

State Implementation Plans’’ at 75 FR 

82549. 

List of Subjects in 40 CFR Part 52 

Administrative practice and 

procedure, Air pollution control, Carbon 

dioxide, Carbon dioxide equivalents, 

Environmental protection, Greenhouse 

gases, Hydrofluorocarbons, 

Intergovernmental relations, 

Incorporation by reference, Methane, 

Nitrous oxide, Perfluorocarbons, 

Reporting and recordkeeping 

requirements, Sulfur hexafluoride. 

Dated: February 24, 2011. 

Lisa P. Jackson, 

Administrator. 

For the reasons stated in the 

preamble, title 40, chapter I of the Code 

of Federal Regulations is amended as set 

forth below. 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart LL—Oklahoma 

■ 2. Section 52.1929 is amended by 

revising paragraph (c)(4)(iii) to read as 

follows: 

§ 52.1929 Significant deterioration of air 

quality. 

* * * * * 

(c) * * * 

(4) * * * 

(iii) The term emissions increase shall 

mean that both a significant emissions 

increase (as calculated using the EPAapproved procedures in Oklahoma Air 

Pollution Control Regulation Title 252, 

Chapter 100, Subchapter 8, Part 7) and 

a significant net emissions increase (as 

defined in the EPA-approved Oklahoma 

Air Pollution Control Regulation 

252:100–8–31, definitions for ‘‘net 

emissions increase’’ and ‘‘significant’’ 

occur. For the pollutant GHGs, an 

emissions increase shall be based on tpy 

CO2e, and shall be calculated assuming 

the pollutant GHGs is a regulated NSR 

pollutant, and ‘‘significant’’ is defined as 

75,000 tpy CO2e instead of applying the 

value in 252:100–8–31 of the EPAapproved definition for ‘‘significant’’ of 

Oklahoma’s Air Pollution Control 

Regulations. 

[FR Doc. 2011–4907 Filed 3–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0021; FRL–8865–3] 

Peroxyacetic Acid; Amendment to an 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing tolerance exemption for 

peroxyacetic acid by establishing an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

pesticide peroxyacetic acid (PAA) and 

its metabolites and degradates, 

including hydrogen peroxide (HP) and 

acetic acid (AA), in or on all food 

commodities, when PAA is used as a 

biochemical pesticide in accordance 

with good agricultural practices. BioSafe 

Systems, LLC submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting that 

EPA amend the existing PAA tolerance 

exemption. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of PAA 

under the FFDCA. 

DATES: This regulation is effective 

March 4, 2011. Objections and requests 

for hearings must be received on or 

before May 3, 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–2008–0021. 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 Office of 

Pesticide Programs (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: 

Cheryl Greene, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0352; e-mail address: 

greene.cheryl@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: 

• 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 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. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), 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–2008–0021 in the subject line on 


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11966 Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Rules and Regulations 

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 3, 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–2008–0021, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: 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. Background and Statutory Findings 

In the Federal Register of February 

13, 2008 (73 FR 8311) (FRL–8349–5), 

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 tolerance petition (PP 7F7262) 

by BioSafe Systems, LLC, 22 Meadow 

Street, East Hartford, CT 06108. The 

petition proposed to establish an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

pesticide, peroxyacetic acid in or on all 

agricultural commodities when used as 

a biochemical pesticide. This notice 

referenced a summary of the petition 

prepared by the petitioner, BioSafe 

Systems, LLC, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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 require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance exemption 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 * * *.’’ Additionally, section 

408(b)(2)(D) of FFDCA requires that EPA 

consider ‘‘available information 

concerning the cumulative effects of [a 

particular pesticide’s] residues and 

other substances that have a common 

mechanism of toxicity.’’ 

Section 408(a)(3) of FFDCA states that 

residues of metabolites or degradates of 

pesticide chemicals ‘‘shall not be 

considered to be unsafe * * * despite 

the lack of a tolerance or exemption 

from the need for a tolerance for such 

residue in or on such food’’ if three 

conditions are met. First, the Agency 

must not have determined that the 

degradation product ‘‘is likely to pose 

any potential health risk from dietary 

exposure that is of a different type than, 

or of a greater significance than, any risk 

posed by dietary exposure to the 

precursor substance’’. Second, for 

purposes of this action, an exemption 

exists for residues of the precursor 

substance. Third, again for purposes of 

this action, the exemption for residues 

of the precursor substance does not 

expressly exclude residues of the 

metabolites or degradates. 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information 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. 

A. Overview 

The purpose of this rulemaking is to 

amend the existing tolerance exemption 

for PAA to allow for residues of PAA 

and its metabolites and degradates, 

including HP and AA in or on all food 

commodities, when such residues result 

from its use as a biochemical pesticide 

in accordance with good agricultural 

practices. At high concentrations, PAA 

is a highly corrosive, colorless, organic 

compound that is formed, and only 

exists in equilibrium, with hydrogen 

peroxide and acetic acid. The current 

exemptions for residues of PAA allow 

application of PAA, after dilution to 

specific concentrations in parts per 

million (ppm), as an antimicrobial 

treatment to fruits, vegetables, tree nuts, 

cereal grains, herbs, spices, and as a 

sanitizing solution to tableware, 

utensils, dishes, pipelines, tanks, vats, 

fillers, evaporators, pasteurizers, aseptic 

equipment, milking equipment, and 

food processing equipment in food 

handling establishments. (40 CFR 

180.1196). 

B. Toxicity of PAA 

1. Acute toxicity. Acute toxicity data 

and information submitted to support 

the exemption from the requirement of 

a tolerance for peroxyacetic acid were 

conducted on the technical blend of 

peroxyacetic acid, acetic acid and 

hydrogen peroxide. PAA is always sold 

in solution with AA and HP to maintain 

stability of the chemical. Further, all 

three active ingredients have an 

identical mode of action as strong 

oxidizing agents that disrupt cell 

membranes because of the low ph. This 

information confirms the toxicity profile 

of peroxyacetic acid, acetic acid and 

hydrogen peroxide. The results of the 

toxicology studies as conducted on the 

technical blend are reported in the table 

of Unit III.B.1. 


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Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Rules and Regulations 11967 

TABLE—TOXICOLOGY STUDIES RESULTS

Study type Study results 

Acute oral toxicity ............................ The acute oral median LD50 = 3,622 milligrams/kilograms (mg/kg) for male and female rats given a solution 

containing 5.6% PAA, 26.9% H2O2, and 7.6% HOAc. This technical blend is Toxicity category III for 

acute oral toxicity. (Master Record Identification Number [MRID No.] 47237802, Ref. 1). (ECETOC, Ref. 

2). 

Acute dermal toxicity ....................... The acute dermal LD50 = 1,040 mg/kg (Tox category II) for female rabbits after a 24-hr semi-occlusive exposure to a solution containing 4.89% PAA, 19.72% H2O2, and 10% HOAc. (Ref. 1 and 2). 

Acute inhalation toxicity .................. The acute inhalation median LC50 > 5.35 mg/L for male and female rats exposed for 4 hr to aerosol of solution containing 4.5% PAA, 27% H2O2, and 16.7% HOAc. (Ref. 1 and 2). 

Primary eye irritation ....................... Due to pH of 0.82 for 2.0% solution and pH 0.82 for 5.0% solution, PAA is assumed to be a severe irritant; 

≥ 0.2% PAA was severely irritating or corrosive to the eye, 0.15% was mildly irritating to the rabbit eye, 

and 0.034% caused very slight irritation. (Ref. 1 and 2). 

Primary dermal irritation .................. Due to pH of 0.82 for 2.0% solution and pH 0.82 for 5.0% solution, PAA is assumed to be a severe irritant. 

(Ref. 1 and 2). 

2. Subchronic toxicity. Based on its 

acute toxicity profile, use pattern and 

biodegradation properties, rapid 

degradation half lives for degradates, 

residues of PAA and its degradates, 

including AA and HP, are not expected 

to result in significant dietary exposure 

beyond the levels expected in 

background dietary exposures. 

Nonetheless, information from the open 

scientific literature to address the 

subchronic oral, dermal and inhalation 

toxicity guidelines testing, satisfied the 

data requirements for subchronic 

toxicity and indicated that PAA and its 

degradates have no subchronic 

toxicological effect. 

C. Degradates of PAA 

PAA degrades rapidly to AA and HP, 

and HP further degrades to water and 

oxygen; therefore, the final degradation 

products of PAA are AA, water, and 

oxygen. As stated in Unit II., section 

408(a)(3) allows degradates of precursor 

substances to be covered by the 

exemption for the precursor substance 

as long as, inter alia, the Administrator 

has not determined that the degradation 

product ‘‘is likely to pose any potential 

health risk from dietary exposure that is 

of a different type than, or of a greater 

significance than, any risk posed by 

dietary exposure to the precursor 

substance’’. For PAA and its degradates 

AA and HP, EPA has made no such 

determination. The following discussion 

summarizes the Agency’s previous 

assessments of AA and HP. 

1. Acetic acid. AA is a substance 

found in most plants and animals, 

including primates and humans, and is 

naturally produced during the 

fermentation process in a wide range of 

foods. Furthermore, AA has a long 

history of use as a food additive, is the 

main acid in vinegar, and is found in 

wine, beer, and similarly brewed 

beverages and fermented food items 

(e.g., sauerkraut). The Food and Drug 

Administration (FDA) classifies AA as 

Generally Recognized as Safe (GRAS) as 

a direct food substance (21 CFR 

184.1005) and as a general purpose food 

additive (21 CFR 582.1005). 

Furthermore, information from the open 

literature indicates that AA has little or 

no toxicity from an acute oral 

perspective (toxicity category III; 

median lethal dose (LD50) = 3,310 mg/ 

kg). Data also indicate that AA has no 

subchronic, developmental, or 

mutagenic toxicological effects. (Ref. 3). 

2. Hydrogen peroxide. Previously, 

EPA assessed HP for potential risks to 

the U.S. population, including infants 

and children, and concluded that, since 

HP itself degrades rapidly into oxygen 

and water, residues of a solution that 

contains 1% HP are not expected to 

remain in or on food. Hydrogen 

peroxide is listed by the FDA as GRAS. 

Additionally, hydrogen peroxide is used 

to treat food at a maximum level of 

0.05% in milk used in cheesemaking, 

0.04% in whey, 0.15% in starch and 

corn syrup, and 1.25% in emulsifiers 

containing fatty acid esters as bleaching 

agents (21 CFR 184.1366). As a GRAS 

substance, hydrogen peroxide may be 

used in washing or to assist in the lye 

peeling of fruits and vegetables (21 CFR 

173.315). The information from open 

literature demonstrated that solutions 

containing 6% hydrogen peroxide have 

an acute oral LD50 >/= 5,000 mg/kg in 

rats (toxicity category III), an acute 

dermal LD50 >/= 10,000 mg/kg in rabbits 

(toxicity category IV), and an inhalation 

LC50 of 4 milligram/liter (mg/L) (toxicity 

category IV). The 6% hydrogen peroxide 

solutions are mild irritants to rabbit skin 

and cause severe irreversible corneal 

injury in half of the exposed rabbits 

(toxicity category I). Toxicology 

information from open literature 

demonstrated that solutions which 

contained 50% hydrogen peroxide have 

an acute oral LD50 < 500 mg/kg in rats 

(toxicity category II), and an acute 

dermal LD50 < 1,000 mg/kg in rabbits 

(toxicity category II). No deaths resulted 

after an 8-hour exposure of rats to 

saturated vapors of 90% hydrogen 

peroxide, LC50 = 4 mg/L (2,000 ppm). 

Solutions which contain 50% hydrogen 

peroxide also are extremely irritating 

(corrosive) to rabbit eyes (toxicity 

category I). EPA has concluded that for 

food use at an application rate of 1%, 

hydrogen peroxide has no apparent 

acute toxicity and subchronic toxicity 

end points exist to suggest a significant 

toxicity. An RfD (chronic toxicity) for 

hydrogen peroxide has not been 

estimated because of its short half-life in 

the environment and lack of any 

residues of toxicological concern. (Ref. 

4). 

IV. Aggregate Exposure 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

Dietary exposure to residues of PAA 

and its degradate components, AA and 

HP, are expected to be virtually 

nonexistent at the time of consumption. 

Even in the event of unlikely exposure, 

the information supporting this 

tolerance exemption demonstrates that 

any dietary risks would be negligible. 

1. Food. When used as a soil 

treatment, the Agency does not expect 

there to be any residues of PAA or its 

degradates because PAA breaks down 

rapidly on contact with soil, which 

precludes uptake of PAA by plants. The 

rate of degradation can be affected by 

the concentration of PAA in a solution 

and environmental conditions (e.g., 

temperature and pH of the environment 


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11968 Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Rules and Regulations 

in which the PAA is applied), but the 

Agency expects that PAA, when used as 

a biochemical pesticide for applications 

to soil or foliage or greenhouse 

structures, will likely degrade within 24 

hours following application. This is 

because good agricultural practices 

generally require a soil pH of 5 to 7, at 

which level PAA degrades in less than 

24 hours. Regardless of the time 

required for PAA to break down, the use 

of this biochemical pesticide as a preplant soil treatment would occur before 

any food crops would be present, and 

degradation would prevent uptake by 

plants; thus, no residues are expected 

from use as a soil treatment to sterilize 

the soil and kill pathogens in soils. 

When used to treat plants directly, the 

Agency anticipates that PAA will be 

applied to the plant at concentrations 

that will not cause damage to the plant. 

At such concentrations, the Agency 

expects PAA to degrade within 24 hours 

into AA, oxygen, and water because 

PAA begins to degrade immediately 

upon contact with organic matter. 

Therefore, the Agency has determined 

that there will be little to no exposure 

to PAA from direct treatment of plants. 

2. Drinking water exposure. The 

Agency expects there to be little to no 

exposure of humans to PAA and its 

degradates in drinking water since PAA 

degrades quickly in water, i.e., within 

24 hours, especially water bodies with 

neutral or alkaline pH levels, into AA, 

oxygen, and water. In the event that 

residues of the degradates are present, 

the levels of the degradates do not 

present a risk concern based on the 

foreseeable rates at which PAA is likely 

to be applied. 

B. Other Non-Occupational Exposure 

Non-occupational exposure is not 

expected since PAA rapidly degrades 

and is non-persistent in the 

environment. 

V. 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, EPA 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 peroxyacetic acid 

to share a common mechanism of 

toxicity with any other substances, and 

peroxyacetic acid does not appear to 

produce a toxic metabolite as its mode 

of action against the target pests. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

peroxyacetic acid does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

1. U.S. population. Based on the lack 

of exposure to much, if any, PAA and 

its metabolites and degradates, 

including HP and AA, the Agency has 

concluded that there is reasonable 

certainty that no harm will result to the 

general U.S. population, including 

infants and children, from aggregate 

exposure to PAA and its metabolites 

and degradates, including HP and AA. 

This includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. 

2. Infants and children. FFDCA 

section 408(b)(2)(C) provides that EPA 

shall apply an additional tenfold margin 

of exposure (MOE) for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

data base on toxicity and exposure, 

unless EPA determines that a different 

MOE will be safe for children. MOEs, 

which are often referred to as 

uncertainty (safety) factors, are 

incorporated into EPA risk assessments 

either directly, or through the use of a 

MOE analysis or by using uncertainty 

factors in calculating a dose level that 

poses no appreciable risk. Because there 

are no threshold effects of concern to 

infants, children, and adults from PAA 

and its metabolites or degradates, 

including HP and AA, the Agency 

concludes that the additional MOE is 

not necessary to protect infants and 

children and that removing the FQPA 

safety factor will be safe for infants and 

children. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since EPA 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 peroxyacetic acid. 

VIII. Conclusions 

EPA concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of peroxyacetic 

acid and its metabolites and degradates, 

including AA and HP. Therefore, the 

existing tolerance exemption for PAA is 

amended to establish a tolerance 

exemption for residues of the 

biochemical pesticide, peroxyacetic 

acid, in or on all food commodities, 

when used in accordance with good 

agricultural practices. 

IX. References 

1. Mileson, B.E. 2007. Biochemical Pesticide 

Data Required for Zerotol 2.0. Submitted 

by BioSafeSystems LLC. MRID 

472378002. 

2. ECETOC, 2001. Peroxyacetic Acid (CAS 

No. 79–21–0) and its Equilibrium 

Solutions. Joint Assessment of 

Commodity Chemicals, JACC No 40. 

European Centre for Ecotoxicology and 

Toxicology of Chemicals. Brussels, pp. 

27–32. January 2001. 

3. Environmental Protection Agency. [EPA– 

HQ–OPP–2010–0561; FRL–8833–8]. 

Acetic Acid: Exemption from the 

Requirement of a Tolerance. Final Rule; 

75 FR 40736, July 14, 2010. 

4. Environmental Protection Agency. [OPP– 

2002–0042; FRL–6835–3]. Hydrogen 

Peroxide; An amendment to an 

Exemption from the Requirement of a 

Tolerance; Technical Correction. Final 

Rule; Technical Correction; 67 FR 41844, 

June 20, 2002; Corrected 67 FR 9214, 

February 28, 2002, FRL–6822–7. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to EPA. 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 


jdjones on DSK8KYBLC1PROD with RULES2
Federal Register / Vol. 76, No. 43 / Friday, March 4, 2011 / Rules and Regulations 11969 

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 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. 

As a result, this action does not 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, 

EPA 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, EPA 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 

EPA consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. 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. 

Dated: February 17, 2011. 

Keith A. Matthews, 

Director, Biopesticides and Pollution 

Prevention 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 § 180.1196, add paragraph (c) to 

read as follows: 

§ 180.1196 Peroxyacetic acid; exemption 

from the requirement of a tolerance. 

* * * * * 

(c) An exemption from the 

requirement of a tolerance is established 

for residues of the biochemical pesticide 

peroxyacetic acid and its metabolites 

and degradates, including hydrogen 

peroxide and acetic acid, in or on all 

food commodities, when used in 

accordance with good agricultural 

practices. 

[FR Doc. 2011–4773 Filed 3–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Chapter 2 

Defense Federal Acquisition 

Regulation Supplement; Appendix A, 

Armed Services Board of Contract 

Appeals, Part 2—Rules 

CFR Correction 

In Title 48 of the Code of Federal 

Regulations, Chapter 2 (Parts 201 to 

299), revised as of October 1, 2010, on 

page 516, in Appendix A, above the 

heading ‘‘Preface’’, the following 

heading and text is added; 

APPENDIX A TO CHAPTER 2— 

ARMED SERVICES BOARD OF 

CONTRACT APPEALS 

* * * * * 

Part 2—Rules 

Approved 15 July 1963. 

Revised 1 May 1969. 

Revised 1 September 1973. 

Revised 30 June 1980. 

* * * * * 

[FR Doc. 2011–5074 Filed 3–3–11; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 660 

[Docket No. 110111018–1095–02] 

RIN 0648–XA109 

Fisheries Off West Coast States; 

Coastal Pelagic Species Fisheries; 

Annual Specifications 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary emergency rule; 

interim measures. 

SUMMARY: NMFS is suspending directed 

fishing for Pacific sardine off the coasts 

of Washington, Oregon and California 

through June 30, 2011. This action is 

necessary because the proposed directed 

harvest allocation total for Pacific 

sardine the first seasonal period 

(January 1–June 30) of 15,214 metric 

tons (mt) is projected to be reached by 

the effective date of this rule. Under this 

rule, Pacific sardine may be harvested 

only as part of the live bait fishery or 

incidental to other fisheries; the 

incidental harvest of Pacific sardine is 


jdjones on DSK8KYBLC1PROD with RULES2