Document ID: EPA-HQ-OPP-2008-0021-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of Tolerance: Peroxyacetic Acid; Amendment
Posted Date: 2011-03-04T05:00Z

[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Rules and Regulations]
[Pages 11965-11969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4773]

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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.

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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

[[Page 11966]]

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.

[[Page 11967]]

                    Table--Toxicology Studies Results
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            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 non-occupational 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

[[Page 11968]]

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 pre-plant 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

[[Page 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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.1196, add paragraph (c) to read as follows:

Sec.  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