[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Rules and Regulations]
[Pages 75168-75173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30679]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301068; FRL-6748-6]
RIN 2070-AB78


Peroxyacetic Acid; Exemption From the Requirement of a Tolerance

AGENCY:  Environmental Protection Agency (EPA).

 ACTION:  Final rule.

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SUMMARY:  This regulation establishes an exemption from the requirement 
of a tolerance for residues of peroxyacetic acid, in or on all raw and 
processed food commodities when used in sanitizing solutions containing 
a diluted end-use concentration of peroxyacetic acid up to 500 ppm, and 
applied to tableware, utensils, dishes, pipelines, tanks, vats, 
fillers, evaporators, pasteurizers, aseptic equipment, milking 
equipment, and other food processing equipment in food handling 
establishments including, but not limited to dairies, dairy barns, 
restaurants, food service operations, breweries, wineries, and beverage 
and food processing plants. Ecolab, Incorporated submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act, as amended by 
the Food Quality Protection Act of 1996 requesting an exemption from 
the requirement of a tolerance. This regulation eliminates the need to

[[Page 75169]]

establish a maximum permissible level for residues of peroxyacetic 
acid. This final rule amends the current peroxyacetic acid exemption; 
and adds the subject peroxyacetic acid exemption. This final rule is 
being published with a companion final rule titled ``Hydrogen Peroxide; 
Exemption From the Requirement of a Tolerance.''

DATES:  This regulation is effective December 1, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301068, 
must be received by EPA on or before January 30, 2001.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301068 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Marshall Swindell, Product 
Manager 33, Antimicrobial Division (7510C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703 308-6341; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
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Industry                          111...............  Crop production
  ..............................  112...............  Animal production
                                  311                 Food manufacturing
  ..............................  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

     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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

     1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
     2. In person. The Agency has established an official record for 
this action under docket control number OPP-301068. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

     In the Federal Register of February 3, 1999 (64 FR 22) (FRL-5273-
7), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide tolerance petition by, Ecolab, Incorporated. This 
notice included a summary of the petition prepared by the petitioner 
Ecolab, Incorporated. There were no comments received in response to 
the notice of filing.
     The petition requested that 40 CFR 180.1196 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of peroxyacetic acid.

III. Risk Assessment

     Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
     EPA 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.

IV. 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. The nature of the toxic effects caused 
by peroxyacetic acid are discussed in this unit.
     Ecolab, Inc. has requested a waiver of all toxicology testing 
requirements for peroxyacetic acid. This includes waivers for all 
acute, 90-day sub-chronic, chronic, oncogenicity, developmental, 
reproductive, mutagenicity, neurotoxicity and metabolism requirements 
for peroxyacetic acid. The Agency has reviewed the data waivers 
requested and concurs that no additional generic toxicology testing 
will be needed for

[[Page 75170]]

peroxyacetic acid for the following reasons.
     1. Peroxyacetic acid is highly reactive and short lived because of 
the inherent instability of the peroxide bond (ie., the O-O bond). 
Agitation or contact with rough surfaces, sunlight, organics and metals 
accelerates decomposition. The instability of peroxyacetic acid to 
exist as itself, along with detoxifying enzymes found in cells (eg., 
catalase, glutathione peroxidase), makes it very difficult to find any 
residues of peroxyacetic acid in or on foods (at proposed use levels), 
by conventional analytical methods.
     The proposed food contact applications also utilize very low 
concentrations of peroxyacetic acid. Therefore, food residues are 
expected to be short-lived, based on half-lives for peroxyacetic acid 
as short as a few minutes under certain conditions. The primary 
degradates are acetic acid, oxygen and water, and these degradates are 
not of toxicological concern.
    2. There are acceptable acute generic data referenced in the 
Reregistration Eligibility Document (RED) for Peroxy Compounds 
(December 1993, Case 4072). Peroxyacetic acid was found to be corrosive 
and severely irritating to the eyes, skin, and mucous membranes but 
only when high concentrations were used. The proposed use patterns 
involve low concentrations and are expected to result in a lack of any 
residues of toxicological concern. The RED document waived all other 
non-acute toxicology data requirements for peroxyacetic acid.
     3. No data exists for the subchronic, chronic, carcinogenicity, 
mutagenicity, developmental and reproductive toxicity of peroxyacetic 
acid. However, peroxyacetic acid shares similar chemical 
characteristics with hydrogen peroxide which has a more extensive 
toxicology data base. For example, peroxyacetic acid and hydrogen 
peroxide both decompose into two identical degradates that do not pose 
any toxicological concern. These two degradates are oxygen and water. 
Acetic acid is also a degradate of peroxyacetic acid and does not pose 
any toxicological concern.
     Peroxyacetic acid and hydrogen peroxide also show similar chemical 
characteristics for corrosivity, pH, rapid peroxide bond dissociation, 
and production of oxygen molecules. Because of these similar chemical 
characteristics, and low expected exposures with the proposed uses, the 
dose-response toxicology relationships (i.e. adverse effects 
experienced only at very high doses) shown by the data for hydrogen 
peroxide, can also be expected with peroxyacetic acid. The remaining 
toxicology testing requirements for peroxyacetic acid were waived 
because of the similar chemical characteristics, similar expected dose-
response relationships with hydrogen peroxide, low exposure levels 
under the proposed uses, and for the reasons given above.

V. Aggregate Exposures

A. Dietary Exposure

     1. Food. For the proposed sanitizer uses, the 15.2% (by weight) 
concentrate of peroxyacetic acid will be diluted with potable water at 
the rate of 1 to 1.8 ounces of concentrated product per 1,024 ounces (8 
gallons) of dilution water for food contact surfaces (eg., food 
packaging equipment), and for eating, drinking, and food preparation 
utensils. For low temperature (120 degrees F) tableware sanitization in 
warewashing machines, the dilution rate is 1 ounce of concentrated 
product per 3,840 ounces (30 gallons) of dilution water.
    These dilution rates correspond to a low concentration range of 
peroxyacetic acid in the sanitizer product at the time of application 
of 40 to 274 ppm. The sanitizer solution, having a low concentration of 
peroxyacetic acid reacts on contact with the surface on which it is 
applied and degrades rapidly to acetic acid, oxygen and water which 
pose no toxicological concern. Therefore, residues of peroxyacetic acid 
resulting from its use in sanitizer solutions up to 500 ppm are 
expected to be negligible on all raw and processed food commodities. 
The difference between the 274 ppm maximum end use concentration, and 
the 500 ppm exemption concentration requested by Ecolab, is warranted 
to overcome any degradation of peroxyacetic acid during transport and 
non-use periods, and to provide flexibility for changes in formulation.
     The following EPA and FDA tolerances and/or exemptions from 
tolerances for peroxyacetic acid are noted:
     Under 40 CFR 180.1196 as a direct application at 100 ppm to 
fruits, vegetables, tree nuts, cereal grains, herbs and spices.
     Under 21 CFR 178.1010(b)(30) for sanitizing solutions used on 
food-processing equipment and utensils and on other food contact 
articles. Sanitizing solutions may contain not less than 100 ppm nor 
more than 200 ppm peroxyacetic acid as per 21 CFR 178.1010(c)(25).
     Under 21 CFR 178.1010(b)(38) for sanitizing solutions used on food 
processing equipment and dairy processing equipment. Sanitizing 
solutions may contain not less than 200 ppm nor more than 315 ppm as 
per 21 CFR 178.1010(c)(33).
     Under 21 CFR 173.315(a)(2) in washing or to assist in lye peeling 
of fruits and vegetables that are not raw agricultural commodities. The 
concentration can not exceed 80 ppm in the wash water.
     In 21 CFR 184.1005, the acetic acid degradate of peroxyacetic acid 
is Generally Recognized As Safe (GRAS) as a direct food additive 
substance when used in baked goods, cheeses, dairy product analogs, 
chewing gum, condiments, relishes, fats, oils, gravies, sauces, and 
meat products.
    2. Drinking Water Exposure. The proposed indoor food contact uses 
for peroxyacetic acid are not expected to result in transfer of 
peroxyacetic acid to any potential drinking water sources. Therefore, 
no risk assessment is warranted.

B. Other Non-Occupational Exposure

    Peroxyacetic acid is currently registered by EPA for a wide variety 
of uses including: agricultural premises and equipment; food handling/
storage establishments premises and equipment; commercial, 
institutional and industrial premises and equipment; residential and 
public access premises; medical premises and equipment; materials 
preservation; and industrial processes and water systems. The Agency 
does not know of all approved or actual uses for peroxyacetic acid. 
However, non-dietary exposures are not expected to pose any 
quantifiable added risk because of the lack of any expected residues 
and degradates of toxicological concern. Minimal residues and 
degradates are expected due to previously discussed unique chemistry 
associated with peroxide bond chemistry.

VI. Cumulative Effects

     The Food Quality Protection Act (1996) stipulates that when 
determining the safety of a pesticide chemical, EPA shall consider, 
among other things, available information concerning the cumulative 
effects to human health that may result from dietary, residential, or 
other non-occupational exposure to other substances that have a common 
mechanism of toxicity. The reason for consideration of other substances 
is due to the possibility that low-level exposures to multiple chemical 
substances that cause a common toxic effect by a common mechanism could 
lead to the same adverse health effect as would a higher level of 
exposure to any of the other substances individually. A person exposed 
to a pesticide at a level

[[Page 75171]]

that is considered safe may in fact experience harm if that person is 
also exposed to other substances that cause a common toxic effect by a 
mechanism common with that of the subject pesticide, even if the 
individual exposure levels to the other substances are also considered 
safe.
     Because of the low use rates of peroxyacetic acid, its low 
toxicity and rapid degradation, EPA does not believe that there are any 
concerns regarding the potential for cumulative effects of peroxyacetic 
acid with other substances, due to a common mechanism of action. 
Peroxyacetic acid is not known to have a common toxic metabolite with 
other substances. Therefore, EPA has not assumed that peroxyacetic acid 
has a common mechanism of toxicity with other substances.

VII. Determination of Safety for U.S. Population, Infants and 
Children

    Peroxyacetic acid is of low toxicity, and the proposed uses employ 
low concentrations. Because of the low toxicity and rapid degradation 
of peroxyacetic acid following application, EPA concludes that this 
exemption from the requirement of a tolerance in or on all raw and 
processed food commodities, when peroxyacetic acid is used in diluted 
sanitizing solutions up to 500 ppm, will not pose a dietary risk to the 
U.S. population, infants, or children, under reasonably forseeable 
circumstances. Further, EPA finds that there is a reasonable certainty 
of no harm from aggregate exposure to peroxyacetic acid and thus that 
the exemption for peroxyacetic acid is safe. The Agency's human risk 
assessment findings are summarized below.
    1. Acute dietary risk assessment. Acute dietary risk assessments 
are performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. No acute exposure and risk assessment is 
applicable for peroxyacetic acid because no acute toxicological effects 
of concern are anticipated with the proposed food contact uses. This is 
due to the lack of any residues of toxicological concern because of the 
rapid decomposition of peroxyacetic acid into acetic acid, oxygen, and 
water. Use of peroxyacetic acid for indoor food equipment sanitization 
uses is not expected to result in the transfer of any residues to 
potential drinking water sources.
    2. Chronic dietary risk assessment. Residues of peroxyacetic acid 
are not expected to remain on the surface of materials which it 
contacts. Therefore, the risk from dietary exposure is expected to be 
negligible. No chronic exposure and risk assessment is applicable 
because no chronic toxicological effects are anticipated with the 
proposed food contact uses for peroxyacetic acid. This is due to the 
lack of any residues of toxicological concern because of the rapid 
decomposition of peroxyacetic acid into acetic acid, oxygen, and water. 
Use of peroxyacetic acid for indoor food equipment sanitization uses is 
not expected to result in the transfer of any residues to potential 
drinking water sources.
    3. Aggregate cancer risk for U.S. population. The Agency believes 
that based on the known chemistry of peroxy compounds, toxic effects 
occur as a result of species formed either during spontaneous 
decomposition or enzymatic conversion of the peroxy bond (i.e. O-O 
bond). These effects occur only after long term administration of high 
dose levels, where the parent compound is continually present. 
Available data show that peroxyacetic acid rapidly breaks down into 
oxygen, water, and acetic acid. Because of this rapid decomposition, 
the Agency does not expect residues of the parent compound when used as 
a sanitizer.
    Based on the proposed use concentrations for peroxyacetic acid, and 
data indicating a lack of residues of concern on food, exposure to 
peroxyacetic acid under the proposed food contact use concentrations is 
not likely to result in any adverse clinical effects, including 
promotion of carcinogenisis. This conclusion is supported by the rapid 
decomposition of peroxyacetic acid into oxygen, water, and acetic acid, 
which are not of toxicological concern, and the existence of specific 
enzymes in the human body (i.e. catalase and glutathione peroxidase) 
which also can break down peroxyacetic acid.
     The Agency concludes that cancer risk for the U.S. population from 
aggregate exposure to peroxyacetic acid is negligible under the 
proposed food contact use concentrations.
    4. Aggregate risks and determination of safety for infants and 
children. In assessing the potential for additional sensitivity of 
infants and children to residues of peroxyacetic acid, EPA considered 
data from developmental and reproductive toxicity studies available 
from the scientific literature and summarized by the Office of Water. 
The developmental toxicity studies are designed to evaluate adverse 
effects on the developing organism resulting from maternal pesticide 
exposure during gestation. Reproduction studies provide information 
relating to effects from exposure to the pesticide on the reproductive 
capability of mating animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the database, unless EPA determines that a 
different margin of safety will be safe for infants and children.
    Margins of safety are incorporated into EPA risk assessments either 
directly through use of a MOE analysis or through using uncertainty 
(safety) factors in calculating a dose level that poses no appreciable 
risk to humans. In either case, EPA generally defines the level of 
appreciable risk as exposure that is greater than 1/100 of the no 
observed adverse effect level (NOAEL) in the animal study appropriate 
to the particular risk assessment. This 100-fold uncertainty factor/
margin of exposure is designed to account for inter-species 
extrapolation and intra-species variability.
    In the case of the proposed food contact uses for peroxyacetic 
acid, because of the lack of any significant residues of toxicological 
concern, a NOAEL was not identified for risk assessment purposes, and 
the uncertainty (safety) factor approach was not used for assessing any 
risk level by peroxyacetic acid. For the same reason, an additional 
safety factor to protect infants and children is unnecessary. 
Additionally, based on the following information, no increased 
susceptibility to infants or children is expected to occur.
    i. Three studies on the developmental and reproductive effects of 
hydrogen peroxide (and by similarity, peroxyacetic acid) are available. 
The data from these studies indicates that no apparent developmental or 
reproductive effects were observed from administration of hydrogen 
peroxide at concentrations up to 1% (1,000 milligrams/kilograms).
    ii. Peroxyacetic acid is a highly reactive and short lived molecule 
because of the inherent instability of the peroxide bond (ie., the O-O 
bond). Agitation or contact with rough surfaces, sunlight, organics, 
and metals accelerates dissociation. The instability of peroxyacetic 
acid to exist as itself, along with natural detoxifying enzymes found 
in plant and animal cells (eg., catalase, glutathione peroxidase), 
makes it very difficult to find any residues of peroxyacetic acid in or 
on foods (at proposed use levels), by conventional analytical methods. 
The proposed food

[[Page 75172]]

contact applications utilize very low concentrations of peroxyacetic 
acid (ppm). Food residues are expected to be short-lived and are not 
expected to accumulate. This is because peroxyacetic acid dissociates 
rapidly into acetic acid, oxygen, and water. The Agency has no 
toxicological concern with acetic acid, oxygen, and water.
    iii. A waiver was granted for all the remaining toxicology testing 
requirements because of the reasons given in items a and b above.
     Therefore, because of the rapid decomposition of peroxyacetic acid 
residues into degradates that are of no toxicological concern (ie., 
oxygen, water, acetic acid), the Agency concludes that there is a 
reasonable certainty of no harm for infants and children from exposure 
to peroxyacetic acid under the proposed food contact use 
concentrations.

VIII. Other Considerations

A. Endocrine Disruptors

     The Food Quality Protection Act (FQPA; 1996) requires that EPA 
develop a screening program to determine whether certain substances 
(including all pesticides and inerts) ``may have an effect in humans 
that is similar to an effect produced by a naturally occurring 
estrogen, or such other endocrine effect....'' EPA has been working 
with interested stakeholders, including other government agencies, 
public interest groups, and industry and research scientists to develop 
a screening and testing program as well as a priority setting scheme to 
implement this program. The Agency's proposed Endocrine Disrupter 
Screening Program was published in the Federal Register on December 28, 
1998 (63 FR 71541). As the Agency proceeds with implementation of this 
program, further testing of peroxyacetic acid for endocrine effects may 
be required. The currently available animal data suggest no significant 
endocrine effects from exposure to hydrogen peroxide.

B. Analytical Method(s)

     Because an exemption from the requirement of a tolerance without 
numerical limitation on residue levels is being granted for 
peroxyacetic acid, an enforcement analytical method is not needed. 
However, an analytical method (designated QATM 202 by Ecolab, Inc., a 
redox titration procedure) is available in cases of gross misuse. The 
analytical method is being made available to anyone interested in 
pesticide enforcement when requested, from Norm Cook, Antimicrobials 
Division (7510C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, DC 
20460. Office location and telephone number: 1921 Jefferson Davis 
Highway, 3rd Floor, Arlington, VA 22202, 703 308-8253.

C. Existing Tolerances

     In 40 CFR Part 180.1196, an exemption from the requirement of a 
tolerance is established for residues of peroxyacetic acid up to 100 
ppm in or on raw agricultural commodities, in processed commodities, 
when such residues result from the use of peroxyacetic acid as an 
antimicrobial agent on fruits, vegetables, tree nuts, cereal grains, 
herbs, and spices.

D. International Tolerances

     There are no Codex Alimentarius (Codex) Commission Maximum Residue 
Levels for peroxyacetic acid.

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

     You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301068 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before January 
30, 2001.
     1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
     Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its

[[Page 75173]]

inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301068, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). 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., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or require OMB review or any Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a petition under FFDCA section 408(d), such as the 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

XI. Submission to Congress and the Comptroller General

     The Congressional Review Act, 5 U.S.C. 801 et seq., as added by 
the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, 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: November 9, 2000.
Frank Sanders,
Director, Antimicrobial 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 180.1196 is revised to read as follows:


Sec. 180.1196  Peroxyacetic acid; exemption from the requirement of a 
tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of peroxyacetic acid in or on raw agricultural 
commodities, in processed commodities, when such residues result from 
the use of peroxyacetic acid as an antimicrobial treatment in solutions 
containing a diluted end use concentration of peroxyacetic acid up to 
100 ppm per application on fruits, vegetables, tree nuts, cereal 
grains, herbs, and spices.
    (b) An exemption from the requirement of a tolerance is established 
for residues of peroxyacetic acid, in or on all raw and processed food 
commodities when used in sanitizing solutions containing a diluted end-
use concentration of peroxyacetic acid up to 500 ppm, and applied to 
tableware, utensils, dishes, pipelines, tanks, vats, fillers, 
evaporators, pasteurizers, aseptic equipment, milking equipment, and 
other food processing equipment in food handling establishments 
including, but not limited to dairies, dairy barns, restaurants, food 
service operations, breweries, wineries, and beverage and food 
processing plants.

[FR Doc. 00-30679 Filed 11-30-00; 8:45 am]
BILLING CODE 6560-50-S