[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Rules and Regulations]
[Pages 75174-75179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30680]



[[Page 75174]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301071; FRL-6748-5]
RIN 2070-AB78


Hydrogen Peroxide; 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 Hydrogen Peroxide, in or on all raw and 
processed food commodities when used in sanitizing solutions containing 
a diluted end-use concentration of hydrogen peroxide up to 1,100 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, (FFDCA) as 
amended by the Food Quality Protection Act (FQPA) of 1996 requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of hydrogen peroxide. This final rule reinserts, and amends 
the hydrogen peroxide exemption that was deleted from the July 1, 1998 
edition of 40 CFR; incorporates the currently published hydrogen 
peroxide exemption, unchanged and adds the subject hydrogen peroxide 
exemption. This final rule is being published with a companion final 
rule titled ``Peroxyacetic Acid; 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-301071, 
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-301071 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; and 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            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-301071. 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 FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170) announcing the filing 
of a pesticide tolerance petition by Ecolab, Inc. This notice included 
a summary of the petition prepared by the petitioner Ecolab, Inc. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.1197 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of hydrogen peroxide.
    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....''

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    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. The nature of the toxic effects caused by 
hydrogen peroxide are discussed in this unit.
    Ecolab, Inc., has requested a waiver of all toxicology testing 
requirements for hydrogen peroxide. This includes waivers for all 
acute, 90-day subchronic, chronic, oncogenicity, developmental, 
reproductive, mutagenicity, neurotoxicity and metabolism requirements 
for hydrogen peroxide. The Agency has reviewed the data waivers 
requested and concurs that no additional generic toxicology testing 
will be needed for hydrogen peroxide for the following reasons:
    1. Hydrogen peroxide 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 hydrogen peroxide to 
exist as itself, along with detoxifying enzymes found in cells (eg., 
catalase, glutathione peroxidase), makes it very difficult to find any 
residues of hydrogen peroxide in or on foods (at proposed use levels), 
by conventional analytical methods.
     The proposed food contact applications also utilize very low 
concentrations of hydrogen peroxide. Therefore, food residues are 
expected to be short-lived, based on half-lives for hydrogen peroxide 
as short as a few minutes under certain conditions. Residues are not of 
toxicological concern because hydrogen peroxide decomposes rapidly into 
oxygen and water. The Agency has no toxicological concern with oxygen 
and water.
     2. There are acceptable acute generic data referenced in the 
Reregistration Eligibility Document for Peroxy Compounds (December 
1993, Case 4072). Hydrogen peroxide 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 are 
expected to result in a lack of any residues of toxicological concern.
     3. A waiver was granted for all the remaining toxicology testing 
requirements because of the reasons given above, and because there is 
an extensive data base assembled by the Agency's Office of Water. 
Although the Office of Water's data does show toxicological effects in 
experimental animals, these effects occur only at high doses that are 
not expected from the proposed uses of hydrogen peroxide. In addition, 
the rapid decomposition of hydrogen peroxide into oxygen and water, 
which are not of toxicological concern, mitigates any concern for 
residues.
     Therefore, the lack of any residues of toxicological concern and 
the existence of toxicological effects only at high dose levels in 
experimental animals minimizes any concern for exposure to the very low 
doses that may be present as a result of the proposed uses.
    The Agency also recognizes that commercially available 3% hydrogen 
peroxide solutions have been used for many years for personal and 
medical uses. The use directions for some of these products state that 
these 3% solutions can be used as a sanitizing mouthwash. Other food 
contact and medicinal uses for hydrogen peroxide include applications 
for wines and liquors (artificial aging), dentifrices, sanitary 
lotions, and pharmaceutical preparations.
    The long use history of hydrogen peroxide and weight of empirical 
evidence and experimental data has led the Food and Drug Administration 
(FDA) to put hydrogen peroxide on the Generally Recognized As Safe 
(GRAS) list when used on food processing equipment, utensils, and food 
contact articles (21 CFR part 178). Potential symptoms of acute over 
exposure to medium or high concentrations of hydrogen peroxide include 
irritation of eyes, nose and throat, corneal ulceration, erythema, 
vesicles on skin, and bleaching of hair.

IV. Aggregate Exposures

A. Dietary Exposure

    1. Food. For the proposed sanitizer uses, the 11.2% (by weight) 
concentrate of hydrogen peroxide 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 concentration range of 
hydrogen peroxide in the sanitizer product at the time of application 
of 29 to 202 parts per million (ppm). The sanitizer solution, having a 
low concentration of hydrogen peroxide, reacts on contact with the 
surface on which it is applied and degrades rapidly into oxygen and 
water which pose no toxicological concern. Therefore, residues of 
hydrogen peroxide resulting from its use in sanitizer solutions even up 
to 1,100 ppm are expected to be negligible on all raw and processed 
food commodities. The difference between the 202 ppm maximum end use 
concentration, and the 1,100 ppm exemption concentration requested by 
Ecolab, is warranted to overcome any degradation of hydrogen peroxide 
during transport and non-use periods, and to provide flexibility for 
changes in formulation.
     Additional dietary sources of the GRAS substance hydrogen peroxide 
are not expected to be significant and range in concentration from 0.04 
to 1.25% in the FDA food contact approvals cited below:
     Under 21 CFR 184.1366, hydrogen peroxide is GRAS when used on milk 
intended for use in cheese making (maximum treatment level of 0.05%), 
whey, during preparation of modified whey by electrodialysis methods 
(maximum treatment level of 0.04%), dried eggs, dried egg whites, and 
dried egg yolks, tripe, beef feet, herring, wine, starch (maximum 
treatment level of 0.15%), instant tea, corn syrup (maximum treatment 
level of 0.15%), colored cheese whey (maximum treatment level of 
0.05%), wine vinegar, and emulsifiers containing fatty acid esters 
(maximum treatment level of 1.25%).
    Hydrogen peroxide presently has the following additional EPA and 
FDA clearances:
    Under 40 CFR 180.1197 as a direct application at 120 ppm to fruits, 
vegetables, tree nuts, cereal grains, herbs and spices.
    Under 21 CFR 172.892 for modification of food starch to be added to 
human food items.
    Under 21 CFR 178.1005 for sterilization of polymeric food surfaces. 
Sanitizing solution is not to contain more than 35% hydrogen peroxide.
    Under 21 CFR 178.1010(b)(30) for sanitizing solutions used on food-

[[Page 75176]]

processing equipment and utensils and on other food contact articles. 
Sanitizing solutions may contain not less than 550 ppm nor more than 
1,100 ppm hydrogen peroxide (21 CFR 178.1010(c)(25)).
     Under 21 CFR 184.136 as GRAS when hydrogen peroxide meets Food 
Chemical Codex specifications, to treat certain foods as a 
antimicrobial, bleaching agent, oxidizing and reducing agent. Residual 
hydrogen peroxide must be removed during processing of food.
     Under 21 CFR 173.315(a)(2) for use in washing or to assist in the 
lye peeling of fruits and vegetables that are not raw agricultural 
commodities. Used in combination with acetic acid. Not to exceed 59 ppm 
in wash water.
     Under 21 CFR 178.1010(c)(33) for sanitizing solutions used on food 
processing equipment and dairy processing equipment. Sanitizing 
solutions may contain not less than 300 ppm nor more than 465 ppm of 
hydrogen peroxide.
    2. Drinking water exposure. Use of hydrogen peroxide for indoor 
food equipment sanitization uses is not expected to result in the 
transfer of any residues to potential drinking water sources. 
Therefore, no risk assessment is warranted.

B. Other Non-Occupational Exposure

     Hydrogen peroxide is currently registered by EPA for a wide 
variety of uses. These includes use as a water additive for control of 
spoilage microorganisms on raw and processed food commodities; use as 
an algaecide, fungicide and bactericide on growing crops and post 
harvest potatoes; use on agricultural premises and equipment, food 
handling/storage establishments premises and equipment; use on 
commercial, institutional and industrial premises and equipment; use on 
residential, public access premises, medical premises and equipment; 
use for materials preservation; and for industrial processes and water 
systems.
     Hydrogen peroxide is also approved for a variety of medicinal uses 
including sanitization of scrapes, cuts, and burns to human and animal 
skin, and as a human oral sanitizing mouthwash. It is also used by 
medical doctors for general cleansing and sanitization of surgical 
areas of the body after operations. Hydrogen peroxide use in homes is 
medicinal and exposures are expected to be infrequent and at extremely 
short topical duration.
     The Agency does not know of all approved or actual uses for 
hydrogen peroxide. However, non-dietary exposures are not expected to 
pose any quantifiable added risk because of a lack of any significant 
residues of toxicological concern.

V. Cumulative Effects

    The FQPA (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 
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 hydrogen peroxide, its low 
toxicity, and rapid degradation, EPA does not believe that there are 
any concerns regarding the potential for cumulative effects of hydrogen 
peroxide with other substances due to a common mechanism of action.

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

    Because hydrogen peroxide is of low toxicity, and the proposed uses 
employ low concentrations of hydrogen peroxide, and hydrogen peroxide 
degrades rapidly following application, EPA concludes that this 
exemption from the requirement of a tolerance in or on all raw and 
processed food commodities, when hydrogen peroxide is used in diluted 
sanitizing solutions up to 1,100 ppm, poses no dietary risk to the U.S. 
population including infants and children, under reasonably forseeable 
circumstances. Further, EPA finds that there is a reasonable certainty 
of no harm from aggregate exposure to hydrogen peroxide and thus that 
the exemption for hydrogen peroxide 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 one day or single exposure. No acute exposure and risk assessment 
is applicable because no acute toxicological effects of concern or 
exposure are anticipated with the proposed food contact uses for 
hydrogen peroxide. This is due to the lack of any residues of 
toxicological concern as a result of the automatic and rapid 
decomposition of hydrogen peroxide into oxygen and water. Use of 
hydrogen peroxide 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 hydrogen peroxide 
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 hydrogen peroxide. This is due to the 
lack of any residues of toxicological concern as a result of the 
automatic and rapid decomposition of hydrogen peroxide into oxygen and 
water. Use of hydrogen peroxide 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. Available data 
suggest that hydrogen peroxide can act as a promoter of carcinogenisis 
at relatively high doses (in excess of 600 milligrams/kilograms (mg/
kg)) after chronic administration in drinking water to experimental 
animals. Epidemiological reports indicate that the major effect from 
accidental ingestion of high doses of hydrogen peroxide in humans (ie., 
1,000 mg/kg) is acute and severe clinical toxicity, which in a few 
cases resulted in death.
     Based on the proposed use concentrations for hydrogen peroxide, 
and data indicating negligible residues on food, exposure to hydrogen 
peroxide 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 further by the rapid 
decomposition of hydrogen peroxide into oxygen and water, which are not 
of toxicological concern, and the existence of specific enzymes (ie., 
catalase and glutathione peroxidases) for breakdown of hydrogen 
peroxide.
     Therefore, the Agency concludes that the cancer risk for the U.S. 
population from aggregate exposure to hydrogen peroxide is negligible 
under the proposed food contact use concentrations.

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    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 hydrogen peroxide, 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 data base, 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 margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors (UF) 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 UF/
MOE is designed to account for interspecies extrapolation and 
intraspecies variability.
    In the case of the proposed food contact uses for hydrogen 
peroxide, because of the lack of any 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 hydrogen peroxide. For the same reason, an additional 
safety factor to protect infants and children is unnecessary. 
Additionally, based on the following, no increased susceptibility to 
infants or children is expected to occur.
     i. Three older studies on the developmental and reproductive 
effects of hydrogen peroxide 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 mg/kg).
     ii. Hydrogen peroxide 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 and metals accelerates 
dissociation. The proposed food contact applications utilize very low 
concentrations of hydrogen peroxide (i.e ppm). Food residues are 
expected to be short-lived and are not expected to accumulate. This is 
because hydrogen peroxide dissociates rapidly in air into oxygen and 
water. The Agency has no toxicological concern with 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, and 
because there is an extensive data base assembled by the Agency's 
Office of Water showing toxicological effects in experimental animals 
only at high concentrations, which are not expected with the proposed 
use patterns.
     iv. The Agency also recognizes that commercially available 3% 
hydrogen peroxide solutions have been used for many years for personal 
and medical uses. The use directions for some of these products state 
that these solutions can be used as a sanitizing mouthwash. The long 
use history of hydrogen peroxide and weight of empirical and 
experimental data has led the FDA to put it on the GRAS list when used 
on food processing equipment, utensils, and food contact articles (21 
CFR part 178).
     Therefore, because of the rapid decomposition of hydrogen peroxide 
residues into degradates that are of no toxicological concern (ie., 
oxygen, water), the Agency concludes that there is a reasonable 
certainty of no harm for infants and children from exposure to hydrogen 
peroxide under the proposed food contact use concentrations.

 VII. Other Considerations

A. Endocrine Disruptors

    The 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 hydrogen peroxide 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 for residues in food is being granted for hydrogen 
peroxide, an enforcement analytical method is not needed. However, an 
analytical method (designated QATM 202 by Ecolab, Inc., a 
redoxtitration 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, U.S. Environmental 
Protection Agency, 1200 Pennsylvania Avenue, NW., 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 180.1197, an exemption from the requirement of a 
tolerance is established for residues of hydrogen peroxide in or on all 
food commodities at the rate of less than or equal to 1% hydrogen 
peroxide per application on growing crops and post harvest potatoes, 
when applied as an algaecide, fungicide, and bactericide.

D. International Tolerances

    There are no Codex Alimentarius (Codex) Commission Maximum Residue 
Levels for Hydrogen Peroxide.

VIII. 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.

[[Page 75178]]

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-301071 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 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301071, 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).

IX. 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

[[Page 75179]]

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).

X. 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 180.1197, is revised to read as follows:


Sec. 180.1197  Hydrogen Peroxide; exemption from the requirement of a 
tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of hydrogen peroxide in or on raw agricultural 
commodities, in processed commodities, when such residues result from 
the use of hydrogen peroxide as an antimicrobial treatment in solutions 
containing a diluted end-use concentration of hydrogen peroxide up to 
120 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 hydrogen peroxide in or on all food commodities at the 
rate of less than or equal to 1% hydrogen peroxide per application on 
growing crops and post harvest potatoes when applied as an algaecide, 
fungicide and bactericide.
    (c) An exemption from the requirement of a tolerance is established 
for residues of hydrogen peroxide, in or on all raw and processed food 
commodities when used in sanitizing solutions containing a diluted end-
use concentration of hydrogen peroxide up to 1,100 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. 00-30680 Filed 11-30-00; 8:45 am]
BILLING CODE 6560-50-S