[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Rules and Regulations]
[Pages 9214-9218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4791]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301217; FRL-6822-7]
RIN 2070-AB78


Hydrogen Peroxide; An 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 establishes an amendment to an exemption from 
the requirement of a tolerance for residues of the biochemical hydrogen 
peroxide in or on all post-harvest agricultural food commodities when 
applied/used at the rate of  1% hydrogen peroxide per 
application. Biosafe Systems, Inc. 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

[[Page 9215]]

regulation eliminates the need to establish a maximum permissible level 
for residues of hydrogen peroxide.

DATES: This regulation is effective February 28, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301217, 
must be received by EPA, on or before April 29, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
OPP-301217 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Diana Hudson, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8713; 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 Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301217. 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 November 1, 2001 (66 FR 55175) (FRL-
6805-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a(e), as amended by the FQPA (Public Law 104-170) announcing 
the filing of a pesticide tolerance petition by Biosafe Systems, Inc., 
80 Commerce Street, Glastonbury, CT 06033. This notice included a 
summary of the petition prepared by the petitioner Biosafe Systems, 
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.

III. Risk Assessment

    New section 408(c)(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(c)(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....'' Additionally, section 408(b)(2)(D) requires that the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA 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.
    Hydrogen peroxide at a concentration of 27.17% has a pH of 1.05 at 
which concentration EPA assumes a toxicity category I for skin and eye 
irritation. Biosafe has submitted toxicology information from open 
literature for aqueous solutions containing 6% hydrogen peroxide and 
for aqueous solutions containing 50% hydrogen peroxide. The concentrate 
(27.17%

[[Page 9216]]

hydrogen peroxide) will be diluted with water at the rate of 1:50 or 
1:100 or 1:300 and thus, the concentration of hydrogen peroxide in the 
product at the time of application will range from 0.09% to 0.54%. The 
information from open literature demonstrated that solutions containing 
6% hydrogen peroxide have an acute oral LD50  
5,000 milligrams/kilograms (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. For similar reasons, an additional 
safety factor was not judged necessary to protect the safety of infants 
and children. Additionally, hydrogen peroxide is listed by the Food and 
Drug Administration as Generally Recognized As Safe (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).

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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

    1. Food. For the proposed uses the concentrate of hydrogen peroxide 
will be diluted with water at the rate of 1:50, 1:100 or 1:300 
corresponding to a low concentration of hydrogen peroxide in the 
product at the time of application (0.09-0.54%). The solution, having a 
low concentration of hydrogen peroxide, reacts on contact with the 
surface on which it is sprayed and degrades rapidly to oxygen and 
water. Therefore, residues in or on treated post-harvest food 
commodities of the algaecide/fungicide/bactericide hydrogen peroxide 
are expected to be negligible. Additional sources of the GRAS substance 
hydrogen peroxide in concentrations range from 0.04% to 1.25% in 
various foods as cited above (21 CFR 184.1366).
    2. Drinking water exposure. At the proposed application rates, the 
use of hydrogen peroxide as an algaecide, fungicide, and bactericide to 
treat all post-harvest agricultural food commodities could result in a 
minimal transfer of residues to potential drinking water sources. This 
is due to the low application rate and the rapid chemical degradation 
of hydrogen peroxide into oxygen and water neither of which is of 
toxicological concern.

B. Other Non-Occupational Exposure

    There may be minimal amounts of non-dietary exposure to hydrogen 
peroxide in homes through the infrequent and short topical use of the 
substance in treating minor skin injuries and in its use in oral 
mouthwashes. Exposure is expected to be minimal also because of the 
rapid chemical degradation of hydrogen peroxide into oxygen and water.

VI. Cumulative Effects

    Because of the low use rates of hydrogen peroxide, its low toxicity 
and rapid degradation, EPA does not believe that there is any concern 
regarding the potential for cumulative effects of hydrogen peroxide 
with other substances due to a common mechanism of action. Because 
hydrogen peroxide is not known to have a common toxic metabolite with 
other substances, EPA has not assumed that hydrogen peroxide has a 
common mechanism of toxicity with other substances.

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

    Because hydrogen peroxide is of low toxicity, 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 post-harvest 
food commodities for hydrogen peroxide when applied at  1% 
will not pose a dietary risk under reasonably foreseeable 
circumstances. Further, the EPA Office of Water has stated that it has 
seen no new data that contradict the assessment previously given, which 
is that low concentrations of hydrogen peroxide do not typically 
persist in drinking water at levels that pose a health risk. 
Accordingly, EPA concludes that there is a reasonable certainty of no 
harm to consumers, including infants and children, from aggregate 
exposure to hydrogen peroxide.

VIII. Other Considerations

A. Endocrine Disruptors

    There is no evidence to suggest that hydrogen peroxide in the 
proposed concentrations will adversely affect the endocrine system.

B. Analytical Method(s)

    An analytical method for the detection of residues of hydrogen 
peroxide is not applicable to this tolerance exemption because of the 
low concentration of hydrogen peroxide in the product at the time of 
application ( 1%) and its rapid degradation to water and 
oxygen on contact with crops.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels established for residues 
on hydrogen peroxide.

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. 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

[[Page 9217]]

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-301217 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 April 29, 
2002.
    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 IX.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 number OPP-301217, 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 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?

    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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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 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); 
or 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

[[Page 9218]]

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). 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications '' is defined in the Executive Order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes.'' This rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

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: February 20, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division.

    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), 346(a) and 371.

    2. Section 180.1197 is revised to read as follows:


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

    An exemption from the requirement of a tolerance is established for 
residues of hydrogen peroxide in or on all post-harvest food 
commodities at the rate of  1% hydrogen peroxide per 
application.

[FR Doc. 02-4791 Filed 2-27-02; 8:45 am]
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