[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Rules and Regulations]
[Pages 33022-33025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15718]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300872; FRL-6083-9]
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 the biochemical hydrogen peroxide on all
food commodities when applied/used as an algaecide, fungicide, and
bactericide at the rate of 1% hydrogen peroxide per
application on growing crops (all food commodities) and postharvest
potatoes. Biosafe Systems 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 establish a maximum
permissible level for residues of hydrogen peroxide.
DATES: This regulation is effective June 21, 1999. Objections and
requests for hearings must be received by EPA on or before August 20,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300872], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300872], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding 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 5.1/6.1 or ASCII file format. All copies of electronic
objections and hearing requests must be identified by the docket
control number [OPP-300872]. No Confidential Business Information (CBI)
should be submitted through e-mail. Copies of electronic objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Anne Ball, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460.
[[Page 33023]]
Office location, telephone number, and e-mail address: 9th fl., Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-8717; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of September 23,
1998 (63 FR 50901 ) (FRL-6028-4), EPA issued a notice pursuant to
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e), as amended by the Food Quality Protection Act of 1996
(FQPA) (Public Law 104-170) announcing the filing of a pesticide
tolerance petition by Biosafe Systems, at that date at 45 E. Woodthrush
Trail, East Medford, NJ 08055, at present at 80 Commerce St.,
Glastonbury, CT 06033. The notice included a summary of the petition
prepared by the petitioner Biosafe Systems, the registrant. There were
no comments received in response to the notice of filing. The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of hydrogen peroxide.
By this final rule, EPA is granting the petition. EPA is amending the
existing exemption for hydrogen peroxide in accordance with the
petition. Based on this action, EPA considers the existing exemption to
be reassessed.
I. Risk Assessment and Statutory Findings
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.
II. 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% 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 milligram/kilogram (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 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).
III. 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 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 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.
[[Page 33024]]
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.
IV. 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.
V. 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 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.
VI. 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 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 (MRLs) established for
residues of hydrogen peroxide.
VII. Objections and Hearing Requests
The new FFDCA 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) and
as was provided in the old section 408 and in section 409. However, the
period for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which governs the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by August 20, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). 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 tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, [email protected]. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
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). 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). 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.
VIII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300872] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[email protected]
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also
[[Page 33025]]
include all comments submitted directly in writing. The official record
is the paper record maintained at the Virginia address in ``ADDRESSES''
at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA 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
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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, 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. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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 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 the rule in the Federal Register. This 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: June 3, 1999.
Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. 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 food commodities at the rate
of 1% hydrogen peroxide per application on growing crops
and postharvest potatoes when applied as an algaecide, fungicide and
bactericide.
[FR Doc. 99-15718 Filed 6-18-99; 8:45 am]
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