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Harpin Protein; Exemption From the Requirement of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: May 3, 2000 (Volume 65, Number 86)]
[Rules and Regulations]
[Page 25660-25663]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my00-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300984; FRL-6497-4]
RIN 2070-AB78
Harpin Protein; 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 pesticide harpin protein
on all food commodities when applied/used in agricultural fields and
greenhouses for the management of plant diseases, the significant
improvement in growth and yields, and the suppression of certain
insects and other pests. EDEN Bioscience Corporation 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 harpin protein.
DATES: This regulation is effective May 3, 2000. Objections and
requests for hearings, identified by docket control number OPP-300984,
must be received by EPA, on or before July 3, 2000.
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-300984 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Diana M. Horne, Biopesticides
and Pollution Prevention Division (7511C), Environmental Protection
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC
20460; telephone number: (703) 308-8367; and e-mail address:
horne.diana@epa.gov.
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
[[Page 25661]]
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'' 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-300984. 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 September 9, 1999 (64 FR 49010) (FRL-
6095-9), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by
the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing
the filing of a pesticide tolerance petition (PP 9F6027) by EDEN
Biosciences, 11816 North Creek Parkway N., Bothell, WA 98011-8205. This
notice included a summary of the petition prepared by the petitioner
EDEN Bioscience Corporation. 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 harpin protein.
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.
Harpin exhibits no adverse effects in Tier I mammalian toxicity
studies; therefore, Tier II and III studies are not required. Acute
toxicity studies indicate that Messenger is a Toxicity Category IV
substance. No toxicity was observed in acute oral toxicity studies
conducted with Messenger. Acute oral and dermal toxicity
LD50 values for Messenger were greater than 5,000 grams/
kilograms (g/kg) in the rat (Toxicity Category IV). The LC50
for Messenger was greater than 2 milligrams/liter (mg/L) in an acute
inhalation study in the rat. Messenger also showed no effect in eye and
dermal irritation studies. For example, the dermal irritation index for
Messenger was zero at 500 mg and no eye irritation was shown in the
rabbit at 100 mg. There have been no reported incidents of Messenger-
induced hypersensitivity in individuals exposed to Messenger during
research, production, and/or field testing and there are no published
reports indicating that harpin proteins are toxic. Further, the harpin
protein has a non-toxic mode of action by eliciting a systemic acquired
resistance response in plants, and it has been demonstrated that the
product has no direct antimicrobial effect on bacteria and fungi, for
species examined to date. For a more complete discussion, see the
Harpin Registration Eligibility Document.
V. Aggregate Exposures
In examining aggregate exposure, FQPA directs EPA to take into
account available information concerning dietary exposures from
pesticide residues in food and drinking water and all other exposures
for which there is reliable information. These other sources of
exposure include such non-occupational exposures as those resulting
from the use of pesticides around the home or in public areas such as
parks and schools. The Agency defines acute and chronic aggregate risks
to include only dietary (food and water) exposures. Short-,
intermediate-, and long-term aggregate exposures are defined to include
non-occupational exposures in addition to dietary exposures. Any or all
of these aggregate risk assessments may be required for a pesticide
depending on its registered uses.
A. Dietary Exposure
Harpin and related harpin proteins are common constituents of plant
pathogenic bacteria which are often found on fruits and vegetables.
Additional dietary exposure to harpin protein resulting from labeled
uses is unlikely to occur because of extremely low use rates and rapid
degradation in the field. Furthermore, the lack of demonstrable
toxicity in acute studies, and the natural occurrence of harpins in the
environment support the establishment of an exemption from the
requirement of a tolerance for harpin protein.
1. Food. Messenger is applied at very low rates of application
(generally 2 to 11.5 grams of active ingredient per acre). Harpin also
degrades rapidly in sunlight, high temperatures, and in the presence of
chlorine. Because of the low use rates and rapid degradation in the
field, no harpin residues are detectable, using available methods, on
treated crops even immediately after application. Therefore, the Agency
believes that dietary exposure to harpin via consumption of treated
food or feed will be negligible.
[[Page 25662]]
2. Drinking water exposure. Because harpin protein is applied at
extremely low use rates and rapidly degrades in the environment,
residues are unlikely to occur in ground or surface water. In addition,
harpin is highly sensitive to small amounts of chlorine, as contained
in many municipal water systems. Therefore, residues of harpin protein
are unlikely to occur in drinking water.
B. Other Non-Occupational Exposure
The Agency believes that the potential for non-dietary exposure and
attendant risks to the general population including infants and
children is minimal to non-existent, due to low use rates, the
instability of harpin protein in the environment, and lack of
demonstrated toxicity. In addition, the label use sites are commercial,
agricultural, and horticultural, as opposed to domestic settings; thus,
non-occupational exposure to the general population is expected to be
minimal.
1. Dermal exposure. Harpin is a Toxicity Category IV product, and
is not expected to pose any risk via the dermal route of exposure.
2. Inhalation exposure. Acute inhalation tests place harpin in
Toxicity Category IV, thus risk via the inhalation route is expected to
be minimal to non-existent.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, 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.
Consideration of a common mode of toxicity is not appropriate,
given that there is no indication of mammalian toxicity of harpin
protein and no information that indicates that toxic effects would be
cumulative with any other compounds. Moreover, harpin does not exhibit
a toxic mode of action in its target pests or diseases.
VII. Determination of Safety for U.S. Population, Infants and
Children
Harpin's lack of toxicity has been demonstrated by the results of
acute toxicity testing in mammals in which harpin caused no adverse
effects when dosed orally and via inhalation at the limit dose for each
study. Thus, based on this and other information in this preamble, EPA
concludes that there is a reasonable certainty that no harm to the
United States population in general, or to infants or children will
result from aggregate exposure to harpin residues. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information.
VIII. Other Considerations
A. Endocrine Disruptors
The Agency has no information regarding endocrine effects of this
biochemical pesticide at this time; however, since there was no
demonstrable toxicity in acute tests, there is no evidence to suggest
that harpin will adversely affect the endocrine system.
B. Analytical Method
Because this notice establishes an exemption from the requirement
of a tolerance, no anlytical method is necessary. The Agency is
establishing an exemption from the requirement of a tolerance without
any numerical limitation for the reasons enumerated in this preamble,
including harpin's lack of toxicity. Accordingly, the Agency has
concluded that an analytical method is not needed for enforcement
purposes for harpin residues.
C. Codex Maximum Residue Level
There are no Codex Maximum Residue Levels nor any tolerances or
exemptions issued for harpin protein outside the United States.
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-300984 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 July 3,
2000.
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, Ariel Rios Bldg., 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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
[[Page 25663]]
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, Ariel Rios Bldg.,
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-300984, to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 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: opp-docket@epa.gov.
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: April 19, 2000.
Susan B. Hazen,
Acting Director, 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), 346(a) and 371.
2. Section 180.1204 is revised to read as follows:
Sec. 180.1204 Harpin protein; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biochemical pesticide harpin protein on all food
commodities when applied/used in agricultural fields and greenhouses
for the management of plant diseases, the significant improvement in
growth and yields, and the suppression of certain insects and other
pests.
[FR Doc. 00-11029 Filed 5-2-00; 8:45 am]
BILLING CODE 6560-50-F