[Federal Register: May 5, 2004 (Volume 69, Number 87)]
[Rules and Regulations]
[Page 24992-24996]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my04-22]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0097; FRL-7356-5]
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 harpin protein on all
food commodities when applied/used to enhance plant growth, quality and
yield, to improve overall plant health, and to aid in pest management.
EDEN Bioscience Corporation submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA), 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 5, 2004. Objections and
requests for hearings must be received on or before July 6, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
ID number OPP-2004-0097. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket/. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis
Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Diana M. Horne, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8367; e-mail address: horne.diana@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
[[Page 24993]]
II. Background and Statutory Findings
In the Federal Register of January 28, 2004 (69 FR 4151) (FRL-7339-
2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 3F6765) by EDEN Bioscience Corporation, 3830 Monte Villa
Parkway, Bothell, WA 98021-6942. 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 a temporary exemption from the requirement of a tolerance
for residues of harpin protein.
Section 408(c)(2)(A)(i) of 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 exemption is``safe.'' Section 408(c)(2)(A)(ii) of FFDCA
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. Pursuant to section 408(c)(2)(B) of
FFDCA, in establishing or maintaining in effect an exemption from the
requirement of a tolerance, EPA must take into account the factors set
forth in section 408(b)(2)(C) of FFDCA, which require 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) of FFDCA 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.
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.
This final rule amends the previously established exemption from
the requirement of a tolerance for harpin protein published in the
Federal Register of May 3, 2000 (65 FR 25660) (FRL-6497-4). Research on
other harpin proteins that are similar to this active ingredient
indicates that many of these proteins also exhibit activities of
commercial value in crop production. Because the existing tolerance
exemption codified in 40 CFR 180.1204 does not specify the scope of
harpin proteins that are exempt, this final rule clarifies the existing
exemption by specifying the criteria a protein must meet in order to be
subject to the exemption. Harpin proteins exhibit no adverse effects in
Tier I mammalian toxicity studies; therefore, Tier II and III study
requirements are waived. Acute oral and dermal toxicity LD
50 values for products containing harpin protein are greater
than 5,000 grams/kilograms (g/kg) in the rat (Toxicity Category IV,
least toxic). Inhalation studies in the rat on products containing
harpin protein resulted in an LC50 of greater than 2
milligrams/liter (mg/L) (Toxicity Category IV). In addition, no adverse
effects are observed in eye irritation studies in the rabbit at 100 mg
(Toxicity Category IV). There have been no reported incidents of
hypersensitivity in individuals exposed to products containing harpin
protein during research, production, and/or field testing, and there
are no published reports indicating that harpin proteins are toxic.
Further, harpin proteins have a non-toxic mode of action and work by
activating the treated plant's own growth and defense systems. In order
to be exempt from the requirement of a tolerance, a harpin protein must
meet the following specification:
1. Consists of protein less than 100 kD in size, that is acidic
(pI<7.0), glycine rich (>10%), and contains no more than one cystine
residue.
2. The source(s) of genetic material encoding the protein are
bacterial plant pathogens not known to be mammalian pathogens.
3. Elicits the hypersensitive response (HR) which is characterized
as rapid, localized cell death in plant tissue after infiltration of
harpin into the intercellular spaces of plant leaves.
4. Possesses a common secondary structure consisting of [alpha] and
[beta] units that form an HR domain.
5. Is heat stable (retains HR activity when heated to 65[deg]C for
20 minutes).
6. Is readily degraded by a proteinase representative of
environmental conditions (no protein fragments >3.5 kD after 15 minutes
degradation with Subtilisin A).
7. Exhibits a rat acute oral toxicity (LD50) of greater
than 5,000 mg product/kg body weight.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA 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
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. Products containing harpin protein are applied at very low
rates of application (grams of active ingredient per acre). Harpin
proteins are also rapidly degraded in the environment by common
proteinases, ultraviolet (UV) irradiation, and oxidizing agents. No
residues of active ingredient are detectable, using available methods,
on treated crops even immediately after application. Therefore, the
Agency believes that dietary exposure to harpin protein via consumption
of treated food or feed will be negligible.
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 protein is highly sensitive to small amounts of chlorine or
similar oxidizing agents as contained
[[Page 24994]]
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, with the exception of turf and
ornamentals, the proposed use sites are primarily commercial
agricultural and horticultural, as opposed to domestic settings.
Increased non-dietary exposures to harpin protein via home and garden
uses is not considered likely because of the typically low-use rates
and lack of persistence in the environment.
1. Dermal exposure. Products containing harpin protein are
classified as Toxicity Category IV (least toxic) for dermal exposure,
and are not expected to pose any risk via the dermal route.
2. Inhalation exposure. Acute inhalation tests place products
containing harpin protein in Toxicity Category IV (least toxic), thus
risk via the inhalation route is expected to be minimal to non-
existent.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires the Agency to consider
the cumulative effects of exposure to harpin protein and to other
substances that have a common mode of toxicity. These considerations
include the possible cumulative effects of such residues on infants and
children. Because of the lack of demonstrable toxicity of harpin
protein in acute toxicity studies, lack of information indicating that
any toxic effects, if they existed, would be cumulative with any other
compounds, extremely low-use rates, and rapid degradation in the
environment, the Agency does not expect any cumulative or incremental
effects from exposure to residues of this product when used as directed
on the label.
VI. Determination of Safety for U.S. Population, Infants and Children
Harpin protein's lack of toxicity has been demonstrated by the
results of acute toxicity testing in mammals in which harpin protein
caused no adverse effects when dosed orally, dermally, and via
inhalation at the limit dose for each study. Therefore, EPA concludes
that there is a reasonable certainty that no harm to the U.S.
population in general, and to infants and children, specifically, will
result from aggregate exposure to residues of harpin protein. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. Accordingly, exempting harpin
proteins that meet the criteria specified in this preamble is
considered safe and poses no risk. Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an additional ten-fold margin of exposure
(safety) for infants and children in the case of threshold effects, to
account for prenatal and postnatal toxicity and the completeness of the
database, unless EPA determines that a different margin of exposure
will be safe for infants and children. Margins of exposure (safety) are
often referred to as uncertainty factors. Here, based on all the
available information and for all the reasons already set forth in this
final rule, the Agency finds that there are no threshold effects of
concern to infants, children, and adults when harpin protein is used as
labeled, and that the provision requiring an additional margin of
safety is not necessary to protect infants and children. As a result,
EPA has not used a margin of exposure (safety) approach to assess the
safety of harpin protein.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA has determined
that there is no scientific basis for including, as part of the
program, the androgen and thyroid hormone systems in addition to the
estrogen hormone system. EPA also adopted EDSTAC's recommendation that
the program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use FIFRA and, to the extent that effects
in wildlife may help determine whether a substance may have an effect
in humans, FFDCA authority to require wildlife evaluations. As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP). When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, harpin protein
may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption. Based on
available data, no endocrine system-related effects have been
identified with consumption of harpin protein. To date, there is no
evidence to suggest that harpin protein affects the immune system,
functions in a manner similar to any known hormone, or that it acts as
an endocrine disruptor.
B. Analytical Method(s)
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 protein's demonstrated lack of
toxicity, and instability in the environment. Accordingly, the Agency
has concluded that an analytical method is not needed for enforcement
purposes for harpin protein residues.
C. Codex Maximum Residue Level
There is currently no CODEX Maximum Residue Limit set for food use
of this active ingredient.
VIII. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA 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) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. 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 ID number OPP-2004-0097 in the subject line on the
first page of your submission. All requests must be in writing, and
must be
[[Page 24995]]
mailed or delivered to the Hearing Clerk on or before July 6, 2004.
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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
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, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
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 20460-0001.
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 ADDRESSES. Mail
your copies, identified by docket ID number OPP-2004-0097, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. 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 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. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of 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). 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 section 408(d) of FFDCA, 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
[[Page 24996]]
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
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.
X. Congressional Review Act
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 23, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
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 individual harpin proteins that meet specified
physiochemical and toxicological criteria when used as biochemical
pesticides on all food commodities to enhance plant growth, quality and
yield, to improve overall plant health, and to aid in pest management.
The physiochemical and toxicological criteria identifying harpin
proteins are as follows:
(a) Consists of a protein less than 100 kD in size, that is acidic
(pI<7.0), glycine rich (>10%), and contains no more than one cystine
residue.
(b) The source(s) of genetic material encoding the protein are
bacterial plant pathogens not known to be mammalian pathogens.
(c) Elicits the hypersensitive response (HR) which is characterized
as rapid, localized cell death in plant tissue after infiltration of
harpin into the intercellular spaces of plant leaves.
(d) Possesses a common secondary structure consisting of [alpha]
and [beta] units that form an HR domain.
(e) Is heat stable (retains HR activity when heated to 65[deg]C for
20 minutes).
(f) Is readily degraded by a proteinase representative of
environmental conditions (no protein fragments > 3.5 kD after 15
minutes degradation with Subtilisin A).
(g) Exhibits a rat acute oral toxicity (LD50) of greater
than 5,000 mg product/kg body weight.
[FR Doc. 04-10212 Filed 5-4-04; 8:45 am]
BILLING CODE 6560-50-S