[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Rules and Regulations]
[Pages 24992-24996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10212]


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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: [email protected].

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 [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-
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: [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?

    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