[Federal Register Volume 65, Number 86 (Wednesday, May 3, 2000)]
[Rules and Regulations]
[Pages 25660-25663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11029]


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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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that

[[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 [email protected], 
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: [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 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