[Federal Register Volume 63, Number 243 (Friday, December 18, 1998)]
[Rules and Regulations]
[Pages 70027-70030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33629]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300750; FRL-6040-5]
RIN 2070-AB78
Harpin; Temporary/Time-Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a temporary/time-limited tolerance
exemption for residues of the biological pesticide Harpin in or on all
food commodities when applied for the broad spectrum control of various
bacterial, fungal, and viral plant diseases. 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) (Pub. L. 104-170) requesting the temporary/time-limited
tolerance exemption. This regulation eliminates the need to establish a
maximum permissible level for residues of Harpin. The tolerance
exemption will expire on October 31, 2000.
DATES: This regulation is effective December 18, 1998. Objections and
requests for hearings must be received by EPA on or before February 16,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300750], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees) and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk identified
by the docket control number, [OPP-300750], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 119,
Crystal Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epama. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300750]. No Confidential Business Information
(CBI) should be submitted through e-mail. Copies of electronic
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Diana M. Horne, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 9th
fl., Crystal Mall 2 1921 Jefferson Davis Hwy., Arlington, VA 22202,
(703) 308-8367, e-mail: Horne.Diana@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 23,
1998 (63 FR 50903) (FRL-6026-1), EPA issued a notice pursuant to
section 408 of the FFDCA, 21 U.S.C. 346a(e) announcing the filing of a
pesticide tolerance petition (PP 8F4975 and subsequently changed to
9G5043). This notice included a summary of the petition prepared by the
petitioner and this summary contained conclusions and arguments to
support its conclusion that the petition complied with the FQPA of
1996. The petition requested that 40 CFR part 180 be amended by
establishing a temporary/time-limited tolerance exemption for residues
of Harpin.
Two comments were received urging the issuance of the Experimental
Use Permit (69834-EUP-1) and temporary tolerance exemption for Harpin
protein. An additional commenter raised questions regarding whether
adequate field testing has been done to justify the acreage requested
in the EUP; the nature of Harpin protein and the inert ingredients used
in the formulation; the nature, if any, of consequences to beneficial
microflora and potential impacts on the development of pathogen
resistance; and whether degradation data support the contention that
residues are expected to be negligible. The Agency has received
summaries on a subset of approximately 200 field trials conducted by
the registrant on a broad range of crops in the United States, Mexico,
and the Peoples Republic of China. Harpin proteins are generally heat
stable, glycine-rich and, in nature, elicit defense mechanisms within
the host plant. While specific inert ingredients utilized in pesticide
formulations are considered confidential business information (CBI),
those used in Harpin formulations are food grade materials, or
contained in lists of inert ingredients cleared for food use by the
Agency. Regarding the mechanism of action of Harpin protein on plant
disease organisms, evidence has been presented which suggests no direct
antimicrobial activity. Instead, the protein has been described in the
published literature as inducing systemic acquired immunity, a
coordinated cascade of defense reactions, within the host plant. Thus,
Harpin has extremely limited potential for direct toxicity to pathogens
or beneficial microorganisms, or for the development of pathogen
resistance. Finally, environmental fate studies submitted in support of
this temporary tolerance exemption indicate that the protein is UV-
labile, and subject to degradation by proteases produced by ubiquitous
microflora on leaf surfaces and in water. Degradation studies indicate
a half-life of less than 48 hours where Harpin was applied at 30-40
times the proposed field rate. Moreover, using current detection
methodology, the active ingredient was undetectable immediately
following foliar application at standard rates.
I. Risk Assessment and Statutory Findings
New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) defines
[[Page 70028]]
``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...'' 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 us in residential settings.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of the 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 is a naturally occuring protein derived from the plant
pathogenic bacterium Erwinia amylovora (E. amylovora) , the causative
agent for fire blight disease. Because of its role in plant host-
parasite relationships, Harpin is presumed to have been present in E.
amylovora for as long as the bacterium has been involved in the fire
blight disease. As such, Harpin protein has been constantly produced
and secreted by E. amylovora in or on edible fruits such as apple and
pear with no apparent adverse effects on humans.
EDEN has conducted studies to evaluate the mammalian toxicology of
the Harpin protein. The results of these studies indicate that Harpin
is a Toxicity Category III substance and that it poses no significant
human health risks. No toxicity was observed in either of the acute
oral toxicity studies conducted with the Harpin technical grade active
ingredient (TGAI) or a concentrated Harpin TGAI. Acute oral
LD50 values for both Harpin protein technical and
concentrated Harpin protein technical were greater than 2,000 mg/kg in
the rat (Toxicity Category III based on the maximum dose administered).
The 4-hour LC50 for Harpin was determined to be greater than
2 mg/L in an acute inhalation study with rats. EDEN has not observed
any incidents of Harpin-induced hypersensitivity in individuals exposed
to Harpin during research, production, and/or field testing. The Harpin
end product produced minimally and mildly irritating results in the eye
irritation and dermal irritation studies, respectively.
The proteinaceous nature of Harpin, in combination with its lack of
acute toxicity, lends an additional measure of safety because when
proteins are toxic, they are generally known to act via acute
mechanisms and at very low dose levels. Therefore, because no
significant adverse effects were observed, even at the limit doses,
Harpin is not considered to be an acutely toxic protein.
III. Aggregate Exposures
In examining aggregate exposure, section 408 of the 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 groundwater or surface water and exposure
through pesticide use in gardens, lawns, or buildings (residential and
other indoor uses).
A. Dietary Exposure
1. Food. Residues of Harpin protein were virtually undetectable
within 3-10 days following application to treated plant surfaces and in
water. Based on these preliminary studies and other submitted
information, it is unlikely that appreciable Harpin residues would
accumulate in the environment. Because of the low rate of application
and rapid degradation of Harpin in the environment, residues of Harpin
in or on treated raw agricultural commodities are expected to be
negligible. Moreover, because Harpin exhibits no mammalian toxicity,
any dietary exposure, if it occurred, would not be harmful to humans.
2. Drinking water exposure. Residues of Harpin are unlikely to
occur in drinking water, due to the low application rate of the product
and its rapid degradation in soil and water and on foliar surfaces.
B. Other Non-Occupational Exposure
The use pattern and acreage proposed for turf application may
increase exposure to Harpin; however, with the demonstrated lack of
mammalian toxicity and rapid environmental degradation of this protein,
such exposure will not be harmful to humans.
IV. Cumulative Effects
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.
V. 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, the aggregate exposure to Harpin over a lifetime should
pose negligible risks to human health. Based on lack of toxicity and
low exposure, there is a reasonable certainty that no harm to adults,
infants, or children will result from aggregate exposure to Harpin
residue. Exempting Harpin from the requirement of a tolerance should
pose no significant risk to humans or the environment.
VI. Other Considerations
A. Endocrine Disruptors
Neither the Agency nor EDEN Bioscience Corporation has any
information to suggest that Harpin will adversely affect the endocrine
system.
B. Analytical Method(s)
An analytical method for residues is not applicable, since the
petitioner has requested a temporary exemption from the requirement of
a tolerance.
C. Codex Maximum Residue Level
There are no tolerances, exemptions from tolerance, or Maximum
Residue Levels issued for Harpin outside of the United States.
VII. Objections and Hearing Requests
The new section 408(g) of the 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)and as was provided in the old section 408 and in section 409.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which governs the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can
[[Page 70029]]
be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by February 16, 1999, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
hearing clerk, at the address given under the ``Addresses'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issues(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issues(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential by marking any part or all
of that information as CBI. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. A copy
of the information that does not contain CBI must be submitted for
inclusion in the public record. Information not marked confidential may
be disclosed publicly by EPA without prior notice.
VIII. Public Record and Electronic Submissions
A record has been established for this rulemaking under docket
control number [OPP-300750]. A public version of this record, which
does not include any information claimed as CBI, is available for
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 119 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division(7502C), Office of Pesticide Programs, Environmental
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, EPA will transfer any
copies of objections and hearing requests received electronically into
printed, paper form as they are received and will place the paper
copies in the official rulemaking record. The official rulemaking
record is the paper record maintained at the Virginia address in
ADDRESSES at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub.L. 104-4). Nor does it require any
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629), February 16,
1994), or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In additions, since tolerance exemptions that are established on
the basis of a petition under FFDCA section 408(d), such as the
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the
[[Page 70030]]
preamble to the rule, a description of the extent of EPA's prior
consultation with representatives of affected tribal governments, a
summary of the nature of their concerns, and a statement supporting the
need to issue the regulation. In addition, Executive Order 13084
requires EPA to develop an effective process permitting elected
officials and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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 the rule in the Federal Register. This 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: December 1, 1998.
Stephen L. Johnson
Deputy Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I, part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1204 is added to read as follows:
Sec. 180.1204 Harpin protein; exemption from the requirement of a
temporary tolerance.
The biological pesticide Harpin is exempted from the requirement of
a temporary tolerance when applied under the terms of Experimental Use
Permit 69834-EUP-1, for the broad spectrum control of various
bacterial, fungal, and viral plant diseases when used on all food
commodities. The exemption from the requirement of a tolerance will
expire on October 31, 2000.
[FR Doc. 98-33629 Filed 12-17-98; 8:45 am]
BILLING CODE 6560-50-F
