[Federal Register Volume 63, Number 155 (Wednesday, August 12, 1998)]
[Rules and Regulations]
[Pages 43085-43088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21521]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300683; FRL-6017-5]
RIN 2070-AB78
Zucchini Juice Added to Buffalo Gourd Root Powder; Exemption From
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of zucchini juice when used as an alternative
source of the inert ingredient gustatory stimulant cucurbitacin in the
pesticide formulations applied to various food commodities. MicroFlo
Company submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act as amended by the Food Quality Protection Act of 1996
(Pub. L. 104-170) requesting the exemption. This regulation eliminates
the need to establish a maximum permissible level for residues of
zucchini juice.
DATES: This regulation is effective August 12, 1998. Objections and
requests for hearings must be received by EPA on or before October 13,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300683], 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-300683], 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,
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@epamail.epa.gov. 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-300683]. 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: Rita Kumar, c/o Product
Manager (PM) 91, 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., CM #2 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)308-
8291. e-mail: kumar.rita@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 1997 (62
FR
[[Page 43086]]
34278) (FRL-5719-7), EPA issued a notice pursuant to section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide tolerance petition by MicroFlo
Company, 719 Second Street, Suite 12, Davis, CA 95616. 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 Food Quality Protection Act (FQPA)
of 1996. The petition requested that 40 CFR 180.1001(d) be amended by
adding zucchini (Cucurbita pepo) juice to buffalo gourd (Cucurbita
foetidissima) root powder's tolerance exemption when used in or on
various food commodities at 3.4 grams of cucurbitacin per acre per
season.
Inert ingredients are all ingredients that are not active as
defined in 40 CFR 153.125, and include, but are not limited to the
following types of ingredients (except when they have a pesticidal
efficacy of their own): solvents such as alcohols and hydrocarbons;
surfactants such as polyoxyethylene polymers and fatty acids; carriers
such as clay and diatomaceous earth; thickeners such as carrageenan and
modified cellulose; wetting, spreading and dispersing agents;
propellants in aerosol dispensers; microencapsulating agents; and
emulsifiers. The term inert is not intended to imply nontoxicity; the
ingredient may or may not be chemically active.
Cucurbitacins, found in plants of the Family Cucutbitaceae, act
specifically on Diabroticine beetles (corn rootworm and cucumber
beetles) as movement arrestants and compulsive feeding stimulants.
These have been used in pesticide products Slam/Adios and Adios AG,
which were developed to replace highly toxic corn rootworm and cucumber
beetle insecticides. When used along with cucurbitacin in the
formulation, a much smaller amount of the pesticide active ingredient
carbaryl is needed to achieve efficacy against these pests.
MicroFlo Company's current source of cucurbitacin is buffalo gourd
root powder. The Agency established an exemption from the requirement
of a tolerance for residues of buffalo gourd root powder (57 FR 40128,
September 2, 1992). Now, MicroFlo Company is adding zucchini juice as
an additional source of cucurbitacin, since production of buffalo gourd
root powder is costly and unreliable, and a notice of filing was
published on June 25, 1997, as mentioned above.
There were no comments received in response to the notice of
filing.
I. Risk Assessment and Statutory Findings
New section 408(b)(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(b)(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...'' 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.
The data submitted in the petition and other relevant material have
been evaluated and were considered in support of this tolerance
exemption amendment.
II. 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.
Acute Toxicity
Acute mammalian toxicity data were submitted on zucchini juice as
well as buffalo gourd root powder(BGRP). Submitted data were found to
be acceptable and performed in accordance with the Subdivision M
Guidelines. A summary of the comparative toxicology data shows a more
favorable toxicological profile for the zucchini juice (Cucurbita pepo
juice), as compared to the buffalo gourd root powder (Cucurbita
foetidissima root powder), as a cucurbit source of cucurbitacins.
The acute mammalian toxicity studies indicate that the zucchini
juice is practically non-toxic to mammals. The acute oral, acute
dermal, acute inhalation, primary eye, and skin irritation are all
toxicity category IV. No acute systemic toxicity, irritation or dermal
sensitization was exhibited in the studies performed with the zucchini
juice.
The pesticide inert ingredient zucchini juice and the associated
component cucurbitacin do not meet the conditions of 40 CFR 158.690(b):
based on the results of Tier I toxicology studies, neither Tier II nor
III toxicology data are required.
Given the small amounts used and rapid degradation of zucchini
juice and associated cucurbitacins, no chronic effects are expected.
Neither the zucchini juice and associated cucurbitacins, nor
metabolites, are known to, or expected to have any effect on the immune
or endocrine systems. Zucchini juice and associated cucurbitacins are
not carcinogenic.
III. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 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. Assumptions, for the purpose of this maximum dietary risk
- worst case scenario, (case crop - corn; the example can be extended
to other crops) include that the zucchini juice and thus, the
cucurbitacin, is applied at the maximum label rate, the maximum number
of times, the day of harvest, and all of the material applied to the
field is concentrated in the grain; with no loss of zucchini juice nor
cucurbitacin due to any environmental, physical, chemical microbial or
milling/processing degradation. This will result in 2.4375 pounds of
zucchini juice and 0.0073125 pounds (3.319875 grams) of cucurbitacins
per acre.
The national average grain yield for corn is 120 - 130 bushels per
acre. At 56 pounds per bushel, for the purpose of the calculation, that
computes to 6,720 pounds per acre using the lower
[[Page 43087]]
yield value. The maximum label rates allow for the application of 3.4
grams of cucurbitacin per acre. Assuming all of the cucurbitacin is
concentrated in the grain, cucurbitacin levels would be 0.00051 grams
cucurbitacin per pound of grain corn. No adverse effects are
anticipated at this low exposure rate.
2. Drinking water exposure. Cucurbitacins are insoluble in water
and transfer of the zucchini juice to drinking water is highly
unlikely. No leaching or groundwater contamination is expected to
result from registered uses according to good agricultural practice. No
uses are registered for application to bodies of water and none are
being sought.
B. Other Non-Occupational Exposure
Registered uses are limited to agricultural crop production use.
IV. Cumulative Exposure to Substances with Common Mechanisms of
Toxicity
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 the zucchini juice is practically non-toxic to mammals and no
information indicates that toxic effects would be cumulative with any
other compounds. Further, no other pesticides or substances are
registered with this mode of action.
V. Determination of Safety for Infants and Children
The use sites for the zucchini juice are all agricultural for
control of Diabroticine beetles. Therefore, nondietary exposure to
infants and children is not expected. The fact that zucchini juice is
practically non-toxic to mammals; and exposure is not likely to occur
from use, lead EPA to conclude that there is a reasonable certainty
that no harm will result to infants and children from exposure to
residue of zucchini juice. Because of the lack of toxicity for zucchini
juice, EPA has not used the a safety factor analysis is evaluating the
risk posed by the compound. This lack of toxicity also supports not
applying an additional tenfold safety factor to protect infants and
children.
VI. Determination of Safety for U.S. Population
The fact that zucchini juice is practically non-toxic to mammals,
and previous Agency actions of granting a temporary exemption (November
30, 1990, 55 FR 49700), and establishing a permanent exemption from the
requirement of a tolerance (September 2, 1992, 57 FR 40128), for
buffalo gourd root powder as a source of cucurbitacin, support an
amendment to the existing tolerance exemption. EPA concludes that
zucchini juice is not likely to present a dietary risk under any
reasonably foreseeable circumstances. Accordingly, EPA finds that
exempting zucchini juice from the requirement for a tolerance will be
safe in that there is a reasonable certainty of no harm from aggregate
exposure to zucchini juice.
VII. CODEX Maximum Residue Level
No international tolerances of tolerance exemptions have been
sought.
VIII. Existing Tolerance or Tolerance Exemptions for This Compound
Prior EPA findings of significant relevance to this petition
include an exemption from the requirements of a tolerance for residues
of buffalo gourd root powder (Cucurbita foetidissima root powder) when
used as an inert ingredient (gustatory stimulant) in pesticide
formulations applied to growing crops only, at application rates not to
exceed 2.5 lbs/acre/season (3.4 gm/acre/season of cucurbitacin). The
proposed rule was published on July 9, 1992 (57 FR 30454), and the
final rule was published on September 2, 1992 (57 FR 40128).
IX. Objections and Hearing Requests
The new FFDCA 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)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 be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by October 13, 1998, 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.
X. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300683]. A public version of this record, including
printed, paper versions of electronic comments, 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,
CM 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
[[Page 43088]]
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing request, 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.
XI. 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) (Pub.L. 104-4). Nor does it require and prior
consultation as specified by Executive Order 12875, entitled Enhancing
the Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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 section 408(d) of the 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. 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.
XII. 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: July 29, 1998.
Stephen L. Johnson,
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. 346a and 371.
Sec. 180.1001 [Amended]
2. In Sec. 180.1001, in paragraph (d), the table is amended by
adding the phrase `` ; or, Zucchini juice (Cucurbita pepo juice)''
after ``Buffalo gourd root powder (Cucurbita foetidissima root
powder)'' in the ``Inert Ingredients'' column.
[FR Doc. 98-21521 Filed 8-11-98; 8:45 am]
BILLING CODE 6560-50-F
