[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: [email protected]. 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: [email protected].

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:
    [email protected]


    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