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Cucurbitacins; Exemption from the Requirement of a Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 22, 2000 (Volume 65, Number 56)]
[Rules and Regulations]
[Page 15248-15252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr00-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300965; FRL-6485-3]
RIN 2070-AB78
Cucurbitacins; 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 cucurbitacins from the powders and
juices of the Hawkesbury melon Citrullus lanatus on various food
commodities when applied/used as an inert (other) ingredient (gustatory
stimulant) in pesticides applied to growing crops only. Agricultural
Research Services, United States Department of Agriculture 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 cucurbitacins from Hawkesbury melon.
DATES: This regulation is effective March 22, 2000. Objections and
requests for hearings, identified by docket control number OPP-300965,
must be received by EPA on or before May 22, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VIII. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300965 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Vera Soltero, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-9359; and e-mail
address: soltero.vera@epa.gov.
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 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-300965. 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 1, 1999 (64 FR 47788) (FRL-
6098-6), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the
filing of a pesticide tolerance petition by, Agricultural Research
Services, United States Department of Agriculture, Agricultural
Research Center, Beltsville, MD 20705. This notice included a summary
of the petition prepared by the petitioner United States Department of
Agriculture. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.1001(d) be amended by
establishing an exemption from the requirement of a tolerance for
residues of cucurbitacins derived from the Hawkesbury melon Citrullus
lanatus. The petitioner noted that the Agency had previously
established exemptions from the requirement of a tolerance for the use
of buffalo gourd and zucchini juice, as sources of the inert ingredient
cucurbitacin (57 FR 40128, September 2, 1992 and 63 FR 43085, August
12, 1998), and is seeking to add the Hawkesbury melon Citrullus lanatus
as an additional source of cucurbitacins.
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
[[Page 15249]]
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.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by
cucurbitacins are discussed in this unit.
The Agency in a previous Federal Register notice reviewed mammalian
toxicity data submitted on zucchini juice and buffalo gourd root powder
as part of the establishment of 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 (63 FR
43085). A summary of the comparative toxicology data showed a more
favorable toxicological profile for the zucchini juice, as compared to
the buffalo gourd root powder, as a cucurbit source of cucurbitacins.
Zucchini juice was shown to be practically non-toxic to mammals. The
acute oral, acute dermal, acute inhalation, primary eye, and skin
irritation were all toxicity category IV. No acute systemic toxicity,
irritation or dermal sensitization was exhibited in the studies
performed with the zucchini juice.
Due to the low levels of cucurbitacins used in the field no acute
effects are expected to occur. In addition, due to their rapid
degradation, no chronic effects are expected to occur. Neither
cucurbitacins nor their metabolites are known or expected to have any
effect on the immune or the endocrine systems. These chemicals are not
known to be carcinogenic.
According to information supplied by USDA, the Hawkesbury
watermelon contains cucurbitacin E-glycoside at levels in the same
order of magnitude those found in buffalo gourd root powder, 0.76
milligrams (mg) cucurbitacin E-glycoside/grams (gm) of melon compared
to 0.59 mg cucurbitacin E-glycoside/gm of root powder. The Hawkesbury
melon does not contain cucurbitacin I. Cucurbitacin I is considered to
be more toxic than cucurbitacin E-glycoside (LD50 of 40
milligrams/kilograms (mg/kg) to 5 mg/kg). Thus, Hawkesbury melon is
also likely to exhibit lower toxicity than buffalo gourd root powder,
providing an additional margin of safety.
IV. 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 nonoccupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
Species of the family Cucurbitaceae, such as melons, pumpkins and
squash, are commonly used as fruits and vegetables throughout the
world, they are naturally occurring and widely available. Seeds of
several species are used as sources of flavorings in bakery goods or
for oils and proteins. All of these species contain some assortment of
naturally occurring cucurbitacins in varying concentrations.
1. Food. In the Federal Register notice published on August 12,
1998 (63 FR 43085), the Agency reviewed available data on the dietary
exposure to cucurbitacins. The use to control corn rootworm is given as
an example. Assuming that the maximum permitted level of 3.4 gm/acre/
season is applied, with no loss either in the field or during
processing, and that all the material is concentrated in the grain, the
following exposure would result. The average yield of corn in the
United States is 120-130 bushels per acre. At 56 pounds of corn per
bushel, the minimum yield is 6,720 pounds per acre and the level of
cucurbitacin would be 0.000506 grams of cucurbitacin per pound of corn.
A gram of ``straightneck'' squash contains 0.00139 grams of
cucurbitacin. Thus, even under these worst case assumptions,
consumption of a pound of treated corn would add less cucurbitacin to
the diet than a gram serving of squash. At the allowable rate of
application the proposed use of these compounds as inert ingredients
would result in a negligible increase in exposure to cucurbitacins over
those levels which would occur naturally as the result of ingestion of
various cucurbit commodities.
2. Drinking water exposure. The Agency review cited in the August
12, 1998, Federal Register notice established that most cucurbitacins
are insoluble in water and transfer of these cucurbitacins to ground
water is unlikely. The more water soluble glycosylated forms of
cucurbitacins are less toxic to humans. No uses are registered for
application to bodies of water.
B. Other Non-Occupational Exposure
There are no cucurbitacin-containing products with residential uses
as all uses are for agricultural crop production only.
V. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity.'' The Agency has
not made any conclusions as to whether or not cucurbitacins share a
common mechanism of toxicity with other chemicals. However, the
Hawkesbury melon juice is expected to be practically non toxic to
mammals. Due to the expected lack of toxicity, a cumulative risk
assessment is not necessary.
VI. Determination of Safety for U.S. Population, Infants and
Children
Cucurbitacins are present in varying amounts in many plants
regularly consumed by the general public, such as squash, gourds and
watermelon. Information available to the Agency indicates that the
maximum projected additional exposure to these compounds is
significantly less than that from a normal serving of these plants, as
previously discussed in section IV(A)(1). The residual amount of
cucurbitacins in a pound of corn, for example, is an order of magnitude
less than the naturally occurring levels of these substances in a
single serving of squash. Dietary exposure to
[[Page 15250]]
cucurbitacins through food is not likely to significantly increase due
to their use as inert ingredients applied to agricultural commodities.
These chemicals are not likely to be found in water. In addition, the
use sites of the cucurbitacins are all agricultural for the control of
Diabriticine beetles (corn rootworm and cucumber beetles). Therefore,
non-dietary exposure to infants and children is not expected.
The Agency had previously established in the Federal Register
notice published on August 12, 1998 (63 FR 43085) that cucurbitacins
contained in zucchini juice were practically non toxic to mammals.
Cucurbitacins in Hawkesbury melon are expected to be of similar
toxicity. Because of this, the Agency did not use the safety factor
analysis in evaluating the risk posed by the compound. This lack of
toxicity also supported not applying an additional tenfold safety
factor to protect infants and children. In conclusion, the Agency is
reasonaly certain that no harm will result to infants and children, or
to the general population from a minimally increased exposure to
residues of cucurbitacins. Based on the information in this preamble,
EPA concludes that there is a reasonable certainty of no harm from
aggregate exposure to residues. Accordingly, EPA finds that exempting
cucurbitacin residues from the requirement of a tolerance will be safe.
VII. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including pesticides and inert ingredients,
``may have an effect in humans that is similar to an effect produced by
a naturally occurring estrogen, or such other endocrine effect....''
The Agency has been working with interested stakeholders to develop a
screening and testing program as well as a priority setting scheme. As
the Agency proceeds with implementation of this program, further
testing of products containing the inert ingredient cucurbitacin for
endocrine effects may be required. At this moment, there is no evidence
that cucurbitacins are endocrine disruptors.
B. Analytical Method(s)
The Agency is establishing an exemption from the requirement of a
tolerance without any change in the previously established limits of no
more than 2.5 pounds/acre/season (3.4 grams cucurbitacin/acre/season).
Therefore, the Agency has concluded that an analytical method is not
required for enforcement purposes of cucurbitacins from the Hawkesbury
melon.
C. Existing Tolerances
Prior EPA findings include a temporary exemption for the
requirements of a tolerance for residues of the buffalo gourd,
Cucurbita foetidissima, root powder as a source of cucurbitacins in or
on the raw agricultural commodity fields corn for the control of adult
corn rootworms (55 FR 49700, November 30, 1990). In addition, the
Agency established a permanent exemption from the requirement of a
tolerance for the residues of buffalo gourd root powder when used as an
inert ingredient (gustatory stimulant) in pesticide formulations
applied to growing crops only (57 FR 40128, September 2, 1992). In
1998, the Agency amended the permanent exemption from the requirement
of a tolerance to add the residues of zucchini juice, Cucurbita pepo,
to the list of inert ingredients (63 FR 43085, August 12, 1998).
D. International Tolerances
There are no international tolerances or tolerance exemptions for
cucurbitacins.
E. Conclusion
Therefore, based on the information and the data considered, as
well as previous tolerance exemptions granted to cucurbitacins from
buffalo gourd root powder and zucchini juice, EPA is establishing an
exemption from the requirement of a tolerance for residues of
cucurbitacins from the Hawkesbury melon.
VIII. 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-300965 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 May 22,
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, 401 M St., SW., 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-
[[Page 15251]]
5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for
information to Mr. Tompkins at Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
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, 401 M St., SW.,
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 VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in Unit I.B.2. Mail
your copies, identified by docket control number OPP-300965, 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: opp-docket@epa.gov.
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).
IX. 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).
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 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: March 7, 2000.
James Jones,
Director, Registration Division, 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. In Sec. 180.1001, the table in paragraph (d), is amended by
adding ``or Hawkesbury melon Citrullus lanatus'' to the end of the
entry for ``Buffalo gourd root powder'' to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance
* * * * *
(d)* * *
[[Page 15252]]
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Buffalo gourd root powder * * * * * *
(Cucurbita foetidissima root
powder), Zucchini juice (Cucur
bita pepo juice) or Hawkesbury
melon Citrullus lanatus.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 00-6863 Filed 3-21-00; 8:45 am]
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