Cucurbitacins; Exemption from the Requirement of a Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

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:

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 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 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) 305-5697, 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

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 § 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: