01-14487. Methyl Anthranilate; 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 the methyl anthranilate on corn and sunflower when applied/used as a bird repellent. Bird Shield Repellent Corporation 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 methyl anthranilate on corn and sunflower and reasses the existing tolerance exemption for methyl anthranilate.

DATES:

This regulation is effective June 8, 2001. Objections and requests for hearings, identified by docket control number [OPP-301127], must be received by EPA, on or before August 7, 2001.

ADDRESSES:

Written objections and hearing requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit IX. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301127 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Jim Downing, c/o Product Manager (PM) 91, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-308-9071; and e-mail address: [e-mail].

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:

Categories	NAICS codes	Examples of 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,” “Regulations and Proposed Rules,” 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/​. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/​nara/​cfr/​cfrhtml_​00/​Title_​40/​40cfr180_​00.html,, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm.

2. In person. The Agency has established an official record for this action under docket control number OPP-301127. 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 [phone].

II. Background and Statutory Findings

In the Federal Register of January 24, 2000 (65 FR 3693) (FRL-6485-5), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of pesticide tolerance petitions (PP 9F5056 and 9F5055) by Bird Shield Repellent Corporation, P.O. Box 785, Pullman, WA 99163. This notice included a summary of the petitions prepared by the petitioner Bird Shield Repellent Corporation. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1143 be amended by establishing an exemption from the requirement of a tolerance for residues of methyl anthranilate on corn and sunflower.

III. Risk Assessment

New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(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. . . .”

Additionally, section 408(b)(2)(D) requires that 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.”

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.

IV. 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.

Methyl anthranilate is naturally occurring in certain foods, such as concord grapes. It is also synthetically produced and used as a flavoring agent (21 CFR 182.60) in beverages, ice cream, candy, baked goods, gelatins, puddings, and chewing gum. It is also exempt from the requirement of a tolerance in or on blueberries, cherries, and grapes (40 CFR 180.1143). A discussion of the rationale supporting that exemption may be found in the proposed rule, as well as in the April 26, 1995 final rule. In addition, methyl anthranilate is classified as generally recognized as safe (GRAS) by FDA (21 CFR 182.60).

Methyl anthranilate, because of volatility, rapidly decomposes into non-toxic components leaving no significant residue relative to levels found in food on corn and sunflower to which it is applied. The residue studies showed that the residues of methyl anthranilate found on corn and sunflower were less than those found naturally in grapes. Moreover, it has been determined that even if ingested, the chemical rapidly metabolizes in the intestines and byproducts are excreted. In addition to this information, the Agency has determined that all toxicology data requirements have been satisfied and it has conducted a review of these studies. Summaries of these studies are presented below. For a more detailed discussion of these studies, see the Data Review Records located in the information docket referred to above.

Mammalian toxicity. Methyl anthranilate exhibits little or no mammalian toxicity. As mentioned before, it metabolizes in the intestine when consumed. The LD₅₀ values for methyl anthranilate were estimated to be greater than 5,000 milligram/kilogram (mg/kg) in an acute oral toxicity study in rats (Toxicity Category IV). Methyl anthranilate was found to cause moderate irritation in a rabbit skin irritation assay after continuous exposure of the compound for 4 hours (Toxicity Category III) and corneal effects that cleared in 8 to 21 days in a rabbit eye irritation assay (Toxicity Category II). Since the mammalian toxicity is low and considering the diluted formulation that is used, no hypersensitivity studies were necessary.

Guideline	Study	MRID No.	Toxicity Category
870.1100	Acute Oral Toxicity -rat	447403-01	IV
870.1200	Acute Dermal Toxicity	447403-02	III
870.1300	Acute Inhalation Toxicity - rat	447403-03	III
870.2400	Acute (Primary) Eye Irritation - rabbits	440703-02	II
870.2500	Acute (Primary Dermal) Skin Irritation	440703-01	III
870.2600	Hypersensitivity (skin sensitization)	NA	Waived

Appropriate labeling (protective eyewear) was used to mitigate these moderately acute toxicological risks. Due to the low toxicity, metabolism, rapid degradation and long history of dietary exposure to this naturally occurring biochemical, chronic and subchronic data were waived. No other toxic endpoints were identified and therefore no reference dose and no observable effect level were established.

V. 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 ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

A. Dietary Exposure

1. Food. Methyl anthranilate residues, when used as a bird repellent, are already exempt from the requirement of a tolerance on blueberries, cherries and grapes, based upon a “worst case” maximum concentration on cherries of 35 ppm (60 FR 9816, February 22, 1995) and the fact that natural levels of 33 ppm occur in commonly consumed foods, such as grapes, and that use of methyl anthranilate as a flavoring agent results in residues of approximately 30 ppm in baked goods and up to 400 ppm in gum. For corn and sunflowers, methyl anthranilate, applied at a rate of only 0.2862 pounds per acre, results in residues of less than 33 ppm on these crops, even when taking into account the 4.5-fold and 14-fold maximum theoretical concentration factors for processed commodities. Because methyl anthranilate is a volatile compound, which rapidly degrades when exposed to ultraviolet light (sunlight), and warm temperatures in the environment, further reduction in residues is expected. The dietary exposure is not anticipated to be increased significantly in a typical human diet by the use of this biochemical pesticide on sunflowers and corn. Further, since methyl anthranilate has shown no mammalian toxicity and is rapidly metabolized in human intestines and liver, no dietary risk from these additional uses of this biochemical pesticide are anticipated.

2. Drinking water exposure. Methyl anthranilate is very unlikely to be found in drinking water, given the extremely low application rate and rapid environmental and microbial degradation (MRID 431194-01).

B. Other Non-Dietary, Non-Occupational Exposure

The primary non-dietary, non-occupational sources of exposure the Agency considered include exposure through use in lawns (turf), and on cherries, blueberries and grapes grown around the home or structures. Methyl anthranilate products are registered for use on residential turf (lawns) but not for any indoor uses. Limited exposure would result from use on home lawns, because of the rapid degradation of methyl anthranilate under sunlight. Even though methyl anthranilate products can be used on household (gardens) grown cherries, blueberries and grapes, the use is expected to be infrequent and very low, because of the limited quantities needed to control the targeted species during any growing season. In addition, methyl anthranilate rapidly degrades, thus limited exposure is anticipated. Use of methyl anthranilate around structures would not significantly increase the exposure, because of the limited use anticipated around the home. Home applicators could be exposed to methyl anthranilate, but this would be in a limited manner due to the infrequent use around the home. The Agency expects little risk from this exposure due to the low toxicity (LD₅₀ of >5,000 mg/kg oral toxicity in rats; dermal LD₅₀ of >2,000 thru 5,000 mg/kg; inhalation LD₅₀ of >0.5 thru 2.0 mg/liter) of this natural constituent of certain plants (i.e., grapes).

VI. Cumulative Effects

Methyl anthranilate does not exhibit a toxic mode of action to the target species (birds) or any mammals to which limit dose were tested. Thus, because there is no indication of mammalian toxicity to this substance, no cumulative effects with other related compounds is expected.

VII. Determination of Safety for U.S. Population, Infants and Children

Methyl anthranilate has been demonstrated by the results of acute toxicity testing in mammals to cause no adverse effects when dosed orally and via inhalation at the limit dose of each study. Further, significant methyl anthranilate residues relative to levels found in foods have not been detected on treated corn and sunflower. Considering the low toxicity and the lack of significant residues of this naturally occurring biochemical, combined with its metabolism in the intestines if ingested, EPA has concluded that there is reasonable certainty that no harm will result from aggregate exposure to the U.S. population, or any significant subpopulation, including infants and children, to residues of methyl anthranilate. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA did not use a 10x safety factor for children in its analysis because of the low toxicity of methyl anthranilate and the lack of significant residue relative to levels found in food when applied to corn and sunflower.

VIII. Other Considerations

A. Endocrine Disruptors

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, to other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Programs (EDSP).

When the appropriate screening and/or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, methyl anthranilate may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. Based on the weight of the evidence of available data, no endocrine system-related effects have been identified.

B. Analytical Method(s)

This action is establishing an exemption from the requirement of a tolerance for the reasons described above. As previously noted, methyl anthranilate exhibits rather low toxicity. For this reason and because no significant residues have been detected on treated corn and sunflower (in other words, residues beyond that of methyl anthranilate found naturally in grapes are unlikely), no analytical method for enforcement purposes is required.

C. Codex Maximum Residue Level

The Agency is not aware of any international tolerances, exemptions from tolerance or Maximum Residue Levels (MRLs) issued for methyl anthranilate. Furthermore, the Agency is not aware of any issues regarding Codex Maximum Residue Levels.

IX. 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-301127 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 August 7, 2001.

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, 1200 Pennsylvania Ave., NW., 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 [phone].

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 [phone], by e-mail at [e-mail], or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 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, 1200 Pennsylvania Ave., NW., 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 IX.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 number OPP-301127, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 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: [e-mail]. 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 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).

X. 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 special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or 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). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XI. 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: May 25, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention 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. Section 180.1143 is revised to read as follows:

§ 180.1143

Methyl anthranilate; exemption from the requirement of a tolerance.

Methyl anthranilate, a biochemical pesticide, is exempt from the requirement of a tolerance when used in accordance with good agricultural practices on the following raw agricultural commodities: Blueberry, cherry, corn, grape, and sunflower.