2010-5491. S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid; Amendment to an Exemption from the Requirement of a Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation amends the current temporary exemption from the requirement of a tolerance for residues of the biochemical pesticide S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid (ABA), to make it a permanent exemption from the requirement of a tolerance for residues of ABA in or on all food commodities when applied or used preharvest as a plant regulator. Valent Biosciences Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting that the Agency amend the existing temporary exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of S-Abscisic Acid.

DATES:

This regulation is effective March 12, 2010. Objections and requests for hearings must be received on or before May 11, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0127. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Chris Pfeifer, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

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 this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any 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 Electronic Access to Other Related Information?

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/​ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a(g), 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. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0127 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 11, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2009-0127, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

II. Background and Statutory Findings

In the Federal Register of May 6, 2009 (74 FR 20946) (FRL-8411-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 8F7391) by Valent Biosciences Corporation, 870 Technology Way, Libertyville, IL 60048. The petition requested that 40 CFR 180.1281 be amended by establishing a permanent exemption from the requirement of a tolerance for residues of S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid (hereafter referred to as ABA). This notice stated that a summary of the petition prepared by the petitioner Valent Biosciences Corporation could be found in the docket for this action, which is available to the public in the docket, http://www.regulations.gov. There were no substantive comments received in response to the notice of filing. Currently, there is a two-part temporary exemption from the requirement of a tolerance for residues of ABA. ABA is exempt from the requirement of a tolerance when used on grapes in accordance with Experimental Use permit 73049-EUP-4, which expires on October 1, 2010; and ABA is exempt when used on grapes, herbs and spices, leafy vegetables, pineapple, pome fruit and stone fruit in accordance with Experimental Use permit 73049-EUP-7, which expires on August 7, 2012. Valent Biosciences Corporation requested an amendment of this two-part temporary exemption to a permanent exemption in or on all food commodities.

Section 408(c)(2)(A)(i) of 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 exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA 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. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require 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) of FFDCA 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.

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.

ABA is a plant regulator present in all vascular plants, algae, and some fungi. Its name derives from its purported role in abscission—the shedding of leaves, fruits, flowers, and seeds. As a plant hormone, ABA is known to be a strong actor in regulating plant growth by aiding in stress resistance, fruit set, ripening, and senescence. It is naturally present in fruits and vegetables at various levels, generally not in excess of 10 parts per million (ppm), and has always been a component of any diet containing plant materials. To date, no toxic effects to humans have been associated with the consumption of ABA in fruits and vegetables.

Summaries of the toxicological data submitted in support of this exemption from the requirement of a tolerance follows:

1. Acute toxicity. Acute toxicity studies, submitted to support the registration of the end-use product containing ABA, confirm a low toxicity profile and buttress the finding that this active ingredient poses no significant human health risk with regard to new food uses. Altogether, the acute toxicity data show virtual nontoxicity for all routes of exposure and suggest that any dietary risks associated with this naturally occurring plant regulator would be negligible.

i. The acute oral median lethal dose (LD₅₀) in rats was greater than 5,000 milligrams per kilogram (mg/kg) and confirmed negligible toxicity through the oral route. There were no observed toxicological effects on the test subjects in the acute oral study submitted (Master Record Identification Number MRID No. 46895611). ABA is Toxicity Category IV for acute oral toxicity.

ii. The acute dermal LD₅₀ in rats was greater than 5,000 mg/kg. These data substantiated ABA's relative dermal nontoxicity to the general public (MRID No. 46895612). ABA is Toxicity Category IV for acute dermal toxicity.

iii. The acute inhalation median lethal concentration (LC₅₀) was greater than 2.06 milligrams per liter (mg/L) in rats and showed no significant inhalation toxicity (MRID No. 46895613). ABA is Toxicity Category IV for acute inhalation toxicity.

iv. A skin irritation study on rabbits indicated that ABA was not irritating to the skin (MRID No. 46895615). ABA is Toxicity Category IV for dermal irritation.

v. Data indicated ABA is not a dermal sensitizer (MRID No. 46895616). Data indicate that ABA is not acutely toxic. No toxic endpoints were established, and no significant toxicological effects were observed in any of the acute toxicity studies.

2. Mutagenicity. Three mutagenicity studies, using ABA as the test substance, were performed. These studies are sufficient to confirm that there are no expected dietary or non-occupational risks of mutagenicity with regard to new food uses.

i. The Reverse Mutation Assay (MRID No. 47030901) showed that ABA did not induce mutant colonies relative to control groups.

ii. The In vitro Mammalian Cells in Culture Assay (MRID No. 47005302) demonstrated that ABA did not damage chromosomes or the mitotic apparatus of hamster ovary cells.

iii. A Bone Marrow Micronucleus Assay (MRID No. 47005301) indicated no mutagenicity in the bone marrow cells of mice up to the limit dose of 2,000 mg/kg.

3. Subchronic toxicity. Based on its biodegradation properties, residues of ABA are not expected to result in significant dietary exposure beyond the levels expected in background dietary exposures. Nonetheless, two subchronic oral toxicity studies satisfied the data requirements for subchronic toxicity and indicated that ABA has no subchronic toxicological effect.

i. A 28-day Oral Toxicity Study (MRID No. 47470509) found no toxicological effects regarding mortality, clinical observations, neurotoxicity assessment, body weight, food consumption, hematology, clinical chemistry, organ weights, and macroscopic or microscopic observations. The no observable adverse effect level (NOAEL) was determined to be 20,000 milligrams per kilogram per day (mg/kg/day).

ii. A 90-day Oral Toxicity Study (MRID No. 47470510) found no statistical difference in hematology, clinical chemistry, or urinalysis between test subjects and the control. The NOAEL was determined to be 20,000 mg/kg/day.

4. Developmental toxicity. The data submitted to the Agency (MRID No. 47470511) demonstrate a clear lack of developmental toxicity and support the Agency's conclusion that there is no risk of developmental toxicity associated with new food uses. Data submitted to the Agency satisfy the data requirements for developmental toxicity and indicate that ABA poses negligible risk with regard to developmental toxicity.

A Prenatal Developmental Toxicity Study (MRID No. 47470512) found no significant treatment-related reproductive effects or fetal abnormalities and established a NOAEL of 1,000 mg/kg/day.

5. Effects on endocrine systems. There is no available evidence demonstrating that ABA is an endocrine disruptor in humans. As a result, the Agency is not requiring information on the endocrine effects of ABA at this time. However, the Endocrine Disruption Screening Program (EDSP) has established a protocol, which guides the Agency in selecting suspect ingredients for review, and the Agency reserves the right to require new information should the program require it. Presently, based on the lack of exposure and the negligible toxicity profile of ABA, no adverse effects to the endocrine are known or expected. Overall, the lack of evidence of endocrine disruption is consistent with ABA's low toxicity profile and supports this exemption from the requirement of a tolerance.

IV. Aggregate Exposures

In examining aggregate exposure, section 408 of FFDCA 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

ABA is a plant regulator present in all vascular plants, algae, and some fungi. It is naturally present in fruits and vegetables at various levels, generally not in excess of 10 ppm, and has always been a component of any diet containing plant materials. Because of the rapid degradation of ABA, the proposed preharvest uses of this active ingredient are not expected to result in dietary residues in or on food above the natural background levels. Even in a worst-case scenario, exposure to ABA residues would not be expected to exceed exposures expected in a vegetarian diet.

1. Food. Residues of ABA applied to food crops are expected to dissipate to background levels before they are distributed for consumption. Data submitted by the registrant confirm ABA's rapid dissipation through metabolization, photo-isomerization, and degradation (MRID No. 47131404). Data demonstrate that ABA residues on grape leaves are 95% degraded within 24 hours of application. Moreover, confirmatory data on the degradation of ABA on wheat leaves show a half-life ranging between 5 and 8 hours. Given ABA's preharvest application and rapid degradation, no significant residues are expected. Even in the unlikely event of dietary exposure to ABA residues, it is noted that ABA is naturally present in fruits and vegetables at various levels up to 10 ppm and has always been a component of any diet containing plant materials. No toxicological hazard has historically been associated with its consumption. In sum, while little to no dietary exposure from use of ABA as a pesticide is expected, dietary exposures would not be expected to pose any quantifiable risk, due to ABA's nontoxic profile as described in Unit III.

2. Drinking water exposure. Applications of ABA are made directly to terrestrial crops. Accordingly, no aquatic exposures are expected. While ABA residues might runoff after application, they are not expected to be able to reach surface water or to percolate through the soil to ground water because of the rapid biodegradation of ABA and the rapid metabolization of ABA by soil microbes (MRID No. 47131404). Modeling of estimated environmental concentrations (EECs) in water indicate that maximum residues in water resulting from an incidental offsite movement of ABA would not exceed the low parts per billion level - an amount that is indistinguishable from the natural level of ABA already found in our water. (Notably, the highest potential EECs in water are many orders of magnitude below the amounts that would be commonly found in a typical serving of fruit and vegetables.) In sum, the Agency concludes that any residues resulting from the application of ABA to crops are not expected to result in any significant drinking water exposure and that any incidental residues resulting from a drift or run-off event would be so negligible that they would not pose any quantifiable risk.

B. Other Non-Occupational Exposure

Non-occupational exposure is not expected because ABA is not approved for residential uses. The active ingredient is applied directly to food commodities and degrades rapidly. Furthermore, the Agency notes that health risks are not expected from any pesticidal exposure to this active ingredient, no matter the circumstances. A December 2009 Agency risk assessment of ABA clearly establishes that even prolonged and regular occupational exposures, which are associated with this active ingredient, pose negligible risks. In the event of incidental non-occupational exposure, no risks are expected due to ABA's low toxicity profile, nontoxic mode of action, and demonstrable lack of dietary effects.

1. Dermal exposure. Non-occupational dermal exposures to ABA are expected to be negligible because of its directed agricultural use. In the event of dermal exposure to residues, the nontoxic profile of ABA (as described in Unit III.) is not expected to result in any risks through this route of exposure.

2. Inhalation exposure. Non-occupational inhalation exposures are not expected to result from the agricultural uses of ABA. Any inhalation exposure associated with this new agricultural use pattern is expected to be occupational in nature.

V. Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA 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.”

EPA has not found S-Abscisic Acid to share a common mechanism of toxicity with any other substances, and S-Abscisic Acid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that S-Abscisic Acid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/​pesticides/​cumulative.

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

Health risks to humans, including infants and children, are considered negligible with regard to the pesticidal use of ABA. As illustrated in Unit III., acute toxicity studies indicate that ABA has negligible toxicity. Furthermore, it is ubiquitous in nature and present in all fruits and vegetables. To date, there is no history of toxicological incident involving its consumption. Of equal note, little to no exposure to the residues of ABA is expected. Pesticidal applications are applied directly to agricultural crops, and data suggest that significant residues are not expected beyond the time of harvest. Accordingly, little to no dietary exposure is expected. As such, the Agency has determined that this food use of ABA poses no foreseeable risks to human health or the environment. Thus, there is a reasonable certainty of no harm to the general U.S. population, including infants and children, from exposure to this active ingredient.

1. U.S. population. The Agency has determined that there is a reasonable certainty that no harm will result from aggregate exposure to residues of ABA to the U.S. population. This includes all anticipated dietary exposures and other non-occupational exposures for which there is reliable information. The Agency arrived at this conclusion based on the low levels of mammalian dietary toxicity associated with ABA, the natural ubiquity of ABA in foodstuffs, and information suggesting that the pesticidal use of ABA will not result in any significant exposure. For these reasons, the Agency has determined that ABA residues in and on all food commodities will be safe, and that there is a reasonable certainty that no harm will result from aggregate exposure to residues of ABA.

2. Infants and children. Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless the EPA determines that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety), which are often referred to as uncertainty factors, are incorporated into EPA risk assessments either directly or through the use of a margin of exposure analysis, or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk. Based on all the information evaluated for ABA, the Agency concludes that there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the considerations of consumption patterns, special susceptibility, and cumulative effects do not apply to pesticides, such as ABA, without a demonstrated significant adverse effect.

VII. Other Considerations

A. Analytical Enforcement Methodology

Through this action, the Agency proposes an exemption from the requirement of a tolerance of ABA when used on all food commodities without any numerical limitations for residues. EPA has determined that residues resulting from the pesticidal uses of ABA would be so low as to be virtually indistinguishable from natural background levels. As a result, the Agency has concluded that an analytical method is not required for enforcement purposes for ABA.

B. International Residue Limits

There are no codex maximum residue levels established for residues of ABA.

VIII. Conclusions

Based on the data submitted to support this tolerance exemption, and other information available to the Agency, EPA is amending the current temporary exemption from the tolerance requirements, pursuant to section 408(c) of FFDCA, to be a permanent exemption from the requirement for a tolerance for residues of ABA in or on all food commodities when applied pre-harvest as a plant regulator.

IX. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of FFDCA 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). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

X. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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: February 25, 2010.

Steven Bradbury,

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. 321(q), 346a and 371.

2. In subpart D, revise § 180.1281 to read as follows:

§ 180.1281

S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid; exemption from the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for residues of S-Abscisic Acid in or on all food commodities when applied or used preharvest as a plant regulator.