Document ID: EPA-HQ-OPP-2009-0127-0010
Agency: epa
Document Type: Rule
Title: Amendment to an Exemption from the Requirement of a Tolerance: S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid
Posted Date: 2010-03-12T05:00Z

[Federal Register: March 12, 2010 (Volume 75, Number 48)]
[Rules and Regulations]               
[Page 11740-11744]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr10-5]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0127; FRL-8814-5]

 
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 (703) 
305-5805.

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: (703) 308-0031; e-mail address: pfeifer.chris@epa.gov.

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

[[Page 11741]]

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 (703) 305-5805.

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

[[Page 11742]]

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.

[[Page 11743]]

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

[[Page 11744]]

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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In subpart D, revise Sec.  180.1281 to read as follows:

Sec.  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.

[FR Doc. 2010-5491 Filed 3-11-10; 8:45 am]
BILLING CODE 6560-50-S