Document ID: EPA-HQ-OPP-2009-0189-0003
Agency: epa
Document Type: Rule
Title: S-Abscisic Acid; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2009-07-29T04:00Z

[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]               
[Page 37618-37621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy09-20]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0189; FRL-8427-3]

 
S-Abscisic Acid; Temporary Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a 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 in or on leafy vegetables, 
herbs and spices, pome fruit, stone fruit, grapes and pineapples when 
applied/used as a plant regulator in accordance with the terms of 
Experimental Use Permit (EUP) 73049-EUP-7. Valent BioSciences 
Corporation submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. 
This regulation eliminates the need to establish a maximum permissible 
level 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 
for the uses permitted under EUP 73049-EUP-7. The temporary tolerance 
exemption expires on August 7, 2012.

DATES: This regulation is effective July 29, 2009. Objections and 
requests for hearings must be received on or before September 28, 2009, 
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-2009-0189. 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), Office of Pesticide Programs, 
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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also 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, 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-2009-0189 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 September 28, 2009.
    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-2009-0189, by one of the following methods.

[[Page 37619]]

     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 April 8, 2009 (74 FR 15969) (FRL-8407-
6), 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 9G7532) by Valent BioSciences Corporation, 870 Technology 
Way, Libertyville, IL 60048. The petition requested that 40 CFR part 
180 be amended by establishing a temporary 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 in or on leafy vegetables, herbs and spices, pome 
fruit, stone fruit, grapes and pineapples. This notice included a 
summary of the petition prepared by the petitioner, Valent BioSciences 
Corporation, which is included in the docket for this rule. In that 
summary, Valent BioSciences Corporation requested an expansion of the 
temporary exemption of a requirement for tolerance for S-Abscisic Acid 
(commonly abbreviated as ABA) to extend to leafy vegetables, herbs and 
spices, pome fruit, stone fruit, grapes and pineapples pursuant to the 
issuance of EPA EUP Number 73049-EUP-7. This EUP is designed to test 
ABA for its ability to aid in fruit thinning, growth control, crop 
stress reduction and crop quality improvement, and proposes a maximum 
rate of 2,000 parts per million (ppm) per acre to be applied up to four 
times annually. The EUP proposes to study ABA over 3 years (until 
August 7, 2012) and would cover a sum total of 6,913 acres. There were 
no comments received in response to the notice of filing.
    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.
    S-Abscisic Acid 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, S-Abscisic Acid 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 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.
    S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-cyclohex-
2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid is virtually non-toxic with 
regard to acute toxicity. The lethal dose (LD)50 for acute 
oral toxicity using the rat was greater than 5,000 milligrams/kilogram 
(mg/kg) of body weight in female rats, so it is classified as a 
Toxicity Category IV for acute oral toxicity. The LD50 for 
acute dermal toxicity using the rat was greater than 5,000 mg/kg body 
weight in male and female rats, so it is classified as a Toxicity 
Category IV for acute dermal toxicity. The lethal concentration 
(LC)50 for acute inhalation toxicity was greater than 2.06 
mg/liter (L) in male and female rats, so it is classified as a Toxicity 
Category IV for acute inhalation toxicity. Primary eye irritation, 
tested in rabbits, showed mild irritation to the eye (Toxicity Category 
III). Iritis and conjunctivitis cleared after 24 hours. Primary skin 
irritation, tested in the rabbit, showed this material to be slightly 
irritating. This irritation cleared within 24 hours after treatment. 
ABA was tested for Sensitization in the Guinea Pig and found not to be 
a skin sensitizer.
    1. Genotoxicity. Three mutagenicity studies (an Ames test, a mouse 
micronucleus assay, and an unscheduled DNA synthesis assay in the rat) 
determined that ABA was not mutagenic.
    2. Developmental toxicity and Subchronic toxicity. The Agency does 
not believe that there is any development toxicity or subchronic 
toxicity concern associated with ABA for several reasons. Public 
literature indicates that there are no grounds for concern with regard 
to the developmental toxicity or subchronic toxicity of ABA. Because of 
the extremely short half-life and dissipation qualities of ABA, the 
Agency expects treated food to return to background levels within 5 
days of application; therefore, there is a lack of potential oral 
exposure. Moreover, ABA is virtually non-toxic through the oral route 
of exposure. Finally, because of the pre-existing ubiquity of ABA in 
our diet without issue, developmental toxicity and subchronic toxicity 
are not considered to be of concern.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information

[[Page 37620]]

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 uses of this product are not expected 
to result in dietary residues in or on leafy vegetables, herbs and 
spices, pome fruit, stone fruit, grapes and pineapples, above the 
natural background levels.
    1. Food. Residues of ABA applied to leafy vegetables, herbs and 
spices, pome fruit, stone fruit, grapes and pineapples can be expected 
to rapidly dissipate to levels consistent with those observed 
naturally. Data submitted by the registrant confirm ABA's dissipation 
through rapid metabolism, photo-isomerization, and rapid degradation. 
Because of its ability to dissipate rapidly, ABA, when used in 
accordance with the terms of EUP 73049-EUP-7, is not expected to result 
in residues in or on leafy vegetables, herbs and spices, pome fruit, 
stone fruit, grapes and pineapples, above the natural background levels 
typically found in other commonly consumed fruits or vegetables. As 
mentioned above, it is noted that ABA is already commonly consumed. It 
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.
    2. Drinking water exposure. Pursuant to the terms of EUP 73049-EUP-
7, applications are expected to be made to leafy vegetables, herbs and 
spices, pome fruit, stone fruit, grapes and pineapples using a maximum 
application rate of 2,000 ppm per acre (using a maximum of 200 
gallons). Due to the low concentration and volume of application 
solution, leaching into groundwater is unlikely. Applications are made 
directly to leafy vegetables, herbs and spices, pome fruit, stone 
fruit, grapes and pineapples; therefore, accidental application to 
lakes or steams is unlikely. However, even if ABA leached into 
groundwater, data show that ABA is rapidly metabolized and photo-
isomerized, further diminishing the likelihood of any extra-normal ABA 
residues being transferred to water. Data submitted to the Agency show 
ABA is also naturally present in water. The Agency therefore concludes 
that any residues resulting from the application of ABA to leafy 
vegetables, herbs and spices, pome fruit, stone fruit, grapes and 
pineapples are not expected to result in any significant drinking water 
exposure beyond natural background levels of ABA already present in 
water.

B. Other Non-Occupational Exposure

    Potential non-occupational exposure is considered unlikely for this 
distinctly agricultural use pattern.
    1. Dermal exposure. Non-occupational dermal exposures to ABA when 
used as a pesticide are expected to be negligible because it is limited 
to an agricultural use under this EUP.
    2. Inhalation exposure. Non-occupational inhalation exposures to 
ABA when used as a pesticide are expected to be negligible because it 
is limited to an agricultural use under this EUP.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when 
considering whether to establish, modify, or revoke a tolerance, to 
consider ``available information'' concerning the cumulative effects of 
pesticide residues and ``other substances that have a common mechanism 
of toxicity.'' These considerations include the cumulative effects of 
such residues on infants and children. Because there is no indication 
of mammalian toxicity from ABA, the Agency concludes that ABA does not 
share a common mechanism of toxicity with other substances. Therefore, 
section 408(b)(2)(D)(v) does not apply.

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

    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 relatively low levels of mammalian dietary 
toxicity associated with ABA, the natural ubiquity of ABA in our 
foodstuffs, and data indicating that the pesticidal use of ABA results 
in residues that approximate natural background levels. For these 
reasons, the Agency has determined that ABA residues on leafy 
vegetables, herbs and spices, pome fruit, stone fruit, grapes and 
pineapples will be safe, i.e., there is a reasonable certainty that no 
harm will result from aggregate exposure to residues of ABA when used 
in accordance with the terms of EUP 73049-EUP-7.
    2. Infants and children. FFDCA section 408 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. Based on all the reliable available 
information the Agency reviewed on ABA, the Agency concludes that there 
are no residual uncertainties for prenatal/postnatal toxicity resulting 
from ABA and that ABA has relatively low toxicity to mammals from a 
dietary standpoint, including infants and children. Accordingly, there 
are no threshold effects of concern and an additional margin of safety 
is not necessary to protect infants and children.

VII. Other Considerations

A. Endocrine Disruptors

    Based on available data, no endocrine system-related effects have 
been identified with the consumption 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.

B. Analytical Method(s)

    Through this action, the Agency proposes a temporary exemption from 
the requirement of a tolerance of ABA when used on leafy vegetables, 
herbs and spices, pome fruit, stone fruit, and pineapples without any 
numerical limitations for residues. It has determined that residues 
resulting from the pesticidal uses 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, would be so low as to be indistinguishable from 
natural background levels. As a result, the Agency has concluded that 
an analytical method is not required for enforcement purposes for this 
use of ABA.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels established 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.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a temporary exemption from the 
requirement of a tolerance under section 408(d) of

[[Page 37621]]

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 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.
    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).

IX. 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: July 20, 2009.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
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. Section 180.1281 is revised to read as as follows:

Sec.  180.1281   S-Abscisic Acid; Temporary Exemption From the 
Requirement of a Tolerance.

    (a) S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-
cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid is temporarily 
exempt from the requirement of a tolerance when used as a plant 
regulator in or on grape in accordance with the Experimental Use Permit 
73049-EUP-4. This temporary exemption from tolerance will expire 
October 1, 2010.
    (b) A temporary exemption from the requirement of a tolerance is 
established for the 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 when used as a plant regulator in or on grape, herbs and spices, 
leafy vegetables, pineapple, pome fruit, and stone fruit in accordance 
with the Experimental Use Permit 73049-EUP-7. This temporary exemption 
from tolerance will expire August 7, 2012.

[FR Doc. E9-17839 Filed 7-28-09; 8:45 am]

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