Document ID: EPA-HQ-OPP-2008-0092-0001
Agency: epa
Document Type: Rule
Title: S-Abscisic Acid, Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2008-03-28T04:00Z

[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Rules and Regulations]               
[Page 16559-16562]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr08-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0092; FRL-8357-4]

 
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 grapes when applied 
or used as a plant regulator in accordance with the terms of 
Experimental Use Permit 73049-EUP-4. Valent Biosciences Corporation 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA), 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. The temporary 
tolerance exemption expires on October 1, 2010.

DATES: This regulation is effective March 28, 2008. Objections and 
requests for hearings must be received on or before May 27, 2008, 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-2008-0092. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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:

[[Page 16560]]

     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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in section 5 of Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the regulations 
promulgated to carry out that provision of FIFRA (40 CFR part 172). 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 an electronic copy of this Federal 
Register document through the electronic docket 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 pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by 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. 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-2008-0092 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before May 27, 2008.
    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-2008-0092, 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'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 30, 2007 (72 FR 21263) (FRL-8124-
7), 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 7G7202) 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 grapes when used in accordance with the 
terms set forth in Experimental Use Permit 73049-EUP-4. Valent has 
requested an Experimental Use Permit (EUP)--EPA Experimental Use Permit 
Number 73049-EUP-4, under which it seeks to apply ABA to grapes in the 
vineyard to enhance color production of the grape berries. The terms of 
73049-EUP-4 provide for a maximum rate of 8.8185 oz. per acre for a 
maximum annual application of 10.681 oz. per acre. This notice included 
a summary of the petition prepared by the petitioner, Valent 
BioSciences Corporation. 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.
    Acute toxicity for S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-
trimethyl-4-oxo-1-cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid 
(commonly abbreviated as ABA): Acute oral toxicity, acute dermal 
toxicity, acute inhalation toxicity, and acute dermal irritation are 
all Toxicity Category IV;

[[Page 16561]]

acute eye irritation is Toxicity Category III; ABA is not a dermal 
sensitizer.
    The LD50 for acute oral toxicity using the rat was 
greater than 5,000 milligrams/kilogram (mg/kg) of body weight in female 
rats. The LD50 for acute dermal toxicity using the rat was 
greater than 5,000 mg/kg body weight in male and female rats. The 
LC50 for acute inhalation toxicity was greater than 2.06 
milligram/liter (mg/L) in male and female rats. Primary eye irritation, 
tested in rabbits, showed mild irritation to the eye. 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 determined that ABA was 
not mutagenic. (The three studies: an Ames test, a mouse micronucleus 
assay, and an unscheduled DNA synthesis assay in the rat.)
    2. Developmental toxicity and subchronic toxicity. The Agency 
accepted the applicant's request to waive the data requirements for 
teratogenicity and 90-day feeding for the active ingredient based on 
the rationales, data and public information submitted. The Agency 
granted a waiver for teratogenicity on the basis of limited exposure 
for females because of directed applications, a lack of residues, and 
the pre-existing ubiquity of ABA in our diet without issue. Ninety day 
feeding was waived based on the limited application, virtual non-
toxicity of oral exposure to ABA, and the commonality of ABA in our 
diets in excess of what would be present on treated grapes. Waiver 
requests for 90-day feeding emphasized the lack of potential oral 
exposure, and the relative non-toxicity of ABA through this route of 
exposure. In short, 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 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. The proposed uses of 
this product are not expected to result in residues in or on grapes, 
above the natural background levels typically found in other commonly 
consumed fruits or vegetables.
    1. Food. Residues of ABA applied to grapes 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 the EUP 73049-EUP-4, is not expected to result in residues 
in or on grapes, 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 the EUP 73049-
EUP-4, applications are expected to be made to grape vineyards using a 
maximum application rate of 200 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 
directed to the grape fruit clusters; 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 grapes 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.
    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.
    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.

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 cannot 
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 food 
stuffs, and data indicating that the pesticidal use of ABA on grapes 
results in residues that approximate natural background levels. For 
these reasons, the Agency has determined that ABA residues on grapes 
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-4.
    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

[[Page 16562]]

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 grapes 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 
proposed 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 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 rule. In addition, This 
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: March 20, 2008.
Debra Edwards,
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. Section 180.1281 is added to subpart D to read as follows:

Sec.  180.1281  S-Abscisic Acid; 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, 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.

[FR Doc. E8-6404 Filed 3-27-08; 8:45 am]

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