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Federal Register / Vol. 73, No.

61 / Friday, March 28, 2008 / Rules and Regulations 16559

Commodity Parts per million

* * * * *
Avocado ....................................................................................................................................... 1.5
Bushberry, subgroup 13B ............................................................................................................ 13.0
Caneberry, subgroup13A ............................................................................................................. 6.0
Canistel ........................................................................................................................................ 1.5
* * * * *
Cotton, gin byproducts ................................................................................................................. 55.0
Cotton, undelinted seed ............................................................................................................... 1.0
Cucumber .................................................................................................................................... 0.5
* * * * *
Mango .......................................................................................................................................... 1.5
* * * * *
Papya ........................................................................................................................................... 1.5
Sapodilla ...................................................................................................................................... 1.5
Sapote, black ............................................................................................................................... 1.5
Sapote, mamey ............................................................................................................................ 1.5
Star Apple .................................................................................................................................... 1.5
* * * * *
Vegetable, root, subgroup 1A, except sugarbeet, garden beet, radish, and turnip 1.0
* * * * *

* * * * * boscalid, 2-chloro-N-(4’-chloro [1, 1’- exemption granted by EPA. This


(b) Section 18 emergency exemptions. biphenyl]-2-yl)-3-pyridinecarboxamide tolerance will expire and is revoked on
A time-limited tolerance is established in connection with use of the pesticide the date specified in the following table.
for the residues of the fungicide under a section 18 emergency

Commodity Parts per million Expiration/Revocation Date

Endive, Belgian 16 12/31/09


Tangerine 2.0 12/31/08

* * * * * permissible level for residues of S- copyrighted material, is not placed on


[FR Doc. E8–6264 Filed 3–27–08; 8:45 am] Abscisic Acid, (S)-5-(1-hydroxy-2,6,6- the Internet and will be publicly
BILLING CODE 6560–50–S trimethyl-4-oxo-1-cyclohex-2-enyl)-3- available only in hard copy form.
methyl-penta-(2Z,4E)-dienoic Acid. The Publicly available docket materials are
temporary tolerance exemption expires available in the electronic docket at
ENVIRONMENTAL PROTECTION on October 1, 2010. http://www.regulations.gov, or, if only
AGENCY DATES: This regulation is effective available in hard copy, at the OPP
March 28, 2008. Objections and requests Regulatory Public Docket in Rm. S–
40 CFR Part 180 4400, One Potomac Yard (South Bldg.),
for hearings must be received on or
[EPA–HQ–OPP–2008–0092; FRL–8357–4] before May 27, 2008, and must be filed 2777 S. Crystal Dr., Arlington, VA. The
in accordance with the instructions Docket Facility is open from 8:30 a.m.
S-Abscisic Acid, Temporary Exemption provided in 40 CFR part 178 (see also to 4 p.m., Monday through Friday,
From the Requirement of a Tolerance excluding legal holidays. The Docket
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
Facility telephone number is (703) 305–
AGENCY: Environmental Protection
5805.
Agency (EPA).
ADDRESSES: EPA has established a FOR FURTHER INFORMATION CONTACT:
ACTION: Final rule.
docket for this action under docket Chris Pfeifer, Biopesticides and
SUMMARY: This regulation establishes a identification (ID) number EPA–HQ– Pollution Prevention Division (7511P),
temporary exemption from the OPP–2008–0092. To access the Office of Pesticide Programs,
requirement of a tolerance for residues electronic docket, go to http:// Environmental Protection Agency, 1200
of the biochemical pesticide S-Abscisic www.regulations.gov, select ‘‘Advanced Pennsylvania Ave., NW., Washington,
Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl- Search,’’ then ‘‘Docket Search.’’ Insert DC 20460–0001; telephone number:
4-oxo-1-cyclohex-2-enyl)-3-methyl- the docket ID number where indicated 703-308-0031; e-mail address:
penta-(2Z,4E)-dienoic Acid in or on and select the ‘‘Submit’’ button. Follow pfeifer.chris@epa.gov.
grapes when applied or used as a plant the instructions on the regulations.gov
SUPPLEMENTARY INFORMATION:
regulator in accordance with the terms website to view the docket index or
of Experimental Use Permit 73049-EUP- access available documents. All I. General Information
4. Valent Biosciences Corporation documents in the docket are listed in
the docket index available in A. Does this Action Apply to Me?
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act regulations.gov. Although listed in the You may be potentially affected by
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(FFDCA), as amended by the Food index, some information is not publicly this action if you are an agricultural
Quality Protection Act of 1996 (FQPA), available, e.g., Confidential Business producer, food manufacturer, or
requesting the temporary tolerance Information (CBI) or other information pesticide manufacturer. Potentially
exemption. This regulation eliminates whose disclosure is restricted by statute. affected entities may include, but are
the need to establish a maximum Certain other material, such as not limited to:

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16560 Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Rules and Regulations

• Crop production (NAICS code 111). In addition to filing an objection or Section 408(c)(2)(A)(i) of FFDCA
• Animal production (NAICS code hearing request with the Hearing Clerk allows EPA to establish an exemption
112). as described in 40 CFR part 178, please from the requirement for a tolerance (the
• Food manufacturing (NAICS code submit a copy of the filing that does not legal limit for a pesticide chemical
311). contain any CBI for inclusion in the residue in or on a food) only if EPA
• Pesticide manufacturing (NAICS public docket that is described in determines that the exemption is ‘‘safe.’’
code 32532). ADDRESSES. Information not marked Section 408(c)(2)(A)(ii) of FFDCA
This listing is not intended to be confidential pursuant to 40 CFR part 2 defines ‘‘safe ’’ to mean that ‘‘there is a
exhaustive, but rather provides a guide may be disclosed publicly by EPA reasonable certainty that no harm will
for readers regarding entities likely to be without prior notice. Submit your result from aggregate exposure to the
affected by this action. Other types of copies, identified by docket ID number pesticide chemical residue, including
entities not listed in this unit could also EPA–HQ–OPP–2008–0092, by one of all anticipated dietary exposures and all
be affected. The North American the following methods. other exposures for which there is
• Federal eRulemaking Portal: http:// reliable information.’’ This includes
Industrial Classification System
www.regulations.gov. Follow the on-line exposure through drinking water and in
(NAICS) codes have been provided to
instructions for submitting comments. residential settings, but does not include
assist you and others in determining • Mail: Office of Pesticide Programs
whether this action might apply to occupational exposure. Pursuant to
(OPP) Regulatory Public Docket (7502P), section 408(c)(2)(B) of FFDCA, in
certain entities. To determine whether Environmental Protection Agency, 1200 establishing or maintaining in effect an
you or your business may be affected by Pennsylvania Ave., NW., Washington, exemption from the requirement of a
this action, you should carefully DC 20460–0001. tolerance, EPA must take into account
examine the applicability provisions in • Delivery: OPP Regulatory Public the factors set forth in section
section 5 of Federal Insecticide, Docket (7502P), Environmental 408(b)(2)(C) of FFDCA, which require
Fungicide, and Rodenticide Act (FIFRA) Protection Agency, Rm. S–4400, One EPA to give special consideration to
and the regulations promulgated to Potomac Yard (South Bldg.), 2777 S. exposure of infants and children to the
carry out that provision of FIFRA (40 Crystal Dr., Arlington, VA. Deliveries pesticide chemical residue in
CFR part 172). If you have any questions are only accepted during the Docket’s establishing a tolerance and to ‘‘ensure
regarding the applicability of this action normal hours of operation (8:30 a.m. to that there is a reasonable certainty that
to a particular entity, consult the person 4 p.m., Monday through Friday, no harm will result to infants and
listed under FOR FURTHER INFORMATION excluding legal holidays). Special children from aggregate exposure to the
CONTACT. arrangements should be made for pesticide chemical residue....’’
B. How Can I Access Electronic Copies deliveries of boxed information. The Additionally, section 408(b)(2)(D) of
of this Document? Docket Facility telephone number is FFDCA requires that the Agency
(703) 305–5805. consider ‘‘available information
In addition to accessing an electronic concerning the cumulative effects of a
copy of this Federal Register document II. Background and Statutory Findings
particular pesticide’s residues’’ and
through the electronic docket at http:// In the Federal Register of April 30, ‘‘other substances that have a common
www.regulations.gov, you may access 2007 (72 FR 21263) (FRL–8124–7), EPA mechanism of toxicity.’’
this ‘‘Federal Register’’ document issued a notice pursuant to section EPA performs a number of analyses to
electronically through the EPA Internet 408(d)(3) of FFDCA, 21 U.S.C. determine the risks from aggregate
under the ‘‘Federal Register’’ listings at 346a(d)(3), announcing the filing of a exposure to pesticide residues. First,
http://www.epa.gov/fedrgstr. You may pesticide tolerance petition (PP 7G7202) EPA determines the toxicity of
also access a frequently updated by Valent Biosciences Corporation, 870 pesticides. Second, EPA examines
electronic version of 40 CFR part 180 Technology Way, Libertyville, IL 60048. exposure to the pesticide through food,
through the Government Printing The petition requested that 40 CFR part drinking water, and through other
Office’s pilot e-CFR site at http:// 180 be amended by establishing a exposures that occur as a result of
www.gpoaccess.gov/ecfr. temporary exemption from the pesticide use in residential settings.
requirement of a tolerance for residues
C. Can I File an Objection or Hearing III. Toxicological Profile
of S-Abscisic Acid, (S)-5-(1-hydroxy-
Request?
2,6,6-trimethyl-4-oxo-1-cyclohex-2- Consistent with section 408(b)(2)(D)
Under section 408(g) of FFDCA, as enyl)-3-methyl-penta-(2Z,4E)-dienoic of FFDCA, EPA has reviewed the
amended by FQPA, any person may file Acid in or on grapes when used in available scientific data and other
an objection to any aspect of this accordance with the terms set forth in relevant information in support of this
regulation and may also request a Experimental Use Permit 73049-EUP-4. action and considered its validity,
hearing on those objections. The EPA Valent has requested an Experimental completeness and reliability and the
procedural regulations which govern the Use Permit (EUP)--EPA Experimental relationship of this information to
submission of objections and requests Use Permit Number 73049-EUP-4, under human risk. EPA has also considered
for hearings appear in 40 CFR part 178. which it seeks to apply ABA to grapes available information concerning the
You must file your objection or request in the vineyard to enhance color variability of the sensitivities of major
a hearing on this regulation in production of the grape berries. The identifiable subgroups of consumers,
accordance with the instructions terms of 73049-EUP-4 provide for a including infants and children.
provided in 40 CFR part 178. To ensure maximum rate of 8.8185 oz. per acre for Acute toxicity for S-Abscisic Acid,
proper receipt by EPA, you must a maximum annual application of (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-
identify docket ID number EPA–HQ– 10.681 oz. per acre. This notice 1-cyclohex-2-enyl)-3-methyl-penta-
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OPP–2008–0092 in the subject line on included a summary of the petition (2Z,4E)-dienoic Acid (commonly
the first page of your submission. All prepared by the petitioner, Valent abbreviated as ABA): Acute oral
requests must be in writing, and must be BioSciences Corporation. There were no toxicity, acute dermal toxicity, acute
mailed or delivered to the Hearing Clerk comments received in response to the inhalation toxicity, and acute dermal
on or before May 27, 2008. notice of filing. irritation are all Toxicity Category IV;

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Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Rules and Regulations 16561

acute eye irritation is Toxicity Category is naturally present in fruits and 2. Inhalation exposure. Non-
III; ABA is not a dermal sensitizer. vegetables at various levels, generally occupational inhalation exposures to
The LD50 for acute oral toxicity using not in excess of 10 ppm, and has always ABA when used as a pesticide are
the rat was greater than 5,000 been a component of any diet expected to be negligible because it is
milligrams/kilogram (mg/kg) of body containing plant materials. The limited to an agricultural use.
weight in female rats. The LD50 for acute proposed uses of this product are not
dermal toxicity using the rat was greater V. Cumulative Effects
expected to result in residues in or on
than 5,000 mg/kg body weight in male grapes, above the natural background Section 408(b)(2)(D)(v) of FFDCA
and female rats. The LC50 for acute levels typically found in other requires the Agency, when considering
inhalation toxicity was greater than 2.06 commonly consumed fruits or whether to establish, modify, or revoke
milligram/liter (mg/L) in male and vegetables. a tolerance, to consider ‘‘available
female rats. Primary eye irritation, 1. Food. Residues of ABA applied to information’’ concerning the cumulative
tested in rabbits, showed mild irritation grapes can be expected to rapidly effects of pesticide residues and ‘‘other
to the eye. Iritis and conjunctivitis dissipate to levels consistent with those substances that have a common
cleared after 24 hours. Primary skin observed naturally. Data submitted by mechanism of toxicity.’’ These
irritation, tested in the rabbit, showed the registrant confirm ABA’s dissipation considerations include the cumulative
this material to be slightly irritating. through rapid metabolism, photo- effects of such residues on infants and
This irritation cleared within 24 hours isomerization, and rapid degradation. children. Because there is no indication
after treatment. ABA was tested for Because of its ability to dissipate of mammalian toxicity from ABA, the
Sensitization in the Guinea Pig and rapidly, ABA, when used in accordance Agency concludes that ABA cannot
found not to be a skin sensitizer. share a common mechanism of toxicity
with the terms of the EUP 73049-EUP-
1. Genotoxicity. Three mutagenicity with other substances. Therefore,
4, is not expected to result in residues
studies determined that ABA was not section 408(b)(2)(D)(v) does not apply.
in or on grapes, above the natural
mutagenic. (The three studies: an Ames background levels typically found in VI. Determination of Safety for U.S.
test, a mouse micronucleus assay, and other commonly consumed fruits or Population, Infants and Children
an unscheduled DNA synthesis assay in vegetables. As mentioned above, it is
the rat.) 1. U.S. population. The Agency has
noted that ABA is already commonly determined that there is a reasonable
2. Developmental toxicity and
consumed. It is naturally present in certainty that no harm will result from
subchronic toxicity. The Agency
fruits and vegetables at various levels aggregate exposure to residues of ABA
accepted the applicant’s request to
(up to 10 ppm) and has always been a to the U.S. population. This includes all
waive the data requirements for
component of any diet containing plant anticipated dietary exposures and other
teratogenicity and 90–day feeding for
materials. non- occupational exposures for which
the active ingredient based on the
rationales, data and public information 2. Drinking water exposure. Pursuant there is reliable information. The
submitted. The Agency granted a waiver to the terms of the EUP 73049-EUP-4, Agency arrived at this conclusion based
for teratogenicity on the basis of limited applications are expected to be made to on the relatively low levels of
exposure for females because of directed grape vineyards using a maximum mammalian dietary toxicity associated
applications, a lack of residues, and the application rate of 200 ppm per acre with ABA, the natural ubiquity of ABA
pre-existing ubiquity of ABA in our diet (using a maximum of 200 gallons). Due in our food stuffs, and data indicating
without issue. Ninety day feeding was to the low concentration and volume of that the pesticidal use of ABA on grapes
waived based on the limited application solution, leaching into results in residues that approximate
application, virtual non-toxicity of oral groundwater is unlikely. Applications natural background levels. For these
exposure to ABA, and the commonality are directed to the grape fruit clusters; reasons, the Agency has determined that
of ABA in our diets in excess of what therefore, accidental application to lakes ABA residues on grapes will be safe,
would be present on treated grapes. or steams is unlikely. However, even if i.e., there is a reasonable certainty that
Waiver requests for 90–day feeding ABA leached into groundwater, data no harm will result from aggregate
emphasized the lack of potential oral show that ABA is rapidly metabolized exposure to residues of ABA when used
exposure, and the relative non-toxicity and photo-isomerized, further in accordance with the terms of EUP
of ABA through this route of exposure. diminishing the likelihood of any extra- 73049-EUP-4.
In short, developmental toxicity and normal ABA residues being transferred 2. Infants and children. FFDCA
subchronic toxicity are not considered to water. Data submitted to the Agency section 408 provides that EPA shall
to be of concern. show ABA is also naturally present in apply an additional tenfold margin of
water. The Agency therefore concludes exposure (safety) for infants and
IV. Aggregate Exposures that any residues resulting from the children in the case of threshold effects
In examining aggregate exposure, application of ABA to grapes are not to account for prenatal and postnatal
section 408 of FFDCA directs EPA to expected to result in any significant toxicity and the completeness of the
consider available information drinking water exposure beyond natural database unless the EPA determines that
concerning exposures from the pesticide background levels of ABA already a different margin of exposure (safety)
residue in food and all other non- present in water. will be safe for infants and children.
occupational exposures, including Based on all the reliable available
B. Other Non-Occupational Exposure
drinking water from ground water or information the Agency reviewed on
surface water and exposure through Potential non-occupational exposure ABA, the Agency concludes that there
pesticide use in gardens, lawns, or is considered unlikely for this distinctly are no residual uncertainties for
buildings (residential and other indoor agricultural use. prenatal/postnatal toxicity resulting
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uses). 1. Dermal exposure. Non- from ABA and that ABA has relatively
occupational dermal exposures to ABA low toxicity to mammals from a dietary
A. Dietary Exposure when used as a pesticide are expected standpoint, including infants and
ABA is a plant regulator present in all to be negligible because it is limited to children. Accordingly, there are no
vascular plants, algae and some fungi. It an agricultural use. threshold effects of concern and an

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16562 Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Rules and Regulations

additional margin of safety is not Since tolerances and exemptions that Agricultural commodities, Pesticides
necessary to protect infants and are established on the basis of a petition and pests, Reporting and recordkeeping
children. under section 408(d) of FFDCA, such as requirements.
the tolerance in this final rule, do not
VII. Other Considerations Dated: March 20, 2008.
require the issuance of a proposed rule,
A. Endocrine Disruptors the requirements of the Regulatory Debra Edwards,
Based on available data, no endocrine Flexibility Act (RFA) (5 U.S.C. 601 et Director, Office of Pesticide Programs.
system-related effects have been seq.) do not apply. ■Therefore, 40 CFR chapter I is
identified with the consumption of S- This final rule directly regulates amended as follows:
Abscisic Acid, (S)-5-(1-hydroxy-2,6,6- growers, food processors, food handlers,
trimethyl-4-oxo-1-cyclohex-2-enyl)-3- and food retailers, not States or tribes, PART 180—AMENDED]
methyl-penta-(2Z,4E)-dienoic Acid. nor does this action alter the
relationships or distribution of power ■ 1. The authority citation for part 180
B. Analytical Method(s) and responsibilities established by continues to read as follows:
Through this action, the Agency Congress in the preemption provisions Authority: 21 U.S.C. 321(q), 346a and 371.
proposes a temporary exemption from of section 408(n)(4) of FFDCA. As such,
the requirement of a tolerance of ABA the Agency has determined that this ■ 2. Section 180.1281 is added to
when used on grapes without any action will not have a substantial direct subpart D to read as follows:
numerical limitations for residues. It has effect on States or tribal governments,
§ 180.1281 S-Abscisic Acid; exemption
determined that residues resulting from on the relationship between the national from the requirement of a tolerance.
the pesticidal uses of S-Abscisic Acid, government and the States or tribal
(S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo- governments, or on the distribution of S-Abscisic Acid, (S)-5-(1-hydroxy-
1-cyclohex-2-enyl)-3-methyl-penta- power and responsibilities among the 2,6,6-trimethyl-4-oxo-1-cyclohex-2-
(2Z,4E)-dienoic Acid, would be so low various levels of government or between enyl)-3-methyl-penta-(2Z,4E)-dienoic
as to be indistinguishable from natural the Federal Government and Indian Acid, is temporarily exempt from the
background levels. As a result, the tribes. Thus, the Agency has determined requirement of a tolerance when used as
Agency has concluded that an analytical that Executive Order 13132, entitled a plant regulator in or on grape in
method is not required for enforcement Federalism (64 FR 43255, August 10, accordance with the Experimental Use
purposes for this proposed use of ABA. 1999) and Executive Order 13175, Permit 73049–EUP–4. This temporary
entitled Consultation and Coordination exemption from tolerance will expire
C. Codex Maximum Residue Level October 1, 2010.
with Indian Tribal Governments (65 FR
There are no codex maximum residue 67249, November 9, 2000) do not apply [FR Doc. E8–6404 Filed 3–27–08; 8:45 am]
levels established for residues of S- to this rule. In addition, This rule does BILLING CODE 6560–50–S
Abscisic Acid, (S)-5-(1-hydroxy-2,6,6- not impose any enforceable duty or
trimethyl-4-oxo-1-cyclohex-2-enyl)-3- contain any unfunded mandate as
methyl-penta-(2Z,4E)-dienoic Acid. described under Title II of the Unfunded DEPARTMENT OF TRANSPORTATION
VIII. Statutory and Executive Order Mandates Reform Act of 1995 (UMRA)
Reviews (Public Law 104–4). Pipeline and Hazardous Materials
This final rule establishes a tolerance This action does not involve any Safety Administration
under section 408(d) of FFDCA in technical standards that would require
response to a petition submitted to the Agency consideration of voluntary 49 CFR Parts 190, 191, 192, 193, 194,
Agency. The Office of Management and consensus standards pursuant to section 195, and 199
Budget (OMB) has exempted these types 12(d) of the National Technology RIN 2137–AE29
of actions from review under Executive Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section [Docket No. PHMSA–2007–0033]
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, 12(d) (15 U.S.C. 272 note).
Pipeline Safety: Administrative
October 4, 1993). Because this rule has IX. Congressional Review Act Procedures, Address Updates, and
been exempted from review under Technical Amendments
Executive Order 12866, this rule is not The Congressional Review Act, 5
subject to Executive Order 13211, U.S.C. 801 et seq., generally provides AGENCY: Pipeline and Hazardous
Actions Concerning Regulations That that before a rule may take effect, the Materials Safety Administration
Significantly Affect Energy Supply, agency promulgating the rule must (PHMSA), U.S. Department of
Distribution, or Use (66 FR 28355, May submit a rule report to each House of Transportation (DOT).
22, 2001) or Executive Order 13045, the Congress and to the Comptroller
ACTION: Interim final rule and request
entitled Protection of Children from General of the United States. EPA will
submit a report containing this rule and for comments.
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997). other required information to the U.S. SUMMARY: This interim final rule
This final rule does not contain any Senate, the U.S. House of conforms PHMSA’s administrative
information collections subject to OMB Representatives, and the Comptroller procedures with the Pipeline
approval under the Paperwork General of the United States prior to Inspection, Protection, Enforcement,
Reduction Act (PRA), 44 U.S.C. 3501 et publication of this final rule in the and Safety Act of 2006 (PIPES Act) by
seq., nor does it require any special Federal Register. This final rule is not establishing the procedures PHMSA
considerations under Executive Order a ‘‘major rule’’ as defined by 5 U.S.C. will follow in issuing safety orders and
804(2).
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12898, entitled Federal Actions to handling requests for special permits,


Address Environmental Justice in including emergency special permits.
Minority Populations and Low-Income List of Subjects in 40 CFR Part 180 This interim final rule also notifies
Populations (59 FR 7629, February 16, Environmental protection, operators about electronic docket
1994). Administrative practice and procedure, information availability; updates

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