Prohydrojasmon; Amendment of Temporary Exemption From the Requirement of a Tolerance, 29548-29552 [2012-12106]
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29548
Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations
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Target Organism Waiver Requests, and
Metabolism/Residue Studies.
Memorandum from R. S. Jones to C.
Greene, dated 04/04/2011.
15. Joint FAO/WHO Expert Committee on
Food Additives (JECFA). 2006. Summary
and Conclusions. Sixty-Seventh Meeting.
Rome, 20–29 June 2006. ftp://ftp.fao.org/
ag/agn/jecfa/jecfa67_final.pdf (Accessed
04/04/2011).
16. Koontz, J. L., J. E. Marcy, W. E. Barbeau,
and S. E. Duncan. 2003. Stability of
Natamycin and Its Cyclodextrin
Inclusion Complexes in Aqueous
Solution. Journal of Agricultural Food
Chemistry. 51 (24): 7111–7114.
17. USEPA. 2011. Science Review in Support
of the Registration of Natamycin TGAI, a
Technical Grade Active Ingredient
(TGAI) Product; and Natamycin L, an
End-Use Product (EP), Respectively
Containing 91.02% and 10.34%
Natamycin, a New Active Ingredient.
Hazard Assessment for Tier I Toxicity
Studies and Waiver Requests, Tier I NonTarget Organism Waiver Requests, and
Metabolism/Residue Studies.
Memorandum from R. S. Jones to C.
Greene, dated 04/04/2011.
18. Subchronic (rat) feeding studies
demonstrate that the No Observable
Adverse Effect Level NOAEL was 500
ppm in the diet (42 mg/kg bw/day for
males and 48 mg/kg bw/day for females)
(MRID 48105511).
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
exemption under section 408(d) of
FFDCA in response to a petition
submitted to the Agency. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
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the tolerance 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) (Pub. L. 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).
XI. 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.
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Dated: May 8, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1315 is added to
subpart D to read as follows:
■
§ 180.1315 Natamycin; exemption from the
requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of natamycin in or on mushrooms when
applied as a fungistat to prevent the
germination of fungal spores on
mushrooms produced in enclosed
mushroom production facilities.
[FR Doc. 2012–12105 Filed 5–17–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0048; FRL–9347–9]
Prohydrojasmon; Amendment of
Temporary Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation revises the
temporary exemption from the
requirement of a tolerance for residues
of Prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate, by
including grapes and extending the date
of expiration of the temporary tolerance
exemption from August 1, 2012, to
August 1, 2014, when used as a plant
growth regulator pre-harvest and in
accordance with good agricultural
practices and with the terms of
Experimental Use Permit (EUP) No.
62097–EUP–1. Fine Agrochemicals,
Ltd., submitted a petition to the U.S.
Environmental Protection Agency (EPA
or the Agency) under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting the amendment to the
temporary tolerance exemption.
DATES: This regulation is effective May
18, 2012. Objections and requests for
hearings must be received on or before
July 17, 2012, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
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Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2010–0048;
FRL–9347–9, is available either
electronically through https://
www.regulations.gov or in hard copy at
the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/
DC), located in EPA West, Rm. 3334,
1301 Constitution Ave. NW.,
Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Gina
Burnett, Biopesticides and Pollution
Prevention Division (7511P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (703) 605–0513;
email address: burnett.gina@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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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 https://
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ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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.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–2010–0048 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 July 17, 2012. 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 . Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0048, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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 February
15, 2012, (77 FR 8755) (FRL–9335–3),
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 1G7947)
by Fine Agrochemicals, Ltd., c/o SciReg,
Inc., 12733 Director’s Loop,
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29549
Woodbridge, VA 22192. The petition
requested that 40 CFR 180.1299 be
amended by including grapes in the
temporary exemption from the
requirement of a tolerance for residues
of Prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate, and that
the expiration date for the tolerance
exemption be extended by 2 years in
order to coincide with a 2-year
extension of the petitioner’s
Experimental Use Permit (EUP) for this
biochemical. The petitioner requests the
tolerance exemption expiration date
extension and EUP extension in order to
better assess the effects of application
timing, geography, and apple variety on
efficacy (color enhancement). Fewer red
apple sites will be treated as compared
to the two initial growing seasons (2010
and 2011), but more acres will be
treated per site, increasing statistical
power and confidence, and providing
the applicant with more useful data.
Under the EUP extension, the petitioner
will also be approved to test PDJ on
grapes. This notice referenced a
summary of the petition prepared by the
petitioner, Fine Agrochemicals, Ltd.,
which is available in the docket via
https://www.regulations.gov. 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
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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.
The Agency established a temporary
tolerance exemption for PDJ in a Final
Rule published in the Federal Register
on August 18, 2010, (75 FR 50922–
50926) (FRL–8839–4), to coincide with
the approval of an Experimental Use
Permit (EUP) granted to Fine
Agrochemicals, Ltd. The temporary
tolerance exemption supported uses on
red apple varieties, and will expire on
August 1, 2012. This amendment
proposes to expand the crops covered
by including grapes, and by extending
the expiration date of the tolerance
exemption to August 1, 2014, to
coincide with the extension of the
petitioner’s EUP for the same time
period. Since the establishment of the
temporary tolerance exemption, no new
toxicology data have been generated. As
such, the toxicological profile as stated
in the August 18, 2010, issue of the
Federal Register, and referenced herein,
has not changed. Copies of the August
18, 2010, document (75 FR 50922–
50926), and the studies cited therein,
are located under docket identification
(ID) number EPA–HQ–OPP–2010–0048.
As discussed in the August 18, 2010,
Federal Register, (75 FR 50923), PDJ is
a synthetic plant growth regulator that
is structurally similar and functionally
identical to jasmonic acid (JA), a
naturally occurring plant regulator
present in all vascular plants. The
jasomates, of which JA is a member, is
a group of plant hormones involved in
multiple stages of plant development
and defense, including the ability to
stimulate fruit ripening (Ref. 1). The
highest levels of naturally occurring JA
are found in actively growing plant
tissues such as leaves, flowers, and
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developing fruit (Refs. 1 and 3), thus JA
has always been a natural component of
diets containing plant materials. To
date, there have been no reported toxic
effects associated with the consumption
of JA in fruits and vegetables.
PDJ, a synthetic version of JA, is
expected to behave in the same manner
and have the same low toxicity profile
as JA because it is structurally similar
and functionally identical to naturally
occurring JA. Studies submitted by the
applicant in support of this temporary
exemption from the requirement of a
tolerance, and reviewed by the Agency,
indicate that PDJ is not acutely toxic.
These studies and the Agency’s
conclusions are summarized at 75 FR
50922–50926, August 18, 2010.
Specifically, no toxic endpoints were
established, and no significant
toxicological effects were observed in
any of the acute toxicity studies (75 FR
50923–50924, August 18, 2010). In
addition, studies submitted indicate that
PDJ is not genotoxic, has no subchronic
toxic effects, and is not a developmental
toxicant (75 FR 50924, August 18, 2010).
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 nonoccupational 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
Dietary exposure to residues of PDJ is
expected to be insignificant, even in the
event of exposure. In a worst case
scenario, such as no degradation of the
applied compound, PDJ residues
consumed by a 70 kg person are four
orders of magnitude below the No
Observed Adverse Effect Level (NOAEL)
that was calculated for this compound
(75 FR 50924, August 18, 2010).
1. Food. PDJ is structurally similar to
the naturally occurring plant growth
regulator jasmonic acid (JA). JA is
naturally present in fruits and
vegetables at various levels, generally
not exceeding 2 parts per million (ppm),
and has always been a component of
any diet containing plant materials
(Refs. 1 and 2). Dietary exposure to
residues of PDJ via exposure to treated
fruit or foliage is not expected to exist
above background levels of naturally
occurring JA (75 FR 50924–50925,
August 18, 2010).
2. Drinking water exposure. Exposure
of humans to PDJ in drinking water is
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unlikely since products are labeled for
application directly to terrestrial plants
and because data demonstrate a soil
half-life for this chemical from 1.6–2.3
hours, as well as rapid degradation in
water (Ref. 3). In addition, the expected
concentrations in surface water are well
below (6 to 7 orders of magnitude) the
maximum doses used in laboratory
testing, where no toxic effects were seen
(e.g., acute oral toxicity LD50 > 5,000
milligrams per kilogram (mg/kg);
developmental toxicity NOAEL > 500
mg/kg) (75 FR 50925, August 18, 2010).
B. Other Non-Occupational Exposure
Non-occupational exposure is not
expected because PDJ is not approved
for residential uses. The active
ingredient is applied directly to
commodities and degrades rapidly.
1. Dermal exposure. Nonoccupational dermal exposures to PDJ
are not expected because the compound
is intended only for agricultural use as
a plant growth regulator applied to
apples and grapes pre-harvest. Any
dermal exposure associated with this
experimental use permit is expected to
be occupational in nature.
2. Inhalation exposure. Nonoccupational inhalation exposures are
not expected to result from the
agricultural uses of PDJ. Any inhalation
exposure associated with this
experimental use permit 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 PDJ to share a
common mechanism of toxicity with
any other substances, and PDJ does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that PDJ
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 Web site at
https://www.epa.gov/pesticides/
cumulative.
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VI. Determination of Safety for U.S.
Population, Infants and Children
FFDCA section 408(b)(2)(C) 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, FFDCA section
408(b)(2)(C) provides that EPA shall
apply an additional tenfold margin of
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
EPA determines that a different margin
of 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.
Relevant data and information
indicate that PDJ has negligible acute,
subchronic, and developmental toxicity
(75 FR 50922–25, August 18, 2010). In
addition, PDJ is structurally similar to
jasmonic acid, which is present in all
fruits and vegetables and for which
there is no reported history of
toxicological incident (EPA, 2010).
Therefore, the Agency concludes that
there is a reasonable certainty that no
harm will result to the U.S. population,
including infants and children, from
aggregate exposure to the residues of
PDJ. This includes all anticipated
dietary exposures and all other
exposures for which there is reliable
information. The Agency has arrived at
this conclusion because the data and
information available on PDJ do not
demonstrate toxic potential to
mammals. Thus, there are no threshold
effects of concern and, as a result, an
additional margin of safety is not
necessary.
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VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes for the
reasons stated above and because EPA is
establishing an exemption from the
requirement of a tolerance without any
numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
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possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL
for Prohydrojasmon (PDJ), propyl-3-oxo2-pentylcyclo-pentylacetate.
VIII. Conclusion
The Agency acknowledges the need to
extend the temporary tolerance
exemption to coincide with the
approved extension of Fine
Agrochemical, Ltd.’s EUP for PDJ. In
addition, the Agency concludes that
there is a reasonable certainty that no
harm will result to the U.S. population,
including infants and children, from
aggregate exposure to the residues of
PDJ. Therefore, the temporary
exemption is amended for residues of
PDJ on red apples to include grapes,
when used pre-harvest as a plant growth
regulator, in accordance with good
agricultural practices and with the terms
of EUP No. 62097–EUP–1, and will
expire on August 1, 2014.
IX. References
The references used in this document
are in the OPP docket listed under
docket ID EPA–HQ–OPP–2010–0048,
and may be seen by accessing the
regulatory.gov Web site.
1. Creelman, R.A. and J.E. Mullet (1995)
Jasmonic acid distribution and action in
plants: Regulation during development
and response to biotic and abiotic stress.
Proceedings of the National Academies
of Science, 92: 4114–4119.
2. Mason, H.S., DeWald, D.B., Creelman,
R.A., Mullet J.E. (1992) Coregulation of
Soybean and Vegetative Storage Protein
Gene Expression by Methyl Jasmonate
and Soluble Sugars. Plant Physiology, 98:
859–867.
3. EPA (2010) Environmental Protection
Agency (EPA) Risk Assessment:
Application for Experimental-Use Permit
and Temporary Tolerance Exemption for
FAL 1800 (Prohydrojasmon). May 18,
2010.
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29551
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
E:\FR\FM\18MYR1.SGM
18MYR1
29552
Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Rules and Regulations
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 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).
DEPARTMENT OF HOMELAND
SECURITY
XI. Congressional Review Act
Suspension of Community Eligibility
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: May 3, 2012.
Keith Mathews,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1299 is revised to read
as follows:
■
srobinson on DSK4SPTVN1PROD with RULES
§ 180.1299 Prohydrojasmon; temporary
exemption from the requirement of a
tolerance.
A temporary exemption from the
requirement of a tolerance is established
for residues of prohydrojasmon, propyl3-oxo-2-pentylcyclo-pentylacetate,
when used as a plant growth regulator
on red apples varieties and grapes preharvest, in accordance with good
agricultural practices and the terms of
Experimental Use Permit No. 62097–
EUP–1, and will expire on August 1,
2014.
[FR Doc. 2012–12106 Filed 5–17–12; 8:45 am]
BILLING CODE 6560–50–P
VerDate Mar<15>2010
16:15 May 17, 2012
Jkt 226001
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2012–0003; Internal
Agency Docket No. FEMA–8231]
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
DATES: The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact David Stearrett,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–2953.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
SUMMARY:
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
participating in the NFIP and identified
for more than a year on FEMA’s initial
FIRM for the community as having
flood-prone areas (section 202(a) of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
public comment procedures under 5
U.S.C. 553(b), are impracticable and
unnecessary because communities listed
in this final rule have been adequately
notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act.
This rule is categorically excluded from
the requirements of 44 CFR part 10,
Environmental Considerations. No
environmental impact assessment has
been prepared.
Regulatory Flexibility Act. The
Administrator has determined that this
rule is exempt from the requirements of
the Regulatory Flexibility Act because
the National Flood Insurance Act of
1968, as amended, Section 1315, 42
U.S.C. 4022, prohibits flood insurance
E:\FR\FM\18MYR1.SGM
18MYR1
]]>Agencies
[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Rules and Regulations]
[Pages 29548-29552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12106]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0048; FRL-9347-9]
Prohydrojasmon; Amendment of Temporary Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation revises the temporary exemption from the
requirement of a tolerance for residues of Prohydrojasmon (PDJ),
propyl-3-oxo-2-pentylcyclo-pentylacetate, by including grapes and
extending the date of expiration of the temporary tolerance exemption
from August 1, 2012, to August 1, 2014, when used as a plant growth
regulator pre-harvest and in accordance with good agricultural
practices and with the terms of Experimental Use Permit (EUP) No.
62097-EUP-1. Fine Agrochemicals, Ltd., submitted a petition to the U.S.
Environmental Protection Agency (EPA or the Agency) under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting the amendment to the
temporary tolerance exemption.
DATES: This regulation is effective May 18, 2012. Objections and
requests for hearings must be received on or before July 17, 2012, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
[[Page 29549]]
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0048; FRL-9347-9, is
available either electronically through https://www.regulations.gov or
in hard copy at the OPP Docket in the Environmental Protection Agency
Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301
Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the OPP Docket is
(703) 305-5805. Please review the visitor instructions and additional
information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Gina Burnett, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0513; email
address: burnett.gina@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 https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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.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-2010-0048 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
July 17, 2012. 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 . Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0048, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online 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 February 15, 2012, (77 FR 8755) (FRL-
9335-3), 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 1G7947) by Fine Agrochemicals, Ltd., c/o SciReg, Inc.,
12733 Director's Loop, Woodbridge, VA 22192. The petition requested
that 40 CFR 180.1299 be amended by including grapes in the temporary
exemption from the requirement of a tolerance for residues of
Prohydrojasmon (PDJ), propyl-3-oxo-2-pentylcyclo-pentylacetate, and
that the expiration date for the tolerance exemption be extended by 2
years in order to coincide with a 2-year extension of the petitioner's
Experimental Use Permit (EUP) for this biochemical. The petitioner
requests the tolerance exemption expiration date extension and EUP
extension in order to better assess the effects of application timing,
geography, and apple variety on efficacy (color enhancement). Fewer red
apple sites will be treated as compared to the two initial growing
seasons (2010 and 2011), but more acres will be treated per site,
increasing statistical power and confidence, and providing the
applicant with more useful data. Under the EUP extension, the
petitioner will also be approved to test PDJ on grapes. This notice
referenced a summary of the petition prepared by the petitioner, Fine
Agrochemicals, Ltd., which is available in the docket via https://www.regulations.gov. 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
[[Page 29550]]
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.
The Agency established a temporary tolerance exemption for PDJ in a
Final Rule published in the Federal Register on August 18, 2010, (75 FR
50922-50926) (FRL-8839-4), to coincide with the approval of an
Experimental Use Permit (EUP) granted to Fine Agrochemicals, Ltd. The
temporary tolerance exemption supported uses on red apple varieties,
and will expire on August 1, 2012. This amendment proposes to expand
the crops covered by including grapes, and by extending the expiration
date of the tolerance exemption to August 1, 2014, to coincide with the
extension of the petitioner's EUP for the same time period. Since the
establishment of the temporary tolerance exemption, no new toxicology
data have been generated. As such, the toxicological profile as stated
in the August 18, 2010, issue of the Federal Register, and referenced
herein, has not changed. Copies of the August 18, 2010, document (75 FR
50922-50926), and the studies cited therein, are located under docket
identification (ID) number EPA-HQ-OPP-2010-0048.
As discussed in the August 18, 2010, Federal Register, (75 FR
50923), PDJ is a synthetic plant growth regulator that is structurally
similar and functionally identical to jasmonic acid (JA), a naturally
occurring plant regulator present in all vascular plants. The
jasomates, of which JA is a member, is a group of plant hormones
involved in multiple stages of plant development and defense, including
the ability to stimulate fruit ripening (Ref. 1). The highest levels of
naturally occurring JA are found in actively growing plant tissues such
as leaves, flowers, and developing fruit (Refs. 1 and 3), thus JA has
always been a natural component of diets containing plant materials. To
date, there have been no reported toxic effects associated with the
consumption of JA in fruits and vegetables.
PDJ, a synthetic version of JA, is expected to behave in the same
manner and have the same low toxicity profile as JA because it is
structurally similar and functionally identical to naturally occurring
JA. Studies submitted by the applicant in support of this temporary
exemption from the requirement of a tolerance, and reviewed by the
Agency, indicate that PDJ is not acutely toxic. These studies and the
Agency's conclusions are summarized at 75 FR 50922-50926, August 18,
2010. Specifically, no toxic endpoints were established, and no
significant toxicological effects were observed in any of the acute
toxicity studies (75 FR 50923-50924, August 18, 2010). In addition,
studies submitted indicate that PDJ is not genotoxic, has no subchronic
toxic effects, and is not a developmental toxicant (75 FR 50924, August
18, 2010).
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
Dietary exposure to residues of PDJ is expected to be
insignificant, even in the event of exposure. In a worst case scenario,
such as no degradation of the applied compound, PDJ residues consumed
by a 70 kg person are four orders of magnitude below the No Observed
Adverse Effect Level (NOAEL) that was calculated for this compound (75
FR 50924, August 18, 2010).
1. Food. PDJ is structurally similar to the naturally occurring
plant growth regulator jasmonic acid (JA). JA is naturally present in
fruits and vegetables at various levels, generally not exceeding 2
parts per million (ppm), and has always been a component of any diet
containing plant materials (Refs. 1 and 2). Dietary exposure to
residues of PDJ via exposure to treated fruit or foliage is not
expected to exist above background levels of naturally occurring JA (75
FR 50924-50925, August 18, 2010).
2. Drinking water exposure. Exposure of humans to PDJ in drinking
water is unlikely since products are labeled for application directly
to terrestrial plants and because data demonstrate a soil half-life for
this chemical from 1.6-2.3 hours, as well as rapid degradation in water
(Ref. 3). In addition, the expected concentrations in surface water are
well below (6 to 7 orders of magnitude) the maximum doses used in
laboratory testing, where no toxic effects were seen (e.g., acute oral
toxicity LD50 > 5,000 milligrams per kilogram (mg/kg);
developmental toxicity NOAEL > 500 mg/kg) (75 FR 50925, August 18,
2010).
B. Other Non-Occupational Exposure
Non-occupational exposure is not expected because PDJ is not
approved for residential uses. The active ingredient is applied
directly to commodities and degrades rapidly.
1. Dermal exposure. Non-occupational dermal exposures to PDJ are
not expected because the compound is intended only for agricultural use
as a plant growth regulator applied to apples and grapes pre-harvest.
Any dermal exposure associated with this experimental use permit is
expected to be occupational in nature.
2. Inhalation exposure. Non-occupational inhalation exposures are
not expected to result from the agricultural uses of PDJ. Any
inhalation exposure associated with this experimental use permit 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 PDJ to share a common mechanism of toxicity with
any other substances, and PDJ does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that PDJ 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 Web site at https://www.epa.gov/pesticides/cumulative.
[[Page 29551]]
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) 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, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of 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 EPA
determines that a different margin of 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.
Relevant data and information indicate that PDJ has negligible
acute, subchronic, and developmental toxicity (75 FR 50922-25, August
18, 2010). In addition, PDJ is structurally similar to jasmonic acid,
which is present in all fruits and vegetables and for which there is no
reported history of toxicological incident (EPA, 2010). Therefore, the
Agency concludes that there is a reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to the residues of PDJ. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
because the data and information available on PDJ do not demonstrate
toxic potential to mammals. Thus, there are no threshold effects of
concern and, as a result, an additional margin of safety is not
necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes for
the reasons stated above and because EPA is establishing an exemption
from the requirement of a tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for Prohydrojasmon (PDJ),
propyl-3-oxo-2-pentylcyclo-pentylacetate.
VIII. Conclusion
The Agency acknowledges the need to extend the temporary tolerance
exemption to coincide with the approved extension of Fine Agrochemical,
Ltd.'s EUP for PDJ. In addition, the Agency concludes that there is a
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to the residues
of PDJ. Therefore, the temporary exemption is amended for residues of
PDJ on red apples to include grapes, when used pre-harvest as a plant
growth regulator, in accordance with good agricultural practices and
with the terms of EUP No. 62097-EUP-1, and will expire on August 1,
2014.
IX. References
The references used in this document are in the OPP docket listed
under docket ID EPA-HQ-OPP-2010-0048, and may be seen by accessing the
regulatory.gov Web site.
1. Creelman, R.A. and J.E. Mullet (1995) Jasmonic acid distribution
and action in plants: Regulation during development and response to
biotic and abiotic stress. Proceedings of the National Academies of
Science, 92: 4114-4119.
2. Mason, H.S., DeWald, D.B., Creelman, R.A., Mullet J.E. (1992)
Coregulation of Soybean and Vegetative Storage Protein Gene
Expression by Methyl Jasmonate and Soluble Sugars. Plant Physiology,
98: 859-867.
3. EPA (2010) Environmental Protection Agency (EPA) Risk Assessment:
Application for Experimental-Use Permit and Temporary Tolerance
Exemption for FAL 1800 (Prohydrojasmon). May 18, 2010.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the
[[Page 29552]]
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 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).
XI. 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: May 3, 2012.
Keith Mathews,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
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 180.1299 is revised to read as follows:
Sec. 180.1299 Prohydrojasmon; temporary exemption from the
requirement of a tolerance.
A temporary exemption from the requirement of a tolerance is
established for residues of prohydrojasmon, propyl-3-oxo-2-pentylcyclo-
pentylacetate, when used as a plant growth regulator on red apples
varieties and grapes pre-harvest, in accordance with good agricultural
practices and the terms of Experimental Use Permit No. 62097-EUP-1, and
will expire on August 1, 2014.
[FR Doc. 2012-12106 Filed 5-17-12; 8:45 am]
BILLING CODE 6560-50-P
