[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Proposed Rules]
[Page 15656-15658]
[DOCID:fr29mr06-28]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0281; FRL-8051-1]

Revisions to the California State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a revision to the existing
Priority Reserve rule, Rule 1309.1, into the South Coast Air Quality
Management District (District) portion of the California State
Implementation Plan (SIP). Rule 1309.1 was approved into the SIP in
1996 to allow the District to provide emission reduction credits (ERCs)
for specific priority sources, such as sources using innovative
technology, conducting research operations or providing essential
public services. The revision to Rule 1309.1 that we are proposing to
approve merely adds specific types of electrical generating facilities
to the list of sources entitled to use ERCs from the Priority Reserve.
We are proposing to approve the revision to Rule 1309.1 and taking
comment on the revision that adds specific types of electrical
generating facilities to the sources eligible for ERCs from the
Priority Reserve. We plan to follow this proposal with a final action.

DATES: Any comments must arrive by April 28, 2006.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2006-0281, by one of the following methods: Federal eRulemaking Portal:
http://www.regulations.gov. Follow the on-line instructions.    1. E-mail<EMAIL_ADDRESS>
    2. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule revision?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rule?
    B. Do the rules meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rule
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the date it
was adopted by District and submitted by the California Air Resources
Board (CARB).

                                            Table 1.--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                       Rule < greek-
             Local agency                   i>               Rule title               Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
SCAQMD...............................       1309.1  Priority Reserve............        05/03/02        12/23/02
----------------------------------------------------------------------------------------------------------------

    On December 30, 2002, the rule submittal was found to meet the
completeness criteria in 40 CFR part 51, appendix V, which must be met
before formal EPA review.

B. Are there other versions of this rule?

    We approved the Priority Reserve rule, Rule 1309.1, into the SIP on
December 4, 1996. 61 FR 64291 (December 4, 1996). The District adopted
revisions to the SIP-approved version of Rule 1309.1 on April 20, 2001,
November 9, 2001 and May 5, 2002 and CARB submitted those revisions to
us on October 30, 2001, January 22, 2002 and December 23, 2002,
respectively. While we can act on only the most recently submitted
version of the rule, we have reviewed materials provided with previous
submittals.

C. What is the purpose of the submitted rule revision?

    The only purpose of revising Rule 1309.1 is to include specific
types of electrical generating facilities (EGFs) to become eligible to
use ERCs in accordance with the previously approved Priority Reserve
rule. The revision adds section 1309.1(1)(4) to the list of priority
sources allowed to use ERCs established by the District.
    The revision to Rule 1309.1 requires qualified EGFs to meet the
specific requirements prior to receiving access to ERCs held by the
District as priority reserve offsets. Such sources must: Apply BARCT
control to all sources at the facility for the pollutants for which
ERC's are obtained from the priority reserve within 3 years of permit
issuance; pay a non-refundable mitigation fee to the District for each
pound of carbon monoxide (CO), sulfur dioxide (SO2), and
particulate matter (PM10) obtained from the priority
reserve; submit a complete application during the specified time
period; conduct a due diligence effort to secure available ERCs from
other sources; operate the source at full capacity within 3 years; and
enter into a long-term contract with the state of California to sell at
least 50% of the power generated by the use of Priority Reserve
credits. EPA's technical support document (TSD) has more information
about this rule.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    Our analysis of Rule 1309.1 in 1996 occurred during approval of a
package of rules submitted to meet the CAA air quality planning
requirements for nonattainment NSR as set out in part D of Title I of
the Act, with implementing regulations at 40 CFR 51.160 through 51.165.
61 FR 64291 (December 4, 1996) The revised version of Rule 1309.1 being
evaluated in this action is a minor change that does not change
fundamental approvability of Rule 1309.1. The revisions to Rule 1309.1
merely establish an additional source category, EGFs, as eligible to
receive ERCs from the priority reserve provided certain criteria are
met. The revisions also add some administrative provisions that EGFs
must meet to obtain ERCs from the Districts Priority Reserve.

B. Do the rules meet the evaluation criteria?

    We believe that the revision to Rule 1309.1 to allow EGFs to
qualify for ERCs from the Priority Reserve is consistent with the Act,
EPA regulations and EPA policy.

C. EPA Recommendations To Further Improve the Rule

    The TSD describes additional rule revisions that do not affect
EPA's current action but are recommended for the next time the District
modifies Rule 1309.1.

D. Public Comment and Final Action

    Because EPA believes revision to the existing Priority Reserve
rule, Rule 1309.1, fulfills all relevant requirements, we are proposing
to fully approve it as described in section 110(k)(3) of the Act. We
will accept comments from the public on this proposal, specifically the
proposal to allow the District to add EGFs to the priority sources for
receiving ERCs from the Priority Reserve, for the next 30 days. Unless
we receive convincing new information during the comment period, we
intend to publish a final approval action that will incorporate revised
Rule 1309.1 into the federally enforceable SIP.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a ``significant regulatory action'' and
therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This
proposed action merely proposes to approve state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this proposed rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this rule proposes to approve pre-
existing requirements under state law and does not impose any
additional enforceable duty beyond that required by state law, it does
not contain any unfunded mandate or significantly or uniquely affect
small governments, as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4).
    This proposed rule also does not have tribal implications because
it will not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000). This action also does not
have Federalism implications because it does not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999). This action
merely proposes to approve a state rule implementing a Federal
standard, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This
proposed rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does
not impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements, Volatile
organic compound.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: March 17, 2006.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. 06-3028 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-P


Request for Temporary Exemption from the Requirement of a Tolerance

AF36 on Pistachios

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER
(7/1/2006)

	EPA has received a pesticide petition  from Interregional Research
Project Number 4 (IR-4), Rutgers University, 500 College Road East,
Suite 201W, Princeton, NJ 08540 on behalf of the Arizona Cotton Research
and Protection Council], [3721 East Wier Avenue Phoenix, Arizona
85040-2933]  proposing pursuant to section 408(d) of the Federal  Food,
Drug, and Cosmetic Act (FFDCA),  21 U.S.C. 346a(d), to amend 40 CFR part
180.1206 to establish a temporary tolerance exemption for the microbial
pesticide Aspergillus flavus AF36 in or on Pistachios.

	Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
[Interregional Research Project Number 4 (IR-4), Rutgers University, 500
College Road East, Suite 201W, Princeton, NJ 08540 on behalf of the
Arizona Cotton Research and Protection Council] has submitted the
following summary of information, data, and arguments in support of the
pesticide petition.  This summary was prepared by [Interregional
Research Project Number 4 (IR-4) Rutgers University, 500 College Road
East, Suite 201W, Princeton, NJ 08540 on behalf of the Arizona Cotton
Research and Protection Council 3721 East Wier Avenue Phoenix, Arizona
85040-2933] and EPA has not fully evaluated the merits of the pesticide
petition.  The summary may have been edited by EPA if the terminology
used was unclear, the summary contained extraneous material, or the
summary unintentionally made the reader conclude that the findings
reflected EPA’s position and not the position of the petitioner.

I.   Interregional Research Project Number 4 (IR-4), Rutgers University,
500 College Road East, Suite 201W, Princeton, NJ 08540 on behalf of the
Arizona Cotton Research and Protection Council 3721 East Wier Avenue
Phoenix, Arizona 85040-2933  Petition Summary

A.  Product name and Proposed Use Practices

	Aspergillus flavus AF36, a non-aflatoxin-producing strain of A. flavus,
 is proposed for application to pistachios to reduce the incidence of
aflatoxin producing strains of A. flavus and thereby reduce aflatoxin
contamination of pistachios.  Aspergillus flavus AF36 which does not
produce aflatoxin, competitively excludes aflatoxin producing A. flavus
strains without increasing A. flavus in the environment in the long
term.  Sterile wheat seed colonized with Aspergillus flavus AF36 is
applied at 10 pounds of end-use product (total amount of active
ingredient less than 0.01 lb/acre) per acre.  The pesticide is currently
being used in certain counties in California and the States of Arizona
and Texas in cotton. The current submission proposes to establish a
temporary exemption from tolerance for residues of A. flavus AF36 on
pistachios.

B.  Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues.  The pesticide
and corresponding residues are identified as Aspergillus flavus AF36.

	2. Magnitude of residue at the time of harvest and method used to
determine the residue.   Aspergillus flavus AF36 is a naturally
occurring fungus that was originally isolated from cottonseed produced
in the Yuma Valley of Arizona.  Aspergillus flavus AF36 has been shown
to be naturally and consistently associated with pistachios grown in
California.  A. flavus is a widespread fungus.  It is particularly well
adapted to the hot regions of California where it is widespread in the
environment.  The communities of A. flavus in the desert and in
agricultural fields are naturally composed of both aflatoxin producing
(toxigenic) and aflatoxin non-producing (atoxigenic) strains.  Both
atoxigenic and toxigenic strains have been found on essentially all
plant material and soils in California.  The goal of applications is to
increase the percent of the Aspergillus flavus community composed of the
strain AF36 and to decrease the percent of A. flavus that produces
aflatoxins on the crop and the field.

	3. A statement of why an analytical method for detecting and measuring
the levels of the pesticide residue are not needed.   A temporary
exemption from the requirement of a

tolerance for residues of the microbial pesticide A. flavus AF36 in/on
pistachios is being proposed for pistachios in California.   All lots of
the active ingredient (A. flavus isolate AF36) and the formulated
product are monitored as part of a rigorous quality control program.
Starter cultures of A. flavus isolate AF36 used in the production of the
end-use product are always screened for aflatoxin production using TLC
and appropriate standards. Quality control standards are zero tolerance
in the starter cultures and in the formulated product for aflatoxin
production, and for A. flavus not identified as A. flavus isolate AF36.
A. flavus AF36 has never been found to produce aflatoxin. Starter
cultures of A. flavus AF36 as well as end-use products containing this
active ingredient are also identified to isolate by vegetative
compatibility analysis.

C.  Mammalian Toxicological Profile

An acute oral toxicity test was performed whereby a single oral dose of
5,000 milligrams/kilogram (mg/kg) per animal of Aspergillus flavus AF36
colonized wheat seed was administered by gavage to five male and five
female Sprague Dawley rats.  The oral LD50 of Aspergillus flavus AF36
was determined to be greater than 5,000 mg/kg rat body weight.  No
clinical signs were observed during the 14 day study and no
abnormalities or adverse effects were observed in any of the rats upon
necropsy.

               An initial pulmonary rat study which resulted in
lethality in a significant number of animals treated with either the
live Aspergillus flavus AF36 in Tween 80 or heat killed Aspergillus
flavus AF36 in Tween 80.  Onset of symptoms was rapid after dosing with
all deaths occurring by day four of the study.  All rats surviving to
day four of the study recovered and all rats sacrificed (as scheduled)
on day 8 or day 15 of the study had totally eliminated viable
Aspergillus flavus AF36 from the lungs, caecal contents, and faeces.
There was no evidence of infectivity.  The aetiology of deaths was
unclear.  It appeared that Aspergillus flavus AF36 prepared using Tween
80 caused a severe acute inflammatory response.  Retrospective
literature review and consultation with a toxicologist supported the
theory that the responses were a result of a synergism with Tween 80
and/or of Tween 80 breakdown products formed during preparation of the
spore suspension.

              A second rat study was therefore undertaken.  In the
second study the conidia were both washed from the wheat and suspended
in sterile physiological saline instead of Tween 80.  Animals (2 male
and 2 female for each treatment level) were dosed at 0, 105, 106, 107,
and 108 colony forming units per rat.  There were no clinical signs in
any of the treatment groups considered to be associated with the test
substance.  Rats were sacrificed at day 8 without treatment associated
mortality.  No abnormalities were observed in any of the animals at the
macroscopic examination at termination.

Based on these two mammalian studies, it was concluded that Aspergillus
flavus AF36 does not present either a toxicological or an infectious
risk to mammals.

	Data waivers were requested for the toxicology studies listed below on
the following basis:(1) researchers and other workers have worked with
Aspergillus flavus AF36 at the Southern Regional Research Center for
over 10 years and in commercial fields (1996 to 1998) and in hand picked
field plots (1989 to 1994) without report of any adverse health effects;
(2) Aspergillus flavus AF36 is widely distributed in the environment and
its occurrence is natural; and 3) the label will require applicators and
other handlers to wear Personal Protective Equipment (PPE) such as
waterproof gloves, a dust/mist filtering respirator with the appropriate
NIOSH approval prefix N-95, P-95, or R-95, coveralls, long sleeved shirt
and long pants, and shoes plus socks, and goggles, so exposure should
not be a problem.  Applications will involve aerial application by
mixers/handlers who are licensed and trained to even handle restricted
materials. At the 10 lb/acre application rate of the formulated
material, the total amount of active ingredient is less than 0.01
lb/acre. Applications of AF-36 do not significantly impact the total
amount of Aspergillus flavus in the soil or crop, but only change the
proportion of the AF-36 strain in relation to the overall soil or crop
population. Since the product is applied as a granular formulation on
wheat,  exposure from drift is minimal.

1. Acute dermal toxicity. This study was waived based upon the lack of
toxicity in animals dosed orally. While Aspergillus flavus has been
reported to be a dermal sensitizer, this testing is not warranted, since
the PPE required on the label will provide adequate protection from
dermal exposure to workers and pesticide handlers.

 2. Primary dermal irritation. This study was waived based upon the lack
of toxicity in animals dosed orally.  Aerial applications will be made
by mixers/handlers and applicators, who are required to wear appropriate
PPE, and are licensed and trained to even handle restricted materials.
At the 10 lb/acre application rate of the formulated material, the total
amount of active ingredient is less than 0.01 lb/acre. Applications of
AF-36 do not significantly impact the total amount of Aspergillus flavus
in the soil or crop, but only change the proportion of the AF-36 strain
in relation to the overall population. Since the product is applied as a
granular formulation on wheat,  exposure from drift is minimal.

3 Primary eye irritation.  This study was waived based upon the use of
appropriate PPE, including goggles, and other factors listed above.
Since the product is applied aerially as a granular formulation on
wheat, exposure from drift is expected to be minimal.

4. Acute Intraperitoneal.  This study was waived based upon the lack of
toxicity in animals dosed orally and by intratracheal instillation.  In
addition, the factors listed above will mitigate exposure, which is
expected to be minimal.

5.  Genotoxicity, reproductive and developmental toxicity, subchronic
toxicity and chronic toxicity testing were not performed, since no
adverse effects were observed in the acute toxicology study Tier 1
studies.   Tier II (885.3550) , subchronic toxicology study (USEPA OPPTS
885.3600) and chronic feeding studies (guideline 152-50) are only
required if triggered by adverse effects observed in Tier I studies.

D.  Aggregate Exposure

	1. Dietary exposure.

	i. Food.   Aspergillus flavus AF36 is a naturally occurring organism,
which does not produce aflatoxin and is thus safer than the
aflatoxin-producing A. flavus isolates that produce aflatoxin.  Proposed
uses and application rates will not result in increases in the total
population of A. flavus on the mature crop beyond naturally occurring
background levels.

Aspergillus flavus AF36, when applied to the soil just prior to bloom,
has been shown to significantly reduce the levels of aflatoxin in
pistachios at harvest without changing the quantity of A. flavus on the
crop.  Furthermore, the proposed use and application rate will not
increase exposure of humans to A. flavus by dietary means.
Applications of Aspergillus flavus AF36 do not increase the indigenous
populations of A. flavus associated with the harvested crop.  The
applications merely alter the composition of the fungal community
associated with the mature crop so that aflatoxin producing strains are
far less frequent.  The result is a much lower incidence of aflatoxins
in the crop and in the environment associated with the developing and
mature crop.

	ii. Drinking water.   Aspergillus flavus AF36 is a naturally occurring
organism that is already widespread in the environment and is not
considered to be a risk to drinking water.  Both percolation through
soil and municipal treatment of drinking water would reduce the
possibility of exposure of A. flavus through the drinking water.
Applications of Aspergillus flavus AF36 do not increase the long-term
populations of A. flavus in the environment, and thus are not expected
to influence the relationship of A. flavus to water sources.
Applications merely change the composition of the A. flavus community so
that aflatoxins are less common in the environment.

	2. Non-dietary exposure.   The potential for non-occupational,
non-dietary exposure to the general population is not expected to be
significant and is not expected to present any risk of adverse health
effects.]

E.  Cumulative Exposure

	There are no other registered products containing Aspergillus flavus
AF36 or any other isolates (strains) of the microbial active ingredient.
 Data submitted show that the fungal metabolite of concern which is
aflatoxin is not produced by Aspergillus flavus AF36 in the crop or in
artificial media in the lab.  Aspergillus flavus AF36 has been shown to
exclude aflatoxin producing fungi competitively from the developing crop
and to reduce aflatoxin contamination of pistachio.  Data show that the
proposed use will not result in appreciable increases in the long-term
population of A. flavus on the crop beyond naturally occurring levels.
Furthermore, there is no expectation of cumulative effects with other
pesticides.

F.  Safety Determination

	1. U.S. population. Aspergillus flavus AF36 is a naturally occurring
organism. This isolate has low toxicity as demonstrated by the acute
oral toxicity study in rats.  A. flavus is ubiquitous throughout the hot
desert valleys in Arizona.  Studies have shown that treatment of cotton
fields just prior to flowering with sterile wheat seed colonized by
Aspergillus flavus AF36 at 10 lbs. per acre does not increase the
long-term populations of A. flavus either on the crop at maturity or in
the soil 1 year after application.  Based on this information, IR-4 is
of the opinion that the aggregate exposure to A. flavus over a lifetime
should not change with application of Aspergillus flavus AF36, and
exposure to both aflatoxin producing A. flavus strains and aflatoxin
should decrease.  This should be beneficial to human health.  Thus,
there is a reasonable certainty that no harm will result from aggregate
exposure to Aspergillus flavus AF36.

	2. Infants and children.   Based on the lack of toxicity and natural
occurrence, there is reasonable certainty that no harm to infants,
children, or adults will result from aggregate exposure to Aspergillus
flavus AF36.  Exempting Aspergillus flavus AF36 from the requirement of
a tolerance should pose no significant risk to humans or the
environment.

G.  Effects on the Immune and Endocrine Systems

	Aspergillus flavus AF36 is a naturally occurring organism, which does
not produce aflatoxin, and is thus safer than the A. flavus isolates
that produce aflatoxin.  To date there is no evidence to suggest that
Aspergillus flavus AF36 functions in a manner similar to any known
hormone, or that it acts as an endocrine disrupter.

H.  Existing Tolerances

	The registrant is not aware of any existing tolerances or tolerance
exemptions for Aspergillus flavus AF36, other than the tolerance
exemption on cotton (40 CFR 180.1206)

I. Efficacy Data

            The following information was presented for a tolerance
exemption for AF36 on cotton.  The information is relevant for pistachio
and for this request for a temporary exemption from the requirement of a
tolerance for AF36 on pistachios, as part of the EUP contained herein.
Existence of aflatoxins in the environment is a public health hazard,
and as such data were submitted to demonstrate that proper use of
Aspergillus flavus AF36 results in reductions in the average aflatoxin
producing potential of fungi resident in treated areas and in reductions
in the quantity of aflatoxins in crops.

	In field tests prior to 1996, the aflatoxin content of cottonseed was
shown to be inversely related to the proportion of the A. flavus
community on the crop composed of Aspergillus flavus AF36. Detailed
analyses of the aflatoxin content of commercial fields from 1996 through
1998 confirmed that reduced aflatoxin levels were associated with
displacement of aflatoxin producers by Aspergillus flavus AF36 from
treated crops and that treatments were associated with up to 90%
reductions in crop aflatoxin content.  Efficacy of applications of
Aspergillus flavus AF36 in displacing aflatoxin producers was
demonstrated for fungal communities both on cottonseed from treated
crops at harvest and in soils of treated fields one year after
treatment.  This included cotton crops treated in 1996 (112 acres
treated), 1997 (463 acres treated), 1998 (499 acres), 1999 (10,488
acres), 2000 (16,725 acres) and 2001 (19,975 acres treated).
Displacement of aflatoxin producers is indicated by the proportion of A.
flavus communities composed of Aspergillus flavus strain AF36.   	In
1996 average incidence of AF36 on treated crops was 88.5% and in the
soil one year after treatment, 85.2%.  Incidences of AF36 on treated
crops were 78% and 67% in 1997 and 1998, respectively, and in the soil
one year after treatment incidences were 72% and 77%, respectively.
Successful displacement was also observed as the acreage treated rapidly
expanded from 1999 to 2001 with average incidences of AF36 on treated
crops ranging from 57% in 1999 to 66% in 2001.  Applications were
particularly effective at displacing the high aflatoxin producing S
strain of A. flavus.  S strain isolates produce more aflatoxins than
other A. flavus isolates and are prominent in soils of cotton producing
areas of Arizona and South Texas.

	During the course of the Experimental Use Program, Aspergillus flavus
AF36 caused long-term reductions in the aflatoxin producing potential of
fungal communities in agricultural fields.  Aspergillus flavus AF36
retained atoxigenicity (failure to produce aflatoxins) upon repeated
reisolation from treated fields one, two, or three years after
treatment. Field averages for aflatoxin production by the displaced S
strain isolates of A. flavus ranged from 7100-ppb aflatoxin to 22700 ppb
aflatoxin. Thus, there was a long-term reduction in the potential of
fungal communities to produce aflatoxins in treated areas.

	There is preliminary data indicating that A. flavus AF36 is effective
in pistachios as well. The purpose of this temporary exemption from
tolerance is to cover the use of A. flavus under an Experimental Use
Permit so that additional efficacy data can be generated.

J.  International Tolerances

	There are no Codex maximum residue levels established for residues of
Aspergillus flavus AF36.  Aspergillus flavus AF36 containing products
are presently not registered for pest control outside of the United
States.

IR-4/Arizona Cotton Research Council submission template
               71693-EUP-R

PP6E7118               EPA-HQ-OPP_2007-0158
                     			03/21/2007


[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Rules and Regulations]
[Pages 8270-8273]
[FR Doc No: 2014-03088]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-1072]
RIN 1625-AA09

Drawbridge Operation Regulation; Terrebonne Bayou, LA

AGENCY: Coast Guard, DHS.

ACTION: Interim rule with request for comments.

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

SUMMARY: The Coast Guard is changing the operating schedule that
governs the St. Ann swing bridge across Terrebonne Bayou, mile 28.8, at
Bourg, Terrebonne Parish, Louisiana. The change will allow the bridge
to operate on signal if at least 24 hours advanced notice is given.
This change increases the efficiency of operations allowing for the
safe navigation of vessels through the bridge while recognizing the low
volume of vessel traffic through the bridge.

DATES: This interim rule is effective February 12, 2014.
    Comments and related material must reach the Coast Guard on or
before March 14, 2014.

ADDRESSES: Documents mentioned in this preamble are part of Docket
Number USCG-2013-1072. To view documents mentioned in this preamble as
being available in the docket, go to http://www.regulations.gov, type
the docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on
``Open Docket Folder'' on the line associated with this rulemaking. You
may also visit the Docket Management Facility in Room W12-140 on the
ground floor of the Department of Transportation West Building, 1200
New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may submit comments, identified by docket number, using any one
of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. David Frank; Bridge Administration Branch, Eighth
Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Cheryl F. Collins, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
USCG United States Coast Guard
NEPA National Environmental Policy Act
Sec.  Section Symbol
U.S.C. United States Code
MGL Mean Gulf Level
SR State Route

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2013-1072), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. If you submit a comment online via http://www.regulations.gov, it will be considered received by the Coast Guard
when you successfully transmit the comment. If you fax, hand deliver,
or mail your comment, it will be considered as having been received by

the Coast Guard when it is received at the Docket Management Facility.
We recommend that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that we can
contact you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2013-1072) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-1072) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the docket using one of the three methods specified
under ADDRESSES. Please explain why one would be beneficial. If we
determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    As provided under the ``Public Participation and Request for
Comments'' section above, this interim rule includes a request for
comments and the Coast Guard encourages the public to participate
through the comment process. Comments received will be reviewed to
determine if this interim rule requires further review or revision
before becoming final.
    The Coast Guard is issuing this interim final rule without prior
notice pursuant to authority under section 553(b)(3)(B) of the
Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.). This
provision authorizes an agency to issue a rule without prior notice
when the agency for good cause finds that those procedures are
``impracticable, unnecessary, or contrary to the public interest.''
While the Coast Guard does not anticipate any adverse comment regarding
this change in bridge opening requirement, this rule includes a request
for comments during the first 30 days that the rule is in effect,
providing the public an opportunity to comment on the change while it
is in place. Should comments received propose or support the need to
revise this change, the Coast Guard will address such comments and
revise this interim rule as necessary. It is unnecessary to provide
prior notice and comment because there have only been 15 openings for
this bridge since 2008 and no requests since 2011. Additionally, if a
vessel does require an opening, the vessel owner may do so by giving
advanced notice.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective in less
than 30 days after publication in the Federal Register. Due to the fact
that there is limited vessel traffic on the waterway, implementation of
the interim rule will not have a significant effect on the mariners
using the waterway. Since 2008, the bridge has opened 15 times for the
passage of vessels, averaging less than 3 times per year. The bridge
owner requested changing the operating schedule to allow the bridge to
remain in the closed-to-navigation position and open for vessel traffic
only upon receiving at least 24 hours advanced notification. This
change allows the bridge to operate more efficiently because it will
not require a full-time tender. Providing a full 30-day notice for
changing the operating schedule of the bridge is unnecessary based on
the low volume of vessels requiring the bridge to open. Additionally,
the bridge will still be able to open to navigation upon giving
advanced notice.

C. Basis and Purpose

    The Coast Guard received a request from the Terrebonne Parish
Consolidated Government, in conjunction with the Lafourche Parish
Council, to modify the existing operating schedule of the new St. Ann
swing bridge across Terrebonne Bayou, mile 28.8, at Bourg, Terrebonne
Parish, Louisiana. The bridge owner would like to open the bridge on
signal if at least 24 hours advanced notification is given.
    This change will allow the bridge owner to open the bridge for
vessel traffic with sufficient notice while removing the requirement
that a bridge tender be on the bridge at all times. Construction of the
new swing bridge was completed late last year and presently the bridge
is required to open on signal for the passage of vessels.
    Since 2008, the bridge has only opened 15 times for the passage of
vessels and during the two years (11/2011 to 11/2013) that the new
bridge was under construction, no requests for openings occurred.
Additionally, since completion of the new bridge, no openings have been
requested by mariners. Several of the bridges downstream of the St. Ann
swing bridge are operated under special operating regulations published
in 33 CFR 117.505. These special operating regulations currently
operate without negative impacts or issue to the waterway users and
increase efficiency. Vessels that would require an opening at the St.
Ann swing bridge, likely passed through or will pass through the SR 24
(Presquille Isle) bridge, located 2.5 miles upstream of the St. Ann
swing bridge at mile 31.3 in Bourg. The Presquille Isle bridge is a
fixed bridge with a vertical clearance of 3.4 feet above mean high
water, elevation 3.4 feet Mean Gulf Level (MGL). Based on the clearance
through the Presquille Isle bridge and the low volume of vessels
transiting into this area, the primary affect of this change is limited
to the property owners located on and vessels transiting this waterway
between the St. Ann swing bridge and the Presquille Isle bridge.

D. Discussion of Interim Rule

    This interim rule will add a new paragraph (b) to the existing 33
CFR 117.505 for this waterway. It will redesignate the already existing
paragraphs for bridges at mile markers above 28.8. This interim rule
will allow the bridge to open on signal if at least 24 hours advanced
notification is given.

As no vessels have transited through this bridge site in the last two
years and only 15 openings were requested since 2008, this regulation
will have a minimal affect on the property owners located in and
vessels transiting the area. Additionally, the bridge can be opened in
less than four hours if there is an emergency on the waterway.

E. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    This rule allows the limited number of vessels using this stretch
of the waterway the opportunity to transit with proper notification. As
this bridge has not opened for vessel traffic during the two years (11/
2011 to 11/2013) that the new bridge was under construction and only 15
times since 2008, this regulation will have a minimal affect on those
property owners and vessels who wish to use the waterway.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule would not have a
significant economic impact on a substantial number of small entities.
    This rule will affect the following entities, some of which may be
small entities: The property owners or vessel operators who wish to
transit on Terrebonne Bayou between mile 28.8 and mile 31.3. However,
as provided in this rule and currently under 33 CFR 117.505, vessel
owners will still be able to transit the bridge if proper notification
is given and in the case of an emergency.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule simply

promulgates the operating regulations or procedures for drawbridges.
This rule is categorically excluded, under figure 2-1, paragraph
(32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.505, paragraphs (b), (c), and (d) are redesignated as
(c), (d), and (e) and a new paragraph (b) is added to read as follows:

Sec.  117.505  Terrebonne Bayou.

* * * * *
    (b) The draw of the St. Ann bridge, mile 28.8 at Bourg, shall open
on signal if at least 24 hours notice is given.
* * * * *

    Dated: January 24, 2014.
Todd A. Sokalzuk,
Captain, U.S. Coast Guard, Commander, Eighth Coast Guard District,
Acting.
[FR Doc. 2014-03088 Filed 2-11-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 4, 2010 (Volume 75, Number 107)]
[Rules and Regulations]
[Page 31713-31716]
[DOCID:fr04jn10-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0033; FRL-8827-4]

2-Propenoic acid polymer, with 1,3-butadiene and ethenylbenzene;
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-propenoic acid polymer, with 1,3-
butadiene and ethenylbenzene, minimum number average molecular weight
(in AMU) 9400 (CAS Reg. No. 25085-39-6); when used as an inert
ingredient in a pesticide chemical formulation under 40 CFR 180.960.
BASF Corporation submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of 2-propenoic acid
polymer, with 1,3-butadiene and ethenylbenzene on food or feed
commodities.

DATES: This regulation is effective June 4, 2010. Objections and
requests for hearings must be received on or before August 3, 2010, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0033. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under 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-2010-0033 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
August 3, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. 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-2010-0033, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP 9E7649) filed
by BASF Corporation, 100 Campus Drive, Florham Park, NJ 07932. The
petition requested that 40 CFR 180.960 be amended by establishing an
exemption from the requirement of a tolerance for residues of 2-
propenoic acid polymer, with 1,3-butadiene and ethenylbenzene, minimum
number average molecular weight (in AMU) 9400; CAS Reg. No. 25085-39-6.
That notice included a summary of the petition prepared by the
petitioner and solicited comments on the petitioner's request. The
Agency did not receive any comments in the docket. However, the Agency
did receive one comment by e-mail. The comment was received from a
private citizen who opposed the authorization to sell any pesticide
that leaves a residue on food. The Agency understands the commenter's
concerns

and recognizes that some individuals believe that no residue of
pesticides should be allowed. However, under the existing legal
framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by the statute.
    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 use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of 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...'' and specifies
factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), 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. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). 2-propenoic acid polymer, with 1,3-
butadiene and ethenylbenzene conforms to the definition of a polymer
given in 40 CFR 723.250(b) and meets the following criteria that are
used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 9400 is greater than 1,000
and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Thus, 2-propenoic acid polymer, with 1,3-butadiene and
ethenylbenzene meets the criteria for a polymer to be considered low
risk under 40 CFR 723.250. Based on its conformance to the criteria in
this unit, no mammalian toxicity is anticipated from dietary,
inhalation, or dermal exposure to 2-propenoic acid polymer, with 1,3-
butadiene and ethenylbenzene.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that 2-propenoic acid polymer, with 1,3-
butadiene and ethenylbenzene could be present in all raw and processed
agricultural commodities and drinking water, and that non-occupational
non-dietary exposure was possible. The number average MW of 2-propenoic
acid polymer, with 1,3-butadiene and ethenylbenzene is 9400 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since 2-
propenoic acid polymer, with 1,3-butadiene and ethenylbenzene conform
to the criteria that identify a low-risk polymer, there are no concerns
for risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

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 2-propenoic acid polymer, with 1,3-butadiene and
ethenylbenzene to share a common mechanism of toxicity with any other
substances, and 2-propenoic acid polymer, with 1,3-butadiene and
ethenylbenzene does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has assumed that 2-propenoic acid polymer, with 1,3-
butadiene and ethenylbenzene does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA 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 data base unless EPA
concludes that a different margin of safety will be safe for infants
and children. Due to the expected low toxicity of 2-propenoic acid
polymer, with 1,3-butadiene and ethenylbenzene, EPA has not used a
safety factor analysis to assess the risk. For the same reasons the
additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of 2-propenoic acid polymer, with 1,3-
butadiene and ethenylbenzene.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency 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 2-propenoic acid polymer,
with 1,3-butadiene and ethenylbenzene.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2-propenoic acid
polymer, with 1,3-butadiene and ethenylbenzene from the requirement of
a tolerance will be safe.

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 rules 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 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).
    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, or otherwise have any unique
impacts on local governments. Thus, the Agency has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not
apply to this final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.

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 rule in the Federal
Register. This 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 24, 2010.
Daniel Rosenblatt,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. In Sec. 180.960, the table is amended by adding alphabetically the
following polymer to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                       Polymer                              CAS No.
------------------------------------------------------------------------
2-propenoic acid polymer, with 1,3-butadiene and              25085-39-6
 ethenylbenzene, minimum number average molecular
 weight (in amu), 9400...............................
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-13320 Filed 6-3-10; 8:45 am]
 BILLING CODE 6560-50-S