[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14243]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Killed, Nonviable Streptomyces acidiscabies Strain RL-110\T\;
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of killed, nonviable Streptomyces
acidiscabies strain RL-110\T\ in or on all food commodities when
applied as a pre- or post-emergent herbicide and used in accordance
with good agricultural practices. Marrone Bio Innovations, Inc.
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 killed, nonviable Streptomyces
acidiscabies strain RL-110\T\ under the FFDCA.
DATES: This regulation is effective June 13, 2012. Objections and
requests for hearings must be received on or before August 13, 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).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0078, is at http://www.regulations.gov or 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 http://www.epa.gov/dockets.
Some documents cited in this final rule are located in a different
docket associated with a notice of receipt (NOR) of an application for
a new pesticide, Streptomyces acidiscabies strain RL-110T,
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
That docket number is EPA-HQ-OPP-2010-0079. Such documents include the
Biopesticides Registration Action Document (BRAD) provided as a
reference in Unit IX. (Ref. 1) of this final rule, and other documents
listed Unit IX. of this final rule.
FOR FURTHER INFORMATION CONTACT: Ann Sibold, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 305-6502; email
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
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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2010-0078 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 13, 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-2010-0078, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for
hand delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
II. Background and Statutory Findings
In the Federal Register of March 10, 2010 (75 FR 11171) (FRL-8810-
8), 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 0F7681)
by Marrone Bio Innovations, Inc., 2121 Second St., Suite B-107, Davis,
CA 95618. The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Streptomyces acidiscabies strain RL-110\T\. This notice
referenced a summary of the petition prepared by the petitioner,
Marrone Bio Innovations, Inc., which is available in the docket via
http://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 exemption 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 EPA consider ``available information concerning the cumulative
effects of [a particular pesticide's] * * * residues and other
substances that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA 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 also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
A. Overview of Streptomyces acidiscabies Strain RL-110\T\
Streptomyces species are commonly found in agricultural settings
(i.e., soils and decaying plant material) and are present on fresh
produce of all kinds with no known adverse effects. Indeed, the Manual
of Clinical Microbiology (9th edition) (Ref. 2) states that the primary
ecological niche for aerobic actinomycetes, such as Streptomyces
acidiscabies strain RL-110\T\, is likely decaying plant material. The
Manual of Clinical Microbiology (9th edition) (Ref. 2) further states
that infections caused by Streptomyces species are infrequent and
limited to species unrelated to acidiscabies and does not identify
Streptomyces acidiscabies as clinically significant. No food borne
disease outbreaks associated with Streptomyces species or mammalian
active toxin production from Streptomyces species, including
Streptomyces acidiscabies, have been reported. Streptomyces species
have been used in pesticide products to control various pests of
agricultural products. In conjunction with the registration of some of
these pesticide products, EPA established the following exemptions from
the requirement of a tolerance:
1. Streptomyces sp. (now griseoviridis) strain K61 (40 CFR
180.1120)--See the Federal Register of April 21, 1993 (58 FR 21402)
2. Streptomyces lydicus WYEC 108 (40 CFR 180.1253)--See the Federal
Register of June 3, 2004 (69 FR 31297) (FRL-7361-3).
Streptomyces acidiscabies strain RL-110\T\ was isolated from scab-
infected potatoes in Maine and New York. The pesticide active
ingredient consists of killed, nonviable Streptomyces acidiscabies
strain RL-110\T\ cells and spent fermentation media. Thaxtomin A, a
phytotoxin produced by Streptomyces acidiscabies strain RL-110\T\,
provides the herbicide mode of action.
B. Microbial Pesticide Toxicology Data Requirements
All applicable mammalian toxicology data requirements supporting
the request for an exemption from the requirement of a tolerance for
residues of killed, nonviable Streptomyces acidiscabies strain RL-
110\T\ in or on all food commodities have been fulfilled with data
submitted by the petitioner or data waiver requests that have been
granted by EPA. Results of acceptable (i.e., data that are
scientifically sound and useful for risk assessment) toxicity tests
(acute oral, dermal, and inhalation toxicity), primary eye and dermal
irritation tests, and a skin sensitization test, all of which addressed
potential routes of exposure to the active ingredient, revealed little
to no toxicity, irritation, or sensitization attributed to killed,
nonviable Streptomyces acidiscabies strain RL-110\T\. Moreover, the
acute toxicity and primary irritation tests received a Toxicity
Category IV classification (see 40 CFR 156.62). Finally, the results of
an acute intravenous injection toxicity/pathogenicity test demonstrated
that live Streptomyces acidiscabies strain RL-110\T\ were not toxic,
infective and/or pathogenic to the test animals.
The overall conclusions from all toxicological information
submitted by the petitioner are briefly described in this unit, while
more in-depth synopses of some study results can be found in the
associated Biopesticides Registration Action Document (BRAD) provided
as a reference in Unit IX. (Ref. 1).
1. Acute oral toxicity/pathogenicity (Harmonized Guideline
885.3050) and acute pulmonary toxicity/pathogenicity (Harmonized
Guideline 885.3150) (Master Record Identification Number (MRID No.)
479468-17). EPA waived the acute oral toxicity/pathogenicity and acute
pulmonary toxicity/pathogenicity data requirements for the killed
microorganism, but required the intravenous injection acute toxicity/
pathogenicity study to verify the product, under a ``worst case''
scenario, would not be toxic and/or pathogenic to the test animals.
The toxicity component of the acute oral toxicity/pathogenicity and
acute pulmonary toxicity/pathogenicity data requirements was fulfilled
by MRID No. 479468-02 (acute oral toxicity, described in this unit) and
MRID No. 479468-04 (acute inhalation toxicity, described in this unit),
2. Acute injection toxicity/pathogenicity (intravenous)--rat
(Harmonized Guideline 885.3200; MRID No. 479468-08). An acceptable
acute injection toxicity/pathogenicity study demonstrated that live
Streptomyces acidiscabies strain RL-110\T\ was not toxic, infective,
and/or pathogenic to rats when administered intravenously in a single
dose of 9.0 x 10\6\ colony-forming units (CFU) per rat.
3. Acute oral toxicity--rat (Harmonized Guideline 870.1100; MRID
No. 479468-02). An acceptable acute oral toxicity study with a test
containing killed, nonviable Streptomyces acidiscabies strain RL-110\T\
demonstrated that the oral median lethal dose (LD50) (i.e.,
a statistically derived single dose that can be expected to cause death
in 50% of test animals) was greater than 5,000 mg/kg for female rats.
This is the limit dose, and no further acute oral testing is required.
(Toxicity Category IV).
4. Acute dermal toxicity--rat (Harmonized Guideline 870.1200; MRID
No. 479468-03). An acceptable acute dermal toxicity study with a test
substance containing killed, nonviable Streptomyces acidiscabies strain
RL-110\T\ demonstrated that the dermal LD50 was greater than
5,050 mg/kg for male and female rats combined. This is the limit dose,
and no further acute dermal testing is required. (Toxicity Category
5. Acute inhalation toxicity--rat (Harmonized Guideline 870.1300;
MRID No. 479468-04). An acceptable acute inhalation study with a test
substance containing killed, nonviable Streptomyces acidiscabies strain
RL-110\T\ demonstrated that the inhalation median lethal concentration
(LC50) was greater than 2.21 mg/L (the limit or maximum dose
required to be tested) for male and female rats combined. (Toxicity
6. Primary dermal irritation--rabbit (Harmonized Guideline
870.2500; MRID No. 479468-06). An acceptable primary dermal irritation
study demonstrated that a test substance containing killed, nonviable
Streptomyces acidiscabies strain RL-110\T\ was not irritating to the
skin of rabbits (Toxicity Category IV).
7. Skin sensitization--guinea pig (Harmonized Guideline 870.2600;
MRID No. 479468-07). An acceptable dermal sensitization study
demonstrated that a test substance containing killed, nonviable
Streptomyces acidiscabies strain RL-110\T\ was not a dermal sensitizer
to guinea pigs.
IV. Aggregate Exposure
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
1. Food exposure. Killed, nonviable Streptomyces acidiscabies
strain RL-110\T\ will be applied as a herbicide to agricultural crops
pre-plant, at-plant and post-plant and may be applied up to the day of
harvest. Exposure to this active ingredient through food is possible
but is expected to be minimal for the following reasons:
i. The proposed pesticide product will be diluted prior to
ii. Pre-plant applications will occur 1-45 days or more before
iii. At-plant applications will be broadcast and incorporated into
the soil mechanically or by rainfall or sprinkler application.
iv. Post-plant applications for trees will be made as a broadcast
or banded application to soil surface below established trees or
between tree rows and incorporated into the soil by rainfall,
irrigation or mechanical incorporation.
v. Post-plant lay-by and split application will be made between
rows and incorporated into the soil.
vi. Application to rice fields is followed by flooding or partially
draining and re-flooding the fields. and
vii. Rainfall and sprinkler irrigation will further wash residues
of the pesticide from treated crops.
Following all applications, killed, nonviable Streptomyces
acidiscabies strain RL-110\T\ will naturally degrade due to consumption
by other biological organisms, including bacteria and fungi (Ref. 3).
In the unlikely event that any residues of the pesticide remain in
or on consumed food, no adverse effects would be expected, based on the
lack of toxicity, infectivity, and/or pathogenicity demonstrated in the
2. Drinking water exposure. Exposure to residues of killed,
nonviable Streptomyces acidiscabies strain RL-110\T\ in consumed
drinking water is unlikely, since the majority of the proposed use
patterns (ground and aerial) include measures to incorporate the
herbicide into the soil; however, residues may appear at low levels in
ground and surface water from these uses due to runoff or drainage from
treated fields, or by spray drift. These residues will be minimized by
natural degradation of the active ingredient by microbial activity
(Ref. 3). Furthermore, since application of the product is concentrated
in upper soil strata, movement through the soils would likely filter
out any remaining product.
The proposed directions for applications to established turf in
landscapes provide for dilution of the product prior to application,
but do not include measures to incorporate the product. Since
established turf constitutes significant ground cover, this, in itself,
would be expected to reduce the potential runoff of the pesticide into
surface water and percolation to ground water. The proposed directions
for applications to ornamentals in landscapes specify dilution prior to
application and incorporation by irrigation or raking into the soil.
These measures, along with natural degradation and incorporation of the
product into upper soil strata, will reduce the potential for runoff
into surface or ground water.
The proposed use in rice provides the greatest potential for
residues of killed, nonviable Streptomyces acidiscabies strain RL-
110\T\ to appear in ground and surface water, since application to rice
fields is followed by flooding the treated fields. If residues of
Streptomyces acidiscabies strain RL-110\T\ are transferred to surface
or ground waters that are intended for eventual human consumption, and
subjected to sanitation (e.g., chlorination, pH adjustments,
filtration, high temperatures) in drinking water treatment plants, the
residues would likely be removed from the finished drinking water (Ref.
4). In the unlikely event that any residues of the pesticide occur in
drinking water even after being processed at a water treatment
facility, no adverse effects would be expected, based on the lack of
toxicity and pathogenicity demonstrated in the submitted studies.
B. Other Non-Occupational Exposure
Given the natural occurrence of Streptomyces acidiscabies in soil
(Refs. 5 and 6), non-occupational and residential exposure may already
be occurring. Application of killed, nonviable Streptomyces
acidiscabies strain RL-110\T\ to established turf in residential and
landscape settings will result in exposure via the dermal and
inhalation routes. Any such exposures are expected to be minimal, since
the concentration of killed, nonviable Streptomyces acidiscabies strain
RL-110\T\ is diluted prior to application and the active ingredient is
not expected to persist (see the food and drinking water exposure
sections in this unit).
In the unlikely event that the proposed uses of the pesticide
result in residential, non-occupational exposure, no adverse effects
would be expected, based on the lack of toxicity, irritation and
sensitization demonstrated in available data (see additional discussion
in Unit III.).
V. Cumulative Effects From Substances With a Common Mechanism of
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a
tolerance exemption, EPA 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 killed, nonviable Streptomyces acidiscabies
strain RL-110\T\ to share a common mechanism of toxicity with any other
substances, and killed, nonviable Streptomyces acidiscabies strain RL-
110\T\ does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, EPA has assumed
that killed, nonviable Streptomyces acidiscabies strain RL-110\T\ does
not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine chemicals that have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that, in considering the
establishment of a tolerance or tolerance exemption for a pesticide
chemical residue, 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 (10X) 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 on toxicity and exposure unless EPA
determines that a different margin of safety will be safe for infants
and children. This additional margin of safety is commonly referred to
as the Food Quality Protection Act (FQPA) Safety Factor. In applying
this provision, EPA either retains the default value of 10X or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
Based on the acute toxicity and pathogenicity data discussed in
Unit III.B., EPA concludes that there are no threshold effects of
concern to infants, children or adults when killed, nonviable
Streptomyces acidiscabies strain RL-110\T\ is used as labeled in
accordance with good agricultural practices. As a result, EPA concludes
that no additional margin of exposure (safety) is necessary.
Moreover, based on the same data and EPA analyses as presented in
this unit, the Agency is able to conclude 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
killed, nonviable Streptomyces acidiscabies strain RL-110\T\ when it is
used as labeled and in accordance with good agricultural practices as a
pre- or post-emergent herbicide. Such exposure includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. EPA has arrived at this conclusion because, considered
collectively, the data and information available on killed, nonviable
Streptomyces acidiscabies strain RL-110\T\ do not demonstrate toxic
potential to mammals, including infants and children.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes for
the reasons stated in this document and because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
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. In this
context, 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 killed, nonviable
Streptomyces acidiscabies strain RL-110\T\.
C. Revisions to Requested Tolerance Exemption
In the Federal Register of March 10, 2010, EPA announced Marrone
Bio Innovations, Inc.'s filing of a pesticide petition that proposed
establishing an exemption from the requirement of a tolerance for
residues of Streptomyces acidiscabies strain RL-110\T\ in or on all
agricultural commodities. Two modifications have been made to the
requested tolerance exemption. First, based upon the data and
information available to the Agency, EPA is adding the qualifiers
``killed'' and ``nonviable'' before the microorganism's taxonomic name
and unique identifier. Use of these qualifiers is now consistent with
the representation of this active ingredient in other associated
regulatory documents and should assist in preventing confusion
regarding its nomenclature in the future. Second, EPA is changing ``in
or on all agricultural commodities'' to ``in or on all food
commodities'' to align with the terminology the Agency currently uses
when establishing tolerance exemptions for residues of other like
EPA concludes that there is reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to residues of killed, nonviable Streptomyces
acidiscabies strain RL-110\T\. Therefore, an exemption from the
requirement of a tolerance is established for residues of killed,
nonviable Streptomyces acidiscabies strain RL-110\T\ in or on all food
commodities when applied as a pre- or post-emergent herbicide and used
in accordance with good agricultural practices.
1. U.S. EPA. 2012. Biopesticides Registration Action Document
Killed, Nonviable Streptomyces acidiscabies strain RL-110\T\ Revised
April 22, 2012 (available as ``Supporting & Related Material''
within docket ID number EPA-HQ-OPP-2010-0079-0019 at http://www.regulations.gov).
2. Murray PR, EJ Baron, JH Jorgensen, ML Landry, MA Pfaller,
editors. 2007. Manual of Clinical Biology. Vol.1. 9th Ed. Washington
(DC): ASM Press.
3. Doumbou CL, Akimov V, Beaulieu C. 1998. Selection and
characterization of microorganisms utilizing thaxtomin A, a
phytotoxin produced by Streptomyces scabies. Applied and
Environmental Microbiology 64:4313-4316.
4. Centers for Disease Control and Prevention. 2009. Drinking
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.
5. Faucher E, Savard T, Beaulieu C. 1992. Characterization of
actinomycetes isolated from common scab lesions on potato-tubers.
Canadian Journal of Plant Pathology 14:197-202.
6. Loria R, Kers J, Joshi M. 2006. Evolution of plant pathology
in Streptomyces. Annual Review of Phytopathology 44:469-487.
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 EPA. 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 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. As a result, this
action does not 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, EPA 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, EPA 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 EPA 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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: April 25, 2012.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1314 is added to subpart D to read as follows:
Sec. 180.1314 Killed, nonviable Streptomyces acidiscabies strain RL-
110\T\; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of killed, nonviable Streptomyces acidiscabies strain RL-
110\T\ in or on all food commodities when applied as a pre- or post-
emergent herbicide and used in accordance with good agricultural
[FR Doc. 2012-14243 Filed 6-12-12; 8:45 am]
BILLING CODE 6560-50-P