Document ID: EPA-HQ-OPP-2010-0078-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirements of Tolerances: Killed, Nonviable Streptomyces acidiscabies Strain RL-110T
Posted Date: 2012-06-13T04:00Z

[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Rules and Regulations]
[Pages 35291-35295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14243]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0078; FRL-9348-7]

Killed, Nonviable Streptomyces acidiscabies Strain RL-110\T\; 
Exemption From the Requirement of a Tolerance

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 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 
address: sibold.ann@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at 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)

[[Page 35292]]

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) 
(FRL-4577-9).
    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), 
respectively.
    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 
substance

[[Page 35293]]

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 
IV).
    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 
Category IV).
    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 
application.
    ii. Pre-plant applications will occur 1-45 days or more before 
planting.
    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 
submitted studies.
    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 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a

[[Page 35294]]

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 
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. 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 
active ingredients.

VIII. Conclusions

    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.

IX. References

    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.

[[Page 35295]]

    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 
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 25, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.1314 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 
practices.

[FR Doc. 2012-14243 Filed 6-12-12; 8:45 am]
BILLING CODE 6560-50-P