[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73934-73937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29903]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0669; FRL-9369-3]
Bacillus subtilis Strain QST 713 Variant Soil; Amendment to an
Exemption From the Requirement of a Tolerance for Bacillus subtilis
Strain QST 713 To Include Residues of Bacillus subtilis Strain QST 713
Variant Soil
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the existing exemption from the
requirement of a tolerance for residues of the Bacillus subtilis strain
QST 713 in or on all food commodities by including residues of Bacillus
subtilis strain QST 713 variant soil. Agraquest, Inc. submitted a
petition to the EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an amendment to an existing exemption from the
requirement of a tolerance for Bacillus subtilis strain QST 713 to
include residues of products containing Bacillus subtilis strain QST
713 variant soil in or on all agricultural commodities. This regulation
eliminates the need to establish a maximum permissible level for
residues of Bacillus subtilis strain QST 713 variant soil under the
FFDCA.
DATES: This regulation is effective December 12, 2012. Objections and
requests for hearings must be received on or before February 11, 2013,
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-2011-0669, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., 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.
FOR FURTHER INFORMATION CONTACT: Michael Glikes, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 305-6231; email
address: glikes.michael@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 OCSPP 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, 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 the EPA, you must
identify docket ID number EPA-HQ-OPP-2011-0669 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 February 11, 2013. 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 (excluding any CBI) for inclusion in the public docket.
Information not marked confidential pursuant to 40 CFR part 2 may be
disclosed publicly by the EPA without prior notice. Submit the non-CBI
copy of your objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0669, 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), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please
[[Page 73935]]
follow the instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of September 7, 2011 (76 FR 55329) (FRL-
8886-7), the EPA issued a notice pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 1F7896) by Agraquest, Inc., 1540 Drew Ave., Davis, CA
95618. The petition requested that 40 CFR part 180.1209 be amended by
including residues of Bacillus subtilis strain QST 713 variant soil.
This notice referenced a summary of the petition prepared by the
petitioner, Agraquest, Inc., which is available in the docket, 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 the 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 the 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 FFDCA section
408(c)(2)(B), in establishing or maintaining in effect an exemption
from the requirement of a tolerance, EPA must take into account the
factors set forth in FFDCA section 408(b)(2)(C), which require EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue * * *.'' Additionally, FFDCA section 408(b)(2)(D) requires that
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.''
The EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, the EPA determines the
toxicity of pesticides. Second, the 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 FFDCA section 408(b)(2)(D), the 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.
The EPA has also considered available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children.
Bacillus subtilis is a rod-shaped, gram-positive, aerobic flagellar
bacterium that is ubiquitous in nature and has been recovered from
water, soil, air, and decomposing plant residues (Ref 1.). The
bacterium produces an endospore that allows it to endure extreme
conditions of heat and desiccation in the environment (Ref. 1).
Bacillus subtilis is not considered toxic or pathogenic to humans,
animals, or plants (Ref. 2). Several strains of Bacillus subtilis are
used predominantly as fungicidal active ingredients in various
pesticides registered with the EPA.
In 2000, the EPA first registered Bacillus subtilis strain QST 713
as a pesticide active ingredient. EPA described the nature and
toxicological profile of Bacillus subtilis strain QST 713 in the
Federal Register of July 5, 2000 (65 FR 41365) (FRL-6555-3) as the
basis for establishing the tolerance exemption for Bacillus subtilis
strain QST 713 in or on all food commodities at 40 CFR 180.1209. A
battery of tests, as described in that Federal Register citation,
determined that Bacillus subtilis strain QST 713 is not pathogenic and
has no significant toxicity. The petitioner is now requesting that this
tolerance be amended to include residues of Bacillus subtilis strain
QST 713 variant soil. Bacillus subtilis strain QST 713 variant soil is
a naturally occurring variant of Bacillus subtilis strain QST 713 and
is present in products containing the active ingredient Bacillus
subtilis strain QST 713, although at low levels (Ref. 3). The variant
strain is distinguished from the parent strain by the presence of the
swrA gene, which is an essential gene for Bacillus to move over solid
substances, and by a phenotype associated with enhanced biofilm
formation, growth promotion and disease protection (Ref. 3). Based on
its review of the variant and studies submitted by the petitioner, EPA
concludes that the variant and the parent strain are substantially
similar for the purposes of assessing toxicity, pathogenicity and
infectivity (Ref. 3).
The applicant, Agraquest, Inc., cited or submitted adequate
mammalian toxicology data and information to support the exemption from
the requirement of a tolerance for residues of Bacillus subtilis strain
QST 713 variant soil in or on all raw agricultural commodities. These
data are cited and described in the EPA's March 2012 Bacillus subtilis
Final Registration Review Decision (Ref. 1). In addition, Agraquest
submitted an acute injection toxicity/pathogenicity study (OCSPP
Guideline 885.3200; MRID 48530909) that showed that Bacillus subtilis
strain QST 713 variant soil TGAI was not toxic, infective, or
pathogenic to rats when injected intravenously at a dose of 6.6 x 10\8\
colony forming units.
The applicant reported that no hypersensitivity incidents occurred
during research, development, or testing of Bacillus subtilis strain
QST 713 variant soil. Acceptable Tier I mammalian toxicology data and
information support registration of the proposed end-use product,
Serenade Soil DPZ. In light of the results of the acute toxicity/
pathogenicity data and the absence of hypersensitivity incidents, the
EPA did not require testing at higher tiers (i.e., Tiers II and III).
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 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. Due to the ubiquitous nature of the Bacillus
subtilis and the concentrations of Bacillus subtilis and other closely
related Bacillus species that already exist in the environment, the EPA
expects human exposure to Bacillus subtilis strain QST 713 variant soil
resulting from the proposed pesticidal uses will be no greater than
existing human exposure to background levels of Bacillus subtilis. The
EPA in its registration review decision (Ref. 1) concluded ``the risk
posed to adults, infants, and children is likely to be minimal because
of the low acute oral toxicity/pathogenicity
[[Page 73936]]
potential of Bacillus subtilis strain QST 713.'' Based on the EPA's
evaluation of the Bacillus subtilis strain QST 713 data and the EPA's
conclusion that Bacillus subtilis strain QST 713 and Bacillus subtilis
strain QST 713 variant soil are substantially similar for the purposes
of assessing toxicity, pathogenicity, and infectivity (Ref. 3), no
adverse effects from dietary exposure to Bacillus subtilis strain QST
713 variant soil from its pesticidal uses are expected (see Unit III.).
2. Drinking water exposure. Because Bacillus subtilis is ubiquitous
in the environment, exposure to the microbe through drinking water may
already be occurring and likely will continue (Ref. 3). EPA expects
exposures to Bacillus subtilis strain QST 713 variant soil to be not
much greater than background levels because the proposed use patterns
are soil directed and/or soil incorporated, thereby limiting contact
with surface water by drift and runoff. Furthermore, ground water is
not expected to have significant exposure to Bacillus subtilis strain
QST 713 variant soil since, like other microorganisms, this microbial
pesticide would likely be filtered out by the particulate nature of
many soil types. If residues of Bacillus subtilis strain QST 713
variant soil were to be transferred to surface or ground waters that
are intended for eventual human consumption (e.g., through spray drift
or runoff) and directed to wastewater treatment systems or drinking
water facilities, Bacillus subtilis strain QST 713 variant soil likely
would not survive the conditions water is subjected to in such systems
or facilities, including chlorination, pH adjustments, filtration, and/
or occasional high temperatures. As discussed in the EPA's Bacillus
subtilis Case 6012, Final Registration Review Decision (Ref. 1), intake
of low levels of ubiquitous Bacillus subtilis in drinking water may
occur, but exposure would represent a minimal risk due to the low
toxicity of the strain. Similarly, exposure to other strains of
Bacillus subtilis would not represent a greater risk. It is reasonable
to conclude, based on the similarity in product composition and
production, measured physical/chemical, and pathogenicity/infectivity
toxicity data, that the risk from any potential exposure to Bacillus
subtilis strain QST 713 variant soil resulting from the proposed
pesticidal use would be minimal and equivalent to the risk from
exposure to Bacillus subtilis strain QST 713.
B. Other Non-occupational Exposures
The use sites proposed for products containing Bacillus subtilis
strain QST 713 variant soil include both agricultural and residential
garden sites, so the EPA expects there to be some non-occupational
exposure as a result of the application of this pesticide. Given
Bacillus subtilis strain QST 713 variant soil's natural occurrence in
soil, the EPA determined that non-occupational exposure to the
bacterium likely is already occurring (Ref. 3). Additional exposure to
the microorganism, due to pesticidal applications, is likely to occur
but is not expected to exceed EPA's level of concern, particularly in
light of available data that demonstrate Bacillus subtilis strain QST
713 is not toxic (acute dermal toxicity and acute pulmonary toxicity/
pathogenicity), non-irritating (primary dermal irritation), and not
pathogenic (acute pulmonary toxicity/pathogenicity) and the EPA's
conclusion that Bacillus subtilis strain QST 713 and Bacillus subtilis
strain QST 713 variant soil are substantially similar for the purposes
of assessing toxicity, pathogenicity, and infectivity (Ref. 3). Based
on the toxicity information submitted to the EPA, aggregate exposure to
Bacillus subtilis strain QST 713 variant soil would be below the levels
in the safety testing conducted on Bacillus subtilis strain QST 713 and
would not represent an undue risk due to the lack of residues of
toxicological concern and the low toxicity of the active ingredient.
The EPA concluded that non-dietary exposures to the general population,
including infants and children, would not be expected to pose any
quantifiable risk due to a lack of residues of toxicological concern.
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.''
Bacillus subtilis strain QST 713 variant soil does not operate via
a toxic mode of action and thus does not share a common mechanism of
toxicity with any other substances. Therefore, section 408(b)(2)(D)(v)
does not apply.
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 exposure (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 exposure (safety) will
be safe for infants and children. This additional margin of exposure
(safety) is commonly referred to as the Food Quality Protection Act
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 information discussed in Unit III.B., EPA concludes
that there are no threshold effects of concern to infants, children, or
adults when Bacillus subtilis strain QST 713 variant soil is used as
labeled in accordance with good agricultural practices. As a result,
EPA concludes that no additional margin of exposure (safety) is
necessary to protect infants and children and that not adding any
additional margin of exposure (safety) will be safe for infants and
children.
Moreover, based on the same data and EPA analysis as presented
directly above, 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 Bacillus subtilis strain QST 713 variant soil when it is used as
labeled and in accordance with good agricultural practices. Such
exposure includes all anticipated dietary exposures and all other
exposures for which there is reliable information. As discussed
previously, there appears to be no potential for harm from this
bacterium in its use as an antifungal agent via dietary exposure since
the microorganism is non-toxic, non-pathogenic, and not infective. This
conclusion is supported by the data on the substantially similar strain
Bacillus subtilis strain QST 713, public literature and EPA's Bacillus
subtilis Case 6012, Final Registration Review Decision (Ref. 1). EPA
concludes that there is a reasonable certainty of no harm to infants
and children from aggregate exposure to Bacillus subtilis strain QST
713 variant soil.
[[Page 73937]]
VII. 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, the EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. The 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 United Nations
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. The 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 Bacillus subtilis strain
QST 713 variant soil.
VIII. Conclusions
The EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of Bacillus subtilis strain QST 713
variant soil. Therefore, the EPA is amending the tolerance exemption
for Bacillus subtilis strain QST 713 to include residues of Bacillus
subtilis strain QST 713 variant soil in or on all food commodities when
used in accordance with good agricultural practices.
IX. References
1. U.S. EPA. 2010. Bacillus subtilis Final Registration Review
Decision. Case 6012. March 2010.
2. U.S. EPA. 1997. Bacillus subtilis Final Risk Assessment.
3. U.S. EPA. July 11, 2012. Memorandum from Dr. Ibrahim S. Barsoum
and Dr. John L. Kough to Michael Glikes: Review of Product Chemistry
and Acute Toxicity Studies for Section 3 Registration of a new TGAI,
Bacillus subtilis strain QST variant soil, and a new EP, Serenade soil
DPZ (EPA Reg. No. 69592-EI).
X. Statutory and Executive Order Reviews
This final rule amends an exiting tolerance under FFDCA section
408(d) in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption from
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 FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the 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
the rule in the Federal Register. This action 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: November 26, 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. Revise Sec. 180.1209 to read as follows:
Sec. 180.1209 Bacillus subtilisstrain QST 713 and strain QST 713
variant soil; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the microbial pesticides Bacillus subtilis strain QST 713
and strain QST 713 variant soil when used in or on all food
commodities.
[FR Doc. 2012-29903 Filed 12-11-12; 8:45 am]
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