[Federal Register Volume 75, Number 125 (Wednesday, June 30, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15465]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Pasteuria usgae; 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 the microbial pesticide, Pasteuria
usgae, in or on all food commodities when applied preharvest and used
as a nematicide in accordance with good agricultural practices.
MacIntosh and Associates Incorporated (on behalf of Pasteuria
Bioscience Incorporated) 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 Pasteuria usgae.
DATES: This regulation is effective June 30, 2010. Objections and
requests for hearings must be received on or before August 30, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0179. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8920; e-mail address: firstname.lastname@example.org.
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://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://www.epa.gov/oppts 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-2009-0179 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 30, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0179, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 8, 2009 (74 FR 15969) (FRL-8407-
6), 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 9F7539) by MacIntosh and Associates Incorporated, 1203
Hartford Avenue, Saint Paul, MN 55116-1622 (on behalf of Pasteuria
Bioscience Incorporated, 12085 Research Drive, Suite 185, Alachua, FL
32615). The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Pasteuria usgae. This notice referenced a summary of the
petition prepared by the petitioner, MacIntosh and Associates
Incorporated (on behalf of Pasteuria Bioscience Incorporated), which is
available in the docket, http://www.regulations.gov. There were no
substantive comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Pursuant to section 408(c)(2)(B) of
FFDCA, in establishing or maintaining in effect an exemption from the
requirement of a tolerance, EPA must take into account the factors set
forth in section 408(b)(2)(C) of FFDCA, which require EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .'' Additionally, section 408(b)(2)(D) of FFDCA requires
that the Agency consider ``available information concerning the
cumulative effects of [a particular pesticide's] residues and other
substances that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Pasteuria, a genus of bacteria, includes a number of species that
have shown potential in controlling plant-parasitic nematodes. These
bacteria are obligate endoparasites, organisms that grow internally in
a limited range of hosts. Pasteuria usgae, a recently discovered strain
isolated from soil samples collected in Florida, is host-specific for
the sting nematode [Belonolaimus longicaudatus]. This strain of
Pasteuria is pending recognition by the Judicial Commission of the
International Committee for Systematic Bacteriology. There is
sufficient evidence from morphology, host specificity, and genomics to
justify Pasteuria usgae as a distinct strain. In developing products
for crop applications, such as uses on strawberries and a wide variety
of vegetables, the difficulty of growing Pasteuria outside of a
nematode host has always been an obstacle. This host specificity is at
the core of EPA's conclusions that Pasteuria usgae may be granted a
permanent exemption from the requirement of a tolerance for all food
commodities. Additional information regarding Pasteuria usgae can be
found in the Biopesticides Registration Action Document (BRAD) on the
Biopesticides and Pollution Prevention Division (BPPD) website: http://www.epa.gov/pesticides/biopesticides.
Studies submitted to the Agency were issued Master Record
Identification (MRID) Numbers and reviewed by BPPD scientists. The
following summaries of the toxicological profile of Pasteuria usgae are
based on an Agency risk assessment memorandum and related data
evaluation records dated April 9, 2009.
a. Acute Oral Toxicity and Pathogenicity - Rat: Harmonized Test
Guideline 885.3050; MRID No. 474267-09. Pasteuria usgae does not appear
to be toxic and/or pathogenic in rats when dosed at 1 x 108
spores/animal. There were no treatment-related clinical signs or
necropsy findings in rats receiving a single oral dose of 1 x
108 Pasteuria usgae spores. Three males in the microbial
pest control agent (MPCA) - treated group gained weight through day 14
but lost weight by day 21. All other animals gained weight prior to
scheduled sacrifice. Microbial enumeration was not performed because
the testing laboratory showed that the test material would not grow on
agar media. Therefore, while no significant adverse effects were seen,
the typical clearance of the microbe could not be confirmed. However,
because the spores are highly specific to sting nematode, infectivity
is unlikely to be a concern. This study was rated ``Acceptable,'' and
Pasteuria usgae was classified as Toxicity Category IV.
b. Acute Injection Toxicity and Pathogenicity - Rat: Harmonized
Test Guideline 885.3200; MRID No. 474267-11. There were no treatment-
related significant adverse effects seen in the rats receiving a single
intravenous dose of 108 Pasteuria usgae spores. One treated
female lost weight by day 7 but gained weight prior to sacrifice on day
14. All other animals gained weight throughout the study. All animals
survived and appeared normal during the study. No abnormalities were
observed in any animal at necropsy or in harvested organs. No
significant variations in organ weight were found between different
groups or sexes. The acute intravenous median lethal dose
(LD50) of Pasteuria usgae was greater than 1 x
108 spores/animal in male and female rats. Pasteuria usgae
does not appear to be toxic and/or pathogenic in rats when dosed at
108 spores/animal. MRID No. 474267-09 reported that
microbial enumeration was not done because the test material would not
grow on agar media. Since microbial enumeration was not performed, the
infectivity was uncertain. However, because the spores are highly
specific to sting nematode, infectivity is unlikely to be a concern.
Pasteuria usgae was not pathogenic as tested in this study. This study
was rated as ``Acceptable.''
c. Acute Dermal Toxicity - Rat: Harmonized Test Guideline 885.3100;
MRID No. 474267-12. Based on the results of this study, Pasteuria usgae
does not appear to be toxic in rats when treated with 2,000 milligrams/
kilogram (mg/kg) at 108 spores/milliliter (mL). Thus, the
acute dermal LD50 was greater than 2,000 mg/kg for
108 spores/mL in male and female rats. There were no
treatment-related significant adverse effects seen in the dosed rats.
Two males and one female had very slight erythema on day 1 with
clearance by day 4. One male lost weight slightly during the second
week and one male and two females lost weight during the first week,
but all gained weight by the end of the study. All other animals gained
weight throughout the study. This study was rated ``Acceptable,'' and
Pasteuria usgae was classified as Toxicity Category IV.
d. Acute Pulmonary Toxicity and Pathogenicity - Rat: Harmonized
Test Guideline 885.3150; MRID No. 474267-10. In an acute pulmonary
toxicity and pathogenicity assessment, there were no test substance-
related significant adverse effects seen in rats receiving a single
dose of approximately 1-3 x 108 spores of Pasteuria usgae.
One dosed female exhibited pale lungs. Additionally, one untreated
control female lost weight by day 21, and another untreated control
female lost weight by day 14 but gained weight by day 21. One MPCA-
treated male did not gain weight by day 7 but gained weight thereafter.
All other animals gained weight throughout the study. Based on these
results, Pasteuria usgae does not appear to be toxic and/or pathogenic
in rats when dosed at approximately 1-3 x 108 spores/animal.
Microbial enumeration was not performed because the testing laboratory
showed that the
test material would not grow on agar media. Therefore, while no
significant adverse effects were seen, the typical clearance of the
microbe could not be confirmed. However, because the spores are highly
specific to sting nematode, infectivity is unlikely to be a concern.
This study was rated ``Acceptable,'' and Pasteuria usgae was classified
as Toxicity Category IV.
e. Hypersensitivity Incidents: Harmonized Test Guideline 885.3400;
MRID No. 474350-02. No hypersensitivity incidents--involving Pasteuria
usgae and occurring during fermentation, processing, formulation, or
research--have been reported to the Agency. Any future hypersensitivity
incidents must be reported per Harmonized Test Guideline 885.3400.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
Dietary exposure to Pasteuria usgae may occur, mainly through food.
However, the lack of acute oral toxicity/pathogenicity, based on the
toxicology test on rats presented in Unit III., along with the
inability of the bacterium to grow outside of a specific nematode host,
support the establishment of a permanent exemption from the requirement
of a tolerance for Pasteuria usgae. There is presently a temporary
exemption from the requirement of a tolerance established for residues
of Pasteuria usgae under 40 CFR 180.1290, which will expire and be
revoked on December 31, 2010. Pasteuria usgae is exempt from the
requirement of a tolerance when applied/used as a nematicide on
strawberries in accordance with the terms of Experimental Use Permit
85004-EUP-1 August 5, 2009, (74 FR 38970) (FRL-8429-1). Additionally,
under 40 CFR 180.1135, a similar active ingredient, Pasteuria
penetrans, was assessed previously and granted a permanent exemption
from the requirement of a tolerance in or on all raw agricultural
commodities, except roots and tubers, when used as a nematicide in the
production of fruits and vegetables in greenhouses December 28, 1994,
(59 FR 66740) (FRL[dash]4924-4).
1. Food. Dietary exposure to the naturally occurring soil
bacterium, Pasteuria usgae, although a possibility, is anticipated to
be negligible. For optimal control of sting nematode, Pasteuria usgae
is applied in a manner that facilitates movement of spores into the
root zone of the affected crop. This requires that end users take two
particular actions that would inevitably minimize the amount of
Pasteuria usgae residues on aboveground food commodities-soil-directed
applications and irrigation with a specified amount of water following
any such applications. For food commodities that develop underground,
exposure to Pasteuria usgae residues is a more likely scenario,
although standard post-harvest practices of washing, cooking, or
processing would reduce such residues. In general, any actual dietary
exposure is expected to be several orders of magnitude lower than the
dose used in the acute oral toxicity/pathogenicity test referenced in
Unit III., during which no toxic or pathogenic effects were observed in
rats. Moreover, Pasteuria usgae is an obligate endoparasitic bacterium
specific to the sting nematode. The Agency concludes that there is a
reasonable certainty that no harm will result from the aggregate
exposure to the residues of Pasteuria usgae in food.
2. Drinking water exposure. Exposure of humans to residues of
Pasteuria usgae in consumed drinking water is unlikely. The currently
approved and proposed use patterns, use sites, and application methods
for Pasteuria usgae do not include direct application to aquatic
environments. Furthermore, given that Pasteuria usgae spores attach
specifically to the sting nematode, which is a plant-parasitic nematode
that thrives only in sandy soil environments and is dependent upon
plant roots to sustain life, future proposals to add aquatic use sites
to pesticide products containing this bacterium are not expected. Even
if oral exposure should occur through consumed drinking water, the
Agency concludes that there is a reasonable certainty that no harm will
result from the exposure to the residues of Pasteuria usgae in all the
anticipated drinking water exposures because of the lack of acute oral
toxicity/pathogenicity to mammals and the host-specific nature of the
bacterium, as stated previously.
B. Other Non-Occupational Exposure
Non-occupational exposure is considered unlikely for Pasteuria
usgae as all currently approved or proposed uses occur in distinctly
agricultural or commercial settings, and there are no currently
approved or proposed uses for residential areas.
The only other non-occupational exposure is that which would
normally be encountered as part of the natural environment (i.e., not
as a result of pesticide use). As expected since Pasteuria usgae is an
obligate endoparasite of the sting nematode, there have been no reports
of adverse effects from human exposure to this bacterium that naturally
occurs in sandy soils, particularly those of the southeastern and
midwestern United States.
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, the Agency
consider ``available information concerning the cumulative effects of
[a particular pesticide's] residues and other substances that have a
common mechanism of toxicity.''
EPA has not found Pasteuria usgae to share a common mechanism of
toxicity with any other substances, and Pasteuria usgae does not appear
to produce a toxic metabolite as its mode of action against the target
pest. For the purposes of this tolerance action, therefore, EPA has
assumed that Pasteuria usgae does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
VI. Determination of Safety for U.S. Population, Infants, and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (MOE) (safety), which are often
referred to as uncertainty factors (UFs), are incorporated into EPA
either directly or through the use of a MOE analysis, or by using UF
(safety) in calculating a dose level that poses no appreciable risk.
Based on the acute toxicity and pathogenicity data discussed in
Unit III., EPA concludes that there is a reasonable certainty that no
harm will result to the United States population, including infants and
children, from aggregate exposure to the residues of Pasteuria usgae.
This includes all anticipated dietary exposures and all other exposures
for which there is reliable information. The Agency has arrived at this
conclusion because the data available on Pasteuria usgae do not
demonstrate toxic, pathogenic, or infective potential to mammals. Thus,
there are no threshold effects of concern and, as a result, the
provision requiring an additional margin of safety does not apply.
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, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for Pasteuria usgae.
Therefore, an exemption is established for residues of Pasteuria
usgae in or on all food commodities when applied preharvest and used as
a nematicide in accordance with good agricultural practices.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000), do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
X. 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: June 11, 2010.
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. In subpart D, revise Sec. 180.1290 to read as follows:
Sec. 180.1290 Pasteuria usgae; exemption from the requirement of a
An exemption from the requirement of a tolerance is established for
residues of Pasteuria usgae in or on all food commodities when applied
preharvest and used as a nematicide in accordance with good
[FR Doc. 2010-15465 Filed 6-29-10; 8:45 am]
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