[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Rules and Regulations]
[Pages 8736-8741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3586]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0807; FRL-9337-2]


Pasteuria nishizawae--Pn1; 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 Pasteuria nishizawae--Pn1 in or on all 
food commodities when applied as a nematicide and used in accordance 
with good agricultural practices. Pasteuria Bioscience, 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 Pasteuria nishizawae--Pn1 under the FFDCA.

DATES: This regulation is effective February 15, 2012. Objections and 
requests for hearings must be received on or before April 16, 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).

[[Page 8737]]


ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0807. 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), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; email 
address: <a href="/cdn-cgi/l/email-protection#cca7adb9bfafa4e2a6a9ada2a2a5a2a98ca9bcade2aba3ba"><span class="__cf_email__" data-cfemail="c6ada7b3b5a5aee8aca3a7a8a8afa8a386a3b6a7e8a1a9b0">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2010-0807 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 
April 16, 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-2010-0807, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001.
    <bullet> 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 February 4, 2011 (76 FR 6465) (FRL-8858-
7), 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 0F7749) by Pasteuria Bioscience, Inc., 12085 Research Dr., 
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 nishizawae--Pn1. This notice 
referenced a summary of the petition prepared by the petitioner, 
Pasteuria Bioscience, Inc., which is available in the docket via http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit VII.C.
    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

[[Page 8738]]

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.

A. Overview of Pasteuria nishizawae--Pn1

    Pasteuria, a genus of bacteria, includes several species that have 
shown potential in controlling plant-parasitic nematodes that attack 
and cause significant damage to many agricultural crops (see, e.g., the 
Federal Register of December 28, 1994 (59 FR 66740) (FRL-4923-4) and 
June 30, 2010 (75 FR 37734) (FRL-8831-9) for final rules that 
established tolerance exemptions for residues of the nematicides, 
Pasteuria penetrans (40 CFR 180.1135) and Pasteuria usgae (40 CFR 
180.1290), respectively). These gram-positive, mycelial, endospore-
forming bacteria are mostly obligate parasites (i.e., organisms that 
depend on particular hosts to complete their own life cycle) of plant-
parasitic nematodes, although one Pasteuria species--Pasteuria ramosa--
is known to parasitize Daphnia species, which are tiny crustaceans 
often called ``water fleas'' due to their flea-like size and appearance 
(Refs. 1 and 2). Pasteuria species are ubiquitous in most environments 
and are found in nematodes in at least 80 countries on 5 continents, as 
well as on islands in the Atlantic, Pacific, and Indian Oceans (Ref. 
2). Higher population densities often occur in areas where there is an 
ample supply of nematode hosts (e.g., where crops susceptible to 
nematodes are cultivated) (Refs. 3, 4, and 5). Pasteuria nishizawae--
Pn1 was specifically isolated from an Illinois soybean field in the 
mid-2000s (Ref. 1).
    Although endospores of Pasteuria nishizawae have been observed to 
attach to the cuticle of 3 nematodes of the genus Heterodera and 1 
nematode of the genus Globodera, it is known only to infect and 
complete its life cycle within the female soybean cyst nematode 
(Heterodera glycines) (Ref. 2). In the following manner, Pasteuria 
nishizawae--Pn1 exerts a pesticidal effect on the soybean cyst nematode 
through parasitism that ultimately results in the death of infected 
females:
    1. Endospores attach to the cuticle of a juvenile soybean cyst 
nematode female.
    2. Once a soybean cyst nematode female invades soybean roots, 
Pasteuria nishizawae--Pn1 produces a germ tube that penetrates the body 
of the nematode.
    3. Primary and secondary microcolonies of Pasteuria nishizawae--Pn1 
develop and proliferate within the body of the nematode, causing its 
death (Ref. 2).
    In light of the demonstrated nematicidal capabilities and host 
specificity of Pasteuria nishizawae--Pn1, Pasteuria Bioscience, Inc. 
has proposed to register pesticide products that could be applied to 
soybean or its seed to control the soybean cyst nematode.

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 Pasteuria nishizawae--Pn1 in or on all food commodities 
have been fulfilled with data submitted by the petitioner. The results 
of the acute dermal toxicity and primary dermal irritation tests 
revealed no toxicity or irritation attributed to Pasteuria nishizawae--
Pn1, and these studies received a Toxicity Category IV classification 
(see 40 CFR 156.62). Moreover, acute oral, pulmonary, and injection 
toxicity/pathogenicity tests indicated that Pasteuria nishizawae--Pn1 
was not toxic and/or pathogenic via the tested routes of exposure. 
Although infectivity and clearance were not evaluated in any of the 
acute toxicity/pathogenicity tests, EPA believes that these endpoints 
are not a concern given the host specificity of Pasteuria nishizawae 
for the soybean cyst nematode (Refs. 1 and 2). Finally, the petitioner 
has reported that no hypersensitivity incidents occurred during 
development and testing of this bacterium. 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 provided as a reference in Unit IX. (Ref. 6).
    1. Acute oral toxicity/pathogenicity--rat (Harmonized Guideline 
885.3050; Master Record Identification Number (MRID No.) 481517-09). A 
supplemental acute oral toxicity/pathogenicity study demonstrated that 
Pasteuria nishizawae--Pn1 was not toxic and/or pathogenic to laboratory 
rats when administered by oral gavage in a single dose of 1.6 x 
10<SUP>9</SUP> spores per animal. Although clearance and infectivity 
were not measured, EPA believes these endpoints are not a concern given 
Pasteuria nishizawae--Pn1's well-established host specificity for the 
soybean cyst nematode (Refs. 1 and 2).
    2. Acute pulmonary toxicity/pathogenicity--rat (Harmonized 
Guideline 885.3150; MRID No. 481517-10). A supplemental acute pulmonary 
toxicity/pathogenicity study demonstrated that Pasteuria nishizawae--
Pn1 was not toxic and/or pathogenic to laboratory rats when 
administered by intratracheal instillation in a single dose of 1.6 x 
10<SUP>8</SUP> spores per animal. Although clearance and infectivity 
were not measured, EPA believes these endpoints are not a concern given 
Pasteuria nishizawae--Pn1's well-established host specificity for the 
soybean cyst nematode (Refs. 1 and 2).
    3. Acute injection toxicity/pathogenicity (intravenous)--rat 
(Harmonized Guideline 885.3200; MRID No. 481517-11). A supplemental 
acute injection toxicity/pathogenicity study demonstrated that 
Pasteuria nishizawae--Pn1 was not toxic and/or pathogenic to laboratory 
rats when administered intravenously in a single dose of 1.0 x 
10<SUP>9</SUP> spores per animal. Although clearance and infectivity 
were not measured, EPA believes these endpoints are not a concern given 
Pasteuria nishizawae--Pn1's well-established host specificity for the 
soybean cyst nematode (Refs. 1 and 2).
    4. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID 
No. 481517-12). The petitioner reported that no hypersensitivity 
incidents, including immediate-type or delayed-type reactions of humans 
and domestic animals, occurred during research, development, or testing 
of Pasteuria nishizawae--Pn1.
    5. Acute dermal toxicity--rabbit (Harmonized Guideline 870.1200; 
MRID No. 481517-14). An acceptable acute dermal toxicity study 
demonstrated that a test substance containing Pasteuria nishizawae--Pn1 
was not toxic to rabbits when dosed at 2,000 milligrams per kilogram 
(mg/kg) for 24 hours. The dermal median lethal dose, which is a 
statistically derived single dose that can be expected to cause death 
in 50% of test animals, was greater than 2,000 mg/kg for male and 
female rats combined (Toxicity Category IV).
    6. Primary dermal irritation--rabbit (Harmonized Guideline 
870.2500; MRID No. 481517-16). An acceptable primary dermal irritation 
study demonstrated

[[Page 8739]]

that a test substance containing Pasteuria nishizawae--Pn1 was 
essentially non-irritating to the skin of rabbits (Toxicity Category 
IV).

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. Dietary exposure to Pasteuria nishizawae--Pn1, a 
naturally occurring soil bacterium (Refs. 7, 8, and 9), is anticipated 
to be negligible. For optimal control of the target pest (soybean cyst 
nematode), Pasteuria nishizawae--Pn1 is applied in a manner that 
facilitates spore movement into or spore placement near the root zone 
of potentially affected plants. This requires that end users take 
certain actions, depending on the treatment type, that would inevitably 
minimize the amount of Pasteuria nishizawae--Pn1 residues on above-
ground commodities. That is, although Pasteuria nishizawae--Pn1 can be 
applied to soil, plants, or seeds, some seeds are incorporated into the 
soil immediately after treatment (at-planting, hopper box, planter box, 
or slurry box seed treatments), and pesticide applications made to 
plants or the soil are always followed by irrigation to incorporate 
Pasteuria nishizawae--Pn1 into the soil. In instances where food 
commodities develop underground or where treated seed is diverted for 
food or feed purposes or to process into oil, exposure to Pasteuria 
nishizawae--Pn1 is a more likely scenario. Regardless of the situation, 
should Pasteuria nishizawae--Pn1 be present on food, its specificity 
for the soybean cyst nematode and available data indicate no toxicity, 
pathogenicity, and/or infectivity is likely to occur with any dietary 
exposure that results from pesticide applications made in accordance 
with good agricultural practices (see additional discussion in Unit 
III.).
    2. Drinking water exposure. Exposure to residues of Pasteuria 
nishizawae--Pn1 in consumed drinking water is possible but not likely. 
The proposed use patterns for Pasteuria nishizawae--Pn1 are soil 
directed, soil incorporated, and/or seed directed, thereby limiting 
contact with surface water by drift and runoff. Furthermore, ground 
water is not expected to have significant exposure to Pasteuria 
nishizawae--Pn1 since, like other microorganisms, this microbial 
pesticide would likely be filtered out by the particulate nature of 
many soil types (Refs. 10, 11, and 12). If Pasteuria nishizawae--Pn1 
were to be transferred to surface or ground waters (e.g., through spray 
drift or runoff) that are intended for eventual human consumption and 
directed to wastewater treatment systems or drinking water facilities, 
it may not survive some of the conditions water is subjected to in such 
systems or facilities, including chlorination, pH adjustments, and 
filtration (Refs. 13 and 14). In the remote likelihood that Pasteuria 
nishizawae--Pn1 is present in drinking water (e.g., water not subject 
to certain conditions in treatment systems and facilities), its 
specificity for the soybean cyst nematode and available data indicate 
no toxicity, pathogenicity, and/or infectivity is likely to occur with 
any drinking water exposure that results from pesticide applications 
made in accordance with good agricultural practices (see additional 
discussion in Unit III.).

B. Other Non-Occupational Exposure

    Given Pasteuria nishizawae's natural presence in soil (Refs. 7, 8, 
and 9), non-occupational exposure to the bacterium is likely already 
occurring. Additional exposure to Pasteuria nishizawae--Pn1 due to 
pesticidal applications is not expected because all proposed pesticide 
end-use products are labeled for use in distinct agricultural settings. 
Even if non-occupational exposures were to occur (e.g., eventual 
expansion of use sites), such exposures would not exceed EPA's level of 
concern in light of Pasteuria nishizawae--Pn1's specificity for the 
soybean cyst nematode and test results that indicated Pasteuria 
nishizawae--Pn1 is not toxic (acute dermal toxicity and acute pulmonary 
toxicity/pathogenicity), is essentially non-irritating (primary dermal 
irritation), and is not pathogenic (acute pulmonary toxicity/
pathogenicity) (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 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.''
    No mechanism of toxicity in mammals has been identified for 
Pasteuria nishizawae--Pn1, and Pasteuria nishizawae--Pn1 does not 
appear to produce a toxic metabolite against the target pest. For the 
purposes of this tolerance action, EPA has assumed that Pasteuria 
nishizawae--Pn1 does not have a common mechanism of toxicity with other 
substances. Therefore, section 408(b)(2)(D)(v) of FFDCA does not apply. 
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 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 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., as well as Pasteuria nishizawae--Pn1's host specificity 
for the soybean cyst nematode, EPA concludes that there are no 
threshold effects of concern to infants, children, or adults when 
Pasteuria nishizawae--Pn1 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.

[[Page 8740]]

    Moreover, based on the same data and EPA analysis 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 
Pasteuria nishizawae--Pn1 when it is used as labeled and in accordance 
with good agricultural practices as a nematicide. 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 
Pasteuria nishizawae--Pn1 do not demonstrate toxic, pathogenic, and/or 
infective 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 Pasteuria nishizawae--Pn1.

C. Response to Comments

    Two comments were submitted. An anonymous commenter (EPA-HQ-OPP-
2010-0012-0019) generally expressed opposition to EPA granting 
tolerance exemptions to several petitioners, including Pasteuria 
Bioscience, Inc. Specifically, this commenter mentioned concern with 
the prevalence of many toxic chemicals in the environment and lack of 
information regarding how such chemicals combine. Another commenter 
(EPA-HQ-OPP-2010-0905-0003) also expressed opposition to granting 
tolerances and tolerance exemptions for several chemicals, including 
Pasteuria nishizawae--Pn1, that were described in the Federal Register 
of February 4, 2011. This commenter stated that the food supply must be 
rigorously tested, that studies submitted by the chemical industry must 
be subjected to independent peer review, and that only long-term 
studies can provide data on the health impact of exposure to the 
chemicals in the February 4, 2011 notice of filing.
    Data provided by the petitioner demonstrated that Pasteuria 
nishizawae--Pn1 is not toxic and/or pathogenic at the doses 
administered orally, intratracheally, intravenously, and dermally to 
rats or rabbits (see Unit III.B.). Although infectivity and clearance 
were not evaluated in any of these studies, EPA believes that these 
endpoints are not a concern given Pasteuria nishizawae--Pn1's well-
established host specificity for the soybean cyst nematode (Refs. 1 and 
2). Moreover, since no mechanism of toxicity in mammals has been 
identified for Pasteuria nishizawae--Pn1, and Pasteuria nishizawae--Pn1 
does not appear to produce a toxic metabolite against the target pest, 
EPA has assumed that Pasteuria nishizawae--Pn1 does not have a common 
mechanism of toxicity with other substances. After conducting a 
comprehensive assessment of the data and information submitted by the 
petitioner, EPA has concluded 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 Pasteuria nishizawae--
Pn1. Thus, under the standard in FFDCA section 408(c)(2), a tolerance 
exemption is appropriate.

D. Revisions to Requested Tolerance Exemption

    Two modifications have been made to the requested tolerance 
exemption. First, since Pasteuria Bioscience, Inc. already created a 
unique isolate identifier (i.e., Pn1) for Pasteuria nishizawae, 
inclusion of the American Type Culture Collection accession number 
(i.e., SD-5833) within this microbial pesticide's taxonomic name was 
unnecessary. Use of just Pasteuria nishizawae--Pn1 throughout this 
document, particularly in the tolerance exemption expression, 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 raw agricultural crops'' 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 a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of Pasteuria nishizawae--Pn1. 
Therefore, an exemption from the requirement of a tolerance is 
established for residues of Pasteuria nishizawae--Pn1.

IX. References

1. U.S. EPA. 2011a. Pasteuria nishizawae strain PN1. Memorandum from 
J.V. Gagliardi, Ph.D. and J.L. Kough, Ph.D. to J. Kausch dated 
August 16, 2011.
2. U.S. EPA. 2011b. Environmental Risk Assessment of Pasteuria 
nishizawae Pn1 (PC 016455) for a Section 3 Registration of the 
Technical Product (EPA File Symbol 85004-A) and Two End Use Products 
(EPA File Symbols 85004-T and 85004-O) for Control of the Soybean 
Cyst Nematode in Soybeans. Memorandum from S. Borges and G. 
Tomimatsu, Ph.D. to J. Kausch dated September 15, 2011 (available as 
``Supporting & Related Material'' within docket ID number EPA-HQ-
OPP-2010-0806).
3. Cetintas R, Dickson DW. 2004. Persistence and suppressiveness of 
Pasteuria penetrans to Meloidogyne arenaria Race 1. Journal of 
Nematology 36:540-549.
4. Tain B, Yang J, Zhang K-Q. 2007. Bacteria used in the biological 
control of plant-parasitic nematodes: Populations, mechanisms of 
action, and future prospects. FEMS Microbiology Ecology 61:197-213.
5. Noel GR. 2008. IPM of soybean cyst nematode in the USA. In: 
Integrated Management and Biocontrol of Vegetable and Grain Crops 
Nematodes. Eds. A. Cianio and K.G. Mukerji. Springer. Pages 119-126.
6. U.S. EPA. 2011c. Draft Pasteuria nishizawae--Pn1 Biopesticides 
Registration Action Document dated December 21, 2011 (available as 
``Supporting & Related Material'' within docket ID number EPA-HQ-
OPP-2010-0806).
7. Atibalentja N, Jakstys BP, Noel GR. 2004. Life cycle, 
ultrastructure, and host specificity of the North American isolate 
of Pasteuria that parasitizes the soybean cyst nematode, Heterodera 
glycines. Journal of Nematology 36:171-180.
8. Noel GR, Atibalentja N, Domier LL. 2005. Emended description of 
Pasteuria nishizawae. International Journal of Systematic and 
Evolutionary Microbiology 55:1681-1685.
9. Sayre RM, Wergin WP, Schmidt JM, Starr MP. 1991. Pasteuria 
nishizawae sp. nov.,

[[Page 8741]]

a mycelial and endospore-forming bacterium parasitic on cyst 
nematode of genera Heterodera and Globodera. Research in 
Microbiology 14:551-564.
10. Pang L, McLeod M, Aislabie J, [Scaron]im[uring]nek J, Close M, 
Hector R. 2008. Modeling transport of microbes in ten undisturbed 
soils under effluent irrigation. Vadose Zone Journal 7:97-111.
11. Aislabie J, Smith JJ, Fraser R, McLeod M. 2001. Leaching of 
bacterial indicators of faecal contamination through four New 
Zealand soils. Australian Journal of Soil Research 39:1397-1406.
12. DeFelice K, Wollenhaupt N, Buchholz D. 1993. Aquifers and Soil 
Filter Effect. Available from http://extension.missouri.edu/p/WQ24.
13. Centers for Disease Control and Prevention. 2009. Drinking 
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.
14. U.S. EPA. 2004. Primer for Municipal Wastewater Treatment 
Systems. EPA 832-R-04-001. Available from http://www.epa.gov/npdes/pubs/primer.pdf.

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: February 1, 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 180.1311 is added to subpart D to read as follows:


Sec.  180.1311  Pasteuria nishizawae--Pn1; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pasteuria nishizawae--Pn1 in or on all food commodities 
when applied as a nematicide and used in accordance with good 
agricultural practices.

[FR Doc. 2012-3586 Filed 2-14-12; 8:45 am]
BILLING CODE 6560-50-P


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