Document ID: EPA-HQ-OPP-2010-0805-0003
Agency: epa
Document Type: Rule
Title: Exemption From the Requirement of a Tolerance: Pasteuria spp. (Rotylenchulus reniformis nematode)-Pr3
Posted Date: 2012-07-09T04:00Z

[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Rules and Regulations]
[Pages 40271-40276]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16695]

[[Page 40271]]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0805; FRL-9353-5]

Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3; 
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 Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3 in or on all food commodities when applied as a 
nematicide and used in accordance with label directions and 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 spp. (Rotylenchulus reniformis nematode)--Pr3 
under the FFDCA.

DATES: This regulation is effective July 9, 2012. Objections and 
requests for hearings must be received on or before September 7, 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-2010-0805, is available 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 (docket ID number: EPA-HQ-OPP-2010-0808) associated with notices 
of receipt of applications for pesticide products containing a new 
active ingredient, Pasteuria reniformis--Pr3 (now recognized as 
Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3 instead), under 
the Federal Insecticide, Fungicide, and Rodenticide Act. Such documents 
include the draft Biopesticides Registration Action Document (BRAD) and 
environmental risk assessment listed in Unit IX. of this final rule.

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: kausch.jeannine@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 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(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-2010-0805 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 
September 7, 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-2010-0805, 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 statue.
     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.
    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 February 4, 2011 (76 FR 6465) (FRL-8858-
7), 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 
0F7745) 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 reniformis--Pr3 [SD-5834]. This 
notice referenced a summary of the petition prepared by the petitioner,

[[Page 40272]]

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.
    Based upon review of data and other information supporting the 
petition, EPA modified the active ingredient name. In addition, EPA 
also changed the commodity to be reflected in the tolerance expression 
from ``in or on all raw agricultural crops'' to ``in or on all food 
commodities.'' The reasons for these changes are explained in Unit 
VII.D.
    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 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 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, FFDCA section 408(b)(2)(D) 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 a pesticide. 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 FFDCA section 408(b)(2)(D), 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 Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3

    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), June 
30, 2010 (75 FR 37734) (FRL-8831-9), and February 15, 2012 (77 FR 8736) 
(FRL-9337-2) for final rules that established tolerance exemptions for 
residues of the nematicides, Pasteuria penetrans (40 CFR 180.1135), 
Pasteuria usgae (40 CFR 180.1290), and Pasteuria nishizawae--Pn1 (40 
CFR 180.1311), 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 (Refs. 1 
and 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. 1, 3, 4, and 5). Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 was specifically isolated from 
soil samples collected in the southeastern United States (Ref. 1).
    Endospores of Pasteuria spp. (Rotylenchulus reniformis nematode)--
Pr3 attach to Rotylenchulus species nematodes at all life stages, 
except eggs (Ref. 1). After an endospore attaches to the cuticle of a 
nematode host, a germ tube penetrates the cuticle, and growth and 
sporogenesis begin in the pseudocoelom of the nematode (Ref. 1). The 
nematode is eventually filled with cells, mycelial hyphae, and 
sporangia, which leads to its death (Ref. 1). In light of the 
demonstrated nematicidal capabilities and host specificity of Pasteuria 
spp. (Rotylenchulus reniformis nematode)--Pr3, Pasteuria Bioscience, 
Inc. proposed to register pesticide products intended for use on 
several food and nonfood crops, primarily as seed or soil treatments, 
to control the reniform nematode (Rotylenchulus reniformis).

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 spp. (Rotylenchulus reniformis nematode)--Pr3 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 spp. (Rotylenchulus reniformis nematode)--Pr3, and these 
studies received a Toxicity Category IV or III classification (see 40 
CFR 156.62). Although infectivity and clearance of Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 were not evaluated in the 
acute oral, pulmonary, and injection toxicity/pathogenicity studies, 
the results indicated that Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3 was not toxic and/or pathogenic via the tested routes of 
exposure. 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 draft 
BRAD provided as a reference in Unit IX. (Ref. 1).
    1. Acute oral toxicity/pathogenicity--rat (Harmonized Guideline 
885.3050; Master Record Identification Number (MRID No.) 481460-09). A 
supplemental acute oral toxicity/pathogenicity study demonstrated that 
Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3 was not toxic 
and/or pathogenic to laboratory rats when administered by oral gavage 
in a single dose of 1.5 x 10\9\ spores per animal.
    2. Acute pulmonary toxicity/pathogenicity--rat (Harmonized 
Guideline 885.3150; MRID No. 481460-10). A supplemental acute pulmonary 
toxicity/pathogenicity study demonstrated that Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 was not toxic and/or 
pathogenic to laboratory rats when administered by intratracheal 
instillation in a single dose of 1.5 x 10\8\ spores per animal.
    3. Acute injection toxicity/pathogenicity (intravenous)--rat 
(Harmonized Guideline 885.3200; MRID

[[Page 40273]]

No. 481460-11). A supplemental acute injection toxicity/pathogenicity 
study demonstrated that Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3 was not toxic and/or pathogenic to laboratory rats when 
administered intravenously in a single dose of 1 x 10\7\ spores per 
animal.
    4. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID 
No. 481460-12). 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 spp. (Rotylenchulus reniformis nematode)--Pr3.
    5. Acute dermal toxicity--rabbit (Harmonized Guideline 870.1200; 
MRID No. 481460-14). An acceptable acute dermal toxicity study 
demonstrated that a test substance containing Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 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 III).
    6. Primary dermal irritation--rabbit (Harmonized Guideline 
870.2500; MRID No. 481460-16). An acceptable primary dermal irritation 
study demonstrated that a test substance containing Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 was essentially non-irritating 
to the skin of rabbits (Toxicity Category IV).

IV. Aggregate Exposure

    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. Dietary exposure to Pasteuria spp. (Rotylenchulus 
reniformis nematode)--Pr3, a naturally occurring soil bacterium (Ref. 
1), is anticipated to be negligible. For optimal control of the target 
pest (reniform nematode), Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3 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 spp. (Rotylenchulus reniformis nematode)--Pr3 residues on 
above-ground commodities. That is, although Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 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 spp. 
(Rotylenchulus reniformis nematode)--Pr3 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 spp. (Rotylenchulus reniformis nematode)--Pr3 is a more 
likely scenario. Regardless of the situation, however, should residues 
of Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3 result in or 
on food when used as a pesticide in accordance with label directions 
and good agricultural practices, its lack of toxicity and pathogenicity 
(as demonstrated in the available data) indicate that no adverse 
effects are likely to occur with respect to any exposures to such 
residues (see additional discussion in Unit III.).
    2. Drinking water exposure. Exposure to residues of Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 in consumed drinking water is 
possible but not likely. The proposed use patterns for Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 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 spp. (Rotylenchulus 
reniformis nematode)--Pr3, given that this microbial pesticide would 
likely be filtered out by the particulate nature of many soil types as 
are other microorganisms (Refs. 6, 7, and 8). If Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 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. 9 and 
10). In the remote likelihood that Pasteuria spp. (Rotylenchulus 
reniformis nematode)--Pr3 is present in drinking water (e.g., water not 
subject to certain conditions in treatment systems and facilities), its 
lack of toxicity and pathogenicity demonstrated by the available data 
indicate that no toxicity, pathogenicity, and/or infectivity is likely 
to occur with respect to any exposures to residues of Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 in drinking water that might 
result from pesticide applications made in accordance with label 
directions and good agricultural practices (see additional discussion 
in Unit III.).

B. Other Non-Occupational Exposure

    Given Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3's 
natural presence in soil (Ref. 1), non-occupational exposure to the 
bacterium almost certainly is already occurring. Additional non-
occupational exposure to Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3 due to pesticidal applications is not expected because 
all proposed pesticide end-use products are labeled for use in distinct 
agricultural settings. Even if additional non-occupational exposures 
were to occur (e.g., eventual expansion of use sites), the lack of 
toxicity, pathogenicity, and irritation demonstrated in the available 
data indicate that no adverse effects are likely to occur with respect 
to any exposures to such residues that might result from pesticide 
applications made in accordance with label directions and good 
agricultural practices (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 spp. (Rotylenchulus reniformis nematode)--Pr3, and Pasteuria 
spp. (Rotylenchulus reniformis nematode)--Pr3 does not appear to 
produce a toxic metabolite against the target pest. For the purposes of 
this tolerance action, therefore, EPA has assumed that Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 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

[[Page 40274]]

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 or no safety factor when reliable data are 
available to support a different additional or no safety factor.
    Based on the acute toxicity and pathogenicity data discussed in 
Unit III.B., as well as Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3's host specificity for Rotylenchulus species nematodes, 
EPA concludes that there are no threshold effects of concern to 
infants, children, or adults when Pasteuria spp. (Rotylenchulus 
reniformis nematode)--Pr3 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 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 spp. (Rotylenchulus reniformis nematode)--Pr3 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 spp. (Rotylenchulus 
reniformis nematode)--Pr3 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 Unit VI. 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 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. 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 spp. 
(Rotylenchulus reniformis nematode)--Pr3.

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 reniformis--Pr3 (now recognized as Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 instead), that were described 
in the Federal Register of February 4, 2011 (76 FR 6465) (FRL-8858-7). 
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 spp. 
(Rotylenchulus reniformis nematode)--Pr3 is not toxic and/or pathogenic 
at the doses administered orally, intratracheally, intravenously, and 
dermally to rats or rabbits (see Unit III.B.). Moreover, since no 
mechanism of toxicity in mammals has been identified for Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3, and Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 does not appear to produce a 
toxic metabolite against the target pest, EPA has assumed that 
Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3 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 spp. 
(Rotylenchulus reniformis nematode)--Pr3. 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, after Pasteuria Bioscience, Inc. petitioned EPA to 
establish a tolerance exemption for Pasteuria reniformis--Pr3 [SD-
5834], EPA reviewed the submitted product identification data and made 
the following determinations:
    1. The active ingredient name was not included in any acceptable 
taxonomic scheme and
    2. Insufficient information was provided to show how this taxonomic 
position was established as a new species (i.e., reniformis).
    Thus, Pasteuria Bioscience, Inc. submitted additional product 
identification data and revised the active ingredient name from 
Pasteuria reniformis--Pr3 [SD-5834] to Pasteuria spp. (Rotylenchulus 
reniformis nematode)--Pr3 to accurately represent what was described in 
this new data (e.g., identification down to this isolate's genus and of 
its primary target pest, the reniform nematode). With this modification 
to the active ingredient name, inclusion of the American Type Culture 
Collection accession number (i.e., SD-5834) was also dropped

[[Page 40275]]

because Pasteuria Bioscience, Inc. already created a unique isolate 
identifier (i.e., Pr3). Use of just Pasteuria spp. (Rotylenchulus 
reniformis nematode)--Pr3 throughout this document, particularly in the 
tolerance exemption expression, is now supported by data, is consistent 
with the representation of this active ingredient in other associated 
regulatory documents, and should assist in preventing confusion 
regarding this active ingredient's 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 tolerances or tolerance exemptions for 
residues of pesticide chemicals under the FFDCA.

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 spp. (Rotylenchulus 
reniformis nematode)--Pr3. Therefore, an exemption from the requirement 
of a tolerance is established for residues of Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 in or on all food commodities 
when applied as labeled as a nematicide and used in accordance with 
good agricultural practices.

IX. References

1. U.S. EPA. 2011a. Draft Pasteuria spp. (Rotylenchulus reniformis 
nematode)--Pr3 Biopesticides Registration Action Document dated May 
8, 2012 (available as ``Supporting & Related Material'' within 
docket ID number EPA-HQ-OPP-2010-0808 at www.regulations.gov).
2. U.S. EPA. 2011b. Environmental Risk Assessment of Pasteuria spp. 
(Rotylenchulus reniformis nematode)--Pr3 (PC 016456) for a Section 3 
Registration of the Technical Product (EPA File Symbol 85004-U) and 
Two End Use Products (EPA File Symbols 85004-L and 85004-I) for 
Control of the Reniform Nematode. Memorandum from S. Borges to J. 
Kausch dated March 26, 2012 (available as ``Supporting & Related 
Material'' within docket ID number EPA-HQ-OPP-2010-0808 at 
www.regulations.gov).
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. 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.
7. 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.
8. DeFelice K, Wollenhaupt N, Buchholz D. 1993. Aquifers and Soil 
Filter Effect. Available from http://extension.missouri.edu/p/WQ24.
9. Centers for Disease Control and Prevention. 2009. Drinking 
Water--Water Treatment. Available from http://www.cdc.gov/healthywater/drinking/public/water_ treatment.html.
10. 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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: June 13, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 40276]]

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 180.1316 is added to subpart D to read as follows:

Sec.  180.1316  Pasteuria spp. (Rotylenchulus reniformis nematode)--
Pr3; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3 in 
or on all food commodities when applied as a nematicide and used in 
accordance with label directions and good agricultural practices.

[FR Doc. 2012-16695 Filed 7-6-12; 8:45 am]
BILLING CODE 6560-50-P