UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL June 25, 2002 Danielle LaRochelle Registration Product Manager Aventis CropScience USA P. O. Box 12014 2 T. W. Alexander Drive Research Triangle Park, NC 27709 Re: Second Error Correction of Carbaryl Risk Assessments Dear Ms. LaRochelle:

Within two weeks from the date of this letter, please identify and comment on any errors in the enclosed risk assessment documents for carbaryl, addressing only typographic, mathematical, or computational type errors. The enclosed documents include the human health and the environmental fate and effects risk assessments. Also enclosed for your reference are supporting documents for the human health risk assessment. Last August, Aventis completed its first error correction review of these documents. As a courtesy, EPA is offering Aventis a second error correction review of these documents because of substantive changes described later in this letter.

On receiving your error correction submission, the Agency will evaluate your comments and will revise the risk assessments as necessary. At this phase, EPA will not address comments concerning matters of policy, interpretation, or applicability of data. Aventis will have ample opportunity to submit such comments during the 60 day public comment period that will begin in the next few weeks.

As part of your two week review, please also inform the Agency in writing of any claims of confidential business information (CBI) contained in these documents. If we do not receive notice in writing of any such claims within the two weeks, we will assume the document is free of CBI.

Please send, in writing, the results of your error correction and CBI review to:

Anthony Britten US EPA (7508C) 1200 Pennsylvania Avenue, N. W. Washington, D. C. 20460 E mail Address: britten. anthony@ epa. gov Fax: (703) 308 8005 2 Background EPA is offering this second courtesy error review because of substantive changes to the risk assessments. These changes were prompted by new data Aventis submitted since its first error correction review. The new data includes a two generation rat reproduction study, data from a developmental neurotoxicity study, and three dermal studies. EPA also rereviewed carbaryl under the latest cancer assessment guidelines.

The two weeks offered for this error review coincides with the time necessary to publish the Federal Register notice announcing the start of the Phase 3 public comment period. The publication process is now underway. Two weeks is also the period EPA usually offers for a second review of typographic, mathematical or computational type errors.

As part of its Phase 1 error review, Aventis submitted substantive comments to the Agency. EPA generally does not consider substantive comments received during Phase 1. However, in this case, EPA considered the comments while awaiting and then analyzing the new data from Aventis. EPA will specifically respond to these comments in a document prepared at the end of phase 3. You need not resubmit your substantive comments.

Please keep your review in the next two weeks focused solely on typographic, mathematical or computational type errors. Again, Aventis will also have the full 60 days of Phase 3 to submit further substantive comments, which EPA will address in its next revision of the risk assessments. The appropriate level of detail for your error response would be the amount of information that would fit in the margins of a pen and ink markup. In fact, a pen and ink markup would be the preferred response. Please complete your review of the comprehensive risk assessments before focusing attention on the supporting documents. Prioritizing your review in this way will help ensure the most significant corrections are made in a timely way. Sending corrections "piecemeal" is also recommended. Adopting these standards of review should allow both Aventis and EPA enough time to correct the enclosed documents before their release for Phase 3 public comment.

If you have questions about this request, please contact Anthony Britten, the Chemical Review Manager for carbaryl, at (703) 308 8179.

Sincerely,

// signed by Anthony Britten for//

Betty Shackleford, Acting Associate Director Special Review and Reregistration Division Enclosures


[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Notices]
[Page 60473-60474]
[DOCID:fr30se10-101]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1932-DR; Docket ID FEMA-2010-0002]

Kansas; Amendment No. 3 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Kansas (FEMA-1932-DR), dated August 10, 2010, and related
determinations.

DATES: Effective Date: September 20, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Michael R.
Scott, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of William J. Doran III as
Federal Coordinating Officer for this disaster.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-24498 Filed 9-29-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Rules and Regulations]
[Pages 40271-40276]
[FR Doc No: 2012-16695]

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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.

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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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
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,

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

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

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

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:

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