Document ID: EPA-HQ-OPP-2005-0316-0002
Agency: epa
Document Type: Rule
Title: Beauveria Bassiana HF23; Exemption from the Requirement of a Tolerance
Posted Date: 2007-01-10T05:00Z

[Federal Register: January 10, 2007 (Volume 72, Number 6)]
[Rules and Regulations]               
[Page 1177-1183]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja07-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0316; FRL-8108-4]

 
Beauveria Bassiana HF23; 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 the microbial active ingredient 
Beauveria bassiana HF23 (B. bassiana HF23) on all food and feed 
commodities when applied/used to

[[Page 1178]]

treat chicken manure which will eventually be processed and used as 
fertilizer on agricultural crops. Jabb of the Carolinas submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
as amended by the Food Quality Protection Act of 1996 (FQPA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of B. bassiana HF23.

DATES: This regulation is effective January 10, 2007. Objections and 
requests for hearings must be received on or before March 12, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0316. All documents in the 
docket are listed in the index for the docket. 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 OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8097; e-mail address: bacchus.shanaz@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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2005-0316 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before March 12, 2007.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0316, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 7, 2005 (70 FR 72831) (FRL-
7748-4), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 5F6960) by the consultant, SHB Scientific, P.O. 
Box 321, Chandler, AZ 85224-0321 on behalf of Jabb of the Carolinas, 
456 E. Main Street, Pine Level, NC 27568. The petition requested that 
40 CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of B. bassiana HF23 on all food 
commodities. This notice included a summary of the petition prepared by 
the petitioner SHB Scientific on behalf of Jabb of the Carolinas. One 
comment was received in response to this publication. The commenter 
inquired if Diquat was included in this pesticide. The Agency's 
response is that Diquat is not included in the formulation.
    Section 408(c)(2)(A)(i) of the 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 the 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

[[Page 1179]]

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 section 408(b)(2)(C), which require 
EPA to give special consideration to exposure of infants and children 
to the pesticide chemical residue in establishing a tolerance and to 
``ensure that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to the pesticide 
chemical residue....'' Additionally, section 408(b)(2)(D) of the FFDCA 
requires that the Agency consider ``available information concerning 
the cumulative effects of a particular pesticide's residues'' and 
``other substances that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.
    B. bassiana HF23 is a naturally occurring ubiquitous fungus in the 
environment that has insecticidal properties. This strain, and other 
strains of B. bassiana that are registered as pesticides, demonstrate 
low toxicity potential and are not likely to harm human adults, 
infants, and children. The applicant has submitted an application to 
the Agency to register the active ingredient, B. bassiana HF23, as a 
manufacturing use product (MP) for formulation into insecticidal end-
use products (EPs) and an application for an EP to control house flies 
in chicken manure.
    This exemption from the requirement for a tolerance only applies to 
the proposed use of the active ingredient for chicken manure treatment. 
Such use would not result in direct pesticidal contact with any food or 
animal feed commodities. Chicken manure, treated with a pesticide 
containing B. bassiana HF23, is composted and then used on agricultural 
crops as a fertilizer. The fungal active ingredient does not survive 
temperatures greater than 37 [deg]C (the average mammalian body 
temperature), and thus, would not be expected to survive the higher 
temperatures of composting (40-50 [deg]C on average). See further 
discussion in Unit IV.A.1. Therefore, potential residues of B. bassiana 
HF23, from its use as a pesticide to control house flies in chicken 
manure, are not expected to exceed or be distinguishable from the 
naturally occurring background levels of the fungus.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the 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.
    The following summaries are taken from the Biopesticide and 
Pollution Prevention Division (BPPD) Data Evaluation Records (DERs), 
which are reviews performed by Agency scientists of the data submitted 
by the registrant for this tolerance exemption.

A. Acute Oral Toxicity (OPPTS 885.3050 Test Guideline)

    A study was reviewed by the Agency to ascertain acute oral toxicity 
and pathogenic effects of the Technical Grade Active Ingredient (TGAI) 
B. bassiana HF23 on rats (Master Record Identification Number (MRID) 
46526003; DER dated 1/31/06). Laboratory rats were treated by oral 
gavage with B. bassiana HF23 at guideline recommended doses: Males were 
treated with 2.10-4.20 x 10\4\ colony forming units of B. bassiana HF23 
per gram (cfu/g) of body weight; females were treated with 1.60-3.60 x 
10\4\ cfu/g. Untreated rats of both sexes served as controls. All of 
the rats, treated and untreated, survived, exhibited normal weight 
gain, and appeared normal throughout the study.
    B. bassiana HF23 was detected in the feces of all treated animals 
collected on the day of dosing. The fungus was not detected in the 
feces, tissues, blood, and cecum contents of these animals collected 3 
and 7 days later. No test organisms were detected in any of the 
untreated (control) animals. The data presented did not indicate any 
significant clinical signs in rats. At the end of the study, B. 
bassiana HF23 was not found in the following organs: Kidney, brain, 
liver, lungs, spleen, and cervical and mesenteric lymph nodes. 
Therefore, based on the presented/submitted data, the Agency has 
determined that the test organism is not acutely toxic, infective, or 
pathogenic to rats at the levels tested in this study. The active 
ingredient is classified as Toxicity Category IV for acute oral 
toxicity/pathogenicity effects in mammals.

B. Acute Dermal Toxicity Study (OPPTS 885. 3100 Test Guideline) and 
Primary Dermal Irritation (OPPTS 870.2500 Test Guideline)

    A study was reviewed by the Agency to ascertain acute dermal 
toxicity and pathogenic effects of the Technical Grade Active 
Ingredient (TGAI) B. bassiana HF23 in rabbits (MRID 46526004; DER dated 
2/1/06).
    B. bassiana HF23 (2,000 mg/kg body weight) was applied to the 
shaved skin on the backs of New Zealand white rabbits (5 per sex) for 
24 hours. The animals were observed twice daily for 14 days for signs 
of irritation and toxicity. All of the rabbits survived, and exhibited 
normal body weight gain. The test organism produced no adverse reaction 
on the skin of the rabbits. The dermal LD50 for B. bassiana 
HF23 in rabbits was greater than 2,000 mg/kg. B. bassiana HF23 is 
classified in Toxicity Category III.
    Based on the lack of irritation to the skin of rabbits in this 
study, and the nature of the inert ingredients in the products being 
registered by the petitioner, the Agency waived the requirement of a 
primary dermal irritation study for their products.

C. Acute Pulmonary Toxicity/Pathogenicity (OPPTS 885.3150 Test 
Guideline)

    A study was reviewed by the Agency to ascertain acute pulmonary 
toxicity and pathogenic effects of the Technical Grade Active 
Ingredient (TGAI) B. bassiana HF23 in rats (MRID 46526005; DER dated 1/
31/06).
    In this study, single doses of the test material were administered 
to laboratory rats by intratracheal instillation at a concentration of 
1.06 x 10\7\ cfu/0.1 ml (purified water). The animals were observed for 
signs of toxicity, clinical signs, morbidity, and mortality twice daily 
until the end of the study.
    One male and one female rat died on the day of dosing, with the 
cause of death likely due to anesthesia. All other rats survived, 
appeared normal, and exhibited normal weight gains until scheduled 
sacrifice. Reduced feces were observed in one female each from the 
untreated (control) groups for one day, but since these animals were 
not exposed to B. bassiana HF23, the effect was not attributed to the 
test material.
    Lungs, kidney, brain, liver, lungs, spleen, cervical and mesenteric 
lymph nodes, cecum contents and blood samples were collected from 
treated and control animals. B. bassiana HF23 was detected in the lungs 
of all treated animals collected on the day of dosing

[[Page 1180]]

(males: 2.10-3.70 x 10\4\ cfu/g lung tissue; females: 4.70-7.60 x 10\4\ 
cfu/g lung tissue).
    No test organisms were detected in the tissues, blood, and cecum 
contents collected from the treated animals on days 3 and 7, and no 
test organisms were detected in any of the untreated animals during the 
study. The presented data show no clinical signs in treated rats. B. 
bassiana HF23 was detected only in lungs immediately following dosing, 
but this cleared by day 3 after dosing. Therefore, based upon the 
results of this study, B. bassiana HF23 is not toxic, infective, nor 
pathogenic to rats via the pulmonary route of administration, and thus 
is considered Toxicity Category IV.

D. Acute Inhalation (Data Waiver Request; OPPTS 870.1300 Test 
Guideline)

    The registration requirement for an acute inhalation study for the 
proposed use as a treatment for chicken manure was waived by the 
Agency, based upon the nature of the inert ingredients of the proposed 
pesticide EP and the low toxicity potential of the active ingredient 
demonstrated in the acute pulmonary toxicity/pathogenicity study 
discussed in Unit III.C. The inert ingredients in the proposed EP 
consist of a solid state matrix with particles which are not 
respirable. Based on the acute pulmonary test and the nature of the 
inert ingredients, the MP is considered Toxicity Category IV.

E. Acute Intraperitoneal Injection (OPPTS 885.3200 Test Guideline)

    A study was reviewed by the Agency to ascertain acute 
intraperitoneal toxicity and pathogenic effects of the Technical Grade 
Active Ingredient (TGAI) B. bassiana HF23 in rats (MRID 46526006; DER 
dated 1/31/06).
    In this study, laboratory rats were dosed with 1 ml of a suspension 
of B. bassiana HF23 in purified water (3.97 x 10\8\ cfu (hemacytometer 
count) or 2.8 x 10\7\ cfu/animal) by intraperitoneal injection. There 
were no clinically significant signs in any of the rats. All animals 
gained weight and survived to the end of the study. One treated male 
and one treated female developed a lump under the skin in the ventral 
abdomen at the injection site. The test organism was not recovered from 
those lesions. One treated male had mottled kidneys and one treated 
female had red lungs. One untreated female and four treated females had 
red/enlarged ovaries/uterus. No lesions or other signs of infectivity 
were observed in the affected kidneys, lungs, ovaries, and uteri. Based 
on the presented/submitted data, the test organism was not toxic or 
pathogenic to rats via the intraperitoneal route.

F. Hypersensitivity Study

    Since no incidents of hypersensitivity have been reported at this 
time for B. bassiana HF23, the Agency has determined that the active 
ingredient is not expected to initiate a hypersensitive response in 
humans. Footnote (iii) of 40 CFR 158.740(c) states that this guideline 
is required if commonly recognized practices will result in repeated 
human contact by inhalation and dermal routes, and based upon the 
proposed uses of B. bassiana HF23 as an insecticide in chicken manure, 
repeated human exposure by these routes are not expected.
    In order to mitigate the potential for B. bassiana HF23 to cause 
hypersensitivity in humans, the Agency will require appropriate 
protective clothing to avoid repeated contact with skin and respiratory 
tract when the active ingredient is used as a pesticide.

G. Hypersensitivity Incidents (OPPTS 885.3400 Test Guideline)

    No incidents of hypersensitivity associated with the TGAI or 
proposed components of the EP have been reported or are found in the 
scientific literature to date. However, as with all pesticides, any 
incidents of hypersensitivity or other adverse effects associated with 
the use of B. bassiana HF23 must be reported to the Agency, in 
accordance with the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) section 6(a)(2).

H. Immune Response (OPPTS 880.3800 Test Guideline)

    The Agency has waived the registration requirements for an immune 
response study based on the following: B. bassiana HF23 is a well-known 
entomopathogenic (pathogenic to insects) fungus, that is ubiquitous in 
nature. As no incidents of hypersensitivity have been reported, B. 
bassiana HF23 is not expected to initiate a hypersensitive response in 
humans. Based upon the proposed uses of B. bassiana HF23 as an 
insecticide in chicken manure, repeated human exposure by these routes 
are not expected.
    In its decision to waive this required study, the Agency considered 
the results of the acute dermal study, in which no adverse dermal 
reaction to a 24-hour exposure to the active ingredient, as previously 
discussed. The Agency also considered the results of the acute 
toxicity/pathogenicity oral, dermal, pulmonary, and intraperitoneal 
tests. These studies demonstrated that the active ingredient is neither 
acutely toxic nor pathogenic when it is administered to test animals 
via intraperitoneal, oral, dermal, or respiratory routes. The results 
from these tests indicate that mammalian immune systems can clear the 
organism, since none were found in any organs or tissues involved in 
immunity (spleen, lymph node, blood).
    In order to mitigate the potential for B. bassiana HF23 to cause 
hypersensitivity in humans, the Agency will require appropriate 
protective clothing to avoid repeated contact with skin and respiratory 
tract when the active ingredient is used as a pesticide.

I. Subchronic, Chronic Toxicity and Oncogenicity, and Residue Data

    The summaries of the data discussed in this Unit comply with the 
Tier I data requirements set forth in 40 CFR 158.740(c), and do not 
trigger the Tier II and Tier III data requirements, which, therefore, 
are not required in connection with this action. In addition, because 
the Tier II and Tier III data requirements were not required, the 
residue data requirements set forth in 40 CFR 158.740(b) also were not 
required.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the 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

    The microbial pesticide containing the active ingredient, B. 
bassiana HF23, is not applied directly to food as discussed previously. 
Food or animal feed commodities could potentially be exposed to 
inadvertent residues of B. bassiana HF23 as a result of treated chicken 
manure being used as fertilizer to agricultural crops.
    1. Food. B. bassiana HF23 is sensitive to warm temperatures (MRID 
46526011) and UV light. The treated chicken manure is processed by 
composting into fertilizer for use on agricultural crops. The high 
temperatures of composting are very likely to destroy any potential 
residual B. bassiana HF23 or other potential microbial contaminants. 
Thus, the amount of viable B. bassiana HF23 spores that may have 
remained after composting treated chicken manure would greatly diminish 
once the manure is spread as a fertilizer and the

[[Page 1181]]

spores exposed to sunlight. However, data show that viable B. bassiana 
HF23 spores will leave poultry production houses upon disposal of 
manure and litter (MRID 46786401; BPPD DER 6/20/06). At the time of 
application of the treated chicken manure, B. bassiana HF23 colonies 
have declined to levels which are no greater than those observed of the 
naturally occurring microbe (MRID 46786401; BPPD DER 6/20/06).
    There is no direct post-harvest treatment of food commodities with 
B. bassiana HF23. Thus, detectable residues of B. bassiana HF23 are not 
expected on agricultural crops or food commodities as a result of the 
proposed use of this active ingredient. Moreover, washing, peeling and 
processing of foods and feed commodities before consumption would 
further mitigate any potential exposure and risk via dietary exposure. 
The active ingredient occurs naturally and is ubiquitous in the 
environment. The toxicological profile discussed in Unit III. indicates 
no acute oral toxicity/pathogenicity effects of this active ingredient. 
In addition, a study conducted for ecological effects, used chickens 
for avian oral toxicology tests. No adverse effects were observed for 
20 day old chickens dosed at acceptable guideline levels. Transfer to 
meat, milk, poultry, and eggs is expected to be negligible to non-
existent, as noted in these discussions of submitted toxicology 
studies. Thus, no harm is expected to human adults, children or infants 
via consumption of food or feed exposed to chicken manure which has 
been treated with B. bassiana HF23.
    2. Drinking water exposure. No drinking water exposure is 
anticipated because of the use pattern and use sites. There are no 
aquatic use sites permitted for this pesticide. Thus, transfer of B. 
bassiana HF23 from soil to groundwater is unlikely. Even if such a 
transfer were to occur, the fungus would not survive the conditions of 
drinking water treatment, such as chlorination, pH adjustments, and 
other water processing conditions. Further, there is no evidence of 
adverse effects from exposure to this ubiquitous organism. Exposure 
from the proposed use of B. bassiana HF23 is not likely to pose any 
incremental risk to adult humans, infants, and children via consumption 
of drinking water.

B. Other Non-Occupational Exposure

    The proposed products are an MP for formulation into pesticide EPs 
and an EP that is intended to be used commercially for treatment of 
chicken manure in poultry houses to control house flies. Non-
occupational residential, school, or day care exposure is not 
anticipated because of the use pattern of this product. The use of B. 
bassiana HF23 should result in minimal to non-existent, non-
occupational risk. No indoor residential, school, or daycare uses are 
currently permitted for this active ingredient.
    1. Dermal exposure. EPA has concluded that this pesticide poses 
minimal risk to human populations via non-occupational dermal exposure. 
This conclusion is based on the low toxicity potential observed in the 
acute dermal studies discussed in Unit III., and the low exposure 
potential based on non-viability of the active ingredient after treated 
chicken manure is used as a fertilizer on agricultural crops. Moreover, 
potential non-occupational dermal exposure to B. bassiana HF23 is 
unlikely because the use sites are commercial and agricultural.
    As previously discussed, no hypersensitivity incidents associated 
with B. bassiana HF23 have been reported to date. Therefore, the Agency 
does not expect pesticides containing B. bassiana HF23 to pose a non-
occupational dermal exposure risk.
    2. Inhalation exposure. Non-occupational inhalation exposure to B. 
bassiana HF23 from its proposed agricultural use as a pesticide to 
treat chicken manure is not anticipated. In the pulmonary study 
described in Unit III.C., no treatment-related effects associated with 
the active ingredient were observed in laboratory rats. In the unlikely 
event that an individual is exposed to the active ingredient by the 
inhalation route, such exposure is not expected to pose an inhalation 
risk.
    In summary, the potential aggregate exposure as a result of the use 
of the pesticidal active ingredient B. bassiana HF23 is not likely to 
pose a hazard via aggregate exposure. This includes hazards derived 
from (a) dietary exposure from the treated food/feed commodities, (b) 
drinking water potentially exposed secondary to treatment of sites with 
this pesticide; and (c) dermal and inhalation non-occupational exposure 
of populations exposed to B. bassiana HF23.

V. Cumulative Effects

    The Agency has considered the potential for cumulative effects of 
B. bassiana HF23 and other substances in relation to a common mechanism 
of toxicity. These considerations include the possible cumulative 
effects of such residues on infants and children. As demonstrated in 
the toxicity assessment, B. bassiana HF23 is non-toxic and non-
pathogenic to mammals. Because no mechanism of pathogenicity or 
toxicity in mammals has been identified for this organism, no 
cumulative effects from the residues of this product with other related 
microbial pesticides are anticipated.

VI. Determination of Safety for U.S. Population, Infants, and Children

    There is reasonable certainty that no harm will result to the U.S. 
population, including infants and children, from aggregate exposures to 
residues of B. bassiana HF23, as a result of its proposed uses. This 
includes all anticipated dietary exposures and all other exposures for 
which there is reliable information. As discussed previously, there 
appears to be no potential for harm from this fungus in its use as an 
insecticide via dietary exposure since the organism is non-toxic and 
non-pathogenic to animals and humans. The Agency has arrived at this 
conclusion based on the very low levels of mammalian toxicity for acute 
oral, pulmonary, dermal, and intraperitoneal effects with no toxicity 
or infectivity at the doses tested (see Unit III.).
    Moreover, potential non-occupational inhalation or dermal exposure 
is not expected to pose any adverse effects to exposed populations via 
aggregate and cumulative exposure (see Units IV. and V.)
    FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional ten-fold margin of exposure (safety) for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base on toxicity 
and exposure, unless EPA determines that a different margin of exposure 
(safety) will be safe for infants and children. Margins of exposure 
(safety), which are often referred to as uncertainty factors, are 
incorporated into EPA risk assessment either directly, or through the 
use of a margin of exposure analysis, or by using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk. In 
this instance, based on all the available information (as discussed in 
Unit III.), the Agency concludes that the fungus, B. bassiana HF23, is 
non-toxic to mammals, including infants and children. Because there are 
no threshold effects of concern to infants, children, and adults when 
B. bassiana HF23 is used as a pesticidal active ingredient, the Agency 
has determined that the additional margin of safety is not necessary to 
protect infants and children, and that not adding any additional margin 
of safety will be safe for infants and children. As a result, EPA has 
not used a margin of

[[Page 1182]]

exposure (safety) approach to assess the safety of B. bassiana HF23.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by 
FQPA, to develop a screening program to determine whether certain 
substances (including all pesticide active and other ingredients) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally-occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there was scientific basis for including, as part 
of the program, the androgen and thyroid systems, in addition to the 
estrogen hormone system. EPA also adopted EDSTAC's recommendation that 
the program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority, to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP).
    At this time, the Agency is not requiring information on the 
endocrine effects of this active ingredient, B. bassiana HF23. The 
Agency has considered, among other relevant factors, available 
information concerning whether the microorganism may have an effect in 
humans similar to an effect produced by a naturally occurring estrogen 
or other endocrine effects. There is no known metabolite that acts as 
an ``endocrine disruptor'' produced by this microorganism. The 
submitted toxicity/infectivity or pathogenicity studies in the rodent 
(required for microbial pesticides) indicate that, following oral, 
pulmonary, dermal, and intraperitoneal routes of exposure, the immune 
system is still intact and able to process and clear the active 
ingredient (see Unit III.). In addition, based on the low potential 
exposure level associated with the proposed uses of the pesticide, the 
Agency expects no adverse effects to the endocrine or immune systems. 
Thus, there is no impact via endocrine-related effects on the Agency's 
safety finding set forth in this final rule for B. bassiana HF23.

B. Analytical Method(s)

    The acute oral studies discussed in Unit III. demonstrate that the 
active ingredient does not pose a dietary risk. In addition, the active 
ingredient is not likely to come into contact with the treated food 
commodities. Furthermore, the low application rate and non-persistence 
on food during applications suggests very low exposure potential via 
the dietary route. Since residues are not expected on treated 
commodities, the Agency has concluded that an analytical method to 
detect residues of this pesticide on treated food commodities for 
enforcement purposes is not needed.
    Nevertheless, the Agency has concluded that for analysis of the 
pesticide itself, microbiological and biochemical methods exist and are 
acceptable for enforcement purposes for product identity of B. bassiana 
HF23. Other appropriate methods are required for quality control to 
assure that product characterization, the control of human pathogens, 
and other unintentional metabolites or ingredients are within 
regulatory limits, and to ascertain storage stability and viability of 
the pesticidal active ingredient.

C. Codex Maximum Residue Level

    There is no Codex maximum residue level for residues of B. bassiana 
HF23.

VIII. Conclusions

    The results of the studies discussed are sufficient to comply with 
the requirements of the FQPA. They support an exemption from the 
requirement of a tolerance for residues of B. bassiana HF23, on treated 
food or feed commodities. In addition, the Agency is of the opinion 
that, if the microbial active ingredient is used as allowed, aggregate 
and cumulative exposures are not likely to pose any undue hazard to the 
adult human U.S. population, children, and infants. Therefore, an 
exemption from the requirement of a tolerance is granted in response to 
pesticide petition 5F6960.

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption from 
the requirement of a tolerance in this final rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. The Agency 
hereby certifies that this rule will not have significant negative 
economic impact on a substantial number of small entities. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This

[[Page 1183]]

final rule directly regulates growers, food processors, food handlers 
and food retailers, not States. 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 the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: December 22, 2006.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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 180.1273 is added to subpart D to read as follows:

Sec.  180.1273  Beauveria bassiana HF23; exemption from the requirement 
of a tolerance.

    An exemption from the requirement of a tolerance is established on 
all food/feed commodities, for residues of Beauveria bassiana HF23 when 
the pesticide is used for chicken manure treatment.

[FR Doc. E7-170 Filed 1-9-07; 8:45 am]

BILLING CODE 6560-50-S