10186 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

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. Section 808 allows 

the issuing agency to make a rule 

effective sooner than otherwise 

provided by the CRA, if the agency 

makes a good cause finding that notice 

and public procedure is impracticable, 

unnecessary or contrary to the public 

interest. This determination must be 

supported by a brief statement (5 U.S.C. 

808(2)). As stated previously, EPA has 

made such a good cause finding, 

including the reasons therefore, and 

established an effective date of March 5, 

2010. The 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 the rule in 

the Federal Register. 

The EPA’s compliance with these 

statutes and Executive Orders for the 

underlying rule is discussed in the 

December 3, 2009, Federal Register 

notice containing the Area Source 

Paints and Allied Products 

Manufacturing final rule (74 FR 63504). 

List of Subjects for 40 CFR Part 63 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Hazardous 

substances, Intergovernmental relations, 

Reporting and recordkeeping 

requirements. 

Dated: February 25, 2010. 

Gina McCarthy, 

Assistant Administrator, Office of Air and 

Radiation. 

■ For the reasons set out in the 

preamble, title 40, chapter I, part 63, of 

the Code of Federal Regulations is 

amended as follows: 

PART 63—[AMENDED] 

■ 1. The authority citation for part 63 

continues to read as follows: 

Authority: 42 U.S.C. 7401, et seq. 

Subpart CCCCCCC—[Amended] 

■ 2. Section 63.11599 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 63.11599 Am I subject to this subpart? 

* * * * * 

(b) * * * 

(1) An affected source is existing if 

you commenced construction or 

reconstruction before June 1, 2009. 

* * * * * 

■ 3. Section 63.11601 is amended by: 

■ a. Revising paragraph (a) introductory 

text; 

■ b. Removing paragraph (a)(3); 

■ c. Redesignating paragraphs (a)(4) 

through (a)(7) as paragraphs (a)(3) 

through (a)(6); 

■ d. Revising newly designated 

paragraph (a)(4)(i) to read as follows: 

§ 63.11601 What are the standards for new 

and existing paints and allied products 

manufacturing facilities? 

(a) For each new and existing affected 

source, you must comply with the 

requirements in paragraphs (a)(1) 

through (5) of this section. These 

requirements apply at all times. 

* * * * * 

(4) You must: 

(i) Capture particulate emissions and 

route them to a particulate control 

device meeting the requirements of 

paragraph (a)(5) of this section during 

the grinding and milling of materials 

containing compounds of cadmium, 

chromium, lead, or nickel; or 

* * * * * 

■ 3. Section 63.11602 is amended by: 

■ a. In paragraph (a)(2)(iii) introductory 

text by revising the last sentence: 

■ b. In paragraph (a)(2)(iii)(A) by 

revising the last sentence; 

■ c. By revising paragraph (a)(2)(iii)(B). 

§ 63.11602 What are the performance test 

and compliance requirements for new and 

existing sources? 

(a) * * * 

(2) * * * 

(iii) * * * If the Method 203C test 

runs indicates an opacity greater than 

the limitation in § 63.11601(a)(5), you 

must comply with the requirements in 

paragraphs (a)(2)(iii)(A) through (C) of 

this section. 

(A) * * * You must continue to take 

corrective action and retest each 15 days 

until a Method 203C test indicates an 

opacity equal to or less than the 

limitation in § 63.11601(a)(5). 

(B) You must prepare a deviation 

report in accordance with 

§ 63.11603(b)(3) for each instance in 

which the Method 203C opacity results 

were greater than the limitation in 

§ 63.11601(a)(5). 

* * * * * 

■ 4. Section 63.11603 is amended by: 

■ a. Revising paragraph (c) introductory 

text; 

■ b. Redesignating paragraph (e) as 

paragraph d). 

§ 63.11603 What are the notification, 

reporting, and recordkeeping 

requirements? 

* * * * * 

(c) Records. You must maintain the 

records specified I paragraphs (c)(1) 

through (4) of this section in accordance 

with paragraphs (c)(5) through (6) of this 

section, for five years after the date of 

each recorded action. 

* * * * * 

[FR Doc. 2010–4754 Filed 3–4–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0316; FRL–8814–6] 

Beauveria bassiana HF23; Amendment 

of Exemption from the Requirement of 

a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

exemption from the requirement of a 

tolerance for residues of the microbial 

insecticide. Beauveria bassiana HF23 

(40 CFR 180.1273) on all food 

commodities when used to treat chicken 

and livestock facilities, from which 

manure will eventually be composted 

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), 

requesting this amendment of the 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

Beauveria bassiana HF23. 

DATES: This regulation is effective 

March 5, 2010. Objections and requests 

for hearings must be received on or 

before May 4, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2005–0316. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 10187 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, 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 May 4, 2010. 

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 Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of March 16, 

2009 (74 FR 11100) (FRL–8405–1), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 8F7467) 

by JABB of the Carolinas, P.O. Box 310, 

Pine Level, NC 27568. The company’s 

supporting documents for the notice of 

filing of the petition incorrectly 

assigned PP 5F6960 to this petition. The 

petition requested that 40 CFR 180.1273 

be amended by expanding the uses 

covered by the existing exemption from 

the requirement of a tolerance for 

residues of Beauveria bassiana HF23. 

This notice indicated that a summary of 

the petition prepared by the petitioner 

was included in the docket for this 

action. 

One anonymous public comment was 

posted to the docket asserting that foods 

should have zero pesticide residues and 

requested labeling for all foods with any 

residue above the zero level. The 

commenter also referred to the toxicity 

of chemicals and their possible link to 

cancer. 

The Agency’s response to this 

comment follows. This active 

ingredient, Beauveria bassiana HF23, 

occurs naturally in the environment and 

the human population is potentially 

exposed to it regardless of whether it is 

registered as a pesticide or not. Thus, it 

is not even possible to eliminate 

exposure to this substance since it is a 

naturally occurring ubiquitous soil 

microbe. 

EPA regulates pesticides according to 

peer-reviewed and publicly available 

guidelines that describe endpoints for 

human health risk assessment. Tests are 

conducted with the active ingredient or 

end-use product in surrogate animals 

through various routes of administration 

(i.e., oral, dermal, pulmonary, etc.). Any 

effects seen are reported to the Agency, 

peer-reviewed, and evaluated to 

determine whether the effects of the test 

material demonstrate infectivity, acute 

toxicity, or pathogenicity. Beauveria 

bassiana HF23 has demonstrated a low 

toxicity profile in such testing and did 

not trigger the need for further testing 

for carcinogenicity. Summaries of data 

reviewed in support of this active 

ingredient are available in the 

Biopesticide Registration Action 

Document (BRAD) on Beauveria 

bassiana HF23 (www.epa.gov/pesticide/ 

biopesticides) and in the final rule 

published for use of the active 

ingredient for chicken manure treatment 

in the Federal Register on January 10, 

2007 (72 FR 1177) (FRL–8108–4). 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 


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10188 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues ’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

Beauveria bassiana HF23 is a fungus 

with insecticidal properties. It is a 

naturally occurring, ubiquitous soil 

microbe. This strain, and other strains of 

Beauveria bassiana that are registered as 

pesticides, demonstrate low toxicity 

potential and are not likely to harm 

human adults, infants, and children. An 

exemption from tolerance has already 

been established in 40 CFR 180.1273 for 

residues of Beauveria bassiana HF23 on 

all food/feed commodities, when the 

pesticide is used to treat chicken 

manure (72FR 1177, January 10, 2007). 

The toxicological profile of this active 

ingredient was published in that final 

rule and summaries of the studies cited 

in support of this tolerance exemption 

amendment are available in the BRAD 

on www.epa.gov/pesticides/ 

biopesticides. The registrant now cites 

those data and provides additional 

information to support expanding the 

tolerance exemption to include residues 

on food/feed commodities from 

agricultural crops fertilized with 

manure from livestock facilities, where 

the manure was treated with Beauveria 

bassiana HF23. Reference to those 

studies are included in the following 

discussion. 

Based on the previously reviewed 

data, the Agency classified the active 

ingredient as Toxicity Category IV for 

acute oral and acute pulmonary effects 

and Toxicity Category III for acute 

dermal effects. These studies indicated 

that the pesticide was not toxic, 

infective or pathogenic via these routes 

of exposure. Also, the test organism was 

not toxic or pathogenic to rats via the 

intraperitoneal route. Immunotoxicity 

testing is not required for this active 

ingredient because it does not contain 

viruses that are known to interact in an 

adverse manner with the mammalian 

immune system. 

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 Beauveria 

bassiana HF23 must be reported to the 

Agency, in accordance with the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) section 6(a)(2). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational 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. The pesticide is intended for 

the control of houseflies in livestock 

and chicken facilities. In livestock 

facilities, the pesticide is to be applied 

as bait in stations that are not within 

reach of livestock or as a spray to the 

facilities. In chicken facilities, the 

pesticide is applied directly onto the 

chicken manure to control houseflies as 

well as to the walls of the chicken 

houses. The pesticide is not applied 

directly either to chicken or livestock, 

nor is it applied directly to food or feed. 

In light of these uses in chicken and 

livestock facilities, the Agency has 

evaluated whether there is any potential 

for residues of the pesticide to result in 

or on meat, milk, poultry, eggs, or other 

products derived from chickens or 

livestock present in such facilities. In 

addition, the Agency has considered 

whether there is any potential for 

residues to result in food or feed crops 

as a result of the use of treated manure 

as fertilizer for agricultural crops. 

With respect to meat, milk, poultry, 

eggs, or other products derived from 

chickens or livestock, the Agency has 

considered the following. First, as 

already explained in the aforementioned 

BRAD and in the prior final rule 

granting a tolerance exemption for 

Beauveria bassiana HF23 (Unit III.A. 

and B., 72 FR 1177, January 10, 2007), 

the acute oral and dermal toxicity tests 

in mammals resulted in the Agency 

classifying the fungus as a low Toxicity 

Category IV for acute oral effects and 

Toxicity Category III for acute dermal 

effects. Second, acute toxicology tests 

involving dermally administered 

Beauveria bassiana HF23 led to a 

toxicity Category III acute dermal 

classification for the fungus. Third, 

there were no signs of infectivity in 

tissues examined during the acute 

intraperitoneal test in mammalian 

rodents. Fourth, an acute oral toxicity 

test conducted in chicken also 

demonstrated that the active ingredient 

is not toxic, infective or pathogenic to 

chicken. Fifth, clearance was observed 

in all tissues analyzed during these 

avian and mammalian tests and they 

were conducted with guideline levels of 

the active ingredient, with no toxic, 

infective or pathogenic effects to the 

avian and mammalian test organisms. 

Summaries of these tests can be found 

in the prior final rule published on 

January 10, 2007 (72 FR 1177, Unit III. 

A, B, and E) and in the BRAD for 

Beauveria bassiana HF23. Based on all 

of this, the Agency concludes that 

residues of the pesticide are not likely 

to be transferred to meat, milk, eggs, 

poultry or other products derived from 

chicken and livestock as a result of 

treating chicken and livestock facilities 

with the pesticide. 

Moreover, to the extent that there 

could be negligible residues resulting in 

meat, milk, eggs, poultry, or other 

products derived from the chicken and 

livestock from such facilities, it is 

expected that they will not be greater 

than naturally occurring background 

levels to which humans already are 

possibly exposed due to the fact that 

this is a ubiquitous soil microbe. In 

addition, to the extent that there were 

any potential negligible residues of the 

fungus Beauveria bassiana HF23 

resulting in meat, milk, eggs, poultry, or 

other products derived from the chicken 

or livestock from treated facilities, 

which, again, is unlikely and not 

expected, it is expected that they would 

be removed in connection with the steps 

taken to prepare such products for 

market and consumption. For example, 

the shells of eggs are washed, and eggs 

are cooked prior to human 

consumption. The shells also can be 

expected to prevent any residues of the 

pesticide from getting into the edible 


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Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 10189 

portions of eggs. Feathers are removed 

from chickens and hides from livestock 

during dressing operations and meat 

and poultry preparation. These 

measures are expected to remove any 

potential negligible residues prior to 

human consumption. Similarly, 

washing, cleaning and other processes 

when preparing meat, as well as the 

pasteurization of milk, would remove 

any potential negligible residues from 

meat and milk. 

In connection with the use of treated 

manure as fertilizer for agricultural 

crops, the Agency has concluded that 

while it is possible for extremely low or 

negligible residues to result in or on 

food and feed derived from those crops, 

this, nonetheless, is unlikely for the 

following reasons. First, prior to being 

used on agricultural crops, chicken and 

livestock manure is composted. This is 

significant because Beauveria bassiana 

HF23 does not survive temperatures 

greater than 37 degrees Centigrade (the 

average mammalian body temperature), 

and thus, would not be expected to 

survive the higher temperatures of 

composting (40-50 degrees Centigrade 

on average) (Master Records 

Identification (MRID)) 46526011. In 

addition, Beauveria bassiana HF23 does 

not survive in Ultraviolet (UV) light, so 

it is likely that any residues that 

survived composting would be 

destroyed by UV light once the treated 

manure is applied to agricultural crops 

in the field if the pesticide is used as 

labeled. 

On the basis of the foregoing 

considerations, and mindful of the 

previously mentioned studies that 

indicate that Beauveria bassiana HF23 

is not toxic, infective or pathogenic via 

the tested routes of exposure, is not 

toxic or pathogenic to rats via the 

intraperitoneal route, and does not 

contain viruses that are known to 

interact in an adverse manner with the 

mammalian immune system, the 

Agency concludes that no harm is 

expected to human adults, children, or 

infants via consumption of any food 

products derived from chicken or 

livestock potentially exposed to the 

pesticide as a result of its use (in 

accordance with label directions) in 

chicken and livestock facilities, or via 

consumption of any food products 

derived from agricultural crops to which 

treated manure has been applied as a 

fertilizer. 

2. Drinking water exposure. No 

drinking water exposure is anticipated 

because of the use patterns, use sites, 

and the nature of the active ingredient 

at issue. The pesticide is to be used for 

indoor treatment of chicken and 

livestock facilities. It will be applied in 

either a suspension or a granular bait 

formulation. Most notably, there are no 

aquatic use sites permitted for this 

pesticide. Thus, there is likely to be no 

access to sources of drinking water as a 

result of applications within such 

facilities. Moreover, even if the 

pesticide did somehow reach drinking 

water as a result of the permitted indoor 

uses, Beauveria bassiana HF23 is not 

known to proliferate in aquatic 

environments (BRAD Chapter III.C). 

The Agency also does not expect any 

residues in drinking water or ground 

water as a result of application of 

treated manure that is used as fertilizer 

on agricultural crops. Beauveria 

bassiana HF23 is a soil microbe. As 

discussed in Unit IV.A.1, this microbe is 

not likely to survive composting 

temperatures or subsequent exposure to 

UV light. In addition, because soil 

microbes generally tend to seek their 

nutrients and grow in the upper levels 

of soil and do not, as a result, penetrate 

lower soil levels that are more akin to 

filtration beds, Beauveria bassiana HF23 

is not expected to percolate into soil and 

reach ground water (see BRAD Chapter 

III.C.). Thus, transfer of this naturally 

occurring, low toxicity, soil borne 

microbe from soil to ground water is 

unlikely. 

Accordingly, the Agency concludes 

that Beauveria bassiana HF23, when 

used as labeled and in accordance with 

good agricultural practices, is not likely 

to pose any incremental dietary risk to 

human adults, children, or infants via 

consumption of drinking water (see 

BRAD and 72 FR 1177, Jan. 10, 2007). 

B. Other Non-Occupational Exposure 

1. Dermal exposure. EPA has 

concluded that there is unlikely to be 

any non-occupational dermal exposure 

because the use sites are commercial 

and agricultural. 

2. Inhalation exposure. Similarly, 

non-occupational inhalation exposure to 

Beauveria bassiana HF23 from its 

proposed commercial and agricultural 

use as a pesticide to treat chicken 

manure or livestock facilities is not 

anticipated. 

In summary, the potential aggregate 

exposure as a result of the use of the 

pesticidal active ingredient Beauveria 

bassiana HF23 is not likely to pose a 

hazard via aggregate exposure. This 

includes potential hazards derived from 

(i.) dietary exposure from the treated 

food/feed commodities, (ii.) drinking 

water potentially exposed secondary to 

treatment of sites with this pesticide; 

and (iii.) dermal and inhalation nonoccupational exposure of populations 

exposed to Beauveria bassiana HF23. 

V. Cumulative Effects 

Three other Beauveria bassiana 

strains are registered. While they show 

the same mechanism as 

entomopathogens, they are involved in 

treatments of specific target pests. In 

this instance, Beauveria bassiana HF23 

is directed against the public health 

hazard, houseflies. Because Beauveria 

bassiana HF23 does not operate via a 

toxic mechanism, section 408(b)(2)(D)(v) 

does not apply. In any event, since none 

of the registered strains are toxic, 

infective or pathogenic to humans and 

other mammals or other non-target 

organisms, cumulative adverse health or 

environmental effects of Beauveria 

bassiana HF23 are not expected. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

The Agency has concluded that there 

is a reasonable certainty that no harm 

will result from aggregate exposures to 

Beauveria bassiana HF23 in or on all 

food commodities, when the pesticide is 

used to treat manure in chicken and 

livestock facilities, which manure will 

in turn be used as fertilizer on 

agricultural crops. The Agency bases 

this conclusion on the data that 

demonstrate this substance has little to 

no toxicity or infectivity. Based on all 

the available information, the Agency 

concludes that the fungus, Beauveria 

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 Beauveria 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 exposure 

(safety) approach to assess the safety of 

Beauveria bassiana HF23. 

VII. Other Considerations 

A. Endocrine Disruptors 

See Federal Register, 72 FR 1177, 

January 10, 2007. 

B. Analytical Method(s) 

See Federal Register, 72 FR 1177, 

January 10, 2007. 

C. Codex Maximum Residue Level 

There is no Codex Maximum Residue 

Level (MRL) for residues of Beauveria 

bassiana HF23 on all food commodities. 

VIII. Conclusions 

In summary, the Agency has 

determined that, based on available data 


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10190 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 

and information, there is a reasonable 

certainty of no harm from aggregate 

exposure to Beauveria bassiana HF23 

on all food commodities, resulting 

either from its use (in accordance with 

all label direction and good agricultural 

practices) in chicken and livestock 

facilities or as a result of the subsequent 

use of treated manure from livestock 

and chicken facilities as fertilizer on 

agricultural crops. Thus, an exemption 

from the requirement of a tolerance is 

being granted for residues of Beauveria 

bassiana HF23 on all food commodities 

in response to pesticide petition PP 

8F7467. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

X. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 25, 2010. 

Keith A. Matthews, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 

180.1273 continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In subpart D, revise §180.1273 to 

read as follows: 

§ 180.1273. Beauveria bassiana HF23; 

exemption from the requirement of a 

tolerance. 

Residues of Beauveria bassiana HF23 

are exempt from the requirement of a 

tolerance on all food/feed commodities, 

when the pesticide is used for the 

treatment of chicken and livestock 

facilities, including the treatment of 

chicken and livestock manure. 

[FR Doc. 2010–4544 Filed 3–4–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 217 

Defense Federal Acquisition 

Regulation Supplement; Payment of 

Costs Prior to Definitization-Definition 

of Contract Action (DFARS Case 2009– 

D035) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Interim rule with request for 

comments. 

SUMMARY: DoD is issuing an interim rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement section 812 of 

the National Defense Authorization Act 

for Fiscal Year 2010 (Pub. L. 111–84, 

enacted October 28, 2009). 

DATES: Effective Date: March 5, 2010. 

Comment date: Comments on the 

interim rule should be submitted in 

writing to the address shown below on 

or before May 4, 2010, to be considered 

in the formation of the final rule. 

ADDRESSES: Submit comments 

identified by DFARS Case 2009–D035, 

using any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: dfars@osd.mil. Include 

DFARS Case 2009–D035 in the subject 

line of the message. 

• Fax: 703–602–0350. 

• Mail: Defense Acquisition 

Regulations System, Attn: Ms. Meredith 

Murphy, OUSD (AT&L) DPAP (DARS), 

Room 3B855, 3060 Defense Pentagon, 

Washington, DC 20301–3060. 

• Hand Delivery/Courier: Defense 

Acquisition Regulations System, Crystal 

Square 4, Suite 200A, 241 18th Street, 

Arlington, VA 22202–3402. 

Comments received generally will be 

posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 


erowe on DSK5CLS3C1PROD with RULES