Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations 16297 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. 

This deviation from the operating 

regulations is authorized under 33 CFR 

117.35. 

Dated: February 18, 2011. 

Waverly W. Gregory, Jr., 

Chief, Bridge Administration Branch, Fifth 

Coast Guard District. 

[FR Doc. 2011–6879 Filed 3–22–11; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2011–0121] 

Drawbridge Operation Regulation; 

Cerritos Channel, Long Beach, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Eleventh 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the 

Commodore Schuyler F. Heim 

Drawbridge across Cerritos Channel, 

mile 4.9, at Long Beach, CA. The 

deviation is necessary to allow the 

California Department of Transportation 

to perform critical repair and 

replacement of electrical components 

for drawspan operation. 

DATES: This deviation is effective from 

7 a.m. to 7 p.m. on March 26, 2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of the docket USCG– 

2011–0121 and are available online by 

going to http://www.regulations.gov, 

inserting USCG–2011–0121 in the 

‘‘Keyword’’ box and then clicking 

‘‘Search’’. They are also available for 

inspection or copying at the Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail David H. Sulouff, Chief, Bridge 

Section, Eleventh Coast Guard District; 

telephone 510–437–3516, e-mail 

David.H.Sulouff@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The 

California Department of Transportation 

requested a temporary change to the 

operation of the Commodore Schuyler 

F. Heim Drawbridge, mile 4.9, over 

Cerritos Channel, at Long Beach, CA. 

The drawbridge navigation span 

provides a vertical clearance of 37 feet 

above Mean High Water in the closedto-navigation position and 163 feet in 

the full open to navigation position. As 

required by 33 CFR 117.147, the draw 

shall open on signal; except that, from 

6:30 a.m. to 8 a.m. and 3:30 p.m. to 6 

p.m., Monday through Friday except 

Federal holidays, the draw need not be 

opened for the passage of vessels. 

Navigation on the waterway is 

commercial, recreational, search and 

rescue, and law enforcement. 

The drawspan will be secured in the 

closed-to-navigation position from 7 

a.m. through 7 p.m. on March 26, 2011 

to perform critical repair and 

replacement of electrical components 

for drawspan operation. The alternative 

path around Terminal Island will be 

available for routine and emergency 

navigation. This temporary deviation 

has been coordinated with commercial 

and recreational waterway users. No 

objections to the proposed temporary 

deviation were raised. 

Vessels that can transit the bridge, 

while in the closed-to-navigation 

position, may continue to do so at any 

time. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: March 9, 2011. 

D.H. Sulouff, 

District Bridge Chief, Eleventh Coast Guard 

District. 

[FR Doc. 2011–6880 Filed 3–22–11; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0101; FRL–8868–7] 

Aspergillus flavus AF36; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the microbial 

pesticide, Aspergillus flavus AF36, in or 

on corn food and feed commodities, 

when applied/used as an antifungal 

agent. The Arizona Cotton Research and 

Protection Council submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

an amendment to the existing 

exemption from the requirement of a 

tolerance for Aspergillus flavus AF36. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of Aspergillus flavus AF36 

under the FFDCA. 

DATES: This regulation is effective 

March 23, 2011. Objections and requests 

for hearings must be received on or 

before May 23, 2011, 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–2010–0101. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The Docket 

Facility is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Shanaz Bacchus, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

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 


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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. 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–2010–0101 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 May 23, 2011. 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–2010–0101, by one of 

the following methods: 

• Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

• Mail: 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 3, 

2010 (75 FR 9596) (FRL–8811–2), 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 9E7662) 

by the Arizona Cotton Research and 

Protection Council, 3721 East Wier 

Ave., Phoenix, AZ 85040–2933. The 

petition requested that 40 CFR 180.1206 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Aspergillus 

flavus AF36 in or on corn food and feed 

commodities. This notice referenced a 

summary of the petition prepared on 

behalf of the petitioner, Arizona Cotton 

Research and Protection Council, which 

is available in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit VII.C. 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

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

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. * * *’’ 

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

FFDCA requires that EPA consider 

‘‘available information concerning the 

cumulative effects of [a particular 

pesticide’s] residues and other 

substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

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. 

The nature and toxicological profile of 

Aspergillus flavus AF36 was previously 

described in the Federal Register of July 

14, 2003 (68 FR 41541) (FRL–7311–6). 

Those health effects data were the basis 

for establishing the tolerance exemption 

for Aspergillus flavus AF36, a nonaflatoxin-producing strain of Aspergillus 

flavus, in or on cotton and its food/feed 

commodities in 40 CFR 180.1206 and 

also for temporary tolerance exemptions 

for experimental use of Aspergillus 

flavus AF36 on pistachio (72 FR 28871, 

May 23, 2007) (FRL–8129–4) and on 

corn (72 FR 72965, Dec. 26, 2007) (FRL– 

8342–1). EPA has reviewed the available 

data in support of this action. 

Aspergillus flavus AF36 is neither 

toxic nor infective via the oral and 

pulmonary routes. It was placed in 

Toxicity Category IV for acute oral 

effects. The Toxicity Category III 

designation for acute inhalation effects 

is based on the granular nature of the 

pesticide and the submitted pulmonary 

studies. This microbial pesticide has 

been used for more than a decade in 

experimental laboratory and field trials 

and in agricultural practice on cotton in 

Arizona, California, and Texas without 

any reports of adverse dermal irritation 

or hypersensitivity effects. Data and 

information from the public literature 


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indicate that there will not be any 

incremental harm from the use of 

Aspergillus flavus AF36 for reduction of 

aflatoxin. No further toxicological data 

are required to support this exemption 

from the requirement of a tolerance for 

Aspergillus flavus AF36 in or on the 

food and feed commodities of corn. 

IV. Aggregate Exposure 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other 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. Current uses of Aspergillus 

flavus AF36 include use on cotton, 

pistachios, and corn. EPA does not 

expect these uses to result in any 

exposure that is greater than background 

levels of Aspergillus flavus. As a 

microbial pesticide for use on corn, 

Aspergillus flavus AF36 is labeled for 

application from the V7 growth stage 

(i.e., approximately 21–25 days after 

plant emergence) until silking (i.e., 

approximately 55–66 days after plant 

emergence). Once applied to corn and 

after exposure to moisture, Aspergillus 

flavus AF36 germinates, using the 

carrier upon which it is placed as a 

nutrient source, and effectively 

displaces aflatoxin-producing strains of 

Aspergillus flavus without increasing 

levels of cyclopiazonic acid (Ref. 1). 

Further, multiple-year studies, which 

monitored air and soil populations of 

Aspergillus flavus, including strain 

AF36, in cotton fields, demonstrated 

replacement of toxigenic (aflatoxinproducing) fungi with atoxic fungi 

without an increase in the overall 

quantity of Aspergillus flavus beyond 

normal background levels (Refs. 2 and 

3). Although residues from the use of 

pesticides containing Aspergillus flavus 

AF36 will likely be present on corn at 

the time of harvest (although likely not 

at higher levels than background), much 

like other microbial pest control agents, 

commodity-processing procedures (e.g., 

peeling, shucking, washing, and 

cooking) should further reduce levels of 

Aspergillus flavus AF36 below typical 

background levels (Ref. 4). Finally, even 

with the potential for negligible 

exposure to Aspergillus flavus AF36 on 

edible corn commodities, a previously 

reviewed and described acute oral 

toxicity and pathogenicity study (see 

Unit III. of the Federal Register of July 

14, 2003 (68 FR 41541) (FRL–7311–6)) 

showed no toxicity or infectivity in 

animals exposed to high levels of this 

active ingredient. 

2. Drinking water exposure. Exposure 

to Aspergillus flavus AF36 via drinking 

water from all uses of Aspergillus flavus 

AF36 is not likely to be greater than 

current/existing exposures to 

Aspergillus flavus strains, which are 

already present in the environment. 

Potential risks via exposure to drinking 

water or runoff may be mitigated by, 

among other things, percolation through 

soil. Thus, EPA expects exposure via 

drinking water from the proposed use of 

this non-aflatoxin-producing strain of 

Aspergillus flavus to be low, or at least 

not greater than existing background 

levels. In any event, any drinking water 

exposure is not likely to pose any 

incremental risk to adult humans, 

infants and children because of the lack 

of toxicity or infectivity of this 

substance. In fact, displacement of the 

toxigenic strains of Aspergillus flavus by 

AF36 may decrease exposure and risk to 

the toxigenic strains of Aspergillus 

flavus in the environment. 

B. Other Non-Occupational Exposure 

Dermal and inhalation nonoccupational exposure are expected to 

be minimal to non-existent for the 

proposed use of Aspergillus flavus AF36 

in or on corn. Aspergillus flavus AF36 

is to be applied to agricultural sites not 

in the proximity of residential areas, 

schools, nursing homes, or daycares. 

Additionally, the Aspergillus flavus 

AF36 product to be applied to corn is 

in a granular form, thereby minimizing 

spray drift even for application methods 

(e.g., aerial) that may be more likely to 

result in pesticide movement offsite. 

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, 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 has not found Aspergillus flavus 

AF36 to share a common mechanism of 

toxicity with any other substances, and 

Aspergillus flavus AF36 does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that Aspergillus flavus AF36 

does not have a common mechanism of 

toxicity with other substances. 

Following from this, therefore, EPA 

concludes that there are no cumulative 

effects associated with Aspergillus 

flavus AF36 that need to be considered. 

For information regarding EPA’s efforts 

to determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

There is reasonable certainty that no 

harm will result from aggregate 

exposures to residues of Aspergillus 

flavus AF36, in its use as an antifungal 

agent, to the U. S. population, including 

infants and children. 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 antifungal agent via dietary 

exposure since the organism is nontoxic and non-pathogenic to animals 

and humans. EPA has arrived at this 

conclusion based on the very low levels 

of mammalian toxicity for acute oral 

and pulmonary effects with no toxicity 

or infectivity at the doses tested (See 

Unit III. above). 

FFDCA section 408(b)(2)(C) provides 

that EPA shall apply an additional tenfold 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 unless 

EPA determines that a different margin 

of exposure (safety) will be safe for 

infants and children. Margins of 

exposure (safety) are often referred to as 

uncertainty (safety) factors. In this 

instance, based on all the available 

information, EPA concludes that the 

fungus, Aspergillus flavus AF36, is nontoxic to mammals, including infants and 

children. Because there are no threshold 

effects of concern to infants, children 

and adults when Aspergillus flavus 

AF36 is used as labeled, the provision 

requiring an additional margin of safety 

does not apply. As a result, EPA has not 

used a margin of exposure (safety) 

approach to assess the safety of 

Aspergillus flavus AF36. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since 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 


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international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. In this context, EPA considers 

the international maximum residue 

limits (MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for Aspergillus flavus AF36. 

C. Response to Comments 

In total, four comments were received 

in response to the Federal Register 

notice published by EPA to announce 

receipt of the Arizona Cotton Research 

and Protection Council’s petition. Three 

comments expressed support for the 

petition, while the other comment was 

filed in opposition. 

The one substantive, negative 

comment indicated overall support for 

Aspergillus flavus NRRL 21882, another 

microbial pesticide intended for 

aflatoxin reduction. Primarily, this 

commenter articulated concern about 

the possible expression of cyclopiazonic 

acid (CPA) by the Aspergillus flavus 36 

atoxigenic strain. That is, the 

commenter asserted that, while 

reduction of aflatoxin is an admirable 

goal, the substitution of one mycotoxin, 

aflatoxin, for another, CPA (albeit a less 

toxic one), was not acceptable. The 

commenter claimed that CPA could 

only be observed in field trials and was 

not directly observed by analysis of the 

active ingredient. 

Field trial data presented by the 

petitioner to EPA demonstrated that 

there was no increase in CPA levels 

above background in treated corn. In 

addition, the use of Aspergillus flavus 

AF36 reduced aflatoxin levels in the 

treated fields compared to untreated 

plots. Given this new information (See 

Ref. 1), as well as previously reviewed 

data on Aspergillus flavus AF36, 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 Aspergillus flavus AF36 in 

or on the food and feed commodities of 

corn, when applied/used as an 

antifungal agent. Thus, under the 

standard in FFDCA section 408(c)(2), a 

tolerance exemption is appropriate. 

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 Aspergillus 

flavus AF36. Therefore, an exemption is 

established for residues of Aspergillus 

flavus AF36 in or on corn, field, forage; 

corn, field, grain; corn, field, stover; 

corn, field, aspirated grain fractions; 

corn, sweet, kernel plus cob with husk 

removed; corn, sweet, forage; corn, 

sweet, stover; corn, pop, grain; and corn, 

pop, stover, when applied/used as an 

antifungal agent. 

IX. References 

1. U.S. EPA. 2011. Aspergillus flavus AF36 

Use on Corn. Memorandum from J.V. 

Gagliardi, PhD and J.L. Kough, PhD to S. 

Bacchus dated February 24, 2011 

(available as ‘‘Supporting & Related 

Materials’’ within docket ID number 

EPA–HQ–OPP–2010–0101 at http:// 

www.regulations.gov.). 

2. U.S. EPA. 2003. Environmental Hazard 

Assessment for the Microbial Pesticide, 

Aspergillus flavus AF36 for Conditional 

Registration in Arizona and EUP 

Extension in Texas. Memorandum from 

G.S. Tomimatsu, PhD and Z. Vaituzis, 

PhD to S. Bacchus dated May 16, 2003. 

3. U.S. EPA. 2003. BPPD Review of Soil and 

Air Monitoring Studies and Product 

Performance Testing (Efficacy) 

Submitted by USDA Southern Regional 

Research Center/IR–4 as a Condition of 

Registration and EUP Extension (Texas) 

for Aspergillus flavus AF36. 

Memorandum from G.S. Tomimatsu, 

PhD and J. Kough, PhD to S. Bacchus 

dated May 15, 2003. 

4. U.S. EPA. 1996. Microbial Pesticide Test 

Guidelines—Background for Residue 

Analysis of Microbial Pest Control 

Agents (OPPTS 885.2000). Available 

from: http://www.epa.gov/ocspp/pubs/ 

frs/publications/Test_Guidelines/ 

series885.htm. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under section 408(d) of 

FFDCA in response to a petition 

submitted to EPA. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

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

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes. 

As a result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

EPA has determined that this action will 

not have a substantial direct effect on 

States or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, EPA has determined that 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

EPA consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 


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Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Rules and Regulations 16301 

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: March 11, 2011. 

Keith A. Matthews, 

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 

continues to read as follows: 

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

■ 2. Section 180.1206, paragraph (c) is 

revised to read as follows: 

§ 180.1206 Aspergillus flavus AF36; 

exemption from the requirement of a 

tolerance. 

* * * * * 

(c) An exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus AF36 

in or on corn, field, forage; corn, field, 

grain; corn, field, stover; corn, field, 

aspirated grain fractions; corn, sweet, 

kernel plus cob with husk removed; 

corn, sweet, forage; corn, sweet, stover; 

corn, pop, grain; and corn, pop, stover, 

when applied/used as an antifungal 

agent. 

[FR Doc. 2011–6545 Filed 3–22–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0099; FRL–8863–8] 

Flubendiamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

modifies and/or revokes tolerances for 

residues of flubendiamide N 2-[1,1- 

dimethyl-2-(methylsulfonyl)ethyl]-3- 

iodo-N 1-[2-methyl-4-[1,2,2,2-tetrafluoro1-(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on 

multiple food and livestock 

commodities which are identified, and 

will be discussed in detail later in this 

document. Bayer CropScience LP in 

c/o Nichino America, Inc. (U.S. 

subsidiary of Nihon Nohyaku Co., Ltd.) 

requested these tolerances, and 

revisions to tolerances under the 

Federal Food, Drug and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

March 23, 2011. Objections and requests 

for hearings must be received on or 

before May 23, 2011, 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–2007–0099. 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 

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: 

Carmen Rodia, Registration Division 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; fax number: 

(703) 308–0029; e-mail address: 

rodia.carmen@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How 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. 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–2007–0099 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 May 23, 2011. 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–2007–0099, by one of 

the following methods: 


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