Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14287 

TABLE 2B TO SUBPART E OF PART 59—REACTIVITY FACTORS FOR ALIPHATIC HYDROCARBON SOLVENT MIXTURES— 

Continued 

Bin 

Average 

boiling 

point* 

(degrees F) 

Criteria 

Reactivity 

factor 

(g O3/g VOC) 

12 ...... >340–460 N- & Iso-Alkanes (≥90% and <2% Aromatics) ............................................................................................ 0.81 

13 ...... >340–460 Cyclo-Alkanes (≥90% and <2% Aromatics) ................................................................................................ 1.01 

14 ...... >340–460 Alkanes (2 to <8% Aromatics) ..................................................................................................................... 1.21 

15 ...... >340–460 Alkanes (8 to 22% Aromatics) ..................................................................................................................... 1.82 

16 ...... >460–580 Alkanes (<2% Aromatics) ............................................................................................................................ 0.57 

17 ...... >460–580 N- & Iso-Alkanes (≥90% and <2% Aromatics) ............................................................................................ 0.51 

18 ...... >460–580 Cyclo-Alkanes (≥90% and <2% Aromatics) ................................................................................................ 0.63 

19 ...... >460–580 Alkanes (2 to <8% Aromatics) ..................................................................................................................... 0.88 

20 ...... >460–580 Alkanes (8 to 22% Aromatics) ..................................................................................................................... 1.49 

* Average Boiling Point = (Initial Boiling Point + Dry Point)/2(b) Aromatic Hydrocarbon Solvents 

■ 6. Table 2C to Subpart E of Part 59 is 

revised to read as follows: 

TABLE 2C TO SUBPART E OF PART 59—REACTIVITY FACTORS FOR AROMATIC HYDROCARBON SOLVENT MIXTURES

Bin 

Boiling 

range 

(degrees F) 

Criteria 

Reactivity 

factor 

(g O3/g VOC) 

21 ...... 280–290 Aromatic Content (≥98%) ............................................................................................................................ 7.37 

22 ...... 320–350 Aromatic Content (≥98%) ............................................................................................................................ 7.51 

23 ...... 355–420 Aromatic Content (≥98%) ............................................................................................................................ 8.07 

24 ...... 450–535 Aromatic Content (≥98%) ............................................................................................................................ 5.00 

[FR Doc. 2012–5648 Filed 3–8–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0158; FRL–9341–5] 

Aspergillus flavus AF36; Amendment 

to an Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing temporary tolerance exemption 

for Aspergillus flavus AF36 by 

establishing a permanent exemption 

from the requirement of a tolerance for 

residues of the microbial pesticide, 

Aspergillus flavus AF36, in or on 

pistachio when applied as an antifungal 

agent and used in accordance with good 

agricultural practices. On behalf of the 

Arizona Cotton Research and Protection 

Council, Interregional Research Project 

Number 4 submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting that 

EPA amend an existing temporary 

tolerance exemption 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 9, 2012. Objections and requests 

for hearings must be received on or 

before May 8, 2012, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA established a docket 

for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0158. 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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; email address: kausch.

jeannine@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 


erowe on DSK2VPTVN1PROD with RULES
14288 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://ecfr.

gpoaccess.gov/cgi/t/text/text-idx?&c=

ecfr&tpl=/ecfrbrowse/Title40/40tab_02.

tpl. 

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–2007–0158 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 8, 2012. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2007–0158, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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 April 20, 

2011 (76 FR 22067) (FRL–8869–7), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 1E7830) by 

Interregional Research Project Number 4 

(IR–4), Rutgers University, 500 College 

Rd. East, Suite 201W, Princeton, NJ 

08540 (on behalf of 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 a permanent exemption 

from the requirement of a tolerance for 

residues of Aspergillus flavus AF36 in 

or on pistachio. This notice referenced 

a summary of the petition prepared by 

the petitioner, IR–4 (on behalf of the 

Arizona Cotton Research and Protection 

Council), which is available in the 

docket via http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance exemption and to ‘‘ensure that 

there is a reasonable certainty that no 

harm will result to infants and children 

from aggregate exposure to the pesticide 

chemical residue * * *.’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that EPA consider ‘‘available 

information concerning the cumulative 

effects of [a particular pesticide’s] * * * 

residues and other substances that have 

a common mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

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 FFDCA section 

408(b)(2)(D), EPA reviewed the available 

scientific data and other relevant 

information in support of this action 

and considered its validity, 

completeness and reliability, and the 

relationship of this information to 

human risk. EPA also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

The nature and toxicological profile of 

Aspergillus flavus AF36, a nonaflatoxin-producing strain of Aspergillus 

flavus, was described extensively in the 

Federal Register of July 14, 2003 (68 FR 

41535) (FRL–7311–6). ‘‘Those health 

effects data were the basis for 

establishing the tolerance exemption for 

Aspergillus flavus AF36 in or on cotton 

(see the Federal Register of July 14, 

2003) and corn (see the Federal Register 

of March 23, 2011 (76 FR 16297) (FRL– 

8868–7)) and their food/feed 

commodities and also for temporary 

tolerance exemptions for experimental 

use of Aspergillus flavus AF36 on 

pistachio (see the Federal Register of 

May 23, 2007 (72 FR 28868) (FRL–8129– 

4)) and on corn (see the Federal Register 

of December 26, 2007 (72 FR 72693) 

(FRL–8342–1)).’’ The petitioner has now 

requested that EPA establish a 

permanent exemption from the 

requirement of a tolerance for residues 

of Aspergillus flavus AF36 in or on 

pistachio by amending 40 CFR 

180.1206. EPA reviewed the available 

data and information in support of this 

particular action. 

Aspergillus flavus AF36 is neither 

toxic nor infective via the oral and 

pulmonary routes. EPA has determined 

that AF36 is practically nontoxic for 

acute oral effects and slightly toxic for 

acute inhalation effects. 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. Based on the comprehensive 

toxicological evaluations set forth in 

earlier actions establishing tolerance 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14289 

exemptions for Aspergillus flavus AF36 

in or on cotton (see the Federal Register 

of July 14, 2003) and corn (see the 

Federal Register of March 23, 2011) 

(also, see Ref. 1), EPA concludes that 

there are no toxicological endpoints of 

concern for Aspergillus flavus AF36. 

IV. Aggregate Exposure 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other 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 exposure. Current uses of 

Aspergillus flavus AF36 include use in 

or on cotton and corn. Use on pistachios 

was also permitted under Experimental 

Use Permit No. 71693–EUP–1, which 

expired on December 31, 2011. EPA 

previously evaluated exposure to 

residues of Aspergillus flavus AF36 

through food, resulting from this 

microbial pesticide’s use as an 

antifungal agent in or on cotton and 

corn, in the Federal Register of July 14, 

2003 and March 23, 2011. Overall, EPA 

concluded that human food exposure 

was not expected with Aspergillus 

flavus AF36’s cotton use and was 

expected (although likely not above 

Aspergillus flavus background levels) 

with Aspergillus flavus AF36’s corn use. 

As a microbial pesticide for use on 

pistachio, Aspergillus flavus AF36 is 

intended for a single broadcast soil 

application from late May to early July. 

Once applied to pistachio and after 

exposure to moisture, Aspergillus flavus 

AF36 germinates, using the carrier upon 

which it is placed as a nutrient source, 

and displaces aflatoxin-producing 

strains of Aspergillus flavus (Ref. 2). 

Further, multiple-year studies, which 

monitored air and soil populations of 

Aspergillus flavus, including strain 

AF36, in untreated and treated cotton 

fields, demonstrated replacement of the 

naturally occurring aflatoxin-producing 

Aspergillus flavus with Aspergillus 

flavus AF36 without an increase in the 

total population of Aspergillus flavus 

beyond normal background levels (Refs. 

3 and 4). Although residues from the 

use of pesticides containing Aspergillus 

flavus AF36 may be present on 

pistachios at the time of harvest, 

commodity processing procedures (e.g., 

roasting and shelling) may further 

reduce residues of Aspergillus flavus 

AF36 (Ref. 5). 

Should this microbial pesticide be 

present on food as a result of the cotton, 

corn, and/or pistachio uses, the results 

of an acute oral toxicity and 

pathogenicity study (see Unit III. of the 

Federal Register of July 14, 2003, as 

well as Ref. 1) demonstrated that no 

toxicity, pathogenicity, and/or 

infectivity is likely to occur with any 

exposure level of Aspergillus flavus 

AF36 resulting from application as an 

antifungal agent in accordance with 

good agricultural practices. 

2. Drinking water exposure. Similar to 

the drinking water exposure scenarios 

described for Aspergillus flavus AF36’s 

cotton and corn uses (see the Federal 

Register of July 14, 2003 and March 23, 

2011) exposure to residues of this 

microbial pesticide in consumed 

drinking water, resulting from pesticidal 

use in or on pistachio, is possible but 

not likely to be greater than current/ 

existing exposures to Aspergillus flavus 

strains, which are already present in the 

environment. Pistachio is grown in an 

arid environment, which minimizes the 

potential for transfer of Aspergillus 

flavus AF36 to surface or ground waters 

that may be used as sources of drinking 

water. Moreover, the pesticide is 

applied only once per growing season at 

a low rate to non-aquatic sites, and 

offsite movement is not anticipated 

since the pesticide is in a granular form. 

If Aspergillus flavus AF36 were to be 

transferred to surface or ground waters 

(e.g., through runoff) that are intended 

for eventual human consumption and 

directed to wastewater treatment 

systems or drinking water facilities, this 

soilborne fungus may not survive some 

of the conditions water is subjected to 

in such systems or facilities, including 

chlorination, pH adjustments, and 

filtration (Refs. 6 and 7). 

Should this microbial pesticide be 

present in drinking water (e.g., water 

not subject to treatment systems or 

facilities) as a result of the cotton, corn, 

and/or pistachio uses, the results of an 

acute oral toxicity and pathogenicity 

study (see Unit III. of the Federal 

Register of July 14, 2003, as well as Ref. 

1) demonstrated that no toxicity, 

pathogenicity, and/or infectivity is 

likely to occur with any exposure level 

of Aspergillus flavus AF36 resulting 

from application as an antifungal agent 

in accordance with good agricultural 

practices. 

B. Other Non-Occupational Exposure 

Non-occupational dermal and 

inhalation exposure is expected to be 

minimal to non-existent for the uses of 

Aspergillus flavus AF36 in or on cotton, 

corn, and pistachio. As described 

previously in the Federal Register of 

July 14, 2003 and March 23, 2011 for 

Aspergillus flavus AF36’s cotton and 

corn uses, this antifungal agent is to be 

applied to agricultural sites and not in 

the proximity of residential areas, 

schools, nursing homes, or day care 

facilities. Additionally, the Aspergillus 

flavus AF36 product to be applied to 

cotton, corn, and pistachio is in a 

granular form, thereby minimizing drift 

even for application methods (e.g., 

aerial) that may be more likely to result 

in offsite pesticide movement and 

exposure. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance exemption, EPA consider 

‘‘available information concerning the 

cumulative effects of [a particular 

pesticide’s] * * * residues and other 

substances that have a common 

mechanism of toxicity.’’ 

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. 

Therefore, section 408(b)(2)(D)(v) of 

FFDCA does not apply. For information 

regarding EPA’s efforts to identify 

chemicals that may have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

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

that, in considering the establishment of 

a tolerance or tolerance exemption for a 

pesticide chemical residue, EPA shall 

assess the available information about 

consumption patterns among infants 

and children, special susceptibility of 

infants and children to pesticide 

chemical residues, and the cumulative 

effects on infants and children of the 

residues and other substances with a 

common mechanism of toxicity. In 

addition, FFDCA section 408(b)(2)(C) 

provides that EPA shall apply an 

additional tenfold (10X) margin of 

exposure (safety) for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure 

unless EPA determines that a different 

margin of exposure (safety) will be safe 


erowe on DSK2VPTVN1PROD with RULES
14290 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 

for infants and children. This additional 

margin of exposure (safety) is commonly 

referred to as the Food Quality 

Protection Act Safety Factor. In 

applying this provision, EPA either 

retains the default value of 10X or uses 

a different additional safety factor when 

reliable data available to EPA support 

the choice of a different factor. 

In this instance, based on all the 

available information, EPA concludes 

that there are no threshold effects of 

concern to infants, children, or adults 

when Aspergillus flavus AF36 is used as 

labeled in accordance with good 

agricultural practices. As a result, EPA 

concludes that no additional margin of 

exposure (safety) is necessary to protect 

infants and children and that not adding 

any additional margin of exposure 

(safety) will be safe for infants and 

children. 

Moreover, based on the same data and 

EPA analysis as presented in this unit, 

the Agency is able to conclude that 

there is a reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposure to the residues of 

Aspergillus flavus AF36 when it is used 

as labeled and in accordance with good 

agricultural practices as an antifungal 

agent. Such exposure 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 microorganism is 

non-toxic and non-pathogenic to 

animals and humans. EPA 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. of this document). 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated in this document and 

because EPA is establishing an 

exemption from the requirement of a 

tolerance without any numerical 

limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. In this context, EPA considers 

the international maximum residue 

limits (MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for Aspergillus flavus AF36. 

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, the existing 

temporary tolerance exemption for 

Aspergillus flavus AF36 is amended by 

establishing a permanent exemption 

from the requirement of a tolerance for 

residues of Aspergillus flavus AF36 in 

or on pistachio when applied as an 

antifungal agent and used in accordance 

with good agricultural practices. 

IX. References 

1. U.S. EPA. 2003a. Aspergillus flavus AF36 

Biopesticides Registration Action 

Document (Dated July 3, 2003). Available 

from http://www.epa.gov/oppbppd1/ 

biopesticides/ingredients/tech_docs/ 

brad_006456.pdf. 

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

use on pistachio. Memorandum from J.V. 

Gagliardi, Ph.D. and J.L. Kough, Ph.D. to 

S. Bacchus dated September 29, 2011. 

3. U.S. EPA. 2003b. 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, Ph.D. and Z. Vaituzis, 

Ph.D. to S. Bacchus dated May 16, 2003. 

Available from 

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

foia/cleared-reviews/reviews/006456/ 

006456-2003-05-16a.pdf. 

4. U.S. EPA. 2003c. 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, 

Ph.D. and J. Kough, Ph.D. to S. Bacchus 

dated May 15, 2003. Available from 

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

foia/cleared-reviews/reviews/006456/ 

006456-2003-05-15a.pdf. 

5. 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. 

6. Centers for Disease Control and 

Prevention. 2009. Drinking Water— 

Water Treatment. Available from http:// 

www.cdc.gov/healthywater/drinking/ 

public/water_treatment.html. 

7. U.S. EPA. 2004. Primer for Municipal 

Wastewater Treatment Systems. EPA 

832–R–04–001. Available from http:// 

www.epa.gov/npdes/pubs/primer.pdf. 

X. Statutory and Executive Order 

Reviews 

This final rule amends a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to EPA. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

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

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ 

(66 FR 28355, May 22, 2001), or 

Executive Order 13045, entitled 

‘‘Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled ‘‘Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are amended on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) 

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

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes. 

As a result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

EPA has determined that this action will 

not have a substantial direct effect on 

States or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14291 

the Federal Government and Indian 

tribes. Thus, EPA has determined that 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

EPA consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 29, 2012. 

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 is amended by 

revising paragraph (b) to read as follows: 

§ 180.1206 Aspergillus flavus AF36; 

exemption from the requirement of a 

tolerance. 

* * * * * 

(b) An exemption from the 

requirement of a tolerance is established 

for residues of Aspergillus flavus AF36 

in or on pistachio when applied as an 

antifungal agent and used in accordance 

with good agricultural practices. 

* * * * * 

[FR Doc. 2012–5769 Filed 3–8–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0349; FRL–9335–7] 

Penthiopyrad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of penthiopyrad 

in or on multiple commodities which 

are identified and discussed later in this 

document. Mitsui Chemical Agro, Inc. 

c/o Landis International Inc. requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 9, 2012. Objections and requests 

for hearings must be received on or 

before May 8, 2012, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0349. 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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; email address: 

maignan.tawanda@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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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–2010–0349 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 


erowe on DSK2VPTVN1PROD with RULES