Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 55799 

POSTAL SERVICE 

39 CFR Part 20 

Outbound International Mailings of 

Lithium Batteries 

AGENCY: Postal ServiceTM. 

ACTION: Final rule; withdrawal. 

SUMMARY: The Postal Service is 

withdrawing a final rule that would 

incorporate new maximum limits for the 

outbound mailing of lithium batteries to 

international, or APO, FPO or DPO 

locations. The Postal Service also 

withdraws the corresponding Code of 

Federal Regulations revision to reflect 

these new limits. 

DATES: The final rule published on 

August 25, 2011 (76 FR 53056–56057), 

is withdrawn effective September 9, 

2011. 

FOR FURTHER INFORMATION CONTACT: Rick 

Klutts at 813–877–0372. 

SUPPLEMENTARY INFORMATION: In a final 

rule with comment period published in 

the Federal Register on August 25, 

2011, the Postal Service provided new 

maximum limits for mailpieces 

containing equipment with lithium 

metal or lithium-ion batteries that were 

to be effective October 3, 2011. These 

revisions were consistent with recent 

amendments to the Universal Postal 

Union (UPU) Convention and 

regulations as announced in 

International Bureau Circulars 114 and 

115, dated June 14, 2011, that affected 

UPU Convention Articles 15 and 16, 

Article RL 131 of the letter post 

regulations, and Article RC 120 of the 

parcel post regulations. 

The withdrawal of the revisions is 

necessary because of a notice to the 

UPU from the International Civil 

Aviation Organization (ICAO) on 

August 19, 2011, requesting that the 

UPU delay implementation of the 

aforementioned amendment until the 

UPU revisions could be reviewed by the 

ICAO Dangerous Goods Panel, and if 

approved, incorporated into The 

Technical Instructions for the Safe 

Transport of Dangerous Goods by Air 

manual. Therefore, the UPU has 

informed its member countries that the 

date of newly adopted UPU 

amendments for lithium batteries will 

be the subject of further notice based on 

the decision of the panel and any 

changes to the ICAO Technical 

Instructions. 

Accordingly, the Postal Service 

withdraws its final rule published on 

August 25, 2011. The Postal Service also 

withdraws the revision to 39 CFR 20.1 

whereby a new section 135.6 was added 

to the Mailing Standards of the United 

States Postal Service, International Mail 

Manual (IMM®) to describe the new 

maximum limits for the outbound 

mailing of lithium batteries to 

international, or APO, FPO or DPO 

locations. The parallel changes that 

were to be made to other USPS 

publications are also withdrawn. 

Stanley F. Mires, 

Chief Counsel, Legislative. 

[FR Doc. 2011–23054 Filed 9–8–11; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[FRL–9460–3] 

Approval of Clean Air Act Prevention 

of Significant Deterioration Permit 

Issued to Avenal Power Center, LLC To 

Construct the Avenal Energy Project 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final Action. 

SUMMARY: This document announces 

that EPA has issued a final permit 

decision granting the Clean Air Act 

Prevention of Significant Deterioration 

(PSD) permit application submitted by 

Avenal Power Center, LLC to authorize 

construction of the Avenal Energy 

Project. 

DATES: The EPA’s PSD permit for the 

Avenal Energy Project became effective 

and final agency action on August 18, 

2011, when administrative review 

procedures were exhausted. Pursuant to 

section 307(b)(1) of the Clean Air Act, 

42 U.S.C. 7607(b)(1), judicial review of 

this permit decision, to the extent it is 

available, may be sought by filing a 

petition for review in the United States 

Court of Appeals for the Ninth Circuit 

within 60 days of September 9, 2011. 

ADDRESSES: The documents relevant to 

the above-referenced action are 

available for public inspection during 

normal business hours at the following 

address: U.S. Environmental Protection 

Agency, Region 9, 75 Hawthorne St., 

San Francisco, CA 94105. To arrange for 

viewing of these documents, call Shirley 

Rivera at (415) 972–3966. 

FOR FURTHER INFORMATION CONTACT: 

Shirley Rivera, Air Division, U.S. 

Environmental Protection Agency, 

Region 9, 75 Hawthorne St., San 

Francisco, CA 94105. The EPA 

Environmental Appeals Board (EAB) 

decision described below is available at 

the following Web site: http://www.epa.

gov/eab/. 

SUPPLEMENTARY INFORMATION: The EPA 

issued a PSD permit on May 27, 2011, 

to Avenal Power Center, LLC for the 

Avenal Energy Project, granting 

approval to construct a new 

600-megawatt natural gas-fired 

combined-cycle power plant in Kings 

County, California. The EPA issued an 

administrative amendment to the permit 

on June 21, 2011, to correct 

typographical errors. The EPA’s 

Environmental Appeals Board (EAB) 

received four petitions for review of the 

permit from the following entities 

within 30 days of the EPA’s service of 

notice of the issuance of the permit: (1) 

El Pueblo Para El Aire y Agua Limpio; 

(2) Greenaction for Health & 

Environmental Justice; (3) Sierra Club 

and Center for Biological Diversity; and 

(4) Mr. Rob Simpson. The EAB denied 

review of these petitions on August 18, 

2011. All conditions of the Avenal 

Power Center, LLC permit for the 

Avenal Energy Project, as amended on 

June 21, 2011, are final and effective. 

Pursuant to 40 CFR 124.19(f)(1), final 

agency action by EPA has occurred 

because of the exhaustion of the agency 

review procedures before the EAB. The 

EPA Administrator has delegated 

authority to the EAB to issue final 

decisions in PSD permit appeals filed 

under 40 CFR part 124. 40 CFR 124.2(a). 

Dated: August 31, 2011. 

Gina McCarthy, 

Assistant Administrator. Office of Air and 

Radiation. 

[FR Doc. 2011–22834 Filed 9–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0639; FRL–8886–8] 

Mandipropamid; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

mandipropamid in or on basil, fresh and 

basil, dried. This action is in response 

to EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on basil. This 

regulation establishes a maximum 

permissible level for residues of 

mandipropamid in or on these 

commodities. The time-limited 

tolerances expire on December 31, 2012. 

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55800 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

DATES: This regulation is effective 

September 9, 2011. Objections and 

requests for hearings must be received 

on or before November 8, 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–2011–0639. All documents in the 

docket are listed in the docket index 

available in 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: 

Marcel Howard, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6784; e-mail address: 

howard.marcel@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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (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–2011–0639 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 November 8, 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–2011–0639, 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 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing timelimited tolerances for residues of 

mandipropamid, 4-chloro-N-[2-[3- 

methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)-benzeneacetamide, in or 

on basil, fresh at 20 parts per million 

(ppm) and basil, dried at 240 ppm. 

These time-limited tolerances expire on 

December 31, 2012. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the safety standard 

to other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires 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 * * *.’’ 

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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 55801 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Mandipropamid on Basil and FFDCA 

Tolerances 

The Applicant stated that a new, 

destructive fungal pathogen, known as 

downy mildew (Peronospora belbahrii), 

has been identified in Illinois and it 

resulted in a 50% yield loss in basil 

production using registered alternatives. 

Illinois recently experienced some 

atypical weather conditions (high 

moisture and temperatures) that were 

conducive to the development and 

spread of the disease. The increase 

presence of the disease and the zero 

tolerance policy for downy mildew 

adopted by the distributors led basil 

grower to seek a spray program to 

maintain season-long control of this 

disease. The registered alternatives have 

been deemed inadequate for season-long 

control due to product application 

restrictions or lack of product efficacy. 

The Applicant stated that because of the 

favorable weather conditions and the 

inadequacy of the registered alternatives 

to achieve season-long control of the 

downy mildew, an emergency situation 

exists and significant economic losses 

will likely incur. Further, the Applicant 

asserts that without a suitable additional 

fungicide, such as mandipropamid, to 

address the issue, the future viability of 

basil industry in Illinois is threatened. 

After having reviewed the submission, 

EPA determined that an emergency 

condition exists for this State, and that 

the criteria for approval of an emergency 

exemption are met. EPA has authorized 

a specific exemption under FIFRA 

section 18 for the use of mandipropamid 

on basil for control of downy mildew in 

Illinois. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of mandipropamid in or on 

basil, fresh and basil, dried. In doing so, 

EPA considered the safety standard in 

section 408(b)(2) of FFDCA, and EPA 

decided that the necessary tolerance 

under section 408(l)(6) of FFDCA would 

be consistent with the safety standard 

and with FIFRA section 18. Consistent 

with the need to move quickly on the 

emergency exemption in order to 

address an urgent non-routine situation 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing this 

tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although these time-limited tolerances 

expire on December 31, 2012, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on basil, fresh and basil, 

dried after that date will not be 

unlawful, provided the pesticide was 

applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these time-limited tolerances at the time 

of that application. EPA will take action 

to revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether 

mandipropamid meets FIFRA’s 

registration requirements for use on 

basil or whether permanent tolerances 

for this use would be appropriate. 

Under these circumstances, EPA does 

not believe that this time-limited 

tolerance decision serves as a basis for 

registration of mandipropamid by a 

State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance by itself serve as the authority 

for persons in any State other than 

Illinois to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for 

mandipropamid, contact the Agency’s 

Registration Division at the address 

provided under FOR FURTHER

INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires 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 * * *.’’ 

Consistent with the factors specified 

in FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

residues of mandipropamid on basil, 

fresh at 20 ppm and basil, dried at 240 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

time-limited tolerances follows. 

A. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for mandipropamid used for 

human risk assessment is discussed in 

Unit III. of the final rule published in 

the Federal Register of January 16, 2008 

(73 FR 2812) (FRL–8346–6). 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mandipropamid, EPA 

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55802 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

considered exposure under the timelimited tolerances established by this 

action as well as all existing 

mandipropamid tolerances in 40 CFR 

180.637. EPA assessed dietary 

exposures from mandipropamid in food 

as follows: 

i. Acute exposure. No such effects 

were identified in the toxicological 

studies for mandipropamid; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

relied upon permanent tolerance level 

residues established for mandipropamid 

and 100 percent crop treated (PCT) 

information for all agricultural 

commodities. An unrefined chronic 

exposure assessment that assumes 100 

PCT was conducted for the proposed 

Section 18 uses of mandipropamid. The 

parent mandipropamid is the residue of 

concern for tolerance monitoring, and 

mandipropamid and its major aquatic 

degradates (SYN 500003 and SYN 

5044851) for the risk assessment. 

iii. Cancer. EPA has determined that 

mandipropamid is classified as ‘‘not 

likely to be a human carcinogen’’ based 

on the absence of treatment-related 

increases in tumors in the rat and mouse 

carcinogenicity studies. Therefore, an 

exposure assessment to evaluate cancer 

risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for mandipropamid. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for mandipropamid in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

mandipropamid. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

mandipropamid for acute exposures are 

estimated to be 25.2 parts per billion 

(ppb) for surface water and 0.05 ppb for 

ground water. The estimated 

environmental concentrations (EECs) for 

the aquatic degradates SYN 500003 and 

SYN 504851 are estimated to be 2.32 

and 8.99 ppb for surface water and 0.6 

and 1.7 ppb for ground water, 

respectively. The combined level of 

mandipropamid and the degradates in 

surface water is 36.5 ppb. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 36.5 ppb 

was used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Mandipropamid is not registered for 

any specific use patterns that would 

result in residential exposure. 

4. 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, 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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

mandipropamid and any other 

substances, and mandipropamid does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

mandipropamid has a common 

mechanism of toxicity with other 

substances. 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s Web site at http://www.epa.gov/ 

pesticides/cumulative. 

C. Safety Factor for Infants and Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence (quantitative or 

qualitative) of increased susceptibility 

and no residual uncertainties with 

regard to prenatal toxicity following in 

utero exposure to rats or rabbits 

(developmental studies) and prenatal 

and/or postnatal exposures to rats 

(reproduction study). 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

mandipropamid is complete except that 

EPA has determined that an 

immunotoxicity study is required as per 

the revised 40 CFR part 158. However, 

there is no need for an additional 

uncertainty factor while the 

immunotoxicity study is completed. 

The overall weight of evidence in terms 

of hematology, clinical chemistry, organ 

weights, and/or histopathology 

indicates that mandipropamid does not 

directly target the immune system. 

Therefore, EPA does not anticipate that 

conducting a functional immunotoxicity 

study will result in a lower point of 

departure than currently selected for the 

overall risk assessment. The 

immunotoxicity study should be 

conducted in conjunction with any 

future petition for the section 3 

registration of mandipropamid. 

ii. There is no indication that 

mandipropamid is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

mandipropamid results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 55803 

mandipropamid in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by mandipropamid. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, mandipropamid is 

not expected to pose an acute risk. 

2. Chronic risk. There are no 

residential uses for mandipropamid, 

and therefore aggregate risk is equal to 

that from consumption of food and 

water. EPA has concluded that chronic 

exposure to mandipropamid from food 

and water will utilize 44% of the cPAD 

for (children 1 to 2 years of age) the 

population group receiving the greatest 

exposure, while the general U.S. 

population utilizes 26% of the cPAD. 

3. Short-term and intermediate risk. 

Short-term aggregate exposure takes into 

account short-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Mandipropamid is not 

registered or proposed for use on any 

sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 

water, which was previously addressed. 

4. Aggregate cancer risk for U.S. 

population. As explained in this unit, 

mandipropamid is not likely to be 

carcinogenic in humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to 

mandipropamid residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(German Multi-residue Method DFG S– 

19) is available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail 

address: residuemethods@epa.gov. 

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. 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. 

There are no specific Codex, Canadian 

or Mexican maximum residue limits 

(MRL) for mandipropamid in or on 

basil. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of 

mandipropamid, 4-chloro-N-[2-[3- 

methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)- benzeneacetamide, in or 

on basil, fresh at 20 ppm and basil, 

dried at 240 ppm. These tolerances 

expire on December 31, 2012. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) of 

FFDCA. 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 in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

such as the tolerances 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) (Pub. L. 

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). 

VIII. 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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55804 Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations 

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: August 31, 2011. 

Lois Rossi, 

Director, Registration 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 180.637 is amended by 

revising paragraph (b) to read as follows: 

§ 180.637 Mandipropamid; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the mandipropamid, 4- 

chloro-N-[2-[3-methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)-benzeneacetamide in or 

on the specified agricultural 

commodities, resulting from use of the 

pesticide pursuant to FFIFRA section 18 

emergency exemptions. The tolerances 

expire on the date specified in the table. 

Commodity Parts per 

million 

Expiration 

date 

Basil, dried ........ 240 12/31/12 

Basil, fresh ........ 20 12/31/12 

* * * * * 

[FR Doc. 2011–22983 Filed 9–8–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0496; FRL–8881–6] 

Dicamba; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dicamba in or 

on teff, forage; teff, grain; teff, straw; and 

teff, hay. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 9, 2011. Objections and 

requests for hearings must be received 

on or before November 8, 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–2010–0496. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: nollen.

laura@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 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–2010–0496 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 November 8, 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 

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