49318 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations 

TABLE 1—EPA-APPROVED NORTH CAROLINA REGULATIONS

State citation Title/subject 

State 

effective 

date 

EPA approval date Explanation 

Subchapter 2D Air Pollution Control Requirements 

*******

Section .0500 Emission Control Standards 

*******

Sect .0530 ..................... Prevention of Significant 

Deterioration.

5/1/2008 8/10/2011 [Insert citation 

of publication].

15 NCAC .0530 incorporates by reference the 

regulations found at 40 CFR 51.166, with 

changes, as of June 13, 2007. This EPA action is approving the incorporation by reference with the exception of the phrase ‘‘except ethanol production facilities producing 

ethanol by natural fermentation under the 

North American Industry Classification System 

(NAICS) codes 325193 or 312140,’’ (as 

amended at 40 CFR 51.166(b)(1)(i)(a), 

(b)(1)(iii)(t), and (i)(1)(ii)(t). 

Sect .0531 ..................... Sources in Nonattainment Areas.5/1/2008 8/10/2011 [Insert citation 

of publication].

15 NCAC .0531 incorporates by reference the 

regulations found at 40 CFR 51.165, with 

changes, as of June 13, 2007. This EPA action is approving the incorporation by reference with the exception of the phrase ‘‘except ethanol production facilities producing 

ethanol by natural fermentation under the 

North American Industry Classification System 

(NAICS) codes 325193 or 312140,’’ (as 

amended at 40 CFR 51.165(a)(1)(iv)(C)(20) 

and (a)(4)(xx). 

*******

* * * * * 

[FR Doc. 2011–20167 Filed 8–9–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0629; FRL–8882–5] 

Import Tolerances; Order Denying 

ABC’s Petition to Revoke Import 

Tolerances for Various Pesticides 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Order. 

SUMMARY: In this Order, EPA denies a 

petition requesting that EPA revoke all 

pesticide ‘‘import’’ tolerances for 

cadusafos, cyproconazole, diazinon, 

dithianon, diquat, dimethoate, 

fenamiphos, mevinphos, methomyl, 

naled, phorate, terbufos, and dichlorvos 

(DDVP) under section 408(d) of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). The petition was filed on July 

23, 2009, by the American Bird 

Conservancy (ABC). 

DATES: This order is effective August 10, 

2011. Objections and requests for 

hearings must be received on or before 

October 11, 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–2009–0629. To access the 

electronic docket, go to http://www.

regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

Web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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: 

Richard Dumas, Pesticide Re-evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8015; e-mail 

address: dumas.richard@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

In this document EPA denies a 

petition by the American Bird 

Conservancy (ABC) to revoke pesticide 

tolerances. This action may also be of 

interest to agricultural producers, food 

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Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations 49319 

manufacturers, or pesticide 

manufacturers. Potentially affected 

entities may include, but are not limited 

to those engaged in the following 

activities: 

• Crop production (North American 

Industrial Classification System 

(NAICS) code 111), e.g., agricultural 

workers; greenhouse, nursery, and 

floriculture workers; farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

• Farm Product Warehousing and 

Storage (NAICS code 493130), e.g., grain 

elevators, private and public food 

warehousing and storage. 

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 NAICS codes have been 

provided to assist you and others in 

determining whether this action might 

apply to certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I access electronic copies of 

this document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

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. Can I file an objection or hearing 

request? 

Under section 408(g) of FFDCA, any 

person may file an objection to any 

aspect of this order and may also 

request a hearing on those objections. 

You must file your objection or request 

a hearing on this order 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–2009–0692 in 

the subject line on the first page of your 

submission. All requests must be in 

writing, and must be received by the 

Hearing Clerk as required by 40 CFR 

part 178 on or before October 11, 2011. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0692, 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’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. Introduction 

A. What action is the Agency taking? 

On July 23, 2009, the American Bird 

Conservancy (ABC) filed a petition with 

EPA which requested that EPA revoke 

the ‘‘import’’ tolerances established 

under section 408 of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 

U.S.C. 346a, for the following 

pesticides: cadusafos (banana); 

cyproconazole (green coffee beans); 

diazinon (kiwi fruit); dichlorvos 

(tomato); dithianon (fruit, pome, group 

11; hop, dried cones); diquat (banana; 

green coffee beans); dimethoate 

(blueberry); fenamiphos (banana; fruit, 

citrus; garlic; grape; pineapple); 

mevinphos (broccoli; cabbage; 

cauliflower; celery; cucumber; grape; 

lettuce; melon; pea; pepper; spinach; 

squash, summer; strawberry; tomato; 

watermelon); methomyl (hop, dried 

cone); naled (cucumber; lettuce; tomato; 

pumpkin; squash, winter; turnip, tops); 

phorate (green coffee beans); and 

terbufos (green coffee beans). (Ref. 1). 

These tolerances are described as 

‘‘import’’ tolerances because the 

pesticide uses associated with the 

tolerances are not registered for use in 

the United States under Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq., and 

thus, in practical effect, their only 

purpose is to govern the amount of 

pesticide residues in imported food. 

ABC argues that the challenged 

tolerances allow use of pesticides 

hazardous to birds in Central and South 

American countries and thus EPA is 

obliged to revoke the challenged 

tolerances under Executive Order 

13186, ‘‘Responsibilities of Federal 

Agencies to Protect Migratory Birds,’’ 

Executive Order 13186, 66 FR. 3853 

(Jan. 17, 2001), and the Endangered 

Species Act (ESA), 16 U.S.C. 1531 et 

seq. For the reasons stated below, EPA 

is denying the petition to revoke 

tolerances. 

B. What is the Agency’s authority for 

taking this action? 

Under section 408(d)(4) of the 

FFDCA, EPA is authorized to respond to 

a section 408(d) petition to revoke 

tolerances either by issuing a final rule 

revoking the tolerances, issuing a 

proposed rule, or issuing an order 

denying the petition. 21 U.S.C. 

346a(d)(4). 

III. Statutory and Regulatory 

Background 

A. Statutory Background 

1. In general. EPA establishes 

maximum residue limits, or 

‘‘tolerances,’’ for pesticide residues in 

food under section 408 of the FFDCA. 

21 U.S.C. 346a. Without such a 

tolerance or an exemption from the 

requirement of a tolerance, a food 

containing a pesticide residue is 

‘‘adulterated’’ under section 402 of the 

FFDCA and may not be legally moved 

in interstate commerce. 21 U.S.C. 331, 

342. Monitoring and enforcement of 

pesticide tolerances are carried out by 

the U.S. Food and Drug Administration 

and the U.S. Department of Agriculture. 

Section 408 was substantially rewritten 

by the Food Quality Protection Act of 

1996 (FQPA), which added provisions 

establishing a detailed safety standard 

for pesticides for protecting humans 

from pesticide residues in foods, 

including additional protections for 

infants and children. 

EPA also regulates pesticides under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), 7 U.S.C. 136 

et seq. While the FFDCA authorizes the 

establishment of legal limits for 

pesticide residues in food, FIFRA 

requires the approval of pesticides prior 

to their sale and distribution in the 

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49320 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations 

United States, 7 U.S.C. 136a(a), and 

establishes a registration regime for 

regulating the use of pesticides. FIFRA 

regulates pesticide use in conjunction 

with its registration scheme by requiring 

EPA review and approval of pesticide 

labels and specifying that use of a 

pesticide in a manner inconsistent with 

its label is a violation of Federal law. 7 

U.S.C. 136j(a)(2)(G). As discussed 

below, the scope of FIFRA extends 

beyond the human safety concerns of 

FFDCA section 408 to encompass 

environmental factors as well. 

2. Safety standard for pesticide 

tolerances. A tolerance permitting 

pesticide residues in food may only be 

promulgated by EPA if the tolerance is 

‘‘safe.’’ 21 U.S.C. 346a(b)(2)(A)(i). 

Correspondingly, a tolerance must be 

revoked if it no longer meets this safety 

standard. (Id.). ‘‘Safe’’ is defined by the 

statute 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.’’ 21 U.S.C. 

346a(b)(2)(A)(ii). Thus, safety 

determinations under FFDCA section 

408 turn on the safety to the 

‘‘consumer’’ of the pesticide residue in 

food. 21 U.S.C. 346a(b)(2)(D)(vi). 

Although residues in food are to be 

aggregated with other pesticide 

exposures, the aggregation requirement 

is bounded by the limitation that these 

other exposures of the consumer to the 

pesticide residue be ‘‘non-occupational’’ 

in nature. Id. Additionally, FFDCA 

section 408 specifically requires that 

these aggregate safety standard 

determinations expressly focus on 

protection of ‘‘infants and children.’’ 21 

U.S.C. 346a(b)(2)(C). In contrast, the 

focus of FIFRA is much broader. Among 

other things, a pesticide may not be 

registered under FIFRA if it poses ‘‘any 

unreasonable risk to man or the 

environment, taking into account the 

economic, social, and environmental 

costs and benefits of the use of any 

pesticide * * *.’’ 7 U.S.C. 136(bb). 

3. Procedures for establishing, 

amending, or revoking tolerances. 

Tolerances are established, amended, or 

revoked by rulemaking under the 

unique procedural framework set forth 

in the FFDCA. Generally, the 

rulemaking is initiated by the party 

seeking to establish, amend, or revoke a 

tolerance by means of filing a petition 

with EPA. See 21 U.S.C. 346a(d)(1). EPA 

publishes in the Federal Register a 

notice of the petition filing and requests 

public comment. 21 U.S.C. 346a(d)(3). 

After reviewing the petition, and any 

comments received on it, EPA may issue 

a final rule establishing, amending, or 

revoking the tolerance, issue a proposed 

rule to do the same, or deny the 

petition. 21 U.S.C. 346a(d)(4). Once EPA 

takes final action on the petition by 

either establishing, amending, or 

revoking the tolerance or denying the 

petition, any affected party has 60 days 

to file objections with EPA and seek an 

evidentiary hearing on those objections. 

21 U.S.C. 346a(g)(2). EPA’s final order 

on the objections is subject to judicial 

review. 21 U.S.C. 346a(h)(1). 

4. Tolerance reassessment and FIFRA 

reregistration. The FQPA requires, 

among other things, that EPA reassess 

the safety of all pesticide tolerances 

existing at the time of its enactment. 21 

U.S.C. 346a(q). In this reassessment, 

EPA is required to review existing 

pesticide tolerances under the new 

‘‘reasonable certainty that no harm will 

result’’ standard set forth in FFDCA 

section 408(b)(2)(A)(i). 21 U.S.C. 

346a(b)(2)(A)(i). This reassessment was 

substantially completed by the August 

3, 2006 deadline. Tolerance 

reassessment is generally handled in 

conjunction with a similar program 

involving reregistration of pesticides 

under FIFRA. 7 U.S.C. 136a–1. 

Reassessment and reregistration 

decisions are generally combined in a 

document labeled a Reregistration 

Eligibility Decision (‘‘RED’’). 

IV. The Petition to Revoke Tolerances 

The ABC Petition seeks the revocation 

of ‘‘import’’ tolerances for 13 pesticides. 

According to ABC, ‘‘[t]hese pesticides 

are highly toxic to birds, and are used 

in crops that many species of U.S. 

migratory birds use as habitat during the 

winter months when they migrate to 

Latin America.’’ ABC contends that 

maintenance of the specified import 

tolerances ‘‘is tantamount to giving U.S. 

approval to foreign countries for the use 

of the pesticides.’’ ABC objects to such 

‘‘approval’’ claiming that, on the crops 

covered by the tolerances, EPA ‘‘has 

already determined [that these 

pesticides pose] unacceptable risks for 

protected U.S. migratory birds.’’ In 

support of these claims, ABC cites to 

various statements in REDs, for 

information on some of the pesticides’ 

toxicity, and to information on use by 

migratory birds of agricultural lands as 

habitat. 

Based on these allegations, ABC 

argues that EPA should revoke the 

tolerances under Executive Order 

13186, addressing federal agency 

responsibilities for protecting migratory 

birds, or the Endangered Species Act 

(ESA). According to ABC, Executive 

Order 13186 obligates EPA ‘‘to avoid or 

rescind regulatory actions that adversely 

affect migratory birds.’’ The ESA, ABC 

argues, requires EPA to identify 

pesticide uses that may cause adverse 

impacts on endangered or threatened 

species and to implement mitigation 

measures to address those impacts, and 

to consult with the Fish and Wildlife 

Service before allowing the identified 

import tolerances to continue. Because 

EPA cannot implement mitigation 

measures in foreign countries, ABC 

contends that EPA must revoke the 

tolerances to meet its obligations under 

the ESA. Alternatively, ABC argues that 

if EPA determines the tolerances are 

‘‘necessary,’’ EPA must consult with the 

Fish and Wildlife Service before 

allowing the tolerances to continue. 

V. Public Comment 

EPA published notice of the petition 

for comment on September 1, 2009. 74 

FR 45200, September 1, 2009. EPA 

received 25 comments: 18 from 

individuals or wildlife protection 

organizations expressing general 

support for the petition; detailed 

comments in support of the petition 

from the Student Animal Legal Defense 

Fund (SALDF) at Lewis and Clark Law 

School; detailed comments in 

opposition to the petition from two 

organizations representing pesticide 

manufacturers and others and from 4 

pesticide manufacturers; and 

supplemental information on the 

petition from ABC. (All comments are 

included in the docket for this action, 

EPA–HQ–OPP–2009–0629.) 

The SALDF premises its arguments in 

support of the petition on its assertion 

that EPA, based on the assessments of 

risk from these pesticides to birds by 

EPA’s Office of Pesticide Programs, ‘‘has 

cancelled the use of the pesticides at 

issue in the United States.’’ Given these 

cancellations, SALDF claims that EPA is 

not complying with its duty to promote 

conservation of endangered species 

under ESA section 7(a)(1) or its duty 

under ESA section 7(a)(2) to ensure that 

no action authorized by EPA is 

deleterious to the conservation of 

endangered species; with its obligations 

under Executive Order 13186 regarding 

the conservation of migratory birds; and 

with the bar in the Migratory Bird 

Treaty Act (MBTA) on the taking of 

migratory birds. 

Crop Life America, an association of 

pesticide manufacturers, makes a series 

of arguments in opposition to the 

petition: Executive Order 13186 does 

not provide a private right of action and 

cannot be enforced against EPA; 

Executive Order 13186, the ESA, and 

the MBTA do not provide a basis for 

revoking pesticide tolerances because 

ecological issues cannot be considered 

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Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations 49321 

under FFDCA section 408; and the 

Petition fails to establish a nexus 

between the pesticide tolerances at issue 

and the claimed effects of the pesticides 

when used in other countries. 

The Pesticide Policy Coalition, an 

organization representing a wide array 

of food- and pesticide-related industries, 

claims that the ABC petition has not met 

the regulatory requirements for a 

petition because ABC does not have a 

‘‘substantial interest’’ in the tolerances 

challenged and because the petition is 

premised on a factor, ecological 

impacts, that is irrelevant to FFDCA 

section 408. 

Syngenta Crop Protection, Inc., which 

is the manufacturer of cyproconazole 

and diquat, commented that both of 

these pesticides are registered in the 

United States and have been cleared by 

EPA after consideration of potential 

effects on birds. BASF Corporation, the 

manufacturer of dithianon, commented 

that, although dithianon is not 

registered in the United States, the lack 

of a FIFRA registration is not due to 

cancellation of such a registration by 

EPA but based on business decisions 

made by the company. BASF also noted 

that it was unaware of any EPA 

assessments that found dithianon to 

pose a hazard to birds. Bayer Crop 

Science provided comments regarding 

the pesticide fenamiphos. Bayer argued 

that ‘‘[e]cological risk assessments have 

strong spatial and temporal components 

associated with them’’ and that countryspecific risk assessments would need to 

be conducted to determine the risks 

posed to birds. Bayer noted several of 

the risk mitigation requirements that 

appear on fenamiphos labels in Central 

and South American countries expressly 

for the purpose of reducing exposure to 

birds. 

During the comment period, ABC 

filed additional information with EPA 

pertaining to use of agricultural fields in 

Latin America by migratory birds. 

According to ABC, these data showed 

206 migratory bird species used 

agricultural fields as habitat and those 

206 species included 12 ESA listed 

species and 54 bird species of 

conservation concern. 

VI. ABC’s Allegations Concerning the 

Harmful Nature of the Challenged 

Pesticides 

As noted above, ABC contends that 

EPA has already determined in 

Reregistration Eligibility Documents 

that the pesticides challenged in this 

petition present ‘‘unacceptable risks for 

protected U.S. migratory birds’’ when 

used on the crops covered by the 

challenged import tolerances. This 

claim, however, is not supported by 

ABC’s petition and records cited 

therein. 

ABC admits that EPA has made no 

finding as to the risk to birds for four of 

the pesticides (cadusafos, 

cyproconazole, dithianon, and 

mevinphos). (Refs. 1, 2, and 3). As to 

another four of the pesticides (diquat, 

methomyl, naled, terbufos), ABC does 

not identify any EPA findings on the 

risks those pesticides pose to birds, and 

instead merely cites EPA’s conclusions 

regarding human risk. (Refs. 1, 4, 5, 6, 

and 7). For the remaining five pesticides 

(diazinon, dichlorvos, dimethoate, 

fenamiphos, phorate), ABC cites to 

statements in the relevant REDs in 

which the pesticides are characterized 

as ‘‘highly toxic’’ to birds. (Ref. 1.) 

However, as to each of these pesticides, 

the RED concluded that the pesticide 

met the standard for reregistration for 

outdoor uses in the United States so 

long as various steps were taken to 

mitigate exposure to birds. (Refs. 8, 9, 

10, 11, and 12). Moreover, in none of 

those REDs did EPA conclude that the 

pesticides posed unacceptable risks to 

birds with regard to the specific crops 

covered by the challenged import 

tolerances. 

VII. Ruling on Petition 

ABC’s petition requests that EPA 

revoke ‘‘import’’ tolerances for 13 

pesticides due to the risks these 

pesticides pose to birds in countries 

outside of the United States. In filing its 

request, ABC does not cite to anything 

in FFDCA section 408, the statutory 

provision authorizing EPA to establish 

such tolerances, which compels 

revocation of the challenged tolerances. 

Rather, ABC argues that EPA must 

revoke the challenged FFDCA tolerances 

due to provisions in EO 13186 and the 

Endangered Species Act. For the reasons 

explained below, EPA has concluded 

that these authorities do not support 

ABC’s contentions. 

A. Executive Order 13186 

ABC’s primary focus in its petition to 

revoke tolerances is EPA’s obligations 

under Executive Order 13186. While 

ABC believes that EPA has an obligation 

under Executive Order 13186 ‘‘to avoid 

or rescind regulatory actions that 

adversely affect migratory birds’’, it 

provides no rationale for why it believes 

that the Executive Order compels that 

action. EPA concludes, however, that 

EO 13186 does not compel EPA to take 

action to revoke the challenged 

tolerances, and it does not even provide 

EPA authority to do so. 

Executive Order 13186 was issued by 

President Clinton in 2001, pursuant to 

the authority provided in the 

Constitution and the laws of the United 

States, and in furtherance of the 

purposes of the MBTA, the Bald and 

Golden Eagle Protection Acts, the Fish 

and Wildlife Coordination Act, the 

Endangered Species Act, NEPA, and 

‘‘other pertinent statutes.’’ Executive 

Order No. 13186, 66 FR. 3853 (Jan. 17, 

2001). The purpose of the Executive 

Order is to ‘‘direct executive 

departments and agencies to take 

actions to further implement the 

Migratory Bird Treaty Act.’’ Id. at 

section 1. The Executive Order fulfills 

this purpose by directing each federal 

agency that is ‘‘taking actions that have, 

or are likely to have, a measurable 

negative effect on migratory bird 

populations * * * to develop and 

implement, within 2 years, a 

Memorandum of Understanding (MOU) 

with the Fish and Wildlife Service 

(Service) that shall promote the 

conservation of migratory bird 

populations.’’ Id. at section 3(a). The 

Executive Order directs that certain 

procedural provisions be included in 

the MOU. See id. at section 3(c) and (d). 

The Executive Order also directs 

agencies to adopt certain substantive 

provisions in their MOUs, ‘‘to the extent 

permitted by law and subject to the 

availability of appropriations and 

within Administration budgetary limits, 

and in harmony with agency missions.’’ 

Id. at section 3(e). Thereafter, Executive 

Order 13186 and the MOU ‘‘are 

intended to be implemented when new 

actions * * * are initiated * * *.’’ Id. at 

section 3(c). Actions are defined as 

including rules, although the Executive 

Order allows each agency to further 

define what action means and what 

programs should be included in the 

MOU. Id. at section 2(h). 

As an initial matter, ABC cannot 

compel the Agency to take any action 

under EO 13186 because there is no 

private right of action under this 

Executive Order. On its face, EO 13186 

expressly precludes such a right. 

Section 5(b) of Executive Order 13186 

states: 

This order is intended only to improve the 

internal management of the executive branch 

and does not create any right or benefit, 

substantive or procedural, separately 

enforceable at law or equity by a party 

against the United States, its agencies or 

instrumentalities, its officers or employees, 

or any other person. 

In fact, one court has confirmed 

explicitly this provision precludes any 

party from obtaining judicial review of 

any claim alleging violations of EO 

13186. See Defenders of Wildlife v. 

Jackson, No. 09–1814 (D.D.C. June 14, 

2011). For this reason alone, any claim 

that EPA must revoke pesticide 

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49322 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations 

tolerance regulations because EPA is 

violating EO 13186 fails. 

Nonetheless, even once an MOU is 

finalized, that MOU would not provide 

a basis for EPA to revoke the challenged 

tolerances. The MOU could not compel 

EPA to take action that it does not 

otherwise have the statutory authority to 

take. As discussed in Unit VII.B., EPA 

does not have discretion under the 

FFDCA in assessing the safety of a 

pesticide tolerance to consider whether 

tolerances would be ‘‘likely to have a 

measurable negative effect’’ on U.S. 

migratory birds that winter in foreign 

countries. 

B. Endangered Species Act 

ABC also argues that EPA has a 

statutory obligation under the 

Endangered Species Act, 16 U.S.C 1531 

et seq., to ‘‘identify all pesticides whose 

use may cause adverse impacts on 

endangered and threatened species and 

to implement mitigation measures to 

address the adverse impacts.’’ 

Presumably, ABC is referring here to 

EPA’s obligations under ESA section 7. 

According to ABC, because EPA cannot 

require ‘‘pesticide use mitigation 

measures’’ in foreign countries, EPA 

should fulfill its ESA obligations by 

revoking tolerances allowing 

commodities containing such pesticides 

to be distributed in the United States or, 

at a minimum consult with the FWS 

prior to allowing the tolerances to 

remain in effect. However, ABC’s claim 

that the ESA provides authority for 

revoking FFDCA tolerances is incorrect. 

ESA obligations only apply where 

EPA has ‘‘existing discretionary 

authority;’’ the ESA does not ‘‘override 

express statutory mandates.’’ Home 

Builders’ Ass’n v. EPA, 551 U.S. 644, 

487 (2007); 50 CFR 402.03. EPA 

establishes pesticide residue tolerances 

under section 408 of the FFDCA. 

Section 408 authorizes EPA to set ‘‘safe’’ 

exposure levels for pesticide residue 

levels in foods distributed in the United 

States. Thus, under FFDCA section 408, 

EPA does not regulate use of pesticides; 

rather, EPA regulates levels of pesticide 

residues in food distributed in interstate 

commerce. ABC’s petition would 

override these statutory mandates in 

FFDCA section 408, and, in effect, 

rewrite section 408 as a provision 

addressing environmental effects of 

pesticide use in foreign countries. 

As noted, the FFDCA scheme is 

explicitly directed at the pesticide 

residue in food when the food is in 

interstate commerce. FFDCA section 

408 establishes that if a food contains a 

pesticide residue for which there is no 

tolerance, or a pesticide residue at a 

level exceeding the applicable tolerance, 

then the food is deemed ‘‘unsafe’’ as a 

matter of law. 21 U.S.C. 346a(a). Foods 

deemed ‘‘unsafe’’ on these grounds are 

considered ‘‘adulterated.’’ 21 U.S.C. 

342(a)(2)(B). It is unlawful under the 

FFDCA to ‘‘introduc[e] or deliver[] for 

introduction into interstate commerce 

any food * * * that is adulterated 

* * * .’’ 21 U.S.C. 331(a). Additionally, 

adulterated food is subject to seizure 

‘‘when introduced into or while in 

interstate commerce or while held for 

sale (whether or not the first sale) after 

shipment in interstate commerce 

* * * .’’ 21 U.S.C. 334(a)(1). 

Consistent with this narrow focus on 

pesticide residues in food in interstate 

commerce, the standard for establishing 

and revoking tolerances is directed 

solely at the safety of the pesticide 

residues in food to the food consumer, 

taking into account other sources of 

pesticide exposure to the consumer as 

well. Specifically, the statute provides 

that ‘‘[t]he Administrator may establish 

or leave in effect a tolerance for a 

pesticide chemical residue in or on a 

food only if the Administrator 

determines that the tolerance is safe.’’ 

21 U.S.C. 346a(b)(2)(A)(i). Invariably, 

FFDCA section 408 directs EPA to 

consider factors relevant to the safety of 

the pesticide residue in food (aggregated 

with other sources of exposure to the 

pesticide residue), placing particular 

emphasis on human dietary risk. See, 

e.g., 21 U.S.C. 346a(b)(2)(B) (addressing 

an exception to the safety standard for 

pesticide residues as to which EPA ‘‘is 

not able to identify a level of exposure 

to the residue at which the residue will 

not cause or contribute to a known or 

anticipated harm to human health’’); 21 

U.S.C. 346a(b)(2)(C) (requiring special 

safety findings as to ‘‘infants and 

children’’ regarding their 

‘‘disproportionately high consumption 

of foods’’ and their ‘‘special 

susceptibility * * * to pesticide 

chemical residues’’); 21 U.S.C. 

346a(b)(2)(D)(iii) (requiring 

consideration of the relationship 

between toxic effects found in pesticide 

studies and human risk); 21 U.S.C. 

346a(b)(2)(D)(iv), (vi), and (vii) 

(requiring consideration of available 

information on ‘‘dietary consumption 

patterns of consumers,’’ ‘‘aggregate 

exposure levels of consumers,’’ and the 

‘‘variability of the sensitivities of major 

identifiable subgroups of consumers’’); 

21 U.S.C. 346a(b)(2)(D)(vi) (requiring 

consideration of ‘‘non-occupational’’ 

sources of exposure); 21 U.S.C. 

346a(b)(2)(D)(viii) (requiring 

consideration of information bearing on 

whether a pesticide ‘‘may have an effect 

in humans that is similar to an effect 

produced by a naturally occurring 

estrogen or other endocrine effects’’); 21 

U.S.C. 346a(l)(2) and (3) (requiring 

revocation or suspension of tolerances 

where associated FIFRA registration is 

canceled or suspended ‘‘due in whole or 

in part to dietary risks to humans posed 

by residues of that pesticide chemical 

on that food’’). In no place, does section 

408 explicitly or implicitly authorize 

EPA to consider environmental factors 

in addition to factors bearing on the 

safety of pesticide residues in food in 

interstate commerce. Thus, under 

section 408, EPA has no authority to 

revoke a pesticide residue food 

tolerance found to contain safe levels of 

pesticide residues in food based upon a 

conclusion that the use of the pesticide 

has negative impacts on endangered or 

threatened species of birds. Because 

EPA has no discretion to insert 

environmental considerations into 

decisions on FFDCA section 408 

tolerances, the ESA, under the Supreme 

Court’s holding in Homebuilders and 

the applicable regulations, is 

inapplicable to decisions made under 

FFDCA section 408. 

Even if the ESA did apply to FFDCA 

section 408 decisions, ABC’s petition 

fails because ABC has not offered 

evidence on an element critical to 

demonstrating that the existence of the 

tolerances in question have either a 

direct or indirect effect on endangered 

species of birds within the jurisdiction 

of the ESA. See 50 CFR 402.02. Clearly, 

pesticide tolerances in food do not have 

a direct impact on wildlife. Tolerances 

establish the legality of pesticide 

residues in food moved through 

interstate commerce in the United States 

and have no applicability to wildlife. 

ABC has not claimed otherwise. 

Nor has ABC shown that the 

challenged tolerances have an indirect 

effect on endangered birds. Applicable 

regulations define an ‘‘indirect effect’’ as 

those that are caused by the action and 

that are later in time, but still are 

‘‘reasonably certain to occur.’’ 50 CFR 

402.02 (defining ‘‘Effects of the action’’). 

ABC argues that the challenged 

tolerances are reasonably certain to 

cause an effect on migratory birds, some 

of which are endangered, because 

‘‘[m]aintaining a U.S. import tolerance 

allows Central and South American 

countries to continue using these 

pesticides on crops for which the U.S. 

has already determined there are 

unacceptable risks for protected U.S. 

migratory birds.’’ To support this 

argument, ABC has proffered evidence 

that the pesticides can be toxic to birds 

and that birds may use agricultural 

lands in these foreign countries. 

However, even assuming this evidence 

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is unassailable, ABC still has failed to 

support a critical aspect of its claim 

because it offered no evidence to show 

the pesticides are used in these 

countries on crops intended for export 

to the United States, the conditions 

under which the pesticides are used 

(e.g., application methods, application 

rates, environmental conditions), and 

why those conditions of use are a threat 

to endangered birds. In the absence of 

such evidence, there is no basis to 

conclude that the tolerances are 

‘‘reasonably certain to cause’’ an effect 

on endangered birds. Essentially, ABC’s 

petition asks EPA to assume that the 

tolerances cause the pesticide to be used 

on crops for export to the United States, 

and, more importantly, cause the 

pesticide to be used in a manner that is 

reasonably certain to affect endangered 

bird species. On the latter point, ABC’s 

argument fails to take into consideration 

the fact that use of challenged pesticides 

in the foreign country would be 

governed by that country. As a policy 

matter, EPA would not presume that the 

mere existence of a U.S. tolerance 

carries such overriding weight that it is 

reasonably certain to cause independent 

sovereign governments to abandon 

regulatory oversight of the pesticide and 

uncritically permit its use under 

conditions that are reasonably certain to 

have an effect on endangered migratory 

birds. Yet, this is the very premise of 

ABC’s petition. Finally, ABC’s claim 

that these pesticides will have an 

impact on endangered birds in Central 

and South America is not rescued by its 

assertion that these pesticides have been 

found by EPA to pose unacceptable 

risks to birds on the crops covered by 

the tolerances. As noted above in Unit 

VI., this is a significant overstatement. 

VIII. Response to Comments 

SALDF makes many of the same 

arguments made by ABC in its petition, 

and EPA disagrees with these claims for 

the reasons provided in Unit VII. Also 

like ABC, SALDF premises its 

comments on the incorrect assertion 

that the challenged pesticides are 

‘‘banned in the U.S.’’ due to the risk 

they pose to birds. Apparently going 

beyond ABC’s petition, SALDF alleges 

that EPA has an obligation to comply 

with provisions of EO 13186, which 

relate to international activities. EPA 

disagrees with this allegation because, 

as discussed in Unit VII.A., the 

Executive Order does not provide a 

basis for revoking the challenged 

tolerances under the FFDCA. Finally, 

SALDF argues that the MBTA compels 

EPA to revoke the tolerances. This 

argument, however, is without legal 

basis. There is no violation of the MBTA 

when the Federal government action is 

not directly causing or will not directly 

cause the take of any migratory birds. 

Courts have found that Federal 

government actions that only impact 

migratory bird habitat without directly 

taking migratory birds (e.g., timber sales 

occurring in the United States approved 

by the U.S. government) do not violate 

the MBTA. See Newton County Wildlife 

Ass’n v. U.S. Forest Serv., 113 F.3d 110 

(8th Cir. 1997) (finding that government 

approval of timber sales only ‘‘indirectly 

results in the death of migratory birds’’; 

MBTA is concerned more with 

‘‘physical conduct of the sort engaged in 

by hunters and poachers’’); Seattle 

Audubon Soc’y v. Evans, 781 F. Supp. 

1502 (9th Cir. 1991) (finding no 

government liability in approving 

timber sales that affected migratory bird 

habitat). EPA’s retention of the 

challenged tolerances does not involve 

any physical conduct directed at killing 

migratory birds nor does it directly 

result in the take or killing of any 

migratory birds. EPA’s action is even 

further removed from any possible bird 

deaths than the timber sales directly 

resulting in destruction of migratory 

bird habitat that were found not to be 

covered by the MBTA in Newtown 

County Wildlife and Seattle Audubon 

Society. In fact, SALDF, by admitting 

that EPA ‘‘is unable to directly regulate 

pesticide use in sovereign nations,’’ has 

essentially conceded that there is no 

direct action by EPA that causes the take 

of migratory birds in Central and South 

American countries. After all, it is 

regulatory action by EPA (i.e., retention 

of tolerances) that SALDF cites as the 

basis for its MBTA argument. Rather 

than allege direct action by EPA against 

migratory birds, SALDF states only that 

revoking the tolerances would 

‘‘contribute to the protection of 

migratory birds.’’ The possibility that 

removing a tolerance might contribute 

to the protection of migratory birds falls 

far short of demonstrating that the 

continuance of a tolerance is a ‘‘take’’ 

under the MBTA and, as discussed in 

Unit VII.B., is not a basis for revoking 

tolerances under the FFDCA. 

EPA generally agrees with the 

comments from CropLife America, the 

Pesticide Policy Council, and the 

various pesticide manufacturers. That 

agreement is reflected in Units VI., VII., 

and VIII. EPA would note, however, that 

the Pesticide Policy Council is mistaken 

in its claim that only pesticide 

registrants may petition to revoke 

tolerances under EPA regulations. 

According to the Pesticide Policy 

Council, EPA regulations specify that a 

petitioner must show a ‘‘substantial 

interest’’ in the challenged tolerance 

and the regulations also define FIFRA 

registrants or applicants for registration 

of a pesticide as the only party with a 

substantial interest in a tolerance for 

that pesticide. The Council errs by 

concluding that the regulation’s 

provision that evidence of registration 

or application for registration ‘‘will be 

regarded as evidence that a person has 

a substantial interest’’ defines the 

universe of persons with a substantial 

interest. 40 CFR 180.32(b). In fact, the 

regulation merely defines one person 

who does have a substantial interest in 

a tolerance without in any way limiting 

persons with a substantial interest only 

to registrants or applicants. 

IX. Regulatory Assessment 

Requirements 

As indicated previously, this action 

announces the Agency’s order denying 

a petition filed under section 408(d) of 

FFDCA. As such, this action is an 

adjudication and not a rule. The 

regulatory assessment requirements 

imposed on rulemaking do not, 

therefore, apply to this action. 

X. Submission to Congress and the 

Comptroller General 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, does not apply 

because this action is not a rule for 

purposes of 5 U.S.C. 804(3). 

XI. References 

1. American Bird Conservancy, Petition to 

Revoke Import Tolerances of 13 

Pesticides (July 23, 2009). 

2. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Report on FQPA 

Tolerance Reassessment Progress and 

Interim Risk Management Decision: 

Cadusafos (June 2000). 

3. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Report on FQPA 

Tolerance Reassessment Progress and 

Interim Risk Management Decision: 

Mevinphos (September 2000). 

4. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Report of the Food 

Quality Protection Act (FQPA) Tolerance 

Reassessment Progress and Risk 

Management Decision (TRED): Diquat 

Dibromide (April 25, 2002). 

5. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Reregistration 

Eligibility Decision (RED): Methomyl 

(December 1998). 

6. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision for 

Naled (January 2002). 

7. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision for 

Terbufos (September 2001). 

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49324 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Rules and Regulations 

8. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision: 

Diazinon (May 2004). 

9. Office of Prevention, Pesticides, and Toxic 

Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision for 

Dichlorvos (DDVP) (June 2006). 

10. Office of Prevention, Pesticides, and 

Toxic Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision for 

Dimethoate (June 12, 2006). 

11. Office of Prevention, Pesticides, and 

Toxic Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision: 

Fenamiphos (May 2002). 

12. Office of Prevention, Pesticides, and 

Toxic Substances, U.S. EPA, Interim 

Reregistration Eligibility Decision for 

Phorate (March 2001). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Endangered species, Pesticides and pest. 

Dated: July 29, 2011. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

[FR Doc. 2011–20200 Filed 8–9–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2000–0003; FRL–9450–4] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of International Smelting and Refining 

Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 8 is publishing a 

direct final Notice of Deletion of the 

International Smelting and Refining 

Superfund Site (Site), located in Tooele, 

Utah, from the National Priorities List 

(NPL). The NPL, promulgated pursuant 

to section 105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is an 

appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the state of 

Utah, through the Utah Department of 

Environmental Quality (UDEQ) because 

EPA has determined that all appropriate 

response actions under CERCLA, other 

than operation, maintenance, and fiveyear reviews, have been completed. 

However, this deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final deletion is 

effective October 11, 2011 unless EPA 

receives adverse comments by 

September 9, 2011. If adverse comments 

are received, EPA will publish a timely 

withdrawal of the direct final deletion 

in the Federal Register informing the 

public that the deletion will not take 

effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–2000–0003, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

online instructions for submitting 

comments. 

• E-mail: Erna Waterman, Remedial 

Project Manager, 

waterman.erna@epa.gov. 

• Fax: 303–312–7151. 

• Mail: Erna Waterman, Remedial 

Project Manager, U.S. Environmental 

Protection Agency, Region 8, EPR–SR, 

1595 Wynkoop Street, Denver, Colorado 

80202–1129. 

• Hand delivery: U.S. Environmental 

Protection Agency, Region 8, EPR–SR, 

1595 Wynkoop Street, Denver, 

Colorado. Such deliveries are only 

accepted during the Docket’s normal 

hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–2000– 

0003. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statue. Certain other 

material, such as copyrighted material, 

will be publicly available only in the 

hard copy. Publicly available docket 

materials are available either 

electronically in http:// 

www.regulations.gov or in hard copy at: 

U.S. EPA, Region 8, Records Center, 

1595 Wynkoop Street, Denver, 

Colorado 80202–1129 (303) 312–6473, 

Hours: M–F 8 a.m. to 4 p.m. 

Tooele City Library, 128 West Vine 

Street, Tooele, Utah 84074, (435) 882– 

2182, Hours: T–F 10 a.m. to 8 p.m. 

and Saturdays 10:30 a.m. to 6 p.m. 

FOR FURTHER INFORMATION CONTACT: Erna 

Waterman, Remedial Project Manager, 

U.S. Environmental Protection Agency, 

Region 8, EPR–SR, 1595 Wynkoop 

Street, Denver, Colorado 80202–1129, 

(303) 312–6762, e-mail: 

waterman.erna@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Introduction 

II. NPL Deletion Criteria 

III. Deletion Procedures 

IV. Basis for Site Deletion 

V. Deletion Action 

I. Introduction 

EPA Region 8 is publishing this direct 

final Notice of Deletion of the 

International Smelting and Refining 

Superfund Site, (Site), from the National 

Priorities List (NPL). The NPL 

constitutes Appendix B of 40 CFR part 

300, which is the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP), which EPA 

promulgated pursuant to section 105 of 

the Comprehensive Environmental 

Response, Compensation and Liability 

Act (CERCLA) of 1980, as amended. 

EPA maintains the NPL as the list of 

sites that appear to present a significant 

risk to public health, welfare, or the 

environment. Sites on the NPL may be 

the subject of remedial actions financed 

by the Hazardous Substance Superfund 

(Fund). As described in 300.425(e) (3) of 

the NCP, sites deleted from the NPL 

remain eligible for Fund-financed 

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