[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Rules and Regulations]
[Pages 49318-49324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20200]


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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.

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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: 
[email protected].

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

[[Page 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

[[Page 49320]]

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

[[Page 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 
country-specific 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

[[Page 49322]]

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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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