Federal Register, Volume 76 Issue 154 (Wednesday, August 10, 2011)

[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Rules and Regulations]
[Pages 49318-49324]
From the Federal Register Online via the Government Printing 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:
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

[[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