Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_05-cv-04093/USCOURTS-cand-3_05-cv-04093-6/pdf.json

Nature of Suit Code: 893
Nature of Suit: Environmental Matters
Cause of Action: 28:1331 Fed. Question

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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

PHYSICIANS COMMITTEE FOR

RESPONSIBLE MEDICINE et al.,

Plaintiff,

 v.

UNITED STATES ENVIRONMENTAL

PROTECTION AGENCY,

Defendant.

 /

No. C 05-04093 CRB

MEMORANDUM AND ORDER

Plaintiffs filed this Administrative Procedure Act (“APA”) action to challenge the

alleged failure of the Environmental Protection Agency (“EPA”) to implement a pesticide

testing program. Now pending before the Court are the parties’ cross-motions for summary

judgment. After carefully considering the papers filed by the parties, and having had the

benefit of oral argument, the Court concludes that plaintiffs have not proven that they have

standing to prosecute this lawsuit.

BACKGROUND

The EPA regulates pesticides under the Federal Food, Drug and Cosmetic Act

(FDCA), 21 U.S.C. sections 301 et seq, and the Federal Insecticide, Fungicide and

Rodenticide Act (“FIFRA”), 7 U.S.C. sections 136 et seq. Under FIFRA no person can sell a

pesticide that is not registered by the EPA. 7 U.S.C. § 136a(a). The EPA can register a

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pesticide only after it determines that the pesticide “will not generally cause unreasonable

adverse effects in the environment.” 7 U.S.C. § 136a(c)(5)(D). 

The FDCA “provides for the regulation of the presence of pesticides in agricultural

commodities by empowering the EPA to establish ‘tolerances’ setting the maximum

allowable levels of pesticide residue in foods.” American Farm Bureau v. EPA, 121

F.Supp.2d 84, 88 (D.D.C. 2000). “Before any agricultural commodity containing pesticide

residue can be sold or distributed, a tolerance that meets statutory safety standards must be

adopted by the EPA for that pesticide.” Id. “Foods containing pesticide residues for which

no tolerance has been set or containing a pesticide residue level greater than the tolerance

established by the EPA are considered ‘unsafe’ and ‘adulterated’ and may not be legally

moved in interstate commerce.” Id. (citing 21 U.S.C. § 331(a), 342(a)(2)(B), 346a(a)). The

EPA “may establish an exemption from the tolerance for a pesticide chemical residue in or

on food if the agency determines that it is safe.” Id. at 88-89 (citing 21 U.S.C. § 346a(c)(1)-

(2)). In 1996 Congress passed the Food Quality Protection Act (“FQPA”). The FQPA

amended the EPA’s regulation of pesticides by, among other things, “increasing the number

of factors that the EPA must consider in establishing a tolerance or exemption.” Id. at 89

(citing 21 U.S.C. § 346(b)(2)(A)(ii)). It also set a series of “deadlines by which EPA was

required [to] reassess the tolerances and exemptions to tolerances for 9,728 pesticide uses.” 

Natural Resources Defense Council v. EPA, 2001 WL 1221774 * 1 (N.D. Cal. Sep. 24,

2001) (NRDC). Of most significance to this lawsuit, the Act required the EPA to “develop”

a pesticide screening program by August 3, 1998 “to determine whether certain substances

may have an effect in humans that is similar to an effect produced by naturally occurring

estrogen, or such other endocrine effect, 21 U.S.C. § 346a(p)(1), and to “implement” the

program by August 3, 1999. Id. § 346a(p)(2). This Memorandum and Order refers to the

testing program as the “Estrogenic Substances Testing Program” or “ESTP.”

A. The First Litigation

Various non-profit organizations, including the Natural Resources Defense Council

(“NRDC”), filed suit in August 1999 alleging that the EPA had failed to meet the FQPA’s

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tolerance-reassessment deadlines. NRDC, 2001 WL 1221774 at *2. They subsequently

amended their complaint to allege, among other things, that the EPA had failed to meet the

FQPA’s deadlines for implementing the ESTP. 

The non-profit organizations People for the Ethical Treatment of Animals (“PETA”)

and the Physicians Committee for Responsible Medicine (“Physicians Committee”)

subsequently intervened as plaintiffs. Their complaint was directed solely to the ESTP and

alleged that: (1) the EPA had failed to adopt the pesticide screening program required by the

FQPA, and (2) had failed to appropriately validate the tests used in the program because it

had decided to subject tests that do not use laboratory animals to a more rigorous validation

process than that used for tests that involve animals. Id. at *2.

The NRDC plaintiffs and the EPA subsequently entered into a settlement. Among

other things, the settlement provided that the EPA would be bound by a consent decree, the

settling plaintiffs would dismiss their cause of action regarding the ESTP, and the EPA

would enter into a private settlement agreement requiring it to use its best efforts to

implement the ESTP. According to the Amended Complaint in this action, the settlement

agreement requires the EPA to use best efforts to implement certain parts of the ESTP by

dates certain, all of which have passed. Amended Complaint ¶ 43.

The intervening plaintiffs, PETA and Physicians Committee, filed an objection to the

proposed consent decree. The court overruled the objections and approved the consent

decree. NRDC, 2001 WL 1221774 at *22. 

The intervening plaintiffs proceeded with their complaint-in-intervention. The

amended complaint-in-intervention included five counts: (i) the EPA has failed to validate

the “full range of necessary screens and test” for an effective ESTP; (ii) the EPA improperly

expanded the screening program beyond pesticides and estrogenic effects; (iii) the EPA

failed to consult with Health and Human Services; (iv) the EPA has failed to develop and

validate protocals to reduce animal distress or reduce or eliminate the use of animals in

testing; and (v) the EPA has discriminated against animals by subjecting animal tests to a

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different level of acceptance than non-animal tests. PETA v. Whitman, 99-0371 WHA,

December 12, 2001 Order at 5; Amended Complaint ¶ 8. 

The EPA and the NRDC moved to dismiss. The court granted the motions and

dismissed the claims on their merits. PETA v. Whitman, 99-0371 WHA, December 12, 2001

Order. Plaintiffs did not appeal.

B. The Second Litigation

The intervening plaintiffs subsequently filed a rulemaking petition with the EPA

under section 533 of the Administrative Procedure Act (“APA”). The petition alleged that

the EPA had failed to “implement” the ESTP as required by 21 U.S.C. section 346a(p)(2). 

The petition sought to limit the ESTP to the testing of endocrine effects in humans; the EPA

had expanded the program to include pesticides’ endocrine effects in animals as well as

humans. Amended Complaint ¶ 37. In 2005, while the petition was pending, PETA and

Physicians Committee filed this action. The EPA subsequently denied the rulemaking

petition and, in response, plaintiffs amended their complaint. Plaintiffs now make two

claims.

First, they allege that the EPA has failed to “implement” the ESTP by the statutory

deadline. They contend that “[i]mplementation would require EPA to conclude the

validation process for all screens and tests and then direct manufacturers as to which screens

and tests must be performed, and in which order.” Amended Complaint ¶ 48. In the second

count they contend that the EPA’s denial of their rulemaking petition was arbitrary and

capricious.

The parties have filed cross-motions for summary judgment. Plaintiffs argue that the

EPA has failed to implement the ESTP and therefore summary judgment must be granted. 

The EPA cross-moves for judgment on the grounds that (1) plaintiffs lack standing; (2)

plaintiffs’ claims are barred by the statute of limitations; and (3) the EPA has implemented

the program.

Also pending before the Court is the NRDC’s motion to intervene in this action. As

explained above, they previously sued the EPA for, among other things, failing to implement

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the ESTP. That claim resulted in a settlement agreement that provides for, among other

things, informal dispute resolution should the NRDC believe that the EPA is not complying

with its obligations under the agreement. The NRDC is currently pursuing such informal

dispute resolution. Accordingly, it does not seek to intervene on the question of liability;

rather, it seeks to intervene on the question of remedy should the Court find that the EPA has

failed to fulfill its statutory obligations. The NRDC is concerned that the relief the plaintiffs

seek here, namely limiting the testing on animals, would unduly narrow the ESTP and

interfere with the EPA’s ability to comply with its obligations under its settlement with the

NRDC. 

DISCUSSION 

A. Standing

1. Legal requirements

The EPA moves for summary judgment on the ground that plaintiffs have not proven

that they have standing to pursue their APA challenge to the EPA’s alleged failure to

implement the ESTP. 

“As with any statute, there are both constitutional and prudential dimensions to

standing under the APA. Article III’s ‘case or controversy’ requirement dictates an

‘irreducible constitutional minimum’ to bring suit in federal court.” Graham v. Federal

Emergency Management Agency, 149 F.3d 997, 1001 (9th Cir. 1998). The constitutional

requirements consist of three elements: (1) an injury in fact that is (a) concrete and

particularized, and (b) actual or imminent, not conjectual or hypothetical; (2) a causal

connection between the injury and the defendant’s conduct; and (3) a likelihood that the

injury will be redressed by a favorable decision. See Ocean Advocates v. U.S. Army Corps

of Engineers, 402 F.3d 846, 859 (9th Cir. 2005) (citing Friends of the Earth v. Laidlaw, 528

U.S. 167, 180 -81 (2000)). “There also is a significant prudential component of the APA’s

standing inquiry. Plaintiffs must show that they fall within the ‘zone of interests’ to be

protected or regulated by the underlying statute in question.” Graham, 149 F.3d at 1001.

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1 See 21 U.S.C. § 346a(6) (“In the case of any substance that is found, as a result of

testing and evaluation under this section, to have an endocrine effect on humans, the

Administrator shall, as appropriate, take action under such statutory authority as is available to

the Administrator, including consideration under other sections of this chapter, as is necessary

to ensure the protection of public health”). 

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Plaintiffs bear the burden of establishing standing. Central Delta Water Agency v.

United States, 306 F.3d 938, 947 (9th Cir. 2002). 

The elements of standing are “not mere pleading requirements.” Rather, they

are an “indispensable part of the plaintiff’s case,” and accordingly must be

supported at each stage of litigation in the same manner as any other essential

element of the case. Thus, at the summary judgment stage the plaintiffs need

not establish that they in fact have standing, but only that there is a genuine

question of material fact as to the standing elements.

Id. 

2. Plaintiffs’ standing evidence

The individual plaintiffs and their children are vegetarians who eat plant-based foods. 

While they attempt to eat foods that are not treated with chemicals or pesticides, that is not

always possible. They allege that because the EPA has not implemented the ESTP, the EPA

has not restricted pesticide manufacturers and food producers from using dangerous

pesticides which have endocrine-like effects.1 “Therefore these pesticides are still being used

in the food supply, and every time individual Plaintiffs ingest these foods, they are also

ingesting the residue from the pesticides, putting themselves, their children, and any children

they may have in the future at risk of endocrine disorders.” Plaintiffs’ Opposition at 14. 

The only evidence plaintiffs cite to support their allegation of harm is a reference to a quote

in the EPA’s cross-motion for summary judgment. That footnote quotes from a scientific

paper that is not in the record:

Recent scientific research indicates that synthetic chemicals may disrupt the

human endocrine system, possibly causing decreased fertility, malformed

reproductive organs, increased levels of cancer in reproductive organs,

impaired fecal development, and neurological, thryroid, and immune disorders. 

These endocrine disrupting chemicals (“EDCs’”), which mimic, block, or

otherwise interfere with normal hormonal signals, are found in pesticides.

EPA’s Cross-Motion for Summary Judgment at 3 n.1. Plaintiffs offer no other evidence to

support their allegations of risk of harm; instead, they rely on Congress’s adoption of the

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FQPA and its testing requirements as evidence that pesticides pose an endocrine risk to

humans.

3. Analysis

Plaintiffs have not met their burden of producing evidence sufficient to create a

genuine dispute as to whether they satisfy the standing elements. See Central Delta Water

Agency, 306 F.3d at 947. 

First, they have not submitted evidence sufficient to create a genuine dispute as to

whether they have suffered an injury in fact. “An injury in fact is an invasion of a legally

protectable interest which is both ‘concrete and particularized,’ as well as ‘actual or

imminent, not conjectural or hypothetical.’” Id. “In suits against the government, therefore,

when plaintiffs have not already suffered a tangible loss at the government’s hands, they

must establish a substantial likelihood that they ‘personally’ will be injured in the future by

the government’s policy.” Graham,149 F.3d at 1002; see also Central Delta Water Agency,

306 F.3d at 947, 948 (holding that a significant risk of injury can constitute injury in fact). 

Assuming that plaintiffs’ alleged injury–threatened harm from pesticides--is “concrete

and particularized,” they have nonetheless not established that it is also “actual or imminent,

not conjectual or hypothetical.” 

In Graham, a typhoon struck the Federal States of Micronesia (“FSM”). The FSM, by

compact with the United States, is eligible for disaster relief funds from the United States.

government, through programs administered by the Federal Emergency Management Agency

(“FEMA”). The program itself was administered by FSM: FEMA pays money to the state,

and the state pays funds to its citizens whom it determines are eligible for disaster relief

under FEMA’s rules. Id. at 1000. FEMA eventually terminated the program with a number

of claims approved by FSM still unpaid and a number of others still pending before FSM for

decision. Id. Plaintiffs, residents of FSM, sued FEMA for violation of the APA seeking an

order requiring FEMA to provide the funds necessary to pay their claims.

FEMA moved to dismiss for lack of standing. The Ninth Circuit held that those

plaintiffs whom FSM had not yet determined were eligible for disaster relief (or, more

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precisely, plaintiffs whose appeals had not been decided) had not shown injury in fact: “Any

right to such funds depends entirely on whether the FSM, which is not a party to this suit,

would reverse its initial determination and grant their appeals. Hence, it is ‘purely

speculative’ whether an injunction from this court would ever result in these plaintiffs

receiving individual and family grants.” 149 F.3d at 1002. 

As with the plaintiffs in Graham, plaintiffs’ alleged injury here is purely speculative. 

As defendants point out, plaintiffs do not identify a single pesticide that they contend has

unreasonable endocrine effects and thus would be banned if the EPA actually began the

testing program. They do not even identify what an unreasonable endocrine effect would be. 

Nor do they identify any particular foods that are treated with these unidentified pesticides. 

Any alleged harm from the EPA’s failure to begin testing pesticides is therefore not actual or

imminent but is instead “conjectual and hypothetical.” 

 The only evidence of harm provided by plaintiffs is equivocal: the quote from the

EPA’s brief merely states that certain chemicals “may” disrupt the human endocrine system

and that such chemicals are found in pesticides. This is hardly evidence that all pesticides, or

pesticides used in foods that plaintiffs eat, or even any pesticides, are “substantially” likely to

harm the plaintiffs if the plaintiffs eat foods treated with such pesticides at the current

tolerance levels. See Graham,149 F.3d at 1002. Nor is this evidence sufficient to establish a

“credible” risk that plaintiffs will be harmed if they eat non-organic produce. See Central

Delta Water Agency, 306 F.3d at 950. 

 The cases relied upon by plaintiffs are distinguishable and, indeed, demonstrate the

inadequacy of plaintiffs’ evidence. In Central Delta Water Agency, the individual plaintiff

farmers challenged the Bureau of Land Management’s decision to release water from a

reservoir during certain months. The farmers alleged that the Bureau’s water release plan

was highly likely to cause the salinity of the water to exceed certain state requirements, and,

because the farmers use the water to irrigate their crops, the farmers alleged that their ability

to grow those crops would be hampered by the excessively saline water. 306 F.3d at 947. 

 The Ninth Circuit held that plaintiffs had submitted evidence sufficient to create at

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least a genuine issue of material fact as to injury in fact, that is, as to “whether they suffer a

substantial risk of harm as a result of the Bureau’s policies.” Id. at 948. The evidence of the

substantial risk of harm was the Bureau’s own report which determined that the water release

plan would cause the saline requirements to be violated at least one month a year in 41

percent of the next 71 years and that the majority of those excessive saline months were

projected to occur during plaintiffs’ peak irrigation months. Id. at 948. The plaintiffs also

submitted reports documenting the negative effects of increased salinity on the crops that the

plaintiff farmers grow. Id. at 949. There was also evidence that the plaintiffs’ crops were

damaged in the past due to high salinity in the water. Id. 

 Here, there is no evidence from which a reasonable trier of fact could find that the

EPA’s alleged failure to implement the ESTP poses a “substantial risk of harm” to plaintiffs. 

Plaintiffs have not submitted any evidence that any pesticides at their current tolerance levels

create harmful endocrine effects in humans; the whole purpose of the ESTP is to determine if

they do, to what extent, and for which pesticides. In Central Delta Water Agency, in

contrast, the plaintiffs produced evidence that the government’s action would, in fact,

increase the salinity of the water used by plaintiffs for irrigation, and evidence that such

increased salinity would, in fact, damage the plaintiffs’ crops. Such specific evidence is

missing here. 

 Plaintiffs’ reliance on a recent decision from this court, Levine v. Johanns, 05-04764

MHP (N.D. Cal. September 8, 2006), is also unavailing. In Levine, the plaintiffs challenged

the USDA’s current policy regarding the slaughter methods of poultry and exotic animals. 

The policy allows such animals to be slaughtered inhumanely. The plaintiffs alleged that the

inhumane slaughter practices increase the risk of bacterial contamination leading to increased

risk of food-borne illnesses in consumers; indeed, they specifically alleged how such

practices increase the risk of bacterial contamination. Sep. 8, 2006 Memorandum and Order

at 3. 

 The court held that plaintiffs had sufficiently alleged an “actual or imminent” injury

because they sufficiently alleged a credible threat of harm from consuming animals that had

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been inhumanely slaughtered. Id. at 11, 14. The credibility of plaintiffs’ allegations was

derived from studies demonstrating that inhumane methods of poultry slaughter increase the

level of bacterial contamination. Id. at 14. The court repeatedly noted, however, that the

case was “at the pleading stage,” id. at 11, 15, and that it “falls at the outer limits of injuries

that a plaintiff may allege for Article III standing.” Id. at 14. 

 This case, unlike Levine, is not at the pleading stage: plaintiffs may not rest on

allegations in their complaint but instead must come forward with admissible evidence

establishing a genuine issue of material fact as to the standing elements. See Central Delta

Water Agency, 306 F.3d at 947. As is explained above, there is a paucity of such evidence;

at most, plaintiffs refer to a scientific article that posits that chemicals found in pesticides

may case harmful endocrine effects in humans. This is not evidence from which a reasonable

trier of fact could find that plaintiffs have demonstrated a substantial likelihood of injury, or

a credible threat of harm, from the EPA’s failure to implement the ESTP, even putting aside

the uncertainties as to whether the EPA would ban any particular pesticide or adjust its

tolerance levels. If Levine “falls at the outer limits” of standing, this case, which is at the

summary judgment stage, is beyond the limits of Article III standing. 

 Second, plaintiffs have not submitted evidence sufficient to create a genuine dispute

as to a causal connection between their alleged injury and the EPA’s alleged failure to

implement the ESTP. Plaintiffs’ failure on this element is related to their failure to prove

injury in fact. Since plaintiffs have not identified any particular pesticides that they contend

have an unreasonable endocrine effect at current tolerance levels, they have not established

that the EPA’s failure to implement the ESTP has placed plaintiffs at a risk of harm. In

Levine, in contrast, the plaintiffs made specific allegations that, if proved, demonstrated that

the USDA’s policy of allowing the inhumane slaughter of chickens placed plaintiffs at a risk

of contracting disease. 

 Third, plaintiffs have also not satisfied the redressability element of standing. Even

if the Court were to order the EPA to immediately implement the testing process (assuming,

for the sake of argument, that it has not already begun implementation), such an order would

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not alleviate plaintiffs’ alleged injury: ingestion of foods treated with what plaintiffs believe

are harmful pesticides. There is no evidence in the record that supports a finding that if the

EPA began the testing program it would conclude that certain pesticides have an

unreasonable endocrine effect at their current tolerance levels and would therefore ban the

pesticide or modify its tolerance levels in food. Nor is there evidence that if the EPA

implemented the ESTP, consumers, such as plaintiffs, would be able to make informed

choices about what foods to eat. As the district court for the District of Columbia noted in a

case involving farmers’ and manufacturers’ standing to challenge the EPA’s alleged failure

to implement the ESTP, the Act “does not confer a broad, legally enforceable right to

information.” American Farm Bureau v. EPA, 121 F.Supp.2d 84, 99 (D.D.C. 2000). 

“Section 408(p) does not require EPA to share the results of the endocrine disruptor

screening program with the public. The only report that the agency is statutorily required to

prepare is a report to Congress after the program has been in effect for four years.” Id. 

 In sum, plaintiffs’ standing evidence has too many missing links to pass

constitutional muster. Congress did not give consumers a private right of action to enforce

the FQPA. And the Court cannot find, based solely on Congress’s enactment of the FQPA,

that plaintiffs are substantially at risk of harm because they eat unidentified foods treated

with unidentified pesticides. Accordingly, the EPA’s motion for summary judgment based

on lack of standing must be granted.

B. The NRDC’s Motion to Intervene

The NRDC’s motion to intervene is dismissed as moot as the NRDC seeks to

intervene only on the issue of remedy. 

 CONCLUSION

 At oral argument plaintiffs suggested that if they do not have standing then no

consumers have standing to challenge the EPA’s alleged failure to implement the ESTP. The

Court’s ruling is not nearly so broad; rather, plaintiffs have failed to meet their summary

judgment burden to come forward with evidence which, at a minimum, creates a genuine

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G:\CRBALL\2005\4093\orderrestanding.wpd 12

dispute as to whether they satisfy the injury in fact, causation and redressability elements of

standing. Accordingly, the EPA’s motion for summary judgment is GRANTED.

IT IS SO ORDERED.

Dated: October 20, 2006 

CHARLES R. BREYER

UNITED STATES DISTRICT JUDGE

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