# ZENECA ZenecaAg ProductsInc. LegalGroup 1800Concord Pike Wilmington,DE 19850-5458 HeatherC. Winett Tel. (302) 886

## -3717 Fax (302)886

## - 1045 heather.winett@agna.zeneca.com October 13,2000 Kathleen Franklin U.S.Environmental Protection Agency Ariel RiosBuilding

### -5104 1200Pennsylvania Avenue,N.W. Washington,DC20460 Re: RequestedDe-Lisfing ofParaquatDichloride from SARA TitleIII,Section302 Dear Kathy: Asafollow-upto our meetinganddiscussions lastyear,Zenecais stillvery seriousabout pursuing EPA's delistingofparaquat dichloridefromthe Section302Iist. Sincethetimewemet inyouroffices, Zenecahasbeendivertedfrom pursuingthisandother significantprojects bypreparationsforour anticipatedmergerwithNovartisCrop Protection. Toensure preservationofourprocedural rights,wehave hadouroutsidecounselfileacomplaintintheU.S. DistrictCourtfortheDistrictofColumbia. Iam enclosing acourtesycopyof thecomplaint (whichisessentiallythesameasthedraftweprovided you in December 1999). Becauseweintendtopursuethedelistingwithyou in

### anon-adversarial manner,wehave not yet served thecomplaintontheAgency. Thus, atthistime,EPAisnot required torespond tothe complaint,andthefilinghasnot initiated anycourtimposedtimetablesorscheduling. Atourmeeting,youand your colleaguesrequested someadditional informationtoassisttheAgency inevaluating our rationalefordelisting. Iexpecttoprovideyouwiththat information inthenear future. Also,youmayrecallthatZenecahadformallypetitioned forasimilar delistingunderCalifornia's Accidental Release Prevention ("CalARP") rules. WehaverecentlylearnedthattheGovernor's Officeof Emergency Services("OES") fullyagreeswith Zeneca'sposition and isintheprocess of obtaining concurrencefromCalifornia's OfficeofEnvironmentalHealth HazardAssessment ("OEHHA"). OES expectstopromulgate anemergencyregulation delisting paraquat dichloridehorntheCalARPrulein December2000,effective January 1,2001. The anticipated CalARP delisting shouldprovideauseful precedent for the SARATitle111, Section 302delisting effort. Sincerely, 

# ~~J;;R-c ather

### C. Winett

# lJjqfEnclosure Sr.EnvironmentalCounsel CC: ElizabethQuarles(Zeneca) DrewDavidson (Zeneca) PeterGray,Esq.(McKenna&Cuneo) SueannePfifferling (JSC)

### ZENECA AG 

### PRODUCTS INC. 1800 

### Concord Pike Wilmington, Delaware 19850 

### plaintiff,

CAROL 

### M. BROWNER, Administrator 

### United States Environmental ~rotection 

### Agency, Ariel Rios 

### Building 1200 Pennsylvania 

### Avenue, N.W. Washington, Q.C. 20460 

### And THE 

### UNITED STATES 

### ENVIRONMENTAL PROTECTION AGENCY Ariel 

### Rios Building 1200 

### Pennsylvania Avenue, 

### N.W. Washington, D.C. 20460 

### Defendants. COMPLAINT 

### Plaintiff, Zeneca Ag 

### Products Inc. ("Zeneca"), 

### alleges the following against 

### Defendants, 

### Carol 

### M. Browner and 

### the United States 

### Environmental Protection Agency 

### (collectively f'EPA1' or "the agencyll) 

### NATURE OF THE 

### ACTION
Zeneca brings 

### this action 

### under Sections 702, 704 and 706 

### of the 

### Administrative Procedure Act 

### ("APA1'), 5 U.S.C. §§ 702, 704. & 706, seeking 

### judicial review of 

### a final 

### decision by EPA. Specifically. Zeneca 

### seeks an order reversing 

### EPA1s

### decision todeny Zeneca's 

### petition to 

### either delete the registered 

### pesticide, paraquat 

### dichloride, from the 

### agency's 

### list 

### of "extremely 

### hazardous substances" or, 

### alternatively, to raise 

### the regulatory threshold applicable to the 

### substance under § 302 

### of the Emergency Planning 

### and Community Right-to-Know Act 

### of 1986 ("EPCRA"), 42 U.S.C. 

### 5 11002. 

### Under EPCRA § 302, EPA is 

### obligated 

### to consider 

### six different factors 

### in deciding whether 

### to remove paraquat dichloride 

### from the 

### list of extremely 

### hazardous substances 

### or to adjust the regulatory 

### threshold. Zeneca's 

### petition presented data under 

### these factors 

### demonstrating that paraquat 

### dichloride would not pose any 

### risk during the emergency 

### release scenarios 

### addressed by 

### Section 302. 

### EPA, 

### without explanation, 

### failed to 

### consider such data 

### in ruling
on the petition. Such failure 

### renders EPA's 

### action arbitrary and capricious 

### under the APA.
JURISDICTION
1. 

### This Court has subject 

### matter jurisdiction 

### of this action pursuant to 28 U.S.C. § 1331 

### in that this is 

### an action arising under the laws 

### of the United States, 

### including EPCRA § 302 and APA §§ 702, 704 and 706.
VENUE
Venue is proper 

### under 28 U.S.C. § 1391(e).

### PARTIES 3, 

### Plaintiff 

### Zeneca is a corporation incorporated under the 

### laws of the State 

### of Delaware. 

### Zeneca is the sole 

### manufacturer 

### of paraquat 

### dichloride 

### in the United States. Paraquat 

### dichloride is 

### an EPA-approved 

### agricultural 

### herbicide registered 

### under the 

### Federal Insecticide, Fungicide and 

### Rodenticide Act ( 

### "FIFRA") 

# .
4. 

### Defendant 

### EPA is 

### the 

### federal agency charged with administering 

### and enforcing 

### both EPCRA 

### and 

### FIFRA.
5. 

### Defendant Carol M. 

### Browner 

### is the 

### Administrator of EPA and has the authority to 

### grant or deny the 

### petition at 

### issue 

### in this case 

### pursuant to EPCRA § 302 

### (a)(4)

### . BACKGROUND ON THE 

### EPCRA LIST OF 

### EXTREMELY HAZARDOUS SUBSTANCES
6. Subtitle A 

### of EPCRA (§§ 301-305) creates a state 

### and local emergency planning and response program 

### aimed at preventing 

### or mitigating potential risks 

### posed by 

### accidental releases of 

### socalled "extremely 

### hazardous substances."
7. Under § 302 

### of 

### EPCRA, Congress 

### directed EPA to 

### publish a 

### list of extremely hazardous 

### substances ("EHS")

### by November 17, 1986. 

### For purposes of the initial 

### EHS 

### list, Congress 

### required EPA to 

### use the 

### same list 

### of chemicals published 

### by the Agency 

### in November 1985 as part of 

### the "Chemical Emergency 

### Preparedness Program 

### Interim Guidance" (hereafter "1985 CEEP 

### List"). Congress, 

### however, 

### authorized EPA to add 

### or delete chemicals fromthe EHS 

### list based 

### on consideration 

### of the toxicity, reactivity, volatility, dispersability, 

### combustability, or flammability 

### of a substance. EPCRA § 302(a) (4).
8. Concurrent 

### with publishing 

### the 

### initial EHS list, Congress 

### also required 

### EPA to 

### establish 

### a "threshold planning 

### quantity1 

### ("TPQ") 

### for each substance 

### on the EHS list 

### (or, alternatively, 

### to designate the 

### default statutory TPQ 

### of 

### two pounds). The TPQ is the total 

### amount of a fisted substance which, 

### if present at a 

### facility 

### at any time, subjects the 

### facility to the emergency 

### planning 

### requirements 

### of EPCRA. As 

### with 

### revisions 

### to the EHS list, EPA 

### may revise the TPQ for 

### listed substances taking 

### into account toxicity, 

### reactivity, volatility, 

### dispersability, combustability, 

### or flammability 

### of a substance.
9. On November 17, 1986, EPA 

### published an interim final 

### rule setting forth, inter 

### alia, the initial EHS list. 51 Fed. 

### -- Reg. 41,570 (Nov. 17, 1986). Paraquat 

### dichloride was 

### one of over 400 substances that 

### EPA 

### had included 

### on its 1985 

### CEEP List, and 

### therefore paraquat dichloride was 

### incorporated into 

### EPA1s November 1986 

### initial EHS list. Id. at 41,585. - 10. EPA stated that 

### a substance would 

### be retained 

### on the 

### final EHS list 

### based on the 

### agency's 

### consideration of 

### only one of 

### the six EHS 

### listing criteria, namely, 

### that 

### a substance 

### is "acutely toxic." Id. at 41,573. 

### EPA 

### deems a substance to be - "acutely 

### toxic" 

### if it meets any 

### of the 

### following 

### three criteria: (1) 

### an 

### "oral LD50" 

### below "25 

### mg/kgN 

### (whichmeans that there 

### is a50% mortality 

### rate 

### among laboratory 

### animals given an oral dose 

### of 25 

### milligrams 

### of the test 

### substance per 

### kilogram 

### of a laboratory 

### animal's body 

### weight) ; (2) 

### a 

### "dermal LD50" 

### below 50 mg/kg 

### (which
means that there is 

### a 50%a mortality rate among laboratory 

### animals 

### given a 

### dermal dose 

### of 50 

### mg/kg) ; and (3) an 

### "inhalation LC50" 

### of below 0.5 mg/L 

### (whichmeans that there 

### is a 50%a mortality rate 

### among laboratory animals 

### given an 

### inhaled dose of 0.5 

### mg of 

### substance 

### per liter of air). 

## Id.
11. 

### In the 1986 

### interim final 

### rule, EPA also 

### established a TPQ for 

### each substance on the 

### initial EHS list. EPA assigned 

### one of the 

### following five TPQs to the 

### substance: 2, 100, 500, 1000
or 10,000 lbs. 

### Id. at 41,577. 

### The greater the 

### hazard posed by 

### a 

### - substance, 

### the lower 

### the TPQ 

### assigned to 

### it.
12. 

### To set 

### these TPQs, EPA 

### utilized the so-called 

### "dispersion/toxicity 

### ranking method," pursuant to 

### which EPA gave each 

### listed substance 

### a hazard score (or 

### "index value") 

### . 51 Fed. Reg. 41593 

### (Nov. 17, 1986).
13. To 

### calculate 

### the "index value" for 

### a substance, EPA 

### divided the substance's 

### relative toxicity (referred to as the "level of 

### concern" factor) 

### by the substance's propensity to 

### become airborne or 

### volatilize during an accident 

### or emergency



### (ref erred to as "V" factor)

# .

14. 

### Those substances that 

### can become 

### completely airborne during 

### an accident or emergency 

### release 

### received 

### the highest 

### possible V factor ("1"). Under 

### this approach, 

### all gaseoussubstances 

### on the EHS list 

### received 

### a V 

### factor of 1, 

### because gases were 

### assumed to become completely airborne upon release 

### from a container.
15. By 

### contrast, for liquid substances 

### on the EHS list, EPA 

### calculated a 

### V 

### factor that 

### would 

### be less than I, 

### because EPA could not 

### assume that 100% of 

### the liquid 

### would become airborne when an 

### accidental release occurs. Rather, some 

### smaller percentage would 

### become airborne.
16. 

### Finally, in 

### determining 

### the V factor 

### for solids, EPA 

### distinguished solids 

### in powder form, 

### which could 

### readily disperse 

### into the air 

### like gases, from 

### all other solids, 

### which would be 

### much less 

### likely to 

### become airborne. EPA 

### assigned a 

### V factor 

### of 1 to 

### solids 

### in powder form on the premise that 100% could become 

### airborne during 

### an accidental 

### release. For all other 

### solids, 

### the agency 

### solicited comment 

### on whether such solids should be 

### deleted from the EHS 

### list 

### or assigned a 

### default 

### TPQ 

### of 10,000 lbs. 51 Fed. Reg. 41,570, 41,578.
17. Pursuant to the 

### above approach, 

### in the 1986 interim 

### final 

### rule, EPA assigned 

### the lowest TPQ, 2 lbs., ta paraquat dichloride 

### in so-called "powder form," whereas 

### for 

### all other 

### forms of paraquat dichloride the default 

### TPQ 

### of 10,000 lbs. 

### was assigned. 

### Id. at 41,585. 

### Because paraquat 

### dichloride 

### is neither 

### - produced 

### nor handled as a powder, the 2 lb. 

### TPQ does 

### not ever apply

## -18. On April 22, 1987, EPA published the 

### final EHS list 

### in the Federal 

### Register. 52 Fed. 

### Reg. 13,378. 

### In so 

### doing, EPA 

### restated that it had 

### relied 

### on only one 

### of the six 

### EHS listing criteria, i.e., 

### evidence of a substance's acute toxicity, to 

### retain it 

### on the 

### final EHS list. EPA, however, stated its 

### intent "to evaluate 

### hazards 

### other than toxicity as identified 

### in section 302 (a)(4) 

### and to 

### develop appropriate criteria 

### based on these physical/chemical 

### properties, e.g., 

### flammability, for revising 

### the list 

### of extremely 

### hazardous substances in the future." Id. - 19. 

### With regard to 

### the final TPQs adopted by EPA, the 

### agency modified 

### its approach 

### in a 

### manner that 

### had a significant impact on the TPQ 

### for paraquat 

### dichloride. Rather than 

### assign a 

### default TPQ of 10,000 lbs. to 

### all solids other 

### than powders, EPA used the 

### following approach: (1) for 

### finely powdered solids



### (those

### with a particle size 

### less 

### than 100 microns), solids 

### in 

### molten form, 

### solids in solution, and 

### reactive 

### solids, EPA calculated 

### an index 

### value and corresponding 

### TPQ; and (2) for 

### all other solids, 

### EPA applied 

### the 10,000-pound default TPQ. 52 

### Fed. Reg. 13378, 13390.
20. As 

### under the interim 

### final rule, EPA treated 

### finely powdered 

### solids 

### like gases and 

### assumed that the entire 

### quantity of 

### such powdered solids would 

### be released 

### if 

### an accident occurred. 

### Thus, finely powdered 

### solids received the 

### highest V factor 

### of 1.21. Without any explanation, EPA also 

### assigned a V 

### factor 

### of 1 

### to 

### "solids in solution," notwithstanding that 

### the physical and chemical 

### characteristics 

### of many 

### solids in 

### solution limit 

### their capacity to 

### become airborne.
22. Paraquat dichloride 

### is just 

### such a 

### substance. It has 

### no 

### measurable vapor pressure and decomposes 

### before reaching a boiling point 

### (i.e., it 

### has no boiling 

### point). EPA used a 

### substance's boiling point to estimate the potential 

### of 

### liquids to become airborne at elevated temperatures. 

### Using EPA's approach, 

### therefore, paraquat 

### dichloride would 

### be regarded 

### as having no potential to 

### become airborne. 

### Nevertheless, EPA 

### assigned to paraquat 

### dichloride a V factor 

### of 1 -- the 

### value signifying the 

### highest potential to become 

### airborne. As a 

### consequence, paraquat 

### dichloride received a 

### low 

### index 

### value and a 

### correspondingly low TPQ 

### of 10 lbs. [Note: 

### in the final 

### rule, instead of assigning 

### a 

### TPQ of either 2, 100, 500, 1,000 and 10,000 

### lbs. to a listed substance, EPA assigned 

### the following revised TPQ levels: 1, 10, 100, 1000, and 10,000 lbs.]
PETITION TO REMOVE PARAQUAT FROM EHS LIST OR TO ADJUST 

### TPQ
23. 

### On October 12, 1989, Zeneca (then 

### known 

### as ICI Americas 

### Inc.), 

### filed a petition to 

### remove paraquat dichloride 

### from the 

### EHS list under EPCRA § 302.
24. In its petition, Zeneca 

### justified removal 

### of paraquat dichloride 

### from 

### the EHS list, because 

### a release of the 

### substance would 

### not 

### pose any 

### meaningful risk to an 

### exposed population.First, Zeneca demonstrated that paraquat dichloride does 

### not meet either the 

### oral 

### or dermal toxicity criteria for listing 

### an EHS.
25. As to the 

### inhalation toxicity criterion, there are 

### two studies 

### which show that under 

### laboratory conditions 

### an inhaled 

### dose of paraquat 

### dichloride at 

### a concentration 

### below 0.5 mg/~ would cause 50%mortality 

### in laboratory animals. However, 

### as Zeneca explained, it is 

### one thing to be able 

### to temporarily atomize paraquat 

### dichloride 

### under laboratory conditions 

### so that 

### it 

### can be 

### administered to 

### laboratory animals. It 

### does not follow, 

### however, that 

### inhalable particles or vapors 

### or paraquat dichloride 

### can become airborne during 

### an accidental release. Indeed, the physical 

### and chemical properties 

### of paraquat dichloride dictate 

### a contrary 

### conclusion.
26. 

### Specifically, paraquat 

### dichloride has 

### no boiling point and 

### no measurable vapor 

### pressure. 

### Thus, paraquat dichloride 

### lacks the propensity 

### to form 

### inhalable particles or vapors. Consequently, 

### paraquat 

### dichloride poses 

### no meaningful 

### risk of 

### inhalation toxicity and should be 

### removed from the EHS list.
27. On September 19, 1990, Zeneca 

### filed a supplemental petition requesting, 

### as an 

### alternative to delisting, 

### that EPA 

### raise 

### the TPQ for paraquat 

### dichloride from 10 lbs. to 10,000 lbs. 

### In its supplemental petition, Zeneca 

### explained that the 

### same flaw that led 

### to the 

### erroneous decision to 

### retain paraquat 

### dichloride
on the EHS 

### list also 

### led to an 

### improper TPQ 

### designation, 

### i.e.,

### EPA's failure to 

### consider the 

### unique physical and 

### chemical properties 

### of the substance.
28. On October 12, 1994, EPA 

### published its decision to deny 

### both Zeneca's petition to remove paraquat 

### dichloride from the 

### EHS 

### list and 

### Zeneca's alternative 

### request 

### to raise the 

### TPQ for paraquat 

### dichloride. 59 

### Fed. 

### Reg. 51816, 51818 (Oct. 12, 1994). As set forth 

### below, 

### EPA's 

### denial was 

### arbitrary and capricious.
EPA'S DECISION TO 

### RETAIN PARAQUAT DICHLORIDE ON 

### THE LIST 

### OF EXTREMELY KAZARDOUS SUBSTANCES WAS 

### ARBITRARY AND CAPRICIOUS
29. 

### In its 

### denial 

### of Zeneca's petition to 

### remove paraquat 

### dichloride 

### from the 

### EHS list, 

### EPA acknowledged that paraquat dichloride does 

### not 

### meet the oral or 

### dermal LD50 

### criteria for 

### listing, but 

### concluded 

### that paraquat 

### dichloride does meet 

### the 

### inhalation LC50 criterion for 

### listing. In so 

### finding, however, 

### EPA did not 

### consider the unique properties 

### of paraquat 

### dichloride 

### which preclude the possibility 

### that an accidental release of paraquat 

### dichloride could pose an 

### inhalation toxicity 

### risk.
30. 

### Congress directed EPA to 

### base decisions to 

### modify the EHS 

### list on 

### consideration of 

### six properties -- toxicity, reactivity, 

### volatility, dispersability, 

### combustability, 

### or flammability 

### -- which may 

### render a substance so 

### hazardous that 

### an accidental release 

### would warrant emergency 

### response measures 

### and 

### advance emergency planning. EPCRA § 302(a) (4).31. 

### Throughout the EHS rulemaking, EPA 

### acknowledged the importance 

### of factors 

### other than acute 

### toxicity, 

### such as the physical 

### and chemical property 

### of a 

### substance, 

### in determining whether a 

### substance 

### belongs on the EHS list. 

### EPA stated its 

### intent to develop 

### criteria based 

### on physical and chemical properties for listing substances. See, e.g., 52 Fed. Reg. 13378, 13388; EPA, Response 

### to Comments on the 

### Interim Final Rule and 

### Notice 

### of Proposed Rulemaking 

### on Superfund Amendments and Reauthorization Act 

### of 1986 (SARA) 

### Sections 302, 304, at 54-55.
32. Yet'

### when presented 

### with Zeneca's data regarding the physical and 

### chemical properties of paraquat 

### dichloride and 

### the significance 

### of 

### such properties 

### for assessing whether 

### the substance 

### would pose 

### a 

### risk during an 

### accident 

### or emergency, EPA without explanation ignored 

### such data and instead 

### relied 

### exclusively on the 

### toxicity of the 

### substance 

### in deciding whether 

### to retain it 

### on the EHS list.
33. 

### In the case 

### of paraquat dichloride, toxicity 

### alone 

### is not indicative 

### of the potential 

### risk posed by 

### an accidental release. 

### To the contrary, other physical and 

### chemical properties 

### -- i.e., its 

### lack of a measurable vapor 

### pressure and lack 

### of 

### boiling point -- render 

### paraquat 

### dichloride incapable of posing any 

### meaningful risk 

### of 

### inhalation toxicity. 

### In its petition to 

### remove paraquat 

### from 

### the EHS list, Zeneca clearly and directly provided EPA with information 

### and 

### data on 

### the physical and chemical properties 

### of paraquat. 

### EPA should 

### have taken these

### properties into 

### consideration 

### in deciding whether to 

### retain paraquat dichloride 

### on the EHS list.
34. 

### In its 

### petition to 

### delete, Zeneca informed EPA that paraquat 

### dichloride is a liquid 

### from its 

### initial manufacture through its 

### application as 

### an agricultural herbicide. Paraquat 

### dichloride is 

### never 

### handled, stored 

### or used 

### in powder form.

[Note: 

### Although EPA 

### has characterized paraquat 

### dichloride as a "solid 

### in solution," there are 

### no particles suspended in paraquat dichloride 

### liquid. Rather, the 

### ions dissociate completely and do not precipitate out 

### of solution.]
35. Paraquat 

### dichloride 

### has no 

### boiling 

### point or measurable vapor pressure; at 

### high temperatures, paraquat 

### dichloride simply decomposes. 

### Therefore, using EPA's 

### methodology for 

### liquids, paraquat 

### dichloride presents no 

### risk 

### of being 

### released into the air and becoming hazardous to the 

### public via inhalation toxicity.
36. Also 

### noteworthy are the 

### conclusions reached by EPA 

### in 

### connection 

### with registering paraquat 

### dichloride 

### under FIFRA. EPA's Office of Pesticide Programs ("OPP") evaluated he 

### risk 

### posed 

### when paraquat 

### dichloride 

### is sprayed 

### on crops. OPP 

### concluded that 

### pesticidal spray application 

### of paraquat dichloride 

### does not cause adverse effects, because the droplets 

### are not 

### inhalable. See Guidance 

### for the Reregistration of Pesticide 

### Products Containing Paraquat 

### Dichloride as the Active Ingredient, GS0262 (EPA 

### June 1987) 

### at 5.37. 

### In view of the 

### foregoing, EPA's decision to 

### retain paraquat 

### dichloride 

### on the list 

### of extremely 

### hazardous substances 

### is arbitrary 

### and capricious.

EPA'S 

### REFUSAL TO ADJUST THE THRESHOLD PLANNING QUANTITY FOR PARAQUAT DICHLORIDE WAS 

### ARBITRARY AND CAPRICIOUS
38. 

### In EPA's 

### denial of Zeneca's alternative request to raise the TPQ 

### for paraquat dichloride, the agency did 

### not explain the 

### pivotal decision to 

### assign a 

### V factor 

### of 1 

### to paraquat 

### dichloride 

## -- the decision which 

### ultimately drove EPA 

### to assign a 10 

### lb. TPQ to-thecompound. 

### Based 

### on statements in EPA background documents, however, it appears that 

### in 

### the final rule, 

### EPA 

### assumed that all 

### "solids 

### in solution" would disperse 

### just 

### like a gas -- i.e.,that 

### all 

### of the substance 

### would become 

### airborne 

### in an 

### accident, thus 

### justifying 

### a V factor 

### of 1.
39. 

### With respect 

### to paraquat 

### dichloride, however, 

### EPA's 

### assumption 

### is demonstrably false. 

### The laws 

### of physics 

### preclude the possibility 

### of a release 

### of paraquat 

### dichloride becoming completely 

### airborne. Regardless 

### of 

### the emergency 

### release 

### scenario (extreme temperature, explosion, etc.), 

### the amount expected to 

### become 

### airborne would 

### not 

### only be less than 100%, 

### it would 

### be 

### virtually zero.
40. 

### As noted above, paraquat 

### dichloride 

### does not have 

### a boiling point. At high temperatures, it does 

### not boil, 

### but rather 

### decomposes. Paraquat dichloride, thus, 

### poses virtually no 

### risk 

### of 

### airborne release.41. 

### Based on 

### invalid assumptions about 

### the capacity 

### of paraquat 

### dichloride to 

### become airborne, EPA 

### incorrectly calculated its 

### index value, 

### which resulted in 

### assignment 

### of an unrealistically 

### low TPQ 

### of 10 

### Ibs.
42. Had 

### EPA considered the data presented in the petition pertaining to 

### the other statutory 

### criteria 

### for listing an EBS, namely, "volatility" and 

### "dispersability," EPA 

### would not 

### have made these 

### invalid assumptions.
43. 

### EPA's failure to 

### consider these other statutory criteria renders 

### its 

### decision to 

### retain a 10 

### lb. TPQ for paraquat dichloride arbitrary, 

### capricious and 

### not in 

### accordance with law.
EPA'S IMPROPER DENIAL OF THE REQUEST TO DELIST OR TO ADJUST THE TPQ FOR PARAQUAT DICHLORIDE HAS HARMED ZENECA

44. EPA1simproper 

### denial 

### of the 

### petition to 

### delete paraquat dichloride from the EHS 

### list 

### or to 

### raise the applicable TPQ 

### to 10,000 lbs. 

### has caused 

### significant harm to Zeneca.
45. Any 

### facility or farmer that 

### handles more 

### than 10 Ibs. 

### of paraquat 

### dichloride as 

### an active ingredient 

### in a product is required 

### to comply wlth 

### the emergency planning requirements 

### under EPCRA § 302. 

### h here are approximately 6.25 pounds 

### of paraquat 

### dichloride in 

### a 2.5 gallon 

### jug of 

### Zeneca's Gramoxone 

### ~xtra?'. ] 

### These requirements 

### include notification to the State emergency 

### response commission, 

### designation of 

### a facility response 

### coordinator who will participate in local 

### emergency planningefforts, and an obligation to provide the local emergency planning committee 

### with any information it requires 

### from the 

### facility to 

### develop 

### and implement the emergency plan.
46. 

### The listing 

### of paraquat 

### dichloride 

### under EPCRA 

### has significant effects at 

### the state level as well. Many states have 

### their own versions of EPCRA 

### which impose additional responsibilities 

### and costs. For example, 

### the Florida 

### Hazardous Materials Emergency 

### Response and Community Right-to-Know Act imposes an annual 

### registration fee 

### on any 

### facility, including farms, 

### handling 

### an extremely 

### hazardous substance as 

### defined under the federal program. Fla. Stat. § 252.85(1).
47. The 

### inclusion of 

### paraquat 

### dichloride on the 

### EHS list adversely 

### affects the sales potential 

### of paraquat 

### dichloride products 

### in the United States. 

### Many 

### of Zeneca's 

### customers are 

### farmers who, 

### because of the cost and burden 

### associated with 

### compliance with 

### the federal and state EPCRA requirements imposed


### on use 

### of paraquat 

### dichloride, find it more attractive 

### to use alternative products.
48. Further, the 

### public could erroneously interpret 

### EPAfs "extyemely hazardous substance" 

### classification of paraquat 

### dichloride as a 

### determination by EPA 

### that products containing the substance 

### are unsafe to store or 

### handle prior 

### to use. 

### This misconception 

### could result 

### in unnecessary 

### alarm about 

### using products 

### containing paraquat 

### dichloride. As 

### a result, the 

### publicreputation and competitive 

### standing 

### of Zeneca suffers 

### substantial and 

### unjustified injury.
COUNT 

### I
49. Plaintiff realleges 

### and incorporates herein by 

### reference paragraphs 1 through 48 

### above.
50. EPA1s

### final decision to deny 

### Zeneca'spetition 

### to delete paraquat dichloride from the EPCRA 5 302 

### list 

### of extremely 

### hazardous substances 

### is arbitrary, 

### capricious, an abuse 

### of discretion, 

### and contrary to 

### law within the meaning 

### of the APA. 5 U.S.C. § 706(2)(A) and (C).
COUNT 11
51. Plaintiff 

### realleges and incorporates 

### herern by reference paragraphs 1 

### through 50 above.
52. EPAts

### final decision to 

### deny Zeneca's 

### alternative request to increase the TPQ for paraquat dichloride 

### from 10 lbs. 

### to 10,000 lbs. 

### is arbitrary, capricious, an abuse 

### of 

### discretion, and contrary 

### to law 

### within the meaning 

### of the APA. 5 U.S.C. 

### 5 706(2)(A) and (C) 

### ..PRAYER FOR RELIEF

WHEREFORE, 

### Plaintiff requests that this Court:
1. Declare that EPA1sdenial 

### of Zeneca'spetitions (published 

### on October 12, 1994, at 59 Fed. Reg. 51816) 

### is 

### invalid;
2. Direct EPA 

### to initiate a 

### rulemaking 

### to remove paraquat 

### dichloride from the 

### EPCRA 1 302 

### list 

### of extremely hazardous 

### substances;
3. In the 

### alternative, direct EPA to 

### initiate a 

### rulemaking to 

### raise the TPQ for paraquat dichloride from 10 lbs. 

### to 10,000 lbs.; and
4. Afford 

### such other relief as the Court may deem appropriate. RespectJlflly 

### submitted,

&.fey Gray r 

### NO. 397544)
MCKENNA & 

## CUNEO,./L.L. P 19CO K Street, N.W. Washington, D.C. 20005

(202) 496-7500 Attorney 

### for Plaintiff Zeneca 

### Ag Products Inc.

### Of 

### Counsel: Heather C. 

### Winett Senior 

### Environmental Counsel Zeneca Ag 

### Products Inc. 1800 Concord 

### Pike Wilrnington, 

### DE 19850 (302) 886-3717 

### Dated: October 11, 2000

### 1-XITEDST,\TES 

### DISTRICTCOT'RT FOR

### THEDISTRICT 

### OFCC>LL2IBI,4 

### ZENECAAG

### PRODUCTSINC.

1800Concord

### Pike Wilmington,

### DE, 19850, 

### Plaintiff,


### CA4ROL 

## M. BROWNER, ADMINISTRATOR,U.S. ENVIRONMENTAL

### PROTECTION AGENCY

Ariel 

### RiosBuilding 1200

### PennsylvaniaAvenue,

### N.W. Washington,

### D


### . C. 

### 20460 and 

### THE

### UNITEDSTATES 

### ENVIRONMENTALPROTECTION AGENCY

Ariel 

### Rios Building 1200

### PennsylvaniaAvenue,

### M.W. Washington,

### D.C. 20460 

### Defendants. CASE NU1,IBER 1:00CV02434 JUDGE: Ellen Segal Huvelle DECK TYPE: Civil General DATE STAMP: 10/11i2000



### CERTIFICATE 

### REQUIRED

### BYRULE 26.1 

### OFTHE

### LOCAL

### RULES

### OF

## THE UNITED

## STATESDISTRICT 

### COURT

### FOR

## THEDISTRICT

### OFCOLUMBIA 

### I,the 

### undersigned 

### counsel

### ofrecord 

### forPlaintiffZeneca

### Ag

### ProductsInc., certify

### that to

### thebest

### ofmy

### knowledge and

### belief,the followingare

### pz:ent companies,

### subsidiariesor

### affiliatesofPlaintiffswhich

### haveany

### outstanding securities

### inthe

### hands

### ofthepublic. Parent: 

### AstraZeneca

### PLC Affiliate: Zeneca

### Wilmington

### Inc.

### Theserepresentationsare

### made

### inorder

### thatjudges

### ofthiscourt

### mag 

### determinethe need

### forrecusal.

Attorneyof

### ~ecordor Plaintiffs 

### MCKENNA &

### CUNEO.

### L.L.P. 1900

### K Street,

### N.W. Washington,

### DC 20006 

### (202)496-7500 October 11,

### 2000