UNITED STATES OF AMERICA

BEFORE THE FEDERAL TRADE COMMISSION

OFFICE OF THE ADMINISTRATIVE LAW JUDGES

Washington, D.C.

In the Matter of

ECM BioFilms, Inc.,

a corporation, also d/b/a

Enviroplastics International,

Respondent.

 

Docket No. 9358

PUBLIC

RESPONDENT ECM BIOFILM’S PRETRIAL BRIEF

Jonathan W. Emord, Esq.

Emord & Associates, P.C.

11808 Wolf Rune Lane

Clifton, VA 20124

Ph: 202-466-6937

Fx: 202-466-6938

Em: jemord@emord.com

Peter A. Arhangelsky, Esq.

Eric J. Awerbuch, Esq.

Bethany R. Kennedy, Esq.

Emord & Associates, P.C.

3210 S. Gilbert Road, Ste 4

Chandler, AZ 85286

Ph: 202-466-6937

Fx: 602-393-4361

Em: parhangelsky@emord.com, eawerbuch@emord.com,

bkennedy@emord.com

07 30 2014
PUBLIC DOCUMENT

TABLE OF CONTENTS

I. STATEMENT OF THE CASE............................................................................................9

II. FACTUAL AND PROCEDURAL BACKGROUND.......................................................21

A. Factual Background........................................................................................................21

1. ECM BioFilms, Inc.....................................................................................................21

2. ECM Additive and Plastics Manufacturing................................................................23

3. FTC Biodegradability Enforcement ...........................................................................28

a. Complaint Counsel’s Allegations....................................................................28

b. The Green Guides............................................................................................29

4. The Scientific Definition of Biodegradation Versus Complaint 

Counsel’s Definition...................................................................................................37

5. The Anti-Competitive Effect of Enforcement of Complaint Counsel’s 

Biodegradation Definition ..........................................................................................40

6. The Financial Interest of Complaint Counsel’s Lead Scientific Expert in 

the Outcome of the Litigation.....................................................................................46

7. The Scientific Evidence that the ECM Additive Biodegrades Plastics......................51

a. Biodegradation Testing Methods.....................................................................53

b. The Kinds, Nature and Functions of Microbes That Biodegrade 

Plastics.............................................................................................................64

c. Microbes that Adhere to Plastic in Landfills, Opportunities for 

Colonization, Enzymatic Destruction of Carbon Bonds, MultiGenerational Development, ECM Additive Acceleration of 

Microbial Degradation.....................................................................................66

d. The Living Nature of Landfills........................................................................67

e. Proof that ECM’s Additive Biodegrades Plastics............................................70

8. Testing of the ECM Additive Confirms that It Accelerates the 

Biodegradation Process ..............................................................................................73

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9. The Qualified Claims Actually Made Versus the Claims Charged............................80

10. The ECM Customer: A Sophisticated Corporation, not an End-Use 

Consumer....................................................................................................................83

11. The Survey Evidence Reveals Absence of Agreement on Meaning of Biodegradation 

Among Industry and End-Use Consumers................................................ 86

a. Well-Designed Telephone Survey Confirms that Not Even a Significant 

Minority of End-Use Consumers or ECM Customers Has a Single Definition 

of Biodegradation or Expectation as to the Rate at Which ECM Plastics Will 

Biodegrade............................................................................. 86

i. Dr. Stewart’s Telephone Survey Was Well-Designed, Incorporated 

Open-Ended Clear Questions, And Incorporated Established Principles 

Of Survey Research.......................................................... 86

ii. Dr. Stewart’s Survey Confirms that Not Even a Significant Minority 

of End-Use Consumers or ECM Customers Has a Single Definition of 

Biodegradation or Expectation as to the Rate at Which ECM Plastics 

Will Biodegrade.............................................................. 90

b. Complaint Counsel’s Survey Expert Relies on Incompetent Google Survey to 

Correct Incompetent Synovate and APCO Surveys.............................. 92

B. Procedural Background and Irregularities......................................................................96

1. Discovery Calculated to Impose Maximum Burdens.................................................96

2. Dr. McCarthy’s Moving Target................................................................................100

III. ARGUMENT...................................................................................................................102

A. FTC Failure to Satisfy Its Burden to Prove that the Biodegradation Claim 

Is Literally False...........................................................................................................102

B. ECM’s Discussions and Claims Concerning the Rate of Biodegradation 

Were Not Material to Purchasing Decisions................................................................104

C. The Legal Significance of ECM’s Sophisticated Customers.......................................113

1. ECM Did Not Engage in Any Typical Advertising or Promotion by 

Virtue of the Fact That ECM Limited All of Its Advertising to 

Sophisticated Customers...........................................................................................113

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2. To Determine Whether a Claim Is False or Misleading, the Trier of Fact 

Must View the Claim from the Perspective of the Target Audience........................114

3. ECM’s Target Audience and Actual Customers Were Sophisticated 

Purchasers Who Studied the Product and Engaged in Sophisticated 

Transactions..............................................................................................................115

4. The Bases for Purchase Among Sophisticated Customers Differ from 

Those of End Use Consumers .................................................................................118

5. No ECM Purchaser Was Misled...............................................................................122

6. The Sophisticated Purchaser Defense Is Applicable In This Context......................122

D. ECM Has Not Made an Implied “One-Year” Claim through Its

“Biodegradable” Claims...............................................................................................124

1. The Legal Significance of Survey Evidence in This Case .......................................124

2. Extrinsic Evidence of High Methodological Quality Reveals that ECM 

Did Not Make Implied Claims Concerning the Rate or Extent of 

Biodegradation..........................................................................................................125

3. Complaint Counsel’s Straw Man: An Arbitrary and Capricious 

Definition of Biodegradation....................................................................................126

E. ECM Possesses a Reasonable Basis, and at Least Competent and Reliable 

Scientific Evidence, that the ECM Additive Causes Plastics to Biodegrade 

in Landfills...................................................................................................................127

1. The Pfizer Factors Demonstrate that Biodegradable Claims Need Not 

Meet a High Standard of Competent and Reliable Evidence. ..................................127

2. The Nature of the Product Involved .........................................................................128

3. The Type of Claims Made ........................................................................................130

4. The Benefits of a Truthful Claim and Ease of Developing 

Substantiation for the Claims ...................................................................................130

5. The Consequences of a False Claim.........................................................................133

6. The Amount of Substantiation Experts in the Field Agree Is Reasonable ...............135

7. ECM’s Scientific Support.........................................................................................137

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F. The Constitution Defines Limits to the Reasonable Basis Standard............................139

G. The Ultra Vires Nature of FTC Assumption of Regulatory Power Vested 

in the EPA ....................................................................................................................143

H. The “One-Year” Rule Is an Industry-Wide Trade Regulation Rule

Adopted Without Required Rulemaking......................................................................146

IV. CONCLUSION................................................................................................................147

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TABLE OF AUTHORITIES

Cases

Akin v. Ashland Chem. Co., 156 F.3d 1030 (10th Cir. 1998) ..................................................... 123

Alliance for Natural Health U.S. v. Sebelius, 714 F.Supp. 2d 48 (D.D.C. 2010)....................... 141

Alliance for Natural Health U.S. v. Sebelius, 786 F.Supp. 2d 1 (D.D.C. 2011)......................... 141

Am.Enviro Prods., Inc., et al., 56 Fed. Reg. 46184 (Sep. 10, 1991) ............................................ 32

Ancient Coin Collectors Guild v. U.S. Customs & Border Prot., Dep't of Homeland Sec., 698 

F.3d 171 (4th Cir. 2012).......................................................................................................... 143

Ariz. Cartridge Remanufacturers Assoc., Inc. v. Lexmark Int’l, Inc., 290 F. Supp. 2d 1034 (N.D. 

Cal. 2003)................................................................................................................................ 115

Armstrong Cork Co. v. World Carpets, Inc., 597 F.2d 496 (5th Cir. 1979)............................... 116

Baker v. Monsanto Co., 962 F. Supp. 1143 (S.D. Ind. 1997)..................................................... 123

Banque Franco–Hellenique de Commerce Int’l., et Maritime, S.A. v. Christophides, 106 F.3d 22 

(2d Cir. 1997).......................................................................................................................... 118

Bristol-Myers Co. v. Fed. Trade Comm'n, 738 F.2d 554 (2d Cir. 1984).................................... 135

Byrd v. Hunt Tool Shipyards, 650 F.2d 44 (5th Cir. 1981)......................................................... 122

Castrol, Inc. v. Pennzoil Co., 987 F.2d 939 (3d Cir.1993) ......................................................... 115

Checkpoint Sys., Inc. v. Check Point Software Tech., 269 F.3d 270 (3d Cir. 2001)................. 116

Cheney Bros., Inc. v Batesville Casket Co., Inc., 47 F.3d 111 (4th Cir. 1995)........................... 119

Coastal Abstract Serv., Inc. v. First Am. Title Ins. Co., 173 F.3d 725 (9th Cir. 1999) .............. 114

Country Tweeds, Inc. v. F.T.C., 326 F.2d 144 (2d Cir. 1964) .................................................... 105

Davidson v. Wilson, 973 F.2d 1391 (8th Cir. 1992)................................................................... 119

Davis v. Avondale Indus., 975 F.2d 169 (5th Cir. 1992) ............................................................ 123

DeSena v. Beekley Corp., 729 F. Supp. 2d 375 (D. Me. 2010) .................................................. 115

Dickinson v. Zurko, 527 U.S. 150 (1999) ................................................................................... 126

Direct Mktg. Concepts, Inc. v. F.T.C., 581 F. Supp. 2d 115 (D. Mass. 2008)............................ 128

Edenfield v. Fane, 507 U.S. 761 (1993) ..................................................................................... 141

Emergent Capital Inv. Mgmt., LLC v. Stonepath Grp., Inc., 343 F.3d 189 (2d Cir. 2003)........ 118

F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 119 (D. Conn. 2008).......................... 103, 124

F.T.C. v. Colgate-Palmolive Co., 380 U.S. 374 (1965).............................................................. 104

F.T.C. v. Garvey, 383 F.3d 891 (9th Cir. 2004).......................................................................... 103

F.T.C. v. Medlab, Inc., 615 F. Supp. 2d 1068 (N.D. Cal. 2009)................................................. 127

F.T.C. v. NHS Syss., Inc., 936 F. Supp. 2d 520 (E.D. Pa. 2013) ................................................ 104

F.T.C. v. Raladam Co., 316 U.S. 149 (1942).............................................................................. 104

F.T.C. v. Simeon Mgmt. Corp., 532 F.2d 708 (1976)................................................................. 139

F.T.C. v. Wash Data Ress., 856 F. Supp. 2d 1247 (M.D. Fla. 2010).......................................... 105

First Health Grp. Corp. v. BCE Emergis Corp., 269 F.3d 800 (7th Cir. 2001) ................... 46, 114

FTC v. Braswell, 2005 WL 4227194 (C.D. Cal. Sept. 27, 2005)............................................... 127

FTC v. Pantron I Corp., 33 F.3d 1088 (9th Cir.1994)................................................................ 127

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Gilchrist Timber Co. v. ITT Rayonier, Inc., 95 F.3d 1033 (11th Cir. 1996)............................... 119

Goodbar v. Whitehead Bros., 591 F. Supp. 552 (W.D. Va. 1984 ) ............................................ 122

Hirsch v. du Pont, 553 F.2d 750 (2d Cir. 1977).......................................................................... 118

Homeowners Grp., Inc. v. Home Mktg. Specialists, Inc., 931 F.2d 1100 (6th Cir. 1991).......... 121

Hunter v. F.E.R.C., 569 F. Supp. 12 (D.D.C. 2008)................................................................... 144

In re Adventist Health Sys./West, 117 F.T.C. 224 (Apr. 1, 1994)............................................... 103

In re Ex-Cell-O Corp., 82 F.T.C. 36 (1973) ................................................................................. 31

In Re Kraft, Inc., 114 F.T.C. 40 (1991) ...................................................................................... 104

In re Matter of BPI Environmental, Inc., No. 902-3225, 1992 WL 696753 (May 5, 1992) ........ 32

In re Matter of N. Am. Plastics Corp., et al., 118 F.T.C. 632, 1994 WL 16011102 (Sep. 7, 1994)

................................................................................................................................................... 32

In re Matter of RMED Int'l, Inc., et al., 115 F.T.C. 572, 1992 WL 12011051 (May 14, 1992)... 32

In re N. Am. Plastics Corp., No. 902-3184, 1993 WL 766976 (Jan. 14, 1993)............................ 32

In re Novartis Corp., 127 F.T.C. 580 (1999).............................................................................. 106

In re Pfizer Inc., 81 F.T.C. 23 (1972) ........................................................................................... 45

In re Stouffer Foods Corp., 118 F.T.C. 746 (Sept. 26, 1994)..................................................... 125

In re Synthroid Mktg. Litig., 264 F.3d 712 (7th Cir. 2001) ........................................................ 120

In the Matter of POM Wonderful LLC, 2013 WL 268926 (F.T.C. Jan. 16, 2013).... 128, 129, 131, 

134

In the Matter of POM Wonderful, LLC, 2012 WL 2340406 (F.T.C. May 17, 2012)........... 20, 103

In the Matter of Removatron Int’l Corp., 111 F.T.C. 206 (Nov. 4, 1988).................................. 129

In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 (Nov. 23, 1984).... 103, 124, 128, 129, 

130, 134

Int’l Ladies' Garment Workers' Union v. Donovan, 722 F.2d 795 (D.C. Cir. 1983) ................. 126

Interstellar Starship Servs., Ltd. v. Epix Inc., 184 F.3d 1107 (9th Cir. 1999)............................ 120

John Crane Prod. Solutions, Inc. v. R2R and D, LLC, 861 F. Supp. 2d 792 (N.D. Tex. 2012).. 91, 

116

Kline v. First Western Gov’t Sec., Inc., 24 F.3d 480 (3d Cir. 1994) .......................................... 119

Kraft, Inc. v. F.T.C., 970 F.2d 311 (7th Cir. 1992)............................................................. 104, 124

Larson v. Domestic & Foreign Commerce Corp., 337 U.S. 682 (1949) .................................... 143

Marketquest Grp., Inc. v. BIC Corp., 2011 WL 5360899 (S.D. Cal. Nov. 7, 2011).................. 120

Mead Data Dent., Inc. v. Toyota Motor Sales, U.S.A., Inc., 875 F.2d 1026 (2d Cir. 1989)....... 120

Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748 (7th Cir. 2010) .................................... 118

Miller v. Berman, 289 F. Supp. 2d 1327 (M.D. Fla. 2003) ........................................................ 122

Mobile Oil Corp; Proposed Consent Agreement, 57 Fed. Reg. 35589-01 (Aug. 10, 1992) ........ 32

Murray Space Shoe Corp. v. F.T.C., 304 F.2d 270 (2d Cir. 1956)............................................. 105

O’Neal v. Celanese Corp., 10 F.3d 249 (4th Cir. 1993)..................................................... 122, 123

Oreck v. U.S. Floor Sys., Inc., 803 F.2d 166 (5th Cir. 1986)..................................................... 116

Pearson v. Shalala, 130 F.Supp. 2d 105 (D.D.C. 2001)..................................................... 141, 147

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999).................................................................... 141

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Perini Corp. v. Perini Constr., 915 F.2d 121 (4th Cir.1990)...................................................... 116

Porter & Dietsch, Inc. v. F.T.C., 605 F.2d 294 (7th Cir. 1979) ................................................. 103

Roberts v. United N. Mex. bank at Roswell, 14 F.3d 1076 (5th Cir. 1994) ................................ 119

Rust Env't & Infrastructure, Inc. v. Teunissen, 131 F.3d 1210 (7th Cir. 1997).......................... 116

Sahaviriya Steel Indus.Pub. Co. Ltd. v. U.S., 601 F. Supp. 2d 1355 (C.I.T. 2009).................... 144

Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990)........................ 115

Schering-Plough Healthcare Prods., Inc. v. Schwartz Pharma, Inc., 547 F. Supp. 2d 939 (E.D. 

Wisc. 2008) ............................................................................................................................. 114

Schwarz Pharma, Inc. v. Breckenridge Pharm., Inc., 388 F. Supp. 2d 967 (E.D. Wis. 2005)... 115

Sears, Roebuck and Co. v. F.T.C., 76 F2d 385 (9th Cir. 1982).................................................. 139

Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379 (5th Cir. 1996) ................................................. 114

Skeen v. C.I.R., 864 F.2d 93 (9th Cir. 1989)............................................................................... 119

Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134 (9th Cir 1997)................................... 114

Specialty Equip. Mkt. Ass’n v. Ruckelshaus, 720 F.2d 124 (D.C. Cir. 1983)............................. 126

Standard Oil C. of Cal. v. F.T.C., 577 F.2d 653 (9th Cir. 1978)................................................ 139

Sterline Drug, Inc. v. F.T.C., 741 F.2d 1146 (9th Cir. 1984) ..................................................... 103

Sterling Drug, Inc. v. FTC, 741 F.2d 1146 (9th Cir.1984)......................................................... 127

Terra Sec. Asa Konkursbo v. Citigroup, Inc., 740 F. Supp. 441 (S.D.N.Y. 2010)..................... 118

Thompson Med. Co., Inc. v. Fed. Trade Comm'n, 791 F.2d 189 (D.C.Cir.1986)............... 127, 135

Time Warner Cable, Inc. v. DIRECTV, Inc., 497 F.3d 144 (2d Cir. 2007) ................................ 125

Tom Hughes Marine, Inc. v. Am. Honda Motor Co., Inc., 219 F.3d 321 (4th Cir. 2000) .......... 119

Whitaker v. Thompson, 248 F.Supp. 2d 1 (D.D.C. 2002)........................................................... 141

Zurich Ins. Co. v. Amcor Sunclipse N. Am., 241 F.3d 605 (7th Cir. 2001) ................................ 114

Statutes

15 U.S.C. § 57..................................................................................................................... 146, 147

15 U.S.C. § 77............................................................................................................................. 122

5 U.S.C. § 553............................................................................................................................. 147

5 U.S.C. § 556............................................................................................................................. 103

5 U.S.C. § 706..................................................................................................................... 126, 144

Other Authorities

FTC Policy Statement on Deception, Federal Trade Commission (1983).................................. 104

Regulations

16 C.F.R. § 260................................................................................................. 33, 43, 44, 113, 146

16 C.F.R. § 3.43.......................................................................................................................... 103

16 C.F.R. § 3.51.......................................................................................................................... 102

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I. STATEMENT OF THE CASE

The totality of the scientific evidence establishes more than a reasonable basis, and at 

least competent and reliable scientific evidence, that plastics infused with the ECM additive (in 

accordance with ECM manufacturing instructions and at a 1% load rate) will biodegrade within a 

reasonably short period of time under conditions of customary disposal, particularly when 

compared with conventional, untreated plastics. The totality of the scientific evidence, including 

generally accepted science on microbiological mechanisms that degrade plastics and on 

biodegradation in landfills as well as at least 33 separate biodegradation tests and assessments of 

the ECM additive by the plastics industry, establish more than a reasonable basis, and at least 

competent and reliable scientific evidence, that ECM’s additive causes biodegradation of the 

most widely used plastic resins in the external environment, including in landfills. 

The term “biodegradable” defines an on-going process: “the chemical dissolution of 

materials by bacteria or by other biological means.”1

 “Biodegradation takes place by the action 

of enzymes, chemical degradation with living organisms.”2 It has been described as a “two step” 

process.3 “The first step is the fragmentation of the polymers into lower molecular mass species 

by means of abiotic reactions, like oxidation, photodegradation or hydrolysis, or biotic reactions, 

like degradations by microorganisms.”4

 The second step is “the bioassimilation of polymer 

fragments by the microorganisms and their mineralization.”5

 Degradation results “from the 

action of naturally occurring microorganisms such as bacteria, fungi, and algae.”6 Scientific 

1 G. Gnanavel, V.P. Mohana Jeya Vali, and M. Thirumarimurugan, 1:3 International 

Journal of Pharmaceutical and Chemical Sciences 670, 671 (July–Sept. 2012).

2 Id.

3 Id.

4 Id.

5 Id.

6 Id.

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definitions in the peer-reviewed literature vary, but all echo that fundamental concept, and none 

attach a specific timeline, extent, or rate of biodegradation before a substance is considered 

“biodegradable.” The evidence amassed in this proceeding complemented by the testimony of 

four experts in the respective fields of environmental science, microbiology, biodegradation, and 

landfill science prove that the ECM plastic additive when mixed into plastic resin during plastic 

manufacture (in accordance with ECM’s precise instructions for so doing) results in a finished 

plastic product that is biodegradable, establishing ECM’s qualified claims of biodegradation to 

be well substantiated and non-deceptive.

The complaint in this case presumes as valid anachronistic, decades-old concepts of 

landfill science. Those concepts have been debunked and are no longer generally accepted in the 

scientific community. Complaint Counsel seek to enforce a standard concerning 

“biodegradability” claims that is in fact unscientific and misleading. To get there, Complaint 

Counsel beg this Court to raise the evidentiary standard above that prescribed in In re Pfizer, Inc.

and its progeny to require a higher degree of proof than is accepted in the scientific community 

that studies plastics biodegradation. In particular, Complaint Counsel seize upon a select subset 

of studies that fail to show biodegradation within the parameters set and the time period 

specified, presuming the absence of evidence of biodegradation in this subset to be the same as 

affirmative evidence that the ECM additive does not cause biodegradation and to be the only 

science creditable as competent and reliable. Those select studies, however, fail to account for 

the affirmative evidence of biodegradation present in over 33 other studies of comparable design 

and the same or longer duration. Complaint Counsel ignores a salient and recurrent fact in this 

artificial test environment which accounts for test failings: that these tests, to be valid, must 

ensure the presence of one or more strains of living bacteria, a perennial confounding factor that 

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contributes to test failures (among other variables that might influence test outcomes). Despite 

that confounding factor, more than 33 independent tests involving bacteria strains from landfills

do show that the ECM additive causes plastic biodegradation under testing conditions in which 

the biota survive. Those redundant, independent positive tests are dispositive.

Complaint Counsel are engaged in an enforcement campaign exclusively against one 

industry sector, the biodegradable additive plastics sector, and in furtherance of the market 

interests and advantage of that sector’s chief competitor, the compostable plastics sector. 

Compostable plastics are ones infused with highly biodegradable ingredients, causing them to 

break down rapidly, within the span of a year. It was that sectors lobbying campaign that led the 

FTC to adopt the arbitrary one year limit. The rapid destruction of compostable plastics in the 

environment makes them of limited utility because they cannot be used in plastics for which 

there is a need for endurance and strength, and they evoke production of a far greater volume of 

pollutants in the form of toxic gasses and by-products at a single time (due to their rapid 

degradation) than occurs with biodegradable additive plastics. 

By vigorously routing out of the market the biodegradable additive plastics sector

through consent orders and this prosecution, Complaint Counsel are effectively establishing a 

national environmental policy. That is an ultra vires action which invades the province of the 

Environmental Protection Agency (EPA). It also conflicts with the duties and responsibilities of 

that agency and supplants EPA policy on waste disposal with that of the FTC. Indeed, if 

successful, Complaint Counsel will not only effect a fundamental change in environmental 

policy but also change the actual environment, fundamentally. By forcing plastics manufacturers 

and waste disposal companies and landfills that prefer biodegradable additives to be without that 

choice, FTC’s enforcement brings about far reaching and adverse environmental consequences. 

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Many plastics now made with biodegradable additives that cannot be made compostable because 

to do so would destroy their market utility will be made without those additives and without 

compostable plastics. Those conventional plastics will accumulate in the environment and in 

landfills and will remain largely intact for thousands of years. The result will be a substantial 

increase in the ambient level, degree, and extent of plastics pollution. Moreover, depriving 

plastics manufacturers of additives like ECM’s and effectively compelling them to rely, if at all,

exclusively on compostable plastics will increase the number of entities using those rapidly 

degrading polymers which produce a greater adverse environmental impact in the volume of 

toxic gasses and by-products at a single time than plastics made with biodegradable additives.

Complaint Counsel depend principally on one witness with plastics experience, Dr. 

Steven McCarthy. Complaint Counsel’s two other experts lack requisite background and 

experience to opine on the science of plastics biodegradation: Dr. Shane Frederick who is a 

purported survey expert and Dr. Thabet Tolaymat who is a purported landfill expert. 

Dr. McCarthy (upon whom Complaint Counsel exclusively depend to meet its burden of 

proof that ECM’s biodegradation claim lacks a reasonable basis) testifies in contradiction to the 

scientific literature and without that degree of independence and integrity necessary to be 

credited. Ab initio, Dr. McCarthy adopts a definition of “biodegradation” admittedly given him 

not by peers but by Complaint Counsel. The definition given him is not from the scientific 

literature (indeed is nowhere found there), but is instead legally contrived and conflicts with the 

definition in the literature (including McCarthy’s own published scientific writings). The given

definition arbitrarily excludes from consideration any degradation of plastic due to biological 

mechanisms unless the biodegradation results in 100% elimination of the plastic, breaking it 

down into oxygen, hydrogen, and carbon (and biomass or humus), within 365 days after 

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customary disposal in a landfill. By this definition, if a plastic on day 365 has degraded by 95% 

and then on day 366 it degrades by 100%, it is not biodegradable. By this definition a banana 

peels is not biodegradable, and neither are tree trunks. The precise definition reads as follows: 

Complaint Counsel asked me to assume that the unqualified marketing claim 

“biodegradable” means that the entire treated plastic will completely break 

down and return to nature (i.e., decompose into elements found in nature) within 

one year after customary disposal (i.e., incinerator, landfill, or recycling).7

That definition is nowhere present in the scientific literature; is not even found in any 

article on biodegradation by Dr. McCarthy in the scientific literature; and conflicts with the 

definition accepted by Dr. McCarthy in his articles and in his own patent for a biodegradable 

plastic resin (wherein he deemed a scientific study of 45 days duration using a test he created, 

not ASTM 5511 and not 14C radiological testing, that resulted in only 14% biodegradation of the 

plastic resin to be proof of “biodegradation”). 

While contending in his scientific report that biodegradation may only be said to exist if a 

plastic resin is tested under, and is completely eliminated during, an ASTM (formerly the 

American Society for Testing and Materials) D5511 test or is proven completely eliminated 

during what he calls “definitive” 14C radiological testing, Dr. McCarthy can cite to no article in 

the peer reviewed scientific literature endorsing that position. Moreover, he contradicts that 

position when, in his own original research on biodegradation of plastics, he has never relied on 

either form of testing, including in his submissions to the United States Patent and Trademark 

Office in support of a “biodegradable” resin he invented, U.S. Patent No. 5883199 (Mar. 1999).

7 CCX-891, at 5 n. 1 (McCarthy Rep.). All citations to Complaint Counsel’s exhibits 

correspond to the numbers assigned by Complaint Counsel to those specific exhibits in their 

Revised Final Proposed Exhibit List, submitted to ECM on July 18, 2014. Complaint Counsel 

subsequently submitted their “Final Proposed Exhibit List” on July 28, 2014. This more recent 

version identified specific exhibits by numbers different from those in their July 18 Exhibit List. 

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In short, at deposition Dr. McCarthy revealed himself to be an expert who testifies 

precisely as his Complaint Counsel handlers would have him and, critically, in opposition to the 

generally accepted science. Moreover, that willingness to be devoid of scientific dependence 

and to abandon the generally accepted science is entirely consistent with his own financial 

interests. Complaint Counsel have selected as their primary witness on the subject of 

biodegradation an individual who has a direct financial stake in the outcome of this litigation. 

Dr. McCarthy is the inventor of a biodegradable plastic resin, the patent holder of which 

is the University of Massachusetts at Lowell (where he works as a professor), the party assigned 

the patent from Dr. McCarthy. Dr. McCarthy receives royalties from the University under that 

patent. The patent is exclusively licensed to Metabolix. Metabolix uses the patented formulation 

to make resin for the creation of biodegradable plastic bags. Metabolix (which also supplies

grants to Dr. McCarthy’s center at the University of Massachusetts at Lowell) lobbied FTC to 

commence the present action against ECM and sells Dr. McCarthy’s biodegradable plastic resin 

to companies for which Metabolix and ECM compete in the market. To the extent plastics 

companies turn to Metabolix for its plastic resin when making biodegradable plastic bags, they 

turn away from ECM for its additive and vice versa. Moreover, Metabolix’s plastic resin is more 

costly than ECM’s additive. Consequently, absent a legal force effectively prohibiting ECM 

from being in the market, ECM has the preferable market position. Dr. McCarthy’s financial 

interest in the outcome of this litigation, combined with his assumption of a position that 

contradicts the generally accepted science in furtherance of a contrived definition of 

biodegradation given him by Complaint Counsel, is proof beyond per adventure of doubt that his 

testimony is not credible. It should be rejected due to its lack of scientific integrity and due to its 

furtherance of McCarthy’s economic bias. If there was any doubt about the prudence of that 

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course, it should be allayed by the fact that two experts in this proceeding, Drs. Sahu and 

Burnette, as well as a professor who is a colleague of Dr. McCarthy in his own department at 

UMass Lowell, Dr. Steven Grossman, all conclude that Dr. McCarthy’s scientific report 

contradicts the totality of the scientific evidence in its assumptions, analyses, and conclusions. 

They note at length that not only is Dr. McCarthy’s report largely bereft of citations for the broad 

propositions he makes, but it also runs counter to the scientific literature and generally accepted 

science in the field of plastics biodegradation.

Thus, at root, Complaint Counsel errs when they presume the ECM additive inherently 

incapable of causing plastics to biodegrade. The evidence substantiates that plastics infused with 

the additive in accordance with ECM’s specific manufacturing instructions do biodegrade faster 

than plastics without the additive. The foundation of Complaint Counsel’s argument that all 

biodegradation claims made by ECM are literally false thus fails.

Contradicting McCarthy, who by his own patent and research, adheres to the view that 

plastics can be made biodegradable in landfills, is Complaint Counsel’s other expert, from the 

EPA, Dr. Thabet Tolyamat. Dr. Tolyamat takes the view that landfills are dry tombs wherein 

microbiological activity is in all material respects non-existent. On this theory, he finds that 

landfills are too inhospitable for plastics biodegradation to occur (effectively robbing Dr. 

McCarthy’s patent of its validity). Dr. Tolyamat is, however, not the expert he is purported to 

be. Indeed, he is not the EPA’s expert on biodegradation in landfills, and he admits a lack of 

basic knowledge of microbiology and plastics biodegradation. He takes the position that because 

he is unaware of the science governing biodegradation in landfills, it must not exist. That 

position is refuted by a man who Dr. Tolyamat has turned to edit papers he has given critiquing 

landfill science and is one of the world’s leading experts in biodegradation in landfills, Dr. 

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Morton Barlaz, an expert for ECM. Dr. Barlaz explains, based on generally accepted scientific 

research, that landfills are in fact not dead but alive with aerobic and anaerobic bacteria and 

fungi, and that landfills present hospitable conditions for aerobic and anaerobic biodegradation.

Next, Complaint Counsel argues that ECM’s claims concerning the rate of 

biodegradation are false and misleading. As to this aspect of Complaint Counsel’s case, it adopts

an erroneous premise. It presumes that ECM’s discontinued claim of biodegradation within 9 

months to 5 years was unqualified. It presumes further that ECM customers purchased the 

additive in reliance on that allegedly unqualified claim. Both presumptions are contradicted by 

the evidence. 

At the outset, we should recognize that ECM permanently discontinued making this 

claim, even in its qualified state, almost three years ago. Despite that fact, Complaint Counsel 

spend considerable effort endeavoring to prove the abandoned claim false. The factual evidence 

reveals five fundamental flaws in the foundation for Complaint Counsel’s argument. 

First, when ECM made a 9 month to 5 year claim, the claim was qualified in ways 

ignored by Complaint Counsel. In particular, ECM explained that while its additive may cause 

biodegradation within 5 years, it is impossible to predict beforehand precisely how much time 

biodegradation will in fact take in any specific location, which rate is inherently variable, not 

only dependent on the kind of plastic involved but also on the precise ambient circumstances 

present at the spot where the plastic comes to rest. 

Second, to the extent that there is any common understanding of the term biodegradable 

among the industry, it refers to a process of microbes producing enzymes that break down carbon 

bonds in plastic resins, which process (dependent upon microbial life cycles) invariably begins 

for the ECM additive within 9 months to 5 years after customary disposal of plastics but does not 

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always end within that period (but, rather, at such time as the environment becomes unsuitable 

for microbial life to remain present, or the substrate is consumed). 

Third, sales of the additive take place over several phone calls wherein ECM explains in 

detail the nature of the additive, its utility, and precisely how it is to be mixed into plastics during 

manufacture. Moreover, ECM remains in contact with its customers, repeatedly explaining the 

technical and scientific aspects of product use and effect. During that interaction variously with 

sales, scientific, and technical representatives of each company, ECM explains that precise

predictions of how much time it will take for elimination of plastics to occur in the environment 

are impossible because they depend on numerous variables, including, inter alia, the kind of 

plastic involved and the peculiar environment present which varies from location to location and, 

within landfills, from locus of deposit to locus of deposit. The most common example given by 

Robert Sinclair to customers is that the rate of biodegradation will not be the same if a plastic 

ends up in a landfill in Antarctica than if it ends up in a landfill in the tropics. 

Fourth, ECM does not sell its additive to end-use consumers. It sells to sophisticated 

plastics manufacturers. Indeed, no end use consumer has ever purchased ECM’s additive. None 

of the plastics manufacturers who purchase ECM’s additive is naïve enough to believe that an 

additive dependent upon a biological process in nature (wherein the additive serves as an 

attractant for living hosts to colonize and initiate enzymatic activity that breaks carbon chains)

will result in elimination of all plastics by an invariable set date or time. Plastics manufacturers 

comprehend differences in the strength of the plastics they sell and appreciate the variable 

longevity of those plastics in the environment based on the composition of the resins that make 

them. Many, if not most, plastics manufacturers rely on their own tests to determine 

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biodegradability, including the numerous independent tests of the ECM additive by plastics 

companies that are evidence in this proceeding. 

To the extent there is a common understanding of the term biodegradation, scientists and 

industry understand the term to refer to a biological process rather than a completed event, 

wherein there are multiple phases, (1) initiation where microbes and fungi attach to the plastic at 

different opportunistic points, colonize, and produce enzymes that break carbon chains; (2) 

continuation accentuated by generation after generation of microbes and fungi, each furthering 

the enzymatic destruction of carbon bonds; and (3) the point at which all enzymatic destruction 

of carbon bonds ends (indicative of the complete death of all microbes and fungi that produce 

biodegrading enzymes), which usually means the plastic has been eliminated to all but residue.

Fifth, a well-designed telephone survey by Dr. David Stewart reveals that not even a 

significant minority of end-use consumers agrees to a single definition of biodegradation, 

including rates of biodegradation. Instead, the evidence reveals that most consumers are bereft 

of knowledge concerning even the basics of biodegradation. Put simply, they lack fundamental 

knowledge to understand the science involved, including, for instance, the expected rate or extent 

of biodegradation in various environments. Arbitrary limitations on the time period for 

degradation before the term “biodegradation” can be employed are unscientific and 

unsupportable. Moreover, rapidly degrading substances are not preferable from an 

environmental standpoint, not possible from a materials perspective, and not supported by 

consumer impression. Consequently, there is no materiality to claims involving those terms 

among end-use consumers. It should be noted that ECM has never sold to end-use consumers 

and, to the extent that companies chose to make end-use consumer claims, they did so without 

ECM’s involvement except to the extent they used ECM’s biodegradation certificate on their 

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products, but that certificate merely affirms that the product containing the ECM additive is 

biodegradable (without mention of rate), which is backed by competent and reliable scientific 

evidence.

Complaint Counsel substantially hangs its argument on claims of biodegradation rate, 

excerpting them from qualified context. ECM’s experts will explain that, from an environmental 

perspective, whether ECM plastics degrade within a few years or decades is scientifically 

irrelevant, so long as they biodegrade, because, in part, plastics disposed in landfills are intended 

for indefinite storage. Neither plastics manufacturers nor end-use consumers nor landfill owners

derive a tangible benefit if ECM’s plastics degrade by a precise time in landfills, and that helps 

explain why so many companies prefer ECM’s additive over compostable plastic resins. 

Complaint Counsel’s campaign against ECM’s additive technology is therefore misleading, 

owing to the demonstrably false supposition that the rate of biodegradation in this context is 

material to plastics manufacturers and end-use consumers, when it is not.

Sixth, a well-designed pilot study by Dr. Stewart of companies that purchased the ECM 

additive likewise reveals that not even a significant minority of ECM’s actual customers agrees 

to a set meaning for the term biodegradation or harbors any notion as to the rate at which ECM’s 

additive will effect complete elimination of ECM plastics in the environment. That data, 

although limited in scope, confirms that there is no consensus at all among purchasers of ECM’s 

technology with respect to core terms here at issue. Put simply, Complaint Counsel cannot 

demonstrate that consumers are misled by “biodegradable” claims where the definitional 

elements differ dramatically from one individual to the next and from one company to the next. 

Consequently, there is no materiality to claims involving those terms among ECM’s actual

customers or the general public.

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Against Dr. Stewart’s telephone survey evidence confirming a complete lack of 

agreement among end-use consumers as to the meaning of biodegradation and as to the rate of 

biodegradation of plastics, Complaint Counsel defends the two surveys the Commission deemed 

flawed in its Green Guides (the Synovate and APCO studies), based on an even more profoundly

flawed Google Consumer Survey—all of which lack required elements for validity and 

reliability. 

In its Complaint, and in its opening brief, the FTC explained what it intended to prove in 

these proceedings, which it must do by a preponderance of the evidence. See, e.g., In the Matter 

of POM Wonderful, LLC, 2012 WL 2340406, at *171 (F.T.C. May 17, 2012) (noting that 

“Complaint Counsel has the burden of proving each of the foregoing factual issues by a 

preponderance of credible evidence”). That proof would consist of competent and reliable 

scientific evidence (1) that the ECM additive did not cause plastics to biodegrade and (2) that 

ECM claimed unqualifiedly that biodegradation occurred within 9 months to 5 years or some 

period greater than a year, and that both claims were false and misleading. Complaint Counsel 

has failed to meet its burden of proof. The evidence demonstrates that, indeed, the ECM additive 

causes plastics to biodegrade more rapidly in the environment than untreated plastics, creating a 

truly beneficial product demanded by many large plastics manufacturers. Moreover, the 

evidence reveals that ECM permanently discontinued its 9 months to 5 years claim almost three 

years ago; that the claim when made was not material to ECM’s customers purchasing decisions; 

that ECM’s customers are sophisticated and frequently tested the ECM product to assess its 

biodegradability; and that all were apprised by ECM truthfully that biodegradation was a natural 

process and that the rate of biodegradation necessarily varies unpredictably in each individual 

case. Moreover, not even a substantial minority of plastics manufacturers or end-use consumers

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have an agreed upon definition of biodegradation or subscribe to the view that biodegradation 

means complete breakdown of plastics into elements found in nature within one year of 

customary disposal in a landfill, the legally contrived definition adopted by Complaint Counsel 

in this case.

Accordingly, void of requisite proof of competent and reliable scientific evidence for its 

case, and surrounded by an abundance of proof contrary to its assumptions and conclusions, 

Complaint Counsel has failed to satisfy its burden and the charges against ECM should be denied 

and dismissed.

II. FACTUAL AND PROCEDURAL BACKGROUND

A. Factual Background

1. ECM BioFilms, Inc.

ECM BioFilms, Inc. is a small Ohio-based corporation started by Patrick Riley of MicroTech Research, Inc. in 1998.8

 Micro-Tech was found in 1995, and years later began marketing a 

biodegradable masterbatch pellet that renders plastics resins (e.g., polystyrene, polyethylene, and 

polypropylene) biodegradable. As the oldest such products in the market today, the ECM 

product has had success as a cost-effective solution for companies looking to have less of a longterm environmental impact.9

 

In 2000, Robert Sinclair assumed leadership of ECM Biofilms.10 Mr. Sinclair had served 

as a lawyer (general practitioner) in the local community prior to that time and before that had 

taught science in northeast Ohio public schools. When he became the President of ECM, he 

8 See CCX-818, at 19–20 (R. Sinclair deposition).

9 Id. at 120 (“cost is a huge thing”); CCX-820, at 56–57; CCX-445.

10 CCX-818, at 7–8.

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inherited the proprietary formula for ECM’s technology from Mr. Riley, the formula’s 

inventor.

11 ECM’s proprietary formula is a trade secret.12 Only two individuals have had 

knowledge of the formula, Messrs. Sinclair and Riley. Mr. Riley is now deceased. Although 

ECM had once considered applying for patent protection, it eventually decided that trade secret 

afforded the best long-term protection for ECM’s intellectual property.13 The ECM proprietary 

formula is a closely held secret. Although analytical laboratories have attempted to assay the 

specific ingredients, none have identified the correct formula.14

Mr. Sinclair also received test data from Micro-Tech, including studies demonstrating the 

efficacy of the product, and claim language that had been used with the product in commerce.15 

Although Mr. Sinclair is not a scientist, he considered himself competent to review the scientific 

material.16 As discussed below, ECM’s customers are sophisticated plastics manufacturers who 

ordinarily perform extensive testing on ECM’s product themselves or rely on such testing 

obtained from others before incorporating the technology in their plastics.17

ECM has employed on average six employees.18 Those employees include Robert 

Sinclair (President and CEO), Kenneth Sullivan (CFO), and one or two administrative employees

and one or two sales people. Although other employees have initiated or maintained business 

relationships, Mr. Sinclair is primarily responsible for communicating with clients concerning 

11 Id. at 19–20.

12 Id. at 27.

13 Id. at 73–74.

14 See, e.g., RX-563, at 1. 15 See RX-551; RX-260; RX-263; RX-264; RX-265; RX-269; CCX-241; CCX-799, at 

135, 138–141, 266.

16 See CCX-818, at 23–24

17 See CCX-818, at 121–123.

18 CCX-819, at 327–28.

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ECM’s technology.19 As a provider of a plastic additive, ECM sells almost exclusively to 

plastics manufacturers and, on occasion, to distributors who sell to plastics manufacturers. 

ECM’s product is not purchased by end-consumers and, in fact, it would be useless to an end-use 

consumer because it is in pellet form and is sold in bulk quantities of no use unless infused into 

plastic during manufacture. Anyone not capable of manufacturing plastics through inclusion 

during the extrusion or molding process has no use for this product. 

ECM markets its technology through sales meetings, published material (e.g., brochures), 

and networking functions. As with most technologies sold between corporate entities at the 

manufacturing level, ECM sales are subject to negotiation. Sales and confidentiality agreements 

are customary. A prospective customer often performs product testing (including performance 

testing) before deciding whether the ECM product is a fit. ECM invites independent testing of 

its product and sells quantities to individual corporate entities to facilitate that testing. In that 

manner, ECM’s sales are best characterized as complex business transactions, in contrast with 

retail sales to end-consumers. 

2. ECM Additive and Plastics Manufacturing

ECM sells a “MasterBatch Pellet” that includes a biodegradable component along with 

an otherwise non-biodegradable (or conventional) plastic carrier resin.20 The formula for the 

“active” component is a trade secret.21 ECM offers a “load rate” of 70% in its pellets, meaning 

that every pellet will contain approximately 70% of the “active” biodegradable formula, along 

with 30% conventional polymer resin. ECM prescribes that plastics manufacturers blend the 

pellet into their plastics at a 1% rate, resulting in a uniform distribution of the pellet throughout 

19 See CCX-813, at 15 (T. Nealis deposition); 

20 See RX-371; RX-656; RX-681.

21 RX-371.

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the plastic and at a level that ensures maximum utility without compromising the plastic’s 

integrity.22

Like many other plastic additives (e.g., coloring agents), manufacturers introduce the 

ECM additive into the plastic during the initial blending process.23 Plastics are commonly 

manufactured using one of several techniques, including extrusion molding, injection molding, 

or blow molding.24 For instance, extrusion molding involves a heated plastic compound 

continuously injected through a long die cast in the desired shape.25 The plastic is cooled under 

blown air and hardens into items such as thin films which are eventually coiled or cut.26 

There are many different types of plastic polymers, but where ECM additives are used, 

the additive is intended to be mixed uniformly throughout the plastic polymer through a heated 

blending process, just like a coloring additive.27 Through testing and history of use, ECM has 

established that a 1% load rating in finished plastics is required to maintain the additive’s 

efficacy vis-à-vis biodegradation.28 Thus, for all plastics properly manufactured with ECM’s 

additive, at least 1% of the final plastic will include the ECM additive based on weight.29 

ECM’s customers manufacture many plastic polymers, but the bulk of the plastics 

incorporating ECM’s technology consist of polypropylene (PP), polystyrene (PS), and 

polyethylenes (PE).30 Over seventy (70) percent of ECM plastics are PE plastics. Companies 

frequently use ECM’s technology in plastics such as films (e.g., grocery “t-shirt” bags, 

22 CCX-20.

23 RX-135.

24 RX-656.

25 RX-783.

26 Id.

27 RX-520.

28 RX-683; CCX-2. 

29 RX-678.

30 RX-458; RX-522.

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packaging cushions, etc.).31 ECM’s additive is included within so-called “conventional” plastics 

to form a blend of ECMs’ copolymer additive within the larger plastic polymer.32 In North 

America, conventional plastics like PE or PP primarily come from domestic natural gas and are 

substances that contain varying formations of hydrocarbon bonds or polymers.33 In the rest of 

the world they are primarily manufactured from the naptha from crude oil distillation. A 

polymer is simply a molecular structure consisting of a string of similar units bonded together.34 

In other words, in certain plastics, a repeating chain of hydrocarbon bonds. For instance, the 

following is a diagram of a simple polyethylene polymer:

ECM offers a cost-effective means to achieve biodegradable plastics.35 There are 

competing technologies available, such as “bioplastics” which are biodegradable plastic 

polymers or resins derived from biological substances instead of petroleum.36 Bioplastic can be 

non-biodegradable such as bio-based polyethylene or they can be biodegradable such as PHA. 

Many of those technologies will produce an end-product that biodegrades more rapidly or readily 

31 RX-520; RX-471; RX-849.

32 RX-458.

33 Id.

34 RX-458.

35 RX-335.

36 RX-748; RX-678.

Figure 1. Polyethylene polymer

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than plastics made with the ECM additive in an industrial composting operation.

37 However, 

those competing technologies come at a substantial cost.38 Companies choosing to invest in 

most bioplastics must change their entire manufacturing process to accommodate the use of the 

new natural resins.39 The bio-based polymers are almost always significantly more expensive.40 

Additional additives are needed to stabilize the bioplastics for the intended use of the end 

product.41 After all, the primary purpose of a plastic product is to serve a function in the market, 

not to biodegrade in landfills. The bioplastics are often suitable only for certain limited uses in 

the market.42 There are thus many reasons why a plastics manufacturer might not be able (or not 

want) to use competing technologies that come at substantial cost and may compromise plastic 

strength or utility.

ECM’s customers are primarily concerned with the balance between product performance 

(i.e., tensile strength, shelf-life, etc.) after the ECM additive is included and ECM additive’s 

effectiveness.43 In fact, most ECM customers first perform product performance testing on their 

finished ECM-infused plastic before ordering product.44 Because the ECM additive can 

accomplish a biodegradable plastic with load rates of just over 1% by weight, plastics 

manufacturers are not required to make substantial changes to their manufacturing process to 

37 RX-725; RX-178.

38 RX-335.

39 RX-520.

40 Id.

41 Id.

42 RX-335.

43 See, e.g., CCX-811, at 44 (Island Plastic Bags (“IPB”) deposition transcript, noting that 

the company experimented for one year with ECM’s additive to determine if it could be 

incorporated into their process). As explained by the manufacturer, “ECM at that time said it’s 

biodegradable, but it doesn’t do us any good if we can’t use it through our machines. So what 

we were doing was putting the additive inside of our plastics to see if it could actually run 

through our extruders and then be cut and sealed as plastic bags.” Id. at 44:10–15.

44 RX-413; RX-412. 

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accommodate the additive, which is included in the plastic in much the same way a colorant or 

plasticizer would be, thus ensuring uniform distribution throughout the plastic.45 As a corollary, 

ECM’s additive technology has a much smaller impact on manufacturers’ cost basis.46 The 

ECM additive thus offers manufacturers the flexibility to add a biodegradable plastic to their 

line, without having to substantially alter business operations. 

ECM customers are often plastics manufacturers who sell to multiple other, second-layer 

manufacturers.47 Those downstream manufacturers place orders for different kinds of plastics, 

and ECM’s customers fill orders accordingly. The ECM technology permits those first-layer 

manufacturers to add the biodegradable component on a project-specific basis, again, without 

overhauling manufacturing practices, or investing in expensive alternative resins and 

components. ECM-infused plastics often pass through at least two levels in the supply chain 

before ever reaching a so-called “end-user.”48

For those manufacturers, and their customers, the first goal is to manufacture a quality 

plastic product that will serve its function in the market. For instance, the shopping bag must 

hold a certain weight load. With ECM’s technology, the biodegradable component is an option 

they can implement, thus helping the environment, where they would otherwise not have the 

resources or financial incentive to invest in the more expensive competing technologies.49 

45 RX-326; RX-520.

46 RX-520.

47 RX-471.

48 In the IPB example, ECM would sell to Island Plastic Bags in Hawaii, who then 

manufactured plastic bags in bulk (without printing) through various manufacturing plants, some 

in China. See CCX-811, at 10, 112. IPB then provides manufactured plastics to distributors in 

Guam or Honolulu. Id. at 11. IPB’s distributor then provides bulk product a sub-manufacturer, 

or printer, who produces finished bags. See id. at 45:11–14. 

49 RX-520. 

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In its pursuit of ECM in this case, Complaint Counsel has entirely ignored the 

fundamental fact that, for plastics manufacturers like ECM’s customers, issues of biodegradation 

rate are, at best, collateral to the primary question concerning the balance between product 

performance and additive effectiveness in achieving biodegradation. Those customers seek only 

to market a “biodegradable” product and frequently do not want or generally do not care if the 

additive achieves biodegradation in the environment by a specific date, within a specific time 

frame, or at a specific rate. The rates of biodegradation matter only to the extent the FTC has 

told industry that rates are required before a claim can be made. Thus it is that FTC in this 

instance that is shaping market realities in ways that detract from actual customer demand and in 

ways that bring about greater harm to the environment. .

3. FTC Biodegradability Enforcement

a. Complaint Counsel’s Allegations

The Complaint presented four essential arguments, supported by anachronistic scientific 

assumptions. In some cases, Complaint Counsel’s theories are supported by scientific 

assumptions over twenty years old. Complaint Counsel alleged that:

• ECM Plastics will not completely break down and decompose into elements 

found in nature within a reasonably short period of time after customary 

disposal.

• ECM Plastics will not completely break down and decompose into elements 

found in nature within a reasonably short period of time after disposal in a 

landfill.

• ECM Plastics will not completely break down and decompose into elements 

found in nature within respondent’s stated qualified timeframes after 

customary disposal.

• ECM Plastics have not been shown to completely break down and decompose 

into elements found in nature within a reasonably short period of time after 

customary disposal, after disposal in a landfill, or within respondent’s stated 

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qualified timeframe, under various scientific tests, including, but not limited 

to, ASTM D5511.50

In support, Complaint Counsel argued that “[a]pproximately 92 percent of total municipal 

solid waste in the United States is disposed of either in landfills, incinerators, or recycling 

facilities. These disposal methods do not present conditions that would allow ECM Plastics to 

completely break down and decompose into elements found in nature within a reasonably short 

period of time.”51 Complaint Counsel also challenges so-called “unqualified” claims made by 

ECM directly or by trade consumers.52 Finally, Complaint Counsel rejects the use of the ASTM 

D5511 standard and test data because, according to Complaint Counsel, the test will not simulate 

or replicate the physical conditions of landfills or other disposal facilities.53 Complaint Counsel 

has not, however, described or presented any evidence concerning the type of testing that it 

concludes would simulate or replicate the landfill environment precisely.

b. The Green Guides

FTC’s interest in regulating degradable claims increased in 1990. “Green marketing” 

claims were investigated by parallel forces including a ten-state task force of Attorneys General 

and the FTC. The AG task force, the FTC, and the EPA held a national Public Forum in March 

1990 for businesses and regulators to discuss environmental claims, including plastic

50 RX-902.

51 Id.

52 Id. (“Consumers likely interpret unqualified degradable claims to mean that the entire 

product or package will completely decompose into elements found in nature within a reasonably 

short period of time after customary disposal.”)

53 Id.

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“degradable” claims.54 After hearing from industry, the AG Task Force published its first report 

in November 1990, finding that:

Products that are currently disposed of primarily in landfills or through 

incineration—whether paper or plastic—should not be promoted as 

“degradable,” “biodegradable,” or “photodegradable.”55 

The FTC held separate hearings in July 1991, which culminated in the FTC’s first issue 

of the Green Guides.56 

In July 1989, the Senate Committee on Governmental Affairs held a hearing on the 

Degradable Commodity Plastics Procurement and Standards Act of 1989.57 The ASTM 

appeared before Congress and introduced testimony concerning biodegradable plastics.58 Dr. 

Ramani Narayan appeared as a researcher with the Laboratory of Renewable Resources 

Engineering at Purdue University.59 It is during his speech that Dr. Narayan “introduce[d] the 

concept of composting.”60 Dr. Narayan also stated that “[b]iodegradaable plastic does not imply 

that that the entire material just completely disappears overnight . . . [t]his is a myth.”61 Dr. 

Narayan discussed prior landfill “digs” and opined that, given the biological inactivity in existing 

54 See Environmental Task Force, The Green Report: Findings and Preliminary 

Recommendations for Responsible Environmental Advertising (1990) (hereinafter “Green 

Report I”), available at, http://infohouse.p2ric.org/ref/24/23677.pdf.

55 Id. at 39–40.

56 See, e.g., Guides for the Use of Environmental Marketing Claims, 16 CFR § 260 

(1994); John M. Church, A Market Solution to Green Marketing: Some Lessons From the 

Economics of Information, 79 Minn. L. Rev. 245, 322 (1994).

57 See Environmental Labeling of Consumer Products: Hearing Before the Subcomm. On 

the Consumer of the Senate Comm. On Commerce, Science, and Transportation, 101st Cong., 2d 

Sess. (1990), available at

http://babel.hathitrust.org/cgi/pt?id=pst.000015610690;view=1up;seq=3.

58 Id. at 28.

59 Id.

60 Id. at 31.

61 Id. at 33.

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MSW landfills, disposal therein was just “preserving garbage for posterity.”62 Dr. Narayan 

explained that:

The degradable plastics, in terms of landfills, which is where you bury them 

and then you come back and you find out whether anything has happened or 

not happened, is dictated by the environment in which it is buried in. If you 

bury it in Arizona maybe it will take you forever for it to degrade under the 

conditions. If it is in Florida, it may happen overnight.63

Dr. Narayan testified that traditional, so-called “sterile,” municipal landfills are inadequate to 

produce appreciable biodegradation, but “active” landfills (e.g., bio-digesters) were preferable.64 

Complaint Counsel have relied on advice of Dr. Narayan during this case, and even 

considered adding him as an expert.65 Dr. Narayan has close affiliations with “compostable” 

groups that support rapidly degrading substances.66 Dr. Narayan has published opinions wherein 

he stated that a plastic product would need to biodegrade within two growing seasons before it 

could be called “biodegradable.”67 

The FTC has a history of enforcement against biodegradable claims. See, e.g., In re ExCell-O Corp., 82 F.T.C. 36 (1973). In 1973, the FTC entered a consent order against the makers 

of Pure-Pak plastic-coated cardboard cartons for milk, juice, and other products. See id. at 38–

39. Ex-Cell-O had advertised its products as “completely biodegradable” and claimed that its 

products would degrade in a “fairly short time.” Id. FTC prohibited Ex-Cell-O from making any 

“biodegradable” claims without disclosing that the rate of biodegradation depends on various 

environmental factors. See id. at 44. Based on the above information generated in the early 

62 Id. at 34.

63 Id. at 42.

64 Id. at 26–42.

65 See, e.g., RX-743; RX-735; RX-452.

66 RX-452. Dr. Narayan also claims a close connection with compostable technologies in 

competition with ECM, including many patents to technologies that so compete. See 

http://report.president.msu.edu/360/soybeans/ramani-narayan/ (last visited July 30, 2014).

67 See, e.g., RX-743

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1990s, FTC enforcement activity increased substantially following enactment of the Green 

Guides. See, e.g., Mobile Oil Corp; Proposed Consent Agreement, 57 Fed. Reg. 35589-01 (Aug. 

10, 1992) (challenging degradability claims concerning “ADM Master Batch” and “Polyclean” 

additive products); In re N. Am. Plastics Corp., No. 902-3184, 1993 WL 766976 (Jan. 14, 1993)

(challenging degradability claims concerning “EnviroGard” plastic trash bags); In re Matter of 

N. Am. Plastics Corp., et al., 118 F.T.C. 632, 1994 WL 16011102 (Sep. 7, 1994) (consent order); 

In re Matter of BPI Envtl, Inc., No. 902-3225, 1992 WL 696753 (May 5, 1992) (challenging 

degradability claims concerning plastic grocery bags); In re Matter of RMED Int’l, Inc., et al., 

115 F.T.C. 572, 1992 WL 12011051 (May 14, 1992) (challenging degradability claims 

concerning “TenderCare” brand disposable diapers); Ame. Enviro Products, Inc., et al., 56 Fed. 

Reg. 46184 (Sep. 10, 1991) (challenging degradability claims concerning disposable diapers).

The complaint in the ECM matter mirrors those same allegations, and is based on similar, 

antiquated apprehensions of the science. For instance, literature supporting the FTC’s position 

was published in 1993.68 The FTC’s core allegations also mirror those in prior degradation 

cases, with one critical addition. In ECM’s case, the FTC also explains that “[c]onsumers likely 

interpret unqualified degradable claims to mean that the entire product or package will 

completely decompose into elements found in nature within a reasonably short period of time 

after customary disposal.”69 That the “reasonably short period of time” must be a year or less

derives from FTC’s 2012 revisions to the Green Guides.70

68 See RX-593 (e-mail from Complaint Counsel to ECM’s former counsel citing a 1993 

article for the antiquated proposition that an additive cannot alter a plastic’s chemical structure or 

its susceptibility to biodegradation); RX-590 (the 1993 article).

69 RX-902.

70 RX-173.

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Complaint Counsel has partnered with experts they intend to call in this case for more 

than four years, including consultants like Dr. Ramani Narayan, who has offered the same 

scientific theories on landfill science since 1990. They have thus relied on the same scientific 

rationale, often untested in litigation, for years to achieve consent judgments against entities, 

including two of ECM’s customers.71

The regulatory activity culminated in the “Green Guides” in 1992, which were eventually 

revised several times, including the most relevant revision here in 2012. For more than twenty 

years, the FTC has required in 16 C.F.R. §§ 260.7–260.8 that companies possess evidence that a 

product or package “will completely break down and return to nature, i.e., decompose into 

elements found in nature within reasonable short period of time after customary disposal.” 

However the concept of a “reasonably short period of time” was never defined, until 2012 when 

the FTC expressly stated:

It is deceptive to make an unqualified degradable claim for items entering the 

solid waste stream if the items do not completely decompose within one year 

after customary disposal. Unqualified degradable claims for items that are 

customarily disposed in landfills, incinerators, and recycling facilities are 

deceptive because these locations do not present conditions in which complete 

decomposition will occur within one year.

See 16 C.F.R. § 260.8(c). Because the overwhelming majority of products are destined for 

Municipal Solid Waste (MSW) landfills (73.89%),72 that so-called “One Year Rule” effectively 

defined the term “biodegradable” for nearly all disposable consumer goods. As explained below, 

the One Year Rule is scientifically invalid. Equally impossible is the collection of data that 

could prove with any confidence the expected timeframe or rate of degradation in an MSW 

71 See FTC Cracks Down on Misleading and Unsubstantiated Environmental Marketing 

Claims (October 29, 2013), available at http://www.ftc.gov/news-events/pressreleases/2013/10/ftc-cracks-down-misleading-unsubstantiated-environmental.

72 RX-511, at 13.

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landfill. The landfill environment is highly variable and heterogeneous, from one landfill to the 

next, but also within each landfill itself.73 Predicting precise rates of degradation sufficient to 

satisfy the Commission is in fact scientifically impossible, whether the product is an additive, 

like ECM’s, or a compostable product, like those favored by the FTC’s choice not to enforce 

against them. 

Perhaps more troubling, the One Year Rule is scientifically baseless. Experts agree that 

even the most biodegradable substances (including food waste, etc.) will not biodegrade in an 

MSW landfill within one year.74 Indeed, not even tree trunks, orange peels, or banana peels, all 

generally accepted to be biodegradable in the environment, can reliably break down into 

elements found in nature within one year of customary disposal.75 That means the FTC’s “One 

Year Rule,” which defines the “reasonably short period of time” for degradation, is unattainable 

for every single product on the market. In fact, under the FTC’s One Year Rule, a banana peel is 

not biodegradable and could not be marketed to consumers as such.76 The rule was based not on 

sound science, but on what the FTC claimed was consumer perception of degradable claims.77 

When national environmental policy is effectively struck based on that perception (which, as we 

shall see is a misperception in any event), it replaces rational science with arbitrary and 

capricious decision-making and it succeeds in aggravating rather than militating the 

environmental goal of lessening pollution.

73 See CCX-893, at 8 (noting that composting accounts for just 11% of disposal waste 

when recycling is excluded).

74 See RX-853, at 11; CCX-893, at 16.

75 RX-841, at 187:2–7 (McCarthy deposition explaining that a tree is biodegradable even 

if it does not completely return to elements found in nature within one year).

76 Id. at 186:1–8.

77 See Green Guide Policies, at 3.2

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The FTC explained that its One Year Rule was supported by “[t]he available consumer 

perception evidence.” 78 FTC explained that:

In a survey by APCO Insight, 60 percent of respondents expected that an item 

marketed as degradable without qualification will fully decompose in less 

than one year. The Commission concludes that this survey is a more reliable 

indicator of consumer perception than the Synovate study in which only 25 

percent of respondents had the same expectation.79

In doing so, the Commission rejected another survey that had, incidentally, a higher sample size 

(the Synovate study).80 In the Synovate study, ninety-three percent (93%) of all respondents 

thought it was acceptable to label a product “biodegradable” provided the product would 

decompose in a landfill.81 The FTC rejected the Synovate study and based its Green Guide 

recommendations on the APCO study instead.82 FTC explained that “[b]oth studies may be 

faulted for lacking control groups and presenting the timeframe questions with close-ended, 

rather than open-ended, answers, but they nevertheless are the only studies in the record.”83 

Based on a well-designed telephone survey from Dr. David Stewart, ECM here presents current 

and reliable survey evidence that establishes the One Year Rule to be devoid of a basis and, thus, 

wholly arbitrary and capricious.84

The FTC chose the APCO study because, “[u]nlike the APCO study, the Synovate study 

results suggest that respondents’ answers may have been not only biased, but also influenced by 

a tendency to avoid extreme answers.”85 FTC also explained that “respondents were informed 

that ‘non-biodegradable plastic products take hundreds of years to decompose,’” but “[s]uch 

78 RX-195, at 121.

79 Id.

80 Id. at 118–122.

81 RX-673.

82 RX-195, at 118–122.

83 Id. at 121 n. 409 (emphasis added).

84 RX-856.

85 RX-195, at 121.

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statements are absent from most marketing contexts, and did not appear in the APCO 

questionnaire.”86 Moreover, according to FTC, the design of the Synovate study revealed a 

“pattern of responses, together with the absence of choices in the range of less than one year,” 

which “suggests that some respondents were avoiding an extreme response.”87 Accordingly, the 

“Commission conclude[d] that the proportion of consumers expecting full decomposition in 

under one year would be closer to 60 percent rather than 25 percent.”88 

ECM’s expert in consumer psychology, Dr. David Stewart, will testify that the One Year 

Rule was based on flawed evidence and remains uncured by the patently unreliable Google 

Consumer Survey evidence from Complaint Counsel’s expert, Dr. Shane Frederick.89 Dr. 

Stewart will explain that consumers actually lack the necessary background to opine on 

biodegradable claims, a complex scientific issue that not even most scientists agree on in full.90 

Furthermore, his consumer survey data reveals that no consensus exists (not even a significant 

minority) among consumers with respect to biodegradable claims.91 

The so-called “reasonably short period of time” for degradation after customary disposal 

must be examined through the scientific evidence, which reveals that void of biodegradable 

additives conventional plastics will last, at least, for thousands of years in the environment. 

Thus, plastics which biodegrade in decades, or even hundreds of years, are environmentally 

beneficial as they degrade in reasonably short periods of time when compared with nonbiodegradable plastics. The evidence will show that ECM plastics should be compared not with 

86 Id. at 122.

87 Id.

88 Id.

89 RX-856. 

90 See, e.g., id. at 26–27.

91 Id. at 25–26.

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an arbitrary and capricious “One Year Rule,” but with untreated plastics that have an almost 

indefinite environmental fate.

4. The Scientific Definition of Biodegradation Versus Complaint Counsel’s 

Definition

The scientific experts in this case will testify that many scientifically accurate definitions 

exist for terms like “biodegradable,” “biodegrade,” and “biodegradation.” The definitions for 

those terms are necessarily broad to accommodate a range of potential mechanisms. For 

example, the Merriam-Webster dictionary defines “biodegradable” as something “capable of 

being slowly destroyed and broken down into very small parts by natural processes, bacteria, 

etc.” or “capable of being broken down especially into innocuous products by the action of living 

things (as microorganisms).”92 Other sources have defined “biodegradable” to mean “capable of 

being decomposed by bacteria or other biological means.”93

ECM’s experts have testified that “biodegradation” is properly described as an ongoing

process, and the word “biodegradable” refers, simply, to a material capable of undergoing that 

process. Noticeably absent from scientific definitions of “biodegradation” or “biodegradable” is 

any reference to a specified rate, extent, or time period for degradation. Outside of this case, 

Complaint Counsel’s experts have never used time or rate limitations on definitions of 

“biodegradation” in their own scientific publications. As relevant here, the term 

“biodegradation” refers to the process by which microorganisms, bacteria, fungi, etc., combined 

with their natural mechanisms of action, effect the breakage of plastic bonds through acids and 

enzymatic action. 

92 See "Biodegradable." Merriam-Webster.com. Merriam-Webster, n.d. Web. 22 July 

2014, available at http://www.merriam-webster.com/dictionary/biodegradable.

93 See “Biodegradable.” Collins English Dictionary, 10th Ed. 2009 (July 22, 2014), 

available at http://dictionary.reference.com/browse/biodegradation.

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By contrast, Complaint Counsel’s experts were asked by Complaint Counsel to adopt a 

peculiar, artificial construct alien to the scientific literature for the definition of “biodegradable,” 

to wit: “that the entire plastic will completely break down and return to nature (i.e., decompose 

into elements found in nature) within one year after customary disposal (i.e., incinerator, landfill, 

or recycling).”94 Dr. McCarthy, Complaint Counsel’s expert, testified that he prepared his expert 

report as a “collaborative effort between [himself] and complaint counsel.”95 He testified that 

the definition of “biodegradable” which included the one-year limitation “was the definition that 

[he] used with respect for this case” throughout his report and in his expert opinion.96 His 

scientifically baffling testimony evidenced the extreme position Complaint Counsel’s 

interpretation of “biodegradation” places upon their witnesses. 

Asked whether a product could be considered “biodegradable” if it degraded 95 percent 

in 364 days, Dr. McCarthy testified that it “would not satisfy the definition.”97 He maintained 

that position even though all other qualified experts in this case have accepted that a product will 

almost never biodegrade to one hundred percent, as most substances will leave behind some 

residue or humus. Dr. McCarthy’s strained attempt to defend Complaint Counsel’s erroneous 

definition of “biodegradable” continued:

Q: Assuming that on day 365 [a product] was only 95 percent 

[biodegraded] still, but on day 366 it becomes 100 percent, would that 

satisfy the definition of biodegradable in [McCarthy’s report]?

A: That wouldn’t satisfy the definition.98

94 See RX-841, at 20:11–21:22 (McCarthy’s deposition transcript); CCX-891 at P. 5, n.1 

(McCarthy’s expert rep.).

95 RX-841, at 20:15–17.

96 Id. at 21:21–22.

97 Id. at 28:21–24.

98 Id. at 29:5–10.

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Consider the implications, from a scientific perspective, of an FTC policy that limits the 

definition of “biodegradability” in that manner, excluding products that are obviously—and 

scientifically proven to be --“biodegradable” simply because the achievement cannot be

documented within one year.

Perhaps most troubling is that no article can satisfy Dr. McCarthy’s definition of 

biodegradable. Complaint Counsel’s purported expert in landfills explained in his report that 

even “rapidly degrading wastes” such as food waste and sewage sludge might take between 7 to 

14 years to fully biodegrade. Moreover, Dr. McCarthy himself has marketed “biodegradable” 

plastic polymers, and even achieved patent protection for same, based on technologies that 

would not degrade completely within one year.99 

Complaint Counsel’s definition of “biodegradable” is designed to trap businesses. It 

cannot be satisfied and, so, any company charged will necessarily fail the arbitrary One Year 

Rule. Complaint Counsel’s approach therefore becomes one where no unqualified claim 

concerning “biodegradation” can ever exist in the market, even if the products are, in fact, 

“biodegradable.” Because plastics manufactured with ECM’s additive ostensibly satisfy the 

generally accepted scientific definitions of “biodegradable,” Complaint Counsel cannot show 

that ECM’s claims are false or misleading absent reference to its scientifically defunct and 

implausible definition. The use of the claim “biodegradable” in marketing is, at worst, 

potentially misleading commercial speech for which the constitutional resort remains imposition 

of a reasonable and succinct claim qualification, not excessive prosecution and prospective 

speech limiting orders on the right to communicate in whole categories, such as in use of the 

term biodegradation.

99 RX-362; RX-755, at 13.

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5. The Anti-Competitive Effect of Enforcement of Complaint Counsel’s 

Biodegradation Definition

Complaint Counsel’s narrow and invalid definition of “biodegradable” substantially 

limits innovation by erecting unpassable obstacles to market, and favors companies that offer 

rapidly-degrading (but economically infeasible) alternatives like compostable bioplastics. 

Private interest groups heavily lobbied the FTC to enact more rigorous regulations in the 2012 

amendments to the Green Guides. Among those groups were organizations like the 

Biodegradable Products Institute (BPI), which is a member-based organization representing 

compostable technologies.100

“Biodegradable” plastics are not the same as “compostable” products. While a 

“compostable” product might also be considered part of the “biodegradable” universe, the 

process of composting involves different environmental elements than those present in landfill 

environments.101 Composting involves aerobic processes (with oxygen) as opposed anaerobic 

processes common in landfills.102 Because composters, including commercial systems, are 

actively managed to promote optimal conditions, composting is expected to yield higher rates of 

degradation over time. 

The ASTM has established testing protocols that assess the compostability of products 

including plastic polymers.103 Partly because compostable systems benefit from rapidly 

degrading waste, the standards concerning “compostability” are generally pass/fail, whereby a 

product must degrade past a certain extent within a specified period of time before the product 

100 See, e.g., RX-172. 

101 RX-875, at 85:3–15.

102 Id.

103 See, e.g., RX-367.

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can be called “compostable.” For instance, the ASTM D6400 protocol is the “Standard 

Specification for Labeling of Plastics Designed to be Aerobically Composted in Municipal or 

Industrial Facilities.”104 That standard requires 60% biodegradation by biological processes 

during composting within 180 days.105 Other similar standards (e.g., EN 13432) require 90% 

biodegradation in that time period.106 Under the D6400 standard, a product that degrades only 

59% in 180 days is not considered “compostable,” but a product that degrades 61% would be 

“compostable.”107 

Witnesses (fact and expert) will testify in this case that the ASTM body is largely a 

political arena, where methods/standards are largely driven by members financially interested in 

the outcome. There are no membership requirements in the ASTM working groups that 

promulgate standards. Any company or individual with a vested interest, and financial support, 

can participate in the voting process that results in industry standards.108 Those standards have 

no legal precedence, and language in the standards that relates to legal issues such as claim 

language or substantiation can logically be ignored. The ASTM standards are relevant to the 

extent they embody methodologically sound methods to gather scientific data, which must then 

be interpreted. 

Members of the compostable industry have heavily influenced the publication and 

revision of certain ASTM standards related to plastics biodegradability testing.109 Tests like the 

D6400 are tailored to rapidly degrading products that can perform well enough within the narrow 

104 CCX-91.

105 Id.

106 See RX-772.

107 CCX-91.

108 RX-875, at 285:4–20.

109 Id. at 172:1–10.

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180 day testing period.110 Those tests, however, are inadequate to measure the long-term 

biodegradability of more slowly degrading products, like plastics manufactured with ECM’s 

technology.111 While it is not the case that ECM plastics are non-biodegradable, those products 

are not expected to degrade rapidly and, so, manufacturers of compostable technologies can use 

the unscientific claim language in the ASTM protocols to limit marketing claims by competitors.

The same outcome occurs with Complaint Counsel’s definition of “biodegradable” which 

includes the narrow one-year window. Products that cannot achieve rapid degradation in short 

periods of time are essentially outlawed because under the One Year Rule they cannot lawfully 

communicate to the market that they are biodegradable when they degrade in a period of time 

greater than a year. Makers of compostable products, like some bioplastics or oxodegradable 

polymers, stand to gain a substantial market advantage as a direct and predictable result of the 

One Year Rule and Complaint Counsel’s campaign of enforcement. After all, compostable 

products cost substantially more than the biodegradable additives (of which ECM is just one of 

many companies selling similar technologies) and without agencies of the government doing 

their bidding, the market favors ECM’s technology from a cost-benefit standpoint. Plastics 

manufacturers are less inclined to use the expensive technology if a cheaper alternative exists 

that will produce an environmentally friendly, biodegradable plastic in the general sense. One 

solution is to restrict the market for “biodegradable” plastics such that only those expensive 

technologies qualify. Because the marketing interest lies primarily with “biodegradable” 

products, as opposed to biodegradable products that disappear within certain time periods, 

manufacturers are willing to pay for the most cost-effective product that satisfies the FTC’s 

110 Id. at 263:23–264:15, 56:21–25.

111 Id. at 89:2–18.

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definition of “biodegradable.” By eliminating alternatives through administrative regulation, 

ECM’s competitors gain market share. 

That process was evident here, where for years ECM’s competitors directly lobbied FTC 

attorneys to pursue enforcement action against additive companies, including ECM. 112 

Representatives from BPI had open channels to FTC attorneys and frequently reported marketing 

claims by additive companies.113 ECM competitors, like Metabolix, Inc., also lobbied for 

enforcement against additive companies and, in particular, against ECM.114 Groups like the BPI, 

and scientists affiliated with same, zealously lobbied the ASTM to incorporate limited language 

in biodegradability test standards that would (unscientifically) limit claim language based on test 

results.115 Finally, organizations like the BPI commissioned biased and methodologically 

unsound consumer perception studies in an attempt to persuade the FTC that end-consumers 

preferred rapidly degrading plastic products. Whether wittingly or unwittingly, the FTC has 

rewarded those efforts by directly incorporating sections of BPI’s comments (almost verbatim) 

into the 2012 Green Guide revisions, and through enforcement actions such as that against ECM 

memorializing the arbitrary concept that a product must fully degrade within one year before it 

can be considered “biodegradable.”116

Perhaps in an effort to limit exposure to an apparent constitutional infirmity, the FTC 

explained in 16 C.F.R. § 260.8(c) that “unqualified” biodegradability claims were deceptive 

unless evidence showed complete degradation within one year, perhaps leaving room for 

qualified claims. In Section 260.8(d), the FTC explained that:

112 See, e.g., RX-211.

113 See, e.g., RX-718–RX-733.

114 RX-211.

115 See, e.g., RX-741. 

116 RX-857, at 16–21.

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Degradable claims should be qualified clearly and prominently to the extent 

necessary to avoid deception about:

(1) The product’s or package’s ability to degrade in the environment 

where it is customarily disposed; and 

(2) The rate and extent of degradation.117

See 16 C.F.R. § 260.8(d). That language is illusory, however, because there are no test methods 

sufficient to satisfy Complaint Counsel’s heavy standards to prove the precise rate and extent of 

degradation occurring in a landfill environment (whether in landfills generally, specific landfills, 

or specific locations within individual landfills). 

In this case, Complaint Counsel has criticized ECM’s reliance on ASTM standards 

because they do not “simulate or replicate” the landfill environment118 (in contradiction, Dr. 

McCarthy cleaves to ASTM standard D5511 as a demonstrative test of biodegradation119). 

Moreover, Complaint Counsel’s own experts have used those same methodologies outside of this 

case to prove that products biodegrade.120 More significantly, Complaint Counsel and its experts 

have never explained precisely what type of scientific testing would be sufficient to show that a 

product biodegrades at a certain rate or to a certain extent within the variable landfill 

environments. When asked directly to explain what type of testing would be sufficient, an 

element to which Complaint Counsel has the burden, Complaint Counsel’s experts were evasive:

Q: You’ve said to me that it’s a multitude of studies that would be necessary, 

in your opinion, to support a claim that a product is biodegradable, but you 

have not said specifically any threshold or standard that has to be met in 

order to establish that the product is biodegradable. Do I have that 

correct?

118 See, e.g., RX-851, at 126:20–127:11 (Dr. Tolaymat’s deposition transcript).

119 CCX-891. 

120 See RX-362.

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A: Yeah, that is.

Q: So I can understand this, is your opinion an I’ll-know-it-when-I-see-it type 

of thing for biodegradability or is there some type of quantifiable 

threshold that we can cross and now we can say our product is 

biodegradable?

A: There is no one test that’ll give you that answer; however, it’s a collection 

of data points, collection of tests, a body of evidence that supports the 

conclusion.121

...

Q: What specific type of scientific evidence do you require ... to show that a 

product is biodegradable in landfills?

A: There isn’t one test. It is a body of evidence. It is the collectiveness of the 

data. It is not just one silver bullet, one test you would run and be able to 

say with a hundred percent accuracy whether something is biodegradable 

or not.122

As will be discussed below, that lack of clarity shows that Complaint Counsel cannot 

demonstrate under its demanded definition of “biodegradation” the type, and accessibility, of 

evidence adequate to form a reasonable basis for making ECM’s claims. See In re Pfizer Inc., 81 

F.T.C. 23 (1972). Its construct is a straw man, bereft of a scientific or survey evidentiary 

foundation, that cannot ever be satisfied. Indeed, even were it to be applied to compostables, 

which Complaint Counsel enforcement to date has assiduously avoided, it would not be capable 

of satisfaction. That is because the variable conditions in landfills worldwide make 

presupposition of a precise rate and extent of biodegradation impossible.

The narrow FTC definition of biodegradation, and the absence of defined standards to 

support it, effects a change in national environmental policy due to its suppression of the entire 

non-compostable biodegradable plastics industry. If FTC insists on compliance with this 

121 RX-851, at 149:16–150:9.

122 Id. at 151:23–152:6

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arbitrary and capricious definition of biodegradation in this case, what company would invest in 

beneficial technologies that could not meet the rigors of the One Year Rule?123 

What Complaint Counsel seeks—a judicial decree that only businesses selling 

compostable products can employ the term “biodegradable”—“is nothing less than an order 

establishing property rights in the language. Words are not born with meanings. They acquire 

meaning with use, and as use changes so does meaning.” First Health Grp. Corp. v. BCE 

Emergis Corp., 269 F.3d 800, 804 (7th Cir. 2001). If compostables are “better” than 

biodegradables, then BPI and the FTC “should be able to explain this to potential 

customers.” Id. at 805. “No business is entitled to a trial after which judge and jury will 

determine how language ought to be used, as if usage were a question of law or logic. It is 

enough to guard against misleading expressions that play on how language is used.” Id.

6. The Financial Interest of Complaint Counsel’s Lead Scientific Expert in 

the Outcome of the Litigation

Complaint Counsel retained Dr. Steven McCarthy approximately two years ago as a 

consultant, and eventually as a testifying witness against ECM in this case.124 Dr. McCarthy’s 

scientific positions were apparent in Complaint Counsel’s pre-complaint decisions. Email 

correspondence from Complaint Counsel to ECM in July 2013 mirrored the content in Dr. 

McCarthy’s expert report.125 Dr. McCarthy is a professor at UMass Lowell in Massachusetts 

123 The FTC’s nearly flawless record in administrative enforcement actions only adds to 

any apprehension. See David Balto, “FTC’s winning streak is over,” TheHill.com (Feb. 11, 

2014) (quoting Chairman of the House Judiciary antitrust subcommittee Spencer Bachus (RAla.): “With this kind of record and an unbeaten streak that Perry Mason would envy, a company 

might wonder whether it is worth putting up a defense at all in a system in which the FTC brings 

a complaint, the case is tried before an administrative law judge at the FTC, and the FTC holds 

the authority to overturn a decision adverse to the agency”).

124 CCX-891.

125 Compare e.g., RX-593 with CCX-891.

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(“UMass”).126 He is not a reliable expert witness.127 He has accepted on behalf of UMass 

millions of dollars in funding from ECM competitors that offer bioplastics and compostable 

products.128 Dr. McCarthy has directly profited from research he performed for ECM 

competitors.129 UMass-Lowell has boasted of Dr. McCarthy’s income earning potential, noting 

in 2012 that Dr. McCarthy “has obtained nearly $9 million in externally sponsored research grant 

and contracts, plus nearly $33 million in intellectual property donations to UMass Lowell.”130 

Dr. McCarthy’s success at UMass appears directly linked with his ability to generate income 

through IP “donations” and grant money.

For instance, Dr. McCarthy directly profits from compostable plastic resin patent 

royalties paid to UMass. Under an agreement with the University and in accordance with UMass 

policy, Dr. McCarthy assigned his patent rights in a compostable plastic resin he invented to 

UMass.131 In exchange, he receives a profit share of the royalty stream.132 One of Dr. 

McCarthy’s patents was purchased, and has been used, by an ECM competitor, Metabolix Inc.133 

To the extent Metabolix’s sales increase based on incursions into ECM’s market, royalties from 

the patent will increase and Dr. McCarthy’s income from those royalties will increase as well.134 

126 RX-841, at 15:21–25.

127 See, e.g., RX-857, at 29–33 (Volokh Expert Rep. detailing McCarthy’s conflicts of 

interest). 

128 CCX-891, at 42–44 (McCarthy’s CV listing contract and grant support from ECM 

competitors such as Solutia, Metabolix, and Warner Lambert). 

129 RX-841, at 60:10–21 (McCarthy’s deposition explaining that he receives $4,000–

$5,000 per year in royalties from a patent he invented and that is licensed to Metabolix). 

130 See Aguirre, “Plastics Engineering Educator Praised for Research, Service” (Sep. 21, 

2012), available at http://www.uml.edu/News/stories/2011-12/University-Professorreception.aspx.

131 RX-841, at 57:14–17.

132 Id. at 59:10–12.

133 See RX-362 (U.S. Patent No. 5,883,199 (issued Mar. 16, 1999)). 

134 See RX-841, at 51:23–52:5, 55:23–61:15.

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Once again, UMass is the patent’s assignee.135 Metabolix is the exclusive licensee of the 

technology.136 Metabolix’s potential royalties from licensing UMass patents surpass $100,000 

per year.137 Dr. McCarthy testified that he receives money directly from the ‘199 patent, which 

is licensed by Metabolix.

138 He acknowledged that Metabolix’s products compete directly with 

ECM’s technology for market share.139 If the Commission is successful against ECM in this 

matter (and by extension against similar additive products), Metabolix’s market share increases 

along with the return to Dr. McCarthy from his royalty payments. Although this patent reveals a 

direct financial interest by Dr. McCarthy in the outcome of the litigation, it is not the only 

evidence revealing such an interest.

Dr. McCarthy also collects a share of research grant money that he secures for UMass 

Lowell from compostable product competitors of ECM, such as Metabolix and other 

compostable product manufacturers.140 

Metabolix supplied grants to UMass of approximately $2.5 million, sponsored more than 

50 students for their master’s and doctorate degrees, and has made substantial equipment 

donations (over $500,000).141 Since 2008, Metabolix has also been lobbying the FTC to act 

135 See RX-761; RX-757 (Metabolix Website Article). 

136 See. RX-209. 

137 Id.

138 See RX-841, at 59:10–60:21 (explaining that, as an inventor, Dr. McCarthy gets ten 

percent (10%) of the royalties of the ‘199 patent if there is a profit). 

139 Id. at 64:22–66:14 (acknowledging that it is a competitive marketplace and that 

products based on the ‘199 patent are in competition with other products marketed as 

biodegradable, compostable, and recyclable).

140 Id. at 52:6–55:22 (explaining that a project account receives forty-six percent (46%) of 

the research grants Dr. McCarthy secures, and that he is in control of that account when he is the 

principal investigator).

141 RX-210. 

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against ECM.142 Dr. McCarthy has worked with BPI, and collected substantial revenue 

(approximately $40,000), performing BPI “certifications” for trade customers in the compostable 

industry which compete with ECM.143 Metabolix is also a member of the Biodegradable 

Products Institute (“BPI”), a primary ECM competitor, and sells approximately a dozen products 

that are “BPI certified” in direct competition with ECM.144 BPI is a vocal opponent of ECM, 

and has lobbied the FTC repeatedly since at least 2005 to act against ECM and ECM’s 

customers.145

Dr. McCarthy’s personal affiliations and financial interest in ECM’s competitors makes 

his scientific opinions unreliable because he has well established financial interests in opposition 

to those of ECM. He is an agent of ECM’s competitors, profiting directly from their success 

either by the receipt of royalties, payment for services (such as his service for years as a certifier 

for BPI, or grants to UMass-Lowell in support of his research). A successful prosecution of 

ECM and the additive market would bestow a substantial windfall on Metabolix, BPI and related 

compostable product manufacturers, who would immediately stand to gain market advantage. 

Dr. McCarthy is compensated $100/hour for his work in this matter (except deposition and trial 

testimony).146 The idea that he would enter an opinion in a high profile FTC case that cut 

against the businesses that support him financially defies credulity. Indeed, the evidence 

suggests that he tailored his opinion to meet Complaint Counsel’s needs, even accepting the 

142 RX-211 (requesting FTC to investigate Good Earth and ECM for alleged deceptive 

environmental claims). 

143 See RX-841, at 92:11–24. 

144 See RX-171; RX-172. 

145 See, e.g., RX-744 (BPI Correspondence to FTC of April 25, 2005).

146 CCX-891.

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fundamental definition of what “biodegradation” means from Complaint Counsel, despite 

contrary representations in his own scientific articles and in his own patent.147

Dr. McCarthy has adopted positions that contradict prior work he performed for ECM’s 

competitors. For example, his expert report stated that radiological marker 14C testing is the only 

test that can dispositively prove that ECM’s additive causes biodegradation of plastics, but he 

himself has relied on extrapolation and other tests (that neither adhere to an ASTM standard nor 

involve radiological markers), such as one he created himself, UML-7645, and measures of 

weight loss, to prove biodegradability of polymer products.148 Plus, in other materials Dr. 

McCarthy was silent on the need for a product to biodegrade within a year to be biodegradable, 

and yet, for ECM’s additive, Dr. McCarthy is adhering to the one year rule contained in FTC’s 

Revised Green Guides in collaboration with Complaint Counsel.149

Moreover, Dr. McCarthy’s report stated that “evidence that a substance is biodegradable 

is not ‘competent and reliable’ unless the tested sample reaches ‘at least 60% biodegradation,’ 

and there is both a ‘negative control’ and a ‘positive control,’” but Dr. McCarthy’s ‘199 patent 

made biodegradable claims even though the rate of biodegradation was lower than 60%.150 

Dr. McCarthy himself has used the very same test methods ECM has used to demonstrate 

a “biodegradable” product before the U.S. Patent and Trademark Office. Dr. McCarthy’s prior 

research on biodegradable plastics did not meet the same 60% threshold that he now requires of 

147 See Supra Part II.A.4.

148 See RX-841 at 74:9–75:8, 148:18–149:9, 165:13–172:5.

149 See id. at 19:7–15, 20:21–42:12. See also id. at 69:8-76:17 (explaining that the ‘199 

patent used the term “biodegradability” without requiring complete biodegradation within a 

year); Id. at 185:10–187:16 (explaining that a banana peel, tree trunk, and orange peel are 

biodegradable even if they do not biodegrade within a year of customary disposal).

150 RX-756, at Figure 11. 

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ECM’s additive.151 Dr. McCarthy’s insistence that ECM obtain 14C testing is not the consensus 

in the relevant scientific community. 

Perhaps caught on the science, Dr. McCarthy’s June 30, 2014 rebuttal report eventually 

presented new theories in response to ECM’s expert testimony that had not before been 

presented by Complaint Counsel. For instance, Dr. McCarthy had previously contended that the 

“priming effect” would have accounted for the positive results in ECM’s testing. When the 

priming effect was eventually debunked (as we discuss below), Dr. McCarthy shifted to a new 

theory concerning the split between amorphous and recalcitrant properties of plastic polymers.152 

He also posited that polyethylene polymer chains could only be reduced through the use of prooxidants, which ECM’s technology did not involve.153 Truth be told, ECM’s additive falls 

within the types of alternative technologies that have been shown to facilitate polyethylene 

degradation. 

Consequently, the evidence reveals that Dr. McCarthy has fashioned his scientific 

opinion to suit Complaint Counsel’s purposes and further Dr. McCarthy’s financial interests. Dr. 

McCarthy is not an objective expert in this case, and his purported scientific opinion should be 

rejected.

7. The Scientific Evidence that the ECM Additive Biodegrades Plastics

Over 30 individual tests from multiple laboratories show plastics made with ECM’s 

additive will biodegrade in various environments, including MSW landfills.

154 ECM’s test data 

(including the inconclusive test results) reveal that Complaint Counsel’s criticisms are 

151 Id.

152 CCX-892, at ¶ 22. 

153 Id. at ¶ 11. 

154 See infra, Part II.A.7.e.

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unfounded or unsupported. Here we address the various levels of proof ECM will supply in 

support of the conclusion that its additive technology renders non-degradable plastics 

“biodegradable” in landfill conditions. We will then address each of the scientific criticisms 

upon which Complaint Counsel erroneously rely to condemn ECM’s product.

When compared with conventional plastics, plastics manufactured with ECM’s additive 

degrade over varying lengths of time in MSW landfills. ECM has consistently explained to its 

customers that the ECM additive is “not a poof and it’s gone” technology.155 The test data and 

peer-reviewed literature demonstrate that ECM plastics will, in fact, biodegrade where untreated 

plastics will not. Complaint Counsel posits a number of criticisms of that theory, but ultimately 

their position distills to the following points not supported by the scientific evidence: that 

ECM’s accelerated testing has not shown that ECM’s technology causes the conventional plastic 

to become biodegradable in a landfill environment because the tests do not precisely mirror those 

conditions in a landfill, and no test has been run long enough to show complete degradation.

156

Given the many tests favoring ECM, and the overwhelming weight of the scientific evidence on 

both the mechanism of action in biodegradation and the fact of it occurring in a wide range of 

plastics, that position is scientifically invalid.

While the scientific disputes are complex and numerous, the crux of Complaint Counsel’s 

position is that test data revealing relatively small amounts of biodegradation (when compared to 

cellulose, a very rapidly degrading substance) is irrelevant because ECM cannot extrapolate test 

results beyond the four corners of each test report. However, ECM will show through peer155 See, e.g., RX-680 (“It’s not a ‘poof it’s gone’ system but simply makes the plastic 

product biodegradable as if it were a stick or a branch off a tree rather than ‘sticking around’ for 

hundreds of years.”); RX-371, at 4 (same).

156 See, e.g., RX-865 (Complaint Counsel stating to another regulated entity that “we 

have serious concerns about these additives and whether they work at all,” and later explaining 

that the additive companies “would have to shut down and close [their] doors”). 

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reviewed literature and test data that the relative amounts of biodegradation observed in ECM 

tests is quite substantial when compared to non-degrading conventional plastics and is accepted 

by experts as predictive of landfill environments (even consistent with Dr. McCarthy’s own 

extrapolation methodology undergirding his ‘199 patent).

157 ECM will prove through test data 

and other scientific evidence that products manufactured with ECM’s additive will continue 

biodegrading to completion in the landfill environment.

a. Biodegradation Testing Methods

Industry has relied on several test models to prove biodegradability, but most experts 

agree that “gas evolution” data is the most practical and widely used measure of biodegradation

(both aerobic and anaerobic).

158 There are no tests that precisely simulate or replicate landfill 

conditions, and Complaint Counsel has offered no such method through its experts, but tests 

showing that one or more common bacteria do in a closed test environment biodegrade plastic 

are generally accepted as predictive of biodegradation in landfills where many multiple kinds of 

biodegrading bacteria and fungi are present.

159 Supporting biodegradability claims therefore 

requires extrapolation of data from the laboratory environment based on known consistencies in 

the natural environment.160 The process of extrapolation is scientifically valid, and is used in 

almost every scientific field that handles laboratory data.161 Nonetheless, the laboratory closedsystem model has limitations that are relevant to this case. Biodegradability testing is often 

accelerated in the laboratory because the testing environment often will not remain viable, e.g., 

the bacteria have difficulty surviving for long enough periods to record complete biodegradation 

157 See RX-362.

158 See RX-853, at 7–8.

159 See, e.g., RX-756, at 6–12; RX-853, at 7–9; RX-865, at 41–47.

160 See RX-855, at 44–45, 54. 

161 Id.

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Figure 3. Carbon dioxide diagram

data.162 Furthermore, because products will take many years (or decades) to fully biodegrade in 

landfill settings, accelerated test conditions are necessary to avoid the many costs and problems 

associated with years of long-term term gas evolution testing.163

Gas Evolution Tests (e.g., ASTM D5511):

A gas evolution reaction is a chemical reaction that produces gas, in this case, methane 

and carbon dioxide.164 The process of biodegradation involves the cleavage of carbon bonds 

from the substrate, which are then combined with available hydrogen and oxygen to produce 

methane and carbon dioxide.165 In a gas evolution test, the laboratory exposes test articles to 

conditions that theoretically favor biodegradation, and then gas emissions are monitored. By 

comparing the levels of gas emitted from the test vessel, the laboratory can measure the amount 

of gas produced from the test articles themselves.166 Figures of methane and carbon dioxide gas 

are shown below:

Gas evolution tests generally have several common characteristics. Within a closed, 

watertight vessel, test articles are exposed to “inoculum” that is comprised, in part, of leachate 

162 See, e.g., RX-854, at 25–27; CCX-799, at 106, 125–26.

163 See, RX-855, at 41–45; RX-842, at 35, 350–52 (Sahu Deposition).

164 See RX-853, at 8.

165 Id. at 8–9.

166 Id. at 8–9.

Figure 2. Methane diagram

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from local municipal waste stations.167 The leachate therefore contains microbes that would also 

be present in the environment.168 Some tests bolster the inoculum by adding minerals and food 

to grow the bacterial colonies before the test period.169 Laboratories usually incubate the 

inoculum for a period beforehand to stabilize the material for testing.170 The test articles are 

mixed with the inoculum in the test vessel and, for anaerobic testing, the vessels are flushed with 

gases like Nitrogen to eliminate most oxygen content that might remain.171 Gas collection tubes 

are connected to the test vessel, and gas produced by the vessel is gathered and later measured.172 

The laboratory records the total amount of gas produced, and the ratios of methane gas to carbon 

dioxide.173 A diagram of the typical ASTM D5511 gas evolution test is presented below:

See RX-356, at 2 (ASTM D5511-12).

167 See RX-385, at 3.

168 See, e.g., RX-854, at 5–6.

169 See CCX-84, at 3 (§ 9) (ASTM D5511 Standard).

170 Id.

171 See, e.g., RX-873, at 46 (NE Labs Deposition).

172 See RX-356, at 2 (D5511 test method, summary and apparatus).

173 See CCX-84.

Figure 4. ASTM D5511 Setup

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Results of the tests are based, in part, on the theoretical carbon yield for a test sample.174 

A sample can contain only so much carbon, and the amount of carbon in a sample can be 

calculated based on the molecular formulas for the substrate plastic.175 The gas evolution tests, 

like ASTM D5511, also test against negative controls, positive controls, and inoculum blanks. 

As is relevant here, the negative control is often a copy of the test plastic without the additive 

technology.176 The inoculum blank is a test vessel that simply records gas production from the 

inoculum by itself. The positive control is always cellulose, which is a rapidly biodegrading 

substance like filter paper.177 The positive control serves only to indicate whether the test 

environment had sufficient life (e.g., fungi, microbes, bacteria, etc.) to adequately measure 

biodegradation.178 The positive control is important because closed-system laboratory vessels 

are inhospitable to long-term testing.179 However, the positive control is not an indication of 

how the test article should perform comparatively.180 Biodegradation should be assessed relative 

to the negative control instead. 

The laboratory can determine the level of gas attributable to the samples by subtracting 

the gas known to have been produced by the inoculum blank.181 The inoculum contains living 

organisms that will emit gases while digesting other parts of the solid waste within the inoculum 

mixture. The laboratory can determine the proper gas level attributable to the test vessel by 

174 See RX-864, at 119–20 (Barlaz Deposition); 

175 See RX-356, at 4 (§ 12).

176 See, e.g., RX-860; RX-839; RX-836; RX-838.

177 See RX-864, at 17:1–12; RX-356, at 4 (§ 13).

178 See RX-356, at 4 (§ 13.2); 

179 See RX-870, at 125–127 (Barber Deposition); RX-854, at 23 ¶ 64.

180 See RX-854, at 24, 25 ¶ 74.

181 See RX-356, at 4 (§ 12).

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comparing the overall gas levels of the inoculum blank to those of the test article and negative 

control.182

The laboratory calculates the percentage of biodegradation by comparing the level of gas 

attributable to test sample with the theoretical maximum yield of gas from that same sample.183 

In sum, because the gas emissions contain carbon, the test sample can only contain so much 

carbon, and the inoculum will produce only a certain amount of carbon, researchers can conclude 

that excess carbon recorded in the gas emissions represent a certain fraction of the carbon that 

had once been locked within the test article.184

ECM has been able to show through gas evolution tests that the ECM additive causes the 

plastic polymer to biodegrade.185 That is evidenced by the amount of biodegradation observed 

through gas evolution data. ECM customers include the ECM additive in varying amounts, 

usually around 1% by weight of the final plastic, but sometimes up to 1.75%.186 The “load rate” 

of ECM’s actual pellet is around 70%, meaning that the ECM additive contains 70% active 

components and 30% carrying resin (which is ordinarily not biodegradable).187 Thus, in a final 

plastic subject to gas evolution testing, the plastic polymer blend with a 1% ECM load rating is 

expected to contain approximately 0.7% of the active proprietary ECM component by mass.188 

ECM’s gas evolution tests report amounts of biodegradation considerably in excess of 

that 0.7% figure. In other words, the gas volumes recorded from the tests exceed what can be 

182 Id.

183 Id.

184 See, e.g., RX-864, at 134–41 (Barlaz Deposition).

185 See id.; RX-855, at 41–49.

186 See, e.g., RX-875, at 60, 62–63; RX-871, at 11–12, 57–58. 

187 This value has changed in recent years. ECM offered a 50% load rating in years past. 

See CCX-818, at 118–120. 

188 See RX-875, at 119.

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produced by the additive alone when adjusted for the inoculum.189 Thus, to the extent the 

additional biodegradation is attributable to the test article (and it is), that extra carbon content 

must have come from the plastic polymer and not the ECM additive. Importantly, in ECM’s 

positive tests, the negative control (i.e., the plastic without the ECM additive) did not 

demonstrate any appreciable biodegradation, which demonstrates that the biodegradation was 

triggered and maintained by the ECM additive. 

ASTM D5511:

Gas evolution tests for biodegradation come in many iterations, but industry has 

consistently relied on the ASTM D5511 standard because it is efficient and cost-effective.190 In 

1994, the ASTM first published the standard titled “Determining Anaerobic Biodegradation of 

Plastic Materials Under High-Solids Anaerobic-Digestion Conditions, ASTM D5511.” The 

purpose of the ASTM D5511 standard was to test for intrinsic anaerobic biodegradability of 

samples. The D5511 test is designed to record data under accelerated conditions. Thus, the test 

calls for environmental conditions that promote biodegradation. The temperature of the test is 

increased to around 52 degrees centigrade. The solids content is lowered to 20%, meaning the 

test is performed under rather wet conditions (80% moisture).191

Although the conditions of D5511 testing do not represent those in all landfills, many 

bioreactors landfills would be expected to exhibit similar conditions, at least in parts.192 Landfill 

189 See infra Part II.A.7.e (table).

190 In fact, when measuring the anaerobic biodegradability of various plastics, one of 

Complaint Counsel’s proposed experts, Dr. Frederick Michel, also used an ASTM D5511 

protocol. Similarly, Complaint Counsel’s other expert, Dr. McCarthy, has used gas evolution 

tests similar to the ASTM D5511 test to support claims of biodegradability for his bioplastic 

polymers. 

191 See RX-356; RX-855, at 41-49.

192 See RX-855, at 42-43; RX-870, at 178-80; RX-864, at 39-40.

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conditions are highly variable, and differ greatly from one landfill to the next, and even within 

each individual landfill.193 In any landfill, there are pockets that likely exhibit conditions similar 

to the D5511, but also pockets that may be considered less conducive to microbial or fungal life. 

The variable and unpredictable nature of landfills substantially limits the ability to predict with 

certainty how the D5511 test data would transfer into the natural environment. However, 

scientists can and do determine that the mechanisms of action observed in the D5511 test also 

occur in the natural environment, including in landfills.

194

Industry has relied on the D5511 test, in part, because the protocol is cost-effective.

195 

Many D5511 tests of short duration will cost several thousand dollars.196 Plastics manufacturers 

seeking to have product-specific data thus prefer the D5511 because it gives scientifically valid 

gas evolution data within a reasonable period of time. The accelerated test conditions allow 

companies to evaluate product samples in months as opposed to years, thus allowing the 

companies to make timely marketing and purchasing decisions.197

ASTM has published other gas evolution test protocols, for instance the ASTM D5526. 

The environmental conditions in the D5526 differ slightly from D5511 test. For instance, the 

D5526 calls for testing at solid levels “more than 30%” rather than 20%, and temperatures at 

about 35 degrees centigrade rather than 52. However, the D5526 also requires large pressureresistant glass vessels capable of withstanding an overpressure of two atmospheres.198 Moreover 

193 See RX-864, at 38–40.

194 See RX-854, at 26–27.

195 See, e.g., RX-876, at 96.

196 See RX-873, at 72–73.

197 See RX-855, at 44–45.

198 See, e.g., RX-358 (ASTM D5526-12).

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the D5526 will return test results at a much slower pace. Thus, the D5526 increases laboratory 

costs associated with the equipment and labor.199 

BMP Testing:

Biomechanical Methane Potential (or “BMP”) testing is a gas evolution test that is 

designed to measure potential biodegradability of a test sample. The BMP test is performed in a 

liquid environment, with very high moisture content.200 BMP testing varies significantly from 

one laboratory to another.201 In many instances, BMP testing calls for grinding the test product 

and screening it through a 1 mm screen.202 That process, if used with ECM’s products, would 

likely dissociate much of the ECM additive from the host plastic, thus nullifying the product’s 

efficacy.

The ASTM D5511 test is comparable to the BMP test and the D5511 test presents 

conditions more like the natural environment.203 Dr. Barlaz, ECM’s expert witness, performed 

several tests of ECM plastics purportedly including the ECM additive. He performed those tests 

prior to, and independent of, his role as an expert witness in this case. Several of the test articles 

appeared to involve recycled ECM plastic, which would likely have contained less additive than 

the 1% necessary to foster biodegradation.204 Drs. Sahu, Burnette, and Barlaz will also testify 

that the presence of inconclusive tests does not nullify favorable tests, which clearly indicate that 

199 See RX-873, at 70–72.

200 See RX-864, at 73–75.

201 See RX-851, at 146:19–25.

202 See RX-851, at 134.

203 See, e.g., RX-851, at 138; RX-870, at 101–02; RX-864, at 74–75.

204 See, RX-477 (“[a] varying percentage of the reclaimed material in the bags is 

reprocessed film containing the biodegradable additive. The purpose of this test is to see what 

effect (if any) the amended film will have as it enters the recycle stream and is mixed with other 

recycled plastic.”). 

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the ECM plastic has degraded.205 A test may produce inconclusive results for many reasons that 

have nothing to do with the plastic substrate, not least of which is the death of the bacteria in the 

inoculum, a persistent problem.

206 In particular, variables in the manufacturing process could 

result in a product that lacks the ECM additive in substantial parts, or the test environment may 

not be conducive to the longer duration testing required. 

Qualitative Testing:

ECM has produced qualitative testing that demonstrates the presence of biodegradation 

through qualities such as mass loss or gravimetric calculations. Dr. Timothy Barber is a 

renowned environmental scientist at Environ Corp.207 Environ is a global leader in 

environmental and human health testing. Dr. Timothy Barber is a principal working out of 

Environ’s Ohio group.208 He designed a test based on the conditions of an ASTM D5526 test 

that would measure biodegradation of test samples based on weight loss over time.209 Dr. Barber 

testified credibly that the gas evolution tests had limitations when testing slowly degrading 

substances over long duration studies.

210 His test results demonstrated that ECM’s additive 

205 See, e.g., RX-864, at 140–41.

206 See RX-854, at 27 ¶ 82.

207 See RX-870, at 246–61.

208 See RX-870, at 256–57.

209 See, e.g., RX-573; CCX-791.

210 See CCX-799, at 106 (Barber deposition transcript) (“The measurement of carbon 

dioxide and methane are required under those test protocols are designed for relatively short 

periods of time. Because we needed to run these test out to 17, 23 months, we needed to use a 

protocol that did not require the capture and analysis of metabolic gases...”); Id. at 125–26 

(“One of the challenges ... of trying to maintain an active microbial community in a static 

enclosure is how long you can maintain a functioning microbial community, and this was 

something in part of why we made modifications to some of the pre-existing ASTM protocols, 

because we knew we would have to run these tests 12 to 18 months”).

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would render plastics such as PVC fully degradable with a 1.9 year half–life.211 He confirmed 

his gravimetric endpoints by looking at free chloride content in the test solution, noting that the 

chloride ions would have come from the degraded sections of the PVC plastic.212 Dr. Barber 

also reviewed test data from other laboratories concerning ECM’s additive technology.213 He 

was convinced based on the test results that ECM’s technology produced a biodegradable 

plastic.214

Other qualitative tests included electron microscopy performed of degraded ECM 

samples. Those tests revealed visual evidence of microbiological formation and attack on the 

ECM-treated plastics.215 Several other laboratories have demonstrated ECM’s effects through 

qualitative evidence as well. ECM employees, including Mr. Sinclair, performed tests of the 

ECM additive in gardens, backyard soils, and in 50-gallon drums to assess biodegradation in 

real-time.216

Radiolabeling Tests:

Complaint Counsel’s experts have suggested that ECM should have performed 14C 

radiolabeling tests to demonstrate that the plastic itself degrades during the gas evolution tests.217 

Complaint Counsel’s reliance on 14C radiolabeling tests is confounding for several reasons. 

First, the test is entirely impractical, and no one runs it. Not even Complaint Counsel’s expert, 

211 See RX-254, at 1 (“[t]he environmental half-life of bioPVC under aerobic conditions 

is estimated at 1.9 years”).

212 See RX-370, at 6; RX-259 (“Certification of Results,” noting that “an increase in soil 

leachate chloride content and reduction in tensile strength was observed, indicated the PVC 

molecules were being effectively degraded”).

213 See RX-269 (“ChemRisk” report).

214 See, e.g., RX-870, at 90 (“the polyethylene film provided to me ... purportedly 

containing the ECM additive was determined to be biodegradable in our study”).

215 See infra Part II.A.7.e (table).

216 See CCX-818, at 63-69; CCX-820, at 8-9.

217 See, e.g., CCX-891, at ¶ 891.

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Dr. McCarthy, who competes against ECM in the market, has performed 14C testing on his 

technology (yet he falsely submits in his report that it is accepted as the definitive test for plastic 

biodegradation).

218 Radiolabeling is very expensive and difficult to perform.219 ECM would 

need to find a plastics manufacturer capable of manufacturing a radiolabeled polymer with the 

ECM additive included in such a way that the 14C content does not mix with the additive.220 

Many laboratories can perform 14C testing if given a suitable sample, but few if any companies 

are willing to prepare the radioactive plastic sample for eventual testing.221 Because 14C is a 

radioactive isotope, the manufacture would need to operate under strict containment conditions, 

and undertake massive burdens to decontaminate their facility following production.222 The 

costs associated with that form of testing are so extreme, Complaint Counsel has not been able to 

produce a single example of a competitor using 14C testing to support biodegradation claims, 

although there are many competing companies selling biodegradable technologies.

Furthermore, even assuming that 14C was feasible, the ultimate test of the plastic must 

still be performed for biodegradation. That test would still be a gas evolution test similar to (or 

perhaps exactly the same as) the D5511 test.223 So the 14C testing does not address Complaint 

Counsel’s central theory of this case, which is that gas evolution studies do not simulate or 

replicate the landfill environment. Radiolabeled testing is just one kind of gas evolution study, 

run under similar conditions as the tests now in the record. If Complaint Counsel’s concern is 

218 See RX-841, at 90; RX-362.

219 See RX-853, at 9; RX-855, at 47–48; RX-755, at 15.

220 See RX-842, at 113–16.

221 See Id. (explaining that ECM had attempted to obtain prices for radiolabeling testing 

but was unable to find manufacturers capable or willing to manufacture the radioactive 

components for testing).

222 See RX-842, at 116–23.

223 See RX-842, at 321–22 (expressing concerns that Complaint Counsel had not seemed 

to appreciate that radiolabeled products must still undergo gas evolution testing, like ASTM 

D5511 testing, to test for biodegradability).

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that ASTM D5511 tests do not simulate landfills, then the radiolabeling test does not appease 

those concerns. Put simply, the kind of testing needed to provide Complaint Counsel what it 

considers competent and reliable scientific evidence of plastics biodegradation in landfills does 

not exist. 

b. The Kinds, Nature and Functions of Microbes That Biodegrade 

Plastics

Complaint Counsel argues that extrapolation of data from the D5511 test environment 

into the landfill is scientifically inappropriate because (1) the test environment does not simulate 

or replicate the landfills; and (2) several studies involving ECM plastic appear to “plateau.” 

ECM expert Dr. Ryan Burnette, a microbiologist with expertise in anaerobic microbiology, 

explains that landfills (and most environments) have been shown to contain an assortment of 

microbiological life, and that biodegrading microorganisms present in the D5511 laboratory 

environments are a subset of those present in landfills.224 He will explain that microorganisms 

have been shown to degrade polymers through processes such as enzymatic digestion, and that 

microorganisms responsible for biodegradation in laboratory environments can thrive and 

metabolize matter under in landfill settings.225

Moreover, Dr. Burnette explains that the so-called “plateau” effect is likely the result of 

environmental conditions, or limitations of the close-system lab test.226 The lab environment is a 

closed, finite system that prevents microbial growth and succession, like a fish tank that is never 

cleaned or emptied. Thus, it is not accurate to describe the conditions of a D5511 test as 

224 See, e.g., RX-854, at 6–14.

225 See id.

226 See id. at 14–15.

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“optimal” in long term tests. 227 For instance, feedback inhibition occurs much more rapidly (and 

is permanent) in a laboratory environment, whereas in the natural environment the flow of liquid 

and the settlement of materials would be expected to disperse or diffuse levels of enzymes and 

byproducts that limit cellular metabolism.228 

Finally, in some instances, the evidence suggests that the testing conditions were never 

adequate to support biodegradability testing. For instance, in at least several of the tests that did 

not show biodegradation of ECM products (but likewise did not prove ECM products fail to 

cause biodegradation), the positive control (cellulose) plateaued prematurely along with the test 

article.229 That is what happened with Complaint Counsel rebuttal expert Dr. Frederick Michel’s 

test, albeit other methodological problems also plague his testing. 230 Because cellulose is wellestablished to completely mineralize and biodegrade, the plateau is a sure sign of the test 

environment.231

Complaint Counsel, by contrast, lack a microbiologist with sufficient credentials to 

address the specific microbiological issues presented in this case. Complaint Counsel’s expert in 

landfills, Dr. Tolaymat, authored a report wherein he specifically claimed that the 

microbiological communities differed in the landfill.232 However, when asked about that point 

in his deposition, he confessed that he had absolutely no knowledge of the bacterial 

227 See RX-854, at 25–27.

228 Id. at ¶¶ 35, 77.

229 See id. at ¶ 33; RX-755, at 4.

230 Id.

231 See RX-870, at 153–54.

232 Compare CCX-893, at ¶ 79 (“ASTM D5511 also calls for use of an inoculum that is 

not available from a U.S. laboratory—and likely not comparable to the bacterial community 

found in the typical U.S. landfill.”); with RX-851, at 76–77, 225–26.

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communities. Likewise, Dr. McCarthy professes ignorance as to what microbial life forms exist 

in landfills and declines the invitation to describe himself as a microbiologist.233

c. Microbes that Adhere to Plastic in Landfills, Opportunities for 

Colonization, Enzymatic Destruction of Carbon Bonds, MultiGenerational Development, ECM Additive Acceleration of 

Microbial Degradation

ECM’s additive permits the biodegradability of otherwise non-biodegradable plastics by 

(1) facilitating the breakdown of plastic polymers into smaller chains suitable for enzymatic 

digestion; and (2) fostering the formation of biofilms at or around the plastic, which, in turn, 

weaken and break the carbon bonds in polymers through enzymatic and acidic digestive 

processes.234 ECM’s expert, Dr. Ranajit Sahu, is an expert in environmental and applied 

sciences.235 He has over twenty years of experience in environmental, mechanical, and chemical 

engineering, much of which includes work related to landfills and materials used in landfill 

construction (e.g., plastic polymers).

236 He explains that the peer-reviewed literature and testing 

data shows plastics to be biodegradable in time, and that the ECM additive acts to exponentially 

increase the rate of biodegradation. 237 Complaint Counsel’s own experts (e.g., Dr. McCarthy), 

have relied on polymer “blends” of conventional plastics with other biodegradable components 

to achieve a “biodegradable” end product.238

233 See RX-841, at 17–19.

234 See RX-855, at 27–29.

235 See RX-855, at 5–6.

236 See id.; see also RX-842, at 26–32.

237 See generally, RX-855.

238 See RX-362 (claiming a “biodegradable blend” of biodegradable components with 

conventional plastics like polyesters).

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Bacteria can achieve initial and minimal adherence to plastics via weak interactions, such 

as hydrophobic, van der Waals, temperature, and other variable interactions.239 Biofilms have 

been shown to grow and accumulate on substrates, including plastics, for purposes of 

degradation.240 Studies in the peer-reviewed literature have documented that bacteria and fungi 

are able to use natural and synthetic plastics as food sources.241 Much research has been 

dedicated to the ability of microbes to degrade plastics such as Polyethylene (PE).242 The ECM 

additive has been shown through testing to result in the formation of biofilms.243 Anaerobic 

bacteria in landfills (and present in the laboratory tests) release enzymes that have the ability to 

weaken and eventually discharge carbon bonds.244 

d. The Living Nature of Landfills

Dr. Morton Barlaz is Professor and Head of the Department of Civil, Construction, and 

Environmental Engineering at North Carolina State University.245 He has a B.S. in chemical 

engineering and an M.S. and Ph.D. in Civil and Environmental Engineering.246 His M.S. and 

Ph.d. research focused on biodegradation in landfills. Complaint Counsel’s witness, Dr. 

Tolaymat, recognizes Dr. Barlaz as an authority in the area of biodegradation.247 Dr. Barlaz will 

explain that Complaint Counsel’s view of landfill science is wholly flawed and anachronistic. 

239 See RX-854, at 14.

240 Id. at 15.

241 Id. at 17.

242 Id. at 18 (citing, e.g., Phanerochaete chrysosoporium, Rhodococcus rubber, A. oryzae, 

Brevibacillus borstelensis, Penicillum simplicissim YK).

243 Id. at 25–27.

244 Id. at 18–20.

245 See RX-853, at 2 (summarizing experience).

246 See RX-853, at Exh. 3 (Barlaz, M., Curriculum Vitae).

247 See RX-851, at 22–23. Dr. Barlaz has reviewed and edited Dr. Tolaymat’s work. Id. 

Dr. Tolaymat supported his opinions throughout his deposition by reference to Dr. Barlaz’s 

work.

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Landfills are characterized by their biological activity and, in fact, most U.S. landfills produce a 

substantial amount of methane and carbon dioxide gas—directly resulting from biological 

activity in the form of biodegradation.248

Thus, Complaint Counsel is incorrect and misleads by characterizing modern landfills as 

“dry tombs” wherein little or no biodegradation can occur. Landfills, while not as biologically 

productive as bioreactor landfills, do indeed permit biodegradation in substantial quantities.

Landfills are also characterized, however, by their variability in environmental 

conditions.249 The moisture content, temperature, density, and composition of MSW landfills 

change constantly, will differ substantially from one landfill to another, and often within each 

landfill from one cell to another.250 There is also variability in the actual time required before 

the microbiological system becomes established for anaerobic biodegradation following waste 

disposal.251

That high degree of variability makes difficult any exact prediction of the time for 

biodegradation in the environment.252 Nonetheless, Dr. Barlaz explains that gas evolution tests 

(such as the ASTM D5511) are useful and accepted as indicative of a substance’s ability to 

biodegrade anaerobically.253 Moreover, if a product is shown to degrade anaerobically in a test 

environment, then it is also likely to biodegrade in a landfill, but perhaps at a slower rate. Thus, 

the dichotomy between the landfill and the test environment should relate more to the rate of 

biodegradation but not the extent.254

248 See RX-853, at 5–6.

249 See RX-853, at 8–9; RX-864, at 39–40.

250 See RX-864, at 39–40.

251 See RX-853, at 6.

252 See RX-853, at 9–11.

253 See RX-853, at 8.

254 See RX-853, at 7–8.

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Landfills are responsible for mostly anaerobic degradation, but also a limited amount of 

aerobic degradation. For instance, the emission of carbon dioxide gases from landfills around 

the country indicates the presence of oxygen, which can be trapped within the landfill or released 

during the degradation of other MSW components.255

Dr. Barlaz has also assessed many of the scientific studies for which the parties possessed 

raw data.256 Moreover, Dr. Barlaz has visited Eden Laboratories to review its test methods and 

facilities.257 Dr. Barlaz will explain that the positive tests in the record before this Court are 

indicative of biodegradation in excess of the ECM additive (contrary to Dr. McCarthy’s “priming 

effect” theory).

258 He has explained that “reactor tests” of the kind ECM presents provide 

“results on what is possible in a landfill given appropriate environmental conditions.”259

Complaint Counsel’s purported expert in landfills, Dr. Thabet Tolaymat, lacks the 

education, experience, or training sufficient to opine on the issues central to this case. Dr. 

Tolaymat lacks an understanding of the microbiology and bacterial communities at work in the 

landfills or test environments.260 Although he testified as an “employee of the federal 

government,” his antiquated opinions concerning “dry tomb” landfills are inconsistent with the 

EPA’s regulation of those landfills and the EPA’s statutory goals. Dr. Tolaymat prepared his 

expert report, which may have far-reaching consequences for environmental policy, without 

consulting with any expert in the areas he is not at the U.S. EPA.261 Not a single EPA employee 

or representative reviewed Dr. Tolaymat’s work product to determine if his views were 

255 See id. at 5–6.

256 See RX-853, at 14.

257 See id.

258 See RX-864, at 175–76.

259 See RX-853, at 8.

260 See, e.g., RX-851, at 225–26.

261 See RX-851, at 29–30.

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consistent with those of that agency.262 Dr. Barlaz will testify that Dr. Tolaymat’s report is 

erroneous on certain fundamental points concerning landfills, landfill management, and 

biodegradation testing.

e. Proof that ECM’s Additive Biodegrades Plastics

The following representative tests have shown that plastics manufactured with ECM’s 

technology biodegrade significantly:

Test Year Method Duration Plastic/ECM % Biodeg.

McLaren/Hart

(RX-269)263 1999

Scientific Evaluation and 

Review of existing study data 

(anaerobic/aerobic report)

15 days

22 months

ECM Pellet

5% ECM Film

24% (pellet)

Qualitative 

evidence of 

biodegradation 

(film)

Univ. of NM 

Electron 

Microscopy

2006

Scanning Electron Microscope 

(SEM) images of treated test 

samples

n/a Treated 

bubblewrap

Qualitative 

evidence of 

biodegradation

Univ. of NM 

Electron 

Microscopy

2007

Scanning Electron Microscope 

(SEM) images of treated test 

samples

n/a Treated PS 

foam

Qualitative 

evidence of 

biodegradation

SSCCP

(RX-465) 2009

UNI EN 14043/2003,264

aerobic265 degradation test of 

Italcom product

91 days

PET

PVC

Film

4.95% (PET)266

50.09% (PVC)

4.80 (Film)

SSCCP

(RX-467) 2013 ISO 14855, UNI EN 14046, aerobic degradation ,Colplast 91 days Unknown 11.9%

262 Id.

263 Respondent/Complaint Counsel Exhibit Nos. RX-269, CCX-266E, CCX-268A.

264 Some of the SSCCP tests involved the grinding of test samples in liquid nitrogen to 

obtain particles with sizes of <1 mm. The grinding process, which could separate the additive 

components from the plastic, is likely to significantly reduce, if not nullify, any expected 

biodegradable effect achieved through biofilm formation and quorum effects.

265 Aerobic tests are relevant to prove the mechanism of action and intrinsic 

biodegradability of ECM plastics.

266 Averages of three datasets recorded.

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Test Year Method Duration Plastic/ECM % Biodeg.

SSCCP

(RX-468) 2013 ISO 14855, UNI EN 14046, aerobic degradation, Colplast 91 days Unknown 6.96%

Ecologia 

Applicata s.r.l.

(RX-273)

2010 UNI EN ISO 14855, aerobic 

degradation, for Co.ind. s.c. 180 days PP/1% 19.3%

Sondor

(RX-274) 2011 Sondor Biofoam degradation test 775 days Various/2%

Qualitative 

evidence of 

biodegradation 

(mass loss, etc.)

Environ

(RX-275) 2012

Environ PS & PE testing for FP 

International (modeled after 

ASTM D5338 & D5511)

120 days PS & PE/1% >5%

Ecologia 

Applicata s.r.l.

(RX-276)

2011 UNI EN ISO 14855, aerobic 

degradation, for Colplast S.r.l. 180 days

Polyammide & 

Nylon/% 

unknown

46.67%

Intertek India

(RX-277) 2012

D5511, ISOE Printpack 

Industries, PVT, LTD, sample 

sheet

45 days Sample sheet 

unknown

Qualitative 

evidence of 

biodegradation; 

gas data; no 

negative control

Clemson Univ. 

Study

(RX-388-91)

2009

In situ testing of various treated 

samples for Dispozo Products 

Inc.

477 days EcoPure

Qualitative 

evidence of 

biodegradation

Case Western

(RX-278) n/a Prof. Morton Litt SEM Examination of ECM plastic in n/a/ n/a/

Qualitative 

evidence of 

biodegradation

Eden 092511B

(RX-248) 2011 ASTM D5511, for FP International 120 days Airbag film/1%

11.5%

15.2%

Eden 070312C

(RX-839) 2012 ASTM D5511, for Shields Bag & Printing 22 weeks Film/1% 7.9%

Eden Fellows

(RX-403) 2012 ASTM D5511 for Fellows 197 days Amended film/1%267

71.8%

16.1%

Eden FPI

(RX-402) 2014 Updated ASTM D5511 standard for FP International 290 days

1% ECM film

1.75% ECM 

film

5.5%

11.5%

267 The Fellows product was treated with additional biodegradable elements.

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Test Year Method Duration Plastic/ECM % Biodeg.

Eden FPI

(CCX-548) 2013 Modified ASTM D5511 for FPI EPS Samples 291 days Expanded PS/1% 30.4%

Eden Smithers

(RX-401) 2013 ASTM D5511 for Smithers Oasis 148 days Foam/1.1%Foam/3%

2.4%

5.8%

Eden FPI

(CCX-546) 2011 ASTM D5511 for FP International 977 days

Air bag 

(TKN)/1%

Air bag 

(HOP)/1%

36.7%

39.8%

Environ

(RX-254) 2008 Anaerobic study based on ASTM D5526 180 days Amended PVC 2.7% (based on gravimetric data)

NE Labs 

N0843980

(RX-399)

2008 ASTM D5511 study for BioTec Environmental LLLC 14 days PP Sheet 8.4% (based on 

gravimetric data)

NE Labs 

N0946510-01

(RX-398)

2009 ASTM D5511 study for 

Masternet Ltd. 15 days PE/1% 4.91%

NE Labs 

1048742-01

(RX-405)

2010 ASTM D5511 study for Eco 

SmartPlastics 45 days LDPE/1.5% 7.37%

NE Labs 

1048819

(RX-396)

2010 ASTM D5511 study for Eco 

SmartPlastics 43 days PET 7.01%

NE Labs 

1150851

(RX-395)

2011 ASTM D5511 study for Sweet 

Tape Enterprise (M) Sdn. Bhd. 45 days PP 4.54%

NE Labs

1150851

(RX-394)

2011 ASTM D5511 study for 

Tycoplas Sdn Bhd 15 days PS foam 5.89%

NE Labs 

1253020

(RX-393)

2012 ASTM D5511 study for 

National Tree Co. 15 days PVCPE

9.89%

5.75%

NE Labs 

1048036

(RX-392)

2011 ASTM D5511 study for 

Transilwrap Co. 233 days FilmLaminate

7.85%

8.53%

NE Labs 

N1048340

(RX-836)

2013 ASTM D5511 study for Pregis 

(PPC) 900 days PE Poly Bags/1% 49.28%

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Test Year Method Duration Plastic/ECM % Biodeg.

OWS PFR-1

(RX-263) 1998

Aerobic Biodegradation under 

controlled composting 

conditions (ISO 14855)

45 days

5% film

5% natural 

film

4.5%

2.6%

OWS PFR-4

(RX-265) 1999 High Solids Anaerobic Digestion (HSAD) concept test 15 days ECM pellet 24.0%

OWS PFR-5

(RX-266) 2000

Aerobic Biodegradation Under 

Controlled Composting 

Conditions (40 Gal Trash Bag)

45 days Treated bag 5.2%

OWS BFI-1

(RX-268) 2010

High Solids Anaerobic 

Digestion (HSAD) Test for 

Covidien

15 days PP 3.9%

Eden 

MicroTek

(CCX-534)

2011 ASTM D5511 test for 

MicroTek 811 days PE 17.9%

Eden EcoLab

(CCX-547) 2013 ASTM D5511 test for EcoLab 452 days Film 19.6%46.5%

NE Labs 

1149980

(RX-838)

2011 ASTM D5511 & D6579 tests 

for Minigrip 365 days LDPE/LLDPE/1.5% 17.07%

NE Labs 

1048215 2010 ASTM D5511 test for Dansko 15 days Rubber/2.5% 1.5%268

8. Testing of the ECM Additive Confirms that It Accelerates the 

Biodegradation Process

Despite the overwhelming evidence of ECM’s additive causing plastics to biodegrade, 

Complaint Counsel presents a variety of inconsistent theories in an effort to discredit the entire 

body of scientific evidence. None of those theories, taken alone or in combination, overcome the 

totality of the evidence showing that ECM’s additive, when properly blended within major 

plastic resins (e.g., PP, PS, and particularly PE), will produce a biodegradable plastic that 

biodegrades in landfills. In short, Complaint Counsel would have this Court rule that every 

268 The unconventional use of the ECM additive in rubber produced a degradation rate of 

1.5% (which was less than the percentage of the additive), which tends to validate the Northeast 

Labs results.

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single one of the dozens of positive ECM tests are each uniquely flawed to the point of 

irrelevance, but that the Court should accept the very same or similar tests that support 

Complaint Counsel’s theory of the case. Consider the following theories crucial to Complaint 

Counsel’s case:

ECM’s testing conditions adequately simulate or replicate landfill settings:

According to Complaint Counsel, no test can actually simulate or replicate the landfill 

environment and, so, every test must be rejected. That position is contrary to the generally 

accepted scientific evidence which routinely extrapolates from closed system tests to the landfill 

environment. The flawed nature of that argument is most apparent when considering that 

Complaint Counsel’s own experts relied on the same testing methodologies as ECM to prove that 

products were biodegradable in the landfill environment. For instance, Dr. Frederick Michel 

performed an ASTM D5511 to assess whether seven plastics would be considered anaerobically 

biodegradable in the environment.269 Dr. McCarthy, Complaint Counsel’s lead scientific 

witness, performed similar gas evolution studies to determine that his own technology was 

aerobically and anaerobically degradable.270 Dr. Tolaymat, Complaint Counsel’s landfill expert, 

testified that a BMP test should be used to measure biodegradability, which is a gas evolution 

test arguably less representative of a landfill than the D5511 standard.271 

In short, Complaint Counsel has failed to identity a single test or analysis that it 

concludes would be representative of the landfill environment. Therefore, their theory appears to 

be that no such claim could ever be substantiated, which is a false premise built on a 

constitutionally infirm prior censorship.

269 See CCX-905.

270 See RX-756.

271 See CCX-893, at 21.

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ECM’s Positive Test Results do not Have Fatal Methodological Flaws:

Complaint Counsel has identified a series of so-called methodological “flaws” to justify 

its categorical rejection of the over 33 tests showing the ECM additive causes biodegradation. 

Significantly, almost all of those “flawed” tests employed suitable negative controls. The use of 

negative controls in those instances mitigates any perceived issues in the methodology, as 

explained below.272

For example, Complaint Counsel contends that tests did not maintain anaerobic 

conditions throughout the test. That is incorrect. In certain situations, laboratories (e.g., 

Northeast Labs) would “re-innoculate” the test vessel with fresh inoculum. The labs reinoculated specifically to test the theory that a plateau effect indicated that the test article had 

finished degrading. NE Labs would flush the vessels with Nitrogen after adding inoculum, 

which effectively purges the system of oxygen and restores immediately the anaerobic 

environment. However, even assuming that some oxygen was introduced in limited quantities, 

the presence of a potentially aerobic condition is irrelevant because the point of the reinoculation was to assess whether the plastic was still biodegradable. In other words, Complaint 

Counsel contends that microorganisms degrade the ECM additive and then stop when the 

additive is finished, leaving nothing but non-degradable, recalcitrant plastic. But Complaint 

Counsel also says that such recalcitrant plastic is non-biodegradable in both aerobic and 

anaerobic environments. Moreover, the tests relied on negative controls involving untreated 

272 Complaint Counsel also refers to their own “well-documented studies” conducted by 

laboratories like O.W.S. and North Carolina State University. See CC Pretrial Br. at 37. 

However Complaint Counsel is unclear what they mean by “well-documented.” Unlike many of 

ECM’s studies, those studies to which Complaint Counsel referenced were not accompanied by 

raw data. Most of them included just final reports or results. Complaint Counsel apparently 

thinks that the data is of more quality simply because the final report can be construed as support 

for its position.

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plastics. So even if the re-inoculation introduced oxygen, if Complaint Counsel was correct, 

then no further degradation would occur—but there was further degradation, which defeats 

Complaint Counsel’s position. If the uptick in activity seen in the inoculum was caused by the 

oxygen, then you would see that as well in the negative control too (which did not occur).

Complaint Counsel contends that tests were missing information required to be reported 

under the methodology. See CC Pretrial Br. at 37. The “method,” however, is just a description 

of a scientific methodology. The failure to describe what is a generally accepted and used 

standard of testing does not render the study invalid. In fact, Complaint Counsel’s own experts 

have followed methodologies that were not even subject to methods, or they created their own. 

The laboratories here followed sound scientific principles, collected reliable data, and produced 

enough information sufficient to assess the data.

For several tests where ECM received the raw datasets, Dr. Barlaz completed statistical 

analyses to determine standard deviations, t-tests, ratios, and other relevant calculations to test 

the sufficiency of the data. Based on the raw data provided, Dr. Barlaz determined that the tests 

revealed that methane generation from the test materials was significantly (p<0.05) greater than 

what could be attributed to the inoculum.273 Moreover, based on calculations of the theoretical 

carbon yield from ECM’s additive (by weight), the tests reveal that significantly more carbon 

would have come from the test article than what could reasonably have been supplied by the 

ECM additive. In other words, the plastic substrate had biodegraded.

Complaint Counsel claims that tests were not run for periods of time validated under the 

methodology. Again, this criticism is hard to comprehend, considering that the methodologies 

273 See RX-853, at 14.

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are unsuited to measure slowly degrading substances. ECM’s experts will explain that there is 

nothing inherently unscientific or problematic with an extension of the test periods.

Last, Complaint Counsel argues that tests did not report load rates, plastic types, etc. 

That information, however, is not necessarily required to assess the efficacy of ECM’s additive, 

particularly where, as here, the tests employed negative controls and actually used the ECM 

product at a 1% load rate. The issue in this case is whether the plastic, combined with ECM’s 

additive, creates a biodegradable plastic. Thus, many of the laboratories were only concerned 

with that question, not whether the biodegradability was owed specifically to the ECM additive. 

However, because we know that the plastics are not otherwise biodegradable (or degrade 

extremely slowly), and because the tests used negative controls as a comparison, the data gleaned 

from the tests is reliable, material, and scientific valid. 

The limited Inconclusive Tests Showing Little to No Biodegradation Are not Evidence 

that ECM’s Product Is Inefficacious:

Complaint Counsel selectively relies on a lesser number of tests said to have shown no 

biodegradation of plastics with ECM’s additive. Those tests are in the minority, and they often 

support ECM’s position that inconclusive tests are likely the result of the laboratory 

environment. Complaint Counsel’s argument also reveals hypocrisy and inconsistency. First, 

these tests were conducted under largely the same conditions and protocols as the positive tests 

ECM relies on. It is disingenuous to argue that ECM’s favorable tests are worthless because 

they are flawed or do not simulate the landfill environment, but then embrace the inconclusive 

tests simply because the outcome better fits Complaint Counsel’s theory of the case.

Second, those tests that reported zero or negative biodegradation totals are highly suspect. 

For context, Complaint Counsel has argued that favorable results in ECM testing are owed to 

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something called the “priming effect.” As used by Complaint Counsel, the “priming effect” 

allegedly occurs when the inoculum gears up to digest the ECM additive, which, as Complaint 

Counsel concedes, is composed of biodegradable material. We address the flaws in the priming 

effect theory below. The crucial point, however, is that the ECM additive is biodegradable. Any 

legitimate test should show a statistically higher rate of biodegradation in the test sample to 

account for the degradable nature of the ECM additive. If the test shows zero degradation, then 

questions immediately arise as to (1) the manufacturing quality of the test sample; (2) the 

inclusion of the additive in the test article uniformly (as ECM requires); or (3) the viability of the 

laboratory environment. For instance, on that latter point, several of the inconclusive tests 

Complaint Counsel rely upon showed that the positive control (cellulose) stopped degrading 

prematurely and plateaued. Cellulose is indisputably biodegradable, so the plateau is a true

indication that the test was inadequate.274 Such is true of the Michel test, for example. Closed 

systems have inherent limitations that might skew data. While those variables may not be to 

blame in every instance of inconclusive test data, evidence of improper testing conditions should 

be ascribed the proper weight.275

The Priming Effect is Mythical:

Complaint Counsel’s experts have tried to diminish ECM’s positive test data by arguing 

that any reported biodegradation is owed to a supposed “priming effect.” They argue, also, that 

274 ECM notes the irony that, in these tests (e.g., the Michel & Gomez study, CCX-905), 

the cellulose would not be considered “biodegradable” under Complaint Counsel’s one-year 

definition, because it plateaued and never reached complete degradation within one year. 

Cellulose is, of course, one of the most biodegradable substances on earth, which is why 

laboratories use it as a positive control.

275 For example, a fish tank is also a closed ecological system. Imagine a fish tank that 

was never cleaned or cared for. Over a short period of time, that closed system would develop 

conditions that rendered certain processes or life unable to continue. Those similar limiting 

factors might not be expected in the ocean.

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the small amounts of biodegradation reported in ECM’s studies are insignificant and should be 

disregarded. Although unclear from Complaint Counsel’s presentation, their experts appear to 

argue that the degradation reported in ECM’s favorable tests is a result of the inoculum 

increasing metabolic activity when exposed to the ECM additive. Dr. Barlaz has testified that 

the concept of “priming effect” has not been seen in anaerobic systems and is invalid in relation 

to tests on the ECM product. 

The major flaw in that theory is that it depends on the idea that biodegradation recorded 

is solely attributed to the additive, or catalyzed by the additive. ECM’s test data frequently show 

amounts of degradation far in excess of the amount of additive present in the test plastic. Thus, 

if the theory is that the inoculum is triggered by the ECM additive, then Complaint Counsel 

cannot explain why the amounts of degradation would continue beyond the amount fairly 

attributed to the additive (e.g., 1% degradation). Moreover, Complaint Counsel’s theory 

presupposes that all of the ECM additive is available to the biota at the start of the test, which is 

also untrue. The ECM additive is uniformly mixed throughout the plastic and, so, only a small 

percentage of the additive is immediately available for consumption at the outset. The biota may 

opportunistically find the additive or a defect in the plastic at or near the surface but must then 

consume the plastic substrate to reach new additive, a food source, which does occur and results 

in the biodegradation recorded.

Finally, Complaint Counsel’s dismissal of ECM tests that reported single digit 

biodegradation is erroneous. Tests must be compared to negative controls, or untreated plastics 

without the ECM additive. For instance, a 2011 test of ECM’s additive in a Low Density 

Polyethylene plastic bag revealed 5.94% biodegradation in 30 days. See RX-838. The product 

contained 1.5% of the ECM additive. When compared to the cellulose positive control the rates 

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seem low. Id. (the cellulose had degraded to more than 86% in the same time period). However, 

in that same 30-day period, and under so-called “optimal” conditions, the negative control had 

degraded just 0.09%. Id. Therefore, 5.94% biodegradation in a short term lab test is powerful 

validation for a product that is not otherwise biodegradable. In fact, in this test, the laboratory 

extended the duration to one calendar year, and recorded total degradation of about 17%. Id. 

The rate of biodegradation slowed, but continued consistently well beyond the amount that could 

fairly be attributable to biodegradable nature of ECM’s additive.

9. The Qualified Claims Actually Made Versus the Claims Charged

Complaint Counsel bases this case on ECM’s marketing claims taken out of context, or 

discontinued long ago. Complaint Counsel also fails to acknowledge the substantial differences 

between this case and many other FTC adjudications. The bulk of ECM’s promotional and 

marketing information is exchanged through detailed business transactions between sophisticated 

corporations, to wit, plastics manufacturers, and ECM.276 Those manufacturers seek only to 

market a “biodegradable” plastic. They have many choices in the market. ECM’s advertising 

budget is less than $12,000 per year, which is mainly devoted to website maintenance.277 The 

web site is of no utility to consumers because the additive is a pellet unusable to consumers; 

interest, if at all, from an individual not within a plastics company, is thus academic. Over the 

past decade, ECM’s qualifications have changed to accommodate an evolution of scientific 

understanding concerning how its additive technology works in landfill environments. In the 

first instance, ECM offered its “9 month to 5 year” degradable claim not as a performance claim, 

276 RX-875, at 258:17–20 (the “vast majority” of ECM’s customer “are very large and 

sophisticated companies”).

277 CCX-820, at 25:7–27:18; Id. at 382:12–13 (“[t]here would have been extensive 

conversations like with all customers”). 

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but as a means to distinguish its technology from competing technologies claiming to satisfy the 

short-term compostability standards.278 Later, the FTC revised its Green Guides to prohibit 

unqualified biodegradable claims without suitable qualifications.279 ECM has always qualified 

its marketed claims280 and explained to customers that the time frame for biodegradation is 

entirely dependent on environmental factors.281 ECM updated its website to include the 

following explanation:

The basic concept is that biodegradation is a natural process that occurs 

around the world but at various speeds due to various conditions. Plastics with 

our additives behave like sticks, branches or trunks of trees. Due to this fact, 

we do not guarantee any particular time because the time depends on the same 

factors that the biodegradation of woods and most other organic materials on 

earth depend – ambient biota and other environmental conditions. Under 

specific composting conditions with additional accelerants sprayed on them, 

some customers have reported biodegradation in as little as a couple of 

months. Under the more usual, commercial composting conditions using high 

heat processes, a time frame of around some period greater than a year is a 

reasonable expectation.282

That type of marketing is consistent with ECM’s position in communications with all 

customers.283 

Troubled with the concept that the FTC would require a specific rate of biodegradation (a 

near impossible task given the environmental variances), ECM has used disclaimer language 

intended to satisfy the FTC’s unattainable standards. The evidence suggests that ECM customers 

are, in fact, only concerned with marketing a “biodegradable” claim and, so, they considered 

278 RX-875, at 274:8–15 (the 9 month to 5 year claim is intended “to distinguish [ECM] 

from shorter biodegradable alternatives—in other words, the composters”).

279 RX-173.

280 RX-875, at 277:18–19 (ECM “always qualified the claims”).

281 See, e.g., RX-135.

282 RX-681, at 61.

283 See Id. (“It is not a ‘poof, it’s gone’ system but simply makes the plastic product 

biodegrade as if it were a stick or a branch off a tree rather than ‘sticking around’ for hundreds of 

years”).

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ECM’s statements concerning the “rate” of biodegradation only to the extent those claims were 

apparently mandated by the Federal Trade Commission.284 

Following the revisions to the Green Guides, ECM dispatched a truthful and nonmisleading email to all of its customers explaining the FTC’s requirements concerning 

biodegradable claims.285 This e-mail, in response to the Green Guide revisions, explained:

If you have evidence that your products with our additives will fully biodegrade 

in one year or less in the environment where it will be customarily disposed you 

may still make an unqualified claim of “biodegradable” for those products. But 

for most of our customers’ plastic products with our additives whose customary 

disposal is in a landfill, they will not be able to use that unqualified claim.286

ECM continued by discussing the benefits of its product: “Municipal Solid Waste that 

biodegrades slowly but surely over periods from a few years to tens of years provides the 

(sic) [landfill gases] that is captured, processed and sold to the public renewable energy or even 

new chemical source. This is the end-of-life scenario that has made plastic products with our 

additives so ever-increasingly popular.” 287

Sophisticated ECM customers have understood that each product is unique, and 

biodegradation testing is likely required to assess how their specific product performs. For 

instance, in response to ECM’s gratuitous 2012 customer email, one ECM customer invited 

ECM to “review the data that was collected by Eden on our products and make a 

recommendation as to what sort of qualifying statement we [they would] have to make.”288 

284 See RX-87 at 193 (J. Blood deposition).

285 See, e.g., RX-35–RX-77. 

286 See id. 287 Id. (emphasis added).

288 See RX-72. 

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The evidence reveals that ECM has truthfully and accurately informed customers that the 

rate of degradation in the environment is highly variable and uncertain, and dependent on many 

factors. 

10. The ECM Customer: A Sophisticated Corporation, not an End-Use 

Consumer

ECM customers are sophisticated manufacturers often several layers removed from endconsumers.289 Moreover, Complaint Counsel has not identified precisely who the “endconsumer” might be here. ECM sells its additive to plastics manufacturers.290 Most (if not all) 

of ECM’s customers extensively test the ECM product before determining whether to 

incorporate ECM’s technology in their plastics.291 Those manufacturers generally sell to submanufacturers or distributors as bulk plastic products.292 The mid-level distributors market and 

sell items like plastic bags or packaging cushions to corporations (e.g., grocery stores or common 

carriers).293 For the majority of products in ECM’s supply chain, therefore, a so-called “end 

consumer” never actually purchases an ECM plastic. They receive the ECM plastic either in the 

mail (for packaging products) or at the grocery store (for plastic grocery bags). Moreover, the 

ECM plastics is received by the consumer after a sale in commerce. Thus, there is no evidence 

at all in in this case that, for the bulk of the products ECM manufactures, a consumer ever makes 

a purchasing decision based on a single ECM claim or a single claim made by an ECM customer. 

289 See, e.g., RX-178, at 34 (page labeled as “BPI 004025”). 

290 RX-875, at 217:16–17 (ECM’s “customer[s] [are] plastic product manufacturers”). 

291 See, e.g., CCX-802, at 92:9 (A. Leiti deposition transcript, noting that Dispoz-o 

conducted its own tests). 

292 See, e.g., RX-178, at 34 (page labeled as “BPI 004025”).

293 See, e.g., CCX-811, at 9:24–10:5 (A. Hong deposition transcript, explaining that 

Island Plastic Bags manufactures and sell plastic bags and plastic cutlery). 

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ECM’s direct customers are ordinarily far larger than and equipped with more knowledge 

of plastics and degradation of their own plastics than ECM possesses.294 ECM’s customers, 

unlike ECM, are plastics manufacturing companies ordinarily with scientific officers and layers 

of corporate review. As plastics manufacturers, those companies are keenly aware of plastics 

chemistry. Moreover, the evidence suggests that most ECM competitors actively review ECM’s 

competition, and even test competing products to determine if ECM is the best fit from a 

performance and biodegradation perspective.295 Most of the test data gathered in this case comes 

from ECM’s customers directly. 

Given that ECM has fully disclosed the nature of its products, there is transparency in 

ECM’s advertising and a distinct lack of deception in the market. First, ECM’s customers 

purchased products hoping to achieve a “biodegradable” plastic. They did that without regard to 

the rates of biodegradation. Complaint Counsel argued in its Pretrial Brief that “[c]ustomers buy 

the ECM additive because they want biodegradable plastic—and they want to be able to 

advertise their plastic as biodegradable.”296 In fact, with the exception of several isolated 

instances, among what Complaint Counsel calls “millions” of customer contacts, claims 

concerning the rate of biodegradation have rarely appeared in the end-consumer market. Almost 

invariably, the end-customer is provided with a naked “biodegradable” claim, which is the only 

claim ECM has in its certificate of biodegradability.297 

Second, ECM has routinely provided its scientific testing in full to corporations and 

customers. That information has included clearly favorable data, but also tests that Complaint 

294 RX-875, at 258:23–25 (ECM’s customer “have all the resources, ten times, hundred 

times the resources that [ECM] may have”).

295 See, e.g. RX-159. 

296 See CC Pretrial Br. at 14

297 See, e.g., RX-17.

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Counsel has used to suggest that ECM’s product is inefficacious. ECM’s willingness to share 

information in its negotiations with customers is evidence that ECM has in good faith attempted 

to explain the level of science supporting its product. It also reveals that ECM’s customers have 

had the information necessary to evaluate ECM’s claims and determine, just as ECM has, 

whether those claims are adequately supported. Unlike traditional retail sales where endcustomers are often presented with little more than the product and a claim, in this case ECM’s 

sales have been preceded (and followed) by substantial interaction with corporate customers. 

Those interactions commonly involve discourse concerning the type and format for product 

claims. However, significantly, many of the claims conveyed in the stream of commerce are not 

ECM’s claims. Those claims are constructed by ECM’s customers based on information 

generated and reviewed by same and based on their finished plastic products, not ECM’s 

additive alone.298 

ECM’s customers were aware of the FTC’s requirements in the Green Guides, and they 

tailored their advertising content according to those policies.299 One of ECM’s leading 

customers testified that they adapted advertising claims to fit their perception of the Green 

Guides:

Q: How did FP come to the decision to transition its claims from the ones we 

discussed earlier to the claim that ECM plastic will biodegrade in landfills 

in one to five years or more?

A: There were several contributing factors. One of them was the FTC’s 

green guides. And even though we didn’t agree necessarily with the oneyear time frame that the FTC decided was appropriate, we decided that we 

298 See, e.g., CCX-48 (EcoSmart Plastic advertising that its products will “compost” in “9 

months–7 years”).

299 See, e.g., RX-871, at 193:10–21 (J. Blood deposition, explaining that one of the 

reasons FP International changed its claim was “The FTC’s green guides [] even though [FP] 

didn’t agree necessarily with the one-year time frame that the FTC decided was appropriate”). 

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would incorporate that to make it clear to our customers that it was not 

under a year. And so that was an element where we decided to go ahead 

and make that component of the claim, instead of the nine months.300

ECM customers have thus demonstrated that they understand the nature of ECM’s advertising 

claims, and have been guided substantially in their decision to choose certain marketing language 

by the FTC’s positions, which have skewed the claims in the market and national environmental 

policy.

11. The Survey Evidence Reveals Absence of Agreement on Meaning of 

Biodegradation Among Industry and End-Use Consumers

a. Well-Designed Telephone Survey Confirms that Not Even a 

Significant Minority of End-Use Consumers or ECM Customers 

Has a Single Definition of Biodegradation or Expectation as to the 

Rate at Which ECM Plastics Will Biodegrade

i. Dr. Stewart’s Telephone Survey Was Well-Designed, 

Incorporated Open-Ended Clear Questions, And 

Incorporated Established Principles Of Survey Research. 

A survey expert whose work has repeatedly been credited by ALJs of the FTC and the 

Commission itself, Dr. David Stewart designed a telephone survey in order to determine how 

consumers who actually purchase products made from or packaged in plastic perceive the 

meaning of the term “biodegradability.”301 Phone surveys are the most common form of survey 

used in marketing research. The primary reason Dr. Stewart opted for a telephone interview is 

because he was interested in “meaning.” In order to understand what people believe a term 

means, a competent researcher needs a real life interviewer appropriately trained to conduct 

research. This survey also assessed the message that consumers take away from claims made by 

300 Id. 301 RX-856, at 15 (Dr. Stewart’s expert report).

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ECM.302 Dr. Stewart’s survey used well-designed, non-leading, and clear open-ended questions 

that allowed real consumers to answer in their own words and to provide qualifications, 

contextual information, or other information that established a richer meaning of consumer 

responses than is typically obtained when only closed-ended questions appear (or single 

questions are posed without human interface) in a survey.303

Dr. Stewart designed and conducted this survey in accordance with well-established 

principles of survey research offered in litigation, as articulated in the Manual for Complex 

Litigation.304 To that end, the survey defined the relevant population as men and women over 

the age of 18 in the United States who reported that they had personally purchased a product in 

the past month that came in a plastic container or was made of plastic.305 From this sample, 

respondents were disqualified if they stated that they did not have a general understanding of 

what the term “biodegradable” means.306 The actual sampling frame was constructed from a 

random digit dialing sample obtained from Scientific Telephone Sampling and an age enhanced 

list was obtained from Survey Sampling, Inc.307 Both of these companies are highly respected,

well-known providers of samples for use in survey research.308

Dr. Stewart determined that a sample size of 400 respondents was the sufficient amount 

of participants because that sample size provides, in the worst case, approximately plus or minus 

5% of the true population statistics 95% of the time.309 The respondents’ answers were 

accurately reported by well-trained interviewers who had been specifically trained in 

302 Id.

303 Id.

304 Id. at 16.

305 Id. at 17.

306 Id.

307 Id.

308 Id.

309 Id. at 18.

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interviewing methodology, were under the supervision of highly qualified and experienced 

research supervisors, had been debriefed on the specific requirements and protocol for this 

survey, and had completed at least one practice interview. Importantly, the interviewers were 

also randomly monitored by supervisors to assure that the interviews were conducted in the 

prescribed manner. These interviewers and their supervisors were blind in the sense that they did 

not know for whom the survey was being conducted.310

Once the respondents were appropriately selected from a list of telephone numbers based 

on an algorithm employed by the CATI system, interviewers clarified to potential respondents 

that the call was for research purposes and not telemarketing.311 The interviewers and 

respondents then went through both parts of the survey. The first part contained a screener, and 

the second part was the main questionnaire.312 The screener was used to determine whether the 

respondent met the screening criteria and was a member of the relevant population. These 

questions ensured that the respondent was over 18, asked their age and gender to ensure that 

appropriate diversity was represented within the sample, ensured that they or anyone in their 

household did not work for a manufacturer of plastic products or a waste disposal 

organization,

313 ensured that they had purchased a product in a plastic container or containing 

plastic within the past month, and ensured they had a general understanding of the term 

biodegradable.314

310 RX-843, at 276:9–14.

311 RX-856, at 19.

312 Id.

313 This exclusion was justifiable on the ground that these respondents would have 

atypical knowledge of the issues, and therefore would not be representative of the larger 

population. RX-856, at 19–20.

314 Id. at 19–20.

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Respondents who qualified in the survey sample based on the screen questions were 

asked a series of substantive questions in the main questionnaire. All but two of the questions in 

the main questionnaire were open-ended questions, which have the advantage of allowing 

respondents to offer answers that are qualified, provide context, or are otherwise nuanced, and 

which are useful for clarifying terminology by gauging the meanings of words and for informing 

variability among respondents.315 

The questions in the main questionnaire were clear and not leading.316 The first few 

questions asked respondents about their perceptions of biodegradability generally.317 For 

example, Q4 asked, “If something is biodegradable, how long do you it would take for it to 

decompose or decay?”318 The next set of questions asked the respondents to indicate in their 

own words what claims adapted from claims used by ECM mean to them. Id.

The survey was conducted by qualified persons following proper procedures. Dr. Stewart 

himself personally designed the survey. Id. A well-known survey research agency, California 

Survey Research Services (CSRS), coordinated interviewing and data tabulation. Id. The field 

work for the survey was $37,500. Id. at 23. In addition, the survey was pre-tested by conducting 

a small pilot project, which confirmed that no changes to the survey design were necessary. Id. 

The coding of the responses to the open-ended questions was carried out by experienced staff 

members at CSRS who were blinded, and the codebook used was suggested by CSRS and 

approved by Dr. Stewart. The coders themselves were blind to both the sponsor and the purpose 

of the survey. Id. All verbatim responses were coded independently by two coders and any 

disagreements were resolved in discussion. Id. 

315 Id. at 20.

316 Id.at 22.

317 Id. at 21.

318 Id.

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ii. Dr. Stewart’s Survey Confirms that Not Even a Significant 

Minority of End-Use Consumers or ECM Customers Has a 

Single Definition of Biodegradation or Expectation as to the 

Rate at Which ECM Plastics Will Biodegrade

Dr. Stewart’s survey first concluded that while consumers do have a conceptual 

understanding of what biodegradability is, that understand is not material to any sizable minority 

of consumers.319 The survey also concluded that 68% of the respondents recognize differences 

in the rate of decomposition depending on the type of material or the context.320 The results also 

made very clear that the vast majority of consumers have an understanding that the process of 

biodegradability is highly varied and that it is not often a rapid process.321 Furthermore, 98% of 

respondents believe that different types of products take different amounts of time to biodegrade, 

decompose, or decay.322 Such differences, according to the respondents, include the type or size 

of the material, the context, or the environment.323 Therefore, Dr. Stewart concluded that 

consumers recognize significant time variances in decomposition, and that there is little evidence 

that their understanding of the term biodegradability is restricted to decomposition processes that 

occur within one year or less.324

As for the questions which incorporated ECM’s claims made to industrial purchasers, Dr.

Stewart found that a common response included a lack of understanding, expressions of 

confusion, expressions of skepticism or disbelief, or a simple restatement of the claim.325 This 

lack of understanding, confusion, and skepticism make it highly unlikely that these claims would 

be material to an end use consumer, even if these claims were directed right at the end use 

319 Id. at 24.

320 Id. at 25.

321 Id. at 25–26.

322 Id. at 26.

323 Id.

324 Id.

325 Id.

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consumer.326 In sum, Dr. Stewart’s survey clarified that two of three criteria required for a 

finding of deception, a false belief attributable to actions of the marketer and that the claim be 

material to consumers, are not present in ECM’s alleged advertising.327

Dr. Stewart also conducted a limited Manufacturers Pilot Survey in an attempt to 

ascertain whether more knowledgeable purchasers have a more common understanding of 

biodegradability.328 To this end, ECM provided Dr. Stewart a list of representatives from 

customer organizations who were involved in the purchase of materials for the manufacturer of 

plastics.329 See John Crane Prod. Solutions, Inc. v. R2R and D, LLC, 861 F. Supp. 2d 792, 799 

(N.D. Tex. 2012) (citations omitted)(explaining that even if “a company’s engineers may be 

distinct from the employees who purchased the [product] . . . [s]uch business transactions are at 

least as complex as transactions that other courts have classified as sophisticated”). 

Representatives from 10 of ECM’s customers participated in this survey, which was also 

carried out by CSRS.330 Like the consumer survey, this survey concluded that even among these 

more knowledgeable and sophisticated customers there is substantial variation in opinions about 

how quickly a biodegradable product should take to decompose.331 Dr. Stewart stopped 

conducting this survey after receiving only ten responses because Dr. Stewart believed he would 

run out of time before he could complete the survey and obtain any meaningful results.332

326 Id.

327 Id. at 27.

328 RX-856, at 27–28.

329 Id. at 27.

330 Id. at 26–27.

331 Id. at 27.

332 RX-843, at 230:5–25; Dr. Stewart held this belief primarily Because it took CSRS 20 

hours of calling to obtain the information reported in the study from the 10 survey respondents. 

RX-843, at 218:11–13. 

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b. Complaint Counsel’s Survey Expert Relies on Incompetent Google 

Survey to Correct Incompetent Synovate and APCO Surveys 

In support of the One Year Rule, FTC relies on a survey conducted by APCO Insight, and 

dismisses a survey conducted by Synovate.333 According to FTC, this APCO survey concluded 

that 60% of respondents expect that an item marketed as degradable will fully decompose in one 

year or less. The problem with the FTC’s reliance on the APCO study is that the APCO study is 

rife with flaws, as acknowledged by both Dr. Stewart and Complaint Counsel’s own expert, Dr. 

Shane Frederick. For example, the APCO study uses closed ended question, which are unhelpful

and misleading when there are many possible answers among respondents.334 Importantly, when 

beginning consumer perception work in a new area, open-ended questions are an essential 

tool.335

One of the critical limitations of closed-ended questions is particularly important where, 

as here, the FTC is trying to pigeon hole a consumers’ perception of the term “biodegradability” 

into one uniform definition. Closed-ended questions inherently suggest greater homogeneity 

within a sample of respondents than may actually exist because closed ended questions exist in a 

universe with only four or five possible response.336 Self-evident is the fact that even where 

there is maximum disagreement, 20% of respondents will nevertheless appear to agree on an 

answer to a question in which there are only five possible answers. This fact makes the FTC’s 

“significant minority” argument problematic when they conclude that a significant minority of 

consumers believe something, when that alleged uniform belief is based upon a question that, if 

333 RX-195, at 121.

334 RX-856, at 7; RX-858, at 165:5–7 (Frederick deposition).

335 RX-856, at 7.

336 RX-856, at 7.

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people answered wholly randomly, would be expected to yield 20% agreement on any one of the 

possible five answers. 

Dr. Stewart explains that an example of misleading homogeneity is found in the APCO 

survey question regarding how long it should take for something to decompose if it is labeled 

biodegradable.337 In that question, four of the six response options are a year or less, so it is not 

surprising that 60% of respondents chose an option of one year or less. Indeed, random 

responses spread among the six options would result in 66% of the responses falling in one of the 

four categories related to one year or less. This is what one must expect when people are asked a 

question about which they have little knowledge—a near perfect proportion of random 

responses. 

Well aware of the problems in the APCO survey, Complaint Counsel engaged the 

services of Dr. Shane Frederick in an attempt to support the One Year Rule. Dr. Frederick, who, 

like Dr. Stewart, unapologetically contests that open-ended questions are superior to closedended questions, performed his own “survey” using largely open-ended questions. The problem 

for Complaint Counsel, however, is that unlike Dr. Stewart’s survey, Dr. Frederick’s survey does 

not meet generally accepted standards for survey research.338 In fact, Dr. Frederick readily 

admits that he is not familiar with the standards that are used to determine the qualifications of 

survey experts in federal court or in proceedings before the FTC.339 Similarly, Dr. Frederick is 

unfamiliar with the Reference Manual on Scientific Evidence, and has no “specific criterion in 

mind” as to what makes a survey valid.340 In fact, Dr. Frederick does not “know what other 

337 Id.

338 RX-856, at 10.

339 RX-858, at 19:8–16.

340 RX-858, at 186:7–12.

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people have written” regarding what constitutes acceptable survey principles that define a valid 

survey.341 

Perhaps Dr. Frederick’s documented lack of knowledge about what constitutes valid 

surveys in the litigation context is the reason why he chose to conduct a Google Consumer 

Survey to attempt to support the One Year Rule.342 He chose the Google Survey interface 

despite the fact that no Google Consumer Survey has ever been relied upon as evidence in an 

FTC proceeding, and that its use has never been approved of or validated in any peer reviewed 

literature.343 The Google Consumer Survey is simply unproven at best. If Dr. Frederick wanted 

to do an Internet survey there are well constructed consumer panels available, that, for example, 

Dr. Stewart often uses. FTC seemingly presents Frederick’s survey as the modern and more 

valid alternative to telephone surveys. That is not a validated position or one supported in the 

peer reviewed literature. The reasons for the lack of support for Google Consumer Surveys are 

obvious. For one, there is no way to ascertain the degree to which the sample of respondents 

used in such surveys is representative of any identifiable population. The sample itself is 

unknown and unknowable. That is because there is no verification of respondents with Google 

Survey; rather information on respondents is merely inferred by Google from information 

associated with or that resides on a computer.344 Google survey uses no screener questions to 

assure that the respondent is of relevant age or even understands the English language.345

341 Id. at 186:25–187:4.

342 Cost was also another factor. RX-858, at 123:3–5. This must be especially true 

because the FTC paid Dr. Frederick a flat fee of $40,000, of which Dr. Frederick was entitled to 

keep whatever amount he did not spend. RX-858, at 8:11–15. 

343 Id. at 189:5–10.

344 RX-856, at 10–11.

345 Id. at 11.

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Google survey generally works by giving internet users access to “premium content” in 

exchange for answering a question, as opposed to paying for a subscription. Therefore, the 

questions are at best a distraction and barrier to respondents whose objective is to access 

information, not complete a survey.346 This type of questioning creates a disinterest bias; a 

concept alien to Dr. Frederick at the time of his deposition.

347 That explains why so many 

respondents answered Dr. Frederick’s survey348 with nonsensical answers.

In addition, Dr. Frederick, and his students who acted as his coders, failed to accurately 

report the data received from the Google Survey. For example, Dr. Frederick coded non-sensical 

answers such as “1 second” as “less than one year.” That may be because, unlike Dr. Stewart’s 

survey which utilized well-trained coders, Dr. Frederick believes that coders only need to be able 

to read and follow directions.349 Moreover, Dr. Frederick’s survey failed to code accurate and 

relevant responses such as “don’t know.”350 Even more bothersome, however, is the fact that Dr. 

Frederick’s supervising coder, Andrew Meyer, was aware that their research was going to be 

used by Complaint Counsel against ECM.351 In short, the coders were not blinded, so bias 

infected the study ab initio. 

In addition, as Dr. Stewart makes clear, even if Dr. Frederick’s survey was valid—it is 

not—its results, like Dr. Stewart’s survey results, suggest that there is considerable diversity 

among respondents in terms of their claimed knowledge about biodegradable products and their 

346 Id.

347 RX-858, at 72:10–16.

348 It is also a stretch to even call the Google surveys “Dr. Frederick’s survey” as many of 

the survey questions were not created by Dr. Frederick, but by his student Andrew Meyer, and 

even Google consumer survey itself. 

349 RX-858, at 168:18–169:6; Based on some of the initial coding disclosed to ECM by 

Dr. Frederick, it appears that Dr. Frederick’s coders were even unable to read and follow 

directions correctly. RX-856, at 13.

350 RX-856, at 12.

351 RX-858, at 176:5–24.

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views about the time it takes various materials to biodegrade.352 Therefore, because Dr. 

Frederick’s “survey” is plainly not valid as judged against generally accepted survey principles, 

and because its results do not show any uniform understanding amongst consumers about how 

long a biodegrade product takes to decompose, the concerns that both he and Dr. Stewart have 

regarding the APCO study cannot be alleviated by the existence of Dr. Frederick’s “survey.”353

B. Procedural Background and Irregularities

ECM, a small corporation with only six employees, has endured significant and atypical 

burdens in this case. Consistent with Complaint Counsel’s desire to “close ECM’s doors” (along 

with the remainder of the additive industry), the discovery in this case has been wrought with 

unfair surprises and unmanageable burdens. 

1. Discovery Calculated to Impose Maximum Burdens

In November 2013, Complaint Counsel began issuing discovery request that would have 

had ECM disclose nearly every business record in its possession, including highly sensitive 

information concerning its proprietary formula. Complaint Counsel’s discovery requests were 

without limitation, seeking all files related to the “ECM’s additive,” which would have included 

every single document in ECM’s possession, custody, or control. ECM opposed those overburdensome requests, and attempted to negotiate reasonable limits in discovery. Eventually, 

owing to the cost of excessive motions practice, ECM agreed to meet Complaint Counsel’s 

remarkable request for ECM’s email files containing more than 100,000 pages of email 

communications with customers. Complaint Counsel moved this court for relief when ECM 

could not keep pace with the volume of information required to be disclosed under Complaint 

352 RX-856, at 13–14.

353 RX-858, at 151:16–152:6.

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Counsel’s discovery requests, arguing that an extension of the parties’ discovery agreements by 

two weeks was unacceptable. 

Complaint Counsel eventually received more than 115,000 responsive emails. Having 

refused to limit their discovery requests or tailor them to seek relevant information, ECM was 

forced to locate and review all of those files within several weeks. Because of delays inherent to 

Complaint Counsel’s blunderbuss discovery approach, Complaint Counsel moved the 

Commission to extend the hearing date by 90 days. ECM opposed that motion, and explained 

that an extension of the hearing would result in a substantial economic hardship. The 

Commission extended the hearing by 45 days.

Meanwhile, on their end, Complaint Counsel had failed to produce documents responsive 

to ECM’s requests of considerable import in this action. This Court Sanctioned Complaint 

Counsel for failing to disclose information to ECM that was later used against ECM’s principles 

in depositions through a planned “gotcha” moment. That document was Dr. Michel’s analysis of 

several competing biodegradable technologies. Although Dr. Michel has been an FTC 

consulting witness since 2012, Complaint Counsel feigned any knowledge of his work. But 

when ECM attempted to subpoena Dr. Michel for information concerning his study, Complaint 

Counsel intervened and instructed him not to timely respond to ECM’s non-party subpoena. 

Complaint Counsel has also escalated costs in an effort to limit ECM’s defense. The cost 

of Complaint Counsel’s erratic, meandering and ill-timed discovery practice has been 

considerable.354 Complaint Counsel has performed nineteen (19) fact depositions of testing 

laboratories and ECM customers all over the country, in Hawaii, California, New York, Ohio, 

354 The transcripts alone in this case have cost over $1,000 per document. Other costs 

include attorney fees, costs of travel and lodging, and document costs. Perhaps the biggest cost, 

however, is the loss of time and resources during the final pretrial phase of this case when 

multiple deadlines arrive each week.

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and the District of Columbia, to name a few.355 Those depositions included the following 

persons and entities:

• Northeast Labs (May 9, 2014)

• BER Plastics (May 8, 2014)

• D&W Fine Pack, LLC (May 5, 2014)

• Down to Earth (Apr. 29, 2014)

• Eagle File Extruders (May 14, 2014)

• Eden Labs (May 19, 2014)

• Elsevier (May 30, 2014)

• Flexible Plastics (May 15, 2014)

• Island Plastic Bags (April 28, 2014)

• Kappus Plastic Company (May 6, 2014)

• Quest Plastics (May 7, 2014)

• 3M Corporation (May 16, 2014)

• ANS Plastic (May 5, 2014)

• FP International (May 1, 2014)

• Timothy Barber, Ph.D. (May 7, 2014)

• Thomas Nealis, ECM Employee (March 5, 2014)

• Alan Poje, former ECM Employee (March 6, 2014)

• Robert Sinclair, ECM President (February 18, 2014)

• Kenneth Sullivan, ECM Officer (February 20, 2014)

Each of the foregoing depositions were noticed and conducted by Complaint Counsel. 

Also, the parties have taken eight 8 additional expert depositions. The burdens and costs 

associated with the many fact depositions forced ECM to appear unrepresented, or have counsel 

appear telephonically at a distinct disadvantage. Knowing that ECM could not appear at the 

depositions themselves, or entered limited telephone appearances, Complaint Counsel intends to 

rely exclusively on the transcripts from those very depositions in lieu of live witness testimony, 

thus ensuring that ECM lacks an opportunity to perform any meaningful examination of 

witnesses Complaint Counsel will rely upon at trial.

355 By contrast, to eliminate extraordinary burden, the Federal Rules of Civil Procedure 

generally prohibit a party from seeking more than ten (10) depositions. See Fed. R. Civ. Pro 

30(a)(2)(A)(i). Parties seeking to expand that number must justify the necessity of each 

deposition. See, e.g., Archer Daniels Midland Co. v. Aon Risk Services, Inc. of Minnesota, 187 

F.R.D. 578, 586 (D.Minn. 1999) (collecting cases).

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Complaint Counsel’s many fact depositions also created an in terrorem effect in the 

market as ECM’s customers fear FTC enforcement. On October 29, 2013 the FTC announced 

six enforcement actions against companies, including ECM, for violating the revised Green 

Guides and the One Year Rule.356 The FTC has already secured two consent orders from ECM 

former customers. Parties participating in depositions have been forced to disclose their business 

records to the FTC. Those customers now reasonably fear FTC action, which renders them more 

willing to please the FTC and offer testimony unfavorable to ECM. 

Knowing that ECM was unable to provide live counsel during depositions of ECM 

customers, Complaint Counsel lead witnesses excessively, effectively testifying for those 

witnesses through counsel’s questions.357 For example, Complaint Counsel asked questions 

concerning ultimate legal issues in controversy:

• “[I]s [company] an entity sophisticated in the biodegradability of plastic?”358

• “Did [company] rely on ECM’s testing as proof that its additive worked?”359

Complaint Counsel now seeks to present that testimony in written form only, where ECM cannot 

cross-examine the witnesses, and the ALJ cannot make assessments of witness credibility. 

Complaint Counsel essentially asks the Court to take these witnesses’ statements at face value. 

Complaint Counsel has suggested that its decision to present the partisan transcripts is out of a 

desire to avoid inconveniencing non-parties. In a case that has already amassed considerable 

costs for both parties, that would be the first instance to date that Complaint Counsel restrained 

themselves in any capacity. Indeed, after having performed literally dozens of fact depositions, 

356 http://www.ftc.gov/news-events/press-releases/2013/10/ftc-cracks-down-misleadingunsubstantiated-environmental

357 See, e.g., CCX-811, at 33–38. 

358 See CCX-811, at 33. Similar questions, which are vague and leading, are replete 

throughout the customer transcripts. 359 See CCX-800, at 24.

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the sudden desire to avoid live testimony is transparently designed to prejudice ECM to the 

greatest extent possible for failing to afford the massive discovery bill imposed by Complaint 

Counsel during fact discovery.360

2. Dr. McCarthy’s Moving Target

Dr. McCarthy submitted an expert report in this case on June 4, 2014. As part of his 

essential opinion, he maintained that “microorganisms do not produce enzymes that metabolize 

plastic.” See McCarthy Rep. at 29-30. He gave short shrift to the notion that naturally produced 

enzymes could metabolize conventional plastics, which, he argued, “remain resistant to 

microbial attack.” See id. Because Dr. McCarthy’s biased expert opinion hinges on the 

presupposition that additive technologies are ineffective, Dr. McCarthy unequivocally explained 

that conventional plastics are not biodegradable. He explained that the “evidence indicates that 

the minimal biodegradation observed in the tests ECM relies on is the result of the ‘priming 

effect,’ i.e., biodegradation of the additive (which contains organic compounds highly 

susceptible to biodegradation) and the organic materials of the test medium (the bacteria used for 

testing) rather than the plastic.” Id. at 36. Dr. McCarthy offered those opinions without the 

benefit of a single supportive citation; indeed, he generally avoided citations of any kind 

throughout his report.

ECM’s experts countered with a large body of peer-reviewed literature showing that 

conventional plastics can be, and are in fact, enzymatically degraded. ECM’s experts explained 

that the phenomena observed in ECM’s tests were supported by the peer reviewed literature. See

Sahu Rep. at 29-40 (collecting references demonstrating the enzymatic biodegradability of 

360 ECM notes that many of the deponents were located in New York, Connecticut, Ohio, 

which are within several hours of Washington, D.C. by flight. Two such depositions (CCX-801 

& CCX-801) were actually conducted at the FTC’s offices at 600 Pennsylvania Avenue.

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certain plastics); Burnette Rep. at 17-22. In response, Dr. McCarthy presented a rebuttal report 

on June 30, 2014, wherein he first presented a new opinion concerning what he terms amorphous 

versus crystalline structures of plastic polymers. See McCarthy Rebuttal at 10. Therein he does 

a volte face, shifting course and explaining that plastics may be biodegradable after all, however, 

only amorphous sections of the plastic biodegrade: “[t]he material to biodegrade is the 

amorphous region of a polymer, which biodegrades at a fast rate. If the material were 50% 

crystalline, then the biodegradation rate would be very rapid until it reached 50% 

biodegradation.” Id. Of course, Dr. McCarthy never posits or explains the percentage he 

actually thinks is “amorphous” in ECM’s plastic products tested; nor does he rely on scientific 

literature to establish a foundation for his opinion. He likewise fails to explain what percentage 

of crystalline polymers are present in his patented “blends” of polyesters that are manufactured 

using blending techniques like ECM’s technology. See McCarthy ‘199 Patent. In reality, his 

new theory is a post hoc construct that permits him to testify that ECM cannot claim complete 

biodegradability unless they present a test showing one hundred percent elimination of the 

plastic. That theory is scientifically erroneous and in direct contradiction to his own peer 

reviewed articles and his own ‘199 patent, wherein he identifies biodegradation without proof of 

one hundred percent elimination of the plastic. 

Complaint Counsel also presented the rebuttal testimony of Dr. Frederick Michel. 

Complaint Counsel had negotiated stipulations concerning Dr. Michel’s testimony as a fact 

witness, and held him out as a potential fact witness. On June 30, 2014, Complaint Counsel 

suddenly added without prior notice Dr. Michel as a rebuttal expert witness, all within 24 hours 

of the expert discovery cutoff. 

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In response, ECM moved to add a surrebuttal witness, Dr. Steven Grossman. Dr. 

Grossman is a colleague of Dr. McCarthy, Complaint Counsel’s scientific expert. He would 

have provided crucial testimony concerning false or misleading statements in Dr. McCarthy’s 

expert report and testimony. He would have explained that Dr. McCarthy is inherently biased 

because of his personal connections, and that, more importantly, his scientific opinion is fatally 

flawed and inconsistent with Dr. McCarthy’s prior work. He would have addressed the new 

argument first presented in Dr. McCarthy’s rebuttal report. As a polymer scientist and patent 

attorney, Dr. Grossman would have testified that Dr. McCarthy’s scientific opinion concerning 

plastics manufactured with ECM’s plastic is erroneous. On July 23, 2014, ECM was denied an 

opportunity to present that critical information. As part of that decision, the Court noted that 

ECM had not submitted a request for leave within five (5) days of the deadline set by Rule 

3.31A. The Court ignored the fact that Complaint Counsel had failed to timely complete their 

service and production of the actual rebuttal report by June 30th. The Court improperly 

calculated the return date of ECM’s motion by failing to include the July 4th holiday. However, 

the Court held ECM strictly to the five day deadline, and compounded the substantial prejudice 

ECM suffers now by prohibiting ECM to call a key witness. Although the purpose of the Part III 

adjudication is to present a recommended decision based on “the whole record relevant to the 

issues decided,” this record will now decidedly be truncated to omit material information in 

ECM’s defense. See 16 C.F.R. § 3.51(a).

III. ARGUMENT

A. The FTC Fails to Satisfy Their Burden of Proof that the Biodegradation 

Claim Is Literally False

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“Counsel representing the Commission . . . shall have the burden of proof, but the 

proponent of any factual proposition shall be required to sustain the burden of proof with respect 

thereto.” 16 C.F.R. § 3.43(a); see also 5 U.S.C. § 556(d) (explaining that “the proponent of a 

rule or order has the burden of proof”). Regardless of the level of substantiation required, the 

FTC will bear the burden of proving advertising claims are false or misleading. See Sterline 

Drug, Inc. v. F.T.C., 741 F.2d 1146, 1150 (9th Cir. 1984); Porter & Dietsch, Inc. v. F.T.C., 605 

F.2d 294, 305 (7th Cir. 1979); F.T.C. v. Garvey, 383 F.3d 891, 900 (9th Cir. 2004) (“we put the 

burden of proving falsity or deception on the FTC”). To prove that an advertisement is false or 

misleading, the FTC must show (1) the existence of a “representation, omission, or practice,” 

that is (2) “likely to mislead consumers acting reasonably under the circumstances,” and that 3) 

“the representation, omission, or practice is material.” F.T.C. v. Bronson Partners, LLC, 564 F. 

Supp. 2d 119, 124 (D. Conn. 2008) (citation omitted). Complaint Counsel must prove each 

element of its case by a preponderance of the evidence. See, e.g., In re Adventist Health 

Sys./West, 117 F.T.C. 224, 297 (Apr. 1, 1994) (explaining that “[e]ach element of the case must 

be established by a preponderance of the evidence”); see also In the Matter of POM Wonderful, 

LLC, 2012 WL 2340406, at *171 (F.T.C. May 17, 2012) (noting that “Complaint Counsel has 

the burden of proving each of the foregoing factual issues by a preponderance of credible 

evidence”).

There are two ways the FTC can prove that an advertisement is likely to mislead consumers. 

“One [way] is to carry the burden of proving that the express or implied message conveyed by 

the ad is false. The other [way] is to show that the advertiser lacked a reasonable basis for 

asserting that the message was true.” F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 119, 

135 (D. Conn. 2008) (citing In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648 (1984)). 

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The FTC must also establish materiality. “A ‘material’ misrepresentation is one that involves 

information that is important to consumers, and that is therefore likely to affect a consumer's 

choice of or conduct regarding a product.” F.T.C. v. Bronson Partners, LLC, 564 F. Supp. 2d 

119, 135 (D. Conn. 2008) (quoting In Re Kraft, Inc., 114 F.T.C. 40 (1991)); see also FTC Policy 

Statement on Deception, Federal Trade Commission (1983)). 

B. ECM’s Discussions and Claims Concerning the Rate of Biodegradation Were 

Not Material

“To establish that an act or practice is deceptive under Section 5, the FTC must 

demonstrate that ‘(1) there was a representation; (2) the representation was likely to mislead 

customers acting reasonably under the circumstances; and (3) the representation was material.’” 

F.T.C. v. NHS Syss., Inc., 936 F. Supp. 2d 520, 531 (E.D. Pa. 2013) (citations omitted). In order 

to determine whether an advertisement is material, “[t]he basic question is whether the act or 

practice is likely to affect the consumer’s conduct or decision with regard to a product or 

service.” Cliffdale Assocs., Inc., 103 F.T.C. 110, at 45 (1984)). “In other words, [information 

that is material] is information that is important to consumers.” Id. at 49. As the Seventh Circuit 

stated, “[a] claim is considered material if it involves information that is important to consumers 

and, hence, likely to affect their choice of, or conduct regarding a product.” Kraft, Inc. v. F.T.C., 

970 F.2d 311, 322 (7th Cir. 1992) (internal quotations and citations omitted); see also F.T.C. v. 

Colgate-Palmolive Co., 380 U.S. 374, 391 (1965) (citing F.T.C. v. Raladam Co., 316 U.S. 149, 

152 (1942)) (“when the Commission finds deception it is also authorized, within the bounds of 

reason, to infer that the deception will constitute a material factor in a purchaser's decision to 

buy”). 

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The FTC applies a presumption of materiality to “(1) express claims; (2) implied claims 

where there is evidence that the seller intended to make the claim; and (3) claims that 

significantly involve health, safety, or other areas with which reasonable consumers would be 

concerned.” Id. The first situation applies “[w]here the seller knew, or should have known, that 

an ordinary consumer would need omitted information to evaluate the product or service, or that 

the claim was false,” and, in such a circumstance, “materiality will be presumed because the 

manufacturer intended the information or omission to have an effect.” Cliffdale, 103 F.T.C. at 

49. The third situation can apply when the advertisement concerns information that “pertains to 

the central characteristics of the product or service.” Clifford, 103 F.T.C. at 49.

“A representation is material if likely relied upon by a reasonable prospective purchaser.” 

F.T.C. v. Wash Data Ress., 856 F. Supp. 2d 1247, 1272 (M.D. Fla. 2010). Importantly, “[r]ather 

than an isolated word, phrase, or sentence, the representations net impression controls.” Id. at 

1272 (citations omitted). “What is important in determining whether a statement is misleading is 

the over-all impression it tends to create on the public.” Country Tweeds, Inc. v. F.T.C., 326 

F.2d 144, 148 (2d Cir. 1964) (citing Murray Space Shoe Corp. v. F.T.C., 304 F.2d 270 (2d Cir. 

1956)).

A respondent can counter a presumption of materiality with extrinsic evidence. See In 

the Matter of Pom Wonderful LLC, 2012 WL 2340406 (F.T.C. May 17, 2012). As explained in 

POM Wonderful and Novartis:

Respondent can present evidence that tends to disprove the predicate fact from 

which the presumption springs (e.g., that the claim did not involve a health 

issue) or evidence directly contradicting the initial presumption of materiality. 

This is not a high hurdle. Unless the rebuttal evidence is so strong that the fact 

finder could not reasonably find materiality, the fact finder next proceeds to 

weigh all of the evidence presented by the parties on the issue. See id. at 516 

(noting that after the presumption drops out, “the inquiry ... turns from the few 

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generalized factors that establish [the presumption] to the specific proofs and 

rebuttals ... the parties have introduced”).

Id. at *235. “Materiality turns upon whether those consumers who have drawn the claim from 

the advertisement and have been misled by it are also likely to have their conduct affected by 

the misrepresentation.” In re Novartis Corp., 127 F.T.C. 580, 691 (1999) (emphasis added). 

ECM’s claims concerning the rate of biodegradation are not material because (1) ECM 

and its customers made those claims ostensibly for regulatory compliance purposes, and not as 

performance claims; (2) the claims largely were not passed along in commerce, and rarely to end 

users and, in any event, the survey evidence proves no materiality to the claims; (3) ECM’s 

customers were only concerned with having the ability to market a “biodegradable” product; and 

(4) the specific rate of degradation is not scientifically or environmentally material.

First, ECM identified a specific rate of biodegradation not as a comparative or 

performance claim in the market. The testimony revealed that ECM began using its “5 year” 

claim as a means to differentiate its technology from more rapidly degrading compostable 

products.

361 Thus, if anything, ECM’s use of the claim should have hurt its business. ECM 

wanted to be clear that its products would not perform like the compostable products, which 

were required to fully degrade in aerobic conditions in under 6 months (180 days). ECM chose a 

period of 9 months to 5 years at a time when the scientific understanding of landfills and 

biodegradation was evolving, thinking that the 5 year qualification would provide an adequate 

buffer. In 2012, when the FTC revised the Green Guides, ECM changed its claim language, 

added different qualifications, and informed customers that biodegradation claims should only be 

made if the specific customer had evidence sufficient to meet the Green Guide policies which, as 

361 See CCX-818, at 77-79, 85–88.

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we have explained, were flawed.

362 The fact that ECM customers were only concerned with 

meeting the FTC requirements, but not with making a rapidly degrading product, proves that the 

only endpoint of interest to ECM’s market was the “biodegradable” claim stamped on product 

packaging. 

ECM customers therefore considered ECM’s “rate” claims only with respect to 

regulatory compliance. The record shows that businesses would purchase the ECM product even 

if it degraded many years later, provided the customer could still use the term “biodegradable” in 

commerce. Customers provided different responses when asked why they would include rate 

claims on packaging (of those few that actually did). But the reason for printing the “rate” of 

biodegradation was only to tell consumers that the products would “biodegrade” generally, not to 

make a specific performance claim. The primary motivation was still to comply with the stilted 

Green Guides. For instance, Island Plastic Bags explained:

Q: How many of the ECM plastic products that have the word 

“biodegradable” also contain language visible to the end consumers 

stating that the products would biodegrade in nine months to five years?

A: So we’ve changed our printing when the new Green Guides came out. 

So they have something like [the image in IPB-8]. So a lot of our 

generic bags have a – have a thing that says it will break down anywhere 

from nine months to five years.

...

A: Yeah, yeah. So we put a description of how the biodegradable bags 

break down because we want them to know what they break down into 

and how long it takes. So our printing on a lot of the printed bags that 

you’re talking about have this, because we want people to know, you 

know, how it breaks down and what it breaks down into.

Q: And why do you want people to know that?

362 See RX-195, at 121 n.409 (noting that studies supporting the “one year” rule “may be 

faulted for lacking control groups and presenting the timeframe questions with closed-ended, 

rather than open-ended, answers, but they nevertheless are the only studies in the record”).

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A: Because people—there’s a lot of people that say they’re degradable or 

they say they’re green, and really all they’re using is recycled plastics, 

they aren’t using anything that breaks down the plastics into, you know, 

water, carbon dioxide and stuff like that. So we want people to know 

how it does that so that they feel like this is an actual technology that is 

biodegrading, it’s for real.363

Thus, the central motivating factor behind use of a biodegradable “rate” on IPB packaging was to 

differentiate the product from recycled material, and that the product is actually “biodegradable.” 

There is literally no evidence that the actual rate of biodegradation was ever important to ECM 

customers or their subsequent customers.364 Another customer, BER Plastics, was asked about 

whether the ECM additive “would make plastic biodegrade in nine months to five years” and, 

tellingly, the witness replied: “Never really thought about the – how long it would take to 

biodegrade.”365 Still more customers testified that rate of biodegradation was only significant to 

the extent it showed the products were “biodegradable” generally or “green.”366 Similarly, 

another customer, Quest Plastics, was generally uninterested in the “rate” of degradation. When 

asked about ECM’s five year claim, the witness testified:

Q: So your assumption, when you read the claims on the website, 

was that if it stated it was fully biodegradable in nine months to 

five years, that it would fully biodegrade in nine months to five 

years?

363 CCX-811, at 54–55 (IPB deposition).

364 Island Plastic Bag’s customer, Down to Earth, testified through its agent only that the 

rate claims was a significant part of the reason for purchasing ECM’s product, but also noted that 

“price” was a major factor. See CCX-803, at 39–40. Complaint Counsel never asked “why” the 

rate claim was important to the customer.

365 See CCX-800, at 32:24–25. Another customer, Kappus Plastics, was asked whether 

they considered the “nine months to five years” claim a “rigid standard,” and the witness 

responded apathetically: “Again, we’re not really saying anything. We took information that 

was provided and moved it from one piece of paper to the other. It says it on the piece of paper.” 

See CCX-812, at 50 (Kappus deposition, noting that the rate claim was not perceived by the 

witness as “rigid”). 

366 See CCX-882, at 12–13.

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A: I didn’t know, and I left it up to my customer to decide whether 

this is what he wanted to use.367

According to the witness, his customer was simply “looking for an additive to make the 

biodegradable – the gold tee biodegradable.”368 

That lack of interest in the rate claim is reflected in the advertising before the Court. 

Throughout the hundreds of thousands of pages of advertising and correspondence in Complaint 

Counsel’s possession, the so-called “rate” claim for biodegradation has appeared relatively 

infrequently, and rarely when compared to the more general “biodegradation” claim. If the rate 

claim was material and important to purchasing decisions, then ECM’s customers would pass 

that information along in commerce routinely, but they didn’t. Indeed, doing so, was the rare 

exception. The claim was unimportant.369 In fact, Complaint Counsel has recorded pictures and 

samples of many ECM goods that actually reached the end consumer, and, with very few 

exceptions, every product includes only a generalized “biodegradable” claim without reference 

to, or reliance on, the rate of biodegradation.370 Complaint Counsel acknowledges that, more 

367 See CCX-817, at 32 (Quest deposition).

368 Id. at 33:1-4.

369 The majority of advertisements that do not mention of focus on rates of 

biodegradation: Exhs. RX-00, RX-02, RX-03, RX-14, RX-15 (focus on cost), RX-16 (logo 

only), RX-17 (general biodegradable claim), RX-22, RX-26, RX-28, RX-29, RX-30, RX-315 

(cost the focus), CCX-30 (general focus on biodegradability); CCX-31 (same), CCX-32, CCX36 (labeling instructions to downstream customers without including rate); CCX-39, CCX-43, 

CCX-46, CCX-47, CCX-49, CCX-50, CCX-52, CCX-59 (focus on shelf life), CCX-60 (same), 

CCX-63, CCX-64, CCX-65 (focus on “green), CCX-66, CCX-79.

370 All of the following exhibits represent photos of the actual consumer goods that are 

eventually labeled “biodegradable,” but without reference or focus on the rate of biodegradation: 

CCX-97, CCX-98, CCX-99, CCX-100, CCX-10, CCX-103, CCX-104, CCX-107, CCX-109, 

CCX-110, CCX-111, CCX-112, CCX-113, CCX-114, CCX-115, CCX-116, CCX-117, CCX118, CCX-119, CCX-120, CCX-121, CCX-122, CCX-123, CCX-124, CCX-125, CCX-126, 

CCX-127, CCX-128, CCX-129, CCX-130 (specifically says time “will vary due to local 

conditions”), CCX-131, CCX-132, CCX-133, CCX-135, CCX-136, CCX-138, CCX-139, CCX140, CCX-142, CCX-143, CCX-144, CCX-145, CCX-146, CCX-147, CCX-148, CCX-149, 

CCX-150, CCX-151. 

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than selling just an additive, ECM really “sells the purported ability to make a ‘biodegradable’ 

advertising claim.” See CC Pretrial Br. at 15. Exactly. Which is why ECM’s customers are 

unconcerned about the rate of biodegradation, except to the extent it would influence their ability 

to make a “biodegradable” claim broadly. That means ECM’s customers did not base their 

purchasing decisions on ECM’s rate claims, but on the fact of biodegradation without regard to 

the precise rate. Customers were primarily concerned just with the “biodegradable” claims, and 

testified as such.371 More importantly, however, the customers were interested in a 

“biodegradable” product that could work with their manufacturing systems, because the plastic 

had to serve a function foremost. Small companies particularly devoted substantial test resources

to that inquiry, as Island Plastic Bags explained:

Q: And in the email David Hong is stating that he was experimenting with 

ECM plastic for over a year.

A: So what we—what I believe he was doing was—and we didn’t, like, test 

it or anything, what we were doing is seeing if we could actually run it 

through our machines, because it could—you know, ECM at that time 

said it’s biodegradable, but it doesn’t do us any good if we can’t use it 

through our machines. So what we were doing was putting the additive 

inside of our plastics to see if it could actually run through our extruders 

and then be cut and sealed as plastic bags.372

The lack of materiality is also confirmed through expert testimony. Dr. Stewart will 

testify that, based on several surveys of high methodological value, end users or consumers have 

no uniform understanding of “how long” it should take an item to decompose in landfills.373 

There is also an understanding among many consumers that the length of time required for an 

item to degrade is dependent on a variety of factors including the material from which it is made 

371 See, e.g., CCX-811 (Island Plastic Bags deposition).

372 Id. at 44.

373 RX-856, at 15 (Stewart Rep.).

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and the conditions under which degrading occurs.374 Consumers also expressed considerable 

skepticism over rate claims that were presented to them in relation to plastic products.375 Thus, 

according to Dr. Stewart, the results of his survey evidence make clear that consumers are highly 

unlikely to be misled by ECM’s product claims because “(1) there is no shared understanding 

among consumers of the length of time required for an item to decompose and (2) the lack of 

understanding and skepticism of the claims make it highly unlikely that the claims will have a 

material influence on the consumer.”376 Put simply, if the consumer has no reasonable or 

accurate knowledge of how long a plastic should take to biodegrade in the environment, then 

they cannot adequately or reasonably interpret whether ECM’s rate claim is good or bad.377 The 

rate claim is very different from other familiar rate claims, for example miles-per-gallon (MPG), 

where consumers can correlate a rate with performance. Furthermore, there is no evidence in 

this case that ECM’s competitors have offered rate claims that differ from ECM’s, such that a 

consumer would be drawn to an ECM product through comparative advertising. 

In deposition testimony, Dr. Barlaz described his attempts to calculate rates of 

degradation in landfill environments.378 He testified that his work was experimental, and that the 

precision of his rates fluctuated sometime by a factor of two.379 Complaint Counsel questioned 

whether the fluctuations would be considered significant, and Dr. Barlaz explained that it was 

not all that important:

Q: Is a factor of two large or small? I really don’t know.

374 Id.

375 Id. 376 Id.

377 Assuming, arguendo, that consumers really do expect a product to biodegrade within 

one year, then ECM’s 5-year claim would have a negative influence on purchasing decisions. 

Those customers would think the product did not meet their expectations.

378 See RX-864, at 106–108 (Barlaz deposition). 

379 Id. at 107:23–25.

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A: Sure. My opinion would be that, for a landfill, a factor of two is fine, 

because the retention time is infinite. If I were in an engineered tank 

where I were putting stuff in, I needed it to biodegrade at a certain rate so I 

knew when to take it out so I could put more in, then the rate affects the 

size of the tank, and the size of the tank affects the cost of the tank. Then 

people would be interested in something better than a factor of two.

Q: So can you just give me an example—I work better with hard numbers, so 

just an example of how—and I understand that you don’t recall the 

specific results were, but the difference between inocula coming from an 

anaerobic digester versus inocula coming from a sewage treatment plant, 

if those were two different types of inocula that you were looking at?

A: They were.

Q: Did you understand my question?

A: Let me—you are asking me, as I understand it, for an example of the 

difference in laboratory scale decay rate as calculated for a substrate, for 

example, copy paper, on two different inocula, for example, anaerobic 

sewage sludge and leachate?

Q: Yes.

...

Q: Okay. You said your testimony was a factor of two is fine for landfills 

because their retention time is infinite. So meaning it could take longer 

than whatever the average is?

A: What I mean is that, if I estimate a half-life of three years and the actual 

half-life is six years or one-and-a-half years, it’s inconsequential for the 

performance of the landfill. Either way, there is biodegradation occurring 

because the material is in the landfill, in essence, forever. That’s what I 

mean by infinite retention time. Whether we are off a few years in either 

direction, it doesn’t really seem to matter.380

The salient point made by Dr. Barlaz is that there is no material benefit to a product that 

biodegrades in a landfill in, say, 15 years versus another that degrades in 30 years. The more 

rapidly degrading product offers no material environmental benefit. Landfill operators do not 

380 Id. at 109–110.

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change waste management techniques based on the biodegradable plastic and, in turn, plastics 

manufacturers are not motivated by a need to somehow ensure any particular rate of 

biodegradation. What, then, is the materiality of a rate claim other than to satisfy the FTC’s 

flawed and unscientific standards in 16 C.F.R. § 260.8?

Finally, ECM no longer uses the rate claims at the center of Complaint Counsel’s case. 

Although ECM had once used a “9 month to 5 years” rate claim, they discontinued use of that 

claim in 2012 when the FTC revised its Green Guides.381

C. The Legal Significance Of ECM’s Sophisticated Consumers

1. ECM Did Not Engage In Any Typical Advertising Or Promotion By 

Virtue Of The Fact That ECM Limited All Of Its Advertising To 

Sophisticated Customers

ECM spends less than $12,000 per year on advertising, almost all of which is devoted to 

website maintenance.382 ECM’s claims are shared with specific, sophisticated customers during 

the negotiations process leading to a corporate sales agreement between the two entities. Mr. 

Sinclair credibly testified that the bulk of his discussions with customers is through verbal 

communication, or targeted emails.383 Brochures and flyers are not shared with the public at 

large, but dispatched to specific corporations who have expressed interest in ECM’s technology. 

“Advertising is a form of promotion to anonymous recipients, as distinguished from faceto-face communication. In normal usage, an advertisement read by millions (or even thousands 

381 Complaint Counsel has identified several limited instances where ECM distributed the 

9 month–5 year rate claim accidentally by releasing outdated brochures or flyers to customers, 

but those have not been shown to have been intentional and were against the direction of Robert 

Sinclair, ECM’s President.

382 As is clear from the record, there is literally no evidence in this case that ECM’s 

claims were designed to target end-consumers, that end-consumers have visited ECM’s website, 

or that ECM receives considerable traffic to its website. To the contrary, the website is clearly 

designed for manufacturers of plastics.

383 See, e.g., CCX-818, at 45, 52–53, 202.

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in a trade magazine) is advertising, while a person-to-person pitch by an account executive 

is not.” First Health Grp. Corp. v. BCE Emergis Corp., 269 F.3d 800, 803–04 (7th Cir. 

2001).

384 Therefore, an in person statement by a company’s sales team is not 

“advertising.” Zurich Ins. Co. v. Amcor Sunclipse N. Am., 241 F.3d 605, 607 (7th Cir. 

2001). Likewise, statements by a company’s executive made in person to other executives 

cannot be called “commercial advertising or promotion.” First Health, 269 F.3d at 

804. Similarly, in order to constitute “promotion,” materials must be “disseminated 

sufficiently.” Coastal Abstract Serv., Inc. v. First Am. Title Ins. Co., 173 F.3d 725, 735 (9th Cir. 

1999); Seven-Up Co. v. Coca-Cola Co., 86 F.3d 1379, 1384 (5th Cir. 1996) (same).

With respect to claims made directly to, and between, ECM’s customers that were not

passed through the chain of commerce to a substantial audience, Complaint Counsel’s theory of 

liability creates substantial policy concerns over the reach and scope of the FTC’s jurisdiction. 

At the very least, prudential considerations should govern whether the FTC is empowered to 

regulate the terms of transactions or sales agreements between two sophisticated corporate 

entities and the weight given any such communications which were not “disseminated 

sufficiently.”

2. To Determine Whether A Claim Is False Or Misleading, The Trier Of 

Fact Must View the Claim from the Perspective of the Target Audience

“In reviewing allegedly false and misleading statements, courts are to read the statements 

in their entirety and in context to determine whether they are actionable.” Schering-Plough 

Healthcare Prods., Inc. v. Schwartz Pharma, Inc., 547 F. Supp. 2d 939, 943 (E.D. Wisc. 2008)

(citing Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134, 1139 (9th Cir 1997) (“When 

384 Black’s law definition defines an “advertisement” as “notice given in a manner 

designed to attract public attention.” 

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evaluating whether an advertising claim is literally false, the claim must always be analyzed in 

its full context.”)); Castrol, Inc. v. Pennzoil Co., 987 F.2d 939, 946 (3d Cir. 1993) (“in assessing 

whether an advertisement is literally false, a court must analyze the message conveyed in full 

context”); Schwarz Pharma, Inc. v. Breckenridge Pharm., Inc., 388 F.Supp.2d 967, 976 (E.D. 

Wis. 2005) (“To determine whether a particular representation is literally false, it must be 

analyzed with its full context.”)). “In addition, the specific audience is part of the context that 

must be considered in deciding whether a statement is literally false.” Id. “Context can often be 

important in discerning the message conveyed and this is particularly true where, as here, 

the target of the advertising is not the consuming public but a more well informed 

and sophisticated audience.” Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 

229 (3d Cir. 1990) (emphasis added) (citation and internal quotation marks omitted); see also 

DeSena v. Beekley Corp., 729 F. Supp. 2d 375, 393 (D. Me. 2010) (“A target audience’s special 

knowledge of a class of products is highly relevant to any claim that it was misled by an 

advertisement for such a product”).

Similarly, under state anti-competition laws, “[w]hen the practice [at issue] is targeted to 

a sophisticated purchaser, the question of whether it is misleading to the public will be viewed 

from the vantage point of members of the targeted group, not others to whom it is not primarily 

directed.” Ariz. Cartridge Remanufacturers Assoc., Inc. v. Lexmark Int’l, Inc., 290 F. Supp. 2d 

1034, 1041 (N.D. Cal. 2003). 

3. ECM’s Target Audience and Actual Customers Were Sophisticated 

Purchasers Who Studied the Product and Engaged in Sophisticated 

Transactions

In business transactions, when the selling company provides the purchasing company 

with specifications or data, such transactions are “classified as sophisticated.” John Crane Prod. 

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Solutions, Inc. v. R2R and D, LLC, 861 F. Supp. 2d 792, 799 (N.D. Tex. 2012). In addition, 

there is less likelihood of confusion when the parties to a business transaction “have a close 

working relationship.” Id. at 801. In fact, “[c]ourts have found that the sophistication of the 

potential purchasers alone is enough to find that there is no likelihood of confusion even when all 

of the other digits [in the trademark context] weigh in favor of such a finding. See, e.g., Perini 

Corp. v. Perini Constr., 915 F.2d 121, 128 (4th Cir.1990) (reversing summary judgment because 

district court did not consider how sophistication of purchasers of construction services affected 

analysis, even though all other digits weighed in favor of finding likelihood of confusion).” Id. 

at n. 16. 

Courts have classified transactions and purchasers as sophisticated in a number of 

contexts. See, e.g., Checkpoint Sys., Inc. v. Check Point Software Tech., 269 F.3d 270, 285 (3d 

Cir.2001) (holding that purchasers of retail store security equipment and computer security 

software were sophisticated); Rust Env't & Infrastructure, Inc. v. Teunissen, 131 F.3d 1210, 1217 

(7th Cir. 1997) (holding that purchasers of services from engineering consulting firms were 

sophisticated); Oreck v. U.S. Floor Sys., Inc., 803 F.2d 166, 173 (5th Cir. 1986) (“Because these 

persons are buying [vacuums and extraction machines] for professional and institutional 

purposes at a cost in the thousands of dollars, they are virtually certain to be informed, 

deliberative buyers.”); Armstrong Cork Co. v. World Carpets, Inc., 597 F.2d 496, 504 n. 10 (5th 

Cir. 1979) (“[A] person buying a ‘big ticket’ item such as carpeting would ordinarily be expected 

to be a more careful buyer than the impulse purchaser or the purchaser of a relatively 

inexpensive item.”).

ECM’s customers are those plastic manufacturers that introduce the ECM additive into 

the plastic polymer during the manufacturing process. ECM does not sell to end-users, or even 

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mid-level distributors. While ECM shares marketing information and literature with customers, 

it does not advertise or promote products directly to end-users. ECM’s additive is of no value to 

end-use consumers in and of itself or to companies that cannot introduce the Masterbatch pellet 

into the plastic as an additive during manufacturing. Recognizing that, Complaint Counsel 

struggles to define ECM’s purchasers misleadingly as “mom and pop”-type businesses (CC Br. 

at 18) that also apparently manufacture bulk plastic polymers. As an example, Complaint 

Counsel cites to Island Plastic Bags, a “very sophisticated” customer in the plastic bag realm. 

See CC Br. at 18. At sixteen (16) employees, Island Plastic Bags is more than twice the size of 

ECM, which has just six employees. That was the best example of a “mom and pop” 

manufacturer Complaint Counsel could marshal. In fact, Island Plastic Bags (“IPB”) has a 

sophisticated operation whereby they manufacture high- and low-density polyethylene products 

through various manufacturing plants in Hawaii and China.385 IPB learned of ECM’s product 

not through website materials or marketing, but through conversations with ECM representatives 

at a trade show.386 Although Island Plastic Bag testified (through extensive leading questions), 

that it did not have experience to review scientific literature concerning biodegradability, they 

could not deny that they were provided that literature over the course of detailed discussions with 

ECM.387 And, certainly, they were able, should they desired it, to test the ECM product for their 

intended uses.

385 See CCX-811, at 10–11 (IPB deposition).

386 Id., at 11–12.

387 As in many of the customer depositions that occurred throughout the country, this one 

in Hawaii, ECM was unable to have counsel appear and instead offered a corporate 

representative. While that decision was ultimately ECM’s, the lack of ECM’s counsel should not 

excuse Complaint Counsel’s objectionable examination throughout. Through leading questions, 

counsel essentially testified for the witness. See, e.g., CCX-811, at 35–39. While “form of 

question” objections are now waived, the flawed examinations limit the credibility of witness 

testimony. Unsurprisingly, Complaint Counsel intends to move in the deposition transcripts 

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4. The Bases for Purchase Among Sophisticated Customers Differ from 

Those of End Use Consumers

In order to succeed in a fraud action, a challenger must establish that he or she reasonably 

relied on the alleged material representation. Terra Sec. Asa Konkursbo v. Citigroup, Inc., 740 

F. Supp. 441, 448 (S.D.N.Y. 2010). “In assessing the reasonableness of a plaintiff’s alleged

reliance, [courts] consider the entire context of the transaction, including factors such as its 

complexity and magnitude, the sophistication of the parties, and the content of any agreements 

between them.” Emergent Capital Inv. Mgmt., LLC v. Stonepath Grp., Inc., 343 F.3d 189, 195 

(2d Cir. 2003). For example, [s]ophisticated investors must investigate the information available 

to them with the care and prudence expected from people with full access to 

information.” Terra, 740 F. Supp. 2d at 448 (citing Hirsch v. du Pont, 553 F.2d 750, 763 (2d 

Cir. 1977)); see also Banque Franco–Hellenique de Commerce Int’l., et Maritime, S.A. v. 

Christophides, 106 F.3d 22, 27 (2d Cir. 1997) (finding that analysis of reasonable reliance in 

fraud cases “has taken account of the degree to which the truth was accessible to the defrauded 

person”). The rationale being that the informed or sophisticated entity has the wherewithal to 

determine whether claims are supported and, so, the need to protect those sophisticated 

“consumers” is lessened.

Other courts outside of the Second Circuit have similar requirements to determine 

whether sophisticated purchasers reasonably relied on misrepresentations. See, e,g,, Metavante 

Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 767–68 (7th Cir. 2010) (finding that the plaintiff’s 

alleged reliance was unreasonable where “two sophisticated businesses negotiated an armslength transaction of a period of several months”); Tom Hughes Marine, Inc. v. Am. Honda 

instead of now calling live witnesses subject to cross-examination. Complaint Counsel has 

represented that it will call no fact witnesses for live testimony. ECM objects to that strategy.

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Motor Co., Inc., 219 F.3d 321, 324 (4th Cir. 2000) (affirming decision that reasoned that the 

plaintiff was “a sophisticated businessman ... and he [was] unable to establish that he had a right 

to rely on [the defendant’s] representation or that he justifiably relied upon it”); Gilchrist Timber 

Co. v. ITT Rayonier, Inc., 95 F.3d 1033, 1035 (11th Cir. 1996) (collecting cases supporting the 

proposition that a fraud claim is not actionable where “the parties are equally sophisticated, and 

have an equal opportunity to discover a defect”); Cheney Bros., Inc. v Batesville Casket Co., Inc., 

47 F.3d 111, 114 (4th Cir. 1995) (citation omitted) (holding that “there is no right to rely, as 

required to establish fraud, where there is no confidential or fiduciary relationship, and there is 

an arm's length transaction between mature, educated people”); Kline v. First Western Gov’t 

Sec., Inc., 24 F.3d 480, 497–98 (3d Cir. 1994) (holding that the “investor could not justifiably 

rely on representations” where the transaction “was on the cutting edge of strategic planning”); 

Roberts v. United N. Mex. bank at Roswell, 14 F.3d 1076, 1080 at n. 4 (5th Cir. 1994) (internal 

quotations and citations omitted) (“If an investor is sufficiently sophisticated and experienced, 

that may be evidence that he did not rely on the seller's representations but on his own 

expertise.”); Davidson v. Wilson, 973 F.2d 1391, 1399 (8th Cir. 1992) (noting that the 

“sophisticated investors should have been on notice not to rely upon those representations”); 

Skeen v. C.I.R., 864 F.2d 93, 95 (9th Cir. 1989) (explaining that where the plaintiffs “are all 

sophisticated businessmen,” the court “simply do[es] not believe that they would enter into 

profit-motivated transactions with an unknown party and rely solely on the representations of 

such part with respect to the most crucial aspect affecting the viability of the proposed venture”).

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5. No ECM Purchaser Was Misled

In the trademark context, courts find that there is a reduced likelihood that a sophisticated 

party, as opposed to an unsophisticated party, will be influenced by a similar mark in an 

advertisement. See, e.g., Mead Data Dent., Inc. v. Toyota Motor Sales, U.S.A., Inc., 875 F.2d 

1026, 1031–32 (2d Cir. 1989). “The degree of consumer care and sophistication can be proven 

by survey evidence, expert testimony, or inference.” Marketquest Grp., Inc. v. BIC Corp., 2011 

WL 5360899, at *12 (S.D. Cal. Nov. 7, 2011) (citation omitted) (finding that the buyers were 

likely to be sophisticated because they were institutional buyers placing bulk orders and because 

the marketing materials “appear to be aimed at institutional purchasers”). 

The issue in Mead was whether the use of the term “Lexus” used by Toyota Motors 

would dilute the profitability of the term “Lexis” as used by Mead. Mead, 875 F.2d at 1027. 

The Second Circuit explicitly made clear that “the recognized sophistication of attorneys, the 

principal users of [Lexis], has substantial relevance.” Id. at 1031 (emphasis added). Given the 

fact that Lexis’ users were principally sophisticated attorneys, the court concluded that there 

would not “be any significant amount of blurring between the LEXIS and LEXUS marks.” Id. at 

1032.

Numerous additional courts likewise find that purchasers are less likely to be confused 

when they are sophisticated, technical, experienced, retailers, or otherwise involved in the 

industry or have any relevant knowledge. See, e.g., In re Synthroid Mktg. Litig., 264 F.3d 712, 

717 (7th Cir. 2001) (noting that “[u]nlike members of the consumers class, [third party payors] 

are sophisticated purchasers”); Interstellar Starship Servs., Ltd. v. Epix Inc., 184 F.3d 1107, 1110 

(9th Cir. 1999) (citation omitted) (holding that confusion is less likely where the “customers are 

sophisticated industry and university researchers” and where the “goods cost in the range of 

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several thousand to tens of thousands of dollars”); Homeowners Grp., Inc. v. Home Mktg. 

Specialists, Inc., 931 F.2d 1100, 1111 (6th Cir. 1991) (“A sophisticated purchaser exercises a 

high degree of care and is less likely to be confused as to a product's origin.”); Pride Family 

Brands, Inc. v. Carl’s Patio, Inc., -- F. Supp. 2d --, 2014 WL 186902, at *7 (S.D. Fla. Jan. 30, 

2014) (noting that “[as] industry participants, retailers are a sophisticated customer base”); 

Acxiom Corp. v. Axiom, Inc., 27 F. Supp. 2d 478, 497 (D. Del. 1998) (citations omitted) 

(explaining that “courts recognize that generally” when a seller “sell[s] relatively expensive 

products and services to sophisticated and knowledgeable purchasers that typically involve 

relatively long sales cycles . . . these factors indicate that great care, effort, and attention go into 

the purchase decision making which lessens likelihood of confusion.”); Giorgio Beverly Hills, 

Inc. v. Revlon Consumer Prods. Corp., 869 F. Supp. 176, 185 (S.D.N.Y. 1994) (citation omitted) 

(explaining that “[t]he more sophisticated the ordinary purchaser of a product is, the less likely it 

is that the use of similar marks or trade dress will lead to confusion” and holding that “women 

tend to be sophisticated purchasers of perfume”); Marketquest, 2011 WL5360899, at *11 (noting 

that “experienced industry distributors or agents [] are likely to be sophisticated consumers and 

investigate any potential confusion”); In re Trans Union Corp. Privacy Litig., 2009 WL 

4799954, at *11 (N.D. Ill. Dec. 9, 2009) (noting that insurance companies are sophisticated 

purchasers of legal services).

Like in the trademark context, parties are held to different levels of duty of disclosure 

when conducting business with sophisticated purchasers as opposed to the general public. For 

example, a purchaser is under no duty to disclose the financial conditions of its business when 

“the parties are represented by sophisticated businessmen, who are active and experienced in the 

area, and are dealing at arm’s length without any fiduciary or confidential relationships or 

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expectations.” Nationwide Book Indus., LLC v. A & S Booksellers, Inc., 950 F. Supp. 2d 264, 

267 (D. Mass. 2013) (citations and quotations omitted). Similarly, in the securities context, 

securities issuers must disclose significantly more information when making public offering as 

opposed to selling the securities only to sophisticated qualified institutional buyers. Gustafson v. 

Alloyd Co., 513 U.S. 561, 569 (1995) (citing 15 U.S.C. §§ 77b(11), 77d, 77e) (“By and large, 

only public offerings by an issuer of a security, or by controlling shareholders of an issuer, 

require the preparation and filing of registration statements.”). This is because the sophisticated 

purchaser, capable of fending for itself and determining the benefits and costs of entering a 

business transaction, are held liable for their own decisions. See, e.g., Miller v. Berman, 289 F. 

Supp. 2d 1327, 1334 (M.D. Fla. 2003) (“Surely, as a sophisticated boat and sail maker, Mr. 

Miller relied on his own expertise in deciding to enter into a contract for the purchase of a highly 

customized catamaran boat with Cougar Marine.”). 

6. The Sophisticated Purchaser Defense Is Applicable In This Context

A manufacturer’s duty to warn of dangers in the products liability context is “precluded 

in situations where the purchaser has particular knowledge of or experience with the inherent 

dangers in the use of a product or in instances when the purchaser has designed and requested a 

product for a particular application.” Byrd v. Hunt Tool Shipyards, 650 F.2d 44, 47 at n. 1 (5th 

Cir. 1981); see also O’Neal v. Celanese Corp., 10 F.3d 249, 252 (4th Cir. 1993) (“The 

[sophisticated purchaser] defense is available not only when the supplier actually warned the 

intermediary, but also when the supplier shows that it was reasonable to believe that a warning 

was unnecessary because the intermediary was already well aware of the danger.”); Goodbar v. 

Whitehead Bros., 591 F. Supp. 552, 561 (W.D. Va. 1984 ) (“Stated another way, when the 

supplier has reason to believe that the purchaser of the product will recognize the dangers 

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associated with the product, no warnings are mandated.”). This rule of law is known as the 

“sophisticated purchaser defense” which is “based upon the principles set forth in the 

Restatement (Second) of Torts.” Akin v. Ashland Chem. Co., 156 F.3d 1030, 1037 (10th Cir. 

1998). “This exception absolves suppliers of the duty to warn purchasers who are already aware 

or should be aware of the potential dangers.” Id. (citing O’Neal, 10 F.3d 249, 251–52 (4th Cir. 

1993); Davis v. Avondale Indus., 975 F.2d 169, 171 (5th Cir. 1992)). 

Indeed, in certain situations, a “manufacturer [may] reasonably [] rely on an intermediary 

purchaser to warn ultimate users of dangers associated with the use of a product.” Baker v. 

Monsanto Co., 962 F.Supp. 1143, 1151 (S.D. Ind. 1997). Such a situation arises where “it would 

be impossible for a manufacturer to access all ultimate users of a product because it had no 

control over the site of usage.” Id.

In this context, the sophisticated purchase defense precludes a finding that ECM’s 

representations to its own customers were misleading. Assuming arguendo that harm results 

from making misleading advertisements to consumers regarding a biodegradable claim, that 

harm is the harm of being misled by the advertisement. ECM’s marketing audience—wholly 

sophisticated distributors and manufacturers of plastics well aware of the Green Guides—were 

aware of this harm when they made what the FTC considers, based on the Green Guides, 

misleading biodegradable claims to end use consumers. Therefore, because ECM’s customers 

were aware of the dangers associated with selling a “biodegradable” product, ECM had no duty 

to the end use consumer. Akin 156 F.3d at 1037; O’Neal, 10 F.3d at 251–52; Davis 975 F.2d at 

171. This is particularly true where, as here, ECM’s customer audience was free and able to test 

the products themselves, consult with legal counsel, and where ECM does not have access to all 

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ultimate users of a product and has no control over the usage of its product. Baker, 962 F. Supp. 

at 1151.

D. ECM Has Not Made an Implied “One-Year” Claim through Its

“Biodegradable” Claims

“[I]n determining what claims are conveyed by a challenged advertisement, the 

Commission relies on two sources of information: its own viewing of the ad and extrinsic 

evidence. Its practice is to view the ad first and, if it is unable on its own to determine with 

confidence what claims are conveyed in a challenged ad, to turn to extrinsic evidence.” Kraft, 

Inc. v. F.T.C., 970 F.2d 311, 318 (7th Cir. 1992). Therefore, the FTC does not need to point to 

extrinsic evidence to determine whether an advertisement makes an objectionable claim. 

Generally the FTC’s own view of the advertisement is sufficient. Id. at 319.

For the vast majority of products that eventually reach end-consumers, consumers only 

receive a “biodegradable” claim, often in the form of a logo or a small stamp on the packaging. 

Using the unscientific positions expressed in the Green Guides, Complaint Counsel has inferred 

that every unqualified “biodegradable” claim is actually a claim that a product will fully degrade 

within one year in the environment. 

1. The Legal Significance of Survey Evidence in this Case

The FTC must use extrinsic evidence to determine what the claim implies when the claim 

is not “reasonably clear from the face of the advertisement.” F.T.C. v. Bronson Partners, LLC, 

564 F. Supp. 2d 119, 126 (D. Conn. 2008). Similarly, Thompson held that the FTC must have 

extrinsic evidence when “the advertisement itself does not allow [the FTC] to conclude with 

confidence” that the advertisement at issue contains a particular implied claim. 104 F.T.C. 648, 

at ¶ 7. And as another case clarified, “if the language or graphic is susceptible to more than one 

reasonable interpretation . . . the district court must look to consumer data to determine what the 

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person to whom the advertisement is addressed finds to be the message.” Time Warner Cable, 

Inc. v. DIRECTV, Inc., 497 F.3d 144, 158 (2d Cir. 2007).

When an implied claim is at issue, “[t]he Commission will carefully consider any 

extrinsic evidence that is introduced, taking into account the quality and reliability of the 

evidence.” In re Stouffer Foods Corp., 118 F.T.C. 746, 799 (Sept. 26, 1994). Such extrinsic 

evidence includes “reliable results from methodologically sound consumer surveys.” Id. In 

weighing survey evidence, the Commission “looks to whether such evidence is reasonably 

reliable and probative. Flaws in the methodology may affect the weight that is given to the 

results of the copy test or other consumer survey.” Id. (citation omitted).

2. Extrinsic Evidence of High Methodological Quality Reveals that ECM 

Did Not Make Implied Claims Concerning the Rate or Extent of 

Biodegradation

In order to determine what consumers believe “biodegradable” means, ECM retained the 

services of expert Dr. David Stewart, an expert whose surveys have often been credited by the 

ALJs at the agency and by the Commission itself. Dr. Stewart conducted a well-designed 

telephone interview based on established principles of survey research that are consistent with 

the guidelines for survey research offered in litigation as articulated in the Manual for Complex 

Litigation. See RX-856, at 16. In sum, Dr. Stewart concluded that consumers have no uniform 

understanding of the term “biodegradable.” In fact, consumers were asked “if something is 

degradable, how long do you think it would take for it to decompose or decay?” In response, 

39% of survey respondents stated that it depends on the material or type of product. Id. at 

25. No other single response was offered by more than 6% of the respondents. Id. As proven 

by Dr. Stewart’s survey, no significant percentage of consumers think that products labeled 

“biodegradable” will degrade within one year or any specific time frame. No significant 

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percentage of consumers have enough understanding or knowledge of the concept of 

biodegradation to properly assess those claims. Therefore, when ECM claims that their plastic 

products are “biodegradable,” ECM is not implying to consumers that the products will 

biodegrade within one year or any other specific time frame.

3. Complaint Counsel’s Straw Man: An Arbitrary and Capricious 

Definition of Biodegradation

A court should “hold unlawful and set aside agency action, findings, and conclusions 

found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with 

law.” 5 U.S.C. § 706. An agency's decision is arbitrary and capricious when the agency “entirely 

failed to consider an important aspect of the problem, offered an explanation for its decision that 

runs counter to the evidence before the agency, or is so implausible that it could not be ascribed 

to a difference in view or the product of agency expertise.” Motor Vehicle Manufacturers 

Association v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983). 

Review of agency action is “not merely perfunctory,” the review should be a ‘searching 

and careful’ inquiry.’” Int’l Ladies' Garment Workers' Union v. Donovan, 722 F.2d 795 (D.C. 

Cir. 1983); Specialty Equip. Mkt. Ass’n v. Ruckelshaus, 720 F.2d 124, 132 (D.C. Cir. 1983)

(“when reviewing agency's determinations under "arbitrary and capricious" standard, "we must 

make a substantial and searching inquiry to ensure that the agency's decisions are the product of 

reasoned thought and based upon a consideration of relevant factors”); Dickinson v. Zurko, 527 

U.S. 150, 155 (1999) (“[t]he APA requires meaningful review; and its enactment meant stricter 

judicial review of agency fact finding than Congress believed some courts had previously 

conducted”).

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The One-Year Rule is arbitrary and capricious, lacking in any reasonable factual basis. 

In applying the rule to the facts of this case, Complaint Counsel attempts to hold industry 

responsible for a “rule” that has literally no support in reality. The rule is a construct from faulty 

survey evidence. Complaint Counsel therefore establishes a so-called “definition” of 

biodegradability for purposes of unqualified claims, but fails to acknowledge that there is 

literally no product or substance of any kind that can meet the definition. A banana peel, for 

example, cannot be called “biodegradable” under Complaint Counsel’s definition. 

E. ECM Possesses a Reasonable Basis, and at Least Competent and Reliable 

Scientific Evidence, that the ECM Additive Causes Plastics to Biodegrade in 

Landfills

ECM Biofilms has proven that plastics made with its additive technology will biodegrade 

within a reasonably short period of time under conditions of customary disposal, particularly 

when compared with conventional, untreated plastic products. 

1. The Pfizer Factors Demonstrate that Biodegradable Claims Need Not Meet a 

High Standard of Competent and Reliable Evidence.

The FTC has the burden of showing that a particular claim was made without a 

reasonable basis. See FTC v. Braswell, 2005 WL 4227194 (C.D. Cal. Sept. 27, 2005); F.T.C. v. 

Medlab, Inc., 615 F. Supp. 2d 1068, 1079 (N.D. Cal. 2009); FTC v. Pantron I Corp., 33 F.3d 

1088, 1096 (9th Cir.1994). In order to have a reasonable basis to make the claim at issue, an 

advertiser must possess “competent and reliable scientific evidence” to substantiate that claim. 

Sterling Drug, Inc. v. FTC, 741 F.2d 1146, 1156–57 (9th Cir.1984). To help determine what 

constitutes “competent and reliable scientific evidence,” the FTC has recognized two types of 

claims: establishment and non-establishment claims. See Thompson Med. Co., Inc. v. F.T.C.,

791 F.2d 189, 194 (D.C. Cir. 1986). Establishment claims contain express or implied 

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representations about the level of support for a particular claim (i.e., the claim states that a 

product has been found to be superior by scientific tests). Id. For such claims, the advertiser 

must possess the level of proof claimed in the ad. Id.

In contrast, a non-establishment claim is a simple claim of efficacy. Id. For such nonestablishment claims, “the reasonable basis inquiry has been defined more flexibly.” Id. This 

standard is a “flexible standard” that calls for an evaluation of a variety of factors suited to the 

particular case at hand. Direct Mktg. Concepts, Inc. v. F.T.C., 581 F. Supp. 2d 115, 118 (D. 

Mass. 2008). Therefore, the Commission’s “reasonable basis cases have identified several 

factors that [the Commission] will weigh in determining the appropriate level of substantiation 

for objective advertising claims.” In the Matter of Thompson Med. Co., Inc., 104 F.T.C. 648, at 

¶ 70 (Nov. 23, 1984). The relevant factors are: “(1) the product involved; (2) the type of claim; 

(3) the benefits of a truthful claim; (4) the ease of developing substantiation for the claim; (5) the 

consequences of a false claim; and 6) the amount of substantiation experts in the field would 

agree is reasonable.” Id. These factors are used to weigh the benefits and costs of developing 

substantiation for the claim. In the Matter of POM Wonderful LLC, 2013 WL 268926, at *30 

(F.T.C. Jan. 16, 2013).

388

The level of proof required to meet the Pfizer test in this case is significantly reduced 

because all of the Pfizer factors favor a more relaxed standard. 

2. The Nature of the Product Involved

388 ECM has not made any “establishment” claims to end-consumers. To ECM’s 

sophisticated manufacturing customers, it has disclosed the types of tests shown to have resulted 

in biodegradation. To the extent ECM’s disclosure of its test data and names of test standards is 

an establishment claim, the claim is truthful and non-misleading. ECM does possess the tests its 

claims to have, and those tests do show that ECM’s technology creates a biodegradable plastic.

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Regarding the first factor, the product involved, the Commission has made clear that 

products like drugs—which improve physical welfare—as opposed to products that do not 

purport to improve physical welfare, “require[] a relatively high level of substantiation.” 

Thompson, 104 F.T.C. 648, at ¶¶ 71–72; see also POM, 2013 WL 268926, at *48 (noting that the 

respondents “made claims regarding serious diseases”); In the Matter of Removatron Int’l Corp., 

111 F.T.C. 206, at *14 at n. 20 (Nov. 4, 1988) (noting that a drug or product that directly affects 

human safety requires more substantiation).

ECM does not market products like drugs, foods, medical devices, or dietary supplements 

that improve physical welfare. ECM has not made claims concerning serious diseases or health 

conditions. Moreover, significantly, ECM has never sold product to end-consumers. ECM sells 

a plastic additive to plastics manufacturers that, when manufactured correctly, will help render 

the finished plastic biodegradable in a landfill over time. 

The intended use of ECM’s product is for customers to dispossess themselves of it. 

Whatever benefit is achievable through ECM’s product comes long after the customer or user 

has discarded the product, and long after the customer can likely remember that they ever once 

possessed same. ECM’s product has no performance benefit or utility to consumers at the time 

of purchase or use of the product. For this reason, Dr. Mort Barlaz credibly testified that the 

actual product performance in a landfill environment was almost irrelevant. When discussing 

rates of degradation, he explained:

I estimate a half-life of three years and the actual half-life is six years or oneand-a-half years, it’s inconsequential for the performance of the landfill. 

Either way there is biodegradation occurring because the material is in the 

landfill, in essence, forever. That’s what I mean by infinite retention time. 

Whether we are off a few years in either direction, it doesn’t really seem to 

matter.

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See Barlaz Tr. at 109-110. So, too, here, where the question involves the nature of the product, 

an item advertised only for its benefit after customers trash it should be subject to much less 

scrutiny than other products that have a chance to hurt or harm consumers during use.

3. The Type Of Claims Made

The second factor is the type of claim being made. One type of claim that requires a high 

a level of substantiation “is a claim that refers to specific facts or figures, rather than making 

generalized descriptions of the product’s capabilities.” Thompson, 104 F.T.C. 648, at ¶ 72. 

Therefore, a generalized claim, such as “biodegradable,” would require a lower level of 

substantiation than a more specific claim. 

Largely the only claim that reached the individual or end-consumer level is that ECM 

plastics are biodegradable. Even those claims presented to sophisticated manufacturing 

corporations conveyed the simple point that ECM plastics were “biodegradable” within a 

reasonably short period of time. Those claims are tantamount to general efficacy claims, and be 

regarded as such under the Pfizer analysis.

4. The Benefits Of A Truthful Claim and Ease of Developing Substantiation for 

the Claims

The third and fourth factors are often considered “in conjunction with each other.” Id. at 

¶ 74. The Commission’s “concern in analyzing these factors is to ensure that the level of 

substantiation [the Commission] require[s] is not likely to prevent consumers from being told 

potentially valuable information about product characteristics.” Id.; see also Removatron, 111 

F.T.C. 206 at n. 20 (“These two factors together seek to ensure that the level of substantiation we 

require is not likely to deter product development or prevent consumers from being told 

potentially valuable information about product characteristics.”). Consumers can be prevented 

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from being told potentially valuable information about product characteristics when the cost of 

developing substantiation for these claims would be high in comparison to the amount of sales 

the product can earn. Id. at ¶¶ 74–75. So, the Commission will not require substantiation that, 

because of its probative costs, will become non-feasible. POM, 2013 WL 268926, at *49. 

ECM’s product provides an environmentally-friendly alternative to conventional plastics. 

Unlike companies selling compostable technologies, or more expensive bioplastics, ECM’s 

technology lives within the reality that the bulk of waste is deposited in landfills. While waste 

reduction and alternative processing techniques are laudable, they are in the minority today. 

Moreover, because financial considerations are always paramount to ongoing businesses, most 

companies are unable to undertake the extreme costs associated with emergency technologies

like bioplastics. ECM offers a middle ground alternative, permitting companies to improve the 

environment in the long-term without incurring substantial increases to their cost bases. The 

ECM additive works, and it reduces the environment lifespan of many conventional plastics by a 

very substantial margin. 

If the technology works, many manufacturers would gain access to a commercially viable 

solution that might encourage more plastics manufacturers to choose environmentally-friendly 

upgrades over conventional plastics used today. 

Imposition of strict, and unobtainable standards here will chill innovation and prevent 

consumer access to valuable information concerning products that biodegrade in a progressive 

manner, over time. A product that biodegrades over a period of decades is not irrelevant in the 

consumer market simply because it will not degrade within one year. ECM and its customer 

base have taken steps to evaluate biodegradability through laboratory testing and a fully 

informed industry has chosen to buy the ECM products cognizant of the test results showing that 

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it causes biodegradation of plastics and not dependent upon proof of any particular rate of that 

biodegradation. 

Complaint Counsel’s experts have failed to even state what type of testing might be 

sufficient to prove biodegradation to FTC’s satisfaction. Dr. McCarthy’s statements, however, 

are revealing. Dr. McCarthy wrote that a “study must last long enough for the sample to reach at 

least 60% biodegradation” in a D5511 context.389 According to Dr. McCarthy, companies can 

also perform 14C radiolabeling tests.390 Both of those requirements are excessive and 

impractical, and not even McCarthy uses them in his own original scientific research or patent. 

First, because ECM’s product slowly degrades when compared to more rapidly degrading 

items like cellulose, the ECM product would need to perform very long-term testing to reach the 

60% value. For instance, in one ECM test of a polyethylene polymer, the test revealed about 

50% biodegradation over 900 days of testing.391 Extensive testing is expensive and, obviously, 

time consuming and, given the inherent vulnerabilities of inocula of a subset of landfill species, 

very difficult to maintain. Moreover, each manufacturer might elect to test their specific 

formulation before marketing an environmentally friendly product. Adopting Dr. McCarhty’s 

position would therefore impose a mandatory delay of many years before environmental claims 

for products of this type could appear in the market. Note, also, that Dr. McCarthy would 

require test conditions that mirror the landfill sites (e.g., temperature, moisture content, etc.). 

McCarthy is actually proposing that a company come as close to an in situ landfill study as 

possible. What if a product results in biodegradation in a landfill in 25 years? When compared 

with a conventional plastic that takes thousands of years to biodegrade, that 25 year span is a 

389 See CCX-891,. at 15–16 (McCarthy Rep.).

390 Id.

391 RX-836.

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substantial benefit but it would not be within the arbitrary and capricious one year limit 

advocated by Complaint Counsel and ensconced as an effective rule in the Green Guides. 

However, under McCarthy’s strict criteria, he would need testing of at least 15 years duration 

before those products could hit the market. Most pharmaceutical cancer drugs are tested and 

approved in half that time.392

In the meantime, consumers would be purchasing and using conventional plastics without 

the additive, having been deprived of essential information about innovative technologies. Some 

degree of accelerated testing is necessary, therefore, to avoid this obvious issue. That 

accelerated testing includes protocols like the D5511 test, which ECM customers ran repeated

with positive results. The D5511 testing, and similar gas evolution data, provides a reasonable

basis for biodegradability claims as the scientific literature in this field reflects, and ECM 

possesses that requisite level of proof.

Dr. McCarthy also posits that 14C radiolabeling should be required. That level of testing 

is impractical, excessively costly, and largely unavailable. Dr. McCarthy himself has labeled 

products “biodegradable” without resort to radiolabeling testing. ECM’s experts each agree (and 

apparently also one of Complaint Counsel’s experts, Dr. Tolaymat, based on his testimony in 

deposition)

393 that radiolabeling tests are not required to prove the type of claims at issue here. 

5. The Consequences of a False Claim

392 See Frequently Asked Questions, The University of Arizona Cancer Center, m 

azcc.arizona.edu (“[m]any standard treatments used today are the result of past clinical trials, 

which involve a strict and rigorous, multi-step process that takes eight years on average to 

complete.”), at http://azcc.arizona.edu/patients/clinical-trials/faq.

393 Dr. Tolaymat testified that radiolabeling was not used frequently because it “could be 

as expensive as doing [testing] in a landfill.” See Tolaymat Tr. at 246-47.

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Under the fifth factor, the consequences of a false claim can be divided into either health 

or economic consequences. See Thompson, 104 F.T.C. 648, at ¶¶75–76 (noting that false claims 

can be “injurious to health and economically harmful”). In order to be economically harmful, 

the economic harm suffered by consumers must be “material” and “substantial.” See POM, 2013 

WL 268926, at *50, n. 31 (noting that a one year supply of the POM Juice costs at least $780); 

Removatron, 111 F.T.C. 206 at n. 20 (noting that the device at issue cost approximately $4,000, 

and required treatments that cost $35 per hour over a period of years). 

Here the consequences of a false claim are economic. Assuming, for this factor only, that 

ECM’s product was ineffective, the economic consequences of a false claim would not be 

material or significant. Complaint Counsel has not offered evidence of an environmental 

detriment. Landfill operators are not designing landfills, or making waste management 

decisions, on the basis of ECM’s claims. Plastic products treated with ECM additive are 

disposed in the normal course, along with other non-degradable plastics. As Dr. Barlaz testified, 

because the intended use is for infinite retention in the landfill, a false or misleading claim has no 

material consequence. Whether the product performs precisely as advertised in the landfill is 

impossible to verify post hoc because of the disposal conditions. 

Thus, if the product does not biodegrade as advertised, the end consumer never discovers 

that fact. That is in contradistinction with other commercial products, like weight loss 

supplements, or devices, whereby the consumer suffers direct loss or injury from use of the 

product. The purchasers or consumers here are the corporate entities who acquire and use 

ECM’s product in commerce. There is no evidence that those companies sell ECM plastics to 

end-consumers for the biodegradable nature of the plastic; indeed, most products containing the 

ECM additive are invisible in that respect to the end-use consumer or if identified as 

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biodegradable, as Dr. Stewart’s survey confirms, are not understood to mean anything in 

particular by consumers. Even if we assume ECM’s product does not perform as well as 

advertised, none of ECM’s customers have been denied the economic benefit of that bargained 

for transaction. 

That point notwithstanding, ECM has always indicated to its direct customers that the 

period for biodegradation is highly variable and depends on environmental factors. ECM’s 

customers reasonably understood, therefore, that biodegradation could occur over significant 

periods of time. Those customers have even tested ECM’s product and reviewed ECM’s 

scientific literature. Customers purchasing the ECM additive for altruistic environmental reasons 

had the information necessary to assess ECM’s claims, and suffered no economic injury as they 

made claims based on that information.

6. The Amount of Substantiation Experts in the Field Agree is Reasonable

The final factor is the amount of substantiation experts in the field would agree is 

reasonable. This factor “must be examined in relation to each field being evaluated.” POM, 

2012 WL 2340406, at *206. Currently, there is no such agreement among experts in the field of 

biodegradable plastics.

The FTC has not defined what constitutes “competent and reliable scientific evidence” in 

the context of biodegradable advertising. However, based on the Pfizer factors outlined above, 

the standard to be applied in this case must be lower than standards applied in other FTC 

proceedings considering advertisements related to medical or health claims. For example, in the 

medical context, advertising claims must be substantiated by double-blind, randomized, placebocontrolled clinical trials. Thompson Med. Co., Inc. v. Fed. Trade Comm'n, 791 F.2d 189 

(D.C.Cir.1986); Bristol-Myers Co. v. Fed. Trade Comm'n, 738 F.2d 554 (2d Cir.1984). 

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Similarly, the standard to apply in this case must necessarily be lower than the standard for 

advertising claims related to food products which purport to have health benefits—“one well 

designed, randomized, and double-blind, placebo-controlled clinical trial involving an 

appropriate sample population and endpoint.” POM, 2013 WL 268926, at *43. While these 

standards obviously cannot apply to biodegradability, they are important benchmarks to 

demonstrate that ECM’s “competent and reliable scientific evidence” need not be as high as that

mandated in Thompson, Bristol-Myers, and POM. See Statement of Commissioner Ohlhausen, 

2014 WL 587857, at *1 (F.T.C. Jan. 7, 2014) (“[T]he burden for substantiation for health- or 

disease-related claims about a safe product . . . should be lower than the burdens imposed on 

drugs and biologics because consumers face lower risks when consuming the safe product.”).

Drs. Sahu, Burnette, and Barlaz will explain that gas evolution tests (like the ASTM 

D5511) are sufficient, and generally accepted in the scientific community, to substantiate claims 

of anaerobic biodegradation. To the extent that a gas evolution test produced evidence that the

test article biodegraded in excess of the additive, the evidence has shown the underlying polymer 

degraded, and that the ECM additive was efficacious. In tests where the ECM additive was 

measured against a negative control, the evidence shows that the ECM additive resulted in 

biodegradation of an otherwise non-biodegradable polymer. Dr. Sahu will testify that the 

amount of positive ECM tests lead inexorably to the conclusion that ECM plastics are 

biodegradable. 

Concerning the rate and extent of biodegradation in a landfill, ECM experts will explain 

that both elements are almost impossible to predict with any certainty (for any product) given the 

uncertainties inherent to the landfill environment. However, Dr. Sahu will testify that the 

substantial evidence of biodegradation is highly probative that the product will continue to 

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degrade completely if within an environment that permits biodegradation. The small margin of 

negative studies does not represent evidence that ECM’s products are ineffective. A test that 

does not produce affirmative evidence of biodegradation is not the same as a test that proves that 

the active under evaluation does not biodegrade; but the over 33 tests showing biodegradation 

do, in fact, prove it to be extant. The evidence must be examined as a whole, considering all 

relevant data points. Many variables can result in outcomes that are inconclusive, but positive 

evidence of a repeated nature such as this is dispositive.

7. ECM’s Scientific Support

ECM has produced competent and reliable scientific evidence proving that plastics 

manufactured with its additive biodegrade anaerobically and aerobically. ECM’s laboratory 

testing, when assessed with the science as a whole, prove that ECM’s product is biodegradable in 

biologically active landfills.394

First, ECM has produced gas evolution studies that tested ECM-infused plastics against 

negative controls (i.e., untreated, conventional plastics that are known to degrade very slowly). 

Those tests included anaerobic lab work (e.g., ASTM D5511), and aerobic lab work related to 

composting (e.g., ISO 14855, UNI EN 14046). Many of the results revealed significant 

biodegradation of the ECM plastic. The biodegradation was measured by the amount of gas 

produced. Researchers can determine the amount of biodegradation in the test article by 

comparing the carbon in the gas emitted from treated vessels with the carbon emitted in the blank 

inoculum and the control vessels. The amounts of biodegradation observed in ECM’s many 

positive tests was sufficient to conclude that the plastic polymer, and not just the ECM additive, 

had biodegraded substantially. 

394 See supra Part II.7.3 (table). 

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Second, ECM supported its gas evolution data with qualitative analyses performed by 

leading environmental scientists. Tests of ECM plastics in landfill simulated conditions 

demonstrated that ECM plastic was biodegradable by gravimetric endpoints. Dr. Timothy 

Barber (Environ Labs) further concluded that the ECM additive cause PVC polymers to degrade 

under simulated landfill conditions based, in part, on gravimetric endpoints, but also through an 

evaluation of free chloride atoms present in the test vessels.

Third, ECM confirmed that anaerobic biodegradation witnessed in the laboratory 

environment would translate into the real word conditions of a landfill. ECM has proven that 

Municipal Solid Waste (MSW) landfills are biologically active enough to support significant 

biodegradation in most instances. The anaerobic processes that result in landfill biodegradation 

are similarly present in the laboratory tests. Moreover, the laboratory tests demonstrate that 

ECM plastics are intrinsically biodegradable when compared with untreated plastics. As a 

biodegradable material, the plastics will biodegrade when environmentally favorable conditions 

exist for biodegradation. 

Fourth, ECM determined through various studies, including those extended gas evolution 

studies and those where labs re-inoculated, that biodegradation of plastics would continue 

beyond the short testing periods. 

Fifth, ECM determined based on peer-reviewed literature and expert opinion that 

conventional plastics of the type most ECM customers use can be enzymatically biodegraded by 

enzymes naturally produced by bacteria and microorganisms. 

Sixth, as explained, supra, ECM has debunked the scientific theories posited by 

Complaint Counsel’s experts in their efforts to prove that additive technologies (not just ECM’s) 

are inefficacious. Those theories were primarily advanced by Complaint Counsel’s scientific 

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expert, Dr. Stephen McCarthy. Dr. McCarthy essentially works for ECM’s competitors. He has 

received substantial research funding (millions of dollars) from those competitors. He has 

licensed his intellectual property to those competitors, and received a revenue stream for that 

technology. He is, therefore, personally and financially interested in the success of ECM’s 

competitors, who, in turn, stand to profit if the FTC forecloses the biodegradable additive 

industry. The same competitors who hire Dr. McCarthy have directly lobbied the FTC to act 

against additive manufacturers, including ECM by name. Dr. McCarthy’s expert opinions are 

unreliable, and as he strains to prove ECM’s technology does not work, his personal objectives 

and biases should be considered. ECM’s experts, included the proffered expert Dr. Grossman 

(Dr. McCarthy’s colleague), have indicated that Dr. McCarthy’s scientific analysis is in error.

Finally, ECM has addressed the limited number of inconclusive test results, several of 

which were prepared by ECM competitors outside ECM’s supply chain. Moreover, ECM’s 

experts are of the opinion that testing should be considered as a whole, and ignoring positive test 

results by focusing exclusively on inconclusive results is not sound science. The data in those 

tests contradict Complaint Counsel’s experts, revealing either that the experts had reached in 

their analyses, or that the inconclusive tests suffered fatal limitations. 

F. The Constitution Defines Limits to the Reasonable Basis Standard

First Amendment protections directly apply to FTC orders and limit the expansion of 

FTC advertising regulation. See, e.g., Standard Oil C. of California v. F.T.C., 577 F.2d 653, 662 

(9th Cir. 1978) (“First Amendment considerations dictate that the Commission exercise restraint 

in formulating remedial orders which may amount to a prior restraint on protected commercial 

speech”); Sears, Roebuck and Co. v. F.T.C., 76 F2d 385, 399 n.31 (9th Cir. 1982); Beneficial 

Corp, 542 F.2d at 611; F.T.C. v. Simeon Management Corp., 532 F.2d 708, 713 (1976)

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(“[a]lthough commercial advertising may be subject to regulation serving an important public 

interest, it is not beyond the protection of the First Amendment”).

ECM’s claims are, at worst, truthful but potentially misleading. ECM plastics are 

“biodegradable” under scientific definitions of the phrase in the peer-reviewed literature.395 The 

addition of ECM’s product to conventional plastic polymers results in an end-product that will 

“biodegrade.” The extent and rate to which that product biodegrades is not at issue for the 

constitutional analysis here, except that the ECM plastics are, in the literal sense, 

“biodegradable.”

Complaint Counsel contends that ECM’s truthful description of its product is misleading

because a small group of consumers allegedly think the word “biodegradable” should mean that 

a product disappears within one year, albeit no competent evidence of that small group exists. 

Never mind that those consumers have no reasonable understanding of the term biodegradable. 

Never mind that the concept of a biodegradable product within one year is nearly impossible for 

most materials known to be rapidly biodegradable. Complaint Counsel maintains that industry 

should aspire to that unscientific and implausible standard, simply because some unreasonable 

consumers think it so. 

Even assuming Complaint Counsel were correct, ECM’s biodegradable claim would only 

then be potentially misleading, because the claim is literally true even if it could potentially be 

misunderstood by unreasonable consumers expecting a scientifically impossible result. The 

Constitution prohibits restriction of potentially misleading speech when there are obvious, less 

395 The dictionary also defines “biodegradable” as that which is “capable of being 

decomposed by bacteria or other living organisms.” ECM plastics have been shown capable of 

being decomposed and, so, the “biodegradable” claim is literally true.

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speech restrictive alternatives to imposing prospective speech burdens. See, Pearson v. Shalala, 

164 F.3d 650 (D.C. Cir. 1999).

In Pearson I, the Court of Appeals for the D.C. Circuit held that perceived deficiencies in 

the scientific record must be proven incapable of being rendered non-misleading by resort to 

reasonable claim qualifications before the government may resort to a prospective speech ban. 

See Pearson I, 164 F.3d at 658 (holding that “[i]t is clear ... that when government chooses a 

policy of suppression over disclosure—at least where there is no showing that disclosure would 

not suffice to cure misleadingness—government disregards a ‘far less restrictive’ means”); see 

also Whitaker v. Thompson, 248 F.Supp. 2d 1 (D.D.C. 2002); Alliance for Natural Health U.S. v. 

Sebelius, 714 F.Supp. 2d 48, 53 (D.D.C. 2010) (“ANH I”); Alliance for Natural Health U.S. v. 

Sebelius, 786 F.Supp. 2d 1, 8 (D.D.C. 2011) (“ANH II”). The same law and logic applies to FTC 

orders that restrain future speech through fencing in orders or other burdens.

Although the government may have an interest in protecting consumers from misleading 

claims, that interest cannot overcome the First Amendment’s preference for disclosure 

(compelled or voluntary) over censorship when claim qualification is a suitable, less speechrestrictive alternative. See Whitaker, 248 F.Supp. 2d at 10. As in this case, when “credible 

evidence supports a claim, that claim may not be absolutely prohibited.” See id. (citing Pearson 

I, 164 F.3d at 659). Moreover, significantly, “[t]he mere absence of significant affirmative 

evidence in support of a particular claim ... does not translate into negative evidence against it.” 

Pearson v. Shalala, 130 F.Supp. 2d 105, 115 (D.D.C. 2001) (“Pearson II”); Edenfield v. Fane, 

507 U.S. 761, 770 (1993) (“[I]t is well established that the party seeking to uphold a restriction 

on commercial speech carries the burden of justifying it”).

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Here, the obvious less speech-restrictive alternatives are abundant. The Commission 

could invest in consumer education. Given the apparent lack of understanding in the 

marketplace, education is likely the most logical choice. The Commission has invested millions 

of tax dollars in an effort to support misguided consumer survey evidence, and through the 

initiation of deceptive advertising actions built on unscientific standards. Instead of forcing 

manufacturers and advertisers to satisfy scientifically invalid standards, the Commission could 

inform customers that their expectations with respect to biodegradable plastics are unreasonable. 

In the alternative, the Commission could require succinct and reasonable qualifying 

language that can be truthful and non-misleading, which ECM would accept. In the Green 

Guides, the FTC states that the only reasonable disclaimer involves a provision of the rate and 

extent of biodegradation in the environment. However those qualifications are impossible to 

craft with any scientific validity, because the actual rate and extent of biodegradation depends on 

countless environmental factors that are beyond the advertiser’s control, and are unpredictable. 

There is no “conservative” calculation of a rate for biodegradation. The rate could be zero, 

because even the most biodegradable product will not biodegrade in a sterile environment (i.e., a 

sterile pocket within a landfill cell that contains antimicrobial chemicals, or a landfill in Alaska 

with conditions very unsuitable for degradation, etc.). The reasonable qualification informs the 

consumer that the rate is variable and dependent an environmental conditions. However, even 

assuming that claim was inadequate, still a more reasonable qualification would involve a 

comparison between the efficacy of the biodegradable plastic to conventional un-treated plastic 

(e.g., “this product biodegrades 10x faster than conventional plastic”). Finally, a qualification 

could simply alert the consumer to the fact that “individual rates of biodegradation vary greatly, 

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depending on numerous factors, which can cause plastics to dissemble over hundreds, if not 

thousands, of years.”

In short, a qualifier that requires an affirmative statement of the specific time or rate for 

degradation is scientifically infeasible and imprudent, but if one is expected, the only 

constitutional resort in this case is for the Commission to allow the claim of biodegradation and 

to require a reasonable claim qualification to be associated with it such as those represented 

above. To the extent the Commission refuses to rely on such a restriction in favor of more 

draconian and speech restrictive prospective limits on speech, it would unconstitutionally

disregard an obvious less speech-restrictive burden.

Finally, shorn of the bogus and unscientific “One Year Rule,” nothing in the record 

suggests that consumers have been misled by the general “biodegradation” claim at issue in this 

case. Accordingly, and unlike other FTC proceedings where the inherently misleading nature of 

speech overcomes the First Amendment analysis, the use of the “biodegradable” claim here is 

literally true and, at worst, only potentially misleading; thus the First Amendment trumps the 

attempt to prosecute the speaker and limit prospective speech. A limitation on the use of a 

broad, but scientifically accepted, definition of “biodegradable” must comply with the First 

Amendment commercial speech doctrine as articulated in Pearson I.

G. The Ultra Vires Nature of FTC Assumption of Regulatory Power Vested in the EPA

Government action is ultra vires if the agency or other government entity “is not doing 

the business which the sovereign has empowered him to do or he is doing it in a way which the 

sovereign has forbidden.” Ancient Coin Collectors Guild v. U.S. Customs & Border Prot., Dep't 

of Homeland Sec., 698 F.3d 171, 179 (4th Cir. 2012) (quoting Larson v. Domestic & Foreign 

Commerce Corp., 337 U.S. 682, 689 (1949)). Courts review ultra vires agency action when an 

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agency “patently misconstrues a statute, disregards a specific and unambiguous statutory 

directive, or violates a specific command of a statute.” Hunter v. F.E.R.C., 569 F. Supp. 12, 16–

17 (D.D.C. 2008). Put differently, “[a]n ultra vires act is one performed without any authority to 

act...” Sahaviriya Steel Industries Public Co. Ltd. v. U.S., 601 F. Supp. 2d 1355, 1366 (C.I.T. 

2009). The Administrative Procedures Act (APA) further contemplates that agency action is 

void if found to be “in excess of statutory jurisdiction, authority, or limitations, or short of 

statutory right.” See 5 U.S.C. § 706 (2)(C). 

Complaints Counsel’s definition of “biodegradable,” which limits the naked term to 

products that degrade within one year, is patently arbitrary and capricious and in conflict with 

environmental policies set by the federal Environmental Protection Agency. Because the FTC 

has effectively regulated environmental policy, beyond simple adjudication of false or 

misleading advertising, the FTC has acted ultra vires and in excess of its statutory authority. By 

restricting the sale and marketing of slowly degrading landfillable products, the FTC has set 

national policy that encourages promotion of rapidly degrading plastics, resulting in greater 

adverse environmental consequences, as explained above.

The U.S. EPA has primary responsibility for enforcing the environmental statutes and 

regulations of the United States. Under the federal Resource Conservation and Recovery Act 

(RCRA), Congress delegated to the EPA the task of managing solid waste disposal. See, e.g., 42 

U.S.C. § 6901. Congress passed the RCRA, in part, to address the “ever-mounting increase ... 

of the mass material discarded by the purchaser of ... products.” 42 U.S.C. § 6901(a)(1). 

Moreover, with respect to energy, Congress explained that “solid waste represents a potential 

source of solid fuel, oil, or gas that can be converted into energy.” 42 U.S.C. § 6901(d)(1). 

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ECM experts testify that U.S. landfills have become a major source of harvestable natural 

gas in the form of methane emissions. The major biproduct of biodegradation in landfills is 

methane and carbon dioxide gas. Methane is released as a result of the biodegradation process as 

microorganisms in the landfill disassemble carbon bonds from the solid waste, often through 

enzymatic digestion. Methane is formed with one carbon atom and four hydrogen atoms. 

Experts in this case will explain that many modern landfills, operated under the auspices of the 

EPA and local regulations, are now designed to harvest gases emitted from landfills. For 

instance, 1 million tons of waste within a landfill generally creates 550,000 cubic feet per day of 

landfill gas, or one megawatt of electricity, which is enough to power 700 homes for one year. 

Moreover, by collecting and using those methane emissions for beneficial use, the landfill 

operators remove methane gas from the atmosphere equal to taking about 8,800 cars off the road 

for a year.

Rapidly degrading waste is inconsistent with the ideals for the operation and maintenance 

of landfills, however. Landfills pass through several phases in their life cycle. In the first phase, 

the landfill is open and accepting waste into “cells.” During that period there is both anaerobic 

and aerobic activity. However, the systems designed for landfill gas collection are not active or 

functional during the open phase of landfill cells. Traditional landfill gas collection models are 

usually not equipped to collect gas emissions for two years.396 Thus, products that rapidly 

degraded within one year would cause methane gas to be released directly into the atmosphere, 

contributing to atmospheric greenhouse gases where they would otherwise be collected or flared. 

Dr. Morton Barlaz is one of the nation’s leading experts in environmental sciences with 

respect to MSW landfills and biodegradation. Complaint Counsel’s purported landfill expert, 

396 See RX-853, at 12.

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Dr. Tolaymat, recognized Dr. Barlaz as an authority in the field and would defer to Dr. Barlaz. 

Dr. Barlaz will testify that increasing the rates of biodegradation for landfilled products is 

antithetical to the goals of gas collection and are detrimental to the environment. He will testify 

that more rapidly degrading substances in landfills provide no appreciable environmental benefit, 

in part, because landfilled products are intended for nearly infinite storage, and landfill sites 

expect to provide same. He will explain that, from an environmental perspective, plastic 

products that degrade in an MSW landfill within a matter of decades are preferable, and that 

decades would be a reasonably short period of time for degradation based on scientific 

principles.

H. The “One-Year” Rule Is An Industry-Wide Trade Regulation Rule

The “One-Year” Rule promulgated in the 2012 revision of the Green Guides is not an 

interpretative, non-binding statement of policy, but an industry-wide rule that redefines scope of 

products that can be marketed. The rule favors short-term degradable products to the prejudice 

of those products that would biodegrade slowly in a landfill, but still within a reasonably short 

period of time compared to conventional plastics. Furthermore, because Complaint Counsel has 

explained through this proceeding that no test can accurately substantiate the time for disposal in 

an MSW landfill, and the rule expressly states that it is “deceptive to make an unqualified 

degradable claim for items entering the solid waste stream if the items do not completely 

decompose within one year after customary disposal,” the Green Guides prohibit technologies 

that do not, in fact, disappear in landfills within one year. See 16 C.F.R. § 260.8(c). In other 

words, the Commission has condemned the use of landfill-able technologies in toto. That is an 

environmental policy that says landfill-able products are not desirable—not a position with 

respect to consumer deception. The FTC has thus enacted a new industry-wide rule equivalent to 

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the FDA’s prior restraint this Court condemned as unconstitutional in Pearson I. See Pearson I, 

164 F.3d at 655-60. 

15 U.S.C. § 57 requires that FTC proceed through Magnuson-Moss rulemaking when 

promulgating rules defining practices which are unfair or deceptive. See 15 U.S.C. § 57a

(requiring heightened procedural safeguards in FTC rulemaking proceedings); see also 5 U.S.C. 

§ 553 (requiring federal agencies, with limited exceptions, to follow notice-and-comment 

rulemaking procedures when promulgating a new rule, regulation, or interpretation of a 

regulation). Because the Commission has not complied with all of the requirements of Section 

57a, the trade regulation rule implemented and now enforced against ECM is invalid and should 

be given no weight in this proceeding.397

IV. CONCLUSION

For the foregoing reasons, as will be proven and elicited at the hearing in this matter, ECM 

requests that this Court deny each of Complaint Counsel’s requests for relief, and enter judgment 

in ECM’s favor.

Respectfully submitted,

/s/ Jonathan W. Emord

Jonathan W. Emord 

Peter A. Arhangelsky

Bethany R. Kennedy

Eric J. Awerbuch

EMORD & ASSOCIATES, P.C.

397 For example, because the FTC did not properly characterize the industry rule as a 

Trade Regulation Rule under Section 57a, the Commission did not apparently notify and seek 

input from the Committee on Commerce, Science, and Transportation of the Senate and the 

Committee on Energy and Commerce of the House of Representatives. See 15 U.S.C. § 57a(2).

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Telephone: 202-466-6937

Fax: 202-466-6938

Email: jemord@emord.com 

DATED: July 30, 2014.

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CERTIFICATE OF SERVICE

I hereby certify that on July 30, 2014, I caused a true and correct copy of the foregoing to 

be served as follows: 

One electronic copy to the Office of the Secretary through the e-filing system:

Donald S. Clark, Secretary

Federal Trade Commission

600 Pennsylvania Ave., NW, Room H-113

Washington, DC 20580

Email: secretary@ftc.gov

One electronic courtesy copy to the Office of the Administrative Law Judge:

The Honorable D. Michael Chappell

Administrative Law Judge

600 Pennsylvania Ave., NW, Room H-110

Washington, DC 20580

One electronic copy to Counsel for Complainant:

Katherine Johnson

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, D.C. 20580

Email: kjohnson3@ftc.gov

Arturo Decastro

Division of Enfoncement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, D.C. 20580

Email: adecastro@ftc.gov

Jonathan Cohen

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, D.C. 20580

Email: jcohen2@ftc.gov

I certify that I retain a paper copy of the signed original of the foregoing document that is 

available for review by the parties and adjudicator consistent with the Commission’s Rules.

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Respectfully submitted,

Jonathan W. Emord (jemord@emord.com)

EMORD & ASSOCIATES, P.C.

11808 Wolf Run Lane

Clifton, VA 20124

Telephone: 202-466-6937

Facsimile: 202-466-6938

DATED: July 30, 2014

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