UNITED STATES OF AMERICA 

BEFORE THE FEDERAL TRADE COMMISSI 

OFFICE OF THE ADMINISTRATIVE LAW JUD 

Washington, D.C. 

In the Matter of 

ECM BioFilms, Inc., 

a corporation, also d/b/a 

Enviroplastics International, 

Respondent. 

Docket No. 9358 

PUBLIC 

RESPONDENT'S RENEWED MOTION FOR LEAVE TO SERVE SUBPOENA DUCES 

TECUM ON DR. STEPHEN MCCARTHY 

Pursuant to Rules 3.21(c) and 3.31A(d) Respondent ECM BioFihns, Inc. (ECM) hereby 

seeks leave to serve Complaint Cmmsel's expett, Dr. Stephen McCatthy ("McCatthy" or 

"Witness"), with a subpoena duces tecum. 

1 

ECM has a right to discover all grounds gennane to expett qualifications, knowledge, 

training, and experience, including expett bias, conflicts of interest, and lack of independence. 

Subpoenas duces tecum are the most appropriate means to achieve that end, particulm·ly because 

ECM has completed Dr. McCatthy's deposition. ECM therefore moves this Comt to compel 

Complaint Cmmsel's expelis to respond to ECM's subpoenas duces tecum. On Jlme 10, 2014, 

this Comt denied ECM's original motion for leave to serve a subpoena on Dr. McCatthy without 

prejudice, thus pennitting ECM to separately move for leave to subpoena Dr. McCatthy after 

completion of his expert deposition. ECM completed Dr. McCatthy's deposition on June 27, 

2014. 

Inf01m ation revealed during that deposition demonstrates that Dr. McCarthy is not an 

objective expert witness. He has considerable personal fmancial investment in the outcome of 

1 Respondent's proposed subpoena is attached as Exhibit RX-1. 

1 
PUBLIC DOCUMENT 

2 

this matter. Dr. Stephen McCarthy has agreed to testify in this matter as Complaint Counsel’s 

lead scientific witness. He will testify that, in his opinion, ECM’s claims are not supported. Dr. 

McCarthy also has established financial relationships with ECM’s competitors. Among other 

facts detailed in ECM’s accompanying memorandum, Dr. McCarthy collects money from ECM 

competitors through licensing agreements involving his patented technologies. If complaint 

counsel is successful in its case against ECM, Dr. McCarthy’s patented technologies increase in 

value, and he likely receives more money from ECM’s competitors who license Dr. McCarthy’s 

technologies. Dr. McCarthy also receives considerable funding from ECM’s competitors 

through grant money paid to UMass where McCarthy teaches, which money is shared with Dr. 

McCarthy. Those competitors have lobbied the FTC to take action against ECM and similar 

businesses, likely to increase their market share. Dr. McCarthy, working individually or on 

behalf of ECM’s competitors, has been involved with the Biodegradable Products Institute 

(“BPI”), a trade organization that favors “compostable” products over landfillable products. BPI 

has also lobbied the FTC against ECM, and had a substantial role persuading the Commission to 

adopt unscientific standards that benefit compostable products over those like ECM’s additive. 

Dr. McCarthy has adopted “opinions” in his Rule 3.31A expert report and deposition that 

conflict with prior work he has done for ECM competitors, as described in his patents. Those 

deviations reveal that his personal bias has influenced the credibility of his testimony. 

Dr. McCarthy’s role as an objective expert is highly questionable because of his bias. 

ECM must subpoena Dr. McCarthy to fully understand the scope of his personal relationships 

that certainly bear on his scientific opinions in this case. 
PUBLIC DOCUMENT 

3 

Respectfully submitted, 

 /s/ Jonathan W. Emord 

 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 7, 2014 
PUBLIC DOCUMENT 

4 

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’S MEMORANDUM IN SUPPORT OF MOTION TO COMPEL EXPERT 

RESPONSE TO SUBPOENAS DUCES TECUM 

Respondent ECM BioFilms, Inc. (“ECM”) hereby seeks leave to serve Complaint 

Counsel’s expert, Dr. Stephen McCarthy (“McCarthy” or “Deponent”), with a subpoena duces 

tecum. Complaint Counsel’s lead scientific witness, Dr. Stephen McCarthy, is an agent of 

ECM’s competitors. He has a direct financial interest in the outcome of this litigation. He 

receives royalties for patented technologies used by ECM’s competitors in the biodegradable 

plastics market. He receives significant funding from grant money given to the University for 

the Center he directs from those ECM competitors. Those same competitors lobbied the FTC to 

prosecute ECM. Put simply, Dr. McCarthy owns technology and financial interests that directly 

compete with ECM Biofilms. If Complaint Counsel succeeds in this action against ECM 

Biofilms, Dr. Stephen McCarthy stands to gain an increase in revenue when his corporate 

connections assume a greater share of the plastics market.2

 

 2

 In a companion motion, ECM requests leave to amend its final witness list to include 

Dr. Steven Grossman. Dr. Grossman is a Professor of Plastics Engineering at UMass Lowell. 

He teaches at the University level in the same Department as Dr. McCarthy. He would testify 
PUBLIC DOCUMENT 

5 

The bias, conflict of interest, and independence of Complaint Counsel’s experts are 

germane to their qualifications and opinions. See 16 C.F.R. 3.31(c); Fed. R. Evid. 702; Behler v. 

Hanlon, 199 F.R.D. 553, 561 (D. Md. 2001). The right to establish the bias of a witness, 

particularly an expert witness, is well-established in state and federal courts. See, e.g., Keystone 

Mfg. Co. v. Jaccard Corp., 394 F.Supp. 2d 543, 568 (W.D.N.Y. 2005); Behler, 199 F.R.D. at 

537; Tuttle v. Perry, 82 S.W.3d 920, 922 (Ky. 2002); Powell v. St. John Hosp., 614 N.W.2d 666, 

670 (Mich. Ct. App. 2000). Moreover, under evidentiary principles, bias is not collateral, 

meaning that counsel may “prove” bias through extrinsic evidence. See, e.g., Wealot v. 

Armontrout, 948 F.2d 497, 500 (8th Cir. 1991) (“[p]otential bias is not a collateral issue”). 

“[T]he nature and extent of a witness’s motives and his interest in the outcome of the case bear 

importantly upon an evaluation of the witness’s objectivity, his bias, and the weight to be 

accorded his testimony.” United States v. IBM Corp., 66 F.R.D. 215, 219 (S.D.N.Y. 1974) 

(granting Rule 26 motion to permit discovery of financial interests). “[O]ne of the purposes of 

discovery is to obtain information and to establish the nature and extent of ... biases.” Id.

(collecting cases). ECM cannot fully explore Dr. McCarthy’s bias in this case without the court 

permitting ECM the document discovery it seeks. 

Evidence revealed during Dr. McCarthy’s deposition establish beyond per adventure of 

doubt that Dr. McCarthy has a vested financial interest in the outcome of these proceedings. 

ECM is entitled under Rule 3.31(c)(1) to probe the full extent of that bias. 

BACKGROUND 

 

concerning Dr. McCarthy’s bias and the lack of scientific integrity in Dr. McCarthy’s report 

arising from that bias. 
PUBLIC DOCUMENT 

6 

 Respondent ECM Biofilms served subpoenas duces tecum on Complaint Counsel’s 

identified experts on April 7, 2014. On May 19, 2014, ECM moved to compel production under 

Rules 3.31 and 3.38. This Court ruled that ECM’s subpoenas were deficient in that they lacked 

the Commission’s seal of authenticity. See June 2, 2014 Order. ECM followed that Order with a 

Motion for Leave to Serve Subpoenas bearing the Commission’s seal (June 4, 2014). On June 

10, 2014, this Court denied ECM’s motion for leave without prejudice. His Honor explained that 

Rule 3.31A(d) provides for document discovery of expert witnesses, but only after depositions. 

See June 10, 2014 Order at 3; see also 16 C.F.R. 3.31A(d) (“Upon motion, the Administrative 

Law Judge may order further discovery by other means, subject to such restrictions as to scope 

as the Administrative Law Judge may deem appropriate.”). His Honor rejected Complaint 

Counsel’s position that subpoenas were per se improper, but held that the ruling did not restrict 

ECM from subsequently moving for leave upon good cause after expert depositions. See June 

10, 2014 Order at 4 (“this ruling is without prejudice to Respondent’s right to move for further 

discovery from Complaint Counsel’s designated expert witness pursuant to Rule 3.31A(d), after 

completion of other expert discovery...”). 

ARGUMENT 

A. ECM Has Evidence that Dr. McCarthy Has a Financial Interest in the Outcome of 

this Litigation 

McCarthy invented a patent for a technology that competes directly with ECM’s 

biodegradable additive. See Exh. RX-A (U.S. Patent No. 5,883,199 (issued Mar. 16, 1999)). He 

profits from that patent. See Exh. RX-B at 47:18-25, 51:17-57:7 (June 27, 2014) (Dr. 

McCarthy’s deposition testimony (rough, condensed)). The University of Massachusetts, Lowell 

(“UMass”), McCarthy’s employer, is the patent’s assignee. See Exh. RX-A; RX-C-1 (Metabolix 
PUBLIC DOCUMENT 

7 

Website Article). Metabolix, Inc. is the exclusive licensee of the technology. See Exh. RX-C-1. 

Metabolix’s potential royalties from licensing UMass patents surpass $100,000 per year. See

Exh. RX-C-2 (UMass Website Article). Dr. McCarthy testified that he receives money directly 

from the ‘199 patent, which is licensed by Metabolix. See Exh. RX-B at 55:4-56:7 (explaining 

that, as an inventor, Dr. McCarthy gets ten percent (10%) of the royalties of the ‘199 patent if 

there is a profit). He acknowledged that Metabolix’s products compete directly with ECM’s 

technology for market share. Id. at 60:15-62:4 (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). 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. Dr. 

McCarthy also collects a share of research grant money that he secures for UMass from 

Metabolix and other compostable product manufacturers, which comes from ECM competitors. 

Id. at 48:1-51:16 (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). 

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). See Exh. RX-C-2. Since 2008, Metabolix has been lobbying the 

FTC to act against ECM. See Exh. RX-D. Dr. McCarthy has worked with BPI, and collected 

substantial revenue (approximately $40,000) performing BPI “certifications” for trade 

customers. See Exh. RX-B at 92:11-24. Since 2008, Metabolix has lobbied the FTC to act 

against ECM. See RX-D (requesting FTC to investigate Good Earth and ECM for alleged 
PUBLIC DOCUMENT 

8 

deceptive environmental claims). 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.” See Exh. RX-E-1; RX-E-2. 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. See Exh. RXF-1 (BPI Correspondence to FTC of April 25, 2005). 

The green plastics industry is divided into two competing camps, those who market 

“compostable” products and those who market “biodegradable” products. “Compostables” are a 

narrow subset of biodegradable plastics. Compare FTC’s Revised Green Guides 16 C.F.R. § 

260.7(b) (for compostability marketing, the marketer must have evidence that “all the materials 

in the item will break down into, or otherwise becomes part of, usable compost”) with FTC’s 

Revised Green Guides 16 C.F.R. § 260.8(b) (for degradability marketing, the marketer must have 

evidence that “the entire item will completely break down and return to nature” within one year o 

customary disposal). Advocates of compostables benefit by regulation that limits what may be 

advertised as “biodegradable” when that limit is based on rate, and they have successfully 

lobbied the Commission to achieve that restriction in the Green Guides. See, e.g., Exh. RX-G 

(Comments of BPI from January 30, 2008) (recommending to FTC that, in order for a product to 

be advertised as biodegradable, the product must break down within 12-18 months); RX-F-1; 

RX-F-2 (BPI Correspondence to FTC of March 30, 2010) (convincing FTC to act against two 

additional companies marketing their products as biodegradable). 

Companies like Metabolix, and many others supported by BPI, offer environmental 

solutions for plastics that compete directly against ECM. Many such technologies are more 

expensive than the additive methods sold by ECM (and many similar companies). The expensive 

plastic resins and polymers sold by ECM’s competitors often require major manufacturing costs 
PUBLIC DOCUMENT 

9 

to implement, making them less desirable for manufacturers. For ECM’s competitors, therefore, 

this case is an opportunity to eliminate an area of strong competition by relying on government 

as a proxy. Dr. McCarthy is an agent of those ECM competitors. 

His bias is apparent in that Dr. McCarthy has adopted positions that contradict prior work 

he performed for ECM’s competitors. For example, his deposition testimony explains that in his 

expert report he states that radiological marker C testing is the only test that can dispositively 

prove that additives like ECM’s cause biodegradation of plastics, but he himself has relied on 

extrapolation and other tests, such as one he created himself, UML-7645, and measures of 

weight loss, to prove biodegrability of polymer products. See Exh. RX-B at 69:20-70:19, 143:6-

2; 159:8-165:22. Further, in his “Report on Bias and Capture in the Promulgation of the Green 

Guides and Enforcement Action Against ECM BioFilms,” Dr. Volokh’s addressed similar 

contradictions. Specifically, Dr. Volokh pointed out how Dr. McCarthy has said in his expert 

report 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 the ‘199 patent made biodegradable claims “even though the rate of 

biodegradation was lower than 60%.” See Exh. RX-H at 32 (Dr. Volok’s report). He also 

mentioned how although Dr. McCarthy’s expert report states that a conventional, nonbiodegradable plastic does not become biodegradable after being melt-blended with ECM’s 

additive because the conventional plastic’s chemical structure remains unaltered, in a 1990 paper 

Dr. McCarthy proposed to test such a blend, which suggested a tension between his past and 

current views. See id. at 32-33. 

B. ECM Requires Document Discovery to Uncover the Full Extent of Dr. McCarthy’s 

Bias 
PUBLIC DOCUMENT 

10 

Despite thus far not being afforded document discovery from Dr. McCarthy, ECM has 

been able to unearth substantial evidence of bias infecting Dr. McCarthy’s testimony in this case. 

However, ECM’s effort will not be complete unless and until this Court ensures that ECM’s right 

to document discovery is not denied through administrative action. ECM has a right to explore 

the full extent of Dr. McCarthy’s ties to ECM’s market competitors, including access to every 

document that reasonably shows a connection between McCarthy and an ECM competitor. 

ECM seeks leave to serve the document attached as Exhibit RX-I, which is tailored to discover 

precisely those connections, seeking documents that expose Dr. McCarthy’s ties with individuals 

and institutions that are ECM competitors, Dr. McCarthy’s financial relationships with those 

individuals and institutions, and Dr. McCarthy’s involvement in building compostable product 

alternatives to biodegradable plastics technologies. ECM completed its deposition of Dr. 

McCarthy on June 27, 2014. Before that deposition, ECM was aware of information in the 

public domain revealing that Dr. McCarthy’s association with ECM’s competitors, and that he 

may be contradicting himself to protect his financial interests. Dr. McCarthy’s responses under 

oath confirmed those conclusions, and provided more than a sufficient basis to warrant complete 

examination of his financial and other relations with companies and individuals who compete 

with ECM (and, indeed, lobby this agency to act against ECM). See, e.g., Exh. RX-B at 40:13-

41:8, 58:7-62:4, 69:20-70:19, 91:5-10, 143:6-2; 159:8-165:22. While ECM has exhausted its 

discovery options permitted under this Court’s June 10, 2014 Order governing subpoena 

practice, ECM still requires, at least, the following information to assess the full extent of Dr. 

McCarthy’s bias: documents and correspondence between Dr. McCarthy and Metabolix, Inc.;3

 3

 Metabolix is an ECM competitor who directly lobbied FTC attorneys to take action 

against ECM. Metabolix is the exclusive licensee of Dr. McCarthy’s patent technology 

concerning biodegradable plastics. 
PUBLIC DOCUMENT 

documents and con espondence exchanged between Dr. McCmihy and 3M C01p oration; 

4 

documents conceming Dr. McCmihy' s fmancial interests in his patents that were assigned to 

UMass; Dr. McCatihy's fmancial interests in grant or research money paid to him from ECM 

competitors; and Dr. McCmihy's documents and con espondence exchanged with BPI and its 

employees, affiliates, etc.

5 The subpoena attached hereto as Exhibit RX-I is tailored to produce 

that infonnation, and ECM respectfully requests that this Comi pennit ECM to serve this duly 

authorized subpoena and to obtain the requested inf01mation promptly so as not to prejudice 

ECM in its hearing preparation. 

RELIEF 

ECM moves this Court for leave to serve Dr. McCmihy with a subpoena duces 

tecum attached as Exhibit RX-I hereto. 

DATED: July 7, 2014 

Respectfully submitted, 

Jonathan W. Emord riEbord@emord.com) 

EMORD & ASSOCIATES, P.C. 

11 808 Wolf Run Lane 

Clifton, VA 20124 

Telephone: 202-466-693 7 

Facsiinile: 202-466-6938 

4 Complaint Counsel has designated 3M as a potential fact witness in this case. Dr. 

McCmihy perf01m ed biodegradability research for 3M. 

5 The Biodegradable Products Institute (BPI) is a trade group devoted to opposing 

products like ECM's additive. BPI has influenced attomeys at the FTC into taking enforcement 

action against ECM and similm· products. 

11 
PUBLIC DOCUMENT 

12 

STATEMENT CONCERNING MEET AND CONFER 

Pursuant to Rule 3.22(g), 21 C.F.R. § 3.22(g), the undersigned counsel certifies that, on 

July 3, 2014, Respondent’s counsel conferred by conference call with Complaint Counsel in a 

good faith effort to resolve by agreement the issues raised in the foregoing Motion. The parties 

have been unable to reach an agreement on the issue raised in the attached motion. 

Respectfully submitted, 

 

 Jonat n W. E jemord@emord.com) 

 EMORD & ASSOCIATES, P.C. 

 11808 Wolf Run Lane 

 Clifton, VA 20124 

 Telephone: 202-466-6937 

Facsimile: 202-466-6938 

 

onathan W. Emord (jem
PUBLIC DOCUMENT 

13 

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 

[PROPOSED] ORDER GRANTING RESPONDENT ECM BIOFILMS, INC.’S MOTION 

TO COMPEL 

 This matter having come before the Administrative Law Judge on July 7, 2014, upon a 

Motion for Leave to Serve Subpoena Duces Tecum (“Motion”) filed by Respondent ECM 

BioFilms, Inc. (“ECM”) pursuant to Commission Rule 3.21(c) and 3.31A(d). 

Having considered ECM’s Motion and all supporting and opposing submissions, and for 

good cause appearing, it is hereby ORDERED that ECM’s Motion is GRANTED; ECM is 

permitted to duly serve its subpoenas duces tecum on Dr. Stephen McCarthy, as described in 

Exhibit RX-1 to ECM’s Motion.

ORDERED: ______________________ 

 D. Michael Chappell 

 Chief Administrative Law Judge 

Date: 

 
PUBLIC DOCUMENT 

14 

CERTIFICATE OF SERVICE 

I hereby certify that on July 7, 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

Elisa Jillson 

Division of Enfoncement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW 

Mail stop M-8102B 

Washington, D.C. 20580

Email: ejillson@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.

 
PUBLIC DOCUMENT 

15 

 

 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: Monday, July 07, 2014 

 

onathan W. Emord (jem
Resp. Renewed Mot. for Leave 

Exh. RX-A 

RESPONDENT 

EXHIBIT 

RX-A 

PUBLIC DOCUMENT
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

United States Patent [19J 

McCarthy et al. 

(54) POLYACTIC AC[I)-BASED BLENDS 

[75] inventors: Stephen P. McCarthy, Tyngsboro; 

Richard A. Gross, Chelmsford; 

Wenguang Ma, Lowell, all of Mass. 

[73] As.signee: University of Massachusett~. Boston, 

Mass. 

[21] Appl. No.: 825,810 

l22] Flied: Apr. 3, 1997 

[51) Int. Cl.

6 ........................ .. .. . C08F 20/00; B29D 22/00 

[52] U.S. Cl . .......................... 525/437; 525/450; 604/212; 

604/370; 604/403; 604/408; 428/35.2; 428/35.7; 

428/36.92 

[58) Field of Search ..................................... 525/437, 450; 

604/403, 212, 358, 370, 408; 428/34.1, 

35.2, 35.7, 36.92 

[56] References Cited 

U.S. PArENT DOCUMENTS 

4,095,600 6/1978 Casey el al. ............................ 525/437 

5,216,050 6/1993 S[nclair ................................... 524/108 

5,252,642 10/1993 S[nclair et al. ......................... 524/108 

5,685,540 11/1997 Kaki7..awa ................................ 525/444 

FOREIGN PArENT DOCUMENTS 

96-231837 2/1995 Japan . 

lllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll 

US005883199A 

[11] Patent Number: 

[45] Date of Patent: 

5,883,199 

Mar. 16, 1999 

OTHER PUBLICAI'IONS 

Cai et al., "Effects of Physical Aging, Crystallinity, and 

Orientation on the Enzymatic Degradation of Poly(Laclic 

acid)", J. Polymer Science, 34:2701-2708 (1996). 

Gajria et a!., "Miscibility and biodegradability of blends o( 

poly(lactic acid) and poly(vinyl acetate)", Polymer, 

37:437-444 (1996). 

Sheth et al., ''Biodegradable Polymer Blends of Polylactic 

Acid (PIA) and Polyethylene Glycol (PEG)", ANTEC '95, 

1829- 1833 (1995). 

Younes et al., Phase Separation in Poly(Etbylene Glycol)/ 

Poly(LacticAcid) Blends,Po/ym. J., 24(8):765-773 (1988). 

Primary Examiner-Nathan M. Nutter 

Attorney, Agent, or Firm-Fish & Richardson P.C. 

[57] ABSTRACT 

Biodegradable blends including a first, poly lactic acid-based 

polymer or copolymer, and a second polymer or copolymer 

including one or more polyesters, e.g., an aliphatic polyester 

or a polyester of one aliphatic Cz to Cz0 diacid or of a 

combination of two more different aliphalic c2 to c20 

diacids, wherein the first and second polymers are present in 

a ratio of 9:1 to 1:9, arc described. 

25 Claims, 7 Drawing Sheets 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 1 of 7 

ro r-----------------------~ 

60 

50 r-PLA A70830 A5~850 - ~ A90BIO \ . · A30B 70 4: : A80820 } I _, / ./ :5 40 ... [ .... . • _, / I 

J• / •· I 

tf .~ .. ~ .. ~~ .~ . ..--·" , ~ 30 : / I 

(I) / 

·".- .- . - .- . - I 

20 I 

B/0#3000 

10 

100 200 300 400 500 600 700 800 

Strain,% 

FIG. 1 

ro ~----------------------~ 

60 

\.B/0#3000 

20 30 40 50 

Strain,% 

FIG. 2 

5,883,199 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 2 of 7 5,883,199 

1.5 r-------------

1.2 

~ t:l 0.9 

....... ~ 

-§ 

0 0.6 

:e 

0.3 

0 0 10 20 30 40 50 60 70 80 90 100 

Bionol/e Content, wt% 

FIG. 3 

60 ~------------

10 

0 

0 10 20 30 40 50 60 70 80 90 100 

Bionolle # 3000 Content, wt% 

FIG. 4 

+ AtYield 

o At Break 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 3 of 7 

1000 r--------------

5,883,199 

+At Yield 

x At Break 

20 40 60 80 100 

Bionolle #3000 Content, wto/o 

FIG. 5 

150 

30 

0 0 10 20 30 40 50 60 70 80 

Bi0#3000 Content, wto/o 

FIG. 6 

90 100 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 4 of 7 5,883,199 

300000--------------......, 

·a 2ooooo 

~ -§ 150000 ~ 

~ 100000 

50000 

20 40 60 80 100 

Bionolle Content, wt% 

-<>- BI0#6000 Blends, Aging tor 7 Days 

---o--- BIO# 7000 Blends, Aging tor 7 Days 

.......... BI0#6000 Blends, Aging tor 21 Days 

- -11- BIO# 7000 Blends, Aging tor 21 Days 

FIG. 7 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 5 of 7 5,883,199 

400~------------------------~ 

#. 

350 

300 

c:::"' 250 

.a 

~ 200 

a, 

~ 150 

I.U 100 

50 

0 0 10 20 30 40 50 60 70 80 90 100 

Bionolle Content, wt% 

+ 810#6000 Blends, Aging for 7 Days 

--•-· 810#7000 Blends, Aging for 7 Days 

···-!:::.···· 810#6000 Blends, Aging for 21 Days 

- -X- BID# 7000 Blends, Aging for 21 Days 

FIG. 8 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 6 of 7 5,883,199 

?!?- 1000 +PLA 

.:.:,"" X Al0830 ~ 

e I B/0#3000 

Q:l 

• A90BIO -~ 100 )+( A50850 r::: 

Q 

:::: ._ ABOB20 

~ e A30870 

r::: 

..5? L.&.j 10 

1

0 10 20 30 40 50 60 70 80 

Aging time, day 

FIG. 9 

30 

FIG. 10 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

U.S. Patent Mar. 16, 1999 Sheet 7 of 7 

120r------------. 

100 

20 

20 30 40 50 

Testing Time, Day 

FIG. 11 

80 ~-------------. 

70 

60 ~ i 50 

f 40 

0 

..... 

- 30 J 20 

10 

5 10 15 20 25 30 35 

Degradation time, day 

FIG. 12 

5,883,199 

0 PLA 

0 A70830 

• 810#3000 

0 A908/0 

• A50850 

!::. A80820 

• A30870 

0 PLA 

X A70830 

• 810#3000 

!::. A50850 

~ A80820 

• A30870 
Renewed Resp. Mot. for Leave

Exh. RX-A

PUBLIC DOCUMENT

5,883,199 

1 

POLYACTIC ACID-BASED BLENDS 

STATEMENT AS TO FEDERALLY SPONSORED 

RESEARCH 

Funding for the work described herein was partially 

provided by the National Science Foundation under grant 

number EEC-9314562. The Government bas certain rights 

in the invention. 

BACKGROUND OF TilE INVENTION 

The invention relates to polylactic acid-based blends. 

Succinic acid and diols can form biodegradable aliphatic 

polyesters and copolyesters through coupling and polycondensation reactions. TI1e main unit structure resulting from 

these reactions is: 

'"'"'[O-(CHz)m-O-C- (CH2).- C-1v "--

II II 

0 0 

Examples of biodegradable aliphatic polyesters and 

copolyesters having the unit structure s hown above are 

polybutylene succinate (PBSU), where m is 4 and n is 2, 

polyethylene succinate (PESU), where m is 2 and n is 2, a 

random copolymer of polybutylene succinate adipate 

(PBSU-AD) where m is 4 and n is 2 or 4, and polyethylene 

succinate adipate (PESU-AD) where m is 2 and n is 2 or 4. 

These polyesters and copolyesters have interesting properties including biodegradability, melt processabil.ity, and 

thermal and chemical resistance. One of these, 

BIONOLLE®, a commercially available aliphatic 

succinate-adipate polyester, has excellent physical properties. For example, the thermal resistance of BIONOLLE is 

equivalent to that of polyethylene, but the yield strength is 

higher than polyethylene. The stiffness of BIONOLLE is 

between high density and low density polyethylene (LOPE). 

Particul arly for BIONOLLE #3000, its impact strength is 

equivalent to that of LOPE, while its elongation at break is 

higher than that of LOPE. 

Polylactic acid can be made from lactic acid (lactate). 

Lactic acid is a natural molecule that is widely employed in 

foods as a preservative and a flavoring agent. It is the main 

building block in the chemical synthesis of the polylactide 

family of polyruers. Although it can be synthesized 

chemicaJly, lactic acid is procured principally by microbial 

fermentation of sugars such as glucose or hexose. These 

sugar feed stocks can be derived from potato skins, corn, and 

dairy wastes. The lactic acid monomers produced by ferruentation are then used to prepare polylactide polymers. 

2 

from renewable sources, and have been classified as "water 

sensitive," because they degrade slowly compared with 

''water soluble" or "water swollen" polymers. However, 

while polylactic acid is a biodegradable polymer with gens erally good processability, it is brittle, and the brittleness 

increases with time due to physical aging, i.e., densillcation 

of the polymer at a molecular level. 

SUMMARY OF THE INVENTION 

10 The invention is based on the discovery that polylactic 

acid (PLA)-based polymers or copolymers and polymers or 

copolymers of polyesters, e.g., polybutylenesuccioate, polybutylene succinate-adipate or polybutylene succinateterepbthalte (wherein tbe diacids of tbe polyester would be, 15 for example, succinic acid, adipic acid, terepbthal.ic acid, or 

any combinations thereof), can be used to make new biodegradable blends that, compared to PLA, have superior 

tensile and mechanical prope rties such as stiffness, 

toughness, and elongation to break, as well as excellent 

20 biodegradability and aging properties. 

In general, the invention featu res a biodegradable blend 

including a first, polylactic acid-based polymer or 

copolymer, and a second polymer or copolymer including 

25 one or more polyesters, e.g., ao aliphatic polyester or a 

polyester of one aliphatic C2 to Czo diacid or of a combination of two more different alip hatic c2 to c20 diacids, 

wherein the first and second polymers are present in a ratio 

of 9:1 to 1:9, by weight, e.g., 5:1 to 1:5, or 2:1 to 1:2, or 1:1. 

30 For example, the first polymer can be a homopolymer of 

polylactic acid, e.g., D-polylactic acid, L-polylactic acid, 

D,L-polylactic acid, meso-polylactic acid, and any combination of D-polylactic acid, L-polylact ic acid, D,Lpolylactic acid and meso-polylactic acid. In addition, the 

35 first polymer can be a copolymer having at least 50, 60, 70, 

or more, up to 100 percent, by weight, of polylactic acid . 

The second polymer or copolymer can be, for example, a 

polybutylenesuccinate homopolymer, polybutyleneadipate 

homopolymer, polybutylenesuccinate-adipate copolymer, 

4o polyetbylenesuccinate homopolymer, polyethyleneadipate 

homopolymer, or a polyetbylenesuccinate-adipate 

copolymer, or a copolyester of an aliphatic polyester and up 

to 50 percent, by weight, of an aromatic polyester, such as 

terephtbalate, as long as the overa U copolyester (and second 

45 polymer) is biodegradable. 

The blend can furt her include a compatibilizer including 

one or more polyesters, polyetbers, or polyvinyl alcohols. 

Tbe new biodegradable blends have an elongation at 

break of at least 10 percent, for example, at least 50, 100, 

50 200, 300, 400, and up to 500 percent or more. The blends 

also have an elongation at break of at least 10 percent, e.g., 

50, 100, 200, 300, 400, and up to 500 percent or more after 

70 days of aging. ln addition, the blends have a toughness of 

Lactic acid exists essentially in two stereoisomeric forms, 

which give rise to several morphologically distinct polymers: D-polylactic acid, L-polylactic acid, D,L-polylactic 

acid, meso-poly lactic acids and any combinations of thereof. 

D-polylactic acid and L-polylactic acid are stereoregular 55 

polymers. D,L-polylactic acid is a racemic polymer obtained 

from a mixture of D- and L-lactic acid, and meso-polylactic 

acid can be obtained from D,L-lactide. The polymers 

obtained froru the optically active D and L monomers are 

semicrystalline materials, but the optically inactive D,L- 60 

polylactic acid is amorphous. 

at leastlO MJ/m3 , e.g., 20, 40, 60, and up to 120 MJ/m3 or 

more. 

The second polymer can be present in U1e new biodegradable blends as a co-continuous phase with tbe first polymer, 

and ai least the first or the second polymer or copolymer is 

present in a continuous phase in the blend. 

The first, poly lactic acid-based polymer or copolymer can 

be a homopolymer of lactic acid or a block, graft, or random 

copolymer of lactic acid having the general formula: Lactic acid bas a hydroxyl group as well as a carboxylic 

group, and hence can be easily converted into a polyester. 

These polyesters have some potential advantages when 

compared to other biodegradable polymers such as polyhy- 65 

roxybutyrate and polycaprolactone, as to their strength, 

thermoplastic behavior, biocompatibility, and availability 

wherein R1 is a lactic acid unit, R., is caprolactone, 

g lycolide, trimethylene carbonate, dioxanooe, bu tyryl 
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3 

lactone, or ethylene oxide, a is 10 to 10,000, e.g., 100 to 

7,500, or 1000 to 5000, and b is 0 to 10,000, e.g., 100 to 

7,500, or 1000 to 5000. 

1l1e polyester of the second polymer or copolymer can 

have the formula: 

--...[O- (CHz),.-0-C-(CH!)n-C- 1'"' 

II II 

0 0 

wherein m is 2 to 20, e.g., 4, 8, or 12; n is 2 to 20, e.g., 2 

and 4, or 6, or 8; and N is 10 to 10,000, e.g., 500, 3,500, or 

5000. 

5 

4 

Other features and advantages of the invention will be 

apparent from the following detailed description, and from 

the claims. 

BRIEF DESCRIP110N OF THE DRAWINGS 

FIG. 1 is a graph showing complete s!res.s-strain curves of 

polylactic acid, BIONOLLE#3000, and their blends. 

FIG. 2 is a graph showing stress-strain curves of poly10 lactic acid, BIONOLLE#3000, and their blends in the strain 

range of 0 to 50%. 

FIG. 3 is a graph showing stiffness (modulus) of polylactic acid, BIONOLLE#3000, and their blends. 

FIG. 4 is a graph showing strcs.s at yield and break of 

polylactic acid, BIONOLLE#3000, and their blends. 

FIG. 5 is a graph showing percent elongation at yield and 

break of polylactic acid, BIONOLLE#3000, and their 

blends. 

FIG. 6 is a graph showing toughness of polylactic acid, 

me~ another embodiment, the invention featu res articles 

20 

BIONOLLE#3000, and their blends. 

manufactured from the new biodegradable blends. For FIG. 7 is a graph showing stiffnes.s (modulus) of polyThe new biodegradable blends can include the first, 

poly lactic acid-based polymer or copolymer as a polylactic 

acid homopolymer, and the second polymer or copolymer as 15 

a polybutylenesucciaate homopolymer, polybutyleaeadipate 

homopolymer, polybutylenesuccinate-adipate copolymer, 

polyethylenesuccinate homopolymer, polyethylencadipate 

homopolymer, or a polyethylcnesuccinate-adipate copolyexample, the invention features sheets or films, bags, lactic acid, BIONOLLE#6000, BIONOLLE#7000, ancltbeir 

containers, such as bottles and disposable cups, disposable blends. 

diapers, and other items including the new blends. 25 A "polylactic acid-based polymer or copolymer" is a 

homopolymer or a copolymer having at least 50% by weight 

of poly lactic acid. As used herein, the term "polylactic acid," 

without further designation, includes any one or more of 

four morphologically distinct polylactic acid polymers: 

D-polylactic acid, L-polylactic acid, D,L-polylactic acid, 30 

and meso-polylactic acid. "D-polylactic acid" and 

"L-polylactic acid" are dextro-polylactic acid and levopolylactic acid, respectively, and both of them are optically 

active polymers that rotate a light vector wben transmitted 

through the polymer. "D,L-polylactic acid" is a racemic 35 

polymer, i.e., a copo lymer of D-polylactic acid and 

L-polylactic acid having a well-defined conformation of Dand L-polylactic acid units. "Meso-polylactic" is a random 

copolymer of D-polylactic and L-polylac!ic. An "aliphatic 

polyester of a diacid and a diol" is a polyester formed by the 40 

reaction of a diacid and a diol. 

lbe invention provides several advantages. Polylactic 

acid by itself is a britt le ma terial having poor toughness and 

low elongation to break, and these properties worsen with 

time due to its physical aging behavior. Furthermore, the 45 biodegradability of poly lactic acid is slow. The new blends 

overcome these deficiencies of polylactic acid. Moreover, 

the new blends arc environmentally friendly and commercially attractive for making biodegradable plastic films, 

sheets, and other plastic products made by conventional 

processing methods such as blown film, extrusion, and 50 

injection molding. These plastic products can be used for 

food packaging, compost bags, and other disposable items. 

The new blends provide an entry for polylact ic acid in the 

potentially large market of biodegradable polymers. 

UnJes.s otherwise defined, all technical and scientific 55 

terms used herein have the same meaning as commonJy 

understood by one of ordinary skill in the art to which this 

invention belongs. Although methods and materials similar 

or equivalent to those described herein can be used in the 

practice or testing of the present invention, suitable methods 60 

and materials are described below. AU publications, patent 

applications, patents, and other references mentioned herein 

are incorporated by reference in their entirety. In case of 

conHict, the present specification, including definitions, wiiJ 

control. Ia addition, the materials, methods, and examples 65 

described herein are illustrative only and not intended to be 

limiting. 

FIG. 8 is a graph showing percent elongation at yield and 

break of po l ylacti c ac id, B IONOLLE#6000, 

BIONOLLE#7000, and their blends. 

FIG. 9 is a graph showing percent elongation at break of 

polylactic acid, BIONOLLE#3000, and their blends as a 

function of aging. 

FIG. 10 is a schematic of a biometer for soil biodegradation testing. 

FIG. 11 is a graph showing net percent biodegradation o( 

polylactic acid, BIONOLLE#3000, aod their blends as a 

function of test time in soiL 

FIG. 12 is a graph showing net percent weight loss due to 

biodegradation of polylactic acid, BIONOLLE#3000, and 

their blends as a function of test Lime in compost. 

DETAILED DESCRIPTION 

Polylactic acid-based polymers and polymers of 

polyesters, e.g., aliphatic polyesters of diols and diacids, can 

be used to make new blends that have surprisingly good 

mechanical and biodegradable properties compared to polylactic acid alone. 'I11e new blends provide tough, biodegradable plastics that can be used to make biodegradable plastic 

fi lms, sheets, and other products made by conventional 

blown fi.lm, extrusion, and injection molding processing 

methods. These plastic products can be used for food 

packaging, compost bags, and other disposable items. 

Compared to polylactic acid, the oew blends provide a 

large increase in elongation (e.g., from 5% to 500%), 

toughness enhancement (from less than 10 MJ/m3 to more 

than 120 MJ/m3

), and increased biodegradation rate. The 

modulus of these blends decreases with increasing amount 

of the aliphatic polyester, i.e., Bionolle#3000 (from 1.3 GPa 

of poly lactic acid to 0.3 GPa of Bionollc#3000), and elongation to break increases with increasing amount of the 

aliphatic polyester (e.g., from 5% lo 500%). The blends with 

more than 20% by weight of Biooollc#3000 possess toughness of more than 70 MJ/m3 , more than 200% elongation at 

break and otber excellent tensi le properties, whicb are 

retained even after the blends have aged for 70 days in the 

temperature range of -15° to 60° C. Compared to poly lactic 

acid, these blends also have a relatively high degTadation 

ra tes in soil and composting environment. 
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5 

Materials 

1be maio components needed to make the new blends are 

polylactic acid-based polymers and polyesters, e.g., aliphatic polyesters of diols and diacids. Optionally, a compatibilizer may be added to the blends. 

lbe simplest polylactic acid-based polymer is polylactic 

acid, which can be obtained from, e.g., Cargill loc. (EcoPla 

Division, Minnesota). The polylactic acid used for the 

experiments described herein bad ao 8% meso cooteot (96% 

L) and a number average molecular weight of 70,100. Other 

polylactic-bascd polymers can also be used to make the oew 

tough blends with alipbatic polyesters of diols and diacids. 

For example, a poly lactic-based polymers can be eitber a 

homopolymer of lactic acid or a block, graf1, or raodom 

copolymer of lactic acid having the general formula: 

wherein RJ is a lactic acid unit and ~ is caprolactone, 

glycolide, trimetbylene carbonate, dioxaoone, butyryl 

lactooe, or ethylene oxide. Wheo the polylactic acid-based 

polymer is a homopolymer, the b term is zero in the general 

formula . 

Commercially available aliphatic polyesters of diols and 

diacids include the BIONOLLE family of polymers, e.g., 

BIONOLLE #1000, #2000, #3000, #6000, and #7000, 

which can be obtained from, e.g., Showa Highpolymer Co., 

Ltd, Japan. Bionolle #3000, #6000, and #7000, which have 

molecular weights (Mw) of 23,300, 250,000 and 270,000, 

respectively, and melting points of about 91°, 102°, and 89° 

C., respectively, were used to make the new blends which 

were tested as described below. Other aliphatic polyesters of 

diols and diacids can also be used. 

Examples of diols in the aliphatic polyesters include any 

aliphatic diols including ethylene glycol and 1,4-butanediol. 

Examples of diacids in the aliphatic polyesters include any 

individual diacids or combinations of two or more aliphatic 

diacids, in the range of C:?. tO C20, in a weight percent from 

0 to 100, e.g., oxalic acid, malonic acid, succinic acid, 

g lutaric acid, adipic acid, n-butylmalonic acid, succiuic acid, 

a7..elaic acid, sebacic acid, ethyl diethylmalooate and dibutyl 

succinate. Specific aliphatic polyesters include polybutylene 

succinate (PBSU), polyethylene succinate (PESU), random 

copolymers of polybutylene succinate adipate (PBSU-AD), 

and polyethylene succinate adipate (PESU-AD). 

Sample 

Code 

PLA 

wt % 

BIONOLLI! 

wl % 

Among other fea tures of the aliphatic polyesters used in 

6 

for example 10,000 to 500,000 or 15,000 to 250,000. Tbe 

range of melting points of Lbe poly lactic acid-based polymer 

and aliphatic polyester that can be used is 50° to 300° C., fo r 

example 60 to 200° C., e.g., 80° to 150° C. 

s Besides a purely aliphatic polyester of diols and diacids, 

a copolyester of an aliphatic polyester and an aromatic 

polyester can be used so long as the copolyester is biodegradable and imparts ductility to polylactic acid-based polymers. An example of an aromatic polyester that can be used 

10 (in up to 50 percent by weigbt) in the copolyester is 

polyethylene terephtbalate. Other aromatic polyesters can be 

used. 

Examples of compatibilizers include AB block or AB 

graft copolymers that consist of a polylactic acid-based 

15 polymer or a polymer which is miscible with the poly lactic 

acid-based polymers, and an aliphatic copolyester of polymers based on diols and diacids or polymers which are 

miscible with these aliphatic copolyesters. These compatibil.izers can be added to the blend in an amount ranging 

20 from, e.g., 0.1 to lO percent, e.g., 2, 3, or 5 percent. 

Preparing Polylactic-Based Polymer Blends 

Standard melt processing equipment and processing conditions can be used to prepare the new blends. Examples of 

polymer melt processing equipment that can be used to 25 make the new blends include melt mixers (Banbury mixer), 

blenders, extruders for sheet, film, profile and blown-film 

eXlrusion, vulcanizers, calenders, and spinoerets for fiber 

spinning, molding, and foaming. 

The polylactic acid-based polymers and the polymers or 30 

copolymers of polyesters were carefully dried at 40° C. 

under vacuum for at least 24 hours to minimize hydrolytic 

degradation of polylactic acid-based polymer during the 

subsequent melt processiog. Blending was dooe on a single 

screw extruder operating between 150° and 160° C. and a 35 - screw speed of 50 rpm. Each sample was extruded twice. 

Tbis protocol can be varied as long as the polymers and 

polyesters form a contiouous or co-continuous phase bleocl. 

The composition and sample code for each blend made up 

40 of polylactic acid and BIONOLLE are reported in Table l. 

The A in each sample code refers to the percentage o( 

polylactic acid-based polymer in the blend, and the B refers 

to tbe polyester, BIONOLLE#3000, BIONOLLE#6000, or 

BIONOLLE#7000, which were used to make the new 

blends with polylactic acid. 

TABLE 1 

PLA J\90B10 A801320 A70B30 A501350 A30B70 Bio#_ 

100 90 80 70 50 30 0 

0 10 20 30 50 70 100 

Sample Preparation 

Lhe new blends are that these polyesters are biodegradable 

and that they impart ductility to polylactic acid-based polymers by forming a continuous or co-continuous phase in tbe 

morphology o( the blends. The polylactic acid-based poly- 60 

mers aud the aliphatic polyesters are immiscible, but synergistically compatible in the bleods, i.e., the properties of 

tbe blends are greater than that of the mixtures of poly lactic 

acid-based polymer and aliphatic polyester determined by 

Rectangular shaped samples of each blend were prepared 

to enable uniform testing of characteristics. The tensile test 

samples were made according to a modified specification in 

ASTM D 882. In particular, sa.mples of about 0.3 mm 

thickness, 12.7 mm width, and 38.1 mm length between the 

grips of the tensile test machine holding the sample, i.e., 

gage length, were compression molded at 155° C. and 

cooled in a cooling press macbine at20° C. and 700 psi. Thin 

film samples were made by melt blending on an extruder and 

tben compression molding to 0.3 rom thickness. The films 

the additive rule of mixture. The range of weight average 65 

molecular weights of the poly lactic acid-based polymer and 

the aliphatic polyester that cao be used is 5,000 to a million, 
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7 were cut into 20 mrnx20 rnm samples for testing biodegradation in soil aod in cornpostiog eovironments. 

Testing Methods 

8 

Specifica lly, tensile testing was done by using an Instron 

Tensile machine, model 1137, at grip separation rates of 0.5 

and 2.0 inches/minute. 

Tensile test properties of blends were obtained 1, 2, 4, 7, Tensile test properties of blends were obtained 1, 2, 4, 7, 

14, 21, 35, 40, and 70 days after making the samples. During 

this interim time period between making and testing, !be 

samples were physically aged at room temperature and 

atmospheric pressure. The teosile test was dooe accordiog to 

ASTM D 882 with the following modifications. The grip 

separation used was 38.1 mm (1.5 inches) iostead of 50 mm 

(2 inches), and the grip separation rate was 2 inches/minute 

even for samples with elongation at break greater than 

100%, while ASTM D 882 specifies that the grip separation 

rate be 20 inches/minute for samples with elongation at 

break greater than 100%. 

s 14, 21, 35, 40, and 70 days after making tbe samples. During 

lhis interim time period between preparing and testing, the 

samples were physically aged at room temperature and 

atmospheric pressure. 

The stiffness of the blends was determined from the slope 

10 of the initial linear portion of the stres.'S-strain curve. Stress 

was measured as tbe nominal stress defined as fo rce per unit 

original area. Strain and e longatioo are used as synonymous 

terms, and !bey were measured as percent change in length 

per unit length of a sample. The yield point of the blends, 

15 i.e., where a large inelastic deformation starts (yielding 

occurs), but the material continues to deform and absorb 

energy long beyond that point, was characterized as the 

intersection of the initial linear portion of the stress-strain 

Biodegradation testing in an artificial soil environment 

was performed oo films of the blends using the respirometric 

method developed at the NSF Biodegradable Polymer 

Research Center, University of Massachusetts Lowell and 

designated UML-7645. Tbis test metbod covers tbe de ter- 20 

mination of the degree and rate of aerobic biodegradation of 

synthetic plastic materials (including formulation additives) 

in contact with moist soil under controlled laboratory conclition. Carbon dioxide production, as a fraction of !be 

measured tbeoretical carbon content of the test materials, is 25 

reported as a function of tin1e. The test is designed to 

determine the biodegradability of plastic materials, relative 

curve and ihe Hat horizontal portion of the stress-strain 

curve. 

The toughness of the blends, which can be defined as the 

tensile energy to break according to ASTM D 822, was 

measured according to ASTM D 822 by integrating the area 

under the stress-strain curve. 

Specifically, a load range such !hat a specimen would fail 

within its upper two thirds was selected. The cross sectional 

area of the specimen at several points along its length was 

measured to an accuracy of 0.0025 mm. The initial grip 

separation was at 38.1 rum. The rate of grip separation rate 

to that of a comparative standard material, in an aerobic 

environment. The test applies to all plastic materials that do 

not inhibit bacteria and fungi present in soil. 

Biodegradation testing in an artificial compost environment was conducted on film samples in a simulated municipal compost as described in Example 4. 

In addition, morphology of !be blends was observed under 

polarizing optical and scanning electron microscopy. 

30 was set at 0.5 inches/minute for samples with les.<; than 20% 

elongation at break, and at 2 inches/minute for samples with 

more !ban 20% elongation at break. The load cell of the 

lnstron tester was balanced, zeroed, and calibrated for 

measuring and recording force. T he rectangular test speciUses of Polylactic Acid-Based Blends 

35 rueo was placed in the grips of the Instron testing machine, 

taking care to align the long axio;; of the specimen with an 

imaginary line joining the points of auachment of the grips 

to the machine. The grips were tightened evenly and firmly 

Like wood and paper, these blends are stable in the 

atmosphere but biodegradable in compost, in moist soil, in 

water with activated sludges, and in the sea, where a large 

number of microorganisms are present. These blends can be 40 

incinerated with only slight damage to the furnace since tbe 

heat of combustion is relatively low, and no toxic gases are 

generated. The blends made by this invention can be used to 

make biodegradable plastic film, sheets, and other products 

by conventional processing methods such as blown film, 45 

extrusion, and injection molding methods. The resulting 

blends can be used to manufacture bags, food packaging, 

laminated papers, food trays, fishing line, net, rope, diapers, 

disposable medical supplies, sanitary napkins, shampoo, 

drug, cosmetic, and beverage bollles, cutlery, brushes, 50 

combs, molded and extruded foamed articles such as packing material and cups, and cushions for flexible packing. 

These blends provide not only the excellent processibility of 

polyethylene, but also posses excellent properties like those 

of polyethylene terephthal ate. ln addition, these blends can ss 

be processed into films that are heat-sealable, unlike polyethylene terephthalate. 

EXAMPLES 

The following examples further describe the invention 60 

without limitation. 

Example 1 

Tensile Testing 

to the degTee necessary tO minimize slipping oft he specimen 

during test. The lnstron machine was started and stress 

versus grip separation was record ed. 

Tensile stres.<; (nominal) was calcu lated by dividing the 

load by !be original minimum cross-sectional area of the 

specimen in the loading direction. The modulus value was 

determined from the initial slope of the stres.s-strain curve. 

Tensile strength (nominal) at break was calculated in the 

same way as tensile stress except that the load at break was 

used in place of the maximum load. Percentage e longation 

at break was calculated by djvidiog the extension (i.e., grip 

separation) at the moment of rupture of the specimen by the 

initial lengtb of the specimen between the grips. Yield stress 

and percentage elongation at yield were determined by 

recording the stress and percent elongation at the yield point, 

which was established as noted above. 

Tensile stress-strain curves of blends of BIONOLLE#3000 and poly lactic acid are shown in FIGS. 1 and 

2. Tbese blends were aged for 14 days. FIG. 1 shows the 

complete stress-strain curves of samples coded in Table 2 as 

PLA, A90B10, A80B20, A70B30, A50B50, A30B70, and 

Bl0#3000. FIG. 2 is a expanded view of the initial portion 

of tbe stress-strain curves in FIG. 1, i.e., up to a strain of 

50%. 'Ibe excellent strain hardening characteristics of these 

blends is exhibited in FIG. 1 by the rapid increase in stress 

prior to break. For example, strain hardening in A30B70 

The tensile test was done according to ASTM D 882 with 

the modifications in the sample length between grip separation and the grip separation rate, as stated above. 

65 occurred in tbe strain range of 300-500%, and the corresponding increase in stress was from about 25 MPa to about 

50 MPa. 
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FIG. 2 shows that both stiffness and stress at yield 

decrease with increasing 1310NOLLE#3000 content, while 

elongation at yield and at break increase with increasing 

BIONOLLE#3000 content Based on tbe data in FIGS. 1 and 

2, FIGS. 3 and 4 show modulus (i.e., stiffness) and stres.s at 5 

yield and break, respectively. The outstanding strain hardening behavior of these blends was further exemplilied by 

the increasing diJierence i n stress at break and stress at yield 

with increasing BIONOLLE#3000 content. 

FIG. 5 shows that the elongation at both yield and break 

10 of polylactic acid/BIONOLLE#3000 blends increase with 

BIONOU.E#3000 content, with a dramatic increase at 

break above 10 percent BIONOLLE. FIG. 6 shows that the 

toughness of polylactic acidf810NOLLE#3000 blends 

increases as a function of BIONOLLE#3000 content above 15 10 percent. Both FIGS. 5 and 6 show a surprising and 

unexpected increase in the elongation at break of the blends 

when the BIONOLLE#3000 content was increased to over 

about 10 weight percent to about 30 weight percent in the 

polylactic acid/BTONOLLE#3000 blends, and in toughness 20 of the blends when the BIONOLLE#3000 content was 

increased to over about 10 eight percent to about 40 or 50 

weight percent in the polylactic acidf8IONOLLE#3000 

blends. 

Tensile properties (modulus and elongation at break) after 25 aging for 7 and 21 days as a function of BIONOLLE#6000 

and BIONOLLE#7000 content are s hown in FIGS. 7 and 8 . 

The modulus decreases (FIG. 7) and the elongation at break 

increases (FIG. 8) with increasing BIONOLLE#6000 and 

BJONOLLE#7000 content. As the aging time increases from 

30 7 to 2l days, the modu lus s hows a slight increase (FIG. 7), 

and the elongation at break shows a slight decrease (FIG. 8). 

Since BIONOLLE#7000 is a softer polymer than 

BIONOLLE#6000, polylactic acid/BIONOLLE#7000 

blends have a lower modulus and a higher elongation at 35 b reak compared wi th those of polylactic acid/ 

BIONOLLE#6000 blends. 

Unlike BIONOLLE#3000, BIONOLLE#6000 and BIONOLLE#7000 do not increase lbe elongation at break significantly when 10 to 40% by weigbt of BIONOLLE#6000 or 40 BIONOU E#7000 is blended with polylactic acid. This may 

be due to tbe fact that pure BIONOLLE#6000 and BIONOLLE#7000 do not possess the same tensile properties of 

BJONOLLE#3000, and also more importanl!y, the compatibility of poly lactic acid with BIONOLLE#6000 and BION- 45 OLLE#7000 is not as good as tbat of polylactic acid and 

BIONOLLE#3000. 1lowever, tbe compatibility of polylactic 

acid with BIONOLLE#6000 and BIONOLLE#7000 can be 

improved with the addition of a suitable compatibilizer, such 

10 

addition, these BlONOLLE#3000 containing blends did not 

exhibit any significant reduction in elongation after aging. 

Example 3 

Biodegradation Testing in Soil 

Soil testing in an artificial soil environment was performed on 0.3 mm thick ftlms of the blends using the 

respirometric method developed at the NSF Biodegradable 

Polymer Research Center, University of Massachusetts 

Lowell and designated UM L-7645. A standard soil mix 

(l :J :0. 1 polling soil:sand:dehydrated cow manure by 

weight) was prepared and characterized. The soil test materials were exposed to tbe soil under controlled aerobic 

conditions at 30+:!:2" C. Carbon dioxide produ.ction, 

expressed as a fraction of lbc measured of theoretical carbon 

content of lbe test materials, was measured as a function of 

time. The degree of biodegradation of lbe test material is 

assessed by comparing the amou:nl o( C02 produced from 

the test material to that produced from a standard material, 

i.e., one thai is known to biodegrade (here PLA was used for 

comparison). 

Specifically, the soil biodegradation test was conducted as 

follows. Fifty grams (oven-dry weight basis) o[ soil was 

weighed into a large (14 em) disposable weighing boat. 

Enough distilled water was added to the soil and mixed 

thoroughly to bring the soil to a moisture content of 60 to 

70%. Approximately 15 g o( the moist soil was set aside. 

The test specimen, or standard material, was added to the 

soil and the amended soil was mixed thoroughly. As shown 

in FIG. 10, tbc amended soil 16 was transferred to a large 

chamber 20 of a 250-mL biometer flask 22, packed to a 

uniform depth (about2.5 em), and covered by the 15 g oft be 

moist soil set aside. The large chamber 20 was then closed 

with a rubber stopper 24 connected to a 3-mL plastic syringe 

26 packed with a material 26 that removes any carbon 

dioxide from air entering the biometer during incubation, 

such as sodium hydroxide-coated silicon (e.g., Ascarite'n'), 

between plugs of a filter material 28, e.g., glass wool or 

colloo, that a.llows air, but not the AscariteTM, to pass. 

The combined weight of the l'lask, rubber stOJ>per, and 

amended soil containing the test specimen was determined 

and recorded. Twcoty mL of 0.4M sodium bydroxide was 

pi petted into the side-arm chamber 30 of the biometer flask 

22 and the side-arm chamber 30 was scaled with a rubber 

stopper 32. The biometer flask was placed in an environmental chamber at 30° C and this chamber was kept dark. 

The carbon dioxide analysis was done by reacting the 

carbon dioxide produced in tbe biometer with the sodium 

hydroxide in tbe side-arm chamber to form an aqueous 

as a small amount of l310NOLLE#3000. 

Example 2 

Aging Effect 

The effect of aging on the blends was measured by 

pbysically aging the samples at room temperan1re and 

atmospheric pressure, and subsequently testing the samples 

by tensile testing according to ASTM D 882 with lbe 

modifications already stated above. 

50 solution of sodium carbonate. The amount of carbon dioxide 

t>roduccd was monitored by removing the sodium hydroxide 

from the trap and transferring it to a g lass test tube to which 

5 mL of L5M barium cbloride was added. The barium 

chloride reacts with lbe sodium carbonate to form a precipi55 tate of barium carbonate. The amount of carbon dioxide 

evolved was calculated by standa.rd stoichiometric calculaFIG. 9 shows elongation at break of polylactic acid, 

BIONOLLE#3000, and their blends, as a function of aging. 

lbe elongation at break of poly lactic acid was below 8%, 60 

and decreased to about 5% with aging. Similarly, the elongation at break of A90Bl0 was rather low (about 50%) and 

decreased to less than 10% with aging. However, blends 

having a BIONOLLE#3000 content of 20% or more by 

weight showed outstanding elongation at break (200% elon- 65 

gaLion fo r 20% BIONOLLE#3000, and similarly, 300% for 

30%, 400% for 50%, and 500% for 70%, respectively). In 

tion. 

Tbe net degradation was measured as the ratio of carbon 

dioxide evolved to the amount of theoretical maximum 

carbon d ioxide production possible by the test specimen. 

Tbe theoretical maximum carbon dioxide production was 

determined by the total organic carbon content of the test 

material (by calculation, if lbe chemical composition was 

well established, or elemental analysis). The maximum 

amount of carbon dioxide that can be theoretica!Jy evolved 

was calculated by the equation: 

Maximum carbo11 dioxide=L(IVxC)JlOO]xl44/l2] 
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11 

where W is the weight of the test specimen; C is the percent 

organic carbon io the test specimen, 44 is the molecular 

weight of carbon dioxide, and 12 is the equivalent weight of 

carbon. 

The biodegradation testing in soil showed that the bio- s 

degradation rate of BIONOLLE#3000 by itself was 

extremely fast, while the biodegradation rate of polylactic 

acid by itself was relatively slow. 

'Jlte soil degradation testing results of the two polymers 

and their blends are reported in FIG. 11. After degradation 10 

for 45 days, BIONOLLE#3000 degraded almost 100%, 

while polylactic acid degraded only about 14% by loss in 

weight. For blends with 70 and 50% BIONOLLE#3000, the 

degradation rate was relatively fasl. After 45 days, the 

1\30870, A50B50, and A70B30 blends degraded about 77%, 15 

65% and 25%, respectively, by loss io weight. FIG.ll shows 

that po lylactic acid biodegrades in soil, but just not quickly, 

and the addition of the second aliphatic polymer, such as 

DIONOLLE#3000, increases the biodegradation rate. 

The importance of the soil biodegradation curves shown 20 

in FIG. ll is that a specific blend can now be designed such 

that this blend would bave a certain oct degradation io a 

given number of days within the soil. 

Example 4 

Biodegradation Testing in Compost 

13iodegradatioo testing in an artificial compost environment was conducted on film samples io a simulated munici25 

pal compost. Biodegradation testing in an artificial compost 

environment was conducted oo compression molded film 

samples of dimensions 20 mmx20 mmx0.3 rom io a simu- 30 

lated municipal compost mixture consisting of 60% by 

weight of water aod the rest containing shredded leaves, 

shredded paper. mixed fro-teo vegetables, meat waste, urea, 

and commercial compost seeds. The carbon to nitrogen 

(C':N) ratio of the starting mix was 14:1. The composting 

35 

process was carried out for 30 days at 55° C. Triplicate test 

samples wen.: removed from the composting bioreactors at 

an interval of 5 days and weighed to measure the weight loss 

per surface area in the units of pg/mm2• 

After 20 days in the com posting environment at 55° C., 40 

BIONOLI.E#3000 had a high weight los.s rate while polylactic acid had negligible weight loss. The weight loss ra tes 

in the blends o f polylactic acid and BIONOLLE#3000 after 

20 days in the composting environment were between the 

rates or polylactic acid and Bl0NOLLE#3000. 45 

·n,e compost degradation testing results of the two polymers and tbeir blends are reported in FIG. l2. After degradation for 20 days, BIONOLLE#3000 degraded almost 

40%, while poly lactic acid degraded only about 3%, by loss 

in weight. For blends with 70 to 20% BIONOLLE#3000, the 50 

degradation percentage was much greater(and the rate much 

faster) than that of polylactic acid, e.g., after 20 days, the 

A30B70, A50B50, and A 70B30 blends degraded about 35%, 

25% and 15%, respectively, by loss in weight. FIG. 12 

shows that polylactic acid biodegrades in compost, but 55 

slowly, and the adclition of even 20% by weight BIONOLLE#3000 increases this biodegradation rate dramatically. 

·me importance of the compost biodegradation curves 

shown in FIG. l2 is that a specific blend cao oow be 

60 designed such that this blend would have a certain oct 

degradation io a given number of days in a composting 

environment. 

Example 5 

Morphologv 65 

Samples were analyzed by microscopy to investigate the 

morphology of the pbascs of polylactic acid versus the 

12 

phases of DIONOLL£#3000. The blends were exposed to 

acetone to dissolve the polylactic acid component without 

affecting the BIONOLLE#3000 component. For the blend 

containing 70% by weight of polylactic acid and 30% by 

weight of BIONOLLE/13000, 67% of the material, or 

approximately 95% of the polylactic acid, was dissolved. 

The remaining material was in a sbeet form, and the BIONOLLE#3000 phase io the original blend formed a continuous 

or co-continuous phase, while the dissolved polylactic acid 

left behind holes in the s heet-like structure of BIONOLLE#3000. This continuous or co-continuous structure of 

the BIONOLL£#3000 phase in the original blend explained 

the outstanding toughncs.<> sbowo io the graph of FIG. 6. 

OTIIER EMBODIMENTS 

It is to be understood that while the ioveotion bas been 

described in conjunction with the detailed description 

thereof, tha t the foregoing description is intended to illustrate and not limit the scope o[ the invention, which is 

defined by the scope of the appended claims. Other aspects, 

advantages, and modifications arc within the scope of the 

following claims. 

What is c laimed is: 

1. A biodegradable blend comprising: 

(a) a first polylactic acid-based polymer or copolymer, 

and 

(b) a second polymer consisting essentially of one or more 

polyesters, 

wherein said first and second polymers arc present in a 

ratio of 9: I to I :9 by weight, and wherein the second 

polymer is a homopolymer or random copolymer that 

forms a continuous or co-contiouous phase in the 

blend. 

2. The biodegradable blend of claim 1, wherein said one 

or more polyesters are of one aliphatic Cz to Czo diacid or 

of a combination of two more different aliphatic Cz to C::o 

diacids. 

3. The biodegradable blend of claim 1, wherein said first, 

polylactic acid-based polymer is a homopolymer of polylactic acid. 

4. The biodegradable blend of claim l , wherein said first, 

polylactic acid-based polymer is selected from the group 

consist ing of D-polylactic acid, L-polylactic acid, D,Lpolylactic acid, meso-polylactic acid, and any combination 

of 0-polylactic acid, L-polylactic acid, D,L-polylactic acid 

and meso-polylactic acid. 

5. The biodegradable blend of claim 1, wherein said first, 

polylactic acid-based polymer is a copolymer having at least 

60% by weight of polylactic acid!. 

6. The biodegradable blend of claim 1, wherein said 

second polymer or copolymer is selected from the group 

consisting of polybutylenesuccioate homopolymer, polybutyleneadipate homopolymer, polybutyleoesuccinate-adipate 

copolymer, polyethylenesuccioate homopolymer, polyethyleneadipate homopolymer and polyethylenesuccinateadipate copolymer. 

7. The biodegradable blend of claim 1, wherein said 

polyester is an aliphatic polyester. 

8 . The biodegradable blend of claim 1, wherein said 

second polymer or <-'Opolymer is a copolyester of ao aliphatic 

polyester and up to 50 percent, by weight, of an aromatic 

polyester. 

9. The biodegradable blend of claim 8, wherein said 

aromatic polyester is polyethylene terepbthalate. 

10. A biodegradable blend of claim 1, further comprising 

(c) a compatibili7.er consisting essemially of one or more 

polyesters or polyvinyl alcobols. 
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13 

U . The biodegradable blend of claim 1, said blend having 

an elongation at break of at least 10%. 

12. Tile biodegradable blend of claim 1, sa id blend having 

an elongation at break of at least 200%. 

13. The biodegradable blend of claim 1, said blend having 5 

an elongation at break of at leastlO% after 70 days of aging. 

14. The biodegradable blend of claim l , said blend having 

an elongation at break of at least 200% after 70 days of 

aging. 

15. The biodegradable blend of claim 1, said blend having 10 a toughnes.s of at least 10 MJ/m3 . 

16. The biodegradable blend of claim 1, said blend having 

a toughness of at least 70 MJ/m3 . 

17. The biodegradable blend of claim 1, wherein said 

second polymer is present in said blend as a co-continuous 

phase. 15 

14 

(b) a second polymer consisting essentially of one or more 

polyesters, 

wherein said first and second polymers are present in a 

ratio of 9:1 to L:O by weight, and wberein th second 

polymer is a homopolymer or random copolymer that 

forms a continuous or co-continuous phase in the 

blend. 

23. A bag comprising a biodegradable blend comprising; 

(a) a first polylactic acid-based polymer or co-polymer, 

and 

(b) a Second polymer consisting essentially of one or 

more polyesters. 

wherein said first and second polymers are present in a 

ratio of 9:1 to 1:0 by weight, and wherein the second 

polymer is a homopolymer or random copolymer that 

forms a continuous or co-continuous phase in tbe 

blend. 

18. The biodegradable blend of claim 1, wherein said first, 

poly lactic acid-based polymer or copolymer is a homopolymer of lactic acid or a block, graft, or random copolymer of 

lactic acid having the formula: 

-{R,).-{R:z)b24. A container comprising a biodegradable blend com20 prising: 

wherein R1 is a lactic acid unit, R:: is caprolaetone, 

glycolide, trimethylene carbonate, d ioxanone, butyryl 

lactone, or ethylene oxide, a is 10 to 10,000, and b is 0 to 

10,000. 

19. The biodegradable blend of claim l , wherein said 

polyester has the formula: 

-... [0- (CHu.,- 0 - C- (CHz).- C- lv-... 

II II 

0 0 

wherein m is 2 to 20, n is 2 to 20, and N is 10 to 10,000. 

25 

30 

20. The biodegradable blend of claim 1, wherein said first, 

polylactic acid-based polymer or copolymer is a polylactic 35 

acid homopolymer, and wherein said second polymer or 

copolymer is a polybutylenesuccinate homopolymer. 

21. The biodegradable blend of claim 1, wherein said first, 

polylactie acid-based polymer or copolymer is a polylactic 

acid homopolymer, and wherein said second polymer or 40 copolymer is a polybutylenesuccinate-adipate copolymer. 

22. A fi lm comprising a biodegradable blend comprising: 

(a) a first polylactic acid-based polymer or copolymer, 

and 

(a) a first polylactic acid-based polymer or copolymer, 

and 

(b) a second polymer consisting essentially of one or more 

polyesters, 

wherein said first and second polymers are present in a 

ratio of 9:1 to 1.0 by weight and wherein the second 

polymer is a homopolymer or random copolymer that 

[onus a continuous or co-continuous phase in the 

blend. 

25. A disposable diaper comprising a biodegradable blend 

comprising: 

(a) a first polylaclic acid-based polymer or copolymer, 

anti 

(b) a second polymer consisting. essentially of one or more 

polyesters, 

wherein sa id first and second polymers are present in a 

ratio of 9:1 to 1:0 by weight, and wherein the second 

polymer is a homopolymer or random copolymer that 

forms a continuous or co-continuous phase in the 

blend. 

* * * * * 
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UNJTED STATES PATENT AND TRADEMARK OFFICE 

CERTIFICATE OF CORRECTION 

PATENT NO. : 5,883,199 Page 1 of 1 

APPLICATION NO. : 08/825810 

DATED :March 16, 1999 

INVENTOR(S) : McCarthy et al. 

It is certified that error appears in the above-identified patent and that said Letters Patent is 

hereby corrected as shown below: 

On the title page item (54), and col. 1, line 1,-replace "Polyactic" with-- Polylactic --

Signed and Sealed this 

Twentieth Day of February, 2007 

JON W. DUDAS 

Direc101· oft he United States Patent and Trademark O.[Jice 
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UNITED STATES PATENT AND TRADEMARK OFFICE 

CERTIFICATE OF CORRECTION 

PATENT NO. 

APPLICATION NO. 

DATED 

INVENTOR(S) 

: 5,883,199 

: 08/825810 

: March 16, 1999 

: McCarthy et al. 

Page 1 of 1 

It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below: 

Column 14, Claim 22, Line 4 

Delete " 1 :0" and Insert --1 :9--

Column 14, Claim 23, Line 15 (Approx) 

Delete " 1 :o·· and Insert --1 :9--

Column 14, Claim 24, Line 27 (Approx) 

Delete " 1.0" and Insert--1:9--

Column 14, Claim 25, Line 39 

Delete "1:0" and Insert --1:9--

Signed and Sealed this 

Eighth Day of March, 2011 

f);JY.t_~ David J. Kappos 

Director of t he United States Patent and Trademark Office 
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RESPONDENT 

EXHIBIT 

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PUBLIC DOCUMENT
In the Matter of: 

June 27, 2014 

Stephen T. McCarthy, Ph.D. 

Condensed Transcript with Word Index 

For The Record, Inc. 

PUBLIC DOCUMENT 

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10 (Pages 37 to 40)

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37

1 its molecular mass down to the formation of CO2,

2 H2O, CH4, and other low molecular-weight products

3 under the influence of microorganisms in both

4 aerobic and anaerobic conditions aided by abiotic

5 chemical reactions like photodegradation,

6 oxidation and hydrolysis (14)"

7 Now, as editor of the journal, did you

8 ever tell the authors that you thought the section

9 entitled Definition of Biodegradation should be

10 changed in any way?

11 A. No, because I was not a reviewer.

12 Q. But you approved the article for

13 publication, I think you said?

14 A. Based on the reviews.

15 Q. Now, did you tell the authors that they

16 ought to alter the section Entitled Definition of

17 Biodegradation to specify that the term required

18 complete break down and return to nature within

19 one year of customary disposal?

20 MS. JOHNSON: Objection.

21 A. If any of the reviewers had changes that

22 they wanted made, I would have then relayed that

23 to the -- and in order for it to be accepted, I

24 would have relayed that back to the author. So

25 that could be construed as me asking the author to

38

1 make changes.

2 Q. But did you specifically ask either the

3 authors or any of the reviewers to include within

4 the definition of biodegradation the requirement

5 that there be a complete break down and return to

6 nature within one year of customary disposal?

7 A. No.

8 Q. Let's take look at another article of

9 yours that is entitled biodegradability and

10 mixability of blends containing

11 poly-hydroxy-butyrate co-hydroxyvalerate in the

12 ANTECH 90 journal at 1439.

13 MR. EMORD: We'll mark this as Exhibit

14 Number 4.

15 (Whereupon, Respondent's Deposition

16 Exhibit No. 4, ^ DESCRIPTION, marked.)

17 BY MR. EMORD:

18 Q. We're going to skip that for the moment.

19 What is PET?

20 A. Do you mean what does the abbreviation

21 PET stand for with respect to a polymer?

22 Q. Right?

23 A. Polyethylene terephthalate.

24 Q. In your report, as I understand it, you

25 say that PET is not biodegradable, correct?

39

1 A. Do you want me to check?

2 MS. JOHNSON: Are you referring to

3 something specific?

4 Q. Do you consider PET biodegradable?

5 A. I do not consider PET to be biodegradable

6 in normal composting.

7 Q. Is there any additive that you know, made

8 by any company, that causes PET to become

9 biodegradable?

10 MS. JOHNSON: Objection. What do you

11 mean by biodegradable? What definition are you

12 using?

13 A. I don't think so.

14 Q. Now, how much have you been paid by the

15 FTC in this proceeding?

16 A. So far?

17 Q. Yes.

18 A. $7500.

19 Q. And what is your financial arrangement

20 with the FTC?

21 A. It is $100 an hour, plus the deposition.

22 Q. You're the director of the U Mass Lowell

23 Bioplastics Institute and Medical Plastic Research

24 Center?

25 A. Bioplastics Medical Plastic Research

40

1 Center, yes.

2 Q. With your permission, so I don't have to

3 say that entire name and all of its parts every

4 time I'm referring to, shorten that to Bioplastics

5 Research Center or research center. Is that okay?

6 A. Yes.

7 Q. So that were both on the same page, if I

8 use the term Bioplastics Research Center or

9 research center I'm referring to U Mass Lowell

10 Bioplastics and Medical Plastic Research Center,

11 okay?

12 A. Okay.

13 Q. Now, when was the Bioplastics Research

14 Center established?

15 A. You're talking the bioplastics and

16 medical plastics?

17 Q. Yes.

18 A. Do you want me to go through the

19 history of --

20 Q. No.

21 A. I would say two and a half years ago.

22 Q. 2011?

23 A. Yes.

24 Q. Now, you created it, right?

25 A. Yes.

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11 (Pages 41 to 44)

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41

1 Q. Does the Research Center include members?

2 A. Yes.

3 Q. What companies are industry members?

4 A. Metabolix, Echo Verde -- let me back up.

5 They aren't really members.

6 Q. What are they?

7 A. There are companies that sponsor

8 research.

9 Q. These are the companies that sponsor

10 research, Metabolix, Echo Verde. Who else?

11 A. MMM, Densified Solutions. Are you

12 talking about just the bioplastics and medical

13 plastics?

14 Q. Correct.

15 A. There might be some others.

16 Q. What's the annual operating budget of the

17 center?

18 A. I'm not sure exactly.

19 Q. That's all right. A close approximation?

20 A. About $70,000 a year. I mean, that's

21 total. That's what the university gets.

22 Q. I'm going to have you take a look at a

23 document from Mass Lowell.

24 MR. EMORD: We'll mark this as exhibit.

25 (Whereupon, Respondent's Deposition

42

1 Exhibit No. 4, document entitled Center for

2 Biogradable Polymer Research, marked.)

3 BY MR. EMORD:

4 Q. Now, do you recognize this document?

5 A. Yes.

6 Q. To your knowledge, is it accurate in its

7 description of the Research Center?

8 A. No.

9 Q. It's not accurate. Where is it

10 inaccurate?

11 A. This is not the Research Center.

12 Q. This is another center, Biodegradable

13 Polymer Research Center is not the same as the

14 center we were just talking about?

15 A. Right. That's why I asked you if you

16 wanted me to go through the history.

17 Q. I appreciate that. This is a predecessor

18 to it?

19 A. This is a predecessor to it.

20 Q. When was the Biodegradable Polymer

21 Research Center established?

22 A. I believe it was `93.

23 Q. 1993. Did you establish the center?

24 A. I established it with a colleague.

25 Q. Who is the colleague?

43

1 A. Richard Gross.

2 Q. He was your mentor?

3 A. Is that a question?

4 Q. Yes.

5 A. No.

6 Q. You studied in collaboration with him?

7 A. No.

8 Q. He has a background in biochemistry,

9 right?

10 A. In chemistry.

11 Q. And he wrote articles in which you were

12 also the co-author, right?

13 A. Yes.

14 Q. He did research on polymers, right?

15 A. Yes.

16 Q. And you worked with him on that research

17 and published with him on that research. Were you

18 the more junior person in that association?

19 MS. JOHNSON: Objection.

20 A. No.

21 Q. You were the senior person?

22 A. Yes.

23 Q. When did he retire?

24 MS. JOHNSON: Objection. That assumes

25 facts not in evidence.

44

1 Q. Has he not retired. Is he still at

2 U Mass?

3 A. No, he's not at U Mass.

4 Q. But he's at another institution now?

5 A. Yes.

6 Q. What institution is that?

7 A. Rensselaer Polytechnic Institute.

8 Q. In France?

9 A. In Troy, New York.

10 Q. How much was the annual budget of the

11 Biodegradable Polymer Research Center?

12 A. In what year?

13 Q. `93 to 2011?

14 MS. JOHNSON: Objection.

15 Q. Annual operating budget.

16 A. It varied.

17 Q. Give me the range.

18 A. I would say it varied from $30,000 to

19 possibly maybe close to $200,000.

20 Q. A year?

21 A. Per year.

22 Q. Is Exhibit 4 a complete and accurate

23 description of the Biodegradable Polymer Research

24 Center, do you think?

25 A. It looks like this was a description as

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12 (Pages 45 to 48)

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45

1 of 2008.

2 Q. And as of that year, is it accurate?

3 MS. JOHNSON: Objection.

4 A. I believe so.

5 Q. Let's take a look at another one of

6 these. This one is an updated version. No. This

7 one is the preceding version. We'll find out.

8 We'll mark this as Exhibit 5?

9 (Whereupon, Respondent's Deposition

10 Exhibit No. 5, document entitled Center for

11 Biogradable Polymer Research, marked.)

12 BY MR. EMORD:

13 Q. Can you tell me what is the, if you know,

14 what is the year, this one, of this document? The

15 other one was 2008.

16 MS. JOHNSON: Is this an excerpt of

17 something? Where is the rest of the document?

18 MR. EMORD: He can tell us.

19 MS. JOHNSON: It's your exhibit.

20 MR. EMORD: This is all we have. I

21 don't -- I have these two documents. Whether

22 there are other documents related to it, I'm sure

23 there probably are.

24 MS. JOHNSON: Did you pull this off the

25 website?

46

1 MR. EMORD: It's in our discovery

2 materials. That's all I know.

3 MS. JOHNSON: There's no Bates number on

4 it.

5 MR. EMORD: Right.

6 A. I'm not sure what this is.

7 Q. You don't know what year it is?

8 A. I mean, there is an indication that it's

9 2007.

10 Q. Is this an accurate description of the

11 functioning and purpose of the center, that is

12 Exhibit 5?

13 A. At that time?

14 Q. At that time, roughly 2007/2008.

15 A. I'm not sure.

16 Q. You say in 2011 the center changed its

17 name?

18 A. Yes.

19 Q. And is the purpose of the center since

20 2011 the same as it has been previously, or has it

21 changed?

22 A. In 2011, we expanded it to include

23 medical plastics.

24 Q. So prior to that time, it didn't include

25 medical plastics?

47

1 A. Not officially.

2 Q. Any other change of note in 2011 from the

3 prior functioning of the organization?

4 A. Yes. It was a new location.

5 Q. Previously, it was located where?

6 A. 333 Aiken Street.

7 Q. And now it's located?

8 A. 1001 Pawtucket.

9 Q. Did you expand the size of the facility?

10 A. No.

11 Q. Roughly the same size?

12 A. No.

13 Q. Smaller?

14 A. Yes.

15 Q. What is your salary as a professor at

16 U Mass?

17 A. Approximately $150,000.

18 Q. Do you have any other income related to

19 biodegradable plastics?

20 A. In terms of anything?

21 Q. Anything.

22 A. The royalty.

23 Q. Royalty income from?

24 A. From a patent that's owned by the

25 university.

48

1 Q. Now, you have been responsible for

2 bringing several research grants to U Mass Lowell,

3 right?

4 A. Yes.

5 Q. And as I understand it, it is the policy

6 of U Mass Lowell, when a professor brings in a

7 grant, to assign a portion of that grant money to

8 do the research. That's the vast majority of it?

9 MS. JOHNSON: Objection. What's the

10 foundation?

11 Q. He can answer. The vast majority of it

12 goes to the Research Center or whatever, the fund

13 for the research. And then a portion goes to the

14 university. Do I have that right? Correct me if

15 I'm mistaken.

16 A. Let me maybe recharacterize the statement

17 so that it's more factual.

18 Q. Thank you.

19 A. So there is the total amount of the money

20 is split between direct costs and indirect costs.

21 So there's an overhead rate of 54 percent that's

22 applied to the research monies on the majority of

23 grants.

24 Q. Now, the overhead rate, that goes to the

25 university?

Renewed Resp. Mot. for Leave

Exh. RX-B

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49

1 A. The university.

2 Q. And the remainder of the 100 percent,

3 the --

4 MS. JOHNSON: 46.

5 Q. The 46 percent.

6 A. The remainder is spent on the research.

7 Q. Now, it goes into a research fund, right?

8 A. No.

9 Q. What account receives that 46 percent?

10 A. The project account.

11 Q. Who controls the project account?

12 A. The principal investigator or principal

13 investigators.

14 Q. And are you in control of that account

15 for research that you bring into the universe?

16 MS. JOHNSON: Objection. What account?

17 Q. The project account you just mentioned.

18 A. For projects in which I'm one the

19 principal investigators, I have some control over

20 that.

21 Q. Do you have signatory authority over the

22 account?

23 A. In some cases.

24 Q. Do you receive a salary out of funds that

25 go into that account?

50

1 A. No.

2 Q. Do you receive any personal financial

3 remuneration whatsoever from the funds that go

4 into that account?

5 A. No.

6 Q. Now, in connection with the research

7 money that you are able to land as grants from an

8 institution, does the university ever give you an

9 increase in salary based on its review of those

10 grants?

11 A. So there are two promotions where there

12 are raises. One is for associate professor and

13 one is for full professor. And there are three

14 areas that are important to achieve in order to

15 get that promotion. One is teaching, one is

16 service, and one is research. And in the research

17 part, that would be where the sponsored research

18 would be important.

19 Q. I see. So it's a factor taken into

20 account in determining salary?

21 MS. JOHNSON: Objection.

22 Mischaracterizes his testimony.

23 A. Not in determining salary. In

24 determining the promotion to associate or full

25 professor.

51

1 Q. I see. Now, once you become a full

2 professor, if you continue to get grant monies

3 brought into the university, does that in any way

4 effect the determination of whether to increase

5 your pay?

6 A. No.

7 Q. It has no effect whatsoever?

8 A. Up until like this last year, it didn't

9 really have an effect. It's not a good thing.

10 It's because the union was -- it's a faculty

11 union. Up to two years ago, I think there's .5

12 percent increase in salary. I'm just guessing.

13 I'm not sure exactly. But I think right now

14 there's .5 percent increase in salary that's

15 possible from merit. And merit, that would enter

16 into merit.

17 Q. The university has a policy about

18 professors inventing something and getting a

19 patent for it, don't they?

20 MS. JOHNSON: Objection. Vague.

21 A. They encourage it.

22 Q. They have a policy related to patents?

23 A. They have many policies related to

24 patents.

25 Q. If you invent something at the lab at the

52

1 university, and you wanted to secure a patent for

2 the invention, what would the university require?

3 A. If I wanted to secure a patent, it would

4 probably have to not be done in the lab, and it

5 would have to be something that's not related to

6 any of my research.

7 Q. But if you did discover something in the

8 lab, what would the university do? Would they

9 say -- under the policy that exists -- would they

10 say we'll get the patent, you can be co-owner of

11 the patent. How does that relationship work?

12 A. If it was something in the lab related to

13 my research, I would not be allowed to get a

14 patent on it.

15 Q. The university would get the patent?

16 A. The university -- if there was a patent

17 to be issued, the university would own it. Or if

18 I did get a patent, they would probably take me to

19 court or something.

20 Q. Let's take a look at patent number

21 5,833,199, which we'll mark as Exhibit 6?

22 (Whereupon, Respondent's Deposition

23 Exhibit No. 6, patent number, 5,833,199, marked.)

24 BY MR. EMORD:

25 Q. Do you recognize this patent?

Renewed Resp. Mot. for Leave

Exh. RX-B

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14 (Pages 53 to 56)

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53

1 A. Do you want me to go through the whole

2 thing?

3 Q. Go through each page and make sure it's a

4 true and correct copy of your patent.

5 A. The question is -- I forgot?

6 Q. Is this your patent?

7 A. No, it's not my patent.

8 Q. Whose patent is it?

9 A. The university of Massachusetts.

10 Q. You're listed as one of the inventors?

11 A. Yes.

12 Q. The university of Massachusetts is listed

13 as the assignee on the patent?

14 A. The assignee?

15 Q. Who assigned the patent to the assignee?

16 A. The university.

17 Q. The university assigned the patent to

18 itself?

19 A. Again, the policy is if it's something

20 that's invented at the lab and related to

21 research, the university owns the rights to that.

22 Q. Is there an agreement between you and the

23 university concerning this patent?

24 A. Yes.

25 Q. Is it in writing?

54

1 A. Yes.

2 MR. EMORD: May we have a copy of the

3 agreement?

4 MS. JOHNSON: I think he's referring to

5 the general policy. I don't think there's a

6 written signed agreement between the parties.

7 Q. Is there a written signed agreement

8 between you and the university?

9 MS. JOHNSON: Not that I'm aware of.

10 A. You mean regarding the patent?

11 Q. Assignment of the patent, yes.

12 A. Yes.

13 MR. EMORD: Could we have that.

14 A. The university has it.

15 Q. And in addition, there are written

16 policies that the university has that pertain to

17 patents such as this?

18 A. Yes.

19 Q. And do you have access to those policies?

20 A. Yes.

21 MR. EMORD: May we have copies of those

22 written policies?

23 MS. JOHNSON: Sure.

24 Q. What are the terms of the assignment

25 agreement, as best you can remember, between you

55

1 and the university?

2 A. That they have exclusive rights to it, to

3 do whatever they want.

4 Q. Now you receive royalties under the

5 patent, right?

6 A. I receive a portion of the royalties.

7 Q. The royalties are assigned to the

8 university?

9 A. The royalties are paid to the university.

10 Q. And the university pays you a portion of

11 the royalties?

12 A. The university pays a portion of the

13 royalties to me.

14 Q. What percentage royalty, do you know,

15 that the university gets?

16 A. The university gets 70 percent of the

17 royalties, and 30 percent is split between the

18 inventors. And that is only on the profit. So

19 there's a long time where you're paying back the

20 lawyer's fees, the prosecution, the maintenance

21 fees, before you see a penny.

22 Q. And the three people who split the 30

23 percent are the inventors listed in the patent?

24 A. That's correct.

25 Q. And they each receive what, 10 percent?

56

1 A. About that.

2 Q. How much money did you receive, let's

3 say, in 2011, from your patent royalties? Let's

4 make it a little easier, 2013.

5 A. Altogether it's been about $28,000.

6 Q. And in 20 --

7 A. No, for all time.

8 Q. Approximately, how much do you get a

9 year, the range?

10 A. It varies. One year, I didn't get any,

11 because it was a challenge and lawyers got

12 involved. Nothing against lawyers. I think I got

13 in the range of 4 to $5,000 this year.

14 Q. How much has Metabolix given to U Mass

15 Lowell in grants for sponsored research that you

16 did? Is the name Metabolix?

17 A. Yes, Metabolix.

18 Q. What did I say? As in metabolic

19 function.

20 A. Yes. That's exactly why they chose the

21 name.

22 Q. Exactly how much money has Metabolix

23 given to the center?

24 A. I'd say approximately 1.7 million

25 dollars.

Renewed Resp. Mot. for Leave

Exh. RX-B

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15 (Pages 57 to 60)

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57

1 Q. And are they committed --

2 A. I mean, that's in sponsored research.

3 Q. Yes.

4 A. Okay.

5 Q. Is there another form of support they

6 give?

7 A. Royalties.

8 Q. And any other form?

9 A. There was a -- there was also a grant

10 that was written, whereby, they paid the

11 university for equipment that was purchased by the

12 university. So it was sort of a repayment for

13 equipment that the university purchased.

14 Q. Are you paid as a consultant by

15 Metabolix?

16 A. I was paid for the expert witness

17 testimony.

18 Q. How much were you paid?

19 A. For the two cases, approximately $5,000.

20 Q. For both cases or independently?

21 A. Both cases.

22 Q. And are you paid in any other way by

23 Metabolix?

24 A. No.

25 Q. Are you paid by any other company

58

1 personally?

2 A. Well, I'm compensated for the expert

3 witness.

4 Q. Yes. But as a consultant to any other

5 company, are you paid?

6 A. I don't think so.

7 Q. With Metabolix, are they going to

8 continue to supply research grants to the center?

9 A. Honestly, I don't think so.

10 Q. Do you know today?

11 A. I don't know today.

12 Q. How many years have they supplied

13 research grants to the center?

14 A. I don't know specifically, but I would

15 estimate it to be over 20 years.

16 Q. And have they given funding annually over

17 that 20 years?

18 A. There may have been some years when they

19 didn't fund anything.

20 Q. When you mentioned the 1.7 million,

21 that's the total over that 20-year period?

22 A. Over the 20 years, yes.

23 Q. Now, this patent that we've marked for

24 identification as Exhibit 6, is Metabolix the

25 exclusive license holder?

59

1 A. Yes. They are the exclusive licensee

2 with the option to sublicense.

3 Q. Have they sublicensed?

4 A. Yes.

5 Q. To which parties?

6 A. The ones I know about are the ASF,

7 Natureworks. Those are the ones that I definitely

8 know about. I know they were talking to

9 Georgia-Pacific, the Dixie people.

10 Q. Solo Cup?

11 A. If it's Solo.

12 Q. Maybe it's Dixie Cup.

13 A. International Paper.

14 Q. Are there biodegradable products on the

15 market made under the 199 patent, Exhibit 6?

16 A. I believe so.

17 Q. What products are on the market?

18 A. I don't know specifically.

19 Q. Do you have general idea?

20 A. I believe it's mainly compost -- plastic

21 compost bags.

22 Q. Any other products?

23 A. I don't know. That's all Metabolix.

24 Q. Do you know whether those products are --

25 have labels or labeling associated with them that

60

1 identifies them as compostable or biodegradable?

2 A. I do not.

3 Q. You've never seen the finished product?

4 A. No.

5 Q. And Metabolix has never supplied you with

6 samples of finished product?

7 A. No.

8 Q. Have you ever seen advertising by

9 Metabolix related to your patent?

10 A. No.

11 Q. Or products that are made under your

12 patent?

13 A. No.

14 Q. Now, customers in the market for

15 biodegradable plastics, compostable products have

16 a lot of choices out there?

17 MS. JOHNSON: Objection. Lacks

18 foundation.

19 Q. Do you know?

20 A. They have -- I mean, there are more than

21 a couple choices. It's not a huge amount.

22 Q. So you're not saying there's a monopoly

23 associated with your 199 patent, it's a

24 competitive marketplace, right?

25 MS. JOHNSON: Objection.

Renewed Resp. Mot. for Leave

Exh. RX-B

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16 (Pages 61 to 64)

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61

1 Mischaracterizes his testimony.

2 Q. To your knowledge.

3 A. I mean, the 199 patent is primarily based

4 on Natureworks' product. And so if -- it would be

5 a monopoly -- there could be other people who may

6 produce polylactic acid, but they're minor

7 compared to Natureworks.

8 Q. But that particular product is in

9 competition with other compostable and

10 biodegradable products in the market, right?

11 A. Sure.

12 Q. So you wouldn't have to buy plastics bags

13 that were compostable from Natureworks, you could

14 go to another company that uses another invention?

15 A. Yes.

16 Q. And you could get biodegradable plastic

17 bags, compostable plastic bags, recyclable plastic

18 bags, you have a quite an array of products to

19 chose from?

20 MS. JOHNSON: You mean products that are

21 being marketed, biogradable compostable, not that

22 they are in fact biodegradable compostalbe.

23 Q. That are marketed as biodegradable

24 compostable, recyclable, there's quite an array

25 that you can choose from, right?.

62

1 A. Yes.

2 Q. In other words, it's a competitive

3 marketplace?

4 A. Yes.

5 MR. EMORD: Let's go off the record.

6 (Off the record.)

7 BY MR. EMORD:

8 Q. Now, have you seen any complaint or -- by

9 complaint, I'm using that term broadly, not just a

10 legal complaint in a court. I'm using the term

11 really as a letter or an objecting document. Have

12 you ever seen such a document before this case was

13 filed that related to ECM Biofilms?

14 A. Before this case was filed, no.

15 Q. For example, you did not see an e-mail to

16 Janice Frankel, an FTC attorney, from Brian Igoe?

17 MS. JOHNSON: Objection. Lacks

18 foundation.

19 Q. Do you know Brian Igoe?

20 A. Yes.

21 Q. Is he with Metabolix?

22 A. No.

23 Q. Is he a lawyer?

24 A. He was with Morrell, when they first spun

25 our Morrell.

63

1 Q. When they first what?

2 A. When Metabolix first spun out Morrell.

3 Q. Before that, was he with Metabolix?

4 A. No.

5 Q. Are you familiar with or have you ever

6 seen an e-mail to Janice Frankel from Brian Igoe

7 complaining about ECM's claims and urging FTC to

8 take action against ECM?

9 A. No, I don't believe so.

10 Q. Have you ever see any other document, any

11 communication, from Metabolix to the Federal Trade

12 Commission concerning ECM?

13 A. I've seen the documents that were

14 provided to me by complaint counsel. So I don't

15 believe anything was from Metabolix.

16 Q. Have you ever seen a document complaining

17 about ECM Biofilms or its claims from Metabolix to

18 the Federal Trade Commission?

19 MS. JOHNSON: Objection. Asked and

20 answered.

21 A. Again, if it was in the documents

22 supplied to me by complaint counsel.

23 Q. Do you have any specific recollection of

24 a document from Metabolix to the FTC complaining

25 about ECM BioFilms?

64

1 A. No.

2 Q. Do you know that Metabolix filed a

3 complaint with the FTC about ECM BioFilms?

4 A. No.

5 Q. You haven't had any discussion with

6 Metabolix about the filing of such a complaint?

7 A. No.

8 Q. They didn't ask you to review any content

9 of the complaint or consult with you at all

10 concerning the complaint?

11 A. No.

12 Q. What is Solutia?

13 A. I believe it's a spin out from Monsanto.

14 Q. And has Solutia -- forgive me if I'm

15 mispronouncing it -- has Solutia given grants to

16 your center?

17 A. I'm not sure. Under the original

18 incarnation of the center, Monsanto was a member

19 of the center. They might have changed. I think

20 the portion -- I don't think Solutia ever gave

21 anything to the center. They donated a patent to

22 the university.

23 Q. Now, in your 199 patent --

24 A. You mean the university's?

25 Q. Yes. When I use that term, we'll

Renewed Resp. Mot. for Leave

Exh. RX-B

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17 (Pages 65 to 68)

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65

1 understand however I refer to Exhibit 6 that

2 actually it is held by the university. Now, let

3 me back up just a little bit here. Have you ever

4 informed any of the parties that give grants to

5 your center that you didn't consider plastics

6 biodegradable, unless they completely break down

7 and return to nature?

8 A. I don't believe so.

9 Q. Have you ever told them that you don't

10 consider plastics biodegradable unless they do

11 that, completely break down and return to nature

12 within one year after customary disposal?

13 A. I don't believe so.

14 Q. Have you ever informed any of the

15 corporate funders for the center that additives to

16 plastics won't cause biodegradation?

17 MS. JOHNSON: Objection. Vague.

18 Plastics?

19 A. So we did a lot of work on additives, and

20 typically we wanted them to be biodegradable to

21 maintain the biodegradability of the total system.

22 Q. And in each of those instances, did you

23 establish with proof that the additive caused the

24 plastics to completely break down and return to

25 nature, that is, decompose into elements found in

66

1 nature, within one year after customary disposal?

2 A. I don't believe so.

3 Q. Let's take a look at paragraphs 17 and 37

4 of your expert report. Paragraph 17 is on page 7.

5 Go ahead and read 17 and 37, if you will, first 17

6 and 37, to yourself.

7 A. Okay.

8 Q. Now, is it the case that if we take a

9 look at 17 and 37, it's your position that the

10 additive in the ECM product is no more susceptible

11 to a -- the plastic is no more susceptible,

12 conventional, no more susceptible to microbial

13 attack after it's blended with the ECM additive

14 than before?

15 A. As long as it's added to a

16 nonbiodegradable polymer.

17 Q. So if it's nonbiodegradable polymer,

18 under what you've identified in the report and the

19 additive is added to it, it's no more

20 biodegradable after its been added than it is

21 before; that's your opinion?

22 A. Yes.

23 Q. Now, can I be -- is this an accurate

24 statement, that conventional plastics are not

25 biodegradable?

67

1 A. That would be an accurate statement.

2 Q. What are conventional plastics?

3 A. Well, the majority of plastics

4 polyethylene, polypropylene, PVC, Teflon, PET,

5 Azdel.

6 Q. And for all of those, is it your position

7 that they're no -- that they are not susceptible,

8 any more susceptible to microbial attack after the

9 ECM additive is added to them than before?

10 A. Yes.

11 Q. Is it further your position that there is

12 no additive that you know of that could transform

13 a conventional plastic into a biodegradable

14 plastic?

15 MS. JOHNSON: Objection.

16 Mischaracterizes his testimony. Assumes facts not

17 in evidence.

18 A. One that degrades completely in one year?

19 Q. Right.

20 A. I don't know of one.

21 Q. Let's take a look at the patent again,

22 Exhibit 6. As I understand the invention, and you

23 can help me understand it better, or correct my

24 misunderstanding, you start with polylactic acid

25 PLA and you blend it with any other polyester, and

68

1 the result is a biodegradable polymer; is that

2 correct?

3 A. No.

4 Q. Tell me where I have that mistaken.

5 A. Do you want me to explain to you what the

6 patent is?

7 Q. Sure.

8 A. The patent is a polylactic acid-based

9 polymer or copolymer, and the polyester is an

10 aliphatic diacid. So the first one is polylactic

11 acid, and the second one is -- a number of them,

12 could be C2 to C20 diacid with two more different

13 aliphatic diacids. The group --

14 Q. I might draw your attention to paragraph

15 12 of the patent, under other embodiments, that

16 might help?

17 A. Column 12?

18 Q. Yes. Under other embodiments. You see

19 there are a listing that proceeds from 1 through

20 10?

21 A. Yes. Proceeding onto the next page to

22 25. Does that give an accurate summation of the

23 claims.

24 A. Yes.

25 Q. And of the blends?

Renewed Resp. Mot. for Leave

Exh. RX-B

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69

1 A. Yes.

2 Q. So that would be a complete and accurate

3 summation of the blends?

4 A. This would be the -- what is claimed in

5 the invention.

6 Q. In particular, if you look at column 6,

7 lines 9 to 12. There it is stated an example of

8 an aromatic polyester that can be used in up to 50

9 percent by weight in the copolyester is

10 polyethylene terephthalate. Other aromatic

11 polyesters can be used. That polyethylene

12 terephthalate, that's PET, right?

13 A. It would be co-PET.

14 Q. Does it say that there?

15 A. It's a copolyester.

16 Q. Yes, copolyester is biodegradable?

17 A. So it would be something like

18 polyethylene buterate co polyethylene

19 terephthalate.

20 Q. As I understands it, the protocol that

21 you've used -- let me back up just a little bit.

22 The protocol that you used here, that is described

23 in the patent to establish the biodegradability of

24 the blend, blends, five blends, is your own

25 testing methodology that you developed at U Mass

70

1 Lowell, right?

2 MS. JOHNSON: Objection.

3 Q. It was your own testing methodology that

4 you developed?

5 A. It was developed within the center, yes.

6 Q. And as I understand it, under column 10

7 of the patent, you have a description of that

8 testing methodology; is that correct, example 3?

9 A. Yes.

10 Q. And that testing methodology is described

11 as UML-7645?

12 A. Yes.

13 Q. The results of your testing are shown at

14 figure 11; is that right?

15 A. Yes.

16 Q. As I have read through this, I don't see

17 any proof of biodegradation being supplied through

18 use of 14C radiologic testing; is that correct?

19 A. That's correct.

20 Q. Also, I do not see any representation in

21 the patent that you established that the

22 product -- the blends would completely break down

23 and return to nature, that is, decompose into

24 elements found in nature, within one year after

25 customary disposal; is that right?

71

1 A. This was not intended to -- yes, that's

2 right.

3 Q. So your claim for this biodegradable

4 plastic in the patent doesn't depend on proof of

5 satisfaction of the definition of biodegradation

6 or biodegrade in footnote 1 of your expert report?

7 MS. JOHNSON: Objection.

8 A. So one of these is polylactic acid, and I

9 think I responded earlier to say that polylactic

10 acid I believe would completely degrade in one

11 year in the correct environment.

12 Q. One of them is, but not all of them?

13 A. The vinyl goes to 100 percent within 50

14 days.

15 Q. Right, but all five of the ones that are

16 listed under figure 11, you have established would

17 biodegrade within one year completely?

18 A. I believe they would.

19 Q. You believe so. Did you prove that? Did

20 you test them to establish that?

21 MS. JOHNSON: Objection.

22 A. If the vinyl goes by itself and the PLA

23 goes, then any blend would go.

24 Q. My question is more specific. Did you

25 test your product to establish within a year that

72

1 it would completely biodegrade?

2 A. No.

3 Q. You're extrapolating then from the 50

4 days in the study to the conclusion that they will

5 eventually completely biodegrade?

6 MS. JOHNSON: Objection.

7 Mischaracterizes his testimony.

8 A. No. I'm using the pure Bionolle to

9 establish that that goes to a hundred percent.

10 Q. The pure Bionolle. But as far as the

11 remaining blends are concerned -- let me back up a

12 little bit. There are a total of five blends,

13 right?

14 A. Yes.

15 Q. For those five blends, you did not

16 perform a test to determine if they would

17 completely biodegrade within a year?

18 MS. JOHNSON: Objection, relevance.

19 A. I did not.

20 Q. If you look at Claim 1 of the patent, you

21 can read along with me and correct me if I'm

22 wrong, a biodegradable blend comprising of first

23 polylactic acid-based polymer or co polymer and a

24 second polymer consisting essentially of one or

25 more polyesters wherein said first and second

Renewed Resp. Mot. for Leave

Exh. RX-B

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23 (Pages 89 to 92)

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89

1 Q. And when a company receives the BPI

2 certification are they, to your knowledge,

3 authorized then to place a logo or other form of

4 certification on the products?

5 A. I believe so.

6 Q. What does that certification or logo

7 provide; do you know?

8 A. It provides a certification that it meets

9 the standard of the D64 -- that it has met.

10 Q. And does it indicate that it's

11 compostable or biodegradable?

12 A. Compostable.

13 Q. And is there any other, to your

14 knowledge, information on the logo other than BPI

15 certified and compostable?

16 A. I don't know.

17 Q. Earlier we had discussed Metabolix grants

18 to the center. And I want to present you with a

19 copy of a document that's from UML Education News.

20 (Whereupon, Respondent's Deposition

21 Exhibit No. 7, article dated 06/30/2010, marked.)

22 BY MR. EMORD:

23 Q. What I would like to do is have you take

24 a look at that. It's a short one-page document.

25 And inform me if the content presents an accurate

90

1 depiction or is inaccurate in any respect?

2 A. Could I correct prior testimony?

3 Q. Go ahead.

4 A. I apparently misspoke when I said that

5 Brian Igoe was an employee of Morrell. He was

6 actually an employee of Telles, which was a

7 spinoff of Morrell into bioplastics.

8 Q. Thank you for that.

9 A. Anything else about this -- anything

10 about this that is an inaccurate representation,

11 to your knowledge.

12 A. I think the 2.5 million is wrong. It

13 should be 1.5. That's about it.

14 Q. Any other change you would make to ensure

15 its accuracy?

16 A. No.

17 Q. Let's look at another similar document.

18 (Whereupon, Respondent's Deposition

19 Exhibit No. 8, UMLEDU News document, marked.)

20 BY MR. EMORD:

21 Q. Take a moment. This is a two-page

22 document. It is a UMLEDU news document again.

23 Take a moment and look at that and inform me if

24 there's anything to your knowledge that's

25 inaccurate about the content of that article.

91

1 A. I don't see anything wrong. The patent

2 holder is not me.

3 Q. Other than that?

4 A. No.

5 Q. Who is Steve mow Joe?

6 A. Steve Mojo is the, I believe, the head of

7 BPI.

8 Q. Do you have a good relationship with

9 Steve?

10 A. Yes.

11 Q. How frequently do you guys talk by phone,

12 for example?

13 A. Not often.

14 Q. E-mail, how frequently do you exchange

15 e-mails?

16 A. Not often.

17 Q. In the last month, how many times have

18 you interacted with Steve Mojo?

19 A. Zero.

20 Q. Last year?

21 A. Zero.

22 Q. Is there anyone else at BPI that you

23 interact with regularly?

24 A. No.

25 Q. Are you on BPI's international advisory

92

1 board?

2 A. I don't believe so.

3 Q. If they list you on their international

4 advisory board, that would be news to you?

5 A. That would be news to me.

6 Q. Are you a member of BPI?

7 A. No.

8 Q. Are you or have you of been an officer of

9 BPI?

10 A. No.

11 Q. Previously you said you have not done

12 consulting work for BPI?

13 A. I did certification that we went through.

14 Q. So that was consulting work?

15 A. That was --

16 Q. Were you paid?

17 A. I was reimbursed for that.

18 Q. How much were you paid?

19 A. For the whole certification of each

20 company it was $1,000.

21 Q. Per company or for every company?

22 A. Per company.

23 Q. How many companies did you certify?

24 A. About 30, over the ten years or so.

25 Q. Do you continue to perform that function?

Renewed Resp. Mot. for Leave

Exh. RX-B

PUBLIC DOCUMENT
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93

1 A. No.

2 Q. When did you discontinue performing that

3 function?

4 A. I believe it was two years ago.

5 Q. So from what period to what period did

6 you perform the certification for BPI?

7 A. Probably 2001 to 2011.

8 Q. Who did you interact with at BPI related

9 to that?

10 A. Steve Mojo.

11 Q. How frequently did you interact with

12 Steve concerning the certification issues?

13 A. It would be on average about three per

14 year. So it would have been like probably four

15 times per certification.

16 Q. Did you contact Steve or did Steve

17 contact you first in relationship to this job?

18 A. Steve contacted me. He had a series, a

19 whole list of reviewers.

20 Q. Do you know who recommended you for that

21 position?

22 A. No.

23 Q. Steve didn't mention that?

24 A. No.

25 Q. Has Steve ever recommended you for other

94

1 work?

2 A. I don't believe so.

3 Q. Has Steve ever been responsible for

4 referring companies to give grants to your center?

5 A. No.

6 Q. Have you ever referred companies to Steve

7 for certification or for becoming member of BPI?

8 A. No.

9 Q. Do you speak at BPI conferences?

10 A. No.

11 Q. Have you ever spoken at any event

12 involving BPI?

13 A. I spoke the an a conference in India that

14 Steve Mojo also spoke at.

15 Q. Were you paid in association with that?

16 A. No.

17 Q. Did they pay for your transportation to

18 and from?

19 MS. JOHNSON: Objection.

20 A. BPI?

21 Q. BPI.

22 A. No.

23 Q. Anyone else, a corporation?

24 A. I think that I had to pay for the air

25 fare to India, and then they covered the hotel,

95

1 the Indian SIPIT they called it, sponsored

2 conference.

3 Q. What is BEPS?

4 A. That's a society for promoting

5 biodegradable and environmentally degradable

6 polymers, not promoting them, but to discuss the

7 science around biodegradable and environmentally

8 degradable polymers.

9 Q. Did BPI create the BEPS?

10 A. No.

11 Q. It's independent?

12 A. In independent.

13 Q. Are you a founding member of BEPS?

14 A. Yes.

15 Q. When was that created?

16 A. That's a good question.

17 A. I think it was `93. No. `92 or `93.

18 Q. Is Metabolix a member or supporter of

19 BEPS?

20 A. No.

21 Q. I think previously I asked you about

22 complaints with regard to your knowledge of

23 whether BPI had filed complaints against ECM. Do

24 you know whether BPI filed comments concerning the

25 FTC's green guides?

96

1 A. Comments in -- no.

2 Q. You weren't involved with the filing of

3 any comments by BPI, if it did file them, with the

4 FTC?

5 A. That's correct.

6 Q. Let's take a look at paragraph 22 of your

7 report. Now, there you refer to hydraulic

8 cleavages. What are hydraulic cleavages?

9 A. Actually, it should be hydrolytic.

10 Q. There you explain that microorganisms

11 secrete enzymes that adhere to the surface of the

12 organic materials and cause fissures in the

13 molecular chain known as hydraulic cleavages, and

14 you meant to say?

15 A. Hydrolytic.

16 Q. These cleavages make long-chain molecules

17 shorter, resulting in the release of carbon and

18 energy heat. Now, assuming I'm a student or

19 whatever, I would like for you to do the same

20 thing, can you take a piece of paper for me and

21 draw the chemical reaction pathway with chemical

22 structures that would illustrate the chemical

23 process that you're defining here in paragraph 22?

24 A. Yes.

25 Q. Let's get a piece of paper. Can you draw

Renewed Resp. Mot. for Leave

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141

1 Synthetic Polyesters Enzymes as Potential

2 Catalysts for Polyester Recycling and Process

3 Biochemistry?

4 MS. JOHNSON: Objection. Do you have a

5 copy of the article?

6 MR. EMORD: No. I'm just seeing if he

7 knows that as a familiar source.

8 A. Yes.

9 Q. You're familiar with that article?

10 A. Yes.

11 Q. What does that article stand for?

12 A. Basically what you read as the title,

13 that he found an enzyme that was able to

14 hydroliticly cleave PET.

15 Q. Okay. Thank you. Do you think synthetic

16 plastics biodegrade in and of themselves?

17 A. Some of them.

18 Q. Have you read the peer-reviewed article

19 by Shaw et al. entitled Biological Degradation of

20 Plastics, a Comprehensive Review in Biotechnology

21 Advances, 2008?

22 A. I believe so.

23 Q. Do you recall the substance of that

24 article?

25 A. I think it was another review like these

142

1 reviews.

2 Q. Do you recall what the gist or

3 proposition of that article?

4 A. It was just reporting on what other

5 people have reported.

6 Q. About the biological degradation of

7 plastics?

8 A. Yes.

9 Q. Now, does low density PE biodegrade?

10 A. High molecular weight low density

11 polyethylene does not biodegrade.

12 Q. Have you read the peer-reviewed article

13 by P-A-R-M-I-L-A et al. entitled Biodegradation of

14 Low Density Polyethylene by Fungi Isolated from

15 Municipal Landfill Areas in the Journal of

16 Microbiological Biotechnology Research 2011?

17 A. I think so.

18 Q. Do you remember what that was about?

19 A. I think it was a report of small amounts

20 of degradation.

21 Q. Does low density polyethylene biodegrade?

22 A. I don't believe so.

23 Q. You mention in your report raid --

24 A. Do you mean biodegrade at all?

25 Q. Biodegrade at all. Do you want to answer

143

1 again?

2 A. In all these polymers there's molecular

3 weight distribution and there could be some low

4 molecular weight chains that could be oxidized

5 that may be able to be degraded.

6 Q. I appreciate that. Radiological marker C

7 testing. Now, in your report you identify that --

8 you said there's one test that you would deem

9 essentially -- and correct me if I'm wrong --

10 dispositive as to whether additives like ECMs

11 cause biodegradation of plastics containing them,

12 and that test is 14C?

13 A. Carbon 14, yes.

14 Q. And just for context, in paragraph 60 on

15 page 24 you write, absent an approved ASTM

16 specification, it is my opinion that to

17 scientifically prove a claim that the plastic --

18 not merely the additive and inoculum -- is

19 biodegrading, the claimant must support its claim

20 with at least one test with positive results from

21 14C labeling of the conventional plastic, right?

22 A. Yes.

23 Q. And are you aware of any peer-reviewed

24 journal article that identifies radiological

25 marker C testing as the only definitive test to

144

1 establish biodegradation of plastics?

2 MS. JOHNSON: Objection.

3 A. So when Eastman was introducing their

4 copolyester that's PET with the aliphatic

5 polyester, they did get some results that there

6 was biodegradation. And it was believed that PET

7 did not degrade. And so they labeled the benzene

8 ring in the PET and then did the degradation test

9 and proved that the -- because they didn't want

10 the benzene rings to be just not degrading in the

11 environment. So they proved that the benzene

12 rings degraded.

13 Again, as long as it was enough -- I

14 think it was 50 percent aliphatic polyester. And

15 that was a very affordable test.

16 Q. My question really is different, in that

17 I'm looking for whether there is -- whether you're

18 aware of a peer-reviewed journal article that has

19 identified radiological marker C testing as the

20 only definitive test to establish biodegradation

21 of plastics?

22 A. Yes, I think that resulted in a

23 peer-reviewed article.

24 Q. Did it identify radiological C testing as

25 the only definitive test?

Renewed Resp. Mot. for Leave

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145

1 A. Yes.

2 Q. Let's get the citation for that. When

3 was it published?

4 A. I'm not sure.

5 Q. Do you have that article?

6 A. Let me see. It was around the time of my

7 patent. Not my patent. The university's patent.

8 Yes, around '98 or '97.

9 Q. Where was it published?

10 A. I don't know.

11 Q. In a peer-reviewed journal?

12 A. Yes.

13 Q. Do you have a copy of it?

14 A. Not on me.

15 Q. Do you have it back in Lowell?

16 A. Probably.

17 Q. May we have a copy of that article? Did

18 you say it was Eastman?

19 A. Yes.

20 Q. Do you remember who the authors were?

21 A. Charles Buchanan.

22 Q. B-U-C-H-A-N-A-N?

23 A. Yes.

24 Q. Anyone else?

25 A. I'm sure there were others.

146

1 Q. Where is Charles Buchanan?

2 A. I'm just guessing. He's probably on his

3 farm in Tennessee because he's retired. Or he's

4 in Florida where everybody else goes.

5 Q. Has the 14C radiological marker that you

6 recommended as a confirmatory test already been

7 used to prove that polyethylene biodegrades?

8 A. It's been used to prove that a small

9 portion of polyethylene biodegrades.

10 Q. Do you remember what the source is for

11 that information?

12 A. That's the Albertsson paper.

13 Q. Are you familiar with that article?

14 A. Yes.

15 Q. Let's take a look at it.

16 (Whereupon, Respondent's Deposition

17 Exhibit No. 14, ^ DESCRIPTION, marked.) 14

18 BY MR. EMORD:

19 Q. Now, did you become familiar with that

20 article before this litigation or after?

21 A. Before.

22 Q. And what's going on here? She's got

23 polyethylene film. She does what with it, and how

24 does this C14 process work? What were the

25 results?

147

1 A. So they bought carbon 14 labeled ethylene

2 and then polymerized it to polyethylene. And then

3 studied the release of carbon 14 labeled carbon

4 dioxide from that polyethylene.

5 Q. They're really studying the gas release,

6 the carbon dioxide release?

7 A. That's correct.

8 Q. What did they determine?

9 A. They determined that they get .4 percent

10 degradation in 800 days.

11 Q. If we look at the synopsis, and can you

12 tell me if the synopsis is in any way not an

13 accurate reflection of the remainder of the

14 article. It says both the soil and the different

15 mold cultures reflected with very good agreement,

16 a definite liberation of 14 CO2 from the 14C

17 labeled polyethylene film. Significantly above

18 produced abiotically from aging samples. This is

19 interpreted as due to an enzymatic cleavage and

20 oxidative conversion of synthetic polymeric or

21 oligomeric alkanes with limited chain length,

22 accessible for biodegradation, right?

23 A. Yes.

24 Q. In your judgment did that 14C marker

25 provide definitive proof in this study of that

148

1 effect?

2 A. .5 percent in two years?

3 Q. Right. Of biodegradation?

4 MS. JOHNSON: Objection. Do you mean to

5 completion?

6 Q. No. Of biodegradation.

7 A. Right. Again, as I stated earlier,

8 there's a distribution of molecular weight. There

9 probably is some low molecular weight that could

10 then be oxidized and then degraded to a very small

11 extent.

12 Q. That's your theory there. But that

13 theory isn't supported in the article itself, is

14 it?

15 MS. JOHNSON: If you need to read the

16 whole thing, feel free.

17 A. Yes. It says the source of the 14C

18 metabolization in these degradational experiments

19 must have been mainly low molecular weight

20 polyethylene.

21 Q. Can you show me the page for that?

22 A. Sure. 3432.

23 Q. And where are you?

24 A. The last paragraph.

25 Q. However, that's not stated as a specific

Renewed Resp. Mot. for Leave

Exh. RX-B

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40 (Pages 157 to 160)

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157

1 Q. I'm going to give you another article.

2 (Whereupon, Respondent's Deposition

3 Exhibit No. 16, ^ DESCRIPTION, marked.)

4 BY MR. EMORD:

5 Q. Let's take a moment to refresh your

6 recollection. This is one of your articles,

7 right?

8 A. Yes.

9 Q. Do you recall whether in this article you

10 said that single test method would not provide all

11 of the answers to time period, loss of priorities

12 and formation of toxic intermediaries, complete

13 mineralization and variable environmental exposure

14 conditions. Take a look at page 294.

15 A. Okay.

16 Q. Now, is it your position in this article

17 that a single test method does not provide all the

18 answers to those questions you delineate in the

19 first full paragraph on page 294, and you

20 enumerated questions?

21 MS. JOHNSON: What was the question?

22 Q. The question is whether it is his

23 position in this article that a single test method

24 would not provide all of the answers to the

25 questions that he specifies enumerated in the

158

1 first full paragraph on page 294.

2 A. It would not -- this could not be, that's

3 correct.

4 Q. That in fact stated there as the last

5 sentence, furthermore, a single test method will

6 not provide all of the answers to the questions

7 above.

8 A. That's correct.

9 Q. And you still stand by that view today?

10 A. Yes.

11 Q. Let's take a look at another of your

12 articles. This one is Exhibit 18.

13 (Whereupon, Respondent's Deposition

14 Exhibit No. 18, ^ DESCRIPTION, marked.)

15 BY MR. EMORD:

16 Q. Now, in this study you measured soil

17 degradation rates of polylactic acid, right? It

18 looks like, and you can tell me, it looks like

19 this may have something to do with your patent.

20 Am I mistaken, I mean the U Mass Lowell's patent

21 based on your invention?

22 A. The question was?

23 Q. It looks like in this study you measured

24 soil degradation rates of polylactic acid, and is

25 this the study that is the principal study

159

1 underlying your 199 patent?

2 A. No.

3 Q. This is one in a series of them?

4 A. This is the biodegradability with the

5 Proteinase K, the soil and the composting for the

6 blends which are the basis of the patent that U

7 Mass owns.

8 Q. As I understand it, under this study you

9 base your determination of biodegradation

10 principally upon a measure of weight loss; is that

11 right?

12 A. I believe the Proteinase -- it's true for

13 the Proteinase K and the composting. I don't

14 recall how we did it for the soil.

15 Q. If you look on page 72 under

16 biodegradability the second paragraph. It looks

17 like the patent description in the 199 patent with

18 regard to biodegradation testing in the soil. I'm

19 going to have the court reporter put into the

20 transcript at this point the second full paragraph

21 under the title biodegradability on page 72 of

22 Exhibit 18 as a point of reference.

23 "The biodegradation testing in soil,

24 Figure 10, shoed the biodegradation rate of

25 Bio#3000 was extremely fast, while the rate of PLA

160

1 was relatively slow. After degrading for 45 days,

2 Bio#3000 degraded almost 100%, while PLA only

3 degraded about 14%. For the blends with 70 and 50

4 wt % Bio#3000, the degradation rate is relatively

5 fast. After 45 days, the A30/B70 blend degraded

6 about 77%, the A50/B50 blend degraded about 65%.

7 These values are equal to those expected on the

8 basis of additivity rule. However, for blends

9 with less than 30 wt% Bio#3000, the degradation

10 percentage values are less than those expected on

11 the basis of additivity rule."

12 Now, as I understand it from this study,

13 you did not use 14C radiological testing, right?

14 A. That is true.

15 Q. And I also do not see anywhere in here

16 reliance upon an ASTM standard test method?

17 A. That is correct.

18 Q. Did you use your own laboratory test

19 method here?

20 A. It was the test method of the center.

21 I'm not sure there was an ASTM test method at that

22 time.

23 Q. What was the test method at the center?

24 A. There's three of them. One is the

25 compost; one is the enzymatic; and one is the

Renewed Resp. Mot. for Leave

Exh. RX-B

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41 (Pages 161 to 164)

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161

1 soil.

2 Q. You concluded that the biodegradation did

3 occur in the test sample plastic, and it is listed

4 there, is it not, in the second paragraph under

5 the title biodegradability on page 72, for each of

6 the blends and for the PLA?

7 A. The question is the numbers are listed?

8 Q. Right. Is that an accurate summarization

9 of the biodegradability or biodegradation results

10 of the study listed on page 72 in paragraph 2

11 under the title biodegradability?

12 A. Yes. That's what we found.

13 Q. And you stand by those test results

14 today?

15 A. Well, at the time, those were the best

16 results that we had. It would have been better to

17 do a measurement of carbon dioxide.

18 Q. But as for the tests that you did do,

19 they're satisfactory for establishing the

20 biodegradation of the test sample?

21 MS. JOHNSON: Objection.

22 A. I mean, at the time -- I mean, they're

23 not the best tests. The weight loss is

24 problematic, as we later found out.

25 Q. Now, when it comes to proof in this

162

1 thing, you didn't prove that the test sample

2 plastic completely biodegrades within one year of

3 customary disposal, right?

4 A. Not with this test.

5 Q. Let's take a look at another one of your

6 articles. This one is Exhibit 19.

7 (Whereupon, Respondent's Deposition

8 Exhibit No. 19, Biodegradable Polymer Blends of

9 Poly(lactic acid) and Poly(ethylene glycol),

10 marked.)

11 BY MR. EMORD:

12 Q. Now we've marked for identification an

13 article of Dr. McCarthy's respondent's Exhibit 19

14 Biodegradable polymer blends of polylactic acid

15 and polyethylene glycol. This is one of your

16 articles?

17 A. Yes.

18 Q. Part of the article explains and

19 enzymatic degradation test, right?

20 A. Part of the material was exposed to an

21 enzyme.

22 Q. Correct me if I'm wrong, but it looks to

23 me that you measured enzymatic degradation on

24 pages 1500 and 1501 based on a weight loss

25 calculation; is that correct?

163

1 A. Yes.

2 Q. Did you rely on any other measure for

3 determining the degradation in this study, other

4 than weight loss?

5 A. No.

6 Q. And you didn't use in this study an ASTM

7 standard; is that correct?

8 A. I don't think one existed at the time.

9 Q. And you didn't use 14C radiological

10 testing?

11 A. No.

12 Q. And let me ask you, do you extrapolate

13 from your lab tests to conclusions about the

14 actual environment in landfills?

15 A. Do I currently?

16 Q. Have you ever?

17 A. I don't know.

18 Q. You don't remember?

19 A. I don't remember.

20 Q. Let's take a look at another article

21 here. I'll mark this as Exhibit 20.

22 (Whereupon, Respondent's Deposition

23 Exhibit No. 2, Degradation Ranking of Plastics in

24 a Landfill Environment, marked.)

25 BY MR. EMORD:

164

1 Q. This article is entitled Degradation

2 Ranking of Plastics in a Landfill Environment.

3 You appear to be one of the authors; is that

4 correct?

5 A. Yes.

6 Q. If we look at page 867, and that's right

7 on front in the second full paragraph, you appear

8 to define the purpose of the study, right?

9 A. Yes.

10 Q. And you write, the purpose of this paper

11 is to compare on a relative scale the degradatrion

12 of various plastic materials in an accelerated

13 test, which is correlatable to the actual

14 degradation in actual landfills, right?

15 A. Yes.

16 Q. So it's fair to say from this study that

17 the accelerated control tests you performed in the

18 lab in this study you correlated to actual

19 landfill conditions in the outside world, right?

20 A. No. We didn't. We weren't able to. I

21 mean, we tried to. That was the purpose of it,

22 but it never happened.

23 Q. Now, in this study you didn't use 14C

24 radiological testing?

25 A. No.

Renewed Resp. Mot. for Leave

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165

1 Q. And what method did you use to measure

2 biodegradability?

3 A. It looks like weight loss?

4 Q. In the third full paragraph of the study

5 on the front, you write, in the preprint we

6 present preliminary results which correlate

7 plastics degradation with a biological environment

8 in the simulator and provide comparative rates for

9 degradation of plastics and materials typically

10 placed in landfills, right?

11 A. Right.

12 Q. Are you extrapolating here from the lab

13 tests to the real world environment of landfills?

14 MS. JOHNSON: Objection.

15 A. No.

16 Q. In the third paragraph, you describe the

17 method you used here, it's not 14C radiological

18 testing, to present it as a quote a methodology

19 for the routine analysis for plastics degradation

20 under a leachate recycled landfill conditions, end

21 quote. Do you see that?

22 A. Yes.

23 Q. So you believe that that methodology, at

24 the time you wrote this article, you believed that

25 the methodology you used, is that a fair

166

1 statement, for the routine analysis for plastics

2 degradation under leachate recycle landfill

3 conditions?

4 A. That was what we had hoped.

5 Q. But the method used you describe as the

6 routine analysis for plastic degradation?

7 MS. JOHNSON: Objection. Asked and

8 answered.

9 Q. As routine?

10 A. No.

11 Q. At the time you wrote this, you didn't

12 believe it was routine?

13 A. No. We presented a methodology that we

14 had hoped could be used in routine analysis, and

15 it ended up not being able to do it.

16 Q. Now, you also evaluated the appearance of

17 samples to determine if they looked weathered; is

18 that correct?

19 A. Do you know where that is?

20 Q. If you look under results and discussion,

21 the second full paragraph, cellophane and PHVD

22 appeared extensively weathered from exposures in

23 simulators G, E and H. Cellophane turned black

24 and disintegrated into small fragments. In fact,

25 none could be recovered from simulator G. PHBV

167

1 became brittle, opaque and extensively eroded on

2 the surface. Only small remnants of PHBV could be

3 recovered after exposure 127 days. In all

4 simulators, polypropylene become discolored and

5 somewhat embrittled but films showed no signs of

6 surface erosion.

7 A. This was the problem with the weight loss

8 is that they fragmented, and it was not accurate.

9 Q. Exhibit 10, page 293, if you look there

10 in the first paragraph, 293, it reads, there is

11 increased recognition that biodegradable plastics

12 can serve an important role in the design of an

13 intelligent, integrated solid waste disposal

14 scheme. Do you believe that statement to be true

15 when you made it?

16 A. Yes.

17 Q. And is it true today?

18 A. I believe so.

19 Q. The same article on the same page right

20 column, you write, biodegradable disposal plastic

21 articles can be designed such that they will be

22 entirely converted by microbial activity in a

23 biologically active environment to biogas CO2 and

24 CH4 CO2 under aerobic and anaerobic conditions

25 respectively biomass and biological byproducts.

168

1 Do you believe that statement to be true when you

2 made it?

3 A. Yes.

4 Q. Do you believe it to be true today?

5 A. If I was to write it today I would say

6 just use aerobic and add biomass.

7 Q. Now, two years after you wrote these

8 words and two years later would 1995 and you wrote

9 in another article, Laboratory-Scale composting

10 Test Methods to Determine Polymer

11 Biodegradability: Model Studies on Cellulose

12 Acetate, which we will mark as Exhibit 21.

13 (Whereupon, Respondent's Deposition

14 Exhibit No. 21, ^ DESCRIPTION, marked.)

15 BY MR. EMORD:

16 Q. Look at that. This is one of your

17 articles, right?

18 A. This is an article and I'm one of the

19 authors.

20 Q. If you'll look an page 614, the first

21 full paragraph under the title Introduction, there

22 is an increased recognition that biodegradable

23 plastics can serve an important role in the design

24 of an intelligent, integrated, solid waste

25 disposal scheme. When you wrote this article did

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517/2014 Metabolix Grants a Patent License to NatureWor~ LLC for New Biopa}m'!r Blerris 

PUBLIC DOCUMENT 

Metabolix Grants a Patent License to 

NatureWorks LLC for New Biopolymer Blends 

~ > ~ > Metabo!jx-Ucense 

El Metabolix 0 

03/14/2012 

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Metabolix, Inc. 

(NASDAQ: MBLX), a bioscience company focused on bringing 

environmentally sustainable solutions to the plastics, chemicals 

and energy industries, today announced that it has granted a 

non-exclusive license to NatureWorl<s LLC for the U.S. patent 

No. 5,883,199, titled "Polylactic Acid-based Blends," to make, 

use and sell blends of polylactic acid (PLA) with certain other 

polymers including polybutylene succinic polymers (PBS). The 

University of Massachusetts Lowell is the owner of the '199 patent, and Metabolix, Inc. is the 

exclusive licensee in the relevant field. NatureWorl<s and the biochemicals company BioAmber 

recently announced a joint venture which will support NatureWorks in bringing to market new 

performance Ingeo polymer colll'ositions. 

"This research greatly expands the uses of PLA in biodegradable plastics because the blends 

allow for a stronger, more flexible form. The basis of my research is to improve the potential uses 

for PLA because it is made from renewable natural resources rather than oil, and is 

environmentally friendly," said inventor and patent-holder Stephen McCarthy, a professor of 

plastics engineering at UMass Lowell and director of the university's Bioplastics Research Center. 

The exclusive license agreement was negotiated on behalf of the university with Metabolix by 

UMass Lowell's Office of Commercial Ventures and Intellectual Property. 

"As a leader in the development of biobased polymer technology, we have assembled a broad 

intellectual property portfolio covering key elements of making and using advanced biomaterials, 

including biopolymer blends," commented Richard P. Eno, President and CEO of Metabolix. "For 

areas outside of our technical and commercial focus, we are amenable to licensing arrangements 

that provide Metabolix the opportunity for a financial participation and pave the way for the 

introduction of new materials to the marketplace." 

About NatureWorks LLC 

NatureWorks LLC is a colll'any dedicated to meeting the world's needs today without 

compromising the earth's ability to meet the needs of tomorrow. NatureWorks LLC is the first 

company to offer a family of commercially available, low-carbon footprint Ingeo biopolymers 

derived from 100 percent annual renewable resources with performance and economics that 

compete with oil-based plastics and fibers. In October 2011, Thailand's largest chemical 

producer, PTT Chemical Public Company Limited, entered into an agreement to make a $150 

million equity investment in NatureWorl<s. The transaction remains subject to regulatory 

clearances. For more information on NatureWorks and Ingeo, visit www.natureworks.com. 

About University of Massachusetts Lowell 

UMass Lowell is a COill>rehensive, national research university located on a high-energy campus 

in the heart of a global community. The campus offers its 15,000 students bachelor's, master's 

and doctoral degrees in education, engineering, fine arts, health and environment, humanities, 

liberal arts, management, sciences and social sciences. UMass Lowell delivers high-quality 

educational programs, vigorous hands-on leaming and personal attention from leading faculty and 

staff, all of which prepare graduates to be ready for work, for life and for all the world offers. 

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www.uni.edu. 

Metabolix Grants a Patent License to NatureWor~ LLC for New Biopa}m'!r Blerris 

PUBLIC DOCUMENT 

About Metabolix 

Founded in 1992, Metabolix, Inc. is an innovation-driven bioscience COrfl>any focused on 

providing sustainable solutions for the world's needs for plastics, chemicals and energy. The 

Company is taking a systems approach, from gene to end product, integrating sophisticated 

biotechnology with advanced industrial practice. Metabolix is developing biobased industrial 

chenicals and plastics, as well as a proprietary platform technology for co-produc ing plastics, 

chenicals and energy, from crops. For more information, please visit www.metabolix.com. 

(MBLX-E) 

Metabolix: Safe Harbor for Forward-Looking Statements 

This press release contains forward-looking statements which are made pursuant to the safe 

harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of 

the Securities Exchange Act of 1934, as amended. The forward-looking statements in this 

release do not constitute guarantees of future performance. Investors are cautioned that 

statements in this press release which are not strictly historical statements, including, without 

linitation, statements regarding future licensing opportunities, constitute forward-looking 

statements. Such forward-looking statements are subject to a nurrber of risks and uncertainties 

that could cause actual results to differ materially from those anticipated and are detailed in 

Metabolix's filings with the Securities and Exchange Commission, including its 10-K for the year 

ended Decerrber 31, 2011, which was filed on March 12, 2012. Metabolix assumes no obligation 

to update any forward-looking information contained in this press release or with respect to the 

announcements described herein. 

Nature Works 

Steve Davies, (952) 562-3343, Steve Davies@natureworksLLC.com 

UMass Lowell 

Christine Gillette, (978) 934-2209, Christine Gillette@uml.edu 

Metabolix Media: 

Lynne H. Brum, (617) 682-4693, LBrum@metabolix.com 

or 

Schwartz MSL Boston 

Keith Giannini or Kirsten Swenson, (781) 684-0770, metabolix@schwartzmsl.com 

Investor Relations Inquiries: 

James R. Palczynski, ICR, (203) 682-8229, james.palczynski@icrinc.com 

University Relations- Cumnock Hall, 31 University Ave., Lowell, MA 01854 

Phone: 978-934-3224 Fax: 978-934-3033 Contact Us 

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UMass Lowell, Metabolix/Telles Celebrate 

Partnership 

Home > News > Metabolix_celebrat on 

More Than $2.5 Million in Funded Research Conducted 

Chancellor Marty Meehan, 

center, Prof Stephen Mccarthy, 

second from right, and Executive 

Vice Chancellor Jacqueline 

Moloney, far right, with executives 

from Metabolix/Telles 

06/30/2010 

By Edwin l. Aguirre 

UMass Lowell recently hosted a reception 

for Metabolix/Telles to celebrate the 

company's 15 years of sponsored 

research and licensing partnership with 

the University. More than 30 students, 

faculty, University administrators and 

company officers attended the gathering, 

which was held at the newly renovated 

UMass Lowell Bellegarde Boathouse. 

Attendees included Chancellor Marty 

Meehan, Executive Vice Chancellor 

Jacqueline Moloney, Administration and Finance Vice Chancellor Joanne 

Yestramski, Provost Ahmed Abdelal and Engineering Dean John Ting as well 

as Metabolix/Telles President and CEO Richard Eno, Chief Scientific Officer 

Oliver Peoples, Telles General Manager Robert Engle and Strategy & 

Commercial Development Vice President Johan van Walsem . 

In his welcome remarks, Meehan thanked Metabolix/Telles for its support 

through the years. 

"Bioplastics and green technology are important to the future of the 

University and the new Emerging Technologies and Innovation Center being 

built on campus," he said. 

"We are very pleased with our partnership with UMass lowell," said Eno. "It 

is one of the best universities in the country." 

Cambridge-based Metabolix is an innovation-driven bioscience company 

focused on providing sustainable solutions for the world's needs for plastics, 

chemicals and energy. For example, the company is now developing and 

commercializing Mire!"' bioplastics, a renewable and biodegradable 

alternative to petroleum-based plastic made from sugarcane. 

"Research in bioplastics is vital to UMass Lowell," said plastics engineering 

Prof. Stephen Mccarthy. "Metabolix located the headquarters of Telles in 

lowell because of its partnership with the University." 

Mccarthy said Metabolix has funded more than $2.5 million in sponsored 

research with UMass Lowell and more than 50 students for their master's and 

doctorates. It has also donated more than a half million dollars' worth of 

bioplastic processing equipment. 

"Metabolix has licensed UMass Lowell patents for bioplastic blends, with 

potential royalties of $100,000 a year," said McCarthy. 

D SHARE /' r{j f'l .. 

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University Relat ons - Cumnock Hall, 31 University Ave., Lowell, MA 01854 

Phone: 978-934-3224 Fax: 978-934-3033 Contact Us

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From: Brian Igoe

To: jfrankle@ftc.gov

Cc: Kristi Guillemette; Steve Mojo

Subject: FW: Good Earth and ECM

Date: Thursday, June 26, 2008 4:55:47 PM

Attachments: goodearthproductclaims.pdf

ECM Exhibits July 17.pdf

Comments on ECM Documents Fnal.pdf

Dear Janice,

Please check out the claims this company is making about a microbial additive to traditional plastics, including PVC and

EPS which makes them biodegradable and harmless to the environment. http://www.goodearthpkg.com/ It is clear they

are making vague and intentionally deceptive claims about environmental benefits and ASTM certifications with no

corroborative data. This is a clear violation of the FTC guidelines for environmental marketing claims. Also, in the Good

Earth “Certification” section on their website they reference ASTM 5338, which is a test method (which yields a rate of

mineralization), and not a certification. 

I am attaching copies of Good Earth and ECM’s selling materials and some comments from the Bioplastic Products

Institute regarding the material. When you review the Good Earth PPT presentation (on their website), and ECM’s material

you’ll see these products use ECM’s additive technology. Most of the photos in the powerpoint document on the Good

Earth website (and signatures) match that of the ECM info attached.

I hope this helps in your pursuit of false claims by these companies.

Sincerely,

Brian Igoe

Brian Igoe

VP and Chief Brand Officer

978-513-1850

CONFIDENTIALITY NOTICE:

This message is intended for the use of the individual or entity to which it is addressed and may contain

information that is privileged, confidential and exempt from disclosure under applicable law. If the reader of this

message is not the intended recipient or the employee or agent responsible for delivering this message to the

intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is

strictly prohibited. If you have received this communication in error, please notify us immediately by email reply or

by telephone and immediately delete this message and any attachments. 

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517/2014 Member profile 

PUBLIC DOCUMENT 

To print this page properly • use Print icon bcated on the page. 

Home 

Portland Oregon "Overs" 

Study Results 

US Composting Council 

Labeling Guidelines 

Find Certified Compostable 

Products 

The BPI Certification 

Process 

BPI Certified Testing Labs 

Information about Certified 

Compostable Products 

All About Compo sting 

The Science of 

Biodegradation 

BPI Position on Degradable 

Additives 

BPI News Center 

About BPI 

Mulch Petition 

UsefuiUnks 

R.acommend G Folow 

L-------------------~ soo~h l 

ABOUT I BLOG I UNKS 

Back 

MirelTM Bioplastics by Metabolix I Send message I 

Member profile details 

ME'rnb r<> 1p IE'v Resins 

Mirei TM Bioplastics by Metabol ix 

r-;t n rr Dave 

a t n rr Sca rlett 

-M scarlett@metabolx.com 

ho 978-513-1870 

Produ t IT'd 

Aff11ia•1 

tory 1ic;t1 

t 

Add 

Contact data 

Materials Suppl ier 

Manufactures and sells a broad family of Mirei TM 

bioplastic including inj ection molding materials 

P1003, P5001, F1005, P1004/F1006, and M.verarM 

B5002 film. 

Personal information 

650 Suffol k Street; Suite 100 

Ci Lowell 

Additional information 

Prov r /St MA 

ost I coc 01854-3639 

Cou • USA 

w b 

ColT' any o 

B 

Productc; 

co po t ble 

Product 

617-492-1 796 

BPI Custom Fields 

www.mireLcom 

Resins 

Compostable Resins 

http://wNw.bpiv.orld.org/Content/MerrbefsiMerrbefPublicProfile.aspX?pageld=372399&memberld=890994 

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517/2014 Member profile 

Copy11g (C' 20~ s·2C 2 

Biodegradable Products Institute, Inc, 

888c 8th Ave # 141 

New York, NY 10019 

1-888-BPI-LOGO (274-5646) (North America)·lntcrnationol +l-646-845-Q776 

Clc;k here to Contact the BPI 

Onlne marketing strategy by SPS Group, Inc. 

PUBLIC DOCUMENT 

http://wNw.bpiv.orld.org/Content/MerrbefsiMerrbei'PublicProfile.aspX?pageld=372399&memberld=890994 

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517/2014 

mirel 

(bttp;//www.metabolix com) 

Company 

Description: 

Metabolixl BPI Product C~og 

Metabolix 

21 Erie St 

Cambridge, MA 02139 

P:978-513-1800 

F:978-513-1886 

PUBLIC DOCUMENT 

4080 Products listed as of 

http: //www.metabolix.com (http://www.metabolix.coml 

G" Metabolix· 

Manufacturers and sells a broad family of degradable p lastics under the Mire! and Mvera tradenames. 

This Company's Products - Manufactured or Licensed 

pownload csy lhttp;//products,bpiworld.org/companies/8205/px/csyl Dowgload XJ1S 

(htm://products.bpiworld.org/companies/8205/px/xls) 

Subcategory: injection molding reeint 

Bhlnd SKU 11tle Category Subcategory Color 

Mire! 1'1004 Mirel-bi'IU\d natural-color Injection Molding Resins 488 microns (19.21 mils) thick Res .ins in•ectioo molding resins natural 

Mire! P1003 P1003 Injection Molding Resin Resins injection molding resins natural 

Mircl F1006 Mird4 brand natu.n1-color Injection Molding Resins 500 microns (19.69 mils) thick Resins injection molding rt'sins natural 

Mircl F1005 PlOOS Injection Molding Resin Resins injection molding rains natural 

Subcategocy: resin• 

Brand SKU 11tle Category Subcategory Color 

Mire! MOOO Mire!® resin grade MOOO Resins resins natural 

~fuel M4300 Mirel® resin gr.>de M4300 Resins resins natural 

~fuel MZIOO Mird® resin grade Z...£2100 Resins resins natural 

!\fire) M2200 Mircl® =in grade M2200 Resins resins natural 

Mircl M4100 Mircl® resin grade M41 00 Resins resins natural 

~fuel P4004 Unoolored resins Resins resins natural 

Subcategory: film rea-ins 

Brand SKU Title Category Subcategory Color 

Mvera® B501 1 Resin for blown and cast films (197 1-lm) Resins film resins natural 

Find a Certificate 

Member 

Certificate D escription 

http://products.bpiv.orld.org/cClfll)anies/metabolix 

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Company 

Metabolix 

Metabolix 

Metabolix 

Metabolix 

Metabolix 

Metabolix 

Metabolix 

Metabolixl BPI Product C~og 

PUBLIC DOCUMENT 

M2100, M2200 and M4100 Resins 

Natural colored resin with a maximum thickness 0.69 mm . 

Uncolored resins, sold under the tradename Mire!®, for max. approved thickness of 

0.69mm (P4004] 

Injection Molding G rades P1003/P1004 (max. thickness 0.48mm) 

Injection Molding Grades F1005/F1006 

MOOOO and M4300 resins, approved up to 0.69 mm 

Uncolored resins for the production of blown and cast films with a max. thickness of 197 

JJ.ffi 

BPI ts a trademark of the Biodegr dablc Products lnstttute 

Copy•tght (( 2003 2U12 

Biodegradable Products Institute, Inc. 

331 \'fest <;7 h Street, Sune 415, 

~ew York, :-.IY 10019 

I· SR.BP .J.OGO ~· 4·~646t 

CJ,ck here to Contact the BPI (http://www.bpiworld.org/BPI-Public /Contact.htmll 

(http· ttwww hpjwgrld org/BPI-PubHc/Coptact btm]) Oplips markstjpg strate gy by SPS Grpup Ips (http· //wmy sgsgc com) 

http://products.bpiv.orld.org/cClfll)anies/metabolix 

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BPI Biodegradable 

Products~ 

Institute~ promoting biodegradable products throughout the world 

April 1.5, 2005 

Ms. Janice Frankie 

Federal Trade Commission 

601 New Jersey Ave NW 

Rm 2122 

Washington D.C., 20001 

Dear Janice: 

It was good to speak with you again. As we discussed, I would like to bring to the FTC's 

attention that there are a growing number of "biodegradable" claims, especially by 

manufacturers of plastic bags for collecting pet waste. These manufacturer's actions are 

misleading, Inappropriate (and in some cases knowingly illegal). 

The BPI is designed to be a multi-stakeholder group, Involving people and companies that 

produce, use or recover biodegradable products. Our goal is to indude organizations and 

individuals ranging from resin suppliers and converters to industry suppliers to waste 

haulers and composters as well as government officials, scientists and leading academics. 

The organization has shown steady growth over the past few years. Current members 

indude leading biodegradable resin suppliers, such as BASF, NatureWorks LLC, DuPont, 

Novamont and Procter & Gamble, converters and distributors, such as Heritage Bag, 

Polargruppen A/S, Farnell Packaging, Georgia Pacific and Biota Spring Water, along with the 

United States Composting Council, The Massachusetts Department of Environmental 

Protection, and R. Narayan, Chairman of ASTM 020.96-Subcommittee on Degradable 

Plastics. 

The issues that the BPI believes need to be addressed are 

• Oaiming to "biodegradable", even when the bags (and pet waste) are customarily 

landfilled. 

• Failure to support "biodegrades in landfill" claims with scientific data. 

• Knowingly breaking the laws in the State of California. 

The 2 products that are emblematic of these offenses are "Oops I Pooped': and "Bags.on 

Board". TI1ese products are sold throughout the United States via large retailers, lil}e 

Petsmart and REI, as well as smaller outJets. 

The BPI supports the FTC's Guides for the Use of Environmental Marketing Cla/ms. ~ 

Moreover, the BPI objects to the use of "biodegradable'' without any qualifications as to 

whe(e this occurs; how long it takes and not having the data to support this claim. 

FTC _Prod_ 064468 
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"An unqualified claim that a product or package is degradable, biodegradable or 

photodegradable should be substantiated by compete~zt and reliable scientific evidence 

that the entire product or package will completely break down and return to nature, f&u 

decompose into elements found in nature within a reasonably short period qf time qfter 

customary disposal. " Section 206. 7 b of the FTC Guides for the Use of Environmental 

Marketing Claim.~. 

Additionally, there are few, if any, benefits derived from putting "biodegradable" materials 

In a landfill, which are designed to be arid tombs according to RCRA. For this reason, the 

BPI beJieves that a claim of "bjodegrades in landfills" is an exaggeration of an environmental 

benefit. 

"Overstatement of environmental attribute: An environmental marketing claim should not 

be presented in a manner that overstates the environmental attribute or benefit, expressly 

or by implication. Marketers should avoid implications of significant environmental 

benefits if the benefit is in fact negligible." Section 206.6 c of the FTC Guides for the Use 

of Enviromnental Marketing Claims 

In fact, in some countries, induding Britain, Germany and Canada, regulations are being 

enacted to keep biodegradable materials out of the landfill as a way of reducing methane 

gas generation (a significant contributor global warming). 

The BPI believes that the claims made by "Oops I Pooped" are misleading (see attached 

page from their websfte (Exhibit 1) because they are not supported by scientific data. 

Further, biodegradation in landfills provides no meaningful environmental benefit and thus 

this is an overstatement of an environmental benefit. 

• "biodegradable waste bags for .. your dog" 

• "will completely degrade in a landfill and leaves behind no harmful residue" 

• Under benefits, "Steady degradation rate, typically 2 years." 

• "1 to 5 years pending landfill conditions" 

• "Our bags will biodegrade in landfills in every State but caHfornia" 

When asked by the BPI, "Oops I Pooped" provided the attached data (Exhibit 2), which 

discusses the test results of polyethylene resins with an additive produced by ECM. The 

document was reviewed by Dr. Ramani Narayan a noted expert in the field of plastics and 

biodegradation, Dr Narayan's findings can be summarized as follows (see Exhibit 3 for 

complete comments): 

• Only 24% of the material was mineralized (or biodegraded). According to the 

test results, seventy six percent of the material remains. 

• The biodegradation process plateaued prior to the end of the test, indicating that 

the process had stopped. (There Is no indication that it will continue). 

• These levels are comparable to those achieved by the first round of 

"biodegradable plastics" 20 years ago, which generated the initial FrC lawsuits in 

this area. 

Clearly, there is no support for complete biodegradation in a landfill, even in 5 years, as 

stated by the supplier and shown on a retailer website (See Exhibit 4). Also, attached is 

a partial listing of retailers carrying this product. according to the manufacturer's website 

(Exhibit 5) 

FTC_Prod_064469 
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Additionally, the last claim, "Our bag will biodegrade in landfills In every state except 

california", shows that the manufacturer knows that it is not complying with applicable 

state laws. As background, the State of California regulations state that any claims of 

"biodegradable, compostable or degradable" by plastic films must comply with a current 

ASTM Spedfication (Exhibiit 6). California enacted this law in order to stop the 

misleading dalms made by plastic bag manufacturers, which were on the Increase. The 

·California law does not create an exemption for products .that a customarily landfilled. 

Moreover, there are no ASTM Specifications for landfill biodegradation. 

In the case of "Bags On Board", the BPI objects to their "100% Biodegradable Bags, 

except as defined by California" claim for 3 reasons (Exhibits 7 & 8): 

• The attached Independent analysis shows that the bags are essentially 

polyethylene with no additives to promote degradation (Exhibit 9). 

• Promoting biodegradation of a product that is landfilled Is Inappropriate and an 

overstatement of an environmental benefit. 

• The packaging dearly shows that the producer is not in compliance with the laws 

of California. 

The plastics industry Is working hard to develop tests and criteria for determining 

acceptable biodegradation performance in appropriate disposal routes. ASTM 06400 for 

Compostable Plastics and ASTM 06868 for Compostable Packaging are good examples. 

Claims such as those used by "Oops I Pooped" and "Bags on Board" harm the credibility 

of all manufacturers that seek to comply with the FTC Environmental Marketing Guides. 

More importantly, their statements mislead consumers by claiming to have 

environmental benefits when in fact they do not. 

Janice, this note requests that the FTC order these 2 companies to cease their 

misleading advertising. Further, the BPI hopes that FTC would recognize and support 

California's effort to use ASTM Specifications as the basis for making biodegradable, .J 

compostable and degradable claims. Rnally, the FTC should reiterate tnat claims of 

biodegradability for products customarily disposed In landfills is an overstatement of an 

environmental benefit. 

Sincerely, 

~Y · 

BPI 

Steven 

Executive 

A. Mojo 

Director 

~ 

Attachments 

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List of Exhibits 

#1: Oops I Pooped claims from their website. You will find 

• "Will completely biodegrade in landfill and leave behind no harmful 

residue" 

• "Steady degradation rate typically 2 years" 

• 1\1 to 5 years pending landfill conditions" 

• "Our bags will biodegrade in landfills in every State but California!" 

#2: Document supplied by Oops I Pooped, providing their substantiation 

• "Ecological Assessment of ECM Plastic" 

#3 Analysis and comment of Exhibit #2 by Dr. R. Narayan. 

#4: Samples from REI's (retailer) website promoting biodegradation In 

landfills 

#5 Partial list of retailers from Oops I Pooped website 

#6 Text of California Labeling Legislation 

#7 Sample of "Bags on Board" product purchased at retail, claiming 100% 

Biodegradable Bags, except as defined in California" 

#8 Materials from retailer website, claiming "100% Biodegradable" 

#9 Analysis by Polimeri Europa, showing that the bags are polyethylene 

FTC _Prod_ 064471 
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B P I Biodegradable 

Pro~ucts~ 

Institute~ 

March 30, 2010 

Mr. Michael Davis 

Federal Trade Commission 

CRC-240 

600 Pennsylvania Ave, NW 

Washington, D.C. 20580 

Dear Mike, 

Enclosed you will find 2 examples of the continuing stream of "biodegradable" 

products. What is interesting about these is that in both cases they use the same 

additive, EcoPure from BioTec (per the packages), and are making somewhat 

similar claims: 

1) Biodegradable Easter Grass (also labeled as Green) 

This product claims to meet ASTM D5511 (an anaerobic test). The back of 

the package states that this product will biodegrade in a landfill and 

achieves 3% biodegradation in 20 days, where ordinary Easter Grass does 

nothing. I don't know if they are saying that 3% is enough to warrant a 

"biodegradable" claim. Or if they believe that the process will continue 

until the product reaches close to 100%. In which case, they should have 

extended the testing period. 

2) Green Genius Biodegradable Bags 

According to the company's website (http://www.thegreengenius.com) 

"We/~ at least not for a thousand years or so. That's why we invented 

Green Genius bags. We figured the world was ready for a biodegradable 

plastic trash bag. They're just as strong as regular plastic bag~ but unlike 

their more stubborn cousin~ they meet ASTM 05511/ an industry 

standard for biodegradability. " 

I would urge you to review the video on their site. This clearly gives the 

impression that the product will fully biodegrade in a landfill. 

Also, they provide consumers and customers with a letter from UL 

(attached). 

''Product is biodegradable in landfills where anaerobic digestion is 

occurring. Based on 36 day ASTM 05511 test result~ it is 

estimated that the Green Genius trash bags will biodegrade within 

a one to ten year time frame/ depending on the exact conditions 
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and operation of the landfill environment into which it is 

disposed. " 

It is clear that UL nor the manufacturer have done the tests to 

demonstrate that the entire product will biodegrade as called for in the 

Environmental Marketing Guides. Further, based on the technology, it is 

reasonable to expect that the overall rate of biodegradation would be 

comparable to what was achieved in the Easter Grass example and well 

short of "complete". 

While I believe that each of the companies bears some responsibility in making 

these misleading claims, it is the additive supplier BioTec, who is the real culprit 

in this situation. You can see from the commonality in claims, that the link is the 

additive supplier, not necessarily the manufacturers of the products themselves. 

BioTec is a New Mexico based company with the following address: 

Bio-Tec Environmental, LLC 

7009 Prospect Ave NE #202 

Albuquerque, New Mexico 

87110 USA 

Website: http://www.bio-tec.biz/aboutus.html 

Regards 

Steve Mojo 

BPI Executive Director 
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January 30, 2008 

Federal Trade Commission 

Office of the Secretary 

Room H-135 (Annex B) 

600 Pennsylvania Ave, NW 

Washington, D.C. 20580 

RE: Green Guides Regulatory Review, 16 CFR Part 260, Comment, 

Project No. P954501 

To Whom It May Concern: 

This provides the comments of the Biodegradable Products Institute (BPI) with regards 

to the FTC’s Environmental Marketing Guides. 

The BPI is a multi-stakeholder trade association, involving people and companies that 

produce, use or recover compostable products. The BPI strongly supports the recovery 

of organic materials via composting and many of the members are actively involved in 

the production of materials from renewable feedstocks. All BPI approved products meet 

stringent scientifically based standards for compostability. Currently the organization has 

42 members including leading suppliers of compostable resins, compostable bags, 

compostable food service items and compostable packaging. Member organizations 

include BASF, NatureWorks LLC, Metabolix, Novamont, Cereplast, BiobagUSA, Heritage 

Bag and Poly-America. The BPI’s “Compostable Logo” is used by organizations in the US, 

Canada, China, Australia, Europe and Brazil. Moreover, it is recognized by composting 

facilities from San Francisco to Prince Edward Island. Also the BPI’s efforts are 

recognized by the US EPA and the Canadian Plastics Industry Association. A complete 

list of BPI approved products and members can be found on our website: 

www.bpiworld.org.

It is important to note that membership in the BPI has grown dramatically over the past 

couple years. I believe that our membership growth parallels the increasing interest in 

environmental claims driven in part by Wal-Mart’s Sustainable Packaging Program and 

increased awareness in global warming. In concert with this interest in the environment, 

the BPI has seen an increasing level of “biodegradable” claims, especially in landfills. 

These are largely unsupported by conclusive scientific data and importantly lead 

consumers to believe that “biodegradation” in landfills is an environmental benefit, when 

it is not. Appendix 1 is a recent example of this trend (Jan 14, 2008 Dispoz-o Plate Press 

Release).

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Overall Comments: 

The BPI and its members believe that the current FTC Environmental Marketing Guides 

have provided significant direction to manufacturers since they were first developed in 

the early 1990’s. Moreover, the BPI fully supports the overall directions of the Guides, 

especially the reliance on sound science to support claims. However, since the last 

revision in the Guides in the late 1990’s, there have been two developments that should 

be incorporated in your next revision, pertaining to the definitions for “biodegradable” 

and “compostable”.

1. The American Chemistry Council (ACC) fielded a national survey to better 

understand consumer attitudes with regards to the terms “biodegradable” and 

“compostable” and “renewable” in September 2006. Over 1000 consumers were 

surveyed in a statistically sound manner. This study, one of the first that I am 

aware of, probes consumers’ knowledge of these terms. The ACC and BPI have 

already discussed the findings of this work with the FTC and provided a complete 

copy of the results and questionnaire1

. I will reference the relevant sections of 

this work in this letter and attach a copy of presentation from 2007. 

2. Development of two specifications by the American Society of Testing and 

Materials (ASTM) that speak to the identification of compostability of plastics and 

plastic coated paper products. These 2 specifications are 

o ASTM D6400: “Standard Specification of Compostable Plastics” 

o ASTM D6868: “Standard Specification for Biodegradable Plastics Used as 

Coatings on Paper and Other Compostable Substrates” 

Products meeting these specifications are in commerce today. They are being 

processed by the growing number of professionally managed composting 

facilities throughout North America and Europe today. Moreover, the ASTM 

Specifications are similar to those used in Europe and its key requirements will 

be incorporated in the ISO standard now under development (#17088). 

The BPI’s comments will focus on the terms in the current Guides: “biodegradable”, 

“compostable” and “degradable as well as the terms relating to “renewable or biobased 

content”. 

“Biodegradable” Comments: 

Based on the ACC’s research, most consumers do not really understand the scientific 

process behind biodegradation. Rather, they believe that something that is labeled as 

“biodedgradable” will somehow disappear into nothing within a year, regardless of 

location. Quoting from the report’s findings: 

x “For most people, this term (“biodegradable”) means that the material is able to 

decompose or break down naturally (on its own).

• Most people believe the material would break down in 1 year or less.

1

 Email correspondence to J. Frankle Podoll FTC) from J. Killinger (ACC) on June 25, 2007. 

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• One key attribute assigned to biodegradable by most people is that when it 

breaks down the material disappears completely - there is nothing left behind. 

When asked how long something should take to “biodegrade”, 60% of the respondents 

stated a year or less. 

Further, over 80% of the people surveyed believed that “biodegradable” products would 

break down in a landfill or in the natural environment. 

Given this level of consumer understanding, the BPI recommends 

1) The term “biodegradable” should have a separate definition from that of 

‘degradable’ and ‘photodegradable’. Consumers expect that a ‘biodegradable’ 

material will be totally eliminated from the environment. The only way that this 

can be accomplished is via microbial assimilation, where these products are used 

as a food source. 

Conversely, ‘degradable’ and ‘photodegradable’ are forms of fragmentation, where 

the polymers become friable, yet remain in the environment. While each has value, 

the end result of the process differs from what occurs during biodegradation. 

2. The FTC should reinforce returning “entirely to products found in nature” and 

cite a specific timeframe for the process. The BPI has seen claims from 

manufacturers, whose materials achieve an overall 5% rate of biodegradation 

and their sales literature states that it will “Fully biodegrade in 9 months to 5 

years” or “Fully biodegrade wherever it is disposed”. These materials have been 

sent to the FTC2

ASTM has developed tests, which conclusively measure the rate and extent of 

biodegradation, for major solid waste disposal avenues, including composting, soil 

burial and even landfilling. These should be referenced as part of any new 

definitions. 

3. It is recommended that the FTC reinforce the limited environmental benefits of 

landfilling “biodegradable” products. Work conducted and published by Prof. 

William Rathje in the 1980’s & 90’s demonstrated that readily biodegradable 

materials, such as food scraps and newspapers, remain in landfills for many 

years if not decades. Further, the US EPA’s Solid Waste Hierarchy establishes 

landfilling and incineration as the least desirable forms of disposal. Manufacturers 

should be discouraged from claiming that “biodegradation” is the panacea to 

solid waste disposal, when their products are landfilled. 

With these factors in mind, the BPI recommends that the FTC definition for 

“biodegradable” be revised to read: 

An unqualified claim that a product or package is biodegradable should be 

substantiated by demonstrating that the entire product or package can be 

2

 Email correspondence to Janice Frankle Podoll (FTC) from Steve Mojo (BPI) on July 17, 2007 

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completely converted to carbon dioxide, methane, water and biomass via 

microbial assimilation within 12-18 months by using the appropriate ASTM Test 

Methods which reflect customary disposal conditions. A claim is deceptive if it 

leads consumers to believe that there is an benefit provided when the product is 

disposed of in a landfill. 

Additionally the FTC should create an example under the definition to address 

biodegradable claims for products that are normally landfilled. 

Example 1 

A trash bag is marketed as “biodegradable”. The marketer relies on soil burial 

tests to show that the product will decompose in the presence of water and 

oxygen. The trash bags are customarily disposed of in incineration facilities or at 

sanitary landfills that are managed in a way that inhibits biodegradation by 

minimizing moisture and oxygen. Biodegradation is irrelevant for those trash 

bags that are incinerated and, for those disposed of in landfills. Also, the 

marketer does not possess adequate substantiation that the bags will completely 

biodegrade in 12 to 18 months, using ASTM Test Methods, which replicate 

landfill conditions. The claim is therefore deceptive.

“Compostable” Comments: 

According to the ACC research, consumers view compostable materials as ones that are 

able to be returned to the soils after composting as a useful soil amendment. 

• “Compostable” means that the material can be put back into the ground to make 

soil, mulch, or fertilizer that can be used in a garden or around your home. 

• The chief attribute of compostable materials is that the decomposition is 

beneficial to the earth. This stands in opposition to biodegradable material which 

most believe disappears completely. 

• Compostable materials are natural or organic materials and include leaves, twigs, 

grass clippings, food products (fruit peels, vegetable parts, etc.) and other 

materials.

• These materials are expected to break down and be usable in a matter of 

months (3 months to a year). 

Consumer perceptions are in line with the requirements found in the 2 ASTM 

Specifications that are in place today. 

Specifically ASTM D6400 and D6868 include criteria which insures that materials will 

disintegrate rapidly; biodegrade completely within a 6-12 months; do not harm the 

resulting compost and do not introduce unwanted levels of regulated metals. Products 

that meet these specifications are being successfully composted in professionally 

managed, large scale facilities, as our found in the US, Canada and Europe. Importantly, 

ASTM D6400 and D6868 are consistent with specifications in Europe as well as those 

under development by ISO. 

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Additionally, these ASTM specifications are recognized by the US Environmental 

Protection Agency, on its Organics page found at the link below: 

http://www.epa.gov/epaoswer/non-hw/organics/reduce.htm

Quoting from the website: 

“Biodegradable and Compostable Plastics 

Plastic products are items you use everyday like bags, bottles, packaging, and 

containers. Conventional plastics used for these products include HDPE, PET, and 

LDPE. These plastics can be easily reused or recycled. 

Other materials that have been developed are biodegradable and compostable 

plastics. This type of packaging will safely disintegrate and biodegrade in a wellmanaged composting site. Many, but not all, of these materials are produced 

from renewable resources (i.e. corn, switch grass, grain). 

Two specifications that identify plastics as biodegradable and compostable have 

been developed by the American Society for Testing and Materials:

x ASTM D6400 (Standard Specification for Compostable Plastics) and 

x ASTM D6868 (Standard Specification for Biodegradable Plastics Used as 

Coatings on Paper and Other Compostable Substrates). 

Composting biodegradable or compostable packaging or products is an effective 

form of recycling. 

The Biodegradable Products Institute provides more information.” 

Further, the State of California has created two regulations that govern the use of the 

terms “biodegradable”, “degradable” and “compostable”. These are found in CA’s Public 

Resources Code Sections: 42359-42359.6 and 42355-42357 and clearly state that plastic 

products must meet ASTM Specifications. These regulations were put in place to help 

minimize the growing confusion in this area. 

For these reasons the BPI, recommends that the FTC strengthen its current definition for 

“compostable” to include the ASTM Specifications as follows: 

Compostable: It is deceptive to misrepresent, directly or by implication, that a 

product or package is compostable. A claim that a product or package is 

compostable should be substantiated by competent and reliable scientific 

evidence that all the materials in the product or package will break down into, or 

otherwise become part of, usable compost (e.g., soil-conditioning material, 

mulch) in a safe and timely manner in an appropriate composting program or 

facility, or in a home compost pile or device. Manufacturers must meet the 

requirements found in ASTM D6400 or ASTM D6868 to demonstrate 

compostability. Claims of compostability should be qualified to the extent 

necessary to avoid consumer deception. An unqualified claim may be deceptive 

if: (1) the package cannot be safely composted in a home compost pile or 

device; or (2) the claim misleads consumers about the environmental benefit 

provided when the product is disposed of in a landfill. A claim that a product is 

compostable in a municipal or institutional composting facility may need to be 

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qualified to the extent necessary to avoid deception about the limited availability 

of such composting facilities. 

Additionally, the BPI recommends that Example 2 under the definition in the Guides be 

modified as follows to recognize California’s labeling regulations. 

Example 2:

A plastic lawn and leaf bag is labeled and sold in California as "Compostable in 

Municipal Yard Trimmings Composting Facilities.'' The bag does not meet ASTM 

D6400. The claim is deceptive as it does not meet the current regulations in the 

State where it is sold. 

Today, over 60% of the yard trimmings collected in the US are composted according the 

US EPA’s Municipal Solid Waste Characterization for 20053

. This is one of the highest 

diversion rates for any solid waste category. Further, according to BioCycle, there are 

over 3000 leaf and yard waste composting sites. So professionally managed composting 

facilities are well established in the US. 

However, the same EPA report states that food scraps recovery and diversion is 

approximately 2%. And while the number of food scrap organics diversion programs 

grows, the BPI believes that it is still necessary to urge consumers to check to see if 

programs exist in their neighborhoods. However, the BPI believes that a more positive 

qualification would also be appropriate. For example: 

“Check to determine if a professionally managed composting facility exists in 

your community.” 

This phrase will continue to alert consumers as to check to determine if appropriate 

programs are available. Also, by being shorter, it will be easier to use on packaging. 

Renewable Content” Comments: 

According the ACC survey, eight out of ten consumers thought that products made from 

natural materials are also ‘biodegradable’. Some manufacturers are capitalizing on this 

idea to convey inappropriate environmental benefits. For example, there is cutlery on 

the web that makes the following claims: 

“Xxx products are made with a GMO free bio based starch and 100% 

biodegradable. 

The BPI had this product analyzed in early 2007 using 2 outside labs. The tests showed 

that the product contained only 28% renewable content (based on ASTM D6866) and 

large amounts of polypropylene and polyethylene. Neither of these resins is 

biodegradable and there is no mention that the percentage of the product from 

renewable resources is less than 30%. 

3

 Source: http://www.epa.gov/epaoswer/non-hw/muncpl/pubs/msw06.pdf

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Additionally, work conducted on biobased cutlery and films for USDA's BloPreferred 

Program showed tha~ the cont~nt coming "from' renewable resources ranged as follows: · 

• 36% to 100% for c:;ut1ery4 & · 

• 2% to 96% for films5 • 0 

The BPI believes that "r~newable", "Q ob<~s~cl" .or "natl.!ral'' content claims are similar to 

"recyded" content in the· early 1990's. ·Direction .should be provided by the FTC as to 

how manufacturers should measure. and coinmuriic~te renewable content and their 

environmental benefits. 

• 0 0 

Wrth this in mind, the BPI recommends the fOilowina directions; 

• All renewable content claims sh9tJid ,be yerifi.~d using ASTM 06866: "Stand{Jrd 

Test Methods for Determining the Biobased Content ofNatural Range Materials 

Using Radiocarbon ~nd iso.irJJie Riitiq Mass Speqiometry Analysis'~ This test cost 

effectively proVides defjr.i'itive. qu~ ntl~catlon as to the Percentage of the material 

that derives from n·on-petroieum: sourc;es. Moreover, the BPI is aware of at least 

3 laboratories that run this test't9day. · 

• Unqualified "renewabl~" or. ''natu,~l ccinte.nt" claims should be limited to products 

with greater than ~S.o/o nor:t-petr:':ll~uni re.so~.;~rces. · . . · · . 

• Products containing ·Jess th~ n 95% renewable content should be required to 

clearly state that percentage. · · 

Respectively submitted, 

3 c: -::A 'fv{, ~ 

Stever, 

BPI Executive 

A Mojo 

Director ~ 

cc. BPI Board Members 

Attachments 

4 http:/ wWw.biopreferred.gov fi s/~tem.,..Desigl')ation_ Cutlery. pdf 

5 http;/ jwww.biopreferred.gov/flles/Biodegradable_Films.pdf 

. . · 

: . . ' 

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REPORT ON BIAS AND CAPTURE IN THE 

PROMULGATION OF THE GREEN GUIDES AND 

ENFORCEMENT ACTION AGAINST ECM BIOFILMS 

Alexander Volokh 

June 18, 2014 

I. INTRODUCTION 

A. Author 

My name is Alexander Volokh. As described further in my cur~ 

riculum vitae, which is attached as an exhibit to this report, I re~ 

ceived a Ph.D. in economics from Harvard University and a J.D. 

(magna cum laude) fi·om Harvard Law School. Currently a tenured 

associate professor at Emory Law School, I am an expert in admin~ 

istrative law, the regulatory process, and the economic analysis of 

legal change. 

I have taught courses in Administrative Law, Constitutional 

Law, Law and Economics (both introductory and specialized), 

Torts, and other fields. My Administrative Law course and the 

specialized course I have taught on the Law and Economics of 

Regulation and Antitrust relate directly to the regulatory process. 

In Law and Economics of Regulation and Antitrust, I discuss the 

public choice theory of decisionmaking by government bodies; and 

in Administrative Law, I discuss regulatory capture and public 

choice and cover the caselaw of agency bias in administrative 

agencies. 

I have published articles in leading law journals, including the 

Harvard Lmv Review (student writing), Stanford Law Review, NYU 

Law Review, University of Pennsylvania Lmv Review, Michigan 

Law Review (co~authored), Em01y Law Journal, Alabama Lmv Re~ 

view, UC Davis Lmv Review, Ohio State Law Journal, Houston 

Law Review, and Harvard Journal of Lmv and Public Policy. 

I have an extensive discussion of agency bias in The New Pri~ 

vate~Regulation Skepticism: Due Process, Non~Delegation, and 

Antitrust Challenges, 37 HARv. J.L. & PuB. POL'Y 931 (2014), as 

well as in the amicus brief I submitted to the Supreme Court in 

April in DOT v. Ass 'n of American Railroads (No. 13~ 1 080). 
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2 VOLOKH 

I have also published articles in peer-reviewed journals, including the American Lmv and Economics Review and International 

Journal of Lmv and Economics, as well as various book chapters 

and encyclopedia entries. 

I have testified about my work (on the constitutionality of a 

medical malpractice reform bill) before the Georgia legislature. 

I have been a peer reviewer for the following scholarly journals: American Journal of Political Science, Criminology, International Review of Law and Economics, Journal of Legal Studies, 

Journal of Policy Analysis and Management, Lmv and Social Inquiry, and Public Choice. 

Additionally, I have clerked for Judge Alex Kozinski, now 

chief judge of the Ninth Circuit Court of Appeals, and Supreme 

Court Justices Sandra Day O'Connor and Samuel Ali to. 

B. This Report 

I have been retained by ECM BioFilms, Inc. to assess issues of 

bias and regulatory capture in the enforcement action against it, as 

well as in the promulgation of the Green Guides, the FTC's policy 

statement on which the enforcement action is partly based. I have 

not previously pmticipated in any cases as an expe11 witness. I am 

being paid $20,000 for my participation in this case. 

Part II of this report discusses the nature of bias (and the closely related concept of regulatory capture) as it is understood in regulatory economics and administrative law. Part III discusses how 

one can prove the presence of bias, and lays out a ("Bayesian") 

probabilistic theory that shows how one may prove the existence of 

bias or capture, even if-having neither participated in it nor sponsored it-one relies on circumstantial evidence. 

The subsequent Parts apply this theory to the promulgation of 

the Green Guides and the facts of the enforcement action against 

ECM as I understand them. Part IV discusses the role played in the 

promulgation of the Green Guides and the enforcement action 

against ECM by ECM's competitors. Part V discusses issues of in 

the testimony of two of complaint counsel's expert witnesses and 

in a scholarly paper that complaint counsel is using as scientific 

evidence. 
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2014] FTC EXPERT REPORT 3 

II. WHAT Is BIAS? 

Bias is any tendency on the part of an actor to take actions con~ 

trary to "the merits"-for instance, by taking into account irrelevant factors like his own self~interest or that of another party. Le~ 

gal bias-for instance, the bias of an agency in administrative proceedings, or the bias an expert witness-may result in the vacating 

of the administrative proceedings1 or the exclusion of the witness's 

testimony? (Henceforth, I will use the term "bias" to refer to this 

sort of legally relevant bias.) 

Bias is roundly condemned in administrative law, both in specific bias~related doctrines3 and, more implicitly, in the general 

rule of hard~ look review that an administrative decisionmaker must 

not have considered irrelevant factors. 4 

Bias also plays a central role in how economists and political 

scientists discuss the work of agencies. One particular form of bias 

is "regulatory capture." The concept of regulatory capture5 had, by 

the late 1960s, come to be regarded as "the universal condition of 

the administrative state,"6 and it is still influential today.7 Michael 

Livermore and Richard Revesz explain: 

1 See, e.g., Cinderella Career & Finishing Schools, Inc. v. FfC, 425 F.2d 583 (D.C. Cir. 1970); 

D.C. Fed. of Civic Ass'ns v. Volpe, 459 F.2d 1231 {D.C. Cir. 1971); Grant v. Comm'r, Ill F. Supp. 

2d 556, 559 (M.D. Pa. 2000). 2 See, e.g., Van Blargan v. Williams Hospitality Corp., 754 F. Supp. 246, 248--49 (D.P.R. 

1991) (denying qualification as an expert witness, in part because "his testimony would not possess 

the professional safeguards ensuring objectivity"); Edgar v. K.L., 93 F.3d 256, 261--{)2 {7th Cir. 

1996). 

J See, e.g., FfC v. Cement Inst., 333 U.S. 683 {1948); Withrow v. Larkin. 421 U.S. 35, 47 

{1975); Cinderella Career & Finishing Schools, Inc. v. FfC, 425 F.2d 583 {D.C. Cir. I 970); Ass'n of 

Nat' I Advertisers, Inc. v. FfC, 627 F.2d 1151 (D.C. Cir. 1979). 

• Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971}; Motor Vehicle 

Mfrs. Ass'n v. State Fam1 Mut. Auto. Ins. Co., 463 U.S. 29,43 {1983). 

~ Some important early works on regulatory capture include George J. Stigler. The 77zeory of 

Economic Regulation, 2 BELL J. ECON. & MGMT. SCJ. 3, 3 (1971); ROGER G. NOLL, REFORMING 

REGULATION (1971}; Richard A. Posner, 77zeories of Economic Regtzlatioll, 5 BELL J. ECON. & 

MGI>IT. SCI. 335, 336 (I 974); Sam Peltzman, Toward a More General 77zeory of Regulation, 19 J.L. 

& EcON. 211, 212 {1976); Gary S. Becker, A 77zeory of Competition Among Pressure Groups for 

Political Influence, 98 Q.J. ECON. 311, 372 (1983). Much of this theory is heavily indebted to MANCUR OLSON, THE LOGIC OF COLLECTIVE ACTION: PuBLIC GooDS AND THE THEORY OF GROUPS 

(1965). 6 Thomas W. Merrill, Capture 77zeory and the Courts: /967-/983, 72 CHI.-KENT L. REV. 

1039, 1060(1997). 

1 According to Merrill, the capture paradigm in adm in istrativc taw has given way to the public 

choice paradigm; "what I call capture theory would be regarded today as a quaint species of public 

choice theory." /d. at 1069. But "there is no sharp anal}1ical break between capture theory and public choice theory," id; public choice theory merely generalizes the insights of capture theory to a 

greater variety of actors beyond just administrative agencies. 
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4 VOLOKH 

Capture describes situations where organized interest 

groups successfully act to vindicate their goals through 

government policy at the expense of the public interest. For 

groups that are repeat players before specialized agencies, 

investments in long-term relationships can have substantial 

returns in terms of influence, raising capture concerns. 

8 

As Judge Skelly Wright put it in his influential opinion in 

Home Box Office, Inc. v. FCC,9 the concern is over "undue industry influence over Commission proceedings" and over rules being 

shaped "by compromise among contending industry forces, rather 

than by exercise of the independent discretion in the public interest 

the Communications Act vests in individual commissioners."10 

What is the difference between bias and capture? Capture is often used to refer to bias in favor of the regulated community and 

against the (more diffuse) interest of consumers or citizens, but 

there is no reason why it cannot also be used to refer to bias in favor of one set of regulated firms against other, less well-organized 

regulated firms. Moreover, the term "bias" is broad enough to include isolated instances-such as the bias that may be present in an 

expert witness's report or in a scholarly paper-while "capture" is 

generally used to refer to a more general and permanent condition 

that stems from long-term interaction. Also, "bias" is broad enough 

to include decisionmaking in line with one's own ideology or idiosyncratic preferences, while "capture" generally refers to acting in 

the (usually economic) interest of some favored group. Nonetheless, the concepts are similar enough that they should be discussed 

together, and I will often use them together in this report. 

How does capture occur? One method is campaign contributions to legislators, who pressure agencies for policy that benefits 

the contributors. 11 Another is the revolving door12 

--or, phrased in 

more general terms that need not encompass purely career concerns, "thick, interlocking personal and professional networks that 

3 Michael A. Livermore & Richard Revesz, Regulatory Review, Caplllre, and Agency inaction, 

101 GEO. L.J. \337, 1340 (2013). 9 567 F.2d 9 (D.C. Cir. 1977). 10 id. at 53. 11 Livermore & Revesz, supra note 8, at 1343-44; Rachel E. Barkow, Insulating Agencies: 

Amiding Capture 111rough institutional Design, 89 TEX. L. REV. 15, 22-23 (201 0). 

u Barkow, supra note II, at 23. 
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2014] FTC EXPERT REPORT 5 

include both agency personnel and outsiders."13 Another is the 

compromises born of the agency's need to cooperate with the reguw 

lated community in the long term. 14 

Another source of capture or bias is through the control of inM 

formation. Agencies rely on outside parties for much of their information about the world-the notice-andMcomment process is 

one example of how agencies become informed through the efforts 

of outsiders-and targets of regulations, or any parties that hope to 

benefit from regulation, can bias the agency's perspective by 

providing information favorable to their perspective. 15 Having access to many perspectives is good, but "bias" emerges when some 

pat1ies are better organized or better connected than others. This is 

one reason why, for instance, ex parte communications are generM 

ally barred in the context of pending cases, 

16 why transparency17 

and public participation 18 are favored, or why a requirement of noM 

ticeMand-comment rulemaking is desirable: 19 enhancing the ability 

of different parties to get information to the agency on more equal 

terms might be expected to alleviate these biasing effects. Even so, 

a pattern of meeting with one set of parties more than another, or 

receiving information from one set of parties more than from anM 

other, can lead to capture or bias even in the absence of legal hindrances to more equal participation.20 

11 /d. at 1344; see also JAMES KWAK, CULTURAL CAPTURE AND 1HE FINANCIAL CRISIS II, 

http://tobinproject.org/sites/tobinprojecl.orf}liles/assets/K wak%20Culturai%20Capture%20%281.16 

.13%29.pdf (discussing "cultural.capture," where "(r]egulators are more likely to adopt positions 

advanced by people v.ilom they perceive as being in their in-group," "whom they perceive to be of 

higher status," or "who are in their social networks"). 14 See Richard B. Stewart, 71re Refomralion of American Administrati1•e Law, 88 HARV. L. 

REV. 1667, 1685-86 (1975); Barkow, srtpra note II, at 22. 15 See id. at 1686; see also Barkow, supra note II, at 23; Nicholas Bagley & Richard L. 

Revesz, Centralized O.·ersight of the Regrtlatory State, 106 COLUM. L. REV. 1260, 1285 (2006) 

("These explanations look to how agencies cooperate with interest groups in order to procure needed 

information, political support, and guidance; the more one-sided that information, support, and guidance, the more likely that agencies will act favorably toward the dominant interest group."); Melissa 

F. Wassem1an, The Changing Grtard of Patent Law: Chevron Deference for the PTO, 54 WM. & 

MARY L. REv. 1959, 2013-14 (2013) (arguing that the PTO has a pro-patentee institutional bias 

because "no third party is present to argue that a patent should not be issued"). 16 See, e.g., 5 U.S.C. §§ 554(d), 557(dXJ ). 17 See Livermore & Revesz, srtpra note 8, at 1356-58. 

ts See id at 1358-59. 19 Cf Stewart, supra note 14, at 1688 (listing "a requirement that agencies crystallize their exercise of discretion through standards" as one proposed solution to the problem of agency bias). 10 See Livermore & Revesz, supra note 8, at 1358 (noting an "imbalance of participation" that 

"raises at least the appearance" that an agency is "more solicitous" to one set of concerns); Wasserman, srtpra note 15, at 2015-16 (arguing that appellate courts are subject to institutional bias in 

(continued next page) 
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Notably, a requirement of notice-and-comment rulemaking21 is 

more helpful in counteracting bias than merely a decision to engage in notice-and-comment rulemaking when it is optional: cou1ts 

are more likely to police whether the agency adequately responded 

to the substance of critical comments if notice-and-comment was 

required.22 When agencies engage in rulemaking knowing that they 

will be subject to somewhat demanding judicial review (even if it 

is relatively deferential Chevron review23), one can have more confidence that they will make more of an effort to not be overtly biased?4 

The orientation of an agency toward a particular set of issues 

also increases the risk of capture (relative to decisionmaking being 

housed in more generalist institutions, like OIRA or the courts), 

because when an agency's docket includes more issues, it becomes 

harder to control by specialized interest groups. For instance, Livermore and Revesz write, in discussing why centralized review of 

agency decisionmaking through OIRA is superior to decisionmaking in individual agencies: 

Generalist institutions are typically harder to capture than 

issue-specific agencies. Because OIRA 's docket includes 

all federal regulatory issues, the return on the investment of 

any particular interest group to build a relationship with 

OIRA is lower than for a specialized agency, reducing capture risks. Additionally, disparate interests and free-rider 

problems stand in the way of having different groups form 

coalitions to control OIRA.25 

Similarly, more generalist organizations can be less subject to 

capture to the extent that they include "political appointees and career staff from several different backgrounds, and with different 

institutional perspectives and interests,"26 and to the extent they 

patent tases because "patent bar associations file amkus briefs in favor of patentees at a significant· 

ly higher rate than the government or high-tech companies"). 21 See 5 U.S.C. § 55J(b), (c). 22 See United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977). 11 See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). 

~ See Livermore & Reves~ supra note 8, at 1360-61 (''Because judicial review is open to all 

affected parties, it can operate as a counterweight to the influence of organi7£d special-interest 

groups in political and regulatory processes."). 21 /d. at 1341. 

26/d. 
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use relatively transparent modes of decisionmakinf such as, in 

Livermore and Revesz's view, cost-benefit analysis? 

It is clear that most bias or capture need not be conscious. Cases where regulators knowingly shape the content of regulation to 

suit the demands of a contributor to the campaign of a powerful 

legislator on the relevant oversight committee are (one hopes) relatively rare. The same goes for regulators who knowingly shape the 

content of regulation to maximize their future career prospects: this 

is (one hopes) not as common as regulators who, while believing 

they are serving the public interest, craft regulations that serve particular entities' material interests because they have been biased by 

the facts they have been exposed to, by resource constraints that 

have subtly made them unwilling to oppose certain well-organized 

entities on all fronts, and by shared cultural and ideological common ground with these entities. Capture and bias affect features 

"that purport to be, and that we experience as, independent, volitional, and benign. "

28 

III. PROVING BIAS: A PROBABILISTIC APPROACH 

A. The Difficulties of Direct Proof 

It is very difficult to prove that an agency decisionmaker was 

biased,29 either in rulemaking or in adjudication, short of being in 

the decisionmaker's head or finding a smoking gun.30 The classic 

case of Cinderella Career & Finishing Schools, Inc. v. FTC31 concerned an FTC action alleging false representations by an organization purpot1ing to offer "courses of instruction which qualify 

students to become airline stewardesses and buyers for retail 

11 Id; see also Stewart, supra note 14, at 1688 (listing "adoption of allocational efficiency as a 

substantive yardstick for agency decisions" as a proposed solution for the problem of agency bias). 

l& Jon Hanson & David Yosifon, The Situation: An Introduction to the Situational Character, 

Critical Realism, Power Economics, and Deep Capture, 152 U. PA. L. REV. 129, 218 (2003). 1

' See, e.g., Wassem1an, supra note 15, at2016; Mark A. Perry, Comment, Municipal Supen•ision and State Action Antiln1st Immunity, 51 U. CHI. L. REV. 1413, 1441 (1990). 10 See Jason D. Vendel, General Bias and Administrati1·e Lm1• Judges: Is T1rere a Remedy for 

Social Security Disability Claimants?, 90 CORNELL L. REV. 769, 773 (2005) ("Because general bias 

involves prejudgment, proving it from the record of a single case requires statements or overt actions 

on the part of the adjudicator that shed light on his internal decisionmaking. Unless an adjudicator is 

reckless with his words or actions, such evidence is rarely available."). 31 425 F.2d 583 (D.C. Cir. 1970). 
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stores."32 While the action was pending, the FTC Chairman made a 

public speech in which he said: 

What kind of vigor can a reputable newspaper exhibit? 

. . . What standards are maintained on advertising acceptance? ... What about carrying ads that offer college 

educations in five weeks, fortunes by raising mushrooms in 

the basement, getting rid of pimples with a magic lotion, or 

becominf an airline's hostess by attending a charm 

school?3 

But most public officials probably refrain fi·om commenting on 

pending cases in their public speeches. Similarly, impermissible 

bias can result from political pressure, as illustrated by the Secretary ofTransportation's decision to approve a bridge (that had been 

previously dropped by his highway plan) after intense pressure 

from a powerful Congressman;34 but this is an unusual case because usually intense pressure occurs behind the scenes. In another 

case, one Social Security administrative law judge had a habit of 

denying benefits to "no-goodniks."35 How did he decide that 

someone was a no-goodnik? 

[He] had a theory about blacks, Hispanics, [and] poor white 

people that he had developed while he was in California, 

and that typically these people are drug addicts or alcoholics or have decided to adopt a lifestyle where they just will 

not work no matter what, that they preferred living on public monies, including welfare payments, Worker's Compensation if they could get it if they had a work history, and 

Social Security Benefits. He said that he did not care what 

the evidence showed, that he did not care if his Decision 

was reversed by the Appeals Council or the Courts, that he 

had no intention of paying the case based on what he had.36 

This ALJ's case is likewise unusual because he stated his bias to a 

staffer, who then testified about his statement. Obviously, this sort 

of evidence is hard to come by.37 

12 ld. at584 n.l. 11 /d. at 589-90. 

ll D.C. Fed. of Civic Ass'ns v. Volpe, 459 F.2d 1231 (D.C. Cir. 1971). 11 Grant v. Comm'r, Ill F. Supp. 2d 556, 559 (M.D. Pa. 2000). 16 Jd at 56~1. 17 Even when there is evidence that a decisionmaker had strong views in favor of a particular 

party, that evidence may not rise to the level necessary to meet the legal standard for disqualification 

based on bias. See, e.g., FTC v. Cement lnst., 333 U.S. 683 (1948); Ass'n ofNat'l Advertisers, Inc. 

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Direct financial interest would suffice to show bias,38 but (absent outright corruption) this path is generally unavailable for federal administrative officials, whose salaries, by design, usually do 

not incorporate incentives. If we had access to a large sample of 

decisions, one could make a strong argument for bias by showing 

that a decisionmaker's actions were sympathetic to a particular 

party even after controlling for the merits.

39 This was possible in 

the Social Security ALJ's case because of the large number of cases he had decided.40 

When certain factors are more likely to appear in the presence 

of bias, their actual appearance should make one think bias is a 

more likely explanation than one previously thought. This is essentially an intuitive application of Bayes's Law, developed by the 

18th-century English statistician Thomas Bayes (1701-61). The 

rest of this Part explains the mathematics behind this approach and 

shows how it relates to showing the bias of agencies or other parties involved in administrative proceedings. 

B. Probabilities, Unconditional and Conditional 

To understand Bayes's Law, first denote the probability of an 

event X happening as Pr(X). For instance, if one flips a fair coin 

and labels the two possible outcomes H (for "heads") and T (for 

"tails"), then one usually assumes that Pr(H) = ~ and Pr(1) = ~. 

A "conditional probability" is the probability that something 

happens or is true given that something else has happened or is 

true. For instance, according to the Social Security Administration's 2009 Period Life Table,41 out of a starting population of 

100,000 men, 1340 are expected to survive to age 99 and 888 are 

expected to survive to age 100. This can be rephrased that in terms 

of probabilities: a newborn boy has a 1.34% chance of surviving to 

age 99 and a 0.888% chance of surviving to age I 00. And these 

v. FTC, 627 F.2d 1151 (D.C. Cir. 1979); Withrow v. Larkin, 421 U.S. 35, 47 (1975) (noting a presumption of honesty and integrity). 31 See Gibson v. Berryhill, 411 U.S. 564 (1973). It See Vendel, supra note 30, at 773 & nn.20-23. 40 Gram, Ill F. Supp. 2d at 558-59. 

'

1 This exercise assumes that the death probabilities reported in this table are accurate for 

someone born today. Of course, the Social Security tables tabulate probabilities based on past mortality, sc--given improvements in health over time-the assumption of constant probabilities is 

inaccurate. I am merely using these numbers for purposes of illustmting probability concepts. 
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10 VOLOKH 

numbers also allow us to express a conditional probability: the 

probability that a man survives to I 00 given that he has already 

survived to 99 is 888/1340 = 66.3%.42 

Let's define the concept of conditional probability more formally. If we assign the label S10o to the event "male surviving to 

I 00" and the label S99 the event "male surviving to 99," we can 

write: Pr(S100) = 0.888% and Pr(S1ooiS99) = 66.3%. This last expression, with the vertical bar, is the probability of a male's surviving 

to 100 conditional on surviving to 99. 

In general, the formula for the probability of event A conditional on event B is: 

Pr(A n B) 

Pr(AIB) = Pr(B) . 

where the "(1" symbol represents "and." Thus, to calculate 

Pr(S100IS99) using this formula, the numerator is Pr(S10(11S99), the 

probability that a male survives to l 00 and he survives to 99. Of 

course, this is just the same as the probability that a male survives 

to 100, which is 0.888%. The denominator is Pr(S99), the probability that a male survives to 99, which is 1.34%. So the formula tells 

us that Pr(S1ooiS99) is 0.888%/1.34% = 888/1340 = 66.3%, just as 

we found earlier. 

C. Reversing the Conditional Probability 

Often it is convenient to reverse the condition. That is, we 

know the probability of A given B, but what we want to know is 

the probability of B given A. 

For instance, suppose we've flipped a coin twice and gotten 

two heads. Suppose we know somehow that there are only two 

possibilities: the coin could be fair (call this possibility F), or it 

could be two-headed (call this possibility - F), but we're not sure 

which.43 

Say we thought originally that Pr(F) = ~ (and therefore that 

Pr(-F) = ~). Those were our initial beliefs. But now, observing 

n Even some of the previous probabilities could be expressed conditionally: 1.34% is the probability that a newborn survives to age 99 gi1•en that it is male, and Y, is the probability that a coin 

lands on heads given/hat it is fair . 

• , There are many types of conceivable coins, including two-tailed coins, or coins that are spe· 

cially weighted so the probability of heads is 60%, and so on, but suppose for purposes of this exer· 

cise that all cases can be ruled out except (I) a fair coin and (2) a two-headed coin. 
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two heads should make us more worried that the coin is twoheaded. The question is, how much more worried? Now that we've 

observed two heads from two flips (call this event HH), what's our 

new estimate of Pr(F)? What we're looking for is the new probability, Pr(FlHH), the probability that the coin is fair given that two 

heads have occurred. 

If we had gotten HT, this exercise would be easy: since we got 

tails once, clearly this isn't a two-headed coin and so it must be a 

fair coin. We can easily say Pr(FIH1) = l. But since we saw HH, 

we can't proceed so easily, because unfortunately HH is consistent 

with both a fair coin and a two-headed coin. 

Now, it's trivial to know Pr(HHJF), the probability of getting 2 

heads from flipping a fair coin twice. Intuitively, we know it's '14-

but let's express it using the formula. The definition of a conditional probability tells us that: 

Pr(HH n F) 

Pr(HHIF) = Pr(F) . 

The numerator is the probability that the coin is fair and we get 

two heads from two flips. Even if we don't know the probability 

that the coin is fair (Pr(F)), we can say that the probability that the 

coin is fair and we get two heads from two flips is equal to: 

So: 

1 1 1 

Pr(HH n F) = Pr(F) X 2 X 2 = 4 Pr(F). 

1 

Pr(HH n F) 4 Pr(F) 1 

Pr(HHIF) = Pr(F) = Pr(F) = 4· 

We didn't have to use our belief that Pr(F) = Y2 here, since in 

this case Pr(F) simply canceled out of the fraction. 

Unfortunately, this result for Pr(HHJF) is trivial; moreover, it's 

not what we were looking for, which is Pr(FlHH). 

Fortunately, Bayes's Law tells us how to switch from Pr(HHJF) 

to Pr(FlHH). By stating the definition of Pr(FlHH) and doing some 

algebra, we get: 

Pr(F n H H) Pr(H H n F) Pr(F) 

Pr(FIHH) = Pr(HH) = Pr(F) Pr(HH) 

Pr(F) 

= Pr(HHIF) Pr(HH)' 

In turn, the denominator of the last term-Pr(HH), the probability of two heads---<:an be decomposed into two components: (l) 
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12 VOLOKH 

the probability of two heads if the coin is fair and (2) the probability oftwo heads if the coin is two-headed: 

Pr(HH) == Pr(HH n F)+ Pr(HH n -F) 

== Pr(HHIF) Pr(F) + Pr(HHI-F) Pr( -F) 

1 1 1 5 ==- Pr(F) + Pr( -F) =-+- =- 4 a 2 a· 

Here, we substituted various known values: Pr(HHjF) = Y.., as 

calculated above; Pr(F) and Pr( -F) are both ~; and since the unfair 

coin is two-headed, it always gives two heads from two flips, so 

Pr(HHj-F) is 1. 

Now that we have a result for Pr(HH), we can substitute it into 

the definition of Pr(FjHH): 

Pr(F) 1 i 

Pr(FIHH) = Pr(HHIF) Pr(HH) = 4 x ~ 

8 

1 1 8 1 

= -X-X-= - = 20% 4 2 5 5 . 

This is the power of Bayes's Law: from a trivial result, 

Pr(HHjF) = Y.., and with original beliefs ("prior probabilities") that 

Pr(F) = ~ and Pr(-F) = ~. we were able to derive new probabilities based on the observed evidence ("posterior probabilities"). We 

started out believing that a fair coin was 50% likely, and a twoheaded coin was 50% likely. Then we observed two heads, which 

made us revise our beliefs. Now, we believe that a fair coin is only 

20% likely, and thus a two-headed coin is 80% likely. 

The intuition here is clear: The event HH was less likely if the 

coin was fair. It was more consistent with a two-headed coin. This 

is why our belief about the probability of a fair coin dropped. Conversely, if the observed evidence had been more consistent with a 

fair coin, then the belief about the probability of a fair coin would 

have increased. This is easy to check fi·om the definition. Recall 

from the coin example that: 

Pr(F) Pr(HHIF) 

Pr(FIHH) = Pr(HHIF) Pr(HH) = Pr(F) Pr(HH) ' 

So the relationship between the posterior probability Pr(FjHH) 

and the prior probability Pr(F) depends on the value of the fraction 

Pr(HHjF)!Pr(HH): 

Pr(HHIF) Pr(FIHH) < Pr(F) ¢:> Pr(HH) < 1 ¢:> Pr(HHIF) < Pr(HH). 
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2014] FTC EXPERT REPORT 13 

The posterior probability of a fair coin is less than the prior 

probability of a fair coin if and only if Pr(HlJIF) is less than the 

unconditional probability Pr(HH): that is, the evidence (HH) is 

more likely if we know the coin is fair than if we don't know. We 

can usefully rephrase: 

Pr(HHIF) < Pr(HH) <=> Pr(HHIF) < Pr(HHI-F), 

so this is equivalent to saying that the evidence (HH) is more likely 

if we know the coin is fair than ifwe know it's unfair.44 

In the extreme case, suppose our only possibilities were a fair 

coin and a two-headed coin, and we observed HT, heads and then 

tails. Since tails is totally inconsistent with a two-headed coin, we 

would now be absolutely sure that the coin was fair; our belief 

would become Pr(f1H1) = 1. 

D. How This Relates to Proving Bias 

The quite intuitive central insight of the probabilistic model is 

this: A state of affairs becomes more likely if we observe evidence 

that is more consistent with that state of affairs than with the alternative state of affairs. Or, rephrasing: A state of affairs becomes 

more likely if we observe evidence that would be more likely if that 

state of affairs is true. 

This discussion relates directly to proving bias: Bias is more 

likely if we observe evidence that would be more likely in case of 

bias. 

In cases such as this one, we cannot directly observe bias. 

Moreover, our ability to observe conditions like financial interest, 

which are commonly held to be highly associated with disqualifying bias, is highly limited: discovery to obtain documentary evidence of the full extent of the financial ties and involvement of the 

parties with interests adverse to respondent ECM has been barred 

in a couple of decisions.45 

But we do know what we would expect to find if there were bias- things that are more likely in the presence of bias than in its 

absence. 

" Pr(HfliF) > Pr(HH) e:. Pr(HHjF) > Pr{HfliF) Pr(F) + Pr(HI+F) Pr(- F) (::) (1- Pr(F)) 

Pr(HlflF) > Pr(Hl+F) Pr(-F) (::) Pr(HfliF) > Pr(HI+F) [Pr(-F)/(1-Pr(F))] = Pr(Hl+F). 4 See Order Denying Motion to Compel, Dkt. No. 9358 (June 2, 2014); Order Denying Without Prejudice Respondent's Motion for Leave to Serve Subpoenas Duces Tecum, Dkt. No. 9358 

(June 10, 2014). 
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14 VOLOKH 

• If decisionmakers are biased in favor of some party, we expect to find that their decisions track that party's interests 

especially closely. 

• If decisionmakers are biased in favor of some party, we expect that their justifications of why they accepted the party's position rather than another one is not very persuasive. 

• Relatedly, if decisionmakers are biased in favor of some 

party, we expect that they would adopt the party's position 

in a document that is not subject to especially demanding 

judicial review. 

Because all these features are more likely to occur in the presence of bias than in the absence of bias, observing them should 

make us more confident that the observed events were the result of 

bias. 

The probabilistic approach breaks down when one can observe 

directly whether someone's decisions or views are substantively 

correct. If it could be shown that an agency or an expert witness 

made the unique right choice-but that right choice was also in 

line with a patty's interests-that would be equally consistent with 

bias and with a high level of substantive expertise. Therefore, it 

would be incorrect to infer bias from the mere fact that the agency's or expert witness's views lined up with a party's interests. But 

such independent verification is rarely available. The point of using expert witnesses is that they have subject-matter knowledge 

that the court lacks, so inevitably there will be some amount of reliance on the expert witness's judgment. Similarly, in a large set of 

cases, reviewing courts defer to agency expertise-it is nearly axiomatic that reviewing courts are not to substitute their judgment 

for that of the agency.

46 So the probabilistic approach remains valid in many cases where the agency (in the case of giving weight to 

expert witness testimony or the probative value of a piece of evidence) or a reviewing court (in the case of reviewing an agency's 

decisions, including an agency's decision to give particular weight 

to expert witness testimony or other evidence) is unable to directly 

verify correctness. 

46 See, e.g., Citizens to Preserve Ovenon Park v. Volpe, 401 U.S. 402 (1971); Motor Vehicle 

Mfrs. Ass'n v. State Fam1 Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). 
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The probabilistic approach can also be used together with other 

ways of inferring bias. For instance, everyone would agree that fiw 

nancial incentives increase the probability of bias, often to unacw 

ceptable levels47 (though, as noted above, the Commission has lim~ 

ited ECM's ability to discover the extent of such financial incenw 

tives48). Expert witnesses are generally paid by the parties, and 

their testimony generally lines up with the interest of the party that 

paid them. Even a disinterested expert can be suspected of biasbecause, per the. probabilistic model, bias would make him more 

likely to adopt a position coinciding with that of the party. But an 

expert paid by the party should be suspected of bias even moredespite the general rule that experts must remain disinterested.49 Of 

course, since expert testimony and reports produced for money are 

quite usual, the probabilistic model merely counsels in favor of an 

attitude of skepticism toward all paid expert testimony;50 it does 

not provide any specific reason to be more skeptical of any pat1icuw 

lar paid testimony or report. An additional measure of skepticism 

(whether produced by expert witnesses or otherwise) is warranted 

when, for instance, the producers of certain evidence have other 

financial interests that would encourage them to take the position 

they do, apat1 from the mere fact of being paid by a party-such as 

outside consulting or other ongoing commercial relationships that 

would be benefited by the position they take. 

Similarly, agencies constantly take positions on one issue or 

another. The probabilistic model suggests that one should suspect 

bias in favor of whoever's interests are served by those positions. 

But because any position an agency takes will probably be in 

someone 's interest, the mere fact that this occurs in a particular 

case counsels in favor of no more than a general attitude of skepti~ 

cism. But other indicia of bias should increase the amount of skep~ 

ticism. For instance, John Shepard Wiley has suggested testing for 

capture by looking for evidence of lobbying: "The most direct way 

... would be to examine the facts surrounding a regulation's 

origin. Judges could demand that plaintiffs, on pain of dismissal, 

identify producers who profit from the regulation's competitive 

47 See, e.g., Tumey v. Ohio, 273 U.S. 510 (1927); Ward v. Village of Monroeville, 409 U.S. 57 

(1972). 43 See supra note 45. 49 See text accompanying infra notes 112- 114. 

so Obviously, this critique of expert reports also applies to this report. 
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16 VOLOKH 

restraint and who played a decisive political role in its adoption."51 

Even the substantively correct approach has its lobbyists, so being 

skeptical of an agency's bias or capture does not necessarily imply 

that the agency's position is invalid. Rather, skepticism implies a 

higher degree of suspicion and a lower degree of deference. 

Other indicia of bias can increase one's skepticism still fm1her. 

If the agency's position is also substantively shaky on other 

grounds, this makes bias still more likely, according to the probabilistic model. Thus, Wiley's approach-which he suggests for 

purposes of applying state-action immunity in antitrust law-also 

requires that the policy or conduct at issue not solve a "substantial 

market inefficiency" and not be covered by an existing antitrust 

exemption.52 Thus, Wiley's test assigns meaning to evidence of 

lobbying only when combined with some other reason to doubt the 

merits. 

The following Parts of this report point out how some of these 

indicia of bias are present in evidence, expert testimony, and agency decisions. 

IV. BIAS IN THE PROMULGATION OF THE GREEN GUIDES AND THE 

DECISION TO BRING THIS ENFORCEMENT ACTION 

This Part discusses the Commission's decision to rely on financially interested parties in its promulgation of the Green Guides 

and in its litigation against ECM. 

As mentioned above, to the extent that there is a correct definition of "degradable," that definition will probably be in someone's 

financial interest, and of course one expects that this party will 

have participated in the process. Indeed, administrative law relies 

to a great extent on interested parties' participation in the process, 

in the hope that the optimal solution will emerge fi·om the combined information submitted by parties with diverse interests. 

But the theory of collective action also counsels caution, since 

small groups with concentrated interests find it much easier to 

overcome the costs of organizing than diffuse groups; and so even 

well-meaning agencies may be overwhelmingly exposed to inforll John Shepard Wiley Jr., A Capture 1J1eory of Anlitmst Federalism, 99 HARV. L. REV. 713, 

769 (1986). 

'

1 /d. at 743. 
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mation favoring the better-organized side and thus succumb-even 

if unknowingly-to bias and regulatory capture. 

The presence of determined and organized "lobbying," both official and unofficial, by one particular group of businesses against 

their competitors' position is thus consistent with bias and capture. 

One expects to see lobbying far more often in cases where bias and 

regulatory capture are present than in cases where they are absent. 

The fact that one sees it in this case is therefore evidence of bias 

and capture; knowing about such lobbying should make one believe that its probability is higher than one previously thought. 

A. The Influence of the Biodegradable Products Institute 

The Biodegradable Products Institute (BPI) is a trade association representing various people and corporations making compostable products-which are thus in direct competition with 

ECM. BPI's member organizations "include BASF, NatureWorks 

LLC, Metabolix, Novamont, Cereplast, BiobagUSA, Heritage Bag 

and Poly-America."53 BPI has a long history of contacts and correspondence with Commission staff, stretching back over a decade. 

BPI has commented on the Green Guides on degradability and 

compostabili7,54 supporting the one-year-or-less standard for biodegradation.5 (These comments were shared with other industry 

members, one of whom noted that the comments had to be kept 

simple for FTC members, who were "not experts in any of this" 

and "lack[ ed] technical understanding. "56) 

In its comments, BPI suggested including, as an example of a 

deceptive claim, the marketing of trash bags as "biodegradable" 

when the claim is based on soil burial tests but the bags are in fact 

customarily disposed of in ways that inhibit degradation-in incineration facilities or landfills: 

j} Letter from Steven A. Mojo, BPI Executive Director, to FTC, Re: Green Guides Regulatory 

Review, 16 CFR Part 260, Comment, Project No. P954501, Jan. 30,2008. Other members include 

Cargill Dow LLC, Eastman Chemical, Dow Chemical, DuPont, Biocorp NA, the Massachusetts 

Department of Environmental Protection, and Michigan State University. See Who Is the BPI. 5

' Letter from Steven A. Mojo, BPI Executive Director, to FTC, Rc: Proposed, Revised Green 

Guides, 16 CFR Part 260, Project No. P954501, Dec. 7, 2010. 

''Mojo 1130/08 letter, supra note 53. 

j6 E-mail from buzz to Steven Mojo, Re: Reply, Draft of Comments to FTC Green Guides 

(Nov. I 0, 20 I 0, 5:20 PM). buzz apparently refers to Buzz Chandler of StalkMarket Products, a compostable products manufacturer. 
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Example 1 

A trash bag is marketed as "biodegradable". The marketer 

relies on soil burial tests to show that the product will de~ 

compose in the presence of water and oxygen. The trash 

bags are customarily disposed of in incineration facilities or 

at sanitary landfills that are managed in a way that inhibits 

biodegradation by minimizing moisture and oxygen. Bio~ 

degradation is irrelevant for those trash bags that are incinerated and, for those disposed of in landfills. Also, the marketer does not possess adequate substantiation that the bags 

will completely biodegrade in 12 to 18 months, using 

ASTM Test Methods, which re~licate landfill conditions. 

The claim is therefore deceptive. 7 

Compare this to the ITC' s language in the actual Green 

Guides: 

Example 1: A marketer advertises its trash bags using an 

unqualified "degradable" claim. The marketer relies on soil 

burial tests to show that the product will decompose in the 

presence of water and oxygen. Consumers, however, place 

trash bags into the solid waste stream, which customarily 

terminates in incineration facilities or landfills where they 

will not degrade within one year. The claim is, therefore, 

deceptive.58 

There is thus direct evidence that BPI influence has affected 

the precise content of the Green Guides. 

Since at least 2002, BPI has frequently communicated with, 

met with, and made presentations to the FTC.59 The e-mails besJ Jd at 4. 

s& Green Guides, 16 CFR Pl. 260, § 260.8(d) ex.l, a-..aifabfe at FTC: 111e Green Guides, Statement of Basis and Purpose, at 284. 

s

9 See Letter from Steven A. Mojo, BPI Executive Director, to Janice Frankie, FTC, Feb. 27, 

2002; E-mail from Janie Podoll Frankie to smojo@gatatech.org, Re: RE: FTC Offsets Meeting (Jan. 

9, 2008, 4:11:49 PM); E-mail from Janice Podoll Frankie to Steve Mojo, Rc: Call on Tuesday, Feb. 

5 {Jan. 31, 2008, II :33:39 AM); E-mail from Steve Mojo to Janice Podoll Frankie, Re: RE: Call on 

Tuesday, Feb. 5 {Jan. 31, 2008, 12:32:00 PM}; E-mail from Janice Podoll Frankie to smojo@gatatech.org, Re: RE: Discussion (Feb. 4, 2008, 8:48:21 AM); E-mail from Janice Podoll 

Frankie to smojo@galatech.org, Re: RE: Follow UP (Feb. 5, 2008, I :00: II PM); E-mail from Anne 

McCormick to four recipients including smojo@galatech.org, Re: Conference Call on Apri19, 2008 

@3:00p.m. (Apr. 8, 2008, 6:26:06 PM); E-mail from Anne McCormick to three recipients including smojo@galatech.org, Re: Powerpoints - Panel 2 (Apr. 15, 2008, 6:17:24 PM}; E-mail from 

Janke Podoll Frankie to steve.mojo@galatech.org, Re: RE: A question (Apr. 22, 2008, 12:59:45 

PM); E-mail from Janice Podoll Frankie to three recipients including steve.mojo@galatech.org, Re: 

FTC Workshop, Panel2 proposed questions (Apr. 28,2008, 12:23:57 PM); E-mail from Steve Mojo 

to Laura Koss and smojo@galatech.org, Rc: RE: The story of the spoon (July 24, 2008, 3:14:00 

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tween FTC staff and BPI generally have a friendly tone, and FTC 

staff have made it clear on several occasions that they welcomed 

BPI's input.

60 

For instance, FTC attorney Janice Podoll Frankie 

wrote to Steve Mojo, BPI's Executive Director, while organizing a 

workshop on green packaging claims:61 "Please know that you and 

your presentation are very important to the discussion at the workshopl"62 And FTC attorney Michael Davis wrote to Steve Mojo: 

"Steve, it's always good to hear from you and I appreciate your 

latest message. I minimize my written traffic, but I wanted to thank 

you again. Mike".63 

BPI has often gointed out degradability claims that it believed 

were unsupported 

4

-including claims by ECM,65 which BPI staff 

PM); E-mail from Steve Mojo to Laura Koss, Re: RE: Follow Up (July 30, 2008, 9:37:00 AM); Email from Michael Davis to Steven Mojo, Re: (Nov. 5, 2009, 2:43:50 PM); E-mail from Michael 

Davis to Steven Mojo, Re: Mar'h 17 powerpoint (Mar. 24, 2011, 11:31:32 AM); E-mail from Mi-

'hael Davis to Steven Mojo, Re: RE: Your Email of March 23, 2011 (Mar. 24,2011, 3:59:06 PM); 

STEVE MOJO, SCIENCE OF BIODEGRADABLE ADDITIVES (presentation to FTC, Apr. 2011); E-mail 

from Steven Mojo to mdavis@ftc.gov, Re: Diobased/Renewable Labeling (Sept. 6, 2011, 10:57:40 

AM); E-mail from Steven Mojo to lkoss@ftc.gov, Re: FW: A question from the BPI (Mar. 12,2013, 

2:42:00 PM); E-mail from Steven Mojo to lkoss@ftc.gov, Re: Labeling Question (May 28, 2013, 

2:18:00 PM). Janice Podoll Frankie, Anne McCormick, Michael Davis, and Laura Koss are FTC 

employees; and smojo@galatech.org and steve.mojo@galatech.org are Steven Mojo, BPI's E:xecutive Director. 

m See E-mail from Steve Mojo to Janice Podoll Frankie, Re: Re: Latest Development in "Degradables" (Aug. 9, 2007, 12:53:22 PM) (discussing claims by Hilex) (Janice Podoll Frankie wrote 

to Steve Mojo: "The staff ... sincerely appreciates all of your communications regarding these issues and welcomes the information."); E-mail from Janice Podoll Frankie to Steve Mojo, Re: RE: 

Latest Development in "Degradables" (Aug. 9, 2007, I :01:23 PM) ("Seriously, we appreciate your 

information."); E-mail from Janice Podoll Frankie to smojo@galatech.org, Re: RE: Follow UP (Feb. 

5, 2008, I :00: II PM) ("Thank you so much for taking the time to speak with us this morning. Thank 

you also for all of the useful information in your email! Janice, Anne and Laura"). Anne and Laura 

are presumably Anne McCormick and Laura Koss. 61 See FTC, Green Packaging Claims, http:/1\'AVW.flc.gov/news-events/events-calendar/2008/ 

04/green-packaging-claims. 62 E-mail from Janice Podoll Frankie to smojo@galatech.org, Re: RE: April 30th Meeting 

(Feb. 27,2008,3:31:44 PM). 61 E-mail from Michael Davis to steve.mojo@galatech.org, Re: Thank you (May I, 2008, 

11:14:34 AM). 60 Letter from Steven A. Mojo, BPI Executive Director, to Janice Frankie, FTC, Feb. 7, 2002 

(discussing claims by Environmental Products Inc.); Letter from Steven A. Mojo, BPI Executive 

Director, to Janice Frankie, FTC, Feb. II, 2002 (apparently identical to the Feb. 7 letter, supra); 

Letter from Steven A. Mojo, BPI Executive Director, to Janice Frankie, FTC, July 10,2002 {discussing claims by EPl and Plastic Solutions); Aug. 9, 2007 e-mail, supra note 60 (discussing claims by 

Hilex); E-mail from Janice Podoll Frankie to Steve Mojo, Re: RE: Favorite Claims (Aug. 15, 2007, 

I :15:46 PM) (discussing claims in a sales flyer); E-mail from Steve Mojo to Janice Frankie, Re: The 

latest biodegradable landfill product (Jan. 29, 2008, 2:38:00 PM) (discussing claims reported in a 

news story from Sacramento); E-mail from Janice Podoll Frankie to smojo@galatech.org, Re: RE: 

The latest biodegradable landfill product (Jan. 30, 2008, 10:02:52 AM) (same); E-mail from Janice 

Podoll Frankie to smojo@galatech.org, Re: RE: An example of poor science(Feb. 19,2008,9:02:50 

AM) (discussing claims by Bio-Tec); E-mail from Janice Podoll Frankie to smojo@galatech.org, Re: 

FW: Article-Hilex introduces biodegradable HDPE bag (Feb. 19, 2008, II :47:41 AM) (discussing 

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20 VOLOKH 

often discussed internally. 66 (BPI has also encouraged others to 

report claims it considered unsupported.67 It has also reported 

claims it considered unsupported to other government organ izations.68) 

claims reported in a Plastics News anicle); E-mail from Laura Koss to smojo@galatech.org, Re: RE: 

The story of the spoon (July 24, 2008, 10:44:19 AM) (discussing claims on a USDA website); E· 

mail from Janice Podoll Frankie to smojo@galatech.org and Laura Koss, Re: RE: Biodegradable 

Shoes (Aug. 4, 2008, 10:39:35 AM) (discussing BrooksR Sports claims about biodegradable sneakers); E-mail from Janice Podoll Frankie to smojo@galatech.org, Re: RE: Info on Paradigm Biodegradable Garbage Bags (Sept. 25, 2008, I :40:21 PM) (discussing claims in a Paradigm Group press 

release); E-mail from Janice Podoll Frankie to smojo@galatech.org, Re: RE: More landfill claims 

(Oct. 15, 2008, 2:28:36 PM) (discussing claims reported in a Plastics News article); Letter from 

Steve Mojo, BPI Executive Director, to Michael Davis, VfC, Mar. 30, 2010 (discussing claims by 

Bio-Tec); E-mail from Steven Mojo to mdavis@flc.gov, Re: Continuing "Biodegradable" Claims 

(Feb. 17, 201 I, 9:44AM) (discussing NomaGreen from Nomaco Engineered Foam Solutions); Email from Steven Mojo to mdavis@fic.gov, Re: The claims keep coming (Aug. 29, 2011, I :52:55 

PM) (discussing claims regarding the product EVRgreen EPS from StyroChem, as well as the prod· 

uct EcoPure); E-mail from Steven Mojo to lkoss@fic.gov, Re: Some still have not gotten the message (Dec. 19, 2013, 2:51 :00 PM) (discussing claims regarding Multiplast additives). lkoss@fic.gov, 

referred to as "Laura," is presumably the same as FTC employee Laura Koss. 

~~Jan. 29, 2008 e-mail, supra note 64 (noting that the claims at issue there were "(o]n the order 

of the ECM documents that [Ste\'e Mojo] fom'llrded to [Janice Podoll Frankie} previously"); E-mail 

from Steve Mojo to Janice Podoll Frankie, Re: Dispozo-o Enviroware Certificate.pdf (Mar. 17, 

2008, 2:24:00 PM) (discussing a company's product claims where "the language reads, as if it is 

ECM's additive"); E-mail from Steven Mojo to Janice Podoll Frankie, Re: RE: A question (Apr. 22, 

2008, 2:55:00 PM) (discussing "the litany of claims" made by ECM in the context of ECM comments to FTC); E-mail from Steve Mojo to Laura Koss, Re: Follow Up (July 29, 2008, 3:05 PM) 

(discussing comments from "Mr. Sinclair," presumably Robert Sinclair ofECM); E-mail from Laura 

Koss to smojo@galatech.org, Re: RE: Follow Up (July 30, 2008, 8:33:44 AM) (same); Aug. 4, 2008 

e-mail, srpra note 64 (containing forwarded e-mail chain about ECM claims); E-mail from Steve 

Mojo to Janice Podoll Frankie and Laura Koss, Re: ECM Follow Up (Aug, 19, 2008, 10:08 AM) 

(discussing claims of a Canadian retailer using ECM additives). 66 E-mail from Ramani Narayan to three recipients, including Steve Mojo, Re: RE: MoU Thai· 

land (Oct. I I, 2007, 4:52:01 PM); E-mail from Steve Mojo to Ramani Narayan, Re: Bio-Degradable 

Power-Point (Mar. 28, 2008, 6:15:00 PM); E-mail from Steve Mojo to Ramani Narayan, Re: ecm 

(July 18, 2008, II :56:00 AM); E-mail from Steve Mojo to Ramani Narayan, Re: FW: Sandia stuff·· 

Biobatch (July 18,2008, 1:37:00 PM); E-mail from Steve Mojo to Ramani Narayan, Re: Bob Sinclair Comments (July 29, 2008, 2:09:00 PM). BPI has also discussed its views against biodegradabil· 

ity claims of plastic additives to outsiders. See E-mail from Ramani Narayan to R.S.Mantri, Re: RE: 

biODEGRADABLE ADDITIVES (Oct. 14, 2011, 7:28:19 AM); E-mail from Ramani Narayan to 

Daniella Russo and Laurie Hansen Sheets, Re: RE: Education and Scientific data on Oxo (Apr. 30, 

2012, 10:37:45 AM). Ramani Narayan is the head of tho Biodegradable Products Institute's (BPI) 

Scientific Review Committee. See BPI, Frequently Asked Questions, http://www.bpiworld.org/BPI· 

Public. R.S. Mantri works at Poddar Pigments Ltd. in India, Daniella Russo is with the Plastic Poilu· 

tion Coalition, and Laurie Hansen Sheets is with the Western Plastics Association. 1 E-mail from Steve Mojo to Darryl Stromberg, Re: RE: (Oct. 21, 2008, 10:14:08 AM) (encouraging Darryl Stromberg, of the food container and packaging corporation Genpak, to report 

ECM claims to Janice Frankie Podoll at VfC); E-mail from Ramani Narayan to Richard Fine, Re: 

RE: Organic Additive Claim (Aug. 29, 2011, 9:02:13 AM) (encouraging Richard Fine ofBioPak in 

Australia to report claims to Australian authorities); see also E-mail from Luke Vernon to smo· 

jo@galatech.org, Re: RE: FTC (July 28, 2008, 6:08:42) (Luke Vernon of Eco-Products told Steve 

Mojo he was "considering reporting Dispozo/Enviroware" for misleading claims, and Steve Mojo 

said he believed "that Dispozo uses the ECM additive"). 63 See E-mail from Steve Mojo to hbranch@ciwmb.ca.gov, Re: Fw: Please review "\Val-Mart 

letter" (July 17, 2007, 9:54:05 AM) (reporting ECM claims to California Integrated Waste Manage-

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BPI has written to the FTC supporting a consent order for misleading advertising in the case of Dyna-E International and suggesting modifications in the consent order.69 In the case of a few 

corporations, BPI has asked that the FTC investigate and take action against claims that BPI argued were misleading.70 BPI has also asked the FTC to commit to investigating similar claims by other corporations.71 

This enforcement action against ECM is the culmination of a 

long process oflobbying by BPI, from BPI's influence in the adoption of the current wording of the Green Guides and support for the 

one-year-or-less standard, to its constant urging that the FTC take 

action against claims that BPI considered unfounded, including by 

ECM. 

B. Unpersuasiveness of the Commission's Treatment 

of Consumer Surveys 

A case for agency bias becomes more persuasive when combined with evidence that the agency's position is unpersuasive on 

the merits. 

"The 1998 Guides stated that an unqualified degradable claim 

should be substantiated with competent and reliable scientific evidence that the entire product or package will completely break 

down and return to nature within a reasonably short period of time 

after customary disposal."72 The new proposed Guides replaced 

this "reasonably short period of time" standard with the more specific standard of one year,

73 based in part on "a consumer perception survey" by APCO that purp011ed to show that "60 percent of 

ment Board); Jan. 29, 2008 e-mail, supra note 64 (noting that the claims at issue there "will be 

brought to the attention of [the California Integrated Waste Management Board]"); Oct. 21, 2008 email, supra note 67 (reporting that BPI members have brought claims to the attention of Canadian 

authorities). hbranch@ciwmb.ca.gov is Harllee Branch, a CIWMB attorney. 69 Letter from Steven A. Mojo, BPI Executive Director, to FTC, Sept. 21, 2009, Ref: Dyna-E 

International, Docket No. 9336. BPI's suggested modifications were not accepted. Letter from DonaldS. Clark, Secretary, FTC, to Steven A. Mojo, BPI Executive Director, Dec. 15,2009, Re: In the 

Matter of Dyna-E International, Inc. and George Wheeler, FTC Docket No. 9336. 70 Letter from Steven A Mojo, BPI Executive Director, to Janice Frankie, FTC, Sept 12, 2003; 

Letter from Steven A. Mojo, BPI Executive Dire~tor, to Janice Frankie, FTC, Apr. 25, 2005. 71 See FTC Goals and Proposed Agenda Items. 12 FTC: 17re Green Guides, StatemeiJI of Bosfs ond Purpose, at I I 6. 

1l /d. 
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22 VOLOKH 

respondents stated they would expect an item labeled biodegradable without qualification to decompose in one year or less. "

74 

One of the commenters that disagreed with the Commission's 

guidance was EcoLogic, which submitted its competing consumer 

perception study by Synovate, in which only 25% of respondents 

expected a product labeled biodegradable to degrade after one 

year, and another 45% expected it to degrade within five years.75 

The Commission granted that "[b]oth studies may be faulted 

for lacking control groups and presenting the timeframe questions 

with closed-ended, rather than open-ended, answers," but noted 

that these two studies "nevertheless are the only studies in the record."76 One approach to bad data would be to hold off on regulation-since, after all, regulation imposes real burdens, and the 

Administrative Procedure Act dictates that, in formal proceedings, 

sanctions not be imposed except when "supported by and in accordance with ... reliable ... evidence."77 

David Stewart's expert report adequately explains the significant flaws in both studies. Perhaps the most significant flaw is the 

reliance on closed-ended questions when potential responses are 

highly heterogeneous and potentially nuanced: a limited set of 

closed-ended questions may manufacture a false sense of homogeneity even when respondents disagree significantly.78 Another 

problem with a limited set of closed-ended responses, that I discuss 

at greater length below, is that they will inevitably produce framing effects-in this case, by suggesting to survey respondents what 

timeframes for biodegradability seem extreme and what 

timeframes seem reasonable. 

But the Commission decided to choose the APCO study over 

the Synovate study because: 

n Jd. 

Unlike the APCO survey, the Synovate study results 

suggest that respondents' answers may have been not only 

biased, but also influenced by a tendency to avoid extreme 

answers. As a result, reliable real-world conclusions cannot 

be drawn from the Synovate study. First, some respondents' answers to the question about decomposition timing 

75 /d. at 118-19. 11'/d. at 121 n.409. 

n 5 U.S. C.§ 556(d) (emphasis added); see also Steadman v. SEC, 450 U.S. 91 (1981). 

'

8 See generally David Ste\\-art expert report. 
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likely were biased by framing from several previous statements and questions. For example, respondents were told 

that the study was paid for by a company that creates products designed to "be helpful to the environment and [] improve the ways that plastic products are disposed." Additionally, respondents were informed that "nonbiodegradable plastic products take hundreds of years to 

decompose." Such statements are absent from most marketing contexts, and did not appear in the APCO questionnaire. 

Second, the Synovate study indicates that some respondents were influenced by an aversion to extreme responses. When asking about decomposition timing, Synovate provided respondents with choices including "less than 

1 year," and five much longer time periods. Unlike the 

APCO questionnaire, the Synovate questionnaire did not 

provide respondents with multiple options of time periods 

less than one year. While 25 percent of Synovate's respondents selected the initial option, a much larger subset 

chose the next available option. This pattern of responses, 

together with the absence of choices in the range of less 

than one year, suggests that some respondents were avoiding an extreme response. By contrast, the APCO survey offered respondents multiple options of less than one year 

and more than one year, and the pattern of answers was not 

clustered next to an extreme. Thus, the Commission concludes that the proportion of consumers expecting full decomposition in under one ~ear would be closer to 60 percent rather than 25 percent. 9 

In the first place, it is unclear how being told that a study is 

paid for by a pro-environmental company should bias respondents' 

views on how long it takes for an item to decompose. 

In the second place, framing effects are ubiquitous, whether or 

not one is given true information about rates of decomposition of 

non-biodegradable plastics. Economists, psychologists, and others 

have produced a massive literature showing how minor differences 

w !d. at 121-22. 
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24 VOLOKH 

in the phrasing of a question can have an immense effect on respondents' answers to survey questions. Here are some examples: 

• People respond differently to ground beef that is described 

as "80% lean" vs. "20% fat"-the 80% lean beef is considered better. 80 

• 54% of respondents believe that the United States should 

forbid public speeches against democracy, but 75% believe 

that the United States should allow public speeches against 

democracy. 81 

• Tversky and Kahneman's "Asian disease" problem is classic: consider two public health interventions against a hypothetical disease, (A) one which will save 200 people for 

sure and (B) another which have a 113 probability of saving 

600 people and a 2/3 probability of saving no one. When 

the interventions as described in this way, survey respondents tend to prefer (A), the more certain intervention. But 

describe the interventions in a "dying" way instead of a 

"saving" way-(A) 400 people die for sure, and (B) no one 

dies with a 113 probability and 600 die with a 2/3 probability-and people tend to prefer (B), the one with some nontrivial chance of saving everyone. 82 

• In "contingent valuation" surveys that seek to elicit how 

much people would pay to preserve an environmental 

amenity or prevent environmental damage (like an oil 

spill), survey respondents report an average of about $84 to 

prevent oil spills off the coast of Alaska-but when asked 

about their total willingness to pay for a range of social 

programs, and then asked to identify how much of that 

amount they'd pay for environmental protection ... and 

how much of that they'd pay to protect wilderness areas ... 

and how much of that they'd pay to prevent human-caused 

problems ... and how much of that they'd pay to prevent 

marine oil spills ... and how much of that they'd pay to 

80 See, e.g., J.P. Levin & G.J. Gaeth, Framing of Attribute Information Before and After Consmning the Product, 15 J. CONSUMER RES. 3 74 ( 1988). 81 D. Rugg, Experiments in Wording Questions: JJ, 5 PUB. OPINJONQ. 91 (1941). 82 A. Tversky & D. Kahneman, 17ze Framing of Ikcisions and the Psychology of Choice, 211 

SCIENCE 453 (1981 ). 
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prevent marine oil spills in Alaska, the average response is 

$0.29.83 

Sometimes the opposite happens: major changes in the question lead to minor changes in answers. For instance-again in the 

context of contingent valuation surveys-people report essentially 

the same willingness to pay to preserve bird populations when 

2000, 20,000, or 200,000 birds are on the line.84 Essentially, people 

are reporting a number that gives them a "warm glow," not their 

actual valuation of that number of birds. 

The problem is not necessarily that some framings give the correct answer while others give a biased answer. It could be that eveJything is framing.85 As political scientists John Zaller and Stanley 

Feldman write: 

The literature on response effects ... makes it clear that 

survey questions do not simply measure public opinion. 

They also shape and channel it by the manner in which they 

frame issues, order the alternatives, and othenvise set the 

context of the question .... [P]eople do not merely reveal 

preexisting attitudes on surveys; to some considerable extent, people are using the questionnaire to decide what their 

"attitudes" are .... 

Despite the evidence from psychologists and survey 

methodologists, public opinion researchers largely ignore 

[this problem].86 

These insights come from diverse sources: political surveys, 

surveys of willingness to pay for environmental amenities, surveys 

of preferences over public health interventions, surveys of reactions to nutritional labeling. These are all cases where many people 

do not have fixed preexisting views, so it is unsurprising to find 

that the way questions are framed affects their answers: their answers are somewhat affected by their real beliefs on the matter, but 

OJ Michael A. Kemp & Christopher Maxwell, E.tploring a Budget Context for Contingent Val· 

tiOtion Estimates, in CmmNGENf VALUATION: A CRITICAL ASSESSMENT 217, 231 cxh. 3, 235 (Jerry A. Hausman ed., 1993). 

"' See William H. Desvouges et al., Measuring Natural Resource Damages with Contingent 

Valuation: Tests of Validity and Reliability, in COrmNGENf VALUATION, supra note 83, at 91, 102 

fig.4. 

uSee also MARIT E. KRAGT & JEFF BENNEIT, DESIGNING CHOICE EXPERIMEl'ITS TO TEST FOR 

ANCHORING AJI.'D FRAMING EFFECTS {Envt'l Econ. Res. Hub, Res. Rept. No. 10, Dec. 2008). 16 John Zaller & Stanley Feldman, A Simple 11reory of the Srnwy RespoiiSe: Answering Questions Versus Re-.·ealing Preferences, 36 AM. J. POLIT. SCI. 579, 582- 83 (1992) (cilations omitted). 
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26 VOLOKH 

are also affected by their broader attitudes, the context of the interview process, and the like. 

Coming back to the case of biodegradability, it is likely that 

here, too, most people have no fixed idea of what the concept 

means because they rarely (if ever) have to deal with differences 

between products that both call themselves biodegradable but that 

degrade at different rates. Their views of what "biodegradable" 

means are partly formed at the moment the question is asked, 

which means they may have little basis in reality and are also 

probably heavily influenced by the wording of the question. 

In terms of the merits, this probably counsels in favor of a rule 

that would not penalize people for using a word unless their usage 

is extremely far fi·om consumer expectations. But, for purposes of 

this report, the more interesting question is what the Commission's 

treatment of the issue, and why it chose the APCO study over the 

Synovate study, tells us about its possible bias. The Commission's 

treatment of framing effects suggested uncritically that the wording 

of one study led to bias and extreme-response aversion, while apparently ignoring even the possibility of framing effects in the other study. It is not clear why it is a virtue of the APCO study that it 

provided multiple options of less than a year and more than a year: 

this choice, too, can bias responses in that "one year" looks like a 

reasonable, moderate result when placed in this context. 

To be sure, in the presence of framing effects, there are better 

and worse ways of proceeding, but the Commission's approach, 

and radically asymmetrical treatment of the two studies, shows a 

surprising naiveness about the issue--especially since complaint 

counsel's own expert, Shane Frederick, concludes that both studies 

are "reasonably reliable and valid."87 (Shane Frederick's own surveys show the pervasiveness of framing effects and-to the extent 

they are valid-at least suggest the absence of a consensus on the 

definition of biodegradability.88) This would be more likely if the 

81 See Shane Frederick expert report, 'I'll 14-25. I do not mean to endorse Dr. Frederick's view 

that both studies are "reasonably reliable and valid": David Stewart's expert report in this case explains the serious problems with the st11dies, which I have also discussed earlier in this section. I 

merely mean to contrast both Dr. Frederick's rosy view of both studies and Dr. Stewart's critical 

view of both studies with the Commission's oddly asymmetric attitude that the APCO study is significantly better than the Synovate study. 18 Later in this report, $ee infra Part V.C,l discuss problems with Dr. Frederick's Google surveys. But~aking these Google surveys at face value for now-many of his surveys show that the 

percentage of respondents who believe that biodegradability must occur in no more than a year is 

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Commission-whether consciously or not-was biased in favor of 

the position of the compostable producers; and so, according to the 

probabilistic model, bias should be deemed more likely, especially 

when combined with the evidence of lobbying in the previous sec~ 

tion. 

C. Bias and the Force of Law 

That the Commission believes that the Green Guides do not 

have the force of law89 is an extra reason to suspect bias. 

The Green Guides themselves can be seen as interpretations of 

the "unfair or deceptive" language in the FTC Act, 90 so they can be 

argued to fall within the exception to notice-and-comment rule~ 

making for "interpretative rules."91 While this is evidently the 

Commission's theory, the "interpretative rule" exception might not 

apply here, which would make the Green Guides a legislative rule 

and thus subject to full notice-and-comment proceedings. As the 

D.C. Circuit has recently written: 

[I] if the relevant statute or regulation "consists of vague or 

vacuous terms-such as 'fair and equitable,' 'just and reasonable,' 'in the public interest,' and the like-the process 

of announcing propositions that specify applications of 

those terms is not ordinarily one of interpretation, because 

those terms in themselves do not sup~ly substance from 

which the propositions can be derived." 2 

Though the Commission has specific statutory authority to prescribe "interpretive rules and general statements of policy with respect to unfair or deceptive acts or practices,"93 this authority coexhighly variable, depending on the phrasing, and often less than 50%. See, e.g., Shane Frederick 

expert report ~1 31-32, 35. This is evidently why Dr. Frederick phrases his results in tenns of "at 

least a substantial minority" or "at least a significant minority," see id 'i'j26-37. 19 FTC: T11e Green Guides, Statement of Basis and P11rpose, at 1; FTC, Guides for the Use of 

Elll'iranmellfal Marketing Claims, 77 Fed. Reg. 62122, 62122 (2012). 90 15 U.S.C. § 45. 91 5 U.S.C. § 553(b}(A). The Commission takes the position that they are "administrative interpretations of the law" and "do not have the force of law," 77 Fed. Reg. at 62122, and agency intent is 

an important detenninant of whether an agency statement is an interpretive rule not subject to notice 

and comment, see Am. Mining Cong. v. Mine Safety & Health Admin., 995 F.2d 1106 (D.C. Cir. 

1993). 91 Catholic Health Initiatives v. Sebelius, 617 F.Jd 490, 495 (D.C. Cir. 2010) (quoting Robert 

A. Anthony, "llllerpretive" Rules, "Legislative" Rules, and "Spurious" Rules: Lifting the Smog, 8 

ADMIN. L.J. AM. U. I, 6n.21 (1994)). 

•l 15 U.S. C.§ 57a(aXI}(A)(emphasis added). 
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ists with an authority to prescribe "rules which define with specificity acts or practices which are unfair or deceptive."94 This statutory 

structure seems to require that "rules," i.e. legislative rules, be issued for highly specific definitions like those in the Green Guides, 

leaving the interpretive rules and policy statements for ancillary 

matters-"with respect to" unfair or deceptive acts already defined 

by legislative rule. The Commission's view that the Green Guides 

are not legislative rules (and thus do not have the force of law) 

therefore seems somewhat dubious. 

Nonetheless, the Commission's view on whether the Green 

Guides have the force of law-whether correct or not-is certainly 

probative of its own view. And since, in the Commission's view, 

notice, comment, and a "concise genera! statement of ... basis and 

purpose"95 were not required, the Commission must have believed 

that the statement accompanying the Green Guides would not be 

subject to stringent judicial review. Generally, agencies are held to 

strict standards of responding to cogent positions argued in comments,96 but the caselaw establishing those requirements was developed in the context of the requirements of notice-and-comment 

rulemaking. 

The agency's voluntary decision to solicit and respond to 

comments is thus not equivalent to actual, legally required noticeand-comment rulemaking: the agency would have believed that its 

own responses to comments would have been subjected to looser 

review-indeed, perhaps treated as laudable because they were not 

required. The Commission would have felt that it had more freedom to not respond to cogent positions argued in comments as 

would otherwise be required, or to respond without as much reasoning. The effect of the give-and-take of the notice-and-comment 

process, where the need to respond to counterarguments alleviates 

the possible effects of bias, is thus significantly muted.97 

94 /d. § 57a(aXIXB) (emphasis added). 95 5 U.S. C.§ 553(c). 96 See United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977). 91 See text accompanying supra notes 21-24. 
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V. BIAS IN SOME OF THE EVIDENCE IN THIS CASE 

This Part discusses indicia of potential bias related to some of 

the evidence in this case. Section A discusses the self-interest of 

Stephen McCarthy, who is one of complaint counsel's experts. 

Section B discusses issues of self-interest in a recent paper by 

Frederick Michel and Eddie Gomez, which complaint counsel is 

relying on in this case (and which McCarthy cites in his expert report98). Section C discusses the substantive validity of the research 

of Shane Frederick, who is one of complaint counsel's experts. 

The discussion of bias serves two purposes: First, recognizing 

the sources of self-interest in this evidence is an argument for giving the evidence reduced weight. Second, to the extent the agency 

nevertheless relies on this evidence in spite of its possible bias, that 

fact can be used to support an argument that the agency is itself 

biased against ECM. 

A. The Self-Interest of Expert Stephen McCarthy 

One of complaint counsel's experts is Stephen McCmthy. 

McCarthy is connected to the biodegradable products industry in 

various ways. He is a founding member of the BioEnvironmental 

Polymer Society/9 has won its lifetime achievement award, 100 and 

(at least as of 201 0) is on its international advisory board. 101 

McCarthy regularly attends102 and speaks at103 plastics conferences. 

98 See McCarthy expert report at 7 n.3. 99 See BioEnvironmental Polymer Society, History, http://w\'Av.beps.org/history.html. 100 See BioEnvironmental Polymer Society, Award DescriptioJIS, http://beps.orgfawards.html. 101 See BioEnvironmental Polymer Society, Polymers and the EIIVironme/11: Emerging Green 

Technologies & Science, 2nd Circular & Call for Papers (conference held Oct. 13-16,2010 in Toronto). 102 &e Final Report to the Office of Naval Research on Grant No. N00014-95-l-1194 for the 

partial support of the 4th International Workshop on Biodegradable Plastics and Polymers, Durham, 

N.H. 

!OJ See 7th A 1tn11al Meeting of tile Bio/Environme/1/a/ly Degradable Polpner Society (Aug. 19-

22, 1998, Cambridge, Mass.}; Soc'y of Plastics Engrs., Auto. & Composites Divs., First Annual 

Global Aulomotil•e Composites Conference (Sept. /9-20. 2001), http://W\V\V.speautomotive.com/ 

pdf~OI%20Files/01%20SPE%20ACCE%20Program%20Guide.pdf; Univ. of N. Tex., Off. of Res. 

& Econ. Dev't, UNT to Host 20th Anniversary BioEnvironmental Polymer Society Conference, 

http://research.unt.edulannouncements!unt-host-20th-anniversary-bioenvironmental-polymer-society 

-conference (2012}. &e also CIPET, APM 2010: Moments, http://W\V\V.cipet.gov.in/apm~2010.html 

(2010}; Edwin L. Aguirre, Prof McCarthy Delivers Plastics Lecture in India, Mar. 31, 2010, 

httpJ/W\vw.uml.edu/News/stories/2009-1 0/mcearthy _india ~trip.aspx. Both McCarthy's institution, 

the University of Massachusetts at Lowell, and Narayan's institution, Michigan State University at 

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30 VOLOKH 

McCarthy also perfonns BPI certification. 104 (Companies with 

BPI certification are allowed to use BPI's compostable logo. 105

) 

McCarthy's connections go further than merely being an active 

participant in this industry and having some connections with BPI. 

McCarthy holds many patents for biodegradable and bioresorbable 

polymers and polymer blends.

106 He has received a considerable 

amount of contract and grant support related to biodegradable 

products. More than $1.5 million of this support comes from 

Metabolix. 107 Metabolix is not only a member of BPI-various of 

its products are BPI-certified108- but also the exclusive licensee 

for one of McCarthy's patents. 109 The patent is for a biodegradable 

blend that is: 

environmentally friendly and commercially attractive for 

making biodegradable plastic films, sheets, and other plastic products made by conventional processing methods 

such as blown fiJm, extrusion, and injection molding. These 

plastic products can be used for food packaging, compost 

bags, and other disposable items. The new blends provide 

an entry for polylactic acid in the potentially large market 

of biodegradable polymers. 

Like wood and paper, these blends are stable in the atmosphere but biodegradable in compost, in moist soil, in 

East Lansing, collaborate with the Centrnl Institute of Plastics Engineering (CIPET} in India .. See 

CIPET, International Relations, http://cipet.gov.in/cipetmou.html; Edwin L. Aguirre, Uni1•ersily and 

C/PET to Forge Collaboration, Sept. 23, 2009, http //www.uml.edu/New~/stories/2009· 

I 0/indian _secretary_ visit.aspx. 

~>~ See Stephen McCarthy's Linked In page. 10' See BPI, 11re BPI Certification Process, http://www.bpiworld.org/BPI-certification-process; 

BPI, 11re BPI Approval Process & Test Requirements, http://www.bpiworld.org/BPJ-certificationrequirements. 

~ See Patent No. 5,439,985 (1995); Patent No. 5,440,007 (1995); Patent No. 5,883,199 

(1999); 6,093,792 (2000); see also \VONDU HOLDINGS, BIOPLASTICS SUPPLY CHAINSIMPLICATIONS AND OPPORTUNITIES FOR AGRJCULTURE 206-<>7 (Australian Guv't, Rurallnds. Res. 

& Dev't Corp., Nov. 2004). 107 See Stephen P. McCarthy CV, ' 'Contract and Grant Support" section. 

'"" See Metabolix, BPI Certified Products Catalog, http://products.bpiworld.org/companiesl 

metabolix. 109 The patent is Polylactic Acid-based Blends, No. 5,883,199, see note 106 s11pra. Press release, Metabolix Grants a Patelll License to Nat11re Works LLC for New Biopolymer Blends, Mar. 14, 

2012, http:l/www.uml.edu/News/press-releases/2012/Metabolix.aspx; see also Edwin L. Aguirre, 

UMaJs Lowell, Metaboli:iffelles Celebrate Parlllerslrip, https:lfwww.uml.edu/News/stories/2009-

IO/metabolix_celebration.aspx ("Metabolix has funded more than $2.5 million in sponsored research 

with UMass Lowell .... II has also donated more than a half million dollars' worth of bioplastic 

processing equipment. 'Metabolix has licensed UMass Lowell patents for bioplastic blends, with 

potential royalties of$100,000 a year,' said McCarthy."). 
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water with activated sludges, and in the sea, where a large 

number of microorganisms are present. These blends can 

be incinerated with only slight damage to the furnace since 

the heat of combustion is relatively low, and no toxic gases 

are generated.110 

This patent competes directly with products like those ofECM. 

To the extent that claims of biodegradability are limited to substances that can degrade in a short amount of time, like compostables, McCarthy's patent(s) would become more valuable if the 

FTC rules against ECM in this case. 

And, in fact, Metabolix has complained to the FTC about 

ECM's claims and urged the FTC to take action against ECM. 111 

McCarthy's self-interest is relevant because ofthe general rule, 

in both federal and state evidence systems, that expert witnesses' 

testimony should be discounted when there is evidence of bias, 

from whatever source.

112 Evidence scholar David Bernstein collects several cases stating the general principle that experts should 

be impartial: 

As one court remarked, "despite the fact that one party 

retained and paid for the services of an expert witness, expert witnesses are supposed to testify impartially in the 

sphere oftheir expertise." Kirk [v. Raymark Indus., 61 F.3d 

147, 164 (3d Cir. 1995)]; see also Selvidge v. United 

States, 160 F.R.D. 153, 156 (D. Kan. 1995) ("An expert 

witness should never become one patty's expert advocate. 

An expert witness should be an advocate of the truth with 

testimony to help the court and the jury reach the ultimate 

truth ... which should be the basis of any verdict."); English Feedlot, Inc. v. Norden Labs., Inc., 833 F. Supp. 1498, 

11 ~ Polylactic acid polymer and copolymer willr polyesters, US 5883199 A, httpJ/www. google. 

com/patents/US5883199. 111 E-mail from Brian Tgoe to jfrankle@ftc.gov, Re: FW: Good Earth and ECM (June 26,2008, 

4:55:47 PM). Brian lgoe is VP and Chief Brand Officer of Metabolix; jfrankle@ftc.gov is Janke 

Frankie, an FTC attorney. 112 See, e.g., 3 STEPHEN SALTZDURG ET AL., FEDERAL RULES OF EVIDENCE MM'IJAL 

702.03[12] (lOth ed. 2011); DAVID H. KAYE ET AL., THE NEW WrGMORE: EXPERT EVIDENCE §§ 

1.3.1, 1.4.1 (2d ed. 2011); COMM. ON PATTERN JURY lNSTRUCTfONS, FfF!ll CIR. DlST. JUDGES' 

Ass'N, PATTERN JURY INSTRUCTIONS: FIFTH CIRCUIT, CJVfL CASES§ 2.19 (2009) (listing bias as a 

reason for juries to discount expert evidence); Pack v. Geico Gen. Ins. Co., 119 So. 3d 1284, 1287-

88 (Fla. App. 2013}; FLA. STAT. ANN.§ 90.608(2}(1isting bias as a factor against the credibility of a 

witness); 286 P.3d 1256, 1260-62 (Utah App. 2012); TEx. R. CN. P. 192.3(eX5} (allowing discoverabi1ity of evidence relevant to expert's bias}; Michael Graham, Impeaching the Professional Expert Witness by a ShowingofFilwnciallnterest, 53 IND. L.J. 35 (1977). 
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32 VOLOKH 

1501 (D. Colo. 1993) ("Experts are not advocates in the lit" 

igation but [] sources of information and opinions."). 

David E. Bernstein, Expert Witnesses, Adversarial Bias, and the 

(Partial) Failure of the Daubert Revolution, 93 IOWA L. REv. 451, 

453 n.l3 (2008). 

Generally, the anti"financial bias principle shows up in the rule 

that federal agencies cannot compensate their witnesses on a con" 

tingency fee basis, 113 "[t]o help ensure the integrity and effective 

supervision of the legal and expert witness services provided to or 

on behalf of the United States." 114 But similar concerns are at play 

when the expert witness is a competitor of the opposing party: 

from an economic perspective, it is difficult to distinguish the in" 

centives of an expert expecting part of the recovery if his competi" 

tor loses the case and those of an expert "merely" expecting to do 

better in his business if his competitor loses the case. 

As mentioned above, the probabilistic model dictates that evi" 

dence presented by an expert should be considered more likely to 

be biased if it is substantively flawed, for instance if it contradicts 

other statements by the same expert. 115 In this case, McCarthy 

writes that evidence that a substance is biodegradable is not "com" 

petent and reliable"116 unless the tested sample reaches "at least 

60% biodegradation,"117 and there is both a "negative control" and 

a "positive control."118 However, McCarthy's patent discussed 

above119 made claims that certain substances biodegraded even 

though the rate of biodegradation was lower than 60%. 120 Moreo" 

ver-though I lack the scientific knowledge to fully appreciate the 

details of the patent-I did not find any discusion of negative or 

positive controls in the patent to support the patent's claim of bio" 

degradability. 

McCarthy also writes in his expert report that a conventional 

(non"biodegradable) plastic (such as polypropylene or polyeth" 

m Exec. Order No. 13,433, §§ 2(b), 3(b), 3 C.F.R. 638 (2007). 

114 ld. § I. 

us See supra Part Ill. D. 116 McCarthy expert report <j 37, at 13. 111 !d., 38, at IS. 111 /d. 138, at 16. 119 See s1pra note 110. 110 See, e.g., '199 patent, supra note 110 {stating that "Fig. II shows that polylactic acid de· 

gmdes in soil," but reporting that "polylactic acid degmded only about 14% by loss in weight" in 45 

days); id. (stating that the A70B30 blend degmded 25% after 45 days). 
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ylene121 ) "remains non-biodegradable" after being "melt-batch 

blended"122 with the ECM additive, because "a physical blend of a 

biodegradable polymer with a conventional plastic does not alter 

the chemical structure of the conventional plastic," and so "the 

non-biodegradable plastic component is no more susceptible to biodegradation after blending than it was before."12 However, 

McCarthy was the co-author of a 1990 paper that proposed to test 

"binary blends of bacterial polyesters with polyethylene (PE) and 

polystyrene (PS)"; the blends were prepared using "melt blending."l24 

I lack the scientific knowledge to fully understand the details of 

this paper, but it seems at a minimum that there is some tension 

between McCarthy's view in his expert report that a physical blend 

of a biodegradable polymer with a conventional plastic cannot biodegrade because blending does not change the conventional plastic's chemical properties, and his willingness in his paper to test 

such a blend. Perhaps there is an explanation, but if McCarthy 

cannot produce such an explanation, this would provide additional 

reason to suspect his expert report of bias. 125 

B. The Self-Interest of Frederick Michel and OARDC 

It has been represented to me that complaint counsel is relying 

on a paper by Eddie G6mez and Frederick C. Michel Jr. called Biodegradation of Conventional and Bio-Based Plastics and Natural 

Fiber Composites During Composting, Anaerobic Digestion and 

LonfTerm Soil Incubation, 126 in which ECM products were tested.1 7 Michel is a professor in the Department of Food, Agricultur121 See McCarthy expert report ~p9-30, 34, at 1()--12. 122 !d.~ 61, at 24. 121 /d. ~ 64, at 25--26; see also id. ~ 17, at 7. 12• S.N. Bhalakla, T. Patel, R.A. Gross & S.P. McCarthy, Biodegradable Blends of Bacterial 

Polyeslers wilh Polyethylene and Polystyrene, 31 POLYMER PREPR!NTS 441 (1990). 12s The same is true of McCarthy's • 199 patent, which covers (in claim 9) a blend involving 

PET. As I have mentioned in the text, I lack the scientific expertise to fully understand the claims in 

this patent, but the consistency of McCarthy's view in his expert report and the claim in the patent 

should be explained. 116 Eddie F. G6mez & Frederick C. Michel Jr., Biodegradation ofConwlllional and Bio·Based 

Plastics and Natural Fiber Composites D11ri1Jg Composting, Anaerobic Digestion and Long-Term 

Soil Incubation, 98 POLYMER DEGRADATION & STABILITY 2583 (2013). 127 !d. at 2585 tb1.2 (testing "PP + 2% additive" and "PS + 2% additive," where the additive is 

ECM Masterbatch Pellets). 
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34 VOLOKH 

al and Biological Engineering at Ohio State University, and Gomez 

is his graduate student. 

One may quarrel with the applicability of the paper to ECM 

products-for instance, it has been represented to me that polypropylene pellets represent under 2% of the applications of ECM's 

products. But the purpose of this report is not to question the merits of the paper, just as it did not question the merits of the testimony of Stephen McCarthy in the previous section; this section merely points out that Michel's self-interest aligns with the results of 

his research, so that the probative value of the results may be appropriately discounted. {In terms of the probabilistic model developed earlier, a researcher driven by his financial self-interest would 

produce a paper supporting that self-interest. Therefore, observing 

a paper whose results align with the researcher's self-interest 

should increase one's belief that the researcher is biased.) 

Michel studies the composting process professionally {as is 

clear from his CV), and he has also done private consulting for 

various composting-related entities, such as the U.S. Composting 

Council and Indian Summer Compost. 128 He has also had some 

dealings with BPI. At one point, he submitted a proposal to BPI to 

test various compostable bioplastics {the cost of this proposal 

would have been $3750), 129 though the proposal was ultimately not 

accepted. 130 Later, on a few occasions, Michel was in correspondence with BPI, with a view toward getting his lab approved for doing testing that would allow him to use the BPI/USCC compostable logo. 131 

It is reasonable to suppose that a market boost to compostables-for instance, if non-compostables have greater trouble using 

113 E-mail from Frederick Michel to Matthew Wiltshire, Re: RE: available for phone call today? (Nov. 15, 2012). 

mE-mail from Steve Mojo to Frederick Michel, Re: RE: proposal (Nov. 20,2008,9:31 AM}. 

The proposal is probably Frederick Michel, Human Health and Ecosystem Risk Assessment of 

Compostable Bioplastics and Their Degradation Products, a proposal to the Biodegradable Products 

Institute, Nov. 21,2008. Though this proposal is dated November 21,2008, the properties of the MS 

Word file, CON-bpiproposal.doc, show that the document was created and last mod ified on Novem· 

ber 20, 2008 (at 12:02 AM and 12:14 AM, respectively), which is the same date as the e·mail cited 

above. 130 E-mail from Steve Mojo to Frederick Michel, Re: Update on your proposal (Nov. 25, 2008, 

2:12PM). Ill E-mail from Steve Mojo to michel.36@osu.edu, Re: RE: Compostable logo (Dec. 9, 2008, 

1 1:52 AM); E-mail from Steven Mojo to michel.36@osu.edu, Re: RE: Samples on the Way (Apr. 

18,2011, 11:51 AM). 
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the term "biodegradable" in their advertising, as will be the case if 

ECM loses this litigation-would redound to Michel's benefit. 

Moreover, the research leading up to the Gomez & Michel article was apparently funded by a competitor of ECM. Michel received funding on various occasions from Myers Industries, Inc. 132 

Myers Industries' Lawn & Garden Group produces "nursery containers made of bioplastics and natural fibers." 133 Michel requested $29,175 from Myers Industries for research to last 12 months 

beginning March 1, 2010, 134 but it is unclear whether that funding 

was received. 135 Myers Industries gave Michel $28,000 for the period between June 2011 and January 2012. 136 In February 2012, 

Myers Industries offered Michel a matching grant of up to 

m See, e.g., E-mail from Eddie Gomez to miche1.36@osu.edu, Re: RE: Tomorrow {Oct. 5, 

2011, II :46 AM) {quoting E-mail from Tarang Shah to michel.36@osu.edu, Re: Re: Tomorrow 

{Oct. 5, 2011, 10:03 AM} ("Fred, would you be available tomorrow? l wanted to stop by and drop 

the check.")). 

m Letter from Tarang Shah, Manager, Corporate Materials Application, Myers Industries, Inc., 

to Dr. Michel, Feb. 2, 2012, attached to E-mail from Frederick Mkhel to Eddie Gome7~ Re: FW: 

(Feb. 6, 2012, 10:48 AM). 

IH E-mail from Frederick Michel to tshah@myersind.com and DThomas@myersla\>mandgarden.com, Re: Proposal for pot degradability testing {Feb. 22, 2010, 10:29 

AM}. 135 E-mail from tshah@myersind.com to michel.36@osu.edu, Re: Re: Proposal for pot degradability testing (Feb. 26, 2010, 4:13PM) ("Professor, We are working on the proposal, and remain 

very interested in moving this forward. The delay has been due to our company's process."). 

B6 Grant application, supra note 132, at 17 (noting support "Evaluation of the Compostability, 

soil degradation and anaerobic digestion of Bioplastics used for nursery pots"). Perhaps this is related to a $31 ,400 proposal that Michel apparently made to Myers for research to last 12 months beginning August I, 2011. See Frederick C. Michel, Biodegradability and Life Cycle Analysis of 

Nursery Pots Made of Ecotainer Formulations, a proposal to Myers Industries, Inc. The document is 

undated, but the properties of the MS Word file, MyersAkroMilproposal20ll.doc, shows that it \\laS 

created on July 14, 2011, and last modified on July 15,2011. Michel also made a $31,400 proposal 

with the same name, starting August 15, 2011, only lasting six months. See E-mail from Frederick 

Michel to Tarang Shah (cc:ing Eddie Gomez), Re: RE: proposal (Aug. 10, 2011, 10:42 AM). I am 

not sure how the $28,000 reporled as received for a period starting in June 20 II relate to these proposals, \\ilich were \\Titten in July and August 20 I I. 
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36 VOLOKH 

$20,000. 137 This money may have gone directly to support Eddie 

Gomez's graduate education. 138 

The purpose of Myers Industries' funding was to evaluate the 

compostability and degradability of its products. 139 Myers Industries had an interest in the issue on several fronts: Any product 

with good results could be a good candidate for Myers to buy and 

offer in the future as part of its catalog. 140 But the results would 

also be useful to the extent they established that Myers Industries' 

products were better than those offered by its competitors. In 

providing the funding, Myers Industries committed to "provide the 

bioplastics and natural fibers that will be required to conduct the 

experiments,"141 though Myers had been providing products for 

testing by Gomez and Michel since at least 2010. 142 

137 See. e.g., Feb. 2, 2012 letter, supra note 133 ("Myers Industries Lav.n & Garden Group is 

pleased to offer matching funds up to $20,000, equal to I 00% awarded to you for studying the biodegradability and 1 ife cycle analysis of nursery containers made of bioplastics and natural fibers."); 

Grant application to OARDC attached to E-mail from Eddie Gomez to Frederick Michel, Re: 

OARDC-Matching_Myers_2012.docx (Feb. 6, 2012, 2:24 PM), at 13 ("Matching Funds will be 

obtained from Myers Industries Inc. as a dollar for dollar match for the project A support letter from 

Myers Industries is attached to the end of the proposal." (attaching Feb. 2, 2012 tetter, supra note 

133)). Michel billed Shah for at least $8600 as "half of the payment for the life cycle analysis pro· 

posat." E-mail from Frederick Michel to Tarang Shah (cc:ing Eddie Gomez). Re: RE: Invoice (July 

27, 2012, 3:24 PM) (quoting E-mail from Tarang Shah to Frederick Michel, Re: Re: Invoice (July 

27,2012, 12:50 PM) ("Fred. Can you break it in to 2 half amount invoices? ($8,600 ea.)")). 118 See Grant application, supra note 132, at 12 ("The study is an extension of work being conducted in collaboration with Myers Industries, an Ohio manufacturer of plastic pots for the nursery 

industry. They have provided tuition and stipend support for Eddie Gomez. The funds will allow 

additional work to be completed that will lead to peer reviewed publications."); Eddie F. Gomez, 

Biodegradation of Bioplastics and Natural Fibers During Composting, Anaerobic Digestion and in 

Soil (SEEDS: The OARDC Graduate Research Enhancement Grant Progrnm, Ph.D. application) 

{applying for fuqding for June 20, 2012 to November 20, 2012) (noting that "{t]he study is an extension of work being conducted in collaboration with Myers Industries, an Ohio manufacturer of plastic pots for the nursery industry. They have provided tuition and stipend support for Eddie Gomez."); 

E-mail from Eddie Gomez to tshah@myerslav.nandgarden.com (cc:ing miche1.36@osu.edu and Jay 

Martin), Re: Myers Final Report (Oct. 21,2011,3:17 PM) ("Tarang ·It was good to talk to you and 

thanks for supporting me with my studies. It's a great learning experience to work together with 

industry."). 119 See supra note 136. 

I<G See Eddie F. Gomez, Life Cycle Assessment and Study of the Biodegradability of Novel 

Plastics and Natural Fiber Composites Under Aerobic and Anaerobic Conditions (Ph.D. proposal), 

attached to E-mail from Eddie Gomez to Frederick Michel, Re: File for Gomez proposal (June 29, 

2012,4:33 PM}. Gomez writes: "Myers Industries Inc., an Ohio manufacturer of plastic pots for the 

nursery industry will be used as the model for this study. The company buys plastics in the form of 

pellets and fibers from different providers around the world. These materials are then transformed 

into nursery pots in several plants around the state and then shipped to retailers. Recently, Myers is 

interested in purchasing materials that are claiming to be biodegradable in order to reduce the impact 

of their activities in the environment." !d. at 13. 141 Feb. 2, 20 12letter, supra note 133. 141 E-mail from Eddie Gomez to Tarang Shah (cc:ing michel.36@osu.edu), Re: Follow-up (Ju· 

ly 9, 2010, I :02 PM) (quoting E-mail from Tarang Shah to Eddie Gomez (cc:ing 

(continued next page) 
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This funding was imp011ant to Michel as well as to G6mez: 

when G6mez expressed concern that he might not be able to complete "Tarang[']s final rep011" 143 because of his graduate coursework, Michel wrote back: "Eddie, I think we need to complete the 

report. It is really the first priority if we want funding to continue. 

If you have to, you may need to drop the class."144 

Michel and G6mez have been corres~onding with Tarang Shah 

of Myers Industries since at least 2010, 45 and Shah has taken an 

active interest in the progress of the research. 146 Shah has been so 

michel.36@osu.edu), Re: RE: Follow-up (July 6, 2010, 1:16PM) ("Eddie, Would you be available 

Thursday morning? I have additional control flower pots and can drop them ofl:")). 141 This report is apparently the one referred to below as G6mez & Michel internal report for 

Myers Industries, infra note 154. 114 E-mail from Eddie Gomez to michel.36@osu.edu, Re: RE: Myers (Oct. 19,2011, 11 :53 

AM). 14s See, e.g., E-mail from Frederick Michel to tshah@myersind.com, Re: RE: Proposal for pot 

degmdability testing (Feb. 26, 2010, 4:29 PM); E-mail from Eddie F. GOmez to 

tshah@myersind.com and michel.36@osu.edu, Re: RE: materials needed (May 19, 2010, II :55 

AM); E-mail from Eddie Gomez to Tamng Shah and miche1.36@osu.edu, Re: Follow-up (June 8, 

2010, 9:21 AM) ("Hi Tarang, The pleasure was mine, thank you for giving OARDC the opportunity 

to work together with Myers ... . I \viii write you again to keep you updated"); E-mail from Eddie 

Gomez to Tamng Shah (cc:ing michel.36@osu.edu), Re: Titrations (June 9, 2010, 3:12PM) ("Tarang- Please take a look to the calendar of titrations, you are more than welcome to join me during 

the process."}; E-mail from Eddie Gomez to michel.36@osu.edu, Re: Lab meeting (June 14, 2010, 

5:26 PM) ("Fred, I will be working with Tarang tomorrow in the morning."); E-mail from Eddie 

Gomez to Tarang Shah and michel.36@osu.edu, Re: Anaerobic Digestion update (July 28, 2010, 

8:18PM) ("!look forward to meet \\lith you next week. Please let me know if any questions or suggestions."); E-mail from Eddie Gomez to TShah@myersind.com (cc:ing michel.36@osu.edu), Re: 

Results for MYERS (Aug. 6, 2010, I :57 PM) ("Tarang- Please take a look to the updated file for 

Myers experiments."); E-mail from Eddie Gomez to michel.36@osu.edu, Re: Lab Meeting (Aug. 16, 

2010, 12:13 PM) ("Fred - I have to meet \\lith Tarang tomorrow at lOam."); E-mail from Eddie 

Gomez to Tarang Shah (cc:ing Frederick Michel), Re: Experiments (Oct. 27, 2010, 3:42PM) ("Tarang - Thanks for meeting \\lith me this Monday. Just wanted to let you know that the AD experiment that I started last Friday is stable . ... I \viii update the database next week and I'll send you a 

copy."). 146 See, e.g., E-mail from Eddie Gomez to Tarang Shah (cc:ing michel.36@osu.edu), Rc: MYERSEXP- Design Results(l-8-201 l).xlsx(Jan. 8, 2011,5:13 PM) ("Tarang- data up to 1-8-201 I"); 

E-mail from Eddie Gomez to Tarang Shah (cc:ing michel.36@osu.edu), Re: Experiments (Jan. 31, 

201 I, 10:42 AM) ("Tarang- I went to Wooster this weekend to check the experiments. "); E-mail 

from Eddie Gomez to Tarang Shah (cc:ing michel.36@osu.edu), Re: MYERSEXP - Design Results 

(2-1 -2011).xlsx (Feb. I, 2011, 8:16 PM) ("Updated soil experiment data."); E-mail from Eddie 

Gomez to Tarang Shah (cc:ing michel.36@osu.edu), Re: AD update (Apr. I, 2011, 7:28 PM) ("Tarang- update for AD 5511 experiment on ECM 2%, Ecopure, Ecobras and Ecotainer. l will continue 

working on this data. Please not that this is not a final report."); E-mail from Eddie Gomez to Tarang 

Shah (cc:ing Fred Michel), Re: Experiments (May 9, 2011, 10:04 PM) ("Tarang- I was this weekend in Wooster checking the experiments."); E-mail from Frederick Michel to Eddie Gomez, Re: 

paper (May 24,2011, 12:44 PM) ("Tarang will be visiting Thursday morning to discuss the summer 

plans and review the tests."); E-mail from Eddie Gomez to Frederick Michel, Re: RE: Myers Report 

201 ldmfllEG.docx (Dec. 20, 2011, 9:52AM) ("I met 111ith Tarang and we went over the report, J 

answered his questions and he was happy with it.") (responding to an e-mail from Frederick Michel 

to Eddie Gomez, Re: RE: Myers Report 201ldraOIEG.docx (Dec. 19, 2011, 5:14 PM), asking: "Did 

you get any response from Myers on the Annual Report? Were they happy with it?"); E-mail from 

Eddie Gomez to Frederick Michel, Re: Meeting with Tarang (June 29, 2012, I 0:56 AM) ("Hi Fred -

(continued next page) 
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38 VOLOKH 

involved in the research that Michel and G6mez listed him as a 

collaborator on a draft grant request; 147 and when Michel and 

Gomez proposed to present a previous version of their paper at a 

2012 meeting in France, 148 Michel suggested that he could add 

Shah as an author "since [he had) been involved in the research 

from the beginning."149 

When Michel and Gomez have presented their work comparing 

the biodegradability of Myers's products with ECM's (among others), their presentation materials have not always indicated the precise provenance of the items tested. Thus, the PowerPoint file presented at an April 2011 conference generally showed the items 

tested without noting what companies produced them; Michel 

wrote to Tarang Shah asking if Shah "would have any problems 

with [Michel's] presenting the ... Powerpoint," adding: "There are 

no references to Myer[s]."150 It thus seems likely that some product 

noted in that PowerPoint is from Myers. A substantially similar 

presentation from May 2011 lists many producers, including ECM, 

Ecobras, and Ecopure, but does not mention Myers Industries. The 

filename, though, is "meyerspreliminaryresults.pdf' [sic], which 

strongly suggests that a Myers product was involved. 151 (In other 

e-mails as well, Michel has checked his presentation of the resu Its 

with Shah. 152) G6mez' s dissertation, which contains substantially 

I would like to meet with Tarang and you to discuss use of data and publications for the LCA 

study."). The "Annual Report" referenced here is the same as G<lmez & Michel internal report for 

Myers Industries, infra note 154. 141 Grant application, Jupm note 138, at I (listing "Tarang Sha" [sic] as "Collaborator I"); 

Grant application at II ("Dr. Frederick Michel and Tarang Shah of Myers Industries Inc. will coordinate the research aspects of the project and design experiments, analyse data and prepare reports 

and publications about the project. Dr. Michel will supervise a graduate student who will conduct the 

experiments .... "). 

us The meeting was the ORBJT2012 conference in Rennes, France, "Global Assessment for 

Organic Resources and Waste Management," http://11M'W.orbit2012.fr/. 

u• E-mail from Frederick Michel to Tarang Shah, R~: RE: Tomorrow (Oct. 24, 2011, 2:12 

PM). 150 E-mail from Frederick M ichelto Tarang Shah, Re: RE: this week (Apr. 25, 20 II, I :07 PM). 151 Presentation attached to E-mail from Frederick Michel to Tarang Shah (cc:ing Eddie 

Gomez). Re: preliminary data (May 2, 2011). 152 See, e.g., Oct. 5, 2011 E-mail, supra note 132 (quoting E-mail from Frederick Michel to Ta· 

rang Shah (cc:ing Eddie Gomez), Re: RE: Tomorrow (Oct. 5, 2011, II :08 AM) ("I would like to ask 

you about presenting the data at a meeting I would like to attend."}}; E-mail from Eddie F. G<lmez to 

Frederick Michel, Re: Fwd: Fwd: Document for publication [Myers revision needed]( Jan. 31, 2013, 

8:06AM) ("Fred - Myers approved publication of this document. l[']m just waiting for your final 

revision."}. quoting E-mail from Eddie F. G<lmez to shahtr@hotmail.com, Re: Document for publi· 

cation {Myers reyision needed], Jan. 15, 2013 (10: I 7:29AM EST}("Piease forward this to your boss 

and let me know if Myer.s name is compromised by any means in the document and I will make 

changes accordingly."). 
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2014) FTC EXPERT REPORT 39 

the same material, likewise lists the ECM products as comin~ from 

ECM but does not list Myers as the source for any products.• 3 

However, in a draft report apparently circulated only to Myers 

Industries, 154 a paper product and a paper-with-asphalt product 

were clearly listed as coming from Myers; 155 the only other paperwith-asRhalt product discussed in that paper was from Western 

Pulps} 6 And in another draft of Michel and Gomez's work, a paper-with-asphalt product was listed as being from Western Pulps 

and a coconut coir pot was listed as being from Myers. 157 

In the final paper published in the Polymer Degradation and 

Stability journal, the ECM additives tested are clearly listed as 

coming from ECM BioFilms Inc., 158 but the "Paper pulp + asphalt" 

and "Coconut coir" are not listed as coming from any particular 

manufacturer. 159 But as noted above, it is clear from various drafts 

and presentations of Gomez and Michel's research that they did 

test some paper-with-asphalt products, one from Myers Industries 

and another from Western Pulps, and a coconut coir product from 

Myers Industries. Indeed, testing Myers products was the goal of 

the funding that Myers provided to Michel and his lab. · 

In light of the foregoing evidence, it seems highly likely that at 

least one of the products in the finished paper is from Myers; and 

in any event, it's clear that Myers Industries provided substantial 

funding and was heavily involved in Michel and Gomez's overall 

research and that Tarang Shah of Myers was heavily involved in 

the day-to-day conduct of the research. These factors, as well as 

Michel's need to clear his presentation of the results with Myers 

tn Eddie Francisco G6mez. Studies Conducted on: Biodegradability of Bio-Based Plastics and 

Polyurethane Foams Under Aerobic and Anaerobic Conditions; and Effects on Particle Size and 

Reactor Performance in Mesophilic Anaerobic Digesters Treating Cavitated Sewage Sludge (Ph.D. 

dissertation, 2013), draft included in E-mail from Frederick Michel to Frederick Michel, Re: eddie 

revise thesis (Oct. 9, 2013,4:36 PM). 

u• Eddie G6mez & Frederick C. Michel, Biodegradation of Biop/aslics and Natural Fibers 

During Composting, Anaerobic Digestion and it1 Soil- Report /, A Report- Only for Myers Indus· 

tries Inc. use, Affellflon Tarang Slra [sic] [hereinafter G6mez & Michel internal report for Myers 

Industries], attached to E-mail from Eddie Gomez to michel.36@osu.edu, Re: FW: Myers Report 

20lldraft!EG.docx (Dec. 5, 2011, 11:25 AM). 

m See id at 7tbl.2, 19-21, 25 tbl.3, 26 tbl.4, 28 tbl.9, 29 tbi.IO, 36 tbl.27, 37 tbl.28. 116 See id. at 7 tbl.2, 21, 25 tb1.3, 26 tbl.4, 32 tbi.IS, 33 tbl.l6. 

tn Eddie F. Gomez & Frederick C. Michel, Relative Biodegradation of Novel Plastics and 

Natural Fiber Composites During Composting, Anaerobic Digestion and Long-Term Soil Incubation, at 27 tbl.2, attached to E-mail from Eddie F. G6mez to Frederick Michel, Re: Paper Eddie to 

revise (Mar. 12, 2013, I :36 PM). 

m See G6mez & Michel, supra note 126, at 2585 tbl.2. IS9 fd. 
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40 VOLOKH 

and Shah, thus point to possible bias of the G6mez & Michel paper. 

C. The Substantive Validity of Shane Frederick's Research 

As discussed above, the probabilistic model suggests that substantively implausible positions should lead one to revise upwards 

one's estimate of the probability of bias. This result may be applied 

to the report of Shane Frederick, one of complaint counsel's experts. 

Expert witness David Stewart explains the problems behind 

this research, so I merely summarize the problems here. We do not 

know the composition of the surveyed sample. Google Surveys 

provides limited demographic information about respondents, and 

there is limited protection against fraudulent demographic responses. Survey respondents are forced to answer the survey to be able 

to access other content, which leads to "disinterest bias." As a result, Shane Frederick's survey picked up many nonsensical answers, like one second, one nanosecond, two minutes, etc. Rather 

than remove nonsensical results from the sample, Shane Frederick 

coded them as half a year. 

These methods are not only inconsistent with sound statistical 

practice but are also inconsistent with the requirements for statistical research in the Manual for Complex Litigation160 or the Federal 

Rules of Evidence. 161 David Stewart's own survey, which has 

greater statistical validity, shows great heterogeneity among respondents, with less than a fifth of respondents responding that biodegradable products must degrade in a year or less. 162 But regardless of the validity ofDavid Stewart's survey, what is clear is that a 

Google survey is inadequate to validate the APCO study and does 

not conform to sound statistical techniques. Such a survey cannot 

160 MANUAL FOR COMPLEX LITIGATION§ 11.493 (4th ed.). 161 See Shari Seidman Diamond, Reference Guide on Sun·ey Research, ill REFERENCE MA>''Ill· 

Al ON SCIENTIFIC EVIDENCE 359, 363-.Q<I (Fed. Jud. Ctr., 3d ed. 2011), http://www.fjc.gov/publid 

pdf.nsfflookup/SciMan3DOI .pdf/Siile/SciMan3DOI.pdf (noting that, under Federal Rule of Evidence 

703, the question with survey data is, "Was the poll or survey conducted in accordance with generally accepted survey principles, and were the results used in a statistically correct way?"); cf Fla. Bar 

v. Went For It, Inc., 515 U.S. 618, 64(}-41 {1995) (Kennedy, J., dissenting) {critiquing offered statistical evidence for inconsistency with sound statistical technique). 161 See generally David Stewart expert report. 
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2014) FTC EXPERT REPORT 41 

provide the "reliable ... evidence"163 that the Administrative Procedure Act requires to impose a sanction in a formal proceeding, 

nor is it sufficient to validate other evidence as reliable. 

Shane Frederick's use of such surveys are thus circumstantial 

evidence of bias. 

VI. CONCLUSION 

Taking bias and regulatory capture seriously requires appreciating the difficulty of finding direct evidence. The 17th-century 

English lawyer noted that it was hard to get satisfactory evidence 

of witchcraft, so that-because of the presumption of innocencemany undoubtedly guilty persons escaped. 164 Witchcraft isn't real, 

but agency bias and regulatory capture are. Because direct evidence is so rarely available, circumstantial evidence becomes highly important; this is why the law generally demands not mathematical certainty or indisputable proof, but merely a level of justified 

belief that exceeds a particular threshold. In this context, proof is 

inherently probabilistic. 

Therefore, to root out bias, one must inevitably be on the lookout for factors that make bias more probable-factors that should 

make the observer more confident that bias exists. This is the essence of the probabilistic model discussed in this report. Wellknown evidence of bias is invaluable; evidence of financial selfinterest is one of the most widely recognized types of evidence of 

bias among law and economics scholars, as is evidence of lobbying.165 But, as statisticians and economists understand, one can 

supplement this evidence with other factors that are more common 

in the presence of bias. Bayesian probabilistic theory dictates that, 

when a factor is more common in the presence of bias, its presence 

makes bias more likely. When such factors are present together 

with familiar evidence of bias like financial self-interest, the inference becomes stronger still. 

This report has documented several aspects of the case that are 

evidence of bias: (1) the Commission's adoption of the Green 

Guides and initiation of this action against ECM based on intense 

~ 5 U.S. C.§ 556(d) (emphasis added); see also Steadman v. SEC, 450 U.S. 91 (1981). 

IH Alexander Volokh,n G11ilty Men, 146 U. PA. L. REv. 173, 182-83 (1997). 16s See Wiley, supra note 51. 
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42 VOLOKH 

lobbying by self-interested industry participants that compete with 

ECM; (2) the Commission's choice of the APCO over the Synovate study based on patently unconvincing reasoning; (3) the selfinterest of complaint counsel's expert witness Stephen McCarthy; 

(4) the self-interest of Frederick Michel, who authored a paper that 

complaint counsel is relying on; and (5) the unconvincing statistical studies of complaint counsel's expert witness Shane Frederick. 

When evidence of bias is present in any one case, it might easily be coincidental; but the chance of coincidence falls when evidence of bias is present in several instances. Moreover, this may be 

only scratching the surface, since the Commission has denied respondent ECM the ability to obtain further evidence of bias 

through discovery. 166 

The already discovered evidence of bias suggests that more 

might lurk below the surface-which suggests that further discovery is warranted. Moreover, it is incumbent on complaint counsel 

to rebut the inference of bias discovered thus far. 

I I Date 

166 See supra note 45. 
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Appendix A 

Alexander Volokh's CV 
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Alexander "Sasha" Volokh 

avolokh@emory.edu 

volokh@post.harvard.edu 

Emory Law School 

1301 Clifton Rd. NE 

Atlanta, GA 30322 

Academic Employment 

ofiftce:404-712-5225 

fax: 404-727-6820 

cell: 626-354-4581 

Emory University School of Law: Associate Professor (2012-present) 

(tenured as of2014) 

Assistant Professor (2009- 12) 

University of Houston Law Center: Visiting Assistant Professor (2008- 09) 

Georgetown University Law Center: Visiting Associate Professor (2006-08) 

Courses: 

• Administrative Law (F'l4, S'l4, S'l3, S'll, S'IO, S'09) 

• Constitutional Law (S'lS, S'14) 

• Torts (F'l2, F'll, F'IO) 

• Law & Economics (S' 13, F'08, F'07) 

• Law & Economics of Antitrust (F' 14, S' 11, S'07) 

• English Legal History (S' 12) 

• Current Issues in Privatization (seminar) (F' 11, F' 09, F' 08, F'06) 

• Law & Economics ofthe Environment (seminar) (S'08) 

Committees: Clerkship Committee (2009- present; chair 20 14- present) 

Colloquium Committee (2010- 12) 

Education 

Harvard University 

Ph.D., Economics, 2004; J.D., 2003, magna cum laude 

John M. Olin Fellow in Law & Economics 

Executive Editor, Harvard Law Review 

UCLA, 1993, summa cum laude 

B.S., Mathematics/Economics 

B.A., English/World Literature 

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Academic Articles (see also http://works.bepress.com/alexander_ volokh) 

• Lmv: Economics of Its Public Enforcement, in INTERNATIONAL ENCYCLOPEDIA OF THE SOCIAL AND BEHAVIORAL SCIENCES (James D. Wright ed., 2d ed. 

forthcoming 2015) 

• Privatization and Competition Policy, in COMPETITION AND THE ROLE OF THE 

STATE (D. Daniel Sokol et al. eds., forthcoming Stanford Univ. Press 2014) 

• The New Private-Regulation Skepticism: Due Process, Non-Delegation, and 

Antitrust Challenges, 37 HARV. J.L. & PUB. POL'Y 931 (2014) 

• Prison Accountability and Performance Measures, 63 EMORY L.J. 339 (20 14) 

• Keynote article, The Modest Effect ofMinneci v. Pollard on Inmate Litigants 

(Symposium: Inside America's Criminal Justice System: The Supreme Court 

and the Rights of the Accused and the Incarcerated), 46 AKRON L. REV. 287 

(2013) 

• Privatization and the Elusive Employee-Contractor Distinction, 46 UC DAVIS 

L. REv. 133 (2012) 

• The Prison Vouchers series 

• Prison Vouchers, 160 U. PA. L. REV. 779 (2012) 

• The Constitutional Possibilities of Prison Vouchers, 72 Omo ST. L.J. 983 (2011) 

• Do Faith-Based Prisons Work?, 63 ALA. L. REV. 43 (2011) 

• Book review, 25 J.L. & RELIGION 323 (2009-10) (reviewing WJNNIFRED FALLERS SULLIVAN, PRISON RELIGION: FAITH-BASED REFORM AND THE CONSTITIJTION (Princeton Univ. Press 2009)) 

• Rationality or Rationalism? The Positive and Normative Flml1S of CostBenefit Analysis, 48 Hous. L. REv. 79 (2011) 

• Property Rights and Contract Form in Medieval Europe, 11 AM. L. & ECON. 

REv. 399 (2009) (peer-reviewed) 

• The Privatization and Lobbying series 

• Privatization and the Law and Economics of Political Advocacy, 60 STAN. L. 

REV. 1197 (2008) 

abridged at LEGAL WORKSHOP (Mar. 17, 2009), 

http :Ill ega lworkshop.org/2009/03/ 17 /privatization -and-the-law-andeconomics-of-political-advocacy 

abridged as The Effect of Privatization on Public and Private Prison Lobbies, 

in 3 PRISON PRIVATIZATION: THE MANY FACETS OF A CONTROVERSIAL INDUSTRY 7 (Byron Eugene Price & John Charles Morris eds., Praeger 2012) 

• Privatization, Free Riding, and Indushy-Expanding Lobbying, 30 INT'L REV. L. 

& ECON. 62 (2010) (peer-reviewed) 

companion paper: Privatization, Free-Riding, and lndust1y-Expanding Lobbying: Additional Materials, Emory Law & Econ. Research Paper No. 

969789 and Georgetown Law & Econ. Research Paper No. 969789 (2007), 

available at http://ssrn.com/abstract=969789 

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• Choosing Interpretive Methods: A Positive The01y of Judges and Eve1yone 

Else, 83 NYU L. REv. 769 (2008) 

abridged at LEGAL WORKSHOP (Apr. 20, 2009), http://legalworkshop.org/2009/ 

04/20/choosing-interpretive-methods-a-positive-theory-of-judges-and-everyoneelse 

• Externalities, in THE ENCYCLOPEDIA OF LIBERTARIANISM 162 (Ronald 

Hamowy ed., 2008) 

• The Appeal, 103 MICH. L. REv. 1391 (2005) (reviewing FRANZ KAFKA, THE 

TRIAL (Breon Mitchell trans., Schocken Books 1998) (1925)) (co-authored 

with Alex Kozinski) 

• Essays on Law and Economics (Economics Ph.D. dissertation, Harvard Univ., 

2004) 

• Case comment, Reynolds v. Beneficial National Bank, 288 F.3d 377 (7th Cir. 

2002), 116 HARv. L. REv. 2702 (2003) 

• Judicia/ Reform, 18 WORLD BANK RESEARCH OBSERVER 61 (2003) (peerreviewed) (co-authored with Juan Carlos Botero, Rafael La Porta, Florencio 

L6pez-de-Silanes, and Andrei Shleifer) 

• The Pitfalls of the Environmental Right to Know, 2002 UTAH L. REv. 805 

• Case comment, Tahoe-Sierra Preservation Council v. Tahoe Regional Planning Agency, 535 U.S. 302 (2002), 116 HARv. L. REV. 200, 321 (2002) 

• Note, A Tale of Two Systems: Cost, Quality, and Accountability in Private 

Prisons, 115 HARV. L. REV. 183 8, 1868-91 (2002) (Part III of Developments 

in the Lmv-The Law of Prisons, 115 HARV. L. REV. 1838 (2002)) 

• A Brief Guide to School Violence Prevention, 2 J.L. & FAM. STUD. 99 (2000) 

• n Guilty Men, 146 U. PA. L. REV. 173 (1997) 

abridged in ANNALS OF IMPROBABLE RESEARCH, May/June 2000, at 6 

abridged as Better That Ten Guilty Men. .. , in BEYOND A REASONABLE DOUBT 

(Larry King ed., Phoenix Books 2006) 

excerpted in DA VfD CRUMP ET AL., CRIMINAL LAW: CASES, STATUTES, AND 

LAWYERING STRATEGIES 258 (2d ed., LexisNexis 2010) 

Works i11 Progress 

• The Emerging Global Law of Private Delegation 

• Why Do Judges Read Statutes? 

• Privatization and the Effectiveness of Monitoring Agencies 

Other Recent Employme11t 

• Law clerk, U.S. Supreme Court, Justice Samuel Alita (2006) 

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• Law clerk, U.S. Supreme Court, Justice Sandra Day O'Connor (2005-06) 

• Law clerk, Ninth Circuit Court of Appeals, Judge Alex Kozinski (2004- 05) 

• Law clerk, Dep't of the Interior, Office of the Solicitor (Summer 2003) 

• Law clerk, Dep't of Justice, Office of Legal Counsel (Summer 2003) 

• Law clerk, Inst. for Justice (Summer 200 1) 

• Policy analyst, Reason Pub. Pol 'y Inst. & Reason Foundation (1994-98) 

• Policy analyst, Competitive Enterprise Inst. (1993-94) 

Other Professional am! Academic Activities 

• Referee for American Journal of Political Science, Criminology, International 

Review of Lmv and Economics, Journal of Legal Studies, Journal of Policy 

Analysis and Management, Lmv and Social Inquby, and Public Choice 

• Adjunct scholar, Reason Foundation (1998-present) 

• Panel co-organizer and presider (Lmv as Culture: Compensation, Punishment, 

and Impunity), Int'l Congress on Medieval Studies, Kalamazoo, Mich. (May 

8, 2014) 

• Substitute taught three lectures of undergraduate Law & Economics class at 

Emory Univ. (Mar. 4, Apr. 8 & 10, 2014) 

• Conference co-organizer and host, Georgia Medievalists Group, Emory Law 

Sch. (Feb. 22, 2014) 

• Panel organizer and presider (Lm~' as Culture: Secular Punishment and Divine 

Retribution in Medieval Ireland), Int'l Congress on Medieval Studies, Kalamazoo, Mich. (May 9, 2013) 

• Panel organizer and presider (Lmv as Culture: Legal Development and Social 

Change), Int'l Congress on Medieval Studies, Kalamazoo, Mich. (May 11, 

2012) 

• Panel organizer and presider (Lmv as Culture: Lords, Lands, and Property), 

Tnt' I Congress on Medieval Studies, Kalamazoo, Mich. (May 12, 2011) 

• Panel chair (Lmv and Economics), Southern Econ. Ass'n annual meeting, Atlanta, Ga. (Nov. 20, 2010) 

• Lecturer, Technische Universitat Dresden, Germany (Summer 2010) 

• Panel organizer (Law as Culture: Lordship, Profit, and Rationality), Int'l 

Congress on Medieval Studies, Kalamazoo, Mich. (May 13, 2010) 

• Co-founder, Emory Medieval Reading Group (2009- present) 

• Faculty advisor, Emory Law School Federalist Society (2009-present) 

• Faculty advisor, Emmy Lmv Journal (2012-14) 

• h-index: 10; Erdos number: 5; Sunstein number: 3; Bacon number: 2 

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Other Major Publications 

(Non-academic policy studies) 

• CHALLENGING GOVERNMENT -SPONSORED PRIVATE REGULATION OF COMPETITORS 

(Reason Found. Pol'y BriefNo. 120, 2014) 

• OVERPROTECTING PUBLIC EMPLOYEE PENSIONS: THE CONTRAIT CLAUSE AND THE 

CALIFORNIA RULE (Fed. Soc. White Paper, 20 13) 

• ENVIRONMENTAL INFORMATION, TifE TOXICS RELEASE INVENTORY, AND TifE RIGHT 

TO KNOW (Reason Pub. Pol'y Inst., Pol'y Studies No. 246 and 247, 1998) 

• RACE TO THE TOP: THE INNOVATIVE FACE OF STATE ENVIRONMENTAL MANAGEMENT 

(Reason Pub. Pol'y Inst., Pol'y Study No. 239, Feb. 1998) 

• A BRIEF GUIDE TO RECYCLED MARKET DEVELOPMENT (Reason Pub. Pol'y lnst., Pol'y 

Brief, 1998) (co-written with Lynn Scarlett) 

• SCHOOL VIOLENCE PREVENTION: STRATEGIES TO KEEP SCHOOLS SAFE (Reason Pub. 

Pol'y Inst., Pol'y Study No. 234, Oct. 1997) (co-written with Lisa Snell) 

• PACKAGING, RECYCLING, AND SOLID WASTE (Reason Pub. Pol'y lnst., Pol'y Study No. 

223, June 1997) (co-written with Lynn Scarlett, Richard McCann, and Robert Anex) 

• PUNITIVE DAMAGES AND ENVIRONMENTAL LAW: RETHINKING THE ISSUES (Reason 

Found. Pol'y Study No. 213, Sept. 1996) 

• ENVIRONMENTAL ENFORCEMENT: IN SEARCH OF BOTH EFFEITIVENESS AND FAIRNESS 

(Reason Found. Pol'y Study No. 210, Aug. 1996) (co-written with Roger Marzulla), 

abridged in AMERICAN V ALOES: AN ENVIRONMENTAL VISION (Bonner R. Cohen et al. 

eds., 1996) 

• RECYCLING AND DEREGULATION: OPPORTUNITIES FOR MARKET DEVELOPMENT (a 

three-study series) 

I. THE FDA VS. RECYCLING: HAS FOOD PACKAGING LAW GONE TOO FAR? (Reason 

Found. Pol'y Study No. 196, Oct. 1995) 

2. RECYCLING HAZARDOUS WASTE: HOW RCRA HAS REcYCLERS RUNNING 

AROUND IN CERCLAs (Reason Found. Pol'y Study No. 197, Oct. 1995) 

3. HOW GOVERNMENT BUILDING CODES AND CONSTRUCTION STANDARDS 

DISCOURAGE RECYCLING (Reason Found. Pol'y Study No. 202, Mar. 1996) 

Presentations at Conferences, Workshops, and Elsewhere 

• Emory Law Sch, Christian Legal Soc'y, Mar. 31, 2014 

Do Faith-Based Prisons Work? 

• Next Generation of Antitrust Scholars Conference, NYU Sch. ofLaw, Jan. 17,2014 

The New Private-Regulation Skepticism: Due Process, Nondelegation, and Antitrust 

Challenges 

• Georgetown Univ. Law Ctr. Federalist Soc'y, Washington, D.C., Oct. 28, 2013 

Is Law and Economics a Right-Wing Conspiracy? 

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• Georgia Senate, Health and Human Services Cmte., Oct. 22,2013 

Testimony, The Constitutionality of the Patientinjwy Act 

• Montgomery (Ala.) Federalist Soc'y, Oct. 17,2013 

A Discussion on Private Prisons 

• Ga. State Law School Federalist Soc'y, Oct. 9, 2013 

Discussant, John Kunich talk on Nuclear Fusion & Free Market Environmentalism 

• Atlanta Federalist Soc'y, Sept. 17,2013 

Panelist, Supreme Court Update: Noteworthy Cases on the Horizon and Key Decisions from Last Spring 

• Emory Law Sch., Sept. 4, 2013 

Scholarly writing workshop 

• Emory fUGa legal scholarship workshop, Athens, Ga., July 17, 2013 

Prison Accountability and Performance Measures 

• Atlanta Objectivist Society conference, May 25, 2013 

Privatization and Its Discontents 

• Greenville (S.C.) Federalist Soc'y, Feb. 28,2013 

The Modest Effect ofMinneci v. Pollard on Inmate Litigants 

• Thrower Symposium (Privatization: Managing Liability and Reassessing Practices 

in Local and International Contexts), Emory Law Sch. (Feb. 7, 2013) 

PeJformance Measures and Private Prisons 

• Thomas Goode Jones Law School Federalist Soc'y, Jan. 31,2013 

Is Lmv and Economics a Right-Wing Plot? 

• Birmingham (Ala.) Federalist Soc'y, Jan. 17,2013 

The Modest Effect ofMinneci v. Pollard on Inmate Litigants 

• George Mason Univ. Law & Econ. Ctr., Arlington, Va., Dec. 12-13,2012 

Discussant, The Law and Economics of Privacy and Data Security 

• Ga. State Univ. Philosophy Dep't, Atlanta, Ga., Nov. 30, 2012 

Privatization and the Elusive Employee-Contractor Distinction 

• Ga. State Univ., Ethics Center brownbag, Atlanta, Ga., Nov. 29,2012 

Fiddling with Contracts; or, How Not to Help People 

• Philosophy in Action (internet radio show), Nov. 7, 2012 

Taking Stock of Tort Lmv 

• Emory Law Sch. Federalist Soc'y, Nov. 6, 2012 

Discussant, Rory Gray (Alliance Defending Freedom) talk on Mt. Soledad Memorial 

Ass 'n v. Trunk, 629 F.3d 1099 (9th Cir. 2011) 

• Mercer Law Sch., Macon, Ga., Oct. 24, 2012 

Is Lmv and Economics a Right-Wing Plot? 

• Emory Law Sch., Sept. 15,2012 

Scholarly writing workshop 

• Federalist Soc'y Faculty Colloquium, Warrenton, Va., Apr. 20-21, 2012 

Discussant, Government Ownership and the Private Sector 

• Vermont Law Sch. Symposium (Optimizing Prison Privatization), South Royalton, 

Vt., Mar. 23, 2012 

Keynote speaker, The Unfulfilled Promise of Prison Privatization 

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Exh. RX-H

PUBLIC DOCUMENT

• SCOTUScast (Federalist Soc'y), Jan. 26, 2012 

Post-decision pod cast on Minneci v. Pollard, 132 S. Ct. 617 (20 12) 

• SCOTUScast (Federalist Soc'y), Nov. 3, 2011 

Post-argument podcast on Minneci v. Pollard, 132 S. Ct. 617 (2012) 

• George Mason Univ. Law & Econ. Ctr., Arlington, Va., Nov. 3-4, 2011 

Discussant, The Law and Economics of Search Engines and Online Advertising 

• Yale Law Sch. Federalist Soc'y, New Haven, Conn., Oct. 27,2011 

Prison Vouchers 

• Emory Law Sch. Christian Legal Soc'y, Sept. 26,2011 

Do Faith-Based Prisons Work? 

• Emory Law Sch. Federalist Soc'y, Sept. 21,2011 

Discussant, David Cortman (Alliance Defense Fund) talk on Bronx Household of 

Faith v. Board of Educ., 650 F.3d 30 (2d Cir. 2011) 

• Emory Law Sch., Sept. 14,2011 

Scholarly writing workshop 

• West Liberty Univ. Economics Club, Wheeling, W.Va., Aug. 18,2011 

Privatization and Its Discontents 

• EmoryiUGa legal scholarship workshop, Athens, Ga., July 14,2011 

Privatization and the Elusive Employee-Contractor Distinction 

• Atlanta Objectivist Society conference, May 28, 20 II 

Tort Law: Necessary or Evil? 

• Prisoners Education and Assistance Project, U. Penn. Law Sch., Philadelphia, Penn., 

Feb.25,2011 

Prison privatization debate 

• Georgia Medievalists Group, Oxford, Ga., Feb. 5, 2011 

Property Rights and Contract Form in Medieval Europe 

• Southern Econ. Ass'n meeting, Atlanta, Ga., Nov. 20,2010 

Prison Vouchers 

• Hous. L. Rev. Symposium, Nov. 3, 2010 

Comments on Richard Revesz paper on cost-benefit analysis and the environment 

• Emory Law Sch. Federalist Soc'y, Oct. 27,2010 

Is Law and Economics a Right-Wing Plot? (with Joanna Shepherd Bailey) 

• Emory Law Sch., Sept. 15,2010 

Scholarly writing workshop (with Hanah Metchis Volokh) 

• Int'l Congress on Medieval Studies, Kalamazoo, Mich., May 13,2010 

Property Rights and Contract Form in Medieval Europe 

• Am. Law & Econ. Ass'n meeting, Princeton Univ., Princeton, N.J., May 7-8,2010 

Why Do Judges Read Statutes? 

• Soc. for Envt'l L. & Econ. meeting, Emory Law Sch., Mar. 26, 2010 

Discussant, Environmental Decisionmaking and Benefit-Cost Analysis 

• Thrower Symposium (The New New Deal: From De-Regulation toRe-Regulation), 

Emory Law Sch. (Feb. 11, 20 10) 

Panelist, Re-Regulation and Government Expansion: A Historical Perspective 

• Emory Political Science Dep't workshop, Feb. 4, 2010 

Why Do Judges Read Statutes? 

A-7 
Renewed Resp. Motion for Leave

Exh. RX-H

PUBLIC DOCUMENT

• Southern Econ. Ass'n meeting, San Antonio, Tex., Nov. 22, 2009 

Why Do Judges Read Statutes? 

• Emory Law Sch. Federalist Soc'y, Oct. 5, 2009 

Is Law and Economics Conservative? 

• Emory Law Sch. faculty workshop, Sept. 16, 2009 

Prison Vouchers 

• Am. Law & Econ. Ass'n meeting, Univ. of San Diego Law Sch., May IS, 2009 

Property Rights and Contract Form in Medieval Europe 

• Law & Economics Workshop, Harvard Law Sch., Cambridge, Mass., Mar. 3, 2009 

Property Rights and Contract Form in Medieval Europe 

• Univ. of Houston Law Ctr. faculty workshop, Feb. 23,2009 

Prison Vouchers 

• Law & Economics Workshop, UT-Austin Law Sch., Feb. 9, 2009 

Why Do Judges Read Statutes? 

• Liberty & Current Issues (Inst. for Humane Stud.), Catholic Univ., Washington, 

D.C., July 27-29, 2008 

The Limits of Privatization 

• Am. Law & Econ. Ass'n meeting, Columbia Law Sch., New York, N.Y., May 16, 

2008 

Privatization, Free-Riding, and Indust1y-Expanding Lobbying 

• Int'l Studies Ass'n conference, San Francisco, Calif., Mar. 28, 2008 

The Economic The01y of Privatization 

• George Washington Law Sch. faculty workshop, Washington, D.C., Feb. 20, 2008 

Privatization and the Law and Economics of Political Advocacy 

• Property Law and Transactions in an Age of Globalization (Ctr. on Prope1ty, Citizenship, & Social Enterpreneurism), Chapman Law Sch., Orange, Calif., Feb. 16, 2008 

Property Rights and Contract Form in Medieval Europe 

• Vanderbilt Law Sch. faculty workshop, Nashville, Tenn., Feb. 12,2008 

Choosing Interpretive Methods: A Positive Theory of Judges and Eve1yone Else 

• Washington Univ. Law Sch. faculty workshop, St. Louis, Mo., Feb. 5, 2008 

Choosing Interpretive Methods: A Positive Theory of Judges and Eve1yone Else 

• Emory Law Sch. faculty workshop, Jan. 31, 2008 

Choosing Interpretive Methods: A Positive The01y of Judges and Eve1yone Else 

• Duke Law Sch. faculty workshop, Durham, N.C., Dec. lO, 2007 

Choosing Inte1pretive Methods: A Positive The01y of Judges and Eve1yone Else 

• Univ. of Pennsylvania Law Sch. faculty workshop, Philadelphia, Penn., Nov. 15, 

2007 

Choosing Interpretive Methods: A Positive The01y of Judges and Eve1yone Else 

• Georgetown Law Sch., Washington, D.C., Nov. 14,2007 

Panelist on Fourth Amendment issues from journal write-on competition 

• Northwestern Law Sch. faculty workshop, Chicago, Ill., Oct. 31,2007 

Choosing Interpretive Methods: A Positive Theo1y of Judges and Everyone Else 

• Georgetown Univ. Law Ctr. faculty workshop, Washington, D.C., Sept. 20,2007 

Choosing Interpretive Methods: A Positive The01y of Judges and Eve1yone Else 

A-8 
Renewed Resp. Motion for Leave

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PUBLIC DOCUMENT

• USC Law Sch. faculty workshop, Los Angeles, Calif., Sept. 17,2007 

Choosing Interpretive Methods: A Positive Themy of Judges and Eve1yone Else 

• UCLA Law Sch. faculty workshop, Sept. 14,2007 

Choosing Interpretive Methods: A Positive Themy of Judges and Eve1yone Else 

• Global Capitalism and Personal Freedom in the 21st Century (fno6anLHb!H 

KamtTamnM u mt'IHM cno6o.na B XXI neKe) (Cato.ru), Alushta, Ukraine, Sept. 2-8, 

2007 

The Legal Foundations of Capitalism (llpaeoeore OCHOBbl Kanun/Wili3-Ha) (Russian) 

Twenty-Five Years of Environmental Legislation: What Americans Have Learned 

(J(eaOIJamb-11fl111b 11em 3aKouooamellocmea o6 oxpaHe OKpy:>~eaJOUfeli cpeObl: 'le.My 

Hay'IU/11/Cb aMepUKalllfbl) (Russian) 

• Third Annual Conglomerate Junior Scholars Workshop (online), July 9, 2007; see 

http://www. theconglomerate.org/2007 /07 /conglomerate--l.html 

Privatization and the Law and Economics of Political Advocacy 

• Georgetown Univ. Law Ctr. summer faculty workshop, Washington, D.C., July 3, 

2007 

Choosing Inte1pretive Methods: A Positive The01y of Judges and Eve1yone Else 

• America's Future Found., Washington, D.C., June 20, 2007 

Panelist, Thinkers vs. Doers Roundtable 

• Stanford/Yale Junior Faculty Forum, Stanford Law Sch., Stanford, Calif., May 19, 

2007 

Property Rights and Conh·act Form in Medieval Europe 

• Am. Law & Econ. Ass'n annual meeting, Harvard Law Sch., Cambridge, Mass., May 

5,2007 . 

Privatization and the Effectiveness of Monitoring Agencies 

• Law & Economics Workshop, Harvard Law Sch., Cambridge, Mass., Apr. 12,2007 

Privatization and the Effectiveness of Monitoring Agencies 

• Privatization of U.S. National Security (Geo. Inst. for lnt'l L. & Politics), 

Georgetown Univ., Washington, D.C., Mar. 20, 2007 

The Economic Theory of Privatization 

• Law & Economics workshop, George Washington Law Sch., Washington, D.C., 

Mar. 19,2007 

Privatization and the Law and Economics of Political Advocacy 

• Georgetown Univ. Law Ctr. faculty workshop, Washington, D.C., Feb. 13,2007 

Privatization and the Law and Economics of Political Advocacy 

• Federalist Soc'y Faculty Conference, Washington, D.C., Jan. 5, 2007 

Privatization and the Law and Economics of Political Advocacy 

• Georgetown Univ. Law Ctr. Federalist Soc'y, Washington, D.C., Oct. 3, 2006 

Privatization and the Lmv and Economics of Political Advocacy 

• Georgetown Univ. Law Ctr. faculty workshop, Washington, D.C., Apr. 24, 2006 

Privatization and the Effectiveness of Monitoring Agencies 

• Am. Enter. Inst. for Pub. Pol'y Res., Washington, D.C., May 26, 2004 

Did Workers Pay for the Expansion of Products Liability Lmv? 

• Cornell Cos. meeting, Houston, Tex., Apr. 14,2003 

A Tale of Two Systems: Cost, Quality, and Accountability in Private Prisons 

A-9 
Renewed Resp. Motion for Leave

Exh. RX-H

PUBLIC DOCUMENT

• Ass'n of Private Correctional & Treatment Orgs. meeting, Charlotte, N.C., Jan. 12, 

2003 

A Tale of Two Systems: Cost, Quality, and Accountability in Private Prisons 

• Beyond Columbine (Independence Inst.), Denver, Colo., Aug. 20, 1999 

School Violence Prevention: Strategies to Keep Schools Safe 

• lost. for Humane Studs. conference, Los Angeles, Calif., June 20, 1999 

Talk on environmental policy 

• lnst. for Humane Studs. conference for college student newspaper editors, Washington, D.C., Apr. 18, 1999 

Talk on environmental policy 

• Liberty & Society (lost. for Humane Studs.), Pitzer College, Claremont, Calif., June 

25, 1998 

Talk on enviromnental policy 

• Le Lycee Fran9ais de Los Angeles, commencement ceremony, June 15, 1998 

Talk on education policy 

• La Cumbre Country Club, Santa Barbara, Calif., Mar. 4, 1998 

Talk on school violence 

• San Diego Libertarian Party meeting, Jan. 10, 1998 

Race to the Top: The Innovative Face of State Environmental Manageme,nt 

• Race to the Top (Reason Pub. Pol'y lost. & Nat'! Envt'l Pol'y lost.), Washington, 

D.C., Nov. 20, 1997 

Introductory comments at conference 

• Institute Libertad y Desarrollo meeting, Santiago, Chile, Nov. 12, 1997 

25 Aiios de Regulacion Ambiental en EE. UU.: Lecciones para Chile (Spanish) 

• Fundaci6n Alberdi public meeting, Mendoza, Argentina, Nov. 10, 1997 

Talk on recycling and solid waste 

• Medio Ambiente Urbano, Fundaci6n de Empresas' III Congreso Internacional, C6rdoba, Argentina, Nov. 7, 1997 

Talk on recycling and solid waste 

• Electronic Industries Ass'n meeting, San Francisco, Calif., Oct. 6, 1997 

Talk on advance disposal fees 

• Alamar/Hope Ranch Republican Women's Club, Santa Barbara, Calif., May 16, 1997 

Talk on recycling and solid waste 

• Crescenta Valley High School (La Crescenta, Calif.), Mar. 18, 1997; Oct. 31, 1997; 

Feb. 17, 1998; Apr. 16, 1998 

Talks on literature, poetry, and Advanced Placement English Literature exam preparation 

• U.S. Environmental Protection Agency, Office of Enforcement and Compliance Assurance, San Francisco, Calif., March 17, 1997 

Testimony on the National Performance Measures Strategy 

• A Safe Environment for Big Cities on the Threshold of the 21st Century 

(3KoJmrnqecKn 6e3onacHa.ll cpe.ua o6nTaHnll 60JlbliiiiX ropo,uos Ha nopore XXI 

seKa) (UrbanEco 97 (American-Russian conference)), San Diego, Calif., Feb. 4-6, 

1997 

Twenty-Five Years of Environmental Legislation: What Americans Have Learned 

A-10 
Renewed Resp. Motion for Leave

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PUBLIC DOCUMENT

(J{eaOI{amb-nJlnlb 11em 3aKOHOOamenbcmea o6 oxpaue oKpy:NCa/Otl{eu cpeObr: 'leMy 

uay'IWIUCb aAtepuKaHIJbl) (Russian) 

• Le Lycee Fran9ais de Los Angeles, Dec. 17, 1996 

Talk on envirorunental policy 

• Los Angeles City Council, Dec. 11, 1996 

Testimony on environmental justice 

• International Polyester Week, Jamesburg, N.J., Oct. 7-10, 1996 

The FDA vs. Recycling: Has Food Packaging Law Gone Too Far? 

• Los Angeles City Planning Comm'n, Aug. 8, 1996 

Testimony on environmental justice 

• Steel Mill Wastes and By-Products conference, Pittsburgh, Penn., June 24-26, 1996 

Men of Steel, Regulations of Kleenex: How RCRA Has Recyclers Running Around in 

CERCLAs 

• North Hollywood High School Zoo Magnet Center, Apr. 23, 1996 

Talk on environmental policy 

• Liberty Tree Convention (Repub. Liberty Caucus), Santa Barbara, Calif., Nov. 11, 

1995 

Moderated panel on affirmative action 

• Conversations About Freedom (The New York Society for International Affairs, Inc. 

and Libertad, Inc.), The Aspen Institute, Wye, Md., Oct. 30, 1994 

Panelist, Round Table Conversation: The Media, the Arts and Entertainment: The 

Need to Preserve Freedom 

Minor Non-Academic Activities 

(Popular Press, Interviews, Media Appearances, etc.) 

Privatization I Public Employees 

• Pension Protection and the Detroit Bankruptcy, REASON.ORG, Apr. 2, 2014, http:// 

reason.org/newslshow/volokh-detroit-pension-protection 

• Eliminate the State's 'Rule 'for Pensions?, L.A. DAILY J. (& S.F. DAILY J.), Feb. 21, 

2014, at 1 

• The Constitutional Protection of Public-Employee Pensions, REASON.ORG, Feb. 19, 

2014, http://reason.org/news/show/pensions-california-rule 

• Philosophical Objections to Prison Privatization, REASON.ORG, Nov. 26,2013, 

http://reason.org/news/show/israeli-private-prison-ruling 

• Privatization and the Constitutional Delegation of Coercive Power in Germany, 

REASON.ORG, Oct. 30, 2013, http://reason.org/newslshow/privatization-delegationgermany 

• The Revival of the Contract Clause, REASON.ORG, Sept. 25, 2013, http://reason.org/ 

news/show/pensions-contract-clause 

• A New Private Delegation Doctrine?, REASON.ORG, Aug. 1, 2013, http://reason.org/ 

news/show/private-delegation-doctrine-amtrak 

• Privatized Regulation and Antitrust, REASON.ORG, July 1, 2013, http://reason.org/ 

news/show/privatized-regulation-and-antitrust 

A-ll 
Renewed Resp. Motion for Leave

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PUBLIC DOCUMENT

• Implications of the Louisiana Supreme Court Voucher Ruling, REASON.ORG, June 4, 

2013, http://reason.org/news/show/louisiana-supreme-court-vouchers 

• Are Federal Contractors Immunefi·om Tort Suits Just Because the Government Is?, 

REASON.ORG, May 9, 2013, http://reason.org/news/show/government-contractorimmunity 

• Recent Developments in the Federal Civil-Rights Liability of Federal Private Prisons, in REASON FOUNDATION, ANNUAL PRIVATIZATION REPORT 2013 (Leonard Gilroy & Harris Kenny eds.), May 6, 2013, http://reason.org/news/show/apr-2013-

federal-liability-prisons 

• Supreme Court Clarifies Standards for Qualified Immunity in Civil Rights Cases-Or 

Does It?, REASON.ORG, Apr. 5, 2013, http://reason.org/news/show/privatizationqualified-immunity 

• What a Recent Labor-Relations Decision Teaches Us About the Meaning of "Public" 

and "Private", REASON.ORG, Mar. 21, 2013, http://reason.org/news/show/nlrbpublic-private 

• Supreme Court Antitrust Ruling Supports Public-Private Neutrality, Reduces Barriers to Privatization, REASON.ORG, Feb. 21,2013, http://reason.org/news/show/ 

scotus-antitrust-privatization 

• appeared on WGCL-TV (CBS, Atlanta) on Atlanta public transit privatization, Sept. 

27,2012 

• interviewed on a radio station in San Antonio on school violence, May 4, 1999 

• School Choice Could Help Alleviate Violence, WALL ST. J., Apr. 29, 1999 

• interviewed on a radio station in Lincoln, Neb., on school violence, Dec. 12, 1997 

• Environmental Regulation, in WILLIAM D. EGGERS ET AL., PRIVATIZATION 1997: A 

COMPREHENSIVE REPORT ON CONTRACTING, PRIVATIZATION, AND GOVERNMENT REFORM 

• Private Consultants Clean Up Brownfields: State Environmental Agencies Lighten 

Their Loads, PRIVATIZATION WATCH, Nov. 1997 

• "Welcome Back, Otter": Private-Sector Species Preservation, PRIVATIZATION WATCH, 

Oct. 1997 

• Water-Users Take Control of Montana Conservation Projects, PRIVATIZATION WATCH, 

Sept. 1997 

• Massachusetts Moves Toward Environmental Compliance Privatization, PRIVATIZATIONWATCH,Aug. 1996 

• Southern California Air Dish'ict Partially Privatizes Permitting Program, PRIVATIZATION WATCH, Aug. 1996 

• Jersey City Privatizes Water Department, PRIVATIZATION WATCH, July 1996 

• Highway Departments Move Ahead with Pe1jormance Standards, PRIVATIZATION 

WATCH, June 1996 

• States Encourage Private Environmental Compliance, PRIVATIZATION WATCH, June 

1996 

• FDA May Contract Out Drug and Device Approvals, PRIVATIZATION WATCH, July 

1995 

Environment I Solid Waste am/ Recycling 

• Is Recycling Good or Bad-or Both?, CONSUMERS' RES., Sept. 1997 
Renewed Resp. Motion for Leave

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PUBLIC DOCUMENT

• Recycling and Deregulation: Opportunities for Mmfet Development, RESOURCE RECYCLING, Sept. 1996 

• FDA Rules Impede Recycling, PLASTICS NEWS, May 20, 1996 

• Environment Might Benefit by Easing Waste Rule, PATRIOT (Harrisburg, Pa.), May 17, 

1996, also appem·ed in EVENING NEWS (Harrisburg, Pa.), May 17, 1996 

• Food Packaging Needs Speedier FDA OKs, PLASTICS NEWS, May 13, 1996 

• Is the Govemment Discouraging Recycling?, DAILY J. (Devils Lake, N.D.), Apr. 22, 

1996, also appem·ed in INDEPENDENT (Gallup, N.M.), Apr. 25, 1996; BG NEWS 

(Bowling Green, Ohio), Apr. 26, 1996; MARTINEZ (CALIF.) NEWS-GAZETTE, Aug. 8, 

1996 

• Bureaucracy Cm1 Be a Barrier to Use of Recycled Materials, PLASTICS NEWS, Mar. 25, 

1996 

• Can Anybody Understand Our Hazardous Waste Law?, SANTA BARBARA NEWSPRESS, Jan. 21, 1996 

• Vague Food Packaging Laws Hurt Recycling, FROZEN FOOD AGE, Dec. 1995 

• Intervention Is No Friend of the Earth, ROANOKE (VA.) TIMES, Nov. 26, 1995, also 

appeared in BRYAN-C. STATION (TEX.) EAGLE, Oct. 27, 1995; DAILY PROGRESS 

(Charlottesville, Va.), Nov. 26, 1995; MONROE{MICH.)EVENINGNEWS, Dec. 1, 1995; 

ANTELOPE VALLEY DESERT MAILER NEWS, Jan. 23, 1996 

Environment I General 

• Shades ofGreen, REASON, May 1998 

• interviewed in Felix lbafiez S., Libre Mercado: Protector del Medio Ambiente (Spanish), EL MERCURIO (Santiago, Chile), Nov. 19, 1997, at B26 

• 25 A nos de Regulacion Ambiental en EE. UU.: Lecciones para Chile (Spanish), Programa de Medio Ambiente Libertad y Desarrollo, Temas Ambientales No. 8, Oct. 

1997 

• Carrots over Sticks, WASH. MONTHLY, June 1997 

• Privileges and Immunities, CAROLINA Bus., Feb. 1997 

• The "Regulat01y Cuckoo Land," ORANGE COUNTY REG., Oct. 27, 1996, also appeared 

in J. COM., Oct. 24, 1996; BRIDGE NEWS, Oct. 17, 1996; EVANSVILLE(IND.) PRESS, 

Oct. 23, 1996; APPLETON (WIS.) POST-CRESCENT, Oct. 26, 1996; BIRMINGHAM (ALA.) 

NEWS, Oct. 27, 1996; DAILY PRESS (Newport News, Va.), Oct. 27, 1996 

• Environmental Goals Suffer When Right-to-Know Laws Go Wrong, GREATERMILWAUKEEBUS. J., Oct. 5, 1996 

• Whallo Do About Punitive Damages, INVESTOR'S BUS. DAILY, Aug. 7, 1996 

• spoke on the environment to high school students, North Hollywood High School 

Zoo Magnet Center, Apr. 23, 1996 

• Tastes Great! More Polluting!, REASON, Jan. 1996, also appeared in L.A. DAJLY J., 

Dec. 14, 1995; S.F. DAILY J., Dec. 14, 1995 

• Nature's Nature, REASON, July 1995 (reviewing GREGG EASTERBROOK, A MOMENT 

ON THE EARTH: THE COMING AGE OF ENVffiONMENTAL OPTIMISM (1995)) 

• How Green Is Our Valley?, REASON, Mar. 1995 (reviewing PETER MARsHALL, NATURE'S WEB: RETHINKING OUR PLACE ON EARTH (lstU.S. ed. 1994), WALLACE 

KAUFMAN, No TURNING BACK: DISMANTLING THE FANTASIES OF ENVIRONMENTAL 

THINKING ( 1994), and CHARLES T. RUBIN, THE GREEN CRUSADE: RETHINKING THE 

ROOTS OF ENVIRONMENTALISM (1994)) 

A-13 
Renewed Resp. Motion for Leave

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PUBLIC DOCUMENT

• Ban Chlorine? Let's Hope EPA Steers Clear of Fuzzy Logic, KNIGIIT -RlDDER FIN. 

NEWS, Sept. 9, 1994 

• Jefferson Group Weighs Risk, CEI UPDATE, Feb. 1994 

• Don't Apply Human Morality to Amorality of Nature, UCLA DAILY BRUIN, Jan. 19, 

1990 

• see also articles under "Privatization" 

Food ami Drug Law 

• Feel a Heart Attack Coming? Go to France, WALL ST. J., Aug. 2, 1994, reprinted in 

CPR INNOVATOR, 4th Quarter 1994 

• Pruning the FDA, NAT'LREV., Aug. 11, 1997 

• Software Pirates, REASON, Nov. 1997 

• appeared on the show Pork on the TV charme1 America's Talking, Dec. 25, 1995 

• Clinical Trials: Beating the FDA in Court, REASON, May 1995 

• Food und Drang Administration (response to letters), REASON, Aug./Sept. 1995 

• Comparable Hurt, REASON, Feb. 1995 

• Left to Their Own Devices, REASON, Jan. 1995 

• Leaving Us to Our Own Devices, RT: J. RESPIRATORY CARE PRAC., Dec./ Jan. 1995 

• Kessler s Clever Mm1euvers "Saved" US. Drug Regulator, BRIDGE NEWS, Dec. 10, 

1996, also appeared in SUNDAY PRESS DISPATCH (Victorville, Calif.), Dec. 15, 1996; 

HIGH POINT (N.C.) ENTERPRISE, Dec. 16, 1996; ASHEVILLE (N.C.) CITIZEN-TIMES, 

Dec. 16, 1996; SUNDAY SUN-JOURNAL (Lewiston, Me.), Dec. 22, 1996 

• Case of Sour Grapes Shows Suing the FDA Doesn 'I Pay, KNIGIIT-RIDDER FIN. NEWS, 

Jan.4, 1996 

• Without a Cure, DEFENDER, July 1995 

• Is the FDA Saving or Costing Lives?, OAKLAND TRIB., Apr. 18, 1995 

• Udder Nonsense, CEI UPDATE, Apr. 1994 

• see also food packaging articles under "Environment I Solid Waste and Recycling" 

• see also article under "Privatization" 

Tobacco and Alcohol 

• Kessler's a Drag, WALL ST. J., Aug. 8, 1995, reprinted in ANNETTE T. ROTTENBERG, 

ELEMENTS OF ARGUMENT: A TEXT AND READER (5th ed. 1996) 

• Rights Advocates Should Toast "44 Liquormm·t" Ruling, L.A. DAILY J., June 18, 1996, 

also appeared in DAILY RECORDER (Sacrarnento, Calif.), July 2, 1996 

• Ad Bans Are a Bad Idea, SAN M.ARINO (CALIF.) TRIB., Aug. 31, 1995, also appeared in 

CfllCO (CALIF.) ENTERPRISE-REC., Sept. 3, 1995; ROME (GA.) NEWS-TRIB., Sept. 10, 

1995; PASADENA (CALIF.) WKLY., Sept. 15, 1995; HERALD SUNDAY (Portsmouth, 

N.H.), Jan. 14, 1996 

• interviewed on WJR radio (Detroit, Mich.), Aug. 8, 1995 

• Lighten Up, CEI UPDATE, July 1994 

• Safety Is a Relative Thingfor Cars; Why Not for Cigm·ettes?, ADVERTISING AGE, Jan. 

31, 1994 

• Alcohol and the Heart: A Review of the Literature, in Petition of the Competitive Enterprise Institute to the Bureau of Alcohol, Tobacco and Fireanns for a rule allowing alcoA-14 
Renewed Resp. Motion for Leave

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holic beverage labels to cany statements on the health benefits of moderate consumption 

(May 9, 1995) (co-written with Sam Kazman and Ben Liebennan) 

Education/ Race I Affirmative Action 

• Lmv Review Has Strong Leadership, HARV. L. RECORD, Oct. 23,2003 

• Lmv Review Alums Respond to Law Review Alums, HARV. L. RECORD, Oct. 9, 2003 

(co-written with I. Glenn Cohen, Adam Raviv, and Matthew Stephenson) 

• Relax, Then Respond Intelligently to Fielding, HARV. L. RECORD, Feb. 9, 2001 

• Quotas in India Have Yet to Create Harmony, L.A. DAILY J., Nov. 5, 1996 

• Mr. Smith Goes to Sacramento, DEFENDER, Jan./Feb. 1996 

• interviewed about race relations at universities, Which Way, L.A.?, KCRW radio (Los 

Angeles, Calif.), Nov. 1, 1995 

• Students Can, and Should, Get Their Money Refunded, UCLA DAILY BRUIN, Oct. 2, 

1995 

• How Race Adds Up for UCLA Enfly, L.A. TIMES, July 18, 1995 (co-written with 

Shechao Charles Feng), reprinted in J. BLACKS HIGHER EDUC., Autumn 1995 

• Chicanalo Vandalism!, UCLA DAILY BRUIN, May 18, 1993 

• Syllabus Confl·oversy Unjustified, UCLA DAILY BRUIN, Apr. 22, 1993 

• intern, ExCEL (Excellent through Choice in Education League) (Spring 1992) 

• see also articles under "Privatization" 

Libertarianism I Free Market I Property Rigltts 

• Interview, KOSMOS, Oct. 29,2010, http://www.kosmosonline.org/group-post/ 

interview-sasha~vo1okh 

• Cult of Capitalism Deserves More Than Ginn's Short Shrift, HARV. L. RECORD, Sept. 

14,2001 

• Letter Author Knocks on Matt Wood, HARV. L. RECORD, Nov. 10, 2000 

• As Martin Luther King Jr. Knew, Freedom Drives a Car, BRIDGE NEWS, Jan. 15, 1997, 

also appeared in CORVALLIS (OR.) GAZETIE-TIMES, Jan. 24, 1997 

• Money Fuels Freedom at the Core of American Society, UCLA DAILY BRUIN, Oct. 3, 

1996 

• Quasimodo, Property and Sanctumy, MIDDLETOWN (Omo) J., Aug. 8, 1996, also 

appeared in MIAMI (OKLA.) NEWS-REC., July 30, 1996; OSHKOSH (WIS.) NW., Aug. 4, 

1996; SAN MATEO COUNTY TIMES, Aug. 12, 1996; DAILY REV. (Hayward, Calif.), 

Aug. 12, 1996; TRI-VALLEY HER&D (Pleasanton & Danville, Calif), Aug. 12, 1996; 

ARGUS (Fremont, Calif.), Aug. 12, 1996; NIAGARA GAZETIE (Niagara Falls, N.Y.), 

Aug. 13, 1996; TEX. CITY SUN, Aug. 18, 1996; CULPEPPER (VA.) STAR-EXPONENT, 

Aug. 19, 1996; VALLEY MORNING STAR (Harlingen, Tex.), Aug. 25, 1996 

• 1995 FEDERAL DISASTER CALENDAR: A MONTHLY COMPENDIUM OF GOVERNMENT~ 

SPONSORED FIASCOS, FROM THE IDIOTIC TO THE CATASTROPHIC (Competitive Enter. 

Inst. 1994) 

• THE VIRTUAL HAND: CEI'S FREE-MARKET GUIDE TO THE INFORMATION 

SUPERHIGHWAY (Competitive Enter. Inst. 1994) 

GilliS 

• Lock and Load: Protecting Individual Rights, Preserving Freedom, Saving Lives, 

HARV. INDEP., Nov. 14,2002 
Renewed Resp. Motion for Leave

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• Target Shooting Club Founder Urges More Gun Debates, HARV. L. RECORD, Sept. 

12,2002 

• interviewed on Simply Put, Bloomberg radio network, Apr. 27, 2002 

• founder and president, Harvard Law School Target Shooting Club (2001-{)3) 

Free Speech 

• Paper Lion: Why the Supreme Court Must Overturn TV Restrictions, E-NET, July 24, 

1996 

• Censoring the Louvre? Congress Just Might, E-NET, Dec. 20, 1995 

• see also items under "Tobacco and Alcohol" 

Religion 

• Faithfiillncentives, REASON, Nov. 1997 

• Hollywood, God Don't Mix, CINCINNA'n ENQUIRER, Sept. 28, 1997, also appeared in 

BRJDGE NEWS, Sept. 19, 1997; JUNEAU EMPIRE, Sept. 24, 1997; ASHEVILLE (N.C.) 

CITIZEN-TIMES, Sept. 24, 1997; STAMFORD(CT.)ADVOCATE, Sept. 26, 1997; 

GREENWICH (CT.) TIME, Sept. 26, 1997; KENTUCKY ENQUIRER, Sept. 28, 1997; DAILY 

RECORD (Morristown, N.J.), Sept. 28, 1997; TALLAHASSEE DEMOCRAT, Sept. 28, 1997; 

SAN BERNARDINO (CALIF.) SUN, Oct. 12, 1997 

Russia I Soviet Union 

• Ushka Comes to Shove, NEW REP., Sept. 13, 1993 

• America OJJ.ers New Beginning, UCLA DAILY BRUIN, Feb. 5, 1993 

• Gorbachev Doesn't Deserve Peace Prize, UCLA DAILY BRUIN, Oct. 22, 1990 

• Glasnost: A Volokh 's View, LE PETIT JOURNAL, Apr. 1988, p. I 5 

Art & Literature 

• ALEXANDER PUSHKIN: NEW TRANSLATIONS (trans. from Russian to English, 1999) 

• TROIS ESSAIS SUR CHALIAPINE (trans. from Russian to French, 1998) 

• performed in UCLA English Dept.'s marathon reading of Charles Dickens's Bleak 

House, May 9, 1997 

• THE OCCASIONAL SCREENFUL, online poetry journal (co-edited with Eugene Volokh, 

1995-96) 

• performed in Gilbe1t & Sullivan's Patience, Georgetown Gilbert & Sullivan Soc., Mar. 

1994 & Apr. 11,2007 

• co-founder, Univ. ofMd. Chaucer Reading Group ( 1993-94) 

• Song of the Young Paleontologist, 262 SCIENCE 1511 (n.s.) ( 1993) 

• WESTWIND: UCLA'S JOURNAL OF THE ARTS (senior ed. & contributor, vol. 36, 1993) 

• president, UCLA Chaucer Reading Group (1991-93) 

Miscellaneous 

• co-blogger on THE VOLOKH CONSPIRACY, volokh.com, 2002-present 

• Graduate Summer Research Fellow, lnst. for Humane Studs. (Summer 2002) 

• appeared on JEOPARDY! (ABC television), Nov. 9, 1996 

• Old Friend Provides Lasting Words of Wisdom, UCLA SUMMER BRUIN, July 24-30, 

1995 

• newsletter editor, UCLA Regents Scholars Society (1992-93) 

A-16 
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• parliamentarian, Bruin Republicans ( 1992- 93) 

• grader, UCLA Dep't of Mathematics (1992-93) 

• Viewpoint: Who's [sic] Point ofView?, UCLA DAILY BRUIN, Sept. 29, 1992 

• membership director, Bruin Republicans (1991-92) 

• lecture note taker, Associated Students UCLA ( 1990-92) 

• A Brief Hist01y of Greek Philosophy, LE PETIT JOURNAL, May 1990, p. 10 

Languages 

• Fluent in French and Russian 

• Somewhat fluent in Spanish and German 

• Reading knowledge of Italian, Latin, Middle English, and Esperanto 
Resp. Renewed Mot. for Leave 

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RESPONDENT 

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SUBPOENA DUCES TECUM 

Provided by the Secretary of the Federal Trade Commission, and 

Issued Pursuant to Commission Rule 3.34(b), 16 C.F.R. § 3.34(b)(2010) 

Dr. Stephen McCarthy 

Dept. of Plastics Engineering 

University of Massachusetts Lowell 

One University Avenue, Office, Ball 207 

Lowell, MA 01854 

2. FROM 

UNITED STATES OF AMERICA 

FEDERAL TRADE COMMISSION 

This subpoena requires you to produce and permit inspection and copying of designated books, documents (as defined in 

Rule 3.34(b)), or tangible things, at the date and time specified in Item 5, and at the request of Counsel listed in Item 9, in 

the proceeding described in Item 6. 

3. PLACE OF PRODUCTION 

Emard & Associates, P.C. 

3210 South Gilbert Road, Suite 4 

Chandler, AZ 85286 

6. SUBJECT OF PROCEEDING 

4. MATERIAL WILL BE PRODUCED TO 

Peter Arhangelsky 

5. DATE AND TIME OF PRODUCTION 

July 25, 2014, 5:00PM EST 

In the matter of ECM BioFilms, Inc., Docket No. 9358 

7. MATERIAL TO BE PRODUCED 

See Attached Schedule A for description of all documents and materials. 

8. ADMINISTRATIVE LAW JUDGE 

Chief Administrative Law Judge 

D. Michael Chappell 

Federal Trade Commission 

Washington, D.C. 20580 

9. COUNSEL AND PARTY ISSUING SUBPOENA 

Jonathan W. Emard, Peter Arhangelsky, Eric 

Awerbuch 

Emard & Associates, P.C. for Respondent, 

ECM BioFilms, Inc. 

DATE SIGNED SIGNATURE OF COUNSEL ISSUING SUBPOENA 

July 7, 2014 v 

GENERAL INSTRUCTIONS 

APPEARANCE 

The delivery of this subpoena to you by any method 

prescribed by the Commission's Rules of Practice is 

legal service and may subject you to a penalty 

imposed by law for failure to comply. 

MOTION TO LIMIT OR QUASH 

The Commission's Rules of Practice require that any 

motion to limit or quash this subpoena must comply with 

Commission Rule 3.34(c), 16 C.F.R. § 3.34(c), and in 

particular must be filed within the earlier of 10 days after 

service or the time for compliance. The original and ten 

copies of the petition must be filed before the 

Administrative Law Judge and with the Secretary of the 

Commission, accompanied by an affidavit of service of 

the document upon counsel listed in Item 9, and upon all 

other parties prescribed by the Rules of Practice. 

FTC Form 70-E (rev. 1/97) 

TRAVEL EXPENSES 

The Commission's Rules of Practice require that fees and 

mileage be paid by the party that requested your appearance. 

You should present your claim to counsel listed in Item 9 for 

payment. If you are pennanently or temporarily living 

somewhere other than the address on this subpoena and it 

would require excessive travel for you to appear, you must get 

prior approval from counsel listed in Item 9. 

A copy of the Commission's Rules of Practice is available 

online at http://bit lylfTCRulesofPractjce. Paper copies are 

available upon request 

This subpoena does not require approval by OMB under 

the PapeiWOrk Reduction Act of 1980. 
1

SCHEDULE “A” TO SUBPOENA DUCES TECUM DIRECTED TO 

DR. STEPHEN MCCARTHY 

INSTRUCTIONS 

A. Documents must be delivered to Counsel for Respondent at the following address: 

Emord & Associates, P.C., 

3210 South Gilbert Road, Suite 4 

Chandler, AZ 85286 

B. A complete copy of each document should be submitted even if only a portion of the 

document is within the terms of the numbered request. The document shall not be edited, cut 

or expunged and shall include all covering letters and memoranda, transmittal slips, 

appendices, tables or other attachments. 

C. All information submitted shall be clearly and precisely identified as to the numbered 

request(s) to which it is responsive. Pages in the submission should be numbered 

consecutively, and each page should be marked with a unique “Bates” document tracking 

number. 

D. Documents covered by these numbered requests are those which are in your possession or 

under your actual or constructive custody or control, whether or not such documents were 

received from or disseminated to any other person or entity, including attorneys, accountants, 

directors, officers and employees. 

E. Documents that may be responsive to more than one numbered request need not be submitted 

more than once. However, your response should indicate, for each document submitted, each 

numbered request to which the document is responsive. Identification shall be by the Bates 

number if the documents(s) were so numbered when submitted or by author and subject 

matter if not so numbered. 

F. Documents that have already been produced to ECM need not be submitted again. However, 

your supplemental response should indicate, for each document previously submitted, each 

numbered request to which the document is responsive. Identification shall be by the Bates 

number if the documents(s) were so numbered when submitted or by author and subject 

matter if not so numbered. 

G. If any of the documentary materials requested in these numbered requests are available in 

machine-readable form (such as CD, DVD, hard disks, drums, core storage, magnetic tapes, 

etc.), state the form in which it is available and describe the type of computer or other 

machinery required to read the documents involved. If the information requested is stored in 

a computer or a file or record generated by a computer, indicate whether you have an existing 

program that will print the information in readable form and state the name, title, business 

address and telephone number of each person who is familiar with the program. Files should 

otherwise be produced in native format. 

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2

H. All objections to these numbered requests, or to any individual request, must be raised in the 

initial response or otherwise waived. 

I. The Federal Trade Commission’s Rules of Practice describes withholding requested material 

responsive to a subpoena under Rule 3.38A For your convenience, Rule 3.38A states: 

(a) Any person withholding material responsive to a subpoena 

issued pursuant to §3.34 or §3.36, written interrogatories requested 

pursuant to §3.35, a request for production or access pursuant to 

§3.37, or any other request for the production of materials under 

this part, shall assert a claim of privilege or any similar claim not 

later than the date set for production of the material. Such person 

shall, if so directed in the subpoena or other request for production, 

submit, together with such claim, a schedule which describes the 

nature of the documents, communications, or tangible things not 

produced or disclosed - and does so in a manner that, without 

revealing information itself privileged or protected, will enable 

other parties to assess the claim. The schedule need not describe 

any material outside the scope of the duty to search set forth in 

§3.31(c)(2) except to the extent that the Administrative Law Judge 

has authorized additional discovery as provided in that paragraph. 

(b) A person withholding material for reasons described in 

§3.38A(a) shall comply with the requirements of that subsection in 

lieu of filing a motion to limit or quash compulsory process. 

J. The Federal Trade Commission’s Rules of Practice describes motions to quash and/or limit 

subpoenas under Rule 3.34(c). For your convenience, Rule 3.34 states in relevant part: 

(c) Motions to quash; limitation on subpoenas. Any motion by the 

subject of a subpoena to limit or quash the subpoena shall be filed 

within the earlier of 10 days after service thereof or the time for 

compliance therewith. Such motions shall set forth all assertions of 

privilege or other factual and legal objections to the subpoena, 

including all appropriate arguments, affidavits and other 

supporting documentation, and shall include the statement required 

by §3.22(g). Nothing in paragraphs (a) and (b) of this section 

authorizes the issuance of subpoenas except in accordance with 

§§3.31(c)(2) and 3.36. 

K. Some documents that you are requested to provide may be confidential. In the Protective 

Order dated October 22, 2013, Chief Administrative Law Judge D. Michael Chappell ordered 

that a party conducting discovery from third parties shall provide such third parties a copy of 

the Protective Order so as to inform third parties of his, her, or its rights. See ALJ Protective 

Order at 2, ¶4. Accordingly, a copy of the Protective Order is attached with this subpoena. 

L. If any requested material is withheld based on a claim of privilege, submit together with such 

claim a schedule of the items withheld. For each item withheld, the schedule should state: (a) 

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3

the item’s type, title, specific subject matter and date; (b) the names, addresses, positions and 

organizations of all authors or recipients of the item; and (c) the specific grounds for 

claiming that the item is privileged. If only part of a responsive document is privileged, all 

non-privileged portions of the document must be submitted. 

DESCRIPTION OF DOCUMENTS REQUESTED 

Please produce the original or copies of the following documents (the term ”documents” 

shall include all records, books of account, worksheets, checks, instructions, specifications, 

manuals, reports, books, periodicals, pamphlets, publications, raw and refined data, memoranda, 

graphs, drawings, notes, lab books, advertisements, list studies, meeting minutes, working 

papers, transcripts, magnetic tapes or discs, punch cards, computer printouts, letters, 

correspondence,1 agreements, drafts of agreements, telegrams, email, drafts, proposals, employee 

records, customer records, log files recommendations, and any other data recorded in readable 

and/or retrievable form, whether typed, handwritten, reproduced, magnetically recorded, coded, 

or in any other ay made readable or retrievable): 

1. All documents received or possessed before engagement as an expert in Docket 

No. 9358 that concern ECM BioFilms, Inc., any past and present employee or principal of ECM, 

and/or the ECM additive. 

2. All documents, materials, correspondence, forms, marketing material, and testing 

used or referenced to form any and all opinions you may offer in this case. 

 1 The term “correspondence” is intended, used, and defined in its broadest sense 

allowable under the FTC Rules of Practice. Such term includes, but is not limited to, emails, 

documents appended to emails, reports and any other written or electronic document of any kind 

that is communicated from the subpoena recipient or its agents to any and all other persons and 

entities. 

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4

3. All contracts, retainers, engagement letters between you and any public or private 

firm that manufactures, sells, and/or produces biodegradable and/or compostable products in 

direct or indirect competition with ECM’s additive technology.

4. All correspondence between you and any public or private firm that manufactures, 

sells, and/or produces biodegradable and/or compostable products concerning: (1) the 

biodegradability of plastics generally; (2) the definition of “biodegradable” generally or in 

context with plastics; or (3) the ability of plastics to biodegrade. 

5. All correspondence, contracts, retainers, data, agreements and other documents 

transmitted to you by, and from you to, Biodegradable Products Institute (BPI), Steve Mojo, or 

any other BPI employee concerning BPI certifications. 

6. All reports, analyses, assessments, tests, related summaries, and conclusions 

issued to any public or private firm that manufactures, sells, and/or produces biodegradable 

and/or compostable products, concerning the ability of such products to biodegrade in landfills or 

composting environments. 

7. All correspondence, contracts, retainers, data, and/or agreements concerning 

research, funding, grants, or studies performed by you during your employment at the University 

of Massachusetts, Lowell (“UMass”) related to Metabolix, Inc. 

8. All correspondence, contracts, retainers, data, and/or agreements concerning 

research, funding, grants, or studies performed by you during your employment at UMass related 

to 3M Corporation. 

9. All copies of receipts, check stubs, bank ledgers, and other documents identifying 

and revealing all payments you have received directly or indirectly from patents for 

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5

biodegradable or compostable polymers concerning patented articles in which you are listed on 

the patent as an inventor. 

10. All pleadings, expert reports, documents, and correspondence related to any law 

suit, administrative proceeding, or arbitration in which you served as a consulting witness or 

expert witness concerning biodegradable polymers and plastics. 

11. All contracts, agreements, memoranda of understanding, correspondence, or 

documents that involve or concern compensation you receive(d) owing to, or stemming from, 

grant or research money paid to UMass. 

12. All studies, reports, and articles, or peer-reviewed literature based on research 

performed under the following research grants at UMass, and listed in your Curriculum Vitae: 

a. Metabolix, “Development of Novel of Biodegradable Materials, 

$1,500,196

b. NSF Center for Biodegradable Polymer Research, $1,200,000 Industrial 

Members (8/93-present), Principal Investigator 

c. Polymer Degradation Research Center, $475,000, Industrial Members 

(8/89-8/93) 

d. Digital, “Plastics Materials Research”, $458,706

e. Metabolix Inc., Performance of PHA Derived Chemicals and Polyols in 

Polyurethane, $141,465 

f. 3M, “Composting Research”, $155,000 

g. Warner Lambert, “Biodegradable Polymer Research”, $116,591

h. National Science Foundation, “Biodegradable Polymer Research Center”, 

$110,000 (8/93-8/95) 

i. Department of the Army, “Polymer Degradation Research”, $104,000

j. Institute for Plastics Innovation, “Injection Molding Research”, $75,000 

k. Massachusetts Centers of Excellence, “Institute for Plastics Innovation”, 

$75,000

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6

l. Metabolix Inc., Performance of Polyhydroxyalkanote Derived Chemicals 

and Polyols in Polyurethane, $71,465 

m. Battelle, “Biodegradable Packaging Development”, $59,865 

n. DuPont Corian, $50,000 

o. Invista, “Evaluation of Plasticizers”, $ 28,000

p. Massachusetts Centers of Excellence, “Polymer Degradation Research”, 

$25,000

13. All correspondence, documents, communications, or information exchanged 

between you and Dr. Ramani Narayan. 

14. All correspondence (not subject to attorney client or work-product privilege and 

received before engagement as an expert in Docket No. 9358) with any employee and/or 

representative of the Federal Trade Commission concerning biodegradable plastics. 

15. All correspondence with any witness, person, and/or consultant used to help form 

any opinion you have in this case. 

16. All documents revealing shares of stock or ownership interests held by you in any 

company involved with plastics, biodegradable products or technologies, and/or compostable 

products or technologies, but excluding any shares of publicly traded securities unless acquired 

or obtained in exchange for services. 

17. All correspondence between you and any private company concerning ECM 

BioFilms. 

18. All documents and correspondence between you and the authors of the article 

Gómez, EF, Michel Jr., FC. “Biodegradability of conventional and bio-based plastics and natural 

fiber composites during composting, anaerobic digestion and long-term soil incubation” Polymer 

Degradation and Stability. Vol. 98 (December 2013): 2583-2591. 

19. All conflict of interest forms or agreements completed or signed by you. 

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7

20. All documents concerning ASTM, including, but not limited to, correspondence 

in which you presented a proposal, voted on a proposal, or opposed a proposal then undergoing 

active consideration by the ASTM. 

21. Regardless of the date, if you have ever served as an expert in any other 

proceeding, copies of all expert reports and testimony given by you in those proceedings. 

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INSTRUCTIONS FOR COMPLIANCE BY DELIVERY OF DOCUMENTS 

If documents are delivered by hand, overnight delivery service, certified mail, or any other 

means your response shall be accompanied by an affidavit, executed by you that provides: 

The names, addresses, positions, and organizations of all persons whose files 

were searched and all persons who participated in or supervised the collection 

of the documents2

, and a brief description of the nature of the work that each 

person performed in connection with the collecting the documents. 

A statement that the search was complete and that responsive documents are 

being produced. 

A statement as to whether the documents were made at or near the time of the 

occurrence of the matters set forth in such documents, kept in the course of 

your regularly conducted business, whether it was your regular practice to 

make and keep such documents, and the custodian of records and/or other 

executive(s) and/or employees of the University of Massachusetts, Lowell 

who have knowledge of such matters, can authenticate the documents and 

materials produced, and who can testify to such matters. 

A statement as to whether any document called for by the subpoena has been 

misplaced, lost or destroyed. If any document has been misplaced, lost, or 

destroyed, identify: type of documents the date (or approximate date) of the 

documents, subject matter of the documents, all persons to whom it was 

addressed, circulated, or shown; its date of destruction, or when it was lost or 

misplaced; the reason it was destroyed, lost or misplaced; and the custodian of 

the documents on the date of its destruction, loss, or misplacement. 

A declaration that states: 

I declare (or certify, verify, or state) under penalty of perjury that the forgoing 

is true and correct. 

Executed on [date]. 

[Signature of party executing the declaration] 

 2 “Document” and “documents” as used in this Attachment are defined in this subpoena’s 

“Description of Documents Requested” section.

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9

 Respectfully submitted, 

/s/ Jonathan W. Emord 

 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

Counsel to ECM BioFilms, Inc. 

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' J 

I 

) 

l 

' I 

I 

·! 

! 

I 

·! 

UNITED STATES OF AMERICA 

FEDERAL TRADE COMMISSION 

OFFICE OF ADMINISTRATIVE LAW JUDGES 

In the Matter of 

ECM BioFilms, Inc., 

a corporation, also d/b/a 

Enviroplastics International, 

Respondent. 

) 

) 

) 

) 

) 

) 

) 

......... 

DOCKETNO. 9358 

PROTECTIVE ORDER GOVERNING DISCOVERY MATERIAL 

Commission Rule 3 .31 (d) states: "In order to protect the parties and third parties 

against improper use and disclosure of confidential information, the Administrative Law 

Judge shall issue a protective order as set forth in the appendix to this section." 16 C.F.R. 

§ 3.3l(d). Pursuant to Commission Rule 3.3l(d), the protective order set forth in the 

appendix to that section is attached verbatim as Attachment A and is hereby issued. 

ORDERED: 

D. Micila'el C aeil 

Chief Administrative Law Judge 

Date: October 22, 2013 
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ATTACHMENT A 

For the purpose of protecting the interests of the parties and third parties in the 

above-captioned matter against improper use and disclosure of confidential information 

submitted or produced in connection with this matter: 

IT IS HEREBY ORDERED THAT this Protective Order Governing 

Confidential Material ("Protective Order") shall govern the handling of all Discovery 

Material, as hereafter defmed. 

1. As used in this Order, "confidential material" shall refer to any document or portion 

thereof that contains privileged, competitively sensitive information, or sensitive personal 

information. "Sensitive personal information" shall refer to, but shall not be limited to, 

an individual's Social Security number, taxpayer identification number, financial account 

number, credit card or debit card number, driver's license number, state-issued 

identification number, passport number, date of birth (other than year), and any sensitive 

health information identifiable by individual, such as an individual's medical records. 

"Document" shall refer to any discoverable writing, recording, transcript of oral 

testimony, or electronically stored information in the possession of a party or a third 

party. "Commission" shall refer to the Federal Trade Commission ("FTC"), or any of its 

employees, agents, attorneys, and all other persons acting on its behalf, excluding persons 

retained as consultants or experts for purposes of this proceeding. 

2. Any document or portion thereof submitted by a respondent or a third party during a 

Federal Trade Commission investigation or during the course of this proceeding that is 

entitled to confidentiality under the Federal Trade Commission Act, or any regulation, 

interpretation, or precedent concerning documents in the possession of the Commission, 

as well as any information taken from any portion of such document, shall be treated as 

confidential material for purposes of this Order. The identity of a third party submitting 

such confidential material shall also be treated as confidential material for the purposes of 

this Order where the submitter has request~d such confidential treatment. 

3. The parties and any third parties, in complying with informal discovery requests, 

disclosure requirements, or discovery demands in this proceeding may designate any 

responsive document or portion thereof as confidential material, including docwnents 

obtained by them from third parties pursuant to discovery or as otherwise obtained. 

4. The parties, in conducting discovery from third parties, shall provide to each. third 

party a copy of this Order so as to inform each such third party of his, her, or its rights 

herein. 

5. A designation of confidentiality shall constitute a representation in good faith and after 

careful determination that the material is not reasonably believed to be already in the 

public domain and that counsel believes the material so designated constitutes 

confidential material as defined in Paragraph 1 of this Order. 

2 
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6. Material may be designated as confidential by placing on or affixing to the document 

containing such material (in such manner as will not interfere with the legibility thereof), 

or if an entire folder or box of documents is confidential by placing or affixing to that 

folder or box, the designation "CONFIDENTIAL - FTC Docket No. 9358" or any other 

appropriate notice that identifies this proceeding, together with an indication of the 

portion or portions of the document considered to be confidential material. Confidential 

information contained in electronic documents may also be designated as confidential by 

placing the designation "CONFIDENTIAL - FTC Docket No. 9358" or any other 

appropriate notice that identifies this proceeding, on the face of the CD or DVD or other 

medium on which the document is produced. Masked or otherwise redacted copies of 

documents may be produced where the portions deleted contain privileged matter, 

provided that the copy produced shall indicate at the appropriate point that portions have 

been deleted and the reasons therefor. 

7. Confidential material shall be disclosed only to: (a) the Administrative Law Judge 

presiding over this proceeding, personnel assisting the Administrative Law Judge, the 

Commission and its employees, and personnel retained by the Commission as experts or 

consultants for this proceeding; (b) judges and other court personnel of any court having 

jurisdiction over any appellate proceedings involving this matter; (c) outside counsel of 

record for any respondent, their associated attorneys and other employees of their law 

finn(s), provided they are not employees of a respondent; (d) anyone retained to assist 

outside counsel in the preparation or hearing of this proceeding including consultants, 

provided they are not affiliated in any way with a respondent and have signed an 

agreement to abide by the terms of the protective order; and (e) any witness or deponent 

who may have authored or received the information in question. 

8. Disclosure of confidential material to any person described in Paragraph 7 of this 

Order shall be only for the purposes of the preparation and hearing of this proceeding, or 

any appeal therefrom, and for no other purpose whatsoever, provided, however, that the 

Commission may, subject to taking appropriate steps to preserve the confidentiality of 

such material, use or disclose confidential material as provided by its Rules of Practice; 

sections 6(£) and 21 of the Federal Trade Commission Act; or any other legal obligation 

imposed upon the Commission. 

9. In the event that any confidential material is contained in any pleading, motion, exhibit 

or other paper filed or to be filed with the Secretary of the Commission, the Secretary 

shall be so informed by the Party filing such papers, and such papers shall be filed in 

camera. To the extent that such material was originally submitted by a third party, the 

party including the materials in its papers shall immediately notify the submitter of such 

inclusion. Confidential material contained in the papers shall continue to have in camera 

treatment until further order of the Administrative Law Judge, provided, however, that 

such papers may be furnished to persons or entities who may receive confidential 

material pursuant to Paragraphs 7 or 8. Upon or after filing any paper containing 

confidential material, the filing party shall file on the public record a duplicate copy of 

the paper that does not reveal confidential material. Further, if the protection for any 

such material expires, a party may file on the public record a duplicate copy which also 

contains the formerly protected material. 

3 
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. 'j 

I 

i ., 

10. If counsel plans to introduce into evidence at the hearing any document or transcript 

containing confidential material produced by another party or by a third party, they shall 

provide advance notice to the other party or third party for purposes of allowing that 

party to seek an order that the document or transcript be granted in camera treatment. If 

that party wishes in camera treatment for the document or transcript, the party shall file 

an appropriate motion with the Administrative Law Judge within 5 days after it receives 

such notice. Except where such an order is granted, all documents and transcripts shall 

be part of the public record. Where in camera treatment is granted, a duplicate copy of 

such document or transcript with the confidential material deleted therefrom may be 

placed on the public record. 

11. If any party receives a discovery request in any investigation or in any other 

proceeding or matter that may require the disclosure of confidential material submitted by 

another party or third party, the recipient of the discovery request shall promptly notify 

the submitter of receipt of such request. Unless a shorter time is mandated by an order of 

a court, such notification shall be in writing and be received by the submitter at least 1 0 

business days before production, and shall include a copy of this Protective Order and a 

cover letter that will apprise the submitter of its rights hereunder. Nothing herein shall be 

construed as requiring the recipient of the discovery request or anyone else covered by 

this Order to challenge or appeal any order requiring production of confidential material, 

to subject itself to any penalties for non-compliance with any such order, or to seek any 

relief from the Administrative Law Judge or the Commission. The recipient shall not 

oppose the submitter's efforts to challenge the disclosure of confidential material. In 

addition, nothing herein shall limit the applicability of Rule 4.ll(e) of the Commission's 

Rules of Practice, 16 CFR 4.11 (e), to discovery requests in another proceeding that are 

directed to the Commission. 

12. At the time that any consultant or other person retained to assist counsel in the 

preparation of this action concludes participation in the action, such person shall return to 

counsel all copies of documents or portions thereof designated confidential that are in the 

possession of such person, together with all notes, memoranda or other papers containing 

confidential information. At the conclusion of this proceeding, including the exhaustion 

of judicial review, the parties shall return documents obtained in this action to their 

submitters, provided, however, that the Commission's obligation to return documents 

shall be governed by the provisions ofRule 4.12 of the Rules of Practice, 16 CFR 4.12. 

13. The provisions of this Protective Order, insofar as they restrict the communication 

and use of confidential discovery material, shall, without written permission of the 

submitter or further order of the Commission, continue to be binding after the conclusion 

of this proceeding. 

4 

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