The BioPVC data is best fit by a logistic model using So, Xo and k values of 2.6%, 0.075% and 0.4 month?
respectively, as shown in the graph below. These parameter values provide a fit nearly identical to that
presented by Dr. Barber in Figure 2 of his report.

However an So value of 2.6% would indicate that only 2.6% of the substrate is biodegradable and the
remaining 97.3% is not. Put another way, taking the mathematical limit of the logistic model used by Dr.
Barber to model BioPVC degradation (by substituting t=infinity into the equation in Figure 6) would
indicate that only 2.6%, and not 100% (or even 20%) mass loss of the BioPVC would ultimately occur.

Ind
o

Loss of Mass (%)
e
uw

=
°

@ Data
—— Barber Logistic Model

Os — — First Order Model

00 «

Time (months)

Figure 5 . Loss of mass expressed as the percent change is presented for BioPVC material over the time
course of the study. A three parameter logistic curve was used by Barber to fit the data (R?=0.97%,
p=0.01). In red a first order model is also shown. The best first order curve fit has an R? value of 0.8945.
Data reproduced from the BioPVC report.

18

ECM Comb. Mot. to Exclude Page 18 of 24
Exh. V


REMARKS

Claims 1 to 25 are pending. Claims 1 to 9 and 11 to 22
have been amended. These amendments add no new matter. in
Particular, support for the claim language "the second polymer
forms a continuous or co-continuous phase in the blend" ig found
in the specification, e.g., page 10, lines 22-26. The concept
that the second polymer is a homopolymer or a random copolymer is
described in the application, e.g., at page 10, lines 17-21.
Support for the term "polyethylene terephthalate" is found in the
Specification, e.g., page 11, line 12. Other amendmenta are
grammatical in nature. Claims 10 and 23 to 25 have been
restricted by the Examiner; however, applicants have not
cancelled these claims, in view of their request for
consideration of the restriction requirement, which is discussed

in further detail below.

The Invention

The invention is based on the discovery that polylactic
acid (PLA)-based polymers or copolymers and polymers of one oz?
more polyesters can be used to make new biodegradable blends:
Compared to PLA alone, these blends have superior tensile and
mechanical properties such as stiffness, toughness, and
elongation to break, as well as ‘excellent biodegradability ana
aging properties. The PLA component can be baged on lactic :acid
homopolymers and/or block, graft, or random copolymers of lactic
acid with other organic units. The polyester component can be

based on homopolymers or random copolymers of C, to Cy aliphatic

2

ECM Comb. Mot. to Exclude

Exh. Z

Page 53 of 80


Respondent’s Exhibit F


EXPERT REPORT OF DR. THABET TOLAYMAT
SUMMARY & CONCLUSIONS

I am environmental engineer with the United States Environmental Protection Agency
(“EPA”). As an EPA engineer in solid waste management, I have substantial responsibility for,
and experience with, United States (“U.S.”) landfills. In my expert opinion:

* Plastic products manufactured with ECM’s additive (“ECM Plastics”) will not
completely biodegrade in five years or less under ordinary U.S. landfill disposal
conditions. The most common waste disposal method in the United States is by landfill,
and most landfills do not have conditions that would allow for complete biodegradation
in that timeframe (or anywhere near that timeframe).

= ECM testing data are not competent and reliable scientific evidence that ECM Plastics
will biodegrade in five years or less in most landfills because none of the tests ECM
offers to substantiate its claims simulate the conditions (e.g., oxygen, moisture level,
temperature) found in typical U.S. landfills. Additionally, the tests are based on
inaccurate assumptions and faulty calculations and have severe methodological shortfalls.

* The materials I analyzed to prepare this report are listed on Exhibit A hereto, and they
include the materials upon which ECM relies to substantiate its claims. I am not aware of
any competent and reliable scientific evidence that ECM Plastics will biodegrade in

typical landfills any more rapidly than plastics made without the ECM additive.

—Liket/,

Dr. Thabet Tolaymat
U.S. Environmental Protection

paren: 6-4- 2014

ECM Comb. Mot. to Exclude Page 1 of 56
Exh. X


ECM Comb. Mot. to Exclude Resp. Mot to Compel and at SaRaige 3 of 12

Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


EF Gémez, EC. Michel Jr / Polymer Degradation and Stabitity 98 (2013) 2583 2591 2585,

plastics. These materials include conventional plastics amended
with additives meant to enhance biodegradability as well as bio
based plastics and natural fiber composites. There has been little
research on the extent to which these materials truly degrade andj
or biodegrade over the time scale of waste management processes
such as composting and anaerobic digestion (AD) or in natural
settings [22].

The objective of this study was to compare the relative biode
gradability of a range of novel plastics and natural fiber composites
during composting, AD and in soil conditions, The hypothesis was
that materials that are referred to as biodegradable, compostable
(or similar terms), and plastics containing additives designed to
enhance biodegradability, mineralize during the time scale of waste
treatment processes and in reasonable amounts of time in the
environment and at rates comparable to natural materials known
to be biodegradable and or compostable (e.g. cellulose paper).

2, Materials and methods

Standardized laboratory scale experiments were conducted to
study the biodegradability of various materials during soil incu
bation, composting and AD conditions [23-25]. The extent of
biodegradation was calculated by measuring the average carbon
(COz and or CH4) mineralized from each treatment minus the
average carbon evolved from blanks, and dividing this by the total
amount of sample carbon added to each treatment. Reactors con
taining only the inoculum (AD), soil (soil tests) or compost
(compost tests) were used as blanks.

2.1. Materials

Materials tested included plastics designed to be biodegradable,
conventional plastics amended with additives that are meant to
enhance biodegradability, bio based plastics and natural fiber
composites (Table: 2 anc 3). The positive and negative controls
used for all experiments were cellulose paper (Fisher Scientific, PA,
US.) and 100% conventional polypropylene (PP), respectively. Ma
terials were tested both after grinding (a preliminary soil experi
ment only) and as 1 x 1 cm squares (thicknesses shown in Tue!=

2.2. Biodegradation in soil incubation
The extent of long term biodegradation of polymeric materials

in contact with soil was determined based on ASTM D5988 03 .
These included PP + 2% additive, polystyrene (PS) + 2% additive,

polyethylene terephthalate (PETE) + 1% additive, plastarch, a co
polyester + corn based plastic, a wheat starch derived plastic and
PHA (Tables 2 and 3). Six natural fiber composite materials were
also tested: paper pulp, paper pulp + asphalt, coconut coir, rice hull,
composted cow manure and peat fiber. All samples were incubated
in triplicate for a period of 660 days.

The soil media used for the experiments was a mixture of 43%
certified organic top soil, 43% no till farm soil collected at co
ordinates: 40.778633, 81.930873 and 14% sand. Soil was sieved to
Jess than 2 mm patticle size and targe plant materials, stones, and
other inert materials were removed. The chemical properties of the
soil mixture are shown in Table 4. The soil media was amended
with ammonium phosphate (Fisher Scientific, PA, U.S.} to maintain
a C:N ratio of 20:1 based on the carbon content of the test
specimen.

The soil mixture (300 g dry) was placed in the bottom of a2 L
(working volume) wide mouth jar (Ball® Corporation, item #
383178). Distilled water was added to bring the moisture content of
the mixture to 60% of the moisture holding capacity. The test
specimens (1 g of sample carbon) were then mixed thoroughly into
the soil. A solution containing 20 ml of potassium hydroxide (KOH)
0.5 N (Fisher Scientific, PA, US.) was placed in a cup suspended
from the lid of each vessel to trap evolved CO>. All vessels were
sealed and incubated at room temperature (20 + 2 °C).

Carbon dioxide produced in each vessel reacted with the KOH in
the cup to form potassium bicarbonate. The amount of CO pro
duced was determined by titrating the KOH solution with 0.25 N
hydrochloric acid (Fisher Scientific, PA, U.S.) to a phenolphthalein
end point. The experiment was designed so that the headspace
volume was sufficient to prevent the oxygen concentration in the
vessel from falling below 18%. The KOH traps were removed and
titrated at time intervals that assured that their absorption capacity
was not exceeded. The KOH traps were refilled at a rate dependent
on the rate of CO2 generation in each flask. At the time of removal of
the traps, the vessel was flushed and allowed to sit open to allow
fresh air to fill the headspace. In addition, distilled water was added
to the soil to the original weight to maintain adequate moisture.

The effect of particle size on biodegradation rate was deter
mined by comparing the biodegradability of 1 cm squares to
ground samples. Samples were ground in liquid nitrogen using a
IKA® A11 basic Analytical mill (IKA® Works Inc., NC, U.S.) for 10 s.
Test specimens included PP + 2% additive, co polyester + com
based plastic, wheat starch derived plastic, paper pulp, paper
pulp + asphalt, coconut coir and rice hull (Tabie: 2 and 2). Samples
were incubated in triplicate for 660 days.

Table 2
Materia! information for commercially available bio-based plastics, plastics amended with additives and natural fiber composites.
Material Material description Formation
process

PP + 2% additive Blend of polypropylene (PP) with 2% ECM MasterBatch PelletsTM additive (ECM BioFilms Inc,, OH, U. S.) 1

PS + 2% additive Biend of polystyrene (PS) with 2% ECM MasterBatch PelletsTM additive (ECM BioFilms Inc., OH, US) 1

PETE + 1% additive Blend of polyethylene terephthalate (PETE) with 1% EcoPure® additive (Bio-Tec Environmental LLC, NM, US) 2
Plastarch A blend of polypropylene with corn starch. 3
Co-polyester + corn-based plastic Blend of an aliphatic aromatic co-polyester with a corn starch-derived polymer (EcobrasTM, BASF). 1

Wheat starch-derived plastic Made from a wheat starch-derived resin (OP-47 Bio®, Summit Plastic Company, OH, US.). 3

PHA Made from polyhydroxyalkanoates-based resin (Metabolix, MA, US.). 1

Paper pulp + soy wax Paper pulp pot permeated with say wax. 4

Paper pulp Recycled (74% minimum) paper puip. 4

Paper pulp + asphalt Blend of recycled (74% minimum) paper pulp + asphalt. 4
Coconut coir Made from coconut husk. 7

Rice hull Made from rice hull, 5
Composted cow manure Made from composted cow manure. 6

Peat fiber Made from Canadian sphagnum peat moss + wood puip. 6

* 1 injection molding; 2 blow molding; 3 thermoforming; 4 vacuum forming: 5 compression forming: 6 pressure forming: 7 _ other.

ECM Comb. Mot. to Exclude Page 3 of 9

Exh. AA


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION
OFFICE OF THE ADMINISTRATIVE LAW JUDGES
Washington, D.C.

In the Matter of
Docket No. 9358
ECM BioFilms, Inc.,
a corporation, also d/b/a
Enviroplastics International, PUBLIC
Respondent.

DECLARATION OF PETER A. ARHANGELSKY
IN SUPPORT OF RESPONDENT’S COMBINED MOTION FOR SANCTIONS, TO
EXCLUDE COMPLAINT COUNSEL’S CONCEALED EXPERT REBUTTAL WITNESS

(NOT IDENTIFIED BY NOTICE IN ACCORDANCE WITH RULE 3.31A AND THE
REVISED SCHEDULING ORDER), AND FOR LEAVE TO INCLUDE SURREBUTTAL

EXPERT.

In accordance with 28 U.S.C. § 1746, I declare under the penalty of perjury that the
following is true and correct:

1. Iam over 18 years of age, and I am a citizen of the United States. I am employed
as an attorney with Emord & Associates, P.C., which represents ECM BioFilms in this matter. I
am an attorney of record in the above-captioned matter, and I have personal knowledge of the

facts set forth herein.

2. The following exhibits, which are attached as Exhibits to the above-captioned
motion, are true and correct copies of files received by ECM:

Exh. A. Complaint Counsel’s Preliminary Witness List

Exh. B. Complaint Counsel’s Expert Witness List

Exh. C. Complaint Counsel’s Supplemental Initial Disclosures
Exh. D. Complaint Counsel’s Supplemental Expert Witness List

Exh.E. Email Correspondence Between Complaint Counsel and ECM Counsel Re
Deposition Scheduling (April 2014)

Exh. F. Complaint Counsel’s Final Proposed Witness List June 11, 2014)


EF Gémez, FC, Michel Jr. / Polymer Degradation and Stability 98 (2013) 2583 2591 2589

(Fig. 3). This was followed by a period of slow mineralization until
the termination of the experiment (Fig. 3). After 660 days, the
mineralization percent of the composted cow manure, paper pulp
and paper pup + asphalt were 35.5 + 2.3, 31.3 + 3.6, 29.4 + 2.1%,
respectively. Lower final conversion values were observed for rice
hull, peat fiber and coconut coir with values of 21.1 + 2.6, 18.3 + 0.7
and 14.4 + 2.5%, respectively. SEM images of coconut coir revealed
some surface changes indicative of biodegradation (Fig. 2G and H).

Approximately 74.2% of cellulose added to soil was converted to
CO2 after 660 days. This is similar to the conversion of cellulose of
80% reported in a 800 day soil incubation conducted to evaluate
how carbon substrates affect microbial biomass yield in soil
biodegradation tests [33].

The highest biodegradability observed during soil incubation
was reported for PHA (70%); a polyhydroxyalkanoate based plastic.
This was similar in magnitude to the extent of mineralization of the
cellulose positive control (cellulose paper). Bacterial poly
hydroxyalkanoates are intracellular aliphatic polyesters of various
chain lengths [34]. Several studies have been conducted to study
the biodegradability of aliphatic polyesters under different condi
tions {35—38]. Mineralization of these polymers is mainly achieved
by cleavage of the ester bonds which occurs due to both enzymatic
and chemical hydrolysis {39].

Statistically analysis revealed that significant differences in the
extent of biodegradation (F}532 822.2, P < 0.0001) existed be
tween group means. Tukey—Kramer HSD analysis revealed that
among bio based plastics, the difference between PHA and the
positive control (cellulose paper) was not significant. Analyses also
revealed that differences were not significant between plastics
amended with additives that are meant to enhance biodegrad
ability and the negative control (PP), For natural fiber composites all
test specimens differed significantly from both the positive and
negative controls (Fig. 3).

The results of this study indicate that conventional plastics
containing additives do not biodegrade any faster than non
additive containing plastics in soil. Manufacturers of these addi
tives claim that if at least 1-5% (by weight) of their additive is
added to plastics products, these will fully biodegrade when
disposed of in microbe rich environments. These claims are not
supported by the findings of this study.

The greatest extent of biodegradation among the fiber com
posite materials tested was the composted cow manure (35%). This
was unexpected since low carbon conversion rates were antici
pated for the composted cow manure since it had previously been
biologically degraded. After undergoing a composting cycle, much
of the carbon contained in the cow manure was expected to be
stable and humified [25,0]. However, much less extents of
degradation were observed for uncomposted composites produced
from rice huils, from peat fiber pot and coconut coir. For these
materials, the extent of degradation in soil ranged from 14 to 21%
(Fis. 3). These materials have been used as natural composites due
to their low price and structural strength [41,42]. Approximately
46% of coconut coir is lignin [43] as is 21-40% of rice hulls [44]
which may have limited their biodegradation.

3.2. Biodegradation during composting

Three different materials were evaluated for their relative rate of
degradation during composting. The materials were composted at
55 °C under aerobic conditions for a period of 115 days. The tested
materials included plastarch, paper pulp + soy wax and PETE + 1%
additive (Table: 2 and 3).

The initial moisture content was adjusted to 60% and the final
mean compost moisture content across all treatments was
64.2 + 3.3% (wet weight basis).

ECM Comb. Mot. to Exclude
Exh. AA

Mineralization under composting conditions occurred at a rapid
initial rate for both the positive control and the plastarch material
during the first 80 days (Fig. 4). Overall, the positive control (cel
lulose paper) exhibited 78.4 + 3.5% conversion during composting.

For paper + soy wax, a majority of the mineralization took place
during the first 15 days. For PETE + 1% additive no significant
conversion was observed over the entire period of study (Fig. 4).
The final cumulative biodegradation during composting for plas
tarch, paper + soy wax and PETE + 1% additive was 51.3 + 4.9,
12.4 + 2.7 and 0.6 + 3.7%, respectively. The ANOVA indicated that
statistically significant differences in the extent of biodegradation
(Faz 496.6, P < 0.0001) existed between group means. Tukey—
Kramer HSD analysis revealed that all test specimens differed from
the positive control. However, PETE + 1% additive did not differ
significantly from the negative control.

None of the tested materials mineralized at rates comparable to
the positive control material. The highest cumulative biodegrada
tion during composting was observed for the plastarch containing
material (51.3%). Starch is made of repeating glucose units linked by
glucosidic bonds that are susceptible to enzymatic attack. Uses and
applications of starch in its native form or blended with other
materials have been discussed [45,44]. Biodegradation of the starch
containing portion of the material has been reported [47,43].
However the reason that the plastarch degraded more slowly than
cellulose is not known.

After 20 days, only 12% of the paper pulp composite was con
verted to CO2 during composting. The low level of cumulative
degradation could be related to inhibitory properties of the soy
derived wax on the microbial consortia or limiting water accessi
bility. For plastics containing additives, no degradation was
observed. Additives did not improve the biodegradability of PETE
during composting.

3.3. Biodegradation during anaerobic digestion

Understanding the biodegradation of different materials in
anaerobic conditions such as in industrial sewage sludge AD sys
tems, landfills and anoxic environments is important since under
these conditions, microorganisms mineralize organic substrates to
both CO2 and methane. Methane itself can be used as a fuel source
but if not captured it has a global warming potential 21 times
stronger than C02. Since in the U.S. only 30% of the landfills capture
methane and among those that do capture, only a small percentage
of the methane produced is recovered, then biodegradable plastics
in landfills have a greater potential than composted biodegradable
plastics to contribute to global warming.

108g repre ore;
[—Pesiiar wetdove papery

gO) me piecarett

2 NO" ty pene mlp + sey ta
B Ute | ooo Here saaaince
3.

2 w.

zm

i we

w
Fee caaysy

Fig. 4. Cumulative carbon loss (CO2 C) as percentage of initial carbon (:cumulative
standard error) for bio-based plastics, conventional plastics amended with additives
and natural fiber composites during 115 days of thermophitic composting. For some
data points standard error bars are smalier than markers.

Page 7 of 9


650

J Polym Environ (2011) 19:637 676

adverse effect on the mechanical properties of LDPE/tice or
potato starch blends [353]. Composites containing various
forms of starch/LDPE blends were prepared by several
teams to study the effect of starch content on mechanical
properties and water absorption [354 356]. High starch
contents promoted brittleness and resulted in lower tensile
strength, elongation at break, and modulus and higher GP
and WVTR. Tsao et al. studied the influence of soil macro
invertebrates such as earthworms, cockroaches, termites,
sowbugs, and crickets on primary biodegradation of starch-
containing polyethylene films [357]. The degree to which
the films were attacked and consumed by macroinverte-
brates was directly related to the starch content of the film.
Doble et al. have reviewed recently biodegradation of
polyethylene and polypropylene giving emphasis on the
mechanism of biodegradation, the various bacterial and
fungal organisms that have been reported for the same,
methods adopted for the studies and different characteriza-
tion techniques followed to measure the extent of degrada-
tion [358].

The modification of either the starch or LDPE is nec-
essary to make compatibilized starch/LDPE blends, which
in turn increase the mechanical properties and the amount
of starch in the blend. Cornstarch treated with a siliane
coupling agent was used by Griffin to provide compati-
bility with hydrocarbon polymers [359]. Kang et al. used a
modified starch (MS) to improve the mechanical property
of starch-filled polyethylene films by introducing choles-
terol moiety as a hydrophobic biomaterial [360]. However,
a decrease in the enzymatic degradation rate of the MS-
filled LDPE than the rate of the native starch-filled LDPE
was observed. Another approach is graft copolymerization
of a vinyl monomer on to the starch backbone. Fanta and
Doane have made an extensive study of the synthesis and
properties of starch-g-poly(methyl acrylate) [161]. Patil
and Fanta prepared S-g-PMA copolymers containing
55 60% PMA from comstarch, high amylase cornstarch,
and waxy cornstarch with ceric ammonium nitrate initia-
tion [361]. Henderson et al. grafted PMA onto wheat starch
by y-irradiation and chemical initiation, respectively [362].
Dennenberg et al. prepared S-g-PMA copolymers having
grafted side chains with molecular weights of less than
500,000 [363]. Although Dennenberg et al. confirmed that
the starch portion of these graft copolymers is indeed
susceptible to fungal attack, PMA is resistant to biodeg-
radation. Jane et al. reported that the tensile strength and
elongation of starch/PE composites was improved by the
addition of oxidized PE (OPE) [364, 365]. Tena-Salcido
et al. used thermoplastic starch to impart biodegradability
to PE. PEI/TPS blends having 32% starch remained ductile
after 45 days of exposure to bacterial attack [366].

Another approach to bring about some compatibility in
starch and synthetic polymer is blending starch with

© Springer

ECM Comb. Mot. to Exclude
Exh. Z

polymers containing polar functional groups such as eth-
ylene acrylic acid (EAA) copolymer, ethylene maleic
anhydride (MAH) copolymer, ethylene vinyl alcohol
(EVA) copolymer etc. that can interact with starch. Of alt
these compatibilizers, EVA is a highly hydrophilic poly-
mer, which restricted its application in moist environments.
EAA is a very effective compatibilizer between starch and
polyethylene, but only a high content of EAA could result
in good compatibility. However, the higher the EAA con-
tent was, the lower was the biodegradability. So far, PE-g-
MAH was considered as the most effective compatibilizer
between starch and polyethylene and only very small
amount of MA is needed to attain a large improvement in
mechanical properties [367 372]. But, its price is high and
the manufacture is difficult. Otey et al. produced blown
films containing up to 40 50 wt% gelatinized starch along
with EAA and ammonia [182, 373]. Bikiaris et al. reported
that the tensile strength of LDPE/PLST blends containing
high amounts of starch (up to 30 wt%) could be retained to
a great extend the tensile strength of LDPE by using PE-G-
MA copolymer as a compatibilizer [332, 374]. The bio-
degradation studies showed a slightly lower biodegradation
rate for the compatibilized blends compared to their un-
compatibilized counterparts. Later Shujun et al. observed
better mechanical properties, morphology properties, ther-
mal properties and rheology properties in the case of TPS/
LLDPE blends compatibilized with MAH compared with
the blends without MAH [371].

Several teams have reviewed the progresses made in the
synthesis of biodegradable polyethylene [21, 56, 359, 375
377]. In a series of works, Bikiaris et al. used ethylene-co-
acrylic acid (EAA) as compatibilizer in LDPE/plasticized
starch (PLST) blends [321, 334]. They reported that EAA
increases the thermal oxidative degradation of LDPE,
where as PLST inhibits it. Sastry et al. synthesized films of
polyethylene (PE) starch blends containing vegetable oil
as a compatibilizer [378]. Kiatkamjornwong et al. used
cassava starch-g-poly(acrylic acid) prepared by y- ray
irradiation which was further modified by esterification and
etherification with poly(ethylene glycol) 4,000 and pro-
pylene oxide, respectively, for a biodegradable LDPE
sheet. They reported that hydrophobically modified starch/
LDPE blends have better mechanical, thermal and mor-
phological properties as well as better biodegradability
than LDPE/native starch [379].

The thermo-oxidative aging studies done by Sharma
et al. revealed that the incorporation of pro-oxidant which
consisted of metal salts (Manganese stearate) and unsatu-
rated elastomer (SBR and ENR-50) enhanced the degra-
dation rate of sago starch filled LLDPE composites [323].
Where as Khabbaz et al. reported that starch have an
inhibiting effect on the thermal degradation of LDPE
containing pro-oxidant and photosensitizers [380, 381].

Page 14 of 80


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 2

TABLE OF CONTENTS

INTRODUCTION .....ocesssssssseessessssseeesenssssescsssssnneseeessnnusssessnnanssssssnmnsessssssessenssssuseeessseseesssesananees 1
EDUCATION, BACKGROUND & EXPERIENCE

SCOPE OF ANALYSIS ..ecssssssssssesssecesessssssssssssssnsunvsesseceeeeeessesssssniauesseececsssssissssnsssneunesecssseseesereeene 5
SUMMARY OF ANALYSIS woesscsssscssccesssssssseesecestsseceeeesansscesssnnsessssecesccassssuuuussseesseseseesssssseseerenees 7

BIODEGRADATION & PLASTICS ..scsscssssssssssssssssssssssnnnnnsneeseessecessssessssseesseesesesecceennssssssssssseeseeeee

WHAT CONSTITUTES “COMPETENT AND RELIABLE SCIENTIFIC
EVIDENCE” FOR CLAIMS OF BIODEGRADABLE PLASTIC .....sscccssssssssessssssssssessseessnnseesee 13

CURRENTLY AVAILABLE TESTS THAT SCIENTIFICALLY EVALUATE
BIODEGRADATION OF PLASTIC . eoseeenee soessesersatenseeseeseeee LB

A. Screening-Level Tests Are Only the First Step.

i, ASTM D551 1 eessssessssesssssescssseecssneescsssnessssesscesneessneessneceesanesnsanesssneesseseed 21
ii. ASTM D5526...cccseessssssscssseeeessseccssnecssssvecssuceccossssansessnseceesssecesnsesessueeessanecee 21
iii. | Proposed ASTM Standard Test Method for Landfill Conditions.............. 22

B. Confirmatory-Level Tests Are Necessary To Establish Biodegradation...............23
ANALYSIS OF ECM’S CLAIMG... cesssssscsssssssseesessssnsecsessnneresseecansesessssssesesssususeseeesssssecssesssnnneseed 24
A. ECM’S False Claims...........scescsseescsseesssecsesresens

B. ECM’s Unsubstantiated Claims.........cecsscesscsssesscsseesssssescsseessssessnssutsesssctessnensereeseees, 26
Cc. Analysis of ECM’s Claims and Testin:

i. ECM’s Substantiation Does Not Support Its Claims......cscscssosseeseseesseseee27

ii. Microorganisms Do Not Produce Enzymes that
Metabolize Plastic.........ecsssessccsssessssesssssseessesssssnnecesascesnssesnssseesesseseessereestanee 29

iii. ECM’s Test Results Are Unreliable.

a. Northeast Laboratories Tests. ......0..ssescsssssssseessesseesesseeesssseeennneeen 34

b. Eden Laboratories Tests...........0::sssessssescstsesseeeeecsseessssesessseesssaene 3D

CONCLUSION,

ECM Comb. Mot. to Exclude Page 2 of 58
Exh. U


Peter Arhangelsky

From: pclarke@ftc.gov

Sent: Tuesday, July 01, 2014 9:14 AM
To: Peter Arhangelsky

Ce: kjohnson3@ftc.gov

Subject: ECM Biofilms (R1502)

You have received 1 secure file from pclarke@ftc.gov.
Use the secure link below to download

Peter,
Here are the materials for Dr. Michel
Thanks.

Katherine

Secure File Downloads:
Available until: 05 July 2014

Click {ink to download

You have received attachment link(s) within this email sent via the FTC Secure Mall system. To retneve the attachment(s), please click
‘on the link(s)

ECM Comb. Mot. to Exclude Page 1 of 1
Exh. $


PUBLIC DOCUMENT

The surprise revelation of a completely new expert witness at this late stage in the case
raises a host of issues, and ECM seeks to file at least three motions addressing each
independently, to wit: (1) a Motion to Exclude Dr. Michel; (2) a Motion for Sanctions; and (3) a
contingent Motion for Leave to Add a Surrebuttal Expert. The factual background and
procedure overlap substantially for these motions and, so, for the Court’s and Complaint
Counsel’s convenience, a combined motion is likely the most appropriate course. ECM cannot
fully develop each of its independent bases for relief arising from the same core of operative
facts within the 2,500 words provided under Rule 3.22(c). To be sure, under that rule, were three
motions filed, the total pages allowed would be 7,500. Accordingly, there is good cause to grant
the relief requested which enables the filing of a single pleading of only 4,580 words. ECM
respectfully requests an additional 2,080 words to submit a combined memorandum of up to

4,580 words. Complaint Counsel does not consent to this motion.

Respectfully submitted,

4s/ 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 9, 2014


ECM Comb. Mot. to Exclude Resp. Mot. to Compel and for Sanense 2 of 2

Exh. RX-C-;
Exh. M CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


knowledge that are relevant to the allegations of the Complaint, Respondent’s affirmative
defenses, or the proposed relief.

13. James Blood, Free-Flaw Packaging International, Inc. (“FP”) General
Counsel, as FP"s designee

Mr. Blood will testify regarding FP’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, FP’s purchase of ECM
additive; reasons for this purchase; FP’s understanding of ECM’s claims and substantiation for
those claims; FP’s resources and ability to test and evaluate ECM’s claims and substantiation;
FP’s use and understanding of the ECM Certificate of Biodegradability, the ECM logo, and other
ECM promotional material; FP’s understanding of how its customers used ECM promotional
materials and products made with the ECM additive; any other issues addressed in his
deposition: any documents introduced into evidence by Respondent or Complaint Counsel as to
which he has knowledge; or any other matters as to which he has knowledge that are relevant to
the allegations of the Complaint, Respondent's affirmative detenses, or the proposed relief

14. Adrian Hong, Island Plastic Bags, Inc. (“Island Plastic Bags”) General
Manager, as Island Plastic Bags’ designee

Mr. Hong will testify regarding Island Plastic Bags’ relationship with ECM and
understanding of ECM’s product, claims, and testing, including, but not limited to, Island Plastic
Bags’ purchase of ECM additive; reasons for this purchase; {sland Plastic Bags’ understanding
of ECM’s claims and substantiation for those claims; Island Plastic Bags” resources and ability to
test and evaluate ECM’s claims and substantiation; Island Plastic Bags’ use and understanding of
the ECM Certificate of Biodegradability, ihe ECM logo, and other ECM promotional material;
Island Plastic Bags’ understanding of how its customers (and their customers) used ECM

promotional materials and products made with the ECM additive: any other issues addressed in

ECM Comb. Mot. to Exclude Page 9 of 16
Exh. F


Sampie A: The above plastisol was mixed using DOA, DBTDL plus 5
parts of Additive A;-a titanium-based adduct containing a
methacrylamide group [3]. Fused samples were consumed in the test
landfill within 10 days, vanishing to'the visible eye. Suspended strips
of moist pH paper remained in the range of 6-7, indicating little or no
HCl evolution. This sample is shown as Figure 2. The experiment
was repeated adding 2.5 parts of Micro-Chek® 11 biocide, with
identical results. Control samples containing calcined clay in place of
Ultracarb® calcium carbonate also decomposed but rapidly acid
discolored pH paper.

Sample B: The above plastiso!l was mixed with the di-isononyl ester
of cyclohexane dicarboxylic acid (DINCH®, BASF) replacing DOA.
Fused samples disappeared in 7 days, with or without added biocide.

Sample C: The last was repeated with Additive B, the zirconate
analog of Additive A, and with basic magnesium carbonate replacing
calcium carbonate. Fused samples disappeared within 10 days.
Again, suspended strips of moist pH paper showed little or no HCI
volatilization.

Sample D: The above plastisol was mixed using DINCH, Additive A
and dibutyltin maleate ester heat stabilizer (PlastiStab 2808, Halstab)
in place of DBTDL. Fused samples disappeared within 10 days.

Sample E: The same plastisol was mixed using DINCH, Additive A,
and 2 parts of a liquid calcium/zinc stabilizer (PlastiStab 3002,
Halstab) in place of DBTDL organotin. After 90 days, the fused
sample had heavy mold growth and had fragmented but was still
visibly of the same dimensions.

Discussion

The systems developed for PVC are quite different from those for
polyolefins, usually based on manganese or cobalt prodegradants.
The latter appear to be ineffective in PVC. In related experiments,
replacement of Additive A or B with cobalt or manganese stearate
yielded samples that appeared unaffected after 60 days landfill
exposure at 30 C, other than the appearance of slight mold growth.

ECM Comb. Mot. to Exclude Page 46 of 80
Exh. Z


lyethylone

d cust te conduct a Univers: ty research

Year Year Year Year Year
1 2 3 4 5

Personne! (3% raise per year)
Principal Investigator (3% time) $ 3,600 $ 3,708 $ 3,708 $ 3,708 $ 3,708
Postdoctoral Researcher (25% Y1, 10% Y2-5) $ 11,250 $ 4635 $ 4635 $ 4635 $ 4,635
Fringe benefits $ 4158 $ 2,336 $ 2336 $ 2,336 $ 2,336
Supplies $ 2,000 $ 750 $ 750 $ 750 $ 750
Synthesis of 14C polyethylene $ 5,000
Indirect Costs (52.5%) $13,264 $ 5829 $ 5829 $ 5,829 $ 5,829
Yearly Total $39,272 $ 17,258 $ 17,258 $ 17,258 $ 17,258
Grand Total $108,303
Notes

OSU has a NRC license for C14, scintillation counters for measuring radioactivity and AD reactor systems
14C polyethylene synthesis would be done by American Radiolabeled Chemicals, Inc. , St Louis, MO, or Perkin Elmer.
Experiment would consist of 16 Anerobic Incubation Reactors. Each would be inoculated with activated sludge

and landfill material and incubated at room temperature for 5 years. The replicates and treatments would be
4- 14€ polyethylene, 4 - 14C polyethylene plus 2% ECM additive, 4 - blanks (no plastic), 4 - cellulose (positive control
Biogas trapped in Tedlar bags, would be combusted to 100% O02, and the radioactivity measured.

23

ECM Comb. Mot. to Exclude

Exh. V

Page 23 of 24


Respondent’s Exhibit U


RETURN OF SERVICE
I hereby certify that 2 duplicate original of the within
‘Subpoena was duly served: {check the method usec)
© inperson. i

©@ by registered mail.

© by leaving copy at principal office or place of business, to wit:
Fed Ex, per FTC Rule 4.4(a)(2)

on the person named herein on:

s/t/2el4

(Month, day, ard yaar)

Elisa Ji \lcon

{Name of peraon making service} |

Atroransy

(Orta to)

j
t
1
Hl
ij

ECM Comb. Mot. to Exclude Page 3 of 8
Exh. G



and covered with at least 6 inches of earthen cover, which is intended to reduce odor, pests, and
wind disturbances. Thus, landfill cells may start as aerobic environments rich with oxygen,
thanks to the void space in non-compacted waste and exposure to air above the landfill, but the
oxygen supply in the landfill does not last for long. Both the compaction and the covering reduce
oxygen: covering the landfill cell reduces the amount of air that permeates the landfill, and
compacting the MSW reduces air pockets. Effectively covering the landfill cells is very
important to the safety and stability of the landfill; air infiltration can cause fires and explosions.
24. The oxygen level in landfills is further minimized by EPA-mandated “gas
collection and control systems” (GCCS). Landfills generate significant amounts of methane and
carbon dioxide, along with trace amounts of other gases that are dangerous to human health and
the environment. GCCSs are designed to limit these gas effects. The efficacy of these systems
depends on a constant landfill gas quality of nearly 50% carbon dioxide and nearly 50%
methane. Emission of any significant amount of oxygen would disrupt the collection system and,
again, create danger for fires and explosions. So, the EPA mandates monthly monitoring of
every gas collection well-point at MSW landfills to ensure oxygen levels below 5% (volume).®
Landfill operators that detect higher levels of oxygen have to recalibrate their gas collection
system to decrease the amount of oxygen in the gas. This is usually done by reducing the
vacuum pressure at the well-head and/or adding and packing new cover soil in the vicinity of the

gas well.

© There are exceptions to the EPA’s rule. On a case-by-case bases, some facilities have
been granted approval for a higher oxygen concentration based on a case by case evaluation and
approval.

11

ECM Comb. Mot. to Exclude Page 11 of 56
Exh. X


PUBLIC DOCUMENT

2. Complaint Counsel Should Be Sanctioned Under Rule 3.38, and that Sanction
Should be the Exclusion of Dr. Michel’s Report and Testimony

Sanctions under Rule 3.38(b) are appropriate where, as here, Complaint Counsel
unjustifiably chose to violate Rule 3.31A and this Court’s Scheduling Order to gain a strategic
advantage. “Rule 3,38 is designed both to prohibit a party from resting on its own concealment
and to maintain the integrity of the administrative process.” In re Grand Union Co., 102 F.T.C.
812 (July 18, 1983). Sanctions are appropriate under Rule 3.38 where the failure to comply was
“unjustified and the sanction imposed is reasonable in light of the material withheld and the
purposes of Rule 3.38(b).” See Matter of Int'l Telephone & Telegraph Corp, 1984 WL 565367,
at *127 (F.T.C. July 25, 1984). In other words, FTC precedent makes clear that “[t]here is no
good reason to allow what is essentially surprise expert testimony,” and that the FTC “should be
vigilant to preclude manipulative conduct designed to thwart the expert disclosure and discovery
process.” In the Matter of LabMD, Inc., 2014 WL 2331056, at *3 (F.T.C. May 8, 2014) (citation
omitted).

Complaint Counsel’s concealment was calculated to maximize ECM’s prejudice, leaving
ECM one day to process Dr. Michel’s files, prepare for a deposition, notice a deposition, and
complete same, an impossibility. ECM was also deprived of an opportunity to develop discovery
surrounding Dr. Michel’s work. For instance, Complaint Counsel took the deposition of Elsevier
on May 30, months after Complaint Counsel’s expert lists were due. Elsevier was Dr. Michel’s
publisher. ECM would have had a different interest while Participating in that deposition had it
known then that Dr. Michel would be called as an expert, particularly because the Elsevier
witness, who is located in Tokyo, will likely not appear at the hearing. Instead, ECM’s interest
in that deposition was altered by the stipulation which admitted Dr. Michel’s study document

into evidence without regard to authenticity and evidentiary concerns. Moreover, ECM had


—dS/dt = ksS(Sp + Xq — S)
_ Sot Xo
1 + (Xp/Solexplks(So + Xt}

Figure 6. Differential and integrated forms of the logistic model of microbial substrate utilization.

Inexplicably, later in the same report, Dr. Barber chooses a totally different model, a “first order model”,
to predict “half-lives” for BioPVC. Half lives are only valid if the biodegradation kinetics are first order,
but in this case a first order model does not fit the data as well as the logistic model and has a lower R”
value of 0.89 (Figure 5). Therefore, the “half lives” he reports in the report are invalid since the kinetic
data are inconsistent with a first order model.

A more appropriate kinetic model would be a two component mode! where one component (the ECM
additive) is biodegradable over a 6-10 month period, while the other (PVC) is not biodegradable over the
time period of the test. For such a two component model, the length of time for the ECM amended PVC
to biodegrade could not be estimated using a first order rate constant as was done in the Environ report.
But such a two component model would reduce mathematically to the very logistic model used by Dr.
Barber (since So and Xo for PVC would be zero).

in summary, from the data presented, and using the logistic model used by Dr. Barber uses, the time to
completely biodegrade BioPVC would be infinite.

Drs. Burnette and Sahu present very well documented, compelling and interesting reports regarding
microbial ecology, plastic degradation, and ECM amended plastic degradation. However they do not
provide convincing scientific evidence that ECM amended plastics will biodegrade in a landfill over 1 to 5
years as ECM has claimed. In fact most all of the studies and reports, including our own, indicate that
the biodegradation of ECM amended plastics in a landfill or most any natural environment, would take
many decades if not centuries. In a report cited by Dr. Burnette, the half lives used to predict the time
required for the biodegradation of ECM BioPVC, are based on erroneous application of a 1% order kinetic
model.

Respirometry tests that have been used to assess the biodegradability of a wide range of different
chemical compounds in the scientific literature, and are accepted by the scientific community, show that
ECM amended plastics degrade very slowly and to a limited extent. These tests are conducted under
conditions where microbial activity and diversity are high and likely much greater than in a landfill
environment.

The “threshold question” addressed by Dr. Sahu, of whether conventional plastics are biodegradable
over long periods of time, such as centuries or millennia, is really a moot point. As shown by nearly all of
the experts, polyethylene will degrade very slowly. Degradation can be marginally improved by

19

ECM Comb. Mot. to Exclude Page 19 of 24
Exh. V


pounds) will remain after 6 years. Comparatively, it would take almost 35 years for the same 50
pounds of mass to decompose in a Subtitle D landfill in an arid climate.

Table 1. Decay Rates and Half Life of Different Types of Landfills

Precipitation | Decay Rate Half Life
Landfill Type Gath EN (yrs)
Arid <20 0.02 346
Moderate 20 to 40 0.038 18.2
Wet >40 0.057 12.2
Bioreactor None 0.12 58

Waste, of course, is heterogeneous: different types of MSW will have different decay rates.
Table 2 below shows the IPCC’s decay values for various types of waste and climate.

Table 2. Ranges of Decay Rate (k) Values by Waste and Climate Type

Waste Type Example of Waste Type Decay Rate (k Values Half-life
(yr) (yrs)

Dry Wet Dry Wet
Climates Climates _| Climates | Climates

Slowly degrading wastes Paper. textiles. wood o1 straw 0.01 to 0.05 | 0.02 to 0.07 | 70to 14 3510 10

Moderately degrading Other [non-food] organic 0.04100.06 | 006to0.1 | 17 to 12 12to7
wastes putrescible/garden and park waste

Rapidly degrading Food waste and sewage sludge 0.05 100.08 | 0.1 to0.2 14to9 7 to 3.5
wastes

Bulk wastes Combination of above materials | 0.04 to 0.06 | 0.08 to 0.1 17 to 12 9to7

These more granular decay rates show that even im wet climates MSW that is readily
biodegradable (e.g, food waste) will take anywhere from 7-14 years to fully biodegrade.” And
the time for slowly degrading wastes takes up to 70 years m the same wet climate.

36. In short. whether considered by the entire landfill site. as um Table 1. or by the
particular biodegradable component of the solid waste mass, as in Table 2,one would not expect
complete biodegradation of even the most readily biodegradable component of MSW in the most

favorable conditions in less than 7 years

° A rough estimate of the time to complete decomposition for fully degradable organics is
double the half-life.

16

ECM Comb. Mot. to Exclude Page 16 of 56
Exh. X



5,883,199

9

FIG. 2 shows that both stiffness and stress at yield
decrease with increasing BIONOLLE#3000 content, while
elongation at yield and at break increase with increasing
BIONOLLE#3000 content Based on the data in FIGS. 1 and
2, FIGS. 3 and 4 show modulus (i.e., stiffness) and stress at
yield and break, respectively. The outstanding strain hard-
ening behavior of these blends was further exemplified by
the increasing difference in stress at break and stress at yield
with increasing BIONOLLE#3000 content.

FIG. 5 shows that the elongation at both yield and break
of polylactic aci¢/BIONOLLE#3000 blends increase with
BIONOLLE#3000 content, with a dramatic increase at
break above 10 percent BIONOLLE. FIG. 6 shows that the
toughness of polylactic acid/BIONOLLE#3000 blends
increases as a function of BIONOLLE#3000 content above
10 percent. Both FIGS. $ 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/BIONOLLE#3000 blends, and in toughness
of the blends when the BIONOLLE#3000 content was
increased to over about 10 cight percent to about 40 or 50
weight percent in the polylactic acid/BIONOLLE#3000
blends.

Tensile properties (modulus and elongation at break) after

Ss

aging for 7 and 21 days as a function of BIONOLLE#6000 *°

and BIONOLLE#7000 content are shown in FIGS. 7 and 8.
The modulus decreases (FIG. 7) and the elongation at break
increases (FIG. 8) with increasing BIONOLLE#6000 and
BIONOLLE#7000 content. As the aging time increases from
7 to 21 days, the modulus shows 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
break compared with those of polylactic acid/
BIONOLLE#6000 blends.

Unlike BIONOLLE#3000, BIONOLLE#6000 and BION-
OLLE#7000 do not increase the elongation at break signifi-
cantly when 10 to 40% by weight of BIONOLLE#6000 or
BIONOLLE#7000 is blended with polylactic acid. This may
be due to the fact that pure BIONOLLE#6000 and BION-
OLLE#7000 do not possess the same tensile properties of
BIONOLLE#3000, and also more importantly, the compat-

ibility of polylactic acid with BIONOLLE#6000 and BION- 4

OLLE#7000 is not as good as that of polylactic acid and
BIONOLLE#3000. However, the compatibility of polylactic
acid with BIONOLLE#6000 and BIONOLLE#7000 can be
improved with the addition of a suitable compatibilizer, such
as a small amount of BIONOLLE#3000.

Example 2
Aging Effect

‘The effect of aging on the blends was measured by
physically aging the samples at room temperature and
atmospheric pressure, and subsequently testing the samples
by tensile testing according to ASTM D 882 with the
modifications already stated above.

FIG. 9 shows elongation at break of polylactic acid,
BIONOLLE#3000, and their blends, as a function of aging.
The elongation at break of polylactic acid was below 8%,
and decreased to about 5% with aging. Similarly, the elon-
gation at break of A90B10 was rather low (about 50%) and
decreased 10 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-
gation for 20% BIONOLLE#3000, and similarly, 300% for
30%, 400% for 50%, and 500% for 70%, respectively). In

ECM Comb. Mot. to Exclude
Exh. Z

50

10
addition, these BIONOLLE#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 per-
formed on 0.3 mm thick films of the blends using the
respirometric method developed at the NSF Biodegradable
Polymer Research Center, University of Massachusetts
Lowell and designated UML-7645. A standard soil mix
(1:1:0.1 potting ‘soil:sand:dehyérated cow manure by
weight) was prepared and characterized, The soil test mate~
rials were exposed to the soil under controlled aerobic
conditions at 30+#2° C. Carbon dioxide production,
expressed as a fraction of the measured of theoretical carbon
content of the test materials, was measured as a function of
time. The degree of biodegradation of the test material is
assessed by comparing the amount of CO, produced from
the test material to that produced from a standard material,
i.¢., one that is known to biodegrade (here PLA was used for
comparison).

Specifically, the soil biodegradation test was conducted as
follows. Fifly grams (oven-dry weight basis) of soil was
weighed into a large (14 cm) 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 of 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, the amended soil 16 was transferred to a large
chamber 20 of a 250-mL biometer flask 22, packed to a
uniform depth (about 2.5 cm), and covered by the 15 g of the
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., AscariteTM),
between plugs of a filter material 28, e.g., glass wool or
cotton, that allows air, but not the AscariteTM, to pass.

The combined weight of the flask, rubber stopper, and
amended soil containing the test specimen was determined
and recorded. Twenty mL of 0.4M sodium hydroxide was
pipetted into the side-arm chamber 30 of the biometer flask
22 and the side-arm chamber 30 was sealed with a rubber
stopper 32. The biometer flask was placed in an environ-
mental chamber at 30° C and this chamber was kept dark.

The carbon dioxide analysis was done by reacting the
carbon dioxide produced in the biometer with the sodium
hydroxide in the side-arm chamber to form an aqueous
solution of sodium carbonate, The amount of carbon dioxide
produced was monitored by removing the sodium hydroxide
from the trap and transferring it to a glass test tube to which
5 mL of 1.5M barium chloride was added. The barium
chloride reacts with the sodium carbonate to form a precipi-
tate of barium carbonate, The amount of carbon dioxide
evolved was calculated by stendard stoichiometric calcula-
tion.

The net degradation was measured as the ratio of carbon
dioxide evolved to the amount of theoretical maximum
carbon dioxide production possible by the test specimen.
The theoretical maximum carbon dioxide production was
determined by the total organic carbon content of the test
material (by calculation, if the chemical composition was
well established, or elemental analysis), The maximum
amount of carbon dioxide that can be theoretically evolved
was calculated by the equation:

Maximum carbon dioxide>{(WxCy100}{44/12]

Page 76 of 80


sloppy methodology—or it could reflect background decomposition of the organic components
in the compost. If 20% of cellulose biodegradation derives from background decomposition,
then a significant portion (or perhaps all) of the 19% biodegradation of the ECM film may
likewise derive from background decomposition. Either way, the data is not reliable.

72. Third, even assuming the methodology and the data were correct, the 50% ECM
film shows only 20% decomposition over the 60-day composting process. Since the ECM
Additive is known to contain 60-70% biodegradable component and composting (unlike
landfills) presents ideal conditions for biodegradation, the 20% decomposition is entirely
consistent with degradation of the biodegradable component only.

73. Fourth, the ChemRisk/McLaren Assessment uses a true statement to present a
misleading conclusion. On page ECM-FTC-0001 1 1, the Assessment states that: “in time,
plastics produced using ECM pellets will biodegrade in aerobic conditions.” That statement is
true but misleading: given enough time—centuries, eons—anything will biodegrade. That does
not mean that ECM plastics will biodegrade in any timeframe close to five years.

74. Fifth, the ChemRisk/McLaren Assessment erroneously conflates disintegration
with degradation. The figure on page ECM-FTC-0001 13 claims to demonstrate that “LLDPE
[plastic comprised of low-density polyethylene and ECM additive] cast film strips totally
degraded” because they are fragmented in the picture. Disintegration does not necessarily entail
biodegradation. To illustrate, consider how wet paper will shred; such disintegration is entirely
unrelated to biodegradation. Without other reliable indicia of biodegradation, it is more likely

that the ECM Additive causes fragmentation than biodegradation.

29

ECM Comb. Mot. to Exclude Page 29 of 56
Exh. X


Synthesis and characterization of pullulan-polycaprolactone core-shell nanospheres encapsulated
with ciprofloxacin, Sally Shady, Peter Gaines, Rahul Garhwal, Charles Leahy, Edward
Ellis, Kathryn Crawford, Daniel Schmidt, Stephen McCarthy, Journal of Biomedical
nanotechnology, Vol. 9, Issue 9, (2013) pg. 1644-1655.

A study on recycling of polyhydroxybutyrate (PHB) copolymer and its effect on material
properties, Annual Technical Conference - Society of Plastics Engineers, Bhavin Shah,
Robert Whitehouse and Stephen McCarthy vol. 70, (2012) pg 260-264.

“Improved dialysis technique for core-shell pullulan-polycaprolactone (PCL) nanospheres
loaded with hydrophobic ciproflaxcin”, Sally Shady-Elghamrawi, Daniel Schmidt &
Stephen McCarthy, (2011), 69" (vol. 3), pp1982-1988.

“Electrospun silk material systems for wound healing”, Scott E. Wharram,.; Xiaohui Zhang;
David L Kaplan.’ Stephen P. McCarthy, Macromolecular Bioscience (2010), 10(3), pp246-
257.

“The Effect of Hyperbranched Polymers on Processing and Thermal Stability of Biodegradable
Polyesters”, Y. Shaked, Hanna Dodiuk, Samuel Kenig and Stephen McCarthy, Polymer
Engineering and Science, (2009).

“Adhesion of Plastics With Bone: A Comparative Study Using Commercially Available
Adhesives and Biodegradable Polymer Melt”, Anshuman Shrivastava and Stephen
McCarthy, 66" Annual Technical Conference — Society of Plastics Engineers, (2008),

“Processing and Blends of Biopolymers”, 66" Annual Technical Conference — Society of
Plastics Engineers, (2008)

“Improving the toughness of poly(lactic acid)(PLA) through co-continuous, immiscible,
biodegradable blends with PHA”. With Jinkoo Lee, Annual Technical Conference -
Society of Plastics Engineers (2007), 65th 1569-1572.

“The effect of polymer surface on the wetting and adhesion of liquid systems”, P.F. Rios, H.
Dodiuk, S. Kenig, A. Dotan, Journal of Adhesion Science and Technology (2007), 21(3-
4), 227-241

“Transparent ultra-hydrophobic surfaces”, P. F. Rios, H. Dodiuk, S. Kenig, A. Dotan, Journal of
Adhesion Science and Technology (2007), 21(5-6), 399-408. CODEN: JATEE8
ISSN:0169-4243.

“The Effect of Nanoclays on the Properties of PLLA-modified Polymers: Part I: Mechanical and
Thermal Properties”, D. Lewitus, A. Ophir, S. Kenig and S. McCarthy, J. Polymers and the
Environment, Vol 14, no. 1, pp. 171-177, (2006).

“Nanotailoring of Polyurethane Adhesive by Polyhedral Oligomeric Silsesquioxane (POSS),
with T. Efrat, H. Dodiuk and S. Kenig; J. Adhesion Science Technology, Vol. 20, No, 12,
(2006), pp. 1413-1430.

“Mechanical Testing and Characterization of Biopolymers”, Society of Plastics Engineers
Annual Technical Conference, (Vol. 64), (2006).

“The Effect of Nanostructure and Composition on the Hydrophobic Properties of Solid
Surfaces”, with P.F. Rios, H. Dodiuk, and S. Kenig, J. Adhesion Science Technology, Vol.
20, No. 6, pp. 563-587, (2006).

“Biodegradable Hollow Nanospheres for Drug Delivery”, with Balint Koroskenyi, Robert
Nicolosi, Society of Plastics Engineers Annual Technical Conference, (2005), (Vol. 63), p.
3096-3099.

“Electrically Conductive Nano-composites in Powdered Injection Molding”, with Ankur
Maheshwari, Society of Plastics Engineers Annual Technical Conference, (2003), (61°)
(Vol. 61), pp. 616-619.

“Biodegradable Polymers”, Stephen P. McCarthy, Plastics and the Environment, Ed. Anthony L.
Andrady, John Wiley & Sons, (2003), pgs. 359-377.

ECM Comb. Mot. to Exclude Page 45 of 58
Exh. U


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ECM Comb. Mot. to Exclude Resp. Mot to Compel and For Safiions 8 of 12

1
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER



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ECM Comb. Mot. to Exclude Page | of 1
Exh. O


J Polym Environ (2011) 19:637 676

Fig. 18 Porous three dimensional structures developed from PLGA
using (a) gas foaming (reprinted from Ref. [527] with permission
from Elsevier), (b) microsphere sintering (reprinted from Ref. [528]

a
3

a
8
3

&
Ss

Swelling ratio (%
$

ia
4:20 1.30

°

cS 4:2 1:6 1:7 1:0
CS/LLA

Fig. 19 Swelling studies of CS and CL graft copolymers

than the original chitosan (showed no significant degrada-
tion in lipase), which indicated that the chitosan segment
consisting of glucosamine residues is not accessible to the
lipase active site and the random distribution of OLLA side
chains is at least required to be adsorbed to the active sites
of the lipase. As lipase is one of the main enzymes present
in the human body, the higher susceptibility of CL graft
copolymers towards lipase than that of chitosan and OLLA
would increase its potential in biomedical field. SEM
micrographs of CL graft copolymers (Fig. 20) taken after
8 h immersion in papain medium showed severe surface
erosion in many of the graft copolymers where the latic
acid content is low. These results indicate that the physico-
chemical properties and the rate of degradation of graft
copolymers as a biomaterial could be controlled by
adjusting the amount of LLA in the CL graft copolymers.

Random Multiblock Poly(Ester Amide)s Containing
Poly(L-Lactide) and Cyclo Aliphatic Amide Segments

The lack of certain optimum properties such as thermal,
mechanical and processing limits their wider use of ali-
phatic polyesters (PE) mainly poly(L-lactic acid) (PLLA),
poly(glycolic acid) (PGA) and their copolymers which are
the best known biodegradable, biocompatible polymers used
intensively in biomedical field. Aliphatic polyamides (PA)
have better thermal and mechanical properties than aliphatic

Q Springer

ECM Comb. Mot. to Exclude
Exh. Z

with permission from Elsivier) and (c) electrospinning (reprinted from
Ref. [529] with permission from Wiley Interscience

polyesters, but their hydrolytic degradation rate is too low to
classify them as biodegradable polymers. Therefore, by
incorporating polyamide segments into the PLLA main
chain, it could be possible to synthesize a polymeric material
Possessing good material and processing properties and
biodegradability than their homopolymer counterparts.

Pillai and Luchachan have prepared random multiblock
poly(ester amide)s containing PLLA macromer and
cycloaliphatic amide segments by the “two-step” interfa-
cial polycondensation method [526]. The resulting poly-
mers exhibit inherent viscosities in the range of
0.37 0.48 dL 4)/g. PEAs having lower content of PLLA,
PEA | and PEA 2, show a single diffraction signal at 20.8°
20 and a single melting transition at 166 and 164 °C,
respectively, indicating an amide-adjacent crystallization
of copolymers. In PEA 3, the diffraction signals (16.7 and
18.8° 26) and melting transition (101 °C) characteristic of
PLLA macromer are also appeared. This was attributed to
the development of a crystalline structure of the PLLA type
at higher ester content, revealing the blocky nature of
PEAs. The random nature of PEAs is confirmed by the
appearance of single T, values. Even though the prepared
PEAs are in low molecular weight (0.35 0.44 dL/g), they
show a thermal stability unto a temperature of 230 °C. This
may be attributed to the presence of strong hydrogen bond
interactions between ester and amide groups and the
presence of rigid cyclic ring structures in the polymer
backbone. Since no evidence of thermal decomposition
was observed below a temperature of 200 °C, they can be
processed from the melt state. All PEAs are susceptible to
lipase promoted degradation and the rate of degradation
increased with increase in PLLA content. Spectroscopic
investigations and thermal analysis of degraded products
show the breakage of ester linkages. The results indicate
that by the incorporation of cycloaliphatic amide segments
onto the PLLA macromer it could be possible to synthesize
PEAs having good thermal properties and biodegradability
at the lower molecular weight that would increase its
potential in the biomedical applications.

Page 24 of 80


Table 1.° Nevertheless, Dr. McCarthy recites in claim 1 of the ‘199 patent that one can
Prepare a “biodegradable blend” of “(a) a first polylactic acid-based polymer or
copolymer, and (b) a second polymer consisting essentially of one or more polyesters.”
Accordingly, Dr. McCarthy extrapolated from the five (5) blends recited in Table 1 and
the data presented in FIGS. 11 and 12 to the claim that PLA copolymers, in
combination with any polyester, would provide a biodegradable blend formulation.
Moreover, I am of the view that contrary to Dr. McCarthy’s assertion, it is accepted
among polymer scientists to extrapolate biodegradation testing to support a conclusion

that a polymer will biodegrade. See, the ‘199 patent.

Comment by Dr. McCarthy

At paragraph 12 of his rebuttal, Dr. McCarthy points out that if a polymer chain such as
polyethylene is short enough it can be attacked by microorganisms. Dr. McCarthy then goes on
to state that “the only way to reduce PE to this molecular weight is through a pro-oxidant (not

ECM technology) or exposure to other oxidative degradation environments.”
Rebuttal

I disagree with Dr. McCarthy that the only way to achieve biodegradation in PE is to utilize a
pro-oxidant. In the above referenced 2011 article entitled “Biodegradable Polymers-A Review
On Recent Trends and Emerging Perspectives,” by G. Luckachan and C. Pillai, at page 647, the
authors review existing methods to facilitate polyethylene degradation. They mention: (1)
insertion of weak links into the polymer; (2) compounding of polymer with preoxidants and
photosensitizers; (3) blends of biodegradable and non-biodegradable polymer; and (4) grafting
of natural monomers onto nonbiodegradable polymers. I note that the ECM Additive falls into
the reported category of facilitating polyethylene degradation by blending of a biodegradable

and non-biodegradable polymer.

Comment by Dr. McCarthy

* Dr. McCarthy asserts that an evaluation for biodegradation should include “a starting molecular weight for the
test sample and the negative control.” McCarthy Expert Report at page 33. As noted, there is no “negative
control” in the ‘199 patent and as noted, there is no indication of the starting MW for the particular PLA-
BIONELLE blends reported in Table 1 and analyzed in FIGS. 11 or 12.

Page 16 of 20

ECM Comb. Met. to Exclude Page 16 of 20
Exh. W


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 37

¢. ECM Plastics will completely biodegrade in most landfills within one to five
years is false and unsubstantiated.

d. ECM Plastics will completely biodegrade in any disposal environment at an
appreciably faster rate and extent than conventional plastics without the ECM
Additive is unsubstantiated.

e. Various scientific tests, including but not limited to ASTM D551 1, have shown

that ECM Plastics perform as indicated in (a)-(d) above is false.

ECM Comb. Mot. to Exclude Page 37 of 58
Exh. U


Bronberg & Sunstein (1996 expert witness/patent infringement, E. Belt, Bailey v.
M&N Plastics et.al.. Bailey v. Therma Systems Corporation. Civil Action No. 94-11
140-DPW: Bailey v. Dart. Inc. (D.C. Mass.)

Calhoun & Associates (1996 expert witness/patent infringement, TFH Publications v.
Edwards. Civil Action No. 94-1945 (D.C.N.J.)

United States Government-Internal Revenue Service-District Counsel (1996, expert
witness,/plastics recycling, Robert Gottsegen v. Commissioner of Internal Revenue. United
States Tax Court Dkt No.23766-93.3. Dawson)

Halloran & Sage, Merocel Corp. v. Ultraceli Medical Technologies. Inc., (Civil Action No.
393CV1041 (D.C. Connecticut)

Bemis Associates

Arthur D. Little Corporation

Megas Manufacturing

Ahiomed Comoration

Sandier & Travis, P.C. (1986-87 expert witness/plastic materials)

Ingersorl Rand

Laflamme, Migliori, Barron & Chabot (1987 expert witness/plastic materials)
Land & Sky Incorporated

Critikon

Kontron

Ciba-Coming

Anglo-American Clays Corporation

Polysar

McDermott, Will & Emery (1987, expert witness/patent infringement for Dennison
Manufacturing before The United States International Trade Commission, Administrative

Law Judge Sidney Harris (1987)) Dennison Manufacturing
Liskow & Lewis

Page 16 of 17

ECM Comb. Mot. to Exclude Page 16 of 17
Exh. Y


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 26

of a biodegradable polymer with a conventional plastic does not alter the chemical structure of
the conventional plastic. Because the additive does not alter the chemical characteristics that
make conventional plastics resistant to biodegradation, the non-biodegradable plastic component
is no more susceptible to biodegradation after blending than it was before.

65. As explained above, conventional plastics are considered non-biodegradable. Of
course, all things will eventually biodegrade. The actual amount of time it would take for
conventional plastics to biodegrade is unknown, but scientists have estimated anywhere from
500 to 10,000 years, depending on the molecular weight of the plastic and the environment.
Even assuming that the addition of 1% ECM additive (biodegradable component) would allow
the ECM Plastic to degrade faster (e.g., by breaking the plastic into smaller pieces), the amount
of time it would take for the conventional plastic to completely biodegrade would not be reduced
to five years or even decades in any environment. ECM Plastic could take as long as the
conventional plastic to biodegrade (because it still consists of 99% conventional plastic), or even
longer (if the fragmented pieces become recalcitrant to biodegradation). Thus, claims that ECM
Plastic will completely biodegrade in periods of time as short as five years cannot be true.

66. I cannot conclude with scientific certainty that ECM’s claim that ECM Plastics
biodegrade faster than conventional plastics is false. Without additional testing, it is impossible
to know whether the resulting degraded plastic would biodegrade faster than untreated

conventional plastic.
B. ECM’s Unsubstantiated Claims.

67. All of ECM’s claims identified above lack scientific support for at least three

reasons. First, ECM did not conduct any confirmatory-level tests, and none of ECM’s screening-

ECM Comb. Mot. to Exclude Page 26 of 58
Exh. U


authenticity of the study during fact discovery. The parties specifically reserved rights to introduce additional evidence
regarding the weight and probative value of the study.

Obviously, we disagree that there is any basis to move to exclude Dr. Michel’s rebuttal report or him as an expert
witness generally. Or that identifying him as a rebuttal expert warrants sanctions. In fact, because you failed to raise
this in the “meet and confer”, | am at a loss to see what basis ECM could possibly have to support sanctions.

As for the word count, we will not consent given that (1) there is no basis to exclude the study given the stipulation; (2)
there is no basis to exclude Dr. Michel as a rebuttal expert; (3) and there is no basis for sanctions. To the extent that
ECM seeks leave of the court to name a surrebuttal expert, we would consent to that relief, provided that, we have the
opportunity to depose the expert regarding the scope of the surrebuttal.

Best,
Katherine

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: kiohnson3@ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emerd.com]

Sent: Tuesday, July 08, 2014 5:58 PM

To: Johnson, Katherine

Cc: Cohen, Jonathan; Jillson, Elisa; Jonathan Emord; Eric Awerbuch
Subject: Meet & Confer; Motion for Leave to Exceed Rule 3.22 Word Count

Counsel:

As we discussed last week, ECM intends to file a combined motion to exclude Dr. Michel, his report, and his study. That
motion stems from the failure to disclose Dr. Michel as a witness. Last week we met and conferred on the relief we
intend to request in those motions. However, ECM now requests a conference concerning its anticipated motion for
leave to exceed the 2,500 word count in Rule 3.22(c). We intend to request an additional 2,000 words in support of a
combined motion: (1) to exclude Dr. Michel and his report; (2) for sanctions; and (3) for leave to add a surrebuttal
expert. Although ECM could use 2,500 words for each motion individually, the overlapping facts and procedure make a
combined motion most appropriate.

ECM would of course agree to a reciprocal extension for your opposition. Please let us know if you consent to the
extension or if you would oppose it by noon Eastern tomorrow. | am available to discuss if you have any questions.

Best,

Peter A. Arhangelsky, Esq. | EMorD & Associates, P.C. | 3210 S. Gilbert Rd., Ste 4 | Chandler, AZ 85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed above. The content of this communication is protected from
disclosure by the ationey-client privilege and the work product doctrine. If you are not the intended recipient, you should trect this

2
ECM Comb. Mot. to Exclude Page 2 of 3
Exh. DD


Dr. Frederick will testify, from his perspective as an expert in the fields of marketing and
consumer decision-making, about his analysis and/or performance of studies concerning
consumers’ perception of biodegradable marketing claims and ECM’s biodegradability claims.

27. Thabet Tolyamet, Ph.D.

Dr. Tolyamet is an Environmental Engineer and researcher in the field of solid waste
management at the U.S. Environmental Protection Agency’s Office of Research and
Development. His research focuses on solid waste management, bioreactor landfills, waste
containment performance, construction and demolition of waste landfills, and the fate and
transport of environmental pollutants. A significant part of his education, training, and
experience has involved conducting and evaluating tests that purport to show biodegradation
and/or replicate landJill conditions.

Dr. Tolyamet will testify, from his perspective as an expert in the field of landfill design
and management, about whether plastic products manufactured with ECM’s additive will
completely biodegrade in five years or less under ordinary U.S. Jandfill disposal conditions, and
whether ECM testing data are not competent and reliable scientific evidence that ECM Plastics

will biodegrade in five years or less in most landfills.

Dated: June 11, 2014 Respectfully submitted,

wh owl tae
(Leh ile 6.
Katherine Johnson (kjohnson3@fic gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)
Federal Trade Commission
600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580
Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

15

ECM Comb. Mot. to Exclude Page 15 of 16
Exh. F


Biodegradability of PVC”, GPEC 2006 Paper, R.F. Grossman Ph.D, RFG Consultants, J.E.
Schleicher, Jr. and L. D’Alessio, Ultraflex Systems.

Conclusion

For the foregoing reasons, ] disagree with the identified opinions and analysis offered by Drs.
Michel and McCarthy in their respective rebuttal reports. In support of my opinion I have
identified various scientific publications and Dr. McCarthy’s U.S. Patent No. 5,883,199. This
information supports my opinion that Dr. McCarthy has applied a standard for evaluation of
whether ECM’s Additive is biodegradable that is not present in the peer-reviewed scientific
literature, and that is contrary to the standard that he adopted to identify a material as
biodegradable in his own publications and in his U.S. Patent No. 5,883,199. With respect to
Dr. Michel, I have identified what I consider to be serious deficiencies of his 2013 article
Biodegradability of Conventional and Biobased Plastics and Natural Fiber Composites During
Composting, Anaerobic Digestion and Long Term Soil Incubation and in his endorsement of

the McCarthy report and analysis.

Dated: 7-7-1 4 JAA ee

Dr. Steven J. Grossman

Page 20 of 20

ECM Comb. Mot. to Exclude Page 20 of 20
Exh. W


S. Grossman and K. Onder, "Anionic Polymerization of Lactam With Azetidine-2,4-Diane
Promoter", U.S. Patent 4,550,157 (1985)

S.Grossman and K. Onder, "Copolyamide-Inmides Based on MDI, TMA and Two
Dicarboxylic Acids", U.S. Patent 4,467,083 (1984)

d. Papers Presented at Meetings

SPE-ANTEC 2012 (Orlando) The America Invents Act: Six Key Changes in U.S. Patent
Law

SPE-ANTEC 2011 (Boston) Recent Procedures Introduced To Challenge Patent Grants At
The USPTO

Eastern New England Society of Plastics Engineers, October 2005 — “Ten Things Plastics
Engineers Should Know About Intellectual Property”

Eastern New England Society of Plastics Engineers, October 2003, “Recent Developments
in Intellectual Propety”, Massachusetts.

Eastern New England Society of Plastics Engineers, October 2001, “Recent Developments
In Intellectual Property, Massachusetts.

M. Huang and S.J. Grossman, "Ethylene Glycol, Polyethylene Glycol and Polypropylene
Glycol as Plasticizers for Nylon-6,6", presented at the 1987 SPE-ANTEC in Los Angeles.

S. B. Driscoll and S.J. Grossman, "Polymer Materials in the Undergraduate Program",
presented at the Spring Meeting of the American Chemical Society, New York, April 13-
18th (1986).

S.S. Chung and S.J. Grossman, "DSC Studies of Polymerization and Crystallization of
Nylon-RIM Materials-P’, presented at the Spring Meeting of the American Chemical
Society, New York April 13-18th (1986).

$.S. Chung and S. J. Grossman, "DSC Studies of Polymerization and Crystallization of
Nylon-RIM Materials-I ", presented at the Spring Meeting of the American Chemical
Society, New York, April 13-18th (1986).

S. Grossman, P.S. Andrews and K. Onder, "Synthesis of Polyamides from Aromatic
Dusocyanates and Dicarboxylic Acids", presented at the International Union of Pure and
Applied Chemistry-28th Macromolecular Symposium-Amherst, Massachusetts (1982).

S. Grossman, "Synthesis of Polyamides from 4-4'~Methy1ene-Bis(isocyanatobenzene),
Poster presentation at the 1981 Gordon Research Conference on Polymers.

Page 11 of 17

ECM Comb. Mot. to Exclude Page 11 of 17
Exh. Y¥


Considerations Affecting Biodegradability of PVC

Richard F. Grossman
RFG Consultants

Background

Polyvinyl chloride (PVC) is one of the most useful materials available
to the fabricator, being capable of formulation so as to produce a
range of forms from soft coatings to durable structural articles. PVC
combines good physical properties, chemical, flame, abrasion and
weathering resistance with low cost. It has, nevertheless, been
subject to strong non-economic competition based on the allegedly
evil effects of chlorine. Thus articles are promoted as “halogen free,”
despite the fact that in the absence of chlorine, all life on earth would
cease.

Much of this attack has been based on perceived difficulty of
disposal. Considerable industrial PVC scrap is recycled as work-off
into the original products or into lower end articles, such as garden
hose tube. Incineration of post-consumer scrap is unattractive since
HCI from combustion must be absorbed, requiring a level of
investment not consistent with the fuel value of the scrap. This places
emphasis on the ability to dispose of post-consumer PVC scrap by
landfilling.

Hitherto PVC has been considered immortal in the landfill [1]. A
number of halogenated compounds are, nevertheless, subject to
biodegradation. Bacteria and fungi exist that can, in their search for
organic carbon, metabolize PCB’s and pentachlorophenol and are, in
fact, in use in remediation of contaminated sites. These compounds
are, however, of low molecular weight. In general, microorganisms
can metabolize almost any organic carbon compound of relatively low
molecular weight, as well as polymers, such as cellulose, if they have
evolved enzymes to reduce it to low MW, such as cellulose to sugar.
To date, microorganisms have not been reported that have
developed enzymes capable of MW reduction of synthetic addition
polymers such as PVC.

ECM Comb. Mot. to Exclude Page 42 of 80
Exh. Z


646

J Polym Environ (2011) 19:637 676

08
=
2s
2 os
5
3 04
3
=
02
oo
o 2 4 6 8 10 12 14 16
Volume of NaOCl (7.5%)(mL)
20 40 60 80 100 420

Temperature (°C)

Fig. 4 Degradation of bacterial polyhydroxyalkanoates. Increasing
the concentration of the C6 comonomer increases the rate of
degradation, (Reproduced from Ref. [227])

MCL-PHAs are of great interest because the functional
groups present in them can improve the physical properties
of the polymers, allowing the creation of tailor-made prod-
ucts [228]. In the very near term, metabolic engineering will
help solve many problems in promoting PHA as a new type
of plastic material for many applications. A similar view is
held by Sun et al. who reviewed the area recently [230].
The process known as “feast and famine” or as “aerobic
dynamic feeding” seems to have a high potential for PHA
production by mixed cultures [202]. Production of PHA by
transgenic plant may be economically viable if efforts are
concentrated at improving this process [231]. It may be
possible in the near future to see farmers growing plastics in
their field and a new agricultural product “plastics fruit” may
appear in our market by transgenic plant [232, 233]. Several
reviews have appeared recently covering various aspects of
the production of biodegradable PHAs listing their properties
and applications [234 242]. There are also attempts to evolve
novel methods of production of aliphatic polyesters with
controlled macromolecular parameters by still “greener”
ways [242]. Copolymerization has been advocated to
improve biodegradability and other properties (243 246]
Industrial firms are now commercializing PHA as nat-
ural plastics made from renewable resources such as corn
sugar and vegetable oils. Within the foreseeable future, this
technology will also enable the production of these plastics
directly in non-food plant crops. These high performing
new materials have the potential to put a large portion of
the plastics and chemicals industry on a sustainable basis.

®D Springer

ECM Comb. Mot. to Exclude
Exh. Z

However, these bioplastics are currently far more
expensive than petrochemical based plastics and are
therefore used mostly in applications that conventional
plastics cannot perform, such as medical applications.
PHAs are immunologically inert and are only slowly
degraded in human tissue, which means they can be used as
devices inside the body. Recent research has focused on the
use of alternative substrates, novel extraction methods,
genetically enhanced species and mixed cultures with a
view to make PHAs more commercially attractive.

Polylactic acid and Copolymers

The significance of polylactic acid as an emerging biode-
gradable polymer can see from the large number of reviews
that have appeared on the system recently (88, 247 279].
(See discussion provided later).

Synthetic Biodegradable Polymers

Synthetic polymers, in general are non biodegradable.
However, polymers with hydrolysable backbones such as
polyesters [97, 119, 276, 280 282], polycaprolactone
[51, 83], polyamides[282 290], polyurethanes [291 299],
polyureas [300], polyanhydrides [301 306}, poly(amide-
enamine)s [96], poly(ester amide)s [96], poly(orthoesters)
[307], poly(phosphoesters) [308, 309] and vinyl polymers
containing easily oxidizable functional groups (eg.,
poly(vinyl alcohol), poly(vinyl esters) and polyacrylates)
are susceptible to hydrolysis and enzymatic biodegradation
[310, 311]. These polymers have interesting properties and
potential applications. The cost of production is the main
barrier for the wide utilization of these polymers. Structural
analysis indicates that a linear polyamide backbone is key
to the total biodegradability of the acid-catalyzed polyas-
partates. Polyesters represent one of the most promising
families of biodegradable polymers which are used in fields
such as packaging for industrial products, mulching for
agriculture, or bioresorbable biomaterials for hard tissue
replacement and controlled drug delivery systems. Their
degradation products are fully nontoxic substances or
the starting monomers that satisfy the environmental
requirements. A few monomers such as 1,3-propanediol,
1,4-butane diol, y-butyrolactone, adipic acid, n-methyl-
pyrrolidone, succinic acid and lactic acid produced by
fermentation from renewable resources are potential can-
didates for production of biodegradable polyesters.

The synthetic strategies involve (1) production of olig-
omeric or copolymeric «,f-dihydroxyl-terminated oligo-
succinates, by thermal polycondensation of succinic acid
with 1,3-propanediol/1,4-butane diol, or a mixture of 1,3-
propanediol and 1,4-cyclohexanedimethanol. (2) Chain
extension with via the chloroformate synthesis, affording

Page 10 of 80


1k. Kristen M. Isabel, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

12. Michelle L. Johnson, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

13. Michael J. Montesanto, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

14. Janet Morcillo, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

15. Jamie S. Morton, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

16. Alan C. Poje, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

17. Edwin J. Senter, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

18. Kathryn M. Stuber, Former Employee of ECM Biofilms, Inc.
Proposed Testimony: We anticipate that this witness will testify about ECM’s products,

distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

ECM Comb. Mot. to Exclude Page 4 of 11
Exh. A



5,883,199

7

Were cut into 20 mmx20 mm samples for testing biodegra-
dation in soil and in composting environmeats.
Testing Methods

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, the
samples were physically aged a! room temperature and
atmospheric pressure. The tensile test was done according to
ASTM D 882 with the following modifications. The grip
separation used was 38,1 mm (1.5 inches) instead 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%.

Biodegradation testing in an artificial soil environment
was performed on films of the blends using the respirometric
method developed at the NSF Biodegradable Polymer
Research Center, University of Massachusetts Lowell and
designated UML-7645. This test method covers the deter-
mination of the degree and rate of aerobic biodegradation of
synthetic plastic materials (including formulation additives)
in contact with moist soil under controlled laboratory con-
dition. Carbon dioxide production, as a fraction of the
measured theoretical carbon content of the test materials, is
reported as a function of time. The test is designed to
determine the biodegradability of plastic materials, relative
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 environ
ment was conducted on film samples in a simulated munici-
pal compost as described in Example 4.

In addition, morphology of the blends was observed under
polarizing optical and scanning electron microscopy.

Uses of Polylactic Acid-Based Blends

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
incinerated with only slight damage to the furnace since the
heat of combustion is relatively low, and no ioxic 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,
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 bottles, cutlery, brushes,
combs, molded and extruded foamed articles such as pack-
ing 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 terephthalate. In addition, these blends can
be processed into films that are beat-sealabic, unlike poly-
ethylene terephthalate.

EXAMPLES,

The following examples further describe the invention
without limitation.

Example 1

Tensile Testing
The tensile (est was done according to ASTM D 882 with
the modifications ia the sample length between grip sepa-
ration and the grip separation rate, as stated above

ECM Comb. Mot. to Exclude
Exh. Z

35

a

4s

s

60

Specifically, 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,
14, 21, 35, 40, and 70 days after making the samples. During
this 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
of the initial linear portion of the stress-strain curve. Stress
was measured as the nominal stress defined as force per unit
original area. Strain and elongation are used as synonymous
terms, and they were measured as percent change in length
per unit length of a sample. The yield point of the blends,
ie., 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
curve and the flat 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 that a specimen would fail
within its upper two thirds was selected. The cross sectional
area of the specimen at several points along its length wes
measured to an accuracy of 0.0025 mm. The initial grip
separation was at 38.1 mm. The rate of grip separation rate
was set at 0.5 inches/minute for samples with less than 20%
elongation at break, and at 2 inches/minute for samples with
more than 20% clongation at break. The load cell of the
Instron tester was balanced, zeroed, and calibrated for
measuring and recording force. The rectangular test speci-
men was placed in the grips of the Instron testing machine,
taking care to align the long axis of the specimen with an
imaginary line joining the points of attachment of the grips
to the machine. The grips were tightened evenly and firmly
to the degree necessary to minimize slipping of the specimen
during test. The Instron machine was started and stress
versus grip separation was recorded.

Tensile stress (nominal) was calculated by dividing the
load by the original minimum cross-sectional area of the
specimen in the loading direction. The modulus value was
determined from the initial slope of the stress-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 elongation
at break was calculated by dividing the extension (ie., grip
separation) at the moment of rupture of the specimen by the
initial length of the specimen between the grips. Yield stress
and perceatage 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 BION-
OLLE#3000 and polylactic acid are shown in FIGS. 1 and
2. These 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, ASOB50, A30B70, and
BIO#3000. FIG. 2 is a expanded view of the initial portion
of the stress-strain curves in FIG. 1, ie., up to a strain of
50%. The 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

5 occurred in the strain range of 300-500%, and the corre-

sponding increase in stress was from about 25 MPa to about
50 MPa.

Page 75 of 80


containing additives that supposedly confer biodegradability to polymers such as polyethylene and
polypropylene did not improve the biodegradability of these recalcitrant polymers”)...”

(Dr. McCarthy is wrong. Gomez and Michel is not the only published and peer reviewed study to address
this question. See my discussion on the threshold question including the numerous citations (and the
many more citations within the cited papers). Several of the papers that | cite specifically address PE/PP
biodegradation.)”

Rebuttal-

Actually, the paper by Gomez and Michel (2013) is the only peer reviewed scientific publication to report
on the biodegradation of ECM amended plastics. Even after very long incubation periods in soil, during
composting and during anaerobic digestion, ECM amended plastics did not biodegrade to a greater
extent than unamended polyethylene. Neither conventional nor ECM amended plastic degraded to a
significant extent in any of the three environments reported in the paper, while the positive control
(cellulose) and biodegradable plastics made from polyhydroxyalkanoate were mineralized to a
significant extent (see Figures 1 and 2).

Sahu Comment-

“These findings of no biodegradation are also consistent with the only peer reviewed article that has
addressed testing of the ECM additive. This article, by Gomez and Michel, entitled “Biodegradability of
conventional plastics and natural fiber composites during composting, anaerobic digestion and long term
soil incubation” tested two types of plastic blended with the ECM additive in soil incubation and
anaerobic conditions. The article reported no statistically-significant biodegradation.”

(Again, “no statistically-significant biodegradation” is quite different than concluding that there was no
biodegradation. Dr. McCarthy is mistaken.)”

| show, unequivocally, that plastic polymers containing the ECM additive will biodegrade on a much
faster timescale than such polymer plastics without the ECM additive.”

Rebuttal -

It is not clear how or where Dr. Sahu has shown unequivocally that this is the case. It is true that ECM
amended plastics will biodegrade to a greater extent than unamended plastics, but only because the
ECM additive itself apparently biodegrades at a much faster rate than the plastics to which it has been
added.

Addition of additives into conventional plastics does not increase the carbonyl! content of the plastic nor
does it reduce the molecular weight of the high molecular weight polymers or add hydrolysable linkages
or unsaturated carbon bonds. Consistent with this fact, studies in which even large percentages of

13

ECM Comb. Mot. to Exclude Page 13 of 24
Exh. V


Respondent’s Exhibit K


CERTIFICATE OF SERVICE

Thereby certify that on January 17, 2014, I caused a true and correct copy of the paper
original of the foregoing Complaint Counsel’s Preliminary Witness List to ECM BioFilms, Inc.
to be served as follows:

One electronic copy to Counsel for the Respondent:

Jonathan W. Emord Peter Arhangelsky

Emord & Associates, P.C. Emord & Associates, P.C.

11808 Wolf Run Lane 3210 S, Gilbert Road, Suite 4
Clifton, VA 20124 Chandler, AZ 85286

Email: jemord@emord.com Email: parhangelsky@emord.com
Lou Caputo

Emord & Associates, P.C.
3210S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: leaputo@emord.com

I further certify that I possess a paper copy of the signed original of the foregoing
document that is available for review by the parties and the adjudicator.

Dated: January 17, 2014 Respectfully submitted,

Katherine Johnson (kjohnson3 @fic. gov)
J ee a (jcohen2@ftc. gov)

© Flisa Jillson (ejillson@ftc.gov)
Federal Trade Commission
600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580
Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

11

ECM Comb. Mot. to Exclude Page 11 of 11
Exh. A



I understood this to be a reference to Dr. McCarthy’s Expert Report at section VI, which posed
the question “What Constitutes “Competent and Reliable Evidence” for Claims of
Biodegradable Plastic.” Dr. McCarthy therein states:

Test Duration. The study must last long enough for the sample to reach at least 60%
biodegradation. The most typical type of biodegradation test is a gas evolution test,
which monitors the end-products of biodegradation. Sixty percent biodegradation is
the minimum landmark for showing that the treated sample will biodegrade to
completion. (Alternatively, radiolabelling the most recalcitrant part of the
conventional plastic can conclusively answer the question whether the conventional
plastic component of the treated plastic is biodegrading. Radiolabelling will also show
that the “biodegradable plastic” can biodegrade to completion.)

I disagree with Dr. McCarthy’s assertion that “biodegradation studies must last long enough
for the sample to reach at least 60% biodegradation.” 1 am unaware of any such standard
established in the peer-reviewed literature. I am also unaware of any such standard adopted by
any industry or scientific standard setting body. As noted above, in the ‘199 patent Dr.
McCarthy presented data for biodegradation in FIG. 11, which identified the “net degradation”
of seven (7) polymer samples identified in Table 1. Dr. McCarthy identified four (4) samples
as having a net degradation of under 60% as nonetheless biodegrading. See also col. 11, lines
9-19 of the ‘199 patent. This is clearly in contradiction to what he states in his report that
“[s]ixty percent biodegradation is the minimum landmark for showing that the treated sample

will biodegrade to completion.” See again, the ‘199 patent.

I also find other inconsistencies between Dr. McCarthy’s rebuttal report and the position he

takes in the ‘199 patent. They are as follows:

¢ Dr. McCarthy’s rebuttal reference to “appropriate scientific report” led me to his
statement that tests must use proper controls and that “proper testing should have a
negative control (i.e. untreated conventional plastic of the same type as the test sample)
and a positive control (typically cellulose). The negative control is a substance known
not to be biodegradable.” McCarthy Expert Report at page 16. Dr. McCarthy’s ‘199

patent makes no reference to the use of a negative control known not to be

Page 14 of 20

ECM Comb. Mot. to Exclude Page 14 of 20
Exh. W


Exhibit B

31. Genaidy, A., Sequeira, R., Tolaymat, T., Kohler, J., Rinder, M. (2009) “Evidence-Based Integrated
Environmental Solutions for Secondary Lead Smelters: Pollution Prevention and Waste Minimization
Technologies and Practices” Science of the Total Environment. (407)10:3239-3268

32. Jang, Y., Jain, P., Tolaymat, T., Dubey, B., Townsend, T. (2009) “Characterization of Pollutants in Florida
Street Sweepings for Management and Reuse” J. Environmental Management. (91)2:320-327

33. Tolaymat, T., Dubey, B., Townsend, T. (2008) “Assessing risk posed by land application of ash from the
combustion of wood and tires” J. Residuals Scinece & Technology. (5) 2:61-75.

34. Jjemba, P., Mortis, B., Tolaymat, T. (2008) “Specific Energy Output from Urban Residues Degraded with
Leachate and an Off-Specification Industrial Carbonated Beverage as Moisture Sources” Biomass and
Bioenergy (32)1:51-59

35. Genaidy, A., Sequeira, R., Tolaymat, T., Kohler, J., Rinder, M.(2008) “An Exploratory Study of Lead
Recovery in Lead-Acid Battery Lifecycle in US Market: An Evidence-Based Approach” Science of the Total
Environment (407)1:7-22

36. Al-Abed, S., Jegadeesan, G., Scheckel, K., Tolaymat, T. (2008) “Speciation, Characterization, and Mobility of
As, Se, And Hg in Flue Gas Desulphurization Residues” Environmental Science & Technology. (42)5: 1693-
1698

37. Townsend, T., Dubey, B., Tolaymat, T. (2006). “Interpretation of SPLP Results for Assessing Risk to
Groundwater from Land-Applied Granular Waste” Environmental Engineering Science. (23)1:239-251

38. Williams, A., Scheckle, K., Tolaymat, T., Impellitterie, C. (2006)”Mineralogy and Characterization of Arsenic,
Tron, and Lead in a Mine Waste-Derived Fertilizer” Environmental Science and Technology. (40)16:4874-4879

39. Stook, K., Tolaymat, T., Ward, M., Dubey, B., Townsend, T., Solo-Gabriele, H., Bitton, B. (2005). "Relative
Leaching and Aquatic Toxicity of Pressure-Treated Wood Products Using Batch Leaching Tests."
Environmental Science & Technology, 39(1), 155-163.

40. Jain, P., Jang, Y., Tolaymat, T., Witwer, M., Townsend T. (2005)*Recycling of Water Treatment Sludge Via
Land Application: Assessment of Risk” J. Residuals Science and Technology 2(1):16-20

41. Townsend, T., Dubey, B., Tolaymat, T., Solo-Gabriele, H. (2005). “Preservative Leaching from Weathered
CCA-Treated Wood." J. Environmental Management, 75(2), 105.

42. Townsend, T., Tolaymat, T., Leo, K., Jambeck, J. (2004). "Heavy Metals in Recovered Fines from
Construction and Demolition Debris Recycling Facilities in Florida.” Science of The Total Environment, 332(1-
3)

43. Townsend, T., Tolaymat, T. Solo-Gabriele, H., Dubey, B., Stok, K., wadanambi, L.(2004). "Leaching of
CCA-Treated Wood: Implications for Waste Disposal." J. Hazardous Materials, 114(1-3), 75.

44. lida, K., Pierman, J., Tolaymat, T., Townsend, T., Wu, C. (2004).”Control of Heavy Metal Emissions and
Leaching from Incineration of CCA-Treated Wood Using Mineral Sorbents.” J. Environmental Engineering,
ASCE. 1302(2), 184-192.

45. Townsend, T., solo-Gabriele, H., Tolaymat, T., Stook, K., Hosein, N. (2003). “Chromium, Cooper and Arsenic
Concentrations in Soil Underneath CCA-Treated Wood Structures.” Soil and Sediment Contamination, 12(6),
779-798.

46. Townsend, T., Solo-Gabriele, H., Tolaymat, T., Stook, K. (2003). "Impact of Chromated Copper Arsenate
(CCA) in Wood Mulch." The Science of the Total Environment, 309(1-3), 173-185.

47. Tolaymat, T., Townsend, T., Solo-Gabriele, H. (2000) “Chromated Copper Arsenate-Treated Wood in
Recovered Wood.” Environmental Engineering Science 17(1):19-28.

EPA REPORTS

1. Tolaymat, T., Kremer, F., Carson, D., Davis-Hoover, W. Monitoring Approaches For Bioreactor Landfills.
U.S. Environmental Protection Agency, National Risk Management Research Laboratory. Cincinnati, OH
EPA/600/R-04/301, 2004.

ECM Comb. Mot. to Exclude Page 54 of 56
Exh. X


120

O PLA

©} A70B30
© 810#3000
O A90B0
A A50B50
4 A80B20
Mi A30B70

Net Degradation, %

0 10 20 30 40 50
Testing Time, Day

FIG. 11

In connection with the above patent FIG. 11, Dr. McCarthy wrote as follows:

The soil degradation testing results of the two polymers and their blends are reported
in FIG. 11. After degradation 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 fast. After 45 days,
the A30B70, A50B50, and A70B30 blends degraded about 77%, 65% and 25%,
respectively, by loss in weight. FIG. 11 shows that polylactic acid biodegrades in soil,
but just not quickly, and the addition of the second aliphatic polymer, such as
BIONOLLE#3000, increases the biodegradation rate.

The importance of the soil biodegradation curves shown in FIG. 11 is that a specific
blend can now be designed such that this blend would have a certain net degradation

in a given number of days within the soil.

As can be seen from the above, Dr. McCarthy asserts that biodegradation can be established by
utilizing his own developed testing protocol, not an ASTM protocol, '“C testing, or any other
method described in his report, and that biodegradation is present in a polymer blend where it
only partially degrades to levels of 20% (A80B20) or 30% (A70B30) after 45 days, with no

Page 10 of 20

ECM Comb, Mot. to Exclude Page 10 of 20
Exh. W


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 12

based conventional plastics have only existed for a hundred years or so. This is not long enough
for microorganisms to evolve to degrade them. Indeed, the characteristics that make
conventional! plastics commercially useful—strength, durability, synthetically derived from
petrochemicals—make them highly resistant to biodegradation.

34. — Unlike petroleum-based, commercial-grade plastics that are not biodegradable, a
subset of plastics called bioplastics do biodegrade.* For example, naturally-occurring polymers
such as cellulose and starch are biodegradable because microorganisms have developed enzymes
to degrade them. Likewise, certain types of synthetic polymers—those made from biomass,
renewable resources, or some fossil materials such as polylactic acid, poly butylene succinate,
and polycaprolactone—are biodegradable. These synthetic polymers are biodegradable because
they are derived from or have physical and chemical properties similar to naturally-occurring
polymers that microorganisms can degrade.

35. These biodegradable plastics currently have limited commercial applications
because they are much more expensive to produce than conventional plastics, or they tend to be
weaker and less durable than conventional plastics. For instance, polyhydroxybutyrate (PHB) is
completely biodegradable under aerobic conditions, but costs several times more than the
conventional plastic PE.

36. There has been significant interest in exploring ways to render conventional
plastics biodegradable, especially in landfills (where most plastic is disposed). Any technology
that could render conventional plastics biodegradable would transform the plastic industry (and
the many subsidiary product and packaging industries that purchase conventional plastic),

5 Bioplastics only biodegrade under very specific conditions, such as aerobic composting

conditions, and none would biodegrade in a landfill in any reasonable amount of time.

ECM Comb. Mot. to Exclude Page 12 of 58
Exh. U


J Polym Environ (2011) 19:637 676

657

Sok + HOR aor Pia H-Ocr
‘cs
OR
eee Soy. =r ai + HOt
iy
Oa
Ub + Laci
2+ 0

Fig. 16 Ring opening polymerization of lactides

polymerization of lactide [425]. Among the innumerable
metal salts and complexes studied, organometallic com-
pounds have been very effective in the synthesis of high
molecular weight PLA. Gupta and Kumar have reviewed
the catalyst performance in their recent review [425].

Properties of PLA

PLA is prepared by a variety of methods involving ring
opening polymerization of lactide [429 436].

A set of unique properties such as good processability,
biocompatibility and biodegradability make PLA an
industrially important polymer for various applications. As
indicated earlier, the chirality at « carbon of lactic acid
gives rise to three isomers, L, D and DL isomers and hence
three polymers, poly(L-lactic acid), poly(D-lactic acid) and
poly(DL-lactic acid) which differ in their degradation rates,
physical and mechanical properties. PLLA has a melting
point of 170 183 °C and a glass-transition temperature of
55 65 °C while PDLLA has (Tg) 59 °C (203, 214]. Den-
sity of PLLA and PDLLA are 1.25 1.29 1.27 g/cc
respectively [258]. PLLA is crystalline whereas PDLLA is
completely amorphous biodegradable polymer. PLLA has
more ordered and compact structure and hence it has better
mechanical properties and longer service time. However,
the annealed PLLA has better mechanical properties than
un-annealed PLLA [425]. The mechanical properties are
mainly dependent on the molecular weight, crystallinity,
the method of production and processing conditions. The
flexural strength of PLLA increased from 64 to 106 MPa
on increasing of molecular weight of from 23 to 67 k, but
the tensile strength remains the same at 59 MPa [439]. In
the case of poly(DL-lactide) when molecular weight is
increased from 47.5 to 114 k [252, 439], tensile and flex-
ural strength increased 49 53 and 84 88 MPa, respectively
[252]. The life cycle of the polymer from crops to the

ECM Comb. Mot. to Exclude
Exh. Z

Ws) — os

Lactic acid

|

ICO, and other Biomass

|
+d

of “cH, H

PLA Oligamer

Fig. 17 Life cycle of PLA (adapted from Ref. [425] with permission
from Elsevier)

Table 1 Comparison of properties of PLA with PS and PET [266,
440, 441]

PLA PET PS
Modulus(GPa) 38 2.8 4.1 32
Density (kg/m3) 1.26 1.40 1.05
Modulus/density 28 71
% Increase in stiffness 38.78
Elongation at break (%) 47 28 4.1 3
Tensile strength (MPa) 59 37 45

monomer, polymer and degradation to carbon dioxide is
presented in Fig. 17. Table I gives a comparison of prop-
erties of PLA with PET and PS.

Mechanism of Degradation of PLA

The physical and chemical structures of the polymers are
the basic properties that affect the degradation and bio-
degradation mechanisms of PLA polymers [5]. PLLA can
form highly crystalline structures that are known to be
more difficult to hydrolyze than the amorphous parts of the
polymer. The mechanism of hydrolytic degradation of PLA
polymers is quite unusual. In general, a bulk erosion
mechanism has been considered as the main degradation
path way for PLA and its copolymers such as PLGA:
random chain scission on the linkage of ester bonds in the
polymer backbone proceeds homogeneously throughout
the device. Recently it was reported that massive devices
(1 mm thick) of PDLA, PLA and PLGA degrade via a
heterogeneous mechanism i.e., the degradation proceeds

®D Springer
Page 21 of 80


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any other matters as to which he has knowledge that are relevant to the allegations of the
Complaint, Respondent’s affirmative defenses, or the proposed relief.
ECM Customers

5. Stephen Joseph, 3M Company (“3M”) Staff Scientist, as 3M’s designee

Mr. Joseph will testify regarding 3M’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, 3M’s purchase of ECM
additive; reasons for this purchase; 3M’s testing of the ECM additive; 3M’s evaluation of ECM’s
claims; 3M’s evaluation of ECM's substantiation for those claims; 3M’s understanding of
ECM’s claims and substantiation for those claims; 3M’s resources and ability to test and evaluate
ECM’s claims and substantiation, 3M’s use and understanding of the ECM Certificate of
Biodegradability, the ECM logo, and other ECM promotional materials; any other issues
addressed in his deposition, any documents introduced into evidence by Respondent or
Complaint Counsel as to which he bas knowledge, or any other matters as to which he has
knowledge that are relevant to the allegations of the Complaint, Respondent's affirmative
defenses, or the proposed relief.

6. Ramy Samuels, A.N.S. Plastics Corp. (“ANS”) Vice President, ANS’s
designee

Mr. Samuels will testify regarding ANS’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, ANS’s purchase of ECM
additive; reasons for this purchase; ANS’s understanding of ECM’s claims and substantiation for
those claims; ANS's resources and ability to test and evaluate ECM’s claims and substantiation;
ANS’s use and understanding of the ECM Certificate of Biodegradability, the ECM logo, and
other FCM promotional material; ANS’s understanding of how its customers used ECM

promotional materials and products made with the ECM additive; any other issues addressed in

ECM Comb. Mot. to Exclude Page 5 of 16
Exh. F


II BIODEGRADATION
18. Biodegradation is the decomposition of organic materials into more elementary
compounds by the action of living organisms such as bacteria or fungi. These microorganisms
break down organic material by using the carbon content as a food source. There are two types

of biodegradation: aerobic and anaerobic.

e Aerobic biodegradation occurs in environments with oxygen, such as composting.
Through aerobic biodegradation, microorganisms use oxygen to break down organic
matter, yielding carbon dioxide, water, and energy, which is released as heat.*
Biodegradation occurs much more rapidly in the presence of oxygen.

e Anaerobic biodegradation occurs in environments without oxygen, such as most landfills.
During anaerobic biodegradation, microorganisms use a chemical other than oxygen
(such as nitrate, sulfate, or iron) to break down organic matter, yielding methane, carbon
dioxide, and energy, which is released as heat.> Biodegradation occurs much more
slowly without oxygen.

19. There are five phases in the biodegradation process that occurs as landfill MSW

stabilizes, each of which is summarized below:

¢ Phase I (Initial Adjustment). This is the brief period during which a new landfill actually
contains oxygen—in the empty space around non-compacted waste. Because oxygen is
at first present, this initial phase experiences the most biodegradation.

¢ Phase Il (Transition). This phase describes the landfill’s transformation from an aerobic
(with oxygen) environment to an anaerobic one (without oxygen). As waste is added to
the landfill and is compacted, the oxygen content of the landfilled solid waste decreases.
As the oxygen supply is depleted, the rate of biodegradation slows and anaerobic
biodegradation takes over.

e Phase III (Acid Formation). During this third phase, microorganisms called “acetogens”
feed on the organic matter to produce acetic acid. As a result, the concentration of
volatile fatty acids in the leachate (the liquid generated in the landfill mainly as a result of
rain water passing through the waste) rapidly increases, and the pH in the landfill
substantially decreases (i.¢., the landfill becomes much more acidic).

4 The formula for this process is as follows: Biodegradable Organic Matter + 0, >
CO, + H,0 + energy.

5 The formula for this process is as follows: Biodegradable Organic Matter +
HO, > CH, + COz + energy. Gases released during the decomposition process are known as
“biogases.”

ECM Comb. Mot. to Exclude Page 9 of 56
Exh. X


"Interactions of Nonaqueous Solvents with Textile Fibers", Text. Res. J., 51, 5, 323 (1981). (with
L. Rebenfeld, and H.D. Weigman).

OTHER PUBLICATIONS

“Polybutadiene Modified Polyaniline Microparticles”, with Changshu Kuo, Lynne A.
Samuelson, Sukant K. Tripathy, and Jayant Kumar, Journal of Macromolecular Science,
part A — Pure and Applied Chemistry, Volume A40, No. 12, pp 1383-1396, (2003).

Shohreh Parandoosh, Robert Jackson, Richard E. Farrell, Stephen P. McCarthy, David T. Eberiel
and Richard A. Gross, “ Biodegradation of Natural/Syndiotactic Poly(3-Hydroxybutyrate)
Blends”, Polym. Preprints, Am. Chem. Soc., Div. Polym. Sci., Vol. 36, (1995)

Richard A. Gross, Ji-Dong Gu, David Eberiel and Stephen P. McCarthy, “Laboratory Scale
Composting Test Methods to Determine Polymer Biodegradability: Model Studies on
Cellulose Acetate”, J Macromol. Sci.-Pure & Appl. Chem., 1995

John E. Kemnitzer, Stephen P. McCarthy, Richard A. Gross, John Liggat, David J. Blundell and
Mike Cox, “Crystallization Behavior of Predominantly Syndiotactic Poly(B-
Hydroxybutyrate)”, J. Environ. Polym. Deg. Vol. 3(2), (1994)

David S. Roesser, Richard A. Gross and Stephen P. McCarthy, “Effects of Substitution Site on
Acetyl Amylose Biodegradability by a-Amylase Enzymes”, Polym. Preprints , Am. Chem.
Soc., Div. Polym. Sci., Vol. 35(2), pgs 433-434, (1994).

Ji-Dong Gu, Shunjuan Yang, Robert Welton, David Eberiel, Stephen P. McCarthy and Richard
A. Gross, "Effect of Environmental Parameters on the Degradability of Polymer Films in
Laboratory Scale Composting Reactors", J. Environ. Polym. Deg., Vol 2, No. 2, 129-135
(1994).

Michael S. Reeve, Stephen P. McCarthy, Milton J. Downey and Richard A. Gross, "Polylactide
Stereochemistry: Effect on Enzymatic Degradability, Macromolecules, Vol. 27, 825-831
(1994).

Ji-Dong Gu, David Eberiel, Stephen P. McCarthy and Richard A. Gross, "Degradation and
Mineralization of Cellulose Acetate in Simulated Thermophilic Compost Environments", J.
Environ. Polym. Deg., Vol 1, No. 4, 281- 291 (1993).

Ji-Dong Gu, Sarah Coulter, David Eberiel, Stephen P. McCarthy and Richard A. Gross, "A
Respirometric Method to Measure Mineralization of Polymeric Materials in a Matured
Compost Environment", J. Environ. Polym. Deg., Vol 1, No. 4, 293- 299 (1993).

Richard A. Gross, Gregory A. Birrer, Anne-Marie Cromwick, Stephen A. Giannos and Stephen
P. McCarthy, "Polymers From Biotechnology: Bacterial Polyesters and g-Poly(Glutamic
Acid)", in Biotechnological Polymers: Medical, Pharmaceutical and Industrial Applications,
Ed. C. G. Gebelin, Technomic Publishing Co., PA, pgs. 200-213 (1993).

Richard A. Gross, Ji-Dong Gu, David T. Eberiel, Marjory Nelson and Stephen P. McCarthy,
"Cellulose Acetate Biodegradability in Simulated Aerobic Composting and Anaerobic
Bioreactor Environments as Well as by a Bacterial Isolate Derived from Compost", in
Biodegradable Polymers and Packaging, Eds. C. Ching, D. L. Kaplan and E. L. Thomas,
Technomic Publishing Co., Lancaster - Basel, pgs. 257-279, (1993).

John E. Kemnitzer, Stephen P. McCarthy, and Richard A. Gross, "Syndiospecific Ring-Opening
Polymerization of -Butyrolactone to Form Predominantly Syndiotactic Poly(B-
Hydroxybutyrate) Using Tin (IV) Catalysts", Macromolecules, Vol. 26, 6143-6150 (1993).

John E. Kemnitzer, Stephen P. McCarthy, and Richard A. Gross, "The Preparation of
Predominantly Syndiotactic Poly(B-hydroxybutyrate) by the Tributyl Methoxide Catalyzed

ECM Comb. Mot. to Exclude Page 51 of 58
Exh. U


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Respondent’s Exhibit S


32. Rickard J. Locke and/or representative of MacNeil! Engineering Company, Inc.

Kerry Timber

Sunstein Kann Murphy & Timber LLP
125 Summer St.

Boston, MA 02110-1618

Tel: (617) 443-9292, ext. 223

Proposed Testimony: We anticipate that this witness will testify regarding their purchase
of ECM Additive, their use of the Certificate of Biodegradability, their use of the ECM logo, and
their understanding of ECM’s claims of biodegradability, and their understanding of ECM’s
claims that it had substantiation for its biodegradable claims.

33. Timothy R. Barber and/or Representative of Environ International Corp.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

34. Timothy R. Barber and/or Representative of ChemRisk

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

35. Richard Tillinger, O.W.S. Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

36. Bruno De Wilde, O.W.S. Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

37. Patrick F, Riley, O.W.S. Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

38. Representative of O.W.S. Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

39. Mike Spilde, University of New Mexico

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

40. Morton Litt, Case Western Reserve University

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

ECM Comb. Mot. to Exclude Page 7 of 11
Exh. A



li. George Collins, Eagle Film Extruders Inc. (“Eagle”) President, as Eagle's
designee

Mr. Collins will testify regarding Eagle’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to. Eagle’s purchase of ECM
additive; reasons for this purchase; Eagle’s under standing of ECM’s claims and substantiation
for those claims; Eagle's resources and ability to test and evaluate ECM’s claims and
substantiation; Eagle’s use and understanding of the ECM Certificate of Biodegradability, the
ECM logo, and other ECM promotional material; Eagle’s understanding of how its customers
used ECM promotional materials and products made with the ECM additive: any other issues
addressed in his deposition; any documents introduced into evidence by Respondent or
Complaint Counsel as to which he has knowledge; or any other matters as to which he has
knowledge that are relevant to the allegations of the Complaint, Respondent's affirmative
defenses, or the proposed relief.

12. David Sandry, Flexible Plastics, Inc. (“F lexible”) Vice President, as Flexible’s
designee

Mr. Sandry will testify regarding Flexible’s relationship with ECM and understanding of
ECM'’s product, claims, and testing, including, but not limited to, Flexible’s purchase of ECM
additive; reasons for this purchase; Flexible’s understanding of ECM’s claims and substantiation
for those claims; Flexible’s resources and ability to test and evaluate ECM’s claims and
substantiation; Flexible’s use and understanding of the ECM Certificate of Biodegradability, the
ECM logo, and other ECM promotional material; Flexible’s understanding of how its customers
used ECM promotional materials and products made with the ECM additive; any other issues
addressed in his deposition; any documents introduced into evidence by Respondent or

Complaint Counsel as to which he has knowledge, or any other matters as to which he has

ECM Comb. Mot. to Exclude Page 8 of 16
Exh. F


Stephen P. McCarthy

University of Massachusetts Lowell
Department of Plastics Engineering
One University Avenue

Lowell, MA 01854

Tel. 978-934-341 7/Fax. 978-934-3065
Email: stephen_mecarthy@uml.edu

EDUCATION

‘Southeastern Massachusetts University, B. S., Textile Chemistry, 1978
Princeton University, M.S.E., Chemical Engineering, 1980

Case Western Reserve University, Ph.D., Macromolecular Science, 1984
Worcester Polytechnic Institute, Medical Device Management Certificate, 2005

PROFESSIONAL APPOINTMENTS

Owens Corning Fiberglas, Advanced R&D Engineer, 1980,
Technical Center, Granville, Ohio

University of Massachusetts Lowell, Assistant Professor, 1984
Department of Plastics Engineering

University of Massachusetts Lowell, Associate Professor, 1988
Department of Plastics Engineering

University of Massachusetts Lowell, Professor, 1991
Department of Plastics Engineering

RESEARCH INTERESTS

Mechanical, Physical, and Rheological ‘Properties of Polymers, Blends and Composites
Medical Devices

Biodegradable Polymers

Plastic Polymer Blends and Reactive Processing

Bonding and Adhesion for Coatings, Co-extrusion, and Co-injection Molding

Design, Analysis and Rapid Tooling for Injection Molded Parts

Part Design

EDITORIAL ACTIVITIES

Editor, Journal of P Polymers and the e Environment, 1991-present
Editorial Board, Journal of Applied Polymer Science, 1995-2003

PROFESSIONAL ACTIVITIES

ECM Comb. Mot. to Exclude Page 38 of 58
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2586

Table 3
Chemical and physical properties of the test specimens.

EE Gémez, EC, Michel jr. / Polymer Degradation and Stability 98 (2013) 2583 2591

Material ‘Chemical and physical properties*
Total solids (%) Volatile solids (%dw) Total carbon (%dw) Total nitrogen (%dw) Film thickness (mm)

Positive 90345 87.4411 418401 0.03 + 0.01 0.35 + 0.01
Negative 99.8 + 0.1 96.3 2 829401 0.06 4: 0,003 0.37 £0.01
PP + 2% additive 99.8 +01 97.7 £01 82903 0.04 + 0.01 037 £0.03
PS + 2% additive 99.9 +01 97.0215 88841 0.05 + 0.01 0.23 + 0.01
PETE + 1% additive 99.4 +05 99.9 40.1 64.6 £01 0.01 + 0,002 036 + 0.01
Plastarch 90.9 +21 57543 60.9 + 0.2 0.07 + 0.01 0.48 + 0.03
Co-polyester + corn-based plastic 95.2401 99.8 +01 519403 0.10 + 0.01 0.72 + 0.02
Wheat starch-derived plastic 978404 98.5405 49.4401 0.74 + 0.004 050 + 0.01
PHA 99.4 +04 90.4 +05 50.7 + 03 0.45 + 0.01 0.62 + 0.01
Paper pulp + soy wax 94341 91.0+04 469403 0.06 + 0.01 2.14 £0.03
Paper pulp 92.0401 920401 421401 0.10 + 0.01 2.74 £0.01
Paper pulp + asphalt 93.4405 906 +03 46.9 + 0.03 0.22 + 0.02 261401
Coconut coir 96.8 +03 985405 46.7 +03 0.26 + 0,002 1,09 + 0.02
Rice hull 94.0404 89.6 £04 383401 14.1 +0.06 1.24 + 0.02
Composted cow manure 92.5 40.1 89.4410 40.5 + 0.01 1.12 + 0.05 2.40401
Peat fiber 92.1403 978 +05 454 +03 0.49 + 0.07 1.74 + 0.05

* Values are means + SD of three repticates.

2.3. Biodegradation during composting

Three materials were tested under simulated composting con
ditions. These included PETE + 1% additive, plastarch and paper
pulp + soy wax (Tables 2 and 3). The experiments were conducted
in triplicate for a period of 115 days.

The test conditions used were based on a protocol described in
ASTM D5338 98 (2003) {25}. This test is a measure of the degree
and rate of carbon conversion to CO) under conditions that mimic a
commercial scale industrial composting facility.

An 80 g sample of each test specimen was mixed with 350 g dry
of mature compost inoculum (Tab! 4). The compost inoculum was
obtained from a full scale windrow composting facility featuring a
concrete surface and controlled aeration system at OARDC. The
compost contained a mixture of dairy manure and hardwood
sawdust as described elsewhere [26].

The compost was collected at various locations on the windrow
and screened to less than 10 mm and large inert items were dis
carded. The screened compost was amended with ammonium
phosphate (Fisher Scientific, PA, U.S.) to give a C:N ratio of 20:1
including the carbon content of the test specimen. The initial
moisture content of the mixture was adjusted to 60% (wet weight
basis).

The compost and test specimens were incubated in 4L
(working volume) vessels (length 30 cm and diameter 15 cm),
made of PVC pipe placed in a 55 °C incubator (BioCold Environ
mental Inc., MO, U.S.). Each vessel contained approximately 1100 g
of material on a wet weight basis. The reactors were aerated from
below at 100 + 1 ml/min to maintain aerobic conditions. To avoid
drying during the experiment, air was saturated by bubbling

Table 4
Initial mean characteristics of the aerobic and anaerobic organic substrates.

through bottles containing water at the incubator temperature.
The air exiting the vessels was passed through flasks in a separate
water bath set at 9 °C to condense moisture from the off gas. The
off gas was then analyzed for percent CO» using an infrared gas
analyzer (Vaisala model GMT 220, range 0—20%). CO2 data was
automatically recorded using a Campbell Scientific model 23XL
data logger for each vessel every hour. Each vessel was also
equipped with a K type thermocouple to measure the tempera
tures of the composts mix near the center of the compost vessel,
and was recorded automatically every 12 min. A more complete
description of the laboratory scale composting system can be
found elsewhere [27].

2.4, Biodegradation during anaerobic digestion

The biodegradation of four materials was compared during high
solids batch anaerobic digestion. These included PP + 2% additive,
PETE + 1% additive, plastarch ‘and a co polyester + corn based
plastic (Tales 2 sn¢ 3), The experiments were conducted in trip
licate for a period of 50 days.

The anaerobic degradation of the polymeric materials was
compared under high solids AD conditions based on a protocol
described in ASTM D551 02 {23} international standard. The test
measured the conversion of samples to CO2 and CHa during incu
bation under controlled anaerobic conditions. For this study test
specimens were exposed to an active methanogenic inoculum
derived from a full scale anaerobic digester treating municipal
sewage sludge. These conditions resemble those found in high
solids AD digestors and in biologically active landfills, but not in
typical landfills where water is excluded and removed.

Organic substrate Chemical and physical properties

Total solids (% ww) Volatite solids (% dw) “Total carbon (% dw) Total nitrogen (% dw) pH

Compost” inoculum 243 +20 889+1.0 48.7 +55 237402 7.95 + 0.04
‘Soi mixture® 874201 296 +01 1.19 40.2 0.13 + 0,02 743 £04
Anaerobic seed" sludge 892+05 59.5+20 368 1.0 721402 8.30 + 0.01
Medina County” OFMSW 472£72 603 +12 89.6 +13 0.92 +02 7.50 + 0.4
® Values are means - SD of three replicates.

» Dairy manure and hardwood sawdust mature compost.

© This is the value before adding water to reach 60% of the water hoiding capacity.

¢ Methanogenically active municipal sewage siudge.

© OFMSW the organic fraction of municipal solid waste.
ECM Comb. Mot. to Exclude Page 4 of 9

Exh. AA


Moldflow Pty Ltd, “Mold Analysis Research”, $20,000

Giner, $20,000

Human Scale, $20,000

World Minerals, Inc., “Barrier Filler Research”, $15,000

Osram-Sylvania Inc., Injection Molding Research, $15,000

Nypro, $10,000

Densified Solutions, “Extrusion Testing”, $5,000

MMM management & Publications LLc, “Processing Polyactic Acid”, $4000

PATENTS ISSUED

“Micro and Nanospheres Based on Natural Materials”, Pending, with Balint Koroskenyi and
Robert Nicolosi

“Novel Biodegradable Bone Plates and Bonding Systems”, with Jeffrey Weinzweig, USA Patent
No. US2008/0234754 Al, Effective from September 25, 2008.

“Polysaccharide-Containing Block Copolymer Particles and Uses Thereof’, with Balint
Koroskenyi and Robert Nicolosi, Pending, USA Patent Application 20110020227.

“Polysaccharide-Containing Block Copolymer Particles and Uses Thereof”, with Balint
Koroskenyi and Robert Nicolosi, USA Patent Application 7,763,663.

“Surface Finishing Compression Molding with Multi-Layer Extrusion”, with Arthur Delusky,
Robert Lucke, Thomas Ellison and Qing Guan, USA Patent No. 6,770,230.

“Surface Finishing Compression Molding with Multi-Layer Extrusion”, with Arthur Delusky,
Robert Lucke, Thomas Ellison and Qing Guan, USA Patent No. 6,964,802.

“Molded Article and Process for Preparing Same”, with Thomas M. Ellison, Arthur Delusky and
Qing Guan, USA Patent No. 6,670,028.

“Process and Apparatus for Preparing a Molded Article”, with Thomas Ellison, and Arthur
Delusky, USA Patent No. 6,506,334.

“Molded Article”, with Thomas M. Ellison, Arthur K. Delusky, Robert Lucke, USA patent No.
6,440,593.

“Refined Vegetable Oils and Extracts Thereof’, with Carl Lawton, Robert Nicolosi, USA Patent
No. 6,197,357 B1.

“Bioresorbable Copolymers”, with Richard A. Gross, Xianhai Chen, USA Patent No. 6,093,792.

“Polylactic Acid-Based Blends”, with, Richard Gross, and Wenguang Ma, USA Patent No.
5,883,199.

“Composition of and Method for Forming High Molecular Weight Predominately Syndiotactic
Substituted-Poly (B-Propioesters)”, with Richard Gross and John Kemnitzer, USA Patent
No. 5,440,007.

“Biodegradable and Hydrogradable Diblock Copolymers Composed of Poly (B-
Hydroxyalkanoates and Poly (Lactones) or Poly (Lactide) Chain Segments”, with Richard
Gross and Michael Reeve, USA patent No. 5,439,985.

“Gamma-Poly(Glutamic Acid) Esters”, with Richard Gross and Devang Shah, USA Patent No.
5,378,807.

PUBLICATIONS

ECM Comb. Mot. to Exclude Page 44 of 58
Exh. U


Exhibit B

Thabet M. Tolaymat Ph.D. Tolaymat.thabet@epa.gov
26 West Martin Luther King Drive

Cincinnati Ohio, 45230
513-457-2860

EDUCATION

Doctorate of Philosophy in Environmental Engineering Sciences

University of Florida Gainesville, FL 2003
Masters of Engineering in Environmental Engineering Sciences

University of Florida Gainesville, FL 1997
Bachelor of Science in Environmental Engineering

University of Florida Gainesville, FL 1995
EMPLOYMENT

Interim Associate National Program Director

USEPA/ORD. Cincinnati, OH 2012- October 2013

¢ Assist the national program director in the areas of emerging materials (e.g., nanomaterials) and
sustainability. Responsible for setting research priority and providing resources to complete the research.
Environmental Engineer
USEPA/ORD Cincinnati, OH September 2004-Present
¢ — Project Lead for Solid Waste Management Systems Research
© Project Lead for Nanomaterials Research
* ORD Project Lead under Safe and Healthy Community Strategic Research Plan for Energy from Solid
Wastes and Construction and Demolition Debris. Work in the Solid Waste Branch and conduct research in
the area of solid waste and nanomaterials and assisting EPA HQ and Regional offices in the following
areas:
© Performance of Solid Waste Containment Units (municipal solid waste, hazardous waste and ash
mono-fill landfills)
© Bioreactor Landfills. New landfill design that promotes the degradation and subsequent removal
of degradable fraction of solid waste as well as organic pollutants.
= Subtitle D “dry tomb” lined landfill
= Remediation of contaminated landfill at superfund sites
© Co-disposal of solid waste and hazardous waste
© Construction and demolition waste
o Metal release, mobility from contaminated wastes
¢ ORD Project Lead under Chemical Safety and Sustainability Strategic Research Plan for Nanomaterials.
Leading EPA’s Office of Research and Development National Risk Management Research Laboratory in
the area of silver nanoparticles.
© Evaluation of the impacts of nanoparticles on human health and the environments.
© The evaluation of the impact of environmental conditions on the fate and transport of silver
nanoparticles.
© The evaluation of the impact of silver nanoparticles use on waste management systems
Research Scientist (Federal Post-Doc)
USEPA/ORD Cincinnati, OH December 2003-September 2004
* Conduct Research on bioreactor technology. Research includes gathering, assimilating and assessing data
gathered at the Outer Loop landfill. Coordinate EPA/ORD efforts with the Solid Waste Association of
North America (SWANA) and Interstate Technology Regulatory Transfer (ITRC) to develop and distribute
bioreactor landfill guidance document. Conduct research to examine the effectiveness of TCLP to simulate
metal mobility in bioreactor landfills.
Graduate Research Assistant (Ph.D. Candidate)
University of Florida Gainesville, FL August 1997-December 2003
° Designed and conducted a battery of tests to evaluate risk associated with the land application of solid
wastes. The research shed light on the appropriate use of dilution attenuation factors when assessing risk

ECM Comb. Mot. to Exclude Page 51 of 56
Exh. X


Eric Awerbuch
a

From: Cohen, Jonathan <jcohen2@ftc.gov>

Sent: Wednesday, May 21, 2014 11:48 AM

To: Peter Arhangelsky

Ce: Johnson, Katherine; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: ECM Biofilms, No. 9358

Peter,

The EPA can host in Cincinnati.
Are we all set?

Jonathan Cohen

Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

(202) 326-2551 | jcohen2@ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Wednesday, May 21, 2014 12:52 PM

To: Cohen, Jonathan

Ce: Johnson, Katherine; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: ECM Biofilms, No. 9358

Jonathan,

Thank you for your flexibility. We need to identify locations for our depositions of your asserted experts. We propose
the FTC building at 400 7th Street for Dr. McCarthy on June 27th. Given the government's resou rces, we ask that you
identify a suitable location for your experts in Cincinnati and Connecticut. Because we need to serve our Notices of
Deposition soon, we may need to designate your experts’ local offices until further notice. Please advise,

Thanks,

Peter A. Arhangelsky, Esq. | EMORD & Associates, P.C. | 3210S. Gilbert Rd, Ste 4 | Chandler, AZ 85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential commurication intended for the recipient listed above. The content of this communication is protected from
disclosure by the attorney-client privilege and the work product doctrine. if you are not the intended recipient, you should treat this
communication as sirictly confidential and provide it to the person intended. Duplication or distribution of this communication is prohibited
by the sender. If th's communication has been sent to you in error, please notify the sender and then immediately destroy the document.

From: Cohen, Jonathan [mailto:icohen2@ftc.gov!

Sent: Monday, May 19, 2014 7:38 PM

To: Peter Arhangelsky

Cc: Johnson, Katherine; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: ECM Biofilms, No. 9358

Per the below.

ECM Comb. Mot. to Exclude Page 1 of 7
Exh. K


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 15

environmental conditions vary, and different microorganisms have different
efficiencies in breaking down organic matter because they secrete different
enzymes that have greater or lesser effect at breaking bonds through hydrolysis or
oxidation. Thus, if the intended disposal environment is a landfill, the inoculum
should be one exposed to household waste as a sole substrate (i.e., sole source of
food) that can survive at the temperatures, moisture and acidity levels found in
landfill conditions.

d. Test Conditions. Test conditions should simulate actual disposal conditions.
Thus, the test should simulate the same moisture content, temperature ranges,
acidity, and oxygen level found in the conditions where the “biodegradable
plastic” will decompose.

e. Sample Weight. The size of the plastic sample will affect biodegradation rate.
Thus, a sample that is thinner may biodegrade faster than a sample that is thicker.
Moreover, it is very important to use the appropriate sample weight relative to the
quantity of inoculum. The smaller the sample, and the larger the quantity of
inoculum, the less reliable the observed biodegradation is, This is because
inoculum itself contains organic material that is a food source for biodegradation.
As a result, when the amount of inoculum is high relative to the amount of plastic,
it is likely that observed biodegradation is attributable to the biodegradation of the
inoculum itself.

f. Test Duration. The study must last long enough for the sample to reach at least
60% biodegradation. The most typical type of biodegradation test is a gas

evolution test, which monitors the end-products of biodegradation. Sixty percent

ECM Comb. Mot. to Exclude Page 15 of 58
Exh. U


ECM Comb. Mot. to Exclude Resp. Mot to Compel and For Pegs 6 of 12

Sal
Exh. RX
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


biodegradable. Moreover, I am of the view that it is an accepted practice among
polymer scientists not.to use a negative control as a condition precedent to a claim of
biodegradation. See again, the ‘199 patent. See also, Dr. McCarthy’s paper “Advances
In Properties and Biodegradability of Co-Continuous, Immiscible, Biodegradable,
Polymer Blends, Macomol. Symp. 144, 63-72 (1999). This published paper identifying
biodegradable polymers includes no use of a negative control.

Dr. McCarthy’s rebuttal reference to “appropriate scientific support” led me to his
statement that “[c]onfirmatory testing such as radiolabelling is essential to establish that
the plastic itself is biodegrading.” McCarthy Expert Report at page 19. McCarthy
underscores this with the assertion that “[a]bsent an approved ASTM specification, it is
my opinion that to scientifically prove a claim that the plastic-not merely the additive
and inoculum-is biodegrading, the claimant must support its claim with at least one test
with positive results from 'C labeling of the conventional plastic.” McCarthy Expert
Report at page 24. Dr. McCarthy’s ‘199 patent does not use ASTM testing and does not
support its claim that the polymer blends therein are biodegradable, with at least one
test with positive results from '*C labeling. Moreover, I am of the view that it is an
accepted practice among polymer scientists not to use “C labeling to advance a claim
that a particular polymer is biodegradable. See, the ‘199 patent. See also, Dr.
McCarthy’s paper “Advances In Properties and Biodegradability of Co-Continuous,
Immiscible, Biodegradable, Polymer Blends, Macomol. Symp. 144, 63-72 (1999). This
published paper includes no use of radiolabelling to identify the subject blends as
biodegradable.

Dr. McCarthy’s rebuttal reference to “appropriate scientific support” led me to his
statement that the “screening level tests ECM relies on to support its claims extrapolate
from minimal biodegradation to a conclusion of complete biodegradation. Such
extrapolation is scientifically invalid because biodegradation is not linear and typically
slows down due to recalcitrance.” McCarthy Expert Report at page 27. Dr.
McCarthy’s ‘199 patent presents data for only five (5) particular blends of PLA with a
polyester identified under the BIONELLE trademark. See Table 1 of the ‘199 patent.
It is not clear what the molecular weight is of the BIONELLE polymers reported in

Page 15 of 20

ECM Comb. Mot. to Exclude Page 15 of 20

Exh. W


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of

ECM BioFilms, Inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International

Vee eee

COMPLAINT COUNSEL’S SUPPLEMENTAL INITIAL DISCLOSURES

Under Commission Rule of Practice § 3.31(b) and (e), Complaint Counsel supplements
its Initial Disclosures. The information disclosed herein is based upon information reasonably
available to Complaint Counsel. Without waiving any privileges or prejudicing the ability to
supplement these Supplemental Initial Disclosures if additional information becomes available,
Complaint Counse! makes the following supplemental disclosures:

I. Individuals and Entities Likely To Have Discoverable Information

In addition to the individuals and entities identified in Complaint Counsel’s original
Initial Disclosures, we have listed in Supplemental Appendices C and D, individuals and entities
that are likely to have discoverable information relevant to the allegations asserted in the
Complaint, the proposed relief, or Respondent’s defenses.'! When available, Complaint Counsel

has set forth each individual’s or entity’s name and, if known, address and telephone number.”

' Documents received from ECM Biofilms, Inc. (“ECM”) in response to Complaint Counsel’s
requests may include other individuals likely to have discoverable information relevant to the
allegations asserted in the Complaint, the proposed relief, or Respondent’s defenses.

? Any contact with Federal Trade Commission (“Commission”) employees must be made
through Complaint Counsel.

ECM Comb. Mot. to Exclude Page 1 of 5
Exh. C


document.

From: Johnson, Katherine [mailto:kjohnson3 @ftc.gov}

Sent: Thursday, May 01, 2014 5:22 AM

To: Peter Arhangelsky

Cc: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

That’s fine, Peter, But we are going to issue the subpoena to Dr. Michel so that we have everything
in place if agreement cannot be reached.

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: kjohnson3@ftc. gov
From: Peter Arhangelsky [mailto: mord.com]

Sent: Wednesday, April 30, 2014 3:36 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Katherine,

We think a stipulation agreement for Dr. Michel likely, but we cannot confirm presently without our
client's authorization. Bob Sinclair is in transit today, and we have not been able to reach him.
Given that we are sanguine about an agreement, may we advise you of the client’s position on or
before Monday next?

Best,

Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ
85286

Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed above. The content of this
communication is protected from disclosure by the attorney-client privilege and the work product cloctrine. If
you are not the intended recipient, you should treat this communication as strictly confidential and provide it to
the person intended. Duplication or distribution of this communication is prohibited by the sender. if this
communication has been sent fo you in error, please notify the sender and then immediately destroy ihe
document.

ECM Comb. Mot. to Exclude Page 2 of 9
Exh. H


PUBLIC DOCUMENT

Respondents stipulation to admit Dr. Michel’s documents. See Exh. I. That stipulation
accompanied several others that were designed to avoid deposition expenses where the primary
purpose was to establish authenticity and admissibility of documents.> The parties agreed to the
joint stipulation (Exh. 1) which admitted Dr. Michel’s documents in lieu of a fact deposition, just
as they had with other testing laboratories. See Exh. I. That stipulation: (1) identified Dr.
Michel as a fact witness (like the other testing labs) and (2) dissuaded ECM from pursuing
additional discovery regarding Dr. Michel or his article. See Exh. H; Exh. I. Complaint Counsel
represented to ECM that, but for the stipulation, they would have taken the deposition of Dr.
Michel as a fact witness. Complaint Counsel did not give notice at any time that Dr. Michel
would be an expert witness or expert rebuttal witness in this case. See Exh. H; Exh. J.

The expert deposition schedule, including eight expert depositions, was the result of
extensive negotiations between the parties. See Exh. K. Configuring a schedule that would
minimize burden and expense was difficult. Id. Even then, the parties were forced to extend the
discovery calendar in this case beyond the deadline set in the Revised Scheduling Order to cover
all of the experts. Jd. Depositions of those experts properly identified continue until July 15,
2014, just 21 days before the hearing commences. Jd. Nevertheless, despite considerable
interaction on experts and scheduling, Complaint Counsel never mentioned to ECM that Dr.
Michel would be an expert or rebuttal expert in this case, or that they planned to add a new
witness. See e.g., Exhibit H; Exhibit J. Surely Complaint Counsel knew before June 30th that it

intended to have Dr. Michel as an expert, because it necessarily had to retain him as a

3 For instance, ECM entered the same stipulation with respect to documents produced in
discovery from O.W.S. labs, another testing group.

6


S. Grossman & B. Filip — Recent Procedures Introduced To Challenge Patent Grants At
the United States Patent Office, 2011 SPE-ANTEC

S. Grossman, B. Filip & J. Placker, Ten Things Plastics Engineers Should Know About
Intellectual Property, 2005 SPE-ANTEC.

S.J. Grossman and C. Gagne. "Science and Scientific Evidence”, University of
Connecticut Law Review, (1993).

S.J. Grossman, "Science and Scientific Evidence", IDEA-The Journal of Law and
Technology, 32(2), 179(1992).

S.J. Grossman and Achal Takar, "Reactive Processing of Nylon-6 and Polypropylene
Resins, 1991 SPE-ANTEC

S.J. Grossman, "Experimental Use Or Fair Use As A Defense To Patent Infringement",
IDEA The Journal of Law and Technology, 30(3), 243(1990).

C. Pai, S. S. Grossman and J. C. Huang, "Effects of Moisture on Thermal and Mechanical
Properties of Nylon-6,6". Submitted to Advances in Polymer Technology (1989).

T. Limtasiri, S. J. Grossman and J. C. Huang, "Kinetic Studies of the Crystallization of
Nylon-6 Block Copolymers”, Poly. Eng. Sci., Accepted, in-press.

T. Limtasiri, S$. J. Grossman and C. C. Huang, "Kinetic Studies of the Polymerization of
Nylon-6 Block Copolymers”, Poly. Eng. Science., 28,1145(1988).

S. Shah, S.F. Wang, N. Schott and S. J. Grossman, “Counter Rotating Twin Screw
Extruder As A Devolatizer and As A Continuous Polymer Reactor, SPE-ANTEC,,.45, 122
(1987).

M. Huang and S.J. Grossman, "Ethylene Glycol, Polyethylene Glycol and Polypropylene
Glycol as Plasticizers for Nylon-6,6", SPE-ANIEC, 45,1284(1987)

A. Dharia and S.J. Grossman, "Variation of the Heat Distortion Temperature of Nylon-6
With Changing Water Content, SPE-ANTEC 45490(1987).

S.F. Wang and S. J. Grossman, "Synthesis of Polyamides from Aromatic Diisocyanates
and Dicarboxylic Acids", Polymer Preprints, 28(1), 264(1987).

S. F. Wang and S.J. Grossman, "Plastic Materials for Insulating Applications", 3. Chem.
Ed., 64(1), 39(1987).

R. Jabba, S. Chung and S. J. Grossman, "Morphological Characteristics of Nylon-RIM

Page 9 of 17

ECM Comb. Mot. to Exclude Page 9 of 17
Exh. Y


Dr. McCarthy Rebuttal Report -- 2

I. THE CONCLUSIONS REACHED BY ECM’S EXPERTS ARE NOT
SUPPORTED BY THEIR UNDERLYING ANALYSIS.

1. The question that complaint counsel asked me to evaluate is whether ECM’s claims were
scientifically true or at least had an appropriate level of scientific support. The claims complaint
counsel asked me to evaluate specifically are:

a. Plastic products manufactured with the ECM additive (“ECM Plastics”) will
completely biodegrade, i.e., will completely break down and decompose into
elements found in nature, within a reasonably short period of time (i.e., one year)
in a landfill.

b. ECM Plastics are completely biodegradable in nearly all landfills.

c. ECM Plastics will completely biodegrade in nearly all landfills between 9 months
to 5 years.

d. ECM Plastic will completely break down and decompose into elements found in
nature in any disposal environment at some rate and extent that exceeds plastic
without the ECM Additive.

e. ECM Plastics have been shown to completely biodegrade in most landfills in one
year, nine months to five years, or faster than conventional plastics under various
scientific tests, including ASTM D5511.

2. In my report, I defined conventional plastics as high molecular weight, commercial-grade
plastics representing more than 90% of the market. See Expert Report of Stephen P. McCarthy
(“McCarthy Expert Report”) {ff 29-31. Thus, I based my evaluation of and conclusions
regarding ECM’s claims on these conventional plastics. I conclude, based on my professional
judgment and after evaluating the Testing Materials, that many of ECM’s claims are untrue and
none have the appropriate scientific support.

3. Before I begin my critique of the evaluations of Drs. Sahu and Burnette, it is important to
note that there are a wide variety of definitions for the term “biodegradable” and
“biodegradability.” As aptly stated by one source cited by Dr. Sahu, “Because of the slightly
different definitions or interpretations of the term biodegradability, the different approaches [to

analyses] are not equivalent in terms of information they provide or the practical significance . . .

. Before choosing an assay to simulate environmental effects in an accelerated manner, it is

ECM Comb. Mot. to Exclude Page 2 of 12
Exh. CC


PUBLIC DOCUMENT

CERTIFICATE OF SERVICE

Thereby certify that on July 9, 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

The Honorable D. Michael Chappell

Administrative Law Judge

One electronic courtesy copy to the Office of the Administrative Law Judge:

600 Pennsylvania Ave., NW, Room H-110

Washington, DC 20580

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@fte.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: jeohen2@fic.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.

One electronic copy to Counsel for Complainant:

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

Arturo Decastro

Division of Enfoncement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, D.C. 20580
Email: adecastro@fte.gov



tonsof waste. Biodegradable organic materials are the largest component of MSW: paper and
paperboard account for approximately 28% of MSW and yard trimmings and food waste account
for approximately another 28%. However, non-organic waste comprises a large portion of
MSW: metals make up 9%; rubber, leather, and textiles 8%; and glass 5%. Other miscellaneous
wastes make up approximately 3%. In 2012, plastic waste constituted over 12% of the total
MSW generated, or about 31.7 million tons of plastic waste.

16. What is Customary Disposal? According to the EPA’s latest evaluation of MSW
management in the U.S. (2011), MSW is managed in one of four ways: recycling (26%),
landfilling (53%), incineration (12%), and composting (8%).” In the United States, after the
recovery of useful materials (e.g., paper, glass, plastic) through recycling, the majority of MSW
is customarily disposed of in incinerators or landfills.? Incineration involves burning MSW to
produce energy, heat, or fuel. Landfilling (the topic of this report) is the placement of MSW in
engineered areas in the ground. As Figure | shows, landfilling continues to be the dominant

method for the management of MSW in the U.S.

? No biodegradation occurs in recycling facilities or incinerators. In incinerators, MSW
is combusted at a high temperature. Through recycling, materials that would otherwise be
thrown away are turned into new products.

3 A small fraction of MSW is also composted in municipal composting facilities.
Composting involves collecting organic waste, such as food scraps and yard trimmings, and
storing it under conditions (mainly aerobic or “with air”) designed to help it biodegrade
naturally. Based on data provided by the EPA, composting continues to be a relatively rare
waste management method in the U.S.

ECM Comb. Mot. to Exclude Page 7 of 56
Exh. X


Respondent’s Exhibit T


o ChemRisk/McLaren Assessment

68. The “ChemRisk/McLaren Assessment” (entitled “Ecologic Assessment of ECM
Plastic, ECM-FTC-000106, conducted by the laboratory ChemRisk, as service of
McLaren/Hart), like the Environ Study, is based on flawed methodology.

69. The first part of the Assessment consists of a short-term, 60-day aerobic
composting test of film comprised of 50% ECM Additive. The second part of the Assessment
discusses a long-term, 22-month aerobic test of a 5% ECM film and ECM pellets (additive). The
third part of the Assessment presents the results of a 15-day anaerobic test of the ECM pellet
(additive) that follows the methods under ASTM D5511-94. The Assessment purports to show
that approximately 20% biodegradation was achieved for the 50% ECM film over about 60 days.
It further purports to show that the ECM pellets achieved approximately 20% biodegradation
over a period of 10 days.

70. | The ChemRisk/McLaren Assessment has at least five defects. Each, by itself,
prevents it from being competent and reliable scientific evidence of biodegradation of ECM
Plastics in five years or less in a landfill. First, the aerobic test (conducted with oxygen) does not
simulate the anaerobic (oxygen-less) conditions found in landfills. As discussed in section III.a.
above, the phase in which MSW in a landfill would be exposed to oxygen is extremely brief, due
to daily compaction of MSW. Thus, only anaerobic tests replicate landfill conditions.

71. Second, the anaerobic test purportedly conducted under ASTM D5511 contains
implausible data. The figure on page ECM-FTC-000111 shows that cellulose control achieved

120% biodegradation under aerobic composting conditions and the 50% ECM film achieved

19% biodegradation over a similar timeframe. It is not possible to achieve more than 100%

biodegradation. Therefore, the reported 120% biodegradation is either an error resulting from

28

ECM Comb. Mot. to Exclude Page 28 of 56
Exh. X


3. Shane Frederick, PhD
Yale University, Yale School of Management
52 Hillhouse Avenue Room 116
New Haven, CT 06511

Dr. Frederick’s anticipated testimony will be described in his expert report, which will be
produced to Respondent by the date set forth in the Scheduling Order. The general
subject matter of this testimony includes, but is not limited to, consumer perception of
biodegradable marketing claims and Respondent’s biodegradability claims.

Dated: March 5, 2014 Respectfully submitted,

/s/ Katherine Johnson

Katherine Johnson (kjohnson3@ftc.gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

ECM Comb. Mot. to Exclude Page 2 of 3
Exh. B


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

400
350 a

hm MS &
Bees
TNS

Elongation, %

~
S
S

a
2s

0 10 20 30 40 50 60 70 80 90 100
Bionolle Content, wt%

—@— 8/0#6000 Blends, Aging for 7 Days
~~ -- BI0#7000 Blends, Aging for 7 Days
~:~ BIO#6000 Blends, Aging for 21 Days
~~X— Bl0#7000 Blends, Aging for 21 Days

FIG. 8

ECM Comb. Mot. to Exclude Page 69 of 80
Exh. Z


5,883,199

3
lactone, or ethylene oxide, a is 10 to 10,000, ¢.g., 100 to
7,500, or 1000 to 5000, and b is 0 to 10,000, ¢.g., 100 to
7,500, ot 1000 to 5000.
The polyester of the second polymer or copolymer can
have the formula:

MONCH KOE (CIE
°

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

The new biodegradable blends can include the first,
polylactic acid-based polymer or copolymer as a polylactic
acid homopolymer, and the second polymer or copolymer as
a polybutylenesuccinate homopolymer, polybutyleneadipate
homopolymer, polybutylenesuccinate-adipate copolymer,
polyethylenesuccinate homopolymer, polyethyleneadipate
homopolymer, or a polyethylenesuccinate-adipate copoly-
mer.

In another embodiment, the invention features articles
manufactured from the new biodegradable blends. For
example, the invention features sheets or films, bags,
containers, such as bottles and disposable cups, disposable
diapers, and other items including the new blends.

A “polylactic acid-based polymer or copolymer” is a
homopolymer or a copolymer having at least 50% by weight
of polylactic 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,
and meso-polylactic acid. “D-polylactic acid” and
“L-polylactic acid” are dextro-polylactic acid and levo-
polylactic acid, respectively, and both of them are optically
active polymers that rotate a light vector when transmitted
through the polymer. “D,L-polylactic acid” is a racemic
polymer, ie., a copolymer of D-polylactic acid and
L-polylactic acid having a well-defined conformation of D-
and L-polylactic acid units. “Meso-polylactic” is a random
copolymer of D-polylactic and L-polylactic. An “aliphatic
polyester of a diacid and a diol” is a polyester formed by the
reaction of a diacid and a diol.

The invention provides several advantages. Polylactic
acid by itself is a brittle material having poor toughness and
low elongation to break, and these properties worsen with
time due to its physical aging behavior. Furthermore, the
biodegradability of polylactic acid is slow. The new blends
overcome these deficiencies of polylactic acid. Moreover,
the new blends are environmentally friendly and commer-
cially attractive for making biodegradable plastic films,
sheets, and other plastic products made by conventional

processing methods such as blown film, 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.

Unless otherwise defined, al! technical and scientific
terms used herein have the same meaning as commonly
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
and materials are described below. All publications, patent
applications, patents, and other references mentioned herein
are incorporated by reference in their entirety. In case of
conilict, the present specification, including definitions, will
control. In addition, the waterials, methods, and examples
described herein are illustrative only and not intended to be
limiting.

ECM Comb. Mot. to Exclude
Exh. Z

4
Other features and advantages of the invention will be
apparent from the following detailed description, and from
the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 isa graph showing complete stress-strain curves of
polylactic acid, BIONOLLE#3000, and their blends.

FIG, 2 is a graph showing stress-strain curves of poly-
lactic acid, BIONOLLE#3000, and their blends in the strain
range of 0 to 50%.

FIG. 3 is a graph showing stiffness (modulus) of poly-
lactic acid, BIONOLLE#3000, aud their blends.

FIG. 4 is a graph showing stress at yicld and break of
polylactic acid, BIONOLLE#3000, and their blends.

FIG. 5 is a graph showirg percent elongation at yield and
break of polylactic acid, BIONOLLE#3000, and their
blends.

FIG. 6 is a graph showing toughness of polylactic acid,
BIONOLLE#3000, and their blends.

FIG. 7 is a graph showing stitfness (modulus) of poly-
lactic acid, BIONOLLE#6000, BIONOLLE#7000, and their
blends.

FIG. 8 is a graph showing percent elongation at yield and
break of polylactic acid, BIONOLLE#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 biodegra-
datioa testing

FIG. LL is a graph showing net percent biodegradation of
polylactic acid, BIONOLLE#3000, and 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 time 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 poly-
lactic acid alone. The new blends provide tough, biodegrad-
able plastics that can be used to make biodegradable plastic
films, sheets, and other products made by conventional
blown film, 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 new blends provide a
large increase in elongation (c.g., from 5% to 500%),
toughness enhancement (from less than 10 MJ/m? to more
than 120 MJ/m?), and increased biodegradation rate. The
modulus of these blends decreases with increasing amount
of the aliphatic polyester, i., Bionolle#3000 (from 1.3 GPa
of polylactic acid to 0.3 GPa of Bionolle#3000), and elon-
gation to break increases with increasing amount of the
aliphatic polyester (¢.g., from 5% to 500%). The blends with
more than 20% by weight of Bionolle#3000 possess tough-
ness of more than 70 MJ/m>, more then 200% elongation at
break and other excellent tensile properties, which are
retained even after the blends have aged for 70 days in the
temperature range of ~15° to 60° C. Compared to polylactic
acid, these blends also have a relatively high degradation
tates in soil and composting environment.

Page 73 of 80


2590 EF, G6mez, EC Michel jr. / Polymer Degradation and Stability 98 (2013) 2583 2591

The biodegradability of polymeric materials exposed to an
active methanogenic inoculum was studied under controlled lab
oratory conditions that resemble those found during active AD fora
period of 50 days. They likely differ somewhat from the conditions
within a landfill where moisture is usually removed and a greater
diversity of materials is present. Yet the extent of biodegradation is
likely similar to what would ultimately occur over many years in a
landfill environment.

Materials tested included plastarch, co polyester + corn based
plastics, PP + 2% additive and PETE + 1% additive (Tables 2 and 3).
The mean methane content in the biogas across treatments during
the entire period of study was 54.1 + 6.1%.

During the AD incubation, the positive control (cellulose paper)
exhibited 74.1 + 4.8% conversion. For plastarch, the carbon con
version rate to biogas was similar to the positive control (cellulose
paper) for the first 7 days (Fig. 5). However, after this period, the
rate of conversion slowed as compared to the positive control
through day 28. In contrast, no significant mineralization was
observed for the plastics containing additive samples over the
entire period of the study.

The final cumulative carbon conversion during AD for plastarch
and co polyester + corn based plastic were 26.4 + 3.5 and
20.2 + 4.4%, respectively. The final conversion values for PP + 2%
additive and PETE + 1% additive were 3.1 + 3.7 and 2.2 + 1.6%,
respectively. The ANOVA indicated that statistically significant
differences in the extent of biodegradation (F512 50.7, P< 0.0001)
existed between group means. The Tukey—Kramer HSD analysis
tevealed that the bio based plastics were significantly different
than the positive control but not different from each other. There
was no significant difference in the carbon conversion of the
negative control (PP) and the plastic containing the additive.

The biodegradability of different bio based materials including
cellulose and starch [49,56] has been investigated previously under
anaerobic conditions ,51,52]. Yagi et al. [53] studied the biode
gradability of cellulose powder under mesophilic (35 °C) and
thermophilic (55 °C) AD conditions. Cellulose powder reached a
cumulative conversion of 80% under both temperature conditions.
Other authors have also studied the anaerobic mineralization of
aliphatic polyesters. Abou Zeid et al. (54] conducted a study to
determine the biodegradability of the natural polyesters poly(b
hydroxybutyrate) (PHB), _poly(b hydroxybutyrate co 11.6% b
hydroxyvalerate) (PHBV) and the synthetic polyester poly(o
caprolactone) (PCL) using different anaerobic sludges and individ
ual strains. Biodegradability of the powdered materials was
measured as the percent of weight loss. They found that almost all
the PHB was converted in 9 days, but only 60 and 30% weight loss

es Posie eros peri

| Tree peisater: er nat poner
rasan

adore

Gls
| ee PELE” Ite addonve

5b,

3
a
in

mn
‘Time Gaysy

Fig. 5. Cumulative carbon loss (CO2 C) as percentage of initial carbon (cumulative
standard error) for bio-based plastics, conventional plastics amended with additives
and natural fiber composites during 50 days of anaerobic digestion. For some data
points standard error bars are smaller than markers.

ECM Comb. Mot. to Exclude
Exh. AA

was observed for the PHBV and PCL, respectively. Similar results
were reported by Shin et al. {55| in which nearly complete con

version was observed for the natural bacterial polyester but no
biodegradability for synthetic analogs was observed under simu

lated landfill conditions.

The results of this study indicate that materials have different
tates of mineralization under different end of life scenarios. For
example, the positive control reached 70% conversion in 25 days
during AD while 75 and 400 days were needed to reach the same
extent of conversion under composting and soil incubation condi
tions, respectively. The plastarch material degraded faster under
composting conditions reaching 50% conversion in 85 days than
under AD and soil incubation conditions where only 26 and 30%
was converted after 50 and 660 days, respectively. For co
polyester + corn based plastic 20% of the material was converted
during 20 days of soil incubation while 50 days were needed to
reach the same value during AD. Ultimately, co polyester + corn
based plastic reached 55% conversion after 660 days of soil incu
bation. Conventional plastics and those containing additives did
not degrade at all under any of the three conditions.

Biodegradable plastics are potential alternatives to petroleum
based materials that can be incorporated into organic recycling
schemes based on anaerobic digestion or composting. They also
could potentially reduce the pollution associated with conventional
plastics and therefore lead to the development of products that are
more environmentally friendly. Ideally, biodegradable materials
must be useful for a predetermined service life and then biodegrade
in a short period of time, leaving no visible fragments and no toxic
residues when composted or anaerobically digested. Disposal of
these materials in landfills as opposed to anaerobic digestions is not
recommended since under anaerobic conditions they biodegrade to
form methane and most landfills capture only a small fraction of
the methane created [56].

4. Conclusion

In this study, the relative biodegradability of a range of poly
meric materials and natural fiber composites used for various
commercial applications was investigated under composting, soil
incubation and anaerobic digestion conditions. The validity of the
tests was confirmed in that positive controls (cellulose paper)
biodegraded by more than 70% in all three systems in a reproduc
ible manner.

While some of the bio based plastics and natural fibers bio
degraded to an appreciable extent, plastics containing additives
that supposedly confer biodegradability to polymers such as poly
ethylene and polypropylene did not improve the biodegradability
of these recalcitrant polymers, SEM analysis confirmed that sub
stantial biodegradation of polyhydroxyalkanoate based plastics
occurred and that some surface changes occurred in co
polyester + corn based plastic and coconut coir materials. How
ever, SEM confirmed that no degradation of polypropylene and
polyethylene occurred, even after amendment with additives
meant to confer biodegradability.

The relative biodegradability of the materials during long term
soil incubation was PHA > co polyester + corn based plastic >
composted cow manure > plastarch > paper pulps > natural
fibers > conventional plastics containing additives to enhance
biodegradability conventional plastics. For anaerobic digestion
and composting the relative biodegradability was plastarch > co
polyester + corn based plastic > conventional plastics with addi
tives and plastarch > paper pulp + soy wax > conventional plastic
with additives, respectively.

Over the time scale of organic recycling processes (composting
and anaerobic digestion) most of the bioplastics biodegraded to

Page 8 of 9


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 9

23. The rate of biodegradation varies depending on numerous factors, including
oxygen levels, moisture levels, pH content, and availability of nutrients. The two most important
variables, however, are moisture and oxygen.

24. When biodegradation takes place in the presence of oxygen (i.e., aerobic
biodegradation), carbon dioxide is released. Aerobic biodegradation occurs in composting
facilities or when items are disposed as litter. When biodegradation takes place without oxygen
(ie., anaerobic biodegradation), methane gas and carbon dioxide are released. Landfills and
anaerobic digesters are types of anaerobic disposal conditions.

25. Importantly, degradation and biodegradation are not identical processes. As
explained above, biodegradation involves microorganisms breaking down material into its
constituent elements, i.e., elements found in nature. Degradation (or disintegration)
involves fragmenting of the polymer chain due to mechanical stress or chemicals.

26. Chemicals can include additives designed to fragment plastic when exposed to
heat or ultraviolet rays. For example, the polyethylene blend used to make six-pack rings for
soda cans is designed to disintegrate upon exposure to sunlight to limit injury to wildlife if the
rings are littered. This is a type of chemically-induced fragmentation known as
Photodegradation. Similar chemical disintegration occurs in oxodegradables, which are
polymers treated with a heavy metal that fosters oxidation in the polymer chain, causing the
chain to disintegrate. Additionally, mechanical stress may disintegrate plastic, such as grinding
or pulverizing (which happens during the recycling process).

27. Thus, although degradation (or disintegration) may change the plastic’s physical
form, it does not involve microorganisms, nor does degradation necessarily mean that the plastic
will degrade into natural elements. Notably, the critical difference between degradation and
biodegradation is significant to my opinions herein because ECM’s Testing Materials sometimes

conflate these two distinct concepts, and erroneously infer that biodegradation has occurred

ECM Comb. Mot. to Exclude Page 9 of 58
Exh. U


Expert Witnesses

25. Steven McCarthy, Ph.D.

Dr. McCarthy is a Professor of Plastics Engineering at the University of Massachusetts
Lowell (the “University”). He teaches graduate level courses in plastics engineering, including
the “Mechanical Behavior of Polymers” and “Polymers and the Environment.” In addition, he is
the Director of the University’s Biodegradable Polymer Research Center, where he orchestrates
research on biodegradable polymers. He is also the Principal Investigator for studies on plastics
engineering and polymer research. Dr. McCarthy has more than three decades of experience
studying both the chemical and mechanical behavior of polymers, including the biodegradability
of polymers used to form conventional, commercial-grade plastics.

Dr. McCarthy will testify, from his perspective as an expert in the fields of plastics
engineering. polymer science, and biodegradable polymers, about whether plastic products
manufactured with the ECM additive: (1) are biodegradable, (2) will completely breakdown and
decompose into elements found in nature in most landfills within 5 yearg, and (3) will
completely breakdown and decompose into elements found in any disposal environment at an
appreciably faster rate and extent than conventional plastics without the ECM additives,

26. Shane Frederick, Ph.D.

Dr. Frederick is a Professor of Marketing at Yale University. His research focuses on the
area of judgment and decision-making: the study of factors that affect attitudes, preferences and
behavior of consumers. In addition, he has taught courses in consumer behavior, behavioral
economics, and marketing, and he has both studied and published extensively concerning
judgment and decision-making, with.a focus on the role of cognitive abilities on preferences,

preference measurement, and cognitive biases.

4

ECM Comb. Mot. to Exclude Page 14 of 16

Exh. F


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
firm(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(f) 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 reccive 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.

ECM Comb. Mot. to Exclude

Page 6 of 8


PUBLIC DOCU}g

UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSIC
OFFICE OF THE ADMINISTRATIVE LAW JUDG

Washington, D.C. 5 933

Stcerany
— Docket No. 9358 ORIG NA L

ECM BioFilms, Inc.,
a corporation, also d/b/a
Enviroplastics International, PUBLIC

Respondent,

RESPONDENT ECM BIOFILM’S MOTION TO EXTEND THE WORD COUNT LIMIT

Pursuant to Rule 3.22(f), Respondent ECM Biofilms requests that the Court extend the
applicable word count limit by 2,080 words for the accompanying Combined Motion. On June
30, 2014, Complaint Counsel supplied Respondent ECM with an “expert” rebuttal report from a
witness Complaint Counsel never listed on Complaint Counsel’s witness lists (expert or fact).
Complaint Counsel intends for that witness, Dr. Michel, to testify as a rebuttal expert in this case.
Dr. Michel has been a controversial source of evidence in this case. This Court sanctioned
Complaint Counsel in its March 21, 2014 Order for another act of nondisclosure, the failure to
disclose documents related to Dr. Michel’s scientific tests. Complaint Counsel then held out Dr.
Michel as one who would not testify in this case. Complaint Counsel even secured a joint
stipulation from ECM that would admit his documents without need for a fact deposition. Now
Complaint Counsel has abruptly reversed course by presenting a rebuttal report from Dr. Michel
the day before expert discovery closed under the Scheduling Order and without any prior notice
that Complaint Counsel would call Dr. Michel as an expert witness. That act violated the Rules
of Practice (e.g., 16 C.F.R. § 3.31A) and this Court’s several Scheduling Orders, which all

required Complaint Counsel to disclose its potential experts months ago.

1


haven’t heard anything back. Accordingly, we’re noticing them per the attached document. Of course, we're still
willing to negotiate the schedule.

Til give you a call regarding the Co/p/ast materials in about an hour.

Jonathan Cohen
Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

(202) 326-2551 | icohen2@fic.zov

From: Cohen, Jonathan

Sent: Wednesday, May 14, 2014 11:21 AM

To: 'Peter Arhangelsky'

Ce: ‘Jonathan Emord’; ‘Lou Caputo’; Jillson, Elisa; Johnson, Katherine; Cohen, Jonathan; Decastro, Arturo
Subject: RE: Expert Deposition Schedule

Peter,
Per your request, we revise the proposal as follows:

June 23: Frederick (New Haven, CT)
June 24: Tolymat (Cincinnati, OH)
June 27: McCarthy (Washington, D.C.)
July 9 — Burnette (Washington, DC)
July 10 — Stewart (Los Angeles, CA)
July 11 — Sahu (Los Angeles, CA)

July 15 — Volokh (Atlanta, GA)

July 16 — Batlaz (Raleigh, NC)

Accordingly, this accomodates ECM’s request that we provide dates for our experts between June 16 and
June 27. Please confirm the rest of the schedule, or let us know when you'll be able to do so, as we'd like to begin
making arrangements.

Best,

Jonathan Cohen
Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

(202) 326-2551 | jcohen2@ific.gor

From: Peter Arhangelsky [maiito:PArhangelsky@emord.com]
Sent: Tuesday, May 13, 2014 2:21 PM

To: Cohen, Jonathan

Cc; Jonathan Emord; Lou Caputo; Jillson, Elisa; Johnson, Katherine
Subject: RE: Expert Deposition Schedule

Jonathan,

Thanks for your proposal. We will discuss the schedule with our experts and report back shortly. Having discussed this
with our team, we have conflicts the first week of July which will require changes to the proposed schedule. Please
inform us when your experts are available between June 16-27. We will need to schedule your experts during that
window in June.

ECM Comb. Mot. to Exclude Page 5 of 7
Exh. K


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 30

iii, | ECM’s Test Results Are Unreliable.
75. The tests that purport to show the ECM Plastic is biodegradable are unreliable for

many reasons. Each of these tests lack one or more of the necessary indicia of reliability. In
addition, a number of these tests were conducted by laboratories whose practices fall far short of
scientific standards.

16. In Section VI above, I identified a number of factors that must be present fora
test to constitute reliable evidence for ECM’s claims. The tests results that I reviewed lack
several or, in some cases, all of these factors rendering each test unreliable. I discuss the factors
lacking from the tests below.

77. Plastic Application. According to the Testing Materials, the only plastics that
have been tested with the ECM additive are : PP, PE, PET, PS, LLDPE, EVA foam, HIPS.
Thus, any claims of performance pertaining to other types of plastics are invalid. ECM’s claims
of biodegradability conferred to plastics generally is not adequately supported.

78. Load Rates. ECM claims that adding 1% of its additive to 99% plastic confers
biodegradability on the ECM plastic as a whole. However, several of the Testing Materials
included tests with higher load rates,

¢ “ChemRisk Assessment” (entitled “Ecologic Assessment of ECM Plastic, ECM-
FTC-000106, conducted by the laboratory ChemRisk, as service of
McLaren/Hart), used samples containing 50% load rate of ECM Additive, 5%
ECM Plastic film, or just the ECM Additive alone.

¢ Advanced Materials Center, Inc. (AMC) Report conducted evaluations of ECM

Plastic at 4.5%, 5% and 3% load rates.

ECM Comb. Mot. to Exclude Page 30 of 58
Exh. U


Dr. McCarthy Rebuttal Report -- 1

SUMMARY OF REBUTTAL REPORT OF STEPHEN P. MCCARTHY, PhD

Complaint Counsel kas asked me to review’and respond to the expert reports of Dr. Sanjit
Sahu and Dr. Ryan Burnette submitted on behalf of ECM Biofilms, inc. ("ECM"). This rebuttal
report responds to the critiques and analyses raised in those reports and can be summarized as
follows:

e Dr. Sahu and Dr. Burnette incorrectly frame the question as whether there is any
eviderice thar plastics biodegrade leading to an irrelevant evaluation of the
scientific literature regarding known biodegradable polymers. ECM dves net
claim (as far as I know) to enhance the biodegradahility ot plastics that are
already biodegradable. Rather, ECM asserts that it can tum “non-degradabie”
plasucs into Siodegradable ones.

® Dr, Sahu and Dr. Burnezte both agree tha: the ASTM D5511 test is not a pertect
test for evaluating ECM’s claims, and thet no singie test is perfect. However,
they offer very }ittle to support whether the ECM Materials or the | itigation
Matetiais support ECM’s claims. nor do they address the issue of recalcitrance.
Instead they both appear to rely on faulty and incomplete understanding of tite
mechanisms at issue. While I do not opine thai any test must be perfect to unswer
the questions raised here, the tesis performed must be of sufficient quality and
quantity to demonstrate that a non-degradable plastic will completely biodegrade.

The Testing Materials I have reviewed simply do not pass muster.

EA
ee ITC?

Dr. Stephen P. McCarthy ‘/

Sar?

DATED: ‘faa fi =

ECM Comb. Mot. to Exclude Page 1 of 12
Exh. CC


ECM Comb. Mot. to Exclude Resp. Mot to Compel and For SBentiend 1 of 12

Exh. RX°C-1
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 7

b. Tests and other materials obtained from other parties during the course of this

litigation (“Litigation Materials”).

16. Talso conducted my own literature research. I refer to my own research, the ECM
Materials, and the Litigation Materials collectively as “Testing Materials.” Appendix B contains
all of the Testing Materials that I considered. In reviewing the Testing Materials and offering the
opinions this Expert Report contains, I have extensively relied on my knowledge of the field of

polymer science.

IV. SUMMARY OF ANALYSIS
17. ECM’s claims that ECM Plastics will completely biodegrade faster than

conventional plastic are false and unsubstantiated. Conventional plastics are resistant to
biodegradation due to their chemical structure and can take thousands of years to biodegrade.
Specifically—whether in a biofilm or otherwise—microorganisms cannot create the enzymes
necessary to break down conventional plastics more rapidly. Physically blending the ECM
additive with a conventional plastic does not change the conventional plastic’s chemical
structure. As a result, post-blending, the conventional plastic is no more susceptible to microbial
attack than it was pre-blending, and ECM’s claims are false.

18. ECM’s claims are also unsubstantiated. For at least three reasons, nothing in the
Testing Materials supports the conclusion that the ECM additive confers biodegradability to
conventional plastics. First, none of the Testing Materials supports the conclusion that ECM
Plastic is biodegradable or will biodegrade to completion; in fact, the only published, peer-

reviewed study to address this question concludes otherwise.? Second, there is no scientific

3 See E. Gomez & F. Michel, Biodegradability of conventional plastics and natural fiber
composites during composting, anaerobic digestion and long term soil incubation, 98 JOURNAL
OF POLYMER DEGRADATION & STABILITY 2583-91 (2013) (testing the ECM additive and

concluding that “plastics containing additives that supposedly confer _biodegradability to
polymers such as polyethylene and polypropylene did not improve the biodegradability of

these recalcitrant polymers”) (emphasis added).

ECM Comb. Mot. to Exclude Page 7 of 58
Exh. U


PUBLIC DOCUMENT

UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION
OFFICE OF THE ADMINISTRATIVE LAW JUDGES

Washington, D.C.
In the Matter of
Docket No. 9358
ECM BioFilms, Inc.,
a corporation, also d/b/a PUBLIC
Enviroplastics International,
Respondent.
PROPOSED

ORDER GRANTING RESPONDENT ECM BIOFILMS, INC.’S MOTION TO EXTEND

THE WORD COUNT LIMIT

This matter having come before the Administrative Law Judge on July 9, 2014, upon a
Motion by Respondent ECM BioFilms, and having considered all related submissions, and for
good cause appearing, it is hereby ORDERED that Respondent’s Motion is GRANTED.

The Court ORDERS that the word count applicable to Respondent ECM’s Combined
Motion to for Sanctions Under Rule 3.38, To Exclude Complaint Counsel’s Rebuttal Witness,

and For Leave to Include a Surrebuttal Expert is extended by 2,080 words.

ORDERED:

D. Michael Chappell

Chief Administrative Law Judge
Date:


Board Member, UMCTTS Steering Committee, 2011-present

Reviewer, Biodegradable Polymer Institute (BPI), 1995 - 2012

Chair, Sections Committee, Society of Plastics Engineers, 2011-2012

Treasurer, SPE Medical Division, 2011-2012

Councilor, Society of Plastics Engineers Eastern New England Section, 2009-2012

Chair, SPE Medical Plastics Division, May 201 1-present

Treasurer, BioEnvironmental Polymer Society (BEPS), July 2011-Present

Chair, SPE ANTEC Student Activities, May 2010-2011

Executive Board, ACS Division of Polymeric Materials and Engineering, 1993-2000

Councilor, Society of Plastics Engineering, 1991-1996

President, Bio/Environmental Polymer Society, 1995

Technical Program Chairman, Biodegradable Polymer Meeting, Boston, June 1994

Chairman, Fourth International Workshop on Biodegradable Polymers, Durham, N.H.,
October 1995

Secretary, U.S. Degradable Plastics Council, 1990-1992

Technical Program Co-Chairman, Society of Plastics Engineers, Inc. RETEC, Boston,
MA, November 1990.

Technical Program Co-Chairman, Society of Plastics Engineers, Inc. RETEC, Boston,

MA, October 1988

MEMBERSHIPS

American Society for Engineering Education
American Chemical Society

American Society for Standards and Materials
Bio/Environmentally Degradable Polymer Society
Biomaterials Society

Materials Research Society

Sigma Xi

Society of Plastics Engineers

AWARDS

SPE Education Award, Society of Plastics Engineers, December 2013

St. Patrick Parish Anam Cara Award, March 2013

Irish Education 100 Award, December 2012

Distinguished University Professor, University of Massachusetts Lowell, April 2012
BEPS James Hammar Memorial Lifetime Achievement Award, October 2008

SPE ANTEC Medical Plastics Division Best Paper Award, Boston, MA, May 2005

SPE ANTEC Color and Appearance Division Best Paper Award, Orlando, FL, May 2000
SPE Dedication of Service 1991-1996 Award, May 1996

SPI 46" Composites Institute Annual Conference Best Paper Award, Washington DC, 1991
The Modern Plastics Best Paper Award, Washington, DC, 1991

SPE ANTEC Advanced Composites Division Best Paper Award, Dallas, TX, May 1990
Plastics Processing Workshop Award, Taipei, Taiwan, June 1986

UNIVERSITY AND SERVICE ACTIVITIES

ECM Comb. Mot. to Exclude Page 39 of 58
Exh. U


Respondent’s Exhibit V


UNITED 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

HD

JON W. DUDAS
Director of the United States Patent and Trademark Office

ECM Comb. Mot. to Exclude Page 79 of 80

Exh. Z


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Page 36 of 80


Best,

Peter A. Athangelsky, Esq. | EMorp & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ 85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient ‘sted above. The content of this commun’

cation is protected from

disclosure by the atiomey-client privilege and the work product doctrine. if you cre not the iniended recipient, you should treat this
communication as strictly confidential and provide if to the person intended. Duplication or distribution of this communication is prohibited
by the sender. If this communication has been sent fo you in error, please notify the sender and then immediately destroy the document.

From: Cohen, Jonathan [mailto:jcohen2 @ftc.gov]
Sent: Tuesday, May 13, 2014 11:43 AM

To: Peter Arhangelsky; Lou Caputo; Jonathan Emord
Ce: Jillson, Elisa; Johnson, Katherine; Decastro, Arturo
Subject: RE: Expert Deposition Schedule

Peter,
One change with respect to the dates we propose for your experts:

July 2 - McCarthy (Washington, DC)
July 3 — Thabet (Cincinnati, OH)
July 8 — Frederick (New Haven, CT)
July 9 — Burnette (Washington, DC)
July 10 — Stewart (Los Angeles, CA)
July 11 - Sahu (Los Angeles, CA)
July 15 — Volokh (Atlanta, GA)

July 16 — Barlaz (Raleigh, NC)

Jonathan Cohen

Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

(202) 326-2551 | jcohen2@ftc.gov

From: Cohen, Jonathan

Sent: Monday, May 12, 2014 5:43 PM

To: ‘Peter Arhangelsky’; 'Lou Caputo’; ‘Jonathan Emord"
Ce: Jillson, Elisa; Johnson, Katherine; Decastro, Arturo
Subject: ECM: Expert Deposition Schedule

Peter,

Per our call, we have cleared dates with our experts. Based on those dates, we propose the following overall

schedule:

July 2 — McCarthy (Washington, DC)
July 3 ~ Thabet (Cincinnati, OH)
July 8 ~ Frederick (New Haven, CT)
July 9 — Burnette (Washington, DC)

ECM Comb. Mot. to Exclude
Exh. K

Page 6 of 7


Complaint Counsel’s Preliminary Witness List
In the Matter of ECM Biofilms, Inc., Docket No. 9358

1. Robert Sinclair, ECM Biofilms, Inc.

Counsel for ECM Biofilms, Inc.
Jonathan W. Emord

Emord & Associates, P.C.
11808 Wolf Run Lane

Clifton, VA 20124

Email: jemord@emord.com

Proposed Testimony: We anticipate that this witness will testify about ECM Biofilms,
Inc. (“ECM”)’s products, distribution and sales channels, financial information, customer base,
customer communications, interactions with ASTM and scientific testing facilities, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

2 Thomas Nealis, ECM Biofilms, Inc.

Counsel for ECM Biofilms, Inc.
Jonathan W. Emord

Emord & Associates, P.C.
11808 Wolf Run Lane

Clifton, VA 20124

Email: jemord@emord.com

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, financial information, customer base, customer communications,
claims of biodegradability of plastics treated with ECM products, and substantiation for those
claims.

3. Ken Sullivan, ECM Biofilms, Inc.

Counsel for ECM Biofilms, Inc.
Jonathan W. Emord

Emord & Associates, P.C.
11808 Woif Run Lane

Clifton, VA 20124

Email: jemord@emord.com

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, financial information, customer base, customer communications,
claims of biodegradability of plastics treated with ECM products, and substantiation for those
claims.

4, Scott A. Fletcher, ECM Biofilms, Inc.

Counsel for ECM Biofilms, Inc.
Jonathan W. Emord

Emord & Associates, P.C.
11808 Wolf Run Lane

Clifton, VA 20124

Email: jemord@emord.com

ECM Comb. Mot. to Exclude Page 2 of 11
Exh. A



Table of Contents

Qualifications .....

Introduction

Rebuttal of points made by Dr. Burnette .....

Rebuttal of points made by Dr. Sahu...

Additional Comments -...

Summary

References

Appendix A. Estimated cost to conduct a University research study on the biodegradability of “Cc
polyethylene and polyethylene amended with ECM additive..

Appendix B: Occasions where Dr. Michel has provided oral testimony in depositions, at trial or in
similar proceedings in the past ten years.

ECM Comb. Mot. to Exclude Page 2 of 24
Exh. V


we can send 2 packet of NE Labs documents that would be subject to the proposed stipulation

Best,

Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd, Ste 4 | Chandler, AZ
85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed above. The content of this
communication is protected from disclosure by the attorney-client privilege and the work product doctrine. If
you are noi the intended recipient. you should treat this communication as strictly confidential and provide it to
the person intended. Duplication or distribution of this communication is prohibited by the sender. #f this
communication has been sent to you in error, please notify the sender and then immediately destroy the
document.

From: Johnson, Katherine [mailto:kjohnson3 @ftc.gov|

Sent: Tuesday, April 29, 2014 1:06 PM

To: Peter Arhangelsky

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Peter:

Attached is the proposed stipulation on the OWS production. Please let me know by the midday
tomorrow if | have your permission to execute and file with the Court.

We will send out the deposition subpoenas for OWS and the other depositions | mentioned
previously by 5 p.m. tomorrow.

Katherine

Katherine E. Johnson, Attorney
Division of Enforcement

Bureau of Consumer Protection
Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, DC 20580

Direct Dial: (202) 326-2185

Fax: (202) 326-2558

Email: klohnson3@ftc.gov

From: Johnson, Katherine

Sent: Monday, April 28, 2014 1:51 PM
To: 'Peter Arhangelsky'

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Peter:

ECM Comb. Mot. to Exclude Page 4 of 9
Exh. H


PATENT
ATTORNEY DOCKET NO. 08698/025001

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

Applicant : McCarthy et al. Art Unit: 1324
Serial No.: 08/825,810 Examiner: A. Woodward
Filed April 3, 1997

Title : POLYLACTIC ACID-BASED BLENDS

Assistant Commissioner for Patents
Washington, DC 20231

RESPONSE TO OFFICE ACTION DATED FEBRUARY 24, 1998

Please enter the following amendments.

In_the Claim:

Amend claims 1, 2-9, and 11-22 as follows.

1. (Amended) A biodegradable blend comprising:

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

Ly { and
{ fl (b) @ second polymer [or copolymer] consisting
essentially of one or more polyesters,

wherein said first and second polymers are present in a

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

a homopolymer or random copolymer that forms a continuous or co-

continuous phase in the blend.

_— a
Claims 2-9 and 11-22, first word, replace "A'

jth
san
--The--. 2o 5
Sort
Claim 9, line 2, insert --polyethylene-- befor@37j
ean
"terephthalate" °

aim 18, line 4, delete "general".

pee ornepasit___Sbatly_944, 1948

Vhetcy cy er 37 CFR 1G) at Conese
‘eee he acs Sines Post Sere Ort
‘Trestle ponageon he ee save a
te Aosta Commmasignet fo Pues, Wasingtn, DC. 202)

Madelung E Befancouet

ECM Comb. Mot. to Exclude

Exh. Z Page 52 of 80


“Biodegradable Polymer Blends for Medical Applications”, with Philip Canale and Sanjay
Mehta, 58th Society of Plastics Engineers Annual Technical Conference Proceedings,
Volume 46, Number 3, pp. 2680-2684, May 2000.

“Advances in Properties and Biodegradability of Co-continuous, Immicisible, Biodegradabity,
Polymer Blends”, Degradability, Renewability and Recycling — Key Functions for Future
Materials, Eds. A.-C. Albertson, E. Chiellini, J. Feijen, G. Scott, M. Vert; Wiley-VCH,
Verlag GmbH., (with W. Ma and A. Ranganthan), pgs. 63-72, (1999).

“Further Investigations on the Hydrolytic Degradation of Poly(D-L Lactide)”, with Su Ming Li,
Biomaterials, Vol. 30, pgs. 35-44, (1999).

“Acylation of Pullulan By Ring-Opening of Lactones”. D. Donabedian and S.P. McCarthy,
Macromolecules, Vol. 31, No. 4, pgs. 1032-1039, (February 1998).

““Single-Site” Catalyzed Polyolefin for Fresh-Cut Produce Packaging — A Comparison Between
Monoextruded Blends and CoExtruded Film”, with V. Patel, S. Mehta, and S. Orroth, 58th
Society of Plastics Engineers Annual Technical Conference Proceedings, Volume 45,
Number 1, pp. 391-395, May 1999.

“Cavity Pressure Studies for Stereolithography Produced Tooling”, with John Dell’ Arciprete
and Robert Malloy, 58th Society of Plastics Engineers Annual Technical Conference
Proceedings, Volume 45, Number 1, pp. 467-471, May 1999.

“Rapid Tooling: A Study of Different Cooling Techniques for Mold Inserts Used in the Direct
AIM (ACES Injection Molding) Process”, with Sandeep Saurkar, and Robert Malloy, 58th
Society of Plastics Engineers Annual Technical Conference Proceedings, Volume 45,
Number 1, pp. 1105-1108, May 1999.

“A New Approach for In-Mold Finishing: The Valyi Surface Finishing/Compression Molding
Process”, with Qing Guan, Sandip Patel, and Thomas Ellison, 58th Society of Plastics
Engineers Annual Technical Conference Proceedings, Volume 45, Number 1, pp. 2911-
2914, May 1999.

“Evaluation of Oxidative Stability of Flexible Polyolefins by Oxidative Induction Testing with y-
Oryzanol and a-Tocopherol Antioxidants for Food and Medical Applications”, with
Shamit Hakani, Sanjay Mehta and Philip Canale, 58th Society of Plastics Engineers Annual
Technical Conference Proceedings, Volume 45, Number 1, pp. 3113-3118, May 1999.

“Biodegradable Bags Comparative Performance Study: A Multi-Tiered Approach to Evaluating
the Compostability of Plastic Materials”, with T.J. Adamezyk, D.C. Broe, R.E. Farrell, J.S.
Lee and B.L. Daniels, 58th Society of Plastics Engineers Annual Technical Conference
Proceedings, Volume 45, Number 1, pp. 3255-3259, May 1999.

“Biodegradable Water Soluble, Liquid Crystalline Polymers Based on Chitin/Chitosan
Derivatives”, with C.L. Yue and R. Kumar, American Chemical Society, Polymer
Preprints, Volume 39, Number 2, pgs. 132-133, (August 1998).

“Liquid Crystalline, Rheological and Thermal Properties of Konjac Glucomannan”. V. Dave, M.
Sheth, S.P. McCarthy, J. Ratto, D. Kaplan, Polymer, Polymer Preprints, Vol. 39, No. 5, pp.
1139-1148, 1998.

"The Influence of Injection Molding Conditions on Biodegradable Polymers", with M. Parikh
and R. Gross, Journal of Injection Molding Technology, Vol. 2, No. 1, pp. 30-36, March
(1998)

“Effect of Fiber Orientation on the Mechanical Properties of an Injection Molded Part and a
Stereolithography-Insert Molded Part”, with M. Damle, S. Mehta, R. Malloy, Society of
Plastics Engineers Annual Technical Conference, Volume 44, pgs. 584-588 (May 1998).

“Analysis of Metal Coating Effects on Stereolithography Tooling for Injection Molding”, with
David T. Burns and Robert Malloy Society of Plastics Engineers Annual Technical
Conference, Volume 44, pgs. 888-892, (May 1998).

ECM Comb. Mot. to Exclude Page 47 of 58
Exh. U


CERTIFICATE OF SERVICE

Thereby certify that on May 1, 2014, I caused a true and correct copy of the foregoing
document to be served by email to Counsel for the Respondent:

Jonathan W. Emord
Emord & Associates, P.C.
11808 Wolf Run Lane
Clifton, VA 20124

Email: jemord@emord.com

Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: leaputo@emord.com

Dated: May 1, 2014

ECM Comb. Mot. to Exclude

Exh. G

Peter Arhangelsky

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: parhangelsky@emord.com

Respectfully submit

Katherine Johnson &johnsot3@ftt-gov)

Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@fic.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

Page 8 of 8


PUBLIC DOCUMENT

His Honor could not have intended when preparing the Revised Scheduling Order to permit just
two days between the time to identify new rebuttal experts and the cutoff date for expert
depositions. The only reasonable interpretation is that Complaint Counsel was to select from a
list of already identified expert witnesses.

The Rules prohibit Complaint Counsel from calling any expert witness to testify at the
hearing that it failed to list on its expert witness list. Parties to an FTC administrative action are
required to “serve each other with a list of experts they intend to call as witnesses at the hearing
not later than 1 day after the close of fact discovery, meaning the close of discovery except for
depositions and other discovery permitted under §3.24(a)(4), and discovery for purposes of
authenticity and admissibility of exhibits.” 16 C.F.R. § 3.3 1A(a).® Therefore, any expert not
designated in the expert witness list is not permitted to testify at the evidentiary hearing, and
cannot later be designated a rebuttal expert. See In the Matter of POM Wonderful, 2011 WL
1429882, at n. 1 (F.T.C. Apr. 5, 2011) (Chappell, A.L.J.) (an expert must first be designated
and provide an expert report in order to be allowed to testify”) (emphasis added, citing Rule
3.31A(b)); 16 C.F.R. § 3.31A(b) (“No party may call an expert witness . . . unless he or she has
been Jisted ...”) (emphasis added). Consistent with Rule 3.31A(b), the only element of the
Scheduling Order that involves “listing” expert witnesses is the April 23, 2014 deadline for
expert witness lists.

Rule 3.31A(d) allows a party to “depose any person who has been identified as an expert
and whose opinions may be presented at trial.” However, the deadline to depose an expert

witness in this case, “including rebuttal experts,” was July 2, 2014. See Third Revised

5 The ALJ is permitted to alter those strict deadlines, which the ALJ did here by resetting
the deadline for expert lists.

10


Michael S. Reeve, Stephen P. McCarthy and Richard A. Gross, “Chemical Degradation of
Bacterial Polyesters for Use in the Preparation of New Degradable Block Copolymers”,
Polym. Preprints, Am. Chem. Soc., Div. Polym. Sci., 31(1), 437-438, (1990)

John E. Kemnitzer, Stephen P. McCarthy and Richard A. Gross, “Polymerization of [S]-B-
Butyrolactone to obtain New Degradable Materials”, Polym. Preprints, Am. Chem. Soc., Div.
Polym. Sci., 31(1), 435-436, (1990).

Jean M. Mayer, Marvin Greenberger, David L. Kaplan, Stephen P. McCarthy and Richard A.
Gross, “Degradation Kinetics of Polymer Films in Marine and Soil Systems under
Accelertated Conditions”, Polymeric Materials: Science and Engineering, Vol. 63, 858-861,
(1990).

Gilbert P. Smith, Barry Press, David Eberiel, Stephen P. McCarthy, Richard A. Gross, and
David L. Kaplan, “An Accelerated In-Laboratory Test to Evaluate the Degradation of Plastics
in Landfill Environments,” Polym. Mat. Sci. and Eng. (Am. Chem. Soc.), 63, 862 (1990).

Gilbert P. Smith, Barry Press, David Eberiel, Richard A. Gross, Stephen P. McCarthy, and David
L. Kaplan, “Degradation Ranking of Plastics in a Landfill Environment," Polym. Mat. Sci. and
Eng. (Am. Chem. Soc.), 63, 867 (1990).

R.D. Deanin, S.P. McCarthy, and H.A. Koslowski, “Three Dimensional Solubility Parameters
and Practical Compatibility of Polymer Blends”, Soc. of Plastics Eng., Technical Papers, 34,
1846, (1988).

Y. Kim, J. Fanucci, and S.P. McCarthy, "Internal Die Pressure Profiles During Pultrusion of
Thermoplastic Composites," SME Fabricating Composites, EM90-657 (1990).

DISSERTATIONS/THESES

A. Completed PhD/D.Eng Theses _ OO

Bhatt, Sanjiv, “A Novel Pressure-Volume-Temperature apparatus for Polymer Melts and
Solids”, 1996

Canale, Philip, “Reactive Processing of Biodegradable Polyesters with Dicumyl Peroxide: A
Structural, Rheological and Property Study”, PhD. Thesis, 1999

Cho, Bong Gyoo, "Fiber Reinforced Nylon-6 Composites by the RIM Pultrusion Process",
D.Eng, 1992

Cinquegrana, David "Knowledge Based Mold Design", D.Eng Thesis May 1990

DeLuca, John, Development of turbine containments for aircraft, 1990

Donabedian, David H., "Plasticization, Chemical Modification and Graft Co-Polymers of
Pullulan", PhD Thesis, 1993

Eagle, Frances, “Ist and 2nd stage commercialization guidelines an indicator test for the
commercialization of a traditionally manufactured product”, 2001

Euaphantasate, Nukul, “An Investigation of Poly(Lactic-Acid) and PEO-PPO-PEO Block
Copolymer Blends as Biomaterials”, D.Eng Thesis, 2001

Fylaktou, Evanthia, “Pharmaceutical Implants: Drug incorporated antimicrobial sutures for
medical applications”, April 2014

Galicia, Gerardo Rocha "Biodegradable Polymers for Medical Devices - Blends of Poly(Glycolic
Acid) with Others" D.Eng Thesis, Dec 1992

Hsu, TM, “Synthesis, Properties and Reactivity of Linear and Branched Hydropolysilane
Copolymer and Terpolymers”, 1991

Im, Heeseok, “The Rheological and Mechanical Properties of Biodegradable Poly(Lactic-
Acid)/Poly(Butylene Succinate-co-Adipate) Blends”, D.Eng Thesis, 2001

ECM Comb. Mot. to Exclude Page 53 of 58
Exh. U


CERTIFICATE OF SERVICE

Thereby certify that on March 19, 2014, I caused a true and correct copy of the paper
original of the foregoing Complaint Counsel’s Expert Witness List to ECM BioFilms, Inc. to be

served as follows:

One electronic copy to Counsel for the Respondent:

Jonathan W. Emord

Emord & Associates, P.C.
11808 Wolf Run Lane
Clifton, VA 20124

Email: jemord@emord.com

Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: Icaputo@emord.com

Peter Arhangelsky

Emord & Associates, P.C.

3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: parhangelsky@emord.com

I further certify that I possess a paper copy of the signed original of the foregoing
document that is available for review by the parties and the adjudicator.

Dated: March 19, 2014

ECM Comb. Mot. to Exclude
Exh. D

Respectfully submitted,

/s/Katherine Johnson

Katherine Johnson (kjohnson3@fic.gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

Page 4 of 4


a. Student Advising

Assistant Graduate Program Coordinator (with R. Deanin) in the Plastics Engineering
Department (1984-1987).

Faculty Advisor for the University of Lowell, Alpine Club (1986-1988)

bd. Committee Membership
Member, University of Lowell, Conflict in Interest Task Force (1989-90).

Chairman (1987) and Member (1985/1986) of the Joint Cumulative Exam Committee,
Polymer Science and Plastics Engineering.

Member and Co-Chairman of the Research Advisory Committee (with Leon E. Beghian,
1987).

Member, Graduate School Summer Research Committee (1 985,1986, 1987).

c. Attendance at Conferences

SPE-ANTEC ~ Spring 2012 (Orlando)

SPE-ANTEC ~ Spring 2011 (Boston)

American Intellectual Property Law Association, Marco Island, January 1997
United States Trademark Association, Toronto, May, 1992

Franklin Pierce Law Center Conference on Enforcing and Litigating Patents & Trademarks,
September, 1991

United States Trademark Association, San Francisco, May, 1991 Franklin Pierce Law
Center, Tonference on Emerging Issues in Intellectual Property",

Boston Massachusetts, September 1990
American Chemical Society, Boston, Massachusetts, Spring 1990
ANTEC-SPE, Los Angeles, Spring 1987.

American Chemical Society, Denver, Colorado, Spring 1987.

Page 14 of 17

ECM Comb. Mot. to Exclude Page 14 of 17
Exh. Y


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 19

additive (rather than the plastic) is biodegrading at ideal temperature, moisture, etc.° In other
words, screening, tests may show biodegradation because they have been “primed” to do so.
45. To substantiate its claims regarding the purported biodegradability of ECM
Plastics and the role of the ECM Additive, ECM should have had both screening and
confirmatory tests. Confirmatory testing such as radiolabeling is essential to establish that the

plastic itself is biodegrading.
A. Screening-Level Tests Are Only The First Step.

46. The purpose of a screening-level test is to evaluate whether the test specimen is
capable of biodegrading at all—under any condition. So, screening level tests are conducted
under optimal conditions for biodegradation.

47. Standard test methods set by the ASTM" are common screening-level tests for
determining biodegradability of plastics. Such ASTM test methods set forth the protocols
established by the scientific community to evaluate a material. They are methods (ie,
procedures and processes), not pass/fail criteria.

48. An example of a standard test method for testing biodegradability of plastics in

the aerobic context is ASTM D5338: “Standard Test Method for Determining Aerobic

9 Id. (describing “material transformations [] due to microbial attacks on additives rather
than mineralization of a polymeric component of a material”).

1° ASTM International, formerly known as the American Society for Testing and
Materials (ASTM), develops and publishes voluntary consensus technical standards for a wide
range of materials, products, systems, and services. Standards are developed within committees,
and new committees are formed by request of interested members. Membership in the ASTM is
open to anyone with an interest in its activities. There are approximately 20 active standards
under the jurisdiction of subcommittee D20.96 on Environmentally Degradable Plastics and
Biobased Products. For the past 20 years, I have been involved in helping to develop standard
test methods and specifications for D20.96.

ECM Comb. Mot. to Exclude Page 19 of 58
Exh. U


than those in a typical landfill. ASTM DS511 thus can provide data about anaerobic
biodegradation, but it categorically cannot provide data about the rate of biodegradation in a
typical landfill.

78. Not surprisingly, then, ASTM D5511 calls for conditions that diverge
dramatically from landfills. For example, the average landfill temperature is 37°C, but ASTM
D551 calls for testing at 52°C. ASTM D5511 requires at least 20% dry solids (i.2., 80%
moisture); the average moisture content in landfills is much lower (15-35% moisture). These
significant differences in temperature and moisture mean that ASTM D5511 tests have
conditions far more favorable to biodegradation than landfills do; that the gas generated in
ASTM D5511 test will, therefore, differ both in quality and quantity from gas generated by the
typical landfill; and ASTM D5511 gas generation will not provide data about the rate of
biodegradation in landfills.

79. | ASTM D551) also calls for use of an inoculum that is not available from a U.S.
laboratory—and likely not comparable to the bacterial community found in the typical U.S.
landfill. Inoculum used in ECM’s ASTM D551} tests (described on page ECM-FTC-000506)
were from organic compost from New Milford Farms (founded to compost food by-product
waste from Nestle USA operations) and Mattabasset Waste Treatment Facility (treats waste
water and not MSW). These inoculums are very different from the bacterial community in the
typical MSW landfill.

80. A limiting factor in the utility of ASTM D551! tests is that the test method does
not provide any means to distinguish biodegradation of the plastic and the additive, because the

method assumes testing of homogenous material. As a result, ASTM D5511 results cannot

31

ECM Comb. Mot. to Exclude Page 31 of 56
Exh. X


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of
ECM BioFilms, Inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International PUBLIC DOCUMENT

Vee eS

JOINT MOTION FOR ENTRY OF PROPOSED ORDER APPROVING
STIPULATION AS TO ADMISSIBILITY OF CERTAIN EVIDENCE

Pursuant to Commission Rule of Practice 3.31 (f) and 3.43(b)-(c), Complaint Counsel and
Respondent ECM Biofilms (“ECM”) respectfully request that the Court enter the attached
proposed order based on the parties’ stipulations regarding certain documents. Specifically, both
parties stipulate and agree as follows:

1, The document produced by The Ohio State University in this matter entitled Gomez,
Eddie & Michel Jr., Frederick, 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 (the “Ohio State Study”), attached hereto as Exhibit CX-1, shall be

admitted into evidence at the evidentiary hearing to take place in this matter.

2. The Ohio State Study is admissible for the truth of the matters asserted therein and for all
other purposes and not excludable on any grounds.

3. The parties reserve their rights to present evidence or argument that goes to the probative

value or evidentiary weight to be accorded to the Ohio State Study.

Dated: May 5, 2014 Respectfully submitted,

ECM Comb. Mot. to Exclude Page 1 of 5
Exh. I


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ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 33

85. Statistical Significance. All but a few tests fail to report the statistical
information that is necessary to understand the significance of the results. For tests conducted
under ASTM methods, the standard deviation and confidence limits calculations are required to
determine whether a percent biodegradation, if any, may be reported.”* Also, as reported in the
ASTM D5511 precision and bias section, the intra-laboratory sensitivity of the test is 5.1%, with
a 95% confidence limit of 10.2%. This means that any single lab conducting the same test, under
those same conditions, will obtain results within a 10% differential 95% of the time.”* Given the
sensitivity of the ASTM D5511 test, many of the results showing low-levels of biodegradation at
the conclusion of the test should be disregarded because they are within the imprecision range of
the test.

86. Qualitative Tests. A number of tests were submitted evaluating changes in the
physical characteristics of the test specimen. For instance, one Northeast Laboratory test reports
changes to molecular weight of the sample, stating that changes in the molecular weight
demonstrate “that the polymer is breaking down.” However, changes in molecular weight could
also be indicative of disintegration rather than biodegradation. Importantly, the evaluation lacks
a starting molecular weight for the test sample or the negative contro]. Assuming that the
untreated sample approximates the starting molecular weight, the final molecular weight of the
ECM Plastic after being exposed to anaerobic conditions for a year, demonstrate that the

molecular weight has not been reduced enough to be metabolized by microorganisms. Only

23 See ASTM D551] supra note 12, at 13.4 (“If the confidence interval on percentage
biodegradation calculated in 12.5 includes zero, then the percentage biodegradation is not
statistically significantly different from zero.”)

+ A ithough the precision and bias section does not report an inter-lab sensitivity, it is
extremely likely that there would be greater error between labs.

ECM Comb. Mot. to Exclude Page 33 of 58
Exh. U


polylactic acid biodegrades in compost, but slowly, and the addition of even 20% by weight
BIONELLE#3000 increase this biodegradation dramatically.”

Consistent with the position Dr. McCarthy took in the ‘199 patent and inconsistent with the
position he takes in his rebuttal report, I am of the view that polymer scientists routinely use
and consider reliable measurement of weight loss to support a claim of biodegradation. See,
the ‘199 patent. See also, “Advances in Properties and Biodegradability of Co-Continuous,
immiscible, Biodegradable, Polymer Blends, Macromol. Symp. 144, 63-72 (1999).

On the issue of free chloride content, I reviewed Dr. Burnette’s report and note that he stated as

follows:

“The observation that the addition of the ECM additive does allow for easier
enzymatic breakage of the carbon-carbon bonds was seen on tests involving
BioPVC®, A component of this test involved measuring the amount of chloride ion
freed from the PVC structure (see structure of PVC above). ECM treated PVC showed
statistically significant amounts of free chloride ion compared to the negative control
of non-ECM treated PVC. The presence of this chloride ion is evidence that the
stability of the ECM molecule is destabilized by the ECM additive, allowing for
breakage or degradation when compared to the control.” Burnette Report at 44.

T do not understand Dr. Burnette to claim that the “free chloride ion” is evidence of “breakage”
of “the PVC” molecule meaning breakage of the C-C bonds. Read in full context, Dr. Burnette
points out that a component of the testing was measurement of the chloride ion freed from the
PVC structure. He points out that ECM treated PVC showed statistically significant amounts
of free chloride ion compared to a negative control. He then pointed out that “the presence of
the chloride ion is evidence that “the stability of the PVC molecule is destabilized by the ECM
additive, allowing for breakage or degradation when compared to the control.” Accordingly,
the presence of the chloride ion was properly interpreted as confirming that the PVC was
destabilized, which itself would then allow for breakage or degradation. This is understandable
as the loss of chiorine from the PVC chain will reportedly result in an unsaturated product
which is more likely to be degraded. In addition, the metabolic needs of bacteria are reported

to include carbon, water, nitrogen and chlorine. See, e.g., “Considerations Affecting

Page 19 of 20

ECM Comb. Mot. to Exclude Page 19 of 20
Exh. W


representatives (e.g., EPA, Department of Energy), academics, industry stakeholders, etc., that
develops guidance regarding alternative landfill covers.

6. As part of my responsibilities for the EPA, I provided expert advice regarding
solid waste disposal for the World Bank and USAID, as well as to countries including Jordan,
Taiwan, Russia, and Hong Kong.

7H A significant part of my education, training, and experience has involved
conducting and evaluating tests that purport to show biodegradation and/or replicate landfill
conditions. In particular, I have considerable experience conducting and evaluating tests based
on large bench scale solid waste decomposition (lysimeter) studies.

8. Based on my education, training, and experience, I consider myself an expert in
the field of landfill design and management.

9. Thave not testified as an expert in the past four years.

10. Tam not being compensated for my work with respect to this case. I volunteered
to serve as an expert in this matter, and could have declined the position.

IL. SCOPE OF REVIEW

11. Complaint Counsel asked me to evaluate whether, based on either (a) materials
ECM Biofilms, Inc. (“ECM”) submitted to the FTC, or (b) any other evidence I reviewed, the
following claims are true:

a. Plastic products manufactured with ECM’s additive (“ECM Plastics”) will
completely biodegrade in a reasonably short period of time (i.e., one year)
after customary disposal (i.e., recycling, incinerator, landfill).

b. ECM Plastics will completely biodegrade in nine months to five years
after customary disposal (i.e., recycling, incinerator, landfill).

c ECM Plastics have been shown to be biodegradable, biodegradable in
most landfills, or biodegradable in nine months to five years under various

scientific tests including, but not limited to, ASTM D5511.

ECM Comb. Mot. to Exclude Page 5 of 56
Exh. X


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. ~ Page 18

42. Anecdotal evidence of biodegradation is not competent and reliable scientific
evidence of biodegradation. Moreover, qualitative tests (e.g., tests that evaluate changes in
appearance, weight, or other physical characteristics) are, by themselves, insufficient to address
the questions posed above, because qualitative changes can result from mechanical processes

rather than from biodegradation.

VII. CURRENTLY AVAILABLE TESTS THAT SCIENTIFICALLY EVALUATE
BIODEGRADATION OF PLASTIC

43. There are three tiers of tests used by polymer scientists to determine whether, and
under what conditions, biodegradation of plastic occurs. First, an initial screening level test can
show whether biodegradation is occurring at all. Second, level-1 confirmatory tests can
determine whether the plastic itself is in fact biodegrading and whether it will biodegrade under
specific (e.g., real-world) conditions. Third, level-2, field-scale tests that are in situ can be used
to evaluate whether biodegradation has adverse environmental effects.°

44, Screening level tests, by themselves, cannot definitively establish
biodegradation,’ because their optimized conditions and lack of control for the “priming effect”
means that they are likely to overestimate biodegradation.’ These factors can cause a screening-

level test to essentially give a false positive—to show biodegradation because the organic

© MICROBIOLOGY OF SOLID WASTE 179 — 180 (Anna C, Palmisano and Morton A. Barlaz,
eds. 1996).

7 Id. at 193 (“screening-level evaluations of materials do not provide definitive evidence
of biodegradation.”).

5 Id. {T]he possibility of overestimation of biodegradation potential exists if the
‘priming effect’ occurs if material transformations are due to microbial attacks on additives
rather than mineralization of a polymeric component of a material, or if a material is exposed to
microbial cultures that are not representative of the environment in which the material will be
disposed.”)

ECM Comb. Mot. to Exclude Page 18 of 58
Exh. U


U.S. Patent Mar. 16, 1999 Sheet 1 of 7
70
60
RP
50% Arop30 90850
eo \ L-A80870
S 40h OF
go foci
S 30
pec B10#3000
20
10
° 400 200 300 400 500 600 700 G00
Strain,%
FIG. 1
70
a PLA
L
soe

Stress, MPa

[_.-cA9OBIO

\ io#3000

ECM Comb. Mot. to Exclude
Exh, Z

20 30
Strain, %

FIG. 2

40 50

5,883,199

Page 65 of 80


Rebuttal

This is again in reference to Dr. Michel’s 2013 paper noted above. I therefore reviewed this

paper to see how Dr. Michel went about preparing samples for testing. I noticed as follows:

1. Dr. Michel indicates in his 2013 paper (page 2585, Table 2) that he apparently prepared
a blend of polypropylene with “2% ECM MasterBatch PelletsTM additive.” However, I
did not see any information as to how such blend of polypropylene was prepared, such
as the conditions for blending. The conditions for blending will have an impact on the
polymer blend produced and can include, e.g., destruction or compromise of the
additive, non-uniform distribution of the additive, inclusion in the blend of substances
toxic to biodegradation, etc. Dr. Michel does indicate that he prepared the blend by
“injection molding” and, as noted, no conditions are reported as to how he or others
prepared the blend, which I understand to be a function ordinarily dictated by ECM
with care in the creation of plastics containing its additive. Injection molding involves
heating a polymer material at elevated temperature and with shear, which if not done
properly, can seriously compromise the polymer as well as the distribution and
integrity of the ECM additive package. It is also unclear as to whether or not the
negative control of conventional polypropylene was the same polypropylene mixed
with the ECM additive package and exposed to similar injection molding conditions.
Such lack of information on how the polypropylene blends were prepared, and whether
or not Dr. Michel followed ECM’s recommended procedures for blending, and
blending levels, raises serious questions regarding the accuracy of the ensuing tests
regarding the ECM additive in polypropylene.

2. Similar to the above, Dr. Michel indicates in his 2013 paper (page 2585, Table 1) that
he prepared a blend of polystyrene with “2% ECM MasterBatch PelletsTM additive.”
Again, Dr. Michel indicates that such blend was prepared by injection molding but no
conditions are reported. As noted above, injection molding involves heating a polymer
material at elevated temperature and with shear, which if not done properly, can
seriously compromise the polymer as well as the ECM additive. Such lack of
information on how the polystyrene blends were prepared, and whether or not Dr.

Michel followed ECM’s recommended procedures for blending, and blending levels,

Page 5 of 20

ECM Comb. Mot. to Exclude Page 5 of 20
Exh. W


Materials", SPE-ANTEC, 685(1986).

S.S. Chung and S.J. Grossman, "DSC Studies of Polymerization and Crystallization of
Nylon-RIM Materials-Il", Polymer Preprints, 54(1), 629(1986).

S. S. Chung and S.J.. Grossman, "DSC Studies of Polymerization and Crystallization of
Nylon-RIM Materials-Polymer Preprints, 54(1), 623(1986).

S. Grossman, A. Stolarezyk and 0. Vogl, "Head-to-Head Polymers XVII. Head-to-Head
Polypropylene”, Monatshefte Fur Chemie, 112(11), 1279(1981).

S. Grossman. A. Yamada and 0. Vogl, "Head-to-Head Polymers XVI. Cis and Trans-1,4-
Poly(2,3-dimethylbutadiene)", Journal of Macromolecular Science-Chemistry, A16 (4),
897 (1981).

A. Yamada, S. Grossman and 0. Vogl, "Head-to-Head Polymers XV. A Facile Synthesis of
2,3-Disubstituted Succinates and Butanediols-1,4, Journal of Polymer Science, Polymer
Chemistry Edition, 18,1739(1980).

W. Deits, S.J. Grossman and 0. Vogl, "Novel Preparation of Specialty Polyamides by
Interfacial and Solution Methods”, Journal of Macromolecular Science-Chemistry, MS (5),
1027 (1981).

S. Grossman, D. Tirrell and 0. Vogl, "Regular Copolyoxamides VII. Water Binding in
Regular Copolyoxamide Membranes", ACS Symposium Series, 127,364(1980).

D. Tirrell, S.J. Grossman and 0. Vogl, "Regular Copolyoxarnides VII. Water Absorption in
Regular Copolyoxamides", Die Maicromolekulare Chemie, 180,721(1979).

0. Vogl, C.D. Dudgeon,, W. Deits, S. Grossman and D. Tirrell, "Functional Condensation
Polymers and Copolyoxamides", Polymer Preprints, 19(2), 75(1978).

A, Monahan, S. Grossman et. at, "A New Synthesis of Indenones", Synthetic
Communications, 7(8), 553 (1977)

c. Patents

S. Dai, S. Grossman and K. Onder, Polymers From Azetidine-2,4-Dione And Polyol or
Polyamine, U.S. Patent 4,604,450 (1986)

S.Dai, S. Grossman and K. Onder, "Polyamnide Block Copolymer From Lactam And
Azetidine-2,4-Dione”, U.S. Patent 4,550,157 (1985)

Page 10 of 17

ECM Comb. Mot. to Exclude Page 10 of 17
Exh. Y


CERTIFICATE OF SERVICE

Thereby certify that on June 11, 2014, I caused a true and correct copy of the paper
original of the foregoing Complaint Counsel’s Final Proposed Witness List to ECM BioFilms,
Inc. to be served as follows:

One electronic copy to Counsel for the Respondent:

Jonathan W..Emord Peter Arhangelsky

Emord & Associates, P.C. Emord & Associates, P.C.

11808 Wolf Run Lane 32108. Gilbert Road, Suite 4
Clifton, VA 20124 Chandler, AZ 85286.

Email: jemord@emord.com Email: parhangelsky@emord.com
Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: Icaputo@emord.com

I further certify that I possess a paper copy of the signed original of the foregoing
document that is available for review by the parties and the adjudicator.

Dated: June 11, 2014 Respectfully submitted,

7} pod 2

1 A ed ie
Katherine Johnsog-(kjohnson3@fic.gov)
Jonathan Cohen (jeohen2@ftc. gov)
Elisa Jillson (ejillson@fic gov)
Federal Trade Commission
600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580
Phone: 202-326-2185: -2551; -3001
Fax: 202-326-2551

ECM Comb. Mot. to Exclude Page 16 of 16
Exh. F


In the Matter of ECM Biofilms, FTC Docket No. 9358

Sur-Rebuttal Report of Dr. Steven J. Grossman

Sur-Rebuttal to Rebuttal Reports of Drs. Frederick C. Michel and Stephen P. McCarthy

Page 1 of 20

ECM Comb. Mot. to Exclude Page 1 of 20
Exh. W


Cumulative % of Initial carbon lost

0
Ss
s

—~— Positive (cellulose paper) —x— PHA
—#— Co polyester ~ com-based polymer. = —#— Plastarch

—4—~ Wheat starch-derived resin PP +2% additive
——— PETE + 1% additive PS + 2% additive

3 Fie

0 100 200 300 400 500 600 700

Time (davs)

Figure 1. Cumulative carbon loss (CO,-C) as percentage of initial carbon (£ cumulative standard error) for

bio-based plastics and for conventional plastics amended with additives during 660 days of soil

incubation. For some data points standard error bars are smaller than markers.

Cumulative % of initial carbon lost

100%

90% +

80%
70%

60% {| —®— PETE + 1% additive

50%
40%
30%
20%
10%

0%

—+— Positive (cellulose paper)
—’— Co-polyester + corn-based polymer
—*— Plastarch

PP +2% additive

0 10 20 30 40 50

Time (days)

Figure 2. Cumulative carbon loss (CO,-C) as percentage of initial carbon (+ cumulative standard error) for
bio-based plastics, conventional plastics amended with additives and natural fiber composites during 50

days of anaerobic digestion. For some data points standard error bars are smaller than markers.

ECM Comb. Mot. to Exclude

Exh. V

Page 7 of 24


41.

42,

43.

45.

46.

47,

48.

49,

50.

ECM Comb. Mot. to Exclude

Exh. A

Paul J. Kappus, BIOPVC, Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Ramani Narayan, Michigan State University

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Representative of Microtech Research, Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

John Lake and/or Representative of Bio-Tec Environmental LLC

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

William W. Ulman, Northeast Laboratories, Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Garrett W. Johnson, Northeast Laboratories, Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Representative of Northeast Laboratories, Inc.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Thomas Poth and/or Representative of Edén Research Laboratory

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Morton A. Barlaz, North Carolina State University

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

Representative of ASTM International

Proposed Testimony: We anticipate that this witness will testify regarding ASTM
standards, ECM’s claims of biodegradability, and the substantiation for such claims.

Page 8 of 11



ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 29

73. At least two additional scientific peer-reviewed publications that have evaluated
blends similar to ECM Plastic conclude that these blends are not biodegradable. For example,
an article reporting on tests of blends of 10% PCL (a biodegradable material) with 90% PE
(conventional plastic) showed no biodegradation after 12 weeks of exposure to microorganisms.
L. Tilstra and D. Johnsonbaugh, “The biodegradation of blends of polycaprolactone and
polyethylene exposed to a defined consortium of fungi,” Journal of Environmental Polymer
Degradation, vol. 1, pp. 257-267, 1993. See also A. Iwamoto and Y. Tokiwa, “Enzymatic
degradation of plastics containing polycaprolactone,” Polymer Degradation and Stability, vol.
45, pp.205-213, 1994 (referring to blends of PCL and conventional plastics as
“biodisentigrable”).

ii. | Microorganisms Do Not Produce Enzymes that Metabolize Plastic.

74. ECM’s assertion that the presence of the additive allows biofilms to form, which
in turn enables microorganisms to metabolize conventional plastic, has no scientific basis. A
biofilm consists of naturally-occurring microorganisms. As discussed above, naturally-occurring
microorganisms do not possess the necessary enzymes to break down high molecular weight
conventional plastics, which otherwise remain resistant to microbial attack.2° The
microorganisms in the biofilm at best could only metabolize the biodegradable component.
Accordingly, the presence of biofilm does not affect the conventional plastic, and ECM’s claims

have no scientific support.

°° Although there has been one documented instance of a particular strain of fungi
capable of biodegrading a petroleum based plastic, see APPLIED AND ENVIRONMENTAL
MICROBIOLOGY 6076-6084, “Biodegradation of Polyester Polyurethane by Endophytic Fungi,”
(Sept. 2011) there is no evidence that any of these strains exist in the U.S. or in landfills in the
US.

ECM Comb. Mot. to Exclude Page 29 of 58
Exh. U


Comment by Dr. Burnett.

“74, Further, cellulose is a better positive control to provide confidence in the overall biological activity of
the test, than it is as a positive control for the biochemistry of biodegradation of plastics. Cellulose is
biodegraded by an enzyme called cellulase, a widely-abundant enzyme in nature. It is unlikely that
cellulase plays a direct role in biodegradation of plastics, however (see discussion on enzymes above).
Therefore, these tests are not an “apples to apples” comparison of the enzymes in biodegradation.
Rather, cellulose, and the cellulase enzyme that biodegrades cellulose, is really a positive control that
verifies the biological viability of the assay generally. It may not verify performance in the presence of
biological activity from other areas of the MSW landfill that might degrade the test article.”

Rebuttal —

While it is true that the test conditions may be optimized for cellulose biodegradation and not for
polyethylene degradation, these types of biodegradation tests are used and widely accepted for many
different types of organic chemicals. Similar tests have been used to test polymers, herbicides, organic
chemicals, natural materials, biopolymers and hydrocarbons very similar in structure to conventional
plastics (Desai et al., 1990; Sanchis et al., 2013; Miles and Doucette, 2001; Gomez and Michel, 2013;
Albertsson, 1977; Albertsson, 1978; Albertsson et al., 1978 ). Furthermore while Dr, Burnette correctly
notes that Cellulase is a widely abundant enzyme produced by many different types of microorganisms,
he does not explain why few if any polyethylene or polypropylene degrading enzymes (plasticases?)
have been isolated from nature nor described in the scientific literature.

Comment by Dr. Burnett -

“76. One common criticism of the results (discussed below) is that the biodegradation witnessed, say, in
change of dry mass, is minimal if not negligible. It is important to consider that biodegradation has only
been tested in one possible environment experimentally replicated. Greater biodegradation would
necessarily be observed if the test material were analyzed in a sampling of different possible MSW
landfill environments, such as manipulating oxygen or pH levels. These changes in variables may provide
for the rise of different microbial populations that can further the biodegradation process.”

Rebuttal-

Dr. Burnette makes the point that test environments have limited ranges of temperature, pH and
oxygen concentration and therefore cannot mimic the more diverse environment within a landfill where
temperatures range from 10 to 50. Yet as noted in reports by FTC expert Dr. Thabet Tolaymat, water is
actively removed and oxygen is not present within a landfill. In this type of environment, microbial
diversity and activity is likely to be lower and limited as compared to environments where
microorganisms are active, temperatures are warm and sufficient moisture and diverse substrates are
present. These conditions are used in biodegradability tests to provide an optimal environment for
microbial degradation. Furthermore, within compost, anaerobic sludge granules and soil aggregates,
gradients of oxygen, pH, substrates, electron donors and minerals exist over very small spatial scales

ECM Comb. Mot. to Exclude Page 9 of 24
Exh. V


Supplemental Appendix C

Individuals or Entities Associated with Scientific Testing

[ Name and Title

Contact Information

Counsel (if known)

Ohio State
University

Through counsel

Jan Alan Neiger

Assistant Vice President and
Associate General Counsel
The Ohio State University
Office of Legal Affairs
1590 North High Street,
Suite 500

Columbus, Ohio 43201
Phone: 614-292-061 1/FAX:
614-292-8699

E-Mail: Neiger.4@osu.edu

Frederick Michel

Contact through counsel

Jan Alan Neiger

Assistant Vice President and
Associate General Counsel
The Ohio State University
Office of Legal Affairs
1590 North High Street,
Suite 500

Columbus, Ohio 43201-
Phone: 614-292-061 1/FAX:
614-292-8699

E-Mail: Neiger.4@osu.edu

Eddie F. Gomez

Contact through counsel

Jan Alan Neiger

Assistant Vice President and
Associate General Counsel
The Ohio State University
Office of Legal Affairs
1590 North High Street,
Suite 500

Columbus, Ohio 43201
Phone: 614-292-061 1/FAX:
614-292-8699

E-Mail: Neiger.4@osu.edu

ECM Comb. Mot. to Exclude
Exh. C

Page 4 of 5



Respondent’s Exhibit M

CONFIDENTIAL


A copy of Dr. Frederick’s curriculum vitea follows as Attachment B, fully describing and
identifying his background and qualifications, and all publications authored by him
within the preceding ten years. Dr. Frederick has not testified and has not been deposed
as an expert within the preceding four years.

Dated: March 18, 2014 Respectfully submitted,

/s/ Katherine Johnson

Katherine Johnson (kjohnson3@ftc.gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

w

ECM Comb. Mot. to Exclude Page 3 of 4
Exh. D


Ring-Opening Polymerization of Racemic B-Butyrolactone " Macromolecules, Vol. 26, pgs.
1221-1229 (1993).

Michael S. Reeve, Stephen P. McCarthy and Richard A. Gross, "The Preparation and
Characterization of [R]-Poly(S-hydroxybutyrate)-Poly(e-Caprolactone) and [R]-Poly(B-
hydroxybutyrate)-Poly(Lactide) Degradable Diblock Copolymers", Macromolecules, Vol. 26,
pegs. 888-894 (1993).

Ji-Dong Gu, David. T. Eberiel, Stephen. P. McCarthy and Richard. A. Gross, "Cellulose Acetate
Biodegradability Upon Exposure To Simulated Aerobic Composting and Anaerobic
Bioreactor Environments", J Environ. Polym. Degrad., 1(2), (1993).

Ji-Dong Gu, Stephen P. McCarthy, G.P. Smith, David Eberiel and Richard A. Gross, “
Degradability of Cellulose Acetate (1.7 D.S.) and Cellophane in Anerobic Bioreactors”,
Polymeric Materials: Science and Engineering, Vol. 67, 230-231, (1992).

Devang T. Shah, Stephen P. McCarthy and Richard A. Gross, “New Polymers Derived From
Natural Origin y-Poly(Glutamic Acid)”, Polym. Preprints, Am. Chem. Soc., Div. Polym. Sci.,
Vol. 33(2), pgs 488-489, (1992).

Michael S. Reeve, Stephen P. McCarthy and Richard A. Gross, “The Preparation and
Characterization of [R]-Poly(B-Hydroxybutyrate)-Poly(e-Caprolactone) and [R]-Poly(B-
Hydroxybutyrate)-Poly(Lactide) Degradable Diblock Copolymers”, Polymeric Materials:
Science and Engineering, Vol. 67, 182-184, (1992).

Michaei S. Reeve, Stephen P. McCarthy and Richard A. Gross, “Thermal and Crystalline Studies
of [R]-Poly(B-Hydroxybutyrate)-Poly(e-Caprolactone) and [R]-Poly(®-Hydroxybutyrate)-
Poly(Lactide) Degradable Diblock Copolymers”, Polymeric Materials: Science and
Engineering, Vol. 67, 232-233, (1992).

Ji-Dong Gu, Manish Gada, G. Kharas, David Eberiel, Stephen P. McCarthy and Richard A.
Gross, “Degradability of Cellulose Acetate (1.7 and 2.5 D.S.) and Poly(Lactide) in Simulated
Composting Bioreactors”, Polymeric Materials: Science and Engineering, Vol. 67, 351-352,
(1992).

John E. Kemnitzer, Stephen P. McCarthy, and Richard A. Gross, "Poly(S-Hydroxybutyrate)
Stereoisomers: A Model Study to Investigate the Effects of Stereochemical and
Morphological Variables On Polymer Biological Degradability", Polymeric Materials:
Science and Engineering, Vol. 67, 179-180 (1992).

Gregory A. Birrer, Anne-Marie Cromwick, Stephen P. McCarthy and Richard A. Gross, “y-
Poly(Glutamic Acid) Biosynthesis by Bacillus LicheniformisATCC 99454: Physiological
Studies”, Polymeric Materials: Science and Engineering, Vol. 67, 134-136,(1992).

Marjorie Nelson, Stephen P. McCarthy and Richard A. Gross, “Isolation of a Pseudomonas
Paucimobilis Capable of Using Insoluble Cellulose Acetate as a Sole Carbon Source”,
Polymeric Materials: Science and Engineering, Vol. 67, 139-140, (1992).

John E. Kemnitzer, Stephen P. McCarthy and Richard A. Gross, “Stereochemical and
Morphological Effects on the Degradation Kinetics of Poly(B-Hydroxybutyrate): A Model
Study”, Polymeric Materials: Science and Engineering, Vol. 66, 405-407, (1992).

John E. Kemnitzer, Stephen P. McCarthy, and Richard A. Gross, "Poly(B-hydroxybutyrate)
Stereoisomers: A Model Study of the Effects of Stereochemical and Morphological Variables
On Polymer Biological Degradability", Macromolecules, Vol. 25, 5927-5934 (1992).

Jean M. Mayer, Marvin Greenberger, David L. Kaplan, Stephen P. McCarthy and Richard A.
Gross, “ Development of Standard Methods for Accelerated Degradation Studies of Polymer
Films”, Polym. Preprints, Am. Chem. Soc., Div. Polym. Sci.,31(1),434, (1990).

ECM Comb. Mot. to Exclude Page 52 of 58
Exh. U


MS. JOHNSON. Well, you have a copy now. So if you want to take some time and take
a look at it, that’s totally fine.

Id.
MR. EMORD: ... You gave us no advanced notice of this document. None. You had it
on Friday, you knew you were going to use it in a deposition —
MS. JOHNSON; I did not know I was going to use it.
MR. EMORD: When did you decide you were going to use it?
MS. JOHNSON: We packed up our stuff on Saturday afternoon.
MR. EMORD: This is highlighted. Who did the highlighting on the document?
MS. JOHNSON: I'm not going to reveal that.
MR. EMORD: ... [I]n any event, you did not tum this document over to us when you
had the opportunity to do it and ~
MS. JOHNSON: This is your opportunity
Tr. 374-375.
MS. JOHNSON: [ apologize for that... Would you like to take a few moments to read
il, we can take a break?
Tr. 375-376
I Analysis

A, Overview

Respondent asserts, and Complaint Counsel does not deny, that the Ohio State Article is
within the scope of Respondent's First Request for Production of Documents, specifically,
Requests 1 and 3, which state:

Document Request 1; Provide all documents that concern whether plastics in general and
ECM Plastics in particular will break down and decompose into elements found in nature
after customary disposal or in a landfill.

Document Request 3: Provide all documents that support or call into question your
conclusion that ECM’s biodegradable claims for degradation are false,

3

ECM Comb. Mot. to Exclude Page 3 of 6
Exh. P


Exhibit B

2. Meer, S., Benson, C., Tolaymat, T., Carson, D. In-Service Hydraulic Conductivity Of GCLs In Landfill Covers
-Laboratory And Field Studies. U.S. Environmental Protection Agency, National Risk Management Research
Laboratory. Cincinnati, OH, EPA/600/R-05/148, 2005.

3. Tolaymat, T. Landfill Bioreactor Performance, Second Interim Report. U.S. Environmental Protection Agency,
National Risk Management Research Laboratory. Cincinnati, OH, EPA/600/R-07/060, 2007.

4. Peggs, I., Tolaymat, T. Non-Destructive Evaluation of Geomembrane Seam Bond Strength. U.S.
Environmental Protection Agency, National Risk Management Research Laboratory. Cincinnati, OH,
EPA/600/R-09/070, 2009,

5. Benson, C., Barlaz, M., Tolaymat, T. Bioreactor Landfills State-Of-The Practice Review. U.S. Environmental
Protection Agency, National Risk Management Research Laboratory. Cincinnati, OH, EPA/600/R-09/071,
2009.

ADJUNCT APPOINTMENTS/CONSULTANCY

Adjunct professor at East Tennessee State University

Executive board member at the Florida Center for Solid and Hazardous Waste Management
Solid waste expert witness for Ohio EPA, 2006

Solid waste consultant to the World Bank

Solid waste consultant to USAID

AWARDS

* U.S. EPA Science Achievement Award in 2010 for service at the Salt River Regional Landfill awarded by
EPA

* U.S. EPA Bronze Medal for Commendable Service in 2007 for service after hurricane Katrina awarded by
EPA

¢ U.S. EPA Bronze Medal for Commendable Service in 2010 for service at the Fort Deveins Superfund Site
awarded by ORD

¢ US. EPA Bronze Medal for Commendable Service in 2010 for service at the County Wide Landfill
awarded by Region 5

¢ — Level HI Scientific and Technological Achievement Award 2007

* U.S. EPA/ORD Superior Accomplishment award every year between 2004 and 2010

INVITED PRESENTATION AND WORKSHOPS

* Developed and taught the Interstate Technology Regulatory Council (ITRC) bioreactor landfill internet
training course in 2006

* Develop web content about bioreactor landfills in 2007 with the Hinkley Center for Solid and Hazardous
Waste Management and the University of Florida (see http://www.bioreactor.org)

¢ Develop 2-day workshops on bioreactor landfills to for EPA Regions 5, 6, and 7 between 2005 and 2006

¢ Develop and coordinate bioreactor landfill section of Solid Waste Association of North America (SWANA)
symposium in 2007.

© Developed a bioreactor landfill workshop for the World Bank October, 2007.

¢ Invited by Taiwan Environmental Protection Agency to organize and host an international workshop in
2005 and 2008.

¢ Environmental Factors and Surface Properties of Nanoparticles Governing Their Fate, Reactivity, and
Mobility. Presented at 10th International Conference on the Biogeochemistry of Trace Elements,
Chihuahua, MEXICO, July 13 - 18, 2009

¢ Monitoring Guidance for Bioreactor Landfills. Presented at SWANA Bioreactor Meeting, San Antonio,
TX, March 22 - 25, 2005.

* Mercury Speciation In FGD: Assessing Transport And Bioavailability Risk. Presented at Research and
Demonstration of Agricultural Uses of Gypsum and Other FGD Materials Workshop, St. Louis, MO,
September 12 - 14, 2006.

* Metal Speciation in Soil, Sediment, and Water Systems Via Synchrotron Radiation Research. Presented at
EPA Science Forum, Washington, DC, May 16 - 18, 2005.

eoeee

ECM Comb. Mot. to Exclude Page 55 of 56
Exh. X


Supplemental Appendix D

Current and Former FTC Employees

Name and Title

Contact Information

Counsel (if known)

Kathleen Pessolano

Unknown

Complaint Counsel

Zachary Hunter

Unknown

Complaint Counsel

Matthew Wilshire,
Attorney

Federal Trade Commission
600 Pennsylvania Ave., NW
Mailstop M-8102B
Washington DC, 20580

Tel: contact through Complaint
Counsel

Complaint Counsel

David Hendrickson,
Investigator

Federal Trade Commission
600 Pennsylvania Ave., NW
Mailstop M-8102B
Washington DC, 20580

Tel: contact through Complaint
Counsel

Complaint Counsel

ECM Comb. Mot. to Exclude
Exh. C

Page 5 of 5


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

10000

a
S
S
=)

@ PLA

X A70B30

| Bl0#3000
@ A90BI0

Elongation at Break, %

100 X A50B50
A A80B20
@ 430870

10

0 10 20 30 40 50 60 70 80
Aging time, day

FIG. 9

ECM Comb. Mot. to Exclude Page 70 of 80
Exh, Z


To date, | have served as an expert witness in three (3) separate proceedings. | was retained by The
City of Kirtland, OH in 2013 and by Canton OH, in 2001 to provide expert testimony on odors produced
during the composting process and in 2013 by Crabbe, Brown & James, of Columbus, OH to provide
expert testimony on a proposed food waste composting facility in that city (see Appendix B).

Based on my education, training and experience | have been retained by the FTC to provide this
rebuttal report and testimony. | am compensated at the rate of $100 per hour and at $200 per hour for
testimony and deposition.

I have previous knowledge of ECM in that my group tested the biodegradability of ECM amended
plastics as part of a larger study in which we tested the biodegradability of various plastics and natural
materials that could be used to make compostable or recyclable nursery pots.

PAC Welk f

Frederick C. Michel Jr., PhD

ECM Comb. Mot. to Exclude Page 4 of 24
Exh. V


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Ma, Wenguang, “An investigation of Poly(lactic acid) (PLA) and Maleic (MAH) Anhydride Graft
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Mahadevaiah, Yogish, “Effect of an Acid and Solvents on the Weld Properties of ‘Kinetic’
Welded and Ultrasonically Welded Parts”, 2000

Mahajan, Vaibhav, “Optimization of Disintegration Behavior of Biodegradable Poly(Hydroxy
Butanoic Acid) Copolymer Mulch Films in Soil Environment”, 2010

Maheshwari, Ankur, “A Study in the Effect of Powder Injection Molding Process Parameters on
the Shrinkage and Tensile Properties of Stainless Steel Samples and Conductivity of the
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Manherz, Karen, "Epiphereal and Fibroblast Growth on Biodegradable Polymers", 1998

McCarthy, Shawn M., “The Development of Thermojet Rapid Tooling, A New Rapid Tooling
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McLaughlin, Richard M, Jr, “A Structural Analysis and Design of Aces Stereolithography Inserts
for Rapid Tooling of Prototype Injection Molds”, 1996

Meckley, Jonathan A., "Rapid Preproduction Prototype Tooling Using Knowledge Based CAE
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Mowva, Anand, “Injection Molding Filling Verification of PC and PBT”,

Naik, Vatsal, “Kinetics and Thermal Characteristics of BMC”, M.S Thesis, 1992

Nikoludis, Vassilos, “Co-relation of Artificial and Natural Weatherability of Ethane co-Polymer
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O’Brien-Angelo, Peggy, “Correlation of Optical Surfaces Through the Use of Designed
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Oak, Shrikant, “Injection Mold filling Verification of PC and PBT”,

Parekh, Hetal, “Development of a Transparent Flame Retardant Thermoplastics Elastomer”,
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Piepiora, Dean R., “Interfacing 3D CAD with Injection Molding Analysis Software to Verify
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Porcaro, Peter, "Environmental Audit of Disposing Plastic Materials and Products", 1991

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ECM Comb. Mot. to Exclude Page 57 of 58
Exh. U


J Polym Environ (2011) 19:637 676

639

Fig. 1 Diagrammatic
representation of the chemistry z
of biodegradation

con oy

rovidasjbiormane

cepa aien,

edited by Griffin in 1994 [30]. MacGregor et al. [31] may
be referred for a discussion on polymers from nature which
is considered mostly biodegradable. Other books on natu-
ral/agricultural polymers are edited by Carraher et al. [32]
and Glass and Swift [33]. Byrom [34] discusses biode-
gradable polymers from point of view of biomaterials.
Rapra Review Reports [35] provide Advances in Bio-
degradable Polymers edited by Moore and Saunders. Some
interesting reviews on biodegradable polymers by Ann
Christine Albertsson (pp 345 382), starch based degrad-
able plastics by Wayne J. Maddever (pp 383 410) and
degradable plastics by Hideki Omichi (pp 335 344) are
available in the book. Glass and Swift discuss biodegra-
dation and utilization of polymers from agricultural
resources in the book, Agricultural and Synthetic Polymers,
Biodegradation and Utilization [33]. Scott and Gilead have
edited a book on Degradable Polymers [36]. Emo et al. [37]
present environmentally degradable polymeric materials
from renewable resources, water-soluble/swellable biode-
gradable polymers, biopolymers and biorelated polymers,
bioresorbable materials for biomedical applications. The
book also provides data on standards and regulations. The
Handbook of Biodegradable Polymeric Materials and Their
Applications, edited by Mallapragada and Narasimhan [38]
provides a comprehensive review of the synthesis, char-
acterization, processing, and applications of biodegradable
polymers (polymeric biomaterials, biomedical engineering,
food science and nutrition, green engineering, drug deliv-
ery, single-dose vaccines, protein stabilization, gene ther-
apy, tissue engineering, orthopedics, and food packaging
covering a broad spectrum of polymers such as polycap-
rolactones, polyesters, phosphazenes, phosphoesters,
polyanhydrides, starch, chitosan and chitin).

ECM Comb. Mot. to Exclude
Exh. Z

ee =

“Abiotic dezradation

=), US
Pots il SO

enzymes

IMA Fegarens

Acomprehensive first review was brought by Cassidy and
Aminabhavi [39]. They considered degradation of the
polymer through the reaction of the components of the
environment that often promotes chemical change and cor-
related hydrolytic process with the enzymatic activity.
Sudesh et al. [40] made an attempt from the chemical angle
to present (1) the prospects for biodegradable plastics fol-
lowed by the principal retrospective aspects of biodeterio-
ration and (2) to identify possible approaches for designing
new biodegradable systems and finally to review the present
status of research with special reference to structure-biode-
gradability relationships, Bastoili [41] provided a discussion
of biodegradable materials in another review. Aminabhavi
et al. [42] later brought out another review focusing on the
biodegradation of those polymers which have relevance in
the packaging industry for food and vegetables (polyolefin
plastics, with a greater emphasis on linear low-density
polyethylene (LLDPE) and low-density polyethylene
(LDPE)). Literature findings are covered from 1970 to 1989.
The chemistry of biodegradation and the relevant methods
used to study biodegradation are discussed. Several reviews
[43 56] appeared between 1990 and 1993 indicating the
significance of this fast growing area. Swift [47, 54, 55]
wrote several reviews during this period on the complexities
and significant definitions of biodegradable plastics. Kaplan
et al. [57] discussed the fundamental aspects of biodegra-
dation in 1993. Albertson [58] analyzed the biodegradation
of synthetic polymers comparing it with the natural bio-
degradation of wood. Lenz [59] also made a good review
during this period and the developments unto 1994 were
summarized by David et al. [60]. The environmental bio-
degradation of synthetic polymers was given ample stress by
Andrady [61] and thoroughly discussed by Scott [62].

D Springer
Page 3 of 80


introduction
| was asked by FTC counsel to provide rebuttal of expert reports by Drs. Sahu and Burnette. Below |
present their comments (in italics) followed by my rebuttal comments.

tale

Comment by Dr. Burnette -

“26. MSW landfills are dynamic environments which attract and sustain a wide variety of microbial life.
The range of conditions in MSW landfills provide ample opportunity for a variety of bacteria to thrive
that possess the biochemical tools necessary for biodegradation, despite what appear at the human level
to be challenging environmental conditions. The studies referenced here provide direct evidence that
these biodegradation-capable microorganisms are present and thriving in MSW landfills, as they were
isolated and characterized directly from MSW landfill leachate. Subsequent sections of this report will
document that this diversity of microbial life possess enzymes capable of degrading both natural and
synthetic plastics, and that these enzymes are biologically active in MSW landfill environments, and can
behave similarly in testing conditions such as the ASTM D5511 protocol. It is reasonable to conclude that
many of these microorganisms and their enzymes are present in the landfill leachate used, and will act
on ECM treated plastics.”

Rebuttal-

| agree with Dr. Burnette that tremendous microbial diversity exists in landfills (Zhang et al., 2011). Yet
equally if not more diverse microbial communities exist in soil, compost and anaerobic digesters,
including those used for biodegradability testing such as the ASTM D5511 protocol. For example Torsvik
and @vreas (2002) have shown that a single gram of soil harbors up to 10 billion microorganisms and
thousands of different species. Studies have also shown extensive microbial diversity in samples of
activated sludge and compost (Liu et al., 1997; Michel et al., 2002).

Since in biodegradability tests typically use more than 100 grams of soil or activated sludge, there likely
is sufficient phenotypic and genotypic diversity for the biodegradation of even recalcitrant materials
such as polyethylene in these test environments (assuming, of course, that such recalcitrant polymers
were, in fact, biodegradable).

Comment by Dr. Burnette —

Regarding a peer review publication I co-authored (Gomez and Michel, 2013) Dr. Burnette makes the
following comments about the “Plateau effect”.

“33, The argument that the testing environment is the reason for the plateau effect, and not the plastic
itself, can be seen even in peer-reviewed literature that contradicts biodegradation of plastics (Gomez &
Michel, 2013). In this report, the positive control cellulose paper exhibited approximately 74%

5

ECM Comb. Mot. to Exclude Page 5 of 24
Exh. V


Dr. McCarthy Rebuttal Report -- 12

components may persist in the environment, even in disintegrated form. Blends of starch, poly
(3 - hydroxybutyrate) or poly (e- caprolactone) with polyolefins are examples of such systems.”
Van der Zee, M., Analytical Methods for Monitoring Biodegradation Processes of
Environmentally Degradable Polymers, Section 11.5.6.3, Chapter 11 in Handbook of
Biodegradable Polymers: Synthesis, Characterization and Applications, First Edition, edited by
Andreas Lendlein, Adam Sisson.

27. Dr. Burnette claims that the existence of “free chloride ion” is evidence of “breakage” of
the “PVC molecule.” In fact, the chlorine atoms of the PVC are located as a side atom on the
polymer chain as shown in Figure 7 of Dr. Burnette’s report. The loss of the chlorine group from
the PVC chain will not result in breakage of the C-C bonds that form the polymer chain. Thus,
the existence of the free chlorine does not indicate anything about the most difficult, i.e.,
strongest and most recalcitrant, bonds that need to be broken to truly result in biodegradation.
Therefore, the tests conducted by Dr. Barber are invalid and ECM’s expert’s reliance on those

reports is unfounded. °

6 Notably, none of the experts identify any peer-reviewed literature discussing whether the

measurement of free chloride is a basis for determining biodegradability.

ECM Comb. Mot. to Exclude Page 12 of 12
Exh. CC


SUBPOENA AD TESTIFICANDUM
DEPOSITION

Provided by the Secretary of the Federal Trade Commission, and
Issued Pursuant to Rule 3.34(a), 16 C.F.R. § 3.34(a) (2010)

Dr. Frederick Michel

clo Jan Alan Neiger, Assistant Vice President and
Associate General Counsel

The Ohio State University, Office of Legal Affairs, 1590
North High Street, Suite 500, Columbus, Ohio 43201

2. FROM

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION

This subpoena requires you to appear and give testimony at the taking of a deposition, at the date and time specified in
Item 5, and at the request of Counsel listed in Item 8, in the proceeding described In Item 6,

3. PLACE OF DEPOSITION

United Stecton KMocney - Colurnbous 68Grce.

303 Marcon Blvd. , Surte 200
Reem 2OF4

Columbus, OH 4321s"

4. YOUR APPEARANCE WILL BE BEFORE

Complaint Counsel and other designated counsel

5, DATE AND TIME OF DEPOSITION

Yau, WS, 2014 at 9:00 Ay

6, SUBJECT OF PROCEEDING

In re: ECM Biofilms, Inc., Docket No. 9358

7. ADMINISTRATIVE LAW JUDGE

The Honorable D. Michael Chappell

Federal Trade Commission
Washington, D.C. 20580

8. COUNSEL AND PARTY ISSUING SUBPOENA,

Compkint Counsel

Katherine Johnson (202) 326-2185
Jonathan Cohen (202) 326-2551
Elisa Jillson (202) 326-3001

DATE SIGNED

sft fr014

SIGNATURE OF COUNSEL ISSUING SUBPOENA

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 decument upon counsel
listed in tem 8, and upon all other parties prescribed
by the Rules of Practice.

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 8 for payment. If you are permanently 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 8.

A copy of the Commission's Rules of Practice is available
online at bttp://bit, Cl ice. Paper copies are
available upon request.

This subpoena does not require approval by OMB under
the Paperwork Reduction Act of 1980.

EGM GambcMot. teyExclude

Exh. G

Page Z of 8



658

J Polym Environ (2011) 19:637 676

more rapidly in the center than at the surface. This was
attributed to the autocatalytic action of the carboxylic acid
end groups of degrading products which were trapped in
the matrix [442, 443]. This heterogeneous degradation was
assigned to the contribution of two phenomena: (1) easier
diffusion of soluble oligomers from the surface into the
external medium than from inside, and (2) neutralization of
carboxylic end groups located at the surface by the external
buffer solution [443]. Both phenomena contribute to reduce
the acidity of the surface layer, where as in the internal
part, the degradation rate is enhanced by autocatalysis due
to carboxylic end groups. If the surrounding tissues cannot
eliminate the acid by products of a rapidly degrading
implant then an inflammatory or toxic response may result.
However, the extent of heterogeneity depends on a number
of factors such as the molecular characteristics of the
polymer and the degradation medium [443]. Grizzi et al.
showed that devices of small-size such as thin films and
microspheres degraded homogeneously since no internal
autocatalysis occurred [444]. The release of the soluble
carboxyl-terminated oligomers depends on their solubility
in the surrounding aqueous medium and thus factors like
pH, ionic strength, temperature and buffering capacity
become important [425].

Recently, there have been an increasing number of
reports on the enzymatic hydrolysis of PLA [445 451).
These studies revealed that enzymatic degradation prefer-
entially occurred in the amorphous regions of PLA. In
addition, the disordered chain-packing regions of crystal-
line lamellae have been suggested to be preferentially
degraded compared with the tight chain-packing regions
[450, 452]. Enzymatic hydrolysis of PLA proceeds mainly
via the surface erosion mechanism and the surface area of
polymer materials would have a great influence on the
enzymatic degradation [451]. Abiotic hydrolysis is known
to participate at the initial stage of microbial biodegrada-
tion of PLA in nature. The released degradation products
could be consumed by microorganisms [419, 453].

PLA Based Copolymers

In 1932, Carothers demonstrated the synthesis of poly(L-
lactide) (PLLA) by ring opening polymerization of lactide
[454]. Since that time PLA has been used as a bioabsorb-
able material in the medical and pharmaceutical fields
[455 457]. However, the application scope of PLA is
limited because of the certain weaknesses mentioned
above. Copolymerization of L-lactide with other monomers
has been recognized as an important tool to modify PLLA
suitable for specific applications in the field [458]. The
most employed comonomers are D-lactide [459], meso-
lactide [460, 461], glycolide {462 466], caprolactone
(&CL) [467 470] and trimethylene carbonate (TMC)

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

[472]. Grijpma and Pennings have done a detailed study on
the synthesis, thermal properties and hydrolytic degrada-
tion of these copolymers [471]. Glycolide copolymers are
much more hydrophilic than PLLA, while ¢-CL and TMC
reduce the glass transition temperature of the L-lactide
copolymer. All comonomers decrease the crystallinity of
the polylactide and provide optimal mechanical properties
to the materials.

Another approach for enhancing the hydrophilicity and
degradation rate of polylactide was the copolymerization
with other polymers such as polyethylene glycol [472 482}
and chitosan [483 487]. PEG has many outstanding prop-
erties such as solubility in water and in organic solvents,
lack of toxicity, and absence of antigenicity and immuno-
genicity, which are essential for drug formulations and
other medical applications in implantation and wound
treatment. To date, there have been many reports focused
on the synthesis and characterization of block copolymer of
L-lactide and poly(ethylene glycol) [472 482] and on their
biomedical applications [473, 488]. However, such AB or
ABA-type block copolymers have difficulty in getting a
PLLA/PEG copolymer with a high molecular weight. Later
many researchers synthesized multiblock copolymers
constructed with alternated short PEG and PLA blocks
having high molecular weight with remarkable mechanical
strength suitable for constructing cell scaffolds for tissue
engineering purposes [489, 490]. Zhou et al. in their review
article focuses mainly on the properties of polylactide co-
poly(ethylene glycol) (PELA) microspheres adjuvant as
vaccine delivery systems [428]. The results indicate that
compared with the commonly used PLA and PLGA, PELA
showed several potentials in vaccine delivery systems,
which may be due to the block copolymer have its capa-
bility to provide a biomaterial having a broad range of
amphiphylic structure. PELA microspheres can control the
rate of release of entrapped antigens and therefore, offer
potential for the development of single-dose vaccines.
They are extremely flexible delivery systems capable of
encapsulating a wide range of antigens. Otsuka et al. gave a
review article regarding the self assembly of poly(ethylene
glycol)-PLA block copolymers for biomedical applications
(491).

Among renewable resources chitosan, a unique amino
polysaccharide has attained great interest because of its
special structure, properties and its inexpensive abundant
resources [157, 182, 492 496]. The specific properties of
chitosan such as biocompatibility, biodegradability, bioac-
tivity, low immunogenicity and multifunctionality increase
its potential as a beneficial material for various applications
in biomedical field [497 506]. However, the extended
applications of chitosan are frequently limited by its
insolubility in water and neutral pH due to its rigid crys-
talline nature and poor processability. The physicochemical

Page 22 of 80


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From: Johnson, Katherine [mailto:kjohnson3@ftc.gov]
Sent: Wednesday, April 30, 2014 9:15 AM

To: Peter Arhangelsky
Cc: Cohen, Jonathan; Jilison, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Peter:

’m glad we're in agreement over OWS. | will notify Christine Haaker, OWS’s counsel that we will not
conduct the deposition and | will file the Joint Motion today.

As for Northeast Labs, upon further consideration, we have decided that it’s best to conduct the

deposition. Northeast is scheduled for May gt in New Haven, CT, which is the day that | cleared
with Northeast.

Lastly, you did not state whether ECM would be willing to enter into a similar stipulation regarding

Dr. Michel. if | hear nothing further, the deposition will be scheduled for Tuesday, May 13th in
Columbus, OH. Or whether you agree to the other proposed depositions: Flexible Plastics and 3M,
both to take place in the St. Paul/Minneapolis, MN area, on May 15th and 16th respectively.

Katherine

Katherine E. Johnson, Attorney

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B.

Washington, DC 20580

Direct Diat: (202) 326-2185

Fax: (202) 326-2568

Email: Kohnson3@ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com’
Sent: Tuesday, April 29, 2014 6:01 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Katherine:

We agree with the stipulation concerning OWS, provided that you agree unequivocally to withdraw
or withhold any subpoena ad testificandum for OWS. We request that you consider the same
stipulation for Northeast Labs’ documents. We are mindful, however, that certain NE Labs
documents have been provided fram various third parties; not all responsive documents have come
from Northeast Labs itself. Nonetheless, if this type of stipulation is something you would consider,

ECM Comb. Mot. to Exclude Page 3 of 9
Exh. H


CERTIFICATE OF SERVICE

Thereby certify that on March 5, 2014, I caused a true and correct copy of the paper
original of the foregomg Complaint Counsel’s Expert Witness List to ECM BioFilms, Inc. to be

served as follows:

One electronic copy to Counsel for the Respondent:

Jonathan W. Emord

Emord & Associates, P.C.
11808 Wolf Run Lane
Clifton, VA 20124

Email: jemord@emord.com

Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: Ilcaputo@emord.com

Peter Arhangelsky

Emord & Associates, P.C.

3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: parhangelsky@emord.com

I further certify that I possess a paper copy of the signed original of the foregoing
document that is available for review by the parties and the adjudicator.

Dated: March 5, 2014

ECM Comb. Mot. to Exclude
Exh. B

Respectfully submitted,

/s/Katherine Johnson

Katherine Johnson (kjohnson3@fic.gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

Page 3 of 3


ECM Comb. Mot. to Exclude Resp, Mot to Compel and For pabiige 9 of 12

Exh. RX-C-4
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


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 has certain rights
in the inventioa.

BACKGROUND OF THE INVENTION

The invention relates to polylactic acid-based blends,

Succinic acid and diols can form biodegradable aliphatic
polyesters and copolyesters through coupling ard polycon-
densation reactions. The main unit structure resulting from
these reactions is:

OCH Ye OF (CHE

Examples of biodegradable aliphatic polyesters and
copolyesters having the unit structure shown above are
polybutylene succinate (PBSU), where m is 4 and n is 2,
polyethylene succinate (PESU), where m is 2 and nis 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 mis 2 or 4.

These polyesters and copolyesters have interesting prop-
erties including biodegradability, melt processability, and
thermal and chemical resistance. One of these,
BIONOLLE®, a commercially available aliphatic
succinate-adipate polyester, has excellent physical proper-
ties. For example, the thermal resistance of BIONOLLE is

equivalent to that of polyethylene, but the yield strength is 7

higher than polyethylene. The stiffness of BIONOLLE is
between high density and low density polyethylene (LDPE).
Particularly for BIONOLLE #3000, its impact strength is
equivalent to that of LDPE, while its elongation at break is
higher than that of LDPE.

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 polymers. Although it can be synthesized
chemically, 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 fer-
mentation are then used to prepare polylactide polymers.

Lactic acid exists essentially in two stereoisomeric forms,
which give rise to several morphologically distinct poly-
mers: D-polylactic acid, L-polylactic acid, D,L-polylactic
acid, meso-polylactic acids and any combinations of thereof.
D-polylactic acid and L-polylactic acid are stereoregular
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 from the optically active D and L monomers are
semicrystalline materials, but the optically inactive D,L-
polylactic acid is amorphous.

Lactic acid has 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-
roxybutyrate and polycaprolactone, as to their strength,
thermoplastic behavior, biocompatibility, and availability

ECM Comb. Mot. to Exclude
Exh. Z

2

8

40

4

5

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 gen-
erally good processability, it is brittle, and the brittleness
increases with time due to physical aging, i.c., densification
of the polymer at a molecular level.

SUMMARY OF THE INVENTION

The invention is based on the discovery that polylactic
acid (PLA)-based polymers or copolymers and polymers or
copolymers of polyesters, e.g., polybutylenesuccinate, poly-
butylene succinate-adipate or polybutylene succinate-
terephthalte (wherein the diacids of the polyester would be,
for example, succinic acid, adipic acid, terephthalic acid, or
any combinations thereof), can be used to make new bio-
degradable blends that, compared to PLA, have superior
tensile and mechanical properties such as stiffness,
toughness, and elongation to break, as well as excellent
biodegradability and aging properties.

Tn general, the invention features a biodegradable blend
including a first, polylactic 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 C, to Cop diacid or of a combi-
nation of two more different aliphatic C, to Cyy 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 Lik.
For example, the first polymer can be a homopolymer of
polylactic acid, ¢.g., D-polylactic acid, L-polylactic acid,
D,L-polylactic acid, meso-polylactic acid, and any combi-
nation of D-polylactic acid, L-polylactic acid, D,L-
polylactic acid and meso-polylactic acid. In addition, the
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,
polyethylenesuccinate homopolymer, polyethyleneadipate
homopolymer, or a polyethylenesuccinate-adipate
copolymer, or a copolyester of an aliphatic polyester and up
to 50 percent, by weight, of an aromatic polyester, such as
terephthalate, as long as the overall copolyester (and second
polymer) is biodegradable.

The blend can further include a compatibilizer including
one or more polyesters, polyethers, or polyvinyl alcohols.

The new biodegradable blends have an elongation at
break of at least 10 percent, for example, at least 50, 100,
200, 300, 400, and up to 500 percent or more. The blends
also have an elongation at break of at least 10 percent, ¢.g.,
50, 100, 200, 300, 400, and up to 500 percent or more after
70 days of aging. In addition, the blends have a toughness of
at least 10 MJ/m°, e.g., 20, 40, 60, and up to 120 MI/m? or
more.

The second polymer can be present in the new biodegrad-
able blends as a co-continuous phase with the first polymer,
and at least the first or the second polymer or copolymer is
present in a continuous phase in the blend.

The first, polylactic 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:

AR) Ry

wherein R, is a lactic acid unit, R, is caprolactone,
glycolide, trimethylene carbonate, dioxanone, butyryl

Page 72 of 80


ECM Comb. Mot. to Exclude
Exh, L

RETURN OF SERVICE

I hereby certify that a duplicate original of the within
subpoena was duly served: — (chook the method used)

© inperson,
CC by registered mail

© by teaving copy et principal office or piace of business, fo wit:
Fed Ex, per FTC Rule 4.4(a)(2)

on the person named herein on

(Month, dey, and yoer}

‘Name af person making eervice)

{0 meta tis)

Page 2 of 5


30. At the time of the regulations, the EPA concluded that for most landfills, the costs
of liquid addition outweigh the benefits. As a result, RCRA Subtitle D (40 CFR 258.27)
prohibits the addition of liquids to most MSW landfills. In addition, Subtitle D mandates
controls for rainwater run-off (rain water flowing away from the landfill) that serve to minimize
natural addition of liquid to landfills via precipitation. In other words, all but a very small
fraction of landfills in the U.S. are operated to reduce moisture content.

31. Without addition of liquid, the moisture content of a typical MSW landfill is
low—in the range from 15 to 30%. This is well below the optimal range for decomposition (34-
45%). The range of moisture content is broad (15-30%) because varying environmental
conditions affect the moisture level. For example, a landfill in a wet environment in Florida
during the rainy season will have a much higher moisture content (closer to 25% or a little
higher) than a landfill in the Arizona desert (closer to 15%).

32. Leachate recirculation (also called leachate recycling}—which is permitted under
Subtitle D—does increase moisture. That is, when leachate (the liquid generated in the landfill
mainly as a result of rain water passing through the waste) is collected at the bottom of the
landfill and added to the top of the landfill, the moisture content increases. However, even with
aggressive leachate recirculation, the moisture content of the typical Subtitle D landfill still
remains low. Leachate recirculation has a limited effect on moisture level because an enormous
amount of liquid is needed to raise moisture content by even a small amount. To illustrate, it
would take the addition of more than 1.3 million gallons of water to a small MSW landfill cell
(500,000 tons MSW) to increase that cell’s moisture content by a mere 1%.

33. Although the overwhelming majority of landfills in the U.S. are Subtitle D

landfills with comparatively low moisture content, approximately 2% of landfills are specially

14

ECM Comb. Mot. to Exclude Page 14 of 56
Exh. X


ECM Comb. Mot. to Exclude Resp. Mot to Compel and For Sige 2 of 12

Exh. RX-C-4
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


Rego Jr., Richard. P, “Insert Injection Molding of Velcro Brand Hook Components” , 1990

Reddy, Hari, “Integrated CAE Environment”, 1991

Reddy, Rahul, “Effects of low energy electron beam on low-density polyethylene and
polypropylene”, 2010

Russell, Stacey Lee, “An In-Vitro Study of the elastic Property Loss of Poly(L-Lactic Acid),
PLLA Filaments Undergoing Hydrolysis in Tissue Engineering Applications”, Co-Advisor,
2004

Saurkar, Sandeep, "Rapid Tooling: a Study of Cooling Techniques for Mold Inserts Used in the
Direct AIM (ACES Injection Molding) Process ", 1998

Schoenberg, Andrew J, “Blend Characterization of Poly (B-Hydroxybutyrate-co-B-
Hydroxyvalerate and Poly(E-Caprolactone)”, 1992

Shah, Dhaval, “Rheological Characterization Studies of PHB Based Bioplastic and it
Nanocomposites”, 2008

Shah, Ketan, “Thermal Conductivity of Polymer Melts”, 1990

Shah, Dhaval, “Rheological Characterization of PHB Based Bioplastic and Its Nanocomposites”,
2008

Shah, Nilesh. M, “Shrinkage and Filling of UHMWPE”, 1992

Shah, Saiyam Kumarpal, “Evaluation of Kinetic Welding Possiblility with Different Boss and Pin
Geometries and Determining Weld Strength, 2003

Shah, Sunit, “Effect of Calcium Carbonate on Permeability and Mechanical Properties of LLDPE
Films”, 1987

Shetty, Malar Rohith, “Design and Study of an Extrusion-Compression Processing Method
Capable of Molding Long-Glass-Fiber-Reinforced Polypropylene, 2001

Shulka, Jimit, "Compatibilization of Blends of PHB Co-polymers and Polyvinyl Alcohol", 2010

Sheth, Mihir, “Processing and Characterization of Biodegradable Polymers”, 1994

Sinha, Arjun, “Sorption in Biodegradable Materials", 1993

Song, Xu, "Polypropylene Glycol and Poly (Propylene Glycol-Ethylene Glycol) Copolymer as
Biodegradable Plasticizers For Polylactic Acid ", 1997

Sonntag, James, “A study of degradation effects on mechanical interlocks using over-molded
biodegradable polymers”, 2006

Sood, Nitin, “Biodegradable Blends of Poly (Lactic Acid) (PLA)/Polyhydroxybutrate (PHB)
Copolymer and Its Effects on Rheological, Thermal and Mechanical Properties”, 2010

Srinivasa, Shanthakumar R., “A Microeconomic Analysis of the Plastics Industry in the United
States of America and the State of Massachusetts”, 1996

Suh, K. Glen, "Short and Long Glass Fiber Composites: Orientation and Moldfilling Simulation ",
1994

Therriault, Donald, “Effect of Polymer Chemistry and Microstructure on the Permeability of
Plastics”, April 1987

Tanna, Sanjeev, “Polymer Blends of Bacterial Polyester with Cor Starch and Polyvinyl
Alcohol”, 1992

Tulsiani, Pawan K., “Multilayer Co-Extrusion of Biodegradable Thermoplastics to Study the
Effect of Interfacial Slip at Polymer Walls”, 2003

Vijayashankar, Deepashri, “Crystallization Behavior, Mechanical Properties and Rheological Studies of
PHB and Cellulose Acetate Butyrate Blends”, 2012

Wagle, Arvind, “Instrumented Disc for Injection Molding”, 1991

Yang, Gang, “Rheological Studies of Thermoplastic/Glass Composites”,

Yee, King .H, “Die Attachment Adhesives and Bonding Processes”, M.S Thesis, 1985

ECM Comb. Mot. to Exclude Page 58 of 58
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ECM Comb. Mot. to Exclude Resp. Mot to Compel and For SaRage 7 of 12

Exh. RX-C-
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


Prasun KR, M Hakkarainen, IK Varma, A-C Albertsson. 2011. Degradable Polyethylene: Fantasy or Reality.
Environ. Env. Sci. Technol. 45, 4217-4227

Sanchis S, AM Polo, M Tobajas, J J Rodriguez and AF Mohedano. 2013. Strategies to evaluate
biodegradability: application to chlorinated herbicides. Environ Sci Pollut Res. DO! 10.1007/s11356-013-

2130-y

Shen J and R Bartha. 1996. Priming effect of substrate addition in soil-based biodegradation tests. Appl.
Environ. Microbiol. 62(4):1428.

Torsvik V, Ovreas L. 2002. Microbial diversity and function in soil: from genes to ecosystems. Curr Opin
Microbiol. 5(3):240-5.

Zhang W., Yue B., Wang Q., Huang Z., Huang Q., Zhang Z. 2011. Bacterial community composition and
abundance in leachate of semi-aerobic and anaerobic landfills. Journal of Environmental Sciences 23:11.

22

ECM Comb. Mot. to Exclude Page 22 of 24
Exh. V


le by Dr.

General response to Dr. Sahu’s “threshold question” —

Much of the report by Dr. Sahu focuses on the “threshold question” which he defines as whether
conventional plastics like polyethylene and polypropylene are “biodegradable”, even over very long time
scales.

The “threshold question” however is really not the central issue. His threshold assessment of
biodegradability would allow even rocks or metals to be defined as “biodegradable” since under certain
conditions, over long eons of time, microorganisms can produce acids or other compounds that lead to
their weathering, corrosion and eventual mineralization.

Biodegradation in the context of disposable consumer products must mean something different. It
means that a material will biodegrade to natural products over a time frame used for municipal waste
management via composting, anaerobic digestion and/or land filling. It also implies that materials will
biodegrade rapidly if they end up in natural environments and will not accumulate. The massive islands
of plastic pollution now collecting in the world’s oceans (Figure 3), plastic particle pollution in natural
bodies of water like the Great Lakes (Erikson et al., 2013) and the plastic that pollutes many of the
world’s beaches and natural areas demand nothing less.

It would be unfortunate if materials that claim to be “biodegradable” actually contribute to these
problems. Therefore convincing scientific evidence must be presented that demonstrates
biodegradation over short time frames, not decades, centuries or millennia. For these reasons, the
“threshold question” in the context of conventional or ECM plastics, is moot.

Figure 3. Accumulated plastic ocean pollution.

Comment by Dr. Sahu

11

ECM Comb. Mot. to Exclude Page 11 of 24
Exh. V


From: Johnson, Katherine

To: Peter Arhangelsky; Jonathan Emord; Eric Awerbuch
Ce: Cohen, Jonathan; Jillson, Elisa; Decastro, Arturo
Subject: ECM Dkt 9358: Deposition Dates for Dr. Frederick Michel
Date: Monday, July 07, 2014 10:49:35 AM

Or. Michel is available for deposition the foliowing dates:

July 17% and 18"; and July 29°" to 15t of August.

The location would likely be in Wooster, OH.

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: kiohnson3@ftc.gov

ECM Comb. Mot. to Exclude

Exh. T

Page 1 of 1


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 3

I. INTRODUCTION

1. Complaint Counsel retained me to provide my expert opinion regarding certain of
ECM Biofilms, Inc.’s biodegradable advertising claims. Specifically, Complaint Counsel has
asked me to opine regarding whether claims that ECM’s additive makes conventional plastics
biodegradable are true and supported by competent and reliable scientific evidence. It is my
expert opinion that ECM’s biodegradability claims are false and unsubstantiated. This Expert
Report sets forth the rationale for my opinions.

2. It is universally accepted that conventional plastics are resistant to biodegradation.
If an additive existed that truly could render these conventional plastics biodegradable, it would
have garnered enormous attention in the scientific community. It would also have untold
commercial applications worldwide and be an enormous commercial success. Unfortunately, no

such revolutionary product exists.

I. EDUCATION, BACKGROUND & EXPERIENCE

3. I have more than three decades of experience studying both the chemical and
mechanical behavior of polymers, including the biodegradability of polymers used to form
conventional, commercial-grade plastics.

4. I received a Ph.D. in Polymer Engineering from Case Western Reserve University
in 1984. Prior to that, I received a Master’s degree in Chemical Engineering from Princeton
University (1980) and a Bachelor’s of Science degree in Textile Chemistry from Southeastern
Massachusetts University (1978).

Ss. I am a Professor of Plastics Engineering at the University of Massachusetts
Lowell where I teach graduate level courses in Plastics Engineering, including the “Mechanical
Behavior of Polymers” and “Polymers and the Environment.” In addition, I am the Director of
the University’s Biodegradable Polymer Research Center, where I coordinate and supervise

research on biodegradable polymers. I am the Principal Investigator for studies on plastics

ECM Comb. Mot. to Exclude Page 3 of 58
Exh. U


640

J Polym Environ (2011) 19:637 676

Several review articles (3, 63 74] on biodegradable
plastics appeared during 1996 1998. Albertsson and
Karlsson [63] in a review identified four main routes for the
design of biodegradable polymers. The most convenient
route is to use cheap synthetic bulk polymers and add a
biodegradable or photooxidizable component. A more
expensive solution is to change the chemical structure by
introducing hydrolyzable or oxidizable groups in the
repetitive chain of a synthetic polymer. The third route to
degradable polymers is to use biopolymers or derivatives
of these where the bacterial polyhydroxyalkanoates are
perhaps the most studied material of them all. The fourth
route is to tailor-make new hydrolyzable structures e.g.,
polyesters, polyanhydrides, and polycarbonates. Beach
et al. [64] assessed the aggregate impact of the substitution
of cornstarch-based biodegradable polymer resins for
petroleum-based plastic materials and resins on the US
economy. The results suggest that for a DLR1.00/lb of
resin subsidy, the substitution of cornstarch-based biode-
gradable polymer resins for petroleum-based plastic
materials and resins will result in an increase in output by
all producing sectors of 0.067% or about DLR542 million,
a rise in the consumption of goods and services of about
0.003% or DLR110 million, a rise in total utility of 0.004%
or DLRI68 million, and a net increase in government
expenditures of 0.047% or DLR369 million. Two com-
prehensive reviews [21, 67] appeared in 1998. Chandra and
Rustgi [21] may be referred for a detailed survey of bio-
degradable polymers with an exhaustive reference collec-
tion. Amass et al. [67] have brought out the uses of
biodegradable polymers in terms of their relevance within
current plastic waste management of packaging materials,
biomedical applications and other uses including a sum-
mary of degradation processes. De Wild and Boelens [68]
enumerate the prerequisites for biodegradable plastic
materials for acceptance in real-life, composting plants and
technical aspects. Between 1998 and 2001, Bastioli [70
72] has several articles on biodegradable polymers giving
present status and future directions and industrial
applications.

Anuradha and Kumar [73] made an attempt at a concise
review of environmentally degradable materials giving
both mechanisms of degradability, photodegradation and
biodegradation. Materials, criteria and evaluation methods
are discussed. Nayak [74] discussed the challenges and
opportunities of biodegradable polymers in 1999. A num-
ber of plant oils, such as castor, Lesquerella palmeri,
vernonia, tung, crambe oils and cashew nutshell liquid,
have been used to prepare a variety of novel bio-based
polymers for industrial applications. This is a very chal-
lenging field of research with unlimited future prospects.
Researchers can focus their attention on agricultural
products for manufacturing monomers and polymers to

D Springer

ECM Comb. Mot. to Exclude
Exh. Z

keep the environment cleaner and greener in the twenty-
first century. The potential of biodegradable plastics food
packaging was discussed by Petersen et al. [75]. Fomin and
Guzeev [76] projected the present status and future pros-
pects of biodegradable polymers. Rouilly and Rigal [77]
also propose the use of biomass to conceive new materials
and discuss “plastic” properties of natural polymers, the
characteristics of the different classes of polymers, the use
of charge in vegetable matrices and the possible means of
improving the durability of these agro-materials. Gross
[78] discussed the need for biodegradable polymers for the
environment and posed problems associated with the use of
biodegradable polymer such as starch, cellulose and lactic
acid. Scott [46, 79] proposes that polymers that degrade by
peroxidation followed by bioassimilation of the oxidation
products (oxo-biodegradable polymers) are in general more
environmentally acceptable (‘green’) than the biologically
produced hydro-biodegradable polymers. Chiellini [80]
also made an overview on environmentally degradable
polymeric materials (EDPM) in agricultural applications.

In reviewing the properties of biopolymers, Van de Vel
and Kiekens [81] brought out the use of biodegradability in
several applications. The available bioplastic technologies
have been reviewed by Naryanan [82]. A review by Flieger
et al. [83] summarizes data on the use, biodegradability,
commercial reliability and production of biodegradable
plastics from renewable resources. (e.g., commercially
successful biodegradable plastics made by chemical syn-
thesis such as polyglycolic acid, polylactic acid, polycap-
rolactone and polyvinyl alcohol, products of microbial
fermentations such as polyesters and neutral polysaccha-
tides and chemically modified natural products such as
starch, cellulose, chitin or soy protein). Like Gross [78],
Stevens [84] also provides a discussion on environmentally
degradable plastics in his review “Environmentally
Degradable Plastics”. Ren [85] posed the question whether
biodegradable polymers is a solution or a challenge. Pillai
[86] recently reviewed the area on natural monomers and
polymers and pointed out that their inherent biodegrad-
ability has been of great value in the emerging initiatives
such as ‘bio-inspired’ polymer design, ‘synthetically-
inspired’ materials and engineered bio-polymers inspiring
prospects for polymer science at the biointerface with new
materials, taking natural and synthetic polymers beyond
nature’s limitations. Ralston et al. [87] introduced the
theme of sustainable polymers and reviewed current
research on biopolymers such as casein and soy protein
based plastics as well as polylactide acid.

Apart from data available in various reviews, there are a
few excellent reviews [88 90] on the synthetic techniques
adopted for the preparation of biodegradable plastics.
Okada [88] in 2002 has brought out the various method-
ologies adopted in synthesizing biodegradable polymers.

Page 4 of 80


PUBLIC DOCUMENT

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 8, 2014, Respondent’s counsel conferred with Complaint Counsel in a good faith effort to

resolve by agreement the issues raised in the foregoing Motion for Leave.

/s/ Jonathan W. Emord
Jonathan W. Emord

EMORD & ASSOCIATES, P.C.
11808 Wolf Run Lane

Clifton, VA 20124

Telephone: 202-466-6937


before the United States Patent Office is not at all close to the “standard” that Dr. McCarthy
asserts in his report and applies to the ECM product.

In addition, Dr. McCarthy again wrote that based upon his biodegradation curves in FIG. 12,
“a specific blend can now be designed such that this blend would have a certain net
degradation in a given number of days in a compositing environment.” Col. 11, lines 58-61.
Accordingly, Dr. McCarthy explains in the ‘199 patent that biodegradation can be assigned to a
polymer blend provided it has a “certain net degradation” in some “given number of days” in

an artificial compost environment.

Once again, such open standard simply requires that there be identification of some amount of
“net degradation” over some “given number of days” in order to characterize a polymer
material as biodegradable. This would not include any need to achieve a complete break-down
into elements found in nature within one year. And here, Dr. McCarthy informs the reader that
PLA “biodegrades in compost” based upon the observation of a weight loss of just 3% after 20

days.

Accordingly, I find Dr. McCarthy’s “Biodegradation Testing in Compost” as recited in the ‘199
patent at col. 11, lines 25-62 inconsistent with the requirements Dr. McCarthy asserts in his
expert report and applies to the ECM product.

Comment by Dr. McCarthy

2, In my report, I defined conventional plastics as high molecular weight, commercial-grade
plastics representing more than 90% of the market. See, Expert Report of Stephen P. McCarthy
(“McCarthy Expert Report) {{ 29-31. I conclude, based upon my professional judgment after
evaluating the Testing Materials that many of ECM’s claims are untrue and none have the

appropriate scientific support.” Emphasis added. McCarthy Rebuttal Report at §2.

Rebuttal:

° At pages 163-164 of his Deposition of June 27, 2014, Dr. McCarthy indicated that he was unable to conduct
accelerated control tests in the Jab that could be correlated to actual landfill condition in the outside world.
Specifically, Dr. McCarthy testified that “No. We didn’t. We weren't able to do it. I mean, we tried to, That was
the purpose of it, but it never happened.” As noted above, Dr. McCarthy presented results of biodegradation in an
artificial compost environment at col. 11, lines 25-62 of the ‘199 patent to support claims of biodegradation,

Page 13 of 20

ECM Comb. Mot. to Exclude Page 13 of 20
Exh. W


15. ECM and its experts assert that there is a mechanism of action initiated by the
attractiveness of the ECM Additive as a food source that results in the depolymerization of
otherwise non-degradable plastics. For instance, Dr. Sahu cites to papers discussing blends of
biodegradable and non-biodegradable polymers. [CITE] But simple blending of two
immiscible polymers (such as PE and PCL) will not increase the biodegradability of the non-
degradable one. See generally, Tilsra and Tokiwa. McCarthy Rebuttal Report at 415.

Rebuttal

I disagree with Dr. McCarthy’s statement that simply blending of two immiscible polymers
(such as PE and PCL) will not increase the biodegradability of the non-degradable one. In the
“199 patent, for example, Dr. McCarthy stated that polylactic acid (PLA) based polymer or
copolymers and polymers of one or more polyesters (such as a polyester including PET) could
be used to make “new biodegradable blends.” See, col. 2, lines 10-21. See claim 9, Dr.
McCarthy also asserted that compared to PLA alone, these blends “have superior tensile and
mechanical properties such as stiffness, toughness, and elongation to break, as well as excellent
biodegradability.” See, Response to Office Action Dated February 24, 1998 in the prosecution
history of the ‘199 patent. Emphasis added. Accordingly, the ‘199 patent claims that a
biodegradable polymer (PLA) can be combined with any type of polyester (e.g. a non-
biodegradable polyester containing PET) and provide a blend that has “excellent
biodegradability.”

Comment by Dr. McCarthy

22. One of the most serious flaws in the conclusions of the experts is that once
biodegradation is established, it will continue to completion. In 1998, my colleagues and I
discovered through research on biodegradable polymers that the amorphous regions of
polymers biodegrade at a greater rate than the crystalline regions. [Footnote omitted.] M.
Parikh, R. Gross, and S. McCarthy, The Influence of Injection Molding Conditions on
Biodegradable Polymers, Journal of Injection Molding Technology, Vol. 2, No. 1, pp. 30-36
(March 1998). This phenomenon is critical as to why extrapolation of biodegradation is
scientifically unsound. McCarthy Rebuttal Report at 22.

Page 17 of 20

ECM Comb. Mot. to Exclude Page 17 of 20
Exh. W


increase in landfill moisture content tends to decrease the landfill’s slope stability; from an
engineering perspective and in my expert opinion, it is impossible for an above-ground landfill to
have a moisture content of more than 78%. If the moisture content in a landfill is high enough it
would lead to slope failure and collapse—a potentially cataclysmic result for a landfill, Because
of this and other risks, EPA requires yearly monitoring reports for bioreactors and severely
restricts the permitting.

48. It is, therefore, important to understand biodegradation-rich bioreactors as the
exception. Biodegradation-inhibiting “dry tombs” remain the norm.

Vv. TYPE OF RELIABLE SCIENTIFIC EVIDENCE REQUIRED TO SHOW
BIODEGRADATION IN LANDFILLS.

49. The optimal form of scientific evidence of landfill biodegradation is to conduct
solid waste decomposition experiments in real landfill environments. Although feasible, such
experimentation is highly time- and resource-intensive—and, therefore, rarely performed.

50. Asa result, to analyze decomposition of solid waste in landfills, researchers
generally simulate landfill environments in laboratory-based studies called “gas evolution tests”
that analyze the Biochemical Methane Potential (BMP)'?. The BMP is a measure of the
anaerobically degradable carbon that is available in MSW for decomposition. In other words, it
measures how much carbon in MSW can be metabolized by microorganisms.

51. To analyze the BMP, a researcher must first take a sample of refuse that has been
dried and ground to pass 1-mm screed and add it to a batch reactor (typically a 160 mL serum

bottle). Also added to the batch reactor is a growth medium (e.g., vitamins and minerals) and an

? Wang, Y.-S., Byrd, C. S. and M. A. Barlaz, 1994, “Anaerobic Biodegradability of Cellulose
and Hemicellulose in Excavated Refuse Samples,” Journal of Industrial Microbiology, 13, p. 147
- 53.

21

ECM Comb. Mot. to Exclude Page 21 of 56
Exh. X


PUBLIC DOCUMENT

CERTIFICATE OF SERVICE

Thereby certify that on March 13, 2014, I caused a true and correct copy of the foregoing
to be served as follows:

One copy through the FTC’s efiling system and one electronic courtesy copy to the Office of the
Secretary:

Donald S. Clark, Secretary

Federal Trade Commission

600 Pennsylvania Ave., NW, Room H-159
Washington, DC 20580

Email: secretary@fic.gov

One electronic and one and one paper 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 the Respondent:

Jonathan W. Emord Peter Arhangelsky

Emord & Associates, P.C, Emord & Associates, P.C.

11808 Wolf Run Lane 3210 S. Gilbert Road, Suite 4
Clifton, VA 20124 Chandler, AZ 85286

Email: jemord@emord.com Email: parhangelsky@emord.com
Lou Caputo

Emord & Associates, P.C.

3210S, Gilbert Road, Suite 4
Chandler, AZ 85286

Email: leaputo@emord.com

I further certify that I possess a paper copy of the signed original of the foregoing
document that is available for review by the parties and the adjudicator.

Kathesafe Johnson (kjohnson3@fic gov)
“LY I an Cohen (jcohen2@ftc.gov)
isa Jillson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

Date: March 13, 2014

ECM Comb. Mot. to Exclude Page 3 of 3
Exh. Q



June 30: Sahu (Los Angeles, CA)

July 1: Stewart (Los Angeles, CA)

July 2: Burnette (Washington, D.C.)

July 14: Barlaz (Raleigh, NC)

July 15 of 16: Volokh (Atlanta, GA) (10:00 AM start as long as ECM guarantees a full day)

We think this is a reasonable compromise. You would have a full day with Volokh, although a July 16th date might make
more sense given the flights available. | am available to discuss today if necessary.

Thanks,

Peter

Peter A. Arhangelsky, Esq. | EMORD & ASSOCIATES, P.C. | 3210 S. Gillbert Rd., Ste 4 | Chandler, AZ 85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for ihe recipient listed above. The content of this communication is protected from
disc'osure by the atforney-client privilege and the work product docirine. If you are not the intended recipient, you shoutd treat this
communication as strictly confidential and provide it to the person intended. Dup*cation or distrioution of this communication is prohibited
by the sender. if this communication has been sent to you in error, please notify the sender and then immediately destroy the document.

From: Cohen, Jonathan [mailto:icohen2@ftc.gov)
Sent: Thursday, May 15, 2014 3:47 PM

To: Peter Arhangelsky
Cc: Johnson, Katherine; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: ECM Biofilms, No. 9358

Peter,

This isn’t perfect, but it accommodates your scheduling issues, as well as scheduling issues on our
end. With respect to our experts, we should be able to make rooms available locally for all three depositions, but I'll
need until next week to confirm that (it’s very likely). Please let me know if we have an agreement.

June 23: Frederick (New Haven, CT)

June 24: Tolymat (Cincinnati, OH)

June 27: McCarthy (Washington, D.C.)

June 30: Barlaz (Raleigh, NC)

July 1: Stewart (Los Angeles, CA)

July 2: Burnette (Washington, D.C.)

July 14: Sahu (Los Angeles, CA)

July 15: Volokh (Adanta, GA) (10:00 AM start as long as ECM guarantees a full day)

Jonathan Cohen
Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

3
ECM Comb. Mot. to Exclude Page 3 of 7
Exh. K


J Polym Environ (2011) 19:637 676

665

Table 2 Biodegradable PLLA based polymers used in medical field [562, 564]

Application Trade Name Composition Manufacturer
Sutures Vicryl PLLA(8%) co PGA@2%) Ethicon
Polysorb PGA LPLA US. surgical
Interference screws Sysorb DLPLA Synos
Endofix PGA TMC or LPLA Acufex
Arthrex LPLA Arthrex
Bioscrew LPLA Linvatec
Phusiline LPLA DLPLA Phusis
Biologically quiet PGA DLPLA Instrument Makar
Full thread bio sheathed LPLA Acthrex
Bio LPLA Arthrex
Phantom LPLA DuPuy
Suture anchor Bio statak LPLA Zimmer
Bankart tack SR LPLA Bionx implants
SmartAnchor D SR LPLA L Bionx implants
SmartAnchor L RLPLA Bionx implants
Phantom suture anchor LPLA DuPuy
BioROC EZ 2.8 mm LPLA Innovasive devices
BioROC EZ 3.5 mm LPLA Innovasive devices
Biologically quiet 85/15 DLPLG Instrument makar
Biosphere 85/15 DLPLG Instrument makar
Bio anchor LPLA Mitek products
GLs LPLA Mite products
Panalok 82/18 LPLG Surgical dynamics
Panalok RC 82/18 LPLG Surgical dynamics
SD sorb 2 mm 82/18 LPLG Surgical dynamics
Dental Drilac DLPLA THM Biomedical AHP
Angioplastic plug Angioseal PGA DLPLA Bionx
Screw SmartScrew LPLA Bionx
Tack SmartTack LPLA Lorenz
Plates, mesh, screws LactoSorb PGA LPLA
Ligating clips, bone pins and rods Biofix LPLA or PGA Bionx
Resor Pin LPLA DLPLA Geistlich
Lactasorb LPLA Davis and Geck
Guided tissue Antrisorb DLPLA Atrix
Resolut PGA DLPLA WL. Gore
Guidor DLPLA Procordia
Drug delivery products Lupron Depot PLA/PLGA TAP
Zoladex PLA/PLGA AstraZeneca
Decapeptyl PLA/PLGA Ferring

Textiles and Hygiene Applications

Woven and non-woven fabrics, made from biodegradable
polymers are used as industrial wipes, filters, and geotex-
tiles for erosion control and landscaping. Personal hygiene
products, such as disposable diapers with a biodegradable
plastic liner or tampon applicators are made from biode-
gradable resins.

ECM Comb. Mot. to Exclude
Exh. Z

Thoughts on Future Perspectives

Biodegradable polymers are expected to play an increas-
ingly important role in a society moving towards a sus-
tainable and environmentally responsible materials base
with possibilities for implementing the principles of
industrial ecology. They offer a possible alternative to
traditional non-biodegradable polymers. One of the main

® Springer
Page 29 of 80


rather it can be linked to a variety of different groups. For
example, the structure shown in claim 19 can be linked to another
polyester unit, or a polylactic acid based polymer or copolymer.
This method of identifying polymer segments is well known to
those of ordinary skill in the art. ‘Thus, applicants submit that
claim 19 as it stands is clear and definite, and respectfully
request reconsideration and withdrawal of the rejection on this
ground.

Applicants believe that the amended claims meet all
requirements of 35 U.S.C. § 112, second paragraph, and
respectfully request reconsideration and withdrawal of the

rejections.

35 U.S.C. § 202(b) and/or 103(a}) over Japanese Abstract 96-

231,837

Claims 1-5, 7-9 and 11-18 have been rejected as
allegedly anticipated, or in the alternative as allegedly obvious
over the Japanese Abstract to shimadzu Corp. Applicants
respectfully traverse the rejection for the following reasons.

.The Shimadzu abstract discloses a composition made by
mixing fraction A, a lactic acid-based copolymer, with fraction
B, a 2-component block copolymer having segments B,, an aliphatic
polyester other than those derived from lactic acid, and B,, a
polyalkylene ether. The ratio of segments B, to B, can be, for
example, 1:2, 1:2, 2:1, etc., but the weight fraction of B, is

desirably 70-95% of the total weight of fraction B. Thus, ‘the

ECM Comb. Mot. to Exclude

Exh. Z

Page 57 of 80


GLOSSARY

Acetogen: Bacteria that generates mainly acetic acid as a byproduct of their respiration
in an environment that lacks oxygen.

Aerobic: An environment where there is oxygen.
Anaerobic: An environment that lacks oxygen.

Anaerobic Digester: A vessel where decomposition of organic matter takes place in an
environment without oxygen. Anaerobic digesters are not common in the U.S. and
typically only treat farm waste or wastewater.

American Society for Testing and Materials (ASTM): A standards organization that
develops and publishes voluntary technical standards for wide range of materials.

ASTM DS5511 1.1: The Standard Test Method for Determining Anaerobic
Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion Conditions.
The test method evaluates the degree and rate of biodegradation in an environment that
lacks oxygen for plastic materials in high-solids environments.

ASTM DS5526: The Standard Test Method for Determining Anaerobic Biodegradation of
Plastic Materials Under Accelerated Landfill Conditions.

Batch reactor: The term used to describe vessels that are used in various chemical and
industrial processes.

Biochemical Methane Potential: A batch test that evaluates the degradation of
materials under an environment lacking oxygen. The BMP results presents the upper
range of decomposition a material can achieve in such environments.

Biogas: The gas generated a result of the decomposition of organics usually under
anaerobic conditions. In these environment the gas consists of methane and carbon
dioxide.

Bioreactor Landfill: A specific type of landfills that is operated with the intent to

enhance the decomposition of materials mainly through but not limited to the addition of
liquids.

35

ECM Comb. Mot. to Exclude Page 35 of 56
Exh. X


COMBINED L .ARATION AND POWER OF A. JRNEY CONTINUED

Full Nome of Inventor: Richard A. Gross “2.2O
Inventor's Signature: CE#., TA vac: Qt” 2/777

: Chelmsford, Massachuserts  /7 A.

len Road, Chelmsfe 1824

Full Name of Inventor: Weoguane My“ OO

Residence Addres

Citizen of U.S.A.

Post Office Address:

Inventor's Signature: 2 2K Date: 9 Se “92
ne
Residence Address: 9 Ellis Avenue, 1st Floor, Lowell, Massachusetts O1854 f TA

Citizen of: China

Post Office Address: 9 Bilis Avenue, Ist Floor, Lowell, Massachusetts 01854

eva Agu 24,1994 Q91OBLEMR

ECM Comb. Mot. to Exclude

Exh. Z

. i
Page 51 of 80


ii. Composting Studies
75. The O.W.S. Composting Study evaluated the biodegradation of 40 gal-trash bag

plastic amended with ECM Additive under aerobic environment following ASTM D5338.98.!°
The temperature was 58°C, cellulose was used as a positive control. The study found that after
45 days the cellulose control decomposed 99.7% and that the trash bag decomposed 5.2% +
8.3%.

76. It is not competent and reliable scientific evidence of ECM’s claims for two
reasons. First, composting studies are carried out under aerobic, oxygen-rich environments
totally unlike typical MSW landfill environments. Second, the statistical analysis and
uncertainties of the test undermine any conclusion that the sample biodegraded. The study
reports 5.2% biodegradation with a standard deviation of 8.3%. This standard deviation is
broader than the purported biodegradation. With such wide standard deviation, biodegradation
could have been zero—or the carbon in the sample could have even increased. In short, the level
of uncertainty is so high that it is impossible to rely on the results.'

iii. Anaerobic Tests Conducted Under ASTM D5511

77. Tests conducted under ASTM D5511 (Standard Test Method for Determining
Anaerobic Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion
Conditions)—no matter how well-conducted—are not competent and reliable scientific evidence
of biodegradation in a landfill, because this ASTM method does not simulate typical landfill
conditions. Indeed, the test protocol itself states that it is intended to replicate an anaerobic

digester, whose conditions (temperature and moisture) are far more favorable to biodegradation

18 «Phe report does not identify what percentage of additive the test specimen contained.
'S And, in fact, ASTM D5511 section 1.4 specifically states that if the error of the test
spans zero, then no biodegradation may be reported.

30

ECM Comb. Mot. to Exclude Page 30 of 56
Exh, X


9. Ashley Leiti, D&W Fine Pack, LLC Southeastern National Accounts
Manager, as D& W’s designee

Ms. Leiti will testify regarding D&W’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, D&W’s purchase of ECM
additive; reasons for this purchase; D&W’s understanding of ECM’s claims and substantiation
for those claims; D&W’s use and understanding of the ECM Certificate of Biodegradability, the
ECM logo, and other ECM promotional material: D&W’s understanding of how its customers
used ECM promotional materials and products made with the ECM additive; any other issues
addressed in her deposition; any documents introduced into evidence by Respondent or
Complaint Counsel as to which she has knowledge; or any other matters as to which she has
knowledge that are relevant to the allegations of the Complaint, Respondent’s affirmative
defenses, or the proposed relief.

10. Frank Santana, Down To Earth All Vegetarian Organic & Natural (“Down
To Earth”) Marketing Director, as Down To Earth’s designee

Mr. Santana will testify regarding Down To Earth’s relationship with ECM and
understanding of ECM’s product, claims, and testing, cluding, but not limited to, Down To
Earth’s purchase of plastic bags containing the ECM additive, reasons for this purchase; Down
To Earths understanding of ECM’s claims and substantiation for those claims, Down To Earth’s
resources and ability to test and evaluate ECM’s claims and substantiation; Down To Earth’s use
and understanding of the ECM Certificate of Biodegradability, the ECM logo, and other ECM
promotional material; any other issues addressed in his deposition, any documents introduced
into evidence by Respondent or Complaint Counsel as to which he has knowledge; or any other
tatters as to which he has knowledge that are relevant to the allegations of the Complaint,

Respondent’s affirmative defenses, or the proposed relief

ECM Comb. Mot. to Exclude Page 7 of 16
Exh. F


Dr. McCarthy Rebuttal Report -- 6

10. Dr. Sahu cites to several articles that discuss biodegradability of PCL and other synthetic
biodegradable plastics. See, e.g., L. Tilstra and D. Johnsonbaugh, “The biodegradation of blends
of polycaprolactone and polyethylene exposed to a defined consortium of fungi,” Journal of
Environmental Polymer Degradation, vol. 1, pp. 257-267, 1993; Shah, A.A., et. al., Biological
degradation of plastics: A comprehensive review, Biotechnology Advances Vol. 26, 2008, p.
246-265. As discussed in my prior report, high-molecular weight synthetic polymers such as
PCL, PLA, and poly butylene succinate, contain similar molecular structure to naturally-
occurring polymers, such that microorganisms have developed enzymes over time that will
biodegrade these. McCarthy Report {| 33-35. The biodegradability of PCL was not discussed in
my report at length, other than to note that if it is the main proprietary “ingredient” of the ECM
Additive, it is considered biodegradable. This, in turn, affects how one designs and conducts a
biodegradation study evaluating a blend containing PCL and a non-degradable plastic.

11. Dr. Sahu also referenced articles and reports addressing the biodegradability of oxidized
and low-molecular weight polyethylenes in support of his conclusion that conventional plastics
(undefined by him) are subject to biodegradation. See Sahu Expert Report at § VI.3. These are
irrelevant for at least two reasons: (1) such technology requires oxidation through additives
(such as pro-oxidants) and/or pretreatments, which does not occur in landfills (no or low-oxygen
environments); and (2) any polyethylene that had undergone such oxidation prior the addition of
the ECM Additive would have no commercial application.

12. As mentioned in my report, if the polymer chain is short enough, it can be attacked by
microorganisms. McCarthy Report §86. For instance, the Tokiwa article discusses

biodegradation of low-molecular weight PE. Tokiwa Y., et al, Biodegradability of Plastics, Int.

turn “non-degradable” plastic into biodegradable plastic) and they only represent less than 5% of
the commercial plastic market.

ECM Comb. Mot. to Exclude Page 6 of 12
Exh. CC


Dr. McCarthy Rebuttal Report -- 8

2. The Papers Cited Do Not Support the Mechanism of Action.
15. ECM and its experts assert that there is a mechanism of action initiated by the
attractiveness of the ECM Additive as a food source that results in the depolymerization of
otherwise non-degradable plastics. For instance, Dr. Sahu cites to papers discussing blends of
biodegradable and non-biodegradable polymers. [CITE] But simple blending of two immiscible
polymers (such as PE and PCL) will not increase the biodegradability of the non-degradable one.
See generally, Tilstra and Tokiwa.
16. If we assume that the ECM Additive is a blend of approximately 20% polyethylene vinyl
acetate (EVA), approximately 60% PCL, 6% linear low density polyethylene (LLDPE),
approximately 7% calcium stearate, and approximately 6% starch as discussed in my expert
report (see McCarthy Expert Report at n.17), then the enzymes produced from the
microorganisms which are attracted to the PCL food source would be hydrolytic enzymes, such
as lipases. The conventional non-degradable plastics discussed in my two reports (PE, PP, PVC,
and PS) cannot be hydrolyzed because they do not have an ester bond that can be cleaved by
hydrolysis. Because the remaining plastic would remain unaffected by the hydrolytic enzymes,
there is no mechanism of action that would result. The statement that addition of the ECM
Additive causes the C-C bonds to “weaken” has no support in the literature (nor did they cite to
any).

B. A Series of Faulty Tests Cannot Support ECM’s Claims.

17. I started this rebuttal report by counter-proposing the following question to Dr. Sahu’s
“threshold question”: given what we know about the non-biodegradability of commercial-grade

conventional plastics, has ECM provided sufficient quantity and quality of scientific evidence to

ECM Comb. Mot. to Exclude Page 8 of 12
Exh. CC


biodegradation of municipal solid waste generally, conditions in municipal solid waste
landfills and bioreactors, and evaluation and analysis of Respondent’s substantiation for
its biodegradability claims.

Dr. Tolaymet is an environmental engineer and researcher in the field of solid waste
management. His research is focused on solid waste management, bioreactor landfills,
waste containment performance, construction and demolition waste landfills, fate and
transport of environmental pollutants.

He received a Bachelor of Science degree in Environmental Engineering from The
University of Florida in 1997. In 2003, he received PhD in environmental engineering
from the University of Florida in Gainesville, Florida. Since 2003, he has worked for the
U.S. Environmental Protection Agency (EPA) Office of Research and Development as an
Environmental Engineer. His research included evaluation of the performance of Solid
Waste Containment Units (municipal solid waste, hazardous waste and ash mono-fill
landfills), bioreactor landfills, which are new landfill design that promotes the
degradation and subsequent removal of degradable fraction of solid waste as well as
organic pollutants, co-disposal of solid waste and hazardous waste, and construction and
demolition waste. In 2010, he led an interdisciplinary EPA evaluating sustainable
materials management and Construction and Demolition Debris. Since October of 2012,
he has been the Acting Associate National Program Director for Emerging Materials and
Sustainability under the Chemical Safety for Sustainability research Program. In this role,
he leads EPA’s national research program in the area of emerging materials and
sustainability. His role is to assist the national program director in these areas and set
EPA’s research priority and providing resources to address the agency’s regulatory needs.

He is also a member of the Interstate Technology & Regulatory Council (TRC)
Alternative Landfill Technology team, a group comprised of state and federal agency
representatives (e.g., EPA, Department of Energy), academics, industry stakeholders,
etc., that develops guidance regarding alternative landfill covers.

As part of his duties at the EPA, he provides expert advice and future direction in the area
of solid waste to the Hashemite Kingdom of Jordan, Taiwan, Russia, and Hong Kong. He
also provided solid waste expertise to the World Bank and USAID.

He has not testified or been deposed in the past four years.

3. Shane Frederick, PhD
Yale University, Yale School of Management
52 Hillhouse Avenue Room 116
New Haven, CT 06511

Dr. Frederick’s anticipated testimony will be described in his expert report, which will be
produced to Respondent by the date set forth in the Scheduling Order. The general
subject matter of this testimony includes, but is not limited to, consumer perception of
biodegradable marketing claims and Respondent’s biodegradability claims.

ECM Comb. Mot. to Exclude Page 2 of 4
Exh. D


control, monitor, and optimize the waste stabilization process rather than simply contain
wastes. !!

45. The EPA Office of Solid Waste and Emergency Response promulgated the
Research, Development, and Demonstration Permits for Municipal Solid Waste Landfills
(RD&D rule) in 2004, which allows approved states to permit bioreactor landfills. Specifically,
the permit waives Subtitle D’s prohibition on bulk liquid introduction, which, as described in
section [IL.c. above, limits moisture, and thereby, biodegradation. Both the RD&D rule and the
permits are temporary modifications to Subtitle D regulations. RD&D permits last for 3 years,
with optional 3-year renewals for a maximum of 12 years.

46. Bioreactor technology relies on maintaining moisture content near field capacity
of solid waste (approximately 35 to 65%) and requires addition of liquids when it is necessary to
maintain that percentage. With more moisture comes faster decomposition. With accelerated
decomposition, the landfill gas generation rate increases. Gas extraction systems are used to
capture and control this gas, oftentimes converting it to electricity.

47. Bioreactors remain rare and experimental: currently, only 16 states are authorized
to permit bioreactors and less than 2% (32 of the approximately 1,900) operational MSW landfill
sites are bioreactors. Although they present exciting possibilities for landfill control and energy

generation, bioreactors do present significant risks that require further study. For example, an

"' The Solid Waste Association of North America defines a bioreactor landfill as: “a
controlled landfill or landfill cell where liquid and gas conditions are actively managed in order
to accelerate or enhance biostabilization of the waste. The bioreactor landfill significantly
increases the extent of organic waste decomposition, conversion rates, and process effectiveness
over what would otherwise occur with the landfill.” In its final rule on National Emissions
Standards for Hazardous Air Pollutants (NESHAPS) for landfills (40 CFR Part 63) Maximum
Achievable Control Technology (MACT), the EPA defined bioreactor landfills as MSW landfills
that utilize liquids other than leachate and gas condensate to achieve an average moisture content
of 40% by weight or more.

20

ECM Comb. Mot. to Exclude Page 20 of 56
Exh. X


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 21

i. ASTM DSS511
51. The ASTM first published the D5511 test method in 1994. It has been

reconsidered periodically by the scientific community through ASTM’s voluntary consensus
committee D20.96 on biodegradable plastics and has undergone minor changes in 2002, 2011,
and again in 2012. But the basic methodology has not changed.

52. | ASTM D5511 is a gas evolution test. The test specimen is exposed to an
inoculum from an anaerobic digester operating on household waste as its sole substrate (ie., sole
food source). This short-term test is designed to run for 15-30 days, and is intended to replicate
anaerobic digesters. In the United States, anaerobic digesters are primarily used at farms to treat
animal waste, although there are also some applications for wastewater treatment. There are no
anaerobic digesters treating household waste in the United States, so the ASTM D5511 inoculum
is not available in this country.

53. When properly conducted, ASTM D5511 can be used as a screening-level test. It
cannot, however, be used to support a scientific conclusion that a biodegradable plastic will
biodegrade to completion in a landfill, for two reasons. First, this short-term test (typically 15-30
days) is not designed to run for the length of time necessary to show complete biodegradation.
Second, this anaerobic-digester test is not designed to simulate conditions in the typical U.S.

landfill.

ii, ASTM D5526
54. | ASTM D5526 is designed to run longer than ASTM DS5511: it has been validated

to a period of 300 days. The method employs temperature and moisture conditions that more
closely resemble a special type of landfill called a “bioreactor,” a rare type of landfill in which

“the gas generated is recovered or even actively promoted, or both, for example by inoculation,

ECM Comb. Mot. to Exclude Page 21 of 58
Exh. U


accessible throughout the blend, as demonstrated by applicants’
Rxample 5 in the present application.

Example 5 shows that when a 70% PLA, 30% Bionolle #3000
blend was exposed to acetone, approximately 95% of the PLA was
dissolved, leaving a continuous sheet of polyester material with
interconnecting holes where the PLA used to be. This result
demonstrates that this polyester component forms a continuous
structure within the blend. Furthermore, since 95% of the PLA
@issolved, the PLA component of the blend is also continuous and
accessible to the acetone, and not "buried," as in Sinclair ‘050.
If PLA were mostly buried in the present blends, 95% PLA
dissolution could not take place.

The presence of spherical, heterogeneous domains in the
blend of Sinclair ‘050 is quite different from applicants’
claimed continuous or co-continuous phase of the second polymer
in the blend, and thus Sinclair ‘050 does not anticipate the
present claims.

In addition, Sinclair ‘050 fails to render the present
claims obvious. Sinclair ‘050 contains no suggestion that blends
of polylactic acid and polyethylene terephthalate have a
continuous or co-continuous nature, or that other polymers could
be added to create such a co-continuous blend. To the contrary,

Sinclair '050 specifically notes that the polylactic acid in his

blends is present in mostly buried spherical heterogeneous
domains of 3 microns or less. This stands in strong contrast to
applicants’ teaching, which is that the polyester is present as a

continuous or co-continuous phase in the claimed blends.

ECM Comb. Mot. to Exclude

Exh. Z Page 60 of 80


Respondent’s Exhibit J


Table of Contents

EDUCATION, EXPERIENCE, AND TRAINING.
SCOPE OF REVIEW .........

I. DISPOSAL OF SOLID WASTE IN THE U.S
What is Municipal Solid Waste? ..........

What is Customary Disposal? ........sssssesscsssssstsesssssseecennnuescecsssneesescesssseessseessanseeeeesenee 7

TI. BIODEGRADATION ......ccssssssssseeesseceecsssssenssnsnsnssveeeseececcesessnnnnsessesecceseeeeesssenssesnsnaneensece
Ml. LANDFILLS: ANAEROBIC, RELATIVELY COOL, “DRY TOMBS”

A. Typical Landfills Are Anaerobic

B. Moderate Temperatures in Typical Landfills

C. Typical Landfills Have Low Moisture Content .......ssssssssssssssssssssssccscccssssssssnseeeees 12
IV. DRY TOMBS VS. BIOREACTORS .un.ssesssssssssssssssssesesssscecsseessnseessssueecssusecessuecessueesns 17
A. Typical MSW Landfills: “Dry Tombs” With Minimal Biodegradation.............. 17
B. Bioreactor Landfills: Rare Landfills That Maximize Biodegradation ............s00-- 19

V. TYPE OF RELIABLE SCIENTIFIC EVIDENCE REQUIRED TO SHOW
BIODEGRADATION IN LANDFILLS. .....ssessscsssssssccssssssnusnssesessccesscesstscsssssssssessusseses 21

VI. ECM’S CLAIMS ARE FALSE AND NOT SUPPORTED BY RELIABLE
SCIENTIFIC EVIDENCE

B. ECM’s Claims Are Not Supported By Competent and Reliable Scientific
Evidence ....

i. ECM’s Primary Substantiatio
a. Environ Study

b. ChemRisk/McLaren Assessment .........-sscsssscsssseesseees 28
Hi, Composting Studies: .......sccssssessessesssssecsssnsesscssssuuessesesssssecsesesssnansessenee 30
iii. Anaerobic Tests Conducted Under ASTM D551: wesssessssecssssecssssccssseeee 30
iv. Other Reports and Tests: ....csesccsssssesescesssseeecesssnessessssuesseceessssseesssesssseeeees 33
a. Ecologica Report ......c..ccsscsssssssssesssssesessssseeceetesesnueesseneees 33
b. Additional Biodegradation Tests of ECM Plastic ............ 33
2
ECM Comb. Mot. to Exclude Page 2 of 56

Exh. X


Exh. G.

Exh. H.

Exh, [.

Exh. J,

Exh. K.

Exh. L.

Exh. M.
Exh. N.
Exh. O.

Exh. P.

Exh. Q.

Exh. R.

Exh. S.

Exh. T.

Exh. U.

Exh. V.

Exh. W.

Exh. X.

Complaint Counsel’s May 1, 2014 Subpoena Ad Testificandum to Dr. Frederick
Michel

Email Correspondence Between Complaint Counsel and ECM Counsel Re
Proposed Stipulation Concerning Dr. Michel’s Documents (May 2014)

Joint Motion for Entry of Proposed Order Approving Stipulation As To
Admissibility of Dr. Michel’s Study Documents (May 5, 2014)

Email Correspondence Between Complaint Counsel and ECM Counsel Re
Stipulation (May 1, 2014)

Email Correspondence Between Complaint Counsel and ECM Counsel Re
Deposition Scheduling (May 2014)

Complaint Counsel’s Subpoena Ad Testificandum to Elsevier, Inc. (May 21,
2014)

Confidential Email Between FTC Counsel and Dr. Michel (Nov. 2012)
Confidential Emails Between FTC Counsel and Dr. Michel (Nov. 2012)
Confidential Emails Between FTC Counsel and Dr. Michel (Sept. 2013)

March 21, 2014 Order Granting in Part and Denying in Part Respondent’s
Motion for Sanctions

Complaint Counsel’s Clarification Regarding Respondent’s Sanctions Motion
(March 13, 2014)

Email Correspondence from Complaint Counsel Disclosing Dr. Michel Rebuttal
Report and Curriculum Vitae June 30, 2014)

Complaint Counsel’s Production of Dr. Michel Files (July 1, 2014)

Email Correspondence from Complaint Counsel Offering Dates for Dr. Michel
Deposition (July 7, 2014)

Expert Report of Dr. Stephen P. McCarthy (June 4, 2014)
Rebuttal Report by Dr. Frederick C. Michel (June 30, 2014)
Proposed Surrebuttal Report of Dr. Steven J. Grossman (July 7, 2014)

Expert Report of Dr. Thabet Tolaymat (June 4, 2014)


In yet another study contradicting Dr. Sahu’s assertions, Busscher and Weerkamp (1987) described the
mechanisms for biofilm formation on surfaces. They do not indicate that additives are necessary for
biofilm formation on the surfaces of plastics, but that the process involves the removal of water from
the surface so that microorganisms can come into direct contact with the surface. The removal of water
from a hydrophilic surface is less energetically favorable than froma hydrophobic surface. The
conclusion of Dr. Sahu that ECM additive improves the hydrophilicity of the surface enhancing biofilm
formation is contrary to this mechanism.

Finally, in actual testing of ECM amended plastic (Gomez and Michel, 2013) electron scanning
microscopy revealed no biofilm formation or degradation of polypropylene or polyethylene
terephthalate containing 2% ECM additive during tests of these materials in soil for nearly 2 years
(Figure 4). Thus biofilm formation is not enhanced by ECM additive and complete biodegradation of
ECM amended plastics in a landfill after 1, 5 or even 50 years, is highly unlikely.

Figure 4. Scanning electron micrograph analysis of polypropylene amended with 2% ECM additive after 0
days (left) and 2 years (right) of soil incubation.

A a} Com
In the report submitted by Dr. Barber (2008 Environ BioPVC Report.pdf), there is a major flaw in the
scientific analysis and modeling of BioPVC biodegradation data.

The first order decay model used by Barber is inappropriate for the data presented in the BioPVC test in
Figure 2 and does not fit the data as well as the model he uses in the presentation of this data. This
figure and its’ legend are reproduced from the report by Dr. Barber below (Figure 5).

In the legend Barber states that a “logistic curve” was used to model the mass loss of BioPVC during the
test. The model fits the data well with an R’ of 0.97 at a 99% confidence level, This type of model
predicts the concentration of the substrate (BioPVC in this case) and has three parameters, one of which
{So) is the initial concentration of the substrate that is biodegradable (Martin and Scow, 1989). The
other two, Xo and k, are the initial concentration of organisms able to degrade the substrate and the
time constant for the rate at which this degradation occurs, respectively (Figure 6).

17

ECM Comb. Mot. to Exclude Page 17 of 24
Exh. V


Respondent’s Exhibit W


PUBLIC DOCUMENT

UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION
OFFICE OF THE ADMINISTRATIVE LAW JUDGES
Washington, D.C.

In the Matter of

Docket No. 9358
ECM BioFilms, Inc.,
a corporation, also d/b/a PUBLIC
Enviroplastics International,

Respondent.

[PROPOSED] ORDER GRANTING RESPONDENT ECM. BIOFILMS, INC.’S MOTION
TO EXCLUDE COMPLAINT COUNSEL’S UNIDENTIFIED EXPERT REBUTALL
——— INE SEL SS UNIDENTIFIED EXPERT REBUTALL

WITNESS AND FOR SANCTIONS

This matter having come before the Administrative Law Judge on July 9, 2014, upon a
Motion to Exclude Complaint Counsel’s Unidentified Expert Witness, filed by Respondent ECM
BioFilms, Inc. (“ECM”) pursuant to Commission Rules 3.38(b), 3.31A(b) & (d), and 3.21(c)

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; Complaint
Counsel’s Expert Witness, Dr. Frederick Michel, is hereby excluded as a witness in this matter,

and his report is stricken from the record.

ORDERED:

D. Michael Chappell

Chief Administrative Law Judge
Date:

20


Jonathan Cohen
Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

(202) 326-2551 | jcohen2@ftc.gov

From: Cohen, Jonathan

Sent: Monday, May 19, 2014 3:52 PM

To: 'Peter Arhangelsky'

Ce: Johnson, Katherine; Jillson, Elisa; ‘Lou Caputo’; ‘Jonathan Emord'
Subject: RE: ECM Biofilms, No. 9358

Peter,

We accept this compromise schedule, which is what you most recently proposed:

June 23: Frederick (New Haven, CT)

June 24: Tolymat (Cincinnati, OH)

June 27: McCarthy (Washington, D.C)

June 30: Sahu (Los Angeles, CA)

July 1: Stewart (Los Angeles, CA)

July 2: Burnette (Washington, D.C.)

July 14: Barlaz (Raleigh, NC)

July 15: Volokh (Atlanta, GA) (10:00 AM start/ECM guarantees a full day)

Jonathan Cohen
Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W., M-8102B Washington, D.C. 20580

(202) 326-2551 | jcohen2@tte.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Friday, May 16, 2014 12:34 PM

To: Cohen, Jonathan

Ce: Johnson, Katherine; Jilison, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: ECM Biofilms, No. 9358

Jonathan,

I think the schedule unnecessarily burdens ECM because it would require excessive travel. Your proposal separates the
California depositions, which would require two separate trips to California instead of one. You have also scheduled Dr.
Sahu on a date we did not say he was available. He is not available the week of July 14th, so his date will need to
change. We have no objection to scheduling Burnette for July 2nd, thus separating the Washington, D.C. pair, and
preventing witness depositions out of order. We are counter-proposing the following dates (swapping Barlaz with

Sahu):

June 23: Frederick (New Haven, CT)
June 24: Tolymat (Cincinnati, OH)
June 27: McCarthy (Washington, D.C.)

ECM Comb. Mot. to Exclude
Exh. K

Page 2 of 7


J Polym Environ (2011) 19:637 676

659

properties and biodegradability of chitosan and polylactide
could be enhanced substantially by graft copolymerization
of L-lactide onto chitosan. The copolymer may be able to
be degraded faster than polylactide. Unlike chitosan, all
chitosan-lactide graft copolymers are converted to hydro-
gels in aqueous environment. Albertsson et al. prepared a
pH- sensitive physically cross linked hydrogel by grafting
D,L-lactic acid onto amino groups in chitosan without
using a catalyst [452]. Later Dutta et al. reported that the
molecular mechanism of gelation involves interaction
between chitosan and lactic acid [507). Yao et al. reported
the in vitro fibroblast static cultivation on a cytocompatible
poly (chitosan-g-L-lactic acid) film and the cell growth rate
on the copolymer film was found to be much faster than
that of the chitosan film [484]. In another work, Liu et al.
have reported the synthesis of a brush like copolymer of
polylactide grafted onto chitosan [485]. Later, Wu et al.
studied the amphiphilic properties of a graft copolymer of
water-soluble chitosan and polylactide prepared by using
triethyl amine as catalyst [508]. In 2005 Peesan et al. [509]
prepared hexanoyl chitosan/PLA blend films and in 2006
Wan et al. [510] prepared a biodegradable polylactide/
chitosan blend film. The biodegradability of these chitosan/
polylactide graft copolymers was, however, not studied in
these works.

The introduction of functional groups in polylactide for
the modification of its properties has been investigated
since 1990s. Barrera et al. synthesized a copolymer of
poly(lactic acid-co-lysine) containing lysine residues [511].
The free amino group in the lysine residue was used to
chemically attach a biologically active peptide GRGDY
{511, 512}. Gonsalves et al. [513] and Ouchi et al. [514]
reported the introduction of hydroxyl and carboxylic acid
groups on the surface of polylactide by copolymerization
with the amino acids, serine (P(lac-Ser)), and aspartic acid
(P(Lac-Asp)) respectively. Recently, Wang et al. synthe-
sized a series of polylactide polyurethanes (PLAUs) having
the property of shape recovery temperature near to the
body temperature from poly(L-lactide) diols, hexamethyl-
ene diisocyanate, and 1,4-butanediol [515].

In 1992, Simone and coworkers [516] and Castaldo et al.
[517] introduced the idea of random multiblock PEAs con-
taining poly(L-lactide) blocks as hydrolytically degradable
segments. They reported that the presence of amide func-
tions in the polymer chain might lead to better physical
properties than aliphatic polyesters usually have. Poly(ester
amide)s are a class of biodegradable condensation polymers
having regular enchainment of ester and amide groups as the
integral part of polymer chain [518]. The ester component,
in fact, reduces the crystallinity of polyamide segments and
increases the chain flexibility of PEAs needed to fit into the
active sites of the enzymes. Since amide groups are polar,
their incorporation into the ester main chain leads to an

ECM Comb. Mot. to Exclude
Exh. Z

increase of hydrophilicity [519]. The enhanced hydrophi-
licity increases the amount of water sorption in the amor-
phous region followed by degradation. Qian et al. reported a
decrease in the degradation rate of PEAs with increase of
amide content, macromolecular weight, and thickness of the
test samples, and increase with incubation temperature and
pH of the degradation medium [520 524]. Angelo et al.
prepared poly(ether-ester-amide)s based on poly(L,L-lac-
tide) macromer for the delivery of bioactive compounds
[525]. They reported that an enhancement of biodegrad-
ability of PEAs could be achieved by the incorporation of
flexible hydrophilic oligo(ethylene glycol) segments into the
main chain. It was reported in the literature that the crystal
structure and physical properties of PLLA could be
increased by the incorporation of cycloaliphatic amide
segments. The rigidity, arising from the conformational
restriction in the cyclic ring, makes them has relatively high
thermal properties in comparison with their linear aliphatic
counterparts [526].

PLGA demonstrates good cell adhesion and prolifera-
tion making it a potential candidate for tissue engineering
applications. Various studies have been performed so far
using micro- and nanofabrication techniques to form three-
dimensional biodegradable scaffolds based on PLGA [527,
529]. Figure 18 shows porous three-dimensional structures
developed from PLGA using (a) gas foaming [527]
(b) microsphere sintering [528] and (c) electrospinning
techniques [529].

Chitosan/oligoL-Lactide Graft Copolymers

The physicochemical properties and biodegradability of
chitosan and polylactide could be enhanced substantially
by graft copolymerization of L-lactide onto chitosan.
Chitosan/oligoL-lactide graft copolymer was synthesized
in DMSO at 90 °C in presence of Ti(OBu), as ring opening
catalyst [530]. Grafting of hydrophobic side chains results
in the decrease of chitosan crystallinity by loosening the
hydrogen bonds and increasing the number of free hydro-
philic hydroxy! groups and amino groups of chitosan,
which in turn can hold water molecules more strongly. The
graft copolymers are converted to hydrogels on exposure to
deionized water. This property is of special interest in
biomedical applications such as wound dressing and in
controlled drug delivery systems. At higher grafting per-
centages due to the self-assembling of longer OLLA side
chains by the hydrogen bonding and dipole interactions, the
hydrophobic nature of the side chains become dominant,
which results in the lower swelling of graft copolymers at
higher grafting percentages (Fig. 19). A decrease in
hydrolytic degradation was observed with increase of lac-
tide content in CL graft copolymers (Fig. 19). CL graft
copolymers showed a higher susceptibility towards lipase

Q Springer
Page 23 of 80


Respondent’s Exhibit AA


Dr. McCarthy Rebuttal Report -- 4

publications of biodegradable polymers and polymer biodegradation. During my 20 years as
editor of this journal, I have seen no publications and no evidence that any conventional plastic
(e., a high-molecular weight synthetic polyolefin such as PE or PVC) will completely
biodegrade in the times claimed by ECM, the conclusion that ECM Plastic will biodegrade faster
than untreated alternatives, or for the mechanism of action proposed by ECM.
6. Although I stated that I cannot conclude with scientific certainty that conventional
plastics treated with the ECM Additive would biodegrade faster than untreated plastics, it is my
professional judgment and expert opinion that these claims are false. Nothing presented in any
of the expert reports presents a compelling argument otherwise.
A. The Experts Rely On Irrelevant Authorities.
7. Dr. Sahu begins his analysis with an unnecessary personal attack before launching into a
largely irrelevant discussion of several inapposite papers.” The threshold question is not whether
there is evidence that plastics (with or without additives) biodegrade. My report discusses
several subsets of plastics that can undergo biological, enzymatic degradation. McCarthy Report
132-35. In order to evaluate the claims identified by complaint counsel, however, the
appropriate threshold question is as follows:
e Given what we (the scientific community) know about the non-
biodegradability of commercial-grade conventional plastics (as I have
defined them in my report), has ECM provided sufficient quantity and

quality of scientific evidence to demonstrate that these plastics treated

It appears that most of Dr. Sahu’s knowledge of plastics and polymers came from merely
reading and quoting Lampman, S., Characterization and Failure Analysis of Plastics, ASM
Incorporated, 2003 and other cited sources. For instance, Dr. Sahu uses the term “mer.” Most
professionals teaching plastics and polymers would never use the word “mer.” The correct term
is “polymer repeating unit.”

ECM Comb. Mot. to Exclude Page 4 of 12
Exh. CC


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. -- Page 10

merely because ECM Plastic has disintegrated. Of course, ECM markets its ECM Plastic as
biodegradable, not merely degradable.

28. What are Plastics? Generically, plastic refers to high-molecular weight
polymers. Polymers are large molecules composed of repeating low molecular weight molecules

called monomers. Through a chemical process known as polymerization, monomers are

O O O O O O EAN
MONOMER oO

POLYMER
H H HH HH H
c= ¢ ox ¢ ae c= ¢ POLYMERIZATION
H HH HH HH H uoH HOM YH
ETHYLENE nn ne oe on rn
H H OH H A
POLYETHYLENE

combined to become polymers.

29. There are various plastics, but synthetic (laboratory-made), petroleum-based
plastics are by far the most common. Plastics derived from petrochemicals are strong, durable,
and inexpensive to manufacture, making them ideal for commercial applications. Such
petroleum-based plastics, which I refer to as “conventional plastics,” represent over 90% of the
commercial plastic market. When laypersons talk about “plastic,” they are usually referring to
these conventional plastics.

30. The most common types of conventional plastic are high-molecular weight
polyethylene (PE), which is commonly used to manufacture plastic bags, packaging material,
bottles, and polyurethane, which is used commonly in medical and industrial applications such

as adhesives and paint. Also common is polypropylene (PP), which is used for disposable cups,

ECM Comb. Mot. to Exclude
Exh. U

Page 10 of 58


Exhibit B

from ground water contamination. Carried out technical advisory group meetings with regulators (USEPA
and FDEP), industry, and the general public. These meetings were designed to increase the understanding
between these interested groups and direct the research to benefit the general public.
© — Assisted in the design, permitting, and construction of the Polk County Bioreactor Landfill. Coordinated
work between the Polk County landfill engineers, landfill operators, the Florida Department of
Environmental Protection (FDEP) and fellow graduate students. Addressed design concerns that were
raised by FDEP.
© Organized and assisted in evaluating risk from the use and reuse of chromated copper arsenate (CCA)
treated wood. Wrote final reports and recommendations for FDEP.
Research Assistant
Applied Environmental Consulting Gainesville, FL May 1996 - August1997
* Coordinated and carried out experiments to evaluate risk associated with the exposure to naturally
occurring radioactive material (NORM). Conducted interviews with phosphate workers to evaluate
radiation exposure time. Assisted with drafting the final report that was submitted to the Florida Institute
of Phosphate.

JOURNAL PUBLICATIONS

1. Jain, P., Powell, J., Smith, J., Townsend, T., Tolaymat, T., (2014) “Life-Cycle Inventory and Impact
Evaluation of Mining Municipal Solid Waste Landfills” Environmental Science & Technology 48 (5), 2920-
2927

2. Huang, X., El Badawy, A., Arambewela, M., Ford, R., Barlaz, M., Tolaymat, T., (2014) “Characterization of
Salt Cake from Secondary Aluminum Production” Journal of Hazardous Materials (273):192-199

3. Ivask, A., El Badawy, A., Kaweeteerawat, C., Boren, D., Fischer, H., Ji, Z., Chang, C., Liu, R., Tolaymat, T.,
Telesca, D., Zink, J., Cohen, Y., Holden, P., Godwin, H., (2014) “Toxicity Mechanisms in Escherichia coli
Vary for Silver Nanoparticles and Differ from Ionic Silver” ACS Nano 8 (1), 374-386

4. Silva, T., Pokhrel, L., Dubey, B., Tolaymat, T., Maier, K., Liu, X., (2014) “Particle Size, Surface Charge and
Concentration Dependent Ecotoxicity of Three Organo-Coated Silver Nanoparticles: Comparison Between
General Linear Model-Predicted and Observed Toxicity” Science of The Total Environment, (468) 15:968-976,

5. Gitipour, A., El Badawy, A., Arambewela, M., Miller, B., Scheckel, K., Elk, M., Ryu, R., Gomez-Alvarez, V.,
Santo Domingo, J., Thiel, S., Tolaymat., T. (2013) “The Impact of Silver Nanoparticles on the Composting of
Municipal Solid Waste” Environmental Science & Technology 47 (24): 14385-14393

6. Nel etl. al., (2013) “A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial
Safety Assessment” ACSNano, (7)8:6422-6433.

7. Xu, Q., Powell, J., Tolaymat, T., Townsend, T. (2013). "Seepage Control Strategies at Bioreactor Landfills.” J.
Hazard. Toxic Radioact. Waste, 17(4), 342-350.

8. Tolaymat, T., Kim, H., Jain, P., Powell, J., and Townsend, T. (2013). "Moisture Addition Requirements for
Bioreactor Landfills." J. Hazard. Toxic Radioact. Waste, 17(4), 360-364.

9. El Badawy, A.; Schekel, K.; Suidan, M.; Tolaymat, T. (2013) “Key Factors Controlling the Transport of Silver
Nanoparticles in Porous Media” Environmental Science and Technology, 2013, 47 (9), 4039-4045.

10. Mwilu, S. K.; El Badawy, A.; Bradham, K.; Thomas, D.; Scheckel, K. G.; Tolaymat, T. M.; Ma, L.; Rogers, K.
(2013) “Changes in Silver Nanoparticles Exposed to Human Synthetic Stomach Fluid: Effects of Particle Size
and Surface Chemistry” Science of the Total Environment, (447): 90-98.

11. Tolaymat, T.; El Badawy, A.; Carson, D. (2013) “Estimate of the Decay Rate Constant of Hydrogen Sulfide
from Drywall in a Simulated Bench-Scale Study. J. Environ. Eng. (139): 538-544.

12. Kim R. Rogers, K., Bradham, K., Tolaymat, T., Thomas, D., Hartmann, T., Ma, L., Williams, A. (2012)
“Alterations in Physical State of Silver Nanoparticles Exposed to Synthetic Human Stomach Fluid” Science of
the Total Environment. (420):334-339.

13. Pokhrel, L., Silva, T., Dubey, B., Elbadawy, A., Tolaymat., T. (2012) “Rapid Screening of Aquatic Toxicity of
Metal-Based Nanoparticles Using the MetPLATE Assay” Science of the Total Environment. (426):414-422.

ECM Comb. Mot. to Exclude Page 52 of 56
Exh. X


The goal, therefore, is to formulate so as to aid the microorganism.
Consider generally the degradation of a polymer that contains
carbon-hydrogen bonds (R-H):

R-H > Re (1)

A proton is removed by one means or another to generate a polymer
radical Re. Normally this reaction is caused by heat, shear or UV light
absorption. We would prefer that it occur at ordinary temperatures,
under no stress, in the dark, in a landfill. Therefore the additive
package must promote the above reaction under these conditions
without unduly compromising processability or service life of the PVC
compound under more usual conditions.

We would like Re to break apart into smaller pieces so as to facilitate
microbial attack:

Re > R’ + R’e (2)
We wish to avoid recombination of the radicals:

Re + Re > RR (3)
This would lead to higher MW and greater resistance to
biodegradation. Normally in PVC, both (2) and (3) occur, but (3)
predominates. High energy in the radical tends to favor reaction (3).
Therefore, an additive system favorable to biodegradation should

complex the radical Re and allow it to dissipate energy in vibration as
heat, favoring reaction (2).

In the presence of oxygen, the Re radicals are readily oxidized:
Re + O2 > R-O-Oe (4)

This does not suit our needs. The resultant R-O-Os radicals are
energetic. They react with the polymer to form more radicals:

R-O-Oe + R-H > R-O-O-H + Re = (5)

ECM Comb. Mot. to Exclude Page 43 of 80
Exh, Z


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 13

because such a discovery would eliminate the significant environmental problem the
accumulation of these non-biodegradable materials poses. Indeed, such technology would be
worth billions of dollars. Although bioplastics have been developed (most notably, starch-based
plastics and oxobiodegradable plastics that biodegrade under certain aerobic conditions), as yet,
no technology exists that enables conventional plastics to biodegrade quickly under anaerobic

conditions, such as those found in a landfill.

VI. WHAT CONSTITUTES “COMPETENT AND RELIABLE SCIENTIFIC
EVIDENCE” FOR CLAIMS OF BIODEGRADABLE PLASTIC

37. In light of the overwhelming scientific consensus that conventional plastics are
not biodegradable after customary disposal, any test evaluating whether a conventional plastic
has been transformed into a “biodegradable plastic” through the means of an additive must be
rigorous enough to satisfy the scientific community that the plastic—and not merely the
additive—will completely biodegrade after customary disposal. In this section, I address what
constitutes competent and reliable scientific evidence to address this fundamental question.

38. To satisfy polymer scientists that 1% additive will make conventional plastics
biodegradable in a stated timeframe and disposal condition, the claimant should provide the
results of well-conducted scientific testing. Specifically, the evidence should take the form of
appropriately-analyzed results of independent, well-designed, well-conducted, well-controlled
testing. The testing should use the appropriate plastic application, load rate, inoculum, test
conditions, and sample weight, over an appropriate duration of time. I discuss the significance of
each of these factors below.

a. Plastic Application. Testing the appropriate “plastic application” means that the

test should be conducted on the type of plastic (e.g., polyethylene, polystyrene,

ECM Comb. Mot. to Exclude Page 13 of 58
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ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 17

39. Fora test to constitute reliable evidence that 1% additive will make conventional
plastic biodegradable in a stated timeframe and disposal condition, it must involve each of these
elements. This is true for three reasons. First, in a test that lacks some or all of these elements,
observed biodegradation may be the result of factors other than biodegradation of the
conventional plastic sample. For example, it could result from biodegradation of the additive,
biodegradation of the inoculum, or testing error. Second, a test that lacks some or all of these
elements cannot show that biodegradation will continue; it is equally plausible from a scientific
perspective that some initial period of biodegradation could yield to subsequent recalcitrance.
Third, a test that lacks some or all of these elements cannot establish whether biodegradation will
occur in a specific environment.

40. Additionally, individuals with the proper educational background and training
must design and oversee these scientific studies. First, only a person with a sophisticated
understanding of the scientific principals involved can design a test or implement changes to a
test method without affecting the validity of the underlying results. As explained above,
changing parameters of the test such as inoculum, test duration, temperature, or moisture
conditions, for example, can have a significant impact on the results. Changes must be planned,
well thought out, and justified by commonly accepted scientific principles.

41. Second, the test should be overseen by a person with the proper education and
training. Certain jaboratory functions may be provided by lab technicians, such as taking
readings or performing routine measurements. However, there are a number of quality control
and quality assurance requirements for the operation of any laboratory that help ensure the
validity and reliability of the results. Only those with the proper training and education can

ensure these quality control measures are being executed properly.

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Exh. U


Dr. McCarthy Rebuttal Report -- 10

discovered through research on biodegradable polymers that the amorphous regions of polymers
biodegrade at a greater rate than the crystalline regions.” M. Parikh, R. Gross, and S. McCarthy,
The Influence of Injection Molding Conditions on Biodegradable Polymers, Journal Of Injection
Molding Technology, Vol. 2, No. 1, pp. 30-36, March (1998). This phenomenon is critical as to
why extrapolation of biodegradation rates is scientifically unsound.
23. The first material to biodegrade is the amorphous region of a polymer, which biodegrades
at a fast rate. If the material were 50% crystalline, then the biodegradation rate would be very
rapid until it reached 50% biodegradation. Once the amorphous region was degraded, the
crystalline region would be left. The biodegradation rate would severely decrease (or even stop
altogether) since the crystalline region is very difficult to biodegrade, as even Dr. Sahu concedes.
Sahu Report at 30. Therefore, during a biodegradation test, if the biodegradation rate calculated
from the first 50% were to be extrapolated to 100%, an unrealistic (or impossible) rate of
complete biodegradation would be the result.

3. The Barber Method Is Scientifically Unsound.
24, — The experts rely on Dr. Timothy Barber’s methodology in support of their conclusions
regarding the environmental fate of ECM Plastics. The experts argue that the Barber
Methodology is defensible because weight loss and the evaluation of free chlorine are
appropriate indicators of biodegradability. Reliance on these metrics to establish complete

biodegradability is improper for two reasons. The measurement of weight loss and loss of

5 It is easy to understand the difference between amorphous and crystalline when

considering water and ice. The liquid phase of water is amorphous. The solid phase of ice is
crystalline. The crystallinity of any given polymer is a result of its chemical structure and
processing history. High density polyethylene is highly crystalline, while low density
polyethylene is less crystalline due to branching.

ECM Comb. Mot. to Exclude Page 10 of 12
Exh. CC


27. All persons identified in ECM’s redacted document production on December 27, 2013
(ates no. ECM-FTC-648-1859).

Proposed Testimony: We anticipate that these witnesses will testify about ECM’s
products, distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims, or
regarding their purchase of ECM Additive, their use of the Certificate of Biodegradability, their
use of the ECM logo, and their understanding of ECM’s claims of biodegradability.

28. Representatives of entities identified in ECM’s redacted document production on
December 27, 2013 (Bates no. ECM-FTC-648-1859).

Proposed Testimony: We anticipate that these witnesses will testify about ECM’s
products, distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims, or
regarding their purchase of ECM Additive, their use of the Certificate of Biodegradability, their
use of the ECM logo, and their understanding of ECM’s claims of biodegradability.

29. Representatives of ECM’s prospective customers.

Proposed Testimony: We anticipate that these witnesses will testify regarding their
purchase of ECM Additive, their use of the Certificate of Biodegradability, their use of the ECM
logo, their understanding of ECM’s claims of biodegradability, and their understanding of
ECM’s claims that it had substantiation for its biodegradable claims.

30. Representatives of ECM’s current customers.

Proposed Testimony: We anticipate that these witnesses will testify regarding their
purchase of ECM Additive, their use of the Certificate of Biodegradability, their use of the ECM
logo, and their understanding of ECM’s claims of biodegradability, and their understanding of
ECM’s claims that it had substantiation for its biodegradable claims.

31. Jewel Vuong and/or representative of American Plastics Manufacturing, Inc.

Mark S. Leen

Inslee, Best, Doezie & Ryder, PS
Symetra Financial Center, Suite 1900
777 108th Ave. Northeast

Bellevue, WA 98004

(425) 450-4219

Proposed Testimony: We anticipate that this witness will testify regarding their purchase
of ECM Additive, their use of the Certificate of Biodegradability, their use of the ECM logo, and
their understanding of ECM’s claims of biodegradability, and their understanding of ECM’s
claims that it had substantiation for its biodegtadable claims.

ECM Comb. Mot. to Exclude Page 6 of 11
Exh, A



ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 23

B. Confirmatory-Level Tests Are Necessary To Establish Biodegradation.

37. As discussed above, screening-level tests establish a threshold for potential
biodegradation, but confirmatory tests are necessary to provide definitive proof of
biodegradation of plastic. '*

58. Standard specifications provide a set of requirements for confirming
biodegradation. In contrast to a test method, a specification is a “pass/fail” test. An example of
a test specification in the aerobic context is ASTM D6400: “Standard Specification for Labeling
of Plastics Designed to be Aerobically Composted in Municipal or Industrial Facilities.” To pass
the specification, a plastic product must biodegrade 90% (using ASTM D5538 test method)
within 180 days. ASTM is considering a proposed specification for plastic materials that
anaerobically biodegrade in landfills (WK34780), but there is currently no specification for
customary anaerobic disposal environments such as landfills.

59. ASTM specifications are not the only way of confirming biodegradation. The
best-known, best-accepted confirmatory test is radiolabeling. Radiolabeling involves tagging
radioisotopes of carbon,'*C of a high-molecular weight plastic, such as polyethylene (PE) before
conducting a gas evolution test. During the gas evolution test, biogases are monitored for the
radiolabeled '4C. If the radiolabeled carbon is detected, then the conventional plastic polymer is
undergoing a material transformation through biodegradation. If the radiolabeled carbon is not

detected in the biogases, then the observed biogases are likely due to other factors, such as

‘4 SoLID WASTE, supra note 6 at 193 (“[d]efinitive proof of biodegradation, or lack
thereof, may be provided through the use of isotopically labeled samples.”)

ECM Comb. Mot. to Exclude Page 23 of 58
Exh. U


extraction points, a piping system to route gas removed from the landfill to a central collection
location, and a gas treatment or energy system.

42. At the end of a landfill’s operating life (which widely varies), the facility must be
appropriately closed, monitored and maintained for a federally-mandated period. Landfill
closure involves construction of a capping system to minimize infiltration of rainfall into the
waste mass and gas escape to the atmosphere. The aftercare period of an MSW landfill, referred
to as post-closure care, consists of facility maintenance to ensure integrity of the containment
and capping systems, removal and treatment of leachate, operation of the GCCS (if present), and
continued monitoring of the environment outside the landfill (groundwater, soil vapor)—all of
which have the incidental effect of suppressing oxygen, moisture, and temperature—and thereby
severely inhibiting biodegradation. Current U.S. regulations require post-closure care for 30
years. Because of the operating conditions of the typical landfill during its life and this post-

closure care, biodegradation will proceed at a slow rate for many decades after disposal of MSW.

b. Bioreactor Landfills: Rare Landfills That Maximize Biodegradation
43. The reality of the typical landfill—a “dry tomb” that incidentally minimizes

biodegradation—is especially clear when the typical landfill is contrasted with a new, specialized
type of landfill called a bioreactor. As discussed in section 30 above, bioreactors are an unusual
type of landfill (approximately 2% of U.S. landfills as concluded in a recent ORD study) that,
unlike “dry tombs,” are operated to maximize biodegradation.

44. The theory behind a bioreactor is that decomposition should be maximized to
limit the “active” life of the facility to those years when the site infrastructure is in its best

condition, and when it is actively being monitored. Bioreactor landfill design attempts to

19

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Exh. X


ECM Comb. Mot. to Exclude Page 48 of 80
Exh, Z


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(2010) Polym Degrad Stab 95:1794 1799 High Perform Polym 13:189 196
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15:17 192 applications and commercial products. Wiley VCH, Verlag
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408. Lindblad MS, Lin Y, Albersson AC, Ranucci E, Karlsson S 48:85. 108
(2001) Adv Polym Sei 157:139 161 442, Park TG (1995) Biomaterials 16:1123 1130
409. Shah AA, Hasan F, Hameed A, Ahmed $ (2008) Biotechnol Adv 443. Li S, McCarthy SP (1999) Biomaterials 20:35 44
26:246 265 444. Grizzi I, Garreau H, Li SM, Vert M (1995) Biomaterials
410. Zheng Y, Yanful EK, Bassi AS (2008) Polym Degrad Stab 16:305 311
93:561 584 445. Iwata T, Doi Y (2001) Sen’i Gakkaishi 57:172 175
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412. Kricheldorf HR (2001) Chemosphere 43:49 54 447. Li S, McCarthy SP (1999) Biomaterials 32:4454 4456
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(ed) Plastics from microbe. Hanser, New York, pp 93 137 romolecules 27:825 831
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Degrad Stab 67:85 90

@ Springer

ECM Comb. Mot. to Exclude
Exh. Z

54:761 772

Page 38 of 80


irradiation to introduce carbonyl groups, by modifying PE by introducing reactive groups, by thermal
treatment to reduce its molecular weight and when incubated with specific microorganisms selected for
their ability to biodegrade recalcitrant materials. However, mixing ECM additive with conventional
plastics causes none of these changes. This implies that ECM amended plastics will persist for very long
time scales in landfills and contribute to plastic pollution if released into natural environments.

Refi nes
Albertsson, A. C. 1977. Studies on the Mineralisation of “C Labelled Polyethylenes in Aerobic
Biodegradation and Aqueous Aging; Royal Institute of Technology: Stockholm, Sweden, 1977.

Albertsson, A. C. 1978. Biodegradation of Synthetic-Polymers Il. Limited Microbial Conversion of C-14 in
Polyethylene to (CO,)-C-14 by Some Soil Fungi. J. Appl. Polym. Sci. 22 (12), 3419-3433.

Albertsson, A. C.; Banhidi, Z. G.; Beyerericsson, L. L. 1978. Biodegradation of Synthetic-Polymers Ill.
Liberation of (Co-2)-C-14 by Molds Like Fusarium-Redolens from C-14-Labeled Pulverized High-Density
Polyethylene. J. Appl. Potym. Sci. 22 (12), 3435-3447.

Alexander, M, Scow, KM. 1989. Kinetics of Biodegradation in Soil. In eds: Sawhney, B. L. Brown, K.,
Reactions and Movement of Organic Chemicals in Soils. p. 243-269. doi:10.2136/sssaspecpub22.c10.
SSSA Special Publication 22, Soil Science Society of America and American Society of Agronomy.

Araujo, JC, R Mortara, JR Campos and RF Vazoller. 2004. Development and analysis of anaerobic biofilms
onto hydrophobic and hydrophilic surfaces. Environmental Technology, Vol. 25. pp 809-817

ASTM D5210: Standard Test Method for Determining the Anaerobic Biodegradation of Plastic Materials
in the Presence of Municipal Sewage Sludge.

ASTM DS5511: Standard Test Method for Determining the Anaerobic Biodegradation of Plastic Materials
Under High-Solids Anaerobic-Digestion Conditions.

ASTM D5526: Standard Test Method for Determining Anaerobic Biodegradation of Plastic Materials
Under Accelerated Landfill Conditions.

Busscher H, Weerkamp A. 1987. Specific and non-specific interactions in bacterial adhesion to solid
substrata. FEMS Microbiol Rev. 46;165-173.

Cerca N, Pier GB, Vilanova M, et al. 2005. Quantitative analysis of adhesion and biofilm formation on
hydrophilic and hydrophobic surfaces of clinical isolates of staphylococcus epidermidis. Res Microbiol
156: SO6-514.

Desai, S, R Govind, and H Tabak. 1990. Determination of Monod Kinetics of Toxic Compounds by
Respirometry for Structure—Biodegradability Relationships. In Emerging Technologies in Hazardous
Waste Management; ed. Tedder, D. ACS Symposium Series; American Chemical Society: Washington,
Dc.

20

ECM Comb. Mot. to Exclude Page 20 of 24
Exh. V


ECM Comb. Mot. to Exclude
Exh. L

Kai (Shnsdn (kjohnson3 @fic. gov)

J Cohen (jcohen2@ftc.gov)
Jillson (qjillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B

Washington, DC 20580

Phone: 202-326-2185, -2551; -3001

Fax: 202-326-2551

Page 4 of 5


This generates a self-sustaining chain reaction. Even worse, the
R-O-O-H hydroperoxide formed itself decomposes:

R-O-O-H > ROe + eOH (6)

Both of these species can remove protons from R-H, forming more
Re radicals. This series of reactions is useful to our purpose to the
extent that reaction (2) above dominates reaction (3). Here the landfill
helps in that it limits oxygen availability so that the system is not
flooded with initiating radicals to the point where reaction (3) cannot
be overcome. Nevertheless, the additive system must be present at a
level such that most Re radicals can be complexed and slowed down.

In the case of PVC, degradation is complicated by the loss of HCI.
This.is-useful:in- that the resultant- unsaturated. product.is.more readily
degraded, but unsuitable in that HCI is not only an undesirable landfill
effluent, but also a hindrance to the extent to which it may convert the
radical reaction sequence into ionic processes. Therefore fillers that
are acid absorbers, such as fine particle calcium or magnesium
carbonate should be present.

If the polymer molecular weight is reduced through degradation to the
point where microbial digestion becomes possible, the fate of residual
chlorine is open to speculation. The metabolic needs of bacteria and
fungi are carbon, water, nitrogen and trace elemenis, including
chlorine. The extent to which chlorine is required seems far less than
would be provided by metabolism of, for example, pentachlorophenol.
When chiorinated biocides are present at too low a level to be
effective, it appears that certain organisms, such as the fungus
Trichoderma and the bacterium Pseudomonas fluorescens then
consume them (if more easily processed diet is unavailable). [2] in
the case of the biocide Captan®, most of the chlorine content
appears to end up as sodium and calcium salts.

A further factor is that the PVC article must contain additional food to
sustain microorganisms as the polymer degrades to a molecular

weight that can be metabolized, or additives that favor conversion of
other ingredients, such as plasticizer, into food. This poses a problem

ECM Comb. Mot. to Exclude Page 44 of 80
Exh. Z


communication as strictly confidential and provide it to the person intended. Duplication or distribution of this communication is Prohibited
by the sender. If this communication has been sent to you in error, please notify the sender and then immediately destroy the document.

ECM Comb. Mot. to Exclude Page 3 of 3
Exh. DD


Figure 1. Management Methods for Municipal Solid Waste

Recycled
/ "26%

Landfilled ~
54%,

t

\ Composted
~8%

| ~~ Incinerated |
| : ~12%

Indeed. when recycling is excluded. landfilling accounts for 73% of MSW disposal and

incinetation 16% as presented in Figure 2.

Figure 2. Disposal of Municipal Solid Waste in U.S.

Glandfiing composing micineradce

17. Landfills obviously have enormous importance to U.S. waste management. so any

technology that would significantly impact landfilling would gamer enormous attention.

ECM Comb. Mot. to Exclude Page 8 of 56
Exh. X


Gordon Conference “Biodegradable Polymers”, San Moniato, Italy, May 1993

Industrial Seminar at the University of Connecticut on Biodegradable Polymers, March 1993
Compalloy Conference, Newark, NJ, April 1993

Moldflow Conference, Valley Forge, PA, April 1993

Tandec Conference, Knoxville, TN, October 1992

Industrial Seminar on Biodegradable Polymers, Beijing, China, June 1992

Cornell University, Ithaca, NY, May 1992

Compalloy Meeting, Short Hills, NJ April 1992

International Polymer Conference, Jakarta, Indonesia, January 1992

Polymer Processing, National Taiwan University, Taipei, Taiwan, June 1986

SEMINARS

“Mechanical, Physical, and Rheological Properties of Polymers" Plastics Engineering Industrial
Seminars, University of Lowell, 1985-present

Industrial Seminar at Clariant Corp. on June 2005

Industrial Seminar at Hewlett-Packard Company, Rehovot, Israel, 2003

Industrial Seminar at Exxon Company, Texas, 1999

“Medical Plastics Seminar’, Plastics Engineering Industrial Seminars, University of
Massachusetts Lowell, 1998

"Biodegradable Polymers and Blends", Plastics Engineering Industrial Seminars, University of
Lowell, 1985

"Computer Aided Injection Molding", Plastics Engineering Industrial Seminars, University of
Lowell, 1985

Industrial Seminar at 3M Company, Minneapolis, May 1992

CONTRACT AND GRANT SUPPORT

Avaya, (Kinetic Welding) (Intellectual property donation), $23,000,000
Solutia, (Nylon Pultrusion) (Intellectual property donation), $5,779,500
Commonwealth of Massachusetts, “Massachusetts Medical Device Development Center”,
$4,000,000
Valyi (CSBM) (licenses of Intellectual property donation), $3,000,000
Metabolix, “Development of Novel of Biodegradable Materials, $1,500,196
NSF Center for Biodegradable Polymer Research, $1,200,000 Industrial Members
(8/93-present), Principal Investigator
David Pernick UMass Lowell/Shenkar College Exchange Agreement, $ 1,000,000
Vaitek, LLC, “Class A” Thermoplastic Automotive Finish without Painting, $625,000
Massachusetts Technology Collaborative John Adams Innovation Institute, “Massachusetts
Medical Device Development Center”, $500,000
Polymer Degradation Research Center, $475,000, Industrial Members (8/89-8/93)
Digital, “Plastics Materials Research”, $458,706
US Army Natick, “Advanced Materials from Renewable Resources”, $365,596,
US Environmental Protection Agency, $300,004, (1998-2000), Principal Investigator
Institute for Plastics Innovation, Co-Director, $300,000, Industrial Members, (1995-
present)
Lucent Technologies, Kinetic Weld, $165,000

ECM Comb. Mot. to Exclude Page 42 of 58
Exh. U


644

J Polym Environ (2011) 19:637 676

<

Fig. 2 Histological sections demonstrating minimal tissue response
in the surrounding tissues: (a) highly cross linked chitosan implant,
(b) lighly cross linked chitosan implant and (c) chronic foreign body

Fig. 3 Scanning electron micrographs of the degraded samples by
aerobic thermophilic compost: N acylated (top) and NM chit (not
modified chitosan) after 21 days (bottom). (Reproduced from Ref.
[188] with permission from Elsevier)

branched structure with concomitant change in properties.
The high strength and rigidity of cellulose originate thus
from the linear structure and the hydrogen bonding made

®) Springer

ECM Comb. Mot. to Exclude
Exh. Z

reaction in the tissues surrounding surgical sutures such as vicryl.
(Reprinted from Ref. [187] permission from Elsevier)

possible. Apart from other uses as gums and adhesives, a
promising application is in the area of biodegradable poly-
mers either after grafting with suitable polymers or after
blending with other synthetic polymers and can be processed
into thermoplastic materials only in the presence of plasti-
cizers and under the action of heat and shear. Poor water
resistance and low strength are limiting factors for the use of
materials manufactured only from starch, and hence the
modification of starch is often achieved by blending ali-
phatic polyesters. The biodegradable rates of blends can be
controlled to a certain extent depending on the constitutions
of blends, and the mechanical properties of blends are close
to those of traditional plastics such as polyethylene and
polystyrene. The reduction of their sensitivity to humidity
makes these materials suitable for the production of biode-
gradable films, injection-molded items, and foams. Ther-
moplastic starch and its blends are known to cater to a
sustainable development, which means that the responsible
use of available natural resources and production processes
take environmental aspects and natural circulations into
consideration [180]. Starch foam is one of the major starch-
based packaging materials. It is produced by extrusion or
compression/explosion technology. This product has been
developed as a replacement for polystyrene which is used to
produce loose-fillers and other expanded items. The major
starch-derived polyesters in the market now are polylactic
acid and polyhydroxyalkanoate [176]. Proteins (gelatin,
casein, soy products etc.) [116, 189] have also found innu-
merable applications in biodegradable products.

Natural biodegradable polymers being renewable can be
considered under the category of green materials [165, 166,
190]. One can alter the structure of natural biodegradable
polymers to impart certain additional properties or to
improve the biodegradability itself [191]. There are a
variety of natural existing monomers which can be poly-
merized to obtain with various degrees of success in bio-
degradability [165, 168, 192 194]. Monomers can also be
obtained by extraction and/or fermentation from biomass

Page 8 of 80


12. Complaint Counsel provided me with the following materials relating to the ECM
additive:

a. Materials, including published and unpublished study reports, protocols,
data, and data analysis that, I understand, ECM submitted.

b. Materials, including published and unpublished study reports, protocols,
data, and data analysis that, | understand, third parties provided in
response to subpoenas from Complaint Counsel or ECM.

c. White papers, including expert reports of Dr. Ranajit Sahu submitted by
ECM during the FTC investigation of ECM, and published articles cited in
the white papers and/or Dr. Sahu’s reports.

13. As I reviewed these materials and prepared this Expert Report, I relied
extensively on my knowledge, expertise, and experience concerning landfill design and

management.

I. DISPOSAL OF SOLID WASTE IN THE U.S.

14. The majority of landfills in the U.S. are “dry tomb” landfills in which
biodegradation occurs very slowly. They are operated to contain waste and most waste
containment protocols have the incidental effect of inhibiting biodegradation. Specifically,
typical U.S. landfills have too little oxygen, are too cold, and too dry to support optimal
conditions for organisms that biodegrade waste. As a result, even common organic materials
such as leaves and food scraps take many years—even decades—to degrade in the average U.S.

landfill.

15. What is Municipal Solid Waste? The EPA defines Municipal Solid Waste
(“MSW”) as waste consisting of everyday items that we use and then discard, such as product
packaging, grass clippings, furniture, clothing, bottles, food scraps, newspapers, appliances,

paint, and batteries. In 2012, the EPA estimated that Americans generated about 250 million

6

ECM Comb. Mot. to Exclude Page 6 of 56
Exh. X


Respondent’s Exhibit X


licensed by EPA to operate as “bioreactors.” Bioreactors are managed as wet environments that
promote biodegradation. In bioreactor landfills, the addition of bulk liquids enables the
bioreactor to operate at a more optimal moisture range for biodegradation (at or above 40%).

But bioreactor landfills remain a small subset of landfills because of the potential risks associated
with them (described further in section IV).

34. One way to understand the differences in biodegradation rate among Subtitle D
landfills and bioreactors is to compare the average predicted decay rates (rate of decomposition)
and half-lives (amount of time required for half of the waste to biodegrade) of waste in each
type. Decay rates and half-lives can be predicted from “landfill gas generation models,” which
measure landfill gas output to estimate biodegradation (because gas output is the best indicator of
biodegradation in landfills). The most widely-used landfill gas generation model in the U.S. is
the EPA’s model (LandGEM),* which assumes a first order decay model. This type of model is
also used by United Nation’s Intergovernmental Panel on Climate Change (IPCC) to evaluate
greenhouse gas emissions from landfills.

35. As Table | below shows, the decay rate increases with moisture, and the half-life
decreases. In other words, the more moisture, the faster the rate of decomposition and the less
time it takes for MSW to decompose. Table 1 demonstrates the enormous disparity in
decomposition rates between wet bioreactors and arid landfills. To illustrate, if 100 pounds of

fully biodegradable organics were disposed of in a bioreactor landfill, half of that mass (50

. ' 7 0 A BLM,
® The equation that is the basis for this model is: Q, =k -L, >

1 f=00 10
Where Q, is CH, generation rate (m? yr) in year n; k is first order waste decay rate (yr"!); Lo is
CH, generation potential (m? Mg” wet waste); Mj is waste mass placement in year i (Mg); and t
is time (yr). The US EPA presents default values for both k and L, in its air emissions database
(AP-42), however, site specific values can be determined. The waste decay constant (k) may be
the most important variable in the determination of the LFG production rate.

15

ECM Comb. Mot. to Exclude Page 15 of 56
Exh. X


starch have been incorporated into PE (50% to >80%) do not show any improvement in the
biodegradation of the PE fraction (Nakashima et al., 2002). For example blends of 50% and 83% starch
added to polyethylene displayed a maximum of 49% and 78% weight loss upon 16 months incubation in
soil (Nakashima et al., 2002).

Sahu comment —

On page 47, Dr. Sahu makes the following comment regarding Dr. McCarthy’s assertions about C**
testing arguing that it is unwarranted and too difficult to do.

“Vil.10 Radiological Testing is Impractical and Unwarranted

Dr. McCarthy states that the only appropriate confirmatory tests are either radiological, using *“C in the
plastic and tracking the resulting “CO, and “CH, that would evolve from biodegradation of this material.
He does not, however, mention how this could be done as a practical matter. He does not mention how
one can formulate (or ask a manufacturer to formulate) such materials with the ECM additive in small
batch quantities, just for testing purposes; nor the many practical impediments associated with such a
task — including handling the radiological materials and their proper disposal; contamination and
decontamination issues in the manufacturing plant and the laboratory when such tests would be done;
and, of course, the time and cost involved. Others have noted same/similar issues with this approach.
“[P]roblems with handling the radioactively labeled materials and their disposal are issues on the down
side to this method. In addition, in some cases, it is difficult to synthesize the target polymer with the
radioactive labels in the appropriate locations, with representative molecular weights, or with
representative morphological characteristics.”74

74 Van der Zee, M., Analytical Methods for Monitoring Biodegradation Processes of Environmentally
Degradable Polymers, Section 11.5.5.2. Chapter 11 in Handbook of Biodegradable Polymers: Synthesis,
Characterization and Applications, First Edition. edited by Andreas Lendlein, Adam Sisson.

It is my opinion that while such test data, if available, would certainly be great, it is unlikely that the
practical difficulties associated with arranging such materials and tests can be overcome. More
importantly, even if they were to be overcome, can only imagine the myriad objections that Drs.
McCarthy and Tolaymat would raise with regards to representativeness, test conditions, qualifications,
etc. of those tests, much like they have criticized the 05511 tests. Lastly, it is my opinion, that one need
not wait for such tests to deliver further proof of biodegradation as Dr. McCarthy suggests. Looking at all
of the evidence, collectively, as discussed in this report with regards to the threshold question (which,
incidentally, also includes confirmation of biodegradation of relatively recalcitrant polymers such as PE
and PP by radiological evidence of the exact type Dr. McCarthy suggests — see the papers by Albertsson
et. al.) as well as the many D5511 test results and using the exercise of commonly applied scientific
judgment (which is unavoidable), it is evident that the existing proof provides more than a reasonable
basis for concluding that plastics containing ECM’s additives biodegrade faster than plastics without
those additives. ”

Rebuttal —
14

ECM Comb. Mot. to Exclude Page 14 of 24
Exh. V


PUBLIC

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.

DOCKET NO. 9358

WS ee

ORDER GRANTING iN PART AND DENYING IN PART
RESPONDENT’S MOTION FOR SANCTIONS

On February 28, 2014, Respondent ECM BioFilms. Inc (Respondent? or “ECM”) filed
a Motion for Sanctions for the asserted failure of Federal Trade Commission (“FTC”) Complaint
Counsel to supplement its document production “in a timely manner,” pursuant to FTC Rule
3.31(€)(2) (“Motion”). 16 CER. § 3.31(e)(2). Complaint Counsel filed an opposition to the
Motion on March 10, 2014 (“Opposition”), and a Clarification Regarding Respondent’s Motion
for Sanctions on March 13, 2014.

On March 12, 2014, Respondent filed a Motion for Leave to Supplement its Motion for
Sanctions by submitting a complete transcript of the ECM deposition, in licu of deposition
excerpts as originally filed as RX-A to the Motion. As of the date of this Order, no opposition to
that motion has been filed. Respondent’s Motion for Leave is GRANTED, and citations to the
deposition transcript shall refer to RX-A as supplemented by Respondent

Having fully reviewed and considered the Motion, Opposition, and Clarification, and the
exhibits thereto, the Motion is GRANTED IN PART AND DENIED IN PART, as more fully
explained below.

iL Background

The Motion is based upon Complaint Counsel’s use of a document at the deposition of
ECM, via its designee, ECM’s Chief Executive Officer Robert Sinclair, which took place on
February 18 and 19,2014. Motion RX-A (T ranscript of Deposition (hereafter “Tr.”)), The
document, marked as Deposition Exhibit 23, is a published article titled, “Biodegradability of
Conventional and Bio-Based Plastics and Natural Fiber Composites During Composting,
Anaerobic Digestion and Long-Term Soil Incubation,” by Eddie F. Gomez and Frederick C
Michel, Jr., who are associated with Ohio State Agricultural Research and Development Center
(the “Ohio State Article” or “Article”). Tr. 366. The Ohio State Article was published on
October 1, 2013, in a journal entitled Polymer Degradation and Stability, 98 (2013) 2583-2591,

ECM Comb. Mot. to Exclude Page 1 of 6
Exh. P


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 25

62. ECM asserts that treatment of conventional plastic with the ECM additive allows
the formation of biofilms, which attract microorganisms that are able to synergistically combine
to metabolize both the ECM additive and the conventional plastic until the plastic is completely
biodegraded.

63. Specifically, ECM claims that: '®

a. ECM Plastics will completely biodegrade within one year in a landfill.
b. ECM Plastics will completely biodegrade in nearly all landfills within nine
months to five years.
¢. ECM Plastics will completely biodegrade in most landfills within one to five
years.
d. ECM Plastics will completely biodegrade in any disposal environment at an
appreciably faster rate and extent than conventional plastics without the ECM
Additive.
e. Various scientific tests, including but not limited to ASTM DS5511, have shown
that ECM Plastics perform as indicated in (a)-(d) above.
Each of these claims is unsubstantiated. Moreover, although all of the claims are likely false as
well, I can conclude with scientific certainty that all but one of ECM’s claims are false. I discuss

the false claims (a-c, e) first.
A. ECM’s False Claims.

64. It is my opinion that after blending the ECM Additive with conventional plastic,

the conventional plastic remains non-biodegradable. The reason for this is that a physical blend

8 See supra at 3-4.

ECM Comb. Mot. to Exclude Page 25 of 58
Exh. U


definitively show biodegradation of the plastic (as opposed to the biodegradable component in
the ECM Additive) or the rate of biodegradation of the plastic.

81. Because the method assumes homogenous test material, it also assumes that any
gas generation is synonymous with biodegradation of the test material. But this is not
necessarily the case. If a non-biodegradable component were mixed with cellulose, the cellulose
would generate gas, giving a false “positive” for the material as a whole. For this reason, it is
impossible to tell from an ASTM D5511 test whether biodegradation resulted from the
biodegradable component in the ECM Additive or from the plastic itself.

82. In addition to these overarching problems with results from ASTM D5511 testing,
individual ECM ASTM D5511 tests have methodological flaws. For example, Analytical Report
ASTM D5511 (ECM-FTC-000497) relies on only four gas composition readings, one of which
was incomplete—even though conclusions based on only three readings are far from definitive.
This same test relies on calculation methods that skewed the results to show more
biodegradability than actually occurred. Indeed, the reported average methane content (39%) is
higher than 6 of the 9 methane readings (reported as 26%, 26%, 26%, 30%, 31%, and 31%) for
ECM Plastic meaning that three readings skewed the entire data set. Moreover, sloppiness
renders the report’s conclusions questionable: the average percent gas composition data used on
page ECM-FTC-000500 to calculate biodegradability does not match the actual average from the
readings on page 000499. The reported average methane content for PE 1% ECM with Slip
Additive used on page ECM-FTC-000500 is reported to be 39%, but the actual average methane
content using the data on page ECM-FTC-000499 is 34%.

83. Statistical uncertainties likewise render its conclusions questionable. The 5%

assessed biodegradability is within the range of uncertainties inherent to the experimental design

32

ECM Comb. Mot. to Exclude Page 32 of 56
Exh. X


J Polym Environ (2011) 19:637 676

643

mechanical properties, degradation rate, and mechanical
property change during degradation in terms of the design
of the elastomer and their advantages and disadvantages for
biomedical applications [155].

The successful performance of the first synthetic poly(-
glycolic acid) based suture system (The first biodegradable
synthetic suture called DEXONs that was approved by the
United States (US) Food and Drug AdministrationFDA) in
1969 was based on Polyglycolide) during the late 1960s led
to the design and development of a new array of biode-
gradable polymers as transient implants for orthopaedic
and related medical applications (152, 156]. Pillai and
Sharma [156] has recently reviewed and brought to focus
the scattered data on chemistry, properties, biodegradabil-
ity, and performance of absorbable polymeric sutures.
Pillai et al. [157] have discussed the significane of chitosan
for various biomedical applications emphasising its bio-
degradability and biocomppatibilty and pointed out the
unique characteristics of chitosan for fiber application.

Biodegradable Polymers from Renewable Resources

Biodegradable polymers can be broadly divided into dif-
ferent categories based on the origin of the raw materials
(renewable or non-renewable) and the processes used in
their manufacture [158 161]. Shifting the resource base for
chemical production from fossil feedstocks to renewable
raw materials provides exciting possibilities for the use of
industrial biotechnology-based process tools [161]. Among
renewable resource based materials, biomass is generally
constituted of polymers, oligomers, monomers, and other
non-polymerizable simple organic compounds including
metallic salts and complexes [159 163]. Polymers are, of
course, the major constituents and have been serving
human civilizations from time immemorial [14, 164, 165].
The outstanding aspect of natural polymers is their wide
variety which gives innumerable opportunities for struc-
tural modifications and utilization. Depending on the nature
of the hetero atom inserted in the main chain, the polymers
can be classified into four major types [166 168] as
hydrocarbon polymers (e.g., natural rubber), carbon-oxy-
gen (¢.g., carbohydrates- cellulose [starch, chitin, chitosan,
pullulan etc.; phenolics - lignin, humus etc. and polyesters-
shellac), carbon-oxygen -nitrogen/sulphur (e.g., proteins
with the exception of phospho proteins) and carbon-oxy-
gen-nitrogen-phosphorus (e.g nucleic acids) containing
polymers. These polymers especially, polysaccharides,
additionally offer CO -neutrality, partial independence
from petrochemistry-based products and the exploitation of
natures synthesis capabilities via photosynthesis [169].
Polysaccharides (cellulose [170 176], starch [l4, 177

182], chitin and chitosan [148, 182], proteins (gelatin,
casein, pectin etc. [107, 183] and others prepared from

ECM Comb. Mot. to Exclude
Exh. Z

natural monomers [184 186] have found innumerable
applications in biodegradable products. Nature has a
plethora of natural enzymes for degrading natural poly-
mers. The rate of degradation and the formation of the
ultimate metabolites depend very much on the structural
complexity of the material and the environmental condi-
tions selected for the degradation trial. Several reviews
have appeared on various aspects of biodegradability and
applications of these natural polymers. Among the poly-
saccharides, cellulose [168 175] is an almost inexhaustible
polymeric raw material with fascinating structure and
properties. Cellulose is a linear condensation syndiotactic
polymer of anhydrogluose units joined together by -1,4-
glycisidic bonds. Properties such as its hydrophilicity,
chirality, biodegradability (readily biodegradable by many
microorganisms due to activity of cellulase enzyme com-
plex.), broad chemical modifying capacity, and its forma-
tion of versatile semicrystalline fiber morphologies etc.
make it a polymer of unique possibilities. Based on general
considerations on the correlation between biodegradability
and molecular structure, cellulose derivatives allow both
thermoplastic processing and post-consumer waste man-
agement via biological decomposition [169].

The significance of natural polymers can be explained
by taking chitosan, as an example, which is well known to
elicite minimal foreign body reactions with little or no
fibrous encapsulation upon implantation. Figure 2 shows
the tissue responses to chitosan gels when compared to
biodegradable surgical suture Vicryls. Chitosan gels elic-
ited very minimal inflammatory response compared to
Vicryls (a copolymer of polyglycolide and polylactide)
which showed a pronounced inflammatory reaction. The
gels with lower cross-linking density (FDG) showed sig-
nificant weight loss after 14 days of implantation;
approximately 80% (subcutaneous) and approximately
91% (intraperitoneal).No significant decrease in weight
was observed for highly cross-linked gels 9SDG) after
14 days of implantation [187] implantation on the in vivo
degradation of chitosan based implants. The study clearly
showed the effect of cross-linking density and the site of
implantation on the in vivo degradation of chitosan based
implants. In vivo, chitosan is also known to elicite minimal
foreign body reactions.

Appropriate chemical modification improves the bio-
degradability. NM-chitosan and partially N-acylated
chitosan films were assessed by exposure of the films to
laboratory-scale aerobic thermophilic compost reactors and
abiotic control vessels (Fig. 3) [188].

Starch [176 182] one of the most inexpensive and most
readily available of all natural polymers, is related in
structure to cellulose by having the same repeat unit. The
1,4-«-glycosidic linkage of glucose units in starch rather
than the 1,6-B-glycosidic linkage in cellulose gives rise to a

® Springer
Page 7 of 80


J Polym Environ (2011) 19:637 676

Fig. 21 SEM images demonstrating the differences in morphology
for 80/20 wi% PLA/LLDPE Blends. (a) binary blend, (b) addition of
Swt% of PLLA PE (5 kg/mole 30 kg/mole) block copolymer,

The Issue of Sustainability and Environmental Impact

Due in part to a growing emphasis on “green” chemical
processes, there has been increasing interest in the devel-
opment and utilization of more environmentally benign
polymeric materials. This classification can describe a
continuum of polymers, ranging from those that are
obtained from annually renewable feedstocks, to those that
ultimately degrade to benign by-products after their useful
lifetime. One of the key polymers in this regard is poly-
lactide, or poly(lactic acid), which is one of a subset of
thermoplastic polymers that is viable in both of these cat-
egories, as it is derived from plant starches and is ulti-
mately degradable into biologically and/or environmentally
manageable by-products when composted [2].

Applications

For economic reasons, for practical reasons, even for health
and safety reasons, biodegradable plastic products are
establishing themselves as viable alternatives in a number
of important niche markets. Some of these lie in the fields
of medicine, textiles (clothing and fabrics), hygiene and
agriculture, as well as some specific packaging applica-
tions. Because of their specialized nature and greater unit
value, medical device applications have developed faster
than the others.

Medical Applications

Biodegradable polymers have been widely used in vascular
and orthopedic surgery as implantable matrices for the
controlled long-term release of drugs inside the body, as
absorbable surgical sutures and plastic staples, various pins

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

(©) addition of 5 wt% of PLLA PE (30 kg/mole 30 kg/mole) block
copolymer. (Reprinted from Reference [547] with permission from
Wiley)

and screws, ligature clips and vascular grafts, artificial skin
and bone fixation devices [564, 565]. Commonly used PLA.
based biodegradable polymers in medical field are given in
Table 2.

A number orthopedic products based on PLLA have come
up: the Phantom Soft Thread Soft Tissue Fixation Screws,
Phantom Suture Anchors (DePuy), Full Thread Bio Interfer-
ence Screws (Arthrex), BioScrews, Bio-Anchors, Meniscal
Stingers (Linvatec), and the Clearfix Meniscal Darts (Inno-
vasive Devices) are gaining momentum [152]. PLLA fiber
was FDA approved in 1971 for the development of an
improved suture over DEXONs. Due to the high strength of
PLLA fibers, it has been investigated as scaffolding material
for developing ligament replacement or augmentation devices
to replace nondegradable fibers, such as Dacron [566 568].

Agricultural Applications

Biodegradable polymers in agricultural field as agricultural
mulches, agricultural planting containers, and in controlled
release of agricultural chemicals are also of interest. Biode-
gradable films based on starch with poly(vinyl alcohol),
poly(ethylene-co-acrylic acid) and poly(vinyl chloride) have
been developed as agricultural mulch films [569]. Starch,
cellulose, chitin, alginic acid and lignin are among the natural
polymers used in controlled release systems and polycapro-
lactone are used as agricultural planting containers [487].

Packaging

The niche markets of biodegradable polymers in packaging
field include composting bags for yard waste or food
scraps, carrier bags, food-service applications, such as
single-use compostable plastic cups, straws, plates and
cutlery, and food wrappers and containers (Table 3) [313].

Page 28 of 80


depositions. We wiil be noticing the deposition of D&W in Greenville, SC for May 6". Please advise
immediately if this date is unavailable.

Katherine

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: Kiohnson3@ftc. gov

ECM Comb. Mot. to Exclude Page 3 of 3
Exh. E


PLAINTIFF'S
EXHIBIT

SUBPOENA AD TESTIFICANDUM
DEPOSITION

Provided by the Secretary of the Federal Trade Commission, and
Issued Pursuant to Rule 3.34(a), 16 C.F.R. § 3.34(a) (2010)

Zz sewer

4.70

Elsevier Inc.
c/o Nicholas Tardif, Corporate Counsel
360 Park Avenue South New York, NY 10040

2. FROM

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION

This subpoena requires you to appear and give testimony at the taking of a deposition, at the date and time specified in
{tem 5, and at the request of Counsel listed in Item 8, in the proceeding described in Item 6.

3 PLACE OF DEPOSITION

600 Pennsylvania Avenue, N.W.M8102B
Washington, D.C. 20580
{TELEPHONICMMITH TRANSLATOR)

4. YOUR APPEARANCE WILL BE BEFORE
‘Complaint Counsel and other designated counsel

5. DATE AND TIME OF DEPOSITION
8.00 PM EST May 8, 2014

6. SUBJECT OF PROCEEDING

in re: ECM Biofilms, inc., Docket No. 9358

Co

Please see attached schedule for deposition topics pursuant to 16 C.F.R. 3. 33(c)(1)

7. ADMINISTRATIVE LAW JUDGE

The Honorable D. Michael Chappell

Federal Trade Commission
Washington, D.C. 20580

8. COUNSEL AND PARTY ISSUING SUBPOENA

Complaint Counsel

Katherine Johnson (202) 326-2185
Jonathan Cohen (202) 326-2551
Elisa Jillson (202) 326-3001

DATE SIGNEt

S/aif\4

SIGNATURE OF COUNSEL ISSUING SUBPOENA

GENERAL INSTRUCTIONS

=
applARANGE
‘The delivery of this subpoena to you by ahy 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
onginal-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 8, and upon all other parties prescribed
by the Rules of Practice,

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 8 for payment. If you are permanently 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 Hem 8.

A copy of the Commission's Rules of Practice is available
online at ih lice. Paper copies are
available upon request.

This subpoena does not require approval by OMB under
‘the Paperwork Reduction Act of 1980.

FTC Form 70-C (rev 1/97)
ECM Comb. Mot. to Exclude

Exh. L

Page 1 of 5


From: Gross, Dana [mailto:DGROSS@ftc.gov]

Sent: Thursday, April 10, 2014 1:13 PM

To: Peter Arhangelsky; Jonathan Emord; Jillson, Elisa; Johnson, Katherine

Ce: Arthaud, Victoria; Gebler, Hillary; Pelzer, Lynnette; Clark, Donald S.; Tabor, April; Frankle, Janice Podoll
Subject: Docket 9358 - 041014 Second Revised Scheduling Order

Dear Counsel,
Attached is a courtesy copy of the above order issued today by Judge Chappell.

Sincerely,

Dana £, Grose

Legal Support Specialist

Office of Administrative Law Judges
Direct:(202) 326-3723

Main: (202) 326-3637

ECM Comb. Mot. to Exclude Page 2 of 2
Exh. BB


Respondent’s Exhibit G


Exhibit B

e Bioreactor Landfill Design. Presented at EPA Region 5 Bioreactor Landfill Workshop, Chicago, IL,
September 27, 2005.

* Monitoring Approaches for Bioreactor Landfills. Presented at EPA Region 5 Bioreactor Landfill
Workshop, Chicago, IL, September 27, 2005.

° Bioreactor Landfills, Theoretical Advantages And Research Challenges. Presented at EPA Region 5
Bioreactor Landfill Workshop, Chicago, IL, September 27, 2005.

« Waste Stabilization Fundamentals For Bioreactor Landfills. Presented at EPA Region 5 Bioreactor Landfill
Workshop, Chicago, IL, September 27, 2005.

EXTERNAL RESEARCH GRANTS

Waste Management Inc. (WM) bioreactor landfill $200K in-kind per year (2001-present)
EPA’s Office of Solid Waste (OSW) “Fee for Service” $150K (2005)

ORD’s national nanomaterials research initiative $480K (2007)

Environmental Education and Research Foundation bioreactor landfill research $40K (2007)
Environmental Education and Research Foundation bioreactor landfill research $40K (2007)
Regional Applied Research Effort (RARE) R5 $50k per year for two years (2008-2009)
Regional Applied Research Effort (RARE) R10 $110k (2008)

Environmental Research and Education Foundation secondary aluminum processing waste research $186K
(2009)

= Aluminum Association secondary aluminum processing waste research $186 (2009)

= U.S. AID/Jordan the remediation of a phosphate mining site in Amman, Jordan $5,000K (2010)

ECM Comb. Mot. to Exclude Page 56 of 56
Exh. X


Respondent’s Exhibit A


J Polym Environ (2011) 19:637 676

645

constituents and biodegradable polymers could be synthe-
sized [191 195]. Monomers such as 1,3-propanediol, 1,4~
butane diol, y-butyrolactone, adipic acid, N-methylpyrr-
olidone, succinic acid, lactic acid etc. are produced by
fermentation from renewable resources [51, 83, 97]. It is,
however, not indented in this review to provide a serious
discussion on natural biodegradable polymers except that
of lactic acid polymers.

Microbially Produced Polyesters

The family of bacterial polyesters commonly referred to as
poly(hydroxyalkanoate)s have generated much interest
because of their useful properties such as biodegradability
for disposable plastic applications. They are the gift of
microbiology community to polymer chemists as described
first by Lemoigne. Biodegradable polyesters enzymatically
synthesized using bacteria have emerged as industrially
important biodegradable plastics [47, 70, 196 224]. Unlike
petroleum based polymers that take several decades to
degrade, polyhydroxyalkanoates (PHA)s can be completely
bio-degraded within a year by a variety of microorganisms to
give carbon dioxide and water. Attempts based on various
methods have been undertaken for mass production of PHAs.
Promising strategies involve genetic engineering of micro-
organisms and plants to introduce production pathways. This
challenge requires the expression of several genes along with
optimization of PHA synthesis in the host. Suriyamongkol
et al. considered that although excellent progress has been
made in recombinant hosts, the barriers to obtaining high
quantities of PHA at low cost still remain to be solved [224].
The commercially viable production of PHA in crops,
however, appears to be a realistic goal for the future.

PHAs are naturally occurring biodegradable polyesters
produced as energy storage materials by many bacteria. The
most common PHA, poly (3-hydrobutyrate) (PHB), is an
isotactic semi-crystalline polyester. Hydrolytic degradation
occurs by surface erosion, making it an attractive material
for controlled release applications. The homopolymer PHB
has relatively high melting point and crystallizes rapidly,
making entrapment of drug technically difficult. The related
copolymers with 3-hydroxyvalerate, P (HB-HV)s, have
similar semi-crystalline properties though their slower rates
of crystallization result in matrices with different properties.
PHB and P (HB-HV) matrices lose mass very slowly when
compared to bulk-degrading poly(lactide-glycolide) sys-
tems. Therefore the applications of these materials in drug
delivery are likely to depend on the formulation of suitable
blends with other biocompatible polymers.

Patnaik suggests that while the biochemistry of PHB
synthesis by microorganisms is well known, improvement of
large-scale productivity requires good fermentation model-
ing and optimization [225]. He proposes hybrid models,

ECM Comb. Mot. to Exclude
Exh. Z

combining mechanistic, cybernetic and neural models that
offer a useful compromise. All three kinds of basic models
are discussed with applications and directions toward hybrid
model development that expresses adequately all the
important features of large-scale non-ideal fermentations.

PHAs are the polymers of hydroxyalkanoates that accu-
mulate as carbon/energy or reducing-power storage material
in various microorganisms. Until now, however, industrial
production of PHAs has encountered only limited success.
The main barrier to the replacement of synthetic plastics by
PHAs has been the higher cost. The use of mixed cultures
and renewable sources obtained from waste organic carbon
can substantially decrease the cost of PHA and increase their
market potential. Lu [226] reviews two main methods of
PHA production by mixed cultures, anaerobic-aerobic pro-
cessing and aerobic transient feeding processing, and ana-
lyzed the metabolic and effective factors.

The isolation and the purification of bacterial polyhy-
droxyalkanoates are the key step of the process profitability
in the fermentation system [227]. Medium-chain-length
polyhydroxyalkanoates (MCL-PHAs), which have constit-
uents with a typical chain length of Cs Cy, are polyesters
that are synthesized and accumulated in a wide variety of
Gram-negative bacteria, mainly pseudomonads [228].
These biopolyesters are promising materials for various
applications because they have useful mechanical proper-
ties and are biodegradable and biocompatible. The versatile
metabolic capacity of some Pseudomonas spp. enables
them to synthesize MCL-PHAs that contain various func-
tional substituents; these MCL-PHAs are of great interest
because these functional groups can improve the physical
properties of the polymers, allowing the creation of tailor-
made products, Moreover, some functional substituents can
be modified by chemical reactions to obtain more useful
groups that can extend the potential applications of MCL-
PHAs as environmentally friendly polymers and functional
biomaterials for use in biomedical fields.

Jn the very near term, metabolic engineering will help
solve many problems in promoting PHA as a new type of
plastic material for many applications. PHA monomer
Structures and their contents strongly affect the PHA
properties. Using metabolic engineering approaches, PHA
Structures and contents can be manipulated to achieve
controllable monomer and PHA cellular contents [229].On
the application side, the rate of degradation is important
where fast or slow degradation may be required. Figure 4
shows that increasing the concentration of the C6 como-
nomer increases the rate of degradation [227].

Medium-chain-length polyhydroxyalkanoates_ (MCL-
PHASs), which have constituents with a typical chain length
of C¢-Ci4 that are synthesized and accumulated in a wide
variety of Gram-negative bacteria, mainly pseudomonads
are promising materials for various applications. These

® Springer
Page 9 of 80


600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: kiohnson3@ite.gov

ECM Comb. Mot. to Exclude Page 9 of 9
Exh. H


654

J Polym Environ (2011) 19:637 676

Acepitoa
CoASH

o

°
ASH
Aw-CH,—cH,—cH,-d on 24S
° °
cn,—d wo scoa rnb, —nn tea

° ¢
fi i
nn 8, E08 bs coa gH ed sco

°
il
An CH, CH, —CH CNS COA

o
oon CH: —CH SCH -d me SCOA

RO

OB °

Fig. 12 Biotic conversion of carboxylic acids (8 oxidation) [407, 408]

belonging to the group of thermally less stable polymers
and have poor physical properties and high cost of pro-
duction [424, 425}. Copolymerization of lactide with other
comonomers and/or polymers is used to modify the prop-
erties of PLA and to control its degradation behavior
suitable for the specific applications in the field. Its
immense applications in a number of growing technologies
such as orthopedics, drug delivery, sutures, and scaffolds
have enhanced the interest of researchers in this novel area
[425].

Lactic Acid

Lactic acid or 2-hydroxypropionic acid is an “Alpha-
Hydroxy-acid” (AHA) and was discovered by the Swedish
Scientist Scheel in 1780 being first isolated from sour milk.
This gave rise to a whole series of claims and counter
claims in the academic literature concerning Scheels’
findings. The French scientist Fremy produced lactic acid
by fermentation and this gave birth to industrial production
in 1881.

Lactic acid exists as in racemate form, made up of ste-
reo-isomers as shown in Fig. 13. The isolated acid is a
white crystalline solid which is hygroscopic. As this is the
case it is typically manufactured and consumed as a con-
centrated solution of around 88% weight. In this form
lactic acid exists not only as individual molecules, but
oligomers and polymers. In addition, lactic acid can self-
esterify providing a mixture of esters in equilibrium with
acid and oligomers. Hence, purifying lactic acid can be a
challenge. Synthetic lactic acid made from petrochemical
feedstocks is optically inactive, ic., a racemate mixture.
Lactic acid made biochemically by fermentation is opti-
cally active and suitable organisms can selectively produce

D Springer

ECM Comb. Mot. to Exclude
Exh. Z

orn
Onn,
1e)

>)
e |
@, 0

@ Carton No
© Oxygen i

DHydrogen

Fig. 13 Lactic acid stereo isomers

laevo- or dextro- rotatory enantiomers. However, salts of
lactic acid tend to be found in the laevo state only [264,
274].

Structural Aspects

The presence of asymmetric carbon atoms generates
structural particularities, which make lactic acid-derived
polymers rather special when compared with other poly-
mers. Because of the chirality of the lactyl unit, the lactic
acid cyclic dimers exist in three diastereoisomeric forms,
ie., L-lactide, D-lactide and meso-lactide, the latter con-
taining a L-lactyl unit and a D-lactyl one in the ring. The
equimolar mixture of L- and D-lactide is referred to as
racemic DL-lactide [2, 417]. The thermal, mechanical, and
biodegradation properties of lactic acid polymers are
known to depend on the choice and distribution of ster-
eoisomers within the polymer chains. High-purity L- and

Page 18 of 80


PUBLIC DOCUMENT

government witness, supply him enough information and time to become familiar with the case,
request and review his report.

In fact, since at least May 21, 2014, Complaint Counsel apparently anticipated using Dr.
Michel as an expert witness. Complaint Counsel deposed Elsevier, the publisher of Dr. Michel’s
study, on two separate occasions. Those depositions concerned only Dr. Michel’s articles, even
though, at the time, the parties had already stipulated to the authenticity and admissibility of his

study. See Exh. L (limiting the deposition to “[t]he [Michel] Study, including without limitation,

its selection for publication, its editing, and the peer-review process”), fe

SR) The possibility that Dr. Michel could serve as a rebuttal witness

was certainly known to Complaint Counsel, yet withheld to achieve strategic advantage over
ECM in violation of the rules, and without seeking leave.

C. Complaint Counsel’s Pattern of Discovery Abuses Concerning Dr. Michel:

On February 19, 2014, Complaint Counsel produced Dr. Michel’s article to ECM during
a fact deposition, after having failed to disclose the article in response to ECM’s document
requests. See Order, Exh. P. When ECM moved for sanctions, Complaint Counsel falsely
stated that it did not possess Dr. Michel’s work until February 14, 2014, and had not
communicated with Dr. Michel in any way. See Exh. P. Shortly thereafter, Complaint Counsel
filed a “clarification”—in contradiction to Complaint Counsel’s sworn statement—explaining
that FTC attorneys actually did “communicate” with Dr. Michel and did receive a copy of Dr.

Michel’s article well before February 14, 2014. See Exh. Q. This Court ultimately found that


United States of America

FEDERAL TRADE COMMISSION
Elisa Jillson
Katherine Johnson 600 Pennsylvania Ave. NW, M-8102B
600 Pennsylvania Aye. NW, M-8102B Washington, DC 20580
Washington, DC 20580 (202) 326-3001; ejillson@fte.gov

(202) 326-2185; kjohnson3@fte.gov
Jonathan Cohen

600 Pennsylvania Ave. NW, M-8102B
Washington, DC 20580

(202) 326-2551; jcohen2@fte.gov

May 1, 2014

YIA EMAIL AND FEDERAL EXPRESS

Dr. Frederick Michel

c/o Jan Alan Neiger, Assistant Vice President and
Associate General Counsel

The Ohio State University, Office of Legal Affairs
1590 North High Street, Suite 500

Columbus, Ohio 43201

Re: In the Matter of ECM BioFilms, Inc, Dkt. No. 9358 — Deposition Subpoena

Dear Dr. Michel:

As you know, the FTC has initiated the above-referenced administrative proceeding
against ECM BioFilms. This letter notifies you that we have subpoenaed the deposition
testimony of a Dr, Frederick Michel for Tuesday, May 13, 2014 at the United States
Attorney’s Columbus Ohio Office, located at 303 Marconi Boulevard, Suite 200, Room 2074,
Columbus, OH 43215, The deposition will begin at 9:00 A.M. before an officer authorized to
take depositions. See FTC Rules of Practice, 16 CFR. §§ 3.33()(1) & 3.34{a).

Enclosed please find the subpoena, which contains the instructions for where and when
you must appear. I am also enclosing a copy of the protective order in this matter. Please call
me at (202) 326-2185 if you have any questions.

Sincerely,
Katherine Johnson aK
Complaint Counsel cK:
Enclosures
|
ECM Comb. Mot. to Exclude Page 1 of 8

Exh. G


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. Ifany 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 10
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 ftom 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 4.11 (e) of the Commission's
Rules of Practice, 16 CFR 4.11(©), 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 tae Commission’s obligation to return documents
shall be governed by the provisions of Rule 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.

ECM Comb. Mot. to Exclude

Exh. G

Page7of8 .


additive and the biofilm are, respectively, attractors and delivery agents for the real actor — namely the
enzymes that the biota secrete;

(e) the unavoidable microbial and enzymatic degradation of the plastic where the biofilms are present,
starting with the weak links in the plastic part and then moving in deeper into the part itself — resulting in
mass loss of the plastic;

(f) all of the above leading to the conversion of the initial mass of plastic to the usual and final products
of organic metabolism such as methane/carbon dioxide, water vapor, and some residual humus (from
the remains of the biofilm when the plastic food source is exhausted).

Rebuttal —

The mechanism described by Dr. Sahu for biofilm formation on surfaces is contrary to the scientific
literature that shows that biofilms can form equally well on hydrophilic and hydrophobic surfaces, and
that they can form on surfaces that are not biodegradable. The presence of a biofilm ona surface does
not necessarily lead to the biodegradation of the surface upon which it is attached. For example in their
study of biofilm formation Cerca et al., (2005) conclude that,

“The clinical isolates exhibited different cell wall physico-chemical properties,
resulting in differing abilities to adhere to surfaces. Adhesion to hydrophobic
substrata for all strains occurred to a greater extent than that to hydrophilic
surfaces. Bacterial cell hydrophobicity seemed to have little or no influence on
adhesion. Microbial adhesion to surfaces has been shown to be a complex process,
involving physico-chemical, protein and polysaccharide factors
[2,6,7,9,13,16,21,25,26,30]. From an overall physico-chemical point of view,
microbial adhesion can be mediated by non-specific interactions, with long-range
characteristics, including Lifshitz-van der Waals forces, electrostatic forces, acid—
base interactions, and Brownian motion forces [3,37]. As soon as microorganisms
reach a surface, they will be attracted or repelled by it, depending on the sum of the
different non-specific interactions [17]. In biological systems, hydrophobic
interactions are usually the strongest of all long-range non-covalent forces [5], and
adhesion to surfaces is often mediated by these types of interactions [35].”

In another study of anaerobic biofilm formation by Araujo et al., (2004) it was found that neither the
ability of biofilms to attach to surfaces nor their community composition were influenced by the
hydrophobicity of the surface. Biofilms formed equally on polypropylene (hydrophobic) and glass
(hydrophilic) surfaces. The biofilms formed rapidly and showed nearly the same microbial composition.
Furthermore, the hydrophobicity of the support material did not influence the initial development or
the microbial composition of anaerobic biofilms that developed. Since both glass and polypropylene are
essentially biologically inert, it can also be concluded that biofilms can form readily on surfaces which
they are not capable of using as a food source or biodegrading.

16

ECM Comb. Mot. to Exclude Page 16 of 24
Exh. V


648

J Polym Environ (2011) 19:637 676

Fig. 5 Insertion of ester group
into vinyl polymer

° °
Il it
SA CH.CH 4 CO sng ~~ tea — CH= CH ~~ CH.CHECECH
k R Rg R
NA+ CH,CH + CH.= CH ——- “ens ca.ce
k tox R COR

Fig. 6 Insertion of ketone
group into vinyl polymer

ae it CH.CH CH.CH +
| t 1
R cor R
8
q Sema i o CHAS
WAeOH, CHL CCH, CH, CHW Reston wee CHs ca, & CH.
“eg
cay
Norruh }
Reactios

9
It
CH, CHLCH Ae + WASHOE C

>: RE

wh-CH, CH-COOH + HOCH, CR. CH

Qo
neu, cn, den, + B.c=cH VA

Fig. 7 Norrish I and Norrish I
reaction mechanisms for the
degradation of copolymers of

1
ethylene R

R

Saecayca + Bye =O 7

A CHCHCH COOH) SCH WA
i f
R R

° °
N ay
(Hy, ee CRC HCH IE CHD
va 1 ~

R 9

= CHR .
ERR Lem ene HAC OO Hy),CH)
1

Compounding of Polymer with Pro-Oxidants
and Photosensitizers

The thermal (A) and/or photolytic (hv) pre-abiotic treat-
ment, which constitutes the major route for promoting
the eventual biodegradation of polyethylene, could be
enhanced by using pro-oxidant additives [321, 322]. The
pro-oxidants most generally used for this purpose are
divalent transition metal salts of higher aliphatic acids,
such as stearic acid and transition metal complexes such as
dithiocarbonates as photosensitizers or photoinitiators
[323 325]. Soaps of transition metal salts such as Mn, Co,
Zn, Ag, Co, Ni, Fe, Cr, V and Cu were reported to act as
effective oxidation catalysts when combined with unsatu-
rated elastomers as autooxidizable substances [321 323).
During photo and thermo oxidative degradation the

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

material degrades by a free radical chain reaction involving
the formation of hydroperoxides, carbonyl groups and
finally to low molecular mass oxidation products such as
carboxylic acids, alcohols, ketones, esters and low molec-
ular mass hydrocarbons (Fig. 4) [326]. Peroxidation and
carbonyl group formation also lead to hydrophilic surface
modification friendly to microorganisms that are thus able
to bioassimilate the low molar mass oxidation products
[327, 328].

Transition metals catalyze the hydroperoxide decom-
position step of the oxidation mechanism according to the
reaction given below (Fig. 8) [322, 329]. The catalytic
activity of the metal was reported to correlate with the
redox potential of the metal and requires several oxidation
states of comparable energy for the metal. The peroxide
decomposition products react further to yield volatile low

Page 12 of 80


processing considerations.

The Plastics Materials Science Courses were designed to provide the
Industrial Technology student the best possible one semester review of plastics engineering.
A discussion of the historical development of polymer materials was followed by a review
of the major methods of materials characterization and testing. Mechanical properties of
polymer materials are studied and methods to predict material performance is related to the
students. Finally, a survey of the prominent resin families is included with a review of end-
use applications with respect to pricing, processing and performance. This course is no longer
offered.

The Plastics Engineering Seminar Courses were taught exclusively at the
graduate level. These courses emphasized techniques of literature survey in plastics
engineering along with effective methods of presentation. Students are challenged to
develop research proposals in order to optimize commercial potential of recent technology.

Polyurethanes (University of Lowell, Continuing Education) reviewed the
principles involved in the synthesis of polyurethanes and how these principles are being
applied in industry. Product manufacture was reviewed (flexible and rigid foams,
elastomers and coatings), the solving of problems relating to the development of improved
products and new trends in formulations and polyurethane processing equipment.

Fundamentals of Plastics/Commercial Polymer Materials (University of
Lowell, Continuing Education) reviewed, in a 2-3 day format, the different plastics,
processes and applications of polymer materials. Basic concepts in plastics materials were
reviewed which served as a foundation for a discussion of each commercial material in
terms of monomer synthesis, polymerization, post-reaction treatment, large-scale
production, additives, structure-property relationships, processing and applications. The
course recognizes different materials as being chemically distinct arid explains actual
physical properties on the basis of polymer structure.

2. Graduate Thesis Supervised (Completed):
a. Thesis Advisor (Completed)
“Plastic Materials Withdrawn From The Market”, T. Richards (Fall 2004)
"Blends of LDPE with Flexible Polyolefins, M. Castillo (Spring 1999)

"Effect of Drying Conditions/Particle Size on the Recycling of PET Resins" December 1998
[M. Yurtseven]

Page 4 of 17

ECM Comb. Mot. to Exclude Page 4 of 17
Exh. Y


PUBLIC DOCUMENT

Sanctions are appropriate under Rule 3.38(b) where, as here, a party “fails to comply with
any discovery obligation imposed by [the] rules.” See 16 C.F.R. § 3.38(b). Moreover, under the
Scheduling Order, where Complaint Counsel submits improper expert rebuttal, the scope of
relief may include “striking Complaint Counsel’s rebuttal expert reports” or providing “leave to
submit surrebuttal expert reports . . .” Finally, it is certainly beneath that minimum standard of
ethics and fair play for government counsel to use an overt act of legerdemain to deceive an
opponent into thinking a specific person will not be called as a witness, only to in fact call the
person and do so without required notice. For the reasons discussed here, the evidence presented
as attachments to the memorandum, and the legal bases defined in ECM’s accompanying
memorandum, the preferred relief is to strike the Michel surrebuttal report and exclude Dr.
Michel’s testimony. If and only if the Court decides against that alternative, we ask that Dr.
Grossman be allowed to present his surrebuttal report and testify as a surrebuttal expert. In

either event, for the reasons explained, sanctions should be imposed on Complaint Counsel.

Respectfully submitted,

4s/ 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 9, 2014.


“Effects of Reactive Processing on Polystyrene/Hyperbranched Polyol Blends", M.S. Thesis,
September 1998, [Thomas I. Mulkern IT]

"Recycling of Nylon-6 and Polypropylene via Reactive Polymer Processing", M.S. Thesis,
August 1990, Achal Takar

"Jeffamine Plasticizers for Nylon-6,6" MS. Thesis, 1989, Arnbarish Dave

"Kinetic Studies of the Polymerization and Crystallization of Nylon Block Copolymers",
Ph.D Thesis, August 1988, Tim Limtasiri, (Co-advisor with Dr. Jan-Chan Huang.)

"Synthesis of Aromatic Amine Based Polyamides from Diisocyanates and Dicarboxylic Acids:
Mechanism of Polymerization and Applications for Reactive Polymer Processing", Ph.D
Thesis, January 1987 (Victor Wang].

"Recent Developments in Plastics Recycling and Biodegradable Materials", MS. Thesis,
January 1989, Rajen Parikh

"Polymer Blends of Recy¢led Poly(ethylene terepthalate) and Polypropylene with Coupling
Agents", MS. Thesis, May 1988, Chong Oh Kim

"Effect of Annealing on the Moisture Absorption of Nylon-6,6 Materials", M.S. Thesis, May
1988, Chio-Chiang Pai

"Evaluation of Sorbitol as a Plasticizer for Nylon-6,6 and Reactive Processing of Nylon-6,6
with Reactive Polystyrene", MS. Thesis, April 1988, Pradleep Damle

"Preliminary Studies on Reactive Polymer Processing for the Purpose of Preparing Aromatic-
Amine Based Polyarnides from Disoeyanates and Dicarboxylic Acids", M.S. Thesis, February
1988, Yu-PengChen

"Thermoplastic Elastomers by Transesterification of Recycled PET and Polyethylene Glycol,
MSS. Thesis, August 1987, Da-Vei Yui

"One-Step vs. Two Step Nylon Block Copolymerization", MS. Thesis, May 1987, Victor
Brandalise

“Polyethylene Glycol, Polypropylene Glycol as Plasticizers for Nylon-6,6", M.S. Thesis,
August 1986, Cheng-Twig Huang,

“Polymer Blends of Recycled Poly(ethylene terepthalate) and Recycled Polycarbonate, M.S.
Thesis, April 1986, Donald Roche

“Recycling of Styrene Polymers and Its Effect on theft Properties and Processing", M.S.
Thesis, January 1986, Shreyms Morakhia

Page 5 of 17

ECM Comb. Mot. to Exclude Page 5 of 17
Exh. Y


Respondent’s Exhibit L


J Polym Environ (2011) 19:637 676

647

polyester-carbonate (PEC), and (3) Production of hydro-
phobic/hydrophilic segmented copolymers between «,f-
dihydroxyl-terminated oligo(propylene succinate)s and
poly(ethylene glycols) (PEG) or alicylclic polyols of dif-
ferent molecular weights were synthesized, affording
poly(ester ether-carbonates) terpolymers [70, 88, 97]. An
alternative to the aliphatic/aromatic polyester approach is
the design and use of cycloaliphatic or aliphatic/cycloali-
phatic copolyester.

As a carbon-intermediate chemical, fermentation-
derived succinate has the potential to supply over
2.7 x 108 kg industrial products/year including: 1,4-
butanediol, tetrahydrofuran, a-butyrolactone, adipic acid,
n-methylpyrrolidone and linear aliphatic esters. Succinate
yields as high as 110 g/l have been achieved from glucose
by the newly discovered rumen organism Actinobacillus
succinogenes [97, 312]. Succinate fermentation is a novel
process because the greenhouse gas CO2 is fixed into
succinate during glucose fermentation. Succinic acid can
be produced by Anaerobiospirillum succiniciproducens,
using glucose, but even lactose, sucrose, maltose and
fructose as carbon sources. New developments in end-
product recovery technology, including water-splitting
electrodialysis and liquid/liquid extraction have lowered
the cost of succinic acid production to U.S. $ 0.55/kg at the
75,000 tonne/year level and to $ 2.20/kg at the 5,000 tonne/
year level.

Biodegradable Polymer Blends

The blending of biodegradable polymers from renewable
and non-renewable resources is a method of reducing the
overall cost of the material and offers a method of mod-
ifying both properties and degradation rates [14, 21, 67,
98, 186, 313, 314] natural polymers, such as starch, pro-
tein and cellulose; (2) synthetic polymers from natural
monomers, such as polylactic acid; and (3) polymers from
microbial fermentation, such as polyhydroxybutyrate are
described with an emphasis on potential applications. The
hydrophilic character of natural polymers has contributed
to the successful development of environmentally friendly
composites, as most natural fibers and nanoclays are
also hydrophilic in nature. More recently there has been
an increasing interest in starch based biodegradable
blends. The melt processability, humidity resistance, and
mechanical properties of starch can be improved by
blending starch with synthetic polymers such as PVA,
PLA, PCL, and PHAs etc. to make these materials suit-
able for the production of biodegradable films, injection

molded items and foams. The strategy adopted for prep-
aration of biodegradable polymer blends usually involves
blending a thermoplastic resin with a biodegradable one.

ECM Comb. Mot. to Exclude
Exh. Z

The blending must produce fine enough dispersion that,
after disintegration of the biodegradable part, the
remaining thermoplastic part will not contaminate the
environment.

Need of Polyethylene Biodegradation

Plastics, made from petrochemical feed stocks are por-
trayed by the “green” lobby as ecologically undesirable,
because they are made from fossil carbon resources and it
is assumed that they are very resistant to biodegradation in
the environment. It is ironical that the very physical
property of durability, that have made the polyolefin so
commercially successful in packaging and other agricul-
tural applications, is a disadvantage, when the material
appears in the waste stream [315, 316]. The environmental
impact of persistent plastic wastes is growing more global
concern, and alternative disposal methods are limited.
Incineration may generate toxic air pollution, and satis-
factory landfill sites are limited. Recycling is, at present,
only viable for high cost, low volume specialty plastics
[317, 318]. The high cost or the lack of commercially
acceptable performance of fully biodegradable polymers
available until recently has meant that they have never
replaced traditional non-degradable plastics in the mass
market [319, 320]. Hence, it is increasingly felt that the
best solution for rectifying the environmental pollution
caused by the non-biodegradability of existing commercial
plastics would be making them biodegradable.

Polyethylene Modifications to Facilitate
Biodegradation

The methods adopted to facilitate polyethylene disinte-
gration and subsequent biodegradation are discussed below
[21]:

Insertion of Week Links into Vinyl Polymer

Particular emphasis on this approach of insertion of ‘weak
links’ on non biodegradable polymers has been placed on
two types of polymer modifications: namely the insertion
of functional groups in the main chain, especially ester
groups (Fig. 5), which can be cleaved by chemical
hydrolysis, and the insertion of functional groups in or on
the main chain that can undergo photochemical chain-
cleavage reactions, typically carbonyl groups (Fig. 6). On
irradiation with ultraviolet light, the activated ketone
groups present can take part in two different types of free
radical bond-breaking reactions referred to as Norrish I and
Norrish II reactions (Fig. 7).

© Springer
Page 11 of 80


motivation in the art to modify the reference to exclude block
polybutylene terephthalate from the compositions of Sinclair
“642, a prima facie case of obviousness has not been established.
Applicants submit that Sinclair ‘642 neither
anticipates nor makes obvious the present invention, and
respectfully request reconsideration and withdrawal of the

rejection over the reference.

Rejection under 35 U.S.C. § 102(e) or 103(a) over Kakizawa (5.8

Patent No. 5,686,540)

Claims 1-9 and 11-22 have been rejected as allegedly

anticipated by, or in the alternative, made obvious by Kakizawa.
Applicants respectfully traverse these rejections because
Kakizawa is not prior art,

The subject. matter of the claimed invention was
invented before the filing date of Kakizawa (September 27, 1996),
and is therefore not prior art. Applicants earlier date of
invention is supported by the appended Declaration under Rule
231, submitted herewith as Exhibit A.! specifically, applicants
formulated various: of the claimed blends of polylactic acid and
polyesters and measured a number of their physical properties

prior to Kakizawa’s filing date (Exhibit A, paragraphs 5 and 6)

ee

* The attached Declaration has been signed by two of the
inventors. Applicants will submit a Supplemental Amendeenc
including the Declaration signed by all three inventors ae soon
as possible.

a1

ECM Comb. Mot. to Exclude

Exh. Z

Page 62 of 80


ATTACHMENT A
a ce a 4
For the purpose of protecting the interests of the patties 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 defined.

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 CFTC”), 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 requested 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 documents
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, ber, 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 counsél believes the material so designated constitutes
confidential material as defined in Paragraph 1 of this Order.

ECM Comb. Mot. to Exclude

Exh. G

Page 5 of 8

|
i
|


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. ~ Page 36

ii. Eden acknowledged replacing the inoculum at the request of its
customers.*?
iii. Eden conducted tests for periods well-beyond the validation period of the
test.
iv. Eden improperly modifies the raw data.*!
90. The evidence indicates that the minimal biodegradation observed in the tests
ECM relies on is the result of the “priming effect,” i.e., biodegradation of the additive (which
contains organic compounds highly susceptible to biodegradation) and the organic materials of
the test medium (the bacteria used for testing) rather than the plastic. Moreover, the minimal
biodegradation observed is nearly always within the error limits of the test—which means that it
is likely the result of testing limitations rather than true biodegradability of the plastic. In short,
there is no competent and reliable scientific evidence to support the conclusion that the ECM
additive—or any other similar additive—will cause plastic to biodegrade completely or more

quickly than conventional plastics.

IX. CONCLUSION

84. In conclusion, in my expert opinion, ECM’s claims that:
a. ECM Plastics will completely biodegrade within one year in a landfill is false and
unsubstantiated.
b. ECM Plastics will completely biodegrade in nearly all landfills within nine

months to five years is false and unsubstantiated.

3° Id. at 72-73.
3! Eden Dep. Tr. at 111.

ECM Comb. Mot. to Exclude Page 36 of 58
Exh. U


Dr. McCarthy Rebuttal Report -- 9

demonstrate that these plastics treated with its additive will completely biodegrade in the stated
timeframes and disposal environments.

18. The conclusions that the Testing Materials in the aggregate demonstrate biodegradation
and that, once it begins, it will go to conclusion, are flawed for three reasons: (1) a series of
faulty tests, conducted with improper controls, over insufficient duration, and under inapplicable
conditions do not answer the threshold question as I presented it; (2) the experts do not address
any authority supporting the conclusion that a polymer’s recalcitrance can be ignored; and (3) the
tests conducted under the Barber Method are methodologically and scientifically unsound.

1. ASTM D5511 Does Not Support ECM’s Specific Marketing
Claims.

19. Although Dr. Burnette and Dr. Sahu seem to be at odds with whether ASTM D5511 is
appropriate, both agree that no one test could simulate every environmental condition and that
the tests performed are not without flaws.

20. I agree with Dr. Sahu and Dr. Burnette in two respects. No test is perfect and test
representativeness involves scientific judgment. While no test is perfect, tests must be well-
designed, well-executed, and well-controlled, and suited to address the relevant question.

21. Asexplained in my report, ASTM D5511 cannot be used to support the types of claims
ECM is making. Specifically, it is not intended to and (without modification under professional
judgment and guidance) cannot address whether a blend like an ECM Plastic will completely
biodegrade in a stated timeframe under landfill conditions.

2. ECM’s Experts Present No Authorities that Support
Extrapolation.

22. One of the most serious flaws in the conclusions of the experts is that once

biodegradation is established, it will continue to completion. In 1998, my colleagues and I

ECM Comb. Mot. to Exclude Page 9 of 12
Exh. CC


(202) 326-2551 | icohen2@fte.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Thursday, May 15, 2014 5:46 PM

To: Cohen, Jonathan

Ce: Johnson, Katherine; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: ECM Biofilms, No. 9358

Jonathan,
Per our conversation this afternoon, ECM proposes the following deposition schedule:

June 23: Frederick (New Haven, CT)
June 24: Tolymat (Cincinnati, OH)

June 26: Burnette (Washington, D.C.)
June 27: McCarthy (Washington, D.C.)
June 30: Sahu (Los Angeles, CA)

July 1: Stewart (Los Angeles, CA)

July 14: Barlaz (Raleigh, NC)

July 16 (or July 15): Volokh (Atlanta, GA)

With respect to your witnesses, please let us know if we can designate a local office in New Haven, Cincinnati, and
Washington, D.C. Although Dr. Volokh is available on July 15th, we would prefer July 16th to eliminate potential travel
issues.

Let me know if we need to discuss this further,

Thanks,

Peter A. Arhangelsky, Esq. | EMorD & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ 85286
Firm: {602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed above. The content of this communication is protected from
disclosure by the atforney-ciient privilege and the work product docirine. if you are not the intended recipient, you should treat this
communication as strictly confidential and provide it to the person intended. Duplication or distribution of this communication is prohibited
by the sender. If this communication has been sent to you in error, please notify the sender ond then immediately destroy the document.

From: Cohen, Jonathan [mailto:jcohen2 @ftc.gov!

Sent: Thursday, May 15, 2014 1:07 PM

To: Peter Arhangelsky

Ce: Jonathan Emord; Lou Caputo; Jillson, Elisa; Johnson, Katherine; Decastro, Arturo
Subject: ECM Biofilms, No. 9358

We've provided ECM with proposed dates for our experts, and when ECM responded with a request that
we provide different dates for our experts within a 12-day period ECM selected, we accommodated that request in
less than a day. However, with respect to the dates for ECM’s experts that we proposed several days ago, we

ECM Comb. Mot. to Exclude Page 4 of 7
Exh. K


Email: kjohnsen3@ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]

Sent: Wednesday, April 23, 2014 6:07 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord; Millard, Joshua S.
Subject: RE: Scheduling Depositions

Katherine,

ECM will make someone available to cover a deposition in South Carolina on May 5th.

Best,

Peter

Peter A. Arhangelsky, Esq. | Emoro & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ
85286

Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOIICE: This is a confidential communication intended for the recipient listed above. The content of this
communication is protected from disclosure by the atlomey-client privilege and the work product doctrine. If
you are not the intended recipient, you should treat this communication as strictly confidential and provide i to
the person intended. Duplication or distribution of this communication is prohibited by the sender, If this
communication has been sent to you in error, please notify the sender and then immediately destroy the
document.

From: Johnson, Katherine [mailto:kiohnson3 @ftc.gov

Sent: Wednesday, April 23, 2014 2:25 PM

To: Peter Arhangelsky

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord; Millard, Joshua S.
Subject: RE: Scheduling Depositions

Peter:

We have several more to notice and will need to coordinate with ECM and counsel for the individual
parties. There are only so many days left before the close of fact discovery and we will invariably
have to have more than one on a given day. In the case of D&W, it’s my understanding that it is
only available May St or 6th So, as between those two dates, is there a preference? ECM has at
least three attorneys, and possibly Mr. Sinclair himself. Surely, you can make someone available to
be there on one of those two dates?

Katherine

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission

ECM Comb. Mot. to Exclude Page 7 of 9
Exh. H


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 28

70. — Several of the tests submitted with the Testing Materials actually conclude that no
biodegradation was observed at the conclusion of the test. For instance, two composting studies
(whose composting environment presents far better conditions for biodegradation than landfill
conditions) report no biodegradation. The composting study completed by 0.W.S., Inc. (ECM-
FTC-000124 and ECM-FTC-000244), the Final Report of Biodegradation Testing, “Aerobic
Biodegradation Under Controlled Composting Conditions for 40-gal trash bags,” Study PFR-5,
Mar. 3, 2000, reported results of 5.2% biodegradation with a standard deviation of 8.3%. Thus,
according to the report, the observed biodegradation was within the error limits of the test and
thus no conclusion can be drawn regarding whether any biodegradation occurred.

71. These findings of no biodegradation are consistent with other tests on ECM
plastic. For example, another composting study performed by 3M Corporation likewise
concludes that the ECM Additive “blended at 1.1% and 2.0% did not enhance the
biodegradability of the polypropylene and polyethylene resins tested.” Final Report:
Compostability Testing of Polypropylene and Polyethylene Plastic Blended with “MasterBatch
Pellets” Biodegradation Enhancement Additive,” 3M Environmental Laboratory Project No.
E10-0178 dated January 20, 2012, 3M-FTC-0000108.

72. These findings of no biodegradation are also consistent with the only peer-
reviewed article that has addressed testing of the ECM additive. This article, by Gomez and
Michel, entitled “Biodegradability of conventional piastics and natural fiber composites during
composting, anaerobic digestion and Jong term soil incubation” tested two types of plastic
blended with the ECM additive in soil incubation and anaerobic conditions. The article reported

no statistically-significant biodegradation.

ECM Comb. Mot. to Exclude Page 28 of 58
Exh. U


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 31

e O.W.S. Inc: Final Report - Biodegradation Testing under Controlled Composting
Conditions for 5% load films.

¢ O.W.S. Inc: Final Report - Biodegradation Testing for ECM Pellets and EMC
Film tested a 50% film, 5% film, and the Additive.

¢ O.W‘S. Inc: High Solids Anaerobic Digestion Test of ECM Pellets tested the
ECM Additive alone.

79. Tests that do not follow the recommended load rate cannot be used to support
claims regarding the recommended 1% load rate. Moreover, use of a high load rate of a known-
biodegradable additive increases the likelihood that observed biodegradation is attributable to the
priming effect.7!

80. Inoculum. As noted earlier, the inoculum called for under the ASTM D5511 is
unavailable in the United States. The inoculum used in quasi-ASTM D551] tests that purport to
show biodegradation of ECM Plastic were derived from a combination of compost (aerobic) and
sludge from wastewater treatment plants. Neither source reflects the bacterial communities that
would be found in landfills. Thus, all of the ASTM D551] tests using this inoculum do not
reflect actual conditions. Moreover, use of aerobic inoculum increases the likelihood that

observed biodegradation is attributable to the priming effect.

>| There are also a substantial number of tests that do not identify the load rates or the
specific type of plastic tested, including several included in the ECM Materials. See, e.g.,
Analytical Report No. 1253020 regarding ASTM D 5511: Determining anaerobic biodegradation
of plastic materials under high solids anaerobic digestion conditions; Update regarding ASTM
DS5511-11 Update on Clear Films 476 & 477 @ 45 days; SEM Examination of ECM Plastic;
SEM imaging of bubble wrap; SEM imaging of EPS samples; SEM imaging of green PET
bottles; SEM imaging of PVC samples.

ECM Comb. Mot. to Exclude Page 31 of 58
Exh. U


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of

ECM BioFilms, Inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International

Lee

COMPLAINT COUNSEL’S FINAL PROPOSED WITNESS LIST

Pursuant to the Court’s Third Revised Scheduling Order, dated May 22, 2014, Complaint
Counsel hereby provides its Final Proposed Witness List to Respondent ECM BiuFilms, Inc.
(“ECM” or “RespondentTM). This list identrfies the wimesses who may testify for Complaint
Counsel at the hearing in this action by deposition and/or investigational hearing transcript,
atfidavit, declaration, or orally by live witness.

Subject to the limitations in the Scheduling Order and Third Revised Scheduling Order
entered in this action, Complaint Counsel reserves the right:

A, To present testimony by deposition and/or investigational hearing transcript,
affidavit, declaration, or orally by live witness, from the custodian of records of
any party or non-party from whom documents or records have been obtained—-
specifically including, but not limited to, those parties and non-parties listed
below—to the extent necessary tv demonstrate the authenticity or admissibility of
documents in the event a stipulation cannot be reached. concerning the
authentication or admissibility of such documents;

B. To present testimony by deposition and/or investigational hearing transcript,

affidavit, declaration, or orally by live witness, from persons listed below and any

ECM Comb. Mot. to Exclude Page 1 of 16
Exh. F


From: Jonnson, Katherine

To: Peter Arhangelsky
Cec: Cohen, Jonathan; Jillson, lisa; Lov Caputo; Jonathan Emord
Subject: Complaint Counsel's Expert Witness List

Date: Wednesday, April 23, 2014 5:58:37 PM

Counsel: our preliminary expert witness list remains unchanged from our prior submission.
Katherine

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]

Sent: Wednesday, April 23, 2014 06:06 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo <LCaputo@emord.com>; Jonathan Emord
<JEmord@emord.com>; Millard, Joshua S.

Subject: RE: Scheduling Depositions

Katherine,

ECM will make someone available to cover a deposition in South Carolina on May Sth,

Best,

Peter

Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ
85286
Firrn: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www. emord.com

NOTICE: This is a confidential communication intended for the recipient listed above. The content of this
communication is protected from disclosure by the attorney-client privilege and the work product docirine. If
you are not the intended recipient, you shou'd treat this communication as strictly confidential and provide it to
the person intended. Duplication or distrioution of this communication is prohibited by the sender. If this
communication has been sent to you in error, please notify the sender ond then immediately destroy the
document.

From: Johnson, Katherine {mailto:kjohnson3@ftc.gov]

Sent: Wednesday, April 23, 2014 2:25 PM

To: Peter Arhangelsky

Ce: Cohen, Jonathan; Jiilson, Elisa; Lou Caputo; Jonathan Emord; Millard, Joshua S.
Subject: RE: Scheduling Depositions

Peter:

We have several more to notice and will need to coordinate with ECM and counsel for the individual
parties. There are only so many days left before the close of fact discovery and we will invariably
have to have more than one on a given day. In the case of D&W, it’s my understanding that it is

sth

only available May 5" or gt. So, as between those two dates, is there a preference? ECM has at

ECM Comb. Mot. to Exclude Page I of 3
Exh. E


PUBLIC DOCUMENT

Expert Report, Exhibit W, at 10-20. Dr. Michel’s report is thus not rebuttal; it is principally
redundant assertion of positions already taken by McCarthy and Tolyamet. The report is thus
cumulative and subject to exclusion under Rule 3.31(c)(2).

4. In the Alternative, ECM Requests Leave to Add Dr. Steven A. Grossman as a
Surrebuttal Witness

If and only if this Court rules that Dr. Michel’s report and testimony will be allowed,
ECM argues that it be allowed a surrebuttal witness, Dr. Steven A. Grossman. If that is the
Court’s ruling, ECM requests leave to include its own surrebuttal expert to rebut and counter the
statements in Dr. Michel’s expert report (including those that extend beyond areas of fair
rebuttal).!?

A copy of Dr. Grossman’s anticipated surrebuttal report is attached as Exhibit X, a copy
of his CV is attached as Exhibit Y, and documentary support underlying his surrebuttal report is
attached as Exhibit Z. Dr. Grossman has a Ph.D. in Polymer Science and Engineering and is in
the very same department at the University of Massachusetts (Lowell) as Complaint Counsel’s
primary expert, Dr. Stephen McCarthy. See Exhibit Y. Dr. Grossman has industrial and
academic experience in polymer materials, polymer chemistry, and polymer structure-property
relationships. Jd. He is also a patent attorney with expertise in patent law. Id.

Importantly, Dr. Grossman is a colleague of Dr. McCarthy (Complaint Counsel’s lead

scientific expert). See Exh. Y. Dr. Michel’s rebuttal report is inextricably intertwined in its

” Rule 3.31A(b) allows a party to call more than five expert witnesses in “extraordinary
circumstances.” Extraordinary circumstances now exist due to the prejudice ECM will suffer if
Complaint Counsel is permitted to call Dr. Michel, an unidentified expert, as a rebuttal
expert. This prejudice cannot be cured but can be somewhat ameliorated by allowing ECM to
designate its own surrebuttal expert. See Sisneros v. U.S., 2008 WL 4170361, at *7 (D. Colo.
Sept. 5, 2008) (holding in that case that “any prejudice to Defendant could be cured by allowing
Defendant to designate its own experts and rebuttal experts out of time”).

16


lens where Dr. el has provided oral testimony in dex

eedings im the nasi ten years.

a. City of Kirtland planning and zoning commission, Kirtland, OH, re: Application of Mr. Excavator,
Inc. for Industrial Permit, February 2011.

b. Analysis of the document entitled, “Operational Procedures and Odor Management Practices for
the proposed OEW Watkins Rd. Composting Facility”, provided to Laura Comek, Esq. July 2013.
Crabbe, Brown & James, Columbus, OH.

¢. Testimony to Columbus, OH. Zoning Board hearing, August 2013, regarding application for a
Food Waste Composting facility by OEW Inc., Retained by Crabbe, Brown & James, Columbus,
OH.

24

ECM Comb. Mot. to Exclude Page 24 of 24
Exh. V


CERTIFICATE OF SERVICE

Thereby certify that on March 18, 2014, I caused a true and correct copy of the foregoing
Complaint Counsel’s Supplemental Initial Disclosures to be served as follows:

One electronic copy to Counsel for the Respondent:

Jonathan W. Emord Peter Arhangelsky

Emord & Associates, P.C. Emord & Associates, P.C.

11808 Wolf Run Lane 3210 S. Gilbert Road, Suite 4
Clifton, VA 20124 Chandler, AZ 85286

Email: jemord@emord.com Email: parhangelsky@emord.com
Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: Icaputo@emord.com

/s/ Katherine Johnson

Katherine Johnson

Division of Enforcement

Bureau of Consumer Protection
Federal Trade Commission

600 Pennsylvania Ave., NW, M-8102B
Washington, DC 20580

Telephone: (202) 326-2185

Facsimile: (202) 326-2558

Email: kjohnson3@ftc.gov

ECM Comb. Mot. to Exclude Page 3 of 5
Exh. C


25. In short, because of these operating conditions—covering, compaction, and gas
capture and collection systems—oxygen in typical MSW landfills in the U.S. is minimal. As a

result, the slower anaerobic biodegradation process dominates landfills.

b. Moderate Temperatures in Typical Landfills
26. The second significant factor that affects biodegradation in landfills is

temperature. Anaerobic decomposition occurs best within a thermophilic or high temperature
range (50 to 60°C or 122°F-140°F). That is, biodegradation that occurs under higher
temperatures happens more rapidly and has a better quality biogas production. Temperatures in
typical MSW landfills in the U.S. are much lower than this: they range between 20°C and 40°C
(68°F-104°F) and average around 37°C (98.6°F).’ Biodegradation occurring at these
temperatures (known as the mesophilic range) takes place more slowly and has relatively lower
quality biogas production. Indeed, higher temperatures would increase the risk of surface fires
and emission of greenhouse gases, so low-to-moderate temperatures are essential to good landfill

management.

c. Typical Landfills Have Low Moisture Content

27. Finally, the third significant factor that affects the rate of biodegradation in
landfills is moisture. The more moisture, the better suited the environment is for biodegradation,
and the faster MSW will decompose. Moisture levels in typical MSW landfills in the U.S. are
usually much too low for optimal biodegradation. Indeed, most landfills in the U.S. are aptly

described as “dry tombs,” for the reasons discussed here.

7 Landfill temperatures are not controlled but are often regulated by environmental
conditions. For example a landfill in a hot climate, say Florida, would have a higher temperature
than a similar landfill in colder climates, say Alaska.

12

ECM Comb. Mot. to Exclude Page 12 of 56
Exh. X


Both MS. and Ph.D. thesis have evolved from these studies. Further work at
the Upjohn Company led to monomers that polymerized to condensation type
polymers (e.g., polyamides) without the evolution of by-products.
Additionally, research was directed at the development of new nylon-6
reaction injection molding systems.

A total of 4 U.S. Patents and 1 European Patent was filed and issued during the
above period of industrial research.

ACADEMIC PROFILE
A. Teaching

1. Area of Courses Taught (1994-2014)

Polymer Materials I

Polymer Materials II

Polymer Materials ILI

Plastic Material Science

Survey of Plastic Materials 1

Survey of Plastic Materials 11

Plastics Seminar I

Plastics Seminar II

Graduate Seminar I

Graduate Seminar II

Survey of Intellectual Property (For Engineers)
New Plastic Materials

Polymer Structure/Properties/Applications

Survey of Intellectual Property was a general elective course for engineering
students developed and offered for the first time in the Fall of 1990. This course allowed
engineers to fully appreciate the legal issues that one may be forced to consider in order to
invoke the legal system to protect technology based innovation. Once legal protection is
established, students consider what. e.g., constitutes patent infringement, and what
constitutes an unfair trade practices, etc. This course has now been approved (2004) as part
of a business minor for students in the Department of Plastics Engineering.

The Polymer Materials Courses have provided an intensive study of the many
generic classes of polymer materials that are in current production. These courses have been
structured to include reviews of important raw materials; polymerization theory and practice
of manufacture (which prepares the students more efficiently for higher level courses in
polymer science and polymer structure/property and applications); correlation of polymer
structure with engineering properties; discussions of polyblends with emphasis of related
polymer chemistry (compatibility); inter and intramolecular bonding and fundamental

Page 3 of 17

ECM Comb. Mot. to Exclude Page 3 of 17
Exh. Y


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of

ECM BioFilms, Inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International

Lee eee

COMPLAINT COUNSEL’S SUPPLEMENTAL EXPERT WITNESS LIST

Pursuant to the Court’s Scheduling Order issued November 13, 2013 (“Scheduling
Order”), Complaint Counsel hereby identifies those experts whom Complaint Counsel may call
to testify in Complaint Counsel’s case-in-chief or in rebuttal at the hearing on this matter. This

list is based upon the information reasonably available to Complaint Counsel at this time.

1. Stephen McCarthy, PhD
Distinguished University Professor
Director and Professor
M2D2 and Plastics Engineering
University of Massachusetts Lowell
One University Avenue, Office: Ball 207
Lowell, MA 01854

Dr. McCarthy’s anticipated testimony will be described in his expert report, which will
be produced to Respondent by the date set forth in the Scheduling Order. The general
subject matter of this testimony includes, but is not limited to, biodegradation generally,
biodegradation of plastic polymers, ASTM tests and standards, and evaluation and
analysis of Respondent’s substantiation for its biodegradability claims.

A copy of Dr. McCarthy’s curriculum vitea follows as Attachment A, fully describing
and identifying his background and qualifications, and all publications authored by him
within the preceding ten years.

2. Thabet Tolaymet, PhD
Environmental Protection Agency
Acting Associate, National Program Director for Emerging Materials and Sustainability
National Risk Management Research Laboratory
26 Martin Luther King Drive
Cincinnati, OH 45268

Dr. Tolaymet’s anticipated testimony will be described in his expert report, which will be
produced to Respondent by the date set forth in the Scheduling Order. The general
subject matter of this testimony includes, but is not limited to, biodegradation generally,

ECM Comb. Mot. to Exclude Page 1 of 4
Exh. D


2588 EF, Gémez, EC. Michel Jr. / Polymer Degradation and Stability 98 (2013) 2583 2591

Fig. 2. Scanning electron micrographs of plastics during 2 years of soil incubation. From top to bottom: PHA (a: initial, b: final), co-polyester + corn-based plastic (c: initial, d: final),

polypropylene + 2% additive (e: initial, f: final) and coconut coir (g: initial, h: final).

surface of the PHA material (Fz. 2A and B) and some degradation of
the co polyester + corn based plastic (ig. 2C and D).

For conventional plastics and the same plastics amended with
additives that were supposed to enhance biodegradability, almost
no biodegradation was observed after nearly two years of incuba
tion in soil (Fiz. 1). The highest observed conversion during soil
incubation was 1.0 + 0.1% (PP + 2% additive). For all other plastics
amended with additives, the final cumulative biodegradation
ranged between 0.9 and 1%. These values were less than that
measured for the negative control (PP) which reached a final cu
mulative conversion of 1.3 +: 0.7%. Although they were not signif
icantly different. SEM images did not reveal qualitative changes in
the appearance of PP or PP + 2% additive after the 2 year incubation
period (fi. 2E and F).

The mineralization in soil of the natural fiber composite mate
rials was most rapid during the first 65 days of the experiment

ECM Comb. Mot. to Exclude
Exh. AA

SS Brice vaaloe pare: ~~ 7
Ta Paget aera = Conpestet ow mesure i
|

Fig. 3. Cumulative carbon toss (CO2 C) as percentage of initia carbon (-cumulative
standard exror) for natural fiber composites during 660 days of soil incubation. For
some data points standard error bars are smaller than markers.

Page 6 of 9


I EDUCATION, EXPERIENCE, AND TRAINING

1, I am an environmental engineer and researcher in the field of solid waste
management at the U.S. Environmental Protection Agency. My research focuses on solid waste
management, bioreactor landfills, waste containment performance, construction and demolition
waste landfills, and the fate and transport of environmental pollutants. My curriculum vitae is
attached hereto as Exhibit B.

2. Thave both a Ph.D. and B.S. in Environmental Engineering (University of
Florida, 2003 and 1997 respectively). For the past eleven years (since 2003), I have worked as an
Environmental Engineer at the EPA Office of Research and Development.

3. My academic research and research for the EPA has focused primarily on waste
disposal and landfills. In particular, I evaluate the performance of Solid Waste Containment
Units (municipal solid waste, hazardous waste and ash mono-fill landfills), bioreactor landfills (a
new landfill design that promotes degradation), organic pollutants, co-disposal of solid waste and
hazardous waste, and construction and demolition waste.

4. In 2010, I led an interdisciplinary EPA team that evaluated sustainable materials
management and construction and demolition debris. Between 2012 and 2013, I was the Acting
Associate National Program Director for Emerging Materials and Sustainability under the
Chemical Safety for Sustainability Research Program. In that role, I lead EPA’s national
research program for emerging materials’ and sustainability. My role was to assist the National
Program Director in these areas in setting EPA’s research priorities and allocating EPA resources
to regulatory needs. Currently, I am the project lead for sustainable waste and materials
management at EPA’s Office of Research and Development.

5. I am also part of the Interstate Technology & Regulatory Council (ITRC)’s

Alternative Landfill Technology Team, a group comprised of state and federal agency

1 “Emerging materials” are newly-designed materials, such as nanomaterials. The term is
typically used to contrast with traditional wastes. Because emerging materials are new, the
implications of their disposal are not yet clear.

ECM Comb. Mot. to Exclude Page 4 of 56
Exh. X


UNITED STATES OF AMERICA OR IGi NAL

Maye.

FEDERAL TRADE COMMISSION TRADE £04
EVEN DOOUHEERTS SY,

OFFICE OF ADMINISTRATIVE LAW JUDGES

)
In the Matter of )
)

ECM BioFilms, Inc., ) DOCKET NO. 9358
a corporation, also d/b/a )
Enviropiastics International, )
Respondent. )
)

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 CER.
§ 3.31). Pursuant to Commission Rule 3.31(d), the protective order set forth in the
appendix to that section is attached verbatim as Attachment A and is hereby issued.

ORDERED:
D. Michael C! am

Chief Administrative Law Judge

Date: October 22, 2013

ECM Comb. Mot. to Exclude
Exh. G

Page 4 of 8


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ECM Comb. Mot. to Exclude

Exh. Y

Plastic Seminars, Continuing Education, University of Lowell, 1985-1995.

Guest Lecturer

Franklin Pierce Law Center, Spring 2014

Franklin Pierce Law Center, Spring 2013

Franklin Pierce Law Center, Spring 2007

Eastern New England Society of Plastics Engineers, October 2013
Eastern New England Society of Plastics Engineer, October 2003

Eastern New England Society of Plastics Engineers, October 1999
Eastern New England Society of Plastics Engineers, October 1997
Rexene Polymers, October 1996

Amoco, Napersville Illinois, May 1996, 1997 and 1998 and 2002

Polysar Incorporated, Leominster Massachusetts, Summer, 1988.
Anglo-American Clays Corporation, Sandersville, Georgia, Summer, 1986.
Army Mechanics and Materials Research Laboratories, Watertown, 1985.
Eastern New England Section of the Society of Plastics Engineers, , 1985.

B. Work Experience

Partner, Grossman, Tucker, Perreault & Pfleger, PLLC, 2002-present

Intellectual property including patents, trademarks, copyrights, and trade secret
protection. Patent prosecution and opinion work, including licensing. Litigation
support is also provided by way of expert testimony in the area of polymer chemistry
and plastic materials/plastics engineering. See: www.gtpp.com.

Hayes, Soloway. Hennessey. Grossman & Hage, P.C., 1989 .2002

Intellectual property including patents, trademarks, copyrights, and trade secret
protection. Litigation support was also provided by way of expert testimony in the
area of polymer chemistry and plastic materials/plastics engineering.

Research and Development Scientist, The Upjohn Company (1980-1984)

This industrial research position was in the Polymer Research Group of the
Upjohn Company. Initial work was conducted on the preparation and
characterization of aromatic amine based polyamides (engineering
thermoplastics). Research continued in the area of preparation of polyamides
via the novel reaction of isocyanates with dicarboxylic acids. These systems
were further analyzed in the Department of Plastics Engineering at the
University of Lowell as strong candidates for reactive polymer processing.

Page 2 of 17

Page 2 of 17


Respondent’s Exhibit Q


Respondent’s Exhibit P


PUBLIC DOCUMENT

Scheduling Order (May 22, 2014). It is nearly impossible—and completely impractical—for
Respondent to depose an expert who is named for the first time on June 30, 2014 at 11:46PM,
just a day before the deadline for expert depositions expires. Jd. The Rules and Scheduling
Order therefore envision a procedural sequence wherein the patties first list “experts they intend
to call as witnesses at the hearing not later than 1 day after the close of fact discovery,” the
parties subsequently take depositions of the listed experts, and Complaint Counsel may
subsequently designate specific expert witnesses from those listed as potential experts. The
Scheduling Order thus affords Complaint Counsel an opportunity to present rebuttal expert
testimony, but not an opportunity to evade the disclosure requirements in Rule 3.31A.°

Other applicable rules support excluding Dr. Michel. First, Rule 3.31A(c) unmistakably
presupposes that any expert witness who files a rebuttal or surrebuttal report must have
previously filed an initial expert report: “[a] rebuttal or surrebuttal report need not include any
information already included in the initial report of the witness.” 16 C.F.R. § 3.31A()
(emphasis added). Second, neither the rules nor the Scheduling Order place a limit on the
number of experts Complaint Counsel could have placed on their initial expert list. See Third
Revised Scheduling Order (May 22, 2014); 16 C.F.R. § 3.31A(a). In the initial list, Complaint
Counsel had the option of designating at least five experts to testify at the hearing, regardless of
whether those experts would testify as case-in-chief witnesses, in rebuttal, in both capacities, or

not testify at all. See 16 C.F.R. § 3.31A(b). By failing to include Dr. Michel on their expert

° The Federal Rules of Evidence also show that any argument that rebuttal experts are
exempt from expert disclosure deadlines “is not supported by law.” Mente Chevrolet Oldsmobile
Inc. v. GMAC, 728 F. Supp. 2d 662, 678 (E.D. Pa. 2010).

11


decomposition. Slight changes alone or in the aggregate will change the quality and quantity of
gas generated, such that it is impossible to reliably compare the results of the test to real landfill
conditions.

VI. | ECM’S CLAIMS ARE FALSE AND NOT SUPPORTED BY RELIABLE
SCIENTIFIC EVIDENCE.

55. My understanding is that ECM describes its additive as a propriety blend of a
biodegradable polymer and conventional plastic, and that blending the ECM Additive with
conventional petroleum-based plastics at 1% loading by weight will achieve a plastic that will
completely biodegrade. According to the materials provided by ECM, the ECM Additive itself
is at least 60%, and as much as 70%, biodegradable polymer.

56. Based on my review of the materials submitted by ECM and my knowledge and
expertise in the area of landfill design and management, any claim that ECM Plastics will
biodegrade in five years or less in most landfills is false. Moreover, the data ECM provided is

not competent and reliable scientific evidence that supports its claims.

a. ECM?’s Claims Are False Because They Are Incompatible With Landfill
Reality

57. Asa threshold matter, it is important to note that even plastic comprised entirely
of the ECM Additive—which is at least 60% known-biodegradable polymer—would not
completely biodegrade in a landfill in five years or less. Based on decay constants adopted by
the EPA and the United Nation’s Intergovernmental Panel on Climate Change, the life of organic
degradable materials in a dry tomb and bioreactor landfills are approximately 70 and 12 years
respectively.

58. And, even if such plastic were located in a faster-degrading area of the landfill, it
would not degrade in five years or less. As the decay rates in Table 2 (page 16) make clear, even
food scraps will take, on average, 7 years to biodegrade. Thus, ECM’s claim that plastics treated

23

ECM Comb. Mot. to Exclude Page 23 of 56
Exh. X


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

Modulus, GPa

0 10 20 30 40 50 60 70 80 90 100
Bionolle Content, wi%

FIG. 3
& @ At Yield
ms O At Break
n
=
n
% 10 20 30 40 50 60 70 80 90 100
Bionolle #3000 Content, wt%
FIG. 4
ECM Comb. Mot. to Exclude Page 66 of 80

Exh. Z


Jd; Opposition CCX-A { 5, Attachment 1.

Based on the parties’ representations and the exhibits offered in support thereof, on
Friday. February 14, 2014, at approximately 8:00 p.m., Complaint Counsel received a copy of
the Ohio State Article. Declaration of Jonathan Cohen, Opposition CCX-A (hereafter, “Cohen
Decl.) 46. Although Mr. Cohen states that the article was received “unsolicited,” Jd 96. he
does not disclose how, or from whom, the Ohio State Article was received. The Declaration
further states that Complaint Counsel had not “communicated in any way” with any of the
authors of the Ohio State Article, or anyone at Ohio State. Cohen Decl 77

Complaint Counsel’s March 13, 2014 “Clarification” regarding the Motion states that on
the previous day, Complaint Counsel learned that “two FTC attorneys (not representing
Complaint Counsel),” one of whom worked on the investigative phase of the case but who has
since left the FTC, had. in fact, received a draft of the Ohio State Article. The Clarification does
not state when the draft was received.! According to the Clarification, the two attorneys had
been working with Mr. Michel “as a consulting expert on unrelated matters involving
biodegradability claims other companies asserted” and received the Article in connection with
that work. Clarification at 1 and n.1.

On the afternoon of February 15, 2014, the day after Complaint Counsel received the
Ohio State Article, Complaint Counsel Johnson packed for her travel to ECM’s offices, where
the deposition was scheduled to take place, taking the Ohio State Article with her Tr. 374-375,
February 17, 2014 was President’s Day, a federal holiday. The deposition commenced on
Tuesday morning, February 18,2014. Tr. 1. After recessing for the night, the deposition
reconyened the following morning, on Wednesday. February 19,2014. Tr. 223. At
approximately 1:24 p.m., after the lunch break, Complaint Counsel produced the Ohio State
Article, marked it as an exhibit to the deposition, and proceeded to question Mr. Sinclair
concerning the Article, including regarding the findings and conclusions of the study. Tr. 366-
378. It 1s undisputed that this was the first time Complaint Counsel had disclosed the document
to Respondent.

In response to the objections of Respondent's counsel, Complaint Counsel stated that it
received the Ohio State Article the previous Friday; that Complaint Counsel “might have” had
the opportunity to send a copy of it to Respondent’s counsel at that time; and that someone on
Complaint Counsel’s staff also “possibly” could have provided a copy to Respondent's counsel.
Tr. 371-372. The dialogue continued

MR. EMORD: So we could have been given a copy of the document so we could
confirm —

' The Clarification also does not state, among other details, by whom the draft was received, where it was located, or
whether or not the draft was relied upon in the investigation or prosecution of this case. See 16 CE.R §3.31(c)(2)
(Complamt Counsel must search for responsive documents “that were collected or reviewed in the course of the
investigation of the matter or prosecutiom of the case and that are in the possession, custody or control of the
Bureaus or Offices of the Commission that investigated the matter, including the Bureau of Economics. . . ).
Respondent has submitted a Motion to Compel and for Sanctions with respect to the draft article and related
correspondence,

2

ECM Comb. Mot. to Exclude Page 2 of 6
Exh. P


Respondent’s Exhibit E


DATED: July 9, 2014

PUBLIC DOCUMENT

Respectfully submitted,

GLE

Jofiathan W. Emord (j¢mord@emord.com)
EMORD & ASSOCIATES, P.C.

11808 Wolf Run Lane

Clifton, VA 20124

Telephone: 202-466-6937

Facsimile: 202-466-6938


Based on applicants’ evidence of prior invention,
Kakizawa ie not prior art. accordingly, applicants respect fully

yequest reconsideration and withdrawal of this rejection.

ONCLUSION

The present invention is not anticipated or made
obvious in light of the prior art cited by the Office Action.
Applicants respectfully request withdrawal of all rejections and
@ Notice of Allowance as the next mailing from the Office.
Please apply any further charges or credits to Deposit Account
No. 06-1050, making reference to attorney Docket No.

08688/025001.

Respectfully submitted

Fish & Richardson P.c.
225 Franklin Street
Boston, MA 02110-2604

Telephone: 617/542-5070
Facsimile: 617/542-8906
36662.N12

12

ECM Comb. Mot. to Exclude Page 63 of 80

Exh. Z


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 22

moisture control in the landfill, and temperature control.”'? Because ASTM D5526 mimics
bioreactors, its conditions are not representative of most landfills. As a result, although ASTM
D5526 can be used as a screening-level test, it cannot be used to support a scientific conclusion
that a plastic will biodegrade to completion in the typical U.S. landfill.

55. Like ASTM D5511, ASTM D5526 prohibits extrapolation of test results.!? This

means that if a test shows 10% biodegradation in 300 days, the test cannot be used to support a

claim of 100% biodegradation in 3000 days. The reason for the prohibition on extrapolation is
simple: there is no evidence that biodegradation is a linear process (and, in fact, the rate of

biodegradation is likely to slow because of recalcitrance).

iii. Proposed ASTM Standard Test Method for Landfill Conditions.
56. To address rising interest in degradable plastics, ASTM is considering a proposed

test method (WK 41850) for determining the rates and rate constants for plastics biodegradation
in an anaerobic laboratory environment under accelerated conditions. This test method currently
proposes to test for 60% conversion of the test material to carbon dioxide and methane within 18
months. In other words, if this gas evolution test shows 60% biodegradation within 18 months,
the testing can be used to support a scientific conclusion that a plastic will biodegrade to

completion in a landfill.

" ASTM Int’l, D 5526: Standard Test Method for Determining Anaerobic
Biodegradation of Plastic Materials Under Accelerated Landfill Conditions 1.2 (2012).
® Id. at 1.4; ASTM Int’l, D 5511: Standard Test Method for Determining Anaerobic
Biodegradation of Plastic Materials Under High Solids Anaerobic Digestion Conditions 1.4 and
13.3 (2012).

ECM Comb. Mot. to Exclude Page 22 of 58
Exh. U


“Biodegradable Plasticizers for Polylactic Acid”, Xu Song & Stephen McCarthy, Journal of
Applied Medical Polymers, Autumn 2002, Vol 6, No.2, 64-69.

“Microwave-Assisted Solvent-Free or Aqueous-Based Synthesis of Biodegradable Polymers”,
with Balint Koroskenyi, Journal of Polymers and the Environment, Volume 10, Number 3,
July 2002, 93-104

“Process Dynamics in Sequential Valve Gate Injection Molding-Processing Strategy and Process
Control”, Shin, Suk-young; Schott, Nick; McCarthy, Stephen., Society of Plastics
Engineers Annual Technical Conference (2001), 59th(Vol. 1), 694-698.

“Biodegradable Plasticizers for Polylactic Acid”, McCarthy, Stephen; Song, Xu. Annual
Technical Conference - Soc. Plast. Eng. (2001), 59th(Vol. 3), 2546-2549.

“Large, Structural, "Class A" Thermoplastic Automotive Part Production Without Painting”,
McCarthy, Stephen; Guan, Qing; McCarthy, Shawn; Shetty, Malar Rohith; Ellison,
Thomas, Annual Technical Conference - Soc. Plast. Eng. (2001), 59th(Vol. 3), 2448-
2452.

“Biodegradable Bags Comparative Performance Study: A Multi-Tiered Approach to Evaluating
the Compostability of Plastic Materials” Farrell, R. E.; Adamezyk, T. J.; Broe, D. C.; Lee,
J. S.; Briggs, B. L.; Gross, R. A.; McCarthy, S. P.; Goodwin, S. ACS Symp. Ser.
(2001),786 (Biopolymers from Polysaccharides and Agroproteins),

“Biodegradable Polymer Blends for Medical Applications”, with P. Canale, S. Mehta, Journal of
Applied Medical Polymers, Volume 5, No. 2, Pgs. 65-71, (Autumn 2001)

“Synthesis of Acetylated Konjac Glucomannan and Effect of Degree of Acetylation on Water
Absorbency”, with Balint Koroskenyi, Biomacromolecules, 2(3), 824-826. (2001).

“Evaluation of Oxidative Stability of Flexible Polyolefins by Oxidative Induction Testing with y-
Oryzanol and «-Tocopherol Antioxidants for Food and Medical Applications”, with
Shamit Hakani, Sanjay Mehta, and Philip Canale, Journal of Applied Medical Polymers,
Volume 4, No. 2, (Winter 2000).

“Hydrolytic Degradation of PCL/PEO Copolymers in Alkaline Media”, with S.M. Li, X.H. Chen
and R.A. Gross, Journal of Materials Science: Materials in Medicine, Volume 11, pgs. 227-
233, (2000).

“Food for Thought: Tomorrow’s Feedstocks”, Plastics News, Edited by Frank Esposito, March,
2000.

“Cavity Pressure Transfer Extends Prototype Tool Life”, with John Dell’Arciprete and Robert
Malloy, Modern Plastics, Edited by William A. Kaplan, pgs. 125-128, (January 2000).
“Kinetic” Welding of Plastic Parts”, with Judith A.H. Jones, Yogish Mahadevaiah, Balint
Koroskenyi, and Sanjay Mehta, 58th Society of Plastics Engineers Annual Technical

Conference Proceedings, Volume 46, Number 1, pp. 1232-1236, May 2000.

“Thermoplastic Paint (A.k.a. Film Finish, Paint Film, Dry Paint) A Complementary Technology
for Exterior Automotive Plastic”, with Thomas Ellison, 58th Society of Plastics Engineers
Annual Technical Conference Proceedings, Volume 46, Number |, pp. 2607-2610, May
2000.

““Class A” Thermoplastic Automotive Part Production without Painting”, with Qing Guan,
Chetan Makadia and Thomas Ellison, 58th Society of Plastics Engineers Annual Technical
Conference Proceedings, Volume 46, Number 3, pp. 2654-2657, May 2000.

“Analysis of Adhesive Properties of Different Engineering Thermoplastics To Elastomers By a
Two-Shot Injection Molding Process”, Sandip Patel, Chetan Makadia, Qing Guan and
Sanjay Mehta, 58th Society of Plastics Engineers Annual Technical Conference
Proceedings, Volume 46, Number 3, pp. 2658-2662, May 2000.

ECM Comb. Mot. to Exclude Page 46 of 58
Exh. U


(Kim and Crowley, 2013). So a range of these conditions is likely present even in biodegradation tests,
not just the average values measured for these systems.

Given the tremendous diversity of microorganisms in these systems, biodegradable substrates should be
able to be biodegraded by some member or combination of members of the community present in the
tests. Therefore, while imperfect, these tests provide a very good estimate of the biodegradation of
compounds under favorable conditions for microbial activity.

Comment by Dr. Burnette -

“78. An argument has been made that when test results are negative, it is because the ECM treated
plastics are not biodegradable. At the same time, supporters of that argument will argue that positive
results are an anomaly of the testing environment. Those arguments are fundamentally flawed; you
must accept negative and positive results together and evaluate the totality of the Scientific evidence.
Either the test method is valid or it is not. It cannot be valid when only one outcome, negative or positive,
is observed. Many of the tests with ECM treated plastics have well-designed controls, where the negative
control does not biodegrade, and the positive control does biodegrade. in these cases, when the ECM
treated material does also appear to biodegrade, the conclusion drawn is that the ECM treated plastics
are biodegradable within design of the experiment. There is great support that the ECM treated plastics
are in fact biodegradable, both in vitro and in situ.”

Rebuttal —

As described by Dr. McCarthy in his report, only a few tests use proper controls and few report the
actual amount of ECM additive present in the plastic. Since the additive itself may be much more
biodegradable than the plastic with which it is mixed, the conclusion that “there is great support that
the ECM treated plastics are in fact biodegradable”, is correct to the extent that the additive itself is
biodegradable. This does not mean that the ECM additive has enhanced the biodegradation of the
conventional plastic.

Many of the reports where ECM amended plastics have been observed to biodegrade greater than the
negative control can be attributed to the biodegradation of the ECM additive, or to the priming effect
(Shen and Bartha, 1996), and not the plastic to which it has been added.

10

ECM Comb. Mot. to Exclude Page 10 of 24
Exh. V


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 11

clothing, storage containers and DVD covers, and polystyrene (PS), which is used most
commonly for foam disposable cutlery and cups, foam packing peanuts, insulation, and fast food
containers. These conventional plastics are often in the hundreds of thousands to millions in

molecular weight (Mn).

31. There are a variety of plastics, but synthetic (laboratory-made), petroleum-based
plastics are by far the most common. Plastics derived from petrochemicals are strong, durable,
and inexpensive to manufacture, which makes them ideally suited for commercial applications.
Such petroleum-based plastics, which I refer to in this report as “conventional plastics,”
represent over 90% of the commercial plastic market. When laypersons talk about “plastic,”
they are usually referring to these conventional plastics.

32.  Bioplastics. Most plastics are organic, which means that they are mostly
carbon. As explained above, bacteria and fungi use carbon in organic materials as a food
source. However, not all carbon-containing organics are biodegradable. Put differently,
microorganisms cannot metabolize all organics. Conventional plastics are a prime
example. They are organic (i.e., carbon-based), but not biodegradable,’ because the chemical
structure of the conventional plastic prevents naturally-occurring microorganisms from accessing
the carbon.

33. Notably, microorganisms have evolved to degrade those polymers that they have
been exposed to. Since cellulose, starch, chitin, etc. are polymers that exist in nature,
microorganisms have developed specific enzymes to degrade these polymers. The petroleum-

* Over time, all things will likely biodegrade. Therefore, the statement that conventional

plastic is not biodegradable should be read to mean “not biodegradable in any timeframe less
than hundreds, thousands, or millions of years.”

ECM Comb. Mot. to Exclude Page 11 of 58
Exh. U


Frederick C. Michel, Jr., and published by the Journal of Polymer Degradation and Stability, an
Elsevier publication, including, but not limited to, conflict-of-interest checking performed on the
article’s authors. Professor Iwata will also testify as to any other issues addressed in his
deposition; any documents introduced into evidence by Respondent or Complaint Counsel as to
which he has knowledge; or any other matters as to which he has knowledge that are relevant to
the allegations of the Complaint, Respondent’s affirmative defenses, or the proposed relief

Current and Former FIC Employees

21. John Aiken, Investigator, Federal Trade Commission, Bureau of Consumer
Protection, Division of Marketing Practices (formerly of the Division of
Enforcement)

Mr. Aiken will testify regarding the admissibility of certam website and webpage

captures produced by Complaint Counsel in this action.

22. William Burton, former Investigator, Federal Trade Commission, Bureau of
Consumer Protection, Division of Enforcement

Mr. Burton will testify regarding the admissibility of certain website and webpage
captures produced by Complaint Counsel in this action

23. Dayid Hendrickson, Investigator, Federal Trade Commission, Bureau of
Consumer Protection, Division of Enforcement

Mr. Hendrickson will testify regaiding the admissibility of certain website and webpage
captures produced by Complaint Counsel in this action.
24. Mary Jo Vantusko, Investigator, Federal Trade Commission, East Central
Region
Ms. Vantusko will testify about photographs she took of various products at ECM’s

office in Painesville, Ohio

ECM Comb. Mot. to Exclude Page 13 of 16

Exh. F


Exh. ¥. Curriculum Vitae, Steven J. Grossman, J.D., Ph.D.
Exh. Z. Dr. Grossman Supporting Materials

Exh. AA. Eddie F. Gomez, Frederick C. Michel Jr., Biodegradability of conventional and
bio-based plastics and natural fiber composites during composting, anaerobic
digestion, and long-term soil incubation, Polymer Degradation and Stability 98
(2013) 2583-2591

Exh, BB. Email between Complaint Counsel and ECM Counsel Concerning Pretrial
Hearing Date (April 11, 2014)

Exh. CC. Dr. McCarthy Rebuttal Report (June 30, 2014)

Exh, DD. July 8, 2014 Correspondence between Complaint Counsel and ECM Counsel

Executed this 9th day of July, 2014 in Chandler, Arizona,

Pbter A. Arhangelsky
Counsel to ECM Biofilms


used ECM promotional materials and products made with the ECM additive; any other issues
addressed in his deposition; any documents introduced into evidence by Respondent or
Complaint Counsel as to which he has knowledge; or any other matters as to which he has
knowledge that are relevant to the allegations of the Complaint, Respondent’s affirmative
defenses, or the proposed relief.

Individuals and Laboratories Associated with Scientific Review or Literature

17. Thomas Poth, Eden Research Laboratory (“Eden”) Lab Director, as Eden’s
designee

Mr. Poth will testify regarding Eden’s relationship and communications with ECM,
ECM's employees, ECM’s customers, and other parties interested in the alleged biodegradabihty
of plastic; Eden’s testing and evaluation of plastic that purportedly contains the ECM additive;
Eden’s testing facilities, resources, procedures, protocols, certifications; Eden’s training and
supervision of its laboratory employees, the qualifications of Eden's employees: Eden’s
knowledge of, use of, and departure from ASTM testing standards; Eden’s financial interest in
testing the purported biodegradability of plastic; any other issues addressed in his deposition; any
documents introduced into evidence by Respondent or Complaint Counsel as to which he has
knowledge; or any other matters as to which he has knowledge that are relevant to the allegations
of the Complaint, Respondent's affirmative defenses, or the proposed relief.

18, Alyssa Ullman, Northeast Laboratories, Inc. (“Northeast”) Biodegradation
Studies employee, as Northeast’s designee

Ms. Ullman will testify regarding Northeast’s relationship and communications with
ECM, ECM’s employees, ECM’s customets, and other parties interested in the alleged
biodegradability of plastic; Northeast’s testing and evaluation of plastic that purportedly contains

the ECM additive; Northeast’s testing facilities, resources, procedures, protocols, certifications;

YW

ECM Comb. Mot. to Exclude Page 11 of 16
Exh. F


Respondent’s Exhibit R


3. Thomas Nealis, ECM Director of Sales

Mr. Nealis will testify about ECM’s advertising and products, including but not limited to
ECM?’s distribution and sales channels; customer base; communications with prospective
customers, customers, former customers, ASTM, testing facilities, scientists studying the
purported biodegradability of plastics, Plastics Environmental Council, and other parties
regarding the ECM additive and purported biodegradability of plastic, ECM’s claums of
biodegradability of plastics treated with the ECM additive; ECM’s substantiation for those
claims; other testing regarding the ECM additive and the alleged. biodegradability of plastic,
tacts alleged in the Complaint; any other issues addressed in his deposition; any documents
introduced into evidence by Respondent or Complaint Counsel as to which he has knowledge; or
any other matters as to which he has knowledge that are relevant to the allegations of the
Complaint, Respondent's affirmative defenses, or the proposed relief.

4. Alan Poje, former ECM Regulatory Specialist

Mr. Poje will testify about ECM’s advertising and products, including but not limited to
ECM?’s distribution and sales channels; customer base; communications with prospective
customers, customers, former customers, ASITM, testing facilities, scientists studying the
purported biodegradability of plastics, Plastics Environmental Council, and other parties
regarding the ECM additive and purported biodegradability of plastic; ECM’s claims of
biodegradability of plastics treated with the ECM additive; ECM’s substantiation for those
claims; other testing regarding the ECM additive and the alleged biodegradability of plastic,
tacts alleged in the Complaint; any other issues addressed in his deposition; any documents

introduced into evidence by Respondent or Complaint Counsel as to which he has knowledge; or

ECM Comb. Mot. to Exclude Page 4 of 16
Exh. F


Respondent’s Exhibit Z


PUBLIC DOCUMENT

RELIEF

For the foregoing reasons, ECM requests that this Court exclude Dr. Michel as a witness
in this case and strike his rebuttal report. If and only if the Court chooses not to exclude Dr.
Michel and his report, ECM moves for leave to permit ECM to call Dr. Steven A. Grossman as a
surrebuttal witness based on the attached surrebuttal report. ECM also requests that this Court
impose sanctions on Complaint Counsel for this second offense in flagrant disregard of the
Court’s first grant of sanctions. In particular, ECM requests that counsel be reprimanded for the
offense and that in addition to the exclusion of Dr. Michel and his report that the Michel/Gomez

article be excluded from evidence.

Respectfully submitted,

Bz.

Jofiathan W. Emord (jdmord@emord.com)
EMORD & ASSOCIATES, P.C.

11808 Wolf Run Lane

Clifton, VA 20124

Telephone: 202-466-6937

Facsimile: 202-466-6938

DATED: July 9, 2014


composition of Shimadzu requires the presence of at least 5% by
weight of a polyalkylene ether in block copolymer B.

The biodegradable blend composition of the present
invention, in contrast, does not contain any polyalkylene ether
component. As summarized above, applicants’ composition
comprises a blend of first lactic acid homo- and copolymers, and
@ second polymer consisting essentially of various polyesters
Polyalkylene ethers do not appear in any claim of the invention,
and the presence of any polyalkylene ethers is not required for
the advantageous properties of the inventive blend.

The biodegradable blend composition of the present
invention also does not utilize a block copolymer as the second
polymer. Instead, the second polymer is a homopolymer or a
random copolymer. The Shimadzu reference requires that fraction
B of that composition be a block copolymer. The present
invention does not mention the use of block copolymers of any of
its components, and refers specifically to the use of
homopolymers and "random copolymere" (e.g., page 10, lines 17-21)
of aliphatic polyesters for the biodegradable blends of the
invention. Therefore, the Shimadzu reference does not anticipate
applicants’ biodegradable blend.

Furthermore, the Shimadzu reference does not make the
inventive blend obvious. Shimadzu does not disclose or otherwise
suggest that polyalkylene ethers could be omitted from thei
compositions. Likewise, Shimadzu does not disclose or otherwise
suggest that block copolymers could be omitted in favor of random

copolymers in their compositions. Absent even a@ suggestion, or

ECM Comb. Mot. to Exclude

Exh. Z

Page 58 of 80


51. Any individual associated with scientific testing that ECM contends substantiates its
claims.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

52. The representative of any entity associated with scientific testing that ECM contends
substantiates its claims.

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

53. Ranajit Sahu

Kelley Drye

Washington Harbour, Suite 4000
3050 K Street, NW

Washington, DC 20007

(202) 342-8588

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

54. Charles Lancelot, Plastics Environmental Council

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

55. Clifford Moriyama, Plastics Environmental Council

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

56. Representative of Plastics Environmental Council

Proposed Testimony: We anticipate that this witness will testify regarding ECM’s claims
of biodegradability and the substantiation for such claims.

57, Mark Benson or Representative of APCO Insight

Judith S. Sapier

Senior Vice President, General Counsel, Secretary
APCO Insight

700 12th Street NW, Suite 800

Washington, DC

(202) 779-1000

Proposed Testimony: We anticipate that this witness will testify regarding consumer
perception of biodegradability claims.

ECM Comb. Mot. to Exclude Page 9 of 11
Exh. A



ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 5

associations related to biodegradable polymers and plastics engineering, including the
Bio/Environmentally Degradable Polymer Society, Society of Plastics Engineers, Biomaterials
Society, American Chemical Society, and the Materials Research Society.

11. | My complete Curriculum Vitae is attached hereto in Appendix A. Based upon my
education, training, and experience, I consider myself an expert in the fields of plastics
engineering, polymer science, and biodegradable polymers.

12. In the past four years, I testified as an expert in a binding alternative dispute
resolution proceeding in a patent infringement case on March 19, 2012. See Display
Technologies, LLC v. Display Industries, LLC, No. 11-civ-6390 (S.D.N.Y.). I do not have a
copy of the transcript.

13. Iam compensated at a rate of $100 per hour for all work in this matter, except

deposition and trial testimony, which will be compensated at a rate of $325 per hour.

Il. SCOPE OF ANALYSIS

14. Complaint Counsel asked me to evaluate whether the following advertising claims
for ECM Biofilms, Inc.’s additive (“ECM additive”) are true and supported by competent and
reliable scientific evidence:

a. Plastic products manufactured with the ECM additive (“ECM Plastics”) are

biodegradable. !

b. ECM Plastics will completely break down and return to nature (i.e., decompose

into elements found in nature) in nearly all landfills within nine months to five

years.

' Complaint Counsel asked me to assume that the unqualified marketing claim
“biodegradable” means that the entire treated plastic will completely break down and return to
nature (i.¢., decompose into elements found in nature) within one year after customary disposal
(ie., incinerator, landfill, or recycling). I use this definition and the scientific definition of
biodegradable interchangeably in this Expert Report, because there is no substantive difference
between the two that affects my analysis or my opinions.

ECM Comb. Mot. to Exclude Page 5 of 58
Exh. U


Environment (2011) 19:637-676 that Dr. McCarthy reviews and edits. The authors of that 2011

article stated:

The various definitions of biodegradation depend on the field of application of the
polymers (biomedical area or natural environment). Many different definitions have
officially been adopted, depending on the background of the defining standard
organizations and their particular interests. Van der Zee and Seal [11,12] review all of
the definitions found in different standards. Albertsson and Karlsson [13] defined
biodegradation as an event that takes place through the action of enzymes and/or
chemical decomposition associated with living organisms and their secretion products.
It is also necessary to consider abiotic reactions like photodegradation, oxidation and
hydrolysis, which may alter the polymer before, during or instead of biodegradation
because of environmental factors. So, strictly speaking, “biodegradation of a
polymer” is defined as the deterioration of its physical and chemical properties and a
decrease in its molecular mass down to the formation of CO2, HO and CH, and other
low molecular weight products under the influence of microorganisms in both aerobic
and anaerobic conditions aided by abiotic chemical reactions like photodegradation,

oxidation and hydrolysis. [14].

In view of the above, I am of the opinion that the fundamental definition of biodegradation
given by Complaint Counsel and relied upon by Drs. McCarthy and Michel, stated as follows
from note 1 of the McCarthy Expert report, does not appear anywhere in the peer reviewed
literature, and is incorrect: “the entire treated plastic will completely break down and return to
nature (i.e. decompose into elements found in nature) within one year after customary disposal
(i.e, incinerator, landfill, or recycling).”’ McCarthy Expert Report of June 4, 2014 at note 1. In
my view, the definition of biodegradation “varies greatly among scientists, manufacturers, and
consumers” (McCarthy 2003) and “many different definitions have officially been adopted”
(Luckachan and Pillai 2011)?

‘It is unclear to me how a plastic material would be labelled as biodegradable on the basis that it was broken down
by an “incinerator” which is reference to a burning of the material, not biological degradation.

* 1 reviewed Dr. McCarthy’s publications produced in this matter to ECM and was unable to find any use by him
cutside of his expert report that the definition for biodegradation of a plastic is that the plastic “will completely

Page 8 of 20

ECM Comb. Mot. to Exclude Page 8 of 20
Exh. W


least three attorneys, and possibly Mr. Sinclair himself. Surely, you can make someone available to
be there on one of those two dates?

Katherine

Katherine E. Johnson, Attorney

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, DC 20580

Direct Dial: (202) 326-2185

Fax: (202) 326-2558

Email: kiohnson3 @ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Wednesday, April 23, 2014 5:10 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Hi Katherine,

The May 6th date is unavailable. You already noticed the deposition for Kappus Plastics on May 6th
in New York. We therefore object to a deposition scheduled on that same day in South Carolina

Best,

Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ
85286
Firm: {602} 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed above. The content of this
communication is prolected from disclosure by the attomey-client privilege and ihe work product doctrine. If
you are not the intended recipient, you should treat this communication as strictly confidential and provide it to
the person intended. Duplication or distribution of this communicction is prohibited by the sender. |f this
communication has been sent fo you in error, please notify the sender and then immediately destroy the
document.

From: Johnson, Katherine [mailto:kjohnson3@ftc.gov]

Sent: Wednesday, April 23, 2014 2:02 PM

To: Peter Arhangelsky; Lou Caputo; Jonathan Emord

Ce: Cohen, Jonathan; Jillson, Elisa; Decastro, Arturo; Millard, Joshua S.
Subject: Scheduling Depositions

Peter:

Pursuant to Scheduling Order paragraph 13, we are consulting regarding scheduling of additional

ECM Comb. Mot. to Exclude Page 2 of 3
Exh. E


the hybrid method used in Dr. McCarthy’s own patent, are inappropriate for determining

polymer biodegradability.
Rebuttal of Points Made by Dr. McCarthy
Comment by Dr. McCarthy:

1. The question that complaint counsel asked me to evaluate is whether ECM’s claims
were scientifically true or at least has an appropriate level of scientific support. The claims

complaint counsel asked me to evaluate specifically are:

a. Plastic products manufactured with ECM additive (“ECM Plastics”) will
completely biodegrade, i.e. will completely break down and decompose into elements found in
nature, within a reasonably short period of time (i.e. one year) in a landfill. McCarthy Rebuttal
Report at fl.

Rebuttal:

I disagree with Dr. McCarthy’s view that the term “biodegradable” would be understood by
scientists, engineers and other professionals in the plastics industry as limited to the
requirement that the plastic in question must “completely break down and decompose into
elements found in nature, within a reasonably short period of time (i.e. one year) in a landfill.”

T have also seen no authority to support Dr. McCarthy’s position.

As an initial matter, I note that Dr. McCarthy’s 2003 publication entitled “Biodegradable

Polymers” appearing in the text “Plastics and The Environment” states as follows:

“The definition of biodegradable polymer varies greatly among scientists,

manufacturers and consumers.”

I agree with that statement of Dr. McCarthy that the definition of biodegradable varies greatly

among scientists, manufacturers and consumers.

In addition, I note a 2011 article entitled “Biodegradable Polymers-A Review On Recent Trends
and Emerging Perspectives,” by G. Luckachan and C. Pillai, which appeared in the J. Polym.

Page 7 of 20

ECM Comb. Mot. to Exclude Page 7 of 20
Exh. W


PUBLIC DOCUMENT

CERTIFICATE OF SERVICE

Ihereby certify that on July 9, 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@fitc.gov

The Honorable D. Michael Chappell

Administrative Law Judge

One electronic courtesy copy to the Office of the Administrative Law Judge:

600 Pennsylvania Ave., NW, Room H-110

Washington, DC 20580

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

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: jeohen2@fic.gov

One electronic copy to Counsel for Complainant:

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

Arturo Decastro

Division of Enfoncement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, D.C. 20580
Email: adecastro@fic.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.

21


PUBLIC DOCUMENT

We are reviewing our prior discovery responses expeditiously to ascertain whether

Complaint Counsel should amend or supplement them.

Dated: March 13, 2014

ECM Comb. Mot. to Exclude
Exh. Q

éhnson (kjohnson3@ftc.gov)
‘ohen (jcohen2@ftc. gov)
illson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

Page 2 of 3



The stipulation for OWS would have to include a waiver of ail hearsay objections — OWS’s statements
(e.g., emails) and documents (e.g., tests) would come in for their truth. If that is acceptable, | can
send you a proposed draft by tomorrow.

If ECM is considering deposing NE Labs, then perhaps we can just schedule the deposition. | spoke
with them last week and cleared May 9°".

We are also proposing to depose Eagle Film, Thursday, May 15” with a backup of Wednesday, May
14%” The depo would be in Grand Rapids, Michigan. Let me know which date works better.

If there are other potential deponents, please put them on the table now, so we can work out
possible stiputations or deposition dates. Another potential deponent for us would be Dr. Michel,

uniess ECM stipulates to the Ohio State Study coming in for the truth.

Lastly, | see that Mr. Sinclair filed his notice of appearance. Please let me know if you would like him
copied on our correspondence and served with filings in the case.

Katherine

Katherine E. Johnson, Attorney

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, DC 20580

Direct Dial: (202) 326-2185

Fax: (202) 326-2558

Email: kKiohnson3 @ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Friday, April 25, 2014 9:15 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Katherine,
! apologize for the delay responding to your below email. ECM is willing to enter stipulations in lieu
of an OWS deposition. We are contemplating taking the deposition of Northeast Labs, although we

might be willing to consider a similar stipulation for documents supplied by them.

Please let us know if you want to discuss this.

Best,

ECM Comb. Mot. to Exclude Page 5 of 9
Exh. H


‘DSC Studies for the Evaluation of Polymerization and Crystallization of Nylon-RIM
Systems", M.S. Thesis, August 1985, Seng-Shiu Chung

b. Thesis Committee Member

Analysis of the Dip-Coating of Solid and Fibrous Substrates", Ph.D Thesis, June 1986, Amit
Dharia

‘Structure-Property Correlations in flexible Main Chain Polymeric Liquid Crystals", Ph.D
Thesis, August 1986, S. Kwnar

"The Effects of Ionic Interactions on the Thennal-Mechanical Properties of Methacrylic
Ampholytic lonomers and their Blends", Ph.D Thesis, May 1986, Christian M. Neculescu

"The Effect of Uterine and Vaginal fluid Constituents on the Structure, Properties and Physical
Breakdown of Nylon-6", Ph.D Thesis, 1985, J. Hudson

"Viscosity of Water Soluble Polymers”. M.S. Thesis, January 1989 Tsai-Jucong Liul
Rheology Study of Kraton Solutions", MS. Thesis, December 1988, Ru-Jong Jeng

"The Use of Three-Dimensional Solubility Parameter Methods to Help Predict Practical
Polymer-Polymer Compatibility” M.S. Thesis, December 1986, Henry Kozlowski

“Binders for Recycled Automobile Scrap Light Fluff Fraction", MS. Thesis, September 1986
Ajay Kharodj.

“Bacterial Breakdown and/or Grow-Through Nylon-6 Film", M.S. Thesis, September 1986,
Sharon Sylvester

"Theoretical and Practical Consideration of Rubber-to-Metal Bonding", MS. Thesis, August
1986, David Butler

“Reliability of Selected Marketing Projections", MS. Thesis, May 1986 (David Gorky].
"Recycling of Epoxy Resins", M.S. Thesis. May 1986. Conchita Tran-Bruni

"Polyblends of Thermoplastic Polyurethane with Acrylonitrile-Butadiene Styrene", MS.
Thesis, April 1986, Ah Monochebri

"Recycling of Mixed Plastics Fraction from Junked Autos by Addition of Thermosetting
Resins and Low Pressure Molding", M.S. Thesis, January 1986, Chaitanya Nadicami

"Modification of Polystyrene by Styrene/Butadiene/Styrene Thermoplastic Elastorner", M.S.

Page 6 of 17

ECM Comb. Mot. to Exclude Page 6 of 17
Exh. Y


63. The Environ Study has at least five defects. Each defect, by itself, prevents it
from being competent and reliable scientific evidence that BioP VC would biodegrade in five
years or less in a landfill. First, the moisture content of 62% greatly exceeds the moisture found
in a typical dry tomb landfill in the U.S. (25-35% moisture). This flaw alone means that the test
does not replicate landfill conditions.

64. Second, the test inaccurately relies on mass loss is the primary indicator of
biodegradation ? rather than following the gas generation model (i.e., measuring the gas resulting
from the decomposition process) set forth in ASTM D5526. Mass loss is an inadequate indicator
of biodegradation because mass loss can result from other mechanical processes, To illustrate,
consider the loss in the weight of a sugar cube in water; mass loss does not mean that the sugar
cube is biodegrading. And, indeed, in these circumstances, it is more likely that the mass loss
resulted from fragmentation of the BioPVC than from biodegradation.

65. Third, the study assumes, without scientific justification, that the initial trend of
observed biodegradation will continue even when biodegradation has plateaued. The study
states: “This typical microbial growth curve is an artifact of the closed system design used in this
study. Under landfill disposal scenario, the microbial community would be replenished by fresh
leachate, including a fresh supply of nutrients.” (ECM-FTC-000075) This explanation suggests
that biodegradation plateaued at 2.5% mass loss due to lack of microbes and nutrients. This
explanation is implausible, because under the same test conditions, the cellulose (the control)

continued to biodegrade. A more likely explanation for the plateau is that the microbes had

3 The study’s method defines biodegradation amount as follows:

Massinitiat ~ MASSpina

X100
Massjniciat

% Biodegradation =

26

ECM Comb. Mot. to Exclude Page 26 of 56
Exh. X


Dr. McCarthy Rebuttal Report -- 3

critical to consider the closeness of fit that the assay will provide between substrate,
microorganisms, or enzymes and the application or environment in which biodegradation should
take place.” Drs. Sahu and Burnette limit their definitions of biodegradation to the mechanism
of break down by biological organisms. While I agree that is one possible definition, this differs
from what complaint counsel asked me to assume. The primary point of departure is whether the
definition includes the concepts of complete biodegradation or complete biodegradation in a
specific timeframe. While I agree that “biodegradable” is not always used to describe complete
mineralization in a specific timeframe, I evaluated the evidence in terms of whether it satisfies
that definition of biodegradation provided to me, which does include those concepts.

4, Dr. Sahu concludes that ECM Plastics will unavoidably biodegrade faster than untreated
conventional plastics.' He reaches this conclusion starting with a faulty “threshold question”:
whether plastics with additives will biodegrade at all. See Expert Report of Dr. Ranjit (Ron)
Sahu (“Sahu Report”) at 24. Likewise, Dr. Burnette concludes that many microorganisms have
enzymes capable of degrading plastics. Expert Report of Dr. Ryan N. Burnette (“Burnette
Report”) 55 and [83(g). I strongly disagree with these conclusions and how they were reached.
5. I have been involved in plastics and polymers since 1976. I currently teach in Plastics
Engineering and have done so for 30 years. Although suggested by ECM’s experts that my
report is “sourced with very few citations,” I included my Vitae as support for my conclusions.
My Vitae includes hundreds of publications, doctoral dissertations and masters theses on
biodegradable polymers and biodegradation of polymers. In addition, I am the Editor of Journal
of Polymers and the Environment, a peer-reviewed journal dominated by peer reviewed

! Dr. Sahu does not define “conventional plastics” but seems to ignore the difference

between high-molecular weight plastics and low-molecular weight plastics that have the same
name.

ECM Comb. Mot. to Exclude Page 3 of 12
Exh. CC


Respondent’s Exhibit CC


Dr. McCarthy Rebuttal Report -- 11

mechanical properties as a measurement of biodegradation rate is not accurate. And the
measurement of free chloride does not indicate biodegradation.

25. In 1992, there was the belief that weight loss was a suitable measurement to demonstrate
biodegradation. In fact, until 2004 ASTM Standard Test Method D5247 utilized this
methodology. Accordingly, it is not unusual that some of the early literature and journals
discussing biodegradability of plastics rely on this measurement. I myself have publications
from this period that also utilize weight loss as a prediction of biodegradability. While weight
loss and loss of mechanical properties are easy to measure, they are inaccurate—the sample may
fragment, making it difficult to retrieve all of the sample for weighing; it is usually difficult to
clean the sample effectively to ensure that weight loss is accurately measured. ASTM Standard
Test Method D 5247 was withdrawn in 2004 for these and similar reasons.

26. This is consistent with many of the sources cited by Dr. Sahu, which indicate that weight
loss is by itself not an accurate predictor of biodegradability on its own. For instance, one of the
papers cited by Dr. Sahu discusses the various methods available to monitor the degradation
process of environmentally degradable polymers. Notably, in the discussion over laboratory-
scale simulated accelerated environments, the author discusses the use of changes in mechanical
and chemical properties as a basis for determining biodegradation. The author recognizes that
one of the “inherent drawbacks in the use of mechanical properties, weight loss, molecular
weights, or any other property which relies on the macromolecular nature of the substrate is that
in spite of their sensitivity, these can only address the early stages of the biodegradation process.
Furthermore, these parameters can give no information on the extent of mineralization.
Especially in materials blends or copolymers, the hydrolysis of one component can cause

significant disintegration (and thus loss of weight and tensile properties), whereas other

ECM Comb. Mot. to Exclude Page 11 of 12
Exh. CC


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 20

Biodegradation of Plastic Materials under Controlled Composting Conditions, Incorporating
Thermophilic Temperatures.” This test method sets forth a protocol for determining the extent to
which a plastic can biodegrade in controlled composting conditions.
49. There are several ASTM standard test methods related to anaerobic
biodegradation:
ASTM D5210: “Standard Test Method for Determining the Anaerobic
Biodegradation of Plastic Materials in the Presence of Municipal Sewage
Sludge”;
ASTM D§5511: “Standard Test Method for Determining the Anaerobic
Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion

Conditions”; and

ASTM DS5526: “Standard Test Method for Determining Anaerobic
Biodegradation of Plastic Materials Under Accelerated Landfill Conditions.”

50. The basic methodology for each of these anaerobic test methods is the same.
They are all “gas evolution tests,” in which the test specimen is exposed to a source of bacteria
(inoculum), and the end-products of biodegradation (biogases) are observed and measured.
These tests vary in terms of test conditions (temperature, moisture, and type of inoculum) and
test duration. Each test is validated only to run for a specific period.'' Thus, each presents the
optimal conditions representing a specific disposal environment (e.g., high-solids anaerobic

digester, or accelerated landfill conditions).

" Bach test protocol is conducted inter-laboratory or intra-laboratory in order to obtain
the precision and bias of the test. If the inter-laboratory tests obtain similar precision and bias
results under the test method, conducted for the same duration, the test method is considered
validated for those factors. Tests conducted outside of these validated parameters cannot be
considered reliable.

ECM Comb. Mot. to Exclude Page 20 of 58
Exh. U


Respondent’s Exhibit C


Respondent’s Exhibit H


Rebuttal

As noted above, Dr. McCarthy’s ‘199 patent presents data for only five (5) particular blends of
PLA with a polyester identified under the BIONELLE trademark. See Table 1 of the ‘199
patent. It is not clear what the molecular weight is of the BIONELLE polymers reported in
Table 1. Nevertheless, Dr. McCarthy recites in claim 1 of the ‘199 patent that one can prepare
a “biodegradable blend” of (a) a first polylactic acid-based polymer or copolymer, and (b) a
second polymer consisting essentially of one or more polyesters.” Accordingly, Dr. McCarthy
extrapolated from the five (5) blends recited in Table 1 and the data presented in FIGS. 11 and
12 to assert that PLA copolymers, in combination with any polyester (such as a polyester
containing PET) would amount to a biodegradable blend formulation. 1 am of the view that
contrary to Dr. McCarthy’s assertion in his report, it is accepted among polymer scientists to
extrapolate biodegradation testing to support a conclusion that a polymer will biodegrade. See,

the ‘199 patent.
Comment by Dr. McCarthy

24, The experts rely on Dr. Timothy Barber’s methodology in support of their conclusions
regarding the environmental fate of ECM Plastics. The experts argue that the Barber
Methodology is defensible because weight loss and evaluation of free chlorine are appropriate
indicators of biodegradability. Reliance on these matrices to establish complete
biodegradability is improper for two reasons. The measurement of weight loss and loss of
mechanical properties as a measurement of biodegradation are not accurate. And the
measurement of free chloride does not indicate biodegradation. McCarthy Rebuttal Report at
(24.

Rebuttal

I disagree with Dr. McCarthy’s assertion that measurement of weight loss and loss of
mechanical properties as a measurement of biodegradation are not accurate, In the ‘199 patent,
which is still in force, Dr. McCarthy relied upon FIG. 12 showing the results of weight loss
versus degradation time. In the specification, Dr. McCarthy wrote that “FIG, 12 shows that

Page 18 of 20

ECM Comb. Mot. to Exclude Page 18 of 20
Exh. W


Thesis, July 1985, Jiko Chang
"Adhesives Based on Starch Graft Copolymers", M.S. Thesis, April 1985, John Martin
"Thermoset Polymers for Electronic Applications", MS. Thesis, April 1985, Philip Papoojian

"An Investigation of the Mechanical Properties and Polyblend Compatibility of Nyion-6,6 with
Sodium and Zinc Based Ethylene lonomers", MS. Thesis, April 1985, Jitendra Jherwar

"Effect of Fiber Orientation on Mechanical Properties of Weld Lines", MS. Thesis, March
1985, Nitin Matini

Summarizing the above indicates the following:
-Thesis Advisor Completed: 2 Ph.D.'s, 18 M.S.

-Thesis Comniittee Member: 4 Ph.D’s, 16 M.S.

B. Research and Publications

I. Grants and Contracts (1984-1992)

a. Representative Research Grants Amount($)

Phillips Driscopipe, Inc. 89,800*
Monsanto 50,000"
Anglo-American Clays 42,650
Gates Formed Fibre Products Inc. 26,700"
Dennison Manufacturing 23,704
Petroleum Research Fund-ACS 15,000
AE. Staley Manufacturing 7,350

Total: $284,804.00

b. Research and Testing Contracts

A variety of small research/testing type contracts have been supervised in the Plastics
Engineering Department. These are administered by the Testing Division of the Research

Foundation.

Page 7 of 17

ECM Comb. Mot. to Exclude Page 7 of 17

Exh. Y


finished degrading the biodegradable carbon in the BioP VC (present because the ECM Additive
is part biodegradable polymer) and could not degrade the conventional plastic.

66. Fourth, the study design assumes—without proving—the desired conclusion: that
bioPVC is entirely biodegradable. The equation defining decomposition provides that the only
means to achieve 100% decomposition is if the final mass (Massfna) equals zero. This
assumption is inaccurate; there will always be some assimilation of the carbon within the various
microorganisms or some recalcitrant carbon that is not bioavailable for decomposition."

67. Fifth, the Environ Study incorrectly reports several, varying decay rates for
different stages of the degradation process, but it is well-accepted in the scientific community
that a single decay rate describes the half-life of the entire degradation process under specified
testing conditions. The study reports that the “first order rate constants ranged from 0.021 to
0.13 yr” which corresponds to half-lives ranging from 4.2 to 29 years (full decomposition
would range from twice that—8.4 to 58 years). Even if mass loss were an accurate indicator of
biodegradation (it is not), the calculated decay constant for the process is incorrect. The correct
decay constant, representing the half-life of the entire degradation process under the specified
conditions, is 0.11 yr'. This was calculated by using the total mass loss (%) observed in the
study over the 9 month period which is a more appropriate method for calculating the decay
constant. Using the proper decay constant shows that (if the study’s other flaws were ignored)
the BioPVC’s half-life would be 6.3 years and complete biodegradation would occur after 12.6

years—much longer than the 5 years to complete biodegradation that ECM claims.

La Basically, think of the microorganisms as humans. Not everything we eat and breathe
is ejected from our bodies. We “assimilate” nutrients and carbon within our bodies, which
makes us grow. Recalcitrant carbon is like “fiber” to humans we can eat it but ultimately not
able to digest it.

27

ECM Comb. Mot. to Exclude Page 27 of 56
Exh. X


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 24

biodegradation of the additive or the inoculum. Radiolabeling is particularly useful for
technologies where the observed biodegradation would happen over a period of years. is

60. Absent an approved ASTM specification, it is my opinion that to scientifically
prove a claim that the plastic—not merely the additive and inoculum—is biodegrading, the
claimant must support its claim with at least one test with positive results from “C labeling of

the conventional plastic. '°

VIII. ANALYSIS OF ECM’S CLAIMS.

61. — It is my understanding, based on the materials provided by Complaint Counsel,
that the ECM additive is mostly a synthetic biodegradable polymer like polycaprolactone
(PCL).'” [understand further that ECM recommends that a small concentration, 1% to 5%, of its
additive be melt-batch blended with a non-biodegradable conventional plastic, such as
polyethylene. The resulting blended plastic, i.e., ECM Plastic, is then used to manufacture a

finished plastic product, such as a plastic water bottle or a golf tee.

9 Id “a radioisotope of carbon (4c) has found many applications in polymer research,
especially in the design of experiments to run for long time periods (one or more years).”).

© See supra note 6.

7 The conclusion that the ECM Additive is a biodegradable polymer is based on the
following. First, the materials submitted by ECM to Complaint Counsel describe the ECM
additive as 60-70% biodegradable polymer. Letter from ECM’s Counsel to the FTC (May 7,
2012). Complaint Counsel also asked me to assume alternatively that, based on certain materials
provided to it and which I have reviewed, the ECM Additive is a blend of approximately 20%
polyethylene vinyl acetate (EVA), approximately 60%, polycaprolactone (PCL), 6% linear low-
density polyethylene (LLDPE), approximately 7% calcium stearate and approximately 6%
starch. “Analysis Report” by Chemir Analytical Services, Chemir Analytical Job #79674, Dated
December 31, 2010. Both show that most of the additive (made of biodegradable PCL) is
biodegradable. Moreover, several of the tests on just the ECM Additive itself have concluded
that it is biodegradable. See O.W.S. Inc: Final Report - Biodegradation Testing for ECM Pellets
and EMC Film, concluding that the biodegradation studies performed on the additive “was
statistically significant.”; O.W.S. Inc: High Solids Anaerobic Digestion Test of ECM Pellets,
concluding that the additive showed 24% biodegradation + 1.5% after 15 days.

ECM Comb. Mot. to Exclude Page 24 of 58
Exh. U


ECM BioFilms, No. 9358

In the Matter of ECM Biofilms, FTC Docket No. 9358

Rebuttal Report by Dr. Frederick C. Michel

Rebuttal of Expert Reports by Drs. Ryan Burnette and Ranajit Sahu

ECM Comb. Mot. to Exclude Page 1 of 24
Exh. V


666

J Polym Environ (2011) 19:637 676

Table 3 The niche markets
of biodegradable polymers

in packaging [313]

Disposable items, bottles, personal
care and hygiene

Use Trade name Composition
Packaging and agriculture Biopot Poly(3 HB co 3 HV)
Bionolle Poly(butylene succinate)

Poly(ethylene succinate)

Aqua NOVON and Vinex Starch/PVOH

BIOCETA Cellulose acetate
Tone and enviroplastic C Poly(e caprolactone)
EcoPLA’ PLA

Natureworks PLA

PLAQUCEL-TM Polycaprolactone

BAK 1095 PEA

Biomax PET modified

Cereplast Com and potato starch
Mater Bi Starch and vegetable oil

driving force behind this technology is the solid waste
problem, particularly with regard to the decreasing avail-
ability of landfills, the litter problem and the pollution of
marine environment by non-biodegradable plastics. Ther-
moplastic starch-based polymers and aliphatic polyesters
are the two classes of biodegradable materials with the
greatest near-term potential. Biodegradability requires
complete assimilation of the plastic by the microbial pop-
ulations present in the selected disposal environment in a
defined time frame as opposed to degradable or partially
biodegradable. Therefore, biobased content and biode-
gradability are essential elements for single use, short-life
disposable packaging and consumer plastics. For example,
thermoplastic starch in combination with poly(vinyl
alcohol) or some aliphatic polyesters like poly(hydroxyb-
utyrate-co-hydroxyvalerate), poly(lactic acid), poly(e-cap-
rolactone) and poly(butanediy! succinate) appears to have
gaining approval as it meets the basic requirements for a
product to be declared compostable [70]. Complete bio-
degradability of the product in a time period compatible
with composting, measured through respirometric tests
(ASTM D5338-9, ISO/CD14855, etc.); disintegration of
the material during the fermentation phase and no negative
effects on compost quality etc. could be easily met by these
combinations.

However, in long term perspectives aliphatic polyesters
such as poly(hydroxybutyrate-co-hydroxyvalerate) and
poly(lactic acid) are expected to gain momentum because
of possible outcomes low cost production possibilities
looming on the research front. For durable, long life arti-
cles bioplastics needs to be engineered for long-life and
performance, so biodegradability may not be an essential
criterion and in this respect also, these aliphatic polyesters
may gain additional support. The biotechnological pro-
duction of bulk biopolymers such as polyhydroxyalkano-
ates and polylactic acid, which act as substitutes for

© Springer

ECM Comb. Mot. to Exclude
Exh. Z

polyolefins might play a major role in building of a sus-
tainable bioeconomy as the next generation of materials
[570]. The success of polylactide highlights the commer-
cial and environmental potential for plastics sourced from
plants, with renewable life cycles and which are carbon
neutral [154]. The applications for polylactide are
enhanced by its biocompatibility and its ability to be
absorbed and degraded in vivo; furthermore, it is an FDA
approved substance for use in therapy. It has been used for
some time in biomedical applications such as sutures,
stents, dental implants, vascular grafts, bone screws and
pins. It has also been investigated as a vector for drug
delivery, for example in the long-term delivery of antimi-
crobial drugs, contraceptives and prostate cancer treat-
ments. PLA has been widely used in the field of tissue
engineering as a scaffold material to support cell and tissue
growth. However, for many applications, PLA is not an
ideal material due to its high crystallinity, brittleness, lack
of total absorption and thermal instability. Further draw-
backs are that it is unfunctionalized and hydrophobic; these
properties impede its biodegradation and prevent targeting
of the treatment their specialist applications in niche
medical markets PLA is currently manufactured on a large
scale in the US and by smaller enterprises in the EU and
Japan.

One of the major developments that may sustain the
growth of biodegradable plastics is the emergence of a
number of industrial firms such as NatureWorks, NE,
owned by Cargill (biobased polylactic acid material from
com sugars; Cargill Dow LLC (a 50/50 joint venture
between Cargill Inc. and The Dow Chemical Co.) has
recently developed a solvent-free, low-cost continuous
process for the reduction of PLA from corn-derived dex-
trose. The resulting PLA, commercialized under the trade
name Nature Works, is the first synthetic polymer to be
produced from annually renewable resources [432]. with

Page 30 of 80


“Survey of Polymer Blends Containing Poly(3-Hydroxybutyrate-co-16% Hydroxyvalerate)”,
Polym. Preprints, Am. Chem. Soc., Div. Polym. Sci.,31(1),442-443, (1990), (with P. B.
Dave, N.J. Ashar, Richard A. Gross).

“Biodegradable Blends of Bacterial Polyesters with Polyethylene and Polystyrene”, Polym.
Preprints, Am. Chem. Soc., Div. Polym. Sci.,31(1),441, (1990) (with S.N. Bhalakia, T.
Patel, Richard A. Gross).

“Biodegradation of Blends Containing Poly(3-Hydroxybutyrate-co-Valerate)”, Polym., Mat. Sci.
Eng., 62, 231 (1990) (with Parasar B. Dave, Richard A. Gross, Cheryl Brucato, Shan
Wong).

“Morphological and Blend Miéiscibility Effects on the Biodegradability of Poly(3-
Hydroxybutyrate-co-3-Hydroxyvalerate) and Blends,” Polym. Mat. Sci. and Eng., (Am.
Chem. Soc.) 63, 726 (1990) (with Parasar B. Dave, M. Parikh, Michael S. Reeve, Richard
A. Gross).

“Behavior of Fiber Reinforcements During Composite Processing”, Journal of Polymer
Composites, (1991) (with Y. Kim).

"Verification Mold for Flow, Cooling, Shrinkage, and Warpage", Technical Papers, SPE, 36, 283
(1990). (with W. Discipio.).

"Study of Pressure, Volume, and Temperature (PVT) Relations and High Temperature Thermal
Analysis (DTA)", Polymer Preprints, 31,1,561 (1990) (with S.M. Bhatt.)

"The Effect of Polypropylene Nucleants on the Rates of Crystallization of Poly (Ethylene
Terephthalate)", Soc. of Plastics Eng., Technical Papers, 36, 1008 (1990) (with X. Chen.).

"Mold Optimization Using Rule-Based Software", Soc. of Plastics Eng., Technical Papers, 36,
1107 (1990). (with D. Cinquegrana.).

"The Effect of Crystallization Conditions on the Multiple Melting Peaks of Melt-Crystallized
PET", Soc. of Plastics Eng., Technical Papers, 36, 1000 (1990). (with S.H. Leu)

"Simulated Landfill Study on the Accelerated Biodegradability of Plastic Materials" , Polymer
Preprints, 31,1,439, (1990) (with S.M. McCartin, B. Press, R. Gross, D. Eberiel).

“Computer Flow Analysis Verification of Phenolics", Technical Papers, SPE, 36, 688 (1990).
(with P.A. O'Brien, J. P. Beaumont.)

"Effect of Glass Fiber Orientation on the Thermal Diffusitivity and Thermal Conductivity of
Polymer Melts", Technical Papers, SPE, 36, 565 (1990) (with K. Shah, S. Orroth.)

"Interfacial Agents for Blends of Polystyrene and Ethylene-Vinyl Alcohol Copolymers",
Polymer Preprints, 31 (1), 560, (1990). (with R. J. Spector.)

"Rheological and Mechanical Properties of Immiscible Blends of EVOH and Styrene-Based
Polymers", Technical Papers, SPE, 35, 1824, (1989). (with O. Chang, and N.R. Schott)
"Compressibility and Relaxation of Fiber Reinforcements During Composite Processing" Soc. of

Plastics Eng., Technical Papers, 36, 1252 (1990). (with Y.R. Kim, J.P. Fanucci,)

"Effect of Blends and Fillers on the Permeability of Linear Low Density Polyethylene", Soc. of
Plastics Eng., Technical Papers, 34, 1441, (1988). (with S. Shah)

"Verification of Material Characterization for Filling Simulation Software Packages", SPE
RETEC , L-1, (with S.A. Orroth, and R. Clarke,) (1988).

"Effects of Plasticizer Desorption, Temperature, and Pressure on the Permeability of Saran",
Journal of Vinyl Technology, 9, 129 (1987) (with J.S. Chen).

"Formation and Mechanical Behavior of Diffuse Banded Zones of PS/PPO Blends Under
Compressive Deformations", Poly. Eng. Sci., 27, 647 (1987).(with C.E. Rogers)

"Permeability of Polyvinylidene Chloride and Effects Due to Plasticizer Desorption", Technical
Papers, SPE, 33, 629, (1987). (with J.S. Chen)

"Diffuse Shear Banded Zones of PS/PPO", Technical Papers, SPE, 34, 497, (1986). (with C.E.
Rogers).

ECM Comb. Mot. to Exclude Page 50 of 58
Exh. U


668

J Polym Environ (2011) 19:637 676

has focused on the use of alternative substrates, novel
extraction methods, genetically enhanced species and
mixed cultures with a view to make PHAs more com-
mercially attractive [242, 580]. The classical microbiology
and modern molecular biology have been brought together
to decipher the intricacies of PHA metabolism both for
production purposes and for the unraveling of the natural
role of PHA [581]. It is easel to develop a commercially
attractive recombinant process for large scale production of
PHAs. PHA synthase (PhaC) enzymes, which catalyze the
polymerization of 3-hydroxyacyl-CoA monomers to
P(3HA)s, were subjected to various forms of protein
engineering to improve the enzyme activity or substrate
specificity [220]. The use of mixed cultures and renewable
sources obtained from waste organic carbon can substan-
tially decrease the cost of PHA and increase their market
potential [198].

Commercially available soy products, e. g., soy oil, soy
protein isolate, soy fiour, and soy protein concentrate, have
attracted significant attention because of their abundance,
low cost, and good biodegradability. Compared to the other
techniques such as heat treatment, co-blending with PCL
enhanced tensile strength and lowered water absorption.
Novel design strategies and engineering to provide
advanced polymers from natural sources are being made
[582]. The belief that sustainable production of chemicals
via “white biotechnology” and “green chemistry” is
indispensable for chemical industry is getting strengthened.
‘What are emerging are new boundaries where synthetic
and natural polymers converge. Initiatives such as bio-
inspired polymer design and engineered biopolymers
‘synthetically-inspired’ materials inspiring prospects for
polymer science at the bio-interface with new materials
taking natural and synthetic polymers beyond nature’s
limitations are promises to deliver advanced biodegradable
plastics. What are emerging are new boundaries where
synthetic and natural polymers converge to ecologically
sustainable and economically viable products and
processes.

Composite panels consisting of blended soybean oil-
based epoxy with synthetic epoxy resin and E-glass fiber
were shown to have a comparable dynamic stiffness,
flexural modulus, and flexural stiffness with those of syn-
thetic systems [583]. Natural fiber-reinforced materials
offer environmental advantages such as reduced depen-
dence on non-renewable energy/material sources, and less
pollutants and greenhouse emissions [100, 584, 585]. Their
low cost, high toughness, low density, good specific
strength properties, reduced tool wear (nonabrasive to
processing equipment), enhanced energy recovery, CO2
neutral when bumed, and biodegradability offer along with
their hollow and cellular nature make excellent reinforce-
ments for a variety of applications [586]. Nano fiber

D Springer

ECM Comb. Mot. to Exclude
Exh. Z

reinforcements give additional edge on properties over
other fibers [587]. Although initially expensive, the
increasing numbers of biodegradable matrices that have
appeared as commercial products offered by various pro-
ducers indicate the growing popularity of biodegradable

polymers.

Conclusions

Biodegradable polymers for short time applications have
attracted much interest all over the world in different
sectors such as surgery, pharmacology, agriculture and the
environment. The reason behind this growing interest is the
incompatibility of the polymeric waste with the environ-
ment where they are disposed after the usage. The recovery
of polymeric waste as a solution to this problem is not easy
or feasible, like in surgery for obvious reasons, or in the
environment in the case of litter. The development of novel
biodegradable polymers satisfying the requirement of de-
gradability, compatibility with the disposed environment
and the release of low-toxicity degradation products are the
ultimate solution to these issues. The recent technological
advances offer great promise towards achieving biode-
gradability with less pollutants and greenhouse emissions.
Linking performance with cost is a tremendous task which
needs imaginative steps in the selection of materials, pro-
cesses, product structures and production schedules. It
appears that there is a peaceable shift to derive more car-
bon from the renewable resources to preserve the eco
system. The petrochemicals as a sole resource for polymers
may have to undergo a shift towards the fermentation
industry wherein developments in genetic engineering
might generate high yielding microbes to produce mono-
mers and polymers at economically viable routes making
way for cost effective and ecologically sustainable biode-
gradable plastics.

Acknowledgments Thanks are due to Ms. Radhika Raveedran for
help in the preparation of the Figures.

References

. Vert M, Santos ID, Ponsart S, Alauzet N, Morgat JL, Coudane J

(2002) Polym Int 51:840 844

Vroman I, Tighzert L (2009) Materials 2:307 344

. Bastioli C (2005) Handbook of biodegradable polymers. Rapra
Technol. Ltd., Shawbury, UK

. Pilla CKS (1999) In: Vyas JN, Panda DL (eds) Saket plastics

hand book. Saket projects Ltd., Ahemadabad, pp 369 386

Middleton JC, Tipton AJ (2000) Biomater 21:2335 2346

Varlet PM, Rahn B, Gogolewski $ (1997) Biomater 18:257 266

Prokop A, Jubel A, Hahn U, Dietershagen M, Bleidistel M,

Peters C, Hofl A, Rehm KE (2005) Biomater 26:4129 4138

PE

—

Naw

Page 32 of 80


Subject to these reservations of rights, Complaint Counsel’s Final Proposed Witness List
is as follows:

Current and Former ECM Employees

1. Robert Sinclair, ECM President, in his individual capacity and as ECM
designee

Mr. Sinclair will testify about ECM’s advertising and products, including but not limited
to ECM’s distribution and sales channels; financial information; customer base; communications
with prospective customers, customers, former customers, ASTM, testing facilities, scientists
studying the putported biodegradability of plastics, Plastics Environmental Council, and other
parties regarding the ECM additive and purported biodegradability of plastic, BCM’s claims of
biodegradability of plastics treated with the ECM additive; ECM’s substantiation for those
claims; other testing regarding the ECM additive and the alleged biodegr adability of plastic;
facts alleged in the Complaint, any other issues addressed in his deposition (in his personal
capacity and as a corporate representative of ECM); any documents introduced into evidence by
Respondent or Complaint Counsel as to which he has knowledge; or any other matters as to
which he has knowledge that are relevant to the allegations of the Complaint, Respondent’s
affirmative defenses, or the proposed relief.

2. Kenneth C. Sullivan, Jr., ECM Chief Financial Officer

Mr. Sullivan will testify about ECM’s advertising and products, including but not limited
to ECM’s distribution and sales channels; financial information; customer base: any other issues
addressed in his deposition: any documents introduced into evidence by Respondent or
Complaint Counsel as to which he has knowledge, or any other matters as to which he has
knowledge that are relevant to the allegations of the Complaint, Respondent’s affirmative

defenses, or the proposed relief

ECM Comb. Mot. to Exclude Page 3 of 16
Exh. F


40. _ A third feature of waste containment is the monitoring protocol, by which the
operator monitors the groundwater and soil vapor surrounding the containment areas, and if
needed, institutes appropriate remedial measures to prevent groundwater contamination. Such
remedial measures, again, often serve to reduce moisture and slow biodegradation.

Figure 3. Typical Subtitle D Landfill Schematics

Gas

andl Gas
Coliection
System

Landfill ;

Leachate
Collection
syste

Leachate

41. A fourth feature of waste containment is the gas collection and control system.
Under the Clean Air Act (CAA), MSW landfills must assess whether a threshold mass of non-
methane organic compounds (NMOCs) are produced per year (50 Mg yr’'), and if so, gas must
be collected and controlled. The CAA regulations require monitoring and maintenance of the
GCCS, which includes evaluating gas quality, landfill gas temperature, and extraction pressure
on a routine basis from required collection points. For GCCS operated without a stringent
regulatory framework, similar monitoring and maintenance measures may be employed to reduce
environmental emissions and to optimize gas recovery when an energy conversion system is
present. Gas collection and control systems usually include wells or trenches constructed in the
waste to provide a conduit for gas removal, well-head controls at individual or clustered

18

ECM Comb. Mot. to Exclude Page 18 of 56
Exh, X


From: lohnson, Katherine

To: Peter Arhangelsky
Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Date: Monday, May 05, 2014 1:49:18 PM

Attachments: Pr pul i

Peter:

As discussed, attached is our proposed stipulation concerning the Ohio State Study. Please review
and let me know whether we have your permission to sign on your behalf and file it tomorrow.

Katherine

Katherine E. Johnson, Attorney

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, DC 20580

Direct Dial: (202) 326-2185

Fax: (202) 326-2558

Email: klohnson3@ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Friday, May 02, 2014 4:52 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Hi Katherine,

I can inform you now that we will formally agree to stipulations with regard to Dr. Michel’s
documents in lieu of the deposition, as we did with OWS. Please let me know if you have any
questions, or if you need to discuss.

Thanks,

Peter

Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ
85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidentiai communication intended for the recipient listed above. The content of this
communication is protected from disclosure by the attorney-client privilege and the work product doctrine. if
you are not the intended recipient, you should freat this communication as strictly confidential and provide it to
the person intended. Dupiication or distribution of this communication is prohibited by the sender. IH this
communication has been sent to you in error, please notify the sender and then immediately destroy the

ECM Comb. Mot. to Exclude Page 1 of 9
Exh. H


of the ASTM D5511. For example, measuring gas volume using a graduated cylinder one would
expect to be off by 5%. This is true because we are using the human eye and human judgment to
decide if the gas volume is 8.3 mL or 9.2 mL. This is true with the ASTM D5511 methodology
as a whole and not particular to this experiment. The gas volume measurement protocol
proscribed in the ASTM D5511 contains an inherent high level of variability.

84. — Similarly flawed is Analytical Report ASTM D5511 (ECM-FTC-000503), which
purports to show 4.54% biodegradability of polypropylene clear tape in 45 days. As with the
report discussed above, this minimal biodegradation is not statistically significant. Moreover,
the report offers no scientific justification for the assumption that biodegradation that plateaued

will resume.

iv. Other Reports and Tests

o Ecologica Report

85. The Ecologica Report, ECM-FTC-000226, “Report about biodegradability of a
plastic artefact [sic] . . .” by Ecologia Applicata srl., Cert No. 130/bio/180/10, Nov. 19, 2010,
purports to show aerobic decomposition of a plastic artifact containing 1% ECM additive, with
20% biodegradation over a period of 180 days. It is generous to describe this as a “test report”
because the document contains no information about methodology or how biodegradation was
calculated. Moreover, the report’s biodegradability (on page ECM-FTC-000228) suggests that at
day zero, there was 1.6% biodegradability—a scientific impossibility which undermines the
accuracy of the biodegradation model and the results of this study.

o Additional Biodegradation Tests of ECM Plastic

85. I reviewed additional biodegradation tests of ECM plastic from various
laboratories. Almost half of the tests showed no biodegradation or incomplete biodegradation of

the plastic. The remaining tests are not competent and reliable evidence to support ECM’s

33

ECM Comb. Mot. to Exclude Page 33 of 56
Exh. X


c, Plastic Seminar Activities

The development of the seminar courses offered through the Department of Continuing Education
(initiated in the Spring of 1985) have led to a total enrollment in excess of 200 students with a
gross income of approximately $275,000.00. The income from these seminars is distributed in a
manner that is similar to income from grants and contracts. Namely, a portion is utilized for salary,
income or the Continuing Education Office, income for the Plastics Engineering Department,

d. Awards

Spring 2003: Plastics Engineering Department Teaching Award — award given to the outstanding
faculty member as voted on by the students in the Department of Plastics Engineering

During the Spring Semester of 1988 received a $750.00 Faculty Scholarship through the office of
President Hogan as support in pursuit of my J.D. degree with a concentration in patent
law/intellectual property.

During the Merit Evaluation period, April 1, 1985 through March 31, 1986, I received a $2000.00
award for Professional Development from the College of Engineering.

During the Merit Evaluation period, April 1, 1986 through March 31, 1987, I received a
$750.00 award for Professional Development from the College of Engineering.

Text Materials, Publications, Conference Papers, Patents, Presentations, Research Reports
and Thesis:

a. Text Materials

S. J. Grossman and 0. Vogl, "Head-to-Head Polymers", Encyclopedia of Polymer Science
and Technology, John Wiley Interscience (1987). [The Encyclopedia of Polymer Science and
Engineering is a collection of extensive reviews by the leading authorities in the field of polymer
science Many consider it as the primary reference for collecting information on advanced research
and the status of current technology.]

b. Publications

S. Grossman & B. Filip — The American Inventors Act: Six Key Changes In U.S. Patent
Law, 2012 SPE-ANTEC

Page 8 of 17

ECM Comb. Mot. to Exclude Page 8 of 17

Exh. Y


662

J Polym Environ (2011) 19:637 676

and metabolic pathways involved in the production of
lactic acid by fungal strains are discussed by Zhang et al.
[535]. In another study involving osteointegration of
poly(L-lactic acid)PLLA and poly(l-lactic acid)PLLA/
poly(ethylene oxide)PEO implants in rat tibiae, Corac et al.
showed that newly formed bone was found around both
PLLA and PLLA/PEO implants. PLLA/PEO blends had a
porous morphology after immersion in a buffer solution
and in vivo implantation. The proportion 50/50 PLLA/PEO
blend was adequate to promote this porous morphology,
which resulted in gradual bone tissue growth into the
implant [536].

Petrie et al. investigated the osteogenic potential of a
novel stem cell was analyzed on biodegradable poly(lactic-
co-glycolic acid) (PLGA) biomaterials as a step toward
creating new cell-materials constructs for bony regenera-
tion [537]. Dura mater stem cells (DSCs), isolated from rat
dura mater, were evaluated and compared to bone marrow
stem cells (BMSCs) for proliferative and differentiative
properties in vitro, DSCs demonstrated greater cell cover-
age and enhanced matrix staining on 2D PLGA films when
compared with BMSCs. These cells can be isolated and
expanded in culture and can subsequently attach, prolifer-
ate, and differentiate on both TCP and PLGA films to a
greater extent than BMSCs. This suggests that DSCs are
promising for cell-based bone tissue engineering therapies,
particularly those applications involving regeneration of
cranial bones.

Cheung et al. showed that the use of silk fibers as
reinforcements in PLA was a good candidate for the
development of polymeric scaffolds for tissue engincer-
ing applications [538}. Lu et al. synthesized a series of
biodegradable poly(L-lactide-co-e-caprolactone) (PCLA)
copolymers with different chemical compositions. These
polymers exhibited shape-memory behaviors [539]. The
tensile strength of copolymers decreases linearly and the
elongation at break increases gradually. By means of
adjusting the compositions, the copolymers exhibit excel-
lent shape-memory effects with shape-recovery and shape-
retention rate exceeding 95%. The degradation results
show that the copolymers with higher e-CL content have
faster degradation rates and shape-recovery rates, mean-
while, the recovery stress can maintain a relative high
value after 30 days in vitro degradation.

Chiu et al. report the fabrication carbon nanotubes
(CNTs) embedded in a polylactic acid (PLA) matrix to
obtain a composite nanostructure. Purified CNTs showed
better dispersing and properties in the CNTs PLA Nano-
composites [540]. The nanoclay-loaded PLLA substrates
were used for preparing polymer photovoltaic devices
[541]. Devices were realized by application of a conducting
transparent anode comprising an aluminium grid with a
thin over layer of silver and spin-coated PEDOT:PSS. The

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

active layer consisted of microfibrillar P3HT and PCBM to
encompass the low processing temperatures for PLLA and
finally an evaporated aluminium cathode. It was found that
PLLA as a substrate holds potential, but there are several
challenges beyond the photovoltaic itself which must be
met before general application within this field can be
envisaged.

With the increasing interest in developing fully biode-
gradable materials for industrial applications, use of natural
fibers in PLLA matrix poses an interesting alternative
economically. Composite combining biodegradable poly-
mer and natural fiber could be a fully biodegradable
material. This work focus on the investigation on China
jute fiber reinforced PLA composites. Composites with
three different fiber volume fractions were fabricated by
film stacking hot press method. Mechanical properties have
been investigated and the microstructure of the composites
was observed. Fiber surface treatment by silane was
applied in order to investigate the effects on the properties
of the composites. The moisture absorption rates in a
hydrothermal environment were also measured. In terms of
the mechanical properties, the wood-fiber-reinforced
poly(lactic acid) composites were comparable to conven-
tional polypropylene-based thermoplastic composites
[542]. The mechanical properties of the wood-fiber-rein-
forced poly(lactic acid) composites were significantly
higher than those of the virgin resin. The flexural modulus
(8.9 GPa) of the wood-fiber-reinforced poly(lactic acid)
composite (30 wt % fiber) was comparable to that of tra-
ditional (i.e., wood-fiber-reinforced polypropylene) com-
posites (3.4 GPa The incorporation of the wood fibers into
poly(lactic acid) resulted in a considerable increase in the
storage modulus (stiffness) of the resin. The addition of the
maleated polypropylene coupling agent improved the
mechanical properties of the composites. Microstructure
studies using scanning electron microscopy indicated sig-
nificant interfacial bonding between the matrix and the
wood fibers. The specific performance evidenced by the
wood-fiber-reinforced poly(lactic acid) composites may
hint at potential applications in, for example, the automo-
tive and packaging industries.

PLA (polylactic acid) was reinforced with Cordenka
rayon fibres and flax fibres, respectively [543]. The
mechanical properties of these composites which are
examples for completely biodegradable composites were
tested and compared. The samples were produced using
injection molding. The highest impact strength (72 kJ/m*)
and tensile strength (58 MPa) were found for Cordenka
reinforced PLA at a fibre-mass proportion of 30%. The
highest Young’s modulus (6.31 GPa) was found for the
composite made of PLA and flax. A poor adhesion between
the matrix and the fibers was shown for both composites
using SEM. The promising impact properties of the

Page 26 of 80


ECM Comb. Mot. to Exclude
Exh. N

Resp. Mot to Compel and For Sait
Exh, RX-
CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER



Tycom, Undersea Photonic Connector, $161,000

Metabolix Inc., Performance of PHA Derived Chemicals and Polyols in Polyurethane, $141,465

Duracell Company, Polymeric Batteries, $140,000

3M, “Composting Research”, $155,000

Massachusetts Technology Collaborative John Adams Innovation Institute, “Massachusetts
Medical Device Development Center”, $150,000

UMass Presidents office Seed Funding “Massachusetts Medical Device Development Center”,
$135,000.

Monsanto Company, “Mold Analysis Research”, $123,000,

Warmer Lambert, “Biodegradable Polymer Research”, $116,591

National Science Foundation, “Biodegradable Polymer Research Center”, $110,000 (8/93-8/95)

Massachusetts Centers of Excellence, “Mold Analysis Research”, $110,000

Department of the Army, “Polymer Degradation Research”, $104,000

Army Research Office “Aqueous Processing of Biopolymers”, $97,502

Digital Equipment Company, “Rapid Prototyping”, $86,500

American Composite Technology “Pultrusion Process Modelling”, $83,300

Cabot Corporation, “Material Research for Ear Plugs”, $77,740

Institute for Plastics Innovation, “Injection Molding Research”, $75,000

Massachusetts Centers of Excellence, “Institute for Plastics Innovation”, $75,000

Metabolix Inc., Performance of Polyhydroxyalkanote Derived Chemicals and Polyols in
Polyurethane, $71,465

Xenith Athletics, Inc., “Development Project for Impact Protection Equipment”, $70,428

Vista Scientific, “Nanosphere-Antibiotic Corneal Contact Lens Delivery System, $ 70,000

Eastman Kodak, “Expert System Research”, $60,000

Battelle, “Biodegradable Packaging Development”, $59,865

DuPont Corian, $50,000

General Electric Company, “Mold Analysis Research”, $50,000

GTE / Sylvania Corporation, “Mold Analysis Research”, $49,000

Johnson & Johnson, “Material Research for Toothbrushes”, $45,500

Monsanto Company, “Polymer Degradation Research”, $40,000

Polysar Inc., “Polymer Degradation Research”, $40,000

Himont USA, Inc., “Mold Analysis Research”, $31,400

University of Massachusetts President Office, CVIP Technology Award, $30,000

Allied Signal, “Mold Analysis Research”, $30,000

Implant Sciences Corporation Biodegradable Implant for Radiation $30,000

Rexam Corporation, $30,000

Invista, “Evaluation of Plasticizers”, $ 28,000

Evenflo Products Company, “Baby Bottle Nipple Materials”, $27,000

Massachusetts Centers of Excellence, “Polymer Degradation Research”, $25,000

Polysar, Inc., “Permeability of Coextruded Sheet”, $24,000

United States Army ARDEC, “Materials Development for Armament Packaging”, $24,988

MoMelan Technologies, Inc., “Skin Grafting”, $23,000

Smart Surfaces Inc., “Smart Mattress”, $23,000

United States Army, “Theoretical Modelling of Transport”, $21,000

Exxon Company, “PVC Plasticizer Desorption”, $20,300

Advanced Electron Beam, “Low Energy Industrial Beams on Polymeric and Plastic Materials”,
$20,000.

Eastman Kodak, “Mold Design Software Development”, $20,000

Dow Chemical Company, “Mold Analysis Research”, $20,000

ECM Comb. Mot. to Exclude Page 43 of 58
Exh. U


motivation to modify the disclosures in the prior art, a prima
facie case of obviousness has not been established. applicants
respectfully request reconsideration and withdrawal of the

rejections based on Shimadzu.

351LS.C. § 102(b) or 103(a) over Sinclair (U.S. Patent No.

5.216,050) or Sinclair (U.S. Patent No. 5,252,642)

Claims 1, 3-5, 11-18, and 22 have been rejected as
allegedly anticipated by, or in the alternative, obvious in view
of the Sinclair '050 or ‘642 patents. Applicants respectfully
traverse these rejections for the following reasons.

Sinclair '050 discloses degradable compositions
comprising blends of polylactic acid and polymers based on
polyethylene terephthalate and other polymers. No other examples
of polyesters which could be blended with polylactic acid are
given in Sinclair ‘050. The compositions are made up of
“heterogeneous domains of 3 microns or less" ay revealed by
optical microscopy at 310 x (Col, 4, lines 63-65). These domains
are spherical, and are believed to consist of polylactic acid
which is "mostly buried" (Col. 8, lines 3-6).

In view of the amendment to claim 1,.veciting the
formation of a continuous or co-continuous phase of the second
Polymer in the blend, applicants submit that the invention is not
anticipated by Sinclair ’050. In applicants’ claimed blends, the
first and second polymers form an interlocking lattice of
materials. The polylactic acid component of the claimed blend is

mot at all "mostly buried," but instead is evenly distributed and

8

ECM Comb. Mot. to Exclude

Exh. Z

Page 59 of 80


ECM Comb. Mot. te Exclude Resp. Mot to Compel and For Saftiions 4 of 12

Exh. RX-C-1
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


The elements of successful landfill biodegradation of PVC comprise a
combination of additives to absorb HCI, promote plasticizer
hydrolysis, facilitate HC/ elimination during degradation, and to
stabilize radicals formed long enough to favor reaction (2) above over
reaction (3). The use of an organotin carboxylate stabilizer provides a
combination heat stabilizer/hydrolysis catalyst.

Variations of samples A through D and the control PVC sample, all
containing 5 phr titanium dioxide, were subjected to 1000 hours UV-A
exposure at 30 C. All showed AE increases in color in the range of
4-2 units, with little or no differences among them. It is likely that such
products would be useful in non-permanent outdoor displays such as
billboard backings. This is an area where landfill disposal of
significant quantities of flexible PVC would have utility.

It remains an open question whether unplasticized PVC could be
formulated to show a similar response. This might be possible with
PVC/wood fiber composites, cellulose substituting for more or less
edible plasticizers.

References

1. |. Mersiowsky, J.Vinyl & Additive Tech., 8, 36 (2002).
2. R.F. Grossman, Vinyltec 2005.
3. US Patent pending. Assignee Ultraflex Systems will license.

ECM Comb. Mot. to Exclude Page 47 of 80
Exh. Z


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

300000

2
s

SI

200000

150000
100000

Modulus, p.

50000 +

0 20 40 6080 Too
Bionolle Content, wt%

—— B10#6000 Blends, Aging for 7 Days
--L+-- BI0#7000 Blends, Aging for 7 Days
tettterses Bl0#6000 Blends, Aging for 21 Days
~~ —- BI0#7000 Blends, Aging for 21 Days

FIG. 7

ECM Comb. Mot. to Exclude Page 68 of 80

Exh. Z


Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

5. Michelle R. Leicher, ECM Biofilms, Inc.

Counsel for ECM Biofilms, Inc.
Jonathan W. Emord

Emord & Associates, P.C.
11808 Wolf Run Lane

Clifton, VA 20124

Email: jemord@emord.com

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

6. Kristen A. Marineau, ECM Biofilms, Inc.

Counsel for ECM Biofilms, Inc.
Jonathan W. Emord

Emord & Associates, P.C.
11808 Woif Run Lane

Clifton, VA 20124

Email: jemord@emord.com

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

7. Vesna Barnjak, Former Employee of ECM Biofilms, Inc.
Proposed Testimony: We anticipate that this witness will testify about ECM’s products,

distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

8. Elizabeth M. Eberly, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims,

9. Chessa C. Gottron, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims,

10. Anne C. Hassoldt-Fenoff, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims,

3

ECM Comb. Mot. to Exclude Page 3 of IL
Exh. A



#8
2 PATENT
ATTORNEY DOCKET NO: 08688/025001

COMBINED DECLARATION AND POWER OF ATTORNEY

4 below named inventor, I hereby declare that:

My residence, post office address and citizenship are as stated below aext to my name,

{ believe I am the otiginal, first and sole inventor {if only one name is listed below) or an original, first
and joint inventor (if plutal names are listed below) of the subject matter whichis eltineg and for which a
Patent is sought on the invention entitled POLYLACTIC ACID BASED BLENDS. the specification of which
Dis attached hereto,
was filed on 04/03/97 as Application Serial No, 08/825,810 and was amended on .
O was described and claimed in PCT Intemational Application No,
filed on and as amended under PCT Article 19 on

J hereby state that I have reviewed and understand the contents of the above-identified specification,
including the claims, as amended by any amendment referred to above.

1 acknowledge the duty to disclose all information know to be material to patentability in accordance |
with Title 37, Code of Federal Regulations, §1.56,

Lag’ BeetY appoint the following atiomeys and/or agents to prosecute this ‘application and to transact all
fad byéiness in the Office connected therewith: J, Peter Fasst lo. 32,983, Rox

a sao, Reg. No. 34,053 i
Address all telephone calls to J. Peter Fasse at telephone number 617/542-5070,

{Address all correspondence to J, Peter Fasse, Fish & Richardson P.C., 225 Franklin Steet Boston,
MA 02110.

‘hereby declare that all statements made berein of my own knowledge are true and tha all statements
nate on information and belief are believed to be tue; and further that these statersente were made with the
knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both,
under Section 1001 of Title 18 of the United States Code and that such willl false ‘statements may jeopardize
‘he validity of the application or any patents issued thereon,

Full Name of Inventor: Stephen P. McCarthy {| —O ©

¢
Inventor's Signature: Date: Uazfe2

v
Residence Address: Tyngsboro, Massachusetts LIA.
7

Cipteen of USA.

Post Office Address: 7 Westland Road, Tyngsboro, Massachusetts 01879

Page 50 of 80
ECM Comb. Mot. to Exclude gi

Exh. Z


638

J Polym Environ (2011) 19:637 676

from renewable resources have attracted much interest in
recent years because of its desirable properties of bio-
compatibility, biodegradability and natural abundance
(2 4]. A number of biodegradable polymers of natural and
synthetic origin with good biodegradability and biocom-
patibility have been made recently. However, they have
their inherent problems that need to be discussed and sci-
entific and technological solutions arrived at. This review
Proposes to discuses the salient features of biodegradable
polymers with special emphasis on the problems and
Prospects of (1) approaches adopted to make nonbiode-
gradable synthetic polymers biodegradable taking poly-
ethylene as an example and (2) biodegradable polymers
and copolymers made from renewable resources such as
lactic acid. Currently, polylactide (PLA)/polyglycolide
polymers are the most widely used synthetic biodegradable
polymer for biomedical applications [5 8]. However, cer-
tain limitations of PLA such as low hydrophilicity and
degradation rate, poor soft tissue compatibility, low ther-
mal and physical properties, lack of processability, high
cost of production along with its increased use in medicine
put forward the necessity in the search of new materials
that exhibit unique properties for specific applicability in
the field [9, 10].

Definition of Biodegradation

The various definitions of biodegradation depend on the
field of application of the polymers (biomedical area or
natural environment). Many different definitions have
officially been adopted, depending on the background of
the defining standard organizations and their particular
interests. Van der Zee and Seal [11, 12] review all of the
definitions found in different standards. Albertsson and
Karlsson [13] defined biodegradation as an event that takes
place through the action of enzymes and/or chemical
decomposition associated with living organisms and their
secretion products. It is also necessary to consider abiotic
reactions like photodegradation, oxidation and hydrolysis,
which may alter the polymer before, during or instead of
biodegradation because of environmental factors. So,
strictly speaking, “biodegradation of a polymer” is defined
as the deterioration of its physical and chemical properties
and a decrease of its molecular mass down to the formation
of CO2, H20, CH, and other low molecular-weight prod-
ucts under the influence of microorganisms in both aerobic
and anaerobic conditions aided by abiotic chemical reac-
tions like photodegradation, oxidation and hydrolysis [14].

According to ASTM D 6400-99 [15 19] biodegradable
plastic is defined as degradable plastic in which the
degradation results from the action of naturally occur-
ring microorganisms such as bacteria, fungi and algae.

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

Compostable plastic is a plastic that undergoes degradation
by biological processes during composting to yield CO»,
water, inorganic compounds and biomass at a rate consis-
tent with other compostable materials and leaves no visi-
ble, distinguishable or toxic residue.

Chemistry of Biodegradation

Biodegradation is the only degradation path way that is
able to completely remove a polymer or its degradation
products from the environment. Biodegradation takes place
in two stages (Fig. i): The first stage is the depolymer-
ization of the macromolecules into shorter chains. This step
normally occurs outside the organism due to the size of the
polymer chain and the insoluble nature of many polymers.
Extra-cellular enzymes (endo or exo-enzymes) and abiotic
reactions are responsible for the polymeric chain cleavage.
During this phase the contact area between the polymer and
the microorganism increases [20, 21}.

The second step corresponds to the mineralization. Once
sufficient small size oligomeric fragments are formed, they
are transported into cells where they are bioassimilated by
the microorganisms and then mineralized [22, 23]. Bio-
degradation takes place in two different conditions
depending upon the presence of oxygen; aerobic biodeg-
radation (in the presence of oxygen) and anaerobic bio-
degradation (in the absence of oxygen). Complete
biodegradation or mineralization occurs when no residue
remains, i.e., when the original product is completely
converted into gaseous products and salts [24].

Biodegradable Polymers: An Overview

Several books and reviews have been published on this
area covering many aspects of biodegradation and biode-
gradable polymers. In one of the earliest texts on the
subject of degradation of polymers, Schnabel [25] dis-
cussed the mode of polymer degradation in four main
categories: biodegradation, oxidation, hydrolysis and pho-
todegradation. Ching et al. [26] and Kaplan et al. [27]
presented biodegradable polymers from the point of view
of packaging materials. The salient features of biodegrad-
able polymers have been brought out by Vert et al. [28] in
their books on Biodegradable polymers and plastics.
Hamid et al. [20] have edited a handbook on polymer
degradation.

The proceedings edited by Doi and Fakuda [29] deal
with biodegradability including environmental biodegra-
dation, synthetic techniques, morphology and blends, test
methods and governmental policies. The chemistry of
biodegradable polymers has been brought out in the text

Page 2 of 80


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. - Page 4

engineering and polymer research. My research has led to seven patents related to polymers or
plastics engineering.

6. Also during my tenure at the University, I have as the Director of the University’s
Bioplastics Institute and Medical Plastics Research Center, Director of the University’s Institute
for Plastics Innovation, and Graduate Coordinator for the Plastics Engineering Department. In
addition, I served as the Director of the National Science Foundation’s Center for Biodegradable
Polymer Research.

7. In addition to my university activities, I am also the Editor of the JOURNAL OF
POLYMERS & THE ENVIRONMENT, the official journal for the BioEnvironmental Polymer Society,
which promotes research to develop degradable polymers. This editorship builds on the work I
did as a member of the Editorial Board of the JOURNAL OF APPLIED POLYMER SCIENCE from
1995 to 2003.

8. I have received a number of awards for my work in the field of plastics
engineering and polymer research, including a BioEnvironmental Polymer Society (BEPS) James
Hammar Memorial Lifetime Achievement Award (2008), two Society of Plastics Engineering
Best Paper Awards (Medical Plastics in 2005 and Color and Appearance in 2000 and the Society
of Plastics Engineering Education Award in 2014). I also received the Society of Plastics
Engineering Education Award earlier this year.

9. Since 1981, I have authored or co-authored more than a hundred publications
related to polymer or plastics engineering. Additionally, I have lectured both around the country
and around the world (in Israel, Ireland, Turkey, Canada, India, Italy, Sweden, Japan, China,
Indonesia, Taiwan, Korea) on plastics engineering, “green” plastics, and biodegradable
polymers. I have also given seminars in plastics engineering to research and development teams
at Hewlett-Packard, Exxon, 3M, and Clariant.

10. Currently, I am a member of the American Society for Testing and Materials

(now known as ASTM International, Inc.). In the past, I belonged to various professional

ECM Comb. Mot. to Exclude Page 4 of 58
Exh. U


GPEC 2006 Paper Abstract #9B
Title: Considerations Affecting Biodegradability of PVC

Authors: Richard F. Grossman, PhD, RFG Consultants, John E. Schleicher, Jr. and Lorna
D'Alessio, Ultraflex Systems

ABSTRACT

Carbon-chlorine bonds are not a barrier to biodegradation. Bacteria and fungi exist that can, for
example, metabolize PCBs and pentachlorophenol. The difficulty with polymers of all types is
molecular weight. Biodegradation of PVC film and sheet under landfill conditions requires an
additive package that, under such conditions, initiates degradation and directs its course to chain
scission rather than crosslinking. A class‘of'such additives -has'been found. Since food
metabolism occurs outside the micro-organism, it is further necessary to direct the sensory
capability of bacteria and fungi towards the article by including migratory components that will
be recognized as nutrients. A discussion of useful fillers and plasticizers is presented as well as
the degradation path envisioned.

ECM Comb. Mot. to Exclude Page 41 of 80
Exh. Z


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 27

level tests adequately supports the conclusion that ECM Plastic is biodegradable or will
biodegrade to completion. (Indeed, many tests indicate otherwise.) Second, there is no scientific
support for the assertion that microorganisms will work synergistically to produce enzymes that
would allow microorganisms to metabolize the plastic. This is contrary to widely-accepted
scientific knowledge regarding how such microorganisms function with respect to conventional
plastic. Third, the tests ECM relies on were conducted and/or reported in a deficient manner
such that the results are insufficient to support ECM’s conclusions.

Cc. Analysis of ECM’s Claims and Testing.

i. ECM’s Substantiation Does Not Support Its Claims.
68. It is my expert opinion that at least one confirmatory test must be conducted to

establish that the plastic component of the ECM Plastics will biodegrade. ECM could have
performed confirmatory testing by radiolabeling or by conducting a gas evolution test showing at
least 60% conversion to methane and carbon dioxide within 18 months.

69. | Without any confirmatory testing, ECM does not have adequate scientific support
for its claims. The screening-level tests ECM relies on to support its claims extrapolate from
minimal biodegradation to a conclusion of complete biodegradation. Such extrapolation is
scientifically invalid because biodegradation is not linear and typically slows down due to
recalcitrance.!? (And, in fact, all of the tests performed on ECM Plastics reflect the typical

plateauing associated with recalcitrance.)

” For those tests conducted under the ASTM D5511 method, the invalidity of
extrapolating these results to completion is reflected in the test method itself, which precludes
extrapolation “Claims of performance shall be limited to the numerical result obtained in the test
.... Furthermore, results shall not be extrapolated past the actual duration of the test.” ASTM
Int’l, D 5511: Standard Test Method for Determining Anaerobic Biodegradation of Plastic
Materials Under High Solids Anaerobic Digestion Conditions 1.4 (2012).

ECM Comb. Mot. to Exclude Page 27 of 58
Exh. U


PUBLIC DOCUMENT

imposing sanctions on Complaint Counsel, warrants imposition of additional, more stringent
sanctions. If and only if this Court does not exclude Dr. Michel and his rebuttal report—despite
Complaint Counsel’s willful violation of the discovery rules—ECM requests leave to present the
surrebutta] testimony of Dr. Steven A. Grossman, a Professor of Plastics Engineering at the
University of Massachusetts-Lowell.

FACTS

A. Complaint Counsel Never Listed Dr. Michel as an Expert Witness:

Complaint Counsel provided ECM with its preliminary witness list on January 17, 2014.
Dr. Michel is not listed. See CC’s Preliminary Witness List, Exh. A. On March 5, 2014,
Complaint Counsel provided ECM with its expert witness list. Dr. Michel is not listed. See Exh.
B. On March 18, 2014, Complaint Counsel supplemented its Initial Disclosures to include Dr.
Michel as someone who may have relevant information. See Exh. C. Despite that disclosure,
and on the very next day, Complaint Counsel provided ECM with a Supplemental Expert
Witness List, which did not include Dr. Michel. See Exh. D. On April 23, 2014, Complaint
Counsel reiterated that their expert witness list, which did not include Dr. Michel, “remain[ed]
unchanged.” See Exh. E. On June 11, 2014, Complaint Counsel provided ECM with its final
proposed witness list, which did not include Dr. Michel in any capacity, although it listed their
other experts. See Exh. F. To date, despite five distinct opportunities, Complaint Counsel has

failed to identify, list, or designate Dr. Michel as a witness.

B. Complaint Counsel Induced ECM to Believe that Dr. Michel Was a Non-Testifying Fact
Witness and Never Represented that He Would be an Expert or Rebuttal Witness:

While never listing, designating, or identifying Dr. Michel as an expert or rebuttal expert
in any disclosure, Complaint Counsel did represent that it intended to depose Dr. Michel as a fact

witness in May 2014. See Exh. G; Exh. H. At that time, Complaint Counsel secured
5


UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION

PATENT NO. 2 5,883,199
APPLICATION NO. _: 08/825810
DATED : March 16, 1999
INVENTOR(S) : McCarthy et al.

Page | 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 “1:0” 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--

ECM Comb. Mot. to Exclude

Exh. Z

Signed and Sealed this
Eighth Day of March, 2011

David J. Kappos
Director of the United States Patent and Trademark Office

Page 80 of 80


J Polym Environ (2011) 19:637 676

667

material mirroring styrenics in mechanical properties)’
Germany’s BASF (biodegradable _aliphatic-aromatic
copolyesters)’ Ecovio L (biodegradable foams that are
making a potential heir apparent to the polystyrene foam
containers)’ Rejuven8 Plus sheet is a strength modified
grade with impact properties similar to polyethylene tere-
phthalate (PET), Braskem Technology, Brazil-based pet-
rochemical firm (biobased high density polyethylene
(HDPE) to cite a few. Researchers at the Pacific Northwest
National Laboratory has also reported a breakthrough in
converting common sugars, fructose, and glucose into fuel
and polyester building blocks. Metabolix is commercial-
izing a family of polymers (PHA natural plastics) made
from renewable resources such as com sugar and vegetable
oils. Within the foreseeable future, this technology will
also enable the production of these Natural Plastics directly
in non-food plant crops. These high performing new
materials have the potential to put a large portion of the
plastics and chemicals industry on a sustainable basis.

There is pressing need to enhance the versatility of these
bioplastics, so that it can compete with conventional
polymers. However, in situations that require a high level
of impact strength, the toughness of polylactide in its
pristine state is often insufficient. As such, there has been
tremendous effort in developing ways to improve this
material property deficiency. Several lines of futuristic
thoughts are on the anvil. Bringing down the production
cost by using better production technologies, toughening
the polylactide through various means such as orientation,
plasticization, copolymerization and blending, using
nanostructured reinforcements, are some of the strategies
being explored [425, 441]. Use of special catalysts in metal
assisted ROP of lactide or use of multifunctional initiators
might provide structure controlled macromolecules with
specific functional properties [432].

Blending is agreeably an area of great promise. For
example, when a small amount of ductile PHA is blended
with poly(lactic acid) (PLA), a new type of polymer alloy
with much improved properties is created. The toughness
of PLA is substantially increased without a reduction in the
optical clarity of the blend. The synergy between the two
materials, both produced from renewable resources, is
attributed to the retardation of crystallization of PHA
copolymers finely dispersed in a PLA matrix as discrete
domains [571]. Similarly, the use of silk fibers was found
to be a good candidate, as reinforcements in PLLA for the
development of polymeric scaffolds for tissue engineering
applications [538]. The combination of biodegradable
polymers and CNTs opens a new perspective in the self-
assembly of nanomaterials and nanodevices [572]. Mod-
eling and related studied might throw more light on the
intrinsic brittle nature of poly(lactide)s. For example, the
stiffness of a polymer chain, expressed as the characteristic

ECM Comb. Mot. to Exclude
Exh. Z

ratio C,, plays an important role in the deformation
mechanism of amorphous polymers [573].

Another question is the recyclability of industrial pro-
duction as the economic viability of PLLA has become
industrially feasible [574]. Large enzyme quantities
(500 600 wt%) are necessary to achieve high to complete
depolymerization in 24 48 h [54]. The enzymatic approach
is interesting not only for the ROP of factide but also for
the PLA recycling via depolymerization. Increasing inter-
est has also been dedicated to chemically modified poly(a-
hydroxy acids). In this regard, the preparation and poly-
merization of various substituted 2,4-dioxane-2,5-diones
have demonstrated that the polymer properties are tunable
across a broad range. Poly (a-hydroxy acids) featuring
pendant functional groups also appear particularly prom-
ising sustainable materials and further developments in this
direction should be facilitated using O-carboxy anhydrides
which are readily available, structurally moldable and
highly polymerizable monomers [575]. Methods such as
organocatalyzed ROP of lacOCA are indeed competitive
routes to make PLAs of controlled molecular weights and
narrow polydispersities under particularly mild conditions
[576].

Reddy et al. demonstrates that with many applications in
food, pharmaceutical, leather, textile industries and as
chemical feed stock, microbial fermentations are preferred
over chemical synthesis of lactic acid due to various factors
and direct conversion of starchy biomass to lactic acid by
bacteria possessing both amylolytic and lactic acid pro-
ducing character will eliminate the two step process to
make it economically viable (577]. Refined sugars, though
costly, are the choice substrates for lactic acid production
using Lactobacillus sps. Complex natural starchy raw
materials used for production of lactic acid involve pre-
treatment by gelatinization and liquefaction followed by
enzymatic saccharification to glucose and subsequent
conversion of glucose to lactic acid by Lactobacillus
fermentation.

Higher activities and better control can be expected in
due course by further optimizing the initiator structure and
polymerization procedure [578, 579]. In particular, further
improvements may be anticipated for the stereocontrolled
ROP of lactide using well-defined complexes, with non-
metallic systems being likely to attract increasing interest
[432].

Poly (hydrohybutyrate-co-hydrohyvalerate) (PHBV)
copolymers have received significant scientific attention
recently due to the fact that they are biodegradable, and
their properties can be easily controlled by the content of
hydroxy valerate (HV). PHBV copolymers with different
content of hydroxyvalerate have been used recently as
matrices in eco-composites [1, 2], where different natural
fibers were applied as reinforcement [100]. Recent research

® Springer
Page 31 of 80


Kuo, Changshu Linus, “Synthesis and Characterization of Polybutadiene-Polyaniline Core-Shell
Microparticles”, D.Eng Thesis, 2002

Park, Sang-Wook, “A Study of the Processing Effect on the Morphology of Biodegradable
Blends of Polystyrene and Hydroxypropylcellulose”, 1992

Rios, Pablo Fabian, “Modeling investigation and formulation of hydrophobic coatings for
potential self-cleaning applications”, 2007

Kim, Young-Roak, "Modelling of Pultrusion Process", D.Eng Thesis, Dec 1990

Kimura, Katsuhiko, “Polymer Blends of Polyesters and Ethylene Vinyl Alcohol Copolymers”,
1996

Kumeiga, Steven, “Synthesis, Characterization and Biodegradability of Polysaccharide-g-Poly(e-
Caprolactone Copolymers”, 2002

Lee, Jinkoo, “Improving the toughness of poly(lactic acid)(PLA)through co-continuous,
immiscible, biodegradable blends with PHA”, 2008

Ma, Wenguang, Polymer Blends of Polylactic Acid (PLA) and Polybutylene Succinate-Adipate”,
2008

Schwillinski, Burkhard, “Object-Oriented Programming in the Simulation of Polymer Flows”,
1995

Shady-Elghamrawi, Sally, “Pullulan — Polycaprolactone (PCL) Core-Shell Nanospheres:
Encapsulated with Hydrophobic Ciprofloxacin and Designed for Ophthalmic Applications,
2010

Shah, Bhavin, “Reverse Temperature Profile Rheology and Recycle Study of Polyhydroxy Butyrate
Copolymer within an Injection Machine”, 2012

Shaked, Yanir, “Enhanced processability of Poly-Hydroxy-Alkanoates by Thermal Stabilization
and Nucleation”, 2008

Shin, Suk-Young, “Process Dynamic of Sequential Valve Gate Injection Molding (Processing
Strategy and Process Control)”, D.Eng Thesis, 2001

Shrivastava, Anshuman, “Melt Adhesives for Craniomaxillofacial Surgery: Alternative
Approach Using Bioresorbable Polymers and Their Blends”, 2010

Sun, Li-Kuo, "Plasticizer Desorption in PVC", D.Eng Thesis, May 1989

Thellen, Christopher, “High Barrier Multilayer Packaging by the Coextrusion Method: The
Effect of Nanocomposites and Biodegradable Polymers on Flexible Film Properties”, 2010

Viswanathan, Arvind, “Structure-Property Relationships in Novel Amphiphilic Polysaccharide
Esters”, PhD, 1999

Wang, Xiujun, "An Introduction to Biodegradable Polymer Blends", PhD, 1994

Wharram, Scott, “Novel Electrospun Silk Biomaterials Systems: An Alternative Approach to
Wound Dressings Using Resorbable Biomaterials for Potential Delivery of Antibiotics,
Immunio-peptides, and Tissue Regeneration Biotherapies, 2009

Wu, Tim (Tiangen), “Biodegradable Drug-Eluting Stent (Powerstent Absorb) for Coronary
Arterial Disease---Development and Commercialization”, 2012

Xu, Jin, “Synthesis and Study of Poly(Beta-Hydroxyalkanoates): Enzymatic Resolution and
Polymerization of Substituted Beta-Propiolactones, 1995

Zonder, Lior, “Thermodynamic and Kinetic Aspects in Melt Mixing of Polymer Blends/Carbon
Nanotubes Composites, 2012

B. Completed Masters Thesis

Agarwal Prashant, “Influence of Composition on the Aging Embrittlement of PHB Copolymers
During its Post Fabrication Annealing at Room Temperature, 2010

Ambekar, Abhishek, “Influence of post-fabrication annealing on PHA film properties”, 2008

ECM Comb. Mot. to Exclude Page 54 of 58
Exh. U


Motion RX-B at 7.

Respondent argues that Complaint Counsel intentionally withheld the Ohio State Article
from Respondent until the afternoon of the second day of ECM’s deposition in order to gain an
advantage of surprise, and that such conduct violated Complaint Counsel's duty to supplement in
atimely manner under Rule 3.31(e)(2). FTC Rule 3.31(e) provides in pertinent part:

A party who has . . . responded to a request for discovery with a disclosure or

response is under a duty to supplement or correct the disclosure or response to
include information thereafter acquired if ordered by the Administrative Law

Judge or in the following circumstances

(2) A party is under a duty to amend in a timely manner a prior response to an
interrogatory, request for production, or request for admission if the party learns that the
response is in some material respect incomplete or incorrect.

16 CFR. § 3.31(e)(2)

Respondent further argues that Complaint Counsel's conduct in withholding the
document was willful and unjustified, and that C. ‘omplaint Counsel’s questioning of ECM on the
previously undisclosed document was prejudicial to Respondent. Thus, Respondent argues,
Complaint Counsel should be barred from introducing into evidence at trial, or “otherwise
relying on” the Ohio State Article, pursuant to Rule 3.38(b)(4). That Rule provides that if a party
“fails to comply with any discovery obligation imposed by these rules, upon motion by the
aggrieved party,” the Administrative Law Judge “may take such action in regard thereto as is
just,” including a ruling “that the party may not introduce into evidence or otherwise rely” upon
“improperly withheld or undisciosed materials, information, witnesses, or other discovery.”

16 CFR § 3.38(b)(4).

3B. Timely Supplementation

Complaint Counsel does not dispute that it was under an obligation to supplement its
previous document production by providing the Ohio State Article to Respondent. The disputed
issue is whether, under the circumstances presented, Complaint Counsel's conduct in delaying
production of the Ohio State Article until five days after its receipt, during the middle of the
second day of a previously scheduled deposition, violated Complaint Counsel’s obligation to
supplement “in a tmely manner.” As explained below, and based on the record presented, by
delaying production of the Ohio State Article and presenting the Article to Respondent for the
first time in the mudst of the second day of the deposition, when Complaint Counsel had clearly
determined the relevance and possible use of the Article before the start of the deposition,
Complaint Counsel did not supplement ina timely manner.

Complaint Counsel clearly recognized the relevance of the Ohio State Article, if not
immediately upon receipt, then certainly no later than Saturday afternoon, February 15, 2014,

4

ECM Comb. Mot. to Exclude Page 4 of 6
Exh. P


EE Gémez, EC. Michel fr. / Polymer Degradation and Stabitity 98 (2013) 2583 2591 2591

only a limited extent. Furthermore, under anaerobic incubation,
some of the bio based plastics biodegraded to generate methane, a
potent greenhouse gas that unless captured may negate the
perceived environmental benefits of using these materials. Biode
gradable plastics made from petroleum (Class II), may have more
adverse environmental impacts than conventional plastics (Class I)
if their ultimate fate is landfilling and anaerobic conversion to
methane.

Acknowledgments

The authors thank the Ohio State University Department of
Food, Agricultural and Biological Engineering for financial support
to the main author during this project. We would also like to thank
the OSU Molecular and Cellular Imaging Center at OARDC for
assistance with scanning electron micrographs.

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end cebon oxi hom Bitescanst 12:34 35:725

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@ Springer
Page 35 of 80


From: Johnson, Katherine

To: Jonathan Emord; Peter Arhangelsky; Eric Awerbuch
Cc: illson, Elisa; Cohen, Jonathan; Decastro, Arturo
Subject: ECM Biofilms, Dkt 9358

Date: Monday, June 30, 2014 8:46:05 PM

Attachments: Michel CV.pdf
Expert Rebuttal Report of Dr. Frederick Michel 2r.pdf

Counsel,

Attached please find the rebuttal expert report of Dr. Frederick Michel. The materials will follow by
FTP link in the morning.

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: kjohnson3@ftc.gov

ECM Comb. Mot. to Exclude Page 1 of 1

Exh. R


Inext reviewed Dr. McCarthy’s U.S. Patent No, 5,883,199 (199) entitled “Polylactic Acid-
Based Blends”? As an initial matter, I note that any inventor who files for patent protection
must sign a Declaration before the United States Patent Office that he or she has reviewed and
understands the contents of the application, including the claims, as well as claims that are
amended. The Declaration also acknowledges a duty to disclose to the USPTO all information
that is considered material to patentability in accordance with the requirements of 37 C.F.R.
1.56. Dr. McCarthy signed such Declaration on September 22, 1997, a copy of which is
attached,

In the ‘199 patent I observed that Dr. McCarthy did not employ the definition he recites in this
case (and incorrectly suggests is accepted in the scientific community). Instead, as discussed
below, under oath before the USPTO Dr. McCarthy adopted a far more general definition as to
what would qualify for a claim that a particular polymer material is “biodegradable.”

The ‘199 patent is directed at Dr. McCarthy’s claim that blends of: (1) polylactic acid (PLA)
based polymers or copolymer; and (2) polymers or copolymers of any polyester, have
“excellent biodegradability and aging properties.” Col. 2, lines 10-20 of the ‘199 patent. See
also, claim 1 at col. 12, lines 23-33.

To support the claim that the subject blends had “excellent biodegradability and aging
properties” Dr. McCarthy identified his own testing protocol in an artificial soil environment as
applied to 0.3 mm thick films. Col. 10, lines 4-10. That test he refers to as UML-7645. That
test is not adopted by ASTM and is inconsistent with his definition of biodegradation in
footnote 1 of his expert report. The soil degradation testing of such films was presented in FIG.

11, which is reproduced below:

biodegrade, i.e. will completely break down into elements found in nature, within a reasonably short period of time
(ie. one year) in a landfill.”

* The data and conclusions presented in U.S. Patent No. 5,883,199 also appear in Dr. McCarthy’s journal
publication entitled “Advances in Properties and Biodegradability of Co-Continuous, Immiscible, Biodegradable,
Polymer Blends, Macromol, Symp. 144, 63-72 (1999).

Page 9 of 20

ECM Comb. Mot. to Exclude Page 9 of 20
Exh. W


5,883,199

5
Materials

‘The main components needed to make the new blends are
polylactic acid-based polymers and polyesters, ¢.g., ali-
phatic polyesters of diols and diacids. Optionally, a com-
patibilizer may be added to the blends.

The simplest polylactic acid-based polymer is polylactic
acid, which can be obtained from, e.g., Cargill Inc. (EcoPla
Division, Minnesota). The polylactic acid used for the
experiments described herein had an 8% meso content (95%
L) and a number average molecular weight of 70,100. Other
polylactic-based polymers can also be used to make the new
tough blends with aliphatic polyesters of diols and diacids.

For example, a polylactic-based polymers can be either a
homopolymer of lactic acid or a block, graft, or random
copolymer of lactic acid having the general formula:

R)-Rads—

wherein R, is a lactic acid unit and R, is caprolactone,
glycolide, trimethylene carbonate, dioxanore, butyryl
lactone, or ethytene oxide. When 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, ¢.g.,
BIONOLLE #1000, #2000, #3000, #6000, and #7000,
which can be obtained from, ¢.g., Showa Highpolymer Co.,
Ltd, Japan. Bionolle #3000, #6000, and #7000, which have
molecular weights (My) of 23,300, 250,000 and 270,000,

15

respectively, and melting points of about 91°, 102°, and 89° 4

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-butanedioi.
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 Cao, in a weight percent from
0 to 100, eg., oxalic acid, malonic acid, succinic acid,
glutaric acid, adipic acid, n-butylmalonic acid, succinic acid,
azelaic acid, sebacic acid, ethyl diethylmalonate 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).

6
for example 10,000 to 506,000 or 15,000 to 250,000. The
range of melting points of the polylactic acid-based polymer
and aliphatic polyester that can be used is 50° to 300° C., for
example 60 to 200° C,, e.g., 80° to 150° C.

Besides a purely aliphatic polyester of diols and diacids,
2 copolyester of an aliphatic polyester and an aromatic
polyester can be used so long as the copolyester is biode-
gradable and imparts ductility to polylactic acid-based poly-
mers, An example of an aromatic polyester that can be used
(in up to 50 percent by weight) in the copolyester is
polyethylene terephthalate. Other aromatic polyesters can be
used.

Examples of compatibilizers include AB block or AB
graft copolymers that consist of a polylactic acid-based
polymer or a polymer which is miscible with the polyiactic
acid-based polymers, and an aliphatic copolyester of poly-
mers based on diols and diacids or polymers which are
miscible with these aliphatic copolyesters. These compati-
bilizess can be added to the blend in an amount ranging
from, ¢.g., 0.1 to 10 percent, e.g., 2, 3, or 5 percent.
Preparing Polylactic-Based Polymer Blends

Standard melt processing equipment and processing con-
ditions can be used to prepare the new blends. Examples of
polymer melt processing equipment that can be used to
make the new blends include melt mixers (Banbury mixer),
blenders, extruders for shect, film, profile and blown-film
extrusion, vuleanizers, calenders, and spinnerets for fiber
spinning, molding, and foaming.

The polylactic acid-based polymers and the polymers or
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 processing. Blending was done on a single
screw extruder operating between 150° and 160° C. and a
screw speed of 50 rpm. Each sample was extruded twice.
This protocol can be varied as long as the polymers and
polyesters form a contiguous or co-continuous phase blend.

‘The composition and sample code for each blend made up
of polylactic acid and BIONOLLE are reported in Table 1.
The A in each sample code refers to the percentage of
polylactic acid-based polymer in the blend, and the B refers
to the polyester, BIONOLLE#3000, BIONOLLE#6000, or
BIONOLLE#7000, which were used to make the new
blends with polylactic acid.

TABLE 1
Sample
Code PLA A90B10 AS0B20A70B30 ASOBSC A30B70—Bio#_
PLA 10090 % 70 50 30 0
wt %
BIONOLLE 0 10 20 30 50 70 100
wt %

Among other features of the aliphatic polyesters used in
the new blends are that these polyesters are biodegradable
and that they impart ductility to polylactic acid-based poly-
mers by forming a continuous or co-continuous phase in the
morphology of the blends. The polylactic acid-based poly-
mers and the aliphatic polyesters are immiscible, but syn-
ergistically compatible in the blends, ie., the properties of
the blends are greater than that of the mixtures of polylactic
acid-based polymer and aliphatic polyester determined by
the additive rule of mixture. The range of weight average
molecular weights of the polylactic acid-based polymer and
the aliphatic polyester that can be used is 5,000 to a million,

ECM Comb. Mot. to Exclude
Exh. Z

6s

Sample Preparation

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, samples 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, ie.,
gage length, were compression molded at 155° C. and
cooled in a cooling press machine at 20° C. and 700 psi. Thin
film samples were made by melt blending on an extruder and
then compression molding to 0.3 mm thickness. The films

Page 74 of 80


Respondent’s Exhibit BB


Respondent’s Exhibit Y


United States Patent 115)
McCarthy et al.

AEA

0 0 a

US005883199A
{11] Patent Number: 5,883,199
[45] Date of Patent: Mar. 16, 1999

154)
175}

(73)
[21}
[22]
[51]
[52]

158]

[56]

POLYACTIC ACID-BASED BLENDS.

Inventors: Stephen P. McCarthy, Tyngsboro;
Richard A. Gross, Chelmsford;
‘Wenguang Ma, Lowell, all of Mass.

Assignee: University of Massachusetts, Boston,
Mass.

Appl. No.: 825,810
Filed: Apr. 3, 1997

Int. C1 . COB8F 20/00; B29D 22/00
US, Cl. . $28/437; 525/450; 604/212;
604/370; 604/403; 604/408; 428/35.2; 428/35.7;
428/36.92

Field of Search .. nennanee S25/43T, 4505
604/403, 212, 358, 370, 408; 428/34.1,

35.2, 35.7, 36.92

References Cited
U.S. PATENT DOCUMENTS

4,095,600 6/1978 Casey et al.
5,216,050 6/1993 Sinclair ..
5,252,642 10/1993 Sinclair et al.
5,685,540 11/1997 Kakizawa ..

FOREIGN PATENT DOCUMENTS

96-231837 2/1995 Japen -

ECM Comb. Mot. to Exclude

Exh. Z

OTHER PUBLICATIONS

Cai et al., “Effects of Physical Aging, Crystallinity, and
Orientation on the Enzymatic Degradation of Poly(Lactic
acid)”, J. Polymer Science, 34:2701-2708 (1996).

Gajria et al., “Miscibility and biodegradability of blends of
poly(lactic acid) and poly(vinyl! acetate)”, Polymer,
37:437-444 (1996).

Sheth et al., “Biodegradable Polymer Blends of Polylactie
Acid (PLA) and Polyethylene Glycol (PEG)”, ANTEC ’95,
1829-1833 (1995).

‘Younes et al., Phase Separation in Poly(Ethylene Glycol)/
Poly(Lactic Acid) Blends, Polym. 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, polylactic acid-based
polymer or copolymer, and a second polymer or copalymer
including one or more polyesters, ¢.g,, an aliphatic polyester
or a polyester of one aliphatic C, 10 Czy diacid or of a
combination of two more different aliphatic C, to Coy
diacids, wherein the first and second polymers are present in
a ratio of 9:1 to 1:9, are described.

25 Claims, 7 Drawing Sheets

Page 64 of 80


EXPERT REPORT OF DR. STEPHEN P. MCCARTHY
SUMMARY & CONCLUSIONS

I am a Professor of Plastics Engineering at the University of Massachusetts Lowell, I

more than thirty years’ experience studying both the chemical and mechanical behavior of
polymers, including their biodegradability, and I currently serve as the Director of the
University’s Biodegradable Polymer Research Center. Complaint Counsel asked me to evaluate
biodegradable claims made by ECM Biofilms. Inc. In my expert opinion, I conclude with at
least a reasonable degree of professional certainty that:
* Plastic products manufactured with the ECM additive (“ECM Plastics”) are not
biodegradable,
* ECM Plastics will not completely break down and decompose into elements found in
nature in most landfills within five years;
" ECM Plastics will not completely break down and decompose into elements found in
nature in any disposal environment at an appreciably faster rate and extent than
conventional plastics without the ECM additive;

Furthermore, no competent and reliable scientific evidence contradicts any of these facts.

OLE if .
Li — ited iophen P Ala,

DATED:

ECM Comb. Mot. to Exclude Page 1 of 58
Exh. U


University of Massachusetts, Lowell, April 2004, Plastics Engineering Department
Teaching Award. This award, voted by the students in the Department of Plastics
Engineering, University of Massachusetts, Lowell, is given to that faculty member
considered to provide outstanding teaching to the students in the Plastics Engineering
Department.

Boston Patent Law Association, Fall 1989. This award is given to an outstanding
contribution in the area of intellectual property. The award-winning paper, "Experimental
Use or Fair Use As A Defense To Patent Infringement”, was subsequently published in
Idea-The Journal Of Law and Technology.

Selected as University Scholar, Fall 1987. This award is given to outstanding faculty for
achievement in teaching and research. In view of this award (a teaching load reduction) I
was able to expand my academic background and initiate studies towards the Juris Doctor
degree with emphasis on the law of intellectual property.

Selected as a Reviewer for the Journal of Polymer Science-Chemistry, February, 1989.

Selected as a Reviewer for the Journal of Polymer Science and Engineering December,
1988

Selected as a Reviewer for the Journal of Polymer Science-Chemistry, January, 1988

Selected as a member of the SPE-ANTEC Paper Review Board, 44th Annual Technical
Conference, Boston 1986.

Selected as a Division/Special Session Technical Program Chairman, SPE-ANTEC, 44th
Annual Technical Conference, Boston 1986.

Selected as a Reviewer for the Journal of Macromolecular Science-Chemistry, October
1986.

Selected as a Reviewer for the National Science Foundation-Chemical Instrumentation
Program, July 1985

Bb. Work with Professional Societies

Former Member of the American Chemical Society.

Former Member of the Division of Polymer Chemistry, American Chemical Society
Foumer Member of the Society of Plastics Engineers

Former Member of the American Bar Association

Member, New Hampshire Bar (Admitted, May 1990)

2. Service To The University

Page 13 of 17

ECM Comb. Mot. to Exclude Page 13 of 17
Exh. Y


With respect to Groups III and Iv, applicants submit
that if the blend of claim 1 is patentable, then products made of
this blend are also patentable, with no additional search
required. Thus, claims 23 to 25: should also be added to Group 1

ang the restriction withdrawn.

33.U.8.C. § 112, Second Paragraph

Claims 1-9 and 11-22 have been rejected as being
allegedly indefinite. Applicants respectfully traverse the
rejections, in light of the claim amendments and for the
following reasons.

The term "polylactic acid-based polymer" in claims 1,
3:5, 18, 20, and 21 was said to be redundant. Applicants submit
that the term “polylactic acid" is in widespread use in the field
of polymer chemistry. ‘The material is commercially available,
and is used to make further polymers. Applicants appreciate the
Examiner’s concern with respect to potential confusion in the
claim language. However, considering the well-eatablished usage
of the term "polylactic acid" to refer to the homopolymer and
copolymers made from that material, applicants respectfully
request that the rejection on this ground be withdrawn.

The phrase “polymer or copolymer consisting essentially
of one or more polyesters" in claim 1 was said to be uncléar. In
light of the claim amendment deleting the words "or copolymex,"
applicants respectfully request that the rejection on this ground

be withdrawn.

ECM Comb. Mot. to Exclude

Exh. Z

Page 55 of 80


II. Documents and Electronically Stored Information

Attached are copies of additional documents and electronically stored information in the

Bureau of Consumer Protection’s possession, custody, or control that are relevant to the

allegations asserted in the Complaint, the proposed relief, or Respondent’s defenses. Complaint

Counsel is in the process of searching for additional relevant documents, except that Complaint

Counsel will not provide any documents, materials, or electronically stored information subject

to the limitations in § 3.31(c)(2), privileged as defined in § 3.31(c)(4), pertaining to hearing

preparation as defined in § 3.31(c)(5), or pertaining to experts as defined in §3.31A. To the

extent that such documents are produced, it is without waiver of any protections or privileges.

Dated: March 17, 2014

ECM Comb. Mot. to Exclude
Exh. C

Respectfully submitted,

/s/ Katherine Johnson

Katherine Johnson —_ (202) 326-2185
Elisa K. Jillson (202) 326-3001
Division of Enforcement

Bureau of Consumer Protection
Federal Trade Commission

600 Pennsylvania Avenue, NW
Mailstop M-8102B

Washington, DC 20580

Page 2 of 5


data after this point. I do not understand the definitions and testing protocols described in his
patent to be at all close to the “standard” that Dr. McCarthy asserts in his report as critically
missing from ECM’s testing of the ECM additive.*

In addition, as noted above, Dr. McCarthy’s ‘199 patent recites that based upon his
biodegradation curves, “a specific blend can now be designed such that this blend would have a
certain net degradation in a given number of days within the soil.” Col. 11, lines 20-24.
Accordingly, Dr. McCarthy has indicated that biodegradation can be assigned to a polymer
blend when it demonstrates a “certain net degradation” in some “given number of days” within
the soil, without articulating the existence of a minimum degradation level or how many days
are relevant. Again I find the position recited by Dr. McCarthy in the ‘199 patent inconsistent
with the definition adopted by Dr. McCarthy at footnote 1 of his report and applied against
ECM.

I next note that at column 11, lines 25-62, Dr. McCarthy reports on biodegradation in compost.
Here, Dr. McCarthy employed an artificial compost environment. The compositing process
was carried out for 30 days at 55 °C. The results were reported in FIG. 12 of his patent which

is reproduced below:

* See again, footnote 1 of Dr. McCarthy’s Expert Report of June 4, 2014, where Dr. McCarthy adopts the
assumption of Complaint Counsel that “biodegradable” means that “the entire plastic will completely break-down
and retum to nature (i.e. decompose into elements found in nature) within one year after customary disposal (i.e.
incinerator, landfill, recycling).” Dr. McCarthy also stated that he used “this definition and the scientific definition
of biodegradable interchangeably” in his report, “because there is no substantive difference between the two that
affects my analysis or opinions.”

Page 11 of 20

ECM Comb. Mot. to Exclude Page 11 of 20
Exh. W


Gada, Manish , “Plasticization of PHBV Using PCL and PEG as Plasticizers”, 1993

Gagnon, Mare, “Birefringence Measurements in Injection Molding”, March 1988

Ghiya, Vatsal P. “Effect of Citric Esters on PHBV, PCL and CA as Biodegradable Plasticizers”,
1994

Gupta, Sunny, “Mechanical Properties of Low-Density Polyethylene (LDPE) Blended with Di-
cumyl Peroxide Modified Ultra-Low Density Polyethylene (ULDPE)”, 2010

Hakani, Shamit, “Evaluation of Natural Antioxidant for Flexible Polyolefin by Oxidative
Induction Time Testing”, 1998

Hanley, Stephen, “Coextrusion Barrier Modelling and Evaluation”, 1988

Haque, Tareq, “A Study of the Biodegradibility of Cellulose Acetate and Polyethylene Glycol
Blends and the Effect of Morphology on the Biodegradation of Cellulose Acetate”, 1995

Hingorani, Arun, “Slit Die Rheometer”, 1992

Jain, Sanjog Shyam, “Neoalkoxy Titanates and Zirconates in Thin-Wall Injection Molding”, 1999

Janezyk, Michael J, “Thermal Design and Analysis of Stereolithography Rapid Tooling for
Injection Molding, 1996

Jing, Ze, “Controlled Rheology Study of Odor Free Polypropylene by Extrusion Process”, 2012

Jones, Scott. M, “Characterization of Flow Properties of BMC Using Reciprocating Screw
Rheometer”, 1992 (Co-advisor)

Joyce, Mark Daniel, “Weld Line Failure in a Thin Wall Ring”, 2000

Kadam, Amruta P., “Sharkskin Melt Fracture Characterization of Poly (Hydroxy Butanoic Acid)
Copolymers, 2010

Kadkol, Prabodh, “Processing of PHBV”, 1991

Khare, Atul, “Diffusion of Gases Through Thermally Treated Polymer Films”, 1989

Kramer, William, “Photodegradation of PVC” , 1990

Krauss, Derek, “Investigation of the degradation and adhesion properties of over-molded
biodegradable polymers:, 2006

Kouloungis, Niclis R., “Aerobic Biodegradability of Citrate Ester Plasticizers and Plasticized
PLA Films in Simulated Soil and Compost Environments”, 1996

Kozlowski, Henry “ Solubility Parameters and Polymer Compatibility”, 1986 (Co-advisor)

Kukade, Pranav, “Biodegradation of Poly (Hydroxy Butanoic Acid) Copolymer Mulch Films in

Soil”, 2010
Kulkarni, Suhas, “Effect of Polyvinyl Alcohol on Crystalline Behavior of Poly(B-hydroxy
butyrate)”, 1992
Labrecque, Lisa V., “The Effects of Citrate Esters as Plasticizers for Poly(Lactic Acid)”, 1995
Labrecque, Roger, "Biodegradable Polymer Blends of Poly Lactic Acid and Poly Ester
Amide, 1997

Laverde, German V., “Analysis of the Mechanical Properties of Biodegradable Films made from
Blends of Polylactic Acid (PLA) and Polybutylene Succinate Adipate Random Copolymer by
Blown Film Extrusion”, 1997

Lewitus, Dan, “PLA/Nanoclay Cast Film Composites Using Various Polymer-Clay
Concentrates”, 2004

Lomasney, Kerry A., “A Study of Fabrication and Characterization of PSF Ultrafiltration
Membranes with PEO-PSF Block Copolymer Additives”, 1995

Li, Qin, “Properties Evaluation of PHB Nanocomposite Using Melts Blending Approach”, 2004

Lipchitz, John “Investigation of the Degradation and Mechanical Properties of Bioabsorbable
Polyesters and Their Blends”, 1999

Lisuardi, Andi, “Reactive Processing of Biodegradable Polymers”, 1991

Lou, Shin Hwa, “Dynamic Mechanical Properties of Polymers”,

Loh, Chi-San, “Plastic Packaging Barrier Properties”,

ECM Comb. Mot. to Exclude Page 56 of 58
Exh. U


Dr. Sahu is aware that exactly this type of testing has been conducted with pure polyethylene
(Albertsson, 1977) since he cited this paper.

In fact it would be a rather straightforward matter to mix ECM additive with “C labeled polyethylene
and conduct a test similar to that performed in the past by Albertsson. If ECM additive improved “c
polyethylene biodegradation, then it would have a significantly faster rate of “C evolution as compared
to unamended “‘C polyethylene.

| have conducted “‘C fate studies of pesticides and PCBs in composts in the past (Michel et al., 1995,
Michel et al., 1997 and Michel et al., 2001) as well as tests of the biodegradation of biopolymers in
compost, soil and anaerobic digestion environments (Gomez and Michel, 2013; Gomez et al., 2014). My
estimate of the cost to conduct such a study under simulated landfill conditions at OSU would be
approximately $100,000 (See Appendix A). This is not much more than the cost of testing ECM claims to
have already performed on its additive (ECM marketing materials claim that ECM has conducted internal
and external studies that have cost hundreds of thousands of dollars). Morever, it is not significantly
more than some of its customers have spent over several years for ASTM 5511 testing. For example for
one such test, PPC was invoiced $37,000 by Northeast Industries (see PPC Industries Invoice #1048340-
O1.xls and PPC Industries Invoice # 20110909-Ext.xls).

Dr. Sahu Comment —

On Page 27 of his report, Dr. Sahu makes a point that ECM will encourage biofilm, formation and
therefore plastic biodegradation:

“it is without question that the biodegradation of the plastic products’ polymer structure (i.e. mass loss
of a plastic material itself by the biota’s conversion of its hydrocarbons into biogases and biomass) will
be enhanced by the presence of ECM additives, which help to set in motion the following series of steps
(together, the “mechanism”):

(a) the attraction/migration of already-present, local, microbial/biological agents to the plastic part at
the locations where the additive is present, since the additive acts as a food source for such agents. This
is enhanced by the presence of hydrophilic defects or groups in the plastic;

{b) the consequent initial formation of biological communities or biofilms, near the additive sites;

(c) the development and growth of the biofilms — ensured by the presence of greater than a critical
minimum amount of ECM Additives that must be present and properly dispersed throughout the plastic
(which is at or above 1%, by weight, in the case of the ECM Additives);

(d) the spreading of the established biofilms to other areas of the plastic (i.e., to areas of the plastic
beyond where additives are present) since the biofilm is no longer dependent on just the initial mass of
additive — in this respect, the additive acts as an attractor/catalyst for biofilm development —i.e., the

a5

ECM Comb. Mot. to Exclude Page 15 of 24
Exh. V


PUBLIC DOCUMENT

UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION
OFFICE OF THE ADMINISTRATIVE LAW JUDGES
Washington, D.C.

In the Matter of
Docket No. 9358
ECM BioFilms, Inc.,
a corporation, also d/b/a
Enviroplastics International, PUBLIC

Respondent.

RESPONDENT’S MEMORANDUM IN SUPPORT OF RESPONDENT’S COMBINED
MOTION FOR SANCTIONS, TO EXCLUDE COMPLAINT COUNSEL’S CONCEALED
EXPERT REBUTTAL WITNESS (NOT IDENTIFIED BY NOTICE IN ACCORDANCE

WITH RULE 3.31A AND THE REVISED SCHEDULING ORDER), AND FOR LEAVE
TO INCLUDE SURREBUTTAL EXPERT

Pursuant to Rules 3.38(b), 3.31A(b) & (d), and 3.21(c), Respondent ECM BioFilms, Inc.

(ECM) hereby moves this Court to exclude testimony from Dr. Frederick Michel and to strike his
purported rebuttal report. In violation of the FTC’s Rules and in violation of the Revised
Scheduling Order, Complaint Counsel failed to list, identify, or designate Dr. Michel as an expert
witness in this case. He was never listed on Complaint Counsel’s several expert and fact witness
lists. Without required notice, Complaint Counsel served Michel’s rebuttal report at 11:46pm
Eastern on June 30th, 117 days after Complaint Counsel was first obliged to list experts per this
Court’s original Scheduling Order, and only 1 day before expert discovery was set to close under
the Third Revised Scheduling Order. Complaint Counsel never sought leave to add Dr. Michel
as a witness. This act of concealment in violation of Rule 3.31A and the Court’s Revised

Scheduling Order, combined with a similar act of concealment condemned in an earlier Order

4


in FIG. 1 above, PHA also appeared to indicate a value that showed some small increase from
day 400+ to day 500+, but then it too appeared to level-off. I did not illustrate that particular

observation on FIG. 1.

In FIG. 2 of the subject 2013 Michel article, once again, the positive control plateaued at about
72%. Plastarch also again appears to level off at about 22%. See below. PHA was not
presented in FIG. 2.

100%
—+— Positive (cellulose paper)

20%
10%
0%

‘This arrow shows that
Plastarch has leveled
off at about about 22%
at 25+ days

B 90%

3 —4— Corpolyester + corn-based polymel:

5 80% + x Prastarch x z

70% S--e- BP 2% addive * +

3 60% -| —@— PETE + 1% additive This arrow shows that.
c= celluiose paper has
2 50% leveled off at about
s 40% 72% at 25+ days
= 10%

g 30%

3

E

5

+7)

0 10 20 30 40 50
Time (days)

Considering the above, 1 do not agree with Dr. Michel that Plastarch and PHA “continued to
biodegrade well after cellulose biodegradation had plateaued.” [ am therefore of the view that
the positive control of cellulose paper plateaued at around 70-75% thereby indicating that the
environment present in his test became inhospitable to biodegradation supporting a conclusion

that the aforementioned substances failed to biodegrade.
Comment by Dr. Michel

Dr. Michel states at page 6 of his Rebutal Report that “{dJuring soil incubation for 660 days, no
significant mineralization was observed for polyethylene or polypropylene plastics or the same
plastics amended with ECM additive.”

Page 4 of 20

ECM Comb. Mot. to Exclude Page 4 of 20
Exh. W


Respondent’s Exhibit B


S. Grossman and 0. Vogl, "Regular Copolyamides by Solution and Liquid-Liquid
Interfacial Polymerization, presented at the 179th ACS National Meeting, Houston, Texas
(1980).

S. Grossman, D. Tirrell and 0. Vogl, "Water Absorption in Regular Copolyoxamides",
presented at the 8th Northeast Regional Meeting. American Chemical Society, Boston,
Massachusetts, (1978)

e. Research Reports

"Protocol, Cardiothane Production, Chemical and Physical Test Series", Kontron
Corporation, Everett, Massachusetts, October (1987). This report was made in connection
with Kontron's efforts to satisfy Food and Drug Administration quality control standards
for the production of polyurethane materials for medical applications.

"Reactive Processing and Compatibilization of PET/PP Mixtures", submitted to Gates
Formed-Fibre Products, Summer (1987).

"New Processing Aids for PVC-Evaluation of Reactive Cellulose Esters", submitted to
A. Staley Manufacturing, Decatur, Illinois (1986).

"Program to Improve the Moisture Resistance of Nylon-6,6 Cable Ties", submitted to
Dennison Manufacturing, Framingham, Massachusetts (1986).

"Materials Testing Program for Angioflex Resin, Angioflex Solution and Angioflex Film,
submitted to Abiomed, Danvers, Massachusetts (J 985).

f. Thesis

"Synthesis and Characterization of Novel Polymer Structures: I. Head-to-Head
Polypropylene; II. Regular Copolyoxamides", Ph.D. Thesis, Polymer Science and
Engineering, University of Massachusetts, Amherst (1979).

C. Service Contributions

1, Professional Leadership and Achievement

a. Recognition by Learned Professional Groups

University of Massachusetts, Lowell, April 2006, Plastics Engineering Department
Teaching Award. This award, voted by the students in the Department of Plastics
Engineering, University of Massachusetts, Lowell, is given to that faculty member
considered to provide outstanding teaching to the students in the Plastics Engineering
Department.

Page 12 of 17

ECM Comb. Mot. to Exclude Page 12 of 17
Exh. Y


Respondent’s Exhibit N

CONFIDENTIAL


My qualifications to rebut the expert testimony include a PhD in Chemical Engineering and
Bachelor’s degrees in Chemical Engineering and Biochemistry. After earning my PhD, | was a
postdoctoral fellow in the NSF Center for Microbial Ecology (CME), a leading research center in this area.
i worked under Center Director and past chair of the American Society of Microbiology, Professor Jim
Tiedje as well as with Drs. Larry Forney and Professor CA Reddy. | am currently a tenured Associate
Professor in the Department of Food, Agricultural and Biological Engineering at the Ohio State University
with an adjunct appointment in the Department of Chemical and Biomolecular Engineering.

For the past 25 years | have conducted research on a wide range of environmental topics including
the biodegradation of plastics, bioplastics, biofoams and natural fiber materials in anaerobic digesters,
composting systems and in soils. | have also conducted research on the fates of pesticides and PCBs
during composting and anaerobic digestion. As a part of these projects | used CTM labeled compounds to
determine the rate and extent of pesticide and PCB biotransformation, mineralization, volatilization and
conversion to humic materials. At the CME | was the lead scientist on a project to investigating the full
scale bioremediation of PCB contaminated soils. My lab is currently involved in investigations of the
degradation of recalcitrant herbicides during composting and anaerobic digestion and has developed
bioassays to measure the phytotoxicity that these residues confer.

For my PhD work, | investigated the production of lignin and manganese peroxidase enzymes by
fungi that grow as biofilms and suspended pellets. | also investigated the ability of these organisms to
decontaminate chlorinated byproducts generated by paper mills. These enzymes are known to initiate
the biodegradation of some of the most recalcitrant molecules in the environment such as lignin and
chlorinated organic compounds. My work at the CME and at the Ohio State University has included
studies of the microbial ecology of composts and anaerobic digesters using novel nucleic acid based
methods. | also have conducted investigations on the effects of composting parameters on compost
quality, odor production and compost microbiology.

I have authored over 40 peer reviewed publications and many other papers and reports in these
areas. In 2010, | received the USCC Rufus Chaney award for research excellence from the US Composting
Council. From 2007 to the present | have served as the Editor of Compost Science and Utilization journal,
an international peer reviewed scientific journal and as an Associate Editor for the Biological Engineering
division of the American Society of Agricultural and Biological Engineers. | also developed, and have
organized and taught the Ohio Compost Operator Education course since 2001.

In addition to my University position, | have served as consultant to a variety companies on topics
related to composting, microbial ecology, and plastic and organic contaminant biodegradation. These
included AllTreat Organics Composting (ON), OEW Recycling (OH), White Barn Farms (OH), United States
Industry Coalition (VA), The Scotts Company (OH), DuPont (DE), Green Paper Products (OH), Keramida
Environmental (iN), Ralston Instruments (OH), Indian Summer Composting (Ml), Economic Development
Generating Excellence (OK), US Composting Council (MD), Federal Trade Commission (DC), GT
Environmental (OH), Barnes Nursery (OH) and Quasar Bioenergy.

ECM Comb. Mot. to Exclude Page 3 of 24
Exh. V


Peter Arhangels’ ky

= =
From: Peter Arhangelsky

Sent: Wednesday, July 09, 2014 11:53 AM

To: ‘Johnson, Katherine’

Cc: Cohen, Jonathan; Jillson, Elisa; Decastro, Arturo; Jonathan Emord; Eric Awerbuch
Subject: RE: Meet & Confer, Motion for Leave to Exceed Rule 3.22 Word Count

Katherine:

Thank you for your response. | explained last Wednesday that the failure to disclose Dr. Michel as an expert in any of
your witness lists was in violation of Rule 3.31A and the Court’s Scheduling Order. Rule 3.38 provides the mechanism for
relief for failing to meet discovery obligations, and sanctions are therefore part and parcel to our motion to

exclude. Moreover, the failure to disclose Dr. Michel seems to have been an attempt to secure a competitive adva ntage
in litigation. Because Rule 3.31A requires that you provide advance notice for experts in the original expert list
(including rebuttal experts who you later designate), and you have no reasonable justification for this unfair surprise,
sanctions are in fact appropriate. We therefore disagree that | failed to raise this point in our meeting; | think the issues
were clearly drawn. You even responded to my concerns that ECM had been deceived.

We also note that you secured Dr. Michel’s “stipulation” based on false pretenses, to wit, the objective representation
that testimony was unnecessary if you could rely on his stipulation atone to introduce documents. We recognize that it
was your intent (not ECM’s) to depose Dr. Michel. But you held him out as a fact witness, and the facts surrounding his
proposed deposition strongly suggested that he either would not testify in this case, or would be doing so as a fact
witness. ECM lost significant discovery opportunities and suffered prejudice from complaint counsel's failure to abide by
the scheduling order.

While we appreciate your offer to depose Dr. Michel, which would certainly be necessary, that remedy alone will not
suffice given the circumstances. However, given your representations below, we would expect that ECM be afforded an
opportunity to present its surrebuttal testimony if that is the direction the AU chooses to take.

Best,

Peter A. Arhangelsky, Esq. | EMorD & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ 85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed agove. The content of this communication is protected from
disclosure by the attorney-client privilege and the work product doctrine. If you are not the intended recipient, you should ireat this
communication as strictly confidentia: and provide it to the person intended. Duplication or distribution of this communication is prohiblied
by the sender. If this communication has been sent fo you in error, please notify the sender and then immediately destroy the document.

From: Johnson, Katherine [mailto:kjohnson3@ftc.gov]

Sent: Wednesday, July 09, 2014 12:14 AM

To: Peter Arhangelsky; Jonathan Emord; Eric Awerbuch

Cc: Cohen, Jonathan; Jillson, Elisa; Decastro, Arturo

Subject: RE: Meet & Confer; Motion for Leave to Exceed Rule 3.22 Word Count

Peter:

ECM already stipulated to the admissibility of the Ohio State Study, so it seems a bit disingenuous to attempt a second
{or third or fourth, as the case may be) bite at this apple. In fact, the whole purpose of the stipulation, as | understood
it, was for Complaint Counsel to avoid having to take Dr. Michel’s deposition solely to establish the admissibility and

1
ECM Comb. Mot. to Exclude Page 1 of 3
Exh. DD


PUBLIC DOCUMENT

content with McCarthy’s opinion, and Dr. Grossman has direct testimony, contained in the
surrebuttal report, that reveals falsities in the representations made by Dr. McCarthy as well as
scientific evidence contradicting the rebuttal reports of both Drs. Michel and McCarthy. See
Exh. U; Exh. V; Exh. X. Dr. Grossman would address new issues first raised in Dr. McCarthy’s
rebuttal report, which were not raised in his original report, or in his deposition testimony. See
Exh. CC. Allowing Dr. Grossman to participate places the parties on an equal footing with
respect to discovery burdens, and reduces ECM’s prejudice resulting from Complaint Counsel’s
concealment of Dr. Michel and failure to serve required notice.

Complaint Counsel would consent to the addition of Dr. Grossman as a surrebuttal
expert, provided that they have an opportunity to depose him. See Exh. DD. Their offer, while
fair on its face, does not address the underlying discovery abuses described above.

5. Complaint Counsel Should Be Sanctioned

Complaint Counsel has no reasonable justification for concealing the expert status of Dr.
Michel, did not seek leave from this Court to excuse its conduct, and without required notice
delivered its Michel Rebuttal report twenty-four hours before the expert discovery deadline,
causing Respondent to suffer prejudice. This Court should not condone those rule violations and
should sanction Complaint Counsel under the general authority conferred in rule 3.38(c). See 16
C.F.R. § 3.38(c). Here, the most appropriate relief should include, at minimum, exclusion of the
Gomez & Michel study (Exh. AA), vitiation of the earlier stipulation which was based on
Complaint Counsel’s false pretenses (Exh. I), exclusion of Dr. Michel’s expert report, and
exclusion of his expert testimony. For the foregoing reasons, ECM also requests that his Honor

order Complaint Counsel to be reprimanded for the offense.

17


I Polym Environ (2011) 19:637 676

649

ROOH— MeTM = —__» nO + Ud 4 On

ROOH— Mel" dy. ROO + Mids BT

Met freer
ane

2ROOH RO + ROO +10

Fig. 8 Reaction of metal catalysts with hydroperoxides

molecular weight fragments. Unsaturated compounds,
which are very prone to oxidation, generate free radicals
much more readily than saturated groups. These free rad-
icals catalyze the initiation step of LDPE degradation by
transforming LDPE from RH into free radical R’.

Blends of Biodegradable and Non Biodegradable Polymers

The most frequently adopted approach to degradability
design of LDPE has been to introduce pro-degradant
additives such as starch and cellulose into synthetic poly-
mers. According to “percolation theory and experiments” a
large amount of starch of the order of 30% by volume
needs to be blended for improving the accessibility of the
whole system to different degrading factors (330, 331]. At
high starch content, the incompatibility of LDPE and starch
due to the different polar character will affect mechanical
properties of the blend negatively. By using compatibiliz-
ers or chemically modified starch and polyethylene the
amount of incorporated starch as well as the mechanical
properties of the blend could be increased. It was found
that the compatibilized blends have only a slightly lower
biodegradation rate compared to the uncompatibilized
blends [332]. The rapid enzymatic hydrolysis of starch
under biotic exposure conditions produces a plastic film
with a porous structure that will further evoke environ-
mental problems [322]. Incorporation of pro-oxidants
containing transition metal ions and unsaturated elastomers
as autooxidizable substances along with starch in LDPE/
starch blends was found to increase the degradation of
LDPE. Where as starch behave as antioxidant by effec-
tively blocking the free radicals and forming inactive

Grafting of Natural Monomers Onto Nonbiodegradable
Polymers

A search on available literature on biodegradable polymers
reveals a number of attempts to achieve biodegradability,
but grafting of naturally available carbohydrate monomers
which can induce biodegradation onto polyolefins has not
been given much emphasis. Successful methods of prepa-
ration of biodegradable polyethylene-natural monomer
graft composites are limited. Grafting of natural monomers

ECM Comb. Mot. to Exclude
Exh. Z

such as cardanol, twelve hydroxy stearic acid, vanilic acid
etc. onto polyethylene can give rise to grafted polymers in
which the biodegradable component is evenly distributed
such that biodegradation can proceed smoothly. Grafting of
the natural monomers onto polyethylene will be conducted
by irradiation polymerization or ionic polymerization.
Anchoring of simple sugars such as monosaccharide or
disaccharides instead of starch onto polyethylene can
reduce the negative effects on physical properties observed
in the case of polysaccharide grafting [335].

Historical Perspective

The potential degradability and ultimate biodegradability
of polyethylene has been started to consider in the early
1970s as specific attributes for applications in packaging
and agricultural market segment. In 1972 Potts and his
collaborators reported that polyethylene was not biode-
gradable, but the linear paraffin molecules below a
molecular weight of about 500 were utilized by several
microorganisms [336]. Later Hueck emphasized the role of
criteria for the inertness of polyethylene as its hydrophobic
mature and its large molecular dimensions [337]. Otake
et al. observed the signs of degradation in pure polyeth-
ylene film during soil burial for 32 years [338]. This sug-
gests that the PE film could not be degraded significantly.
Albertsson studied the oxidative effects of microbes and
abiotic forces on the degradation of PE by measuring the
conversion of *C present in the HDPE film to respiratory
TMCO, during a 2 year aerated cultivation with soil or with
Fusarium redolens. She reported that the effective oxida-
tion of somewhat longer polyolefin chains was done by
microbes than abiotic forces [339, 340].

In 1978 Griffin had first presented the idea of using
granular starch as filler in polyethylene in order to increase
the biodegradability of the resulting material. Where as the
opposite polarity of starch and LDPE affected the mechan-
ical properties of the blend negatively [341]. Since that time
several techniques in which starch is used as a biodegradable
additive have been patented [341 351]. Peanasky et al.
investigated the accessibility of starch in PE starch blends
by computer simulation, percolation theory, and acid
hydrolysis experiments. If the concentration of starch (p) is
less than the percolation threshold concentration (pe =
31.17%)., a small amount of starch is removed from the
surfaces only, but at p < . pc connected pathways existing
throughout the bulk of the material facilitate large amounts
of starch extraction [331]. Goheen and Wool reported a
similar conclusion in the biodegradation of PE starch
blends in soil over a period of 8 months [352]. They did not
observed any significant chemical changes in the polyeth-
ylene matrix after 240 days. Arvanitoyannis et al. reported
that the presence of high starch contents (>30%, w/w) had an

D Springer
Page 13 of 80


PUBLIC DOCUMENT

witness list, Complaint Counsel waived its opportunity to call Dr. Michel as a rebuttal witness or
submit Dr. Michel’s rebuttal report without seeking leave of Court.!°

Finally, Rule 3.31 A(a) unambiguously states that “Complaint counsel shall serve
respondents with a /ist of any rebuttal expert witnesses ...”. 16 C.F.R. § 3.31A(a). Complaint
Counsel failed to supply Respondent with any such list. Complaint Counsel never “designated”
Dr. Michel as an expert and instead ignored the notice requirement, supplying Michel’s rebuttal
expert report the day before the end of expert discovery; actions of that ilk are forbidden. See In
the Matter of POM Wonderful, 2011 WL 1429882, at n. 1 (F.T.C. Apr. 5, 2011) (Chappell,
ALJ).

Given the Scheduling Order and its deadlines for expert discovery, the text of Rule
3.31A(a), and the impracticalities that would arise otherwise, Complaint Counsel cannot be
allowed to identify, for the first time, an expert a day before the deadline for expert depositions
closes. Complaint Counsel undertook no effort to seek leave for that late disclosure. Instead,
they simply proceeded in a cavalier manner, without respecting Rule 3.31A or the Revised

Scheduling Order.

'° Scheduling orders in FTC actions prior to the 2009 amendments are consistent. See
e.g., In re Polypore International, Inc., Dkt. 9327 (Oct. 22, 2008); In re Gemtronics, Inc., Dkt.
No. 9330 (Oct. 28, 2008). In those illustrative cases, a similar scheduling order was issued. The
orders differentiate between the expert “list” and the process of “identifying” rebuttal experts.
The word “identify” does not have the same meaning as “disclose” or “list.” That distinction is
recognized by the Courts. The paragraph concerning rebuttal expert reports provides that
Respondent has the right to seek appropriate relief for unfair rebuttals, which includes “striking
Complaint Counsel’s rebuttal expert reports or seeking leave to submit sur-rebuttal expert
reports,” but not excluding or introducing a new witness. All of these scheduling orders leave
precious little time between the rebuttal report and the “deadline for depositions of experts
(including rebuttal experts),” which, again, strongly suggests that the Courts have not intended
for the vague language to permit surprise witnesses at the buzzer. Even the Scheduling Order in
this case has a distinction between when an expert is “first listed as a witness” ({ 19(a)) and
when their “expert report is produced” (§ 19(b)). Here Complaint Counsel has never actually
“listed” Dr. Michel in any of the required disclosures, they just provided his report.

12


U.S. Patent Mar. 16, 1999 Sheet 3 of 7 5,883,199

1000
se 100
s @ At Yield
= X At Break
I~
Ss
70
0

0 20 40 60 80 100
Bionolle #3000 Content, wt%

FIG. 5
180

~
an
So

iS
Ss

Toughness, MJ/m* 3
gs 8s

oxy
S

0 10 20 30 40 50 60 70 80 90 100
8i0#3000 Content, wt%

FIG. 6

ECM Comb. Mot. to Exclude

Page 67 of 80
Exh. Z


PUBLIC DOCUMENT

UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION
OFFICE OF THE ADMINISTRATIVE LAW JUDGES
Washington, D.C.

In the Matter of
Docket No. 9358
ECM BioFilms, Inc.,
a corporation, also d/b/a
Enviroplastics International, PUBLIC

Respondent.

RESPONDENT’S COMBINED MOTION FOR SANCTIONS, TO EXCLUDE
COMPLAINT COUNSEL’S CONCEALED EXPERT REBUTTAL WITNESS OT
IDENTIFIED BY NOTICE IN ACCORDANCE WITH RULE 3.31A AND THE REVISED
SCHEDULING ORDER), AND FOR LEAVE TO INCLUDE SURREBUTTAL EXPERT

Pursuant to Rules 3.38(b), 3.31A(b) & (d), 3.21(c), and this Court’s Revised Scheduling
Order, Respondent ECM BioFilms, Inc. (ECM) moves this Court to exclude all testimony from,
and the rebuttal report of, Dr. Frederick Michel, a rebuttal expert first disclosed to ECM by
Complaint Counsel on June 30, 2014 at 11:46PM, fully 68 days after the deadline in the Revised
Scheduling Order for disclosure of Complaint Counsel’s expert list and one day before the close
of expert discovery.! In the alternative, if this Court permits Dr. Michel to testify despite
Complaint Counsel’s violation of FTC Rule 3.31 A? and this Court’s Revised Scheduling Order,
ECM requests leave to present the attached surrebuttal report and surrebuttal testimony from Dr.

Steven A. Grossman, Professor of Plastics Engineering at the University of Massachusetts-

Per Rule 3.31A(a), ECM files this motion within five business days from the time it
received Complaint Counsel’s rebuttal report and Rule 3.31A disclosures, excluding weekends
and holidays. As this motion seeks relief under Rule 3.38, however, the time periods in Rule
3.31A do not apply to the bulk of ECM’s requested relief.

? Complaint Counsel never served ECM with notice as required under Rule 3.31A and
the Revised Scheduling Order at 1; instead on June 30, 2014, ECM was served Dr. Michel’s
rebuttal report without the required notice.


Resp. Mot to Compel and For 42 of 12
ECM Comb. Mot. to Exclude esp. Mo or Posen o

Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


J Polym Environ (2011) 19:637 676
DOL 10.1007/s10924 011 0317 1

ORIGINAL PAPER

Biodegradable Polymers- A Review on Recent Trends

and Emerging Perspectives

Gisha E. Luckachan - C. K. S. Pillai

Published online: 29 June 2011
© Springer Science+Business Media, LLC 2011

Abstract Recent trends in biodegradable polymers indi-
cate significant developments in terms of novel design
strategies and engineering to provide advanced polymers
with comparably good performance. However, there are
several inadequacies in terms of either technology or cost
of production especially in the case of applications in
environmental pollution. So, there is a need to have a fresh
perspective on the design, properties and functions of these
polymers with a view to developing strategies for future
developments. The paper reviews the present state-of-art
on biodegradable polymers and discusses the salient fea-
tures of the design and properties of biodegradable poly-
mers. Special emphasis is given to the problems and
prospects of (1) approaches adopted to make non-biode-
gradable synthetic polymers such as polyethylene biode-
gradable and (2) biodegradable polymers and copolymers
made from renewable resources especially poly(lactic acid)
based polymers and copolymers which are emerging as the
candidate biodegradable materials for the future.

Keywords Biodegradable polymers - Environmental
aspects - Recent trends - Future perspectives -
Polyethylene - Poly(lactic acid)

Introduction: The Relevance of Biodegradable
Polymers

Synthetic polymers are considered to be an invaluable gift
of modern sciences and technology to mankind. They have

G. E. Luckachan - C.K, S. Pillai (&2)
National Institute for Interdisciplinary Research and Technology
(formerly Regional Research Laboratory), CSIR,
Thirwvananthapuram 695 019, India

e mail: ckspillai@yahoo.com

ECM Comb. Mot. to Exclude
Exh. Z

become indispensable to our life with their wide range of
applications in diverse fields such as packaging, agricul-
ture, food, consumer products, medical appliances, build-
ing materials, industry, aerospace materials etc. However,
the resistance of synthetic polymers to chemical, physical
and biological degradation has become a serious concern
when used in areas such as surgery, pharmacology, agri-
culture and the environment, and as a consequence time-
resistant polymeric wastes are becoming less and less
acceptable [1]. Naturally, the necessity for polymeric
materials satisfying the conditions of biodegradability,
biocompatibility and release of low-toxicity degradation
products, as an alternative to these existing polymers is
apparent.

The severe environmental problems, including the
increasing difficulties of waste disposal and the deepening
threat of global warming (due to carbon dioxide released
during incineration) caused by the nonbiodegradability of a
number of polymers such as polyethylene (used in pack-
aging and agriculture field) have raised concerns all over
the world. We must confront them in order to build a new
society and economy free of plastic pollution in the twenty-
first century. The use of biodegradable counter parts as an
alternative to non-biodegradable polymers is, therefore,
evoking considerable interest lately. Unfortunately, the
degradable polymers available until recently have inferior
physical properties in terms of strength and dimensional
stability and most of them are very expensive and are
technically difficult to process. As a result, attempts have
been made to solve these problems by including biode-
gradability into polymers in everyday use through appro-
priate modifications of their structure.

Degradability is not only a concern from the environ-
mental point of view. Today the medical applications of
polymers are at an all time high. Biodegradable polymers

® Springer
Page 1 of 80


IPCC: Intergovernmental Panel on Climate Change.

Landfill Containment Liner System: Layers of plastic and earthen material that
contains the contaminants within the landfill rather than allow them to contaminate the
environment.

LandGEM: Landfill Gas Emissions Model. An automated estimation tool with a
Microsoft Excel interface that can be used to estimate emission rates for total landfill gas,
methane, carbon dioxide, nonmethane organic compounds, and other air pollutants from
municipal solid waste landfills.

Leachate: The liquid that is generated from the bottom of landfills as a result of water
contacting the solid waste mass.

Leachate Collection System: A liner and piping system that is installed at the bottom of
landfills. The system is designed to collect the leachate from the landfill and direct them
to tanks for treatment.

Leachate Recirculation: A landfill leachate management method where the liquids
generated at the bottom of the landfill are collected and then reintroduced into the top of
the landfill.

Low-Density Polyethylene (LDPE): A type of plastic.

Mesophilie: Bacteria that likes moderate temperature — not too hot and not too cold.

Methanogen: Bacteria that generates methane in the process of breaking down organic
matter.

Municipal Solid Waste: Any solid material that is thrown out from residential homes.

Non-methane organic compounds (NMOC): Carbon based trace compounds that are
commonly found in the landfill gas (e.g., benzene).

37

ECM Comb. Mot. to Exclude Page 37 of 56
Exh. X


July 10 — Stewart (Los Angeles, CA)
July 11 — Sahu (Los Angeles, CA)
July 14 — Barlaz (Raleigh, NC)

July 15 — Volokh (Atlanta, GA)

Please let us know whether this works. Hopefully, getting this set soon will make the process easier on
everyone.

Thanks,

Jonathan Cohen

Enforcement Division | Bureau of Consumer Protection | Federal Trade Commission
600 Pennsylvania Avenue, N.W.,M-8102B Washington, D.C. 20580

(202) 326-2551 | jcohen2@fte.gov

ECM Comb. Mot. to Exclude Page 7 of 7
Exh. K


his deposition, any documents introduced into evidence by Respondent or Complaint Counsel as
to which he has knowledge; or any other matters as to which he has knowledge that are relevant
to the allegations of the Complaint, Respondent's affirmative defenses, or the proposed relief

13. Annette Gormly, Kappus Plastic Company, Inc. (“Kappus”) Vice President,
as Kappus’ designee

Ms. Gormly will testify regarding Kappus’ relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, Kappus’ purchase of ECM
additive; reasons for this purchase; Kappus’ understanding of ECM's claims and substantiation
for those claims, Kappus’ resources and ability to test and evaluate ECM’s claims and
substantiation; Kappus’ use and understanding of the ECM Certificate of Biodegradability, the
ECM logo, and other ECM promotional material; Kappus’ understanding of how its customers
used ECM promotional materials and products made with the ECM additive; any other issues
addressed in her deposition; any documents introduced into evidence by Respondent or
Complaint Counsel as to which she has knowledge; or any other matters as to which she has
knowledge that are relevant to the allegations of the Complaint, Respondent's affirmative
defenses, or the proposed relief.

16. James Bean, Quest Plastics, Inc. (“Quest”) President and Chief Executive
Officer, as Quest’s designee

Mr. Bean will testify regarding Quest’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, Quest's purchase of ECM
additive; reasons for this purchase; Quest's understanding of ECM’s claims and substantiation
for those claims; Quest’s resources and ability to test and evaluate ECM’s claims and
substantiation, Quest’s use and understanding of the ECM Certificate of Biodegradability, the

ECM logo, and other ECM promotional material; Quest’s understanding of how its customers

10

ECM Comb. Mot. to Exclude Page 10 of 16
Exh. F


Arumugam, Sathappan, A study of crystallization behavior of PHB homopolymer and copolymer

blends as a function of aging conditions, 2012

Berthiume, William A. "Percutaneous Transluminar Coronary Angioplasty Electrode Guide Wire
for Blood Flow Measurement", 1993

Bandyopadhyay, Rahul, "Verification of Fiber Orientation Prediction Software", 1992

Bardzik, John J., "Nitrogen Gas Permeability in y irradiated PVC film", 1992

Bhogesara, Anil Rajubhai., "Injection Molding Productivity Machine Setup", 1994

Ben-Daat, Dan, “Extrusion of Biodegradable Foam”, 1996

Berube, Alfred, "Pressure Monitoring of Injection Molding for Moldflow", 1993

Bhalakia, Sujal, "Biodegradable Polymer Blends", 1993

Bhoyar, Renuka, “Characterization of the Microstructure of Poly Hydroxybutyrate (PHB)
Copolymer During Their Post-Fabrication Annealing at Room Temperature, 2010

Burns, David T, Analysis of 1 Micron Thickness Metal Spray coating Effects on
Stereolighography Rapid Tooling for Injection Molding, 1997

Cai, Hua, “A Study of Biodegradable Plasticized Cellulose Acetate, 1993

Cai, Xu., “Plasticization of Cellulose Acetate and Preparation of its Composites with Poly-e-
Caprolactone ", 1993

Cecere, Daniel A, “Rapid Tooling for Optical Molding Utilizing Cast ItTM 2000 Aluminum Epoxy
Alloy”, 2003

Chang, Oliver, "Rheological Properties of Blends of EVOH and Styrene Based Polymers", 1989

Chen, Chin-Ho, "An Investigation into PVC/MBS Blends", August 1986

Chen, Jih-Sang, "Effect of Plasticizer Desorption on Permeability of Saran", August 1990

Chen, King-Ming, "Polyblends of Amorphous Nylon with Polystyrene Materials", 1990.

Chen, Xin, "Crystallization Kinetics of Thermal Parameters of CPET", 1990

Cheng, Yao, “Optimal Product and Process Design for the Plastic Corrugated Board”, 1995

Chheda, Harsh D., “Study of the properties of foamed wood flour filled polypropylene and
poly(3-hydroxybutyrate-co-3-hydroxyvalerate) using direct extrusion”, 2006

Choi, Jinseog, “Thermoplastic Composite for Ballistic Applications”, 1996

Clarke, Rosemary, "Verification of a Computer Simulation Injection Mold Filling Software
Package", 1988 (Co-advisor)

Daga, Rahul, “Enhancing Thermal Conductivity of Poly-Hydroxy-alkanoates (PHA) to Reduce
Flash In Injection Molded Parts”, 2008

D’ Amico, Lisa, "Computer Aided Mold Filling ", 1991

Damle, Mandar, "Effect of Fiber Orientation on The Mechanical Properties Of A

Injection Molded Part And A Stereolithography Insert Molded Part", 1997

Dave, Parasar, "Biodegradable Blends of PHBV", 1990

Dell’Arciprete, John “Cavity Pressure Studies for Stereolithography Produced Tooling”, 2001

Discipio, William, Computer Aided Shrinkage Verification ", 1991

Dollinger, Harli M., “Novel Bicontinuous Poly(D, 1-Lactic Acid) Ethylene/Vinyl Acetate Blends
for BioMedical Applications”, 1991

Dubey, Dharmesh K. "Compatabilization Studies of Biodegradable Polymers by Reactive
Processing", 1992

Efrat, Tehila, “Nano Tailoring of Polyurethane Adhesive by Polyhedral Oligomeric Silsesquioxane
(POSS)”, 2005

Faletra, Christopher, "Computer Integrated Injection Molding",

Fitzgerald, Cheryl A., "Case Study on How to Improve Production", 1998

Frost, David, "Expert System for Part Design",

Gajria, Ajay M., "Effects of Physical Aging and Miscibility on Biodegradability of Poly(Lactic
acid)/Polyvinyl Acetate Blends", 1994

ECM Comb. Mot. to Exclude Page 55 of 58
Exh. U


DATED: July 9, 2014

22

PUBLIC DOCUMENT

Respectfully submitted,

Joftathan W. Emord (jémord@emord.com)
EMORD & ASSOCIATES, P.C.

11808 Wolf Run Lane

Clifton, VA 20124

Telephone: 202-466-6937

Facsimile: 202-466-6938



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D Springer
Page 33 of 80


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of
ECM BioFilms, Inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International PUBLIC DOCUMENT

Leer

COMPLAINT COUNSEL’S CLARIFICATION REGARDING RESPONDENT’S
SANCTIONS MOTION

In Complaint Counsel’s Opposition to Respondent’s sanctions motion, we submitted a
declaration stating, in material part, that “Complaint Counsel received the article [published in
POLYMER DEGRADATION & STABILITY] well after business hours on Friday, February 14, 2014,
at approximately 8:00 p.m.” J. Cohen Dec. 6 (Mar. 10, 2013). This is accurate.

Additionally, the declaration also provides that “Complaint Counsel has not
communicated in any way with Frederick Michel, Eddie Gémez, OARDC [Ohio State
Agricultural Research & Development Center}, or anyone at Ohio State.” Id. at 47. This is also
accurate.

Out of an abundance of caution, however, Complaint Counsel brings to the Court’s
attention that yesterday, we learned that two FTC attorneys (not representing Complaint
Counsel) worked with Michel as a consulting expert on unrelated matters involving
biodegradability claims other companies asserted.! In the course of evaluating Michel’s
credentials, these attorneys received a draft of the article ultimately published. Complaint
Counsel never had any knowledge regarding Michel’s engagement (or the draft articl e) until
yesterday. Additionally, as our Opposition explains, Complaint Counsel had no knowledge

regarding the article itself before Friday evening, February 14.

' One of the two attomeys was involved in the pre-Complaint investigation of
Respondent, but departed the. agency approximately eight months before the Complaint was
filed.

ECM Comb. Mot. to Exclude Page 1 of 3
Exh. Q



Introduction

I was requested by counsel for ECM Biofilms to review and provide my comments on the

rebuttal reports of Drs. Michel and McCarthy.
Rebuttal of Points of Dr. Frederick Michel

Comment by Dr. Michel

At page 6 of his Rebuttal report, Dr. Michel responds to the point that in his 2013 article
(Biodegradability of Conventional and Bio-based Plastics and Natural Fiber Composites
During Composting, Anaerobic Digestion and Long Term Soil Incubation) it was observed that
the positive control (cellulose paper) plateaued at around 70-75%. This certainly was a
relevant observation supporting the view that conditions promoting degradation had been
significantly compromised. Dr. Michel’s response was that this was somehow irrelevant since
“some of the other materials (e.g. Plastarch, a corn starch polyester blend and PHA) continued
to biodegrade well after cellulose biodegradation had plateaued.” Dr. Michel asserted that such
plateau is not evidence of a flawed test and presented FIG. 1 and FIG. 2 of his article.

Rebuttal

Looking at FIG. 1 of the subject 2013 Michel article, when the positive control plateaued at
about 72% after 400+ days, Plastarch also appeared to plateau at a level of about 28%. See

below:
100% —2— Posilive (cellufose paper) }— PHA

$2 90% -| —m— Copolyester+ combased pobyrier p— Plasarch

2 ke Wheat starch-derived resin

g 80% PETE + 1% additive

% 70% iW

4 “Wissrow shows that

ie ‘calllose paper has
leveled of a about

E am nana

2 40%

2 30% U

g

20% ‘This aerow shows that

3 Fastrch es leveled

é 10% ‘off at about 28% at

"00 dys
0%
a 100 200 300 400 500 600 700
Time (lava,
Page 3 of 20
ECM Comb. Mot. to Exclude Page 3 of 20

Exh. W


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Page 40 of 80


PUBLIC DOCUMENT

Complaint Counsel violated the discovery rules, and sanctioned them for the guerrilla “gotcha”
tactics employed. See Exh. P.

By submitting Dr. Michel’s expert rebuttal report on June 30, 2014, at 11:46 P.M. EST,
and by wholly failing to list, identify, or designate Dr. Michel as an expert witness or expert
rebuttal witness at any point during this litigation, Complaint Counsel essentially recommitted
the very same kind of willful non-disclosure that led this Court to impose sanctions on March 21,
2014. See Exhs. A-F; Exh. P; Exh. R. Complaint Counsel first served Dr. Michel’s “expert”
production files related to his rebuttal report on July 1, 2014, a day after the deadiine to submit
rebuttal reports, and just one day before the deadline to conduct expert depositions lapsed.* See
Exh. S (FTP Transfer Link).

ECM cannot hope to obtain full discovery of Dr. Michel at this late stage without yet
another move of the hearing date (necessitating Commission intervention), as it is exceedingly
difficult for ECM to prepare for Dr. Michel’s testimony while simultaneously managing the
remaining obligations under the Court’s third revised scheduling order. Only during a meet and
confer on this matter conducted on July 2, 2014 did Complaint Counsel offer Dr. Michel for
deposition, providing at that late date the following unworkable dates: July 17, 18, 29, and
August 1. See Exh. T. By July 18, the following deadlines in this case will have passed: the
deadline for filing motions for in camera treatment; the deadline for filing objections to witness
lists; the deadline for expert exhibits; and the deadline for motions in limine to exclude

evidence.> ECM would likely not receive a copy of the deposition transcript until the week

4 As part of the previously negotiated expert deposition schedule, the parties agreed to
extend this deadline for Drs. Barlaz and Volokh only.

> The Scheduling Order in this Case states that “{iJt shall be the responsibility of a party
designating an expert witness to ensure that the expert witness is reasonably available for

8


1983 FTC LEXIS 61 at *594 (July 18, 1983). Sanctions may be imposed for failing to comply
with a discovery obligation where the failure to comply was “unjustified and the sanction
imposed ‘is reasonable in light of the material withheld and the purposes of Rule 3.38(b).’” See
Matter of International Telephone & Telegraph Corp., 1984 WL 565367 at **127 (July 25, 1984
(quoting Grand Union, 1983 FTC LEXIS 61 at *595)).

Regardless of whether exclusion of the Ohio State Article would be an appropriate
remedy had Complaint Counsel delayed production of the document until after the discovery
deadline or the start of trial — conduct present in the cases cited by Respondent — in the instant
case the extent of Complaint Counsel’s delay does not warrant this sanction. The fact discovery
deadline in this case is presently April 3, 2014, and the close of expert discovery is presently
May 16, 2014, Trial 1s currently scheduled to begin on June 18, 2014. Under these
circumstances, exclusion of the Ohio State Article is not necessary or appropriate to remedy the
asserted prejudice. Accordingly, Respondent’s request to exclude the Article, as a sanction for
Complaint Counsel’s delayed production of the Article, is DENIED.

However, Respondent has demonstrated that Complaint Counsel violated its discovery
obligation to supplement in a timely manner with respect to the Ohio State Article, and based on
the facts presented, a sanction is appropriate. Accordingly, the Motion is GRANTED IN PART
Complaint Counsel has failed to show that its conduct was Justified, and a sanction under these
circumstances will aftirm the integrity of the administrative process. Moreover, Complaint
Counsel should not be permitted to benefit from its conduct. In the instant case, a reasonable and
Just sanction under Rule 3.38(b) is an order prohibiting Complaint Counsel from using or in any
way relying upon any of Mr. Sinclair’s deposition testimony regarding the Article. Rule 3 38(b)
(stating that ALJ may enter any sanction order that is “Just”), see also Rule 3.38(c) (stating that
ALJ shall order relief “as may be sufficient to compensate for withheld testimony. documents, or
other evidence”).

Il. Conclusion and Order

For all the foregoing reasons, Respondent’s Motion for Sanctions is GRANTED IN
PART, and it 1s hereby ORDERED, that Complaint Counsel may not introduce into evidence, or
otherwise rely, for any purpose, including without limitation impeachment, upon testimony given
at the deposition of ECM on February 18 and 19, 2014, regarding the Ohio State Article. ‘The
Motion is in all other respects DENIED.

ORDERED: Dry rapedl
D. Michael Chappell
Chief Administrative Law Judge

Date: March 21, 2014

ECM Comb. Mot. to Exclude Page 6 of 6
Exh. P


J Polym Environ (2011) 19:637 676

663

presented PLA/Cordenka composites show their potential
as an alternative to traditional composites.

In another work focus was on the investigation on China
jute fiber reinforced PLA composites [544]. Composites
with three different fiber volume fractions were fabricated
by film stacking hot press method. Mechanical properties
have been investigated and the microstructure of the
composites was observed. Fiber surface treatment by silane
was applied in order to investigate the effects on the
properties of the composites. The moisture absorption rates
in a hydrothermal environment were also measured.

Standards developed by ASTM and ISO evaluate the
biodegradation of biodegradable plastic materials in sim-
ulated controlled composting conditions. However, a more
detailed understanding of the biodegradation of complete
packages is needed in order to have a successful com-
posting operation. Kale et al. investigated the biodegrada-
tion performance of polylactide (PLA) bottles under
simulated composting conditions according to ASTM and
ISO standards using two simulated composting methods
were used in this study to assess biodegradability of PLA
bottles: (a) a cumulative measurement respirometric
(CMR) system and (b) a gravimetric measurement respi-
rometric (GMR) system [545]. Both CMR and GMR sys-
tems showed similar trends of biodegradation for PLA
bottles and at the end of the 58th day the mineralization
was 84.2 + 0.9% and 77.8 + 10.4%, respectively. The
biodegradation observed for PLA bottles in both conditions
explored in this study matched well with theoretical deg-
radation and biodegradation mechanisms.

To make PLA economically viable, Bhtia et al., used
blends of PLLA with poly (butylene succinate) (PBS) to
explore suitability of these compositions for packaging
applications [346]. Tensile strength, modulus and per-
centage (%) elongation at break of the blends decreased
with PBS content. However, tensile strength and modulus
values of PLA/PBS blend for up to 80/20 composition
nearly follow the mixing rule. Rheological results also
show miscibility between the two polymers for PBS
composition less than 20% by weight. PBS reduced the
brittleness of PLA, thus making it a contender to replace
plastics for packaging applications. This work found a
partial miscibility between PBS and PLA by investigating
thermal, mechanical and morphological properties.

Several attempts are reported to improve the mechanical
properties of PLLA [441, 540, 547]. Possessing the stiff-
ness and tensile strength of polyethylene terephthalate
(PET), polylactide is being marketed for a variety of fiber
and packaging products. Fibers produced from polylactide
exhibit low odor retention and excellent moisture wicking
properties. Additionally, polylactide bottles, films, and
thermoformed containers are becoming increasingly pop-
ular for food packaging because of their resistance to fats

ECM Comb. Mot. to Exclude
Exh. Z

and oils, as well as their ability to “block” flavors and
aromas. The use of clay composites for maintaining the
stiffness and tensile modulus of polylactide on toughening
have shown promise. Andertson et al. discuss three most
common strategies for polylactide toughening : orientation,
plasticization, and blending. It is well known that in gen-
eral, semi-crystalline polylactide homopolymer shows
improved tensile and impact properties relative to the
amorphous. So, orientation is expected to increase the
tensile modulus and elongation at break. The use of small
molecule plasticizers (e.g., lactide, citrate esters) as well as
oligomeric/polymeric plasticizers (such as PEG) in poly-
Jactide are useful ways to obtain significant increases in the
elongation at break, making polylactide much more elastic.
Blending with other bio degradable non biodegradable
fibers and composite formation are good toughening
mechanisms. The use of clay composites for maintaining
the stiffness and tensile modulus of polylactide on tough-
ening have shown promise.

A significant increase in impact resistance (540 +
100 J m21) was observed in a PLA/LLDPE blend com-
patibilized with 5 wt% of a PLLA-b-PE block copolymer
[547] (See Fig. 21).

Copolymer formation is considered a good method to
improve properties [548 560]. To tailor the properties of
PLA for a particular application, several parameters, apart
from what have been discussed such as catalyst and catalyst
concentration, molecular weight, crystallinity, end capping,
copolymer ratio etc. have to be controlled [425]. The
selection and use of an appropriate catalyst is of paramount
importance to produce PLA at a lower cost. The mechanical
properties of PLA can be varied to a large extent ranging
from soft, elastic plastic to stiff and high strength plastic.
With the increase of molecular weight the mechanical
properties also increase. With the increase of molecular
weight of PLLA from 23 to 67 k, flexural strength increased
from 64 to 106 MPa but the tensile strength remains the
same at 59 MPa [561]. In the case of poly(DL-lactide) when
molecular weight is increased from 47.5 to 114k [561]
tensile and flexural strength increased 49 53 MPa and
84 88 MPa, respectively. Tissue engineering is the most
recent domain where poly(lactic acid) is being used and is
found to be one of the most favorable scaffold materials
[562]. PuraSorbsPLG is a semicrystalline bioresorbable co-
polymer of L-lactide and glycolide with a monomer ratio of
80L: 20G [563] A co-polymer containing 90% glycolic acid
(GA) and 10% L-lactic acid (LA) was initially used for the
development of the multifilament suture Vicryls [156]. An
irradiated version of Vicryls to increase the rate of degra-
dation is currently in the market under the trade name, Vicryl
Rapids. PANACRYL s is another commercially developed
suture from the co-polymer with a higher LA/GA ratio in
order to decrease the rate of degradation.

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Page 27 of 80


642

J Polym Environ (2011) 19:637 676

based composites. The use of biodegradable natural fibers
which are biodegradable has also got a new dimension as
reinforcement in natural fiber composites [106 113).
Inherent shortcomings of natural polymer-based packaging
materials such as low mechanical properties and low water
resistance can be recovered by applying a nanocomposite
technology. Natural biopolymer-layered silicate nanocom-
posites exhibit markedly improved packaging properties
due to their nanometer size dispersion. These improve-
ments include increased modulus and strength, decreased
gas permeability, and increased water resistance. Conse-
quently, natural biopolymer-based nanocomposite pack-
aging materials with bio-functional properties have a huge
potential for application in the active food packaging industry
[£14]. Yang et al. have reviewed recently the preparation,
characterization, properties, and applications of nanocom-
posites based on biodegradable polymers such as polylac-
tide (PLA), poly(e-caprolactone) (PCL), poly(p-dioxanone)
(PPDO), poly(butylenes succinate) (PBS), poly (hydrox-
yalkanoate)s such as poly(f-hydroxybutyrate) (PHB), poly(3-
hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), and natural
renewable polymers such as starch, cellulose, chitin, chitosan
lignin, and proteins [115]. The nanoparticles that have been
also utilized to fabricate the nanocomposites include inor-
ganic, organic, and metal particles such as clays, nanotubes,
magnetites, Au and Ag, hydroxyapatite, cellulose, chitin
whiskers and lignin.

Biodegradable Polymers in Medicine and Surgery

The property of biodegradability of polymers when applied
to medicine and surgery has immense applications. Fol-
lowing Kronenthal [116], several authors [117 151] have
reviewed and contributed to various applications of bio-
degradable polymers in medicine and surgery. According
to Kronenthal, the polymer degrades in vivo in four steps:
(1) Hydration- disruption of van der waals forces and
hydrogen bonds. (2) Strength Loss- initial cleavage of
backbone covalent bonds. (3) Loss of Mass Integrity- fur-
ther cleavage of covalent bonds to polymer molecular
weight levels insufficient for mass coherence. (4) Mass
Loss- (Solubilization) dissolution of low molecular weight
species and phagocytosis of small fragments. He also gives
a list of characteristics for a biodegradable implant to be
successful. They are: formability, adequate initial strength
and dimensional stability, controlled rate of strength loss,
complete absorbability, low order of toxicity of both
implant and degradation products and_ sterilizability.
Among the different classes of biodegradable polymers, the
thermoplastic aliphatic poly(esters) such as poly(lactide)
(PLA), poly(glycolide) (PGA) and especially the copoly-
mer of lactide and glycolide referred to as poly(lactide-co-
glycolide) (PLGA) have generated tremendous interest

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

because of their excellent biocompatibility, biodegrad-
ability and mechanical strength. They are easy to formulate
into various devices for carrying a variety of drug classes
such as vaccines, peptides, proteins and macromolecules.
Most importantly, they have been approved by the United
States Food and Drug Administration (FDA) for drug
delivery. This review presents different preparation tech-
niques of various drug-loaded PLGA devices, with special
emphasis on preparing microparticles. An excellent treat-
ment on the synthesis, properties and applications of ali-
phatic polyesters can be found in the review by Albertsson
and Varma [119]. Pillai et al. induced biodegradability in
the otherwise non-biodegradble liquid crystalline aromatic
polyesters by introducing an aliphatic carbonyl [121, 122,
128}. In another work, Pillai et al. showed that biode-
gradable aliphatic poly(ester amides) having interestig
properties for biomedical applications could be prepared
through an amido diol route [137, 138, 140]. In the area of
tissue engineering, the design and fabrication of biode-
gradable synthetic scaffolds is driven by four material
categories: (1) common clinically established polymers,
including polyglycolide, polylactides, polycaprolactone (2)
novel di- and tri-block polymers (3) newly synthesized
or studied polymeric biomaterials, such as polyorthoest-
er, polyanhydrides, polyhydroxyalkanoate, polypyrroles,
poly(ether ester amide)s, elastic shape-memory polymers
and (4) biomimetic materials, supramolecular polymers
formed by self-assembly and matrices presenting distinc-
tive or a variety of biochemical cues [139]. Degradable
polymeric biomaterials are preferred candidates for
developing therapeutic devices such as temporary pros-
theses, three-dimensional porous structures as scaffolds for
tissue engineering and as controlled/sustained release drug
delivery vehicles. Each of these applications demands
materials with specific physical, chemical, biological,
biomechanical and degradation properties to provide effi-
cient therapy. These aspects including the synthesis, bio-
degradability and biomedical applications of biodegradable
synthetic and natural polymers as biomaterials have been
discussed in a recent review by Nair and Laurencin [152].
The use of biodegradable natural polymers in tissue engi-
neering has\been reviewed by Mano et al. [153]. Williams
recently reviewed the synthesis and characterization of
functionalized aliphatic polyesters which are attracting
attention as sustainable alternatives to petrochemicals for
applications in medicine [154]. Biodegradable elastomers
have a number of potential applications in the biomedical
area, especially in the emerging field of soft-tissue engi-
neering where the mechanical properties of the polymer
scaffold should match those of the tissue to be grown. The
synthesis strategies and the properties of these elastomers
are discussed by Amsden elaborating the factors that
influence the characteristics of these elastomers including

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641

Kricheldorff [89] also has reviewed the synthetic tech-
niques for the preparation of cyclic metal alkoxides and
their use as initiators for ring opening polymerization of
lactones, cyclic diesters and cyclocarbonates which are
biodegradable. Hori et al. [90] also have reviewed the
technique used for preparing novel biodegradable polyes-
ters. Based on polymer structure, polymer physical prop-
erties and environmental conditions, it is possible to design
biodegradable polymers for a particular application. Some
guidelines are as follows: a higher ratio of hydrophilic/
hydrophobic ratio is better for degradation, fully carbon
chain polymers are less likely to degrade than hetro atom
containing polymers, chain branching is deleterious to
biodegradation, condensation polymers are more likely to
undergo biodegradation, lower molecular weight oligomers
are more susceptible to biodegradation, crystallinity redu-
ces biodegradation, lower surface area reduces biodegra-
dation etc. Water solubility and purity add to possibilities
for biodegradation. Environmental conditions to be con-
sidered for evaluation are temperature, pH, moisture,
oxygen, nutrients, suitable microbial population, concen-
tration and test duration. In short, parameters such as
chemical structure, chemical composition, distribution of
Tepeat units, presence of functional groups, presence of
chain defects, configurational structure, molecular weights
and polydispersity, presence of low molecular weight
compounds, processing conditions, shape, sterilizing con-
ditions, morphology, annealing effects, storage history etc.
might be considered in selecting a biodegradable polymer.

Tang et al. [91] published a review covering research,
development and production of environmentally degrad-
able plastics, including photo degradable plastics, biode-
gradable plastics and disintegratable plastics; defines
problems to be solved in relation to the situation in China.
The biodegradation of plastic waste was considered by
Zheng et al. [92] also in a recent review. In discussing the
impact of Biotechnology and next generation materials,
Stowers [93] has brought out the need for biodegradable
plastics in many applications. In a recent review, Raquez
et al. [94] discussed how reactive extrusion (REx) tech-
nique can participate in the design and development of
biodegradable polymeric materials. Gunatillake et al. [95]
in a recent article discuss developments in biodegradable
synthetic polymers focusing on tailoring polymer structures
to meet material specification for emerging applications
such as tissue engineered products and therapies. This
review may be referred for data on properties and biode-
gradability of major classes synthetic polymers such as
polyesters and their copolymers including polyglycolides,
polylactides and their copolymers, polyurethanes, poly-
phosphazenes, polyanhydrides, polycarbonates, polyester-
amides and recently developed injectable polymer systems
based on polypropylenefumarates, polyurethanes and

ECM Comb. Mot. to Exclude
Exh. Z

acrylate/urethane systems. Demirbas [96] introduces natu-
ral biodegradable plastics based on primarily on renewable
resources. The biodegradability of plastics is dependent on
the chemical structure of the material. The biodegradation
of plastics proceeds actively under different soil conditions
according to their properties. Biodegradation of starch
based polymers occurred between the sugar groups leading
to a reduction in chain length and the splitting off of
mono-, di- and oligo-saccharide units by a result of enzy-
matic attack at the glucosidic linkages. Wang et al. [97]
reviewed the current development of biodegradable plas-
tics, namely poly(lactic acid), poly(hydroxyalkanoate),
poly(¢-caprolactone), poly(butylenes succinate), poly(vinyl
alcohol) and its copolymer, and starch. Attention was also
paid to relevant existing problems of the above biode-
gradable plastics.

Biodegradable Polymers in Composites

The emergence of composites and lately nanocomposites
has brought in a revolution in materials science. Several
articles have highlighted the importance of biodegradable
polymer matrix in the development and use of composite
materials [98 103]. Recent advances in polymer blends
and composites from renewable resources and their
potential applications have been reviewed recently by Yu
et al. [98]. Among these products, natural fiber eco com-
posites [100 106] are emerging rapidly. Bogoeva-Gaceva
et al. [100] provides a brief review of the most suitable and
commonly used biodegradable polymer matrices and nat-
ural fiber (NF) reinforcements in eco-composites, as well
as some of the already produced and commercialized NF
eco-composites. The structural aspects and properties of
several biofibers and biodegradable polymers, recent
developments of different biodegradable polymers and
biocomposites are discussed by Mohanty et al. [101, 102]
and Lodh et al. [103]. The recycling of biocomposites was
reviewed by Bhakat et al. [104].

Pandey et al. [105] addresses the technical difficulties
and suggest solutions in the application of biodegradable
nanocomposites. Renewable resource-based biodegradable
polymers including cellulosic plastic (plastic made from
wood), corn-derived plastics, and polyhydroxyalkanoates
(plastics made from bacterial sources) are some of the
potential biopolymers which, in combination with nanoclay
reinforcement, can produce nanocomposites for a variety of
applications. Nanocomposites of this category are expected
to possess improved strength and stiffness with little sac-
tifice of toughness, reduced gas/water vapor permeability,
a lower coefficient of thermal expansion and an increased
heat deflection temperature, opening an opportunity for the
use of new, high performance, light weight green nano-
composite materials to replace conventional petroleum-

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653

Fig. 11 Weight changes of
polyethylene after incubation in +, TM
the Baltic Sea water.

(Reproduced from Ref. [397])

»

acid (PCL) and poly(caprolactone) (PLA), in a co-rotating
twin-screw extruder [400]. A polyethylene modified with
maleic anhydride was used as compatibilizer. The
mechanical results showed that the addition of PLA
improves the blends stiffness while the addition of PCL
leads to materials with a greater elongation at break and a
lower Young modulus. This feature is related with the
mechanical properties of each material as well as the
adhesion between them. Concerning the biodegradability
tests, it was found that HDPE/PCL blend presents the
highest degree of biodegradability.

Chemistry of Polyethylene Biodegradation

Biodegradation of polyethylene involve a complex inter-
action of abiotic and biotic mediated oxidative processes
[402 404]. The carboxylic acids formed by the abiotic
reactions undergo f-oxidation, where two carbon frag-
ments are removed from the carboxylic molecule by
reaction with coenzyme A, leaving behind a still activated
acid, The activated acid repeatedly participates in the same
process until the whole chain is split into two carbon
fragments (Fig. 12). The two carbon fragments enter the
citric acid cycle, from which carbon dioxide and water are
released [405 408}. The various mechanisms, which
include photo-oxidative degradation, thermal degradation,
ozone-induced degradation, mechanochemical degradation,
catalytic degradation and biodegradation, are discussed in
detail by Shah et al. and Zheng et al. (409, 410].

It appears there is a limit in enhancing the biodegrad-
ability of PE. Incorporation of photosensitizers is consid-
ered a mechanistic way by which one may approach this
problem. But, this method has to be in combination use
biodegradable blend components. This was shown by
Wiles et al. when they used antioxidants and stabilizers,
developed to increase the durability of polyolefins, in
combination with prooxidant transition metal complexes to

ECM Comb. Mot. to Exclude
Exh. Z

| —er Pee
| a Peeen,

—o PES
~O— PENNE

provide industrial products with widely variable but con-
trolled lifetimes [411]. The low molar mass oxidation
products formed during photo-oxidation and thermal oxi-
dation are biodegradable and oxo-biodegradable polyole-
fins are now widely used in agricultural applications and in
degradable packaging as examples.

Polylactide, a Dominating Biopolymer

There is a growing interest in utilizing renewable resources
as a functional biopolymer in a broad range of scientific
areas such as biomedical, agricultural, food, cosmetics,
wastewater management and environmental field [77, 98,
408}. Polylactides (PLA) are considered as the most versatile
material among biodegradable polymers because of its
inherent biodegradability, biocompatibility, high mechani-
cal strength and Young’s modulus comparable with those of
polyethylene and polystyrene and the easy availability from
renewable agricultural sources.

Recent develqpments indicate a great increase in the
Publication of polylactide (PLA) polymers spurt in the
[412 418]. These attributes make them a leading candidate
in biomedical and pharmaceutical industries as a resorbable
implant material, wound closure, bone fixation devices and
a vehicle for controlled drug delivery [416 418). It is also
used as an environment friendly plastic, although their
market is still limited due to its higher cost and slow
degradation rate as compared to the waste accumulation
rate (419, 420}. However, their clinical applications are
sometimes affected by the high hydrophobic and conse-
quent poor water uptake, which results in a slow hydrolytic
degradation rate [2, 421]. Another potential disadvantage is
the complications resulting from the accumulation of lactic
acid produced in the process of PLA degradation, and its
poor processability [422, 423]. Ultra high molecular weight
is required for processing PLA into strong fibers. PLA is

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Page 17 of 80


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 32

81. Test Conditions. The temperatures for almost all of the tests are inconsistent with
anaerobic conditions found in landfills. For instance, several tests were conducted under the
thermophilic range more commonly associated with composting conditions. As a result, these
tests cannot be used as valid scientific support for claims regarding typical landfills.

82. Sample Weight. Almost all of the gas evolution tests employ a low sample size to
high inoculum weight ratio. Since the inoculum contains organic components, this skewing of
the sample-to-inoculum ratio increases the likelihood that observed biodegradation is attributable
to the priming effect.

83. Test Duration. No test was conducted long enough for the test samples to
achieve 60% biodegradation. There are a handful of tests that were conducted for several
years,” but the results of these tests are dubious because of the poor methodologies (¢.g.,
refreshing of inoculum, which reinvigorates the priming effect). Significantly, even these tests—
conducted for as long as 900 days—did not show 60% biodegradation.

84. Proper Controls. No test controlled for the priming effect. As explained,
observed biodegradation could be the result of the biodegradation of the ECM Additive itself (or
the additive and the inoculum). One way to account for this possible overestimation is to use a
control that includes the inoculum and the additive itself. By comparing these results to the
negative control and the inoculum control, it is possible to calculate the amount of increased gas
production due to the priming effect of the additive. Because no test included this type of
control, none of the tests can rule out the possibility that the low-levels of biodegradation

observed in the test are a result of the priming effect.

» See, e.g., Northeast Laboratories Report N1048340 testing ECM Plastic for 900 days;
see also Northeast Laboratories Report 1149980 testing ECM Plastic for 365 days.

ECM Comb. Mot. to Exclude Page 32 of 58
Exh. U


ANTEC-SPE, Boston, Spring 1986.

SPE-SPI Plastics South, Atlanta, Spring 1986.

American Chemical Society, New York, Spring 1986.
ANTEC-SPE, Washington D.C., Spring 1985.

Gordon Research Conference on Polymers, Summer, 1983.

International Union of Pure and Applied Chemistry-28th Macromolecular Symposium,
Amherst, Massachusetts, Spring 1982.

Gordon Research Conference on Polymer, Summer 1982.

Gordon Research Conference on Polymers, Summer 1981. American Chemical Society,
Houston, Spring 1980.

Northeast Regional Meeting of the American Chemical Society, Boston, Summer 1978.
d. Consulting Activities

Carmody, Torrrance, Sandak & Hennessey, Incardonia v. Medical Components, et al, Judicial
District of Waterbury Connecticut, Docket X02-UWY-CV-07-6000812S (expert witness)

Greenburg-Traurig (G. Herbert), Orlando, Florida, expert witness, Goswami v. Universal Air-

2002-CA-101 (2008)

April 2000, National Business Institute, Concord, New Hampshire, Lecturer on "Patent
Infringement"

Morgan & Finnegan (M. Nicodema, 1999), expert witness, Triple S Plastics v. Capital Vial
No. CV 97-499 TUC AZ.

Jenner & Block (J. Benak, 1999) expert witness, Tenneco Packaging & Consumer
Products, Inc.. v. S.C. Johnson & Son. Inc and KCL Corporation, Case No.
98C2679 N.D. Ill.

Pierce Atwood (Robert Stier, 1999 expert witness, Cohesive Technologies Inc. y. Waters
Corporation, Civil Action 98-12308(DPWI)

Halloran & Sage (John Farley~1997/1998 expert witness/patent ownership, Fenn v. Analvtica
(D.C. Connecticut))

Bernstein, Shur, Sawyer & Nelson (Robert H. Stier, Jr.) (1997 expert witness/patent
infringement, Pastore/Produits y. Hydro-Innovation. (D.C. Maine))

Page 15 of 17

ECM Comb. Mot. to Exclude Page 15 of 17
Exh. Y


ECM Comb. Mot. to Exclude Page 49 of 80
Exh. Z


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

)
In the Matter of )
)
ECM BioFilms, Inc., ) Docket No. 9358
a corporation, also d/b/a )
Enviroplastics International )
)

COMPLAINT COUNSEL’S PRELIMINARY WITNESS LIST

Pursuant to the Court’s Scheduling Order, Complaint Counsel hereby submits its
Preliminary Witness List identifying individuals who may testify in Complaint Counsel’s case-
in-chief (excluding expert witnesses, rebuttal witnesses and rebuttal expert witnesses) and a brief
description of their proposed testimony. This list is based upon the information reasonably
available to Complaint Counsel at this time.

Significantly, Respondent’s failure to comply with either its Initial Disclosure obligations
or Complaint Counsel’s discovery requests prevents Complaint Counsel from providing a
complete list or fully detailing the subjects upon which potential witnesses may testify. Among
other things, Respondent did not provide its customer list to Complaint Counsel until late
yesterday and still has not complied with a majority of Complaint Counsel’s document requests
(including the most important requests). Respondent’s failures have substantially limited the
information reasonably available to Complaint Counsel, and we reserve the right to amend this

list as more information becomes available,!

‘Where Complaint Counsel understands that the potential witness is represented, we will
provide contact information.

ECM Comb. Mot. to Exclude Page 1 of 11
Exh. A



ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 14

etc.) that the additive will in fact be incorporated into. Testing the intended type
of plastic application is necessary, because different types of plastics have unique
chemical and physical characteristics that affect their susceptibility to
biodegradation. For instance, flexible polyvinylchloride (PVC) contains
“plasticizers” that themselves could be biodegradable. Therefore, a test involving
treated flexible PVC will likely yield different results than a plastic that does not
contain biodegradable plasticizers.

b. Load Rates. The study must accurately reflect the recommended “load rate.” In
other words, if the additive is advertised to work when it comprises 1% of the
plastic, then the test must be conducted on plastic that is 1% additive. Using the
recommended load rate is important because the additive itself has biodegradable
properties. Simply because a certain amount of biodegradation was observed at
5%, one cannot assume that one-fifth of that observed biodegradation will occur
at 1% load rate. Rather, 5% may be the threshold amount needed to have any
effect. Thus, studies of larger load rates of the additive do not constitute reliable
evidence that a smaller amount of that ingredient will cause a proportionally
reduced effect, or any effect at all. Only a study that uses the recommended load
rate can yield reliable evidence.

e. Inoculum. Inoculum is the source of bacteria or other microorganisms that will
use the test sample as a food source and thus cause biodegradation. It typically
consists of partially digested organic material and microorganisms. The study
must accurately reflect the type of bacteria that the treated plastic would be

exposed to after disposal. The types of microorganisms operating in particular

ECM Comb. Mot. to Exclude Page 14 of 58
Exh. U


IV. DRY TOMBS VS. BIOREACTORS

a. Typical MSW Landfills: “Dry Tombs” With Minimal Biodegradation

37. All Subtitle D landfills are designed primarily as waste containment systems
rather than waste treatment systems. The goal of landfilling is to minimize harms to humans and
the environment (¢.g., groundwater pollution, greenhouse gas emission, fires, odor)—not to
facilitate biodegradation. In fact, as discussed below, most of the tools for harm minimization
have the effect of retarding biodegradation. A schematic of a typical Subtitle D landfill is
presented in Figure 3.

38. The most significant feature of landfills as containment systems is the landfill
containment liner system. Containment liner systems are typically constructed from two types of
material: compacted earth with low permeability (¢.g., clay soil) and geosynthetic products such
as plastic membranes. The liner system captures leachate (liquid that contacts or emerges from
solid waste), and removes it from the landfill using natural and synthetic drainage layers and
mechanical pumping systems.!° As discussed in section 24 above, this feature reduces moisture,
which slows biodegradation.

39. A second feature of waste containment is the waste filling plan. Waste is
deposited on top of the containment system after a suitable protective layer has been placed, with
the waste in designated cells. A cover of soil or alternative materials, waste compaction,
grading, and rainwater run-off controls further serve to minimize odor, litter, fires, and runoff of
rainfall that has contacted the waste. Again, as discussed in section 24 above, these features

reduce both oxygen and moisture, which slows biodegradation.

'°U.S. Subtitle D landfill regulations require a bottom liner system to contain at least two
feet of compacted soil with a permeability of less than 10’ cm sec’! overlain by a plastic
geomembrane (typically 60-mil HDPE) and a leachate collection and removal system capable of
maintaining the depth of ponded leachate on the liner to less than 30 cm (I ft).

17

ECM Comb. Mot. to Exclude Page 17 of 56
Exh. X


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 34

short-chain, low-molecular weight polymers in the range of 500Mn are capable of being
metabolized by naturally occurring microorganisms. This study reports the molecular weight of
the test sample at the conclusion of the test to be almost 80,000Mn. Thus, this test, like many
others, actually supports a conclusion that no biodegradation occurred and is consistent with
possible fragmentation. Other evaluations of physical changes in appearance, mass, or chloride
content of the leachate are likewise consistent with disintegration.

87. Not only do the Testing Materials reflect the lack of elements necessary for
reliability, many of the tests were not conducted consistent with proper laboratory techniques or

by qualified personnel.

a. Northeast Laboratories Tests
88. Based on the transcript provided to me, Northeast Laboratories, Inc. (“NE Labs”)

did at least four things that call into question the validity of the test results.

i. NE Labs replaced the inoculum.” This would likely lead to
overestimation of biodegradation, expose the inoculum to oxygen, thus not
simulating anaerobic conditions. This deviates from the ASTM method
and calls into question the credibility of those conducting the lab.

ii. NE Labs used an inappropriate apparatus.”° The apparatus used
deteriorated over time, causing leaks and other potential problems in the

system.

bad Transcript for the Deposition of Northeast Laboratories, Inc. (“NEL Dep. Tr.”) May 9,
2014 at 87.
76 Id. at 22-23, 88 (identifying metal paint cans as the containers for the test samples).

ECM Comb. Mot. to Exclude Page 34 of 58
Exh. U


652

J Polym Environ (2011) 19:637 676

Fig. 10 SEM micrographs of
Su g LDPE: (a) before
biodegradation, (b) after 4
months biodegradation, (c) after
12 months biodegradation

showed better biodegradation results than those prepared
by other methods of grafting. Simialrly, Maharana and
Singh investigated graft copolymerization of low-density
polyethylene (LDPE) onto starch using glucose-cerium(IV)
redox initiator in an aqueous sulfuric acid medium under
nitrogen atmosphere [389]. The graft yield was influenced
by various parameters like reaction time, temperature, and
concentrations of acid, glucose, polyethylene (PE), starch,
and initiator. A maximum graft yield of 85.66% was
obtained at a temperature of 50 °C and at higher concen-
tration of starch. Biodegradability of starch-grafted PE has
been tested applying soil-burial test.

Low-density poly(ethylene) (LDPE) was modified by
graft copolymerization of acrylonitrile/acrylic acid by El-
Arnaouty et al. who showed that that the increase of AAc
ratio in the composition increases the hydrophilicity of the
films and the degradation rate [390]. In comparison, they
found that PET polymer is generally found to be more
resistant to the biodegradation than LDPE in the two types
of soils tested. Highest degradation rate was found to be
achieved using agricultural soil. It is found that the isolated
strains belonging to the genus Pseudomonas were mainly
responsible for the degradation of both polymers. Ghosh
et al. also report preparation of starch-based biodegradable
low-density polyethylene (LDPE) films by graft copoly-
merization of vinyl acetate with ceric ammonium nitrate
(CAN) in aqueous acidic medium as redox initiator with
nitric acid [391].

© Springer

ECM Comb. Mot. to Exclude
Exh. Z

Copolymers and Blends

Several groups have investigated copolymer formation and
blends for improving the biodegradability [392 400]. High
energy irradiation is reported to enhance biodegradation as
shown by Senna et al. [401]. Cassava mesocarp carbohy-
drate and its modified form were used as fillers in low
density polyethylene to give plastic films that were bio-
degradable [396]. It was found that the tensile strength of
the films decreased with an increase in the amount of the
filler incorporated. The water absorption results of the films
showed that modification of the cassava mesocarp carbo-
hydrate made it hydrophobic and therefore more compati-
ble with the polyethylene.

Rutkowska et al. report very little microbial degradation
was observed for polyethylene blends in the sea water,
which was explained by low sea water temperatures,
moderate biological activity of microorganisms and low
amounts of solar radiation reaching the films [397]. The
introduction of pro-degradant additive into the polyethyl-
ene improves biodegradability of this blend in natural
aqueous biological environment. Figure 11 shows weight
changes of polyethylene after incubation in the Baltic Sea
water indicating biodegradation of the starch containing
batches [397].

Moura et al. prepared biodegradable polymeric materi-
als based on blends of a synthetic high density polyethyl-
ene (HDPE) and biodegradable polymers such as polylactic

Page 16 of 80


28. — The primary reason for low moisture level in typical landfills is a regulatory
prohibition on addition of liquids. Regulations under the Resource Conservation and Recovery
Act (RCRA), 40 CFR 239, et seg., are the principal federal regulations governing disposal of
solid waste. Just over 98% of the approximately 1,900 landfills in the U.S. are operated under
Subtitle D of the RCRA guidelines. These are the so-called “Subtitle D landfills.” A small
fraction, less than 2%, operate under limited waivers.

29. The preamble to EPA’s regulations under RCRA, Subtitle D recognizes that
landfills are biological systems that require moisture for decomposition to occur, and moisture
has real benefits:

 — faster waste stabilization (because biodegradation occurs and concludes faster);
* improved leachate quality (i.e., the liquid generated by landfills is less harmful); and
¢ better methane gas production (which can be valuable if properly captured).
But, RCRA Subtitle D also recognizes moisture causes problems as well. The preamble
identifies the following negative effects from the addition of liquid:
« increased leachate production (i.e., more liquids coming out of the bottom of the landfill);
¢ more frequent leachate collection system clogs;
¢ increased depth of leachate buildup on the bottom liner of the landfill, called the
“hydraulic head on the liner.” By law, the hydraulic head on the liner cannot exceed 30
cm.
¢ increased greenhouse gas generation (harmful to health and the environment if not
properly collected); and

° increased odor problems.

ECM Comb. Mot. to Exclude Page 13 of 56
Exh. X


5,883,199

i
where W is the weight of the test specimen; C is the percent
organic carbon in 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-
degradation rate of BIONOLLE#3000 by itself was
extremely fast, while the biodegradation rate of polylactic
acid by itself was relatively slow.

‘The soil degradation testing results of the two polymers

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

for 45 days, BIONOLLE#3000 degraded almost 100%,
while polylactic acid degraded only about 14% by loss i
weight. For blends with 70 and 50% BIONOLLE#3000, the
degradation rate was relatively fast. After 45 days, the
A30B70, AS0B50, and A70B30 blends degraded about 77%,
65% and 25%, respectively, by loss in weight. FIG. 11 shows
that polylactic acid biodegrades in soil, but just not quickly,
and the addition of the second aliphatic polymer, such as
BIONOLLE#3000, increases the biodegradation rate.

The importance of the soil biodegradation curves shown
in FIG. 11 is that a specific blend can now be designed such
that this blend wouid have a certain net degradation in a
given number of days within the soil.

Example 4
Biodegradation Testing in Compost

Biodegradation testing in an artificial compost environ-
ment was conducted on film samples in a simulated munici-
pal compost. Biodegradation testing in an artificial compost
environment was conducted on compression molded film
samples of dimensions 20 mmx20 mmx0.3 mm in a simu-
lated mmmicipal compost mixture consisting of 60% by
weight of water and the rest containing shredded leaves,
shredded paper, mixed frozen vegetables, meat waste, urea,
and commercial compost seeds. The carbon to nitrogen
(CN) ratio of the starting mix was 14:1. The composting
process was carried out for 30 days at 55° C. Triplicate test
samples were 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 yg/mm?.

After 20 days in the composting environment at 55° C.,
BIONOLLE#3000 bad a high weight loss rate while poly-
lactic acid had negligible weight loss. The weight loss rates
in the blends of polylactic acid and BIONOLLE#3000 after
20 days in the composting environment were between the
rates of polylactic acid and BIONOLLE#3000.

The compost degradation testing results of the two poly-
mers and their blends are reported in FIG. 12. After degra-
dation for 20 days, BIONOLLE#3000 degraded almost
40%, while polylactic acid degraded only about 3%, by loss
in weight. For blends with 70 to 20% BIONOLLE#3000, the
degradation percentage was much greater (and the rate much
faster) than that of polylactic acid, e.g., after 20 days, the
A30B70, A50B50, and A70B30 blends degraded about 35%,
25% and 15%, respectively, by loss in weight. FIG. 12
shows that polylactic acid biodegrades in compost, but
slowly, and the addition of even 20% by weight BION-
OLLE#3000 increases this biodegradation rate dramatically.

The importance of the compost biodegradation curves
shown in FIG. 12 is that a specific blend can now be
designed such that this blend would have a certain net
degradation in a given number of days in a composting
environment.

Example 5

Morphology
Samples were analyzed by microscopy to investigate the
morphology of the phases of polylactic acid versus the

ECM Comb. Mot. to Exclude
Exh. Z

5

2s

40

12

phases of BIONOLLE#3000. The blends were exposed to
acetone to dissolve the polylactic acid component without
affecting the BIONOLLE#3000 component. For the biend
containing 70% by weight of polylactic acid and 30% by
weight of BIONOLLE#3000, 67% of the material, or
approximately 95% of the polylactic acid, was dissolved.
‘The remaining material was in a sheet form, and the BION-
OLLE#3000 phase in the original blend formed a continuous
or co-continuous phase, while the dissolved polylactic acid
left behind holes in the sheet-like structure of BION-
OLLE#3000. This continuous or co-continuous structure of
the BIONOLLE#3000 phase in the original blend explained
the outstanding toughness shown in the graph of FIG. 6.

OTHER EMBODIMENTS

It is to be understood that while the invention has been
described in conjunction with the detailed description
thereof, that the foregoing description is intended to illus-
trate and not limit the scope of the invention, which is
defined by the scope of the appended claims. Other aspects,
advantages, and modifications are within the scope of the
following claims.

What is claimed is:

1. A biodegradable blend comprising:

(@) 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 1:9 by weight, and wherein the second
polymer is a homopolymer or random copolymer that
forms a continuous or co-contimuous phase in the
blend.

2. The biodegradable blend of claim 1, wherein said one
‘or more polyesters are of one aliphatic C, to Cy9 diacid or
of a combination of two more different aliphatic C, to Cog
diacids.

3. The biodegradable blend of claim 1, wherein said first,
polylactic acid-based polymer is a homopolymer of poly-
lactic acid.

4. The biodegradable blend of claim 1, wherein said first,
polylactic acid-based polymer is selected from the group
consisting of D-polylactic acid, L-polylactic acid, D,L-
polylactic acid, meso-polylactic acid, and any combination
of D-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 polybutylenesuccinate homopolymer, polybu-
tyleneadipate homopolymer, polybutylenesuccinate-adipate
copolymer, polyethylenesuccinate homopolymer, polyethyl-
eneadipate homopolymer and polyethylenesuccinate-
adipate 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 copolymer is a copolyester of an 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 terephthalate.

10. A biodegradable blend of claim 1, further comprising
(©) a compatibilizer consisting essentially of one or more
polycsters or polyvinyl alcohols.

Page 77 of 80


e Phase IV (Methane Fermentation). Microorganisms called “methanogens” convert
organic matter into methane and carbon dioxide. As methanogens consume volatile fatty
acids, the acidity of the landfill (i.2., the pH) moves towards neutrality. During this
phase, the majority of the wastes stabilizes.

¢ Phase V (Final Maturation and Stabilization). During this final (and Songest-lasting)
stage, biological activity decreases even more. The landfill has become mature and
stable, with conditions that do not readily support biodegradation (oxygen-less, cool,

dry).

20. Active landfills are dynamic and heterogeneous environments. As long as waste

continues to be added to a landfill, all of the processes described in Part II above continue to
occur. Indeed, in a single landfill—and even within a single landfill cell—all of the processes
will occur simultaneously. Further contributing to the heterogeneity within landfills is the fact
that the duration of the phases of biodegradation are highly dependent on the amount and type of
organic matter, the pH (i.e., acidity level), the presence or lack of oxygen, the moisture content,
and the temperature.
Wl. LANDFILLS: ANAEROBIC, RELATIVELY COOL, “DRY TOMBS”

21. Biodegradation in landfills is remarkably slow because typical U.S. landfills are
primarily anaerobic environments that are relatively cool with low-moisture. U.S. landfills are
anaerobic, temperate, “dry tombs” by design: these conditions are engineered (and largely

mandated by federal law) to facilitate the containment rather than stabilization of MSW.

a. Typical Landfills Are Anaerobic

22. The first significant factor that affects biodegradation in landfills is oxygen. The
more oxygen, the faster the rate of biodegradation, because aerobic organisms decompose
organic matter much faster than anaerobic organisms. In general, aerobic decomposition is more
efficient than anaerobic and as a result faster.

23. Inany given landfill, there is only one location (or “cell”) that actively accepts
waste. Waste is deposited into the active cell and after a day’s activity, the MSW is compacted

10

ECM Comb. Mot. to Exclude Page 10 of 56
Exh. X


PUBLIC DOCUMENT

UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

)

In the Matter of )
)

ECM BioFilms, Inc., ) Docket No. 9358

a corporation, also d/b/a )

Enviroplastics International ) PUBLIC DOCUMENT
)

[PROPOSED] ORDER GRANTING JOINT MOTION
APPROVING STIPULATION AS TO ADMISSIBILITY OF CERTAIN EVIDENCE

This matter having come before the Chief Administrative Law Judge on May 5, 2014,
upon a Joint Motion for Entry of Proposed Order Based on Stipulations Regarding Admissibility
of Certain Evidence, it is hereby ORDERED that:

1. The Joint Motion is GRANTED;

2. The document produced by The Ohio State University in this matter entitled Gomez,

Eddie & Michel Jr., Frederick, 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 (the “Ohio State Study”), attached hereto as Exhibit
CX-1, shall be admitted into evidence at the evidentiary hearing to take place in this
matter.

3. The Ohio State Study is admissible for the truth of the matters asserted therein and for

all other purposes and not excludable on any grounds.

4. The parties reserve their rights to present evidence or argument that goes to the

probative value or evidentiary weight to be accorded to the Ohio State Study.

ORDERED:
D. Michael Chappell

ECM Comb. Mot. to Exclude Page 3 of 5
Exh. I


when Complaint Counsel packed thé document in order to use it at ECM’s deposition. See Tr
374-375. Yet Complaint Counsel declined numerous opportunities to provide the Article to
Respondent and thereby fulfill its duty to supplement Complaint Counsel's prior document
production. Putting aside whether, in the current age of instant communications, including via
government issued Blackberry, Complaint Counsel had an obligation to transmit the Article to
Respondent over the long holiday weekend, Complaint Counsel fails to explain or justify why it
did not supplement its document production by providing the Ohio State Article to Respondent
before the start of the ECM deposition, during the first day of the deposition, or at any other time
prior to marking the Article as a deposition exhibit on the afternoon of the second day of the
ECM deposition.

Rule 3.31(e) does not define what constitutes a “timely manner” for purposes of the duty
to supplement. Furthermore, the parties do not point to a case defining the phrase in the context
of the type of delayed supplementation present in this case. However the phrase “timely
manner” might be defined, it manifestly does not include a conscious withholding of a
responsive document that was planned to be used as a deposition exhibit, as occurred in this case.

Having determined that Complaint Counsel violated its obligation to supplement
discovery in a timely manner, the analysis now turns to whether a sanction is appropriate, as
requested by Respondent.

C. Sanction

Respondent argues that the appropriate sanction for Complaint Counsel's violation is to
bar any use of the Ohio State Article for purposes of trial. Respondent contends that Complaint
Counsel's conduct was willful and unjustified. In addition, Respondent asserts that Complaint
Counsel’s delay in producing the Article until the second day of the deposition prejudiced
Respondent, because the delay put Mr. Sinclair in the position of answering questions about the
Article without adequate preparation. According to Respondent. where a discoverable document
is improperly withheld, the customary remedy is to exclude the document from any use at trial

Complaint Counsel responds that there has been no prejudice to Respondent because Mr.
Sinclair “admitted essentially nothing” about the Ohio State Article; Mr. Sinclair is free to testify
at trial that he believes the study was faulty;? ECM’s experts have until April 30, 2014 to analyze
the study; and providing the document earlier “would not have affected [ECM’s experts’] ability
to respond. ...” Opposition at 6.

“Bule 3.38 is designed both to prohibit a party from resting on its own concealment and
to maintain the integrity of the administrative process.” Jn re Grand Union Co., 102 F.T.C. 812,

? Indeed, Complaint Counsel contends that ECM has, is in fact, gained an advantage vis a vis Mr. Sinclait’s potential
trial testimony concerning the study Complaint Counsel states; “{I]f Complaint Counsel had forwarded ECM the
Ohio State Study early (in the middle of the night on Friday the 14th, or at the end of the day on Tuesday February
18 (after one business day had elapsed)), Sinclair could not have testified that he had never seen the study before,
which might have made it difficult for him to supplement any hastily-prepared deposition testimony at trial.”
Opposition at 6. Instead, according to Complaint Counsel, the fact that Sinclair had not seen the study before “gives
ECM several months to figure out some sort of response.” Jd.

5

ECM Comb. Mot. to Exclude Page 5 of 6
Exh. P


claims, because the tests suffer from the same faulty assumptions, poor methodology, and/or use
of conditions inconsistent with typical landfills as ECM’s substantiation tests. Appendix A of
this report is a table that summarizes my review of the additional biodegradation tests. The table
identifies each test by name and document number and provides my assessment of the test.

VIL. CONCLUSION

86. In conclusion, in my expert opinion, ECM’s claims that its additive will make
conventional plastic biodegrade in approximately five years or less in a landfill is false and

unsubstantiated.

34

ECM Comb. Mot. to Exclude Page 34 of 56
Exh. X


Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd , Ste 4 | Chandler, AZ
85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emerd.com

NQIICE: This is a confidential communication intended for the recipient listed above. The content of this
communication is protected from disclosure by the attorney-client privilege and the work product doctrine. if
you are not the intended recipient, you should treat this communication as strictly confidential and provide it 1o
the person intended. Duplication or distribution of this communication is prohibited by the sender. If this
communication has been sent to you in error, please nofify the sender and then immediately destroy the
document.

From: Johnson, Katherine [mailto:kjohnson3 @itc.gov]

Sent: Thursday, April 24, 2014 8:04 AM

To: Peter Arhangelsky

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Thanks Peter.

We will be sending out a few more deposition subpoenas in the next week. In advance of that, |
wanted to see whether ECM would be willing to enter into a stipulation to avoid the cost of
conducting multiple additional depositions. | believe that Jonathan and you discussed the possibility
of deposing OWS previously. Will ECM be noticing that deposition? If not, then perhaps we can
stipulate to the authenticity and admissibility of the documents produced by OWS to avoid having
to conduct that deposition? Otherwise, then we're looking to depose OWS the week of May 12",
depending on its availability.

In addition, we would like to know whether ECM is planning to issue any of its own deposition
subpoenas. |f so, it would be nice to know which ones and proposed dates so that we could
coordinate for the remainder and avoid double-booking the rest of the days in May. At this point

only the week of the 12°" remains before the close of fact discovery.
If it would be easier, we could arrange another call about this.

Thanks,
Katherine

Katherine E, Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission
600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

ECM Comb. Mot. to Exclude Page 6 of 9
Exh. H


STEVEN J. GROSSMAN
EDUCATIONAL BACKGROUND
J.D. Degree (Law) Franklin Pierce Law Center, Concord, New Hampshire, January 1990.

Ph.D in Polymer Science and Engineering, University of Massachusetts,
Amherst,Massachusetts, 1979. Full Research Assistantship, Thesis Topic: "Synthesis and
Characterization of Novel Polymer Structures: 1. Head-to-Head Polypropylene; 2. Regular
Gopolyoxamides." Thesis Advisor; Professor Otto Vogl, former Herman F, Mark Professor
of Polymer Science at the Polytechnic Institute of New York. The Polymer Science and
Engineering Department at the University of Massachusetts, Amherst. is recognized by
industry and academic institutions as one of the world's leading centers for polymer
education and research.

B.S. in Chemistry, University of Connecticut, Storrs Connecticut, 1975.

PROFESSIONAL ACCREDITATION

Member, New Hampshire Bar Association - admitted, licensed attorney at law — June 1990
Member, Federal District of New Hampshire, admitted, July, 1990.

United States Patent Office (USPTO)-Admitted To Practice-1991

Court of Appeals for the Federal Circuit -1994

EMPLOYMENT HISTORY:

A. Academia: 1984-Present

Full Professor

Plastics Engineering Department, University of Lowell, 1992 to present.
Associate Professor

Plastics Engineering Department, University of Lowell, 1987-1992
Assistant Professor
Plastics Engineering Department, University of Lowell, 1984-1987.

Lecturer

Page 1 of 17

ECM Comb. Mot. to Exclude Page 1 of 17
Exh. Y


This plateau is observed in nearly every biodegradation test of this type and is recognized in ASTM 5210,
ASTM 5511 and ASTM 5526 standard tests of aerobic and anaerobic biodegradation. The reason for the
plateau js that biodegradation includes not only mineralization to terminal electron acceptors like CO,
and CH, but also metabolism of compounds such as proteins, cell wall components, chitin, and other
biological materials by cells. Microorganisms also generate waste products including humic and fulvic
acids that are recalcitrant. The carbon used for respiration is proportional to the mineralization to CO,
and CH, while metabolic products do not leave this signature until they are biodegraded when cells die,
which may not occur for a much longer period of time.

An analogy would be when humans consume food. One hundred percent of the food is not converted to
CO. Some is converted to muscle, fat and other products. These products are not converted to CO,
until a person dies. Microorganisms likewise create products other than CO, from the substrates they
consume and these typically biodegrade much more slowly. Therefore 100% mineralization of the
Positive control is not expected. This is why one criterion for a valid ASTM test is that more than 70% of
the positive control has been converted to CO2, not 100%.

Burnette is mistaken in his interpretations that the plateau is evidence of a flawed test, or that the test
environment has become toxic to further degradation, and that conditions are “not hospitable to
biodegradation”. The plateau is evidence that the biotransformation of cellulose was com plete and that
the remaining carbon had been converted into more recalcitrant residues.

Comment by Dr. Burnette-

30. Biofilms are easily developed on PVC surfaces (Pedersen, 1990), as evidenced by J and S traps on sinks
and toilets with PVC fittings. It is likely that formation of biofilms aided in the biodegradation of an ECM
treated PVC product, BioPVC®. Over a test period of 6 months, appreciable loss of mass, compared to the
negative control PVC material, was witnessed with the BioPVC®. In fact, even after one month, there was
statistically significant loss of mass of the BioPVC® compared to the control PVC (Environ Corp. Lab,
Report dated November 29, 2007).

Rebuttal

In this study of BioPVC biodegradation (2008 Environ BioPVC Report.pdf), only a 2.5% mass loss was
observed after 10 months and the loss plateaued after 7 months and did not increase from 7 to 10
months. A more likely conclusion from these data is that the ECM additive did biodegrade, but that the
PVC did not.

ECM Comb. Mot. to Exclude Page 8 of 24
Exh. V


Rouge, Louisiana, May, 2006
SPE Annual Technical Conference, Charlotte, NC., May 2006
Pacifichem Conference, Honolulu, HI, December 2005
BioEnvironmental Polymer Society 12" Annual Conference, Monterrey, Mexico, December,
2004
Green Chemistry, Gordon Conference, Bristol, RI, July, 2004
Palsto-Ispack Conference, Tel Aviv, Israel, September 2003
BioEnvironmental Polymer Society 11" Annual Conference, Denver, CO, August, 2003
Biodegradable Polymers Conference, Pisa, Italy, June 2002
BioEnvironmental Polymer Society 10th Annual Conference, Albuquerque, NM, September,
2002
ACS meeting, Polymers from Renewable Resources, Orlando, April, 2002
IOF Meeting, Washington, DC, July, 2002
Nedo Meeting, Brussels, March 2002
2001 BIOPOLYMERS - Advances in Medical and Material Science Applications, Cambridge,
MA, October, 2001
Massachusetts Green Chemistry Research Symposium, University of Massachusetts, Amherst,
MA October, 2001
Gordon Conference - Biodegradable Polymers, Queen’s College, Oxford, UK, July, 2001
Gordon Conference, Ventura, CA, March, 1999
American Chemical Society Meeting, Anaheim, CA, March, 1999
Sth International Scientific Workshop, Stockholm, Sweden, June, 1998
BioEnvironmental Degradation Polymer Societies Biodegradable Polymer Conference, Boston,
MA, August, 1998
4th International Conference on Frontiers of Polymers and Advanced Materials, Cairo, Egypt,
January 1997
Hamburg Makromolekulares Symposium, Hamburg, Germany, October, 1996
AICHE “Fifth World Conference of Chemical Engineering”, San Diego, CA, July 1996
Corn Utilization Conference VI, St. Louis, MO, June, 1996
23rd Aharon Katzir-Katchalsky Conference, Tel Aviv, Israel, May, 1996
Thermoplastic Engineering and Design Conference, Detroit, MI, December, 1995
Pacifichem Conference, Honolulu, HI, December, 1995
“Plastics Waste Management Exhibition and Symposium”, University of Connecticut, Storrs,
CT, November, 1995
Annual Mold flow Conference, April 1995
TAPPI Conference, Orlando, FL, March 1995
Design Conference, Schenectady, NY, March 1995
Gordon Conference “Biodegradable Polymers”, Oxnard, CA, February 1995
“Polymers from Renewable Resources and Their Degradation Symposium”, Stockholm, Sweden,
November 1994
“Environmentally Conscious Manufacturing for the Electronics Industry: Research on Advanced
Materials and Processing, Yorktown Heights, NY, October, 1994
TUPAC Meeting, Akron, OH, July, 1994
BEDPS Conference, Boston, MA, June 1994
NSF Conference, Washington, DC, January 1994
3rd International Scientific Workshop on “Biodegradable Plastics and Polymers”, Osaka, Japan,
November 1993
Polymer Blends Conference, Akron, OH, October 1993
3rd Biochemical Engineering Conference, Taejon, Korea, September 1993

ECM Comb. Mot. to Exclude Page 41 of 58
Exh. U


656 J Polym Environ (2011) 19:637 676
Fig. 14. Cationic
: . Oo
polymerization of lactides CR SOME + cue eet oe Cae econs
~CH-4 Me2CH~ Ke a crs eo
ee EY H- ed
Me=CH
i-Me Me Me
C-0-CH-CO- > CH-COMe
C80? Se. Seno 2
+ nw |
f
i
e
Mic Ae.
NO-eet-CO-0-2n +OO-O- CH CO-O-8H-COnMe
Fig. 15 Anionic
polymerization of iactides O-- Cu pate . 2 5 ec Sine Soe R
MecH-c
ty + U-facid
2) + HO
r Me
n-to-dit-co-o- CH-COF-O-8
an
oe TEM a.
: + 16-R
Me=CH-O 2

opening polymerization of lactide typically involves
metallic promoters. Recent achievements report metal-free
systems via organocatalytic (nucleophilic, cationic and
bifunctional) as well as enzymatic approaches [434].

Enzymatic polymerization is an ecofriendly process of
polymer synthesis and is based on using easily renewable
resources as starting materials. Enzyme catalyzed poly-
merizations have several advantages over conventional
chemical methods. These include (a) mild reaction condi-
tions, i.e., temperature, pressure, pH, and absence of
organic solvents, (b) high enantio and regioselectivity, and
(c) recyclabiliy of catalysts [435].

Direct solution polycondensation of lactic acid has been
reported recently, and the process is much simpler. How-
ever, the azeotropic solvent used in polymerization is not

® Springer

ECM Comb. Mot. to Exclude
Exh. Z

easy to purge. Therefore, direct polycondensation without
solvents has attracted increasing interest [436]. Melt/solid
state polymerization involves heating a semi-crystalline,
solid prepolymer (of relatively low molecular weight) in
powder, pellet, chip or fiber form up to a temperature below
the melting temperature with the simultaneous removal of
by-products from the surface of the material either (by
volatilizing) under reduced pressure or with a carrier, for
example, blowing inert gas [437, 438]. This method uses low
operating temperatures and hence gives polymer of
improved properties because of control over the side reac-
tions as well as thermal, hydrolytic, oxidative degradations.

Catalysts have played a very important role in the pro-
duction of PLA with controlled properties. A large number
of catalysts have been studied for the ring opening

Page 20 of 80


PUBLIC DOCUMENT

before the hearing. July 29, 2014 is actually the date of the pretrial hearing, thus making that
recommendation surreal. As Complaint Counsel knows, August Ist is unavailable to ECM’s
counsel because they will be traveling back from an appearance in an unrelated matter in the
U.S. District Court for the District of Utah, a fact made known to Complaint Counsel months
ago.® See Exh. BB. This Court had provided the Respondent with fully 70 days to prepare for
and conduct expert depositions following Complaint Counsel’s expert list. Now Complaint
Counsel intends to give ECM just two weeks to do the same, all while ECM must satisfy the pre-
hearing demands in the Revised Scheduling Order, an accommodation made more difficult given
the agreement of the parties to conduct two additional expert depositions during those two
weeks.
ARGUMENT

1. Complaint Counsel’s Failure To List, Identify, Or Designate Dr. Michel As An

Expert Witness or Expert Rebuttal Witness Violates The Discovery Rules, and

Precludes Complaint Counsel From Calling Dr. Michel To Testify and From

Offering His Rebuttal Report Into Evidence.

Complaint Counsel’s non-disclosure of Dr. Michel as an expert or rebuttal expert witness
is deliberately calculated to prejudice ECM, in blatant violation of Rule 3.31A and the Revised
Scheduling Order and in contumacious disregard of this Court’s prior Sanctions Order.
Complaint Counsel has noticed a new expert witness in this case more than two months after the

deadline this Court set (April 23, 2014) to identify Complaint Counsel’s expert witnesses, The

Revised Scheduling Order makes manifest the need for expert disclosures by April 23, 2014.7

deposition in keeping with this Scheduling Order.” Scheduling Order, at {19(c). Thus,
Complaint Counsel’s deposition dates would per se violate the Scheduling Order.

6 That date is also just days before the hearing begins, and after ECM files its prehearing
brief.

7 Under the original Scheduling Order Issued November 21, 2013, Complaint Counsel
was obliged to disclose its expert list by March 5, 2014.

9


PUBLIC DOCUMENT

/s/ Katherine Johnson

Katherine Johnson (kjohnson3@ftc.gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

And

/s/ Peter Arhangelsky

Jonathan W. Emord (jemord@emord.com)
Peter A. Arhangelsky
(parhangelsky@emord.com)

Lou F. Caputo (Icaputo@emord.com)
Emord & Associates, P.C.

11808 Wolf Run Lane, Clifton, VA 20124
Phone: (202) 388-8899

Fax: (202) 466-6938

ECM Comb. Mot. to Exclude Page 2 of 5
Exh. I


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Page 34 of 80


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 35

iii. NE Labs did not have someone with the proper education or training
overseeing the test. 27 This is critical to ensure reliability. For instance,
the gas results reported in all of its tests are inconsistent with typical
biogas composition, which is roughly 55% to 70% CH, and 30% to 45%
CO». Trace gases usually make up the remaining 5%. Because none of
the tests report biogas compositions typical of anaerobic biodegradation, a
properly trained and educated person overseeing these results would have
likely evaluated the test method, apparatus, calculations, among other
things, to determine the source of this anomaly.

iv. NE Labs conducted tests for periods well beyond the validation period of

the test.8

b. Eden Laboratories
89. Likewise, Eden Laboratories, Inc. (“Eden”) conducted tests using questionable

modifications.
i. Eden is run by a person lacking the proper credentials and has received
guidance from NE Labs on conducting biodegradation studies, indicating
they likely follow common (improper) practice and techniques in this

regard.”

”” See, e.g., id. at 38 (identifying Ms. Ullman, a high school graduate completing her
online degree in accounting as one of the people responsible for training lab techs).

°8 See supra note 22.

9 See, e. g., Transcript for the Deposition of Eden Research Laboratories, Inc. (“Eden

Dep. Tr.”) at 117-118.

ECM Comb. Mot. to Exclude Page 35 of 58
Exh. U


Eric Awerbuch

From:
Sei
To:

Cc:

Subject:
Attachments:

Counsel,

Jillson, Elisa <ejillson@ftc.gov>
Thursday, May 01, 2014 6:58 AM

Lou Caputo; Peter Arhangelsky; Jonathan Emord
Johnson, Katherine; Cohen, Jonathan

ECM, No. 9358 - subpoena
MX-M503N_20140501_091022.pdf

Please find attached a copy of the subpoena for Dr. Michel’s deposition. If the parties reach an agreement about a

stipulation that obviates the need for Dr. Michel's deposition, we will cancel the deposition.

Elisa K. Jillson
Attorney

Division of Enforcement, Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW, M-8102B

Washington, DC 20580
Phone: 202.326.3001
Fax: 202.326.2558

ECM Comb. Mot. to Exclude
Exh. J

Page 1 of 1


On Page 8, Para 2 of his report Dr. Sahu states that,

“It is my opinion that the expectation that all plastics with the ECM additive added in the usual amount
(i.e., at a level of 1 or at most a few percent) should completely (another term that is used throughout
the reports of Drs. McCarthy and Tolaymat) degrade in typical landfill conditions, in a time period of 1
year or even 5 years, is unrealistic.”

Rebuttal

Dr. Sahu appears to agree with the central point in the case which is that it has not been demonstrated
that ECM amended conventional plastics will biodegrade in a landfill in 1-5 years.

To obtain accurate evidence of biodegradation, experiments are best performed using “C-labeled
substrates and measuring evolved **CO; over time. One such long-term biodegradation study
{Albertsson, 1970), on “C-labeled polyethylene that utilized CO, trapping and liquid scintillation
counting, indicated that PE biodegradation is extremely slow requiring extremely long periods. After 10
years of soil incubation, <0.5% polymeric carbon (as CO,) by weight was evolved from a UV-irradiated
polyethylene sheet. The extent of conversion was even lower (0.2% w/w) in the absence of irradiation
{Albertsson, 1970).

Only when PE is modified through UV irradiation for long periods of time so that carbonyl bonds are
formed, or when hydrolysable linkages or unsaturated sites are introduced into the polymer does it
display a very limited ability to biodegrade (Prasun et al., 2011). Pretreatment by incubating PE at high
temperatures can also modify PE by reducing the molecular weight of the polymer which improves
biodegradation. However without these abiotic and chemical and physical modifications, the extent of
PE biodegradation is essentially nil.

Comments by Dr. Sahu
On page 52, Dr. Sahu rebuts Dr. McCarthy’s Comments:
“Vil.13 Specific Rebuttal to Dr. McCarthy’s Testing Comments

“Next, | address some of the more specific criticisms by Dr. McCarthy. His comment/discussion is first
noted in italics followed by my discussion/response within parentheses below.

[SM report para] “18.....First, none of the Testing Materials supports the conclusion that ECM Plastic is
biodegradable or will biodegrade to completion; in fact, the only published, peer reviewed study to
address this question concludes otherwise.3

3 See E. Gomez & F. Michel, Biodegradability of conventional plastics and natural fiber composites during
composting, anaerobic digestion and long term soil incubation, 98 JOURNAL OF POLYMER
DEGRADATION & STABILITY 2583-91 (2013) (testing the ECM additive and concluding that “plastics

12

ECM Comb. Mot. to Exclude Page 12 of 24
Exh. V


Exhibit B

14. El Badawy, A., Scheckel, K., Suidan, M., Tolaymat, T. (2012) “The Impact of Stabilization Mechanism on the
Aggregation Kinetics of Silver Nanoparticles” Science of the Total Environment. (429):325-331.

15. El Badawy, A., Scheckel, K., Suidan, M., Tolaymat, T. (2011) “Surface Charge-Dependent Toxicity of Silver
Nanoparticles” Environmental Science and Technology (45)1:283-287.

16. Costanza, J., El Badawy, A., Tolaymat, T. (2011) “Comment on 120 Years of Nanosilver History: Implications
for Policy Makers” Environmental Science and Technology. (45)17:7591-7592

17. Jain, P., Townsend, T., Tolaymat T., (2010) “Steady-State Design of Vertical Wells for Liquids Addition at
Bioreactor Landfills” Waste Management. (30)11:2022-2029.

18. Jain, P., Townsend, T., Tolaymat T., (2010) “Steady-State Design of Horizontal Wells for Liquids Addition at
Bioreactor Landfills” Waste Management. (30)12:2560-2569.

19. Bareither, C., Benson, C., Barlaz, M., Edil, T., Tolaymat, T. (2010) “Performance of North American
Bioreactor Landfills. I: Leachate Hydrology and Waste Settlement” J. Environmental Engineering-ASCE.
(136)8:824-838

20. Barlaz, M., Bareither, C., Hossain, A., Saquing, J., Mezzari, I., Benson, C., Tolaymat, T., Yazdani, R. (2010)
“Performance of North American Bioreactor Landfills. II: Chemical and Biological Characteristics” J.
Environmental Engineering-ASCE. (136)8:839-853

21. Genaidy, A., Sequeira, R., Tolaymat, T., Kohler, J., Wallace, S., Rinder, M. (2010) “Integrating Science and
Business Models of Sustainability for Environmentally-Challenging Industries such as Secondary Lead
Smelters: A Systematic Review and Analysis of Findings”. J. Environmental Management. (91)9:1872-1882

22. Musson, S., Campo, P., Tolaymat, T., Suidan, S., Townsend, T., (2010) “Assessment of the Anaerobic
Degradation of Six Active Pharmaceutical Ingredients” Science of The Total Environment, (38)9: 2068-2074

23. Jang, Y., Jain, P., Tolaymat, T., Dubey, B., Singh, S., Townsend, T. (2010) “Characterization of Roadway
Stormwater System Residuals for Reuse and Disposal Options” Science of the Total Environment.
(407)12:3686-3701

24. Tolaymat, T., Green, R.,Hater, G., Barlaz, M., Black, P., Bronson, D., Powell, J. (2010) “Evaluation of Landfill
Gas Decay Constant for Municipal Solid Waste Landfills Operated as Bioreactors” J. Air & Waste Management
Association. (60)1:91-97

25. Tolaymat, T., El Badawy, A., Genaidy, A., Scheckel, K., Luxton, T., Suidan, M. (2010) “An Evidence-Based
Environmental Perspective of Manufactured Silver Nanoparticle in Syntheses and Applications: A Systematic
Review and Critical Appraisal of Peer-Reviewed Scientific Papers” Science of the Total Environment.
(408)5:999-1006

26. Scheckel, K., Luxton, T., El Badawy, A., Impellitteri, C., Tolaymat, T. (2010) “Synchrotron Speciation of
Silver and Zinc Oxide Nanoparticles Aged in a Kaolin Suspension” Environmental Science and Technology.
(44)4:1307-1312

27. El Badawy, A. Luxton, T., Silva, R., Scheckel, K., Suidan, M., Tolaymat, T. (2010) “Impact of Environmental
Conditions (pH, Ionic Strength, and Electrolyte Type) on the Surface Charge and Aggregation of Silver
Nanoparticles Suspensions” Environmental Science and Technology. (44)4:1260-1266

28. Folaymat, T., Al-Abed, S., Jegadeesan, G. (2009) “Impact of Bioreactor Landfill Leachate Quality on As, Cd,
Pb and Zn Leaching from Mine Residues” J Residuals Science & Technology (6)2: 89-96

29. Impellitteri, C., Tolaymat, T., Scheckel, K., (2009) “The Speciation of Silver Nanoparticles in Antimicrobial
Fabric before and after Exposure to a Hypochlorite/Detergent Solution” J. Environmental Quality. (38) 4:1528-
1530

30. Genaidy, A., Tolaymat, T., Sequeira, R. (2009) “Health Effects of Exposure to Carbon Nanofibers: Systematic
Review, Critical Appraisal, Meta Analysis and Research to Practice Perspectives” Science of the Total
Environment. (407) 12:3686-3701

ECM Comb. Mot. to Exclude Page 53 of 56
Exh. X


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Dr. McCarthy Rebuttal Report -- 5

with its additive will completely biodegrade in the stated timeframes and
disposal environments.
The answer to this question is no.
8. Dr. Sahu’s supporting evidence is irrelevant to ECM’s technology for two reasons:
(1) the authorities cited (except one)? do not evaluate non-degradable plastics, the subject of
ECM’s claims; and (2) they do not support ECM’s claimed mechanism of action.

1, ECM Additive is intended to enhance the biodegradability of
non-degradable plastic.

9. The ECM Additive is intended to enhance the biodegradability of non-degradable
plastics. For example, in the exhibits attached to the ECM complaint, ECM distinguishes the
ECM additive from other “alternative products” on the market such as bioplastics (PLA, Mater-
Bi®, PHB and combinations) and oxo-biodegradable plastics. Thus, ECM has distinguished its
technology as NOT belonging to this subset of plastics, making many of the authorities

referenced by Dr. Sahu irrelevant.*

7 Both experts cite to the 1978 study by Albertsson establishing that untreated, virgin

polyethylene could biodegrade under certain environmental conditions. They omit three
significant points in their discussion. First, the test condition was a super-oxygenated
environment, not applicable to any landfill. Second, the rate of degradation was extremely slow
(0.36 + 0.03% over two years for PE film) and attributed by the author to biodegradation of the
low-molecular weight portion of the polyethylene. See Albertsson at 3432 (“It is assumed that
the source of the '“C metabolization in these degradational experiments must have been mainly
low molecular weight polyethylene ... .”). And third, Albertsson utilized radiotagged '4C to
evaluate the biodegradation, thus establishing that radiolabeling is the appropriate method for
evaluating slowly degrading materials.

If Dr. Sahu’s analysis is relevant at all, it is with respect to the extremely limited subset
of high-molecular weight, commercial-grade, synthetic plastics that are similar enough to
naturally occurring polymers to be susceptible to enzymatic attack. In this group are certain
aliphatic polyesters, aliphatic-aromatic polyesters, certain polyurethanes, polyvinyl alcohol,
etc. These high-molecular weight plastics mimic naturally-occurring polymers and are
susceptible to hydrolysis. Because they are recognized as biodegradable, it is also likely that
these are not the type of plastics to which ECM is referring (because, again, ECM states it can

ECM Comb. Mot. to Exclude Page 5 of 12
Exh. CC


“Effect of Physical Aging on Enzymatic Degradation of Poly(Lactic Acid)” Polym. Preprints,
Am. Chem. Soc., Div. Polym. Sci., Vol. 36, (1995),( with Hua Cai, Vipul Dave, Richard A.
Gross)

“Citrate Esters as Plasticizers for Poly(Hydroxybutyrate-co-Valerate)”, Polym. Preprints, Am.
Chem. Soc., Div. Polym. Sci., Vol. 36, (1995), (with Vatsal Ghiya, Vipul Dave, Richard A.
Gross)

“Biodegradable Polymer Blends of Poly(Lactic Acid) and Poly(Ethylene Glycol)”, Soc. of
Plastics Eng., Technical Papers, Vol. 40, (1995), (with Mihir Sheth, Vipul Dave, Richard
A. Gross).

“Miscibility and Biodegradability of Blends of Poly(Lactic Acid) and Poly(Vinyl Acetate)”,
Soc. of Plastics Eng., Technical Papers, Vol. 40, (1995), (with Ajay M. Gajria, Vipul Dave,
Richard A. Gross).

“Citrate Esters as Biodegradable Plasticizers for Poly(Lactic Acid)”, Soc. of Plastics Eng.,
Technical Papers, Vol. 40, (1995), (with Lisa V. Labrecque, Vipul Dave, Richard A.
Gross).

“Effects of Crystallinity and Orientation on the Enzymatic Degradation of Poly(Lactic Acid)”,
Soc. of Plastics Eng., Technical Papers, Vol. 40, (1995), (with Hua Cai, Vipul Dave,
Richard A. Gross).

“Composting Studies of Poly(Hydroxybutyrate-co-Hydroxyvalerate)”, Soc. of Plastics Eng.,
Technical Papers, Vol. 40, (1995), (with C.L. Yue, Richard A. Gross).

“Enzymatic Degradation of Blends Containing Poly(3-Hydroxybutyrate-co-3-Hydroxyvalerate)”,
Polym Degrad. and Stability, 45, 197-203, (1994). (with Parasar Dave, T. Jahedi, David
Eberiel, Richard A. Gross).

“Liquid Crystalline Behavior of Konjac Glucomann in Aqueous Solutions”, Polym. Preprints,
Am. Chem. Soc., Div. Polym. Sci., Vol. 35(2), pgs 448-449, (1994). (with Vipul Dave, Jo
Ann Ratto, Deeleep Rout, Richard A. Gross, David L. Kaplan)

“Miscibility Studies of Blends of Poly(Glycolic Acid) with Other Biodegradable Polymers”,
Polym. Preprints, Am. Chem. Soc., Div. Polym. Sci., Vol. 33(2), pgs 454-455, (1992).(with
G. Rocha, Richard A. Gross)

“Biodegradation of Blends of Poly(S-Hydroxybutyrate) and Poly(e-Caprolactone)”, Polymeric
Materials: Science and Engineering, Vol. 67, 298-300, (1992) , (with A. Lisuardi, Andrew
Schoenberg, Manish Gada).

“Biodegradation of Blends of Bacterial Polyester and Starch in a Compost Environment”,
Polymeric Materials: Science and Engineering, Vol. 67, 294-295, (1992).(with Sanjeev T.
Tanna, Richard A. Gross)

“Plasticization and Reactive Processing of Pullulan”, Polymeric Materials: Science and
Engineering, Vol. 67, 301-302, (1992), (with David H. Donabedian, Richard A. Gross).

"Study of Melt Processed Blends Containing Poly(Hydroxybutyrate-co-Hydroxyvalerate)
Copolymers-Incorporation of a "Diblock" Interfacial Agent, Society of Plastics Engineers,
Inc., Vol. 37, 982 (1991), (with Parasar Dave, Michael Reeve, Cheryl Brucato, Richard
Gross).

"Biodegradation of Blends Containing Poly(3-Hydroxybutyrate-co-Valerate)", in Biotechnology
and Polymers, Ed. Charles G. Gebelein, Plenum Press, New York, pgs. 53-62, 1991, (with
Parasar Dave, Richard A. Gross, Cheryl Brucato, Shan Wong).

"Biodegradability and Miscibility of Blends Containing Poly(Hydroxybutyrate-co-
Hydroxyvalerate)", Soc. of Plastics Eng., Technical Papers, Vol. 36 1439 (1990), (with
Parasar Dave, Richard Gross).

ECM Comb. Mot. to Exclude Page 49 of 58
Exh. U


with rigid PVC compositions where little in the way of foodstuffs is
normally included. The systems developed for plasticized PVC
should, however, apply to foamed rigid PVC composites with wood
fiber or other cellulose derivatives.

Experimental

Following ASTM D 5526 — 94 (Reapproved 2002), Standard Test
Method for Determining Anaerobic Biodegradation of Plastic
Materials Under Accelerated Landfill Conditions, a mixture was
prepared comprising 60% by weight of sterilized dehydrated manure
(to simulate processed household waste), 30% distilled water, and
10% fermenting inoculum from an active composter. 50 g were used
in sealed Petri dishes with 1/2 by 1 in. plastic samples. All
experiments were run at 35° C in a dark incubator.

Control samples. Samples of untreated filter paper showed mold
growth with in week and were consumed in 30 days. A sample of
polylactic acid (PLA) 2 mil film was completely consumed in 7 days. A
sample of 1 mil LDPE film was unchanged after 90 days. Samples of
polyolefin film described as biodegradable (brown trash bags)
showed slight embrittlement but were otherwise unchanged after 90
days.

Control PVC sample: A plastisol was mixed consisting of 100 parts
PVC (Geon® 121), 80 parts di-isodecyl phthalate (DIDP), 10 phr
Ultracarb® fine particle calcium carbonate and 2 parts dibutyltin
dilaurate (DBTDL) heat stabilizer; coated as a 2 mil film on release
paper and fused. Samples were unchanged after 90 days landfill
exposure. This was repeated using di-octyl adipate (DOA) in place of
DIDP. After 90 days, there was visible mold growth on the film but no
other evidence of decomposition. This sample is shown as Figure
1.This was repeated with the addition of 2.5 parts of a 4% solution of
isothiazolone biocide (MicroChek 11, Ferro). In this case, there was
no evidence of mold growth after 90 days. DBTDL was used as the
stabilizer because it is also an active hydrolysis catalyst to promote
plasticizer degradation.

ECM Comb. Mot. to Exclude Page 45 of 80
Exh. Z


Faculty Athletic Rep, UMass Lowell Athletics Department

Graduate Coordinator, Plastics Engineering Department

Director, Massachusetts Medical Device Development Center

Director, UMass Lowell Bioplastics Institute (formally) Institute for Plastics Innovation
Director, NSF Center for Biodegradable Polymer Research, UMass Lowell
Co-Director, UMass Lowell Center for Irish Partnerships

Committee Member, Committee for Federated Centers and Institutes

Committee Member, Research Foundation Advisory Board

Committee Member, Plastics Engineering Department Computer Committee

Community activities

Eagle Scout Banquet Dinner for Sponsoring Scouts interested in Plastics Engineering

Spoke at Lowell High School Career Day

Assisted in helping children understand about plastics at the Plastics Museum, Leominster MA

Manufactured sled hockey bucket seats for the USA Para-Olympic Sled Hockey Team for
Nagano Olympics

Lectured and gave laboratory tours of the University of Mass. Lowell Plastics Engineering
Department to Local Boy Scouts for the Chemistry Merit Badge

Additional sled hockey bucket seats for the USA Para-Olympic Sled Hockey Team

Society of Plastics Engineers (SPE),

Shanghai, China, December 2013

Plastics in Medical Devices 2013, Waltham, MA, May 2013

UMass Lowell Delegation Trip, Kuwait City, Kuwait, January 2013

NIMAC Conference, Boston MA, October 2012

Shenkar College of Engineering & Design, Ram Gant, Israel, October 2012

MedinIreland Conference, Dublin, Ireland, October 2011

Emerging Technologies Conference, Dublin, Ireland, October 2011

Assistant Technology Turkish Workshop, Istanbul, Turkey, June 2011

Green Plastics —- Current Developments & Future Perspectives Conference, Ram Gant, Israel,
June 2011

BioEnvironmental Polymer Society 18" Annual Meeting, Toronto, Canada, October 2010

Boston-Ireland MedTech Conference, Galway, Ireland, October 2010

European Medical Polymers Conference 2010, Dublin, lreland, September 2010

International Conference on Advancements in Polymeric Materials —- AOM 2010 Trends &
Technology, Bhubaneswar, India, February 2010

TAPPI — 2009 North American PLACE Flexible Packaging Summit, Columbus, OH, April 2009

Queens College, Belfast, February 2009

BioPharma EHS Forum, Cambridge, MA, September 2009

Medi 2008, Hartford, CT, September 2008

EASTEC 2008, West Springfield, MA, May 2008

SPE ANTEC Structures and Properties, Milwaukee, WI, May 2008

MassMEDIC’s 9th Annual MedTech Investors Conference, Boston, MA, November 2007

SPE ANTEC Structures and Properties, Cincinnati, OH, May 2007

BioPlastics Processing Conference, Charlotte, NC, October 2006

The 7" Annual CAMD / CBM? Summer Workshop, Louisiana State University (LSU), Baton

ECM Comb. Mot. to Exclude Page 40 of 58
Exh. U


ECM Comb. Mot. to Exclude Resp. Mot. to Campet and for San lof2

Exh. RX-C-
Exh. M CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


his deposition; any documents introduced into evidence by Respondent or Complaint Counsel as
to which he has knowledge; or any other matters as to which he has knowledge that are relevant
to the allegations of the Complaint, Respondent’s affirmative defenses, or the proposed relief,

7 Robert Ringley, BER Plastics, Inc. (“BER”) Vice President, as BER’s
designee

Mr. Ringley will testify regarding BER’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited 10, BER’s purchase of RCM
additive; reasons for this purchase; BER’s understanding of ECM’s claims and substantiation for
those claims, BER’s resources and ability to test and evaluate ECM’s claims and substantiation;
BER’s use and understanding of the ECM Certificate of Biodegradability, the ECM logo, and
other ECM promotional material: BER’s understanding of how its customers used ECM
promotional materials and products made with the ECM additive; any other issues addressed in
his deposition, any documents introduced into evidence by Respondent or Complaint Counsel as
to which he has knowledge; or any other matters as to which he has knowledge that are relevant
to the allegations of the Complaint, Respondent's affirmative defenses, or the proposed rehtef.

8. Donald Kizer, D&W Fine Pack, LLC (“D&W”) Purchasing Manager, as
D&W’s designee

Mr. Kizer will testify regarding D& W’s relationship with ECM and understanding of
ECM’s product, claims, and testing, including, but not limited to, D&W’"s purchase of ECM
additive; reasons for this purchase; D& W’s resources and ability to test and evaluate ECM’s
claims and substantiation, any other issues addressed in his deposition; any documents
introduced into evidence by Respondent or Complaint Counsel as to which he has knowledge; or
any other matters as to which he has knowledge that are relevant to the allegations of the

Complaint, Kespondent’s affirmative defenses, or the proposed relief.

ECM Comb. Mot. to Exclude Page 6 of 16
Exh. F


raises serious questions regarding the accuracy of the ensuing tests regarding the ECM

additive in polystyrene.
Comment by Dr. Michel

At page 10 of his report, Dr. Michel writes “[a]s described by Dr. McCarthy in his report, only
a few tests use proper controls and few report the actual amount of ECM additive present in the

plastic.”

Tunderstand this to be Dr. Michel’s reference and adoption of the analysis of Dr. McCarthy that
only certain tests are proper for the testing of a material to establish it is biodegradable. I report
below that Dr. McCarthy’s “standard” as to what makes for a material to be identified as
biodegradable, and the testing protocols that he identifies as being necessary to establish a
material as biodegradable, are: (1) inconsistent with U.S. Patent No. 5,883,199 where Dr.
McCarthy is a named inventor; (2) not advanced in any of Dr. McCarthy’s various peer-
reviewed publications; (3) contrary to what Dr. McCarthy previously authored in 2003; and (4)

inconsistent with a 2011 paper that appeared in the journal for which he is the reviewing editor.

Comment by Dr. Michel

At page 12 of his Rebuttal Report, Dr, Michel writes that “[t]o obtain accurate evidence of
biodegradation, experiments are best performed using ‘C-labeled substrates and measuring

Cp over time.”

I disagree with Dr. Michel. I note that Dr. Michel’s own study did not rely on C labeled
substrates. As noted below, Dr. McCarthy’s U.S. Patent No. 5,883,199 identifies certain
polymer blends as biodegradable, without the use of C-labeled substrates and measuring
CO, over time and without reliance on any ASTM recommended testing methodology
(relying instead on his own testing methodology). In addition, Dr. McCarthy did not teport or
rely upon “C-labelled substrates in any of his published articles. As a plastics material
scientist and polymer chemist, I can affirm, based on the peer reviewed literature in the field
and my own years of experience, that it is not the standard among polymer scientists to rely on
¥C labelling to advance a claim that a particular polymer is biodegradable, and there is no
evidence that accepted methods of testing reported upon in the literature, and even including

Page 6 of 20

ECM Comb. Mot. to Exclude Page 6 of 20
Exh. W


Northeast’s training and supervision of its laboratory employees; the qualifications of
Northeast’s employees; Northeast’s knowledge of, use of, and departure from ASTM testing
standards: Northeast’s financial interest in testing the purported biodegradability of plastic; any
other issues addressed in her deposition; any documents introduced into evidence by Respondent
or Complaint Counsel as to which she has knowledge, or any other matters as to which she has
Knowledge that are relevant to the allegations of the Complaint, Respondent's affirmative
defenses, or the proposed relief.

19. Timothy Barber, Principal at Environ International Corp. (“Environ”)

Dr. Barber will testify regarding his relationship and communications with ECM, ECM’s
employees, ECM's customers, and other Parties interested in the alleged biodegradability of
plastic; his testing and evaluation of plastic that purportedly contains the ECM additive: his
testing facilities, resources, procedures, protocols, and certifications; his taining and supervision
of its laboratory employees; the qualifications of personnel involved in his testing of plastics; his
knowledge of, use of, and departure trom ASTM testing standards; his financial interest in
testing the purported biodegtadability of plastic; any other issues addressed in his deposition; any
documents introduced into evidence by Respondent or Complaint Counsel as to which he has
knowledge; or any other matters as to which he has knowledge that are relevant to the allegations
of the Complaint, Respondent's affirmative defenses, or the proposed relief.

20. Tadahisa Iwata, Professor of Polymer Chemistry at the University of Tokyo

and Editor for Journal of Polymer Degradation and Stability published by
Elsevier Inc. (“Elsevier”), as Elsevier's designee

Professor Iwata will testify regarding the review and evaluation of the article entitled

“Biodegradability of conventional and bio-based plastics and natural fiber composites during

composting, anaerobic digestion and long-term soil incubation,” written by Eddie F. Gomez and

ECM Comb. Mot. to Exclude Page 12 of 16
Exh. F


“Analysis of the Mechanical Properties of Biodegradable Films Made From Blends of Polylactic
Acid (PLA) and Polyesters by Blown Film Extrusion”, with German V.

Laverde., Society of Plastics Engineers Annual Technical Conference, Volume 44, pgs. 2515-
2519, (May 1998).

“Biodegradable Polymer Blends of Polylactic Acid (PLA) and Polybutylene Succinate”, with
Wenguang Ma, Society of Plastics Engineers Annual Technical Conference, Volume 44,
pgs. 2542-2545,

“Advances in Properties and Biodegradability of Co-Continuous, Immiscible, Biodegradable,
Polymer Blends”, 5th International Workshop on Biodegradable Plastics and Polymers,
(ISBP98), (June 1998).

“Review of Konjac Glucomannan”, V. Davé & S. McCarthy, Journal of Environmental Polymer
Degradation, Vol. 5, No. 4, pg. 237-243 (1997).

“Biodegradable Polymer Blends of Poly(Lactic Acid) and Poly(Ethylene Gyicol)” M. Sheth,
R.A. Kumar, V. Dave, R.A. Gross, $.P. McCarthy, Journal of Applied Polymer Science,
Vol 66, pg. 1495-1505 (1997).

“Reactive compatibilization of Biodegradable Blends of Poly(lactic acid) and Poly(e-
caprolactone), L. Wang, W. Ma, R.A. Gross & S.P. McCarthy, Polymer Degradation and
Stability, 59, pg 161-168, (1997).

“Citrate Esters As Plasticizers for Poly(Lactic Acid)”. L.V. Labrecque, R.A. Kumar, V. Dave,
S.P. McCarthy, R.A. Gross, Journal of Applied Polymer Science, Vol 66, 1507-1513,
(1997).

“Pultrusion of Composites”, Advanced Composites Manufacturing, Ed. Timothy G. Gutowski,
John Wiley & Sons, Inc., New York, (with J. Fanucci and S. Nolet), pgs.259-295, (1997).

“Rapid Stereolithography Tooling for Injection Molding: The Effect of Cooling Channel
Geometry”, (with M. Janczyk and R. McLaughlin), J.Injection Molding Technology, Vol.
1, No. 1 (1997).

“Effects of Physical Aging, Crystallinity, and Orientation on the Enzymatic Degradation of
Poly(Lactic Acid)”. (with H. Cai, V. Dave, R.A. Gross), J. Polym. Sci., Polymer Physics,
40, pgs. 2701-2708, (1996).

“Self-Reinforcement of Polypropylene by Oscillating Packing Injection Molding Under Low
Pressure”. (with Q. Guan, X. Zhu, D. Chu, K. Shen, F.S. Lai), J-Appl.Polm. Sci., 62, Pgs.
755-762, (1996).

“Biodegradability of Cellulose Acetate Plasticized with Citrate Esters”. (with V. Ghiya, V.
Dave, R.A. Gross) J. Material Science, Pure Appl. Chem., A33(5), pgs. 627-638, (1996).

“Miscibility and Biodegradability of Blends of Poly(Lactic Acid) and Poly(Vinyl Acetate)”.
(with A. Gajria, V. Dave, R.A. Gross), Polymer, 37(3), pgs. 437-444, (1996).

“Composting Studies of Poly(B-Hydroxybutyrate-co-B-Hydroxyvalerate)”. (with C.L. Yue, R.A.
Gross) Polymer Degradation and Stability, 51, pgs. 205-210, (1996)

“Fiber Reinforced Nylon-6 Composites Produced by the Reaction Injection Pultrusion Process”.
(with B.G. Cho, J. Fanucci, S. Nolet), Polymer Composites, 17(5), pgs. 673-681, October
(1996)

“Polymers in Biodegradable Surgical Devices: Blending Poly(Glycolic-Acid) with Other
Biodegradable Plastics”, (with G. Rocha), Medical Plastics and Biomaterials, May/June
1996, Pgs. 44-48.

“Design of Polymer Blends for Biodegradable Plastics: Reactive Extrusion of Poly(lactic Acid)
and Poly(Ethylene Glycol)”, AIChE Preprints, Vol. 5, July, 1996, July 1996, pgs. 205-209.

“Miscibility and Degradability of Poly(Lactic Acid)/Poly(Ethylene Glycol)/Poly(Ethylene
Oxide) Blends”, Poly. Preprints, Am. Chem. Soc., Div. Polym. Sci., Vol. 36, (1995), (with
C.L. Yue, Vipul Dave, Richard A. Gross)

ECM Comb. Mot. to Exclude Page 48 of 58
Exh. U


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Thua, the claimed invention is neither anticipated by,
nor made obvious by the Sinclair ‘050 patent, and applicants
respectfully request reconsideration and withdrawal of the
rejection on.this ground.

Sinclair '642 discloses degradable compositions
comprising blends of lactic acid with block copolymers of hard,
stystalline segments of polybutylene terephthalate and soft, long
chain pegments of polyether glycol. ‘The block copolymers act as
impact modifiers, are “present as small spherical domains" (Col.
8, lines 27-21) and "must be elastomeric and intimately bound
into the poly(lactic acid) as a discrete heterogeneous phase"
(Col. 8, lines 36-40).

The present invention, in distinct contrast, does not
Contain block copolymers of polybutylene terephthalate blended
with polylactic acid as a discrete heterogeneous phase in small
spherical domains, ‘The presently claimed blends contain a
continuous er co-continuous phase of homopolymers or random
Copolymers of polyesters with polymers or copolymers of
polylactic acid. Thus, Sinclair ‘642 does not anticipate the
Present invention,

Moreover, Sinclair ‘642 does not render the présent
invention obvious. As noted with respect to Sinclair +050,
Sinclair '642 does not @isclose or suggest compositions which
could be made by replacing the block polybutylene terephthalate
with another polyester to achieve Applicants’ claimed blends,
which have a continuous or co-continuous phase of polyester

within the polylactic acid. again, absent 4 suggestion or

10

ECM Comb. Mot. to Exclude

Exh. Z

Page 61 of 80


3. Miscellaneous

Member, National Intercollegiate Soccer Officials Association and the New England
Intercollegiate Soccer Officials Association. Active intercollegiate soccer official over the
period 1976-2013 (37 years of active service).

Member, New Hampshire Baseball Umpires Association (inactive)

Licensed Ham Radio Operator

Licensed Commercial Pilot/Instrument Rating/Certified Flight Instructor (Helicopters)

Page 17 of 17

ECM Comb. Mot. to Exclude Page 17 of 17
Exh. Y


PUBLIC DOCUMENT

subpoenaed Dr. Michel for information relating to his study of various plastic products, but ECM
would have performed additional discovery, including subpoenas directly to the manufacturers
who provided plastics to Dr. Michel for testing and related to Dr. Michel’s financial interests in
dealing with those manufacturers had it known Michel would be an expert. ECM forwent those
opportunities because Complaint Counsel held Dr. Michel out as a non-testifying fact witness,
like other similarly situated testing laboratories. ECM even agreed to a stipulation that would
admit Dr. Michel’s study documents, something ECM never would have done had it known Dr.
Michel would be testifying as an expert.

Adding depositions for experts at this stage presents herculean scheduling burdens and a
prejudicial timetable. Dr. Michel’s deposition would come after the remaining depositions, on or
beyond July 17, 2014. See Exh. T. That would be after the following deadlines: motions for in
camera treatment of expert exhibits; motions in limine; responses to motions in limine; responses
for motions for in camera treatment of proposed trial exhibits; the exchange of objections to final
proposed witness lists and exhibit lists; and responses to motions in limine.

In accordance with the rules Complaint Counsel has violated and in light of the prejudice
suffered by ECM because of those rule violations, Dr. Michel and his rebuttal report should be

excluded altogether.!!

* Prejudice inures not because Michel was entirely unknown but because Michel was not
identified as an expert. Evaluation of a Michel study is a far cry from an evaluation of whether
that specific study author is a competent expert possessed of requisite scientific acumen born of
education, training, experience, publication, a lack of bias, and evidence sufficient to meet the
standard of review. Many laboratories have performed tests relevant to this matter, and the
parties have taken fact discovery from all of them. The fact that ECM possesses some of Dr.
Michet’s discovery files before Complaint Counsel’s surprise identification of Dr. Michel
himself as its expert, does not excuse Complaint Counsel’s legerdemain, which would have
ECM prepared to address Michel’s study alone, not to vet Michel as an expert witness.

14


2584 EF Gomez, FC Michel jr. / Polymer Degradation and Stability 98 (2013) 2583 2591

The fact that plastics are made from non renewable resources
and their persistence in the environment and during organic
recycling has resulted in global concern and intensive efforts to
develop plastic materials that not only have acceptable prices and
similar performance to conventional plastics, but also are made
from renewable feedstocks and/or undergo biodegradation in a
reasonable amount of time without leaving toxic residues [5].

Although biodegradable bio based plastics are meant to
improve the sustainable use of resources, a complete life cycle
analysis including disposal must be conducted '6} to insure that
the solution is not worse than the problem. Many factors impact the
life cycle carbon balance of plastics including the source of the
feedstock used to make them, whether the material is recycled and
the extent and type of biodegradation during disposal. For example,
most plastics are derived largely from fossil sources such as natural
gas or crude oi! [7 }. However the monomers used to make them can
also be made from renewable resources. In Brazil, ethylene, the
building block of one of the most widely used plastics, polyethylene
[8] is made from ethanol derived from sugar cane. Although made
from a biomass feedstock, this type of polyethylene is still essen
tially not biodegradable. On the other hand, petroleum can also be
used to make plastics that are biodegradable. The lactic acid used to
make polylactic acid (PLA) can be produced both by fermentation
and synthetically from petroleum {9}, and either type is biode
gradable. On this basis, plastics can be classified into four types
with respect to whether they are biodegradable and the source of
the feedstock used to make them. These four types are conventional
plastic, bio based plastic, biodegradable plastic and biodegradable
bio based plastic (Tab!: %). Understanding the environmental
benefits of these four classes of materials ({able 1) and the impact
of their use on GHG emissions can be confusing and is not always
straightforward.

Plastics made from petroleum, such as polyethylene, have a
well defined life cycle. When landfilled, the carbon in the plastic
will be sequestered and not contribute to global warming. Recycled
polyethylene may contribute even less fossil CO2 to the environ
ment if less energy is used to recycle it than is used to make it in the
first place. In these cases, conventional plastics may have less
impact on GHG emissions that those designed to biodegrade.

For reasons presented above, efforts have been made to develop
durable plastics made from renewable biomass feedstocks {5].
These are called “bio based plastics”. On balance this type of plastic
offers a great potential to reduce greenhouse gases in the atmo
sphere by sequestering carbon. This is because atmospheric CO, is
fixed into the carbohydrates used as their feedstock. If the plastic is
eventualiy landfilled, this carbon will become locked for millennia
within the landfill and on balance reduce atmospheric CO2. How
ever these plastics also pose pollution problems [10].

Biodegradable bio based plastics, are also made from biomass
but are designed to be compostable and/or biodegradable. These
types include PLA and polyhydroxyalkanoates based resins (PHA)

Table 1
Classes of plastics.
lass Source Biodegradable Example Reference
1 Petroleumjnatural No Polyethylene, 7]
gas polypropylene,
I Petroleum/naturai Yes PLA’ from petroleum. {9]
gas
Il Biomass (Corn, sugar No Polyethylene derived |8]
cane, etc) from corn ethanol,
Vv Biomass (Corn, sugar Yes PHA , PLA derived {14}
cane, etc) from starch.

* Polylactic acid.
© Polyhydroxyalkanoates-based resin.

ECM Comb. Mot. to Exclude
Exh. AA

made from corn. This class of polymer is carbon neutral from the
standpoint of the carbon in the plastic, but a substantial amount of
fossil energy is used to produce the plastic and the biomass
feedstocks.

The class with perhaps the greatest potential to contribute to
greenhouse gas emissions is biodegradable plastics made from
petroleum. This is because not only is fossil energy used to produce
them in the first place, but fossil carbon is released when the ma
terial ultimately biodegrades. If this biodegradation occurs in a
landfill, then it usually will generate methane (CHa), which is a
greenhouse gas with 21 times the warming potential of CO>. Most
landfills do a poor job of capturing this gas, even those with
methane recovery systems [11]. So landfilled biodegradable plas
tics, eventually contribute both methane and carbon dioxide to the
atmosphere when they degrade.

Some novel polymers combine both biomass and fossil derived
resins to decrease production prices, increase the bio based content
and improve material performance (5] (e.g. a plastarch containing a
blend of a starch based polymer and conventional plastics such as
polypropylene). The biogenic renewable carbon contained in these
and other biomaterials can be determined from the radioactive C14
signature of the product [12]. Yet these hybrid materials likely are
neither recyclable nor completely biodegradable and therefore are
likely worse than conventional plastics from a GHG emissions
perspective.

Composting plays an important and growing role in sustainable
organic waste management and recycling. However, plastics are
one of the main contaminants in composts. Biodegradable plastics
are meant to address this problem. Composting of these materials
also reduces their environmental impact in that they will largely be
converted to COz and not to CH, as they would be in a landfill. Since
this CO2 was originally fixed from the atmosphere into renewable
biomass, on balance it will not increase atmospheric CO2.

Biodegradation is the mineralization of materials as a result of
the action of naturally occurring microorganisms such as bacteria
and fungi [13]. The biodegradation of plastics is limited by their
molecular weight, chemical structure | 14), water solubility and the
fact that most plastics are xenobiotic. That is, they were not present
in the environment until very recently so that the evolution of
metabolic pathways necessary for their biodegradation, a process
that takes millions of years, has yet to occur.

In contrast, the biodegradation of natural polymers, such as
starch or cellulose by microorganisms occurs relatively rapidly. it
begins with the excretion of extracellular enzymes that depoly
merize these materials. Once the polymer is reduced to a size that is
water soluble and able to be transported through the cell wall,
microbial metabolic pathways can then mineralize it [15]. Even
though microorganisms drive the biodegradation process, other
non biotic chemical processes such as photo oxidation and
chemical degradation may also take place before or in parallel.

Biodegradable materials are used in diverse applications. Many
different biodegradable plastics are used for food packaging and for
waste containment. They have also been developed for medical
applications, including medical devices and for drug delivery |16}.
Biodegradable plastics are used widely in agriculture, as mulching
films and low tunnels [17,18] as well as guide strings and plant
nursery containers [19]. The physical properties and performance
of biodegradable plastics made from PLA and natural fibers were
found to be similar to conventional plastics for greenhouse crop
production {201. In addition, biodegradable potting containers have
gained a high degree of acceptance among consumers [21].

Recently, various materials have begun to be marketed that
claim to be biodegradable or compostable. Terms such as
“degradable”, “oxo biodegradable”, “biological”, “compostable”
and “green” are often used to describe and promote different

Page 2 of 9


The preambular --The-- was suggested by the Examiner
instead of the preambular "A" in claims 2-9 and 11-22. Although
applicants do not agree that this amendment is required, or
changes the scope of the claims, they have made this change
requested bythe Examiner in the interest of moving the
application towards allowance. The rejection on this ground can
thus be withdrawn.

The term "homopolymer of polylactic acid" in claima 3,
20, and 22 was said to be unclear. In light of the arguments
made above regarding the well-established use of the term
“polylactic acid," applicants respectfully request withdrawal of
the rejection on this ground.

The term "terephthalate" in claim 9 was said to be
indefinite. In view of the claim amendment changing the term to
~-polyethylene terephthalate~- (supported in applicant's
specification, e.g., at page 11, lines. 10-12), applicants
respectfully request withdrawal of the rejection on this ground.

The term “general in claim 18 was found to be
indefinite. This word has been deleted from the claim;
applicants respectfully request withdrawal of the rejection on
this ground.

The formula in claim 19 was asserted to be indéfinite
because it lacked end groups. Claim 19 depends from claim 1
which is @irected to a biodegradable blend comprising first and
second polymers. End groups are not included in the structure
shown in claim 19 because the claim does not require the

polyester structure to be linked to any particular group, but

ECM Comb, Mot. to Exclude

Exh. Z

Page 56 of 80


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 8

support for ECM’s hypothesis that microorganisms will combine synergistically to produce
enzymes that would allow them to metabolize conventional plastic. Third, all tests that purport
to show biodegradation of ECM Plastics are flawed.

19. These fatal flaws include, among many defects, test desi igns that do not measure
biodegradation at all, gross imprecision in testing methods, misuse (or nonuse) of statistics to
calculate results, and experimenters who lack the minimum qualifications necessary. To the
extent that, notwithstanding these significant issues, some tests report minimal biodegradation,
that purported biodegradation is the result of the “priming effect,” i.c., biodegradation of the
additive (which contains organic compounds highly susceptible to biodegradation) and the
organic materials of the test medium (the bacteria used for testing) rather than the plastic.
Moreover, the minimal biodegradation reported is nearly always within the test’s error limits,
which underscores that the reported biodegradation is the result of flawed testing rather than the
molecular transformation of conventional plastic into a biodegradable material.

20. In short, there is no competent and reliable scientific evidence that the ECM

additive—or any other similar additive—causes plastic to biodegrade completely.

Vv. BIODEGRADATION & PLASTICS

21. To understand what constitutes competent and reliable scientific evidence of
biodegradation in plastics, it is important to understand (i) the mechanisms of biodegradation;
and (ii) the nature of plastics in general. I will describe each briefly below.

22. What Is Biodegradation? Biodegradation is a chemical process by which
microorganisms such as bacteria and fungi use the carbon found in organic materials as an
energy source (i.¢., as a food source). Microorganisms secrete enzymes that adhere to the
surface of the organic materials and cause fissures in the molecular chain known as hydrolic
cleavages. These cleavages make long-chain molecules shorter, resulting in the release of

carbon and energy (heat).

ECM Comb. Mot. to Exclude Page 8 of 58
Exh. U


Erikson, M., S. A. Mason, S. Wilson, C. Box, A. Zellers, W. Edwards, H. Farley, and S. Amato. 2013.
Microplastic Pollution in the Surface Waters of the Laurentian Great Lakes. Marine Pollution Bulletin 77:
177.

Gomez E and FC Michel. 2013. Biodegradability of conventional plastics and natural fiber composites
during composting, anaerobic digestion and long term soil incubation. J Polymer Degrad. Stabil. 2583:91

Gomez, EF, X Luo, C Li, FC Michel Jr., Y Li. 2014. Biodegradability of crude glycerol-based polyurethane
foams during composting, anaerobic digestion and soil incubation. Polymer Degradation and Stability
102:195-203

Kim J and D. E. Crowley. 2013. Size fractionation and microbial community structure of soil aggregates
Journal of Agricultural Chemistry and Environment, Vol. 2 No. 4, 2013, pp. 75-80. doi:
10.4236/jacen.2013.24011.

Liu, WT, TL Marsh, H Cheng, and L J Forney. 1997. Characterization of microbial diversity by determining
terminal restriction fragment length polymorphisms of genes encoding 16S rRNA. Appl Environ Microbiol.
63(11): 4516-4522.

Michel Jr., F.C., J. Quensen, C.A. Reddy. 2001. Bioremediation of a PCB contaminated soil via composting.
Compost Science and Utilization 9(4)274-284,

Michel Jr., F.C., CA. Reddy, LJ. Forney. 1997. Fate of [A-2-14C]-labeled diazinon during the composting
of yard trimmings. Journal of Environmental Quality 26:200-205.

Michel Jr., F.C., C.A. Reddy, L.J. Forney. 1995. Microbial degradation and humification of 2,4
dichlorophenoxy acetic acid during the composting of yard trimmings. Applied and Environmental
Microbiology 61:2566-2571.

Michel Jr., F.C., E.A. Grulke, C.A. Reddy. 1992. A kinetic model for the fungal pellet life cycle. American
Institute of Chemical Engineers Journal 38:1449-1460.

Michel Jr., F.C., S.B. Dass, E.A. Grulke, C.A. Reddy. 1991. The role of manganese peroxidases and lignin
peroxidases in the decolorization of Kraft bleach plant effluent by Phanerochaete chrysosporium.
Applied and Environmental Microbiology 57:2368-2375.

Michel Jr., F.C. ,T.L. Marsh, C.A. Reddy. 2002. Characterization of Microbial Community structure during
composting using analysis of terminal restriction fragment length polymorphisms of 16S rRNA genes.
tnsam H, Riddech N, Klammer S (eds.) Microbiology of Composting, Springer Verlag, Heidelberg, p. 25-
42.

Miles, R., WJ Doucette. 2001. Assessing the aerobic biodegradability of 14 hydrocarbons in two soild
using a simple microcosm/respiration method. Chemosphere 45:1085-1090.

Nakashima T, S Nagasaki, C Xu, Y Bin, M Matsuo. 2002. Biodegradation of Biaxially Stretched
Polyethylene-Starch Composite Films. Polymer Journal 34(3):234-241.

21

ECM Comb. Mot. to Exclude Page 21 of 24
Exh. V


J Polym Environ (2011) 19:637 676

651

Abd El-Rehim et al. observed an accelerating effect in
biodegradation of LDPE/starch blend subjected to soil
burial treatment after UV-irradiation [382]. Jakubowicz
[383, 384], Bonhomme et al. [385], Chiellini et al. [315]
and Manzur et al. [386] have done the biodegradation of
thermally-oxidized polyethylene to evaluate their ultimate
biodegradation (e.g., mineralization) in soil. They observed
bioassimilation of PE films after its thermo-oxidative
degradation into low molar mass products. More recently
Raghavan et al. prepared starch/PE/poly(lactic acid) com-
posites [387].

An economical and commercially viable approach to
form graft or block copolymers is in situ reactive blending
by using polymers containing reactive functional groups so
that reaction occurs during melt blending, which improves
the compatibility and interfacial adhesion of the two
immiscible polymers. Chandra and Rustgi reported the
synthesis and biodegradation studies of MA-g-LLDPE/
starch blends. Biodegradation studies showed only the
degradation of starch, while the MA-g-LLDPE matrix
remained intact [320]. It has, however, been noted that the
starch gets enzymatically hydrolyzed in a biologically
active environment leaving the polymer in a disintegrated
form. It is also now well understood that the molecular
weight of LDPE remains unaffected even after the com-
plete degradation of starch causing further environmental
pollution [322]. A combined methodology of in situ oxi-
dative modification of polymer backbone by introducing
>C = O groups followed by grafting of simple sugars was
tried by our team [335] to prepare a sugar grafted LDPE
(Su-g-LDPE). They reported that the increase in the
amount of grafted sugar moieties in the polymer enhances
intermolecular interactions such as hydrogen bonding at
higher grafting percentages giving rise to improved
mechanical properties. During biodegradation in soil
environment, the microbial oxidation of LDPE backbone
was established by observing a decrease in carbonyl index
of Su-g-LDPE with time of degradation.

Grafting Reactions on to Polyethylene to Improve
Biodegradability

Sugar End-Capped Polyethylene: Melt Phase Grafting
of Glucose on to Polyethylene

A combined methodology of in situ oxidative modification
of polymer backbone by introducing >C = O groups fol-
lowed by grafting of simple sugars is expected to be an
another interesting technique to graft sugar/carbohydrate
molecules that can reduce the negative effects observed in
the case of polysaccharide grafting. Low density polyeth-
ylene (LDPE) was modified to introduce biodegradability
by grafting highly hydrophilic monomers (which can act as

ECM Comb. Mot. to Exclude
Exh. Z

8
=

©
to

Om @3m c6m 12m |

C1(1719/1645)
°
io

2

&

ral

LDPE OxiLDPE Su-g-LDPE

Fig. 9 Carbonyl index of LDPE samples subjected to biodegradation

nutrients for microorganisms) such as glucose by a novel
melt phase reaction in Brabender plasti-corder in the
presence of ceric ammonium nitrate (CAN) to obtain 4-O-
hydroxymethyl D-arabinose (Sugar) end-capped LDPE
(Su-g-LDPE) at a maximum grafting of 16%. The increase
in the amount of grafted sugar moieties in the polymer
enhances intermolecular interactions such as hydrogen
bonding at higher grafting percentages giving rise to
improved mechanical properties. The biodegradability of
Su-g-LDPE was carried out by soil burial test and by
optical density measurements in presence of an aerobic
bacterium Pseudomonas sp. During biodegradation studies
in compost soil environment a decrease in ketone carbonyl
index (CI (¥y719/¥1465)) of Su-g-LDPE with time of deg-
radation was observed, indicating the initiation of LDPE
chain degradation (Fig. 9). A stepwise cleavage of LDPE
from the chain ends can be envisaged with microbes con-
suming the sugar units on the surface of Su-g-LDPE and
further oxidizing the ketonic carbonyl to carboxylic acid.
The microbial degradation resulted in the increase in
crystallinity and the decrease in viscosity of the degraded
samples. SEM showed surface erosion caused by microbial
degradation on Su-g-LDPE (Fig. 10) [335].

Grafting of Vinyl Monomers

Kaur et al. report that gelatin grafting improved biodeg-
radation [388]. They modified PE through the graft copo-
lymerization of vinyl monomers such as acrylamide
{AAm) and acrylic acid (AAc) by a phase-transfer-catalyst
method to impart biodegradability. The grafting percentage
of AAm and AAc for PE was found to be dependent on the
dibenzoyl peroxide concentration, monomer concentration,
time, temperature, and concentration of the phase-transfer
catalyst. Some AAm- and AAc-grafted PE samples were
prepared by chemical, UV, and »-radiation methods. The
biodegradation of samples of PE, PE-g-polyacrylamide,
and PE-g-poly(acrylic acid) prepared by all these methods
was studied. The weight loss of the samples over a period
of time was observed with soil-burial tests. The grafted
samples prepared by the phase-transfer-catalyst method

® Springer
Page 15 of 80


PUBLIC DOCUMENT

Chief Administrative Law Judge
Date:

ECM Comb. Mot. to Exclude Page 4 of 5
Exh. I


PUBLIC DOCUMENT

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 2, 214, Respondent’s counsel conferred in person with Complaint Counsel in a good faith
effort to resolve by agreement the issues raised in the foregoing Motion. The parties again
conferred by email on July 8th. The parties have been unable to reach an agreement on the issues

raised in the attached motion.

Respectfully submitted,

LEB.
Joviathan W. Emord (émord@emord.com)
EMORD & ASSOCIATES, P.C.
11808 Wolf Run Lane
Clifton, VA 20124

Telephone: 202-466-6937
Facsimile: 202-466-6938

19


Respondent’s Exhibit D


Respondent’s Exhibit I


Contents lists available at

Polymer
. . Degradation
Polymer Degradation and Stability Stability
journal homepage: www.elsevier.com/locate/polydegstab =]
—_e — a

Biodegradability of conventional and bio-based plastics and natural
fiber composites during composting, anaerobic digestion and

4 CrossMark

long-term soil incubation

Eddie F. Gémez, Frederick C. Michel Jr.

Department of Food, Agricultural and Biological Engineering, The Ohio State University, OARDC, 1680 Madison Avenue, Wooster, OH 44691, USA

ARTICLE INFO

ABSTRACT

Article history:
Received 21 August 2013
Accepted 21 September 2013
Available online 1 October 2013

Keywords:
Biodegradable plastics
Anaerobic digestion
Composting

Soil

Biodegradation
Bioplastics

Plastics are a major constituent of municipal solid waste that pose a growing disposal and environmental
pollution problem due to their recalcitrant nature. To reduce their environmental impacts and allow
them to be transformed during organic waste recycling processes, various materials have recently been
introduced to improve the biodegradability of plastics. These include conventional plastics amended
with additives that are meant to enhance their biodegradability, bio based plastics and natural fiber
composites. In this study, the rate and extent of mineralization of a wide range of commercially available
Plastic alternative materials were determined during composting, anaerobic digestion and soil incuba

tion. The biodegradability was assessed by measuring the amount of carbon mineralized from these
materials during incubation under conditions that simulate these three environments and by exami

nation of the materials by scanning electron micrography (SEM). The results showed that during a 660
day soil incubation, substantial mineralization was observed for polyhydroxyalkanoate plastics, starch

based plastics and for materials made from compost. However, only a polyhydroxyalkanoate based
plastic biodegraded at a rate similar to the positive control (cellulose). No significant degradation was
observed for polyethylene or polypropylene plastics or the same plastics amended with commercial
additives meant to confer biodegradability. During anaerobic digestion for 50 days, 20 25% of the bio

based materials but less than 2% of the additive containing plastics were converted to biogas
(CH4 + C02), After 115 days of composting, 0.6% of an additive amended polypropytene, 50% of a plas

tarch material and 12% of a soy wax permeated paper pulp was converted to carbon dioxide. SEM
analysis showed substantial disintegration of polyhydroxyalkanoate based plastic, some surface changes
for other bio based plastics and coconut coir materials but no evidence of degradation of polypropylene
or polypropylene containing additives. Although certain bio based plastics and natural fibers bio

degraded to an appreciable extent in the three environments, only a polyhydroxyalkanoate based resin
biodegraded to significant extents during the time scale of composting and anaerobic digestion processes
used for solid waste management.

© 2013 Elsevier Ltd. All rights reserved,

1. Introduction

are moving toward more sustainable waste management practices
such as recycling, composting and anaerobic digestion.

Plastics are synthetic and semi synthetic polymeric compounds,
derived primarily from fossil carbon sources such as crude oil and
natural gas. Their mechanical properties and characteristics such as
low cost, durability and processability, have led to their widespread
use for diverse applications, However most commonly used plastics
are very resistant to biological degradation | 1}. This has led to major
challenges for waste management operations especially those that

* Corresponding author. Tel.: +1 330 263 3859; fax: +1 330 263 3670,
E-mait address: mii Ca (RC, Michel),

0141-3910/5

see front matter © 2013 Elsevier Ltd. All rights reserved.
Ki

1 SAN fh.polnade te 125.2613.6 501

ECM Comb. Mot. to Exclude
Exh. AA

It is estimated that of the 31 million tons of plastic waste
generated annually in the USS. only 8% is recycled [2]. Therefore, a
large percentage of plastic waste is currently landfilled, or released
into the environment. Throughout the world, roadsides, parks,
beaches, oceans and natural areas are inundated with plastic debris
pollution [3]. Waste management systems are also affected by high
volumes of plastics that are often commingled with organic wastes
(food scraps, wet paper, yard trimmings, soil and liquids), making it
difficult and impractical to recycle both organic fractions and/or the
plastics mixed with them without expensive cleaning, separation
and sanitizing procedures {4}.

Page 1 of 9


Qualifications

My qualifications to respond to the rebuttal reports include a B.S. in Chemistry and a
Ph.D in Polymer Science and Engineering and both industrial and academic experience in the
field of polymer materials, polymer chemistry, and polymer structure-property relationships,
More specifically, after earning my Ph.D. in Polymer Science and Engineering from the
University of Massachusetts-Amherst I served as a research and development scientist in the
polymer research group at the Upjohn Company, North Haven, Connecticut (1980-1984). In
1984 I joined the University of Massachusetts-Lowell as an Assistant Professor of Plastics
Engineering, and was later promoted to Associate Professor and then Full Professor. I teach
undergraduate and graduate courses on polymer materials which include a consideration of
issues such as commercial polymer synthesis, polymer structure and property relationships,
influence of additives and fillers along with a consideration of recycling and biodegradation.
For example, my courses deal with issues of polymer degradation in the environment as well as
a detailed consideration of polymer hydrolysis which is a key part of many biodegradation
pathways.

In addition, in 1990 I obtained my J.D. degree and became a member of the New
Hampshire Bar and am also licensed to practice before the United States Patent Office. I have
practiced intellectual property law (patent law) since 1990 and am also the founding member of
the law firm of Grossman, Tucker, Perreault & Pfleger, 55 South Commercial Street,
Manchester, New Hampshire 03101.

I note that I am a colleague of Dr. McCarthy at the University of Massachusetts-Lowell,
in the Department of Plastics Engineering. My observations herein are my own evaluations of

the analysis and opinions Dr. McCarthy has offered in this particular case,

My complete curriculum vitae is attached which identifies prior cases where I have

provided expert testimony. I note that I am being compensated at the rate of $330.00 per hour.

Page 2 of 20

ECM Comb. Mot. to Exclude Page 2 of 20
Exh. W


19. Jean A. Sweigert, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

20. Stacy Adams, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

21. Debra K. Browning, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

22. Kelly A. Dean, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

23. Anjie Kacperski, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

24. Brenda L. Peters, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

25. Annet A. Retofsky, Former Employee of ECM Biofilms, Inc.

Proposed Testimony: We anticipate that this witness will testify about ECM’s products,
distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

26. All current and former employees of ECM Biofilms, Inc.
Proposed Testimony: We anticipate that these witnesses will testify about ECM’s

products, distribution and sales channels, customer base, customer communications, claims of
biodegradability of plastics treated with ECM products, and substantiation for those claims.

ECM Comb. Mot. to Exclude Page 5 of 11
Exh. A



ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. — Page 16

biodegradation is the minimum benchmark for showing that the treated sample
will biodegrade to completion. (Alternatively, radiolabeling the most recalcitrant
part of the conventional plastic can conclusively answer the question whether the
conventional plastic component of the treated plastic is biodegrading.
Radiolabeling will also show that the “biodegradable plastic” can biodegrade to

completion.)

g. Proper Controls. Tests should involve proper controls, so that the results of the

tested sample can be compared to the results of the control samples to ensure that
the results are meaningful. In other words, using proper controls decreases the
likelihood that apparently meaningful results are in fact the product of testing
error. Proper testing should have a negative control (i.e., untreated conventional
plastic of the same type as the test sample) and a positive control (typically
cellulose). The negative control is a substance known not to be biodegradable,
and, therefore, it should produce little to no methane. The positive control is a
substance known to be readily biodegradable; this validates the viability of the
inoculum. Ifthe amount of methane produced by the test sample is statistically
different than the negative control, and the standard deviation does not span zero,

biodegradation can be reported.

h. Statistical Significance. Once a study has been completed and all data have been

collected, the data for the sample and control groups must be compared through
appropriate statistical analysis that will depend upon various design factors of the
study. If the standard deviation spans zero, then there is a significant probability

that some of the samples did not biodegrade.

ECM Comb. Mot. to Exclude Page 16 of 58

Exh. U


J Polym Environ (2011) 19:637 676

Fig. 20 SEM micrographs of hydrolytically degraded samples taken after 80 days of immersion in deionized water: (a) CL graft copolymer
before degradation, (b) Chitosan, (€) CL 2, (d) CL 10 and (a) CL 30 graft copolymers

Current developments [531 563] include continued
stress on new techniques of production and processing
novel applications [531, 532]. In a comparative evaluation
of two synthetic routes: direct polycondensation reactions
without organic solvents, and in a supercritical medium,
Jahno et al. showed that the poly condensation reaction
proved to be an excellent synthetic route to produce PLA
polymers with different molar mass [533]. It was observed
that cell adhesion and viability was not disturbed by the
presence of the polymer, although the proliferation rate was
decreased when compared to control.

Microbial fermentations are preferred over chemical
synthesis of lactic acid due to various factors [534].
Refined sugars, though costly, are the choice substrates for
lactic acid production using Lactobacillus sps. Complex

ECM Comb. Mot. to Exclude
Exh. Z

natural starchy raw materials used for production of lactic
acid involve pretreatment by gelatinization and liquefac-
tion followed by enzymatic saccharification to glucose and
subsequent conversion of glucose to lactic acid by Lacto-
bacillus fermentation. Reddy et al. showed that economical
production of lactic acid can be done by direct conversion
of starchy biomass to lactic acid by bacteria possessing
both amylolytic and lactic acid producing character thus
eliminating the the two step process. Lactobacillus amy-
lophilus GV6 is an efficient and widely studied amylolytic
lactic acid producing bacteria capable of utilizing inex-
pensive carbon and nitrogen substrates with high lactic acid
production efficiency [534].

Recent advances in simultaneous saccharification and
fermentation, molecular genetic approaches, and enzymetic

® Springer
Page 25 of 80


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

120
100
x $¢ ¢ tt O PLA
> pol + $ <> A70B30
§ + af & | | 6 210#3000
3 + za x | | 5 Asoai0
3 60 yi? 74 A A50B50
> eat at A A80B20
8 7 ‘i z4 430870
40 p res
2 =
| aie ge 8 55
; B passes 8
0 7 20 #30 40 50
Testing Time, Day
FIG. 11
80
70
- OF O PLA
a) X ATOB30
" © B10#3000
8 40 A A50B50
S > A80B20
x 90 lm A30B70
gy 20
10
-10
(| a ne
Degradation time, day
FIG. 12
ECM Comb. Mot. to Exclude Page 71 of 80

Exh. Z


Respondent’s Exhibit O

CONFIDENTIAL


PUBLIC DOCUMENT

For the foregoing reasons, ECM requests that his Honor order Complaint Counsel to be
reprimanded for the offense, and in addition that Dr. Michel and his report be excluded, that the
Michel/Gomez article (Exh. AA) be excluded from evidence, and that the Joint Stipulation
concerning that article (Exh. I) be rescinded or voided.

3. Dr. Michel Should Be Excluded and His Report Should Be Stricken Because His
Testimony and Report Are Incompetent Under Rule 3.31.

“Rebuttal evidence is appropriate only if it is offered in response to evidence first
presented to the court during the defendant’s case.” Heatherly v. Zimmerman, 15 F.3d 1 159, at
*2 (D.C. Cir. 1993). Therefore, testimony and evidence used merely to buttress prior testimony
“is not proper rebuttal testimony.” Jd. Rebuttal testimony must be limited to “that which is
precisely directed to rebutting new matter or new theories presented by the defendant’s case-in-
chief.” Bowman v. Gen. Motors Co., 427 F. Supp. 234, 240 (E.D. Pa. 1977) (emphasis added).

Here, Complaint Counsel uses Dr. Michel’s report and testimony to buttress the reports
and anticipated testimony of its primary scientific experts, Dr. Stephen McCarthy and Dr. Thabet
Tolyamat. For example, Dr. Michel’s purported rebuttal report attempts to validate Dr.
McCarthy’s discredited “priming effect” theory. Compare Dr. McCarthy’s Expert Report, Exh.
U, at 8, with Dr. Michel’s Rebuttal Report, Exh. V, at 8-10. Similarly, Complaint Counsel uses
Dr. Michel’s rebuttal report to buttress Dr. McCarthy’s theory void of published peer reviewed
support that radiolabeling is the “best-known, best accepted confirmatory test” to confirm
biodegradation. Compare Dr. McCarthy’s Expert Report, at 23, with Dr. Michel’s Report, at 12
(‘To obtain accurate evidence of biodegradation, experiments are best performed using '4C-
labeled substrates and measuring evolved '4CQ2 over time.”). Dr. Michel’s purported rebuttal
report also attempts to buttress Dr. Tolaymat’s theory that landfills are “dry tombs” and not

biologically active. Compare, e.g., Dr. Michel’s Rebuttal Report at 8-9, with Dr. Tolyamat’s

15


Polyethylene (PE): A type of plastic.
Polymer: A large molecule composed of many repeated subunits.
Polypropylene (PP): A type of plastic.

Polyvinylchloride (PVC): A type of plastic.

Research, Development, and Demonstration (RD&D) Permits: Permits that some
states issue landfills for research and demonstration purposes.

Resource Conservation and Recovery Act (RCRA): The federal law that governs the
management and disposal of solid and hazardous waste.

Subtitle D: The specific provision in the federal solid waste regulations (RCRA) that
governs nonhazardous solid waste.

Subtitle D Landfill: Any landfill that is designed and operated in accordance with
RCRA Subtitle D.

Thermophilic: An organism that thrives at relatively high temperatures, between 45 and
122°C.

UN IPCC: See IPCC.

Volatile Fatty Acids: Organic acids that are by-products of anaerobic decomposition.
An example is acetic acid (vinegar).

Waste Filling Plan: A plan that is developed by landfill operators that shows the
sequence to be followed when filling the landfill with solid waste.

38

ECM Comb. Mot. to Exclude Page 38 of 56
Exh. X


5,883,199

13

11. The biodegradable blend of claim 1, said blend having
an elongation at break of at least 10%.

12. The biodegradable blend of claim 1, said blend having
an elongation at break of at least 200%.

13. The biodegradable blend of claim 1, said blend having
an elongation at break of at least 10% after 70 days of aging.

14. The biodegradable blend of claim 1, 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 baving
a toughness of at least 10 MJ/m>.

16. The biodegradable blend of claim 1, said biend having
a toughness of at least 70 MJ/m?.

17. The biodegradable blend of claim 1, wherein said
second polymer is present in said blend as a co-continuous
phase

18. The biodegradable blend of claim 1, wherein said first,
polylactic acid-based polymer or copolymer is a homopoly-
mer of lactic acid or a block, graft, or random copolymer of
lactic acid having the formula:

Re Ra)e—
wherein R, is a lactic acid unit, R, is caprolactone,
glycolide, trimethylene carbonate, dioxanone, butyryl
lactone, or ethylene oxide, a is 10 to 10,000, and b is 0 to
10,000.
19. The biodegradable blend of claim 1, wherein said
polyester has the formula:

LOCH O-F (Ce Fe
° °

wherein m is 2 to 20, n is 2 to 20, and N is 10 to 10,000.
20. The biodegradable blend of claim 1, wherein said first,
polylactic acid-based polymer or copolymer is a polylactic
acid homopolymer, and wherein said second polymer or
copolymer is a polybutylenesuccinate homopolymer.

21. The biodegradable blend of claim 1, wherein said first,
polylactic acid-based polymer or copolymer is a polylactic
acid homopolymer, and wherein said second polymer or
copolymer is a polybutylenesuccinate-adipate copolymer.

22. A film comprising a biodegradable blend comprising:

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

and

ECM Comb. Mot. to Exclude
Exh. Z

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 1:0 by weight, and wherein 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 the
blend.

24. A container comprising a biodegradable blend com-

prising:

(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
forms a continuous or co-continuous phase in the
blend.

25. Adisposable diaper comprising 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 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.

Page 78 of 80


other person that Respondent identifies as a potential witness in this action;

c. To amend this Final Proposed Witness List to be consistent with the Court’s
ruling on any pending motions, including any motions in fimine Filed in this
matter;

D. To question the persons listed below about any topics that are the subjects of
testimony by witnesses to be called by Respondent;

E Not to present testimony by deposition and/or investigational hearing transcript,
affidavit, declaration, or orally by live witness, from any of the persons listed
below;

FL To question any person listed below about any other topics that the person
testified about at his or her deposition or investigational hearing, or about any
matter that is discussed in any documents to which the person had access and
which are designated as exhibits by either party or which have been produced
since the person’s deposition was taken;

G. To present testimony by deposition and/or investigational hearing transcript,
affidavit, declaration, or orally by live witness, from any persons, regardless
whether they are listed below, to rebut the testimony of witnesses proffered by
Respondent;

HL For any individual listed below as being associated with a corporation,
government agency, or other non-party entity, to substitute a witness designated
by the associated non-party entity; and

I To supplement this Final Proposed Witness List in light of Respondent’s Final

Proposed Witness List and Exhibit List, or as circumstances may warrant.

ECM Comb. Mot. to Exclude Page 2 of 16
Exh, F


biodegradation under anaerobic conditions at approximately 30 days incubation. Further biodegradation
of the cellulose paper was negligible between 30 and 50 days, when the test concluded. In other words,
even a known positive control experienced a plateau effect under laboratory testing conditions.”

“72. These are all important confounding considerations when evaluating the results of biodegradation
tests. For example, Complaint Counsel has pointed to a particular peer-reviewed journal article where
ECM treated plastics were tested for biodegradation under anaerobic conditions, and they reported
biodegradation of these samples was not observed (Gomez & Michel, 2013). These authors utilized a
modified ASTM D5511 test protocol. You must interpret the results against the controls presented in the
test. In this series of tests, the positive control cellulose paper only reached 74% biodegradation, and
plateaued from 30 days until the conclusion of the test at 50 days. From this, it is reasonable to conclude
that conditions that promote biodegradation expired close to the 30 day point. This is a perfect example
of the importance of experimental limitations, and the impact they can have on the interpretation of
results. We may surmise from this defect in test design that the environment present was not hospitable
to biodegradation, because even the positive control cellulose, established in many tests to bea
biodegradation catalyst, failed to sustain biodegradation beyond 30 days.”

Rebuttal -

In our study (Gomez and Michel, 2013), we examined a wide range of commercially available materials
used to manufacture plastic products. The biodegradability of these materials was assessed by
measuring the amount of carbon mineralized from them during incubation in three environments; soil,
anaerobic digestion and composting.

During soil incubation for 660 days no significant mineralization was observed for polyethylene or
polypropylene plastics or the same plastics amended with ECM additive. During 50 days of anaerobic
digestion, less than 2% of ECM additive containing plastics were converted to biogas (CH, + CO,). After
115 days of composting, only 0.6% of an ECM additive amended polypropylene was converted to carbon
dioxide. In all three tests more than 70% of the Positive control (cellulose) was converted to CO,. Two
figures from this manuscript are copied below (Figures 1 and 2).

In all three environments, the biodegradation of the positive control “plateaued” at around 70-75%
mineralization. Dr. Burnette states that this plateau is due to accumulation of byproducts that hinder
further mineralization of the cellulose or that the environmental conditions were no longer conducive to
biodegradation. However contrary to this it can be seen in the figures that some of the other materials,
(e.g., Plastarch, a corn starch polyester blend and PHA) continued to biodegrade well after cellulose
biodegradation had plateaued. They continued to degrade in a linear fashion to the end of the
experiment. Since the plastics are a small component of the material in the reactors, this indicates that
the environment was not inhibitory to the biodegradation process, but that the plateau occurred while
there was still an environment conducive to biodegradation (Figure 1 and 2).

ECM Comb. Mot. to Exclude Page 6 of 24
Exh. V


ECM Comb. Mot. to Exclude Resp. Mot to Compel and For Pegerdo of 12

Exh.
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of

ECM BioFilms, inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International

eee

COMPLAINT COUNSEL’S NOTICE OF RULE 3.33(c)(1) DEPOSITION

To: Elsevier Inc.
DEFINITIONS

A “Include” and “including” mean “without limitation,” or “<ncluding but not limited to,”
so as to avoid excluding any documents or information that might otherwise be construed
to be within the scope of any specification.

B. “Study” refers to Gomez, Eddie & Michel Jr., Frederick, 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,

Cc. “You” and “Your” means Elsevier Inc, (“Elsevier”) or (‘the Company”) along with any
affiliates, successors, predecessors, entities You acquired, entities You control, and
entities whose information You control.

INSTRUCTIONS

AL Protective Order: On October 22, 2013, the Coutt entered an order governing discovery
material in this matter. A copy of the Protective Order is attached hereto as Exhibit A
with instructions on the handling of confidential information.

B. Petitions to Limit or Quash: Pursuant to Commission Rule of Practice 3.34(c), any
motion to limit or quash this subpoena must be filed within ten days of service hereof.

DEPCSITION TOPIC

PLEASE TAKE NOTICE that Complaint Counsel will depose Elsevier, upon oral
examination, pursuant to Rules §§ 3.33(c)(1) and 3.34(a), as to the matters set forth below:

The Study, including, without limitation, its selection for publication, its editing, and the
peer-review process.

ECM Comb. Mot. to Exclude Page 3 of 5

Exh. L


VII. CONCLUSION

GLOSSARY

ECM Comb. Mot. to Exclude Page 3 of 56
Exh. X


J Polym Environ (2011) 19:637 676

655

D-lactides form stereoregular isotactic poly(L-lactide)
(PLLA) and poly(D-lactide)(PDLA), respectively. These
are semicrystalline polymers (crystallinity around 37%)
with a high melting point (Tm ~180 °C) and a glass
transition temperature in the 55 80 °C range. These types
of materials exhibit high tensile strength and low elonga-
tion, and consequently have a high modulus that makes
them more suitable for load-bearing applications such as in
orthopedic fixation and sutures [412, 426 428]. PLLA
finds a wide range of uses, from biomedical implantation
devices, e.g., sutures, rods, plates and pins, through artifi-
cial skin and drug delivery agents to environmentally
benign film and fibers for packaging and clothing [427,
428]. The meso- and DL-lactide, on the other hand, form
atactic poly(DL-lactide) (PDLLA) which is an amorphous
transparent material with a glass transition temperature of
50 + 60 °C. It can be used for the production of trans-
parent films and glues. This material has lower tensile
strength, higher elongation, and a much more rapid deg-
radation time, making it more attractive as a drug delivery
system [412]. The degradation time of PLLA is much
slower than that of DLPLA, requiring more than 2 years to
be completely absorbed. The presence of CH; side groups
impart a hydrophobic nature to PLLA. Copolymers of
L-lactide and DL-lactide have been prepared to disrupt the
crystallinity of L-lactide and accelerate the degradation
process. The methyl substituent’s steric shielding effect of
the ester group reduces the hydrolytic degradation rate of
PLLA on comparing with that of other polylactones [67].

Synthetic Methods of PLA

Lactic acid polymers are prepared by two quite different
ways: (1) polycondensation (condensation polymerization)
of lactic acids and (2) ring-opening polymerization of
lactides [429, 430]. Polycondensation method is relatively
simple and inexpensive, but it has several disadvantages.
Only low-molecular-weight polymers can be derived by
the direct condensation of the corresponding alpha-hydroxy
acids. The molecular weight, the molecular weight distri-
bution and the end groups are difficult to control and
syntheses of copolyesters with controlled sequences are
impossible. Therefore, high molecular weight PLA are
prepared by the ring-opening polymerization (ROP) of
lactides. The ROP of lactides can be induced by four dif-
ferent classes of initiators and reaction mechanisms [10,
412, 429 433).

(a) cationic polymerizations,

(b) anionic polymerizations,

(c) coordination-insertion mechanisms,
(d) enzymatic polymerizations.

(e) solid state polymerization.

ECM Comb. Mot. to Exclude
Exh. Z

Extremely strong acids or carbenium ion donors are
capable of initiating a cationic polymerization of lactides.
The cationic mechanism consists of a protonation or
alkylation of the carbonyl O-atom (exocyclic oxygen) with
the consequence of an electrophilic activation of the O-CH
bond. This bond is then cleaved by the nucleophilic attack
of another monomer, a process which is repeated in every
Propagation step until a monofunctional nucleophile (e.g.,
water) causes a termination step [431]. (Fig. 14). This
mechanism involves a nucleophilic substitution at the
chiral carbon, and it was found that optically pure poly(L-
lactide) can be prepared only at temperatures <50 °C.At
higher temperatures the cationic polymerization causes
more or less racemization, which dramatically changes the
physical and mechanical properties of the resulting poly-
lactide. Where as the cationic polymerization is rather slow
below 50 °C and only yields low to moderate molecular
weights, and thus, this polymerization method is not
attractive from the preparative point of view.

The anionic polymerization of lactides is initiated by
alkali metal alkoxides. At higher temperatures phenoxides
and carboxylates are also active. Both the initiation and the
Propagation step consist of a nucleophilic attack of an
anion onto the CO-group of the lactide, followed by the
cleavage of the CO O bond (Fig. 15). Therefore, the chain
growth proceeds via an alkoxide, which is so basic that is,
can also deprotonate the monomer in a-position. Due to the
planarity of the delocalized anion this deprotonation/
reprotonation reaction involves racemization. Hence,
racemization is an unavoidable side reaction of anionic
polymerization.

Coordination-insertion mechanism is based on metal
alkoxides having a covalent metal-oxygen bond and the
character of weak Lewis acids. The lactide plays tempo-
rarily the role of a ligand coordinated with the metal atom
via the carbonyl O-atom [432, 433] (Fig. 16). This coordi-
nation enhances the electrophilicity of the CO-group and
the nucleophilicity of OR-groups, so that an “insertion” of
the lactone into the metal O-bond may occur. Typical
initiators of this mechanism are the alkoxides of magne-
sium, aluminium, tin, zirconium, titanium and zinc. Another
advantage of the covalent initiators is the easy control of the
molecular weights via the monomer/initiator ratio. Fur-
thermore, the risk of side reactions is much lower compared
to ionic initiators so that much higher molecular weights
can be obtained. Moreover, the covalent nature of these
initiators significantly reduces the risk of racemization even
at high temperatures. This aspect is important for the
technical production of polylactides, because a final reac-
tion temperature around 190 200 °C is needed to extrude
the molten poly(L-lactide) from the reactor. In summary,
the coordination-insertion initiators are for preparative
purposes and far more useful than ionic initiators. The ring-

D Springer
Page 19 of 80


with its additives will biodegrade in five years or less (claimed half-life less than 2.5 years) in a
landfill is tantamount to a claim that these plastics will biodegrade faster than quickly
biodegrading food waste (half-life of 3.5 years from Table 2). In short, the claim that ECM

Plastics will biodegrade in five years in a landfill is clearly false.

b. ECM)’s Claims Are Not Supported By Competent and Reliable Scientific

Evidence

59. In addition to the claims of complete biodegradation in less than five years being

false, these claims are unsubstantiated by the testing provided by ECM. I reviewed the following

tests:
i. ECM)’s Primary Substantiation:

o The Environ Study: ECM-FTC-000069, “Anaerobic Biodegradation of
bioP VC” conducted by the laboratory Environ

o The ChemRisk/McLaren Assessment: ECM-FTC-000106, “Ecological
Assessment of ECM Plastic” conducted by the laboratory ChemRisk, as a
service of McLaren/Hart

ii. Composting Studies:

o O.W.S. Composting Study: ECM-FTC-000124 and ECM-FTC-000244, the
Final Report by O.W.S. Inc. of Biodegradation Testing, “Aerobic
Biodegradation Under Controlled Composting Conditions for 40-gal trash
bags,” Study PFR-5, Mar. 3, 2000;

iii. ASTM D5511 Reports:

oc Analytical Report No. N0946510-01 regarding “ASTM D 5511” Update
regarding ASTM D5511-11 Update on Clear Films 476 & 477 @ 45 days”

o Analytical Report No. 1150851 regarding “ASTM D 5511 Extension Testing”

co Analytical Report No. 1253020 regarding “ASTM D 5511: Determining
anaerobic biodegradation of plastic materials under high solids anaerobic
digestion conditions”

24
ECM Comb. Mot. to Exclude Page 24 of 56

Exh. X


CERTIFICATE OF SERVICE

Thereby certify that on May 21, 2014, I caused a true and correct co

document to be served by email to Counsel for the Respondent.

Jonathan W. Emord
Emord & Associates, P.C.
11808 Wolf Run Lane
Clifton, VA 20124

Email: jemord@emord.com

Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: Jcaputo@emord.com
Dated: May 21, 2014

ECM Comb. Mot. to Exclude

Exh. L

Peter Arhangelsky

Emord & Associates, P.C,
32108. Gilbert Road, Suite 4
Chandler, AZ, 85286

Email: parhangelsky@emord.com

gohnson3 @ftc. gov)
‘ohen (jcohen2@fitc.gov)
ElisaJillson (ejillson@fitc.gov)

‘éderal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

py of the foregoing

Page 5 of 5



inoculum of anaerobic bacteria that typically appear in landfills. The sample is then incubated in
a warm (mesophilic) environment for 60 days.

52. At the end of the 60-day period, the researcher measures the volume of methane
gas that can be attributed to the refuse, because methane is a byproduct of anaerobic
decomposition. By measuring the gas generated during decomposition, the rate of
decomposition can be determined. This data are typically used to calculate the ultimate methane
yield of a sample (i.e., Lo) and thus providing information necessary for the calculation of a
waste decay constant (k), which measures the half-life (i.e., how long it takes for half of the
material to degrade). It is noted that even the BMP gas generation value is referred to as ultimate
methane yield. Meaning the maximum amount of methane generation under optimal conditions.
Often, in landfill environment methane is generated at a lower rate and/or volume than the BMP
predicts.

53. Other measures can provide evidence of degradation but are not themselves
sufficient to establish biodegradation. For example, mass reduction can be evidence of
degradation, but does not definitively establish biodegradation, because mass reduction can
result from mechanical changes unrelated to biodegradation (e.g., disintegration, evaporation or
dissolution).

54. Changing these experimental parameters—even by a smal] amount—drastically
impacts experimental outcomes and conclusions. For example, introducing even a small amount
of oxygen will change a landfill simulation (anaerobic environment) into a compost test (aerobic
environment). Increasing the moisture can change a typical landfill simulation to a bioreactor
simulation. Increasing the temperature will cause activity by different bacterial communities,

i.e., thermophilic bacteria rather than the mesophilic bacteria that dominate dry tomb landfill

N
v

ECM Comb. Mot. to Exclude Page 22 of 56
Exh. X


2
s

3

2
Ey

O PIA
 AT0B30
© 8/0#3009
A A50B50
> A80B20
mi A30870

wos
sss

Weight Loss, wt%
bs
8

0 5 10 15 20 25 30 35
Degradation time, day

FIG, 12

In connection with FIG. 12, Dr. McCarthy wrote as follows:

The compost degradation testing results of the two polymers and their blends are
reported in FIG. 12. After degradation for 20 days, BIONOLLE#3000 degraded
almost 40%, while polylactic acid degraded only about 3%, by loss in weight. For
blends with 70 to 20% BIONOLLE#3000, the degradation percentage was much
greater (and the rate much faster) than that of polylactic acid, e.g., after 20 days, the
A30B70, ASOBS0, and A70B30 blends degraded about 35%, 25% and 15%,
respectively, by loss in weight. FIG. 12 shows that polylactic acid biodegrades in
compost, but slowly, and the addition of even 20% by weight BIONOLLE#3000

increases this biodegradation rate dramatically.

-The importance of the compost biodegradation curves shown in FIG. 12 is that a

specific blend can now be designed such that this blend would have a certain net

degradation in a given number of days in a composting environment.

As can be seen from the above, Dr. McCarthy asserts that a weight loss of 3% after 20 days

was sufficient to identify polylactic acid as a material that “biodegrades in compost.” Dr.
McCarthy also wrote that 20 days of testing for blends A30B70, ASOB50 and A70B30, with
degradation levels well below 100% (specifically, 35%, 25% and 15%) was nonetheless

sufficient to identify them as biodegradable. Once again, the position that he took under oath

ECM Comb. Mot. to Exclude
Exh. W

Page 12 of 20

Page 12 of 20


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Dr. McCarthy Rebuttal Report -- 7

J. Mol. Sci. Vol. 10, 3722-3742, at 3735 (“PE cannot be easily degraded with microorganisms,
However, it was reported that lower molecular weight PE oligomer (MW= 600-800) was
partially degraded . . . while high molecular weight PE could not be degraded.”). The only way
to reduce PE to this molecular weight is through a pro-oxidant (not ECM technology) or
exposure to other oxidative degradation environment. See for example Tokiwa, discussing
blends of PE with starch, which enhances the auto-oxidation, but concludes “despite all these
attempts to enhance the biodegradation of PE blends, the biodegradability with microorganisms
on the PE part of the blends is still very low”; Shah, discussing attempts to make traditional
polyolefins that are “non-susceptible to degradation by microorganisms” into ones that are
biodegradable and concluding that polyethylene can only be degraded following
“photodegradation and/or chemical degradation.” While this technology does result in an
increase in aerobic biodegradation, the lack of oxygen in landfills would be problematic for such
a mechanism.

13. ECM’s technology likely does not pertain to low-molecular weight PE for another
reason: such low-molecular weight plastics would serve few commercial applications. Plastics
at this low molecular weight would have the consistency of wax. It is extremely unlikely that
ECM is confining its technology to these low-molecular weight plastics— these are not the
plastics possessing the mechanical characteristics that ECM’s customers would be
manufacturing.

14. Therefore, whether this small subset of plastics are susceptible to biodegradation with or

without the ECM additive is not the starting point of the analysis.

ECM Comb. Mot. to Exclude Page 7 of 12
Exh. CC


PUBLIC DOCUMENT

Lowell. Complaint Counsel’s concealment of Dr. Michel as an expert witness, in violation of
Rule 3.31A and the Scheduling Order, is an act of deception, deliberately calculated to prejudice
ECM. Complaint Counsel deceived ECM into thinking Dr. Michel would not testify in this
matter as a fact or expert witness, even going so far as to procure a stipulation from ECM that
ECM would admit certain documents offered by Dr. Michel on the assumption that he was not
providing testimony. In addition, Dr. Michel’s role in this case has been controversial since at
least March 2014, when this Court sanctioned Complaint Counsel for failing to disclose Dr.
Michel’s material in response to ECM’s discovery requests. See March 21, 2014 Order, Dkt. No.
9358. Complaint Counsel’s present further act of concealment is thus part of a pattern, one not
only in violation of Rule 3.31A and the Revised Scheduling Order but also in contumacious
disregard of this Court’s prior sanctions decision. See Order Granting in Part and Denying in
Part Respondent’s Motion for Sanctions (March 21, 2014) (Exh. P). After the decision to
sanction Complaint Counsel, one would have expected circumspection and conscientious effort
to ensure timely disclosures required under the rules. The present act of concealment reveals that
the prior Order had no such effect and that a more potent sanction is now warranted.

Given the remaining schedule in this case and prior limits on access to correspondence
between Dr. Michel and FTC and Dr. Michel and companies in competition with ECM, ECM
lacks adequate time and opportunity to vet fully Dr. Michel, a witness Complaint Counsel led
ECM to believe would not be called to testify in this case. The content of the Dr. Michel rebuttal
report additionally reveals it to be incompetent under Rule 3.31A (it does little more than vouch
for Complaint Counsel’s other scientific experts and thus does not present a true rebuttal opinion
under the rule). ECM has been deprived of opportunities to pursue discovery earlier in this case

which, had ECM known Dr. Michel would testify as an expert, it would have pursued with vigor.


600 Pennsylvania Avenue, NW
Mail stop M-8102B
Washington, DC 20580

Direct Dial: (202) 326-2185
Fax: (202) 326-2558

Email: klohnson3@ftc.gov
From: Peter Arhangelsky [mailto:PArhangelsky@emord.com’

Sent: Wednesday, April 23, 2014 5:10 PM

To: Johnson, Katherine

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Scheduling Depositions

Hi Katherine,

The May 6th date is unavailable. You already noticed the deposition for Kappus Plastics on May 6th
in New York. We therefore object to a deposition scheduled on that same day in South Carolina.

Best,

Peter A. Arhangelsky, Esq. | Emorp & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ
85286
Firm: (602) 388-8899 | Direct: {602} 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for ihe recipient listed above. The content of this
communication is protected from disclosure by the attorney-client privilege and the work product doctrine. If
you are not the intended recipient, you should treat this communication as strictly confidential and provide it fo
the person intended. Duplication or distribution of this communication is prohibited by the sender. If this
communication has been sent to you in error, please notify the sender and then immediately destroy the
document.

From: Johnson, Katherine [mailto:kiohnson3 @ftc.gov]

Sent: Wednesday, April 23, 2014 2:02 PM

To: Peter Arhangelsky; Lou Caputo; Jonathan Emord

Ce: Cohen, Jonathan; Jillson, Elisa; Decastro, Arturo; Millard, Joshua S.
Subject: Scheduling Depositions

Peter:

Pursuant to Scheduling Order paragraph 13, we are consulting regarding scheduling of additional

depositions. We will be noticing the deposition of D&W in Greenville, SC for May 6". Please advise
immediately if this date is unavailable.

Katherine

Katherine E. Johnson, Attorney
Division of Enforcement
Bureau of Consumer Protection
Federal Trade Commission

ECM Comb. Mot. to Exclude Page 8 of 9
Exh. H


58.

59.

60.

61.

62.

Dated: January 17, 2014

ECM Comb. Mot. to Exclude

Exh. A

Keith Christman or Representative of American Chemistry Council
Karen Schmidt

Assistant General Counsel

American Chemistry Council

1300 Wilson Boulevard

Arlington, VA 22209

Proposed Testimony: We anticipate that this witness will testify regarding consumer
perception of biodegradability claims.

Representative of Synovate (acquired by Ipsos)

Proposed Testimony: We anticipate that this witness will testify regarding consumer
perception of biodegradability claims.

John Aiken, Investigator, Federal Trade Commission

Complaint Counsel

Proposed Testimony: Authentication of exhibits.

William Burton, Investigator, Federal Trade Commission (retired)
Complaint Counsel

Proposed Testimony: Authentication of exhibits.

Representative of The National Advertising Division of the Council of Better Business
Bureaus, Inc.

Proposed Testimony: We anticipate that this witness will testify regarding complaints
and challenges filed against ECM or customers of ECM; any investigation and outcomes
of those complaints and challenges, including any analysis of ECM’s substantiation
materials; resulting case reports; and authentication of exhibits.

ohnson (kjohnson3 @ftc.gov)
fan Cohen (jcohen2 @fic.gov)

isa Jillson (ejillson@fic.gov)

Federal Trade Commission

600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580

Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

10

Page 10 of 11



Peter Arhangels ky _

= —
From: Johnson, Katherine <kjohnson3@ftc.gov>

Sent: Friday, April 11, 2014 10:48 AM

To: Peter Arhangelsky

Ce: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: RE: Docket 9358 - 041014 Second Revised Scheduling Order

Peter, we don’t have any objection to moving the pre-trial conference to another date, but it doesn’t seem pragmatic to
move it to the day before the evidentiary hearing (and I’m not sure the ALJ would approve it). Is there really no other
date, e.g., 1* or the 30"? We would agree that both parties could file final stipulations on the 29", if the 30" would
work for the pre-trial.

Katherine E. Johnson, Attorney

Division of Enforcement

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Mail stop M-8102B

Washington, DC 20580

Direct Dial: (202) 326-2185

Fax: (202) 326-2558

Email: kiohnson3@ftc.gov

From: Peter Arhangelsky [mailto:PArhangelsky@emord.com]
Sent: Friday, April 11, 2014 1:32 PM

To: Johnson, Katherine

Cc: Cohen, Jonathan; Jillson, Elisa; Lou Caputo; Jonathan Emord
Subject: FW: Docket 9358 - 041014 Second Revised Scheduling Order

Katherine,

Under the Second Revised Scheduling Order issued yesterday, we have a calendaring conflict for the July 31, 2014
Pretrial Conference date. We are scheduled to appear in Salt Lake City for a hearing in the U.S. District Court for the
District of Utah on that same day. Given our travel schedules, the next date we are available is Monday, August

4th. Please let us know if you agree to moving the prehearing conference from July 31 to August 4. If you are in
agreement, we would prepare a joint motion to continue the pretrial conference date to August 4. | am available this
afternoon to speak about this if needed.

Thanks,
Peter

Peter A. Arhangelsky, Esq. | EmMorD & Associates, P.C. | 3210S. Gilbert Rd., Ste 4 | Chandler, AZ 85286
Firm: (602) 388-8899 | Direct: (602) 334-4416 | Facsimile: (602) 393-4361 | www.emord.com

NOTICE: This is a confidential communication intended for the recipient listed cbove. The content of this communication is protected from
disclosure by the attomey-client privilege and the work product docirine. If you are not the intended recipient, you should ireat this
communication as strictly confidential and provide it to the person intended, Dupication or distribution of this communication is prohibited
by the sender. If this communication has been sent to you in error, please notify the sender and then immediately destroy the document.

ECM Comb. Mot. to Exclude Page 1 of 2
Exh. BB


ox aromatic diacids and diols. ‘The polyester component forms a
continuous or co-continuous’ phase in the biodegradable blends of

the invention,

Restriction Requirement

Applicants hereby affirm the election of Group I,

claims 1 to 9 and 21 to 22. This election is made with traversal
of the restriction requirement for the following reasons.

Applicants respectfully submit that with respect to at
least Group II, claim 10, there would be no serious additional
burden on the Examiner to include this claim in her search.
M.P.E.P. at section 803 provides, "If the search and examination
of an entire application can be made without serious burden, the
examiner must examine it on the merits, even though it includes
claims to distinct or independent inventions."

With respect to the claims of Groups I and iT,
applicants submit that the addition of a compatibilizer (Group
II) to the constituents of the bicdegradable blend (Group I) does
not impose a serious additional search burden on the Examiner.
Purthermore, the compositions in the already cited prior art of
Sinclair ‘050, Sinclair ‘642, and Kakizawa are all three
component polymer blends. The search already conducted therefore
presently encompasses three component blends. Accordingly,
applicants respectfully request reconsideration and withdrawal of
the restriction requirement between Group I and Group IT, which

includes only a single claim, claim 10.

ECM Comb. Mot. to Exclude

Exh. Z

Page 54 of 80


ECM Biofilms, No. 9358
Stephen P. McCarthy, Ph.D. - Page 6

c ECM Plastics will completely break down and return to nature (i.e., decompose
into elements found in nature) in most landfills within one to five years.

d. ECM Plastics will completely break down and return to nature (i.e., decompose
into elements found in nature) in any disposal environment at an appreciably
faster rate and extent than conventional plastics without the ECM Additive.

e. Various scientific tests, including but not limited to ASTM D5511, have shown
that ECM Plastics perform as indicated in (a)-(d) above.

15. Complaint Counsel provided me with materials, including published and
unpublished study reports, protocols, data, and data analysis. These materials fall into one of
two broad categories:

a. Tests and other materials ECM submitted to the FTC during the pre-complaint

investigation and litigation in this matter (“ECM Materials”);” and

? The ECM Materials include:

(1) Anaerobic Biodegradation of bioPVC; Analytical Report No. 1150851 regarding
“ASTM D 5511 Extension Testing;

(2) Analytical Report No. 1253020 regarding ASTM D 5511: Determining anaerobic
biodegradation of plastic materials under high solids anaerobic digestion conditions;

(3) Analytical Report No. 946510-01 regarding ASTM D 5511;

(4) Analytical Report No. N0946510-01 regarding ASTM D 5511;

(S) Update regarding ASTM D5511-11 Update on Clear Films 476 & 477 @ 45 days;

(6) Biopolymers and additived [sic] plastics: biodegradability, degradability and
compostability. Basic concepts, comparisons and legislation: The case of ECM
MasterBatch Pellets additive;

(7) Ecological Assessment of ECM Plastic;

(8) Final Report: Biodegradation Testing, Aerobic Biodegradation Under Controlled
Composting Conditions for 40-gal trash bags”;

(9) Report about biodegradability of a plastic artefact (full coffee capsule) produced with
a compound containing Polypropylene and a biodegradability adjuvant addictive
(ECM MasteBatch Pellets) for 1% of its total weight;

(10) SEM Examination of ECM Plastic;

(11) SEM imaging of bubble wrap;

(12) SEM imaging of EPS samples; SEM imaging of green PET bottles;

(13) SEM imaging of PVC samples; and

(14) _ Time Elapse Photographs of the ECM MasterBatch Pellets Formula in 5-Mil Cast
LLDPE Film on Tryptic Soy Agar Plates.

ECM Comb. Mot. to Exclude Page 6 of 58
Exh. U


ECM Comb. Mot. to Exclude Resp. Mot to Compel and For SeRaige 5 of 12

Exh. RX-C-1
Exh. N CONFIDENTIAL - SUBJECT TO PROTECTIVE ORDER


iv. Other Reports and Tests:

o The Ecologica Report: ECM-FTC-000226, “Report about biodegradability of
a plastic artefact [sic] . . .” by Ecologia Applicata srl., Cert No.
130/bio/180/10, Nov. 19, 2010

© Additional Biodegradation Tests of ECM Plastic
(See Appendix A)

60. Each test suffers from faulty assumptions, poor methodology, and/or employs
conditions inconsistent with typical landfills. Because of this, no test that ECM provided is
competent and reliable scientific evidence to establish biodegradability, let alone
biodegradability in a landfill.

i. ECM’s Primary Substantiation

61. | My understanding is the ECM has particularly relied on the results of two studies:
the “Environ Study” and the “ChemRisk/McLaren Assessment.” Neither of these highly flawed
studies is competent and reliable evidence to support ECM’s claims, for the reasons discussed
below.

o Environ Study

62. The “Environ Study” (“Anaerobic Biodegradation of bioP VC,” ECM-FTC-
000069, conducted by the laboratory Environ) purports to provide data on the biodegradability of
BioPVC (a type of plastic called polyvinylchloride (PVC) amended with the ECM additive).
The Environ Study purports to show 2.6% biodegradation. The study design states it followed
recommendations in ASTM D5526, “Standard Test Method for Determining Anaerobic
Biodegradation of Plastic Materials Under Accelerated Landfill Conditions.” The moisture
content under the test was 62% (adjusted using landfill leachate); pH 8.0; temperature 40°C; and

cellulose was used as a positive control.

25

ECM Comb. Mot. to Exclude Page 25 of 56
Exh. X


PUBLIC DOCUMENT

CERTIFICATE OF SERVICE

Thereby certify that on May 5, 2014, I caused a true and correct copy of the foregoing
document to be served as follows:

One hard copy original and one courtesy copy to the Office of the Secretary:

Donald S. Clark, Secretary

Federal Trade Commission

600 Pennsylvania Ave., NW, Room H-159
Washington, DC 20580

Email: secretarv@ftc.gov

One electronic and one paper courtesy copy to the Office of the Administrative Law Ji udge:

The Honorable D. Michael Chappell
Administrative Law Judge

600 Pennsylvania Ave., NW, Room H-110
Washington, DC 20580

One electronic copy to Counsel for the Respondent:

Jonathan W. Emord Peter Arhangelsky

Emord & Associates, P.C. Emord & Associates, P.C.

11808 Wolf Run Lane 3210 S. Gilbert Road, Suite 4
Clifton, VA 20124 Chandler, AZ 85286

Email: jemord@emord.com Email: parhangelsky@emord.com
Lou Caputo

Emord & Associates, P.C.
3210 S. Gilbert Road, Suite 4
Chandler, AZ 85286

Email: leaputo@emord.com

I further certify that I possess a paper copy of the signed original of the foregoing
document that is available for review by the parties and the adjudicator.

Date: May 5, 2014 /s/ Katherine Johnson
Katherine Johnson (kjohnson3@ftc.gov)
Jonathan Cohen (jcohen2@ftc.gov)
Elisa Jillson (ejillson@ftc.gov)
Federal Trade Commission
600 Pennsylvania Ave., N.W. M-8102B
Washington, DC 20580
Phone: 202-326-2185; -2551; -3001
Fax: 202-326-2551

ECM Comb. Mot. to Exclude Page 5 of 5

Exh. I


UNITED STATES OF AMERICA
BEFORE THE FEDERAL TRADE COMMISSION

In the Matter of

ECM BioFilms, Inc., Docket No. 9358
a corporation, also d/b/a

Enviroplastics International

eee

COMPLAINT COUNSEL’S EXPERT WITNESS LIST

Pursuant to the Court’s Scheduling Order issued November 21, 2013 (“Scheduling
Order”), Complaint Counsel hereby identifies those experts whom Complaint Counsel may call
to testify in Complaint Counsel’s case-in-chief or in rebuttal at the hearing on this matter. This

list is based upon the information reasonably available to Complaint Counsel at this time.

1. Stephen McCarthy, PhD
Distinguished University Professor
Director and Professor
M2D2 and Plastics Engineering
University of Massachusetts Lowell
One University Avenue, Office: Ball 207
Lowell, MA 01854

Dr. McCarthy’s anticipated testimony will be described in his expert report, which will
be produced to Respondent by the date set forth in the Scheduling Order. The general
subject matter of this testimony includes, but is not limited to, biodegradation generally,
biodegradation of plastic polymers, ASTM tests and standards, and evaluation and
analysis of Respondent’s substantiation for its biodegradability claims.

2. Thabet Tolaymet, PhD
Environmental Protection Agency
Acting Associate, National Program Director for Emerging Materials and Sustainability
National Risk Management Research Laboratory
26 Martin Luther King Drive
Cincinnati, OH 45268

Dr. Tolaymet’s anticipated testimony will be described in his expert report, which will be
produced to Respondent by the date set forth in the Scheduling Order. The general
subject matter of this testimony includes, but is not limited to, biodegradation generally,
biodegradation of municipal solid waste generally, conditions in municipal solid waste
landfills and bioreactors, and evaluation and analysis of Respondent’s substantiation for
its biodegradability claims.

ECM Comb. Mot. to Exclude Page 1 of 3
Exh. B


EF Gémez, FC. Michel Jr. / Polymer Degradation and Stability 98 (2013) 2583 2591 2587

The AD assays were conducted in 2 (working volume)
laboratory scale batch reactors. Temperatures were maintained at a
mesophilic (37 + 1 °C) range by means of incubators. Test speci
mens (25 g of sample carbon) were mixed with 750 g wet of
methanogenically active sludge obtained in October of 2010 from a
full scale (3000 m*) anaerobic digester located at the City of Akron
wastewater treatment plant and operated by KB Compost Services,
Akron, Ohio {28}. This was mixed with 187.5 g wet of the organic
fraction of municipal solid waste (OFMSW) of the Medina County,
Ohio Solid Waste District to achieve the desired solids content for
the test and to provide supplemental nutrients for the anaerobic
microbial consortia. The chemicat properties of the seed sludge and
OFMSW substrate are shown in T:ble 4. Ammonium phosphate
(Fisher Scientific, PA, U.S.) was added to the mixture to adjust the
C:N ratio to a value of 20:1 considering the carbon content of the
test specimen.

The volumetric production and CO2 and CH, content of the
biogas produced in the AD experiments were analyzed by volume
placement and gas chromatography as described by Gémez et al.
122], respectively. This information was used to calculate the moles
of carbon emitted from each reactor.

2.5. Analytical methods

Solids content in soil, organic substrates and test specimens was
determined by drying samples to a constant weight at 80 °C. The
volatile solids content was determined using an ashing oven set at
500 °C for 4 h. pH was determined using a pH electrode (TMECC
04.11 A 1:5 slurry method, mass basis). Carbon (TMECC 04.01 A
combustion with CO2 detection) and nitrogen content (TMECC
04.02 D oxidation, Dumas method) were determined by the Ser
vice Testing and Research laboratory at the OARDC.

Selected test specimens were also analyzed before and after soil
incubation using scanning electron microscopy (SEM) (Hitachi $
3500N, Hitachi High Technologies America, Inc., CA, U.S.). Samples
were coated with platinum to a thickness of 0.2 kA° using a
Hummer® 6.2 sputtering system (Anatech USA, CA, US.). A 15 Kv
electron beam was applied.

2.6, Statistical analysis

‘Three independent replicates were used for each treatment.
Analysis of variance (ANOVA) was calculated for the average final
cumulative percent of carbon loss for each of the studies. Com
parisons for ail pairs of final cumulative biodegradation means
were performed using Tukey—Kramer HSD analysis. All conclusions
were based on a significant difference level of « 0.05. The sta
tistical analyses were performed using JMP statistical program
version 9 (SAS Institute Inc., SAS Campus Drive, NC, U.S.).

3. Results and discussion
3.1. Biodegradation during soil incubation

The importance of understanding the biodegradability of plas
tics in soil has increased since these are released inadvertently into
the environment where they may persist. Plastics comprise a
relatively large fraction of the ubiquitous pollution found world
wide in both land and ocean environments [29]. In addition,
intensive and semi intensive agriculture utilizes large quantities of
these materials annually in the form of mulches, as plantable pots,
nursery containers [30].This has resulted in the recent develop
ment of biodegradable agricultural plastics for these applications
[31.52]. One example of this is biodegradable plant nursery pots.
Some containers are designed to be plantable pots (e.g. rice hull and

ECM Comb. Mot. to Exclude
Exh. AA

coconut coir) allowing them to degrade in the soil after planting, or
to be composted at plant nurseries rather than being landfilled.

An initial experiment was conducted to assess the effect of
particle size on biodegradation during soil incubation. Seven ma
terials were tested and the amount of carbon converted to CO2 was
compared using student’s f method for particle size effect. Student's
t method revealed that out of the seven materials studied in this
experiment, only one, aco polyester + corn based plastic, showed
a significant effect of particle size on biodegradability. A signifi
cantly greater extent of biodegradation was observed for co
polyester + corn based plastic in 1 x 1 cm square film form
(55.1 + 2.1%) after 660 days as compared to a ground sample of the
same material (39.71 + 2.4%). For the rest of the materials, there
was not a significant effect of particle size on biodegradation. Re
sults from this study suggested that for most of the materials
studied, biodegradability in soil was not greatly affected by particle
size under the experimental conditions used in the study.

Asecond soil experiment was conducted to evaluate the relative
biodegradability of thirteen different test specimens in 1 x 1 cm
square film form. These included bio based plastics, plastics
amended with additives that are meant to enhance biodegrad
ability and natural fiber composites. The experiment was con
ducted for a period of 660 days. The initial moisture content of the
mixes was 16.6 + 2.1% and the final mean soil moisture content ona
wet weight basis across all treatments was 14.3 + 3.3% (wet
weight basis) which is 84.9 + 2.4% of the 60% moisture holding
capacity of the soil mixture. The positive control (cellulose paper)
exhibited 74.2 + 4.5% conversion during the period of incubation.

For some bio based plastics and the positive controls (cellulose
paper), the initial rate of mineralization was rapid (Fig. 1). Most of
the mineralization took place during the first 300 days of incuba
tion (Fis. 1). The most rapid initial rate of conversion was observed
for co polyester + corn based plastic with almost 346 + 2.4%
mineralized during the first 55 days of the experiment. The extent
of PHA biodegradation was initially lower, but its extent surpassed
that of co polyester + corn based plastic after approximately 280
days reaching a value of 48.5 + 4.6%. For the wheat starch derived
plastic and plastarch conversion rates were 14.2 + 0.8 and
24.46 + 1.4% after 110 and 280 days of experiment, respectively.

Final (660 days) cumulative biodegradation values during soil
incubation for the positive control, PHA and co polyester + corn
based plastic were 74.2 + 4.5, 69.2 + 6.4 and 55.1 + 6.1%, respec
tively. For the wheat starch derived plastic and plastarch the final
conversion reached 19.7 + 1.1 and 31.3 + 1.7%, respectively.

SEM images of PHA and co polyester + corn based plastic
before and after mineralization showed substantial changes in the

400
oral

at reper
Sem cinpetieses + cothmd peline
See Wheat uarch.ckeved ean

ee | og vE- Ira saduare

i
i
&

ae

an. 70 oo

300
Tame (aps)

Fig. 1. Cumulative carbon loss (CO, C) as percentage of initial carbon (cumulative
standard error) for bio-based plastics and for conventional plastics amended with
additives during 660 days of soil incubation. For some data points standard error bars
are smaller than markers.

Page 5 of 9