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PRODUCTS SUBMITTED FOR ENVIRONMENTAL TESTING IN CONTROLLED CONDITIONS
ADDITIVE "X" TREATED PRODUCTS USED BY BIOGREEN PRODUCTS Inc.,
ENVIRONMENTAL TESTSADDITIVE "X" TREATED PRODUCTS USED BY BIOGREEN PRODUCTS Inc.,
Ecological Assessment
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TABLE OF CONTENTS
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1.0 INTRODUCTION ......................................................................................... 1
2.0 BIODEGRADATION TESTS..........................................................................2
2.1 SHORT-TERM AEROBIC BIODEGRADATION (composting).................. 2
2.2 LONG-TERM AEROBIC BIODEGRADATION..........................................4
2.3 ANAEROBIC BIODEGRADATION (microbiodegradation)...........................6
3.0 CHEMICAL ANALYSIS OF END PRODUCT .............................................7
4.0 TOXICITY TEST..............................................................................................8
4.1 PLANT GROWTH ...........................................................................................9
4.1.1 SUMMER BARLEY TEST...........................................................................9
4.1.2 CRESS TEST.................................................................................................10
4.2 EARTHWORM ACUTE TOXICITY TEST.................................................. 11
4.3 DAPHNIA ACUTE TOXICITY TEST............................................................12
5.0 SUMMARY AND CONCLUSIONS...............................................................14
6.0 LETTER TO FDA from Additive "X" manufacturer
7.0 CERTIFICATION OF ADDITIVE "X"
INTRODUCTION:
During the past 25 years, plastic materials have gained widespread use in the food, clothing, shelter, transportation, construction, medical and leisure industries. Plastics offer a number of advantages over alternative materials – they are lightweight, extremely durable, and relatively unbreakable. However, plastic materials also have several disadvantages, one of the largest being that plastic does not break down in the environment. Materials such as wood and paper are subject to breakdown from microorganisms (biodegradation). Plastics are composed of petroleum-based materials called resins (e.g., polyethylene, polypropylene) – materials that are resistant to biodegradation and because of this resistance, plastics that are disposed of in landfills will remain in their original form in perpetuity. Every year, large volumes of plastics are disposed of in U. S. landfills – in 1995 alone, an estimated 20 million tons of plastic products were disposed of in landfills.
TYPES OF BIODEGRADABLE PLASTIC
1) Starch based plastics:
These are 'compostable' plastics made from various food substances and they compostable because they will completely biodegrade within 4 months in a commercial composting plant. Please be aware that they do not decompose in a home composting facility because elevated heat is required to compost them. PLA is the best known type. The largest manufacturer of starch based plastic is reported as saying that they will create methane if placed into the anaerobic zone of landfills. This kind of plastic is best suited for composting in commercial composting facilities where food and garden waste are composted but undesirable in landfills.
2) Oxo-biodegradable conventional plastics:
These are conventional plastics with an additive added to them that cause them to biodegrade. They require a two part process to biodegrade, all parts of which must occur in the open air or in soil that is aerated . The first half of the process requires either heat, UV light or mechanical stress. The second part of the process occurs when bacteria consume the partly decomposed plastic. This type of plastic is best suited where littering is the primary concern. Important to note that this type of plastic cannot be composted and there is no ecological advantage when placed in landfills.
3) Microbiodegradable conventional plastics:
These are conventional plastics to which a special additive has been added causing them to biodegrade naturally. This additive works only in soil that has naturally occurring micro organisms. It will biodegrade without the need for oxygen, UV light, heat or mechanical stress. In an oxygenated environment it decomposes into humus, carbon dioxide, and water. In an oxygen deprived atmosphere it decomposes into humus, methane and water. This kind of plastic is not recommended for composting because it takes somewhat longer to biodegrade than the typical commercial composting cycle, but it is excellent for disposal in landfills.
In order to produce plastics that degrade in a landfill setting another scientific approach was necessary. Company Y has developed an alternative method for creating microbiodegradable plastics. This method involves a proprietary combination of organic and inorganic chemical materials which have been mixed in a very precise formulation and compounded into a reactor-grade master batch pellet. When this pellet is compounded with any polyethylene or polypropylene resin, the resulting plastic is biodegradable. The biodegradation of X-treated plastic occurs through aerobic (oxygen dependant) and anaerobic (dependent on the absence of oxygen) pathways. Micro organisms consume the plastic, assimilating the material for cellular processes and producing a mixture of metabolic products (principally methane, carbon dioxide, and water).
PLASTICS SYNTHESIZED
The C process may be utilized in the manufacture of bags, agricultural film, landscape netting, diaper liners, and numerous other products. The viability of C-treated plastic as an environmentally safe, biodegradable product was evaluated by conducting standard tests on X pellets and plastic film which were created using the X process. Biodegradation tests were conducted to determine the susceptibility of the products to biodegradation. In addition, chemical analyses and standard plant and animal toxicity tests were conducted on the end product of the biodegradation process to determine the safety of the product. The results of these tests are discussed below.
2.0 BIODEGRADATION TESTS
Laboratory testing is a common method used to determine the susceptibility of compounds to biodegradation. Testing methods have been developed and standardized by several organizations including the American Society of Testing Materials (ASTM), Organization for Economic Cooperation and Development (OECD), and European Standards Organization (CEN). The method employed by the various tests involves adding a small amount of test compound (in this case, X pellets or plastic film) to a large amount of a material called inoculum (a highly active substance used to grow microorganisms).
The test is run at the same time using a reference compound that is known to be biodegradable, also added to inoculum. Biodegradation can be evaluated by measuring the amount of methane and carbon dioxide produced. Using this result, the percentage of sample that has biodegraded is calculated as the percentage of solid carbon of the sample that has been converted to gaseous, mineral carbon. If the results from the test and reference materials are similar, the test material has biodegradable properties.
2.1 SHORT TERM AEROBIC BIODEGRADATION (Composting)
Refuse that is composted degrades under aerobic conditions. The susceptibility of X-treated plastic to biodegradation under aerobic conditions was evaluated using the controlled composting biodegradation test (ASTM method D.5338.92). This test is conducted under optimum oxygen, Ecological Assessment of February 16, 1999 X Plastic temperature, and moisture conditions, simulating an intensive aerobic composting process. The test was conducted on plastic films (the base compound from which plastic bags are manufactured) composed of 50% X and 50% resin.
Cellulose (the main constituent of plant tissues and fiber) was used as the reference material. The test or reference compound was added to an inoculum consisting of mature compost. Mixtures were placed in test vessels and intensively composted for 60 days. At the end of the test, the carbon dioxide production rate and the cumulative carbon dioxide production were measured. The percentage of biodegradation was calculated using this information.
The cellulose degraded quickly (Figure 1), especially within the first 10 days of the test. By the end of the test, essentially all the cellulose had degraded. The 50% X film did not degrade as completely or as quickly as the cellulose. At the end of the test, 19% of the film had degraded. Cellulose is a completely biogenic material that degrades quickly. Since the composition of the 50% X film is half resin (a material that does not degrade on its own), biodegradation of this material should take much longer than degradation of biological materials. Plastics that contain a lower percentage of X (e.g., 5% X film) will degrade more slowly than the 50% X film.
The results of the aerobic degradation tests indicate that, in time, plastics produced using X-pellets will biodegrade in aerobic conditions.(oxygen & UV light are a prerequisite).
2.2 LONG TERM AEROBIC BIODEGRADATION
The long-term susceptibility of X pellets and films to biodegradation under aerobic conditions was evaluated using tests for determining resistance of plastics to fungi (ASTM G.21) and bacteria (ASTM G.22 ). These tests measure the degradation of plastics due to fungi and bacteria – they are usually used to prove the resistance of plastics to these organisms but can be used to prove susceptibility.
X pellets and 5% Xfilm were placed onto petri dishes (small, flat containers) coated with a growth medium called agar, which were then placed into an incubator. In addition to the X microorganisms in the plastic, opportunistic microorganisms were introduced to test materials through non-sterile handling and from the room air. Petri dishes were periodically removed and test materials were observed for signs of microbial growth and sample appearance (disintegration of test material). The test duration was 22 months.
During the test, the plastics displayed evidence of attack by microorganisms. All of the petri dishes began to show microbial growth between day 5 and day 9 of the test. After 11 months of incubation, the film samples showed heavy cracking and separation and the X pellets showed significant reduction in size and disintegration of the pellet form. After 19 months of incubation, the microbial growth appeared to diminish. At this time, the film and X pellet samples were no longer distinguishable as discrete pieces and were easily crushed.
The results of the aerobic tests indicate that both X pellets and X film will eventually biodegrade in an aerobic environment. The process of aerobic degradation for these substances takes time. Within 2 years, X pellets or film disposed of in a compost situation should be completely degraded. Since it is generally recommended that materials used in composting degrade within 90 days, it would appear that X treated plastics are not ideally suited for composting.
Ecological Assessment of February 16, 1999 X Plastic Figure 2. 5% X Film, Day 1 and Day 672 (Laboratory Video, Y Research) LLDPE cast film strips totally degraded. Tests conducted from 1/6/97 through 11/9/98 – 672 days exposure time.
2.3 ANAEROBIC BIODEGRADATION (oxygen and UV light are NOT prerequisites)
Refuse (including plastics) disposed of in landfills eventually becomes buried and cut off from any supply of oxygen. For an item to biodegrade in a landfill, it must be susceptible to breakdown by anaerobic microorganisms. The biodegradation of products in a landfill can be determined through a test involving high-rate dry anaerobic batch fermentation (ASTM D.5511-94).
The optimal conditions of this fermentation method are stationary (no mixing) and dry conditions similar to those found in landfills. In order to evaluate the biodegradability of the product in landfills, this test was conducted using the X pellet as the test material and cellulose as the reference material. The test began by adding a small amount of test or reference material to an inoculum consisting of a concentrated medium of the same bacteria found in landfills. Test vessels were then filled with the mixtures, closed airtight, and placed in an incubator for 15 days. At the end of the test, the amount of methane and carbon dioxide produced per gram of test substance was calculated. This information was used to calculate the percentage of biodegradation (percentage of solid carbon that has been converted into biogases) for both cellulose and X pellets. As in the aerobic tests, biodegradation of cellulose started at a high rate (Figure 3). After 5 days, more than 70% of the original sample had biodegraded. At the end of the 15-day test, 87% of the sample had degraded. The X pellets biodegraded at a moderate rate; after 15 days, 24% of the sample had biodegraded. Since these values account for carbon released in respiration but not carbon assimilated by the microorganisms, the degree of degradation of both the pellets and cellulose may be underestimated. The results of this test indicate that X pellets do biodegrade under anaerobic conditions, although at a slower rate than cellulose. If disposed of in landfills, the X pellets should completely break down. X-treated plastics should also break down in anaerobic conditions, although at a slower rate than the 100% X pellets.
3.0 CHEMICAL ANALYSES OF END PRODUCTS
The final degradation product of X pellets or film may contain residues of the original material such as metabolites, undegraded components and inorganic components. Chemical analyses of the degradation product were conducted to evaluate whether these residues are environmentally safe.
Samples of the final product from the 22-month aerobic biodegradation test, including both the degraded pellets and degraded film, were subjected to three standard EPA analyses: total extractable metals, volatile organic compounds (VOCs), and Toxicity Characteristic Leaching Procedure (TCLP) – a procedure designed to determine the mobility of chemicals present in liquid and solid wastes.
The total extractable metals analysis measured cadmium and lead. These two metals are used in the production of plastics and are often present in the final product. Cadmium was not detected in the degraded film or pellets. :Lead was detected in both the degraded film (0.7 mg/kg) and pellets (4.6mg/kg). The average concentration of lead present in United States soil is 16 mg/kg, more than two times higher than the detected concentrations. Since the levels of lead present in the final degradation products of X pellets are lower than the levels present in U.S. soil, they will not have an impact on soil-dwelling organisms.
A total of 33 VOCs were analyzed in the degradation products of the film and pellets. Twenty-nine of the chemicals were not detected in either sample. All four of the detected chemicals (acetone, 2- methylene chloride, and styrene) were present in low levels. Detected concentrations of all four chemicals were lower than the U.S. EPA Region 5's Ecological Data Quality Level (EDQL) benchmarks. The U.S. EPA uses EDQLs to identify chemicals that could possibly pose a risk to exposed wildlife. Since none of the detected chemicals exceed the EDQL, the end product does not contain harmful levels of any of the tested VOCs.
TCLP analyses were conducted for eight metals and 13 semi-volatile organic compounds (SVOCs).The results of the TCLP indicate whether any of the analyzed chemicals are likely to migrate from their disposal area into surrounding soil. Lead was the only chemical detected. The concentration of lead detected in the TCLP analysis (1.5 mg/L) was lower than the U.S. EPA's regulatory level for lead using TCLP (5 mg/L). Solid wastes with concentrations above the regulatory level are considered to “exhibit the characteristic of toxicity.” All of the chemical analyses indicate that chemicals in the final degradation product of X pellets are not present in concentrations that would be harmful to exposed organisms.
4.0 TOXICITY TESTS
Although the results of the chemical analyses of the end products indicated that none of the tested chemicals were present at harmful concentrations, it would not be possible to analyze every potentially toxic chemical that might be present in the degraded products. For this reason, the possible toxicity of the degradation product was further assessed using toxicity tests. Laboratory toxicity tests are commonly used to determine whether or not a substance is harmful to the organisms that may come into contact with it. Test organisms are exposed to a known quantity of the test substance in the medium (e.g., soil, water) occupied by the organisms. At the end of the test, the survival or growth of the organisms are measured.
X-treated plastics may be disposed of in landfills or may be composted. While compounds in landfills are generally not exposed to organisms, composted plastics are exposed to plants and soil.
DWELLING ANIMALS (e.g., earthworms and aquatic organisms).
These plants and animals will also be exposed to the degradation products of improperly disposed plastics (i.e., litter). Four toxicity tests were conducted on X pellets – two with plant species and two with animal species. The medium used in these tests was a mixture of soil and compost (or, in one case, a solution of water and compost). The test compost was produced by composting X pellets in a 10% concentration with municipal solid waste for 3 months. For each toxicity test, a reference was run with control compost (compost without X pellets). At the end of the exposure period, the survival or growth of the organisms exposed to the test compost was compared to that of organisms exposed to the control compost.
4.1 PLANT GROWTH
The possible effect of X compost on flowering plants was evaluated using two toxicity tests. Angiosperms, or flowering plants, are the most diverse and widespread class of plants and are divided into two classes: monocots (plants with one embryonic seed leaf) and dicots (plants with two embryonic seed leaves). Representatives from both of these classes were used in toxicity tests – summer barley was used to represent monocots, and cress was used to represent dicots.
4.1.1 SUMMER BARLEY TEST
A European test (RAL GZ 251) was used to determine the tolerance of summer barley to compost. Summer barley is a species of cereal grass. The summer barley test involves the germination and growth of this plant in mixtures of standard soil and compost. After approximately 10-12 days of exposure, the plants were dried and weighed to obtain the dry weight. If there is no significanthe difference between results obtained from the test (X) compost and those obtained from the control compost, the X residuals are considered to be non-toxic.
The mixtures of soil and compost tested were 25/75 and 50/50 ratios of compost/soil. The five soil mixtures tested were X25, X50, Control25, Control50, and untreated soil (numbers associated Ecological Assessment X Plastic with the X and control mixtures indicate the percentage of compost in the mixture). The results (presented as a percentage of results obtained using soil) are presented in Figure 4.
Results of Summer Barley Test (dry weight)
The barley grown in the X test compost performed well compared to that grown in soil or the control compost. There was no significant difference between the yield obtained on the control compost and the yield from the X test compost. In fact, barley grown in the X50 compost produced a greater yield than that grown in the Control50 compost. These results indicate that the end product of the biodegradation of X pellets is not toxic to monocotyledonous plants.
4.1.2 CRESS TEST
Cress is a dicotyledonous; leafy plant. The cress test is a European test (RAL GZ 251) that involves the germination and growth of cress seeds on 100% compost. After 7 days of exposure, the dry weight is obtained. Cress tests were conducted with three substances –X compost (X 100), control compost (Control 100), and soil. The results (expressed as a percentage of the soil results) are presented in Figure 5.
Ecological Assessment of February 16, 1999 X Plastic
Results of Cress Test (dry weight)
At the end of the test, all emerged plants had a healthy appearance. On a dry weight basis, the yield was about the same for all three treatment groups. These results indicate that the X compost is not toxic to dicotyledonous plants. The results of the cress and barley tests demonstrate that the final degradation product of X pellets is not toxic to either of the classes of flowering plants.
4.2 EARTHWORM ACUTE TOXICITY TEST
In order to examine the possible toxic effects of X pellet degradation products on soil-dwelling organisms, an earthworm acute toxicity test was conducted. In an acute toxicity test, organisms are exposed to high concentrations of a test substance for short periods of time. Since the earthworm feeds on soil, this organism is suitable for the toxicity testing of X compost. The toxicity test used was a European test (OECD Guidelines #207) in which earthworms are exposed to soil and compost combined in varying ratios. After 14 days of exposure, the number of surviving worms is counted and percent survival is calculated.
Earthworms were exposed to mixtures of compost (control or X) and soil in ratios of 65/35, 80/20, and 100/0 of compost/soil. Earthworms were also exposed to 100% soil. The results are shown in Figure 6. Ecological Assessment of February 16, 1999 X Plastic Figure 6.
RESULT OF THE EARTHWORM TESTS
All of the tested concentrations produced satisfactory results (between 90 and 100% survival) except for X100. At this concentration, only 25% of the earthworms survived the test, a result that is significantly different than the result at Control 100. The results of this test indicate that, when undiluted, X compost causes mortality in earthworms. When X compost is added to soil, acute mortality is not evident.
4.3 DAPHNIA ACUTE TOXICITY TEST
Substances in landfills or compost heaps can migrate to nearby bodies of water through liquids percolating in the ground (leaching) or rainfall (runoff). Through these processes, X degradation products may be transported into lakes, rivers, or other water bodies. Organisms inhabiting these water bodies would be exposed to any toxic residues that may be in the degraded plastic. For this reason, an acute toxicity test was conducted with an aquatic animal, the small freshwater crustacean Daphnia.
In order to expose Daphnia to the X compost, several solutions of “compost tea” were prepared by diluting compost with water in a range of dilutions. Daphnia were placed in containers filled with the solutions and exposed for 24 hours. After exposure, the number of surviving organisms was counted and percent survival calculated.
Control and X compost were diluted with water to produce solutions of 1.6%, 3.1%, 6.3%, 12.5%, and 25% compost in water. A control test was also run in which organisms were exposed to fresh water. Results are presented in Figure 7.
RESULTS OF DAPHNIA TEST (survival)
The survival of Daphnia was above 80% at all dilutions except at 25%. At this concentration, there were low survival rates in both control and test solutions – only 20 to 30% of the Daphnia survived. The low survival rates observed at this dilution were not caused by any X residuals present in the test compost. Rather, the large amount of solids in the water at this dilution caused the observed mortality in both the control and X tests. There is no significant difference between survival observed in the control compost and that observed in the test compost at any of the dilutions. In fact, the X compost produced higher rates of survival in all but one dilution (1.6% compost). The results of the Daphnia test indicate that X compost is not toxic to freshwater organisms.
SUMMARY AND CONCLUSIONS
The successful production and marketing of biodegradable plastics will help alleviate the burden placed on the environment by consumers. Although many biodegradable plastics have been introduced into the marketplace, all of them must be composted and none of them biodegrade in landfills. For this reason, none of these products has gained widespread use in the United States.
The technology developed by Y allows the manufacture of plastics that biodegrade in aerobic or anaerobic conditions. Biodegradation tests indicate that products made using this technology will degrade when disposed of in landfills. Toxicity tests completed on the end product of degradation demonstrate that it should be safe under anticipated environmental exposures.
Products made using X treated plastics (garbage bags, diaper liners, agricultural film, etc.) can be marketed as biodegradable and safe for the environment, filling an empty niche in today's market.
A LETTER SENT TO THE FDA FROM THE MANUFACTURER OF ADDITIVE "X"
I am sending you this letter for the purpose of assuring both you and your customers that all United States FDA and SCF (the food safety authority in Europe; the Scientific Committee on Food of the European Commission) requirements for direct food contact will be satisfied for products with our additives as well as that all provisions of California Proposition 65 and it subsequent modifications and regulations will be satisfied for products with our additives as long as the same product without our additives would comply. As you are probably aware, neither the United States FDA nor the SCF require active testing and evaluation of items that are manufactured within the parameters of their guidelines and regulations. This is the case with our additives to plastic products. Therefore plastic products manufactured with our additives at their recommended loading percentages comply with all FDA and SCF regulations for direct food contact packaging as long as the same product without our additives would comply.
signed by
President of the manufacturing company of Additive X
PROPERTIES of Additive X and Regulatory Information
Additive "X" is made only from FDA recognized materials and processes regulated according to 21 CFR 175.300, 177.1200, 177.1350 and other sections and fully complies with SCF (the Scientific Committee for Food), EFSA (The European Food Safety Authority), for food contact applications.
CERTIFICATION OF ADDITIVE "X"
This is to certify that numerous plastic samples, submitted by X Inc., have been tested by independent laboratories in accordance with standard test methods approved by ASTM, ISO and other such standardization bodies to determine the rate and extent of biodegradation of plastic materials.
A Degradable Plastic is defined (ASTM 1991) as a plastic that is designed to undergo a significant change in its chemical structure under specific environmental conditions resulting in a loss of some properties that may vary as measured by standard test methods appropriate to the plastic and the application in a period of time that determines its classification.
A Biodegradable Plastic is defined as a degradable plastic in which the degradation results from the action of naturally occurring micro organisms such as bacteria, fungi and algae. The biodegradation of the submitted plastic samples was tested using ASTM D5209-91, “Standard Test Method for Determining the Aerobic Biodegradation of Plastic Materials in the Presence of Municipal Sewage Sludge”, ASTM D5338.98, “Standard Test Method for Determining Aerobic Biodegradation of Plastic Materials under Controlled Composting Conditions”, which is equivalent to CEN prEN WI 261085, and the ISO 14855 method.
“Evaluation of the Ultimate Aerobic Biodegradability and Disintegration of Plastics under Controlled Composting Conditions”, ASTM 5511. “Standard Test Method for determining anaerobic biodegradation of plastic materials under high solids anaerobic digestion conditions.”
The results of these tests and the related biodegradation and ecological impact experiments in various environments are contained in the Ecological Assessment of Additive X report dated February 16, 1999, which certifies that plastic products manufactured with Additive X can be marketed as biodegradable and safe for the environment.
This Certificate and the Ecological Assessment X Plastic report and also the Scanning Electron Microscope and other studies that have been conducted since the publication of the Ecological Assessment, all of which use a one percent loading rate for the X Additive than the higher additive levels used earlier, have been presented to Y Company , and may be used by it to validate its claims to the biodegradability and environmental safety of plastic products that it manufactures that are made consistent with the manufacturing guidelines for uses of Additive X presented to it by XX Inc.
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These extensive tests were carried out in a private laboratory. Further information is available by submitting a written request to BIOGREEN PRODUCTS EUROPE.
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