State v. Fermenta ASC Corp.

• Decision Date: 06 July 1995
• Citation: 630 N.Y.S.2d 884,166 Misc.2d 524
• Parties: STATE of New York, Thomas C. Jorling as Commissioner of Environmental Conservation, County of Suffolk and David Harris, M.D., as Commissioner of the Department of Health Services of Suffolk County, Suffolk County Water Authority, Plaintiffs, v. FERMENTA ASC CORPORATION and SDS Biotech Corporation, Defendants.
• Court: New York Supreme Court

Page 884

630 N.Y.S.2d 884

166 Misc.2d 524

STATE of New York, Thomas C. Jorling as Commissioner of

Environmental Conservation, County of Suffolk and David

Harris, M.D., as Commissioner of the Department of Health

Services of Suffolk County, Suffolk County Water Authority, Plaintiffs, v. FERMENTA ASC CORPORATION and SDS Biotech Corporation, Defendants.

Supreme Court, Suffolk County,

Trial Term, Part 28.

July 6, 1995.

Robert Cimino, County Attorney and Derrick Robinson, County Attorney's Office, Hauppauge, for County of Suffolk and another, plaintiffs.

John S. Guttman, Christopher W. Mahoney and Kathryn B. Fuller, Beveridge & Diamond, P.C., New York City, for defendants.

Albert A. Natoli, New York City, for plaintiff, Suffolk Cty. Water Authority.

ALAN D. OSHRIN, Justice.

FACTS

The defendants and their predecessors have been and are the manufacturers and distributors of a herbicide known as Dachtal. Dachtal had been sold in Suffolk County for more than twenty years until 1989. The active ingredient found in Dachtal is dimethyl tetrachloroterephthalate (DCPA). Since 1958 DCPA has been registered for use as a herbicide with the United States Department of Agriculture (later the United States Environmental Protection Agency). Although not now used in Suffolk County, DCPA is registered for use in New York State by the New York State Department of Environmental Conservation. DCPA is no longer registered for use in Suffolk County.

DCPA acts at the soil surface to inhibit or prohibit the growth of plants which would interfere with the growth of the crops. After DCPA is placed on the soil surface it does not enter the subsurface. It changes or degrades into monomethyl tetrachloroterepthalic acid (MCPA). MCPA has a very short half life and in turn changes or degrades into tetrachloroterephthalic acid (TCPA). TCPA does enter the subsoil and has been found in the water supply of Suffolk County. Since 1977 ISK Biosciences Corporation (hereinafter "ISK") (an earlier corporate form of the defendants) has engaged in a ground water monitoring program. As a result of the program, ISK became aware that TCPA was found in the Suffolk County ground water and so informed the New York State Department of Health and the Suffolk County Department of Health Services in 1982. At that time representatives of the State requested toxicology data relating to TCPA.

Suffolk County's water supply is contained in its aquifers. An aquifer is an area beneath ground surface. Water enters the aquifer from the ground and moves generally down through the aquifer and also in a northerly or southerly direction dependent upon the location in relation to the center of the island. While moving to the north, the water moves to the Long Island Sound, or while moving to the south to the Atlantic Ocean. The aquifer is composed of sand through which the water moves. There are layers of clay separating the aquifers. The water does not pass through the clay. As the water moves from the surface to the subsurface, and then through the subsurface, it carries with it certain substances. Among these substances is TCPA.

Prior to 1982, the New York State Department of Health had developed and applied guidelines with respect to classification of substances known as unspecified organic contaminants (UOC) which may be found in the water supply. Rather than fix guidelines which would set forth the amount of a particular substance which might be found in the water supply, and also found not to be harmful on a chemical by chemical basis, the department applied guidelines to all substances known as unspecified organic contaminants and provided that no such single substance should be found in the water supply in excess of 50 ppb. In November 1988, effective January 1989, the guidelines became regulations within the State Sanitary After being advised that TCPA had been detected in the Suffolk County ground water, the Health Department requested toxicology data with respect to TCPA because no such data had been reviewed in developing the drinking water guidelines referred to above. A Ninety Day TCPA Study conducted in 1977 was supplied by the defendant's representatives. Concomitantly, the defendants sought an increase in the 50 ppb guideline as it pertained to TCPA. That request was denied. Dr. Kim, on behalf of the State Health Department, after reviewing the data, stated that it did not support an increase in the 50 ppb guideline, and said the data "appeared inadequate for characterizing chronic toxicity".

Code (10 NYCRR 5-1.52 Table 3). Anticipating this regulation in June of 1988, the defendants had petitioned the Environmental Protection Agency to permit an amendment to the Dachtal label prohibiting the use of the product in Suffolk County. The request was approved in October of 1988, and the Dachtal labels were immediately modified.

With respect to the public nuisance causes of action, the State, County and SCWA needed to establish that TCPA in the water supply in excess of 50 ppb was harmful or potentially harmful to the health, safety and comfort of a considerable number of persons. The plaintiffs attempted to do so primarily by use of the Ninety Day TCPA Study in Rats conducted in 1977, and a comparison of the nature and properties of TCPA and DCPA. At the outset the Court makes the following observations. At no time did the State, County or SCWA conduct an independent toxicity study. Four other studies of TCPA were conducted (a battery of mutenogenocy studies to determine whether TCPA could be cancerous by reacting with DNA; a teratology test to determine whether TCPA would induce birth defects and a 30 day gavage study to determine the toxicity of TCPA) but were not viewed as significant by the plaintiffs' experts.

Doctors Kim, Blanck, Bradlow, Nisbet and Luttinger testified on behalf of the plaintiffs. The Ninety Day Study involved feeding rats TCPA at dosage levels of 50, 500, 1000 and 10,000 parts per million (ppm). Fifteen male and fifteen female rats were used at each dosage level and also in a control group. The study report is comprised of a] the summary, b] analysis of the clinical studies, c] a results section, d] a pathological studies section, and e] a section containing the raw data. The summary of the study concluded that no changes were found in general behavior, appearance, body weight, food consumption, ophthalmoscopic examinations and hematological, biological and urine analysis studies. Further the summary of the report noted no microscopic lesions and no compound related gross pathological lesions or organ weight variations observed in any rats.

Dr. Kim is the Director of the Division of Environmental Health Assessment for the New York State Department of Health. It is Dr. Kim's function to assess the risk to humans from exposure to chemicals. Dr. Kim who had reviewed the report in the 1980's in connection with the defendants' request for an increase in the 50 ppb standard had found, as noted previously, that the data contained in the study "appeared inadequate for characterizing chronic toxicity". During the trial Dr. Kim testified when asked whether TCPA is not carcinogenic: "correct, I don't know that it is not a carcinogen. There are no data elucidating whether it is a carcinogen right now". Dr. Kim also testified that she did not assume TCPA to be a cancer causing agent. Dr. Kim later testified "the way I would phrase that is that it is above a level that we have calculated using scientific and regulatory procedures that it is thought to be without appreciable risk" and "the most I feel comfortable saying, would I feel comfortable saying is that above a level that is thought to be without appreciable risk", continuing "it doesn't necessarily mean that something is going to happen". In response to the Court's inquiry "is there an appreciable risk?", Dr. Kim stated, "one could [say] that's the inference, yes". Dr. Kim also testified that she has low confidence in the reference dose of TCPA insofar as the amount which she believes would cause harm, conceding there are significant data gaps in her knowledge of TCPA and states that "if I can't say that you will have an adverse effect, I can say they are at risk of Dr. Kim concludes that the standard of 50 ppb should be lowered to 18 ppb as a result of her analysis of the Ninety Day Study and because of her conclusion that DCPA is structurally very similar to TCPA. In analyzing the Ninety Day Study, Dr. Kim bases her conclusion upon the fact that the organ weights of some of the rats which were the subject of the study decreased in size as a result of the administering of the TCPA.

having an adverse effect". Prior to her testimony at trial, Dr. Kim had opined that TCPA was not toxic.

While the number of rats tested is small, Dr. Kim seeks to buttress her conclusion by stating that there is a statistically significant change in various organs, including the thyroid, pituitary and adrenal glands. When asked whether ingesting TCPA in excess of the State regulations would cause harm to the individual, Dr. Kim stated that "it doesn't necessarily mean something is going to happen ...".

Drs. Nisbet and Luttinger upon their initial review of the Ninety Day Study concluded that TCPA was not harmful. Drs. Nisbet and Luttinger changed their respective opinions upon the trial after being provided with a complete legible copy of the Ninety Day Study. Each witness's initial conclusion was based upon a "review" of a copy of the study report with illegible backup material. Experts who offer an opinion based upon only the summary of a report or upon part of a report without the opportunity to examine the backup material offer opinions which are suspect. Further, Dr. Nisbet initially characterized the Ninety Day Study as "not very useful" because it did not show toxic effects and the sample size was too small. While he later found toxic effects he failed to explain why the small sample size...