United States v. Allen, 80-C-133.

• Decision Date: 11 June 1980
• Docket Number: No. 80-C-133.,80-C-133.
• Citation: 494 F. Supp. 107
• Parties: UNITED STATES of America, Petitioner, and Dow Chemical Company, Intervening Petitioner, v. Dr. James R. ALLEN and John Van Miller, Respondents, and James P. Wachtendonk, Mary S. Wachtendonk, Ree Anne Wachtendonk and Zachary James Wachtendonk; Robert W. Green, now Deceased, and Cheryl A. Green, the widow of the veteran Robert W. Green, now Deceased; Charles Chapman and Kuniko Chapman, Individually and on behalf of each of the "Vietnam Veterans" who have been affected, individually and on behalf of those so unfortunate as to have been similarly affected by the toxic effects of phenoxy herbicides such as 2, 4, 5-trichlorophenoxy herbicides such as the 2, 4, 5-trichlorophenoxy aliphatics manufactured, formulated, advertised, promoted, marketed and sold, individually and collectively by the corporate defendants in MDL # 381, although known to be contaminated with the toxic synthetic organic chemical 2, 3, 7, 8-tetrachlorodibenzo p-dioxin (TCDD or "dioxin"), Intervening Respondents.
• Court: U.S. District Court — Western District of Wisconsin

494 F. Supp. 107

UNITED STATES of America, Petitioner, and Dow Chemical Company, Intervening Petitioner, v. Dr. James R. ALLEN and John Van Miller, Respondents, and James P. Wachtendonk, Mary S. Wachtendonk, Ree Anne Wachtendonk and Zachary James Wachtendonk; Robert W. Green, now Deceased, and Cheryl A. Green, the widow of the veteran Robert W. Green, now Deceased; Charles Chapman and Kuniko Chapman, Individually and on behalf of each of the "Vietnam Veterans" who have been affected, individually and on behalf of those so unfortunate as to have been similarly affected by the toxic effects of phenoxy herbicides such as 2, 4, 5-trichlorophenoxy herbicides such as the 2, 4, 5-trichlorophenoxy aliphatics manufactured, formulated, advertised, promoted, marketed and sold, individually and collectively by the corporate defendants in MDL # 381, although known to be contaminated with the toxic synthetic organic chemical 2, 3, 7, 8-tetrachlorodibenzo p-dioxin (TCDD or "dioxin"), Intervening Respondents.

No. 80-C-133.

United States District Court, W. D. Wisconsin.

June 11, 1980.

Richard E. Cohen, Asst. U. S. Atty., Madison, Wis., for petitioner.

Richard J. Lewandowski, Madison, Wis., for intervening petitioner.

Robert K. Aberg, Madison, Wis., for respondents Allen and Miller.

David J. Ghilardi, Madison, Wis., for intervening respondents.

CRABB, District Judge.

The United States of America has petitioned this court to enforce administrative subpoenas issued by an Environmental Protection Agency ("EPA") Administrative Law Judge to respondents, Dr. James R. Allen and John Van Miller, for certain documents, records and information related to respondent Allen's scientific studies of the chemical 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin ("TCDD"). The subpoenas were issued pursuant to Section 6 of the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136d, concerning the possible cancellation of the registration of the herbicides 2, 4, 5-T and silvex. Dow Chemical and James P. Wachtendonk, et al., have been allowed to intervene. Jurisdiction of this court is based on 7 U.S.C. §§ 136d(d) and 136n.

For purposes of this proceeding only, I make the following findings of fact.

FACTS

On February 28, 1979, the Administrator of the EPA ordered emergency suspension of the pasture, forestry and rights-of-way uses of 2, 4, 5-T and silvex under Section 6 of FIFRA, 7 U.S.C. § 136d. Along with the suspension orders, the EPA issued cancellation hearing notices under Section 6(b)(1) of FIFRA for each of the suspended uses setting hearings to determine whether these uses of 2, 4, 5-T and silvex should be cancelled.

On February 1, 1980, over the objection of the Office of General Counsel of the EPA, Administrative Law Judge Edward B. Finch issued subpoenas duces tecum to Dr. James R. Allen and to John Van Miller, ordering that they appear before attorneys for the Dow Chemical Company on February 14, 1980, and produce certain documents. Dr. Allen was served on February 5, 1980.

The subpoenas required that Dr. Allen and Mr. Van Miller produce the following materials for the 500 part per trillion ("ppt"), 50 ppt, 25 ppt and 5 ppt Monkey Studies:

a. All documents and records related to Dr. Allen's study of TCDD administered to monkeys in the diet at ppt TCDD.

b. All documents and records related to the sources, breeding, care, and maintenance of the animals used in this study.

c. Summaries or data compilations of the ancestral breeding records for animals used in the study.

d. All documents and records related to the possible presence of PCBs or other toxic substances in the tissues of animals used in this study, and all documents and records related to possible routes of exposure for such PCBs or toxic substances, including possible contamination of food or water supplies or previous exposure to PCBs or toxic substances.

The term "documents and records" was defined in the "Schedule of Documents to be Produced" as including:

All letters, memoranda, correspondence, reports, notes, drafts, working papers, protocols for scientific studies, laboratory notebooks, raw data, data compilations, graphs, charts or papers of any kind, whether hand-written, typed, printed, or reproduced photostatically or photographically, all film, photographs, videotapes, drawings, or other visual representations, and all magnetic, mechanical, or electronic recordings or other form of data compilation. The term "documents and records" does not include articles published in recognized scientific journals of wide circulation.

On February 11, 1980, a Motion to Quash the Administrative Subpoenas was filed.¹ Administrative Law Judge Finch granted the motion to quash with respect to the documents relating to the 500 ppt and the 50 ppt studies, and denied the motion with respect to the documents for the 25 ppt and the 5 ppt studies. He also extended the return date of the subpoenas to March 11, 1980.

The "Order Granting In Part and Denying In Part Motion to Quash Subpoenas Duces Tecum Against Dr. James Allen and Mr. John Van Miller" contains the following paragraph:

The court is aware of the distinction and usefulness of both complete and incomplete scientific studies and between third party witnesses as opposed to party witnesses. However, this distinction is overcome by the desire of the parties to have before them at the outset any and all relevant evidence which might bear on the final decision. There is no question as to the relevance of the data to be discovered. This is not to say that there has been a determination at this time as to whether or not any such discovered data will be probative or substantive in nature. If any of the data finds it sic way into the record of this proceeding, such evidence will be considered as to its weight.

Respondents notified Judge Finch on March 10, 1980 that they declined to honor the subpoenas.

At the time the subpoenas were issued both Allen and Van Miller were employed by the Department of Pathology of the University of Wisconsin Medical School.

The studies which Dow seeks to discover are studies of the effect of the chemical TCDD on primates. In a grant application to the Department of Health, Education and Welfare prepared for the 50 ppt and the 5 ppt studies² the objectives of the studies were described as follows:

The injurious effects of 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin (TCDD) at doses as low as 500 parts per trillion (ppt) on general health and reproductive efficiency of non-human primates, the presence of TCDD at levels ranging from 10 to 30 ppt in the milk fat of lactating humans, and the development of tumors in rats fed doses that ranged between 1 ppb and 5 ppt, indicate the potential danger that may be experienced by man and lower animals exposed to this toxic compound. Since exposure to TCDD is continuing through the use of contaminated industrial materials, it is of prime importance to establish a clearer understanding of the injurious effects that may arise from low level, long term contact of primates to this compound. . . . These studies will clarify what may be expected to occur in the human population as a result of low level, long term TCDD exposure.

In the same application the methods of procedure were summarized as follows:

In the proposed experiments the animals will be placed on a diet containing TCDD for 6 months prior to breeding. During this time the general body health of the animals will be evaluated. . . . Once the animals are bred, their ability to conceive and carry their infants to term will be determined. Following birth the infants will be evaluated clinically for abnormalities and for levels of TCDD in the tissues. After four months of nursing, the animals will be weaned and evaluated for learning and behavioral abnormalities.

Following approximately 2 years of exposure to the TCDD and after having given birth to infants and nursing them for 4 months, the animals will be placed on a normal diet. The rate of recovery from TCDD intoxication will be determined in the manner outlined below. After the adult female animals have been off of the TCDD diet for 6 months, they will be bred again and the residual effects of TCDD on conception and fetal and neonatal development evaluated. Following birth, the levels of TCDD in the infants sic tissues as well as that which is present in the milk they are nursing will be determined. After 4 months the infants will be weaned and evaluated for behavioral and learning abnormalities, similar to that of the original group. Following the completion of the psychological evaluation, a portion of the animals will be sacrificed, and a thorough gross and microscopic evaluation of the tissues conducted.

The 25 ppt study was begun on November 11, 1978, by starting the monkeys on the experimental diets, and the 5 ppt study was begun on March 23, 1979, in the same manner.

In his affidavit filed in this court on June 3, 1980, Van Miller explains that a "cumulative no-effect level"³ can not be determined even tentatively until the total amount of TCDD ingested by the study animals reaches the level⁴ at which effects have first been observed in earlier studies of higher doses. This is not disputed by the affidavits of R. J. Kociba, an associate scientist employed by Dow Chemical. In his affidavit Kociba states that useful information should be available from the 5 ppt and the 25 ppt studies, that whether there is a no effect level of TCDD is likely to be an issue in the EPA hearing; and that Allen's studies may "shed light" on a no-effect level for TCDD toxicity in primates.

At the dosage of TCDD given to the monkeys in the 25 ppt study it will be 60 months before the animals will have ingested the amount of TCDD which was found to produce adverse effects on adult female monkeys (maternal toxicity) in an earlier study using higher doses. It will be substantially longer for the 5 ppt study. No "critical intake level" has yet been...