Monsanto Co. v. Kennedy
| Citation | 198 U.S.App.D.C. 214,613 F.2d 947 |
| Decision Date | 06 November 1979 |
| Docket Number | Nos. 77-2023,77-2026 and 77-2032,77-2024,s. 77-2023 |
| Parties | MONSANTO COMPANY, Petitioner, v. Donald KENNEDY, as Commissioner of Food and Drugs, and Joseph A. Califano, Jr., as Secretary of Health, Education and Welfare, Respondents. The SOCIETY OF the PLASTICS INDUSTRY, INC., Petitioner, v. Donald KENNEDY, as Commissioner of Food and Drugs, and Joseph A. Califano, Jr., as Secretary of Health, Education and Welfare, Respondents. VISTRON CORPORATION, Petitioner, v. Joseph A. CALIFANO, as Secretary of Health, Education and Welfare and Donald Kennedy, as Commissioner of Food and Drugs, Respondents. The CONTINENTAL GROUP, INC., Petitioner, v. Donald KENNEDY, Commissioner of Food and Drugs, Respondent. |
| Court | United States Courts of Appeals. United States Court of Appeals (District of Columbia) |
John H. Pickering, Washington, D. C., with whom Jerome H. Heckman, William T. Lake and Michael S. Schooler, Washington, D. C., were on the brief, for petitioner in No. 77-2023.
Joel E. Hoffman, Washington, D. C., with whom Gloria Phraes Stewart, Washington, D. C., was on the brief, for petitioner in No. 77-2032.
Edward B. Williams, Washington, D. C., with whom John F. Jones, Cleveland, Ohio, George Meader and Daniel S. Orci, Jr., Washington, D. C., were on the brief, for petitioner in No. 77-2026.
Jerome H. Heckman, Washington, D. C., with whom John B. Dubeck and John S. Eldred, Washington, D. C., were on the brief, for petitioner in No. 77-2024.
Richard M. Cooper, Chief Counsel, Food and Drug Administration, Rockville, Md., with whom Charles R. McConachie, J. Patrick Glynn, Attys., Dept. of Justice, and Thomas Scarlett, Attys., Food and Drug Administration, Washington, D. C., were on the brief, for respondents.
Marcia J. Cleveland, New York City, was on the brief, for Amicus curiae, Natural Resources Defense Council, Inc. urging affirmance.
Eugene I. Lambert, Allan J. Topol and Richard F. Kingham, Washington, D. C., were on the brief, for amicus curiae, American Can Co. et al., urging that the Commission's order to be set aside with directions to reinstate the regulations.
Malcolm D. MacArthur, Washington, D. C., was on the brief, for amicus curiae, National Flexible Packaging Ass'n urging Commissioner's order to be vacated and set aside.
Ronald A. Zumbrun, Robert K. Best, Raymond M. Momboisse, Sacramento, Cal., Albert Ferri, Jr. and Donald C. Simpson were on the brief, for Amicus Curiae, Pacific Legal Foundation, Washington D.C., urging the order be reversed and vacated.
Before BAZELON, Senior Circuit Judge, and LEVENTHAL and ROBINSON, Circuit Judges.
Opinion for the Court filed by Circuit Judge LEVENTHAL.
This case arises on a petition for review of a Final Decision and Order of the Commissioner of Food and Drugs 1 in which he ruled that a substance used to fabricate unbreakable beverage containers, acrylonitrile copolymer, is a "food additive" within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (the Act). 2 He further concluded that the data of record failed to provide the demonstration of safety established by section 409(c)(3) (A) of the Act as a precedent to FDA approval for use of any "food additive." 3 The Commissioner's Final Order amended the pertinent FDA regulations to provide: "Acrylonitrile copolymers (of the type identified in the regulations) are not authorized to be used to fabricate beverage containers." 4
For the reasons set forth below, the decision of the Commissioner is affirmed in part, and in part is remanded to provide the opportunity for reconsideration.
The FDA determination that acrylonitrile copolymers used in beverage containers are "food additives" within the statute is based on the finding that such containers invariably retain a residual level of acrylonitrile monomer that has failed to polymerize completely during the manufacturing process and that will migrate from the wall of the container into the beverage under the conditions of intended use. Although the administrative proceedings focused on beverage containers with a residual acrylonitrile monomer (RAN) level equal to or greater than 3.3 parts per million (ppm), the Commissioner made findings and conclusions applicable to all beverage containers manufactured with acrylonitrile, and the Final Order prohibited manufacture of such containers irrespective of their RAN levels. 5
FDA began to focus on acrylonitrile copolymer beverage containers in 1974, when the duPont Company submitted test results on a container fabricated from a somewhat different substance which alerted FDA to the possibility of significant migration from acrylonitrile containers. Subsequently, the Commissioner determined that, because of this putative migration, acrylonitrile copolymer was a "food additive" within the statute, and, on February 12, 1975, he published a regulation prescribing the conditions under which the chemical might be used safely in beverage containers: RAN levels in the wall of the container were limited to 80 parts per million (ppm), and acceptable migration of acrylonitrile monomer into the food was set at 300 ppb (parts per billion). 6
Two years later, FDA issued test results indicating that acrylonitrile caused adverse affects in laboratory animals. The Commissioner announced that he would lower the acceptable migration threshold for nonbeverage containers to 50 ppb, and would withdraw approval entirely for acrylonitrile beverage containers, on the assumption that no such container could satisfy the 50 ppb migration limitation. 7 Upon judicial review, this court held FDA's suspension of its food additive regulation without a hearing to be invalid. The court stayed the administrative action on March 18, 1977 8 and ordered that the required hearing be completed within 60 days. Monsanto Co. v. Gardner (No. 77-1245, 3/18/77). Subsequently, on a joint motion of the parties, the time limitation was extended by 120 days.
At the administrative hearing, petitioners introduced results from tests on a newly developed acrylonitrile beverage container having a RAN level of approximately 3.3 ppm. Tests on the container, employing a detection method sensitive to 10 ppb, detected no migration of acrylonitrile monomer. Nevertheless, the administrative law judge found that acrylonitrile copolymer was a "food additive," since migration had been detected from beverage containers composed of the same chemical compounds, though with higher RAN levels than those present in the "new" container. 9 The Final Order prohibited manufacture of beverage containers containing acrylonitrile copolymer irrespective of their RAN levels. 10
This case brings into court the second law of thermodynamics, which C. P. Snow used as a paradigm of technical information well understood by all scientists and practically no persons of the culture of humanism and letters. 11 That law leads to a scientifically indisputable prediction that there will be Some migration of Any two substances which come in contact. The Commissioner's Final Decision, which upheld the ALJ's determination, is unclear on whether and to what extent reliance was placed on this "diffusion principle" rather than on a meaningful projection from reliable data. At one point in the Final Decision the Commissioner stated: "the migration of any amount of a substance is sufficient to make it a food additive" 12 a passage evocative of the diffusion principle. Elsewhere, the Commissioner stated that he was able to make a finding of migration based on a projection from actual data on the assumption that a roughly linear relationship (as a function of time and temperature) existed between the RAN levels in a container and the concentration of acrylonitrile that would migrate into a test fluid. On this premise, though migration from the 3.3 ppm RAN container was itself below the threshold of detectability (10 ppb), it could be projected from the testing data obtained from containers with higher RAN levels. 13
This was a troublesome aspect of the case. As it was presented to us, the Commissioner had made a projection of migration from 3.3 ppm RAN containers without the support of any actual data showing that migration had occurred from such containers. One of petitioners' experts put it that the relationship might not be linear at very low RAN levels; but this was dismissed by the Commissioner as "speculative." 14 One could not say that the expert's contention of no migration from very low RAN containers was improbable as a concept of physical chemistry, but it was put to us that the validity of this contention could neither be demonstrated nor refuted for 3.3 ppm RAN containers because, under the conditions of intended use, migration was projected to occur in amounts below the threshold of detectability.
Our own study showed the possibility of using experimental data to check the FDA's projection analysis. The FDA revealed that a projection of migration from low RAN containers had in fact been made for test conditions of prolonged duration and above-normal temperature. Under such conditions migration was projected in concentrations greater than 10 ppb, the threshold of detectability at the time of the Final Decision. 15 Therefore, this court requested post-argument memoranda from the parties on whether tests had been performed, or would be feasible, to confirm by actual data the hypothesis that migration occurs from containers with a RAN level of 3.3 ppm.
The responses to our inquiry have revealed the probable existence of data unavailable to counsel during the administrative proceedings that bear importantly upon the assumptions made by the Commissioner in reaching his findings and conclusions. This discovery buttressed our earlier conclusion that the Commissioner did not have sufficient support for his decision to apply the "food additive" definition in this case.
In light of the inadequacy of the...
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