Opinion ID: 4227268
Heading Depth: 2
Heading Rank: 1

Heading: Overview of PCB-Containing Plasticizers

Text: Monsanto began to manufacture and sell PCB mixtures, trademarked as Aroclors, in 1935. Aroclors were a popular plasticizer -- an additive used in building materials to increase 1 As a threshold matter, we must resolve two outstanding motions which affect the content of the record before us. (1) Westport asks us to reconsider its motion to supplement the record with two studies that it alleges Pharmacia improperly withheld during discovery. In the alternative, Westport seeks to reverse the district court's entry of judgment and asks us to remand the case with instructions to allow these studies to be introduced. We deny Westport's motion, which is too little, too late. Westport's counsel waited nearly a month after Pharmacia produced these studies to file this motion. In any case, Westport's counsel should have filed a Rule 60(b)(2) motion in the district court, which has far greater familiarity with the record than we do, but it did not. (2) We grant Pharmacia's motion to strike a settlement agreement contained in the addendum to Westport's amended reply brief and all citations to it. The settlement agreement was not presented to the district court, so Westport cannot include it in its appellate briefing. See Rosaura Bldg. Corp. v. Municipality of Mayaguez, 778 F.3d 55, 64 (1st Cir. 2015) (Appellate review concentrates on considering the factual record presented in the trial courts.). The agreement is also irrelevant to our disposition of this case. - 3 - fluidity -- because they were viscous, thermally stable, and nonflammable. By August of 1970, however, Monsanto pulled PCBcontaining Aroclors from the market because of their environmental impact.
Before August 1970, Monsanto sold PCB-containing Aroclors to formulators of building materials, who then incorporated them into various end products. For major customers and major applications, Monsanto likely sold Aroclors in bulk, in 55-gallon drums. Some of Monsanto's direct customers were companies that manufactured end products, such as paint and caulk, while others produced polymer components of end products. Monsanto continually updated its direct customers with information about the chemical properties and health effects of its PCB mixtures. For instance, the record includes Monsanto's technical bulletins for Aroclor plasticizers from 1943, 1955, 1966, and 1970. These bulletins included information about the plasticizers' rate of vaporization, as well as warnings about their toxicity and environmental impact. Beginning in 1937, Monsanto warned customers that experimental studies in animals showed that prolonged exposure to Aroclor vapors evolved at high temperatures or by repeated oral ingestion would lead to systemic toxic effects. These warnings - 4 - were present in all subsequent technical bulletins. The bulletins also prescribed precautions for industrial workers, such as ventilation and protective gear. In addition, Monsanto warned its customers about the environmental hazards of PCBs. In its March 1970 bulletin, Monsanto explicitly advised against certain uses of Aroclors: Some specific applications where the use of PCB should definitely be avoided are in paints and sealants for swimming pools, paints and waterproofing agents in silos and other buildings where food products for humans or animals are stored, and as a component of any container of wrapping used in packaging food products. These warnings were only given to Monsanto's direct customers, and not to end users.
Between 1934 and 1972, Monsanto sponsored 300 studies on the health effects of PCB exposure through inhalation and skin contact. These included skin patch and inhalation tests, as well as studies of the long-term reproductive and toxicological effects of PCBs in lab animals. In 1938, one study showed that PCBs were linked to liver toxicity. However, a series of studies in the 1950s, sponsored by Monsanto, and conducted by Dr. Treon, demonstrated that at ordinary temperatures, the hazard of inhaling PCBs from Aroclors may well be slight or entirely - 5 - absent. These studies concluded that the Aroclors tested only volatilized at levels sufficient to cause adverse health effects in animals when they were heated to 100 degrees Celsius (212 degrees Fahrenheit). Although Monsanto was not legally required to test the volatilization of PCBs from consumer end products that it did not manufacture -- such as paints and resins -- it sometimes did so. These studies only showed elevated levels of volatilization at room temperature from latex paints and resins. Specifically, Monsanto's U.S.-based research division and U.K.-based medical department conducted at least three studies on the volatilization of PCBs from latex paints between 1952 and 1955. Around that time, one of Monsanto's clients, Dow Chemicals, had expressed interest in using Aroclors in its latex paints. Monsanto's paint studies revealed that air samples collected from rooms covered in latex paint containing Aroclors, with temperatures between 70 and 100 degrees Fahrenheit, contained elevated PCB concentrations (above 0.15 mg per cubic meter) that persisted for one month (the duration of the study). Based on these findings, in 1953, Monsanto U.S. recommended against incorporating Aroclors into latex paints for indoor use. Monsanto U.K. later followed suit by recommending that the company continue to manufacture paints based on chlorinated rubber and - 6 - to sell Aroclors for production of paints intended for exterior application, but to discontinue sale of Aroclors for use in the manufacture of all other paints. However, neither Monsanto nor any other research entity studied the rate of PCB volatilization from caulk. According to Westport's own experts, even though Monsanto had conducted weightloss tests to ascertain the amount of Aroclor vaporization from caulk, the first study on the rate of PCB volatilization did not take place until the early 2000s -- more than three decades after WMS was constructed in 1969. And there are still no studies to date that establish PCBs volatilize from caulk at levels harmful to human health.
Six years after Monsanto removed PCB-containing Aroclors from the market, Congress enacted the Toxic Substances Control Act (TSCA), 15 U.S.C. § 2601, et. seq., which prohibited (with limited exceptions) the manufacture and distribution of PCBs in commerce. Id. § 2605(e)(2). The TSCA authorized the Environmental Protection Agency (EPA) to implement specific regulations regarding PCB use and disposal. See id. Following this authorization in 1976, the EPA promulgated regulations which required entities to obtain an exemption for the continued use of PCBs in a non-enclosed manner - 7 - at concentrations above 50 parts-per-million. See 40 C.F.R. § 761.20(c)(1). As justification for its decision, the agency pointed to, inter alia, the well-documented human health and environmental hazard of PCB exposure, [and] the high probability of human and environmental exposure to PCBs and PCB Items from manufacturing, processing, or distribution activities. Id. § 761.20.