Date: Feb 12, 2009
The objective of TSCA is to achieve an approach that will identify and restrict hazardous chemical substances that would otherwise pose an unreasonable risk of injury to human health and the environment. Unfortunately, the focus of reform efforts generally has been limited to a discussion of additional control measures. What is called for is a balanced approach in this area that maximizes the safe use of our resources. This means putting (and keeping) policies in place that give companies an incentive to accelerate the design and promotion of greener chemistry. Green incentives would be a welcome breath of fresh air in any legislative initiative.
A logical place to start is to retain the current way we review new chemistries. Imposing substantial base set data requirements would make many promising chemistries dead in the water, due to the substantial investment required before there is any sale on the books. Importantly, the Environmental Protection Agency's (EPA's) screening program for new chemistries has been effective. When US regulatory outcomes have been compared with EU result, the parity in results has been strikingly similar.
Green chemistry is virtually stymied in Europe due to up front test costs and now the focus of the REACH program in identifying hazardous chemicals that have somehow escaped notice despite years of use. Only after this hazard identification stage, prodded by the threat of hammers such as use restrictions and potential product bans, will green chemistry see the light of day in Europe. Certainly, this is an area the US can learn from and resist the urge to overburden the very products we want to see advanced.
Two other areas that Congress can look to in achieving significant green progress are biopolymers and enzymes.
Biopolymers: Biopolymers face a significant hurdle right now under TSCA, as EPA is insisting on premanufacture notifications for polymers manufactured through fermentation, and distinguishing them based on the chemicals that are charged to the reactor and the production source. In addition, biopolymers are not eligible for EPA's exemption for low risk polymers. EPA's polymer exemption exempts qualifying polymers from TSCA section 5 premanufacture notification requirements. In crafting this exemption, EPA recognized that polymers are among the safest classes of chemicals in the world. Persons relying on this exemption need only (1) make a certification of compliance with the exemption as of the time of first manufacture or import under the exemption, (2) notify the EPA by January 31, of the number of polymers first manufactured or imported under the exemption in the preceding calendar year, and (3) keep certain records.
The most exceptional feature of the amended exemption is that one can manufacture or import an eligible new polymer virtually without delay. This is because polymers that are eligible for the exemption are not required to undergo a review by the EPA. In addition, one does not have to satisfy many of the other requirements of premanufacture notification: filing a detailed submission, paying a $2500 user fee, or obtaining a Chemical Abstracts Service name for the polymer. Manufacturers and importers must make a determination of eligibility, keep adequate records, and file an end-of-year report in connection with the use of the amended exemption. Not all polymers will qualify. Overall, the polymer exemption significantly reduces the impediments to the commercialization of new polymers, which, in turn, greatly facilitates more rapid introduction of less risky polymers in commerce. Consistent with encouraging safer chemistries, TSCA reform should include a basis for exempting biopolymers. Serious consideration should be given to providing a platform to set conditions under which biopolymers (or some subset of biopolymers) could qualify for an exemption from premanufacture reporting, and be allowed to biodegrade without changing the prohibition on biodegradation for synthetic polymers.
Enzymes: EPA has put the enzyme industry on notice of its desire to put new rules in place for identification of these substances. Notice of EPA Proposal to Change Inventory Nomenclature for Enzymes and Proteins. 69 Fed. Reg. 65565 (Nov. 15, 2004). EPA is considering naming enzymes based on function, source, processing, and amino acid sequence. Traditionally, enzyme names are based primarily on function (catalytic activity), e.g. alpha amylase. Changing the way enzymes are named for TSCA would be an extremely cumbersome and tedious exercise, with no quantifiable environmental benefit attached. Enzymes (with snake venom being one of the few notable exceptions) are low risk and high benefit: think household cleaners, hospital sanitizers, laundry and dish detergents, and food production. With longstanding systems already in place to name and regulate enzymes, increasing the regulatory hurdles here will serve most significantly to increase the competitive pressures faced by US industry abroad.
TSCA specifically provides that "authority over chemical substances and mixtures should be exercised in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of the Act to assure that such innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment." 15 U.S.C. § 2601(b)(3). Emphasis on risk identification as a prerequisite to the regulation of biotechnology is echoed in the two major U.S. policy documents in the field, the Coordinated Framework for The Regulation of Biotechnology (1986) and the Policy on Planned Introductions of Biotechnology Products into the Environment (1992). These documents are the product of discussions under the direction of the White House Office of Science and Technology Policy (OSTP) concerning the legal rules that should govern the technology, which was then and is now viewed as vital to U.S. competitiveness. In 1980, the U.S. Supreme Court first held that a bacterium, engineered for improved oil spill clean ups, could be patented. Diamond v. Chakrabarty, 447 U.S. 303. The Chakrabarty decision, the Framework, and the Planned Introduction policy made critical contributions to the development of GMO and products derived from them. Chakrabarty gave private parties a stake in the outcome of this technology. The Framework was designed to harmonize the different legal authorities of the various agencies involved and create a common terminology to promote the technology. The Planned Introduction Policy instructed agencies as follows:
"unreasonable risk is the threshold for exercising oversight within the scope of discretion afforded by statute. The term does not denote a fixed absolute number. Rather, a risk is "unreasonable" where the environmental benefits achieved by oversight measures to reduce the risk are greater than the social cost of those oversight measures."
57 Fed. Reg. 6753, 6757 (Feb. 27, 1992).
A system that replaces one Inventory listing for an enzyme with several hundred or thousand Inventory listings is not a workable solution and cannot be reconciled with federal policies instructing the EPA to promote technological advancement. As an example, the potential new listings for lipases that catalyze the hydrolysis of triglycerides into free fatty acids and glycerol (CASRN 9001-62-1; E.C. 22.214.171.124) have been estimated at 22,400 to 67,200, based on their 56 possible bacterial sources (Gupta, R. et al. 2004, Applied Microbiology and Biotechnology), 8 to 12 known processes, and from 50 to 100 variations in amino acid sequences. The current TSCA Inventory consists of a total of over 82,000 commercial chemical substances. EPA's thinking on enzymes has the potential to literally quadruple the size of the TSCA Inventory, dwarfing any reductions in the size of the Inventory accomplished by its re-set initiative. This kind of departure for safe chemicals is, quite simply, unprecedented and well beyond the reform efforts underway in Europe.
Through effecting favorable treatment in TSCA, Congress can help steer a course that promotes US economic growth and the advancement of low-risk but highly useful chemistries. The progressive approach is to see that we do not make safe substances more scarce.