Abstract
Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. 1 In addition to all the elements great companies need to succeed—a great product, a great brand, inspiring leadership, and vision—biobased product companies need to understand how the US Environmental Protection Agency (EPA) occupies a virtual seat at their management table, whether or not they know it. This is because EPA implements the Toxic Substances Control Act (TSCA), a federal law that applies broadly to all chemical substances and mixtures, including renewable and biobased chemical products. In short, TSCA requires that before any “new” chemical can be offered for sale in the US, chemical manufacturers (including importers) must obtain EPA's pre-market approval, a process that takes no less than 90 days and often much, much longer. This often overlooked fact can put a real crimp in even the best laid commercialization plans. Understanding how, when, and to which entity or entities in the value chain TSCA applies, and what a renewable chemical innovator must do to comply with TSCA's requirements are critically important components of any company's commercialization game plan and ultimate market success.
Why BRAG, Why Now?
A coalition of companies and trade associations committed to enhancing the legal and regulatory positioning of biobased products has formed the Biobased and Renewables Products Advocacy Group, better known as BRAG. The primary driver in forming BRAG was the recognized gap that exists among biobased product coalitions and trade associations in addressing issues specific to biobased chemical products and, in particular, the unique and somewhat complicated regulatory issues that are front and center under TSCA for those chemical products and their derivatives. While there is a growing number of coalitions committed to emerging biobased product science, marketing, and commercialization issues, none is specifically focused on addressing regulatory and legislative challenges and opportunities imposed under TSCA. By bringing together biobased and renewable products innovators, TSCA legal experts, government affairs professionals, and science policy specialists, BRAG offers members a level of expertise, sophistication, and presence in Washington, DC—where all things TSCA originate—necessary to identify and address quickly and efficiently these challenges.
BRAG fills the void left by others. It effectively and efficiently leverages members' interests with other coalitions and groups focusing on different, complementary aspects of biobased chemicals and biofuels, thus avoiding redundancy and maximizing efficiency. Originally named the Biobased Products Advocacy Consortium (or B 2 PAC), BRAG unveiled its new name and logo at the 2013 Biotechnology Industry Organization (BIO) World Congress on Industrial Biotechnology in Montreal, in June 2013.
TSCA and Renewable Chemicals
As highlighted in an article in Industrial Biotechnology,TSCA regulates all chemicals in commerce, except those regulated under other statutes: specifically, pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); tobacco and tobacco products; certain materials regulated under the Atomic Energy Act; firearms and ammunition; and foods, food additives, drugs, cosmetics, and devices regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA). 2 Enacted almost 40 years ago, TSCA is now being stretched and manipulated to apply to emerging chemical production technologies—including the manufacture of chemicals from renewable feedstocks.
Indeed, when TSCA was passed in 1976, biobased chemistries and the need for renewable processes may not have been foremost in Congress's mind. Then, the manufacture of synthetic chemicals from petroleum feedstocks was very much the norm, and the nomenclature of chemical identification—a critically important element under TSCA — was premised largely on petroleum derivatives. Renewable and biobased feedstocks, while not unheard of then, were certainly not as common as they are currently. Similarly, these feedstocks were not considered as much when EPA developed its implementing regulations and core TSCA policies and practices. While the Obama-lead EPA is fully supportive of the concept of renewable and more sustainable chemistries, and recognizes the critically important role such products play in achieving sustainability, EPA is also focused on discharging its new chemical review and risk management duties under TSCA.
It is an inconvenient fact that the current regulatory framework under TSCA does not always give EPA nimble tools with which to work efficiently in addressing these new chemistries. While EPA scientists and managers work hard to commercialize newer, greener chemicals, the opportunities for a lack of alignment between an old law and new chemistries are many and complicated. These may result in commercial and regulatory anomalies that can significantly diminish the commercial promise of a new technology.
What chiefly causes these problems? In a nutshell, under TSCA, older petroleum-based chemistries were for the most part “grandfathered” when TSCA was enacted in the late 1970s. Generally speaking, existing chemicals in commerce at that time were automatically listed on the TSCA Inventory by means of a simple notification to EPA without any Agency review for risk assessment and risk abatement purposes. This lack of review has been a chronic criticism by TSCA detractors and a key reason fueling current demands for TSCA “modernization.” As its name suggests, the TSCA Inventory is merely a compendium of all chemicals in US commerce. Unless exempt, chemicals must be listed on the Inventory before commercialization can lawfully commence.
Newer biobased chemicals are not, in many cases, listed on the TSCA Inventory and thus are subject to “new chemical” review and evaluation processes by EPA scientists under TSCA's new chemical notification program. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of renewable chemicals; restrictions that may not apply to older petroleum chemistries even though they may be functionally identical. Ironically, the new chemical may offer a more benign environmental footprint, but nonetheless be subject to stricter operating conditions.
The imposition of regulatory controls on newer chemicals, largely by operation of law, can create commercial, engineering, and communication challenges. Downstream purchasers of new renewable chemicals have a hard time understanding why this new, greener chemical product is saddled with operating conditions and/or discharge limitations that dramatically lessen the commercial vitality of the product. That these challenges arise at all can be frustrating. If they arise late in the business commercialization cycle, they can have a devastating impact on the rollout of a new product, and even delay or kill a product and its commercial promise. Even worse, such adverse outcomes affecting commercialization may not apply to just one product, but would be continued through other products in the same biobased chemical family. BRAG addresses this discrepancy through focused communication, education, and advocacy efforts with EPA and other key government and non-government stakeholders.
As noted, BRAG recognizes that EPA remains committed to promoting cleaner and more efficacious technologies. Often, however, it is legally constrained to address product approval requests in ways that do not necessarily optimize the promise of the technology. BRAG's team of government affairs experts, scientists, and legal TSCA experts is well suited to deploy its significant expertise in TSCA and related science policy issues to address these challenges and bring products to market in ways that position them to succeed.
As a member-driven coalition, BRAG addresses those issues and activities of highest concern to its membership. BRAG is currently focusing on several projects and actions: • Monitor regulatory proposals impacting renewables. As one of its core objectives, BRAG remains vigilant and active in addressing regulatory actions that may result in commercially adverse impacts on the biobased chemicals industry. BRAG has, for example, submitted comprehensive comments opposing the recently proposed significant new use rules (SNUR) for six biobased chemical substances manufactured by KiOR, Inc. (Pasadena, TX). The comments highlighted BRAG members' concerns that EPA's proposed action set a disturbing precedent for future regulatory actions on other biobased chemical materials. BRAG questioned EPA's reluctance to rely on information derived from similar complex mixtures already listed on the TSCA Inventory, which could result in long-term impediments for the commercialization of other biobased chemical substances. • Communicate benefits and challenges for biobased chemical products to government decision-makers. The need to educate legislative and administrative decision-makers on issues of concern is a top priority. BRAG is planning a series of meetings with key congressional and White House staff over the next several months. As part of that effort, BRAG hopes to meet with staff from the EPA Office of Pollution Prevention and Toxics (OPPT) in support of a continuation of the OPPT Green Chemistry Market Roundtable. EPA budget cuts and staff furloughs have resulted in an unfortunate reality in which EPA is struggling to sustain the momentum for the Roundtable, and BRAG would like to work with EPA to consider options to keep this important line of communication open and available to the biobased chemicals industry. An important element in communicating with government stakeholders is how biobased chemicals fit within ongoing TSCA reform discussions. With the release of the bipartisan “Chemical Safety Improvement Act” (S. 1009) on May 22, 2013, it is now clear that the opportunity for true TSCA reform is a possibility. BRAG remains focused on monitoring the ongoing actions on Capitol Hill related to the TSCA debate. BRAG is exploring opportunities to highlight the importance of biobased materials in the legislative goal of safer consumer products, while at the same time ensuring that legislative language does not result in unintended adverse consequences for renewable chemistries. • Education and training. Because there are entities that may not fully understand or appreciate TSCA's implications with respect to biobased products, BRAG is actively engaged in outreach education and training sessions on renewable chemicals and TSCA regulations. BRAG recently coordinated with the Society for the Commercial Development of Industrial Biotechnology (SCD-iBIO) on the webinar “Commercializing Renewable Chemicals: What You Need To Know About TSCA” (June 12, 2013), intended to assist in educating smaller, start-up companies engaged in biobased chemistries on the reporting and recordkeeping obligations of TSCA. On Tuesday, June 18, 2013, at the BIO World Congress, BRAG sponsored a workshop entitled “Commercializing Renewable Chemicals and TSCA: Getting To Yes.” The workshop highlighted the potential pitfalls awaiting biobased and renewable chemicals on their way to EPA approval. These pitfalls are often unanticipated, resulting in delays, expense, and even termination on the road to commercialization. BRAG will also be sponsoring an in-depth TSCA workshop on November 11, 2013, in Philadelphia. The webinar will be co-presented with SCD-iBIO at the 2nd International SCD-iBIO Forum “Commercializing Global Green: Markets From The Value Chain Perspective.” In addition to these training and awareness opportunities, BRAG hopes to sponsor a training session for members on EPA's Sustainable Futures (SF) Initiative. The SF program gives new chemical developers access to the same risk-screening models that EPA uses to evaluate new chemicals before they enter the market. This, in turn, will allow BRAG members to understand how new biobased chemical products will be reviewed by EPA. It will highlight certain categories of concern and provide opportunities to address potential problems or issues of concern prior to formal review. In addition, graduates of the SF program are also eligible for expedited review of subsequent new chemical notifications, which allows products to become commercialized sooner. More information on the SF Initiative is available at • BRAG Biobased Products News and Policy Report, and web materials. BRAG provides a weekly news and policy report on issues pertaining to biobased products and biofuels, with news from Capitol Hill affecting the industry including sections on federal and state policy, research, tax policy, the Renewable Fuel Standard, Department of Energy and US Department of Agriculture developments, industry news, and more. The group's website,
BRAG-ging Rights for Members
Through strategic insight into regulatory and legislative issues, collective advocacy on Capitol Hill and before EPA, education and training opportunities, and hands-on guidance from a deep bench of TSCA legal and scientific policy experts, BRAG offers value, and is needed. The time for smart biobased product advocacy is now. We encourage all companies in the biobased and renewable products markets to join the effort.