This week, the Biobased and Renewable Products Advocacy Group (BRAG™) participated in the Biotechnology Industry Organization's Pacific Rim Summit on Biotechnology and Bioenergy in San Diego, California. The Summit included over 400 attendees with broad interest and involvement in biofuels and renewable chemicals. During the Summit, BRAG Executive Director Kathleen M. Roberts gave a presentation titled "The Here and Now of TSCA," in which she emphasized the criticality of including regulatory compliance into any company's commercialization plans, and outlined certain sections of the Toxic Substances Control Act (TSCA) applicable to biobased chemical manufacturers. Ms. Roberts highlighted the TSCA Inventory and Chemical Data Reporting (CDR) issues that can catch biobased chemical manufacturers off-guard and potentially lead to six-figure penalties, curtailed production, and/or very non-"Green" warnings and restrictions being required on labels and packaging. Her presentation helped clarify reporting thresholds and what role byproducts play in an entity's TSCA reporting requirements. A copy of the presentation is available online.
On December 4, 2013, EPA published a final rule requiring the electronic submission of certain documents under the Toxic Substances Control Act (TSCA). EPA is promulgating amendments to reporting requirements under TSCA Section 4 (including test rules and Enforceable Consent Agreements (ECA)), TSCA Section 5, TSCA Section 8(a) Preliminary Analysis Information Rule (PAIR) at 40 C.F.R. Part 712, and TSCA Section 8(d) Health and Safety Data Reporting Rules at 40 C.F.R. Part 716. A copy of the rule, including a more detailed description of the new reporting requirements, is available online. The rule will become effective on March 4, 2014.
Attendees at the Society for the Commercial Development of Industrial Biotechnology's (SCD-iBIO) 2nd Annual "Commercializing Global Green" forum in Philadelphia this week participated in a practical, in-depth three-hour workshop presented by the Biobased and Renewable Products Advocacy Group (BRAG™) on the critical policy, legislative, and regulatory issues impacting the commercialization of renewable chemicals. Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®) and Of Counsel with BRAG, shared the latest developments from Capitol Hill on the Chemical Safety Improvement Act of 2013 (CSIA) (S. 1009), in what she referred to as a "groundbreaking legislation" with bi-partisan support. Ms. Bergeson cautioned that "many difficulties remain and the likelihood of success is unclear." Ms. Bergeson also emphasized the need for the biochemical industry to engage with the U.S. Environmental Protection Agency (EPA) and identified strategies for companies to move successfully new chemicals through the regulatory process with EPA under the current version of the Toxic Substances Control Act (TSCA).
Kathleen M. Roberts, Executive Director of BRAG, updated workshop attendees on BRAG's efforts to petition for partial reporting exemptions under the TSCA Chemical Data Reporting (CDR) rule, and other efforts BRAG is making to level the regulatory playing field for biobased chemical manufacturers. Attendees learned about the complexities surrounding byproduct reporting under the CDR. They also learned that a number of listed chemicals, mainly derivative of the petroleum process stream, are exempted from Part III reporting, but those from renewable feedstocks are not, so the renewable chemicals may face higher regulatory hurdles than manufacturers anticipate. BRAG will be petitioning EPA early in 2014 for exemptions using a list of Chemical Abstract Service (CAS) numbers provided by members, and Ms. Roberts urged renewable chemical manufacturers to contact her to be included on this list.
Copies of BRAG's workshop presentations are available by contacting Chad Howlin at Tags: TSCA, workshop
On Wednesday, November 13, 2013, the House Committee on Energy and Commerce held a hearing on CSIA, a bill to reform TSCA. CSIA was introduced earlier this year by Senator David Vitter (R-LA) and the late Senator Frank Lautenberg (D-NJ). Senator Vitter and Senator Tom Udall (D-NM) are now working to move CSIA forward through the legislative process. A Law360 article recently published by Lynn Bergeson contains a detailed discussion of the significance and provisions of this legislation. With 25 bipartisan co-sponsors, CSIA is a "potentially politically viable framework for TSCA reform and renewed hope that badly needed modernization of this ancient law may occur."
The hearing included three panels of nine witnesses and focused on CSIA and potential reform to TSCA. A detailed memorandum on the hearing issued by B&C is available online.
Senators Vitter and Udall are working to address concerns about CSIA raised during a hearing held in July 2013 before the Senate Committee on Environment and Public Works on TSCA reform. The BRAG report on that hearing may be found online.
On October 29, 2013, hundreds of parents and children participated in a "stroller brigade" on Capitol Hill during which they lobbied Senate offices to provide greater protections against harmful chemicals during reform of the Toxic Substances Control Act (TSCA). The stroller brigade also joined actress Jennifer Beals at a press conference on TSCA reform sponsored by the Safer Chemicals, Healthy Families Coalition.
Following the July 31, 2013, Senate Environment and Public Works hearing on TSCA reform, Committee Members reportedly continue negotiations on S. 1009, the bi-partisan TSCA reform bill sponsored by Senator David Vitter (R-LA) and the late Senator Frank Lautenberg (D-NJ). The Biobased and Renewable Products Advocacy Group's (BRAG™) previous report on the bill and hearing is available online.
Also on October 29, 2013, the Center for Progressive Reform released a report critical of TSCA and the two current Senate bills designed to reform it, S. 1009 and S. 696, which is sponsored by the late Senator Frank Lautenberg (D-NJ). The report, "TSCA Reform: Preserving Tort and Regulatory Approaches," makes several specific recommendations for reform, including making it easier for EPA to obtain toxicity data from chemical manufacturers. A copy of the report is available online.
The number of Significant New Use Rules (SNUR) issued by EPA has greatly increased in recent months, causing long and costly delays for companies trying to market biobased chemicals and products. The Biobased and Renewable Products Advocacy Group (BRAG™) is holding a workshop to help companies avoid these delays by explaining how, when, and to which entity or entities in the value chain the Toxic Substances Control Act (TSCA) applies, and what a renewable chemical innovator must do to comply with TSCA's requirements.
Getting to Yes: A Focused Workshop Addressing Key Policy, Legislative, and Regulatory Issues in Commercializing Biobased Products
Presented by the Biobased and Renewable Products Advocacy Group in conjunction with the Society for the Commercial Development of Industrial Biotechnology
2:30-5:30 p.m., November 11, 2013, at the Chemical Heritage Foundation Center in Philadelphia, PA
Innovation is great, but commercializing innovations is even better. BRAG's Washington, D.C.-based team of government affairs experts, scientists, lawyers, and public policy managers will present a workshop to identify and discuss critical policy, legislative, and regulatory issues impacting the commercialization of renewable chemicals. Attendees will engage in focused discussions on current regulatory issues impacting the market, as well as a robust dialogue on expectations for the evolution of policy considerations from varied players, including those from academia, environmental groups, Capitol Hill, and EPA.
Join us at the beautiful Chemical Heritage Foundation's Library, Museum, and Conference Center in Philadelphia's historic district for this essential workshop prior to the 2nd International SCD-iBIO Commercializing Global Green Forum. For more information and to register click here.
On October 7, 2013, House Committee on Energy and Commerce Ranking Member Henry Waxman (D-CA) sent a letter to American Chemistry Council (ACC) President Calvin Dooley asking him whether ACC is "abandoning its 2009 principles for reform of the Toxic Substances Control Act." The letter is available online.
In his letter, Representative Waxman tells Dooley that he has been hopeful that reform of the Toxic Substances Control Act (TSCA) would include many of the principles for reform released by ACC in 2009. He alleges that ACC appears to have abandoned six key reform principles and asks Dooley to clarify ACC's current position. In closing, Representative Waxman states that "t would be disappointing and a blow to the chances for successful TSCA reform if the ACC has abandoned its 2009 principles."
ACC has publicly supported S. 1009, the bi-partisan Chemical Safety Improvement Act (CSIA). Bergeson & Campbell, P.C. has issued a section-by-section in-depth analysis of CSIA, which is available online.
The U.S. government is shut down until the U.S. Senate and House of Representatives approve the same version of legislation to fund it and the President then signs it into law. House Republicans have been trying to tie funding the government with defunding certain parts of the Affordable Care Act (ACA), which went into effect on October 1. The Senate has rejected every funding bill sent to it by the House because each has contained provisions to marginalize the ACA. The Senate has also rejected a piecemeal approach to funding the government. This has created a very high stakes game of ping pong between the two chambers of Congress.
Aside from the impact on the entire economy, the government shutdown directly impacts all regulatory and legislative efforts affecting the biofuels and renewable chemicals industries, including work on the Toxic Substances Control Act (TSCA) and the Renewable Fuel Standard (RFS). It will almost certainly delay upcoming expected rulemakings, including the U.S. Environmental Protection Agency's (EPA) proposed rule setting the 2014 renewable volume obligations (RVO) under the RFS. It is reported that nearly 95 percent of EPA's staff has been furloughed during the shutdown, leaving only 17 employees working in EPA's Office of Air and Radiation and three working in the Office of Water.
The shutdown also postpones hearings and other legislative efforts impacting industry, including the hearing scheduled October 3, 2013, before the Senate Agriculture, Nutrition and Forestry Committee on "Advanced Biofuels: Creating Jobs and Lower Prices at the Pump."
If the Continuing Resolution (CR) currently funding the government is allowed to expire on September 30, it could prove devastating to the U.S. Environmental Protection Agency (EPA). Unlike other federal agencies, EPA cannot claim exceptions for many of its employees. In the event the CR expires, as EPA Administrator Gina McCarthy asserted in public remarks this week, EPA "would effectively shut down." It would only have skeletal staff and would surely impact Renewable Fuel Standard (RFS) and Toxic Substances Control Act (TSCA) work, among others.
This fear about current EPA funding comes at a time when the Republican Members of the Senate Committee on Environment and Public Works sent a letter this week to Committee Chair Barbara Boxer (D-CA) urging her to move ahead with a hearing on EPA's Fiscal Year (FY) 2014 budget request. EPA requested $8.2 billion for FY 2014, which is 3.5 percent less than 2012 enacted funding levels for the Agency.
On September 18, 2013, the U.S. House Committee on Energy and Commerce held a hearing on "Regulation of Existing Chemicals and the Role of Pre-Emption under Sections 6 and 18 of the Toxic Substances Control Act." This was the third hearing in a series held by the Committee on the Toxic Substances Control Act (TSCA). It comes at a time when the Senate Committee on the Environment and Public Works (EPW) is also considering TSCA reform, including S. 1009, the "Chemical Security Improvement Act" (CSIA). Senate EPW Chair Barbara Boxer (D-CA) has indicated that preemption is an important issue and that she wishes to ensure that any TSCA reform protects state laws, including California's Proposition 65, the state's law regulating unsafe chemicals.
Bergeson & Campbell, P.C. (B&C®) has issued a detailed summary of the hearing, which is available online.