On May 28, 2014, policy researchers from the J. Craig Venter Institute (JCVI), the University of Virginia, and EMBO released a report on challenges faced by regulators with the increased use of more sophisticated synthetic biology technologies to engineer plants and microbes. According to the press release on the report, "[t]he authors conclude that while the United States governmental agencies tasked with oversight of products derived through synthetic biology have adequate legal jurisdiction to address most, but not all, environmental, health and safety concerns, several key issues could challenge these agencies including: the advent of newer plant engineering technologies that are outside the authority of some agencies, and increased use of more complex engineered microbes that could overwhelm regulators both from a science and safety review and increasing cost perspective." A copy of the press release on the report issued by JCVI is available online. A copy of the full report is available at online.
On May 29, 2014, the Woodrow Wilson Center's Synthetic Biology Project and the Massachusetts Institute of Technology released a report entitled "Creating a Research Agenda for the Ecological Implications of Synthetic Biology." The report suggests key research areas for government agencies, including species for comparative research; phenotypic characterization; fitness, genome stability and lateral gene transfer; control of organismal traits; monitoring and surveillance; modeling; and standardization of methods and data. A copy of the press release on the report is available online. A copy of the full report is available online.
Georgia Tech has announced that it is renaming its Institute of Paper Science and Technology the Renewable Bioproducts Institute (RBI). According to the announcement, the school has committed to doing the following to further the Institute:
* Recruit at least one new tenure track professor in the School of Chemistry and Biochemistry with relevant bioproducts experience to join more than 40 Georgia Tech faculty now working with RBI.
* Recruit a new tenure track professor in the School of Chemical and Biomolecular Engineering to contribute to the educational and research mission of the RBI.
* Recruit a professor of the practice with relevant industrial experience to work at the academic and research interface between industry and the RBI.
* Invest significant capital funds to expand and repurpose core lab facilities in the existing IPST building to better align with the expanded research focus areas of biorefining, biopolymers, and new materials.
* Draw on the full range of Georgia Tech's many industrial and political relationships to help promote and capture the opportunities in the bioproducts area.
A copy of Georgia Tech's press release on the announcement is available online.
On Friday, May 23, 2014, the U.S. Department of Agriculture (USDA) released its semi-annual regulatory agenda (Agenda) indicating its intended actions and priorities for the remainder of the year. A copy of USDA's Agenda is available online.
According to the Agenda, USDA intends to issue its final rule addressing how its BioPreferred® Program will designate complex products and intermediate materials and feedstocks in July 2014. USDA published its proposed rule on this matter in the Federal Register on May 1, 2012, and accepted public comment until July 2, 2012. A copy of the proposed rule is available online.
On Thursday, May 29, 2014, Biofuels Digest published an article by Biobased and Renewable Products Advocacy Group (BRAG™) Executive Director Kathleen Roberts titled “How to Make Friends and Win EPA Approvals: tips for biobased chemicals.” A copy of the article is available online.
The article highlights the B&C© affiliate BRAG™ and the session it co-presented with B&C during the Biotechnology Industry Organization’s World Congress on Industrial Biotechnology, which was held in Philadelphia, Pennsylvania May 12-15, 2014. The session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process,” was moderated by Lynn Bergeson of Bergeson & Campbell and included the following speakers: David Widawsky, U.S. Environmental Protection Agency; Tracy Williamson, U.S Environmental Protection Agency; Frank Pacholec, Stepan Company; and, Nancy Clark, DuPont Industrial Biosciences. The article published in Biofuels Digest includes summaries of the top tips for successfully navigating the regulatory process presented by Drs. Tracy Williamson and David Widawsky.
On May 20, 2014, the House Committee on Appropriations' Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (House Agriculture Appropriations Subcommittee) and the Senate Committee on Appropriations' Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Senate Agriculture Appropriations Subcommittee) marked up and passed their separate versions of a Fiscal Year (FY) 2015 spending bill for USDA. A copy of the House Agriculture Appropriations Subcommittee's draft bill is available online. A copy of the Senate Agriculture Appropriations Subcommittee's "Mark-up Bill Summary" for its version of the FY 2015 USDA spending bill is available online.
The House Agriculture Appropriations Subcommittee's bill is controversial and includes steep cuts to Farm Bill Energy Title programs recently expanded and provided mandatory funding by the Agricultural Act of 2014 (the 2014 Farm Bill), including to the Biomass Crop Assistance Program and Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance Program. Mandatory funding is not usually subject to cuts through the annual appropriations process. The biofuels and renewable chemicals industries are working to ensure mandatory funding for these programs is included in the final FY 2015 USDA spending bill.
The Biobased and Renewable Products Advocacy Group (BRAG™) reported on the significance of the expanded Energy Title programs and mandatory funding for them provided under the 2014 Farm Bill. A copy of that report is available online.
The California Department of Toxic Substances Control (DTSC) announced that Director Debbie Raphael will be leaving her position on May 30, 2014, to lead San Francisco's Department of the Environment. Raphael's replacement has not yet been announced.
In Raphael's place, Dr. Meredith Williams, DTSC Deputy Director, gave the keynote address at the 4th Safer Consumer Products Summit in Santa Clara, California, sponsored by B&C. Dr. Williams discussed DTSC's decision-making process with regard to its three selections in its draft initial Priority Product list (Paint and Varnish Strippers, and Surface Cleaners containing Methylene Chloride; Spray Polyurethane Foam Systems containing Unreacted Diisocyanates; and Children's Foam-padded Sleeping Products containing tris or tris(1,3-dichloro-2-propyl) (TDCPP)) and other DTSC efforts, including its development of a work plan identifying potential future Priority Products and guidance for companies to prepare alternative analysis assessments. DTSC also held on May 7, 2014, the first of three workshops related to its draft initial Priority Product list. The other two workshops are scheduled for May 28, 2014, and June 4, 2014.
Dr. Williams was introduced by Summit Chair Lynn L. Bergeson, whose comments are excerpted below.
"We have witnessed over the past years a dramatic shift in environmental law and policy from the regulation of end-of-pipe discharges of chemical substances into the environment (and their subsequent cleanup) to a more proactive focus on the presence of chemicals in products -- especially consumer products, and disciplined efforts to make better choices about ingredient selection and smarter production decisions to prevent pollution at the source. This shift is to ensure that product design and manufacture utilize greener materials and engage in smarter manufacturing processes to lessen the environmental footprint of product manufacture and use, and ensure the sustainability of product development and use.
"The Safer Consumer Products Regulation that went into effect last October is a bold, game-changing, historic development. The regulations reflect the newest chapter in California's implementation of its 2007 Green Chemistry Initiative. Whether the program in practice will be a faithful fulfillment of the goals underlying the Green Chemistry Initiative or evolves into something else remains to be seen. We are, after all, at the very early stages of the implementation phase of the SCP program. What is indisputable, however, is that the Safer Consumer Products Regulations are here to stay. They will have a considerable impact here in California and far beyond the state's borders."
Next week's Biobased and Renewable Products Advocacy Group (BRAG™) Report will include a full recap of the Summit, which will include contact information to receive copies of select presentations, including Dr. Williams' detailed PowerPoint.
On May 6, 2014, INVISTA, a large U.S. headquartered integrated producer of chemical intermediaries, polymers, and fibers, and owner of the LYCRA Brand, announced the introduction of the "only commercial offering of a bio-derived spandex available globally and for use in a wide variety of apparel fabrics and garments." The company explains that "[a]pproximately 70 percent by weight of the new LYCRA® bio-derived spandex fiber comes from a renewable source made from dextrose derived from corn." A copy of the Company's press release is available online.
On April 29, 2014, the U.S. House Committee on Energy and Commerce's Subcommittee on Environment and the Economy held a hearing on the revised version of the Chemicals in Commerce Act (CICA2). Details of the hearing provided by the Subcommittee, including its background memorandum, are available online.
Subcommittee Chair John Shimkus (R-IL) issued the original version of CICA in March 2014. CICA2 was released on April 22, 2014. Bergeson & Campbell, P.C.'s (B&C®) detailed summary and analysis of CICA2 is available online. B&C also issued a detailed summary and analysis of the April 29, 2014, Subcommittee hearing, which is available online.
The following witnesses testified at this week's hearing: The Honorable Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA); The Honorable Calvin Dooley, President and Chief Executive Officer, American Chemistry Council; Dr. Beth Bosley, President, Boron Specialties, LLC, on behalf of the Society of Chemical Manufacturers and Affiliates; Mr. Mark Greenwood, Principal, Greenwood Environmental Counsel, PLLC; Dr. Len Sauers, Vice President, Global Sustainability, Proctor & Gamble Company; Mr. Steven Goldberg, Vice President and Associate General Counsel, Regulatory & Government Affairs, BASF; Mr. Andy Igrejas, National Campaign Director, Safer Chemicals, Healthy Families; and The Honorable Michael Moore, on behalf of the National Conference of State Legislatures.
As discussed in more detail in the B&C summary, the hearing was very partisan. Shimkus defended his revised draft of CICA2 and argued that it attempts to address concerns raised by the Democrats on the Subcommittee. Subcommittee Democrats, including Ranking Member Paul Tonko (D-NY), argued that the revised bill fails to address their concerns. Jones asserted that CICA2 would need to be strengthened in certain areas to ensure necessary protection against harmful chemicals. For instance, he stressed the need for Toxic Substances Control Act (TSCA) reform legislation to include Administration principles on TSCA reform established in 2009. As explained in B&C's analysis, Jones also "claimed in his written testimony that CICA2 'does not include a mechanism that would provide for the timely review of existing chemicals that may pose a concern.' He also stated that 'y including a standard very similar to the current TSCA Section 6 authorities, the draft bill fails to address another key element of meaningful chemical safety reform' and also criticized CICA2 for including a consideration of costs or the availability of substitutes in risk management."
Given the continued partisan nature of the TSCA reform debate, particularly within the House of Representatives, prospects for enactment of reform in this shortened election year appear to be slim.
BRAG will present "Regulatory Landscape & Implications for Innovation," Thursday, June 19, 2014, at the 18th Annual Green Chemistry & Engineering Conference hosted by the American Chemical Society's Green Chemistry Institute.
Speakers and topics include:
Lynn L. Bergeson
American Chemistry Council
"State chemical management initiatives: Green chemistry? Or, something else?"
3E Company Department of Regulatory Research
"REACHing Asia in a green chemistry environment: Initiative, implementation and impact"
Elevance Renewable Sciences
Center for Environmental Health
"Moving California towards flame retardant-free furniture and baby products"
For information and to register click here.
EPA Presidential Green Chemistry Challenge Awards promote the environmental and economic benefits of developing and using novel green chemistry. These prestigious annual awards recognize chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use. Biobased and Renewable Products Advocacy Group (BRAG™) member Elevance Renewable Sciences was a Presidential Green Chemistry Award Winner in 2012. While applications for 2014 are due on April 30, 2014, it is not too soon to begin thinking and preparing for a 2015 submission. EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) sponsors the Presidential Green Chemistry Challenge Awards in partnership with the American Chemical Society (ACS) Green Chemistry Institute® and other members of the chemical community, including industry, trade associations, academic institutions, and other government agencies.
Throughout the 18 years of the awards program, EPA has presented awards to 93 winners. Since its inception in 1996 through 2012, EPA has received 1,490 nominations. By recognizing groundbreaking scientific solutions to real-world environmental problems, the Presidential Green Chemistry Challenge has significantly reduced the hazards associated with designing, manufacturing, and using chemicals.
According to EPA, through 2013, 93 winning technologies have made billions of pounds of green chemistry progress, including:
* 826 million pounds of hazardous chemicals and solvents eliminated each year -- enough to fill almost 3,800 railroad tank cars or a train nearly 47 miles long.
* 21 billion gallons of water saved each year -- the amount used by 820,000 people annually.
* 7.8 billion pounds of carbon dioxide equivalents released to air eliminated each year -- equal to taking 810,000 automobiles off the road.
More information is available online.