A post from the Environmental Law Institute's "Vibrant Environment" Blog
By Lynn L. Bergeson
The last thing the push for TSCA reform needs is another delay, and Senator Paul's unexpected interest in H.R. 2576 has caused just that. Under typical circumstances, a Member's focused interest in legislation is refreshing, and as today highlights, entirely too infrequent. In this instance, the circuitous road to TSCA reform is anything but typical—the complexity of the legislation has invited an unusual divisiveness that has frustrated passage—and delay is the enemy of the good.
When TSCA reform achieved bipartisan support in 2015, the Miracle on 34th Street quality of it all invited cautious optimism that reform of our ancient chemical management law just may be possible after all. Through 2015 and early 2016, the roller coaster ride the legislation took between the House and Senate was both nerve-wracking and energizing. Members and others "close to the legislation" metered out bits of information, sufficient to telegraph the patient was alive but requiring extreme measure to stay afloat. When the House voted on May 24, 2016, by an overwhelming majority to approve H.R. 2576, there was a palpable buzz in the chemical community and a real sense that this insanely stubborn law was finally going to relent and get its much- needed overhaul.
Seemingly out of nowhere, Senator Paul put a hold on the bill's further consideration. Taking his explanation at face value, wishing to read the legislation is not an unreasonable request. In addition to wanting to read the legislation closely, Senator Paul reportedly is concerned about the enhanced criminalization provisions in the bill that raise fines for TSCA violations and enhance penalties for knowingly putting someone in imminent danger. Both of these changes are consistent with penalties stipulated in other federal environmental laws. Paul’s request to put a hold on TSCA, however, disturbs a fragile balance that is not well-suited to sustain disruption, and plainly breaks the momentum the legislation enjoyed before the Memorial Day recess.
It is imperative that days do not turn into weeks, or worse. We need this law, and we need it yesterday. TSCA has not kept pace with chemical innovation and EPA desperately needs enhanced authorities to manage potential risks from existing chemical substances. The Senate must make this vote a priority when it reconvenes so President Obama can sign it, as we expect he will, and we can start the important work of implementing the law.
On April 5, 2016, the biofuel trade associations Advanced Biofuels Business Council, Algae Biomass Organization, Biotechnology Innovation Organization (BIO), Growth Energy, National Biodiesel Board, and Renewable Fuels Association sent a letter to House and Senate Leaders asking for a multiyear extension of advanced biofuel tax credits. The six organizations are specifically asking that the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, the Alternative Fuel and Alternative Fuel Mixture Excise Tax Credit, and the Alternative Fuel Vehicle Refueling Property through the Protecting Americans From Tax Hikes Act of 2015 are extended before they expire at the end of 2016. Other energy production tax credits have been extended, and the biofuel trade associations argue that extending certain energy tax provisions and not others creates investment uncertainty across the energy sector, and puts biofuel producers at a disadvantage.
On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6 Office in Dallas, Texas. Representatives from EPA, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the White House Office of Science and Technology Policy (OSTP) discussed their current roles and responsibilities regarding biotechnology products under the Coordinated Framework for Regulation of Biotechnology (CF) by reviewing case studies of hypothetical products.
Two documents were released prior to the public meeting: (1) Table of the oversight of biotechnology products and relevant coordination across EPA, FDA, and USDA; and (2) Regulation of Biotechnology Products -- Clarifying Roles and Responsibilities through Hypothetical Case Studies. A copy of the agenda is available here.
According to OSTP’s blog item on the meeting, the table document summarizes current responsibilities and the relevant coordination across USDA, EPA, and FDA for the regulatory oversight of biotechnology products. OSTP cautions that it should not be interpreted as a guarantee that specific products in any of the product areas described in the table have been in the past, or will be in the future, determined to be safe by the relative regulatory agencies.
The case studies document states that its intention is to provide general information to developers who believe they have, or are uncertain as to whether they may have, a biotechnology product that is subject to regulation under one or more of the federal laws described in the CF. It also demonstrates how an innovator might navigate the regulatory framework, starting from research activities in the laboratory to full commercialization of the product. OSTP states that all of the case studies are of hypothetical products, selected because they cover multiple biotechnology product areas with different characteristics and intended uses, and because they illustrate how agencies coordinate their oversight under the CF. The case studies discussed included the following hypothetical, genetically engineered organisms:
1. Corn, a field crop used for food. In the first case study, corn with pesticidal properties is engineered with a plant pest component to have pesticidal activity against certain insects.
2. Plum, a fruit tree/crop used as food. In the second case study, plum with pesticidal properties is genetically engineered without a plant pest component to resist a fungus.
3. Canola, a field crop, used as food. In the third case study, herbicide-tolerant Canola is genetically engineered with a plant pest component to tolerate an already registered herbicide.
4. Rose, an ornamental plant. In the fourth case study, a rose is genetically engineered with a plant pest component to increase the production of a pigment in its petals.
5. Microbial Pesticide, a bacterium that is not considered a plant pest. In the fifth case study, a microbial pesticide is genetically engineered to enhance its pesticidal properties.
6. Microbial Pesticide, a phytopathogenic bacterium. In the sixth case study, a microbial pesticide that is genetically engineered to express a pesticidal substance that protects against insects.
7. Algae for Biofuels. In the seventh case study, a unicellular alga is genetically engineered with a plant pest component to produce industrial oils for conversion into biofuels.
8. Rabbit, an animal. In the eighth case study, a rabbit is genetically engineered to make a therapeutic protein (recombinant insulin) for treatment of humans lacking this protein activity.
The first public engagement session took place on October 30, 2015, at FDA’s White Oak Campus in Silver Spring, Maryland. A transcript from the meeting is available online. The third public meeting will be held on March 30, 2016, at the University of California, Davis Conference Center in Davis, California.
More information regarding the CF is available in Bergeson & Campbell, P.C.’s (B&C®) memoranda OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology, White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology, and Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9.
On February 18, 2016, at the Advanced Bioeconomy Leadership Conference 2016 (ABLC2016), Dr. Catherine Woteki, Chief Scientist and Undersecretary for Research, Education, and Economics at the U.S. Department of Agriculture (USDA), announced the release of the Federal Activities Report on the Bioeconomy. The report was created to share current federal agency activities that help to develop and support the bioeconomy. The report first introduces the importance of fostering the bioeconomy and the purpose of the Biomass Research & Development Board. From there the report covers all research, loan, and other projects that federal agencies are currently engaged in. The agencies covered in this report are:
- The U.S. Department of Energy (DOE);
- The U.S. Environmental Protection Agency (EPA);
- The U.S. Department of the Interior (DOI);
- The National Science Foundation (NSF);
- The U.S. Department of Defense (DOD);
- The U.S. Department of Transportation (DOT); and
- The Executive Office of the President of the United States.
On May 21, 2015, Senators Chris Coons (D-DE) and Susan Collins (R-ME) introduced the Sustainable Chemistry Research and Development Act of 2015 (S. 1447). The legislation is intended to help coordinate and expand the many different programs that have been enacted across the federal government to promote and assist the development of sustainable chemistry that reduces risks to human health and benefits the environment. The bill would create a federal Interagency Work Group (IWG), lead by the National Science Foundation and the U.S. Environmental Protection Agency (EPA), that would work with a diverse Advisory Council (AC) to develop and implement a strategy to advance sustainable chemistry. This would streamline existing federal activities that promote the development of sustainable chemistry through grants and prize competitions. The Act does not create any regulatory components or authorize new spending by taking advantage of programs that are already in place and making them more efficient.
The bill calls for an examination of methods that the government could use to provide additional incentives and would require the IWG to track the amount spent on sustainable chemicals by the federal government and include those amounts in a report to Congress and the Government Accountability Office. The report will also analyze the progress that has been made and evaluate future strategies to ensure that efforts are not duplicated and interagency coordination is streamlined. The overarching goal of the IWG and the AC will be to produce a national strategy and implementation plan for sustainable chemistry that will advance research, development, technology, commercialization, education, and training within two years of the start of the program.
On June 2 and 3, 2015, the House Committee on Energy and Commerce held a markup hearing for the TSCA Modernization Act of 2015 (H.R. 2576) after years of progress on Toxic Substances Control Act (TSCA) Reform. The bill was praised for its bipartisan support as well as the removal of burdensome testing that has hindered the implementation of TSCA. The modernized TSCA will change how EPA regulates existing chemicals, with EPA first deciding if a chemical poses an unreasonable risk under its conditions of use, and then deciding how to manage the risk. A technical amendment was added to the Act and the Committee passed the amended bill. Committee Chair Fred Upton (R-MI) expects the bill to be on the House floor by the end of June 2015. Bergeson & Campbell, P.C. has published a memorandum on the hearing and a memorandum providing a detailed analysis of the slightly revised version of the bill on its website.
B&C has no involvement in or knowledge of the award selection process.
This year's Presidential Green Chemistry Challenge winners will be announced at the 20th Annual Presidential Green Chemistry Challenge Awards Ceremony, July 13, 2015, at the National Academy of Sciences in Washington, D.C.
The Presidential Green Chemistry Challenge, administered through a partnership between EPA and the American Chemical Society Green Chemistry Institute® (ACS GCI), promotes the environmental and economic benefits of developing and using novel green chemistry, and has significantly reduced the hazards associated with designing, manufacturing, and using chemicals.
Since 1996, the 98 winning technologies have made billions of pounds of real, measurable 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; and
- 7.8 billion pounds of carbon dioxide equivalents released to air eliminated each year -- equal to taking 810,000 automobiles off the road.
Past winners include:
- An environmentally safe alternative to toxic and bioaccumulating ships' hull coatings;
- A water-based, catalytic method used to produce gasoline, diesel, or jet fuel from sugar, starch, or cellulose;
- A process to create tiny micelles, or "nanoreactors," in water, within which a variety of chemical reactions can occur, eliminating the need for organic solvents;
- A polymer that coats titanium dioxide to reduce pigment clumping in paint, so less pigment needs to be used to achieve the same results, lowering carbon footprint, water use, and release of volatile compounds; and
- An enzyme that increases the ability of cellulose fibers to bind together, therefore reducing the paper's weight without sacrificing performance, and making it possible to use higher percentages of recycled pulp.
Detailed descriptions of all the winning technologies, processes, and discoveries are available on EPA's Green Chemistry website.
Presidential Green Chemistry Challenge Awards are awarded in six categories:
- Focus Area 1: Greener Synthetic Pathways;
- Focus Area 2: Greener Reaction Conditions;
- Focus Area 3: The Design of Greener Chemicals;
- Small Business (for a technology in any of the three focus areas developed by a business with annual sales of less than $40 million);
- Academic (for a technology in any of the three focus areas developed by an academic researcher); and
- Specific Environmental Benefit: Climate Change (for a technology in any of the three focus areas that reduces greenhouse gas emissions).
Information and instructions on nominating a product, process, or technology for an award are available on the Presidential Green Chemistry Challenge Award website.
ACS GCI offers a wealth of resources regarding green chemistry, including the brochure "Design Principles for Sustainable and Green Chemistry and Engineering," the What's Your Green Chemistry? YouTube channel, and Green Chemistry: The Nexus Blog.
Journalists interested in covering the safer, cleaner, greener chemistry that is being done by this year's winning chemistry innovators are encouraged to contact the EPA and ACS representatives listed below. There are both compelling business and consumer stories to be told about the companies and scientists who are working to make the products and services traded every day more profitable, sustainable, and renewable.
On March 18, 2015, Senator Ted Cruz (R-TX) introduced S. 791,
American Energy Renaissance Act of 2015." Representative Jim
Bridenstine (R-OK) introduced companion legislation, H.R. 1487. The legislation
would phase out the Renewable Fuel Standard (RFS), approve the Keystone XL
pipeline, open Alaska's Arctic National Wildlife Refuge for oil and gas
exploration, and stop EPA from regulating GHG emissions. Under the bill, the
RFS would start to be phased out in 2016 with a 20 percent reduction in the
volumetric requirements proposed by EPA. The 20 percent reductions would
continue each year until 2020
when the requirements would reach zero.
The legislation is unlikely to pass, but it is another example of
the ongoing RFS fight in Congress. The majority of the biofuels industry is
united in its advocacy to maintain the current RFS law, while the oil industry,
among others, has been fighting for its repeal.
March 10, 2015, Senators Tom Udall (D-NM) and David Vitter (R-LA) introduced
R. Lautenberg Chemical Safety for the 21st Century Act, a
bipartisan bill that would reform the Toxic Substances Control Act (TSCA). The
bill has 15 co-sponsors -- seven Democrats and eight Republicans. The bill
builds on the proposed Chemical Safety Improvement Act offered by Senator
Vitter and the late Senator Frank Lautenberg (D-NJ) in 2013. According to the
overview provided on Senator Udall's webpage, the 2015 bill
clarifies that cost cannot be a consideration factor in determining chemical
safety, provides a definition for "vulnerable populations," and
implements specific deadlines for the U.S. Environmental Protection Agency
(EPA) in evaluating existing chemicals. The bill attempts to address the most
contentious issue surrounding TSCA reform -- state preemption. Under the
proposal, state chemical regulations in place prior to January 2015 would be
grandfathered. In addition, states would be able to act on chemical
restrictions until and unless EPA takes up the same chemical for the same use
applications, and can request a waiver to set different regulations than EPA
during the safety assessment and final rule. The goal is to have a uniform
federal standard for the entire nation, which increases regulatory certainty
while still protecting citizens. See the detailed analysis of the Lautenberg Chemical Safety for the 21st Century Act prepared by BRAG affiliate Bergeson & Campbell, P.C.
On February 25, 2015, the U.S. House of Representatives' Committee
on Energy and Commerce's Subcommittees on Energy and Power and Environment and
the Economy held a joint hearing on "The
Fiscal Year 2016 EPA Budget." During the hearing, both
supporters and opponents of the federal Renewable Fuel Standard (RFS)
criticized U.S. Environmental Protection Agency (EPA) Administrator Gina
McCarthy on the Agency's implementation of the program. RFS supporters pointed
out that EPA's delay in issuing the 2014 RFS rule in final has compromised the
stability of the RFS. RFS opponents argued that the RFS itself is unworkable
and that EPA's implementation of the program harmed the refining industry.
Members of the Subcommittees also expressed concern that EPA was spending too
much time on other policies, including the ozone standard, thus taking away
from its implementation of the RFS.
This hearing occurred in the same week that Senators Dianne
Feinstein (D-CA) and Pat Toomey (R-PA) introduced the Corn Ethanol Mandate
Elimination Act of 2015. The bill would eliminate the corn ethanol requirements
under the RFS. The biofuels industry has expressed its strong opposition to
this legislation, arguing that eliminating the corn ethanol requirements under the
law would destabilize the RFS policy and investment in the entire biofuels
industry, including advanced and cellulosic biofuels. In a win for the biofuels
industry, this week, U.S. Senate Committee on Environment and Public Works
Chair, James Inhofe (R-OK), reportedly expressed doubt that the bill would be
considered by his Committee this year because he does not expect to be able to
build enough support to pass it.