The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

On July 15, 2016, Environmental Leader published "What Does the Loss of 'Green Chemistry' Provision from Amended TSCA Mean for Biochemicals?," featuring comments by Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®). Ms. Bergeson expanded on a previous blog post titled "Inside EPA Reports On Loss Of Green Chemistry Provision From TSCA Reform," stating:

"While regrettable, the absence of the green chemistry provisions in the amended Toxic Substances Control Act (TSCA) is a setback, not a deal breaker," Bergeson told Environmental Leader. "The green chemistry provisions in Section 24 of H.R. 2576 were taken from Senator Chris Coons' (D-DE) Sustainable Chemistry Research and Development Act. Section 24 was eliminated reportedly because its inclusion would have been subject to review by the House Science, Space, and Technology Committee, a different House Committee from the House Energy and Commerce Committee that had primary jurisdiction over TSCA reform, potentially complicating and delaying an already complicated and time-sensitive Congressional review process. The decision to forego this review and eliminate the green chemistry provisions is disappointing, but a failed TSCA reform effort would have been more so."

Bergeson notes that the provision's absence in the updated chemical safety law eliminates -- for now -- the development of and funding for a green chemistry strategy at the federal level. Senator Coons is expected to introduce a similar bill next year.

Senators Coons, Susan Collins (R-ME), and Ed Markey (D-MA) have asked the U.S. Government Accountability Office (GAO) for a technology review of sustainable chemistry. "The report, expected to be complete in the spring of 2017, can help illuminate the options available to the federal government to promote green chemistry whether by instigating new legislation or by serving as a resource which existing legal authorities can use to support this field that is so vital to economic competitiveness and/or use to diminish the less positive impacts of chemistry throughout our economy," Bergeson stated.


 

On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House's amendment to S. 764, with further amendment. While the bill is being referred to as a genetically modified organism (GMO) labeling bill, there is no actual requirement to print GMO ingredients on labels. Instead, companies would be required to print information on the packaging (through text, a symbol such as a QR code, or an electronic link) directing consumers to a website or phone line for more information. The national bioengineered food disclosure standard includes a definition for "bioengineering": "a food - (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature," as well as specifics on how the new standard will be established through requirements and procedures. The new requirements and procedures include the following:

  • Prohibition of a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance;
     
  • Determination of the amounts of a bioengineered substance that may be present in food for the food to be a bioengineered food;
     
  • Establishment of a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a bioengineered food;
     
  • Provision of alternative reasonable disclosure options for food contained in small or very small packages; and
     
  • Requirements and procedures specific to small food manufacturers.

Subtitle F includes a section on federal preemption, which states that any state regulations on "labeling of whether a food (including food served in a restaurant or similar establishment) or seed [in interstate commerce] is genetically engineered ... or was developed or produced using genetic engineering," and also a section on exclusion from federal preemption -- that nothing in the subtitle, or in Subtitle E, "shall be construed to preempt any remedy created by a State or Federal statutory or common law right." The bill will allow producers with a U.S. Department of Agriculture "certified organic" designation to display an additional "non-GMO" label on their products. S. 764 is now back in the House and is expected to be taken up before Congress's seven week recess beginning July 15, 2016.


 

On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology Committee, further complicating the fragile House and Senate negotiations. Inside EPA's source stated: "Nobody wanted to step on anybody's toes. [...] Pretty much everything else [was] in [Energy and Commerce's] jurisdiction or was sufficiently small enough [to not raise concerns.] There were a lot of concessions on all sides." The green chemistry provision was originally added to the Senate version of the TSCA Reform, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), by Senator Chris Coons (D-DE), and was primarily focused on funding the research and development of green chemistry.

The green chemistry provision of S. 697 called for a study of how to best incentivize sustainable chemistry research and development, as well as support "economic, legal and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry." The bill also created a working group to coordinate federal sustainable chemistry activities that would be lead by EPA's research chief and the National Science Foundation (NSF) director, as well as an advisory council to coordinate with the working group. Although green chemistry language in S. 697 did not remain in the final version of the bill, there are still supporters in Congress who are prepared to work to get the programs outlined in S. 697 into law.


 

On June 15, 2016, H.R. 5489, Agriculture Environmental Stewardship Act of 2016, was introduced to the House Ways and Means Committee on Science, Space, and Technology. The bill would add additional biogas applications to the list of technologies that qualify for the federal Section 45 energy investment tax credit, increasing acceptable biogas technologies from only biogas-based electricity projects to "qualified biogas property" defined as:

property comprising a system which--
 
(i) uses anaerobic digesters, or other biological, chemical, thermal, or mechanical processes (alone or in combination), to convert biomass (as defined in section 45K(c)(3)) into a gas which consists of not less than 52 percent methane, and
 
(ii) captures such gas for use as a fuel.

Qualified biogas properties, as well as qualified manure resource recovery properties, will be eligible for a 30 percent tax credit under this bill. H.R. 5489 was introduced with bipartisan support by Representatives Tom Reed (R-NY) and Ron Kind (D-WI), and signed by 12 other House members. A similar bill is expected to be introduced in the Senate,


 

On June 22, 2016, President Obama signed H.R. 2576, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) during a signing ceremony. Lautenberg represents years of negotiation and is a towering achievement to enhance the U.S. Environmental Protection Agency's (EPA) authority to review industrial and consumer chemicals and provide the public with confidence that chemical products do not pose unreasonable risks.

Of particular interest to biobased chemical manufacturers and users, Lautenberg requires that EPA maintain the use of Class 2 nomenclature and the Soap and Detergent Association Nomenclature System. In addition, if a manufacturer or processor demonstrates that a "substance appears multiple times on the [Inventory] under different [Chemical Abstracts Service] numbers, [EPA] may recognize the multiple listings as a single chemical substance." While it is not yet clear how the nomenclature provisions of Lautenberg will affect the ability of novel biobased chemicals to be incorporated into supply chains without triggering new chemical notification, it does raise the profile of Class 2 nomenclature and may enable additional high-level discussions related to source-based nomenclature and the barriers that such nomenclature present to new chemicals.


 

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.

TSCA

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:

  • USDA;
  • 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.


 
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