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 March 2, 2017, Kathleen M. Roberts, Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG®), participated as a panelist alongside four other trade associations in the “Domestic Policy Forum” at the 2017 Advanced Bioeconomy Leadership Conference (ABLC2017).  Ms. Roberts discussed the challenges facing the bioeconomy, including the implementation of the amendments to the Toxic Substances Control Act (TSCA), issues with the TSCA nomenclature system, and the potential for increased scrutiny of renewable products under the current Administration, as well as the work being done by BRAG to address these challenges and to level the playing field for biobased chemicals.  If companies wish to ensure equitable regulations for biobased chemicals and products, they should consider joining BRAG to assist with future engagement with EPA.

On March 2, 2017, Richard E. Engler, Ph.D., Senior Chemist for Bergeson & Campbell, P.C. (B&C®), presented “New TSCA: How Renewable Chemicals Survive and Thrive” at ABLC2017.  Dr. Engler presented as part of the Renewable Chemicals Summit and provided an overview of amended TSCA with a focus on the fundamental changes that will impact the bioeconomy.  Amendments to TSCA Section 5 require EPA to make an affirmative determination on every new chemical review, which has resulted in significantly more regulations for new chemicals.  Additionally, under amended TSCA, Congress has the authority to preempt state action, and EPA has increased testing authorities, as well as the authority to determine chemical substances as equivalent and the authority to increase fees under Sections 4, 5, 6, and 14.  For a copy of this presentation, please contact Dr. Engler at .(JavaScript must be enabled to view this email address).

Tags: ABLC, TSCA, B&C, BRAG

 

On January 17, 2017, Neste, a member of BRAG, announced a research and development cooperation with Bioenergy La Tuque to study the potential of using forest residues as a raw material in biofuel production in La Tuque, Canada.  The cooperation will expand Neste’s raw material selection, which currently consists of ten raw materials for renewable product production, and will increase the use of waste and residues.  The project will assess the biomass availability at a competitive cost, identify technology bottlenecks in process lines, and validate the acceptable level of risk.


 

The Algae Biomass Summit is the largest algae conference in the world.  This is where leading producers of algae products go to network with industry suppliers and technology providers, where project developers converse with utility executives, and where researchers and technology developers rub elbows with venture capitalists.  Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) is a proud sponsor.  B&C Senior Chemist Richard E. Engler will chair “Legal, IP, and Regulatory Challenges and Opportunities” on Tuesday, October 25, 2016.


 

On July 12, 2016, Neste, a BRAG member, published "4 Reasons Why The World Needs Biofuels," highlighting the positive results of seeking alternative, low-carbon sources of renewable energy. The article mentions that "biofuels offer a solution to reduce carbon emissions of traffic when other solutions, such as switching to electric vehicles, is not an option due to high vehicle costs or lack of vehicle charging network." Biofuels also help to combat climate change, respond to higher energy consumption, safeguard energy security, and best utilize scarce resources.


 

Scientists, executives, investors, and media representatives gathered in San Diego, California on Monday evening for a fascinating and wide-ranging panel discussion on current issues facing bioeconomy leaders and innovators. The reception, hosted by the Biobased and Renewable Products Advocacy Group (BRAG®), Bergeson & Campbell, P.C. (B&C®), and Industrial Biotechnology, included panelists Christophe Schilling, Ph.D., Founder and CEO of Genomatica; Blake A. Simmons, Ph.D., Chief Science and Technology Officer and Vice-President of the Deconstruction Division of the Joint BioEnergy Institute; and Anna Rath, President and CEO of NexSteppe and recipient of the 2016 BIO Rosalind Franklin Award honoring outstanding women in the field of industrial biotechnology. The panel took advantage of the relaxed atmosphere of Southern California and sat at a table amongst the invited guests to field questions from moderator Richard E. Engler, Ph.D., Senior Chemist with B&C, and from many of the attendees.

Asked to name the most important factor in the success of their respective companies and labs, each panelist mentioned the quality of the people on their scientific and management teams as being more critical than any other factor. In response to the question "[d]o you discover a product and then find or create a market for it, or do you notice a market opportunity and then develop a product to meet it?," all three responded that they start with a market focus and seek ways to satisfy that market need. When asked about whether regulatory or policy hurdles have impacted them at all, Ms. Rath mentioned those concerns as a factor in NexSteppe's approach to product lines and bases of operation. By creating different sorghum varieties using traditional breeding and hybridization techniques, NexSteppe can optimize its products for biofuels, biobased chemicals, bioenergy, and biogas so that its operations are not overly impacted by any one policy or regulatory change, such as the Renewable Fuel Standard (RFS) in the U.S. Dr. Schilling identified regulatory issues as one of the reasons Genomatica initially focused on applying its bioengineering processes to create sustainable versions of existing industrial chemicals, that is, chemicals already in commerce that would not face regulatory scrutiny as a new substance.

After lamenting the lack of scientists in politics, a guest somewhat jokingly asked if anyone on the panel would consider running for office. While fervently denying any chance of that (eliciting an audience member to wonder if this was only a "Paul Ryan-esque disclaimer?"), the panelists went on to point toward the many outstanding scientists working at federal agencies, in the White House Office of Science and Technology Policy (OSTP), the National Science Foundation (NSF), and in other advisory roles. Dr. Simmons particularly lauded the scientists in the 17 U.S. Department of Energy (DOE) National Laboratories, who not only create scientific breakthroughs for the benefit of U.S. business and citizens, but also advise political leaders on science issues, mentioning that after the reception, he needed to work on notes for a briefing he will give Energy Secretary Ernest Moniz later in the week. At the conclusion of the scheduled panel portion of the evening, many guests stayed to continue in conversation with the panelists, attendees, and sponsors.


 

In less than two months, renewable fuel and biobased chemical companies that have successfully moved from research and development to commercialization will be required to respond to the U.S. Environmental Protection Agency's (EPA) Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA). This may come as a surprise to some biobased chemicals companies that are under the misperception that they are not regulated under TSCA. This is simply wrong. Unless otherwise regulated as a pesticide, food, food additive, drug, cosmetic, or nuclear material, biobased chemicals used for a commercial purpose, including fuels regulated under the Renewable Fuel Standard program, are subject to the rules and requirements under TSCA. Companies that do not comply are subject to enforcement actions and significant fines of up to $37,500 per violation, per day.

The reporting window for the 2016 CDR is June 1, 2016, to September 30, 2016. CDR reporting includes detailed information on volumes of chemicals produced, imported, used on site, and exported. It also requires information on amounts and functions for downstream uses in industrial, commercial and consumer applications. CDR reporting is further complicated with numerous potential exemptions that must be carefully analyzed for applicability. Bergeson & Campbell, P.C. (B&C®) is hosting an informational webinar on CDR reporting on May 3, 2016, from 1:00 p.m. - 2:00 p.m. (EDT). All impacted stakeholders are invited to participate, but companies new to the TSCA arena and CDR reporting are urged to attend.


 

As reported in last week's Update, EPA published its final rulemaking expanding the list of chemicals partially exemption from certain additional chemical data under the CDR. This action, which formally amended the list of chemicals that do not have to report the onerous downstream processing and use information under the CDR Form U, Part III, occurred because of the forward thinking actions of the Biobased and Renewable Products Advocacy Group (BRAG®). In October 2014, recognizing an advocacy opportunity to equalize what had been an uneven regulatory reporting field for biodiesel products, BRAG submitted a petition to EPA outlining the reasons why the six biodiesel chemicals listed below should be afforded reduced reporting requirements under the CDR:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No. 129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

EPA quickly concurred with BRAG's view and issued a direct final rule to add the listed chemicals to the partial reporting list in January 2015. Unfortunately, due to one adverse comment submitted, which did not provide information pertinent to EPA's planned actions, the listing process under the direct final rule was halted. Instead, EPA had to proceed with a proposed rulemaking under the Administrative Procedures Act, a significantly more time and resource consuming approach. At that time, BRAG members were very concerned that EPA may not complete the rulemaking process to add the biodiesel chemicals to the partial reporting exemption list in time for the 2016 reporting cycle.

Knowing the industry's concerns with the upcoming reporting cycle, EPA staff worked diligently to issue the proposed rulemaking in July 2015. No adverse comments were submitted, and the final rulemaking was issued six months later, which is lightening fast action within a regulatory context.

While BRAG members took the initiative to request the partial reporting exemption and worked with EPA to ensure the listing occurred, any company that manufactures or imports the listed biodiesel products can take advantage of the listing. Thus, for the 2016 reporting cycle, companies that produce or import the above-listed six biodiesel chemicals do not have to report the following information elements for the exempted chemicals:

  • Top ten combinations of industrial process, industrial sector, and industrial functions;
     
  • Production or importation volumes associated with each combination;
     
  • Number of industrial sites using the chemical within each combination;
     
  • Number of workers potentially exposed within each combination;
     
  • Top ten consumer and/or commercial downstream applications;
     
  • Indication of whether reported consumer or commercial categories result in products intended for children;
     
  • Production or importation volumes associated with each reported consumer or commercial category;
     
  • Maximum concentration within each reported consumer or commercial category; and
     
  • Number of workers potentially exposed within each reported consumer or commercial category.

Per EPA's estimate, companies that utilize this reporting exemption will save 65.63 hours or almost 1.5 weeks of staff time, per report. Companies that produce more than one of the listed chemicals or have more than one reporting site will save even more.


 

On March 29, 2016, the U.S. Environmental Protection Agency (EPA) published the Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data final rule in the Federal Register. This final rule amends the list of chemical substances that are partially exempt from additional reporting requirements under the Chemical Data Reporting (CDR) rule. The rule applies to six biodiesel chemicals that are very similar to petroleum based biodiesel chemicals that are already on the exempt list. EPA determined that CDR processing and use information for these chemical substances is of low current interest and, while the chemical substances can be removed from the exempt list in the future, manufacturers are now exempt from submitting processing and use information for:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No.129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

This exemption was created after the Biobased and Renewable Advocacy Group (BRAG®) petitioned EPA in 2014 to create an equivalent exemption for six biodiesel versions of petroleum based chemicals that were already exempt from submitting processing and use information under the CDR rule.


 

On August 26, 2015, Malama Composites, Inc. (Malama) announced that its Studio BioFoam® product had earned the U.S. Department of Agriculture (USDA) Certified Biobased Product Label. This news was followed by a second announcement on August 27, 2015, when another biobased foam produced by Malama, Pacific BioFoam™, also received the Biobased Product Label from the USDA. Malama is a Biobased and Renewable Products Advocacy Group (BRAG®) member that develops and manufactures foams made from sustainable resources. Studio BioFoam is the first and only biobased rigid urethane foam to receive a Certified Biobased Product Label while Pacific BioFoam has the highest biobased content of all commercially available two-part urethane foam systems. Both products are made of zero emission materials, including vegetable polyol and water as a blowing agent.


 

On March 30, 2015, the U.S. Environmental Protection Agency (EPA) withdrew a Direct Final Rule for Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data. The direct final rule, issued in January 2015, would have exempted manufacturers of six biobased diesel chemicals from reporting processing and use information for the compounds under the Chemical Data Reporting (CDR) rule. It resulted from a regulatory petition filed by the Biobased and Renewable Advocacy Group (BRAG®). The EPA decision to withdraw the rule was in response to a single comment posted during the short comment period.

Kathleen Roberts, BRAG's Executive Director, stated: "Albeit disappointing, the response is not unexpected given the strict procedures associated with direct final rules. EPA has stated it plans to proceed with a proposed rulemaking to list the chemicals soon and we will urge them to move as quickly as possible. Our hope is EPA can complete the rulemaking process in time for the next reporting CDR cycle, which starts in June 2016."

Until the new rule is completed, manufacturers of the six affected biobased diesel chemicals should be prepared to submit processing and use information under the CDR in 2016.

 

 
 1 2 >