Biobased and Renewable Products News: Federal
November 6, 2020
FDA Requests Comments On Reauthorization Of BsUFA
On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. Under BsUFA, FDA collects user fees to support its process for the review of biosimilar and biological products and the current legislative authority is set to expire in September 2022. At the aforementioned time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA requests public comments as it begins the process to reauthorize ... read more >
September 4, 2020
ELI Report Looks At Trump Administration’s Impact On Environmental Law And Policy And What Lies Ahead
The Environmental Law Institute (ELI) recently released Environment 2021: What Comes Next?, a report that looks at the Trump Administration’s impact on environmental law and policy and what lies ahead. ELI states that the report is “a response to growing demand for analysis of how deregulatory initiatives by the Trump Administration will affect environmental protection, governance, and the rule of law with a focus on what might happen in a second Trump administration or a new administration.” According to ELI, the report:
Assesses the Trump Administration’s steps to ... read more >
August 7, 2020
FDA DHHS Announces 2021 Biosimilar User Fee Rates
On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through September 30, ... read more >
March 6, 2020
Guidance On Biological Product Transition Issued By FDA
On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be a license for the biological product under Section 351 of the Public Health Service Act (PHS Act) as ... read more >
March 6, 2020
FDA Requests Comments On Its Licensed Biological Products Database
On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. These upgrades will be released in multiple phases. FDA has now completed phase I, which consists of the full search functionality of ... read more >
February 28, 2020
FDA Issues Final Rule Amending The Definition Of “Biological Product”
On February 21, 2020, the U.S. Food and Drug Administration (FDA) issued a final rule to amend its regulation that defines “biological product.” The new definition incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act). Under the final rule, the statutory term “protein” is interpreted to mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. Intended to clarify the statutory framework under which such ... read more >
February 28, 2020
FDA Upgrades Its Database Of Licensed Biological Products
On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full search functionality is the first step. Subsequent phases will include the expansion of the number of FDA-licensed ... read more >
August 23, 2019
FDA Announces Collection Of Information Submission To OMB
On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for fiscal years 2013 through 2021. OMB is ... read more >
August 16, 2019
FDA Announces Biosimilar User Fee Rates For FY 2020
On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in an application. The established fees will apply to the period from October 1, 2019, ... read more >
August 9, 2019
Utility Workers Announce Apprenticeship Program In The Renewable Energy Sector
On August 6, 2019, the Utility Workers Union of America (UWUA) announced its partnership with The Power for America Training Trust Fund (P4A) for the launch of a renewable energy specialist apprenticeship program. Certified by the U.S. Department of Labor (DOL), the program aims at assisting individuals with a path to employment for highly demanded jobs in the renewable energy sector. Under this program, individuals will be taught specialized skills in the fields of solar generation, battery storage, and offshore and onshore wind. An earn-while-you-learn program, this two-and-a-half-year ... read more >
July 12, 2019
USDA To Amend Guidelines For Designating Biobased Products For Federal Procurement
On July 5, 2019, the U.S. Department of Agriculture (USDA) Office of Procurement and Property Management published a final rule that will amend the Guidelines for Designating Biobased Products for Federal Procurement (Guidelines) to add 30 sections designating the product categories within which biobased products would be afforded procurement preference by federal agencies and their contractors. These 30 product categories contain finished products that are made, in large part, from intermediate ingredients that have been designated for federal procurement preference. Additionally, USDA is ... read more >
May 24, 2019
HHS Announces Availability Of Draft Guidance On Therapeutic Protein Biosimilars
On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” It provides recommendations on the design and evaluation of ... read more >
March 29, 2019
FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Developers
In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards. Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced ... read more >
March 15, 2019
FDA Commissioner Releases Statement On Biotechnology Innovations
On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon. In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S. According to FDA’s recent framework for the efficient development of safe biotechnology products, Plant and Animal ... read more >
November 9, 2018
Call For Candidate Chemicals For Equivalency Determinations
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” ... read more >
August 3, 2018
Senators Collins, Coons Introduce Bipartisan Bill To Promote Innovation In Sustainable Chemistry
On July 30, 2018, Senators Susan Collins (R-ME) and Chris Coons (D-DE) reintroduced their sustainable chemistry bill, the Sustainable Chemistry Research and Development Act of 2018 (S. 3296). This bill encourages the development of new and innovative chemicals, products and processes with an improved “environmental footprint” through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment. The legislation is intended to support new innovations in chemistry that benefit the ... read more >
June 29, 2018
FDA Withdraws Draft Guidance On Evaluation Of Analytical Similarity Between A Proposed Biosimilar Product And A Reference Product
On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.” Further, comments submitted to the docket “addressed a range of issues that could impact ... read more >
December 15, 2017
DOC Postpones LTFV Final Determinations Related To Biodiesel From Argentina And Indonesia
On December 8, 2017, the U.S. Department of Commerce (DOC) issued in the Federal Register a notice on the postponement of final determinations of sales in less than fair value (LTFV) investigations into biodiesel from Argentina and Indonesia and the extension of provisional measures. As reported in the Biobased and Renewable Products Advocacy Group (BRAG®) blog post “DOC Initiates Biodiesel Antidumping, Countervailing Investigation,” DOC initiated LTFV investigations of imports of biodiesel from Argentina and Indonesia on April 12, 2017. DOC is postponing ... read more >
October 20, 2017
EPA Final Rule On Use Of TOFA Confirms Safety Of Unsaturated Fatty Acids
On October 10, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its final rule establishing exemptions for a tolerance limit to use tall oil fatty acids (TOFA) as an inert ingredient “[i]n pesticide formulations applied to growing crops and raw agricultural commodities after harvest; in pesticides applied in/on animals, and in antimicrobial formulations for food contact surfaces.” Pursuant to Section 408(c)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA has the authority to establish exemptions from the ... read more >
September 1, 2017
DOC Publishes Preliminary AD/CVD Determination For Argentina And Indonesia
On August 28, 2017, the U.S. Department of Commerce (DOC) announced in the Federal Register that a preliminary determination had been issued in the antidumping (AD) and countervailing duty (CVD) investigations on biodiesel from Argentina and Indonesia. DOC preliminarily determined that countervailable subsidies are being provided to producers and exporters of biodiesel from Argentina and Indonesia. The period of investigation for both countries is January 1, 2016, through December 31, 2016.
Pursuant to Section 703(e)(1) of the Tariff Act of 1930, DOC preliminarily ... read more >
August 18, 2017
DOC Postpones Biodiesel AD/CVD Investigation Preliminary Determinations
On August 15, 2017, the U.S. Department of Commerce’s (DOC) International Trade Administration (ITA) announced in the Federal Register that the preliminary determination in the antidumping (AD) and countervailing duty (CVD) investigations on biodiesel from Argentina and Indonesia will be postponed. A request to postpone the determinations was submitted by a petitioner on July 6, 2017, and, pursuant to Section 733(c)(1)(A) of the Tariff Act of 1930, ITA determined that there was no compelling reason to deny the request. The preliminary determination will now be due by October ... read more >
January 13, 2017
White House Releases Updated Coordinated Framework for the Regulation of Biotechnology
On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture ... read more >
December 28, 2016
Biobased Chemical, Fuel Makers Seek Parity For Their Products Under Trump
Lynn L. Bergeson was quoted in the December 28, 2016, Bloomberg BNA Daily Environment Report story "Biobased Chemical, Fuel Makers Seek Parity For Their Products Under Trump" (subscription required):
Biobased chemical and fuel manufacturers want their products to be treated equally with their fossil fuel-based counterparts under the incoming administration's policies.
[...] Lynn Bergeson, managing partner of the Washington D.C.-based Bergeson & Campbell, P.C., which manages the Biobased and Renewable Products Advocacy Group (BRAG), said Pruitt’s alignment with ... read more >
October 28, 2016
BIO Writes Open Letter To Congress Encouraging Multi-Year Extension Of Biofuel Incentives
On October 18, 2016, the Biotechnology Innovation Organization (BIO) sent a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of expiring renewable energy tax credits. The Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling Property are set to expire at the end of 2016, with BIO urging congress for multi-year extensions. ... read more >
September 30, 2016
Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Register
On September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of biotechnology products. More information about what this means for the future of biotechnology and the ... read more >
September 23, 2016
Biotechnology: White House Releases Proposed Update To The Coordinated Framework And National Strategy For Modernizing The Regulatory System For Biotechnology Products
On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of ... read more >
July 15, 2016
Senate Passes GMO Bill Creating A National Bioengineered Food Disclosure Standard With Federal Preemption And Exclusion Information
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 ... read more >
April 8, 2016
Companies with Commercial Biofuels and Biobased Chemicals -- Get Ready For CDR
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 ... read more >
April 8, 2016
Biodiesel Companies Can Thank BRAG For Cost Savings On CDR Reporting
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 ... read more >
April 1, 2016
EPA Publishes Final Rule on Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data In The Federal Register
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 ... read more >
March 25, 2016
EPA Signs Final Rule Granting Partial CDR Exemptions For Biodiesel Products
On March 23, 2016, Bloomberg BNA Daily Environment Report announced that EPA signed a final rule exempting manufacturers of six biodiesel chemicals from reporting processing and use information under the Chemical Data Reporting (CDR) rule under Section 8(a) of the Toxic Substances Control Act (TSCA). In 2014, BRAG filed a regulatory petition to exempt the chemicals, requesting the same exemption that EPA currently provides to manufactures of petroleum-based versions of the chemicals. The rule was originally issued as a direct final rule in February 2015 before being withdrawn due to a single ... read more >
March 18, 2016
Richard E. Engler, Ph.D. Presents On Green Chemistry Issues At Chemical Watch Global Business Summit In Brussels
Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), made two presentations at the Chemical Watch Global Business Summit held in Brussels, Belgium from February 22-25, 2016. Dr. Engler presented during the "Green (Sustainable) Chemistry: The business and economic case for sustainable chemistry" seminar. His presentations are described below. For a full copy of either of these presentations, please contact Dr. Engler at rengler@lawbc.com.
"Latest Developments in Green Chemistry in the US and possible ... read more >
March 4, 2016
More Information Available On Upcoming "Modernizing The Regulatory System For Biotechnology Products" Meetings
On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the Regulatory System for Biotechnology Products." The memorandum, issued under the Executive Office of the President (EOP) and jointly by (OSTP), the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality, directs the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. ... read more >
February 5, 2016
Dates And Locations Of "Modernizing The Regulatory System For Biotechnology Products" Meetings Announced
On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the U.S. Food and Drug Administration (FDA) website. The second of the three meetings will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office in Dallas, Texas. The third meeting will be held on March 30, 2016, at the University of California's David ... read more >
January 13, 2016
EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open
On January 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of EPA’s response to a petition it received from the Biobased and Renewable Products Advocacy Group (BRAG®) under Section 21 of the Toxic Substances Control Act (TSCA). BRAG requested EPA to promulgate a rule pursuant to TSCA Section 8 that would establish a process to amend the list of natural sources of oil and fat in the “Soap and Detergent Association” (SDA) nomenclature system by considering the chemical equivalency of additional ... read more >
January 8, 2016
Weekly Roundup of Other Biobased News
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USDA, "USDA Shares 2015 Results: Building A Stronger Rural America Through Partnership, Progress And Promise"
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Plastics Today, "Made Of Bioplastic: The Best Of 2015"
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Environmental Leader, "Can Bio-Based Chemicals Improve Products' Performance and Sustainability?"
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CORDIS, "Cost-Effective New Process Gets Chitin Out Of Its Shell"
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Journal of the American Chemical Society, "Key Roles Of Lewis Acid–Base Pairs On Znxzryoz In Direct Ethanol/Acetone To ... read more >
December 22, 2015
Final Rule For Renewable Fuel Standard Program Published In Federal Register
On December 14, 2015, the U.S. Environmental Protection Agency (EPA) published the Renewable Fuel Standard (RFS) Program: Standards for 2014, 2015, and 2016 and Biomass-Based Diesel Volume for 2017 in the Federal Register. The final rule will become effective on February 12, 2016, and establishes annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for motor vehicle gasoline and diesel produced or imported in the years 2014, 2015, and 2016 and biomass-based diesel for 2017. More information regarding the RFS final rule is ... read more >
December 4, 2015
EPA Releases Final Renewable Fuel Standard Rule
On November 30, 2015, the U.S. Environmental Protection Agency (EPA) released the final Renewable Fuel Standard (RFS) rule. This RFS rule sets the volume requirements and percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for 2014, 2015, and 2016, and for biomass-based diesel for 2017. This rule decreases the amount of required ethanol from the original RFS volume requirements set in 2007. The 2016 volume requirements will decrease from 15 billion gallons to 14.5 billion gallons of corn-based ethanol, and from 22.3 billion gallons to ... read more >
December 4, 2015
Advisory Committee On Biotechnology And 21st Century Agriculture To Meet
On November 19, 2015, USDA published a Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational process, and member responsibilities of AC21; update committee members on relevant regulatory developments, initiatives, and USDA activities; and outline new tasks for the committee to address. There will also be an opportunity for members of the public to make oral statements, as long as they contact Dr. Michael Schechtman about presenting a statement at least three business days ... read more >
October 23, 2015
Public Meeting Announced To Discuss Modernizing the Regulatory System For Biotechnology Products Memorandum
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) announced in the Federal Register a public meeting Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology. The meeting is intended to discuss FDA's role in responding to the July 2015 Executive Office of the President ... read more >
October 16, 2015
EPA Safer Choice Partner And Stakeholder Summit Announced
On October 7, 2015, the U.S. Environmental Protection Agency (EPA) announced the first ever Safer Choice Partner and Stakeholder Summit. The summit will be the first of several meetings intended to explore topics of importance to stakeholders and the Safer Choice Program. The Safer Choice label was created to help consumers identify products with safer chemical ingredients, previously known as the Design for the Environment (DfE) label. Over 2,000 products are qualified to carry the Safer Choice label. The summit will occur on November 12-13, 2015, in Washington, D.C., with the time and venue ... read more >
October 16, 2015
WEBINAR - Bioproducts In The Federal Bioeconomy Portfolio, 10/26/15
On October 8, 2015, the U.S. Department of Energy's (DOE) Office of Energy Efficiency & Renewable Energy announced the upcoming Bioproducts in the Federal Bioeconomy Portfolio Webinar. Bioenergy Technologies Office Technology Manager Nichole Fitzgerald, U.S. Department of Agriculture (USDA) BioPreferred Deputy Program Manager Kate Lewis, and the Ohio State University Bioproducts Innovation Center's Director Dennis Hall will discuss how the federal government supports bioproducts research, commercialization, and market development as part of the expansion of the U.S. bioeconomy. ... read more >
October 9, 2015
NST Council Requests Clarification Of Coordinated Framework Responsibilities
On October 6, 2015, the National Science and Technology Council, Science and Technology Policy Office published a notice of request for information (RFI) on "Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (CF) and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology" in the Federal Register. The purpose of the RFI is to obtain relevant data that will be used to update the CF to reflect the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food ... read more >
October 2, 2015
FTC Sends Warning To Businesses About Misleading Green Certification Marketing
The Federal Trade Commission (FTC) announced in a September 14, 2015, press release, "FTC Sends Warning Letters about Green Certification Seals," that it sent warning letters to five providers of environmental certification seals and 32 businesses using those seals, "alerting them to the agency's concerns that the seals could be considered deceptive and may not comply with the FTC's environmental marketing guidelines." FTC states that environmental certification seals are intended to help consumers tell whether a product has the environmental attributes it claims. ... read more >
October 2, 2015
EPA Holds Workshop For Input On Risk Assessment Of Genetically Engineered Algae
On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs to ask and answer when it receives a Microbial Commercial Activity Notice (MCAN) for GE algae. Dr. ... read more >
October 2, 2015
Sustainable Federal Procurement Recommendations Published In Federal Register
On September 25, 2015, EPA published Recommendations for Specifications, Environmental Performance Standards, and Ecolabels for Federal Procurement. The notice describes EPA's recommendations for federal agencies that are purchasing environmentally-friendly products. Section 3(i) of Executive Order 13693, Planning for Federal Sustainability in the Next Decade, directs federal agencies to adhere to certain environmental performance and sustainability standards when practicable. The new EPA recommendations list acceptable environmentally sustainable product brands and service providers that ... read more >
September 25, 2015
American Energy Innovation Act Of 2015 Introduced By Senate Democrats
On September 22, 2015, Senator Maria Cantwell (D-WA) of the Senate Committee on Energy and Natural Resources, Democratic Leader Senator Harry Reid (D-NV), Senator Charles Schumer (D-NY), and Senator Ron Wyden (D-OR) released The American Energy Innovation Act of 2015, a bill designed to improve economic growth in the energy sector, invest in clean energy, and support research and development while cutting carbon pollution. Senator Wyden stated the proposed legislation "... is built around the proposition that the law ought to reward clean energy with incentives that spark innovation in ... read more >
September 18, 2015
Gina McCarthy Speaks About The Future Of The RFS
On September 15, 2015, the head of the EPA, Gina McCarthy, spoke at the Growth Energy Advocacy Conference about the need of the upcoming RFS rule to encourage long-term investment in advanced biofuels to successfully grow capacity. McCarthy went on to say that the November 30, 2015, deadline is a priority for her to have the RFS rule finished to improve investment conditions for biofuels. She considers the RFS to be one of the best tools that the Administration has in the long-term fight against climate change. EPA is currently looking at approximately 650,000 comments from the proposed rule ... read more >
September 18, 2015
Multiple Algae-related Agency And Industry Events In Coming Weeks
Stakeholders working with algae to produce chemicals and fuels should take note of these upcoming opportunities:
EPA's "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," September 30, 2015. Registration closes on September 25, 2015;
The U.S. Department of Energy's (DOE) Request for Information (RFI) from algae stakeholders regarding their views on the requirements necessary to develop reliable and sustainable supplies of algal biomass, algal intermediates, and metabolites closes September 30, 2015; and
The ... read more >
September 4, 2015
"Legal, Regulatory & Political Considerations In Commercializing Algal Products" Panel Presented At ABO, October 1, 2015
"Legal, Regulatory & Political Considerations In Commercializing Algal Products" Panel Presented At ABO, October 1, 2015
Hear BRAG's Richard E. Engler, Ph.D., and other panelists on Thursday, October 1, at the Algae Biomass Summit, which runs September 29 - October 2, 2015, in Washington, D.C. 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. Bergeson & Campbell, ... read more >
September 4, 2015
EPA To Hold Public Workshop on Biotechnology Algae
On August 25, 2015, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae. The public meeting, entitled "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," is intended to receive public input and comments on the data needs of EPA to support risk assessments of biotechnology products using genetically engineered algae and cyanobacteria under the Toxic Substances Control ... read more >
August 14, 2015
EPA Announces Three Webinars Covering PMN Submission Systems And Inviting Discussion Of Biotechnology Algae Project
On August 12, 2015, the U.S. Environmental Protection Agency (EPA) announced three webinars to review the new features of the updated online Premanufacture Notifications (PMN) Submission System. The new web-based submission system for the Toxic Substances Control Act (TSCA) Section 5 submissions is replacing the ePMN reporting software that is currently in use. The first webinar is on August 26, 2015, from 1:00 p.m. - 4:00 p.m., and will cover the process of registering with the Central Data Exchange (CDX) and user roles. The second webinar is on September 16, 2015, from 1:00 p.m. - 4:00 ... read more >
August 7, 2015
EPA Announces Beginning Of Public Dialog For Synbio Algae Development And Use
The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (Synbio) algae. EPA has oversight responsibility for the production and use of intergeneric microorganisms, including cyanobacteria, eukaryotic microalgae (genetically modified (GM) algae), and their products by application of genetic engineering approaches, including those called Synbio. EPA's recently posted document, US Environmental Protection Agency GM/Synbio Algae Project, states that it is ... read more >
July 10, 2015
White House And Agencies Release Coordinated Biotechnology Regulatory Framework
With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a ... read more >
July 10, 2015
Senators Sign Letter Of Support For Consistent Federal Biomass Policy
On June 30, 2015, 46 U.S. Senators sent a letter to the EPA, U.S. Department of Energy (DOE), and USDA stating that "[f]ederal policies across all departments and agencies must remove any uncertainties and contradictions through a clear, unambiguous message that forest bioenergy is part of the nation's energy future." Senator Susan Collins (R-ME) and Senator Jeff Merkley (D-OR) headed the letter and pointed to the recognized carbon neutrality of forest biomass as a renewable resource and asked that the federal government consistently recognize the energy source when making ... read more >
June 12, 2015
Sustainable Chemistry Research And Development Act Of 2015 Introduced To Senate
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 ... read more >
May 29, 2015
America COMPETES Reauthorization Act Of 2015 Includes Cuts To Clean Energy Research Funding
On May 20, 2015, the House voted to pass the America COMPETES Reauthorization Act of 2015 (H.R. 1806) (COMPETES), a research funding bill that was originally enacted in 2007 to further U.S. scientific and technological advantages. The new version of COMPETES increases funding for nuclear energy and fossil fuel research programs, while cutting clean and renewable energy programs. The U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy will have funding reduced by 30 percent, or nearly $500 million, while the DOE's Advanced Research Projects Agency-Energy will ... read more >
May 8, 2015
BIO Assesses Impact Of EPA Delays On RFS Investment
On May 4, 2015, the Biotechnology Industry Organization (BIO) released a new white paper on "Estimating Chilled Investment for Advanced Biofuels Due to RFS Uncertainty," along with an accompanying press release.
BIO examined the impact of EPA's recent inability in administering the federal Renewable Fuel Standard (RFS) on investment in advanced and cellulosic biofuels. It has found that EPA's delay in issuing the final 2013 and 2014 RFS rules, among other delays in RFS administration, is responsible for most of the "$13.7 billion shortfall in necessary investments for ... read more >
May 1, 2015
EPA Requests Comment On Analysis Of Carinata Oil Feedstock
On April 24, 2015, EPA released a Federal Register notice inviting comment on analysis of the greenhouse gas (GHG) emissions produced during the production and transport of Brassica carinata (carinata) oil feedstock for use in the production of biofuels. The plant is not used for food in the U.S., and has high concentrations of erucic acid, making it attractive for use in biolubricants and biopolymers, as well as biofuels. EPA anticipates that biofuels produced using carinata oil will qualify as advanced biofuels, and the analysis will be used to determine if the biofuels will meet necessary ... read more >
April 3, 2015
EPA Withdraws Direct Final Rule Exempting Six Biobased Chemicals From CDR
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 ... read more >
March 27, 2015
President Obama Signs Executive Order Reducing Federal GHG Emissions
On March 19, 2015, the White House published an Executive Order
signed by President Obama that would further a preference for U.S. Department
of Agriculture (USDA) BioPreferred products. Planning
for Federal Sustainability in the Next Decade sets new greenhouse
gas (GHG) emission targets for federal agencies to reach by 2025 and increases
renewable energy use and building efficiency, while reducing fleet emissions in
the federal government. The new targets would reduce total GHG emissions by 26
million metric tons, and will be met in part by increasing the share of
electricity from renewable ... read more >
February 12, 2015
Senators Urge EPA To Set And Increase Biodiesel RFS Volumes
On February 9, 2015, a bi-partisan group of 32 Senators led by Senators Heidi Heitkamp (D-ND), Roy Blunt (R-MO), Patty Murray (D-WA), and Chuck Grassley (R-IA) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy regarding 2014 and future biodiesel volume requirements under the federal Renewable Fuel Standard (RFS). In their letter, the Senators urge EPA to get the biodiesel renewable volume requirements (RVOs) under the RFS back on schedule. To this end, the Senators request that EPA set the 2014 biodiesel RVOs at actual production volumes and ... read more >
February 12, 2015
Weekly Roundup of Other Biobased News
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Domestic Fuel, "New President for Poet-DSM Joint Venture"
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Packaging Europe, "The Future of Corrosion Protection with Nature's Best"
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Biobased Industries Consortium, "Newly-formed Bioeconomy Alliance Calls for EU Action"
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eLife Sciences, "Expanding Xylose Metabolism in Yeast for Plant Cell Wall Conversion to Biofuels"
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ACS Sustainable Chemistry & Engineering, "A New Class of Bio-Based Paper Dry Strength Agents: Synthesis and Characterization of Soy-Based Polymers"
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Business Standard, ... read more >
January 22, 2015
Proposed Amendment To The Keystone Bill Would Remove Corn Ethanol from RFS
On
January 16, 2015, Senators Dianne Feinstein (D-CA) and Pat Toomey (R-PA) proposed
an amendment to the Keystone XL pipeline bill to eliminate corn ethanol from
the RFS called the “Corn Ethanol Mandate Elimination Act of 2015.” Senator Feinstein stated that the “bill is a
simple and smart modification of the Renewable Fuel Standard program. Once we
remove the corn ethanol mandate, the RFS program can finally serve its intended
purpose: to support the development of advanced, environmentally friendly
biofuels like biodiesel, cellulosic ethanol and other revolutionary fuels.” ... read more >
December 18, 2014
National Defense Authorization Act For 2015 Moves Forward In Senate
On December 12, 2014, the
Senate passed a House amendment to the Carl Levin and
Howard P. “Buck” McKeon National Defense Authorization Act for Fiscal Year 2015
(NDAA FY15). The final version of
the NDAA FY15 places restrictions on how the military is able to acquire
biofuels by prohibiting funding from being used for bulk purchase of drop-in
biofuels where the fully burdened cost of the biofuels is not cost competitive
with the fully burdened cost of available traditional fuels. The bill defines a fully burdened cost as
“the commodity price of the fuel plus the total cost of ... read more >
December 18, 2014
Senate Passes Tax Extender Legislation
On December 16, 2014, the
Senate followed the House of Representatives and passed tax extender
legislation that is expected to be signed by the President. The final package that passed would
retroactively extend incentives that expired on December 31, 2013, through the
end of 2014. It does not extend the
incentives through the end of 2015, as Senate Finance Committee Chair Ron Wyden
(D-OR) and other leaders would have liked.
The final tax extender package
includes important incentives for the biofuels industry, including the
dollar-per-gallon biodiesel tax credit, as well ... read more >
November 7, 2014
Agencies Request Public Comment On Collection Of Biobased Procurement Product Types And Value Data
In the October 30, 2014, Federal Register, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued a notice of request for public comments regarding an extension of a previously approved information collection requirement regarding Biobased Procurements. The original notice was published in the Federal Register on August 20, 2014, and no comments were received. Comments are now due on December 1, 2014.
As summarized by the notice, the "Federal Acquisition Regulation clause 52.223-2, ... read more >
November 7, 2014
Article Explores TSCA Application To Synthetic Biology
The October 2014 issue of Industrial Biotechnology features the article Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act (TSCA), written by Lynn L. Bergeson, Of Counsel with the Biobased and Renewable Products Advocacy Group (BRAG®), Charles M. Auer, former Director of the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), and Oscar Hernandez, former Director of the Risk Assessment Division (RAD) of EPA OPPT.
Synthetic Biology is delivering on its promise as an emerging scientific ... read more >
October 31, 2014
USDA Proposes Amended Guidelines For Biobased Products For Federal Procurement
On October 27, 2014, the U.S. Department of Agriculture (USDA) proposed to amend the regulations for the Voluntary Labeling Program for Biobased Products under USDA's BioPreferred Program. As explained in the Federal Register notice, the proposed amendments are needed to address certain legislative requirements in the 2014 Farm Bill that cannot be implemented without further guidance. Specifically, the proposed amendments allow for USDA promotion of biobased products regardless of date of entry into the marketplace, which overrides previous provisions that excluded mature market ... read more >
October 31, 2014
President Obama Announces $300 Million Investment In Emerging Manufacturing Technologies
On October 27, 2014, President Obama announced new plans to strengthen the manufacturing sector. One of the listed plans involved the Departments of Defense, Energy, and Agriculture, and the National Aeronautics and Space Administration (NASA) coming together to invest in advanced materials, advanced sensors, and digital manufacturing. These three areas were determined to be critical to U.S. competitiveness and include biobased materials in the advanced materials category. Over $300 million is going to be invested across the three categories and the research investments by the federal ... read more >
October 27, 2014
BRAG® Petitions EPA for Biodiesel Products CDR Exemptions Already Granted to Petroleum Products
On October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted petitions to the U.S. Environmental Protection Agency (EPA) requesting that biodiesel fuel manufacturers be granted the same Chemical Data Reporting (CDR) exemptions that petroleum-based diesel manufacturers already receive. BRAG made its petitions through two mechanisms allowed under Toxic Substances Control Act (TSCA) rules. BRAG's petitioning of EPA was reported in the Bloomberg BNA Daily Environment Report story "Biobased Diesel Companies Petition EPA For Rules Comparable To Traditional ... read more >
October 24, 2014
BRAG Petitions EPA for Biodiesel Products Exemptions Already Granted to Petroleum Products
On October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted two petitions to the U.S. Environmental Protection Agency (EPA) requesting that biodiesel fuel manufacturers be granted the same Chemical Data Reporting (CDR) exemptions that petroleum-based diesel manufacturers already receive.
The Bloomberg BNA Daily Environment Report covered the petitions in an October 22, 2014, feature story that stated "[t]he Biobased and Renewable Products Advocacy Group (BRAG) filed the petitions in an attempt to be exempted through either of two mechanisms allowed under ... read more >
October 24, 2014
DOE Announces Funding For Landscape Design For Sustainable Bioenergy Systems
The Bioenergy Technologies Office within the U.S. Department of Energy (DOE) has issued a Funding Opportunity Announcement (FOA), "Landscape Design for Sustainable Bioenergy Systems."
DOE is looking for interdisciplinary projects that integrate landscape design approaches with cellulosic feedstock production within existing agricultural and forestry systems. Projects must maintain, or preferably enhance, environmental and socio-economic sustainability. The FOA includes funding up to $14 million.
This funding will help take the next steps for previous DOE-funded projects ... read more >
October 24, 2014
Green Chemistry Market Roundtable And Presidential Green Chemistry Challenge Awards
October 16, 2014, was a banner day for green chemistry in the nation's capital with the 2014 Presidential Green Chemistry Challenge awards ceremony, and the Green Chemistry Market Roundtable preceding it. The roundtable included representatives from industry, including the 2014 award winners; EPA and other federal agency officials; and others involved with green chemistry and biobased chemicals and products. BRAG Executive Director, Kathleen Roberts, and Bergeson & Campbell, P.C.'s (B&C®) Lynn Bergeson were invited guests and participated in the roundtable discussion on ... read more >
October 3, 2014
Bridge To A Clean Energy Future Act Of 2014 Introduced In The U.S. House Of Representatives
On September 19, 2014, Representatives Earl Blumenauer (D-OR) and Dave Loebsack (D-IA) introduced the Bridge to a Clean Energy Future Act of 2014 (H.R. 5559), which was referred to the House Committee on Ways and Means. The bill would extend clean energy tax incentives, including those benefiting the biofuel and bioenergy industries. Among the tax credits being extended are the second generation biofuel producer credit, the $1.00 per gallon tax credit for biodiesel and renewable diesel, and the Section 45 renewable energy production tax credit. More information is available ... read more >
August 1, 2014
Energy And Commerce Chair Working On RFS Reform
Reportedly, U.S. House Energy and Commerce Committee Chair Fred Upton (R-MI) plans to introduce a bill to modify the federal Renewable Fuel Standard (RFS). The bill is expected to be introduced soon after EPA releases its final rule setting the final 2014 RFS volume requirements for obligated parties under the law. Just this week the Administration has made public statements to suggest that the final 2014 rule will increase volume requirements from the proposed version published last fall. Generally, the oil and gas industry supports reducing annual RFS volume requirements, while biofuels ... read more >
July 11, 2014
Department Of Energy Makes Available $4 Billion In Loan Guarantees For Renewable Energy
On July 3, 2014, the U.S. Department of Energy (DOE) announced that it is making an additional $4 billion available in loan guarantees for innovative renewable energy and energy efficiency projects located in the U.S. that avoid, reduce, or sequester greenhouse gases. Part one of the solicitation is due October 1, 2014. Copies of the solicitation and fact sheet about the solicitation are available online.
According to DOE's press release on the announcement, "the Department has identified five key technology areas of interest: advanced grid integration and storage; drop-in ... read more >
June 6, 2014
New Reports Released On Synthetic Biology
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 ... read more >
May 30, 2014
USDA Signals Action On BioPreferred Program In Semi-Annual Regulatory Agenda
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 ... read more >
May 30, 2014
House And Senate Pass FY 2015 NDAA Legislation With Conflicting Biofuels Provisions
Last week, the U.S. House of Representatives and the U.S. Senate Committee on Armed Services passed versions of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2015 that included starkly different provisions on biofuels. The House version would severely limit U.S. Department of Defense (DOD) authority to promote the procurement of biofuels. For instance, it included a provision that would allow DOD to procure biofuels only if their costs were "equivalent to" conventional fuels. In addition, it included provisions preventing DOD from supporting the planning and ... read more >
May 23, 2014
House Agriculture Appropriations Bill Would Make Significant Cuts To Mandatory Funding For Farm Bill
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. ... read more >
May 16, 2014
RFS Advocacy Continues As Final 2014 Rule Expected Soon
Renewable Fuel Standard (RFS) advocacy is continuing at a steady pace in anticipation of the expected imminent release of the U.S. Environmental Protection Agency's (EPA) 2014 final RFS rule. Some biofuels advocates believe that they are making an impact with their stepped-up advocacy, as they believe the Administration will adjust the total renewable and advanced biofuel targets upwards from its proposed reductions to those categories of renewable fuels. The final rule is expected to be issued in June 2014.
On May 8, 2014, nine members of the pro-biofuels Fuels America coalition ... read more >
May 16, 2014
B&C
Bergeson & Campbell, P.C. (B&C®) and BRAG presented an informative session on Tuesday, May 13, 2014, at the Biotechnology Industry Organization (BIO) World Congress in Philadelphia. The session, "Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process" brought together high-level EPA staff and industry leaders to inform, equip, and assist the renewable chemical community in finding the path of least resistance on the road to commercialization.
Speakers included David Widawsky, ... read more >
May 9, 2014
Appeals Court Rules For EPA In Challenge To Its 2013 RFS Rule
On May 6, 2014, in what is largely seen as a win for the U.S. Environmental Protection Agency (EPA) and the biofuels industry, the U.S. Court of Appeals for the District of Columbia Circuit rejected the challenge to EPA's final 2013 Renewable Fuel Standard (RFS) rule by Monroe Energy, LLC (Monroe Energy), a refinery and subsidiary of Delta Airlines. In Monroe Energy, LLC v. EPA, the court held that EPA properly utilized its authority under the federal RFS to set the 2013 RFS volume requirements. The court disagreed with Monroe Energy that EPA did not sufficiently consider factors in ... read more >
May 2, 2014
House Energy And Commerce Subcommittee Holds Hearing On Revised Chemicals In Commerce Act
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 ... read more >
May 2, 2014
ACS Green Chemistry & Engineering Conference, June 17-19, 2014, North Bethesda, Maryland
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
B&C
"Moving California towards flame retardant-free furniture and baby products"
Emily Tipaldo
American Chemistry Council
"State chemical management initiatives: Green chemistry? Or, something else?"
Sookie Hong
3E Company Department of Regulatory ... read more >
April 25, 2014
Not Too Soon To Be Thinking Of 2015 Presidential Green Chemistry Challenge Submissions
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 ... read more >
April 25, 2014
Industry And Policymakers To Hold Summit On California SCPR
With the March 2013 release of its first draft list of Priority Products (PP) (more information is available in the Bergeson & Campbell, P.C. (B&C®) memorandum), the California Department of Toxic Substances Control (DTSC) has opened the floodgates for scrutiny, controversy, and debate on their game-changing Safer Consumer Products Regulations (SCPR). EPA's Jim Jones, DTSC's Meredith Williams, industry leaders, and policy experts will gather at the 4th Safer Consumer Products Summit in Santa Clara, California, on May 6-8, 2014, to drill down on the rapidly evolving state ... read more >
April 11, 2014
House Ways And Means Hearing On Tax Extenders
On April 8, 2014, House Committee on Ways and Means Chair Dave Camp (R-MI) held a hearing on the "Benefits of Permanent Tax Policy for America's Job Creators." The hearing focused on the expiring business tax provisions that are made permanent or extended under Camp's recently released discussion draft of the "Tax Reform Act of 2014" (TRA). Unlike his Senate counterpart -- Senate Committee on Finance Chair Ron Wyden (D-OR) -- Camp is not very supportive of passing a tax extender package to extend retroactively the approximately 50 incentives that expired at the ... read more >
April 11, 2014
Senate Agriculture Committee Holds Hearing On Advanced Biofuels
On April 8, 2014, the Senate Committee on Agriculture, Nutrition and Forestry held a hearing on "Advanced Biofuels: Creating Jobs and Lower Prices at the Pump." The following witnesses testified at the hearing: Mr. Richard Childress, CEO, Richard Childress Racing, LLC; Mr. Jan Koninckx, Global Business Director for Biorefineries, DuPont Industrial Biosciences; Mr. Brooke Coleman, Executive Director, Advanced Ethanol Council; Dr. Sumesh Arora, Vice President, Innovate Mississippi, Director of Strategic Biomass Solutions; and, Ms. Nancy Young, Vice President, Environmental Affairs, ... read more >
April 4, 2014
Senate EPW Committee Marks Up Chemical Safety Bill
On April 3, 2014, the Senate Committee on Environment and Public Works (EPW Committee) marked up S.1961, the "Chemical Safety and Drinking Water Protection Act." Senators Joe Manchin (D-WV), Barbara Boxer (D-CA), Chair of the EPW Committee, and Jay Rockefeller (D-WV) introduced the bill following the January 9, 2014, chemical spill in West Virginia that left thousands without drinking water for days. The bill would amend the Safe Drinking Water Act (SDWA) by adding "Part G -- Protection of Surface Water from Contamination by Chemical Storage Facilities." The bill is ... read more >
March 21, 2014
EPA Moves Forward On TSCA Rulemaking Related To Fracking Chemicals
On March 13, 2014, the U.S. Environmental Protection Agency (EPA) sent a pre-rule notice to the White House Office of Management and Budget (OMB) on "Hydraulic Fracturing Chemicals and Mixtures." This action shows that EPA is moving forward on a rulemaking under TSCA Sections 8(a) and 8(d) to obtain data on chemical substances and mixtures used in hydraulic fracturing. Hydraulic fracturing is a process used in oil and gas production.
EPA explained in the Fall 2013 Unified Agenda that although the Agency "has granted the petitioners' request to initiate a rulemaking ... read more >
March 21, 2014
OCSPP Develops A Vision Plan
On March 12, 2014, Jim Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), shared with his colleagues a vision plan that was developed to guide OCSPP's work over the next several years. The document, entitled Office of Chemical Safety and Pollution Prevention Envisioning Accomplishments in 2017, outlines several actions that will be taken by OCSPP regarding pesticide registration, existing chemicals, the EDSP, creating a whole new Design for the Environment (DfE), and employing green solutions. Actions that will be taken in implementing ... read more >
March 7, 2014
President Obama Releases FY 2015 Budget Proposal
On March 4, 2014, President Obama released his fiscal year (FY) 2015 Budget request, which includes aggressive proposed funding to carry out the Administration's Climate Action Plan designed to reduce harmful greenhouse gas (GHG) emissions and the impacts of climate change. The President's FY 2015 Budget includes funding for several programs and initiatives to help facilitate the continued development and production of biofuels and biobased products. Consistent with the newly enacted Farm Bill, the Budget for the U.S. Department of Agriculture (USDA) includes increased funding for ... read more >
February 14, 2014
House Transportation And Infrastructure Committee Field Hearing On Elk River Spill
On February 10, 2014, the U.S. House Committee on Transportation and Infrastructure convened a field hearing in Charleston, West Virginia, on "The Charleston, West Virginia Chemical Spill." On January 9, 2014, a coal processing chemical, 4-methylcyclohexane methanol (MCHM), stored in an aboveground tank owned by Freedom Industries leaked into the Elk River in West Virginia. The leak compromised the water supply to nine counties in the state affecting some 300,000 residents. Due to a lack of toxicological data on MCHM, health officials were delayed in identifying a safe use level ... read more >
February 7, 2014
President Obama Expected To Sign New Farm Bill Into Law This Week
President Obama is expected to sign H.R. 2642, the Agriculture Act of 2014 (the new five-year Farm Bill), into law on Friday at Michigan State University in East Lansing, Michigan. He is scheduled to speak there about the importance of the legislation.
The Farm Bill is critically significant to the biofuels and renewable chemicals and products industries because the new Farm Bill continues and expands on the majority of the energy programs covered under the 2008 Farm Bill and provides $881 million in mandatory funding to carry them out. For instance, the new Farm Bill continues the ... read more >
January 31, 2014
Biofuels And Renewable Chemicals Win Under Farm Bill Agreement
On Monday, the 41 member bicameral Farm Bill Conference Committee announced that it had reached agreement on a compromise Farm Bill, the Agriculture Act of 2014. A copy of the legislation is available online. The Conference Committee was led by House Agriculture Committee Chair Frank Lucas (R-OK), Ranking Member Collin Peterson (D-MN), Senate Agriculture, Nutrition and Forestry Committee Chair Debbie Stabenow (D-MI), and Ranking Member Thad Cochran (R-MS). A copy of the Senate Agriculture Committee press release on the compromise legislation is available online.
The bill includes $881 ... read more >
January 31, 2014
Chemical Safety And Drinking Water Protection Act Introduced In The Senate
The January 9, 2014, chemical spill in which 7,500 gallons of a coal processing chemical, 4-methylcyclohexane methanol, stored in an above-ground tank owned by Freedom Industries leaked into the Elk River upstream from the local water utility's intake pipe serving Charleston, West Virginia, has prompted new calls for chemical safety and security legislation. For instance, concerns have been expressed about the adequacy of information regarding chemical safety and health risks, an issue that has been repeatedly raised with respect to chemicals "grandfathered" under the Toxic ... read more >
January 31, 2014
EPA Updates Safer Chemicals Ingredient List
The U.S. Environmental Protection Agency (EPA) has taken two actions this month to update Design for the Environment's (DfE) Safer Chemical Ingredients List. On January 23, 2014, EPA announced that it is adding 50 chemicals to the list, "bringing the number of safer fragrance chemicals to 150 and the total number of safer chemicals to nearly 650." The list is available online.
On January 29, 2014, EPA announced that it has issued final DfE alternatives assessments for Decabromodiphenyl ether (DecaBDE) and Bisphenol A (BPA). The 901 page report on alternatives for the flame ... read more >
January 10, 2014
Continuing Efforts On The RFS
There have been several efforts in the last few weeks to convince the Obama Administration to reconsider its proposal to reduce the 2014 Renewable Fuel Standard (RFS) statutory renewable volume obligations (RVO) for advanced and total renewable (corn ethanol) biofuels, and to maintain in 2014 and 2015 the status quo for biodiesel. Senators David Vitter (R-LA) and Benjamin Cardin (D-MD) are expected to introduce a bill in the coming weeks, which would amend the RFS and reduce its corn ethanol targets.
On December 18, a group of 16 Senators met with EPA Administrator Gina McCarthy to urge ... read more >
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2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-833-6580 | www.braginfo.org
Contact
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