By Richard E. Engler, Ph.D.
In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production, and use of new chemicals.
In the United States, all new chemicals must be reviewed by the U.S. Environmental Protection Agency (EPA) before they can enter commerce. The Agency looks at new chemicals to determine whether their manufacturing, processing, and use would adversely affect people or the environment. If EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through EPA for review and have been allowed into U.S. commerce.
In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).
By Lynn L. Bergeson
The Ministry of Industry and Trade of the Russian Federation formally announced that the May 1, 2020, deadline to submit substances and mixtures to its chemical inventory is extended to August 1, 2020.
Entities exporting products to the Russian Federation should nominate their substances and mixtures to the Russian chemical inventory to ensure continued access to the Russian market. New substance registration is required for substances or mixtures not on the inventory after the nomination process closes.
A company without a legal entity in Russia can appoint an Authorized Representative (AR) to submit information on its behalf and cover importation by its customers in the region. The appointment of an AR and timely submission allow a non-Russian company to maintain an uninterrupted supply chain into the region and support its Russian customers.
More information is available in The Acta Group’s (Acta®) April 2, 2020, memorandum, “Russian Federation Accepting Nominations to New Chemical Inventory,” as well as Acta’s website. Acta’s “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements” webinar on May 27, 2020, will provide an overview of the Eurasian Economic Union (EAEU) Technical Regulation (TR) EAEU 041/2017 (Eurasia REACH) and its implementation status, including insights into the Eurasian regional political dynamics and impacts to implementation, and cover the requirements for submitting substances and mixtures to the Russian chemical inventory. Registration for the webinar is still open. Acta assists clients with AR appointment and provides broad-based, hands-on support in the Russian Federation to support its clients’ regulatory compliance and business success.
By Lauren M. Graham, Ph.D.
On August 1, 2017, the U.S. Environmental Protection Agency (EPA) held a public hearing to hear from all segments of the fuel industry on the proposed rule to set the 2018 renewable volume obligations (RVO) under the Renewable Fuel Standard (RFS) program. Among the nearly 150 individuals and organizations scheduled to testify at the hearing were numerous biofuel industry stakeholders who praised EPA for issuing the proposed rule on time and for maintaining the statutory 15 billion gallon volume requirement for conventional renewable fuels, but urged the agency to increase the proposed requirements for advanced and cellulosic fuels.
During its testimony, the Renewable Fuels Association (RFA) stated that it believes that EPA “erred on the side of pessimism with regard to the potential for significant growth in cellulosic ethanol commercialization.” According to Bob Dinneen, Chief Executive Officer (CEO) of the RFA, many plants are in the process of adding bolt-on fiber conversion technology to their existing facilities, which could dramatically increase cellulosic ethanol production next year. RFA intends to provide EPA with updated projections for cellulosic fuel before the comment period ends. Dinneen also highlighted concerns with Renewable Identification Number (RIN) market manipulation and suggested that EPA continue to allow imported biofuels to help comply with the RFS program.
With a group of approximately 20 speakers, the National Biodiesel Board (NBB) highlighted key data and information regarding market realities and underutilized capacity, and the impacts on small businesses and manufacturing, feedstock availability, and consumer choice. Donnell Rehagen, NBB CEO, stated that the “current numbers shortchange the progress we have made. They are a step back for the RFS, job creation, small businesses and rural economies.” Rehagen clarified that “these steps backwards are not about paper but people.”
The Renewable Energy Group (REG) informed EPA that ample feedstocks, technology and quality advances, and subsidized imported biofuel are three reasons why the agency should increase the biomass-based diesel and advanced biofuel minimum volumes. Derek Winkel, Executive Director of Manufacturing, stated that “investments [into the biofuel sector] would not have been made without increasing demand for biodiesel and renewable diesel. This demand, in part, is supported by a strong, growing and consistent RVO and RFS.” Paul Nees, Executive Director of REG’s Operations Control Team, testified that “[t]he domestic biodiesel industry is ready and able to fulfill demand gaps with low-cost, high-quality fuel with no market disruption.”
During its testimony, the Iowa Renewable Fuels Association (IRFA) suggested that the recent verdict in Americans for Clean Energy v. EPA should radically alter the factors EPA considers when determining RFS levels this year and going forward. “The Court clearly affirmed that Congress’ intent for the RFS from the very beginning was to crack the petroleum monopoly and to push biofuels into the marketplace,” stated Monte Shaw, IRFA Executive Director. “Whether in a reset discussion or in setting biodiesel and ethanol levels, the EPA must act according to the clear directive from the Court.”
The American Coalition for Ethanol's (ACE) testimony highlighted its view on conventional biofuel levels, the general waiver authority as it relates to inadequate domestic supply, the use of the reset provisions, and updating the greenhouse gas modeling for corn ethanol as it relates to Brazilian sugarcane ethanol. The Coalition intends to detail its position on these topics in written comments. Jonathon Lehman, ACE legislative counsel, also praised Nebraska Governor Pete Ricketts and Iowa Governor Kim Reynolds for their strong public support for keeping the RFS on track.
Stakeholders representing the oil industry were also present to testify to the problems they see with the RFS program, including the representatives from the American Petroleum Institute (API), the American Fuel and Petrochemical Manufacturers (AFPM), and Valero.
Written statements and supporting information concerning the proposed rule are available under Docket ID No. EPA-HQ-OAR-2017-0091. As stated in the Federal Register notice, EPA will consider the written comments with the same weight as any oral comments presented at the public hearing.
Last week, the U.S. Environmental Protection Agency (EPA) published two announcements in the Federal Register regarding an extension of the comment period for the proposed Renewables Enhancement and Growth Support (REGS) rule and the proposed denial of petitions for the rulemaking to change the Renewable Fuel Standard (RFS) Point of Obligation.
On December 9, 2016, ten biodiesel and agricultural industry stakeholders, including the Renewable Fuels Association, Growth Energy, American Soybean Association, and the Corn Refiners Association, sent EPA a joint request for additional time to evaluate the proposed changes to the REGS rule. In a December 27, 2016, Federal Register notice, EPA stated that the deadline for written comments would be extended due to the significant number of proposed revisions. Comments on the proposed rule are now due by February 16, 2017.
On November 22, 2016, EPA published a proposed denial of petitions requesting a rulemaking process to reconsider the point of obligation under the RFS program. After receiving a request from the Small Retailers Coalition for additional time to prepare comments, EPA extended the deadline for written comments. Comments are now due by February 22, 2017.
A post from the Environmental Law Institute's "Vibrant Environment" Blog
By Lynn L. Bergeson
The last thing the push for TSCA reform needs is another delay, and Senator Paul's unexpected interest in H.R. 2576 has caused just that. Under typical circumstances, a Member's focused interest in legislation is refreshing, and as today highlights, entirely too infrequent. In this instance, the circuitous road to TSCA reform is anything but typical—the complexity of the legislation has invited an unusual divisiveness that has frustrated passage—and delay is the enemy of the good.
When TSCA reform achieved bipartisan support in 2015, the Miracle on 34th Street quality of it all invited cautious optimism that reform of our ancient chemical management law just may be possible after all. Through 2015 and early 2016, the roller coaster ride the legislation took between the House and Senate was both nerve-wracking and energizing. Members and others "close to the legislation" metered out bits of information, sufficient to telegraph the patient was alive but requiring extreme measure to stay afloat. When the House voted on May 24, 2016, by an overwhelming majority to approve H.R. 2576, there was a palpable buzz in the chemical community and a real sense that this insanely stubborn law was finally going to relent and get its much- needed overhaul.
Seemingly out of nowhere, Senator Paul put a hold on the bill's further consideration. Taking his explanation at face value, wishing to read the legislation is not an unreasonable request. In addition to wanting to read the legislation closely, Senator Paul reportedly is concerned about the enhanced criminalization provisions in the bill that raise fines for TSCA violations and enhance penalties for knowingly putting someone in imminent danger. Both of these changes are consistent with penalties stipulated in other federal environmental laws. Paul’s request to put a hold on TSCA, however, disturbs a fragile balance that is not well-suited to sustain disruption, and plainly breaks the momentum the legislation enjoyed before the Memorial Day recess.
It is imperative that days do not turn into weeks, or worse. We need this law, and we need it yesterday. TSCA has not kept pace with chemical innovation and EPA desperately needs enhanced authorities to manage potential risks from existing chemical substances. The Senate must make this vote a priority when it reconvenes so President Obama can sign it, as we expect he will, and we can start the important work of implementing the law.
On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” The Committee is beginning a study to provide an independent and objective examination of the future products of biotechnology, as commissioned pursuant to the White House Office of Science and Technology Policy’s (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products.” The first Committee meeting is scheduled for April 18, 2016, from 1:00 p.m. - 5:00 p.m. (EDT).
According to the Agenda, the speakers for the April 18 meeting include representatives from the study sponsors: the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and OSTP. The Chair of the Committee, Richard Murray, and the Study Director, Douglas Friedman, will be providing the welcoming remarks and introduction.
Registration, available online, is strongly encouraged for in-person attendance and for viewing the webcast. A limited public comment period will be offered to in-person registrants only. A sign-up sheet will be available at the meeting starting at noon on April 18. The Committee will accept written comments and materials over the course of the study via input form on the study’s website.
The Committee members have been appointed, but will only be confirmed once the formal comments on the appointments, which were due April 6, 2016, have been reviewed. The Committee members’ biographies are available online. More information regarding the study and the Committee appointees is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum NAS to Study Future Products of Biotechnology.
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 March 3, 2016, The Advocate reported that the U.S. Occupational Safety and Health Administration (OSHA) fined a biodiesel plant run by The Renewable Energy Group (REG) $70,000 over a September 3, 2015, hydrogen gas explosion. The explosion injured four workers and resulted in three willful safety violations from OSHA. According to The Advocate, OSHA's citation stated that REG failed "to ensure a hazardous and flammable chemical was no longer in a plant pipeline that was under repair." A separate State Police investigation into the incident determined that the explosion occurred as a result of a failure in "lockout/tagout" procedures which should have made it clear that the flow of hydrogen gas through the pipeline had not been shut off. A spokesman for REG stated: "[w]hile we have been working with OSHA throughout its investigative process, we respectfully disagree with its findings and the classification of the citation and will contest it. We expect to meet with OSHA in the coming weeks to discuss its findings, the safety measures already in place at the Geismar facility and our commitment to continuous improvement." The OSHA citation gave REG through March 18, 2016, to correct the safety violations that led to the explosion occurring.
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. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Three public engagement meetings were announced to develop a strategy to prepare the federal biotechnology regulatory system for the future of the biobased industry. The first meeting occurred on October 30, 2015, and more information has recently become available for the second and third meetings.
The second meeting will focus on current federal roles and responsibilities regarding biotechnology products. This meeting will occur on March 9, 2016, from 9:30 a.m. to 1:00 p.m. at EPA's Region 6 Office in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. The third and final meeting does not yet have an agenda, but will be held on March 30, 2016, at the University of California's Davis Conference Center in Davis, California.
The Administration's efforts to modernize the Coordinated Framework are essential, laudable, and timely. It is imperative that stakeholders participate actively and effectively in sharing their experiences under the Coordinated Framework with the Administration. The forthcoming public meeting in Dallas is an excellent opportunity to communicate both successes and less successful experiences with the government's regulation of products of biotechnology. There is only one remaining public meeting opportunity after Dallas. After the third and final meeting, the Administration will assess all of the comments provided in response to the public meetings, and then will seek the public's comments on its thoughts on modernizing the Coordinated Framework. Stakeholders are urged to attend or participate virtually in the public meeting, and to help develop a more timely, efficient, and current governance framework for products of biotechnology.
Sign up through the EOP's website to be notified of future modernizing the biotechnology regulatory system activities.