Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

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).


 

A post from the Environmental Law Institute's "Vibrant Environment" Blog

By Lynn L. Bergeson

The last thing the push for TSCA reform needs is another delay, and Senator Paul's unexpected interest in H.R. 2576 has caused just that. Under typical circumstances, a Member's focused interest in legislation is refreshing, and as today highlights, entirely too infrequent. In this instance, the circuitous road to TSCA reform is anything but typical—the complexity of the legislation has invited an unusual divisiveness that has frustrated passage—and delay is the enemy of the good.

When TSCA reform achieved bipartisan support in 2015, the Miracle on 34th Street quality of it all invited cautious optimism that reform of our ancient chemical management law just may be possible after all. Through 2015 and early 2016, the roller coaster ride the legislation took between the House and Senate was both nerve-wracking and energizing. Members and others "close to the legislation" metered out bits of information, sufficient to telegraph the patient was alive but requiring extreme measure to stay afloat. When the House voted on May 24, 2016, by an overwhelming majority to approve H.R. 2576, there was a palpable buzz in the chemical community and a real sense that this insanely stubborn law was finally going to relent and get its much- needed overhaul.

TSCA

Seemingly out of nowhere, Senator Paul put a hold on the bill's further consideration. Taking his explanation at face value, wishing to read the legislation is not an unreasonable request. In addition to wanting to read the legislation closely, Senator Paul reportedly is concerned about the enhanced criminalization provisions in the bill that raise fines for TSCA violations and enhance penalties for knowingly putting someone in imminent danger. Both of these changes are consistent with penalties stipulated in other federal environmental laws. Paul’s request to put a hold on TSCA, however, disturbs a fragile balance that is not well-suited to sustain disruption, and plainly breaks the momentum the legislation enjoyed before the Memorial Day recess.

It is imperative that days do not turn into weeks, or worse. We need this law, and we need it yesterday. TSCA has not kept pace with chemical innovation and EPA desperately needs enhanced authorities to manage potential risks from existing chemical substances. The Senate must make this vote a priority when it reconvenes so President Obama can sign it, as we expect he will, and we can start the important work of implementing the law.


 

On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6 Office in Dallas, Texas.  Representatives from EPA, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the White House Office of Science and Technology Policy (OSTP) discussed their current roles and responsibilities regarding biotechnology products under the Coordinated Framework for Regulation of Biotechnology (CF) by reviewing case studies of hypothetical products.

 

Two documents were released prior to the public meeting:  (1) Table of the oversight of biotechnology products and relevant coordination across EPA, FDA, and USDA; and (2) Regulation of Biotechnology Products -- Clarifying Roles and Responsibilities through Hypothetical Case Studies.  A copy of the agenda is available here.

 

According to OSTP’s blog item on the meeting, the table document summarizes current responsibilities and the relevant coordination across USDA, EPA, and FDA for the regulatory oversight of biotechnology products.  OSTP cautions that it should not be interpreted as a guarantee that specific products in any of the product areas described in the table have been in the past, or will be in the future, determined to be safe by the relative regulatory agencies.

 

The case studies document states that its intention is to provide general information to developers who believe they have, or are uncertain as to whether they may have, a biotechnology product that is subject to regulation under one or more of the federal laws described in the CF.  It also demonstrates how an innovator might navigate the regulatory framework, starting from research activities in the laboratory to full commercialization of the product.  OSTP states that all of the case studies are of hypothetical products, selected because they cover multiple biotechnology product areas with different characteristics and intended uses, and because they illustrate how agencies coordinate their oversight under the CF.  The case studies discussed included the following hypothetical, genetically engineered organisms:

 

1.                  Corn, a field crop used for food.  In the first case study, corn with pesticidal properties is engineered with a plant pest component to have pesticidal activity against certain insects.

 

2.                  Plum, a fruit tree/crop used as food.  In the second case study, plum with pesticidal properties is genetically engineered without a plant pest component to resist a fungus.

 

3.                  Canola, a field crop, used as food.  In the third case study, herbicide-tolerant Canola is genetically engineered with a plant pest component to tolerate an already registered herbicide.

 

4.         Rose, an ornamental plant.  In the fourth case study, a rose is genetically engineered with a plant pest component to increase the production of a pigment in its petals.

 

5.         Microbial Pesticide, a bacterium that is not considered a plant pest.  In the fifth case study, a microbial pesticide is genetically engineered to enhance its pesticidal properties.

 

6.         Microbial Pesticide, a phytopathogenic bacterium.  In the sixth case study, a microbial pesticide that is genetically engineered to express a pesticidal substance that protects against insects.

 

7.         Algae for Biofuels.  In the seventh case study, a unicellular alga is genetically engineered with a plant pest component to produce industrial oils for conversion into biofuels.

 

8.                  Rabbit, an animal.  In the eighth case study, a rabbit is genetically engineered to make a therapeutic protein (recombinant insulin) for treatment of humans lacking this protein activity.

 

The first public engagement session took place on October 30, 2015, at FDA’s White Oak Campus in Silver Spring, Maryland.  A transcript from the meeting is available online.  The third public meeting will be held on March 30, 2016, at the University of California, Davis Conference Center in Davis, California.

 

More information regarding the CF is available in Bergeson & Campbell, P.C.’s (B&C®) memoranda OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology, White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology, and Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9.


 

On February 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 Conference Center in Davis, California. A Federal Register notice will be published with additional details on meeting times, agendas, and how to participate.


 

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, P.C. is a proud sponsor. Register online.


 

The Green Chemistry Clearinghouse Conference held on September 16, 2014, in San Francisco included several interesting panels discussing topics including California Safer Consumer Products Regulations' (SCPR) recently released Work Plan, the future of Toxic Substances Control Act (TSCA) reform, and the increasing push by retailers to require information from the supply chain.

Jim Jones, EPA's Assistant Administrator at the Office of Chemical Safety and Pollution Prevention (OCSPP), spoke regarding several EPA activities under TSCA, including but not limited to the schedule for risk assessments of Work Plan chemicals, the recently released proposal to redesign EPA's Design for the Environment (DfE) label, and the ChemView database providing access to health and safety data on chemicals regulated under TSCA. Jones stated EPA will be revising its list of Work Plan chemicals based on recent data indicating that production volumes of certain chemicals have decreased sufficiently to warrant EPA removing these substances for risk assessment and instead selecting other substances.

There also was discussion about another draft bill to reform TSCA to be released shortly, perhaps even this week, that many are hopeful will bridge the gaps in sections of prior bills that have been particularly contentious, including but not limited to the scope of preemption. As discussed at the Conference, the new legislation rumored to be under consideration in the Senate may have significant bipartisan sponsors. This would not increase any likelihood of action this year (zero), but definitely will put an important marker down for the starting point of future attempts to craft a bipartisan bill in 2015. According to trade press reports, last ditch efforts to draft a bipartisan bill cratered in the Senate Wednesday night. Certain environmental groups, specifically the Environmental Working Group, were reported to reject the revised measure claiming it was no better than current law. Whether the bipartisan group intends to surface a Senate bill without Senator Barbara Boxer's (D-CA) support remains to be seen.


 

On September 12, 2014, the California Department of Toxic Substances Control (DTSC) released its much anticipated draft Initial Priority Product Work Plan under SCPR. The Regulations require that DTSC, by October 2014, develop an Initial Priority Product Work Plan that describes product categories it will use to evaluate and identify product-chemical combinations to be added to the Priority Products. The Work Plan is available online and more detailed memoranda from BRAG affiliate Bergeson & Campbell, P.C. (B&C®) about the Regulations and the Work Plan are available online.


DTSC is seeking comments on its Work Plan, which can be submitted using the California Safer Products Information Management System (CalSAFER) until October 13, 2014. DTSC also is holding two workshops, one in Sacramento on September 25, 2014, and one in Cypress on September 29, 2014.


BRAG's full memorandum on the draft Initial Priority Product Work Plan and the seven Priority Products Categories identified is available online. The Work Plan will be discussed in detail at the upcoming 5th Annual Safer Consumer Products Summit -- more information below.
 


 

With the draft initial Priority Product Work Plan now released, it is important for manufacturers, importers, and retailers of consumer products in the categories listed by DTSC in the Work Plan to understand and address any issues. The upcoming Safer Consumer Products Summit, of which BRAG is a proud sponsor, will bring together DTSC staff, brand owners, chemical companies, and industry associations to discuss these developments in sessions including:


* "Strategies and Tactics in Response to Initial Priority Products and Work Plan for Future Priority Products"

* "Alternatives Assessments: Where Are We?" -- an interactive roundtable on approaches

* "Managing the Chemical Data, Confidentiality and Trade Secret Challenge"

* "Supply Chain Transformation in Response to Chemical and Safer Products Regulations"


The one and one-half-day summit will feature federal and state decision makers including Meredith Williams, Deputy Director, Safer Products and Workplaces Program, California DTSC; Bob Boughton, Senior Hazardous Substances Engineer, Safer Consumer Products Program, California DTSC; John Katz, Pollution Prevention Coordinator, Region 9, EPA; Alex Stone, Senior Chemist, Washington State Department of Ecology; and Kerry Malinowski, Manager, Safer Chemicals in Children's Products Program, Maine Department of Environmental Protection, as well as major brand owners, chemical companies, and consumer industry associations. The Summit Chair is Lynn L. Bergeson, Managing Partner of B&C, and Of Counsel with BRAG.


BRAG members and friends are eligible for a 15 percent discount on registration for the Safer Consumer Products Summit by using discount code: 141611. For more information and registration details click here.
 


 

The 4th Annual Safer Consumer Products Summit was held May 6-8, 2014, in Santa Clara, California, and with the first draft Priority Products (PP) having been announced by California's Department of Toxic Substances Control (DTSC) in March 2014, the regulators, manufacturers, brand owners, and retailers gathered for the Summit were able to engage in substantive and practical discussion and learn from case studies on California's implementation of the Safer Consumer Products Regulations (SCPR), the most expansive Green Chemistry law in the world. B&C was the Platinum sponsor of the Summit.


Summit Chair Lynn L. Bergeson introduced Meredith Williams, Ph.D., DTSC Deputy Director, who gave the Keynote Address. Dr. Williams discussed DTSC's decision-making process with regard to its three selections in its draft initial PP list (paint and varnish strippers, and surface cleaners containing methylene chloride; spray polyurethane foam systems containing unreacted diisocyanates; and children's foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP)) and other DTSC efforts, including its development of a work plan identifying potential future PPs and guidance for companies to prepare "Alternatives Analysis" assessments. DTSC also held on May 7, 2014, the first of three workshops related to its draft initial PPs. The other two workshops are scheduled for May 28, 2014, and June 4, 2014. B&C's memorandum on the draft PP list is available online.


Lisa R. Burchi, Of Counsel with B&C, moderated a panel discussion focused on the immediate challenges of complying with SCPR, including panelists from the consulting and legal community, as well as Chin Kuay, Senior Manager, Regulatory Compliance, Office Depot, and Mary-Ann Warmerdam, Regulatory Affairs Leader, Global Stewardship, The Clorox Company. The panel discussed immediate steps manufacturers and retailers are taking, how companies can prepare their long-lead-time products without knowing if or when they might be affected by a PP listing, and what steps companies should consider if there is confidential information they need to protect.


The afternoon session Keynote Address was made by Jim Jones, EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), who provided an overview of the federal chemicals management program, and the many critically important initiatives that OCSPP is spearheading to give expression to the Obama Administration's commitment to improving chemical safety.


For copies of Dr. Williams', Mr. Jones', and other presentations made at the Summit please contact .(JavaScript must be enabled to view this email address).
 


 

The California Department of Toxic Substances Control (DTSC) announced that Director Debbie Raphael will be leaving her position on May 30, 2014, to lead San Francisco's Department of the Environment. Raphael's replacement has not yet been announced.


In Raphael's place, Dr. Meredith Williams, DTSC Deputy Director, gave the keynote address at the 4th Safer Consumer Products Summit in Santa Clara, California, sponsored by B&C. Dr. Williams discussed DTSC's decision-making process with regard to its three selections in its draft initial Priority Product list (Paint and Varnish Strippers, and Surface Cleaners containing Methylene Chloride; Spray Polyurethane Foam Systems containing Unreacted Diisocyanates; and Children's Foam-padded Sleeping Products containing tris or tris(1,3-dichloro-2-propyl) (TDCPP)) and other DTSC efforts, including its development of a work plan identifying potential future Priority Products and guidance for companies to prepare alternative analysis assessments. DTSC also held on May 7, 2014, the first of three workshops related to its draft initial Priority Product list. The other two workshops are scheduled for May 28, 2014, and June 4, 2014.


Dr. Williams was introduced by Summit Chair Lynn L. Bergeson, whose comments are excerpted below.


"We have witnessed over the past years a dramatic shift in environmental law and policy from the regulation of end-of-pipe discharges of chemical substances into the environment (and their subsequent cleanup) to a more proactive focus on the presence of chemicals in products -- especially consumer products, and disciplined efforts to make better choices about ingredient selection and smarter production decisions to prevent pollution at the source. This shift is to ensure that product design and manufacture utilize greener materials and engage in smarter manufacturing processes to lessen the environmental footprint of product manufacture and use, and ensure the sustainability of product development and use.


"The Safer Consumer Products Regulation that went into effect last October is a bold, game-changing, historic development. The regulations reflect the newest chapter in California's implementation of its 2007 Green Chemistry Initiative. Whether the program in practice will be a faithful fulfillment of the goals underlying the Green Chemistry Initiative or evolves into something else remains to be seen. We are, after all, at the very early stages of the implementation phase of the SCP program. What is indisputable, however, is that the Safer Consumer Products Regulations are here to stay. They will have a considerable impact here in California and far beyond the state's borders."


Next week's Biobased and Renewable Products Advocacy Group (BRAG™) Report will include a full recap of the Summit, which will include contact information to receive copies of select presentations, including Dr. Williams' detailed PowerPoint.
 


 
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