EPA Public Meeting on Guidance for Algae Submissions

The Algae Biomass Organization recently announced that EPA will be hosting a public meeting entitled, “Opportunity for Public Comment on Algae Guidance for The Preparation of TSCA Biotechnology Submissions” in Tempe, AZ on October 27, 2016, immediately following the Algae Biomass Summit being held in Phoenix earlier that week. This meeting is to continue to seek public comment as EPA works on developing guidance for submitters of MCANs and other notices to EPA for the use of intergeneric algae for industrial purposes. EPA has not yet announced details of this meeting or its physical location, except that webcasting and teleconferencing will be available.

This meeting follows one that was held last year, also timed to coincide with the Algae Biomass Summit. I reported on that meeting from September 2015 in a previous blog entry, and I have also submitted comments to EPA during the public comment period that followed that meeting.

I’ll post updates as EPA provides more information about this meeting in the weeks to come.

D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Updating the Biotechnology Coordinated Framework: New Developments

As I’ve reported in previous blog posts, in July 2015 the White House Office of Science and Technology Policy issued a memorandum to the heads of the EPA, the U.S. Department of Agriculture, and the Food and Drug Administration, directing these agencies to begin a review of their biotechnology regulations under the 1986 “Coordinated Framework”, to determine whether revisions, updating, or other changes might be needed in view of new technologies and other developments since the adoption of the framework, as well as “to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system”. As I’ve previously reported, and as covered elsewhere in the media, these agencies held a series of public meetings running from the fall of 2015 through March 2016, and solicited public comment on these questions.

Last Friday, September 16, the White House announced that EPA, FDA, and USDA have released two documents resulting from this process. The first is billed as “A Proposed Update to the Coordinated Framework for the Regulation of Biotechnology”, and the second is entitled “National Strategy for Modernizing the Regulatory System for Biotechnology Products”. The notice from OSTP said that
“Together, these documents present a comprehensive summary of the current roles and responsibilities of the three primary regulatory agencies with respect to the regulation of biotechnology products and a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology”.

I have not yet had the chance to review them in detail (the first document runs 60 pages), and I will plan to post a more detailed analysis on the blog in the days to come. But at first glance, these documents don’t contain a great deal of new information and certainly (in spite of the title of the first document) do not appear to contain any proposals for significant revisions or amendments to the regulations. The first document simply restates well-known agency jurisdiction, albeit in convenient tabular form, and perhaps better identifying potential areas of overlap for some product categories. It also reprints the various “case studies” that were presented at the public meetings in March 2016. And the second document primarily discusses ways in which these three agencies keep the public informed about their activities and the contents of their regulations, along with proposals for how such transparency could be improved in the future. To be sure, the documents characterize one goal of the effort as the mission to “update the Coordinated Framework … by clarifying current roles and responsibilities”, so by this token, the first of these documents can be seen as fulfilling this mission, while not offering very much new information.

I plan to follow up this post with a more complete analysis of these documents, and the status of the OSTP effort to update the Coordinated Framework, in the days to come.

D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

President Obama Signs TSCA Reform Bill

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which is the first major update of U.S. chemical regulation law in 40 years. The new law makes important revisions to the Toxic Substances Control Act (TSCA), which has been the U.S.’s primary law regulating the many chemicals produced for industrial purposes, consumer products, and other uses. Modified microorganisms developed for the production of fuels or chemicals may be covered under EPA regulations that are based on authority under TSCA, and my most recent blog post contains a summary of how this new law will affect EPA’s biotechnology regulations. More information about the law can be found on EPA’s website.

D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Impact of TSCA Reform (H.R. 2576) on EPA’s Biotechnology Program

As I’ve previously reported in several blog posts over the years, many modified microorganisms that are being developed for use in the manufacture of fuels or chemicals are potentially subject to regulation under the U.S. EPA’s biotechnology regulations (40 CFR Part 725) under the Toxic Substances Control Act (TSCA). TSCA has been in the news in recent weeks because, after many years of hearings and negotiations, the U.S. Congress has passed new legislation that would revise TSCA to substantially overhaul the way chemicals are regulated in the U.S.. This bill, H.R. 2576, formally entitled “The Frank R. Lautenberg Chemical Safety for the 21st Century Act”, was passed by the Senate on June 7, 2016, and at this writing is awaiting signature by President Obama, who is expected to sign it within days.

Passage of this bill is quite significant, not only because it passed with strong bipartisan majorities in Congress and was supported by the chemical industry, but also because TSCA has been the subject of criticism from environmental groups for years. These groups have maintained that the law gave EPA very limited ability to review the safety of chemicals already on the market, and this aspect of the law has been significantly strengthened in “new TSCA”. In fact, this was the driving force behind TSCA reform, and is its major impact.

There are already a number of excellent, detailed summaries of H.R. 2576 posted online by several Washington law firms (e.g. from Bergeson & Campbell; Keller & Heckman; and Beveridge & Diamond). So I won’t provide a general summary of the law, except to note that some of the key provisions of the bill are requirements for EPA to conduct reviews of existing chemicals on the market, provisions governing when state chemical safety laws can or cannot be pre-empted by federal law, and some revisions to the way confidential information must be claimed in submissions under TSCA and to what information may not be claimed as confidential. I’ll summarize the few provisions of H.R. 2576 that might affect EPA review of modified microorganisms that are the subject of Microbial Commercial Activity Notices (MCANs) or other TSCA notices.

It is important to note that there is nothing in H.R. 2576 that explicitly mentions microorganisms or biotechnology. The provisions of H.R. 2576 most likely to affect EPA’s biotechnology program are those which amend Section 5 of TSCA, “Manufacturing and Processing Notices”. This is the section on which the regulations requiring premanufacture notification (PMN) of new chemicals and MCAN notifications of new microorganisms are based. H.R. 2576 made only minor changes to TSCA Section 5, and none of these changes would affect the authority for EPA’s 1997 decision to create MCANs, TERAs, and the other parts of the biotech regulatory program. But some of these changes may affect the way EPA reviews MCANs and PMNs, as follows.

Consideration of affected populations. First, the bill says that, when evaluating the risk of a substance covered in a notification, EPA cannot consider costs or other nonrisk factors, but is required to consider the potential impact of the substance on populations that may potentially be exposed to the substance. EPA arguably had this authority under existing law, but H.R. 2576 would make it a requirement. For biotechnology notices, this would likely require the agency to explicitly review whether the proposed uses of the microorganism might affect specific populations found near the anticipated locations where the organism would be used, and it might therefore be desirable for applicants to consider whether any such populations exist near their production sites and whether any additional measures would be needed to inform local communities about the intended activities. (As an aside, it would be interesting to consider how this requirement would affect EPA’s review of a microorganism that might someday be intended for use in a consumer product or non-centralized manufacturing).

Provision for fee refunds. Second, the bill provides that, if EPA does not make a definitive decision and/or take action within 180 days of the submission of the notice (i.e. the statutory 90 days for review plus the additional 90 days EPA can unilaterally impose), EPA must refund all applicable fees to the submitter, but the agency would still be required to complete its review and render a determination. This is of course favorable to industry, but may have little practical impact, particularly on the biotech program, since EPA’s usual procedure when it needs more time for the review is to ask the submitter to voluntarily agree to suspend the review period (thus stopping the 180-day clock), making it less likely that decisions would not be reached within the stated deadline (unless a submitter refused to agree to a voluntary suspension, for whatever reason).

EPA determinations of risk. Of more importance, the bill requires EPA to reach one of the following three determinations for each notice submitted:

  • A finding that the substance presents an unreasonable risk.
  • A finding that either the information is insufficient to permit a reasoned evaluation of the substance; or in the absence of sufficient information and evaluation, the substance may present an unreasonable risk; or the substance may be produced in substantial quantities or may enter the environment in substantial quantities, which may lead to substantial human exposure.
  • A finding that the substance is not likely to present an unreasonable risk.

In the case of the first two determinations, EPA must then restrict the use of the substance through a consent order or a Significant New Use Rule.

Although this formulation is quite similar to what has previously been found in TSCA, the statement is potentially broader through the use of the word “or” to delineate all three options under the second determination. At least one law firm has cautioned that this might provide EPA broader authority to reject a notice based on insufficient data or information, and this firm is advising applicants to be sure that their PMNs and other notices contain enough information to avoid this possibility. The firm has also speculated on whether any notifications pending at the time H.R. 2576 takes effect would be assessed under the new standards or those originally found in TSCA.

In my opinion, this change will have a very limited impact on the biotechnology program. In its “Points to Consider” document, EPA provides ample guidance on the data it wants to see in MCANs and other biotech submissions like TERAs, and the agency encourages presubmission consultation, so it is rare for a biotech submission to be rejected solely on account of missing important data. Most MCANs are reviewed and cleared by EPA with very few concerns over the safety of the microorganism, and receive the “no unreasonable risk” finding, but even where the agency had substantive questions, the process to request and obtain additional data from the submitter is straightforward. In the rare case where a submitter is unable to provide any requested information, it would be more common for the submitter to withdraw the MCAN or place it on indefinite hold, rather than to force the agency to issue a finding of insufficient information.

There have been a handful of situations under the biotech program where EPA felt it had sufficient information only to allow certain limited industrial uses of an MCAN microorganism, and in those cases, the agency has used its existing authority to determine that it lacked sufficient information to allow unrestricted commercial use of a microorganism, and instead asked the submitter to enter into a consent order limiting the allowed uses of the microorganism. For example, because the MCANs from Joule and Algenol both proposed the use of photobioreactors to culture modified cyanobacteria, which had never been the subject of any prior MCANs, EPA used the “insufficient information” finding to ask each company to voluntarily enter into consent orders, initially limiting the use of the MCAN strain to the specific facility and photobioreactor described in the MCAN. So, the new language under H.R. 2576 may come into play for a small number of MCAN submissions, but would not substantially change current practice.

Biotechnology exemptions. Unlike some of the earlier versions of TSCA reform bills that Congress has considered, H.R. 2576 makes no significant changes to Section 5(h)(4) of TSCA. This is the section under which EPA created the tiered exemptions and other exemptions from MCAN reporting, and in reviewing one of the earlier Congressional drafts  a few years ago, I had some concerns that an unintended consequence of modifications to this section would have been to place the basis for the biotech exemptions in doubt. As far as I can tell, the one change that H.R. 2576 makes to Section 5(h)(4) is minor and does not affect the portion of this section allowing EPA to grant exemptions, so this is not a concern.

Confidential business information. As mentioned above, H.R. 2576 makes changes to the process of claiming confidential protection for certain information in chemical substance notifications. It establishes by statute the requirement that confidential business information (CBI) claims be substantiated at the time the notification is submitted (with certain exceptions such as marketing and sales data); but this has been required under the biotech regulations for MCANs and TERAs (and I believe also for chemical PMNs), so this will have little practical impact on the biotech program. However, the bill carries forward the provision, as under original TSCA, that health and safety information cannot be claimed as CBI, but it clarifies that process information, explicitly including molecular formulas and structures, contained in health and safety information (e.g. test results) can be claimed as CBI. Such CBI claims have been common in MCANs, and this is likely to continue unless EPA makes a shift in its policies. There are other provisions relating to CBI that have been changed – see some of the law firm general summaries referenced above for more information.

EPA biotech website updated. Finally, I’d note that EPA’s biotech program has recently updated its website listing of MCANs it has received and reviewed. The website had previously listed only those MCANs received through the end of the federal government’s fiscal year 2014 (i.e. September 30, 3014). The site now lists the MCANs received in fiscal year 2015 (there were at least 36 MCANs received that year, not all of which were reviewed favorably and cleared) and six additional MCANs received in the first six months of fiscal year 2016 (trough March 31, 2016). Many of the new MCANs covered modified strains of S. cerevisiae, and as always there were a number of MCANs where the identity of the company and the microorganism were claimed as confidential. There were also listings of three new TERAs received and approved by EPA during FY15. I hope to review and comment on these new MCANs and TERAs in a future blog post.

In summary, although H.R. 2576 represents a significant event that may substantially change many aspects of chemical regulation in the U.S., its impact on the biotechnology program will be minimal. After all, the biotech program is a minor component of EPA’s regulatory programs under TSCA — the agency receives about 1,000 chemical notices a year, but received only 36 MCANs in its busiest year (FY15). I don’t expect any major procedural changes or policy shifts in the biotech program as a result of TSCA reform, although I do see the chance for an unintended consequence: because the biotech staff in EPA’s Office of Pollution Prevention and Toxics also have responsibilities in the New Chemicals Review program, it is possible that new regulatory requirements in the chemical review program might result in less staff time for review of biotech submissions. Otherwise, I expect it will be “business as usual” for the biotech program under TSCA.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Slides Posted from BIO World Congress Presentation on Updating U.S. Biotechnology Regulations

I’ve posted my slides from my presentation last month at the 2016 BIO World Congress on Industrial Biotechnology. My talk was entitled “Updating the Coordinated Framework: What does it mean for biofuels and bio-based chemicals?”, and you can find the slides here.

The presentation described the ongoing effort, initiated by the White House in July 2015, to review and update (“modernize”) the federal government’s Coordinated Framework for Biotechnology Regulation, which has been in place since 1986 with only relatively minor revisions since that time. Since beginning this effort in July, the White House Office of Science and Technology Policy (OSTP) has convened an interagency Working Group, it has coordinated several public meetings to discuss the Framework and how it regulates biotech products, and it has commissioned the National Academy of Sciences to conduct a study predicting the future landscape of biotechnology products. In addition, both EPA and USDA have held public hearings and/or public comment periods on specific topics within their biotechnology regulatory programs.

Although this interagency effort remains in progress, the original charge from the White House was to come up with results and recommended changes to the Framework within one year. OSTP says it will meet this goal by publishing its recommendations and any proposed revised regulations by the summer of 2016. Until then, it is hard to know exactly what will be the result of the process, but in my talk, I predicted the outcomes would include:

  • Few, if any, significant changes in agency regulations that might affect industrial biotechnology, other than the possibility of substantial revisions to the USDA biotechnology rules to broaden their scope to allow the agency to assess noxious weed risks and other potential ecological impacts.
  • Clarification of how new technologies such as synthetic biology, gene-editing methods like CRISPR, and other new tools of biotechnology might be treated under the agency regulations in the Framework.
  • Greater communication and coordination between the agencies, including the possible creation of a central clearinghouse for regulatory information.
  • The possibility that the agencies may need to address the substantial volume of comments that can be expected from the sector of the general public opposed to some aspects of biotechnology, and the risk that this could lead to stricter biotechnology regulations, particularly in agriculture and foods.
  • The likelihood that industrial biotechnology will be impacted to a greater extent by other regulatory changes, such as the political fate of the Renewable Fuel Standard, the possible (although likely limited) impact of any TSCA reform bill that Congress may pass, and the ongoing efforts by FDA and the Association of American Feed Control Officials to better harmonize their review processes for new animal feed ingredients.

I’ll report on any further developments in this process as they occur later this year.

D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

 

 

Joule’s ethanol pathway approved by EPA under the RFS

Developers of novel renewable fuels or new methods of manufacturing biofuels may need to obtain EPA approval for their production pathway in order to qualify to generate Renewable Identification Numbers (RINs) under the U.S. Renewable Fuel Standard (RFS). This is a topic I’ve covered in several previous blog entries, particularly in 2014 when EPA revised its procedures and guidelines for submitting petitions for new pathway approvals. Briefly, if a fuel is produced by a pathway that is not already qualified under the RFS regulations, the developer must submit a detailed petition to the Agency describing the process to substantiate that it meets the requirements of the law, including achieving the applicable threshold of reduction of greenhouse gas (GHG) emissions.

I’m happy to report the success of one petition process with which I’ve been involved. Joule Unlimited Technologies recently announced that it received EPA approval for its Sunflow®-E ethanol process as an advanced biofuel, thus qualifying the pathway to generate advanced biofuel (D-5) RINs. To make its Sunflow-E ethanol, Joule converts CO2 to ethanol directly in a continuous process, using engineered bacteria as living catalysts. To qualify for the category of “advanced biofuels” under the RFS, the production pathway must reduce lifecycle GHG emissions by more than 50% when compared to traditional petroleum based fuels. In the EPA’s analysis of Joule’s petition, Joule’s Sunflow-E was found to reduce lifecycle GHG emissions by 85%, significantly above the required threshold.

Working as a consultant to Joule, I was the company’s liaison to EPA throughout this petition process, and I helped coordinate the in-house work of a very talented and dedicated technical team to draft the petition and to make this approval possible.

EPA’s approval letter of the Joule pathway can be found on EPA’s website. You can see Joule’s press release for more information on Joule and the Sunflow-E ethanol process. Please contact me if you have any questions or would like assistance with any matter relating to the Renewable Fuel Standard or other renewable fuels-related issue.

D. Glass Associates, Inc.is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

I’ll be speaking at the 2016 BIO World Congress next week

I will be in San Diego this April 17-20 for the BIO World Congress on Industrial Biotechnology to moderate and speak on the panel “Regulatory Growth and Commercial Development in Alternative Feedstocks and Algae. My talk will provide an update on the ongoing U.S. federal government efforts to update and modernize the Coordinated Framework for Biotechnology Regulation. As always, I’ll be posting my slides online after the conference.

The BIO World Congress provides 3 days of robust programming, networking and partnering meetings via the BIO One-on-One Partnering™ System. According to BIO:

  • 50% of attendees are international, coming from 30+ countries
  • 30% of attendees are NEW industry professionals attending the event for the very first time
  • 40% of attendees are C-Level or VP-level + hundreds of speakers.

There will be over 100 sessions featuring industry thought leaders in plenary sessions, breakout sessions across 8 dedicated tracks, GreenTech Investor sessions, an IP Symposium (new in 2016) and dedicated workshops. The conference affords an opportunity to catch up with colleagues, make new connections, and enjoy the networking opportunities at ten dedicated receptions, refreshment breaks, and other events throughout the week.

Here are some useful links:

Email worldcongress@bio.org if you have questions. Hope to see you in San Diego!

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.