Tag Archives: Regulations

US Biotechnology Coordinated Framework Gets a Reboot

Reworking the 1986 U.S. Coordinated Framework for the Regulation of Biotechnology

The White House issued a memorandum on July 2, 2015 directing the three Federal agencies that have oversight responsibilities for these products the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA) to update the Coordinated Framework, 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 biotechnology products to support this effort.

Increasing transparency & predictability in biotechnology regulation

The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system.  Here is a bit more detail about the efforts three components:

  • First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
  • Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies authorities, practices, and basis for decision-making.
  • Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.

More details on the elements of each of these components can be found in the memo to agencies that was issued today.

APHIS Withdraws 2008 Proposed Biotechnology Rules

WASHINGTON, February 27, 2015”The Animal and Plant Health Inspection Service (APHIS) is withdrawing its 2008 proposed rule that would have amended the regulations regarding the introduction (importation, interstate movement, and environmental release) of certain genetically engineered organisms.

APHIS received over 88,300 comments on the proposed rule. Based on the scope of comments received, and in light of the experience we have gained over the past 28 years as well as continuing advances in biotechnology, APHIS has decided to withdraw the rule and begin fresh stakeholder engagement aimed at exploring alternative policy approaches.

APHIS intends to utilize an open and robust dialogue to drive the development of future regulatory or policy approaches, as well as new scientific knowledge whenever it is available. That engagement will begin with a series of webinars that will be announced in the coming month.

From their Q&A:
Q: When can stakeholders and the public begin to share their input?
A: Once the 2008 proposed rule is officially withdrawn, APHIS can begin having conversations with stakeholders about regulatory issues that were not possible due to ex parte communication rules that apply during rule making. These rules are designed to prevent unequal access or the perception of favoritism during the active rulemaking period after a new rule is proposed.

IFB Comment: We see this as an opportunity to have even more meaningful discussions about biotechnology regulations that pertain to GM Trees.

Source: http://www.aphis.usda.gov/stakeholders/downloads/2015/sa_withdrawal.pdf

GE Apples Deregulated

The U.S. Department of Agricultures (USDA) Animal and Plant Health Inspection Service (APHIS) is announcing its decision to deregulate two apple varieties genetically engineered (GE) to resist browning.

APHIS is taking this action based on a final plant pest risk assessment (PPRA) that finds the GE apples are unlikely to pose a plant pest risk to agriculture and other plants in the United States. APHIS also completed an environmental assessment (EA) to comply with the National Environmental Policy Act (NEPA) that finds deregulation is not likely to have a significant impact on the human environment.

Under APHIS regulations, pursuant to the Plant Protection Act (PPA), APHIS is specifically required to evaluate if the apple varieties are a plant pest risk to agricultural crops or other plants or plant products. The Act defines a plant pest as organisms, such as bacteria, fungi, or insects that can cause harm to agricultural crops or other plants or plant products. If APHIS finds through its rigorous scientific review that a new GE plant is unlikely to pose a plant pest risk, then under the law and its regulations, it is required to deregulate the GE plant.

These varieties, developed by Okanagan Specialty Fruits Inc. (OSF), will be marketed as the Arctic Granny and Arctic Golden. OSF is also currently engaging in a voluntary food safety assessment consultation with the Food and Drug Administration regarding its Arctic Apples.

APHIS final PPRA and final environmental assessment can be found at

No Regulatory Authority Over GM Pine Tree – Follow Responsible Use Principles

Even when GM trees are not regulated, there are stewardship principles in place that promote the long-term, responsible use of them.

ArborGen sent this letter to USDA asking if their Loblolly Pine would be regulated. USDA responded with this letter to ArborGen stating it does not have regulatory authority over the tree based on the genetic construct and process used to develop it.

However, the USDA recommended that the Responsible Use Principles be followed.

The Responsible Use: Biotech Tree Principles were developed to help protect forests wherever biotech trees are used. These Principles are the first of their kind and were developed through a transparent, multi-stakeholder mechanism, to achieve the following objectives:

  • Establish a high level of performance for managing biotech trees that is recognized around the world.
  • Create a simple and effective set of practices so users along the biotech tree value chain know how to use the trees responsibly.
  • Increase societal benefits when biotech trees are used by promoting interaction and education between foresters, biotechnologists, and other stakeholders.

Embodied throughout is an understanding that biotech trees and their products should create sustainable benefits. Benefits may be derived from the biotech tree, its products, or scientific insight gained through forest biotechnology research. The Practices give users tools to help them enhance the benefits of forest biotechnology, mitigate risks and maintain the integrity of a biotech tree’s history as it moves along the value chain. Learn more about the Principles at ResponsibleUse.org

The following excerpt is from an article published by Capital Press

A pine tree genetically engineered for greater wood density can be grown without restrictions after the USDA decided it lacks authority to regulate the variety.

The finding has alarmed critics of genetically modified organisms who fear the new cultivar will cross-pollinate with trees in the wild, resulting in unknown consequences for forests.

ArborGen, a tree seedling producer, altered the loblolly pine variety with a gene gun inserting genetic material from the Monterey pine, the American sweetgum tree, mouse ear cress and E. coli bacteria.

None of these organisms are plant pest risks, so the USDA has determined the pine is not a regulated article and can be freely cultivated without undergoing environmental studies, unlike crops that rely on plant pathogens for their transformation.

Higher density in wood is generally associated with strength and durability in lumber as well as higher energy content for biomass uses, said Steven Strauss, a forest biotechnology professor at Oregon State University.

Biotech cultivars that rely on plant pests for gene transfer often undergo lengthy government scrutiny before theyre brought to market, he said.

The regulatory process is highly political. Its not just based on science Strauss said.

For this reason, companies are seeking alternate ways of commercializing genetically engineered crops, he said. Thats understandable from the commercial point of view.

Arborgen, for example, has tried to gain USDAs approval since 2008 for a freeze-tolerant eucalyptus tree, which was transformed with a soil pathogen and thus must receive the agencys permission for widepsread commercialization.

Environmental groups filed a lawsuit to block the company from field testing the trees, but that request was denied by a federal judge.

Even so, Arborgen was asked to submit additional data about the biotech tree in 2011 and the variety remains regulated while the USDA conducts an in-depth environmental review.

Critics of genetically modified organisms such as the Center for Food Safety worry that Arborgen was able to circumvent field trial permits and other regulatory procedures with its loblolly pine cultivar.

The group claims its unprecedented for USDA to allow a genetically engineered tree to be cultivated without any government oversight.

This is a genetically engineered organism that is going completely unregulated said Martha Crouch, biotechnology consultant for the organization.

Strauss, of OSU, said he would like to see more nimble regulations governing biotech crops but is nervous about USDAs lack of authority over GMOs produced without plant pests.

While the USDA may not consider such crops to be regulated articles, other countries may disagree ” creating the potential for chaos in the marketplace he said.

The Center for Food Safety is concerned about potential environmental impacts, alleging that changes in wood density could affect decomposition rates and forest species.

Because the USDA decided it lacks regulatory authority over the tree, the agency only considered the method of transformation without assessing any other potential risks that it might pose, said Crouch.

This is an end run around that Crouch said.

Very little information is available to the public in Arborgens request letter seeking regulatory clearance or the USDAs response, she said. We dont really know how they did it or how big of a change it is.

Arborgen was formed in 2000 by combining the biotechnology divisions of three forest products companies.

In 2010, the company filed reports with U.S. financial regulators in preparation for an initial public offering of its stock.

Those records show Arborgen losing nearly $15 million on roughly $22 million in revenues during that fiscal year. The firm later withdrew its plans to sell shares to the public due to poor market conditions.

The IFB Publishes Regulation, Certification, and Use of Biotech Trees Report

We are pleased to announce the release of both the printed, and community updated online version of the report: Regulation, Certification, and Use of Biotech Trees. The information in this report has been refined and presented at the IUFRO 2011 Tree Biotech meeting in Porto Seguro Brazil, and at the 2012 International Symposium on Biosafety of Genetically Modified Organisms in St. Louis Missouri U.S.A.

The regulatory frameworks of biotech trees in Brazil, Chile, Uruguay, U.S., Canada, South Africa, China, and New Zealand are reviewed. The approaches that top sustainable forest management systems in these countries take toward biotech trees are compared to show where regulations and certification systems overlap and diverge. Finally, there is an analysis of where, when, and for what purpose biotech trees are likely to be used commercially.

This report distills biotech material oversight into tables to more easily compare how countries approach regulation and certification of biotech trees. As an example, we show why Brazil and the U.S. are likely to commercialize biotech trees in the next few years, and why it will probably take South Africa a bit longer.

The tables make it easy to compare the total forested areas of each country, which certification schemes are predominant, and how many hectares are certified under each system.

The data are referenced and updated as of August 2013. The online version has a comment forum for the community to discuss and contribute updated information. While comments will be screened for appropriateness, the intent is to promote dialogue on certification and regulation of biotech trees.

Sponsors of the Responsible Use Initiative, and the Forest Biosciences Partnership made this report possible. You can learn more about these efforts at responsibleuse.org and forestbio.org/partners.

We appreciate your interest in the responsible use of biotech trees. We hope you and your colleagues will join in the online discussion to keep the information up to date and insightful.

Responsible Use Meeting: São Paulo Brazil, October 25-26, 2012

The IFB organized a two-day meeting in São Paulo Brazil to help establish a common understanding of the mandatory (regulation) and voluntary (certification) systems that affect the responsible use of biotech trees in Brazil. We had excellent attendance from forest product companies, industry organizations, and researchers.

Presentations from researchers set the stage for discussions on CTNBios Normative Resolution Nr5 requirements. These are high-level requirements that leave interpretation and scope up to the organization requesting deregulation of a biotech product. Progress Nr5 has 10 human and animal health related biosafety requirements, and the 13 environmental risk aspects.

The IFB gave an introduction to the Responsible Use: Biotech Tree Principles (www.responsibleuse.org) focusing on how the Principles might be used to bridge the gap in certification and global governance of biotech trees. Finally, the three sustainable forestry certification systems relevant to Brazil; CERFLOR, PECF, and FSC were discussed in regarding their individual approaches to biotech trees. The IFB combed through each system in detail. For example, we translated and annotated the Brazilian national system, CERFLOR, which is only available in Portuguese. Each system is summarized below:



Certified Area
(x 1,000 ha)

Biotech Tree Approach / Rationale

PEFC :Programme for
Endorsement of Forest Certification



Banned / Precautionary approach

based on lack of data

FSC : Forest Stewardship



Banned / Precautionary approach

based on lack of data

CERFLOR: Certificação Florestal



Banned via
PEFC registration /

No additional rationale

Notice that there are no certification systems in Brazil able to certify a forest as sustainable if there are biotech trees grown for commercial production.

The Institute of Forest Biosciences does not endorse any particular sustainable forest management or certification system. The IFB will work with systems to provide a scientific basis for making determinations about the use of biotech trees. Whether a system ultimately decides that some biotech trees can be used responsibly and certified in a sustainable forest, or not, is not the IFBs purview. The Responsible Use initiative is focused on helping to establish decision-making based on current science, open dialogue, and long-term stewardship of responsibly used biotech trees. 

Working toward these goals, the group agreed on the need to increase transparency and foster stewardship of biotech trees around the world. The IFB will work to achieve these goals through specific efforts.                                               

We would like to thank our Sponsors, and members of the Forest Biosciences Partnership for making this meeting and forthcoming Responsible Use: Biotech Tree Principles work possible.

Environmental Assessment (EA) & Finding of No Significant Impact (FONSI) for field release of Biotech Eucalyptus

APHIS announces today the availability of a Final Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for a proposed field release of a genetically engineered variety of Eucalyptus.

This action by APHIS is not a determination of nonregulated status for GE Eucalyptus by the Agency. Rather, it is a response by APHIS approving a field test permit application request from the developer of the GE Eucalyptus. From 2002-2011, APHIS has issued numerous authorizations to ArborGen LLC for the importation and field testing of GE eucalyptus trees in the southeastern United States. ArborGen is currently growing GE eucalyptus on 28 research sites in Alabama, Florida, Georgia, Louisiana, Mississippi, South Carolina, and Texas, and the current permits allow flowering on up to 330 acres across 27 of the 28 sites. These field trials have been approved by APHIS under strict permit conditions designed to prevent the movement of the regulated GE traits outside of the field test sites. Developers of new GE products typically conduct field trials under approval by, and conditions set by APHIS, for some time before either concluding field trials, or petitioning APHIS for a determination of nonregulated status for the GE product.

On February 21, 2011, APHIS received a permit application from ArborGen, LLC for a controlled field release of genetically engineered Eucalyptus hybrids in six small locations in four southern US states, totaling 14.7 acres. In comparison to previous permits issued to ArborGen, this permit would authorize ArborGen to conduct field trials at a few new locations, evaluate new traits, and allow flowering of trees at one location. The purpose of the field release is to assess the effectiveness of gene constructs intended to confer cold tolerance, to test the efficacy of genes introduced to alter lignin biosynthesis, growth rate, and flowering. In response to this new permit application from ArborGen, LLC, APHIS prepared an environmental assessment to consider whether there will be any significant environmental impacts resulting from authorization of the new field trials.

On February 10, 2012, APHIS published a draft of the environmental assessment for public comment for 30 days; 246 comments were received by APHIS. APHIS has reviewed all of the comments and concluded in its final EA that there will not be a significant impact to the quality of the human environment resulting from authorization of the field trials. APHIS also concludes that the strict permit conditions imposed by APHIS will effectively limit the reproductive capabilities and establishment of this GE Eucalyptus outside the confined field trial locations, and reduce the possibility of unintended exposure from moving GE Eucalyptus trees. APHIS has determined that it is appropriate to issue a FONSI based on its conclusions in the final EA.  APHIS will conduct inspections of the field trials to ensure compliance with the required conditions.

Permits authorizing the field trials will be issued once the notice of availability of the final EA and FONSI is published in the Federal Registernext week.
To view the final EA and FONSI, click the links below:

  1. ArborGen Permit No. 11-052-101rm Final EA
  2. ArborGen Permit No. 11-052-101rm FONSI

Reference Source: http://www.aphis.usda.gov/biotechnology/11_052101rm.shtml

New US Biotechnology Permit Users Guide from BRS

The U.S. Department of Agricultures Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) has released the USDA-APHIS-BRS Permit Users Guide. This online guidance was developed to consolidate previous permit guidance documents and to clarify the process for obtaining a USDA APHIS permit to import, move interstate, or release into the environment genetically engineered organisms regulated under 7 Code of Federal Regulations part 340.

This document places special focus on navigating the ePermits system. You will find helpful information on a wide range of ePermits topics, including how to submit an ePermits application, what type of permit to apply for, and what information to include, as well as permit examples.  The document explains what is covered under 7 CFR part 340 and offers resources to obtain additional information beyond the Permit Guidance. Additionally, it discusses containment facilities, time frames for permitreview and APHISs implementation of the National Environmental Policy Act (NEPA).

This new guidance is effective immediately and supersedesprevious APHIS-BRS guidance documents. The guide can befound at: http://www.aphis.usda.gov/biotechnology/guidance.shtml

APHIS – Feb. 27 Public Meeting and Stakeholder Survey

February 10, 2012, APHIS published a notice in the Federal Register announcing that  Administrator Dr. Parham and  Associate Administrator Kevin Shea will host a stakeholder meeting on Monday, Feb. 27, from 1 p.m. to 3 p.m. in USDAs Jefferson Auditorium to talk about the Agencys budget, modernization and process improvement initiatives.  APHIS is also seeking input from stakeholders through a survey that asks a series of open ended questions on partnerships and the Agencys critical services.  To learn more about the meeting and survey, please read Dr. Parhams Open Letter to Stakeholders:  http://www.aphis.usda.gov/stakeholders/downloads/public_meeting_letter.pdf

APHIS Stakeholder Information Page includes a link to the survey and the Federal Register Notice.  All meeting details will be posted on this page.  For those unable to attend the meeting in person, we will host a live Webcast in listen only mode, which will also be accessible from the stakeholder information page:  http://www.aphis.usda.gov/stakeholders/

– Hallie Zimmers

National Stakeholder Liaison
Animal and Plant Health Inspection Service
or 202-799-7029

USDA Biotechnology Regulatory Services Process Improvement Remarks

USDA APHIS (Animal and Plant Health Inspection Service) BRS (Biotechnology Regulatory Services) recently held a call about improvements to their process for evaluating petitions to determine nonregulated status for genetically engineered organisms. Copied below are the remarks that Clint Nesbitt used on the conference call to describe the process improvements.  Additional information will be available from APHIS-BRS in the future on this topic. 

The following statement was read by Clint Nesbitt, Chief of Staff of APHIS Biotechnology Regulatory Services, in a stakeholder call on November 14, 2011:

As you know, APHIS has a process by which developers of new genetically engineered organisms may petition APHIS to grant the organism nonregulated status if the organism does not pose a plant pest risk.

The process has been a part of APHIS regulations since 1992, and we have considered well over 130 petitions in that time.  Over the course of the last decade or so, however, the time it takes the agency to reach a decision has increased significantly”it now often takes 3 years or more”and the timeframe varies considerably from petition to petition.

APHIS understands the importance of making timely decisions, while carrying out its mission of protecting U.S. agriculture and the environment from the harmful impacts of potential plant pests.

Over the course of the last year, I led a team of APHIS subject matter experts and, using Lean Six Sigma business process improvement techniques, we have taken a hard look at the way we have been reviewing petitions.

To do this, we reviewed the process that all petitions followed since 1992, and took a much more detailed look at the petitions we have reviewed in the last five years.

We used this information to identify the causes of the delays and timeline variability, and have developed innovative solutions specifically tailored to address those key root causes.

As a result, we have created an improved petition process that we think will cut the overall timeline in half and reduce its variability significantly, without cutting any corners on the quality of analyses supporting our decision making.

That last point is worth repeating.  The process improvements were talking about are just that”process improvements”that is, changes to the behind-the-scenes steps we follow,  who does what steps, the timing of the steps, how we allocate staff resources, and so on” improving process efficiency.  We were very deliberate in not making any changes that would adversely affect the quality of the decision-making.  In fact, we think some of these changes will have the added benefit of improving the quality of our decision making and the documents that support them.

Most of the improvements in the overall timeline come from standardizing and streamlining process steps behind the scenes and improving the overall efficiency of the process.  There are a few changes, however, which will be more visible to petitioners and stakeholders, and I want to take the time to walk you through some of those new features now [these are roughly in the order they occur in the process].

  • First, at the beginning of the process, APHIS will greatly compress the amount of time it takes to review the petition for completeness.  Within one month of submission of a new petition, petitioners should expect to hear back from APHIS whether the petition has been deemed complete or whether APHIS needs additional information.  We are able to gain this time savings largely by changing the way we allocate staff resources to petitions as they are received.

  • Another change to the completeness review period is that it will be focused entirely on a review of data required by 7 CFR 340.6; that is, data needed by APHIS to prepare its plant pest risk assessment.  No NEPA specialists will be involved in the completeness review, and any NEPA-related supporting documents submitted by petitioners will be reviewed later in the process.

  • If APHIS does require additional information from the petitioner, APHIS will ask that the petitioner respond to the request within 30 days.  Most companies are currently responding within that timeframe, but some responses may require additional experiments or analysis and take considerably longer.  If a petitioner is unable to respond to APHIS request within 30 days, the petition will be treated as incomplete and will be given a new petition number once the petitioner responds.  This is primarily an administrative change on our part, to take the petitions we are waiting on off of our books and free resources to do other things.  The petitioner should not perceive any significant change”they are still free to resubmit a revised petition at any time and it shouldnt take any longer to review once it comes back in” it will just be given a new petition number, and depending upon how long it takes for the petitioner to respond, it may or may not be assigned a different reviewer.

  • The next big change to the process is that as soon as the petition has been deemed complete, we will publish the petition itself in the Federal Registerfor a 60-day public comment period (i.e. within a few months of receipt).  This is the way the process is described in 7 CFR 340.6, and the process we followed in the 90s.  By publishing the petitions for comment earlier in the process, we will be able to use the feedback as scoping for preparation of our NEPA analysis, and use that input to prepare our analysis up-front”that is, to help us inform the issues we should be analyzing in our environmental analysis” as opposed to waiting for and responding to public input after we have prepared our analysis.  We hope that this change will help make more effective use of stakeholder input in our decision making process.  Holding this comment period early in the process is also a time-savings, because it allows us time to prepare some other work in parallel with the comment period.

  • Next, using the public input as scoping, APHIS would spend the next 6 months preparing its environmental analysis, at which time the process would take one of two possible paths:

    1. For more routine petitions” those petitions that are very similar to things we have reviewed in the past and dont raise any new issues” we would publish the EA with a preliminary determination to grant nonregulated status to the organism for a 30-day public review period.  At the end of that period, the decision would become effective unless APHIS receives new information that would cause us to change the decision.
    2. For petitions that might raise new issues”either those we identify in our scoping notice or those raised during the comment on the petition”we would publish the EA as a draft and solicit public comment for 30-days. After this time, we would prepare a response to comments and revise our documents if needed, and then publish the final documents and decision in a subsequent notice.

    –  We will be publishing a Federal Register notice in the near future which will describe in more detail the changes we intend to make in the way we solicit public input, and we will not implement any of those particular changes until after the notice is published.

Altogether, we expect these process changes to represent a timeline that will take approximately 13-16 months to complete, from first receipt of a petition to final determination.

I want to stress that the process Ive described is the process that we expect most petitions to follow, based upon past experience.  However, there are a few notable exceptions I should mention that would cause a petition to follow a different timeline:

  1. If we receive a very large number of substantive comments during a comment period, it will likely take us more time to review and respond to them. 
  2. Timeline assumes that we are able to reach a FONSI after preparation of our EA.  If we are not, and preparation of an EIS is necessary, the timeline will likely be considerably longer.
  3. It should also be stressed that not every petition will be granted.  If the organism is found to pose a plant pest risk, then the petition process will take a different path.

In terms of implementation, these improvements will not take place overnight, but will be phased in gradually over the course of the next several months.  We are still working out some of the last details about when and how the new changes will be implemented. We will keep stakeholders informed as implementation plans are finalized.

It is also important to recognize that we currently have a backlog of 22 pending petitions under consideration.  Even once we implement the process changes, the backlog will continue to slow the overall process until we catch up.  Our preliminary estimates are that it may take a year or more before we are fully achieving the new timeframes.  How to address that aspect of the transition is part of what we are still working out.

Finally, we will be hosting a stakeholder meeting on December 13 in Riverdale, MD, and the process improvements will be one of the topics we discuss.  So we hope to have more details about implementation plans to give you by then.

So please stay tuned.  More details will follow in the near future.  Well keep you informed through a combination of email, web postings, the Federal Register, and at our upcoming stakeholder meeting.