Search results for: "coordinated framework"

  • The Office of Science and Technology Policy (OSTP) issued a request for information (RFI) today in which it invites public comment on the Coordinated Framework for the Regulation of Biotechnology (the “Coordinated Framework”).
  • The Coordinated Framework, which is a Federal regulatory policy for ensuring the safety of biotechnology products, was first issued in 1986, updated in 1992— to affirm that federal regulation should focus on characteristics of the product and the environment into which it being introduced, and not on the process by which it is produced—and then updated again in 2017 to clarify the roles of EPA, FDA, and USDA. And, in September of this year, Executive Order 14081 directed the three agencies to clarify and streamline regulations to support the safe of use of biotechnology products.
  • Accordingly, the RFI requests comment on seven questions related to the Coordinated Framework. The questions include a request for comment on identification of any regulatory gaps, inefficiencies, or uncertainties; data or information to improve any identified issues; and new or emerging biotechnology products that the agencies should be prepared to address. Comments to the RFI are due by February 3, 2023. Also, on January 12, 2023, OTSP will host a virtual event in which it will listen to public feedback on the RFI.

 

  • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates genetically modified organisms (GMOs) for “plant pest risk” under the Plant Pest Act.  Plant pest risk is the potential for direct or indirect injury to, damage to, or disease in any plant or plant product resulting from introducing or disseminating a plant pest, or the potential for exacerbating the impact of a plant pest.  On January 19, 2017, APHIS published a proposed rule to revise the Agency’s biotechnology regulations (82 Fed. Reg. 7008), as discussed in our previous coverage of the regulation of GMOs by multiple agencies under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The January 2017 proposed rule was withdrawn, as discussed here, and replaced with a January 2019 proposed rule that was considered more favorable by the regulated industry.
  • On May 18, 2020, APHIS published the final rule amending its regulations at 7 CFR Part 340, ‘‘Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests.’’  As announced on its website, APHIS dubs this the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (“SECURE”) Rule.  The final rule is largely unchanged as compared to the January 2019 proposed rule.  Some of the major changes to be implemented under the new SECURE Rule include:
    • Replacement of the mandatory “Am I Regulated?” (AIR) process for determining whether a GMO requires regulation as a plant pest risk and the exemption process under the AIR process with criteria for a self-determination regarding exemption status and a voluntary process for seeking confirmation from APHIS;
    • Replacement of the current petition process with a new procedure for requesting a regulatory status review (RSR) to determine if a genetically engineered plant poses a plant pest risk; and
    • Discontinuing the notification process for alerting APHIS of new GMOs and replacing it with a process for applying for a permit for a GMO that is self-determined as not meeting an exemption and which does not undergo or pass a RSR.
  • According to industry press, the American Seed Trade Association has praised the SECURE Rule.  Opponents, however, such as the Center for Science in the Public Interest (CSPI) fear the rule will let potentially unsafe GMOs enter the food supply without sufficient oversight.  Both sides agree that the SECURE Rule is a major step in deregulating the introduction of GMOs for crop production.
  • For decades, the U.S. government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:
    • The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.
    • The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed.  EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).
    • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act.  APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.
  • On January 19, 2017, APHIS published a proposed rule to revise the Agency’s biotechnology regulations (82 Fed. Reg. 7008).  The proposed rule seeks to update the regulations in a number of areas, all within the Agency’s current statutory authority under the Plant Protection Act.
  • More specifically, APHIS is proposing a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks. If APHIS concludes that a GE organism does not pose a plant pest or noxious weed risk, then APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the GE organism. If, on the other hand, the Agency determines – based on a risk analysis – that controls on movement are needed, APHIS would require a permit and work with the regulated entity to establish appropriate permit conditions to manage identified risks to allow safe movement (i.e., import, interstate movement, or environmental release (regulated controlled outdoor use such as in field trials)).
  • In recent comments submitted to USDA, industry stakeholders have applauded the Agency’s proposed rule as underscoring the need to promote innovation in biotechnology and for proposing to ease regulation of gene-edited products.  But at the same time, industry has called out a number of proposed revisions as improperly expanding USDA’s review process in certain respects which could effectively hamstring developers before they can even begin testing products.
  • For example, one key provision would leverage USDA’s authority under the Plant Protection Act (PPA) to begin assessing genetically engineered  plants for their potential to become a “noxious weed,” which would potentially expand the Agency’s review process.  The existing regulatory review process is focused on assessing whether a biotech plant would be a “plant pest.”  The Agency’s proposed new approach would thus add a new layer of regulatory review.  The Biotechnology Innovation Organization, contends in its comments that APHIS already assesses plants for weediness under its existing regulatory review process and argues that the proposed rule “would create two parallel regulatory systems to evaluate the same risk, under the same statutory authority, in potentially inconsistent ways.”
  • In another set of comments, the National Grain and Feed Association and other organizations that represent companies that process and export grain and oilseeds urged USDA to withdraw the proposed rule on the basis that USDA did not consult with foreign markets and international regulators in preparing the proposed rule to ensure they would approve U.S. crop traits that would be commercialized under the proposed new system.
  • In light of industry’s feedback on the proposed rule, and with a new administration taking office since the issuance of the proposed rule, it is possible that USDA will go back to the drawing board on its plan to revamp its biotechnology regulations.  We will be sure to monitor developments on this issue as they unfold and report them to you here.
  • For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:
    • The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.
    • The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed.  EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).
    • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act.  APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.
  • On January 19, 2017, APHIS published proposed revisions to its biotechnology regulations (82 FR 7008).  The proposed rule seeks to update the regulations in a number of areas, all within the Agency’s current statutory authority under the Plant Protection Act.
  • In particular, APHIS is proposing a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks. If APHIS concludes that a GE organism does not pose a plant pest or noxious weed risk, then APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the GE organism. If, on the other hand, the Agency determines based on risk analysis that controls on movement are needed, APHIS would require a permit and work with the regulated entity to establish appropriate permit conditions to manage identified risks to allow safe movement (i.e., import, interstate movement, or environmental release (regulated controlled outdoor use such as in field trials)).
  • In crafting the proposed rule, APHIS considered comments received during public scoping and comment periods related to withdrawal of its 2008 proposed rule, as well as comments relative to a March 2016 notice of intent to conduct a programmatic environmental impact statement, recommendations made in two Office of the Inspector General audits, recent advances in biotechnology, provisions in the 2008 Farm Bill, and the Agency’s accumulated experience in implementing the current regulations. Should the rule proposed on January 19, 2017 ultimately become law, this would be the first comprehensive revision of the regulations since they were established in 1987.
  • APHIS will be accepting public comments through May 19, 2017.  Once the public comment period closes, APHIS will then determine how or whether to finalize the proposed rule based on its evaluation of public comments to the proposed revisions.

White House announces planned revision of federal GMO regulatory standards.

  • For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:
    • The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.
    • The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed.  EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).
    • The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act.  APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.
  • The White House recently announced that FDA, EPA, and USDA will update the Coordinated Framework to reflect advances in science and technology that have occurred since the framework was last revised in 1992.  In a memorandum to the heads of the responsible agencies, the White House indicated that the existing GMO regulatory framework has created “unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes….”  The White House urged the Agencies to update and modernize their rules to continue to protect the public health while facilitating innovation in a transparent manner.
  • GMO regulation continues to be a topic of heated discussion and legislative/regulatory activity among federal, state, and local regulatory officials, as well as stakeholders in the agricultural industry and the consumer safety sphere.  The White House’s memo classifies the “development of an updated [Coordinated Framework]” as a “one-year objective,” although the actual implementation time frame remains to be seen.  It will be interesting to see whether and how a potentially comprehensive (and long-overdue) update to the Coordinated Framework will influence national regulatory policy with respect to the safety and labeling of GMOs and GMO-derived food and feed products in the future.