August 13, 2019, Administrator Kevin Shea Animal And Plant H

1august 13 2019administrator Kevin Shea Animal And Plant Health Insp

This document contains comments submitted by an individual regarding the proposed rule updating the USDA’s approach to regulating genetically engineered (GE) organisms. The submission emphasizes concerns about the reduced regulatory oversight, transparency issues, and potential increased risks to public health associated with the new framework, advocating for maintaining existing premarket approval processes and transparent public comment procedures.

Paper For Above instruction

The regulation of genetically engineered (GE) organisms is a critical aspect of ensuring the safety and health of Americans and the environment. As biotechnological innovations advance rapidly, it is essential for regulatory frameworks to evolve accordingly. The recent proposal by the U.S. Department of Agriculture (USDA) to modernize its approach to assessing and managing risks related to GE organisms has raised significant concerns among stakeholders committed to public health, environmental safety, and regulatory transparency.

The USDA’s Animal and Plant Health Inspection Service (APHIS) has historically maintained oversight under the Plant Protection Act (PPA), requiring premarket review and permits for the importation, interstate movement, or environmental release of GE plants. These regulations aim to mitigate potential risks that GE organisms may pose as plant pests or threats to agriculture. However, the recent proposed rule suggests a shift towards less regulatory oversight, allowing more GE plants to enter the market with minimal review and self-assessment by developers. This change could undermine the protective regulatory measures established over the past several decades and potentially jeopardize public health and environmental integrity.

One of the primary concerns with the proposed rule is the reduction in transparency and public participation. Under existing regulations, decisions about GE organism approval and risk assessments involve public notices, environmental assessments, and opportunities for comment, typically through mechanisms such as the Federal Register. The proposal appears to diminish these mechanisms, making the regulatory process less transparent and reducing public oversight. Transparency and public participation are fundamental to maintaining trust in regulatory agencies and ensuring that scientific and community concerns are adequately addressed. Without these safeguards, the process risks becoming insular and less accountable.

Furthermore, the proposed framework permits developers to self-determine whether their GE plants should be exempted from premarket review, a major departure from the current mandatory review process. This self-exemption mechanism introduces a conflict of interest, as developers may lack the incentive or expertise to accurately assess risks, leading to the possibility of harmful or unintended consequences entering the food supply and environment. An independent, rigorous review process by USDA ensures that decisions are based on scientific evidence rather than commercial interests. The absence of such a process could increase the likelihood of GE plants that pose health or ecological risks being authorized without adequate scrutiny.

Scientific research underscores the importance of regulatory oversight in preventing unintended environmental consequences and protecting consumer health. For instance, studies have shown that some genetically engineered crops may have unintended effects on non-target organisms or contribute to increased herbicide use, which can have downstream health and ecological impacts (Frewer et al., 2013). Regulatory frameworks must therefore be stringent enough to evaluate these potential risks comprehensively.

The deregulation trend also conflicts with the precautionary principle, a widely accepted concept in environmental health that advocates for caution in the face of scientific uncertainty. Applying this principle to GE organisms necessitates thorough risk assessments before market approval to safeguard public health and biodiversity. The proposed rule’s emphasis on greater deregulation and developer self-exemption could undermine this foundational principle, leading to increased exposure to risk.

Maintaining and strengthening regulatory oversight is crucial, especially because the long-term effects of many GE organisms are still unknown. While biotechnology offers promising solutions for agriculture, such as increased yield and pest resistance, these benefits must not come at the expense of safety. As highlighted by Kuzma (2019), recent shifts in regulatory policies in the US signify a move towards lighter regulation under political influences, potentially prioritizing industry interests over public safety.

Additionally, global regulatory standards such as those set by the Codex Alimentarius emphasize the importance of transparency, risk assessment, and public participation in the regulation of biotech crops. Aligning US policies with these international standards enhances credibility and fosters international trade and cooperation (FAO, 2020).

To address these concerns, it is advisable that USDA revises the proposed rule to retain the current oversight framework that mandates premarket evaluation based on scientific assessments. Public notification processes should be preserved and expanded to include timely notices and opportunities for comment in the Federal Register, allowing for meaningful stakeholder engagement. Such measures ensure transparency, accountability, and public confidence in the regulatory system.

In conclusion, while innovation in biotechnology holds promise for sustainable agriculture and food security, it must be balanced with rigorous safety assessments. The proposed deregulation approach jeopardizes this balance by reducing oversight and public oversight opportunities. Maintaining a strong, transparent regulatory process aligned with scientific principles and public interests is essential for safeguarding health, environment, and trust in agricultural biotechnology.

References

  • Frewer, L., Scholderer, J., & Bredahl, L. (2013). The role of social trust in the global acceptance of genetically modified food products. Science and Engineering Ethics, 19(4), 979–991.
  • Kuzma, J. (2019). Biotechnology oversight gets an early make-over by Trump’s White House and USDA: Part 2 – The USDA-APHIS rule. Genetic Engineering and Society Center, North Carolina State University.
  • Food and Agriculture Organization (FAO). (2020). Codex Alimentarius and biosafety standards. FAO Publications.
  • U.S. Department of Agriculture, Animal and Plant Health Inspection Service (USDA-APHIS). (2019). Proposed regulatory framework for genetically engineered organisms. Federal Register.
  • Beaver, N., et al. (2019). Key takeaways from USDA’s biotech regulation proposal. Foley & Lardner LLP.
  • National Academies of Sciences, Engineering, and Medicine. (2016). Genetically engineered crops: Experiences and prospects. National Academies Press.
  • European Food Safety Authority (EFSA). (2021). Guidance on risk assessment of genetically modified plants. EFSA Journal.
  • Lucht, J. M. (2015). Public acceptance of plant biotechnology and GM crops. Viruses, 7(8), 4254–4278.
  • James, C. (2019). Global status of commercialized biotech/GM crops: 2019. ISAAA.
  • Mehta, S., et al. (2019). Linking science and regulation: The future of biotech crop governance. Plant Biotechnology Journal.

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