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Industry viewpoint on thresholds for genotoxic carcinogens.

M A Morelli1

  • 1FMC Corporation, Agricultural Products Group, Philadelphia, Pennsylvania 19103, USA.

Toxicologic Pathology
|June 22, 2000
PubMed
Summary

Modern pest control chemicals improve public welfare but include carcinogens. The nonthreshold regulation approach, used for many pesticides, impacts industry and may not offer significant public health benefits over threshold approaches.

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Area of Science:

  • Environmental Science
  • Toxicology
  • Public Health Policy

Background:

  • Chemical pesticides have significantly improved public welfare for 50 years by controlling disease vectors and enhancing food production.
  • However, hundreds of active pesticidal ingredients include genotoxic and nongenotoxic carcinogens, necessitating regulatory oversight.
  • The U.S. Environmental Protection Agency (EPA) regulates carcinogens using threshold and nonthreshold approaches based on weight-of-evidence determinations.

Purpose of the Study:

  • To evaluate the effectiveness of the nonthreshold regulatory approach for carcinogens in protecting public health.
  • To compare the public health protection offered by the nonthreshold approach versus the threshold approach.
  • To assess whether the incremental public health benefits of nonthreshold regulation justify its economic impact on the pesticide industry.

Main Methods:

  • Analysis of the U.S. Environmental Protection Agency's (EPA) regulatory framework for carcinogenic pesticides.
  • Comparative assessment of threshold and nonthreshold regulatory approaches.
  • Evaluation of the impact of nonthreshold regulation on industry, including product availability and research and development funding.

Main Results:

  • Over half of pesticides with carcinogenic potential are regulated by the nonthreshold approach.
  • Nonthreshold regulation has led to limitations on pesticide product availability for growers and the public.
  • These limitations have negatively impacted industry's commercial success and ability to fund new compound development.

Conclusions:

  • The study questions the extent to which nonthreshold regulation effectively protects public health compared to the threshold approach.
  • The findings suggest that the incremental public health benefits may not justify the significant economic impacts on the pesticide industry.
  • A re-evaluation of regulatory strategies is warranted to balance public health protection with industry innovation and economic viability.

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