PMA Comments on Proposed EPA Rule on Exemptions of PIPs
Fresh produce and flowers
Produce Marketing Association

PMA Comments on Proposed EPA Rule on Exemptions of PIPs

The Produce Marketing Association’s comments on the plant-incorporated protectants rule relate to the fresh produce sector and more.

December 11, 2020

NEWARK, Del. — The Produce Marketing Association (PMA) submitted comments on the U.S. Environmental Protection Agency’s (EPA) proposed rule for Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies. The intent of the rule is to streamline regulations to allow for a partial exemption under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) for certain PIPs that are created in plants using biotechnology. 
PMA notes that the potential benefits of the proposed rule for the specialty crop sector includes lower costs from reduced regulatory burden, increased research, development and commercialization of pest control options for farmers and reduced use of conventional pesticides, all of which could provide environmental benefits. 
PMA’s comments on the proposed rule noted the following key points for the fresh produce and floral sectors:
  • Gene editing techniques are low-risk and a variety developed using modern biotech tools can be indistinguishable from a variety developed through conventional breeding. PMA believes that EPA’s approach to regulations of crop varieties bred using modern biotechnology should be risk-based and create an exemption from FIFRA and FFDCA regulations that is functionally indistinguishable from the exemptions given to conventionally bred crops.
  • PMA encourages the alignment of the EPA’s proposed regulations with USDA’s counterpart Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule regarding the introduction of certain genetically engineered organisms.
  • PMA encourages a focus on regulation that is appropriate to the level of scientifically validated risk, rather than focusing on the regulation of the process used to create the new variety.
  • PMA believes that notification to EPA for these limited set of traits is not necessary, as gene-edited crops containing changes that could otherwise have been accomplished through conventional breeding should be exempt from FFDCA and FIFRA, except for the adverse effects reporting requirements, just as conventionally bred crops are treated.
  • In reviewing the proposed reporting requirements on trait expression in plant tissues and developmental stages, PMA believes the significant research and data requirements would prevent adoption of new breeding technologies in specialty crops, many of which are just entering the genomics era and could gain tremendous value from the technologies. The risk associated with these products that are commensurate with a conventionally bred counterpart do not warrant the data burden called for in the proposal.
  • PMA asked EPA to consider that crops with new traits that were accomplished through gene editing practices, that could have otherwise been accomplished through conventional breeding, have no additional risk and therefore warrant the exemption of conventionally bred crops. PMA suggested EPA consider a mechanism similar to USDA’s SECURE rule exemptions that could be expanded once the agency has had experience with a certain product concept without going through additional rulemaking.
PMA concluded the comments by noting that one of the greatest opportunities for EPA and the industry to meet the growing global demand for healthy and nutritious food is to encourage the development of new varieties through breeding innovations. PMA added that access to this technology is vital to efforts to improve nutrition along with the reduction.