|Programmatic Environmental Impact Statement (EIS)|
Summary of Public Comments
Questions from the Notice of Intent (NOI) and representative public comments received in response to them by APHIS are given below. Each comment may have been summarized from one or more people, and the collected responses to each question are usually from numerous persons or entities, not extracted from the same comment. Only a few questions have been summarized here, to provide an indication of the breadth and scope of the comments.
More detailed summaries were made by APHIS Program Planning and Development, but these are for the internal use of APHIS staff. The summaries offered here do not represent APHIS policy or deliberations.
APHIS is considering broadening its regulatory scope beyond GE organisms that may pose a plant pest risk to include GE plants that may pose a noxious weed risk and genetically engineered organisms that may be used as biological control agents. Do regulatory requirements for these organisms need to be established? What environmental considerations should influence this change in regulatory scope?
Representative Public Comments:
”The focus of the regulations should be on the potential to become a plant pest or noxious weed, and consciously avoid an inference that plants modified through biotechnology are considered to be pests or weeds.“
“Genetically engineered plants that have any cross pollination potential and are closely related to any economically important crops must therefore be considered a noxious weed risk.”
“The existing regulatory requirements used by APHIS under their previous authority should and can be used with any broadening of regulatory scope.”
“The possibility that certain biotechnology derived plants could have noxious weed potentials indicates to us that it is appropriate to put these groups under the same regulatory oversight control that is currently being used for plants that may have a plant pest potential.”
“There is no scientific justification to consider GE plants to have noxious weed potential, unless a transgene moves into a noxious weed species by crossing, e.g. herbicide tolerance moving from cultivated rice to red rice, which is a noxious weed.”
“In the absence of evidence that single genes have high potential to convert a weed or a crop into a noxious weed, regulatory oversight should not be broadened to include noxious weeds.”
“Any changes in the evaluation process, however, should be consistent with the generally accepted principle that the risks present from genetically modified plants are not fundamentally different from those present with crops derived through traditional breeding.”
“We believe that APHIS should not attempt to differentiate GEs as plant pests or noxious weeds.”
“Ten years of experience with herbicide resistance has not resulted in a case where a plant is a noxious weed and attempting to classify or regulate a potential noxious weed is mere speculation.”
APHIS should invoke authorities granted to regulate noxious weeds to ensure that each GE crop receives a thorough environmental evaluation before it is released into the environment.
Should APHIS provide for expedited review or exemption from review of certain low-risk GE commodities intended for importation that have received all necessary regulatory approvals in their country of origin and are not intended for propagation in the United States? What environmental considerations should be applied to determination of any such allowances?
Representative Public Comments:
”Traits should generally go through the same mandatory safety review process regardless of whether they are intended for propagation or not. Importing a trait in a commodity may initially be intended for non-propagation, but the use cannot be effectively limited to non-propagation unless the transportation and eventual destination of the shipment are monitored.”
“Specifically, APHIS should provide for expedited review or exemption in the importation of low risk genetically engineered commodities even in cases where these are intended for propagation so long as regulatory standards in the country of origin meet or are comparable with those of the United States or established international standards.”
“Where exporting countries do not yet meet recognized standards for science-based regulatory oversight of genetically engineered products, there should be mechanisms to allow APHIS to work with them on a case-by-case basis to develop and obtain appropriate regulatory data prior to importation in order to ensure the safety of consumers in the U.S.”
“APHIS should consider expedited review or exemption from review for certain low-risk GE products intended for importation. However, this should be done only when the commodity has received all the necessary regulatory approvals in the country of origin and only if their regulatory requirements conform to those in effect here in the U.S.”
I do not believe that importation should be exempted from review based solely on a regulated article receiving all necessary approvals in the country of origin.
“APHIS should consider expedited review of GE commodities and work with harmonizing validated data collection with major countries that export GEs. The commodity should meet the minimum regulatory standards for the US, but should consider data from the exporting country to avoid duplication of validated data.”
“Expedited review, not exemption from review, seems to us to be a reasonable policy. However, it is essential that the regulatory standards of the country of origin are equivalent to ours and to international standards, if applicable.”
“Although it may be appropriate to grant certain low-risk GE commodities intended for importation an expedited review if the risks posed are negligible, it is not appropriate to base that expedited review on the fact that the imported product received regulatory approval in its country of origin. Thus, any expedited review process should be based on objective scientific risk-based criteria and should not rely on regulatory determinations from other countries as a proxy for safe introduction into the U.S.”
What environmental considerations should be evaluated if APHIS were to move from prescriptive container requirements for shipment of genetically engineered organisms to performance-based container requirements, supplemented with guidance on ways to meet the performance standards?
Representative Public Comments:
”The best strategy would be to free the market to develop and use innovative containers to meet the objective.”
“The current requirements for packaging are outdated and inappropriate for anything except small shipments of material.”
“APHIS should allow permittees the flexibility to devise innovative solutions to meet those requirements while maintaining containment.”
“Whatever decisions that APHIS reaches regarding container requirements, it is essential that potentially hazardous GE microbes, and plants engineered to generate pharmaceutical or industrial chemicals be effectively 100% contained. Requirements must not be relaxed for the benefit of industry.”
“Under some conditions the current prescriptive container types are detrimental or lethal to the valuable living plant material they contain.”
“Environmental factors such as exposure and hazard (i.e., projected risks associated with unintended persistence of the material) should be considered for each species or species-trait combination.”
“The biology of material intended for movement should also be considered.”
“The ability to mitigate or remediate an inadvertent release should also be considered as an important environmental factor.”
“Anything that is safe enough to permit free interstate shipment is also safe enough to be exempt from any particular container requirements.”
“APHIS should retain the prescriptive container requirements rather then adopt a performance-based container requirement because the prescriptive container requirements are better suited to address risk.”