On Tuesday, April 30th the EPA released their Proposed Interim Registration Review Decision for glyphosate, an important step in the registration review process. The EPA responses contain several key comments, including:
“The EPA conducted an independent evaluation of the carcinogenic potential of glyphosate and has determined that glyphosate is “not likely to be carcinogenic to humans.” The agency’s cancer classification is based on a thorough weight-of-evidence review of all relevant data and is in accordance with the agency’s 2005 Guidelines for Carcinogen Risk Assessment.”
“EPA’s cancer evaluation is more robust than IARC’s evaluation. IARC’s evaluation only considers data that have been published or accepted for publication in the openly available scientific literature. As a result, IARC only considered a subset of the studies included in the EPA’s evaluation.”
“The Agency’s cancer evaluation for glyphosate is also more transparent. EPA’s draft cancer evaluation was presented to a FIFRA SAP for external peer review. EPA solicited public comment on the carcinogenic potential of glyphosate as part of the SAP process, which is well-documented with an agenda, transcript, meeting notes, and final SAP report. EPA responded to the SAP report, addressed panel recommendations, and made revisions to its cancer assessment that were transparent and provided to the public. EPA also solicited public comment on its full human health and ecological risk assessment for glyphosate in February 2018. In contrast, IARC meetings are not accessible to the public. Its deliberations are closed, its process does not allow for public comments to be submitted for consideration, there are no materials provided in advance of the meeting, and IARC’s reports are final without an external peer review.”
“The EPA has not identified any new information received during the public comment period which ended on April 30, 2018 that would result in changes to the conclusion of its cancer assessment. The agency’s cancer conclusion is consistent with other regulatory authorities and international organizations, including the Canadian Pest Management Regulatory Agency, the Australian Pesticide and Veterinary medicines Authority, the European Food Safety Authority, the European Chemicals Agency, the German Federal Institute for Occupational Safety and Health, the Joint FAO/WHO Meeting on Pesticides Residues, the New Zealand Environmental Protection Authority, and the Food Safety Commission of Japan.”
In addition to the posting of the proposed decision, the EPA also issued strong comments in an interview with the Des Moines Register and in an official press release. The press release includes comments from EPA Administrator Andrew Wheeler and U.S. Secretary of Agriculture Sonny Perdue.
A 60-day public comment period will follow as a next step and then EPA will respond to the comments and issue the Interim Review Decision. That decision will not become final until EPA conducts an Endangered Species Act assessment. There is no set timeline for the final decision.
Tuesday’s comments by the EPA are important and consistent with the findings of regulatory authorities around the world for more than 40 years. Bayer’s official statement can be found online here.