APS REGULATORY ALERTS

Subject: EPA Seeks Comments on Emergency Exemption for Pesticides; FDA Seeks Comments on Guidance on Consultation Procedures; Captan Reevaluation; EPA's Re-registration Eligibility Decision for Thiophanate-Methyl; Risk Assessments for the EBDC pesticides

Date: December 2, 2004

 

EPA seeks public comments by December 22, 2004 on the paperwork and regulatory burdens associated with the extension of an existing Information Collection Request, titled "Application and Summary Report for an Emergency Exemption for Pesticides." Complete information can be found at: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-25821.htm 

The FDA Office of Management Programs seeks public comments within 60 days of the date of publication in the Federal Register, expected on Nov. 24, on the regulatory and paperwork burdens associated with the implementation of a new Information Collection Request, titled "Guidance on Consultation Procedures; Foods Derived From New Plant Varieties” (http://www.access.gpo.gov/su_docs/fedreg/frcont04.html). This ICR is a companion to another Federal Register notice, seeking public comments on a document, titled "Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use" (http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0369-nad0001.pdf).

The Captan Task Force voluntarily pursued a process to reclassify captan's initial cancer classification, as a probable human carcinogen, by supporting a third-party review of data to support a mode of action determination for captan. Based on the third-party review and subsequent agency review, EPA has determined that captan acts through a non-genotoxic threshold mode of action. Although the agency is issuing a single FR to announce both the amendment to the RED and the reevaluation of the cancer classification, the change in cancer classification does not change the risk management conclusions nor amend the 1999 Captan RED, and is not considered a re-registration action. Electronic copies of available documents are available at http://www.epa.gov/edocket/. Comments due to EPA by January 24, 2005. http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-26083.htm 

EPA announces availability of the Re-registration Eligibility Decision (RED) documents for the pesticide active ingredient thiophanate-methyl. The RED represents…”the agency's determination regarding which pesticidal uses are eligible for re-registration..." Electronic copies of available documents are posted at http://www.epa.gov/edocket/. An electronic copy of the RED is posted at http://www.epa.gov/pesticides/reregistration/status.htm. Comments due to EPA by January 24, 2005. http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-26082.htm 

EPA announces the availability of the "...Re-registration Eligibility Decision (RED) document for the pesticide active ingredient cycloate (S-ethyl cyclohexyl(ethyl)thiocarbamate). The RED represents the agency's determination regarding which pesticidal uses are eligible for reregistration ..." Electronic copies are available at http://www.epa.gov/edocket/. An electronic copy of the RED is posted at http://www.epa.gov/pesticides/reregistration/status.htm. Comments due to EPA by January 24, 2005. http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-26084.htm 

EPA announces the availability of EPA's risk assessments, preliminary risk reduction options, and related documents for the EBDC pesticides mancozeb, maneb, metiram, plus a common degradate, ethylene thiourea (ETU), and opens a public comment period on these documents to suggest risk management ideas or proposals to address the risks identified. EPA is developing a Re-registration Eligibility Decision (RED) for mancozeb, maneb, metiram, which will include a common degradate, ETU through a modified, 4-phase public participation process. Electronic copies are posted at http://www.epa.gov/edocket/. Comments are due by February 22, 2005 on Risk Assessment and Preliminary Risk Reduction Options. http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-26132.htm