FDA has released a multitude of FSMA resources, announcements and guidance documents in August and September including: Constituent Update: Produce Safety Rule Compliance Dates Delayed, September 12, 2017 Compliance Guide for Small Entities on the Produce Safety Rule, September 2017 Sixth Chapter of Guidance for the Human Food Preventive Controls Rule, August 30, 2017 Small [...]
On Wednesday, September 13, FDA published a proposed rule in the Federal Register that extends the compliance dates for the agricultural water requirements in the Food Safety Modernization Act (FSMA) Produce Safety Rule for produce other than sprouts. For sprouts the agricultural water compliance dates remain unchanged. Note the proposed rule does not impact compliance [...]
On August 2, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register the Domestic and Foreign Facility Reinspection, Recall and Importer Reinspection Fee Rates for Fiscal Year 2018. The fees are $248 per hour if domestic travel is required and $285 per hour if foreign travel is required. The fees are [...]
On April 6, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register a notice that the agency was waving retail food establishments from requirements of the Sanitary Food Transportation Act (SFTA) regulations. FDA issued a document dated March 2017 responding to comments on the retail waiver and other waivers. The waivers [...]
On December 6, 2016, the U.S. Food and Drug Administration (FDA) released final guidance intended to assist industry and FDA staff by recommending standards for accrediting third-party certification bodies for the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The final guidance document fulfills section 808(b)(2) of the FD&C Act [...]
On December 14, 2016, the U.S. Food and Drug Administration (FDA) published a final rule entitled Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program (the “Final Rule”). The Final Rule is effective January 13, 2017, and provides for a user [...]
In October 2016, the U.S. Food and Drug Administration (FDA) released draft guidance to industry entitled “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA).” The draft guidance may be found here. For more details, please see this Lieberman PLLC [...]
On August 23rd 2016, the U.S. Food and Drug Administration (FDA) released draft guidance (“Draft Guidance”) to assist industry in complying with the Preventive Controls for Human Food Rule. The agency also announced that it is delaying compliance dates for certain aspects of the PC Rule and other FSMA Rules. For more information please see [...]
On August 1, 2016, the U.S. Food and Drug Administration (FDA) published in the Federal Register the Domestic and Foreign Facility Reinspection, Recall and Importer Reinspection Fee Rates for Fiscal Year 2017. The fees are $221 per hour if domestic travel is required and $285 per hour if foreign travel is required. The fees are [...]
On July 14, 2016, the U.S. Food and Drug Administration published in the Federal Register the final rule on Amendments to Registration of Food Facilities (Final Rule). The Final Rule was issued to implement section 102 of the Food Safety Modernization Act and makes many significant changes to the food facility registration process. The Final [...]
