The U.S. FDA kept itself busy in August. Here is an update on the agency’s actions.
Exemptions from FSMA
FDA has published three guidances to help producers of food commodities covered by FDA’s regulations for low-acid canned foods (LACF), juice HACCP, and seafood HACCP understand which parts of the Food Safety Modernization Act (FSMA) rules apply to them and how the FSMA rules may affect their operations.
FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products. However, there are still some requirements in the FSMA regulations that apply to these processors.
The new guidances aim to help industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements.
Major Sampling Study of Sprouts
In response to recent foodborne illness outbreaks linked to various types of sprouts, the FDA has completed a large-scale sampling study as part of its efforts to learn more about potential contamination in these products. The testing program was designed to estimate the prevalence of Salmonella, Listeria monocytogenes, and E. coli O157:H7 in sprouts, and to identify patterns in hopes of preventing these pathogens from contaminating sprouts.
The FDA collected 825 samples from 37 states, Puerto Rico, and the District of Columbia, and found that most of the positive samples came from a small number of sprouting operations: A total of 14 positive samples were found at eight of the 94 growers, and 10 of these samples came from just four growers. For complete summary report, click here.
Intentional Adulteration Rule Compliance Guide for Small Businesses
The FDA’s new Small Entity Compliance Guides (SECG) help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA. It was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. SECG provides nonbinding recommendations on such topics as developing a food defense plan and records management.
The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.
6th Chapter of Guidance for PC-Human Food Rule
FDA recently released guidance for food facilities that explains how to establish and implement a heat treatment, such as baking or cooking, to prevent contamination by disease-causing bacteria. This is the sixth chapter of the draft guidance, entitled “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food,” designed to help food facilities comply with FSMA’s preventive controls for human food rule.
The final rule, entitled “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” published on Sept. 17, 2015, builds on previous food safety requirements and introduces others that together establish a more modern, preventive, and risk-based approach to food safety.
This draft guidance is intended to help food facilities comply with specific requirements of the rule, such as developing a written food safety plan, establishing preventive controls, and taking corrective actions. The FDA intends to publish at least 14 chapters of the guidance and will continue to announce the availability of each chapter as it becomes available.
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