The following are questions and answers related to the Food Safety Modernization Act (FSMA).
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Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic Act must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies). It is important to note that applicability of the CGMPs is not dependent upon whether a facility is required to register.
The Foreign Supplier Verification Programs (FSVP) training curriculum was developed by the Food Safety
Preventive Controls Alliance (FSPCA).
The FSPCA is a broad‐based public‐private alliance of key industry, academia and government stakeholders. It was established in late 2011 by grants from U.S. Food and Drug Administration (FDA) to Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) (U01FD003801, U19FD005322, U01FD005661).
© 2017 Illinois Institute of Technology Institute for Food Safety and Health (IIT IFSH). All rights reserved.
FSPCA PREVENTIVE CONTROLS FOR HUMAN FOOD – TRAINING CURRICULUM
First Edition – 2016 (Version 1.2, February 2016)
The information provided by the Food Safety Preventive Controls Alliance (FSPCA) is for training purposes only. The FSPCA is not your attorney and cannot provide you with legal advice. The FSPCA curriculum is intended as a training tool to assist companies in complying with the FDA Food Safety Modernization Act (FSMA) preventive controls regulation; however, following this curriculum does not ensure compliance with the law or FDA’s regulations. For advice regarding the legal compliance with FSMA, please consult your legal counsel. The information provided by the FSPCA will vary in applicability to each food manufacturer. It is not possible for the FSPCA training curriculum to address every situation. Companies should implement the practices and programs that will function best to produce safe foods based on the nature of their individual operations. FSPCA materials do not outline the only approach to developing and implementing a Food Safety Plan. Companies can follow any approach that satisfies the requirements of the applicable statutes and regulations related to FSMA. The information provided by FSPCA does not create binding obligations for the Food and Drug Administration or industry. FSPCA does not guarantee the accuracy, adequacy, completeness or availability of any information provided in its
curriculum and is not responsible for any errors or omissions or for any results obtained from the use of such information. FSPCA gives no express or implied warranties, including but not limited to, any warranties of merchantability or fitness for a particular purpose or use. In no event shall FSPCA be liable for any indirect, special or consequential damages in connection with any use of this training curriculum.