An illustration of where the FDA may believe that food or feed will cause serious adverse health effects might be horse feed contaminated with elevated levels of antibiotics. Under the Expanded Records Access, the firm must provide access to records for the product in question as well as access to records for any other article of food or feed that may also have been affected. This access pertains to processing, packing, distribution, receipt, holding or importation records.
Preventive standards and food safety plans
Animal food facilities will be required to analyze food or feed hazards in their manufacturing systems, identify and implement preventive controls to these hazards, monitor the controls and maintain monitoring records, and conduct verification activities. The FDA will be using a Hazard Analysis Critical Control Points (HACCP) approach in developing this new regulation, and firms must document their controls through a “Food Safety Plan.” This might include labeling of pet and animal feed, control of feed nutrient content or control of salmonella in pet food which could cause illness in humans by cross-contact during pet feeding.
How should you prepare?
Any process which has as a goal to prevent problems and improve your
The first order of business is to become familiar with the requirements of the law and perform an initial gap assessment of
1) Find the balance between your available resources and your business objectives;
2) Make a commitment to feed safety and communicate this to all parties involved (put this commitment in your strategic plan, and communicate this to all stakeholders: employees and customers alike);
3) Establish a budget line item for feed safety and regulatory compliance.
Develop Emergency Response Plan
Consider establishing a regulatory compliance team. This team is charged with implementing compliance to
After the regulatory team has been established, you need to make sure that your feed safety programs are in place and are continuously monitored. These key areas of best practice will be spelled out in the soon to be released preventive standards mandates by
Corrective Action Plan
The final stage of managing compliance with FSMA involves working with in-house or external counsel to bring them up to speed on compliance issues and associated liability concerns. Another strongly suggested management strategy is to develop a set of written FDA compliance policies and guidelines. The audit program should be built upon a corrective action system. Emphasis should be put on education and training, with a focus on awareness of the regulations and working with your staff so that they understand proper compliance methods.
Invest in Warehouse Management System (WMS)
If you are managing any portion of your manufacturing, warehouse or supply chain manually, this is the time to make the shift. Automation is not as intimidating or costly as it may seem. Finding the right
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