Analysis of the Food Safety Modernization Act
Analysis of the Food Safety Modernization Act
The U.S. Congress passed the Food Safety Modernization Act in December. The congressional process was neither fast nor pretty. First caught behind health care reform and then squeezed into the post-election congressional wrap up, President Barack Obama signed food safety bill in early January 2011. Long after the tortured process that produced the final bill is forgotten, the statutory language and the U.S. Food and Drug Administration’s (FDA) implementation of it will remain. Though the bill often specifies timelines for the rulemaking process and while the agency has already begun working on the rules, the actual date that the implementing regulations will go into effect. Stay tuned to PMA for the latest information. The following are key components of the bill that will affect PMA members. The next step is that FDA will implement the new law with regulations, and this summary will give companies a sense of what is to come from FDA. Produce Standards. Within one year of enactment of the law, FDA must issue proposed regulations on produce standards. The science-based standards are to be issued for those types of fruits and vegetables (including specific mixes or categories) the agency determines need standards in order to minimize risk to human health. Before becoming effective one year after the close of the comment period on the proposed rules, the agency must conduct public hearings across the country and the rules must take into account environmental, organic, and possibly even regional differences. FDA must prioritize the implementation based on known risks, including the history of outbreaks. Food Safety Plans. Each food facility must have a written food safety plan that includes hazard analysis and preventive controls, a description of verification and recordkeeping, and procedures for monitoring, recall, and tracing. The plans, which are available to FDA during an inspection, must also address risks from
The U.S. Congress passed the Food Safety Modernization Act in December. The congressional process was neither fast nor pretty. First caught behind health care reform and then squeezed into the post-election congressional wrap up, President Barack Obama signed food safety bill in early January 2011. Long after the tortured process that produced the final bill is forgotten, the statutory language and the U.S. Food and Drug Administration’s (FDA) implementation of it will remain. Though the bill often specifies timelines for the rulemaking process and while the agency has already begun working on the rules, the actual date that the implementing regulations will go into effect. Stay tuned to PMA for the latest information. The following are key components of the bill that will affect PMA members. The next step is that FDA will implement the new law with regulations, and this summary will give companies a sense of what is to come from FDA. Produce Standards. Within one year of enactment of the law, FDA must issue proposed regulations on produce standards. The science-based standards are to be issued for those types of fruits and vegetables (including specific mixes or categories) the agency determines need standards in order to minimize risk to human health. Before becoming effective one year after the close of the comment period on the proposed rules, the agency must conduct public hearings across the country and the rules must take into account environmental, organic, and possibly even regional differences. FDA must prioritize the implementation based on known risks, including the history of outbreaks. Food Safety Plans. Each food facility must have a written food safety plan that includes hazard analysis and preventive controls, a description of verification and recordkeeping, and procedures for monitoring, recall, and tracing. The plans, which are available to FDA during an inspection, must also address risks from