This is the second article in a three-part series that examines developments in and the future of the FDA Food Safety Modernization Act. To read the first article, "Outbreaks Persist as FSMA Implementation Lags", go here.
By Bradd Eldridge
Signed into law by President Obama on January 4, 2011, the FDA Food Safety Modernization Act (FSMA) is one of the more significant changes to food law in nearly 75 years. The new law is designed to move the U.S. Food and Drug Administration (FDA) into a more proactive, preventive mode to address an outbreak of foodborne illnesses.
The previous version of the Food and Drug Cosmetic Act was enacted in 1938. If you imagine how most food was harvested, distributed and prepared during that time, you will realize how different things are today. In the 1930s, most food consumed was self-grown or grown on a rural farm, transported to the local market, and purchased and consumed by the community.
Today, food is no longer just for local consumption. Food is now a global commodity where the apples grown in China can be in the United States days after being picked from the tree. Food manufactured and released from Mexico can be sitting on a store shelf ready for sale in California the next day. The world is much more connected, especially within food distribution and supply chain models. These changes over the years demand new global food-safety laws and systems to protect people who consume foods produced, manufactured and shipped from countries outside their own.
The United States Congress, FDA and many other stakeholders within the food manufacturing and food-safety industry seized the opportunity from several significant food-safety outbreaks and breaches to enact FSMA. The cornerstone of FSMA, and FDA’s subsequent regulations, establish a framework for industry to adopt more preventive controls. To that end, FDA has been seeking public comment on a proposed rule entitled, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.
Abbott, like most food companies, already places a strong emphasis on food quality and safety for its consumers around the world. With the new FSMA regulations, Abbott will take its best-in-class quality system and ensure our procedures and format for reporting reflect the new policy.
Rule Requires More Stringent Preventative Controls and Hazard Identification
The proposed rule is much more prescriptive and imposes new requirements for food manufacturers, compared to current regulations. Some of these new requirements include stricter hazard identification and implementation of preventive controls to reduce or eliminate identified hazards within the facility.
This extended form of Hazard Analysis and Critical Control Point (HACCP) principles must be documented and maintained in the “food safety plan." Food-safety planning will be expected of all food facilities that are required to be registered, excluding those that meet a defined exemption in the rule. In addition to defining the hazards that are reasonably likely to occur and implementing subsequent preventive controls, the food-safety plan must include sections describing monitoring, corrective action and verification.
· Monitoring will be supported by written procedures describing how the facility monitors its preventive controls. Confirming the monitoring results are documented is an important step, as those records will be used to verify the adequacy of the facility’s preventive controls.
· Corrective Actions describe the procedures that should be followed in the event that a preventive control is not properly implemented or found to be ineffective.
· Verification of the elements in the food-safety plan is critically important and will confirm that the plan is effective. At a minimum, the food-safety plan must be reviewed and updated every three years. However, the plan must be updated before that time if 1) a significant change is made within the facility, 2) new information about a potential hazard emerges or 3) a preventive control is found to be ineffective or improperly implemented.
FSMA Has Impacts Far Beyond United States
The proposed rule also will have implications beyond U.S. borders. The regulations, when they become effective, will impact food facilities around the world that export products or ingredients into the U.S. for consumption.
Although the new law will be implemented through the U.S. food regulatory system, ultimately, FSMA established a shared responsibility that places obligations on food importers as well. Organizations responsible for importing food into the United States must have knowledge of the origin of the imported food, the effectiveness of the sources’ quality systems and the preventive controls used to produce and distribute those foods. The regulation also requires compliance with safe food programs and systems for any manufacturers whose food and food ingredients are made for U.S. distribution and consumption.
While industry may face hurdles adjusting to these new regulations, there are likely to be significant challenges for regulators as well when they begin inspecting and assessing food manufacturing facilities to ensure they are compliant with the new requirements.
For example, the proposed rule requires that every registered facility prepare a food-safety plan that can be reviewed by the investigator when he arrives at the facility. However, there is considerable latitude in how a facility chooses to organize and draft its food-safety plan. It is not yet known how an investigator might evaluate whether the facility has correctly identified all the hazards or whether the facility has implemented adequate preventive controls. While the proposed rule offers more clarity as to FDA’s thinking, it also creates more questions concerning how the FDA will inspect for compliance.
As I described earlier, the world is a much different place than it was 75 years ago. The ways food is manufactured and distributed today is far different than it was in the early to mid 1900s. New food regulations were needed in order to implement more prescriptive food-safety requirements.
All Food Stakeholders Will Benefit under New Regulatory Regime
A regulatory environment that creates a risk-based framework, focuses on good quality systems and prescribes food-safety programs in a way that can be utilized worldwide will benefit all food stakeholders. This shift places the responsibility where it should be—with the manufacturers and importers—and imposes an extra layer of responsibility on investigators, where resources are currently stretched thin.
Collaboration will be a key driver to the successful implementation of FSMA. At Abbott, we continuously look for ways to partner with industry, regulatory bodies and academia to share best practices, and implementing FSMA procedures and ensuring overall food safety are no exceptions.
While FSMA will require significant resources to implement the proposed requirements, those resources will be used in an effort to improve overall food-safety programs and move the industry toward a more harmonized approach to global food manufacturing standards.
Developing a food-safety plan under FSMA will either confirm that a facility has good hazard controls and a strong quality system in place, or it will identify areas where a food facility can improve. The rule also will enhance food-safety systems and overall awareness of food safety among food manufacturers around the world.
Most importantly, the expected outcome from this effort put forth by the U.S. government, industry, academia and other global stakeholders will be reduced food illness outbreaks.
To truly understand the benefits of FSMA, the legislation must continue to adapt as our food industry evolves into the future. More immediately, the new regulations hopefully will instill confidence in parents that the foods they are serving their children at the dinner table—from apples made in China, canned food goods from Mexico and prepared desserts produced in the United States—are safe to eat and will not produce any ill effects.
Bradd Eldridge is the Director of Quality with Abbott Nutrition. His responsibilities include understanding global regulations and developing and implementing programs to assure successful product quality, safety and compliance programs across the Abbott Nutrition division. Bradd holds a Bachelor of Arts Degree with major studies in Chemistry and Computer Science from Catawba College in North Carolina, and a Masters of Business Administration from Indiana University.