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DairyFoods April 2012 : Page-54

FOOD SAFETY Time to get ready for FSMA The Food Safety Modernization Act became law in 2011. The FDA is now writing proposed regulations that will likely take effect next year. What do dairy companies need to do to get ready? Ⅲ Joseph A. Levitt, By Joseph A. Levitt partner, Hogan Lovells US LLP, Washington, D.C. T he most sweeping set of food safety reforms of our lifetime was signed into law by President Obama in January 2011. Called the FDA Food Safety Modernization Act (FSMA), the Food and Drug Administration is now writing pro-posed regulations that will likely take effect next year. What do dairy companies need to do to get ready? Here are four critical areas for you to focus on now. It’s all about prevention The guiding principle behind FSMA is that the food safety system— as instituted by the food industry and overseen by the FDA—should be based on prevention. Enactment of the law followed a series of foodborne illness outbreaks, and Congress decided it would be better to prevent food safety problems from occurring, rather than reacting to outbreaks and recalls after the fact. To achieve this goal, FSMA requires each dairy facility to have a food safety plan. Based on well-known HACCP (Hazard Analysis and Critical Control Points) principles, each dairy company will soon be required to conduct a detailed analysis of the reasonably foreseeable hazards present in each facility and then design and implement pre-ventive controls to significantly minimize those hazards. Many food companies have implemented HACCP in their facilities for years, and those companies should simply review their HACCP plans and tweak them as needed to meet the new law’s requirements. This means making sure the plan addresses all the potential hazards listed in the law, as well as ensuring there is scientific validation that each set of controls is indeed effective. These steps can all be undertaken now. Other steps will need to await FDA’s regulations; particularly the scope and extent of testing FDA will want to see. FSMA envi-sions a robust set of verification activities to be sure the controls in the food safety plan are effective. These activities are to include product and environmental testing, but the jury is still out on the scope and extent needed. Oversight of suppliers will be in the spotlight The prevention theme extends not just to a dairy company’s own facilities, but to its ingredient suppliers as well. Congress recog-nized the fact that a single contaminated ingredient could cause the recall of literally hundreds, or in some cases, even thousands of finished products. Congress also recognized the fact that there were simply too many ingredient suppliers for the FDA to monitor all by itself, so the law places responsibility on the finished product manufacturer to do so. Supplier verification applies to both domestic and foreign sup-pliers, and FDA is expected to apply comparable requirements to both. FSMA gives dairy companies some latitude to decide how, and how extensively, to oversee their suppliers. For example, dairy companies might choose to conduct an on-site inspection of the supplier, to test incoming ingredients, and/or to review the sup-plier’s HACCP plans. The key is that the manufacturer’s oversight needs to be sufficient to ensure the supplier is meeting the same food safety requirements as the manufacturer. It is expected that FDA will provide for some role, particularly for foreign suppliers, for third party certification programs, such as those benchmarked under the Global Food Safety Initiative 54 Dairy Foods | April 2012

Food Safety: Preparing For FSMA

Joseph A. Levitt

Time to get ready for FSMA<br /> <br /> The Food Safety Modernization Act became law in 2011. The FDA is now writing proposed regulations that will likely take effect next year. What do dairy companies need to do to get ready?<br /> <br /> The most sweeping set of food safety reforms of our lifetime was signed into law by President Obama in January 2011. Called the FDA Food Safety Modernization Act (FSMA), the Food and Drug Administration is now writing proposed regulations that will likely take effect next year. What do dairy companies need to do to get ready? Here are four critical areas for you to focus on now.<br /> <br /> It’s all about prevention <br /> <br /> The guiding principle behind FSMA is that the food safety system— as instituted by the food industry and overseen by the FDA—should be based on prevention. Enactment of the law followed a series of foodborne illness outbreaks, and Congress decided it would be better to prevent food safety problems from occurring, rather than reacting to outbreaks and recalls after the fact.<br /> <br /> To achieve this goal, FSMA requires each dairy facility to have a food safety plan. Based on well-known HACCP (Hazard Analysis and Critical Control Points) principles, each dairy company will soon be required to conduct a detailed analysis of the reasonably foreseeable hazards present in each facility and then design and implement preventive controls to significantly minimize those hazards.<br /> <br /> Many food companies have implemented HACCP in their facilities for years, and those companies should simply review their HACCP plans and tweak them as needed to meet the new law’s requirements. This means making sure the plan addresses all the potential hazards listed in the law, as well as ensuring there is scientific validation that each set of controls is indeed effective. These steps can all be undertaken now.<br /> <br /> Other steps will need to await FDA’s regulations; particularly the scope and extent of testing FDA will want to see. FSMA envisions a robust set of verification activities to be sure the controls in the food safety plan are effective. These activities are to include product and environmental testing, but the jury is still out on the scope and extent needed.<br /> <br /> Oversight of suppliers will be in the spotlight <br /> <br /> The prevention theme extends not just to a dairy company’s own facilities, but to its ingredient suppliers as well. Congress recognized the fact that a single contaminated ingredient could cause the recall of literally hundreds, or in some cases, even thousands of finished products. Congress also recognized the fact that there were simply too many ingredient suppliers for the FDA to monitor all by itself, so the law places responsibility on the finished product manufacturer to do so.<br /> <br /> Supplier verification applies to both domestic and foreign suppliers, and FDA is expected to apply comparable requirements to both. FSMA gives dairy companies some latitude to decide how, and how extensively, to oversee their suppliers. For example, dairy companies might choose to conduct an on-site inspection of the supplier, to test incoming ingredients, and/or to review the supplier’s HACCP plans. The key is that the manufacturer’s oversight needs to be sufficient to ensure the supplier is meeting the same food safety requirements as the manufacturer.<br /> <br /> It is expected that FDA will provide for some role, particularly for foreign suppliers, for third party certification programs, such as those benchmarked under the Global Food Safety Initiative (GFSI). The food industry has provided FDA with extensive information on such programs, and the agency appears to recognize this could be a feasible way for medium and smaller food companies to oversee foreign suppliers. Stay tuned for more details, but start preparing by taking a close look at what you are doing currently.<br /> <br /> Records access changes character of inspections<br /> <br /> Perhaps the biggest change for food companies will be in the fundamental character of FDA on-site inspections. This is because FSMA grants FDA broad access to a company’s food safety records. Instead of an inspection focusing on what the company is doing the day of the inspection, FDA will instead try to look back—through a company’s own records—to see if the company has been operating at a high level of safety ever since the previous inspection.<br /> <br /> What kind of records will FDA have access to? Virtually everything related to the food safety plan and its implementation. This includes: (a) the hazard analysis; (b) the system of controls and the scientific validation supporting them; (c) monitoring records; (d) verification records, including testing; and (e) corrective actions.<br /> <br /> Accordingly, food companies should start planning now on how to develop and maintain the kinds of records that will demonstrate to the FDA inspector that the company is “in control” of its processing operations. Instead of being viewed as potentially documenting “bad news,” a company’s records can now be your best tool to show the FDA that you do a good job. The new mantra will be, “If you didn’t document it, it didn’t happen!” <br /> <br /> And don’t forget re-registration <br /> <br /> Starting in October of this year, all food facilities will need to re-register with the FDA via the online registration system set up under the Bioterrorism Act of 2002. Re-registration will be required every 2 years, each October, which is the beginning of FDA’s fiscal year. Since initial registration occurred nearly 10 years ago, it is a good idea for dairy companies now, especially smaller companies, to go back and refresh your memories on how to do this.<br /> <br /> Enforcement will follow final FDA regulations<br /> <br /> Although FSMA states the new rules will go into effect on a certain date, with or without new regulations, the agency has wisely stated it will not enforce the new requirements until final regulations are promulgated. That is expected to be sometime next year.<br /> <br /> But it is never too soon to start. FDA’s inspections have already begun to anticipate the new requirements, and FSMA new enforcement tools, like mandatory recall and suspension of registration, are already in effect. So the time to get ready is now!<br /> <br /> HACCP is the path to compliance<br /> <br /> A good Hazard Analysis Critical Control Point system will help ensure your plant is in compliance with the Food Safety Modernization Act.<br /> <br /> As leaders of one of our nation’s safest and most highly regulated industries, dairy manufacturers have long understood the benefits of keeping our products safe for consumers. As you are aware, the new Food Safety Modernization Act (FSMA) will require all dairy food processors to implement new standards of food safety compliance by July 3, 2012. This includes having a written preventative controls plan to identify potential contamination hazards in your plant and describe how you will prevent or resolve them. FSMA requires your plan to have these five components:<br /> <br /> 1. Evaluation of hazards that could affect food safety<br /> <br /> 2. Specific preventative steps or controls<br /> <br /> 3. Specific monitoring procedures<br /> <br /> 4. Maintenance of routine records<br /> <br /> 5. Specific actions to correct problems While you certainly have the option to create your own preventative controls plan from scratch, there are several models already in existence that will save you the time, effort and expense. I recommend a good Hazard Analysis Critical Control Point (HACCP) system to help ensure your plant is in compliance with FSMA.<br /> <br /> What makes HACCP a good choice? Let’s look at the basics.<br /> <br /> What is HACCP?<br /> <br /> Hazard Analysis Critical Control Point (HACCP) was first developed by Pillsbury and the U.S. Army in 1959 as a response to NASA’s request to manufacture food products safe for space travel. The concept went public in 1971. Essentially, HACCP<br /> <br /> Is a system designed to ensure the safety of your food products, protect your consumers and protect your business. Come July, a detailed hazard analysis plan is the first thing the Food and Drug Administration inspectors will be asking to review when they visit your plant. A good HACCP plan provides a detailed structure to help you comply with FSMA requirements. It should contain the seven basic HACCP principles:<br /> <br /> 1. Conduct a hazard analysis and identify control measures<br /> <br /> 2. Identify Critical Control Points<br /> <br /> 3. Establish Critical Limits<br /> <br /> 4. Monitor each Critical Control Point<br /> <br /> 5. Establish corrective action to be taken when a Critical Limit deviation occurs<br /> <br /> 6. Establish verification procedures<br /> <br /> 7. Analyze and update plan regularly <br /> <br /> Appointing a HACCP team (employees involved in your technical processes as well as other plant functions) to develop, implement and maintain your HACCP plan is essential to successful compliance with FSMA.<br /> <br /> Hazard analysis and preventative controls <br /> <br /> While I can’t cover every detail of a HACCP system here, I can give you some highlights. The first step in developing a HACCP-based system is to conduct a thorough analysis that identifies and evaluates potential hazards associated with your product or process, and establishes preventative controls, including Critical Control Points. A “hazard” is any biological, chemical or physical agent that is reasonably likely to cause illness or injury if it is not controlled.<br /> <br /> A Critical Control Point (CCP) is any step in your process where a control can be applied and is essential to prevent a hazard or reduce it to an acceptable level. For example, a hazard analysis in dairy processing could identify pasteurization as the critical control point. Your CCP Critical Limits (CL) would be the minimum pasteurization holding temperatures and times, which is defined as 161 degrees F for 15 seconds in the Grade “A” Pasteurized Milk Ordinance. A CL is a maximum and/or minimum value set to prevent, eliminate or reduce the CCP hazard to an acceptable level.<br /> <br /> CCPs under HACCP require that monitoring, verification, corrective action and record keeping procedures be established in order to ensure that CCPs are properly implemented, that Cls are met and the process is under control.<br /> <br /> Under FSMA, preventative controls may also include: safety of process water; cleanliness of food contact surfaces; prevention of cross contamination; maintenance of hand washing; protection of food, packaging and food contact surfaces; proper labeling and storage of toxic compounds; employee health conditions and hygiene training; exclusion of pests; environmental monitoring; and supplier and food allergen control programs. FSMA will also require training of employees and supervisors. Most processors already have a preventative controls program in place that may be sufficient to meets the requirements of FSMA.<br /> <br /> Monitoring and corrective actions <br /> <br /> FSMA and HACCP require your plan to include documentation of how you monitor your CCPs and the actions you will take to correct any controls that are ineffective or not properly implemented. Inspectors will want to see what you plan to do to correct the problem and reduce the likelihood that it will happen again. Your monitoring and corrective action plans need to include how you will: evaluate affected food for safety; segregate and hold the affected product; determine acceptability for distribution; and prevent it from entering into commerce. You’ll also need to identify how you’ll correct the cause of the deviation from your CCP.<br /> <br /> Verification and validation <br /> <br /> HACCP provides guidance for establishing the verification and validation steps required by FSMA. FSMA verification is similar to an internal plant audit of your operational practices. It simply “verifies” that you are actually practicing the steps you’ve laid out in your written hazard plan and that those steps are functioning effectively. Validation is a periodic “hands on” evaluation of your written plan to ensure that your plan is consistent with current science and technology standards.<br /> <br /> Records and re-analysis <br /> <br /> Finally, FSMA requires you to maintain records of your actions including: monitoring of preventative controls and instances of nonconformance having to do with food safety and verification processes (such as test results). Records must be kept for two years. Re-analysis of your entire hazard prevention plan will be required every three years.<br /> <br /> I suspect the majority of the dairy food companies already have preventative controls in place that may meet FSMA standards. The new regulations will require the industry to review — and possibly enhance — its hazard management and documentation. I believe a robust HACCP system is the most effective way to achieve that goal and assure compliance with FSMA. The good news is that you don’t have to start from scratch. There are fully developed HACCP models ready for implementation. IDFA has developed HACCP models specifically for dairy and juice processing facilities. For more information about our HACCP program and training, visit our website: www.idfa.org and search for HACCP<br /> <br /> After nine years working for the FDA, Jonathan Gardner joined the International Dairy Foods Association as vice president for regulatory affairs and international standards. He works with the new FSMA regulations, teaches and develops HACCP courses.

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