FDA focuses on FSMA Phase 2 implementation

The Food and Drug Administration (FDA) focused on implementation of Phase 2 of the Food Safety Modernization Act (FSMA) at its public meeting in Chicago on October 20, 2015.
According to Roberta Wagner, associate director for FSMA operations, Center for Food Safety and Applied Nutrition at FDA, FSMA is being implemented in three phases:

• Phase 1: Setting standards by developing regulations and policy.
• Phase 2: Designing strategies to promote and oversee industry compliance by identifying performance metrics to measure success.
• Phase 3: Transitioning strategies and performance metrics from design to operation and evaluating their success.

To implement Phase 2, which is the next step in the process, FSMA workgroups were established by FDA’s food and veterinary medicine executive council. Those workgroups are charged with developing the framework and multi-year implementation plan for ensuring compliance.
“We’ve set ourselves up so we are not operating in silos within the agency,” Wagner said.
Guiding Phase 2 FSMA implementation is a Program Alignment Initiative that relies on several factors to result in successful FSMA implementation:

• Vertically integrated, commodity-based programs
• Specialization of inspection and compliance staff and regulatory labs
• Clear, current and consistently applied policy
• Streamlined decision-making
• Risk-based allocation of program resources
• Agreed-upon performance and public health metrics

Key implementation principles

Joann Givens, food and feed program director for FDA Office of Regulatory Affairs, explained that Phase 2 implementation relied on several key principles. Those are:

• Industry education, outreach and technical assistance: This can be achieved by facilitating industry compliance with prevention-oriented standards through guidance documents, tools and resources for education, alliances with stakeholders, and technical assistance networks.
• Regulator training: Stringent training will promote uniform, quality inspections, which will result in consistent decision-making by regulators.
• Inspections: Systems-based inspections, as opposed to observation-focused ones, will be interactive and cooperative.  
• Compliance and enforcement: The development and implementation of explicit inspection and enforcement strategies will facilitate consistent decision-making by regulators. FDA also will encourage the industry to comply with regulations and make corrections on its own. The agency says it realizes that not all observations are equal relative to risk and the potential for public health impact and that it is aiming for a dynamic regulatory strategy.
• Accountability and stakeholder engagement: FDA is looking to develop meaningful public health and performance metrics to measure the success of FSMA implementation. It says it recognizes the role of the marketplace in influencing and expanding industry compliance with FSMA rules and therefore plans to work closely with industry, government agencies, academia, other key stakeholders and partners.

AFIA to host FSMA Phase III training

The American Feed Industry Association (AFIA) will host its second Food Safety Modernization Act Phase III training January 27, 2016, as part of the International Production & Processing Expo (IPPE) in Atlanta, Georgia. The one-day session will cover various components of the new law, published in the Federal Register on September 17, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.
The seminar is ideal for all employees involved in feed, ingredient and pet food manufacturing. AFIA staff experts and Daniel McChesney, PhD, of the US Food and Drug Administration’s Center for Veterinary Medicine, will address:

• Completing an animal food safety plan
• Current Good Manufacturing Practices
• Developing an effective supply chain program
• Foreign Supplier Verification Program and Third-Party Rules
• Records for FSMA compliance

AFIA’s next steps

“AFIA was ready for the release of the FSMA final rule and you can rest assured our staff is preparing to make the implementation process as smooth as possible,” said Henry Turlington, PhD, AFIA director of quality and manufacturing regulatory affairs. “This training will help plant managers, quality associates and feed industry personnel gain a better understanding of the animal food rule.”
You can register online or on site.
IPPE is expected to attract more than 28,000 attendees and is a collaboration of three trade shows — International Feed Expo, International Poultry Expo and International Meat Expo — representing the entire chain of protein production and processing. The event is sponsored by the American Feed Industry Association, US Poultry & Egg Association and the North American Meat Institute.

Pet food, feed meeting focuses on feed safety rule

Implementation and enforcement of the Current Good Manufacturing Practices and Hazard Analysis and Preventive Controls for Food for Animals, the Food Safety Modernization Act (FSMA) regulation most relevant to pet food safety, was a key focus of the 2015 Feed and Pet Food Joint Conference held September 29-October 1 in Columbus, Ohio, USA. The two organizations hosting the conference, the National Grain & Feed Association (NGFA) and Pet Food Institute (PFI), have played a leadership role in providing industry response to the Food and Drug Administration (FDA) on the rule.
The conference’s opening sessions were presented by two FDA representatives: Daniel McChesney, PhD, director of the agency’s Center for Veterinary Medicine Office of Surveillance and Compliance, who provided an overview of how the rule will be implemented; and Scott MacIntire, director of FDA’s Division of Enforcement/Office of Enforcement and Import Operations within the Office of Regulatory Affairs, who spoke about enforcement of the rule. A workshop on the second day of the conference helped attendees understand the rule’s requirements and how to demonstrate compliance.
McChesney reiterated that the regulation, commonly referred to as the animal feed preventive controls rule, establishes current good manufacturing practices (cGMPs) for animal feed and pet food for the first time and requires all registered manufacturing facilities within those industries to have written preventive controls plans. After several hundred comments from industry members, FDA also looked at existing industry standards and revised the requirements for cGMPs in the final rule, making them more flexible and less prescriptive because of the wide range in types of facilities, products being made and species of animals the products are manufactured for.
The cGMPs in the rule cover personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and holding and distribution of human food by-products for use as animal food, McChesney said. He added that it is up to each company/facility to determine which of these might have hazards that need control.
He also discussed the food safety plan, which must include hazard analysis, preventive controls (including process, sanitation, supply chain controls, plus a recall plan), monitoring of hazards/controls, corrective actions and controls, verification, validation, verification of implementation/effectiveness and re-analysis of plan itself. “This rule is heavy on documentation; everything must be documented,” McChesney said.
The rule also includes a supply-chain program, which involves supplier verification activities (such as on-site audits), sampling and testing, and review of relevant safety records, among other elements. The activity and frequency should be based on the nature of the hazard, where it is controlled and the supplier performance.
To help pet food and feed manufacturers comply with the rule, FDA is issuing guidance documents. One on cGMPs is finished, McChesney said, and in the process of being cleared through the federal government’s channels; a document on hazard and analysis and preventive controls is under development.
MacIntire discussed the training requirements of FSMA and FDA’s role. The agency has established a Food Safety Preventive Controls Alliance, in conjunction with NGFA and PFI, which is developing and providing training to industry as well as regulators. Food and feed safety staff from FDA will be required to attend this training, and industry members will receive a certificate proving they did the training, which will count under FSMA, MacIntire said. The preventive controls training will take three to four years because of the sheer number of people needing training, he added. In addition, the agency has formed a Food Safety Technical Assistance Network to provide central, consistent sources of outreach and real-time technical assistance to industry and regulators before, during and after inspections. Training for that is also under way.
MacIntire emphasized that the underlying philosophy for his division’s enforcement of FSMA is to try and change the culture in FDA, from one of enforcement only to gaining industry compliance. That includes having an open-door policy to industry at all levels and recognizing companies when they self-identify problems and fix them, coming up with different ways to address things. Because of the flexibility of the animal feed preventive controls rule, FDA will not use a one-size-fits-all approach, MacIntire said. That likely means spend less time in facilities with very good safety records and more time in ones that need more help.
Other speakers at the conference, including Bob Ehart, senior policy and science advisor for the National Association of State Departments of Agriculture, questioned whether FDA would receive full and adequate funding from the US Congress to enforce FSMA regulations.

AFIA to host FSMA training session

The American Feed Industry Association (AFIA) will host a one-day Food Safety Modernization Act Phase III "The Future is Now" training on Dec. 8, 2015.
The session is part of AFIA’s 2015 Regulatory Training Seminar (RTS), which will be held at the Westin Arlington Gateway in Arlington, Virginia.
RTS provides an opportunity for regulatory professionals in the feed, ingredient and pet food industries to come together to develop the necessary skills to navigate through the regulatory maze. The program is ideal for regulatory directors with several years of industry experience and will cover advanced topics and regulatory strategies.
"It is important for regulatory professionals to have the opportunity for continued education, learning the latest changes in regulations and honing their skills by working through case studies," said Leah Wilkinson, AFIA director of ingredients, pet food and state affairs. "This seminar will help participants wade through regulations, ask questions, get answers and learn from each other's best practices."
 The interactive agenda consists of discussions with expert panelists about preparation for U.S. Food and Drug Administration inspections, training exercises concerning reportable food registry and recalls, how to work with state regulators and Association of American Feed Control Officials, and much more.

AFIA’s Safe Feed/Safe Food program updated to comply with FSMA

The American Feed Industry Association (AFIA) has updated the requirements of its FSC36 Safe Feed/Safe Food Certification Program to support the new requirements outlined in the Food Safety Modernization Act (FSMA) as well as help drive continuous improvement within a location's quality and feed safety program.

The updated requirements are listed as the FSC36 Safe Feed/Safe Food Guidance Document on the Safe Feed/Safe Food website and will take effect beginning March 1.
The goals of the updated document are to assist facilities with designing, developing, implementing and maintaining a quality and feed safety program that complies with the desired requirements and to assist auditors with auditing locations seeking certification for FSC36 Safe Feed/Safe Food. The guidance offers numerous examples to assist facilities with preparation for compliance of the requirements.
"The new guidance document provides a 'user-friendly' FSC36 Safe Feed/Safe Food certification," said Henry Turlington, AFIA director of quality and manufacturing regulatory affairs. "The new requirements improve the certification process that drives continuous improvement of a company's quality and food safety program. FSC36 Safe Feed/Safe Food certification is tool AFIA recommends because it supports compliance with FSMA."
The requirements for FSC36 Safe Feed/Safe Food certification include Current Good Manufacturing Practices for animal feed production as well as the requirements for an effective animal food safety program. FSC36 requirements support a risk-based management system that is documented and implemented by a facility (supplier) of feed or feed-related products to control animal food safety.
"The changes to the requirements to obtain FSC36 Safe Feed/Safe Food are minimal; however, the process for completing the certification has been streamlined to create a more user-friendly program," Turlington said.
"The number of elements has been reduced from 230-plus elements to 77 elements to allow auditors to spend more time reviewing documentation and manufacturing processes," he said. "And, FSC36 will now be a 'Continuous Improvement' program versus a 'Compliant' program."
Previously, facilities were required to comply with each element in order to obtain certification. The new process will allow the auditor to assess the effort and progress by a facility to comply with the FSC36 Safe Feed/Safe Food Guidance Document. The facility will be scored based on these efforts. The assessment process will provide the facility with better direction for continuous improvement and compliance with FSMA. The continuous improvement process is consistent with the FSC32 and FSC34 programs. This also allows AFIA to take advantage of the Safe Quality Food Institute tools more effectively.
"Another change to the program is the 'self-audit' is being replaced by a 'surveillance audit' (or remote audit) that will be completed by the certifying body (CB). The surveillance audit is an abbreviated version of the on-site audit and covers 'mandatory' elements," said Turlington. "The process and the quality of the audit will be greatly improved as the CB is more involved with the assessment and the facility provides supporting evidence only, and an on-site audit will continue to be completed every two years."
Safe Feed/Safe Food launched in 2004, with the first facilities obtaining certification the next year. Since the beginning of the Safe Feed/Safe Food program, the number of certifications has expanded to four options. FSC36 is the most popular certification and is considered the core offering of the program. In 2013, AFIA partnered with SQFI to administer the Safe Feed/Safe Food program.

AFIA food safety seminar clarifies FSMA regulations

Henry Turlington, AFIA director of quality and manufacturing regulatory affairs, talks compliance at the Food Safety Modernization Act—Building a Foundation for Compliance seminar.
The American Feed industry Association (AFIA) hosted a full-day seminar on the US Food Safety Modernization Act (FSMA) at the International Production & Processing Expo (IPPE) in Atlanta, Georgia, Jan. 28. Part of a three-phase training program, AFIA's Phase I Food Safety Modernization Act–Building a Foundation for Compliance seminar is designed to educate and update feed and petfood manufacturers and ingredient suppliers on the various components of the new US law. Nearly 120 expo attendees attended the seminar.
"The implementation of the proposed FSMA rules has been a huge undertaking for the feed and petfood industry, and it is important for industry professionals to understand how to comply with the different requirements," said Henry Turlington, AFIA director of quality and manufacturing regulatory affairs.
The seminar was part of a line-up of 25 educational programs at IPPE. The show attracted an estimated 30,000 poultry, meat and feed industry leader attendees from all over the world. IPPE had 1,288 exhibitors with more than 490,000 net square feet of exhibit space.
Turlington opened the AFIA seminar with an overview of newly proposed FSMA rules and what the regulatory changes mean to the feed industry. He discussed AFIA's recommendations for complying with the new law and how the organization will assist its members during the implementation process.
The seminar provided information on how to build a solid foundation with current good manufacturing practices, key components of a supplier verification program, what is required for an animal food safety plan and why having a plan is beneficial to a facility. Turlington stressed the importance of implementing both a recall plan and training program for preventative measures.
Phase II of the FSMA trainings are slated to take place in 2015. They will educate feed and petfood industry professionals on the next steps in the implementation process.

AIB International releases free FSMA guide

AIB International is offering its updated "What You Need to Know About FSMA" guide as a free download from its Facebook page through February 8, 2015. The guide reflects recent changes to the FDA Food Safety Modernization Act in the US.
"Navigating the regulatory language of the Food Safety Modernization Act is a daunting task," said Lance Reeve, director of food safety services innovation for AIB International. "Our guide condenses the information and makes it easier for readers to understand the basis of FSMA's sections, key dates and industry responsibilities."
The offering is part of the kick-off for AIB International's new FSMA Readiness Assessment, an in-person assessment of existing plant programs that provides suggestions for bringing them into compliance. AIB International also offers webinars, seminars and consulting services to help facilities adhere to FSMA regulations.

AIB International, Kansas State University to host FSMA workshop

AIB International and Kansas State University’s IGP Institute have joined forces to help petfood companies meet new federal regulations. The AIB-KSU Pet Food Safety Simulation Workshop will take place in Manhattan, Kansas, on Feb. 23–27, 2015.

The Food Safety Modernization Act (FSMA) is impacting the animal food industry in a big way. For the first time, The US Food and Drug Administration (FDA) has a legislative mandate to require comprehensive, prevention-based controls across the food supply, including animal food. Now petfood manufacturers are working hard to ensure they meet FSMA’s requirements for hazard analysis and preventive controls.
The workshop will help petfood companies get up-to-speed with the newest regulations. In this simulation workshop AIB, K-State experts and industry guest speakers will teach participants how to construct a HACCP (Hazard Analysis and Critical Control Points) plan, identify GMPs (good manufacturing practices), establish sanitation procedures and microbial control measures, and develop an environmental monitoring program. The four-day course is targeted to petfood company personnel, specifically food safety and quality assurance managers, line supervisors, sanitation supervisors and operational leads.
“We are very excited about the partnership between AIB and K-State’s IGP Institute," said Carlos Campabadal, IGP Institute feed manufacturing and grain quality management specialist. "This unique training experience will provide petfood manufacturers with real, hands-on experiences so that they fully understand the principles, technical concerns and role of food safety in their facilities.” 

AFIA reiterates FSMA costs trump benefits

The American Feed Industry Association (AFIA) has submitted comments to the US Food and Drug Administration (FDA) on the Food Safety Modernization Act (FSMA)'s supplemental proposed animal food rules, flagging the cost as the lead concern if the rules are implemented as-is. The comment submission echoed comments AFIA submitted in March 2014 on the originally proposed "Current Good Manufacturing Practices and Hazard Analysis Risk-Based Preventive Controls for Food for Animals." Nineteen regional and state feed associations also signed on to AFIA's letter as a statement of their support.

"We recognize the inclusion of many of the industry's suggested changes by FDA to the proposed rules as they continue to reduce the cost of the implementation of the final rule," said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs. "However, it is not enough. Our comments urge the agency to take additional steps to lower the rule's cost while strengthening any overall benefits to the animal food industry."
Other comments submitted by AFIA revolved around the language of the rule. The organization believes there is still language within the rule that could be confusing to industry despite its attempt in its March comments to offer alternative wording and definitions. AFIA urged FDA to more closely align with the agency's medicated feed CGMPs that have been in place for more than 40 years, as there is already an understanding and excellent compliance, according to FDA's own data.
"Compliance with the rules and the implementation period is still a large and looming issue with AFIA," said the comments. "We urge the agency to closely examine our request for changing FDA's one, two and three year implementation period for regular, small and very small businesses, respectively, and consider the two, three and four year approach AFIA has advocated in previous comments."
AFIA said it will continue to work with its membership and the industry as FDA moves forward in the comment review process. The final animal food rule is mandated by a court order to be published by Aug. 30, 2015.

AFIA addresses FDA on Food Safety Modernization Act

The American Feed Industry Association (AFIA) addressed the US Food and Drug Administration (FDA) during a Nov. 13, 2014 public meeting on the four re-proposed Food Safety Modernization Act (FSMA) rules. AFIA and the 575 members it represents submitted comments to FDA in March 2014 and are taking the additional time provided to prepare feedback on the supplemental proposed rules published Sept. 29, 2014.
AFIA said it remains concerned with items addressed in its original comments that are not fully addressed in the supplemental, particularly the differentiation between human food and animal food as well as the looming high costs of the rule for its members. "There are a few proposed CGMP provisions that still appear geared toward human food, not animal food," said Paul Keppy, AFIA government affairs specialist. "This is frustrating because the spirit of the law clearly allows for treating animal food and human food regulations differently. On the other hand, there are places where animal food is left out of important rules."
Keppy said the additions in the supplemental represent significant cost increases. He said FDA's own numbers in the original Preliminary Regulatory Impact Analysis (PRIA) concur, showing the cost of the rule to far exceed the benefit. "Feed is already 70% of the cost of raising an animal," said Keppy. "AFIA members want to make animal food safer, not more expensive. We continue to believe the costs can be reduced by a less prescriptive set of CGMPs and a strong approach to controlling significant hazards through CGMPs."
AFIA will submit comments on the proposed supplemental rules, which are due by Dec. 15.

FDA official discusses FSMA petfood safety supplemental proposed rule

During the 2014 Feed and Pet Food Joint Conference, October 7-9 in Omaha, Nebraska, USA, Daniel McChesney, PhD, director of the office of surveillance and compliance for the US Food and Drug Administration’s (FDA) Center for Veterinary Medicine, highlighted key revisions to the preventive control rule for petfood and feed under the Food Safety Modernization Act (FSMA).

McChesney said FDA received more than 2,100 comments to the original proposed animal feed preventive control rule released in October 2013, including many from consumers. Industry organizations, such as the Pet Food Institute and National Grain and Feed Association (co-organizers of the Feed and Pet Food Joint Conference), along with the American Feed Industry Association, also offered in-depth feedback on the original rule.
With the re-proposed rule, which FDA released September 29, 2014, and McChesney referred to as the supplemental proposed rule, the agency is only asking for comments on new or revised areas, though it will accept comments on other areas. FDA is accepting comments for 75 days from the release date.
The major revisions included in the supplemental rule, McChesney said, include:

• A “very small business,” which would be exempt from complying to some elements of the rule, is now defined as having less than US$2.5 million in total annual sales of animal food, adjusted for inflation. McChesney commented that 98% of the animal food (including petfood) industry in the US would be covered outside this exclusion. However, he also said FDA is seeking comments on whether dollar sales are the best measure for feed and petfood. Would units of sale, for example, be better?
• Current good manufacturing practices (CGMPs), which were a big area and focus of comments received, McChesney said; feedback to the original proposed rule said it made CGMPs too prescriptive, too similar to ones for human food and too stringent to be prerequisites because of the diversity of animal food facilities. In response, FDA modified that section of the rule, keeping the structure of human food CGMPs but rewriting the ones for animal food to be less prescriptive. McChesney said he thinks they're much closer to being appropriate for animal food but FDA is still looking for comments.
• Under hazard analysis and critical control points (HACCP) plans, comments to the original proposed rule expressed concern with use of the word “known” in terms of identifying hazards, because that might have led to food facilities needing to control every single conceivable hazard out there. While McChesney said that was never FDA’s intent, the agency did change the wording in the supplemental proposed rule to “significant hazards,” also replacing the wording “reasonably likely to occur.”
McChesney commented that in written food safety plans, which FSMA will require of every facility but very small businesses, manufacturers will need to define hazards they are controlling—and how—outside of CGMPs. So, if a facility has comprehensive CGMPs, it might have a very narrowly focused, short safety plan.
With supplier verification, comments to the original proposed rule agreed it's a good idea but didn't like how FDA proposed doing it. So, McChesney said, FDA looked at the foreign supplier verification rule under FSMA and how that might apply to domestic suppliers. In the supplemental proposed rule, FDA is providing flexibility for each facility to determine appropriate verification activities of its suppliers. However, it will likely require an annual audit of significant hazards; unless you're controlling that hazard at your facility, you should verify your supplier is controlling it.
Finally, in response to a question about how FDA inspectors will be trained to enforce FSMA rules, McChesney said that at least initially, inspectors will be looking mainly to see that facilities and their personnel understand the rules and how their company is following them; they would not be looking to write tickets for noncompliance. In other words, initial visits will be focused on education, not compliance.

AFIA completes first phase of FSMA seminars

The American Feed Industry Association (AFIA) completed two more phase I Food Safety Modernization Act (FSMA) regional seminars in Des Moines, Iowa, and Atlanta, Georgia, Aug. 11–12 and Aug. 14–15, respectively. Both of the two-day seminars discussed the developing need for an industry-wide understanding of the largest set of rules to impact the feed and petfood industries. The first training session was held in Sacramento, California, in late July.

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The sold-out Des Moines meeting was attended by more than 130 feed manufacturers, petfood manufacturers and ingredient suppliers interested in learning more about quality and food safety practices. "Our goal is to provide a solid foundation to the quality and food safety programs for businesses as they begin to implement practices and prepare documentation for compliance with the new FMSA requirements," said Dr. Henry Turlington, AFIA director of quality and manufacturing regulatory affairs.
AFIA hosted a second sold-out training course in Atlanta, where one-third of the room represented the poultry integrator sector of the industry. Dr. Adam Fahrenholz of North Carolina State University joined Turlington, speaking on the topic of "CGMPs: The Foundation for an Effective Food Safety Plan." Fahrenholz chaired AFIA's Current Good Manufacturing Practices FSMA Working Group that prepared comments to the US Food and Drug Administration on the proposed CGMP rules.
Turlington said that participants at the training sessions expressed concern and asked questions about efforts to reach compliance. "It is important facilities understand how FMSA impacts them as requirements may differ based on the business and facility's animal food safety plan," said Turlington. "The information shared during the meetings, as well as references provided electronically, will help businesses determine the right steps for them."
AFIA will be back in Atlanta to host an additional phase I FSMA regional seminar training program at the International Production & Processing Expo on Jan. 28, 2015. The one-day meeting will discuss the FSMA proposed rules and the fundamentals for complying with FSMA as was done in all three meetings completed this summer. Registration and event information will be available on Sept. 1, 2014, at http://ippexpo.com/.
Phase II and phase III FSMA regional seminars will be hosted by AFIA in 2015 along with a series of other training tools under construction along with the in-person meetings.

AFIA comments on proposed FSMA sanitary transportation rule

The American Feed Industry Association (AFIA) has submitted comments to the US Food and Drug Administration (FDA) on the proposed Sanitary Transportation of Human and Animal Food rule.

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The FSMA requires FDA to create regulations for shippers, carriers by auto transit or railway vehicles, and receivers to use sanitary transportation practices to ensure food—including animal food—being transported does not become contaminated. The goal of the sanitary transportation rule is to ensure that transportation practices do not create food safety risks.
Although AFIA openly agrees with FDA in certain areas, such as allowing "the industry to continue to use bulk transport equipment in accordance with best practices without limiting industry, by rule, to hauling non-food exclusive of or preceding any food items," the organization listed several points of difference in their nine pages of comments for FDA to review.
In the rule, FDA proposed exemptions for farms and shelf stable products. AFIA suggested those exemptions be broadened to include intra-company shipments (when the company maintains control of the product), short haul transports (as defined by the US Department of Transportation) and finished product or raw agricultural commodities transported from facilities to farms in dedicated vehicles. AFIA also commented that FDA should lower the recommendation on the definition of "non-covered business" to engage businesses with transportation operations with less than US$10,000 in total annual sales.
The organization also made note of the temperature control measures and hand washing facility requirements originally proposed are not appropriate across the animal food industry and would induce unnecessary cost on the industry without improving the safety of animal food products. AFIA would like these requirements to be removed for animal food.
The comments on the proposed sanitary transportation rule were drafted by AFIA members who volunteered as part of a work group to review the rule. FDA, under a court ordered deadline, must issue the final rule on this topic by March 31, 2016. 

AFIA hosts successful FSMA regional training

The American Feed Industry Association (AFIA) hosted its first of three Phase I Food Safety Modernization Act (FSMA) regional seminars July 27–28, 2014, in Sacramento, California. The sold-out, two day meeting was developed to assist the industry in understanding the largest set of rules to impact feed and petfood since the 1950s.

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"Providing FSMA-related training for our members is a top priority for AFIA," said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs. "In order to make this information as convenient as possible, we decided to hold a number of regional seminars throughout the US."
The training course, taught by AFIA legislative and regulatory staff, was attended by animal feed and petfood manufacturers as well as ingredient suppliers interested in gaining a better understanding of how FSMA will affect their businesses. The course provided an overview of the new law and covered topics such as "CGMPs: The Foundation for an Effective Food Safety Plan," "What are the Key Components of a Supplier Verification Program?" and "Hazard Identification and Analysis.
Dr. Henry Turlington, AFIA director of quality and manufacturing regulatory affairs, began the seminar saying, "FSMA will have a major impact on our industry and that can be overwhelming, but this thing is doable! We will take this one step at a time to make sure we all have the knowledge needed to comply with FSMA."
Attendees of the meeting said they considered the materials provided by the course instructors "good information," "very timely" and think it "will help with developing documents and preparing for FSMA compliance" as the rule comes into effect.
The remaining two phase I trainings will be held in Des Moines, Iowa, and Atlanta, Georgia, Aug. 11–12 and Aug. 14–15, 2014, respectively. The Atlanta training remains open for registration while the Des Moines training sold out shortly after registration opened.
AFIA plans to host phase II and phase III FSMA regional seminars in 2015 and also offer a webinar series in correlation with the in-person meetings.

AFIA applauds FDA on FSMA animal food exemption proposal

The American Feed Industry Association (AFIA) has submitted comments to the US Food and Drug Administration (FDA) applauding the agency's proposal to exempt animal food from the Food Safety Modernization Act (FSMA)'s intentional adulteration rule. The "Focused Mitigation Strategies to Protect Food Against Intentional Adulteration" would require registered domestic and foreign food facilities to address hazards that may be intentionally introduced by acts of terrorism.

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AFIA said in its comments that there are significant differences between risks in human food and animal food, particularly when dealing with intentional adulteration, which is recognized by Congress in the Food, Drug and Cosmetic Act. "What is nutritious for a ruminant cow may not be nutritious for a pig," said AFIA. "Sheep, for example, have an increased sensitivity to copper. Risk varies between humans and animals as well. For example, humans can be allergic to a host of things from peanuts to shellfish, while animals simply do not have this same risk."
The creation of Section 420 in the FD&C Act states FSMA requires FDA to establish regulations for facilities to review the potential risk of intentional adulteration of food—further noted in Part C, this applies only to human food. "AFIA fully supports FDA's findings and proposed exemption of animal food in the intentional adulteration rule as we believe it is Congress' intent," said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs. "FDA has indicated the proposed rule's purpose is 'to protect food from intentional adulteration when the intent is to cause large-scale public harm' and AFIA firmly believes animal food has a significantly lower risk of impacting human health."
The final rule on intentional adulteration will be published by May 31, 2016.

FDA reopens comment period on Reportable Food Registry proposed rulemaking

The US Food and Drug Administration (FDA) has reopened the comment period for an additional 60 days on its advance notice of proposed rulemaking entitled, “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.” In the advance notice of proposed rulemaking, FDA requested comments, data and information that will help to implement the new provisions to the RFR requirements added by FSMA.

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The RFR is an electronic portal for industry to use to submit reports to FDA regarding reportable foods. A reportable food is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. On March 26, 2014, FDA published a Federal Register notice inviting comments on issues related to the FSMA amendments, including the following:

• what information responsible parties should be required to provide FDA that would enable consumers to accurately identify whether they possess such foods
• manners and locations used by grocery stores to provide food recall information to consumers
• information regarding potential impacts to and costs incurred by chain grocery stores related to posting consumer notifications
The agency is reopening the comment period based on a request for an extension to allow interested persons additional time to submit comments. You may comment electronically on www.regulations.gov using docket number FDA-2013-N-0590.

PMMI highlights FSMA perceptions, next steps in Food Safety & Traceability Report

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Many stakeholders across the food industry appear to be confused about implementation deadlines surrounding the Food Safety Modernization Act (FSMA), according to a recent study from PMMI, The Association for Packaging and Processing Technologies. Compiled from 64 interviews with manufacturing professionals, the report details food manufacturers’ perceptions of FSMA, and how equipment manufacturers can best help them respond to the upcoming regulations.

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“Since 2011, FSMA has been a source of anticipation and anxiety for many food and beverage manufacturers," said Paula Feldman, director, Business Intelligence, PMMI. "The legislation can impact companies differently depending on their size and vertical market. Our aim with this study was to shed light on industry concerns and advise manufacturers on ways they can ensure compliance.”
The study identifies the industries most affected by the anticipated rules. Fresh produce manufacturers are expected to see the greatest impact. Producers of baby food, infant formula and nutraceuticals will see little impact as they have already been subject to rigorous standards for preventative controls, traceability and sanitary equipment design. Industries overseen by the US Department of Agriculture are less likely to be impacted and juice, low-acid canned foods and seafood manufacturers are exempt.
The report also expands on ways that manufacturers affected by FSMA can make strides towards compliance—whether they have one, two, three or four years to do so. These steps include reducing liability with greater traceability capabilities, evaluating equipment design for improved sanitary construction and easy cleaning, and training operators thoroughly and often.

New FSMA requirements require further FDA work

Under the proposed Food Safety Modernization Act rules governing animal feed and petfood, each covered facility must prepare and enforce a hazard analysis and risk-based preventative controls process (a written food safety plan). Among the items that must be included in such a plan is the requirement that a "qualified individual" prepare and oversee the entire process. Unfortunately, what makes someone qualified has not yet been fleshed out.

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The definition of a "qualified individual" is someone who has successfully completed training in the development and application of risk-based preventive controls under a standardized curriculum recognized as adequate by the US Food and Drug Administration (FDA), under a program that is at least equivalent to that standardized FDA-approved curriculum, or be otherwise qualified through job experience. But, as of yet, there is no FDA-approved curriculum to either attend or compare job experience to.
The Food Safety Preventative Controls Alliance (FSPCA), a private alliance of leaders in the industry, academia and state and local food protection agencies, will be responsible for creating the standardized curriculum, with FDA offering input. The ultimate goals are that the FSCPA will:

• Develop standardized hazard analysis and preventive controls training and distance education modules for food industry and regulatory personnel. The first individuals who will receive the training are those individuals who will then train others. The second to receive the training will be federal and state regulatory inspectors. Finally, training will be made available to industry members.
• Design and deliver a state-of-the-art distance learning training portal at the IIT IFSH Moffett Campus in Bedford Park, Illinois. In addition to in-person training, it is anticipated that training will be offered online.
• Create a technical assistance network, such as a website community, where small- and medium-size food companies can go to for help with their preventative control or food safety plans.
• Develop commodity/industry sector-specific guidelines for preventive controls.
• Over time and as technology develops, assess knowledge gaps and research needs for further enhancement of preventive control measures.
• Identify and prioritize the need for, and compile, critical limits for widely used preventive controls.
Once the curriculum is completed and approved, the "qualified individual" will have much more solid measurements to meet.

AFIA requests animal food exemption in FSMA Reportable Food Registry

The American Feed Industry Association (AFIA) filed comments on June 6, 2014, with the US Food and Drug Administration (FDA) requesting an exemption of animal food from provisions made to the Reportable Food Registry (Sec. 417) of the Federal Food Drug & Cosmetic Act (FD&C) as amended by the Food Safety Modernization Act (FSMA). 

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According to AFIA, Congress' intent when generating Sec. 211 of FSMA, which amends Sec. 417 of the FD&C regarding the Reportable Food Registry requirements, was only designated for human food products and not intended to affect animal feed or petfood. "The statutory language does not mention 'animal food', it addresses notification to 'consumers' and requires that notifications be published in 'grocery stores' only," said AFIA. "The 'consumers' of animal food products are livestock or companion animals. These animals are not capable of purchasing the products or reading a notification regarding a product. Customers or purchasers would have been the more appropriate term if Congress intended this provision to apply to animal food products."
AFIA also said the law's exemptions only include "raw agricultural commodities" of fruits and vegetables—not including grains used that occur in their raw or natural state—further stressing Congress' focus on human food versus animal food. The organization highlighted its support for every animal food facility having a recall plan under FSMA in combination with an effective Reportable Food Registry system enforced by FDA, which AFIA said would prevent "most products that could cause serious or adverse health consequences or death to humans or animals should be in the process of being recalled or will not have ever reached a grocery store shelf." 

By-products in animal food will be regulated under FSMA

By-products from human food, alcohol and produce are all under discussion as part of the Food Safety Modernization Act (FSMA) regulations covering human and animal foods.

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The regulations modify and/or create current Good Manufacturing Practices (cGMPs), and provide for a completely new process of analyzing food adulteration hazards and creating a written safety plan that includes risk-based preventative controls designed to eliminate or minimize those adulteration risks. But questions have come up about what requirements would be imposed on suppliers of various by-products that ultimately end up as ingredients in animal foods. 
As far as human food by-products goes, facilities that are covered by the FSMA human food regulation must follow human food cGMPs and create a safety plan for the manufacturing of their human food. According to reports, it is likely that when the revised proposed regulations are issued, human food manufacturers will need to make their safety plan broad enough to consider any risks associated with the by-products used as ingredients in animal food or feed.
Regarding by-products from alcohol, the FDA has said that the potential hazards associated with the use of spent grains in animal food were minimal. FDA also said that they wanted brewers and distillers to take common sense and reasonable measures to ensure that the spent grains were safe from chemical and physical hazards.
By-products from produce have not been discussed as extensively, and whether produce growers could fall within the requirements of animal food manufacturers by reason of their by-products going into animal food or feed has yet to be addressed.