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fsma law faqs

On April 8, 2013 the FDA released some frequently asked questions on Registration and Registration Renewal.  The following is taken directly from the FDA 's www.fda.gov website.

IC. 3.1 Does FSMA require a food facility to submit additional registration information to FDA in order for the facility to receive a food facility registration number?

Yes, Section 102 of FSMA amends section 415(a)(2) of the FD&C Act by requiring food facilities to submit registrations to FDA containing additional information.  Specifically, a registration for a domestic facility is required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States agent for the facility.  All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

IC.3.2  Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registration?

Yes.  All food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.

IC.3.3  Has the scope of who is required to register under section 415 of the FD&C Act changed?

No. At this time, the same types of food facilities that required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations.

IC.3.5  What form do I use to renew a food facility registration?

Registrants must use Form 3537 to register, update, or renew a registration.  Facilities may register online via the Internet at www.fda.gov/furls

IC 3.8 Is there a fee for registration, updating a registration, or renewal of registration? No IC. 3.9 Do new food facilities need to wait until October 1st to register?

No.  The owner, operator or agent in charge of a facility that begins to manufacture/process, pack, or hold food for consumption in the U.S. on or after December 12, 2003 must register before the facility begins such activities (21 C.F.R. 1.230)

 New Questions as of 8-1-13

Preventive Controls Rule

Below ​FAQs on the Proposed Rule for Preventive Controls for Human Food: 

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (PDF: 246KB) The Proposed Rule for Preventive Controls as it Relates to Dairy Products Produced under the Pasteurized Milk Ordinance (PMO) NEW

PCR.1 Do facilities operating under the PMO meet the requirements of the proposed preventive controls rule?

The preventive controls provision of FSMA (section 103) does not exempt dairy facilities that are required to register with FDA. FDA is interested in receiving comment on whether and how a facility complying with the PMO would be in compliance with the requirements of the proposed PC rule.

PCR.2 If a firm implements the PMO’s voluntary HACCP program, will the preventive controls requirements of FSMA be satisfied? If not, what are the additional requirements? Beginning on page 3662 of the preamble of the proposed Preventive Controls Rule, FDA discusses the voluntary HACCP program of Appendix K in the PMO in relation to other HACCP programs. Beginning on page 3785, Section XVI. B discusses the comparison of hazard analysis and preventive controls standards; this comparison includes the PMO HACCP Appendix. The proposed rule would require a food safety plan, and outlines specific components that are very similar but not identical to the requirements for a HACCP plan in the PMO HACCP Appendix. FDA is interested in receiving comment on the comparison of requirements under the proposed Preventive Controls Rule and the PMO HACCP Annex and any specific differences, as well as whether and how the PMO voluntary HACCP program satisfies the proposed rule’s requirements.

PCR.3 After the Preventive Controls Rule becomes effective, when FDA conducts a Grade A milk plant inspection, what inspection criteria will be used - Preventive Controls, PMO or both sets of rules?

Grade A milk plants currently inspected under the PMO would be required to meet any additional requirements of the Preventive Controls Rule. FDA would like to receive comments on how the requirements of the PMO and the Preventive Controls Rule can be implemented in a way that avoids duplication and makes sense with respect to ensuring food safety.

PCR.4 Does the Preventive Controls Rule apply to dairy farms?

Dairy farms that conduct manufacturing/processing activities on food not consumed on that farm or that pack or hold food not grown, raised or consumed on that farm are subject to registration under section 415 of the FD&C Act and would be subject to requirements of the Preventive Controls Rule unless a specific exemption applies.

PCR.5 What environmental and finished product testing for milk and dairy products is required under FSMA and the proposed Preventive Controls Rule?

The proposed Preventive Controls Rule did not include requirements for environmental monitoring or finished product testing. Instead, the proposed rule discusses FDA’s current thinking and poses a number of questions seeking input on when and how such testing is appropriate in verifying that hazards are being effectively controlled. We encourage the submission of comments on when it would be appropriate to use environmental monitoring and/or finished product testing for milk and dairy products. FAQs on the Proposed Rule for Produce: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Product Tracing- General

PT.1.1 What is product tracing and why is it important?

In general, a product tracing system involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels. Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses. Actions include removing a product from the marketplace and alerting the public if a product has already been distributed. Many producers, manufacturers and retailers have product tracing systems in place but they vary depending on the amount of information the system records, how far forward or backwards in the supply chain the system tracks, technologies used to maintain records and the precision with which a system can pinpoint a product’s movement.

PT.1.2 What are the FSMA requirements for product tracing?

Sec. 204, Enhanced Tracking and Tracing of Food and Recordkeeping, has two major requirements. First, FDA, working with the U.S. Department of Agriculture (USDA) and State agencies, must establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods. Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high risk foods to help in tracing products.

PT.1.3 Where can I find the statutory language for the requirements?

The statutory language for FSMA SEC 204, Enhanced Tracking and Tracing of Food and Recordkeeping, can be found on the FSMA website.

PT.2.1 What did the pilots involve? Information from the pilots will help to determine what data are most needed to trace a product that has been distributed widely in the marketplace back to a common source. Tracing product forward, such as in the case of an ingredient known to be contaminated, was also tested. Two pilots were required by the FDA Food Safety Modernization Act (FSMA)—one with the processed food sector and one with processors or distributors of raw fruits and vegetables. FSMA required that the pilots reflect the diversity of the food supply, take into account practicality for small businesses and include at least three different types of foods that have been the subject of significant outbreaks during the five-year period preceding the enactment of FSMA in January 2011. FDA also was required to consider international product tracing practices and consult with a diverse and broad range of experts and stakeholders. A report to Congress on the findings of the pilot projects and FDA’s recommendations for improving product tracing is required.

PT.2.2 Does this mean that FDA carried out the pilot studies?

No; these two pilot projects were conducted through an existing contract with the Institute of Food Technologists (IFT). However, IFT carried out the pilots at the direction of FDA, and the Agency retained the ultimate decision making authority.

PT.2.3 Did IFT consult with stakeholders before and during the pilots?

Yes, IFT involved multiple stakeholders throughout the process. IFT obtained input from the processed food and produce industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. IFT held three stakeholder input sessions in different geographical locations and offered opportunities for written input as well. Food industry representatives, trade associations, consumer groups, third party technology providers, academicians, and others responded to these requests.

PT.2.4 What types of industries were asked to participate in the pilot?

IFT solicited participation in the pilots. FDA indicated it wanted to include industries representing the entire supply chain—from growers to point of sale, such as a restaurant or grocery store. FSMA required that the pilots include at least three different types of foods that have been associated with significant outbreaks in the recent past.

PT.2.5 Will there be additional pilot projects beyond those required under FSMA?

FDA may decide at a later date that additional pilots or studies are needed.

PT.2.6 If I was unable to participate in these pilots, how can I provide input?

There will be additional opportunities for stakeholders to have input on improving product tracing. First, FDA is specifically requesting comments about IFT’s report on the pilot projects, along with other comments and information to help the agency as it implements the FSMA provisions about tracking and tracing and as it develops recommendations for its report to Congress. You can submit comments by (see PT.2.17). Second, FDA must publish a notice of proposed rule making to establish record keeping requirements for high-risk foods to help in tracing products; there will be a comment period during rule making. In addition, FDA must hold at least three public meetings during the comment period in diverse geographical areas of the U.S. to provide persons in different regions of the country with the opportunity to provide input.

PT.2.7 What foods were part of the pilots?

With input from a variety of stakeholders, the following types of foods were selected for the pilot projects: Tomatoes, grown in fields and greenhouses; whole and sliced; and distributed to restaurants and other institutions like hospitals, schools and nursing homes, and through grocery stores. We looked at tomatoes because they have been involved in a number of significant and repeat outbreaks. Tomatoes represent a complex food supply chain and were identified by most industry associations as a top candidate for the produce related pilot; Frozen Kung Pao-style dishes that contain peanut products, red pepper spice, and chicken were chosen because they contain multiple ingredients involved in significant outbreaks. They also offered a variety of supply chain distribution channels, and, like tomatoes, involved both domestic and imported products. Jarred peanut butter and dry, packaged peanut/spice were added to the pilot projects to enhance the complexity of the pilots.

PT.2.8 What is the status of the product tracing pilots required by FSMA?

FDA has just released a report on two product tracing pilot projects conducted by the Institute of Food Technologists under an existing contract with FDA. The report can be found at this link: Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB). FDA announced the pilots on September 7, 2011, indicating that they will enhance the agency's and industry's ability to trace products through the food supply. In conducting these two pilot projects, one for processed foods and one for produce, IFT obtained input from the industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. The pilot report contains IFT’s recommendations to FDA, and FDA retains the ultimate decision-making authority on how to proceed.

PT.2.9 What does IFT’s report cover?

The IFT report covers baseline studies, pilot execution using trace scenarios, use of technology, cost and benefits, domestic and global practices, findings, recommendations and suggested next steps.

PT.2.10 In the pilots, what were some of the costs to industry to implement a product tracing system?

Available data to assess costs is limited. Within the context of the pilot projects, the report estimated the costs associated with improved record keeping and product tracing, and costs varied greatly based on a number of factors such as using a paper-based or electronic system, scanning labels, nomenclature standardization, and electronically linking supply chain partners.

PT.2.11 In the pilots, what were found to be some of the benefits to implementing a product tracing system?

Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses. As part of the overall project, cost savings, driven by reductions in illness, were estimated for reducing trace back duration by 25, 50, 75, and 100 percent. The range of public health benefit per outbreak ranged from $18,000 to $14 million, depending on the characteristics of the outbreak. In addition to quickly discovering which food(s) may be causing an outbreak, we may also be able to determine what foods can be eliminated from consideration, reducing economic impact on the industry. Product tracing also is helpful to industry for other functions, such as inventory control.

PT.2.12 In the pilots, what enhancements did technology provide to improve tracing?

The pilot projects found that technology was no substitute for quality data. Once challenges with data quality could be overcome, significant improvements in the speed and accuracy were achieved with the aid of technology. A variety of technology solutions were explored for data capture, visualization, and analysis. 

PT.2.13 What were the IFT recommendations?

IFT has 10 recommendations: From an overarching perspective, IFT recommends that FDA establish a uniform set of record keeping requirements for all FDA-regulated foods and not permit exemptions to record keeping requirements based on risk classification. FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as determined by FDA. Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan. FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed Rule making or use other similar mechanisms to seek stakeholder input. FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations. FDA should develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations. FDA should accept summarized CTEs and KDEs data that are submitted through standardized reporting mechanisms and initiate investigations based on such data. If available, FDA should request more than one level of tracing data. FDA should consider adopting a technology platform that would allow efficient aggregation and analysis of data submitted in response to a request from regulatory officials. The technology platform should be accessible to other regulatory entities. FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies, using existing commissioning and credentialing processes. In addition, FDA should formalize the use of industry subject matter experts in product tracing investigations. For more details on IFT’s recommendations and their report, please go to Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).

PT.2.14 How will FDA use IFT’s report on the pilot projects?

The findings of the pilot projects and corresponding stakeholder input will inform FDA’s report to Congress, which will include FDA recommendations for improving product tracing. In addition, FDA will use the information from these most current pilot projects as well previous pilots studies, public meetings, and information FDA has gathered over the last several years to inform the rulemaking process to establish record keeping requirements for high-risk foods to help in tracing products.

Record Keeping Requirements for High Risk Foods

PT.3.1 Did Congress provide any specifics about the record keeping requirements FDA is to establish for high-risk foods?

Yes. Congress has established certain record keeping requirements, including the following: they must relate only to information that is reasonably available and appropriate they must be science-based; they may not prescribe specific technologies to maintain records; the public health benefits must outweigh the cost of complying with the requirements; they must be practical for facilities of varying sizes and capabilities; to the extent practical, they may not require a facility to change business systems to comply; they must allow for the maintenance of records at a reasonably accessible location, provided that the records can be made available to FDA within 24 hours of a request; and they may not require a full pedigree, or a record of the complete previous distribution history of the food from the point of origin.

PT.3.2 Did Congress provide specifics about how FDA should determine what foods are high risk?

Yes. FDA must consider such factors as the known safety risks of a food based on foodborne illness data and the likelihood that a particular food has a high potential risk for contamination.

PT.3.3 Will there be opportunity to comment on the foods FDA determines are high risk?

Yes. The proposed rule that FDA develops will have a comment period, and FSMA requires that at least three public meetings be held during that comment period in diverse geographical areas of the U.S. to provide persons in different regions the opportunity to provide input.

PT.3.4 When will FDA begin developing record keeping requirements for high-risk foods, as directed by FSMA?

​Once the product tracing pilots are completed, and other data are gathered, the Agency will begin the development of a proposed rule.

PT.3.5 Will FDA expand requirements for recordkeeping requirements to foods that are not designated as high risk?

No. FSMA specifies that additional record keeping requirements developed under section 204 must apply only to high risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain.

PT.3.6 Will FDA recommend certain product tracing technologies either for the pilot or for future regulations and potential guidance? ​

FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Under section 204, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional record keeping requirements for high-risk foods.

PT.3.7 Will FDA use information other than that provided by the pilot projects and the additional data gathering FSMA requires to develop record keeping requirements for high risk foods and any potential guidance? ​

Yes, FDA has studied product tracing for more than a decade. In 2008, FDA held two public meetings on product tracing for fresh produce. In 2009, FDA, in conjunction with USDA’s Food Safety and Inspection Service, held a public meeting on how to enhance product tracing systems for all foods. FDA also has worked with IFT on various product tracing scenarios. FDA has been gathering information by listening to stakeholders’ input, learning about various technologies, and staying abreast of industry and other government product tracing initiatives. The information that has been accumulated will be used by FDA in fulfilling the requirements of section 204.


​S.1 Do all sections of the law apply to pet food as well?

Yes. However, FDA is expressly authorized to modify the preventive controls requirements for facilities that are solely engaged in the production of animal foods or to exempt those facilities entirely from the preventive controls requirements. FDA would need to promulgate a regulation to accomplish such a modification or exemption.

S.2 Does the legislation apply to restaurants and food retailers? ​​

Some but not all provisions of the law exclude restaurants and food retailers. For example, restaurants and retail food establishments are not required to register with FDA, so they are not subject to requirements for registered facilities, such as preventive controls. Other provisions could apply to restaurants and food retailers, such as the foreign supplier verification program, which applies to importers.  

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