Archive for the ‘Food Safety Modernization Act’ Category

Avoiding The Pitfalls Of FSMA’s Recordkeeping and Sanitation Rules

By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting

Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.

Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit your records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.

Record Requirements
There are general requirements for all records that must be followed. All records must:

  • Be kept as original or electronic records or true copies
  • Contain factual observations and values
  • Be legible, permanent, and accurate
  • Must be done in real time
  • Include the detail required to create a history of performed work
  • Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product

Record Retention Requirements

  • You must store and retain your records for a minimum of two years
  • Any documentation relating to supporting the status of a facility as being a qualified facility should be kept as long as necessary to support the status of the facility
  • Records that have been discontinued (records related to changes) must be kept for a minimum of two years
  • Records, other than the Food Safety Plan, must be able to be present at the facility within 24 hours of being requested by an official for review.
  • The Food Safety Plan may only be transferred to another accessible location only if the facility is closed for an extended period. The document still must be able to be obtained and given to an official at the facility within 24 hours of an official review request

Food Safety Plan

  • Must be kept on-site at the plant or facility
  • Upon completion of the food safety plan, the owner, operator, or agent in charge of the plant or facility is required to sign and date the plan. Any changes to the plan must also be signed and dated by this person of authority.

Three Categories Of Records To Keep
There are three categories of records you may need to keep, depending on your hazard evaluation. The records needing to be kept reflect the entire supply chain process and potential hazards from prior to receiving at the facility through to the customer carrying the product.

First are hazards controlled by the supplier (prior to delivery to the receiving facility). Once the hazard evaluation has been completed, if it is determined that a hazard will be controlled by the supplier, then a written supply chain program (or Foreign Supplier Verification Program for facilities that are importers) is required.

Documentation in this program includes but is not limited to:

  • Approval of the supplier
  • Supplier verification
  • Sampling and testing
  • Suppliers food and safety records
  • Procedure for receiving ingredients and raw materials
  • Reanalysis documentation

Next come hazards controlled at the receiving facility. If the receiving facility will control the hazards, then the receiving facility will be required to develop, implement, and document preventative controls.

Documentation requirements include, but are not limited to:

  • Preventative control monitoring and verification of monitoring
  • Any corrective measures that were taken and verification of actions taken
  • Environmental monitoring
  • Product testing
  • Training documentation
  • Reanalysis documentation

Finally, there are hazards controlled by the customer. If the receiving facility relies on a customer or another first receiver to control a hazard, then there are some records that must be developed and kept.

Documentation requirements include but are not limited to:

  • Written disclosure (included in the food’s shipping documents) that an identified hazard was not controlled by the facility
  • A written assurance (submitted annually) that contains the established procedures the customer must follow to prevent (or drastically reduce) the identified hazard

Sanitation Controls
A large part of controlling hazards is creating sanitation regulations that will drastically reduce or prevent hazards before they can occur. The environment, equipment, and employees should all be part of the sanitation control solution. Sanitation controls should include:

  • Food contact surfaces (including utensils, equipment, and food packaging)
  • Food handling
  • Cross contamination
  • Food allergens

Sanitation can be costly, but you could lose so much more if your product quality or shelf life is affected by unsanitary facility conditions. The best sanitation departments audit their facility and then create a structure for consistency. When creating this structure, a facility should consider the type of soil that needs to be cleaned, what the chemical needs to do when used (dissolving, emulsification, wetting agents etc.), and the state of the plant’s water.

There are many products designed to properly manage each type of sanitation control. Depending on the type of food a facility is working with or the equipment utilized, the needs may be different. For example, facilities handling meat, poultry, or seafood should include in their sanitation controls antimicrobial treatments to maintain product quality and yield. And, depending on the type of conveyor a facility has, a wet or dry lubrication system is required to both lubricate and sanitize the conveyor.

Working with an experienced cleaning and sanitation company can ensure that a company’s unique needs are covered. Working with the sanitation department to identify the hazards, a sanitation company will implement a customized program and routinely test to ensure you are meeting food safety standards. These results should be kept in your records as evidence your facility has taken preventative measures and taken steps to control the environment.


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Sanitary Transportation of Human and Animal Food, FSMA Rule going into effect March 31. Previously just guidelines set forth by the FDA, it’s now law for those involved in the transportation of perishable to meet requirements in sanitation, temperature control and record keeping. Full text of the FDAs guidelines and who is covered can be found here: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm

I spoke with three cold chain logistics professionals who have a focus on food safety in transportation to help you prepare facilities, written agreements and transportation operations.

Jim Fox has more than 30 years experience in shipping and warehousing operations and is the founder of Verispect Smart Inspections™, a cloud-based documentation program to track shipping processes and protocols for compliance.

Edgar Vargas is the founder of Food Safety Now! A 3rd party fresh produce sampling operation as well as KleenTrans, an equipment and container sanitizing service that also offers training and assessment programs to food transportation and logistics professionals.

Dr. John Ryan has extensive international manufacturing quality and operations experience and is the President of Sanitary Cold Chain and author of the book “Guide to Food Safety and Quality During Transportation”. He is also managing partner with Edgar Vargas in TransCert, providing the cold chain industry worldwide with guidance, certification and audit services.

What do you foresee the biggest challenges will be for food transport pros with FSMA rule #7?

Jim Fox: “There are a lot of little companies out there servicing this industry. They are the least prepared and most adverse to what will be going on within the year with FSMA. The record keeping in any small business is naturally – let’s say – limited. Large companies already have it boiled into a system, they are used to process and paper controls. The little guys – not so much.”

Edgar Vargas: “What I hope to see, and I know it’s going to be a challenge, is a standardized, uniform Food Safety in Transportation program much like what auditing

firms such as Primus, LGMA, Global GAP or Harmonised look for. There is no such thing right now. The importing and exporting of temperature controlled perishables during transport is a need all countries share in common. The health and safety of humans and animals is the goal for everyone and sanitary transportation has been a big black hole in food safety.”

How will it impact operations for raw material suppliers? distributors? transportation and logistics providers/transportation brokers?

Jim Fox: “Most importantly the onus is on each step of the supply chain knowing and having written proof (documentation) of compliance by the previous holder of the commodity. If it does not have that documentation and proof of it, the receiver is holding the bag if there is an issue.”

Edgar Vargas : “Everyone is going to need to change their mindset and start thinking of sanitation on the surfaces of shipping containers the same way they think of food contact surfaces in processing and shipping surfaces. Everyone has to do his part to make sure that this chain is safe and everyone is in compliance”

When it comes to data and records retention of sanitation and inspection of containers, what do food transportation operations need to do to comply?

Dr. John Ryan: “As an example, temperature records must be delivered by the carrier to the shipper and receiver. Generally that calls for updating contracts of carriage to show agreement between them. Rules formalize the requirements and will cause written agreements. All washing, storage and precooling of containers with perishables is required. Maintenance stations (wash and temperature monitoring systems) must have written procedures and be able to document what was done in detail for each container washed.”

Jim Fox: “They need to get rid of forms on paper! 20% of it gets misplaced, they are prone to error and falsification. I know a 3PL here that had a facility in Connecticut. They had to find an inspection form for a customer and could not find it. The customer pulled all their product out of the warehouse.”

What are the training requirements and who needs it?

Jim Fox: “There should be a certification for drivers and warehousemen that includes basic inspection rules and why they need to be followed. It is very basic and these people already are in the habit, or should be, of inspecting things like forklifts, trailers and trucks. It is the same process, just different things.”

Edgar Vargas: “Anyone loading containers with perishables needs to be trained to inspect containers for damage that may cause temperature fluctuations or cause food to become contaminated or spoiled. Drivers carrying perishables are supposed to have food safety training as well.”

Shippers and carriers already have strict mandates and standards set by some of their customers, how is FSMA Rule #7 different?

Dr. John Ryan: “It may not impact them if they are in compliance with details of the law. When rolled into the preventive control rules, their customers must now be able to prove the shippers and carriers are qualified and certified and have valid preventive control systems in place.”

Edgar Vargas: “Requirements in the communication between the shippers/brokers and carriers about pre-cooling of containers, prior cargoes, and their next destination being included on the Contract of Carriage makes everyone comply, not just those working with the big retailers.”

What, if any, are the different container sanitation requirements for each industry, Fresh Produce, Seafood, Raw Meat, Dairy?

Dr. John Ryan: “Many – it depends on the industry. Dairy and bulk carriers are impacted differently since they must have cleaning and temperature data for three previous loads. Other industries only need to show cleaning and temperature records for one previous load”

Jim Fox: “They all are based on HACCP in one way or another. It all has to do with process steps, time and temperature and sanitation. The biggest hurdles I believe are the cross contamination issues that can occur in a vehicle or a storage location in a warehouse – like raw chicken stored on top of lettuce.”

Edgar Vargas: “There is no one-size-fits-all answer but in all cases water source testing and certification needs to be done- non-potable or recycled water will not be acceptable in sanitation procedures.”

What training will need to happen for inspecting containers?

John Ryan: “More than container inspectors are expected to be trained and to comply.
We provide certification and other training for internal audit teams and external auditors. All training must be documented and matched to the person actually doing the job.

Edgar Vargas “They are going to need to know what to look for and smell for in containers. Pathogens and bacteria are not visible to the naked eye. Physical damage to doors and seals of containers can affect temperature. It’s important that there’s consistent implementation by anyone loading containers and that any corrective action is documented. An untrained substitute or stand-in on the dock checking off boxes is not going to be acceptable.”

Is this rule going to force the retirement of some food carrying containers? Old reefers? Pallets? Bins?

Dr. John Ryan: “Maybe. While not specifically stated, FDA is now hitting those as part of preventive control rules – not clean = not preventive = FDA audit fail.”

Edgar Vargas: “It should. No one should be shipping fresh produce in containers with wooden floors or interior damage where pathogens could potentially enter cracks or holes in walls.”

Jim Fox “It could. It is all about maintenance of equipment. There is no reason in my mind that a trailer, properly maintained, shouldn’t be ok. Pallets on the other hand, you don’t know if people were shipping arsenic on them before you put lettuce on them.”

If you’re on the shipping side your next steps should be updating your food safety plan to document your protocols around temperature and avoiding cross contamination through sanitation of containers, pallets and loading equipment. Be sure you have a process in place for communicating temperature tracking, violations and pre-cooling requirements with carriers. Also, hire competent loading staff who can ensure compliance to the regulations.

Next steps for carriers include; phase out any reefers with wood interiors, train all drivers on the use of refrigeration units and loading procedures for temperature sensitive loads and implement a system to communicate with shippers for pre-cooling requirements as well as temperature violations and issues.

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Food Safety Modernization Act: What You Didn’t Know.

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This is an example of a farm record that will follow the commodity throughout the supply chain. Complete and secure.



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The U.S. Department of Agriculture today announced that the National Agricultural Statistics Service (NASS) and World Agricultural Outlook Board (WAOB) have cancelled or postponed publication of selected USDA statistical reports impacted by the lapse in federal funding.

NASS’s Crop Production and Cotton Ginnings reports and the WAOB’s World Agricultural Supply and Demand Estimates (WASDE) scheduled for October 11th are canceled. The next scheduled release for these reports is November 8, 2013. Additionally, NASS’s Crop Progress reports scheduled for October 7th and 15th are cancelled. NASS’s Cattle on Feed and Peanut Prices reports scheduled for October 18th are postponed.

While the lapse in federal funding has ended, NASS has not been able to engage in the necessary data collection and analysis over the past few weeks. NASS is assessing its data collection plans and evaluating the timing of upcoming reports.

Will this have any impact on your operations?

http://www.trackmycrop.com offers FSMA compliance solutions.


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With FDA already over the original due date for FSMA rules, extending comment periods, and being subjected to lawsuits and court mandates because of that, the government shutdown certainly has not helped to move things along. However, this does not mean that the food industry should sit back and wait for the rules to be finalized or compliance to take effect. There are numerous reasons you should be working toward compliance now – many of which are, like the rules themselves, interdependent.

Following are 10 Reasons you should be working toward FSMA compliance now:

1. Prevention vs. Reaction –

Moving the industry from reaction to prevention is the foundation of FSMA. Acting now is preventive; waiting until all the rules are in place and the deadline is pending is reactive. Further, much of what is in FSMA is good for brand protection, so paying attention to these rules today will help you develop systems that have other important impacts on your business. (See #9.)

2. The Devil is in the Details –

If you’ve taken a look at the proposed rules, you know that they are quite detailed. The longer you wait to review the rules and apply them to your business, the more you can expect to be scrambling to try to meet the compliance dates – particularly if you find that you are subject to more than one rule with interdependent clauses. (See #3.) When you rush to complete a task, you are more likely to make mistakes or miss those devilish details. Think about any project you recently undertook. Did you give yourself enough time to thoroughly review the specifications, strategize and plan, take action to implement the plan, then evaluate it to ensure that it not only fits the specifications but also is effective for your business? If you waited until the last minute to start the project, you probably did not have enough time to implement each of the steps needed for success. In the same way, if you wait until the last minute to begin working on the FSMA rules, it’s unlikely you will give yourself enough to do much more than simply take action and hope for the best.

3. Multiple Rule Compliance –

The complexity and interdependence of the FSMA provisions are a primary reason that FDA has had to take extra time to develop the rules and has extended the comment periods. In much the same way, every business will have to interpret the complex details of at least one rule; and most businesses will be subject to multiple rules and have to take into consideration the interdependence of each. For example, the Preventive Controls rule will impact most businesses in one way or another; if you grow, harvest, pack, or hold produce, you will also be subject to the Produce Safety rule; and if you use any imported ingredients or supplies, you may be impacted by the Foreign Supplier Verification Program (FSVP) and the Accredited Third-Party rule – all of which are interdependent.

4. Training –

Implementing practices and standards in your operation to ensure compliance with the rules will require personnel training. If you are still in the process of developing compliant standards when the deadline looms, you will have no opportunity to educate or train your workers in your new standards.

5. ROI –

Start monitoring critical operations and save time and money by seeing that things need a correction before you have a problem on your hands. Identify corrective actions before there is an issue so that you don’t need to reinvent the wheel or waste time trying to remember what you did last time. Similarly, have a recall plan so that there isn’t mass confusion on who does what when (not if) you have a recall.

6. Improve Food Safety

Besides the direct standard-making practices of the first four reasons there is also a business case to be made for implementing improved practices that meet or exceed FSMA rules. If the proposed rules contain preventive controls or safety measures that you are not already implementing in your facility, you are likely at risk for a food safety violation and/or recall – and all the negative media attention and economic reprisals that entails. (See #7 and #8.) If you have any doubts along these lines, read our blog from last week: Are We in a New Era of Federal Prosecutions for Food Safety?

7. Brand Protection

While business closure and complete loss of brand is an extreme result, any food safety violation (unintended or not) or recall can, and usually does, garner undesirable media attention. And today, media is not only the local paper or national TV news, it is also the homemaker blogger, the teenage tweeter, and the cause-centric consumer activist, all of whom have open access to Internet posting of information – and misinformation. The more you protect the safety of your food through regulated or unregulated preventive-based controls, the more you protect your brand.

8. Move Toward or Maintain Certification to a GFSI-benchmarked Scheme –

There are many parallels between the FSMA Preventive Controls rule and GFSI standard. Take SQF for example – Although there are elements of SQF and other GFSI-benchmarked schemes that are not as prescriptive as FSMA, there are several areas addressed by SQF that have not been addressed in the proposed rule. Thus, as the food industry looks to protect customers and their brand as well as be in compliance with the proposed new rules, our own analysis indicates that being SQF level 2 certified to today’s SQF standards is a very strong start. If you’re already certified, keep improving (#9); if you’re not, consider if implementing preventive controls warrants the pursuit of certification to a GFSI scheme.

9. Best Practices for Continuous Improvement

Implementing best practices should be a basic practice for every food facility, and there are plenty of best practices written into the proposed rules that will enable a facility to improve. Implementing best practices gleaned from this review of the rules will not only move you toward compliance, it will help you continuously improve.

10. Just Do It –

Although the final rules are unlikely to be exactly the same as the proposed rules, getting started will certainly give you a leg up. And if you work toward complying with the strictest of the proposed rule, you will be closer to being ready if the final rule is even stricter. And if the final rule is less strict? Worst case, you will be over safe; certainly not a bad thing! The bar of FSMA is not that high – do you really want to be only as good as the lowest common denominator?

By David Acheson
The Acheson Group


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State agricultural officials say that when it comes to writing rules to implement the Food Safety Modernization Act, the U.S, Food and Drug Administration needs to take a mulligan and Congress should give the agency time for a do-over.

The ever-so-gentle pushback on FDA’s work on the FSMA took shape a few days ago at the annual meeting of the National Association of State Departments of Agriculture (NASDA) when members voted unanimously to go back to Congress “to assure adequate due process for the promulgation of FSMA rules.”

To get there, the state agricultural directors want Congress to give FDA more time and it wants FDA to produce a second draft of rules for more public input. The state ag bosses are mostly concerned with rules on produce safety and preventive controls.

“We have appreciated FDA’s willingness to meet one-on-one to hear many states’ concerns,” says North Carolina Commissioner of Agriculture Steve Troxler, the outgoing NASDA president who hosted this year’s annual meeting in Asheville.

“It is important that we continue these conversations so the FDA can hear concerns from real farmers across the country,” Troxler added. “Postponing these rules will allow needed time for FDA and the states to make progress on state-federal partnership on food safety. This partnership must be in place before implementation begins.”

The incoming NASDA president, Vermont Secretary of Agriculture Chuck Ross, plans to make food safety a priority for the association during the year ahead.

“NASDA is fully committed to food safety and the successful implementation of FSMA,” Ross said. “We must take the time to get this right for the sake of our producers, processors and consumers. I look forward to working with our partners and consumers groups to engage Congress and FDA in developing an implementable food-safety program.”

Some of the groups NASDA hopes to work with, such as the Center for Food Safety, went to federal court to get FDA to move faster, not slower. In response, Judge Phyllis Hamilton of the U.S. District Court for Northern California has FDA on a schedule to complete the work by June 30, 2015, roughly three years later than Congress mandated in the 2011 law. Congress, however, could override the judge.

Bob Ehart, a senior policy advisor for NASDA, penned an editorial for the association on Tuesday that further explained where the state ag officials are coming from. He said it’s more important for FDA to “get the rules right” than to do it fast.

“Two concerns are primary to NASDA members: FDA has little experience inspecting farms, and, while anyone seeking to sell products to the U.S. will have to adhere to the ‘Produce Safety’ and the ‘Preventive Control’ rules, producers are questioning whether a process that allows food brokers to verify food coming into the U.S. is a level playing field,” Ehart wrote.

The NASDA resolution covers the Animal Feed, Import, and Third-Party Verification rules being drafted by FDA, in addition to those on Produce Safety and Preventive Controls.

The FSMA was signed into law in early January 2011 after being passed in 2010 by bipartisan majorities in Congress. It is the first major change in U.S. food-safety law in almost 60 years.

NASDA is a nonpartisan, nonprofit association representing the elected and appointed commissioners, secretaries and directors of departments of agriculture in all 50 states and four U.S. territories.

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Docket Number: FDA-2011-N-0143
Proposed Rule:

Proposed Rule (PDF: 1MB)

Federal Register Notice
Comment Now! Due November 26, 2013 at 11:59 PM ET
Fact Sheet (including Summary and Background Information)
Also available in a Print Friendly PDF (256KB).
Explanatory Diagrams (PDF: 5MB)
These diagrams illustrate the proposed FSVP regulations and include exemptions, the “standard” requirements (including two alternative approaches to requirements for supplier verification activities), and modified requirements for certain types of importers and imported food. The diagrams do not include all aspects of the proposed regulations.
Preliminary Regulatory Impact Analysis
Questions & Answers COMING SOON!
Consumer Update: Strengthening Oversight of Imported Foods
Blog: Proposed Rules Will Strengthen Global Food Safety

On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP) regulations, importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act (FSMA).
The proposed regulations vary based on the type of food product (such as processed foods, produce, and dietary supplements), the category of importer, the nature of the hazard in the food, and who is to control the hazard.
Food arrives in the United States from farms and producers around the world. About 15 percent of the U.S. food supply is imported, and for some commodities, such as produce, that percentage increases greatly. It is important that food imported into the United States meets the same level of public health protection as food produced domestically.
FSMA, signed into law on January 4, 2011, enables the FDA to better protect public health by helping to ensure the safety and security of the U.S. food supply. The vision of FSMA is prevention — preventing food safety problems before they occur, rather than reacting to problems when they happen. One of the most significant changes that FSMA made to FDA’s food safety authorities is in the area of imports. These new import authorities will help FDA transition from its historical focus on catching food safety problems at the border to one that builds safety in throughout the supply chain, from foreign producers to U.S. consumers.
Although FSMA directs the FDA to increase its inspections of foreign food facilities, Congress also provided FDA with the authority to develop regulations that would require industry to share responsibility and be accountable for preventing food safety problems.
Highlights of the Proposed Rule
FSVP Requirements

All importers must establish and follow an FSVP, unless otherwise exempted. An importer of food under the proposed FSVP regulations is the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. Under the proposed FSVP regulations, an importer would be required to develop, maintain, and follow an FSVP for each food it imports, which, in general, would need to include the following:
Compliance Status Review: Importers would be required to review the compliance status of the food and the potential foreign supplier before importing the food and periodically thereafter. Such review would need to include any FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).
Hazard Analysis: Importers would be required to analyze the hazards associated with each food they import. The hazard analysis would identify the hazards that are reasonably likely to occur for each type of food imported, and evaluate the severity of the illness or injury if such a hazard were to occur.
Verification Activities: Importers would be required to conduct activities that provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled. Verification activities could include: onsite auditing of foreign suppliers; periodic or lot-by-lot sampling and testing of food; and periodic review of foreign supplier food safety records; or other appropriate risk-based procedures. Verification activities applicable to all FSVPs, regardless of identified hazards, include maintaining a written list of foreign suppliers from which food is imported, and establishing and following adequate written procedures for conducting verification activities.
Corrective Actions: Importers would be required to review complaints they receive concerning the foods they import, investigate the cause or causes of adulteration or misbranding in some circumstances, take appropriate corrective actions, and revise their FSVPs when they appear to be inadequate.
Periodic Reassessment of the FSVP: Importers would be required to reassess their FSVPs within three years of establishing the FSVP or within three years of the last assessment. However, importers would have to reassess the effectiveness of their FSVP sooner if they become aware of new information about potential hazards associated with the food. Examples of such information might include information on changes to the source of raw materials or to product formulation.
Importer Identification: Importers would be required to obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number for their company and to ensure that, for each food product offered for importation into the United States, their name and DUNS number are provided electronically when filing for entry with Customs and Border Protection.
Recordkeeping: Importers would be required to keep certain records, including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations and corrective actions, and FSVP reassessments.
Control of Hazards

The FDA is proposing a flexible, risk-based approach to foreign supplier verification. The proposed regulation focuses on foreseeable food safety risks identified through a hazard assessment process, rather than all risks covered by the adulteration provisions in the FD&C Act. Because the principle of hazard assessment is well accepted and understood throughout the food industry, the FDA believes that it provides the most effective way to implement a risk-based framework in which importers can evaluate potential products and suppliers and conduct appropriate verification efforts.
The requirements for supplier verification in the proposed rule on FSVP are primarily based on who is to control the hazards that are reasonably likely to occur with a particular food and the nature of the hazard. In the proposed rule, the FDA is proposing two options for the supplier verification activities for hazards that the foreign supplier will control or that the foreign supplier verifies are being controlled by its raw material or ingredient supplier.
Option 1

Under Option 1 of the proposal, if the foreign supplier controls the hazard at its establishment and there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required to conduct or obtain documentation of onsite auditing of the foreign supplier. Onsite auditing would also be required for microbiological hazards in certain raw agricultural commodities. For non-SAHCODHA hazards that the foreign supplier controls, the importer would be required to conduct one of more of the verification activities mentioned above (onsite auditing, sampling and testing, review of the supplier’s food safety records, or some other appropriate procedure) before using or distributing the food and periodically thereafter. In determining the appropriate verification activities, the importer must consider the risk presented by the hazard and the food and foreign supplier’s compliance status.
Option 2

Under Option 2 of the proposal, for all hazards that the foreign supplier will either control or verify that its supplier is controlling, importers would need to choose a verification procedure from among onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure. In determining the appropriate verification activities and how frequently they should be conducted, the importer would need to consider the risk presented by the hazard, the probability that exposure to the hazard will result in serious harm, and the food and foreign supplier’s compliance status.
If the importer, rather than the foreign supplier or its supplier, will be responsible for controlling a hazard that it has identified as reasonably likely to occur, the proposed rule would require the importer to document, at least annually, that it has established and is following procedures that adequately control the hazard. If the importer’s customer will be controlling a hazard identified by the importer, the importer would need to obtain written assurance, at least annually, that its customer has established and is following procedures (identified in the written assurance) that adequately control the hazard.
The proposed rule also states the FDA’s intent to align the supplier verification provisions in the FSVP regulations with any supplier verification provisions that are included in the final rules on preventive controls for human and animal food. This would avoid imposing duplicative requirements on entities that would be subject to both the FSVP and preventive controls regulations (because the entity is both a food importer and a registered food facility).
Modified Requirements and Exemptions

Under the proposed rule, modified FSVP requirements would apply in certain circumstances, including the following:
Importation of a dietary supplement or dietary supplement component;
Importation of food by a very small importer or importation of food from a very small foreign supplier; and
Importation of food from a foreign supplier in good compliance standing with a food safety system that FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
The proposed rule would exempt the importation of the following from the FSVP requirements:
Juice and seafood from facilities that are in compliance with the Hazard Analysis & Critical Control Points (HACCP) regulations, which contain their own supplier verification provisions;
Food imported for research or evaluation purposes;
Food imported for personal consumption;
Alcoholic beverages; and
Food that is transshipped or imported for further processing and export.
Effective and Compliance Dates
The FDA is proposing that the FSVP regulations become effective 60 days after the final rule is published in the Federal Register, but FDA is proposing to provide additional time before importers would be required to come into compliance. The compliance dates would vary depending on the circumstances. In general, the compliance date would be 18 months after the publication date of the final FSVP regulations. However, recognizing that the FSVP proposed rule is closely tied to the proposed rules on preventive controls and produce safety, the compliance dates for importers in many cases would depend on the compliance dates for those rules. In general, the importer would be required to comply with the FSVP regulations six months after the foreign supplier of the food is required to comply with the new FSMA preventive controls regulations.
Economic Impact of the Proposed Rule
The proposed rule is aimed at reducing the public health burden of foodborne illness by helping to ensure that imported food is produced in compliance with applicable food safety regulations. The annual cost of the illnesses associated with imported foods that would be subject to the FSVP regulations is approximately $1.18 billion, which is more than one-fifth of the entire estimated burden of illness related to foods consumed in the United States.
For option 1, the proposed rule has a first-year cost to industry of $492 million and an annualized cost of $473 million, ,using a 7 percent discount rate according to Office of Management and Budget guidelines.
For option 2, the proposed rule has a first-year cost to industry of $480 million and an annualized cost of $462 million, using a 7 percent discount rate according to Office of Management and Budget guidelines.
View the entire Preliminary Regulatory Impact Analysis.
Rulemaking Process and How to Submit Comments
When the FDA issues a proposed rule on a matter, it publishes the proposed rule in the Federal Register so that the public can review it and submit comments. The FDA considers comments received during the comment period on a proposed rule and then considers revising the rule based on the Agency’s review of the comments before issuing a final rule. In the preamble to the final rule, we discuss the significant comments received. The proposed and final rules and supporting documents are filed in the FDA’s official docket on http://www.regulations.gov and also can be accessed at http://www.fda.gov/fsma. Comments on the proposed rule “Food Supplier Verification Programs for Importers of Food for Humans and Animals,” which publishes in the Federal Register on July 29, 2013, are due by 120 days after the publication date.
The FDA has conducted extensive outreach to industry, the consumer community, other government agencies, and the international community to gain input and perspective on how to structure this and other proposed rules to implement FSMA. That input and perspective helped shape the proposed regulations in a way that will help to ensure that they are practical and flexible as well as effective. The FDA held a public meeting on FSMA provisions concerning imported food, including FSVPs, in March 2011, and we will be holding three additional public meetings during the comment period on the FSVP proposed rule.
Assistance to Industry
The FDA plans to publish, at the time of the final rule on FSVPs, draft guidance to assist importers in developing and following FSVPs as well as how to comply with the other requirements of the FSVP rule.
Additional Information
Federal Register Notice for the Proposed Rule on FSVP
Preliminary Regulatory Impact Analysis
Fact Sheet: Accreditation of Third Party Auditors/Certification Bodies to Conduct Food Safety Audits and Issue Certifications
Fact Sheet: Preventive Controls for Human Food
Fact Sheet: Standards for Produce Safety
The Food Safety Law and the Rulemaking Process: Putting FSMA to Work
Video: The Rulemaking Process – A Primer by FDA
Video: FDA Food Safety Modernization Act – A Primer

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FDA has published a “Frequently Asked Questions” document that describes a new activity that the Agency has been developing and piloting over the past few years called Systems Recognition. While not a FSMA provision, systems recognition is part of FDA’s broader toolbox for import safety and is referenced in the recently-published Proposed Rule for Foreign Supplier Verification Programs (FSVPs) under FSMA. FDA is accepting public comments on the Systems Recognition document.

For more information on FDA’s Food Safety Modernization Act, visit http://www.fda.gov/fsma.

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