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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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FSMA Public Meeting February 10, 2015:

FSMA Meetings, Hearings, & Workshops Main Page

Environmental Impact Statement (EIS) for the FSMA Proposed Rule for Produce Safety


February 10, 2015
1:00 pm – 4:00 pm EST

Harvey W. Wiley Federal Bldg., Wiley Auditorium,
5100 Paint Branch Pkwy., College Park, MD 20740

The purpose of this public meeting is to discuss the Draft Environmental Impact Statement (EIS) for the proposed rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption. This rule was proposed in January 2013 to help implement the FDA Food Safety Modernization Act (FSMA), with updates to certain provisions published in September 2014.

The FDA is seeking public input on the impacts identified in the Draft EIS. The purpose of the public meeting is to

  • inform the public of the provisions of the proposed rule that may significantly affect the quality of the environment and the identified impacts,
  • to provide information about the EIS process (including how to submit comments, data, and other information to the rulemaking docket),
  • to solicit oral stakeholder and public comments on  the Draft EIS, and
  • to respond to questions about the EIS.

For general questions about the meeting, contact: Cynthia Wise, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, telephone: 240-402-1357, e-mail: cynthia.wise@fda.hhs.gov.

Meeting Information

Please note the following important dates:

  • March 10, 2015: Approximate closing date to submit either electronic or written comments to FDA’s Division of Dockets Management. See Docket No. FDA-2014-N-2244 on http://www.regulations.gov for the official closing date.

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Take a moment to consider some of the foods found in a supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that food went through to get all the way to those shelves.

While the ice cream likely went through more processes than, say, the tomatoes, most food items found in a supermarket likely underwent a multitude of steps and passed through several hands before ultimately reaching their destination. The decision of food suppliers to record those steps could make a significant difference in the impact those products have on public health in the event of an outbreak or recall.

But when it comes to food, the variety of traceability systems in the marketplace nearly parallels the number of ingredients in a pint of that chocolate chip peppermint brownie ice cream. Not only do most competitors use different systems and technology, most firms along the same supply chain — from farm to processing plant to retailer — record and translate their data in different ways.

Picture a pile of tomatoes in the produce section. Farms supply tomatoes to a distributor, who gives them a product code before passing them onto a retailer who may give them a different identifying code. Go find a can of diced tomatoes in another aisle and the number of changed hands and identification codes may have doubled. Find a jar of salsa — the ingredients, codes and suppliers compound exponentially.

Now, throw a Salmonella outbreak into the mix. Hundreds of people around the country report illnesses and face interviews with investigators asking them to recall several weeks of meal histories.

At first, interviews seem to point to tomatoes as the most likely source — maybe a lot of the victims ate salsa — and so investigators begin tracing back through the tomato supply chain in search of the contamination. Eventually, however, the investigation into tomatoes dries up, and it only later becomes apparent that the outbreak was instead likely caused by contaminated jalapeño peppers.

That’s what happened across 43 states in the spring of 2008, and while investigators were tracing back through tomato supply chains, the jalapeños were granted more time to sicken additional consumers, according to Christopher Waldrop, director of the Food Policy Institute at the Consumer Federation of America.  Investigators might have ruled out tomatoes and moved on to jalapeños faster if suppliers had implemented better functioning traceability systems, saving more people from illness, Waldrop said.

“If you work quickly, you can save lives,” said Jennifer McEntire, Ph.D., senior director of the Food and Import Safety Practice at Leavitt Partners.

McEntire served as lead author of a report published by the Institute of Food Technologists (IFT) and commissioned by the U.S. Food and Drug Administration which details pilot projects for improving tracing through the food system. That report, in part, looked at a number of well-researched outbreaks to perform a cost-benefit analysis of using traceability systems.

If the duration of tracebacks during outbreak investigations could be reduced by half — or even a quarter — through the use of effective traceability systems, the impact of outbreaks could be significantly reduced, McEntire said. The money saved on healthcare alone would have reached into millions of dollars in some of the outbreaks IFT studied — and that’s not to mention the damage caused to industry when investigations persist in the spotlight and the public loses trust in a food product.

The FDA asked IFT to compose that report to better inform rules on traceability to be proposed as part of the Food Safety Modernization Act (FSMA), signed into law in 2011. While the FDA has released detailed proposals for some rules in the FSMA, the current section on traceability is still relatively open-ended, McEntire said.

Thus far, the FDA has suggested that it will require producers of “high-risk foods” to implement traceability programs, though no one has yet established what counts as a high-risk food. Given that there are a wide variety of traceability systems available to food makers, McEntire said it is highly unlikely that the FDA would endorse any particular traceability technology.

“I assume FDA will come out with an objective-based requirement: ‘Here is what you need to be able to do. Here are the data that need to be captured. Here’s the format you need to share it in,’” McEntire said.

The first goal should be to make sure producers and distributors are working with the same information and everyone knows what information they need to have, McEntire said. Data as simple as names, locations, and lot numbers can get muddled as product switches hands on the way to the supermarket, and everyone prioritizes information differently.

One of the biggest challenges for traceability systems, both McEntire and Waldrop agreed, is that they require human input at every link in the supply chain to function effectively. But traceability can require a lot of paperwork, and data may be subject to human error — assuming companies can find the resources and interest to have someone record it in the first place.

Companies view traceability as an additional cost, McEntire said, and so few of them adopt traceability systems for the sake of having traceability in the event of an outbreak. It’s better sold as a tool to improve supply chain efficiency and accuracy.

“Traceability is best positioned as a byproduct,” McEntire said. “Companies want to have it for other reasons, like improved record-keeping, inventory purposes, a better grasp of suppliers in order to gauge quality. That’s how you build traceability — sneaking it in on the side.”

Until the FDA makes its formal proposal on FSMA traceability rules, both IFT and the Consumer Federation of America are encouraging the agency to reconsider requiring all foods to have some sort of traceability — not just those deemed “high-risk.”

That’s mainly for two reasons, Waldrop said.

First, food once thought to be low-risk could become high-risk. Cucumbers, for example, were never connected to a foodborne illness outbreak until last month. The second reason is that some producers would be making both low-risk and high-risk foods, meaning that their facilities could theoretically be operating under two different record-keeping rules.

For now, though, Waldrop expressed a hope that the FDA would soon form a more clear impression of its plans for traceability requirements.

“FDA needs to articulate its traceback information needs so that everyone has a better sense of the information they should be collecting,” Waldrop said. “If FDA could provide that, it would help push this issue along and address concerns about what information they’re collecting and not collecting.”

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

https://www.scoringag.com/scoringag/3/Ag.cfm?sfa=main.PSA&entity_id=SSI_A7237BA48A

 

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Consistent with recent years, the Food and Drug Administration inspected just less than 2% of food and feed imports in 2012, according to a new report.

The report said the agency examined 1.9%, or 207,839, of more than 11.1 million food import shipments in fiscal year 2012.

In fiscal year 2012, the FDA reports that imported fresh fruit and vegetables totaled 2.189 million shipments out of a total 11.13 million U.S. imported food shipments, or 19.7% of the total. That compares with 1.92 million shipments of imported fresh fruits and vegetables in fiscal year 2011, which represented 18.5% of total imported food shipments of 10.44 million that year, according to the FDA. FDA defines food shipments to include human food, infant formula/food, animal feed, dietary and food and color additives.

The FDA’s 2012 inspection rate of 1.9% of food import shipments compares with a rate of 2.3% in fiscal year 2011, when the FDA said it examined 243,000 food import shipments out of total imports of 10.43 million. For fiscal year 2010, the FDA physically examined 2.1% of food import shipments, or 206,723 lots out of a total of 9.94 million shipments imported.

However, this year’s report said the FDA’s reach was greater than the percent of imports inspected.

“All import entries are electronically screened using an automated system, which helps field inspectors determine which products pose the greatest risk and, therefore, should be physically examined,” according to the report.

When needed, the report said the FDA can issue import bulletins which trigger greater scrutiny for a product or range of products from a supplier.

The average cost of physically inspecting/sampling is about $160 per field exam and $3,100 per sample analyzed, according to the report.

The FDA also provided statistics on the number of inspections the agency performed on domestic and foreign food facilities. In fiscal year 2012, FDA and the states under contract with FDA inspected (or tried to inspect) 24,462 domestic food facilities, according to the report; FDA officials inspected 1,342 foreign food facilities.

As of October 2012, the FDA said there 172,969 registered domestic food facilities and 285,977 foreign food facilities.

The FDA has identified 22,325 domestic food firms as high-risk. Of that total, the FDA said 11,007 were inspected in fiscal year 2011. In fiscal year 2012, another 8,023 high-risk facilities were inspected (or inspection was attempted), totaling 19,030 or 85% of the total high risk domestic food firms. In addition, another 3,736 firms inspected in fiscal year 2011 were re-inspected (or inspection was attempted) in fiscal year 2012.

In fiscal year 2012, the average FDA inspection cost for a high-risk domestic food facility was $15,500, according to the report. while the non high risk domestic food facility inspection average cost was $9,200. Foreign facility inspections were more expensive, the report said; foreign-high risk food facility inspections averaged $23,000 in fiscal year 2012.

Food facility inspections performed by the Food and Drug Administration cost nearly $200 million in fiscal year 2012 according to the FDA’s annual report to Congress on food imports and food facilities.

The report said the total budgeted money for inspections totaled $198.5 million in fiscal year 2012. Of that total, the FDA said $145.2 million was used for FDA inspections of domestic facilities and $34.7 million for FDA inspection of foreign facilities. In addition to those amounts, the FDA said $18.6 million was provided to state agencies, through contracts, to perform domestic inspections on behalf of FDA. Those figures don’t include the cost of inspections at the border, the FDA said, since those inspections are not performed in registered facilities, according to the report. The agency devotes more than 1,300 full time equivalent staff to conduct inspections and food safety investigations, according to the report.

– See more at: http://www.thepacker.com/fruit-vegetable-news/FDAs-report-shows-2-inspection-rate-for-imports-233635361.html?view=all#sthash.1qs6LwAU.dpuf

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Cost effective FSMA Compliance: Recordkeeping, labeling and field barcoding applications

Why Should You Attend:

Recent federally-adopted rule mandates that FDA is able to detain for up to 30 days food products it believes may be adulterated or mis-branded. Such foods would be kept out of the marketplace until the agency determines whether there is a need for further enforcement actions, such as seizure or an injunction to prevent the suspect products from being distributed.

This webinar will discuss mitigate your risks of having detainment of or recall of products With proper record-keeping, labeling and barcoding applications. While these requirements mandate FDA’s action in the area of food safety, and despite the activity in this area, the Agency has had difficulty in adopting a final rule to date.

This session is designed for growers, shippers, carriers, packers, producers, retail grocers and wholesalers and it is focused towards helping both domestic and foreign entities in ensuring compliance with FDA regulations. The presenter will highlight FSMA, and offer solutions for all levels of the supply chain. She will share and highlight a solution that encompasses everything necessary to meet, 2002 Bio-Terrorism Law, Food Defense, Country of Origin, GAP’s, SSOP, HAACP, USDA-FSIS and EU trace back laws for all food handlers.

Areas Covered in the Webinar:

  • Brief overview of FSMA.
  • Highlighting law pertaining to recordkeeping documentation.
  • Choosing a system to properly document recordkeeping.
  • Why field label?
  • When choosing a barcoding system what to look for and why.
  • Regulatory status of FSMA as the law is currently written and timeline of FDA action
  • What FDA expects to gain with FSMA

Who Will Benefit:

Food manufacturers and facilities responsible for packaging/labeling food products will benefit from this training. Titles include:

  • Regulatory affairs
  • Food packaging suppliers and manufacturers
  • Labeling
  • Documentation
  • Food technologists
  • Food safety
  • Food inspectors
  • Marketing
  • QA/ QC
  • Growers
  • Shippers

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DENVER (AP) — Two Colorado cantaloupe farmers who pleaded guilty to charges related to a deadly listeria outbreak personally apologized Tuesday to some of the family members of people who got sick or died, an attorney said.

The meeting with Eric and Ryan Jensen, the two brothers who owned and operated Jensen Farms in Holly, Colo., was part of an agreement with prosecutors.

The brothers apologized during what William Marler, an attorney representing victims in lawsuits against Jensen Farms, described as a sober meeting at the federal courthouse in Denver. In turn, some of the victims told the Jensens about their loved ones who fell ill, he said.

“Everybody — prosecutors, the FDA — none of us had ever had a meeting like this,” Marler said. “It’s a tragedy for everybody.”

By agreement with prosecutors, the Jensens’ statements at the meeting cannot be used against them either in their misdemeanor criminal case or in numerous civil lawsuits that are pending, Marler said.

The listeria outbreak traced to tainted fruit from the Jensens’ farm caused 33 deaths and sent scores of people to hospitals. Officials have said people in 28 states ate the contaminated fruit and 147 were hospitalized.

Eric and Ryan Jensen have pleaded guilty to six misdemeanor counts of introducing adulterated food into interstate commerce. The federal charges carry penalties of up to six years in prison and $1.5 million in fines. A sentencing hearing has been set for Jan. 28.

Marler said stores that sold the tainted fruit and inspectors who approved it should have also been at Tuesday’s meeting, but they weren’t invited.

“This isn’t just about the Jensens,” Marler said.

Eric Jensen refused to comment when reached by phone Tuesday.

A statement from the Jensens’ attorneys after the guilty pleas said the brothers were shocked and saddened by the deaths, but the guilty pleas do not imply any intentional wrongdoing or knowledge that the cantaloupes were contaminated.

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Suppy Chain

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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

Summary
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.
Background
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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