FSMA Update: Mitigation Strategies to Protect Food against Intentional Adulteration

Written by Errin McCaulley - Research Assistant

On May 27, 2016, The Food and Drug Administration (FDA) released its last final rule under the Food Safety Modernization Act (FSMA) titled Mitigation Strategies to Protect Food against Intentional Adulteration (81 Fed. Reg. 34,165). This final rule mandates compliance requirements that are similar to a  Hazard Analysis and Critical Control Point (HACCP) program, albeit more flexible. Whereas traditional HACCP programs focus on the analysis of hazards in food production, such as biological and chemical hazards, and the identification of critical control points (CCPs) to mitigate these hazards, the final rule on intentional adulteration is concerned with vulnerabilities which, if exploited, could result in the deliberate tampering of food products.

Because this final rule deals with potential acts, such as terrorism, and not identified or present hazards, as in HACCP, FDA added flexibility throughout this final rule to ease the burden of compliance. This final rule is intended to prevent the intentional introduction of harmful agents into the food supply during the manufacturing/processing, packing, or holding of human food. FDA requires, absent certain exemptions, that all facilities that must register under 21 U.S.C. § 350d (§ 415 FD&C Act) are required to implement this final rule. FDA did, however, provide for a handful of exemptions (see 81 Fed. Reg. 34,220-21) which will be codified as 21 C.F.R. § 121.5.

The requirements of FSMA’s last rule are not as robust as either the Preventive Controls for Human Food (PCHF) or Preventive Controls for Animal Food (PCAF) final rules which preceded it; rather, FDA responded to numerous comments and added flexibility throughout this final rule.

First, covered facilities must create a “food defense plan” as drafted by a “qualified individual” (21 C.F.R. § 121.126). The food defense plan must contain the written vulnerability assessment, the written procedures for (1) “food defense monitoring,” (2) “food defense corrective actions,” and (3) “food defense verification” (Definitions of quoted terms can be found at 34,219 of this final rule).

Second, a qualified individual must carry out a vulnerability assessment for each type of food manufactured, processed, packed, or, in the event of liquid storage tanks, held at the facility and identify “significant vulnerabilities” at each “actionable process step” (21 C.F.R. § 121.130). A vulnerability assessment must consider (1) the potential impact a contamination of the assessed food could have on the public health, (2) the physical accessibility of the food product being assessed, and (3) a determination of an attacker’s ability to carry out a contamination of the assessed food product. FDA, in response to several comments, stressed that the focus of a vulnerability assessment is upon the potential inside attacker, such as an employee, rather than an attacker from outside the facility.

Third, a qualified individual must craft mitigation strategies aimed at minimizing the vulnerabilities identified during the assessment and ensure their implementation (21 C.F.R. § 121.135). This provision also requires a written explanation as to how the mitigation strategy sufficiently minimizes the vulnerability. In response to several comments, FDA clarified that, while perhaps not fulfilling all requirements for mitigation strategies, facilities that are already parties to a security program, such as Customs-Trade Partnership Against Terrorism (C-TPAT) or Chemical Facility Anti-Terrorism Standards (CFATS), may be able to use certain procedures from these programs as mitigation strategies.

Fourth, along with the creation of mitigation strategies, facilities are also required to establish and implement the “management components” for mitigation strategies which include written procedures for (a) “food defense monitoring” (21 C.F.R. § 121.140), (b) “food defense corrective actions” (21 C.F.R. §121.145), and (c) “food defense verification” (21 C.F.R. § 121.150). In response to concerns raised by several comments regarding food defense verification, FDA modified the proposed rule’s language to emphasize that the purpose of verification in this final rule is not to verify the effectiveness of the mitigation strategies, but rather to ensure that the procedures a facility puts in place, such as food defense monitoring, are being carried out properly.

The last major requirement of this final rule concerns the reanalysis of the food defense plan (21 C.F.R. § 121.157). A qualified individual must carry out a reanalysis of the food defense plan as a whole at least once every three years. A reanalysis of the food defense plan in part is required in the event a mitigation strategy is implemented improperly, a change is made to the facility, such as construction, and a new vulnerability could reasonably arise. Further events which would require either a complete or partial reanalysis of the food defense plan are listed in § 121.157.

The final rules under FSMA, including this most recent one, require record retention for a period of no less than two years. Under this final rule, except for the food defense plan, all records may be kept off-site from the facility, as long as their retrieval is possible within twenty-four hours, and electronic medium is permitted. Finally, after reviewing numerous comments regarding records, FDA is allowing the use of existing records, to avoid the need for duplication, and facilities that already take part in a security program, such as C-TPAT or CFATS, may use applicable records, either combined or separate, to form the records required under this final rule.

The effective date of this rule is July 26, 2016. The compliance dates are as follows: facilities, excluding “small” (<500 full-time equivalent employees) and “very small” (<$10,000,000 in annual sales of human food for last three years, including market value of human food manufactured, processed, packed, or held without sale), have three years from the effective date to comply (July 26, 2019); small businesses have four years from the effective date to comply (July 26, 2020); and very small businesses are exempt from the requirements of this rule, although FDA may, upon request, require documentation from a very small business which show the facility meets the requirements of the exemption.

FDA Issues New Food Safety Rules

Written by Katharine Richter

On November 13, 2015, the United States Food and Drug Administration (FDA) finalized new rules updating the bipartisan Food Safety Modernization Act (FSMA).  The new rules will “establish enforceable safety standards for produces farms and make importers accountable for verifying that imported food meets U.S. safety standards.”  A rule was also established that created third-party certification bodies which will perform food safety audits in foreign food facilities.

The three rules released are “referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule.”  The stream of recent foodborne illnesses that have occurred over the last few years highlighted to the FDA the need for updates to food safety rules.

The Produce Safety rule “establishes science-based standards for growing, harvesting, packing, and holding produce” which are designed to minimize risk of illness when consuming contaminated produce.  The Foreign Supplier Verification Programs rule requires food importers in the U.S. that have received imported foreign foods, that these foods are meeting U.S. safety standards and meet the same standards of food safety as domestic farms.  The importers are required to conduct various verification activities.  The Accredited Third-Party Certification creates a program where “third-party certification bodies…conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.”

Sentencing for Peanut Paste Salmonella Outbreak Continues

Written by Tyler R. Etter

On October 1, 2015, two former Peanut Corporation of America (PCA) employees were sentenced for
their part in the shipping of tainted peanut paste that caused a salmonella outbreak. The sentenced
employees were Samuel Lightsey and Daniel Kilgore, both former operations managers at PCA’s Blakley,
Georgia plant. The two were sentenced to 36 and 72 months in prison respectively, each followed by
three years of supervised release.

The 2008-2009 outbreak occurred across 46 states, with over 700 individuals falling ill. PCA has shipped
contaminated products, either before receiving test results or falsifying the tests. The prosecution has
been focused on the officials for conspiracy to defraud. Both Kilgore and Lightsey pleaded guilty to
conspiracy, mail and wire fraud, and the sale of misbranded and adulterated food.

On the same day, the victims of the outbreak urged the full funding of the Food and Drug
Administration’s (FDA) food safety program. The letter to Congress was signed by six families affected by
the outbreak, four of whom had lost a family member. The letter urged Congress to allocate $109.5
million to the FDA to fund the program designed to prevent a similar outbreak.

The families of the victims from the outbreak were instrumental in the passing of the Food Safety
Modernization Act. The families stated that without proper funding, “the law’s potential will be
squandered, and families such as ours will continue to be put at needless risk...” The current bills in the
House and Senate are proposing less than half of the requested budget for the food program.

FDA Publishes Draft Guidance for Qualified Importer Program

On Thursday June 4, 2015, the Food and Drug Administration (FDA) released draft guidance outlining the implementation of the Voluntary Qualified Importer Program (VQIP). VQIP is a fee-based program, established by the Food Safety Modernization Act, that expedites the importation process for importers with a proven track record of food safety.

                                       

The aim of the program is to incentivize the adoption of practices that will improve importers’ supply chains and allow the FDA to focus resources to higher risk areas of food safety. The program rewards those importers that have maintained a strong record of food safety and benefits public health by allowing the FDA to shift focus to those importers with poorer track records.

The guidance contains the expected benefits of and the criteria for participation in the program. The document also details the instructions for applying to the program, as well as the scenarios that may result in an importer being removed from the program.

The draft guidance, once finalized, will represent the FDA’s current thoughts on the implementation of the program, and will not create any new binding regulations or duties on the part of the FDA or importers. There is no obligation on the part of an importer to take part in the program, as participation is purely voluntary.

The complete draft guidance is available here. Public comments on the draft are open until August 4, 2015, and can be submitted here.

Written by Tyler R. Etter- Research Assistant

June 9, 2015

FDA Releases Draft Guidance for Mandatory Food Recalls

On May 7, 2015, the Food and Drug Administration (FDA) published a draft of planned guidance for the implementation of the mandatory recall authority established with the Food Safety Modernization Act of January 2011.

The guidance serves to highlight the FDA’s current thinking on the recall authority and how industries can comply with the existing regulations, creating no new duties or regulations on the part of the FDA or industry in general.

The draft provides the definition of “food”, “responsible parties”, and “person” within the Food, Drug, and Cosmetics Act. The draft also explains how the FDA determines when a food is considered adulterated or misbranded and what evidence might be considered.

The criteria for a recall are met when there is a reasonable probability of adulteration or misbranding as well as a reasonable probability of serious adverse health consequences or death to humans or animals. The draft then outlines the process for the recall, beginning with the opportunity for a voluntary recall and in the event of non-compliance the FDA may order a recall. To date, this power has only been exercised twice.

Public comment on the draft guidance is open until July 6, 2015, and may be submitted here.

Written by Tyler R. Etter - Research Assistant
June 3, 2015

FDA Publishes New Proposed Rule on Animal Food Safety Under FSMA

On October 29, 2013, the U.S. Food and Drug Administration published a proposed rule under the Food Safety Modernization Act (FSMA) in the Federal Register. The rule, titled “Current Good Manufacturing Practice and Hazard Analysis and Preventive Controls for Food for Animals,” deals with the regulation of domestic and foreign facilities that are required to register under the Federal Food, Drug and Cosmetic Act. It requires them to establish current good manufacturing practices in the manufacturing, packing, and holding of animal food. The proposed rule also requires certain facilities to establish and implement hazard analysis and risk-based preventive controls for food and animals. These preventive controls include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards.

For the full text of the proposed rule, please see the Federal Register.

Written by Sarah L. Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

November 4, 2013

EPA Seeks Comments Regarding Produce Safety Regulation

Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) has been charged with creating a new produce safety regulation that reduces the risk of illnesses associated with fresh produce.  In turn, FDA has announced its intention to “prepare an Environmental Impact Statement (EIS) that will evaluate the potential environmental effects of the proposed rule.” 

As part of preparing the Produce Safety Regulation EIS, FDA has initiated a “scoping process” which seeks public comments to help determine which issues will be included within the scope of the environmental analysis.  FDA has established that the public comment period will open on August 19, 2013 and close on November 15, 2013.  

For information relating to submitting comments, please see the following Center for Food Safety and Applied Nutrition Constituent Update. 

For information relating to FSMA, please see FDA'S FSMA Website. 

Written by M. Sean High – Research Fellow

The Penn State Law Agricultural Law Resource and Reference Center

August 20, 2013

Court Denies FDA Motion for Reconsideration of Deadlines for FSMA Rule Implementation

On August 13, 2013, the U.S. District Court for the Northern District of California denied the Food and Drug Administration’s motion for reconsideration of the court’s previous order that set a schedule of deadlines for Food Safety Modernization Act rule implementation. Specifically, the FDA asked the court to reconsider the deadlines for intentional adulteration and sanitary transport rulemaking (two of seven areas the court previously ruled on). The FDA argues that the complexity of the rulemaking for these two areas of FSMA will prevent the FDA from meeting the deadline set by the court.

The court did grant the FDA part of its motion by extending the deadline for publishing the proposed sanitary transport rule and the comment period, although, the date for the final rule implementation remains unchanged. The court denied the request to extend the deadline for promulgation of the intentional adulteration rule, noting that this dispute is between the FDA and Congress. The court states that it is unwilling to permit the FDA to continually delay implementation of this rule because of the clear Congressional directive that FSMA rule implementation be a closed-ended process.

For more information, please see the order filed by the court.

Written by Sarah L. Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

August 15, 2013

FDA Extends Comment Period for FSMA Regulations

On August 8, 2013, the U.S. Food and Drug Administration issued Federal Register notices that the comment periods for the “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” proposed rule and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” proposed rule are extended until November 15, 2013.

The Preventive Controls for Human Foods proposed rule contains provisions requiring hazard analysis and risk based preventive controls as well as revisions to the Current Good Manufacturing Practice requirements found in 21 CFR part 110.

The Produce Safety proposed rule sets science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. Please see our previous blog post on the Produce Safety proposed rule for more information.

Please visit the FDA’s website and the Federal Register concerning the two proposed rules for further information.

Written by Sarah Doyle - Research Assistant
The Agricultural Law Resource and Reference Center
@PSUAgLawCenter
August 9, 2013

FDA Releases “Toolkit with Resources for Farmers” Addressing FSMA Proposed Produce Safety Rule

On July 15, 2013, the U.S. Food and Drug Administration posted a “Toolkit with Resources for Farmers,” focusing on the proposed Produce Safety rule, under the Food Safety Modernization Act (FSMA) page of its website. The resources include factsheets on FSMA and the proposed Produce Safety rule, a diagram on how the rule applies to farmers, and an interview with Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor, as well as a number of other resources.

The proposed Produce Safety rule is designed to establish science-based standards for growing, harvesting, packing, and holding produce on farms. The rule covers most fruits and vegetables while they are in their raw or unprocessed state. It does not apply to raw agricultural commodities that are rarely consumed raw, like potatoes, or those produced for on-farm consumption or commercial processing such as canning. Some farms are exempted from the rule or are partially exempted based on the monetary value of the commodities they sell or based on to whom they sell.

The proposed rule was published in the Federal Register on January 31, 2013 and was updated on February 13, 2013. The comment period for the proposed rule ends on September 16, 2013.

For more information, please see the FDA’s website on the proposed Produce Safety rule or its FSMA webpage.

Written by Sarah Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

July 18, 2013

Court Issues Proposed Order Setting Schedule of Deadlines for FDA Implementation of FSMA Rules

** Updated 8/15/2013: See Final Order

Enacted on January 4, 2011, the Food Safety Modernization Act (FSMA) imposed many obligations on the Food and Drug Administration (FDA). Attached to these obligations were deadlines for implementation of rules. Due to the failure of the FDA to implement rules according to these deadlines, on August 29, 2012, the Center for Food Safety (CFS) filed a complaint in the Northern District of California alleging that the FDA was in violation of FSMA and the APA, and asked the court to compel the agency to implement rules. On April 22, 2013, the court ordered the FDA and the CFS to jointly submit a schedule of deadlines for the implementation of FSMA rules.

On June 10, 2013, both the FDA and the CFS submitted implementation schedules. These schedules were submitted separately, however, as neither party could agree to a compromised schedule of deadlines. The plaintiffs (CFS) did not agree that the schedule submitted by the FDA was an actual schedule of deadlines and therefore submitted its own schedule. CFS stated that the FDA’s submission contained “target dates” for implementation, rather than the “firm dates” demanded by the court order. The FDA’s submission contained target time frames for implementation. It also contained factors that could potentially affect the time frames, such as the potential need for additional information or the need for re-proposal of a rule.

The court issued a proposed order on June 10, 2013, that requires the FDA to comply with the CFS schedule of deadlines. The order also stated that the FDA is enjoined from seeking additional time for rulemaking related to review by the Office of Management and Budget.  In addition, the FDA must submit quarterly progress reports detailing the rulemaking process to the court with the first report due September 1, 2013.

This case is docketed at 12-cv-04529.

Written By Sarah Doyle – Research Assistant

The Agricultural Law Resource and Reference Center
June 20, 2013

FDA Issues Final Rule Under FSMA

On May 30, 2013, the FDA issued a final rule entitled “Information Required in Prior Notice of Imported Food” under the Food Safety Modernization Act. This final rule expands the Bioterrorism Preparedness and Response Act to require that a person submitting prior notice of imported foods must also report the name of any country to which the food article has been refused entry for food safety reasons.  The rule was implemented under an interim final rule on May 5, 2013, and, without changes, is now the final rule.

For more information, please see the FDA's website.

Written By Sarah Doyle, Research Assistant

Penn State Law - Agricultural Law Center

May 31, 2013

FDA Announces First Seizure of Food Administratively Detained Under Food Safety Modernization Act

On October 11, 2011, the FDA announced its first seizure of food product subject to the administrative detention allowance under the new Food Safety Modernization Act (FSMA). The FSMA, which amends the Food, Drug and Cosmetic Act, lowers the FDA's threshold to exercise administrative detention of food products. Before the amendment, credible evidence that food posed a threat of death or serious health consequences, to humans or animals, was needed prior to detention.  Now, the FDA needs only a "reason to believe" the food is adulterated or misbranded.

During an inspection of Dominguez Foods of Washington, Inc, on Sept. 2, 2011, the FDA issued its detention order upon detecting evidence of a rodent and insect infestation in the facility's warehouse and processing area. The detention order was issued for all food in the facility not hermetically sealed in containers by the close of the inspection. On Sept. 30, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized the product from the facility in Zillah, Washington.

Read the full FDA Press Release here.

Read more about the FSMA here.

Written/Posted by Tanya J. Cramoy, Research Assistant

FDA Establishing Pilot Projects to Trace Foodborne Illness Sources

The U.S. Food and Drug Administration (FDA) announced that two pilot projects will explore ways to trace sources of foodborne illness. Under requirement of the Food Safety Modernization Act (Jan. 2011), the FDA must establish, at a minimum, one pilot involving produce and a second involving processed foods. These pilots will examine the types of data that are useful for tracing, the speed with which data is made available to the FDA, the means of connecting points on the supply chain, and other methods and technologies for tracing foods.  The pilots will be directed by the FDA and carried out by the Institute of Food Technologists (IFT) under an existing FDA contract. Upon completion of the pilots, the FDA will begin the rulemaking on recordkeeping requirements for high-risk foods, in an attempt to facilitate tracing of foodborne illness sources.

Read the FDA Overview of Product Tracing Pilot Projects here.
Access the FDA's Food Safety Modernization Act Web page here.

Written/Posted by Tanya J. Cramoy, Research Assistant