Food Safety & Quality Blog
Mérieux NutriSciences is dedicated to helping companies worldwide find practical solutions to today's food safety and quality challenges throughout the supply chain.

Patrick Kennedy

Recent Posts

Regulatory Round-Up: Third-Party Audits, GFSI and FSMA – FDA Seeks Strategic Partnerships for Imported Foods

Posted by Patrick Kennedy

February 23, 2017 at 10:00 AM

reg_roundup_2.23.jpgQuestions about the role of industry standards for complying with the Food Safety Modernization Act (FSMA) have existed since the law was enacted more than six years ago. Due to the upcoming requirements for foreign supplier verification, industry stakeholders are urging the FDA to extend the compliance date, and to clarify the role of private entities for supporting compliance with the new FSMA requirements for imported food. 

The role of strategic partnerships for improving the safety of imported food was the focus of a two-day FDA public hearing held last week (February 14-15, 2017). The hearing followed public meetings held last year on imported food safety, which raised questions about the role of private certification schemes and third-party audits for supporting compliance with FSMA by foreign suppliers.

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Topics: Food Safety Modernization Act (FSMA), GFSI, FSMA, Imported Food, Foreign Suppliers, Foreign Suppliers Verification Program, FSMA Compliance

Regulatory Round-Up: New Canadian Food Safety Regulations Target International Harmonization

Posted by Patrick Kennedy

February 9, 2017 at 10:00 AM

sfca_blog.jpgBelieve it or not, it's been nearly five years since Canada approved its comprehensive food safety legislation known as the Safe Food for Canadians Act (SFCA). The legislation was developed to streamline Canada’s food safety regulations, improve regulatory oversight, and increase international regulatory alignment with its key trading partners, particularly the United States. To implement the legislation, Canada recently published the proposed Safe Food for Canadians Regulations. 

Foodborne illness affects an estimated four million Canadians annually, resulting in 238 deaths and nearly 12,000 hospitalizations. Since 2011, the Canadian Food Inspection Agency (CFIA) has reported 84 recalls related to fresh fruits and vegetables, and more than 1,500 food product recalls attributed to non-federally registered establishments not covered by the existing commodity-based regulations. Health Canada has suggested the increasing incidents of food safety issues have been attributed to expanding consumer preferences for minimally processed foods (e.g. bagged salads) as well as new production and distribution systems.

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Topics: Food Safety, Regulations, Canada, CFIA, Preventive Controls, Safe Food for Canadians Act, Canadian Food Inspection Agency, SFCA

Regulatory Round-Up: Strategies for Controlling Listeria in Ready-To-Eat Foods

Posted by Patrick Kennedy

January 26, 2017 at 10:00 AM

rte regulatory blog.jpgIf you are subject to the final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule), then you should be aware of FDA’s new recommendations for controlling Listeria monocytogenes in ready-to-eat (RTE) foods. Manufacturers, processors, packers and holders of RTE foods will benefit from an understanding of the strategies and recommendations described within the new draft guidance. 

Released this month, the draft guidance sheds light on the agency’s thinking regarding effective strategies for controlling L. monocytogenes in RTE foods, including identifying the risks associated with raw materials and ingredients, listericidal process control, environmental monitoring, product testing, and the analysis of verification data trends.

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Topics: FDA Regulation Updates, FDA, Pathogens, Preventive Controls, Listeria, Ready-to-Eat Foods, CGMPs, Hazard Analysis

Regulatory Round-Up: Food Labeling Changes From 2016 and Beyond

Posted by Patrick Kennedy

January 9, 2017 at 10:00 AM

regulatory_blog_1.9.jpegOn the regulatory front, 2016 presented many challenges for the North American food industry. While the year featured the initial implementation of FSMA regulations and passage of the GMO labeling law, the North American food industry was also confronted by a slew of regulatory changes related to food labeling. 

Last year, the food industry monitored the development of several potentially significant regulatory initiatives with upcoming compliance dates, including the revision of the FDA Nutrition Facts Panel (July 26, 2018), menu labeling for restaurants (May 5, 2017) and the withdrawal of the GRAS status of PHOs (June 18, 2018).

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Topics: FSIS, USDA, Nutritional Labeling, FDA, Nutrition, Nutrition Facts Label, Canada, CFIA, Nutrition Facts

Regulatory Round-Up: FSIS Unveils Strategic Food Safety Goals

Posted by Patrick Kennedy

December 12, 2016 at 10:00 AM

regulatory_blog2.jpegThe USDA Food Safety and Inspection Service (FSIS) recently unveiled its five-year strategic plan for ensuring the safety of meat, poultry and processed egg products. Covering the fiscal years 2017-2021, the objectives of the Strategic Plan are classified within the core goals of preventing foodborne illness, modernizing inspection systems and scientific techniques, and improving operational excellence. 

To prevent product contamination and related illness from FSIS-regulated products, the agency intends to strengthen sampling programs, promote food defense practices, and ensure domestic establishments are meeting pathogen reduction performance standards. The alignment of domestic and international program sampling objectives and the strengthening of existing testing activities for imported products were identified as additional priorities. 

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Topics: FSIS, Food Safety, Food Safety Modernization Act (FSMA), FDA Regulation Updates, FDA, FSMA, Voluntary Qualified Importer Program, Whole Genome Sequencing

Regulatory Round-Up: New FSMA Guidance Tackles Hazard Disclosure, VQIP

Posted by Patrick Kennedy

November 28, 2016 at 10:00 AM

regulatory_blog.jpegImplementation of the Food Safety Modernization Act (FSMA) regulations will continue despite the outcome of the recent presidential election and suggestions to reduce federal oversight of the food industry. The U.S. Food and Drug Administration (FDA) recently published two guidance documents to support industry compliance with upcoming FSMA regulations, including the controversial FSMA requirement for disclosing hazards, and the Voluntary Qualified Importer Program (VQIP). 

Written disclosure statements for identifying hazards are mandated by four of the seven foundational FSMA rules, including the rules for preventive controls for human food, preventive controls for animal food, produce safety, and foreign supplier verification program (FSVP). 

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Topics: Food Safety, Food Safety Modernization Act (FSMA), FDA Regulation Updates, FDA, FSMA, Foreign Suppliers, Foreign Suppliers Verification Program, Voluntary Qualified Importer Program

Regulatory Round-Up: Industry Seeks Harmonization of Nutrition Compliance Dates

Posted by Patrick Kennedy

November 11, 2016 at 10:00 AM

Industry Seeks Harmonization of FDA Nutrition Mandates 

regulatory_roundup_2.jpegResponding to food industry requests to harmonize the compliance dates of upcoming food labeling and nutrition initiatives, the Food and Drug Administration (FDA) recently clarified that the compliance dates are already coordinated to take effect in summer 2018. 

Industry groups contend, however, that it will be difficult for manufacturers to comply with the revised nutrition labeling rules since the agency has not yet provided key pieces of the regulatory puzzle. 

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Topics: Food Safety, Nutritional Labeling, FDA Regulation Updates, FDA, Nutrition

Regulatory Round-Up: New Criteria for "Healthy" Foods

Posted by Patrick Kennedy

October 31, 2016 at 10:00 AM

FDA Revising Criteria for “Healthy” Food

regulatory_round_up_blog.jpegReflecting the latest scientific information, including the link between diet and chronic diseases, the Food and Drug Administration (FDA) issued a final guidance in late September to stipulate the approved use of the labeling claim “healthy” on packaged foods and to request industry comments regarding the use of the term. Industry comments should inform FDA’s efforts to redefine the term “healthy” in order to align with the new final rules for updating the Nutrition Facts Panel and serving size information for packaged foods.

The final guidance advised food manufacturers of the agency’s intent to exercise enforcement discretion regarding use of the implied nutrient content claim “healthy” relative to the latest recommendations. The guidance highlights acceptable uses for the labeling term relative to low fat, and beneficial nutrients such as potassium and vitamin D.

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Topics: Food Safety, Nutritional Labeling, FDA Regulation Updates, FDA, Nutrition, Health Claims

Regulatory Round-Up: Implementation of FSMA Produce Safety and Foreign Suppliers Verification Programs

Posted by Patrick Kennedy

October 17, 2016 at 10:00 AM

States Preparing to Implement Produce Safety Rule

fruit_and_vegetable.jpgA partnership between federal and state regulators is vital for the successful implementation of the produce safety programs mandated by the Food Safety Modernization Act (FSMA). On September 9, the Food and Drug Administration (FDA) announced that 42 states will receive $21.8 million over a five-year period to facilitate the implementation of the produce safety rules. The participation of state regulators in the implementation of state produce safety programs is dependent upon federal funds, according to the National Association of State Departments of Agriculture (NASDA). State and federal agencies will begin to coordinate efforts soon as certain produce safety requirements will take effect in January 2018 for large farms.

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Topics: Food Safety, FDA Regulation Updates, FDA, Produce, Foreign Suppliers, Foreign Suppliers Verification Program, Produce Safety

Regulatory Round-Up: Proposition 65 and Infant Formula Health Claims

Posted by Patrick Kennedy

October 3, 2016 at 10:00 AM

Proposition 65 Update – Aspartame, Vinyl Acetate, Nitrite 

regulatory_compliance-3.jpgAn upcoming meeting of California’s Office of Environmental Health Hazard Assessment (OEHHA) will consider the carcinogenic risks of several food, pesticide and packaging chemicals, including aspartame. OEHHA, the agency responsible for maintaining the state’s Proposition 65 list of chemicals known to cause cancer, recently released hazard identification materials for several chemicals to facilitate public consultation. Under Proposition 65, products containing a listed chemical in excess of the regulatory threshold must display a warning label indicating the presence of a known carcinogen or toxin.

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Topics: Food Safety, FDA Regulation Updates, FDA, Infant Formula, Proposition 65, Health Claims

FSMA and Imported Food – Will the FDA’s New Strategy Improve Food Safety?

Posted by Patrick Kennedy

July 29, 2016 at 9:30 AM

containers.jpgAll domestic and foreign food facilities that manufacturer, process, pack or store food for sale in the United States must register with the Food and Drug Administration (FDA). According to recent government data, approximately 114,000 foreign food facilities exporting to the U.S. are located in more than 200 countries, and 19% of the American food supply is now imported.

The growing number of foreign food facilities and expanding volume of imported food is fueling an increasingly complex U.S. food supply chain. Imported food has been linked to several high profile food safety events in recent years and remains a significant concern. In fact, one of the core objectives of the Food Safety Modernization Act (FSMA) was to ensure the safety of imported food.

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Topics: Food Safety, Food Safety Modernization Act (FSMA), FSMA, Imported Food

Final FSMA rule targets intentional adulteration – Eight things to know about the new regulation

Posted by Patrick Kennedy

June 10, 2016 at 10:00 AM

fsma_blog_size_image.jpegThe seventh and final major rule mandated by the Food Safety Modernization Act (FSMA) was recently published paving the way for the full implementation of the law. The final rule for mitigation strategies to prevent the intentional adulteration of food, also known as ‘food defense’, imposes new requirements for foreign and domestic food facilities. Following are eight points to know about the ‘food defense’ final rule and a few notes regarding the related issue of economically motivated adulteration.

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Topics: Food Safety, Food Safety Modernization Act (FSMA), FDA Regulation Updates, FDA, FSMA, Food Defense

FSMA Regulations to Watch in 2016

Posted by Patrick Kennedy

February 12, 2016 at 1:05 PM

EnviroMapThe Food and Drug Administration is preparing to make 2016 the ‘Year of FSMA’. Responding to statutory deadlines and mounting pressure to implement the landmark food safety law, the agency issued five regulations mandated by Food Safety Modernization Act (FSMA) within the past six months, and plans to introduce additional FSMA regulations in the coming months. Enforcement of several significant FSMA regulations will also begin this year. 

Although the food safety law was enacted more than five years ago, FDA regulations to implement the law have been slow to come. While several new requirements were rolled out with the law in 2011, the most significant regulations were first proposed in 2013.

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Topics: Food Safety Modernization Act (FSMA), Regulations, FSMA

Keys to Understanding the Preventive Controls Rule for Human Food

Posted by Patrick Kennedy

September 25, 2015 at 11:00 AM

FSMAFor more than four years, food industry stakeholders have been eagerly awaiting publication of the final versions of the “seven foundational rules” mandated by FDA Food Safety Modernization Act (FSMA). This month, the Food and Drug Administration (FDA) issued the two final rules requiring facilities to identify potential hazards and implement controls for human food and animal food.

In the simplest terms, the final rule for human food requires firms to identify significant food safety risks, implement controls to mitigate the risks, monitor and verify the effectiveness of the processes, manage supply chain risks, and document activities.

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Topics: Food Safety Modernization Act (FSMA), FDA

Will FSMA rules impact FDA food recall trends?

Posted by Patrick Kennedy

August 21, 2015 at 10:00 AM

Mérieux NutriSciences ConestogaAn upward trend in U.S food recalls during the past decade and a recent spike in recalls due to hidden allergens underscore the importance of global food supply chain management and Good Manufacturing Practices (GMPs).

The complex global food supply chain, involving the sourcing of multiple ingredients from numerous suppliers, is often linked to a higher risk of recalls due to microbial or chemical hazards. To combat the upward trend in recalls and improve the safety of imports, the Food and Drug Administration (FDA) is expected to implement several key regulations of the Food Safety Modernization Act (FSMA) this year to bolster preventive controls and supplier verification.

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Topics: Food Safety Modernization Act (FSMA), FDA

Questions Surround FSMA Mandate for Lab Accreditation

Posted by Patrick Kennedy

May 22, 2015 at 9:46 AM

World HealthLaboratory accreditation was mandated by the Food Safety Modernization Act (FSMA) over four years ago, but the Food and Drug Administration (FDA) has yet to propose regulations for implementing the new requirements. The agency’s court-ordered deadlines to complete certain FSMA regulations, including preventive controls, produce safety standards, and the foreign supplier verification program, has delayed the laboratory accreditation mandate. Laboratory testing is an important component of several FSMA regulations, however, prompting many stakeholders to urge the agency to expedite the accreditation rule.

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North American Food Recalls Headed by Allergens

Posted by Patrick Kennedy

January 28, 2015 at 8:54 AM

Screen_Shot_2014-03-27_at_10.46.56_AMFood products are recalled from the North American market for various reasons, but historically the vast majority of recalls are attributed to public health hazards. A review of food recall data reported by the U.S. Food and Drug Administration, USDA Food Safety and Inspection Service, and the Canadian Food Inspection Agency revealed annual trends in the reasons for North American food recalls. In particular, the review confirmed the majority of food recalls in recent years were due to food allergens and microbial hazards. Following is a summary of recent trends in recalls attributed to food allergens, including product types, root causes and related regulatory issues.

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Topics: Allergens,, Recalls

Food Safety Modernization Act – What’s New?

Posted by Patrick Kennedy

October 2, 2014 at 12:06 PM

FSMA_flag_us_squareFor years, the Food Safety Modernization Act (FSMA) has been promoted as a comprehensive reform of the U.S. food safety system yet the ‘slow and steady’ pace of implementing the law has prompted food industry stakeholders to question if the food safety law will ever be fully realized. Enacted in January 2011, the comprehensive food safety law requires the Food and Drug Administration (FDA) to develop and execute several regulations that are likely to present challenges and potential burdens for the industry.

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Topics: Food Safety Modernization Act (FSMA)


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