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Regulatory concerns include audits and inspections, government agencies, the pivotal Food Safety Modernization Act (FSMA), Hazard Analysis and Critical Control Points (HACCP), and international standards and guidances.

Topics

Audits/Certification/GFSI

Audits are an important tool for verifying the safety and quality of a company's or facility's food products. Audits are conducted both internally and by certified third-party certification entities. The Global Food Safety Initiative (GFSI) is a private organization that benchmarks different auditing certification platforms as meeting its criteria to provide a harmonized umbrella certification.

FDA

The U.S. Food and Drug Administration (FDA) is responsible for regulating about 80 percent of the U.S. food supply, encompassing all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture (USDA).

FSMA

The 2011 Food Safety Modernization Act (FSMA) gave FDA new authority to regulate the way foods are grown, harvested, and processed. FSMA grants FDA the authority to impose mandatory recalls and has paved the way for the issuance of more than a dozen rulemakings and at least ten guidance documents. FDA's New Era of Smarter Food Safety builds on the work done to implement FSMA.

Guidelines

Guidelines for industry include draft guidance from regulatory agencies and recommended practices for industry to help ensure the production of safe food that is free from contamination.

HACCP

Hazard Analysis and Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of microbiological, chemical, and physical hazards from raw material production, procurement, and handling, to manufacturing, distribution, and consumption of finished products.

Inspection

Inspections cover many areas of food and beverage production, from farms and ranches to food processing facilities to restaurants. Inspectors are trained to ensure that facilities and equipment are in proper working order and properly sanitized, maintained, and permitted.

International Standards/Harmonization

Food safety standards vary by country and world region, and different aspects of food safety are regulated differently depending on the region. Harmonization and tightening of food safety standards around the world are important as emerging countries seek to improve quality of life by ensuring safer food for all people.

USDA

The U.S. Department of Agriculture (USDA) oversees meat, poultry, and egg products, accounting for 20 percent or less of the food supply. The majority of the food supply (80 percent or more) is regulated by FDA. USDA's Food Safety and Inspection Service (FSIS) ensures that the U.S. meat, poultry, and processed egg supply is safe and properly labeled.

ARTICLES

FDA logo full

FDA Webinar on FSMA Food Traceability Final Rule

November 17, 2022

The U.S. Food & Drug Administration (FDA) will hold an informational webinar on Wednesday, December 7, 2022, from 1:00–5:00 P.M. ET on the recently released Food Traceability Final Rule, issued under the FDA Food Safety Modernization Act (FSMA).


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chicken breasts on a cutting board

FDA Evaluates First Cell-Based Meat Product, Raises No Food Safety Concerns; Believes Cultured Meat Ready for Market in Near Future

November 16, 2022

The U.S. Food and Drug Administration (FDA) has completed its first premarket consultation for cultured meat (also known as “cell-based” or “lab-grown” meat), in response to a submission from company UPSIDE Foods, and has raised no questions about the products’ food safety. FDA expects cell-based meat products to be ready for the U.S. market in the near future.


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white house

President Biden Signs NSM-16 to Strengthen U.S. Food Safety, Security; Highlights Climate Change, Cybersecurity

2022 05 18 16 22 52.302 0400
Bailee Henderson
November 15, 2022

On November 10, 2022, U.S. President Joe Biden signed the National Security Memorandum-16 (NSM-16), which aims to strengthen the security and resilience of the U.S. food supply and agricultural systems. NSM-16 focuses on threats such as climate change, supply chain disruption, cyberattacks, worker safety and workplace development, and other topics.


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white powder with fda logo overlay

FDA Prevention Strategy to Enhance Infant Formula Food Safety Supports Elevating Cronobacter Infection to Nationally Notifiable Disease

2022 05 18 16 22 52.302 0400
Bailee Henderson
November 15, 2022

The U.S. Food and Drug Administration (FDA) has released an outline of a prevention strategy that is under development for Cronobacter sakazakii contamination of powdered infant formula and enhance food safety. A notable action includes supporting the elevation of Cronobacter sakazakii infection among infants as a nationally notifiable disease.


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EVENTS

Webinar

9/20/22 to 9/20/23
Contact: Vania Halabou

FDA's Smarter Tools—How Remote Regulatory Assessments Help Ensure Food Safety

On Demand: The first in this webinar series focuses on Core Element 2 of the New Era blueprint, smarter tools and approaches for prevention and outbreak response.

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