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Guidelines for industry include draft guidance from regulatory agencies and recommended practices for industry to help ensure the production of safe food that is free from contamination.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

Utilizing Risk to Develop Food Safety Systems

Food safety systems can be examined in a systematic, risk-based way to aid food safety practitioners in their work

John Surak, Ph.D.

August 15, 2022

A risk-based approach is rapidly being incorporated into food safety systems. This can be attributed to the efforts of regulatory agencies and non-governmental organizations to develop requirements for food businesses. This article examines these food safety systems from a systematic, risk-based approach to allow the food safety practitioner to develop and improve food safety.

FDA Releases Paper-Based Agricultural Water Assessment Builder Tool in Spanish, English

August 11, 2022

The U.S. Food and Drug Administration (FDA) has released English and Spanish paper-based versions of its agricultural water assessment builder tool.

FDA Issues Final Guidance for Shell Egg Producers on Outdoor Access for Laying Hens

August 10, 2022

The U.S. Food and Drug Administration (FDA) has issued final guidance for shell egg producers on how to comply with certain provisions in its Egg Rule that is designed to prevent Salmonella Enteritidis contamination of shell eggs.

FDA Releases Pesticide Residue Report for FY 2020

August 10, 2022

The U.S. Food and Drug Administration (FDA) has released its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2020 (FY 2020).

Food Industry, Advocates Urge FDA to Review Center of Veterinary Medicine

August 9, 2022

A coalition of consumer organizations, industry, and government officials has written to the U.S. Food and Drug Administration (FDA), urging the agency to expand the planned external review of its food safety program to include FDA’s Center of Veterinary Medicine.

FDA Releases New Dashboard for Laboratory Accreditation for Analyses of Foods Program

August 5, 2022

The U.S. Food and Drug Administration (FDA) has released a new dashboard for the Laboratory Accreditation for Analyses of Foods (LAAF) program.

FDA Plans to Continue Remote Regulatory Assessments

August 5, 2022

The U.S. Food and Drug Administration (FDA) recently released a draft guidance on the expanded use of remote regulatory assessments (RRAs).

FDA Provides Overview of Data Modernization Efforts, Challenges

Bailee Henderson

August 4, 2022

On a webinar with the Alliance for a Stronger FDA, the U.S. Food and Drug Administration’s (FDA’s) Deputy Commissioner, Dr. Janet Woodcock, discussed FDA’s data and information processing modernization efforts.

USDA FSIS Publishes FY2023 Public Health Regulations

August 4, 2022

The U.S. Food and Drug Administration’s Food Safety and Inspection Service (USDA’s FSIS) has published its Public Health Regulations for fiscal year 2023 (FY2023).

USDA-FSIS to Study Effect of Poultry Line Speed Waivers on Worker Safety, Eligible Establishments Must Apply for Modified Waivers

August 3, 2022

The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) has announced that it will conduct a study about the effect of increased poultry line speeds on worker safety. Establishments that have received a line speed waiver under the New Poultry Inspection System must apply to participate in the study and receive a modified waiver.