Food distribution in the U.S. has changed drastically since the first food safety law was passed in 1938, but food safety laws remained essentially the same until last year when the 2011 FDA Food Safety Modernization Act was passed.
Its provisions, to be carried out by the U.S. Food and Drug Administration and other food agencies, focus on avoiding the distribution of potentially harmful food, improving government’s ability to fix food safety issues when they do occur and ensuring the safety of imported food.
The provisions include:
Section 101: Inspections of Records
The FDA can inspect companies’ records related to food that is likely – but not proven to be – adulterated or is likely to cause adverse health effects.
Section 102: Registration of Food Facilities
The FDA can put companies with serious food safety problems out of business by suspending their registrations.
Section 103: Hazard Analysis and Risk-Based Preventive Controls
All processing facilities must have written science-based plans in place to prevent food from being contaminated.
Section 104: Performance Standards
The FDA will work with the U.S. Department of Agriculture to research the most prominent contaminants and offer guidance on how to control them.
Section 105: Standards for Produce Safety
The FDA will research and develop enforceable regulations for fruits and vegetables for the first time.
Section 106: Protection against Intentional Adulteration
The FDA will research and develop strategies to prevent intentional adulteration.
Section 107: Authority to Collect User Fees
Companies will have to pay for the FDA to re-inspect their facilities if the agency finds significant food safety problems in an initial inspection. Companies also have to cover the costs of recalls if they initially refuse to comply with a recall order.
Section 108: National Agriculture and Food Defense Strategy
The FDA will work with the USDA to develop a “National Agriculture and Food Defense Strategy” to prepare for, detect, respond to and recover from contamination of the agricultural and food system.
Section 109: Food and Agriculture Coordination Councils
Federal food safety agencies will prepare and present to Congress an annual report on the actions of councils designed to encourage inter-agency cooperation.
Section 110: Building Domestic Capacity
The FDA will report to Congress on the progress on preventive food safety programs in order to measure their effectiveness.
Section 111: Sanitary Transportation of Food
The FDA will carry out requirements in a previous amendment to regulate the safe transportation of food.
Section 112: Food Allergy and Anaphylaxis Management
The FDA will develop voluntary guidelines for schools and other early childhood education programs to manage food allergies. Grants will be awarded to educational agencies for development of such programs.
Section 113: New Dietary Ingredients
The FDA will promulgate new guidelines on establishing the safety of new ingredients.
Section 114: Requirement for Guidance Relating to Post Harvest Processing of Raw Oysters
The FDA will work with the oyster industry to improve regulations regarding the handling of raw oysters.
Section 115: Port Shopping
There will be improvements in communication between the FDA and the Department of Homeland Security to prevent “port shopping,” when import shipments are granted access in one port after being refused at another.
Section 201: Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities and Ports of Entry, Annual Report
The FDA will increase inspections by first determining high-risk facilities and then inspecting those facilities once before 2016 and every three years after that. Non-high-risk facilities will be inspected once before 2018 and every five years after that.
Section 202: Laboratory Accreditation for Analysis of Foods
The FDA will develop a program for recognizing non-government laboratories as credible facilities for testing food and will develop a network of such facilities to be used in response to emergency food safety problems. The agency will identify standards to be met by labs in order to reach accreditation.
Section 203: Integrated Consortium of Laboratory Networks
There will be universal testing procedures and requirements in accredited non-government labs.
Section 204: Enhancing Tracking and Tracing of Food and Recordkeeping
The FDA will research and develop an efficient way of tracking high-risk food through the distribution chain. This tracking program must be applicable to all sizes of businesses.
Section 205: Surveillance
The FDA and U.S. Centers for Disease Control and Prevention will research and implement strategies to improve the existing surveillance system used to monitor and report foodborne illness outbreaks. State and local surveillance systems also will be improved.
Section 206: Mandatory Recall Authority
The FDA can order a recall if a company refuses to follow a recommendation to recall food. (The company will cover the costs of a forced recall. See “Section 107.”) In the event of a mandatory recall, the FDA will set up an incident command center to ensure efficiency.
Section 207: Administrative Detention of Food
The FDA can detain food that investigators deem to be likely adulterated or misbranded. This means the FDA no longer has to provide “credible evidence” to detain food that is potentially contaminated.
Section 208: Decontamination and Disposal Standards and Plans
The U.S. Environmental Protection Agency will work with federal food safety agencies in safely disposing of contaminated food.
Section 209: Improving the Training of State, Local, Territorial, and Tribal Food Safety Officials
The FDA will conduct training programs for officials in state and local food safety agencies, and a grant program will be established for the development of effective training programs. The FDA will work with state and local agencies to enforce food safety laws.
Section 210: Enhancing Food Safety
Grants will be awarded to food safety entities that pair with higher education universities to research and develop programs to improve the safe distribution of food. “Centers of Excellence” will be developed and serve as sources of research and information for further improvement of food safety.
Section 211: Improving the Reportable Food Registry
The FDA will require food companies to provide additional information on foods that are likely to cause adverse health effects, not including produce. Grocery stores are required to post notices of foods reported as potentially dangerous in a prominent area.
Section 301: Foreign Supplier Verification Program
Importers must evaluate foreign suppliers to verify they are in compliance with U.S. food safety laws. The FDA will promulgate regulations on the specific requirements to be met through such verifications.
Section 303: Authority to Require Import Certifications for Food
The FDA can require certain imported foods to be accompanied with certification from the government of its country of origin or from an accredited third-party auditor.
Section 304. Prior Notice of Imported Food Shipments
Importers must inform the FDA of other countries to which a shipment of food was denied entry.
Section 305. Building Capacity of Foreign Governments with Respect to Food
The FDA will develop a program to improve the abilities of foreign governments to ensure the safe export of foods to the U.S.
Section 306: Inspection of Foreign Food Facilities
The FDA has the power to inspect foreign facilities. If a facility refuses to allow inspection, food produced there would be denied entry to the U.S.
Section 307: Accreditation of Third-Party Auditors
The FDA will implement a program by which non-government agencies can be accredited to inspect foreign facilities. Accredited agencies will be required to pay a user fee.
Section 308: Foreign Offices of the Food and Drug Administration
The FDA will establish offices in foreign countries to ensure the safety of food that is exported to the U.S.
Section 309: Smuggled Food
The FDA will develop a strategy to better recognize and prevent the smuggling of food items into the U.S.
Section 401: Funding for Food Safety
The implementation of this law is expected to require additional funds through 2015. The FDA will increase its staff steadily over the next four years.
Section 402: Employee Protection
Employees are protected from being punished by their companies for cooperating with the FDA.