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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

S. 510 FDA Food Safety Modernization Act (Introduced in Senate)

The House has passed its version of the Food Safety Act, now it is the Senate’s turn – We shall see if they can pass anything.  Here is my summary:

Inspections of Records

• Secretary can access business records relating to any food (under FDA jurisdiction) the Secretary believes is adulterated or any other food the Secretary believes is likely to be affected in a similar manner.
• Records access provisions do not apply to farms or restaurants.
• Applies to all records relating to manufacturing, processing, packing, distribution, receipt, holding, or importation.

Registration of Food Facilities (1)

• Facilities (not including farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or most fishing vessels) engaged in manufacturing, processing, packing, or holding food for consumption in the United States must renew registrations every two years, alerting the Secretary to, among other things, any changes in food manufactured at the facility.
• The registration must contain an assurance that the Secretary will be permitted to inspect the facility at the times and in the manner permitted by the Act.
• The Secretary may suspend a registration if the Secretary determines that a food product is reasonably probable to cause adverse health consequences to humans or animals.
• If the registration of a facility is suspended, such facility shall not import food or offer to import food into the United States, or otherwise introduce food into interstate commerce in the United States.

Hazard Analysis and Risk-Based Preventive Controls

• Requires owners, operators, or agents in charge of facilities to evaluate the hazards that could affect the food manufactured, processed, packed, or held by the facility and create preventive controls to minimize the risk.
• The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment.
• Nothing in this subsection can be construed to provide the Secretary with the authority to apply specific technologies, practices, or critical controls to an individual facility.
• Does not limit the Secretary from revising, issuing, or enforcing product and category-specific HACCP regulations under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

(1)  Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term farm includes: (i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.



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Performance Standards

• The Secretary must review relevant health data at least every two years to determine the most significant foodborne contaminants and, when appropriate, shall issue contaminant-specific and science-based guidance documents, actions levels, or regulations.

Standards for Produce Safety

• Requires, within one year of enactment of the Act, proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of fruits and vegetables where the Secretary has determined that such standards would minimize the risk of serious adverse health consequences or death.
• Implementation is prioritized based on specific fruits and vegetables that have been associated with foodborne illness outbreaks.
• States and foreign countries that import food into the United States may request variances from the requirements of the regulations.
• This section does not limit HACCP authorities.

Protection Against Intentional Adulteration

• Requires, within two years of enactment of the Act, promulgation of regulations to protect against intentional adulteration of food subject to the Act.
• Applies only to food (1) for which the Secretary has identified clear vulnerabilities (such as short shelf-life or susceptibility to intentional contamination at critical control points); (2) in bulk or batch form, prior to being packaged for the final consumer; and (3) for which there is a high risk of intentional contamination, as determined by the Secretary, that could cause serious adverse health consequences or death to humans or animals.
• Does not apply to food produced on farms except for milk.

Authority to Collect Fees

• Secretary can collect fees from (1) domestic facilities subject to reinspection to cover reinspeciton related costs for the year; (2) domestic facilities and importers subject to a food recall in that fiscal year, to cover recall activities (up to $20 million per year); (3) importers participating in the qualified importer program, to cover administrative costs; and (4) importers subject to reinspection at a port of entry, to cover reinspection related costs (up to $25 million per year combined with domestic reinspection fees).
• Fees collected are available until expended – can be used for FDA salaries, as necessary.

National Agriculture and Food Defense Strategy

• Requires, within one year of enactment of the Act, preparation of a National Agriculture and Food Defense Strategy.
• Goals: enhance preparedness of agriculture and food system by assessing vulnerabilities and improving communication; improve detection capabilities by conducting surveillance; improve emergency response; and work with the private sector to develop business recovery plans.

Building Domestic Capacity

• Secretary must, within two years of enactment of the Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities.
• Report must include analysis of the need for regulations, potential sources of emerging threats, communication strategies, surveillance strategies, education strategies, and the estimated resources needed to implement the proposed programs over a five year period.
• Reviewed every two years.
• Must include methods to increase food sampling and testing capacity and better communication between foreign, State, local, tribal, Federal agencies, the food industry, laboratories, and consumers.
• Also to include description of progress toward developing an automated risk assessment system for food safety surveillance.

Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry

• Inspections based on a risk profile, which is calculated by considering the type of food, the facility’s history of recalls, the rigor of the facility’s hazard analysis, and whether there is priority on imports for inspection for adulteration.
• Frequency of inspections to be increased – at least every two years for high risk facilities and at least every four years for non-high risk facilities.
• Inspections of imports based on risk profile, which is calculated by considering the risk of the countries of origin and countries of transport, the history of recalls associated with the importer, the rigor of the foreign supplier verification program, whether the importer is in the qualified importer program, and whether there is priority on the imports for inspection for adulteration.

Recognition of Laboratory Accreditation for Analysis of Foods

• Provides for the recognition of accreditation bodies that can accredit laboratories (including those run by a State or locality) to conduct analytical testing of food products.
• Foreign laboratories can also become accredited.
• Model accreditation standards to ensure appropriate sampling and analytical procedures, internal quality systems, systems to evaluate and respond promptly to complaints regarding analysis, and a qualified staff.
• Accreditation to be reviewed at least every five years.
• In limited circumstances, food testing is to be conducted solely by accredited laboratories (circumstances include specific testing requirements of the act; testing under an Import Alert that requires successful consecutive tests; or where the Secretary deems such testing appropriate).
• Secretary is to report, within 180 days of enactment of the Act and every two years thereafter, on the progress in implementing a national food emergency response laboratory network.

Integrated Consortium of Laboratory Networks

• A national laboratory network is to be established in which members agree on common methods, means to work cooperatively, and dialogue to create a more effective response to emergencies.

Enhancing Traceback and Recordkeeping

• Within nine months of enactment of the Act, the Secretary is to establish a pilot project in coordination with the produce industry to explore and evaluate methods for effectively tracking and tracing fruits and vegetables that are raw agricultural commodities.
• Pilot program is to include at least three types of fruits or vegetables that have been the subject of outbreaks during the past five years.
• Within two years of enactment of the Act, the Secretary is to propose standards for the type of information, format, and timeframe for persons to submit records to aid the Secretary in effectively and rapidly tracking and tracing, in the event of an outbreak, fruits and vegetables that are raw agricultural commodities.


• Secretary to enhance surveillance systems by (1) coordinating Federal, State, and local foodborne surveillance systems, (2) facilitating sharing of findings on a more timely basis, (3) developing improved epidemiological tools, (4) expanding the capacity of such systems, including working toward automatic electronic searches, for implementation of fingerprinting strategies for foodborne infectious agents, (5) allowing timely public access to data, (6) establishing a mechanism for rapidly initiating scientific research by academic institutions, and (7) integrating foodborne illness surveillance systems with other biosurveillance.
• Secretary is to review State and local capacities and needs regarding foodborne illness within one year of enactment of the Act.

Mandatory Recall Authority

• If Secretary determines that there is reasonable probability to believe an article of food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals, the Secretary is to provide the responsible party with an opportunity to cease distribution and recall the article.
• If the responsible party does not voluntarily cease distribution within the time prescribed, the Secretary may order person to immediately cease distribution of the article or immediately notify all manufacturing facilities to which the article has been distributed.
Foreign Supplier Verification Program

• Regulation to include a process for verification by a United States importer, with respect to each foreign supplier from which it obtains food, that the imported food is produced in compliance with FDA regulations.

Voluntary Qualified Importer Program

• Importers can request for expedited review and importation of designated foods; certification reevaluated every three years.
• Factors considered for allowing expedited review: (1) nature of the food being imported; (2) compliance history of foreign supplier; (3) capability of foreign regulations to ensure compliance with United States standards; (4) record keeping, inspections, audits, traceability, temperature controls, testing; and (5) risk of adulteration.

Authority to Require Import Certifications for Food

• Secretary can require foreign importers to provide a certification that the article of food complies with some or all applicable requirements of the Act.

Review of a Regulatory Authority of a Foreign Country

• Secretary can review information from foreign statutes, regulations, standards, and controls, and conduct on-site audits, to verify implementation of those statutes.
• Within two years of enactment of the Act, the Secretary is to develop a plan to expand the technical, scientific, and regulatory capacity of foreign governments from which foods are imported into the United States.

Inspection of Foreign Food Facilities

• Food is to be refused entry into the United States if it is from a foreign facility in which the operator or government refuses to permit entry of United States inspectors, upon request, within 48 hours of request.

Foreign Offices of the Food and Drug Administration

• Foreign offices of the FDA to be established in at least five foreign countries by October 1, 2010.
• Offices will provide foreign governments with assistance in food safety measures, directly conduct risk-based inspections, and assist foreign governments in conducting inspections.

Funding for Food Safety

• $825,000,000 for fiscal year 2010
• 3,800 field staff in 2010; 4,000 in 2011; 4,200 in 2012; 4,600 in 2013, and 5,000 in 2014

(Thanks to Alex Ferguson)

  • Interesting article as for me. It would be great to read something more concerning this matter.

  • This umbrella reactionary legislation will provide a huge obstacle to existence of the business of small organic family farms. Corporations have the ability to just pay the price of doing business meaning both lawsuits from illness from poor handling, and pay for the new federally mandated protocols.
    Small farms work hard to keep the food safe because their direct marketing means continual accountability. If a small organic farm had food safety problems it would be the end of them as a business. Much unlike huge national and multinational corporations who can afford to pay the price.
    Senate bill s 510 is a poorly thought through piece of legislation, that puts food corporations into the same playing field as small family farms, Even worse this allows for the growing niche market of farmers markets, CSAs, and other forms of direct marketing to be subverted by the premise that the government is doing something to protect the consumer from food that is grown with no accountability.
    These new safety protocols hardly mean that corporations, especially the voluntary ones of foreign or multinational corporations will make our food safer and companies more responsible and transparent.

  • Jason Janacek

    We (American public) have only ourselves to blame! I never believed in doom and gloom, until now. Our country is wasting away. Shame on me,

  • Jason Janacek

    We (American public) have only ourselves to blame! I never believed in doom and gloom, until now. Our country is wasting away. Shame on me,