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FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act was passed by Congress on December 21, 2010 and signed by the President in early January 2011. This page highlights some of the provision of the legislation.

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The FDA Food Safety Modernization can be found at http://www.gpo.gov/fdsys/pkg/CREC-2010-12-21/pdf/CREC-2010-12-21-pt1-PgH8861.pdf.

The FDA Food Safety Modernization Act has been described as a significant step in the evolution of the U.S. food law.  The intent of the legislation is to advance a pro-active approach to concerns about food safety, rather than a reactive approach after a problem arises.  The legislation advances the concept that food law should be based on science, and that food businesses and government agencies aggressively pursue reducing the risk of unsafe food.

The legislation addresses the authority of the Food and Drug Administration and does not explicitly address the USDA's food safety responsibilities for meat, poultry and eggs.

The following paragraphs summarize some of the key points of the legislation and suggests how these changes may impact U.S. food law. 

1. Registration of food facilities

Since the Bioterrorism Act of 2002, domestic and foreign food facilities have been required to register with the FDA. This mandate is an attempt to identify the businesses and locations or facilities used to process and store food.  The assumption is that knowing where food is located as it moves from producers, through processors and retailers on its way to consumers will help address a food safety issue when it arises, as well as furthering the strategy of reducing the risk of unsafe food.  The Bioterrorism Act law contained the following provisions:

  • Persons in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for consumption in the U.S. must register the facility with the FDA.
  • Domestic facilities are required to register whether or not food from the facility enters interstate commerce.

The Food Safety Modernization Act now requires that facilities re-register every two years; re-registration was not provided for by the 2002 law.  This new requirement should allow FDA to maintain a more up-to-date data base of U.S. and foreign food facilities operating in the U.S. food industry.

Comment:  increasingly Congress uses the term "registered facilities" to identify food businesses that are within the scope of FDA's jurisdiction.

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2. Hazard Analysis and Risk-based Preventive Controls

The Food Safety Modernization Act requires that all food facilities regulated by the FDA to develop and implement harard analysis and critical control point (HACCP) plans.  Prior to the 2010 legislation, only juice and seafood were subject to FDA's HACCP authority.  Of course, USDA was already implementing mandatory HACCP for meat, poultry and egg processors, and States were urging HACPP plans for retail and food service sector via the FDA's recommendation in the Food Code.  Some commentators may suggest that requiring HACCP plans is one of the most significant provision of the 2010 legislation.  With this provision, all food businesses in the processing sector are required to adopt and implement a HACCP strategy.

The new legislation provides detail expectations for HACCP plans; this too may be preceived as an aggressive step by Congress to direct the food industry and leave less to the discretion of the FDA.  HACCP plans must address the following points:

  • Identify, evaluate and prepare a written analysis of known or reasonably foreseeable hazards that may be associated with the facility, including (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; (B) hazards that occur naturally or may be unintentionally introduced; and (C) hazards that may be intentionally introduced, including hazards intentionally introduced by acts of terrorism.

Comment:  note the explicit mention of intentional attacks on the food business.

  • The owner, operator, or agent in charge of a facility shall identify and implement preventive controls at critical control points to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented; and any food manufactured, processed, packed, or held by such facility will not be adulterated or misbranded.
  • The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the implemented preventive controls to assure that the described outcomes will be achieved.
  • The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the implemented preventive controls are not properly implemented or are found to be ineffective, (1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; (2) all affected food is evaluated for safety; and (3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated or misbranded.
  • The owner, operator, or agent in charge of a facility shall verify that (1) the preventive controls implemented are adequate to control the hazards identified; (2) the owner, operator, or agent is monitoring as required by this statute; (3) the owner, operator, or agent is making appropriate decisions about corrective actions taken; (4) the implemented preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, through the use of environmental and product testing programs and other appropriate means; and (5) there is documented, periodic re-analysis of the plan to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.
  • The owner, operator, or agent in charge of a facility shall maintain, for not less than two years, records documenting the monitoring of the implemented preventive controls, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.
  • The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with these requirements, including analyzing the hazards and identifying the adopted preventive controls to address those hazards. Such written plan, together with the documentation, shall be made promptly available to a duly authorized representative of the FDA upon oral or written request.
  • The owner, operator, or agent in charge of a facility shall conduct a re-analysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, but not less frequently than once every three years, whichever is earlier. Such re-analysis shall be completed and additional preventive controls necessary to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. The owner, operator, or agent will revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The FDA may require a re-analysis in response to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

Exempts small businesses

As frequently debated, an issue is whether mandating a HACCP plan would be onerous on small food businesses.  In recognizition of this concern, the legislation provides some exemption for smaller food businesses.

FDA will (A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls.  The regulations shall

  • (A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses (such as a small food processing facility co-located on a farm); and
  • (B) comply with the ‘Paperwork Reduction Act, with special attention to minimizing the burden on the facility, and collection of information associated with such regulations;  
  • (C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and
  • (D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.

In promulgating the regulations, the FDA shall review regulatory hazard analysis and preventive control programs in existence, including the Grade ‘A’ Pasteurized Milk Ordinance to ensure that such regulations are consistent with exsiting applicable domestic and internationally-recognized standards.

The 2010 legislation also provides several definitions:

  • 'Critical control point’ means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.
  • 'Facility’ means a domestic facility or a foreign facility that is required to register with the FDA.
  • 'Preventive controls’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis, and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding. Those procedures, practices, and processes may include
    • (A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.
    • (B) Supervisor, manager, and employee hygiene training.
    • (C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.
    • (D) A food allergen control program.
    • (E) A recall plan.
    • (F) Current Good Manufacturing Practices (cGMPs) under 21 CFR part 110.
    • (G) Supplier verification activities that relate to the safety of food.

 

To assist food businesses accomplish the task of adopting and implementing HACCP, Congress directed the FDA to issue a "guidance document" relative to hazard analysis and preventive controls.  Likewise, Congress has directed the FDA  to promulgate regulations with respect to

  • (i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm; and
  • (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm.

The 2010 Legislation expands the definition of prohibited acts to include operating a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with the required HACCP plan.

3. Administrative Detention

Under previous law (U.S.C. 334(h)(1)(A)), an officer of the FDA could detain any article of food if, during an inspection, examination, or investigation, the officer has credible evidence or information indicating that the food presents a threat of serious adverse health consequences or death to humans or animals.

This authority to detain food has now be broaden so the food can be detained if the officer has "reason to believe" the food is "adulterated or misbranded".

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3A.  Refined the scope of food for which records can be requested by FDA.

The 2010 legislation also broadens the FDA's authority to inspect the records of a food business.  Under prior law, FDA could request business records if there was "a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals..." (21 U.S.C. §350c).

The new legislation authorizes the FDA to request records if there is "a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner..."  It will be interesting to follow the practical implication of this additional language.

The amended language did not change other aspects of the FDA's authority to inspect records, such as

  • excludes farms and restaurants
  • includes businesses that manufactures, processes, packs, distributes, receives, holds, or imports food
  • requires FDA employee to present appropriate credentials and a written notice, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to the food or "any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner", and
  • the authority applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such food maintained by or on behalf of the business in any format (including paper and electronic formats) and at any location.

4.  Standards for Produce Safety

Food safety issues during the past several years that were traced back to the production of fresh vegetables led Congress to impose standards on the production and harvesting of fruits and vegetables that will remain raw to the consumer.  This may not be the first time that FDA has been authorized to address production agriculture, but this oversight may be another step in a process that could lead to more substantial regulation of commodity production.

FDA will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities, for which FDA has determined (based on known safety risks which may include a history of foodborne illness outbreaks) that standards to minimize the risk of serious adverse health consequences or death are needed.

  • Provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities;
  • Include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;
  • Consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including intentional introduction by acts of terrorism;
  • Consider, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies;
  • In the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act;
  • Provide for coordination of education and enforcement activities by State and local officials;
  • Set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices determined to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated

FDA shall publish, after consultation with USDA, state agriculture departments, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce.

A farm that is exempt from the requirements: 

  • with respect to a food for which a food packaging label is required, will include prominently and conspicuously the name and business address of the farm where the produce was grown on the label; or
  • with respect to a food for which a food packaging label is not required, will prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.

Comment:  This section will require the industry to implement processes that assure traceability.

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5. Protection against intentional attack

In the past decade, especially since September 11, 2001, there has been increased focus on the threat of an intentional attack on food.  However, international terrorism is not the only potential intentional attack.  A frustrated employee in a food processing or an angry farmer neighbor could intentional contaminate food or an agricultural commodity.  Accordingly, Congress has directed with the 2010 legislation that FDA will promulgate regulations to protect against the intentional adulteration of food.  Such regulations shall

  • (1) specify how a person should assess whether to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; and
  • (2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points.

The regulation will apply only to food for which there is a high risk of intentional contamination that could cause serious adverse health consequences or death to humans or animals and shall include those foods

  • (1) for which the FDA has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); and
  • (2) in bulk or batch form, prior to being packaged for the final consumer.

This requirement does not apply to farms, except for those that produce milk.

FDA is required to Issue guidance documents relating to protecting against intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration.  The guide should

  • (A) include a model assessment;
  • (B) include examples of mitigation strategies or measures; and
  • (C) specify situations for the examples of mitigation strategies or measures

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6. National Agriculture and Food Defense Strategy

Congress directed that several federal departments collaborate to prepare a stategy that addresses concerns about food safety.  This section lists the goals that Congress has set for this collaborative effort.

The collaborative effort should describe a process to be used by the Departments of Health and Human Services, Agriculture, and Homeland Security to achieve the following goals:

  • (A) PREPAREDNESS GOAL- Enhance the preparedness of the agriculture and food system by (i) conducting vulnerability assessments of the agriculture and food system; (ii) mitigating vulnerabilities of the system; (iii) improving communication and training relating to the system; (iv) developing and conducting exercises to test decontamination and disposal plans; (v) developing modeling tools to improve event consequence assessment and decision support; and (vi) preparing risk communication tools and enhancing public awareness through outreach.
  • (B) DETECTION GOAL- Improve agriculture and food system detection capabilities by (i) identifying contamination in food products at the earliest possible time; and (ii) conducting surveillance to prevent the spread of diseases.
  • (C) EMERGENCY RESPONSE GOAL- Ensure an efficient response to agriculture and food emergencies by (i) immediately investigating animal disease outbreaks and suspected food contamination; (ii) preventing additional human illnesses; (iii) organizing, training, and equipping animal, plant, and food emergency response teams of (I) the Federal Government; and (II) State, local, and tribal governments; (iii) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; and (iv) ensuring consistent and organized risk communication to the public by (I) the Federal Government; (II) State, local, and tribal governments; and (III) the private sector.
  • (D) RECOVERY GOAL- Secure agriculture and food production after an agriculture or food emergency by (i) working with the private sector to develop business recovery plans to rapidly resume agriculture, food production, and international trade; (ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results; (iii) rapidly removing, and effectively disposing of (I) contaminated agriculture and food products; and (II) infected plants and animals; and (iv) decontaminating and restoring areas affected by an agriculture or food emergency.
These federal departments should also develop metrics to measure progress for the evaluation process towards achieving these goals.
Comment: Even though this strategy may not immediately impact food businesses, it may set the foundation for future regulatory oversight.

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7. Building Domestic Capacity

The Secetary shall submit a report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:

  • (A) Analysis of the need for further regulations or guidance to industry.
  • (B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.
  • (C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.
  • (D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.
  • (E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.
  • (F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 108 and 205.
  • (G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.
  • (H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities.
  • (I) Specific efforts taken pursuant to the agreements authorized under section 421(c) of the Federal Food, Drug, and Cosmetic Act together with, as necessary, a description of any additional authorities necessary to improve seafood safety.

On a biennial basis, the Secretary shall submit to Congress a report that (A) reviews previous food safety programs and practices; (B) outlines the success of those programs and practices; (C) identifies future programs and practices; and (D) includes information related to any matter described in subparagraphs (A) through (H) (above).

  • The report shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.
  • The report shall describe methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities and progress toward laboratory accreditation.
  • The report shall describe information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system and the prior notice system with other information technology systems that are used by the Federal Government for the processing of food offered for import into the United States.
  • The report shall describe progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.

In addition, the Secretary shall analyze the FDA's performance in foodborne illness outbreaks during the 5-year period preceding December 2010 involving fruits and vegetables that are raw agricultural commodities and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback.

The Secretary on a biennial basis, shall submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. Such plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.

The Secretary shall study the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each registered food facility and, as appropriate, each broker that imports food into the United States. Such study shall include an evaluation of the costs of developing and and implementing such a system, and make recommendations about what new authorities, if any, would be necessary

Comment:  These Congressional mandates illustrate a desire for pro-active food safety practices.

8.  Sanitary Transportation

Following instances of adulterated foods nearly 20 years ago, Congress enacted 21 U.S.C. 350e(b)).  This statute requires that FDA set forth practices relating to A) sanitation; (B) packaging, isolation, and other protective measures; (C) limitations on the use of vehicles; D) information to be disclosed (i) to a carrier by a person arranging for the transport of food; and (ii) to a manufacturer or other person that (I) arranges for the transportation of food by a carrier; or (II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and (E) recordkeeping; and include A) a list of nonfood products that, if shipped in a bulk vehicle, would adulterate any food subsequently transported in the same vehicle; and (B) list of nonfood products that, if shipped in a motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), would adulterate food that is simultaneously or subsequently transported in the same vehicle.

The 2010 legislation requires that by July 2012, FDA have regulations implementing the statute.  Comment: These regulations have been long overdue. 

The 2010 legislation also requires that the FDA conduct a study of the transportation of food for consumption in the United States, including transportation by air, that includes an examination of the unique needs of rural and frontier areas with regard to the delivery of safe food.

9.  Food Allergy

The Secretary shall (i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and (ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.

The voluntary guidelines developed shall address each of the following:

  • (A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with (i) documentation from their child’s physician or nurse (I) supporting a diagnosis of food allergy, and any risk of anaphylaxis; (II) identifying any food to which the child is allergic; (III) describing any prior history of anaphylaxis; (IV) listing any medication prescribed for the child for the treatment of anaphylaxis; (V) detailing emergency treatment procedures in the event of a reaction; (VI) listing the signs and symptoms of a reaction; and (VII) assessing the child’s readiness for self-administration of prescription medication; and (ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.
  • (B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where (i) the children are capable of self-administering medication; and (ii) such administration is not prohibited by State law.
  • (C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.
  • (D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.
  • (E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.
  • (F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.
  • (G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.
  • (H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.
  • (I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs, and school-sponsored or early childhood education program-sponsored programs held on weekends.
  • (J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.

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10.  Targeting Inspection

A goal of the 2010 legislation is to expand FDA inspections of food facilities.  Congress set forth the following steps to accomplish this goal

Identify high-risk facilities and allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:

  • (A) The known safety risks of the food manufactured, processed, packed, or held at the facility.
  • (B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.
  • (C) The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls.
  • (D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 801(h)(1).
  • (E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) or 806, as appropriate.
  • (F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

The Secretary shall increase the frequency of inspection of domestic facilities identified as high-risk facilities such that each such facility is inspected not less often than once before December 2015 and not less often than once every 3 years thereafter.

The Secretary shall ensure that each domestic facility that is not identified as a high-risk facility is inspected at least once before December 2017 and not less often than once every 5 years thereafter.

During 2011, the Secretary shall inspect not fewer than 600 foreign facilities. Between January 2012 and December 2016, the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year.

In meeting the inspection requirements, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.

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11.  Food Testing Labs

A component of a quick response to a food safety concern is the ability to conduct food tests.  To acheive this goal:

  • The Secretary shall work with the laboratory accreditation bodies to increase the number of qualified laboratories that are eligible to perform testing
  • Develop model standards that a laboratory shall meet to be accredited.  In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include methods to ensure that (i) appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate; (ii) internal quality systems are established and maintained; (iii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and (iv) individuals who conduct the sampling and analyses are qualified by training and experience to do so.

To ensure compliance with the requirements of this section, the Secretary (A) shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and (B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by such body to continue to perform testing.

Maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall (1) agree on common laboratory methods to reduce the time required to detect and respond to foodborne illness outbreaks and facilitate the sharing of knowledge and information relating to animal health, agriculture, and human health; (2) identify means by which laboratory network members could work cooperatively (A) to optimize national laboratory preparedness; and (B) to provide surge capacity during  emergencies; and (3) engage in ongoing dialogue and build relationships that will support a more effective and integrated response during emergencies.

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12.  Tracking and Tracing Food

Another strategy in responding to a food safety concern is being able to track the movement of the food item and any other items the suspect food article may have contacted.  Accordingly, Congress mandates that the FDA establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated or misbranded.

  • Develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses; (B) develop and demonstrate appropriate technologies, including existing technologies, that enhance the tracking and tracing of food.

Establish within the FDA a product tracing system to receive information that improves the capacity to effectively and rapidly track and trace food that is in the United States or offered for import into the United States.

Establish additional recordkeeping requirements for facilities that manufacture, process, pack, or hold high-risk foods.

Designate high-risk foods for which the additional recordkeeping requirements are appropriate and necessary to protect the public health. Such designation shall be based on

  • (i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;
  • (ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
  • (iii) the point in the manufacturing process of the food where contamination is most likely to occur;
  • (iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
  • (v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and (vi) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

The requirements under this subsection shall not apply to a food that is produced and packaged on a farm if (i) the packaging of the food maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and (ii) the labeling of the food includes the name, complete address, and business phone number of the farm (unless the Secretary waives the requirement to include a business phone number of the farm, as appropriate, in order to accommodate a religious belief of the individual in charge of such farm).

During an active investigation of a foodborne illness outbreak, or if the Secretary determines it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak, the Secretary may request that the owner, operator, or agent of a farm identify potential immediate recipients, other than consumers, of an article of the food that is the subject of such investigation if the Secretary reasonably believes such article of food (A) is adulterated (B) presents a threat of serious adverse health consequences or death to humans or animals; and (C) was adulterated on a particular farm.

13. Surveillance of Food-borne Illness

Centers for Disease Control and Prevention (CDC) shall enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses by (A) coordinating Federal, State and local foodborne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories; (B) facilitating sharing of surveillance information on a more timely basis among governmental agencies, including the FDA, USDA, the Department of Homeland Security, and State and local agencies, and with the public; (C) developing improved epidemiological tools for obtaining quality exposure data and microbiological methods for classifying cases; (D) augmenting such systems to improve attribution of a foodborne illness outbreak to a specific food; (E) expanding capacity of such systems, including working toward automatic electronic searches, for implementation of identification practices, including fingerprinting strategies, for foodborne infectious agents, in order to identify new or rarely documented causes of foodborne illness and submit standardized information to a centralized database; (F) allowing timely public access to aggregated, de-identified surveillance data; (G) at least annually, publishing current reports on findings from such systems; (H) establishing a flexible mechanism for rapidly initiating scientific research by academic institutions; (I) integrating foodborne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels, including by sharing foodborne illness surveillance data with the National Biosurveillance Integration Center.

The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals: (A) Improve foodborne illness outbreak response and containment. (B) Accelerate foodborne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews. (C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards. (D) Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of foodborne illness. (E) Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public.(F) Strengthen the capacity of State and local agencies to achieve these goals.

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14. Mandatory Recall (and introduction to Reportable Food Registry)

In the past, FDA had limited authority to mandate a recall of a food product.  This legislation now authorizes the FDA to mandate a recall.  The practical implications, however, may not be extensive because many food companies voluntarily recall a food product if there is a suspected problem.

The following points introduce some of the steps that will be followed if a recall is mandated.

  1. If the FDA determines, based on information gathered through the reportable food registry or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated or misbranded, and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, FDA shall provide the responsible party an opportunity to cease distribution and recall such article.
  2. If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the FDA, the FDA may order such person to (A) immediately cease distribution of the article; and (B)immediately notify all persons (i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and (ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of the article.
  3. The FDA shall provide the responsible party with an opportunity for an informal hearing no later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.
  4. If after providing opportunity for an informal hearing, the FDA determines that removal of the article from commerce is necessary, the FDA shall (A)require recall of such article or other appropriate action; (B) specify a timetable in which the recall shall occur; (C) require periodic reports describing the progress of the recall; and (D) provide notice to consumers to whom such article was, or may have been, distributed.

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For background about Reportable Food Registry for Industry, see http://www.fda.gov/food/foodsafety/foodsafetyprograms/rfr/default.htm.

RFR is "...an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences.

"Registered Food Facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States ... are required to report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals.

"Federal, state, and local government officials may voluntarily use the RFR portal to report information that may come to them about reportable foods."

Reportable food is food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals (21 USC 350f(a)(2) ). 

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15. Reportable Food Registry & Grocery Store Notification

The 2010 legislation includes three new provision for reportable foods.

  1. Except with respect to fruits and vegetables that are raw agricultural commodities, the Secretary may require a responsible party to submit to the Secretary consumer-oriented information regarding a reportable food, which shall include (1) a description of the article of food; (2) affected product identification codes, such as UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of food; (3) contact information for the responsible party; and (4) any other information the Secretary determines is necessary to enable a consumer to accurately identify whether such consumer is in possession of the reportable food.
  2. GROCERY STORE NOTIFICATION -- The Secretary shall (A) prepare the critical information for a reportable food as a standardized one-page summary; (B) publish such one-page summary on the FDA website in a format that can be easily printed by a grocery store for purposes of consumer notification.
  3. ACTION BY GROCERY STORE -- A notification shall include the date and time such summary was posted on the FDA website.

If a grocery store sold a reportable food that is the subject of the posting and such establishment is part of chain of establishments with 15 or more physical locations, such establishment shall, not later than 24 hours after a one page is published, prominently display such summary or the information from such summary via at least one of the methods identified below maintain the display for 14 days.

The Secretary shall develop and publish a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, for providing the notification. Such list shall include

  • (A) posting the notification at or near the register;
  • (B) providing the location of the reportable food;
  • (C) providing targeted recall information given to customers upon purchase of a food; and
  • (D) other such prominent and conspicuous locations and manners utilized by grocery stores as of the date of the enactment of the FDA Food Safety Modernization Act to provide notice of such recalls to consumers as considered appropriate by the Secretary.

21 U.S.C. 331 (Prohibited Acts) is amended by adding "The knowing and willful failure to comply with the consumer notification requirement.

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16. Decontamination and Disposal Plan

The Environmental Protection Agency shall provide support for, and technical assistance to, State, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.

EPA shall develop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamination and disposal of specific threat agents and foreign animal diseases.

EPA shall [jointly} develop and disseminate model plans for (1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and (2) the disposal of large quantities of animals, plants, or food products that have been infected or contaminated by specific threat agents and foreign animal diseases.

17.  Improve Training

Secretary shall set standards and administer training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this Act, including programs for

  • (1) scientific training;
  • (2) training to improve the skill of officers and employees authorized to conduct inspections;
  • (3) training to achieve advanced product or process specialization in such inspections;
  • (4) training that addresses best practices;
  • (5) training in administrative process and procedure and integrity issues;
  • (6) training in appropriate sampling and laboratory analysis methodology; and
  • (7) training in building enforcement actions following inspections, examinations, testing, and investigations.

Secretary shall enter into memoranda of understanding with USDA to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to (A) owners and operators of farms; (B) small food processors; and (C) small fruit and vegetable merchant wholesalers.

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18. Foreign Verification, et al

Safety is not a concern only for domestically produced food, but also is a consideration for imported foods. All foods in the United States, including imported foods, must comply with U.S. food law. The 2010 Legislation addreses concerns about imported foods through several steps.

Foreign supplier verification program

Importing food not only involves the exporting business in the exporting nation, but also an importing business in the United States. This legislation allows the U.S. importing business to verify that the foreign exporting business meets the requirements of U.S. law, especially the HACCP standard mandated by the 2010 legislation.

Voluntary qualified importer program

An importer can qualify for expedited review and importation if it has provided a facility certification for the foreign business.

Authority to require import certifications for food

Nations often provide certificates for their producers who are intending to export their food product to another nation. The purpose of the certificate is to indicate to the importing nation that the exporting business has produced the food according to the laws of the exporting nation. The assumption is that if the importing nation accepts the standards of the exporting nation, and the exporting nation certified that the food complies with the laws of the exporting the nation, the importing nation should be confident that the food is acceptable. The exporting business does not to request a certificate from its government, but may do so if the importing business requests the certificate or if the exporting business believes a certficate will enhance the exporter's opportunity to import into the other nation.

The 2010 legislation authorizes the FDA for the first time to require the foreign food business provide a certificate from the exporting government.

Prior notice of imported food shipments

The 2002 legislation required that notice be provided before food arrives at the United States. The notice must indicate the manufacturer and shipper of the article; the grower of the article; the country from which the article originates; the country from which the article is shipped; and the anticipated port of entry for the article. The 2010 legislation requires that the notice also indicate whether the food has been rejected by another nation.

Building capacity of foreign governments with respect to food safety

Congress has indicated that the United States will take an active role in helping countries and businesses that export food to the United States enhance their food safety efforts.

Inspection of foreign food facilities

FDA has been authorized to inspect foreign facilities that export to the United States. This legislation includes a Congressional mandate that FDA take a more active role (despite the cost) in inspecting food businesses in nations that export to the United States.

FDA is authorized to enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered with the FDA and to direct resources to inspect foreign facilities, suppliers, and food types, especially facilities, suppliers, and food types that present a high risk, to help ensure the safety and security of the food supply of the United States.

Food shall be refused admission into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, that refuses to permit entry of United States inspectors to inspect such factory, warehouse, or other establishment.

Accreditation of third-party auditors

The Secretary shall use certification provided by accredited third-party auditors to (i) determine whether a food satisfies the requirements of the law; and (ii) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program.

An accredited third-party auditor shall issue a food certification or a facility certification only after conducting a regulatory audit.

Only an accredited third-party auditor or the Secretary may provide a facility certification.

Prior to accrediting a foreign government as an accredited third-party auditor, the accreditation body or Secretary shall perform such reviews and audits of food safety programs, systems, and standards of the government or agency of the government as the Secretary deems necessary, including requirements under the model standards, to determine that the foreign government is capable of adequately ensuring that eligible entities or foods certified by such government meet the requirements of this Act with respect to food manufactured, processed, packed, or held for import into the United States.

Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party to be an accredited third-party auditor, the accreditation body or the Secretary shall perform such reviews and audits of the training and qualifications of audit agents used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative as the Secretary deems necessary, including requirements under the model standards, to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity or food meets the requirements of this Act. 

Foreign offices of the Food and Drug Administration

Consistent with taking a more active role in nations that export to the United States, Congress has authorized FDA to establish offices in those nations so FDA has a presence near the food industry that is providing food to the United States.

19.  Port Shopping

The FDA shall notify the Department of Homeland Security of all instances in which the FDA refuses to admit a food into the United States so the Department of Homeland Security, acting through Customs and Border Protection, may prevent food refused admittance into the United States by a United Statesport of entry from being admitted by another United States port of entry, through the notification of other United States ports of entry.

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20. Smuggled Food

The FDA shall develop and implement a strategy to better identify smuggled food and prevent entry of such food into the United States.

Within 10 days after identifying smuggled food that could cause serious adverse health consequences or death to humans or animals, the FDA shall provide the Deparment of Homeland Security a description of the smuggled food and, if available, the names of the individuals or entities that attempted to import such food into the United States.

If the FDA (1) identifies a smuggled food; (2) reasonably believes exposure to the food would cause serious adverse health consequences or death to humans or animals; and (3) reasonably believes that the food has entered domestic commerce and is likely to be consumed, the Secretary shall promptly issue a press release describing that food and shall use other emergency communication or recall networks, as appropriate, to warn consumers and vendors about the potential threat.

Smuggled food means any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead.

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21. Employee Protection

There often is concern that an employee who "blows the whistle" will suffer consequences on the job from the employer.  For this reason, Congress included a provision to offer employee protection.

No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee’s initiative or in the ordinary course of the employee’s duties

  • (1) provided information regarding any violation of any provision of the Food, Drug and Comestic Act;
  • (2) testified in a proceeding concerning such violation;
  • (3) assisted or participated in such a proceeding; or
  • (4) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee reasonably believes to be in violation of the Food, Drug and Comestic Act.

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Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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