FAQ's about the Food Safety Act

What is the Food Safety Act in general?

The Food and Drug Administration Food Safety Modernization Act (FSMA), also known as the Food Safety Act or S. 510, was signed into law on January 4, 2011.  The Act amends the Federal Food, Drug, and Cosmetic Act with respect to safety of the food supply.  The Act is aimed at helping the Food and Drug Administration (FDA) prevent food safety problems, and it gives FDA new enforcement authorities and new tools for managing imported foods.  In addition, it requires food facilities to identify potential food safety hazards and to develop and implement preventive control plans.

Among other things, the Act directs FDA to: 

• Issue guidance for risk reduction;
• Establish fruit and vegetable harvesting standards;
• Collect fees related to reinspections and recalls; and
• Develop food allergy guidelines for schools. 

To enable faster detection and response to food safety problems, the Act requires FDA to: 

• Inspect facilities and imported foods more frequently;
• Establish a product tracing system; and
• Alongside the Centers for Disease Control (CDC), improve data on foodborne illnesses.

FDA is also charged with improving the safety of imported foods by requiring importers to verify that food is produced in compliance with hazard analysis and product safety standards, and is not adulterated or misbranded.  The Act authorizes FDA to require certification showing that an article of food imported or offered for import complies with food safety requirements, and FDA is instructed to enter into arrangements with foreign governments to facilitate the inspection of foreign facilities.

In addition, the Act authorizes appropriations for the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of FDA for Fiscal Years 2011 through 2015. 

The Act also establishes whistleblower protections for employees of entities involved in the manufacturing, processing, packing, transporting, distribution, reception, holding, or importation of food that provide information related to food safety violations.

The FDA has started the process of writing the regulations required by the Act, which will dictate how the agency will implement the law’s provisions.  Click here to read when the new regulations will take effect and how to impact them.

What are the roles of the Food and Drug Administration and the U.S. Department of Agriculture when it comes to food safety?

The Food and Drug Administration (FDA) is part of the Department of Health and Human Services, and is responsible for the safety of roughly 80% of food in the United States, including fresh and fresh-cut produce.  The Food Safety and Inspection Service (FSIS), part of the U.S. Department of Agriculture (USDA), is responsible for protecting the United States’ commercial supply of meat (excluding game), poultry, and egg products against contamination.  The Food Safety Modernization Act focuses primarily on FDA and its role in preventing food safety problems, detecting and responding to potential problems, and improving the safety of imported foods.  It thus does not impact the regulation of meat, poultry, or egg products.  It does impact most everything else, including grains, oilseeds, dairy, and produce, though it has a particular focus on produce.

How does the Food Safety Act affect small and midsize family farms?

The Act addresses small and midsize family farms through a variety of provisions, including:

• The Food and Drug Administration (FDA) is given the authority to either exempt small farms engaged in low or no risk processing or co-mingling activities from new regulatory requirements, or FDA can modify particular regulatory requirements for such farming operations.
• FDA is instructed to provide sufficient regulatory flexibility for all sizes and types of facilities, including small businesses such as small food processing facilities co-located on farms.
• FDA is prohibited from requiring any farm to keep records beyond the first point of sale when the product leaves the farm, except in the case of farms that co-mingle products from multiple farms, in which case those farms must also keep records one step back (to their suppliers) as well as one step forward (to their buyers).
• Certain small and midsize family farms that primarily direct market to consumers may not have to register with FDA as food facilities.  The Act mandates that, others, including very small farms and processors, and larger farms who primarily direct market to consumers, restaurants, or grocery stores in their region, will qualify for alternatives to the Hazards Analysis and Risk-Based Preventive Controls (HARPC) that other facilities will be required to develop and implement, and may also qualify for alternatives to the produce standards.  Specific qualifications for these alternatives can be seen below in the FAQ.
• USDA is authorized to run a food safety training, education, and outreach competitive grants program with an emphasis on small and mid-scale farms and small wholesalers and processors.

          
What is a Hazard Analysis & Risk-Based Preventive Control (HARPC) plan?

The Act requires food facilities to develop and implement Hazard Analysis & Risk-Based Preventative Control (HARPC) plans.  According to the Food and Drug Administration (FDA), a HARPC plan is similar to the Hazard Analysis and Critical Control Points (HACCP) plan.  According to FDA, HACCP is a management system that was created to ensure that food safety hazards are controlled to prevent unsafe food from reaching the consumer.  HACCP plans address food safety through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement, and handling to manufacturing, distribution, and consumption of the finished products (1). HACCP is designed for use in all segments of the food industry.  Every segment is responsible for providing the conditions necessary to protect food while it is under that segment’s control. This has traditionally been accomplished through the application of current Good Manufacturing Practices. These conditions and practices are now considered to be prerequisites to the development and implementation of effective HACCP plans.

Farms that are not food facilities do not have to develop and implement HARPC plans to be in compliance with the regulations of the Act. 

What is a food facility?

A food facility includes any factory, warehouse, or establishment that manufactures, processes, packs, or holds food.  Manufacturing/processing activities include making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food crops or ingredients. 

On farm washing, trimming of outer leaves of, and cooling produce are considered part of harvesting and would not require classification as a facility (2).

Which farms are required to register as food facilities with the Food and Drug Administration?

Farms must register as food facilities with the Food and Drug Administration if they:

• Manufacture, process, pack, or hold food beyond what is considered harvesting, and
• Direct market less than 50% of their product.
• In this instance, direct marketing means direct farmer-to-consumer sales and does not apply – like in other direct marketing specifications in the Act – to stores and restaurants. 

Manufacturing/processing activities include making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food crops or ingredients.  Examples of manufacturing/processing include:

• Cutting,
• Peeling,
• Trimming,
• Washing,
• Waxing,
• Eviscerating,
• Rendering,
• Cooking,
• Baking,
• Freezing,
• Cooling,
• Pasteurizing,
• Homogenizing,
• Mixing,
• Formulating,
• Bottling,
• Milling,
• Grinding,
• Extracting juice,
• Distilling,
• Labeling, or
• Packing.

On farm washing, trimming of outer leaves of, and cooling produce are considered part of harvesting and would not require classification as a facility.

What is the Food and Drug Administration directed to do to determine whether those farms that must register as food facilities must do Hazard Analysis & Risk Based Preventive Control plans (HARPC)?

For farms that must register with the Food and Drug Administration (FDA) as food facilities, the FDA must either:

• Exempt farms engaged in low or no risk on-farm processing or co-mingling activities from the requirement to do Hazard Analysis & Risk Preventative Control (HARPC) plans, or
• Modify HARPC requirements to make them appropriate for such farming operations.
• Farms that are not food facilities do not have to develop and implement HARPC plans to be in compliance with the regulations of the Act.  Please refer to the previous question for the definition of a food facility.

           
Which farmers qualify for less costly alternatives to the Hazard Analysis and Risk-Based Preventive Control (HARPC) plans and what are the alternatives?

Farms that are also food facilities qualify for less costly alternatives if they:

• Direct market more than 50% of their products directly to consumers, stores, or restaurants that are in the same state or within 275 miles of the farm;
• Have gross sales (direct and non-direct combined) of less than $500,000; and
• Display or otherwise provide their business name and address at the point of sale (e.g., on an invoice to a store or restaurant, on a label, on a sign posted at a farmers market table, etc.)

If a farm that is also a food facility meets these requirements, then there are two alternatives to developing and implementing a Hazard Analysis and Risk-Based Preventive Control (HARPC) plan:

• The farmer must provide documentation that his or her farm is in compliance with state regulations—including providing licenses, inspection reports, or other evidence. 
• If there are no state regulations or if the farmer prefers option two for whatever reason, he or she must provide the Food and Drug Administration (FDA) with documentation showing that he or she has identified potential hazards, has implemented preventive controls, and is monitoring those controls for their effectiveness.  FDA will further detail the exact nature of this option, sometimes referred to as HARPC-Lite, in its rulemaking.
•  Farms that are not food facilities do not have to develop and implement HARPC plans to be in compliance with the regulations of the Act.

What provision in the Act is specific to produce farms?

To be in compliance with the Act, produce farmers will have to meet production and harvesting standards.  The Act requires the establishment of 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.  The Food and Drug Administration (FDA) will develop these standards through rulemaking that will begin no later than one year after the date of the Act’s enactment.
 
The Act requires the produce standards to:

• Be scale appropriate;
• Include standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;
• Consider natural, unintentional, and intentional hazards;
• In the case of certified organic, not conflict or duplicate the requirements of the National Organic Program Regulations;
• Take into consideration conservation and environmental practice standards established by federal conservation and environmental agencies;
• Define the terms ‘small business’ and ‘very small business’; and
• Prioritize the implementation for specific fruits and vegetables based on known risks.

Are any farms exempt from the produce standards?

There are alternatives to the produce standards for farms that:

• Direct market more than 50% of their products directly to consumers, stores or restaurants;
• Have gross sales (direct and non-direct combined) of less than $500,000; and
• Sell to consumers, stores, or restaurants that are in-state or within 275 miles.
• Farms that meet these requirements must prominently and conspicuously display the name and address of the farm on its label, or prominently and conspicuously display (on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business) at the point of purchase, the name and business address of the farm where the produce was grown.  In the case of internet sales, this information must be available in an electronic notice.

Does the Food Safety Act restrict organic farming in any way?

The Act requires the Food and Drug Administration (FDA) to consult with the U.S. Department of Agriculture’s National Organic Program to ensure that food safety standards do not conflict with or duplicate organic certification standards. 

How does the Act address the issue of food safety rules conflicting with farm conservation and environmental management?

The Act requires the Food and Drug Administration (FDA) to take federal conservation and environmental standards and goals into account prior to issuing food safety regulations.   FDA must apply sound science to any requirements that might impact wildlife and wildlife habitat on farms.  FDA must take into account, 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.

Do the alternatives for small farmers and processors pose a threat to food safety?

The alternatives do not inherently pose any additional threats to food safety. The Act requires the frequency of inspections by the Food and Drug Administration (FDA) to be based on risk, and prioritizes implementation of regulation based on known risks.  The Act aims to develop and implement strategies to enhance food safety and defense capacities at the State and local levels. FDA has the authority to withdraw any exemption small farmers and processors have received if FDA is concerned about a foodborne illness outbreak. 

Can the Food and Drug Administration issue a mandatory recall?

The new law gives the Food and Drug Administration (FDA) the authority to recall a product if there is a reasonable probability that it is adulterated or misbranded and is capable of causing a serious adverse health consequence.  Once advised of a recall, the responsible party has an opportunity to voluntarily recall the product.  If that does not occur, FDA can order the immediate cease of distribution.  After such action, an informal hearing will occur within two days.  If the recall is still deemed necessary, FDA will establish a timeframe and require reports.  Failure to comply with FDA could result in civil penalties.  If the recall is determined unnecessary, FDA will withdraw it.

Will farmers be subject to new fees?

In most cases, farmers will not be subject to new fees.  A controversial fee (tax) provision was included in the Administration’s proposal and incorporated into the House version of the Act, but was rejected by the Senate and not included in the final Act.  There are fees in the final Act, but only for:

• Reinspection costs,
• Food recall activities,
• Administrative costs of the voluntary qualified importer program,
• Costs associated with issuing food export certification, and
• Costs to establish and administer the third party accreditation program for imported foods.

 
There is no fee for an initial inspection.  Food facilities will not be required to pay a registration fee to register with the Food and Drug Administration (FDA).  FDA will publish fee requirements each August with the methodology the agency used to arrive at those fees for the activities that are subject to fees.  

What about other compliance costs?

Several new provisions are intended to decrease costs and burdens for small and midsize farms, by providing alternatives to expensive traceability and recordkeeping requirements and to Hazard Analysis & Risk-Based Preventive Control (HARPC) requirements.  In addition, the Food and Drug Administration is prohibited from requiring farms and other food facilities to hire outside consultants to write HARPC plans.

Will the Food and Drug Administration inspect farms?

The Food and Drug Administration (FDA) has long had the authority to inspect manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations.  FDA inspects food processing facilities, dairy farms, and animal feed processors.  A farm will be inspected only if, in addition to being a farm, it is also considered a food facility.  A facility includes any factory, warehouse, or establishment that manufactures, processes, packs, or holds food.  On farm washing, trimming of outer leaves of, and cooling produce are considered part of harvesting and would not require classification as a facility.  The term ‘facility’ does not inherently include farms, restaurants, or other retail food establishments.  The new Food Safety Act directs FDA to either exempt farms engaged in low or no risk on-farm processing or co-mingling activities from new regulatory requirements, or to modify regulatory requirements to make them appropriate for such farming operations.

The Act requires an increase in the inspection of facilities.  It states that high-risk facilities should be inspected at least once within five years of the Act’s enactment, and no less than once every three years after that.  Non-high-risk facilities should be inspected within seven years of the Act’s enactment, no less than once every five years thereafter.

What new record-keeping requirements are farmers subject to?

The Food and Drug Administration (FDA) has been instructed to minimize the number of different standards that apply to separate crops and foods and make requirements scale appropriate. 

Farmers who qualify for the less costly alternative to Hazard Analysis and Risk-Based Preventive Control plan (HARPC) must still provide documentation that their farm is in compliance with state regulations. 

Farmers who are exempt from specific produce standards and preventive control standards must still display the name and address of the farm on their products and for foods without a label then by poster, sign, or placard, at the point of purchase or, in the case of internet sales, in an electronic notice, or in the case of sales to stores and restaurants, on the invoice.

Farmers who sell directly to consumers or to grocery stores, and whose labels preserve the identity of the farm through to the final consumer, may be exempt from extensive/expensive traceability and recordkeeping requirements.

FDA is prohibited from requiring any farm to keep records beyond the first point of sale when the product leaves the farm, except in the case of farms that co-mingle products from multiple farms, in which case they must also keep records one step back (to their suppliers) as well as one step forward (to the buyers).

What training is available to farmers to comply with food safety regulations?

The Food and Drug Administration and the U.S. Department of Agriculture will establish a competitive grant program within the National Institute of Food and Agriculture.  The grant program will provide food safety training, education, extension, outreach, and technical assistance to owners and operators of farms, small food processors, and small fruit and vegetable merchant wholesalers, with a priority on small and midsize farms, to be delivered by NGOs, Extension, producer groups, etc.  The budget for this grant program is to be determined by appropriations.

Do food safety regulations apply to home gardens?

Food safety regulations do not apply to home gardens that are not in the business of selling food to customers. 

Does this law change state and local food safety guidelines?

Not directly, but the Act suggests increased communication with state and local governments.  The Food and Drug Administration is still likely to rely on state and local agencies to do much of the implementation and enforcement of the new law.  Also, given the provision which allows compliance with state regulation rather than federal for very small farms and processors and for direct market farms, it would not be surprising to see more attention given to any potential gaps in the state and local rules and procedures.

Will entities like farmers markets need to take on any new responsibilities because of this law?

No.  However, it is strongly recommended that farmers markets require producers to adhere to all relevant state and local regulations.  Market managers may want to remind producers of their obligation to clearly post their business name and address at their stands.

Does the Food Safety Act regulate food safety risks such as genetically modified organisms (GMOs), pesticide use, and antibiotic use in animal agriculture?

The Food Safety Act does not regulate GMOs, pesticide use, or antibiotic use in animal agriculture.  The Act and the law that it amends are primarily only interested in pathogen contamination, not any other food safety or public health risks.

When will the food safety regulations take effect?

The food safety regulations will go into effect at various times.  The Food and Drug Administration (FDA) is attempting to have a set of proposed rules for preventive control plans and for produce standards out for public comment before the end of the 2011 calendar year.

The Act mandates each specific regulation to take effect no later than a time that is individualized for that regulation.  The agency has already said publicly that there are many deadlines contained in the Act that it will not be possible to meet.
 
Timeline extracted from Registrar Corp website:

On or before July 3, 2011:

• FDA may suspend registration (effectively closing) of any facility that:
• Created, caused, or was responsible for food having a reasonable probability of having adverse health consequences for humans or animals, or
• Knew or had reason to know of such reasonable probability, and packed, received, or held such food.
• FDA will issue a small entity compliance guide within 180 days of issuing the interim regulations concerning facility registration.
• FDA and the U.S. Department of Agriculture (USDA) will establish a competitive grant program within USDA’s National Institute of Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance.

On or before October 4, 2011:

• FDA will publish a notice of proposed rulemaking in the Federal Register to promulgate regulations that further define farms and exemptions applicable to farms.  Specifically, the regulations will address:
• Activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, and
• Activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership.

On or before January 4, 2012:

• FDA will begin to issue new rules for produce standards and safety.  The rules will be staggered to give priority to specific fruits and vegetables based on known risks and history of incidents.  

On or before July 4, 2012:

• FDA will issue Hazard Analysis & Risk-Based Preventative Control (HARPC) regulations for all products except seafood and juice (which are already subject to Hazard Analysis and Critical Control Points regulations).
• FDA will report to Congress on the results of a study of the food-processing sector mandated by the statute. The study is to determine:
• The distribution of food production by size and type of operation, including the monetary values of food sold;
• The proportion of food produced by each type and size of operation;
• The number and types of food facilities co-located on farms, segregated by commodity and by manufacturing or processing activity; and
• The incidence of foodborne illness originating from each size and type of operation, and assessments of risk of foodborne illness associated with commingling, processing, transporting, and storing food and raw agricultural commodities.
• The results of the study shall include information necessary to enable the Secretary to define the terms ‘small business’ and ‘very small business.’
• FDA will issue regulations to protect against intentional adulteration of food.  Farms will be exempt, except those that produce milk.

Click here for a more detailed timeline