Food Safety Modernization Act



Passed by Congress in 2010 and signed into law in 2011, the Food Safety Modernization Act (FSMA) is the first major overhaul of our nation’s food safety practices since 1938. The law includes new regulations for farms that grow fresh produce (fruits and vegetables) and for facilities that process food for people to eat. This means it represents some big changes to our food system –FSMA gives the FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods.

To do so, FSMA authorizes new regulations for farmers who grow certain kinds of fresh produce (fruits and vegetables) and for certain facilities that process food for people to eat.  The regulations focus on addressing food safety risks from microbial pathogen contamination (e.g., Salmonella, E. coli O157:H7, and Shigella). and it is extremely important for the Food and Drug Administration (FDA) to get these regulations right so that they improve food safety without placing an unfair burden on family farms and our developing local food system.

Specifically, FSMA requires FDA to establish new regulations for:

  • Standards for produce production (Produce Rule), and
  • Food safety measures for facilities that process food for human consumption (Preventive Controls Rule)


Current Situation

November 13, 2015

Today, the Food and Drug Administration released its final produce safety rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. This rule will impact how a number of farms in the Carolinas that grow and sell produce commonly eaten raw. The rule is 801 pages long. CFSA’s policy team is currently reviewing the rule.  We will provide analysis and action steps in the near future.

October 5, 2015

FSMA Food Processing Rule—What’s Covered, and Who Isn’t

The Food & Drug Administration has started publishing final regulations under the federal Food Safety Modernization Act.  On September 10, 2015, the U.S. Food and Drug Administration (FDA) issued final rules establishing new ‘preventive controls’ standards for food processing facilities and animal feed manufacturers under the Food Safety Modernization Act (FSMA).  (CFSA will publish information about the rules on animal feed soon.)  Five other FSMA final regulations will be out over the next several months, including the rule on standards for growing produce on farms (the Produce Rule), which is due at the end of October, 2015.

The rule on Preventive Controls for Human Food (‘Preventive Controls Rule’, or PCR) updates existing law on food processing (Good Manufacturing Practices, or GMPs) and adds new requirements for certain food processing facilities to establish Hazard Analysis and Risk-based Preventive Controls (HARPC).  Human food facilities covered by the PCR must come into compliance with the rules on a staggered schedule, based on business size.  The deadline is September 2016 for businesses with over 500 employees; September 2017 for businesses with fewer than 500 employees but more than million in human food sales; and September 2018 for businesses with less than million in food sales.

The PCR governs food manufacturing facilities, but there are many exclusions or exemptions from the rule or portions of it.  A food or farm business’ first task, therefore, is to figure out whether the PCR applies to it.

Excluded Operations

The Bioterrorism Act of 2002 requires that all ‘facilities’ that manufacture, process, pack or hold human food register with FDA.  Registration triggers PCR compliance.  But the registration requirement doesn’t apply to:

  • Restaurants;
  • Charitable non-profits that serve food directly to consumers, such as food banks, soup kitchens, and ‘meals on wheels’ programs;
  • Fishing vessels;
  • ‘Retail food establishments’ (RFEs), which are businesses that pack, hold, process or manufacture food and make more than half of their food sales directly to consumers, such as grocery stores.  FDA earlier this year issued a proposed rule that would expand the RFE definition to include Community Supported Agriculture (CSA) operations;
  • Businesses regulated by the US Dept. of Agriculture under the Federal Meat Inspection Act; and
  • Farms.

However, as those of us engaged in local food understand, many operations that we know as ‘farms’ may ‘manufacture, process, pack or hold’ human food.  The PCR defines ‘farm’, and these provisions of the final rule are beneficial for many farms.  The regulation allows agriculture operations two means for being classified as a farm, either as a ‘primary production farm’ (PPF) or a ‘secondary activities farm’ (SAF).

PPFs are entities:

  • In one general location, although not necessarily contiguous:  all the various plots of land that a farmer might manage can be part of one farm if they’re a reasonable distance away from each other, even if they’re not in the same state.
  • Under one management: whether the land being farmed is owned or leased by the farmer doesn’t matter, nor does the legal structure under which the farm is managed.
  • That grow or harvest crops and/or raise animals (including ‘seafood’ animals).

Moreover, FDA has clarified that PPFs can do certain food-related activities without losing their status as farms.  So a farm can pack (place in a container for distribution) or hold (store) the raw agricultural commodities (RACs) produced on that farm; it can pack or hold RACs grown on another farm(s); it can dry/dehydrate RACs to produce a distinct commodity, such as raisins, prunes, dries hops or cured shelled walnuts, so long as that new product is not further processed (such as by pitting, chopping or slicing); and it can package (place in a container for sale to the end-user) and label intact RACs and dried commodities.  These clarifications are significant, as previously farms were potentially subject to regulation as ‘facilities’ for labeling, packaging, and dehydrating any RACs, or for packing and holding other farms’ RACs.

By creating ‘secondary activities farm’ category, FDA allows for an operation that isn’t located at the site where crops are actually produced to still be a ‘farm’ excluded from the mandates of the PCR.  Specifically, a SAF is

an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.

In other words, a packing house majority-owned by a farmer or a group of farmers will be treated as a farm if the owner(s) of the packing house supply the majority of the crops that are packed or held at that location.  This is an important protection for farmer cooperatives and farmers that operate a packing shed in a location different from where their crops are grown.  SAFs can also carry out all the same packing/holding/packaging/labeling/ dehydrating activities as PPFs.

FDA also expands the definition of ‘harvesting’ and ‘packing’ to make clear that a wide range of activities that farms do to prepare RACs for market are not ‘processing/ manufacturing’ that would trigger PCR compliance requirements.  This includes shelling beans and nuts; trimming roots, stems and foliage; washing and hydro-cooling produce; sifting and filtering; threshing; mixing intact RACs (such as intact leaves of leafy greens for a salad mix); and waxing.

RAW MILK NOTE:  FDA specifically states in the preamble to the PCR that producing raw milk is a ‘farm’ activity, and that selling raw milk to consumers within a state where such direct distribution is legal does not trigger the treatment of that farm as a ‘facility.’

Exempt Operations

If a food business does not fall into one of the excluded categories above, then it must register with FDA as a food processing facility.  This includes ‘farm mixed-type facilities,’ which are entities that grow or harvest crops but also conduct food manufacturing activities that are not protected within the farm definition, such as making jams, candies, salsas or cheese.  The next questions are whether a registered facility has to comply with the PCR’s Good Manufacturing Practices and Hazard Analysis and Risk-based Preventive Controls requirements.  Below we address rule coverage questions for some of the ‘facilities’ that are most common in the local food market.

  • A ‘qualified facility’ is exempt from the full brunt of HARPC under the Tester Amendment to FSMA, but must comply with ‘modified requirements’ under the PCR (they were already subject to GMPs under prior law).  ‘Qualified facility’ means a food business with less than million in annual human sales that either (a) is in compliance with existing state food safety rules relevant to the foods and products it sells, or (b) has identified food safety hazards in its operations, implemented preventive measures to address those hazards, and monitors the implementation of those measures to ensure that they are working.  In effect they must have a ‘HARPC-lite’ program.  (We will provide further analysis in the future on these ‘modified requirements.’)
  • FDA has designated a long list of food preparation and processing activities performed to make specific foods where the food safety risks are inherently minimal.  Farm-mixed type facilities with fewer than 500 employees or less than million in annual food sales that perform only ‘low risk activity/food combinations’ on this list are not subject to HARPC.  The PCR provides a detailed list of these combinations here, and these exemptions will be very useful to many farm-based local food enterprises.  Activities involving milk or milk products or that produce sliced raw low-acid fruits and vegetables do not qualify as low-risk.
  • Farm-mixed type facilities are not subject to HARPC or GMPs with respect to the ‘farm’ activities they perform (growing, harvesting, packing, and holding RACs as described in the farm definition section above).
  • Establishments that only store non-produce RACs that are intended for further distribution and processing, such as grain elevators, are not subject to HARPC.
  • If a facility is already subject to Hazard Analysis and Critical Control Points (HACCP) requirements for juice or seafood under other federal law, then the PCR’s HARPC requirements don’t apply.
  • If a facility only produces low-acid canned foods, it is already regulated under existing federal HACCP-like rules, and so doesn’t have to comply with HARPC with respect to pathogen risks.  However, the low-acid canned food rules don’t cover physical or chemical contamination, so these facilities have to follow HARPC with respect to those food safety risks.
  • Most alcoholic beverage manufacturers are exempt from HARPC.
  • The manufacture, processing, packing and holding of dietary supplements is not subject to HARPC.
  • Facilities that solely hull, shell, dry, pack and/or hold nuts are not subject to GMPs.
  • Businesses that solely hold and/or transport RACs are not subject to GMPs.

Food Hubs in Limbo

Produce packing and distribution facilities that aren’t located on farms and not majority-owned by farmers, and that have annual human food sales worth million or more, not only must register with FDA, but are subject to both HARPC and GMPs under the PCR.  Likewise, small (less than 500 employee) and very small (less than million in annual human food sales) facilities not located on farms that perform only the activity/food combinations on FDA’s ‘low-risk’ list still must comply with HARPC.  This inconsistent treatment has the potential to significantly increase the financial and regulatory burdens on food hubs that are owned by non-profits, government agencies or private individuals who aren’t farmers.  In the preamble to the PCR, FDA discusses various alternatives for these facilities that may limit those impacts, but none of those reduced-burden alternatives are specifically included in the text of the regulations.  We will publish soon more detailed analysis of the options for food hubs to reduce the cost of compliance with HARPC.

For More Information

Find the full text of the PCR here.

The National Sustainable Agriculture Coalition has published a three-part series of blogs with greater detail on who and what is exempt from the PCR, who is partially exempt, and who is fully subject to the rule.

September 14, 2015

The Preventive Control rules are long; over 1000 pages! We’ve read through them and have posted our initial impressions on the Sweet Potato, CFSA’s blog. We’ll dig deeper in the coming weeks and months, and will continue to provide information and opportunities to influence this new policy.

September 10, 2015

The Food and Drug Administration published the Preventive Controls for Human Food rule today. This rule may impact farms and food businesses that process fruits and vegetables. CFSA’s policy team is currently reviewing the newly published rules and will provide analysis and action steps in the near future.

July 24, 2015

When Congress enacted the Food Safety Modernization Act (FSMA), one of the key protections for local food systems was that the Food and Drug Administration (FDA) was prohibited from requiring farmers or food entrepreneurs to undergo third party compliance audits. One of these audits can be expensive—costing anywhere from 0 to ,000 per year—and Congress recognized that this was an unnecessary financial burden on farms and small food businesses. FSMA is crystal clear: FDA cannot require such audits to prove, or as a condition of, compliance with either the rules governing practices for growing produce, or those for food and feed manufacturing.

Unfortunately, it looks like FDA didn’t read the law. When the agency published proposed FSMA rules last year, it included a requirement that food facilities—which includes everything from produce packing houses to animal feed mills to factories making Cheeze Whiz—have a ‘Supplier Verification’ program. Supplier Verification means those facilities must obtain annual documentation from their suppliers, including farms, that those suppliers are in compliance with FSMA. The only way to prove compliance? A third-party audit.

The final versions on the rule are due to be published soon, so there’s still time to put pressure on FDA and the White House to withdraw this costly and unlawful Supplier Verification mandate. One way to do that is to get members of the US Senate to complain to FDA about the proposal. Read the “Take Action” section below for information on how you can call your Senator.

March 2015

FDA is currently in the rule-making stage – turning the FSMA bill passed by Congress in 2010 into actual rules and regulations that will affect farmers, food businesses, and everyone who eats food. The opportunity for the public to comment on FDA’s proposed rules ended in late 2014, but the rules are not yet final, and are not yet being implemented on the ground on farms and businesses.

January 2015

Before FDA can finalize the proposed rules, the agency needs to read the input it received in 2014 from the public. Comments from consumers, farmers, on-farm processors and food businesses will directly shape the final rules and were critical to ensuring that the final rules work for small and mid-sized farmers, sustainable and organic growers, value-added businesses and conservation systems.

Thank you to everyone who submitted a comment!

Take Action

Sept. 10, 2015

We are currently reviewing the rules.  Please stay tuned for our comments and any action alerts.


July 24, 2015

Call your US Senator today and ask him to contact the FDA to demand that the agency abide by the law and strip the Supplier Verification requirement out of the final rules.

When you call, here’s you can say:

  1. Introduce yourself (first and last name) and explain that you are a citizen of North or South Carolina (if you are a farmer or run a food business, be sure to say so).
  2. Say that you are calling because you are concerned about the FDA’s Supplier Verification requirement in its proposed preventive controls rules under FSMA.
  3. Say that you oppose the requirement because:
  • Congress specifically forbade FDA to require third-party compliance audits, and FDA cannot be allowed to violate Congressional intent.
  • The costs of these audits will be devastating for small farms and food businesses—anywhere from 0 to ,000 for one audit, not counting the cost to the farm or business in record keeping and paperwork.
  • Small farms and businesses will lose markets when they can’t afford these audits.

If you feel nervous about making a phone call, watch CFSA’s “How To Call Your Representative” video.

Here is contact info for the Carolinas’ Senators:

North Carolina
Richard Burr: (202) 224-3154
Thom Tillis: (202) 224-6342

South Carolina
Tim Scott: (202) 224-6121
Lindsey Graham: (202) 224-5972

January 2015

If you have a chance to speak to a member of your US Congressional delegation, please let them know that you are concerned about the FDA’s FSMA rules.

Let your Congressional delegation know about the problems with the FDA’s proposed rules and ask for their help in making sure that the FDA publishes rules that preserve safety AND preserve local, organic farms.

1. Issue: Definition of a “Farm”

The final rules don’t provide a clear definition the term ‘farm.’ FDA must clarify the difference between a farm and a facility using common sense and risk-based distinctions that have clear connections to promoting food safety. Specifically:

  • FDA should clarify the “farm” definition to ensure that farmer-operated businesses that engage in “farm” activities — growing, harvesting, packing, or holding raw agricultural commodities — are considered farms.
  • FDA should remove the phrase “in one general physical location” from the farm definition, to reflect the modern-day reality that farms are not always contiguous, and that farms may include structures in different locations or on different parcels of land.

2. Issue: All Food vs. Regulated Food

In the final regulations, FDA should provide clarity and consistency across the rules for farms and food businesses covered by the rules. To do so, FDA should base all calculations used to determine whether and to what extent a farm or food business is covered under the rules on sales of what the rules regulate. Specifically:

  • For all coverage determinations, FDA should base thresholds on sales of either “covered produce” under the Produce Rule, or “covered human food” under the Preventive Controls rule.

3. Issue: Protections for Local Farms and Food Businesses (Qualified Exemptions and Modified Requirements)

The process to get an exemption from or modification of FSMA requirements should be the same under both the Produce and Preventive Controls Rules, and the content of a withdrawal notice or order should clearly state the individualized nature of the determination. Specifically:

  • FDA should ensure that both rules follow a clear and consistent process.
  • FDA should never withdraw a farm or business’ qualified exemption without specific proof that that specific entity has caused or presents a verifiable threat of causing serious adverse consequences to human health.
  • FDA should include – in both the initial notice of intent to withdraw and the withdrawal order itself – facts specific to the business that holds the qualified exemption, to ensure that each withdrawal is made on an individualized basis and that the farmer or facility has a meaningful opportunity to rectify the situation.
  • FDA should retain the reinstatement process, and should clarify that FDA will reinstate an exemption within a reasonable period of time.

 4. Issue: Agricultural Water

FDA must not overly burden farmers to test and address water quality issues outside of their control. FDA must take a science- and risk-based approach to agricultural water that provides clarity and flexibility to allow farmers to respond to specific risks in their water systems, and should defer finalizing a numeric water quality standard until a full risk assessment is completed. Any numeric standard should be in guidance, not regulations, to provide an ongoing mechanism to adjust the standard to reflect new science and to provide meaningful opportunity for farms to offer input. Additionally:

  • FDA should reduce the frequency of testing. As currently proposed, the testing frequencies are overly burdensome, lack scientific justification, and will impose great costs on farmers to repeatedly test the quality of water that will remain impaired for reasons beyond their control.
  • For water sources that are outside the farmer’s control and consistently exceed the standard, or water sources that are controlled and consistently satisfy the standard, FDA should provide the farmer with the flexibility to determine the number of tests needed to establish a baseline and characterize the water quality profile of the source.
  • FDA should align with the USDA GAPs standard, and limit testing frequencies to three samples per growing season.

5. Issue: Manure and Compost

As FDA undertakes this research and risk assessment approach to regulating raw manure and supporting compost use, the sustainable and organic farming community must be engaged as stakeholders and advisors in this process. Specifically:

  • FDA should form two advisory boards – one that advises the process and one that reviews the science. Both boards should have members representative of the diversity of American agriculture, including sustainable and organic farmers and the researchers that work with them.
  • To align with current best management practices and support the increased use of compost, insulation of compost should not be required as part of acceptable compost treatment processes.
  • We support FDA’s decision to not take exception to farmers adhering to the National Organic Program application interval for raw manure until such time as the risk assessment is completed, a new standard is proposed for public comment, and an interval finalized after considering public input.

6. Issue: Conservation Practices

FDA should incorporate stronger incentives into the rule for on-farm conservation that supports food safety and protects our soil, water, and wildlife habitat. Specifically:

  • FDA should state in the final regulations that farmers are encouraged to use sustainable conservation practices that enhance food safety. FDA should also specifically identify co-management of conservation and food safety as a type of activity that is not prohibited by the rules.
  • FDA should define co-management in the regulations.
  • FDA should not treat grazing like manure application and should not restrict grazing through unrealistic intervals, such as nine months, between grazing a field and harvest of a crop.

7. Records and Recordkeeping Requirements

Records should be limited those kept in the ordinary course of business, particularly records required of farmers that pack or hold produce from other farms. Specifically:

  • FDA should require farms that pack or hold produce from other farms to retain, for no more than one year, a one-up-one-down record, not to exceed that kept in the ordinary course of business, such as an invoice.
  • FDA must allow records to be written or on paper; FDA cannot require electronic records.

8. Issue: Supplier Verification Program

FDA must follow the law and remove the onsite audit requirement from the supplier verification program. FDA should also remove the supplier verification program from the Preventive Controls rules. FDA must ensure flexibility for farms and food businesses, and that produce farms subject to the Produce Rule are not subject to multiple and duplicative compliance requirements.

9. Issue: Excessive Compliance Costs (Environmental and Product Testing) 

FDA should find ways to decrease the costs of compliance with the new rules, especially for small and very small farms. Specifically, FDA should provide flexibility for farms and food businesses by including environmental and product testing in guidance for public comment, not the regulations.

10. Issue: Direct-to-Consumer Marketing

In the final regulations, FDA must clarify that CSAs, roadside stands, farmers markets, and other direct-to-consumer vendors fall under the definition of a “retail food establishment” and are not facilities that must register with FDA and, therefore, are not subject to the Preventive Controls Rule. Specifically:

  • FDA must issue the separate rulemaking on the retail food establishment clarification immediately, to allow sufficient time for the public to review and comment while still finalizing the clarification no later than when the rules themselves are finalized.


 Stay Informed  

CFSA will issue regular updates and information on this website as we analyze the rules’ impact on sustainable farm and food systems.

Sign up for our federal action alerts to follow this issue as it moves forward.


CFSA’s Fight for Food Safety

Background Information 

At the Carolina Farm Stewardship Association, we believe that local and regional food networks do the best job of protecting your family’s health and safety because they deliver fresher, more nutritious foods. That’s why it’s so important that we protect our small and organic food producers from being crushed by regulations meant for industrial farms and factories.


Making ‘Food Safety’ Safe for Small Farms and Local Food

In 2010, CFSA helped lead the successful effort to protect small farms and businesses serving local food markets from new federal authority under the Food Safety Modernization Act (FSMA). FSMA gives the US Food and Drug Administration new powers to dictate farming practices for fresh produce, and to put a wide range of food-making businesses out of business. But the legislation was just the first step.


In 2013, the FDA published proposed rules for implementing FSMA.  These rules were badly flawed and threatened to put many small, sustainable farmers out of business.  CFSA and our allies rallied farmers, entrepreneurs and consumers nation-wide to protest these bad proposals—over 20,000 comments poured in demanding major changes.  In another huge victory for our movement, FDA went back to the drawing board.


In fall 2014, FDA issued revised proposed regulations relating to several key issues, including the use of compost and manure, food hubs and cooperatives, the definition of a farm, water standards, animal feed, conservation practices and record-keeping.  Again, CFSA and other sustainable ag organization’s rallied local organic farming supporters to demand further changes.  The comment period on those rules ended in December, with another 4,000 comments from the public.


Learn More