New Food Safety Regulations


By Patrick G. Rowe | Sussman Shank LLP | August 2015 (Updated 01/21/2016)

The Food Safety Modernization Act (FSMA), signed into law in January 2011, shifts the United States’ food safety system from a reactive position to a preventative one.  The Food and Drug Administration (FDA) regulations provide guidance for preventive controls of human and animal foods (adopted in September 2015), for produce safety, third-party accreditation and a foreign supplier verification program (adopted in November 2015), for sanitary transportation (due by March 31, 2016), and for protection of food against harmful adulteration (due by May 31, 2016).

Following is an overview of the preventive controls of human foods and the produce safety regulations, both of which have a significant and immediate impact on food-related industries.

Preventive Controls for Human Foods

These new food safety measures require facilities that manufacture, process, pack, or hold food for human consumption to analyze hazards and establish correlating risk-based preventative controls (HARPC) and to refine existing good manufacturing practices.

Manufacturing and processing includes chopping, cooking, and canning. Packing and holding includes storing and cooling, but will generally exclude on-farm packing and holding of produce (which will be subject to the produce safety regulations).

Certain facilities are exempt from the HARPC requirements, including facilities that manufacture products covered by separate regulations (e.g., juice, seafood, dietary supplements, alcoholic beverages, and low-acid canned foods), facilities such as grain elevators that only store agricultural commodities (other than fruits and vegetables) intended for further processing, and small facilities that conduct certain low-risk manufacturing and processing, packing, or holding activities (such as making jams, honey, or maple syrup).

The new HARPC rules require maintaining and implementing a written food safety plan that includes:

  • Hazard Analysis: identify and evaluate hazards for each type of food manufactured, processed, packed, or held at the facility.
  • Preventative Controls: identify preventative controls for minimizing or preventing hazards, including process controls, food allergen controls, sanitation controls, and a recall plan.
  • Supplier Program: the plan must establish and implement a risk-based supplier program for raw materials and ingredients for which the receiving facility identifies a significant hazard and the hazard is controlled by the supplier.
  • Monitoring and Verification Procedures: document procedures for verifying that preventive controls are effective and consistently performed. Verification measures must include product testing and environmental monitoring, as appropriate to the facility, the food, and the nature of the preventative control.
  • Corrective Actions: identify steps to take, if preventative controls are not adequately implemented, to minimize the likelihood of problems reoccurring, to evaluate the food for safety, and to block problem food from entering commerce.

Only an individual qualified through training or experience can write the food safety plan. Food safety plans must be reassessed every three years, or more frequently if there are problems.

Facilities that are exempt or subject to modified requirements under the new HARPC requirements generally are subject to the good manufacturing practices (GMP) requirements. GMP requires plant management to take all reasonable measures and precautions to ensure the following:

  • Disease control: e.g., exclude from operations any person who is ill or otherwise could be the source of microbial contamination;
  • Cleanliness: all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty; and
  • Education and training: personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food.

GMP updates will also clarify protective processes for avoiding cross-contact of food by allergens.

Very Small Businesses, defined as having less than $1 million in total annual sales of human food, adjusted for inflation, have to comply within 3 years after publication of the final regulations. Considered “qualified facilities,” they would be subject to modified preventative control requirements.  Small Businesses, that employ fewer than 500 persons, generally have 2 years to comply, unless they qualify for an exemption.

Other businesses, which do not qualify as “Very Small” or “Small,” will only have one year to comply, unless they qualify for an exemption.

The FDA estimates that the annual costs of compliance for facilities that are subject to the full requirements of the Preventative Controls for Human Foods regulations will be about $13,000 per facility.  For qualified facilities subject to modified requirements, the compliance costs are expected to range from $300 to $2,000 per facility.  Facilities that are exempt from the HARPC requirements are, nonetheless, expected to have about $1,000 in compliance costs.

The total compliance costs for facilities are estimated to be 0.0001 percent of the amount that U.S. consumers spend on processed food each year, so the compliance costs are expected to cause minimal cost increases to consumers.

The full text of the final Preventive Controls for Human Foods rules is here.

Produce Safety

Businesses who grow, harvest, pack, or hold produce that is usually consumed raw (like lettuce or apples) and have gross produce sales of at least $25,000 a year, based on a 3-year average, are subject to the new produce safety regulations establishing minimum standards for the safe production and harvesting of fruits and vegetables.

Modified standards are available to certain exempt businesses, such as farms with less than $500,000 in annual gross sales who sell the majority of their produce to a “qualified end-user” (generally a restaurant or grocery store) that is located in the same state or not more than 275 miles from the farm.

The regulations establish safety protocols relating to agricultural water; animal biological soil amendments; domesticated and wild animals; equipment, tools and buildings; health and hygiene; sprouts; training; and record keeping.

The new regulations for agricultural water, including irrigation water, have caused significant concern among growers in the Northwest, including onion farmers, tree-nut producers, and blueberry growers.

Growers will have to ensure that water that is intended or likely to contact produce covered by the rules is of adequate sanitary quality. This includes water that is used in the growing, harvesting, packing, or holding of covered produce, such as irrigation water that is directly applied to the harvestable portion of a crop; water used for preparing crop sprays; water used for washing or cooling harvested produce; and water used for hand washing during and after harvest. These regulations are designed to minimize the chances that produce is contaminated by pathogens in water used in these processes. Compliance will be achieved through inspection and periodic testing of the water.

The FDA rules include a tiered approach to testing and using untreated surface water that is directly applied to the harvestable portion of a crop, which includes the following elements:

  1. Conduct a baseline survey to initially develop the water quality profile of each water source. A water quality profile is developed by calculating the geometric mean (GM) and the statistical threshold value (STV) of generic E. coli (in CFU per 100 mL) using at least 20 samples over at least two years.  Water is to be sampled as it is used (e.g., at the end of the sprinkler) and at a time as close as practical to harvest.
  2. Verify the water quality profile through annual sampling. At least five new samples must be taken each year to verify the accuracy of the baseline water quality profile.  If the annual survey is sufficiently different from the existing water quality profile, then the water quality profile would have to be updated, and existing practices may need to be modified (e.g., wait additional time before harvesting as necessary to allow for microbial die-off).
  3. Re-establish the baseline: The FDA is proposing that the baseline survey be re-established every ten years, or sooner if the annual survey samples do not support the initial baseline water quality profile, and then practices adjusted accordingly.

Produce growers have been very concerned about the costs of complying with these proposed new regulations for irrigation water testing.

Other new produce safety regulations address:

  • Biological Soil Amendments of Animal Origin, specifying types of treatment, methods of application, and time intervals between application of certain soil amendments (e.g., manure and composted manure) and crop harvest, which regulations are of particular interest to sustainable and organic producers who rely on manure and compost instead of synthetic chemicals to fertilize their fields;
  • Domesticated and Wild Animals, seeking to prevent the contamination of covered produce by liquid or solid animal excreta.  The three main animal populations that the FDA identifies are: 1) domesticated animals (livestock, working animals, and pets); 2) nearby domesticated animals (from a neighboring farm); and 3) wild animals (including deer and wild swine), implementing waiting periods between grazing domesticated animals and crop harvest if there is a reasonable probability of contamination and requiring growers to monitor for wildlife intrusion and not harvest produce visibly contaminated with animal waste;
  • Equipment, tools, and buildings, establishing cleanliness standards for equipment and tools that come into contact with produce, as well as for buildings and other facilities;
  • Health and Hygiene practices for farm personnel, including hand washing, not working when sick, and maintaining personal cleanliness; and
  • Sprouts production, including treatment of seed before sprouting and testing of spent irrigation water for pathogens.

The definitions of very small businesses and small businesses vary among the FDA regulations. For the Food Safety regulations, Very Small Businesses are those with annual produce sales of $25,000 to $250,000, which Very Small Businesses will have to comply with the Food Safety regulations within four years of the effective date.  Small Businesses, those with more than $250,000 up to $500,000 in annual produce sales, have 3 years to comply.  All others must comply within two years, unless they qualify for an exemption.

However, businesses will have an additional two years beyond these compliance deadlines to meet the water quality standards and related testing and recordkeeping provisions.

The FDA estimates the average cost of implementing the regulations will be:

  • $4,477 per year for Very Small Businesses;
  • $12,384 per year for Small Businesses; and
  • $29,545 per year for all other businesses

The FDA has not estimated correlating potential cost increases to consumers, but expects the Food Safety regulations will reduce the 3.1 million illnesses each year that are attributable to produce, and the total potential benefit of eliminating all those illnesses is estimated to be about $1.88 billion.

The full text of the final Produce Rule is here.


About the Author – Patrick focuses on litigation and transactions involving environmental, natural resources, toxic tort and real property issues.  He has extensive experience representing clients in court and before administrative agencies, including the United States Environmental Protection Agency and the Oregon Department of Environmental Quality.  He has particular expertise in matters involving contaminated properties and water quality issues.  Patrick emphasizes big picture strategies in order to prevent problems before they occur, while working in a focused, efficient manner to solve problems after they arise. Patrick is currently a partner at Sussman Shank LLP in Portland, Oregon. For his contact information, click here.


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