On November 13, 2015, the U.S. Food and Drug Administration (FDA) published three final rules issued under the Food Safety Modernization Act.  The new rules are: (1) the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule), (2) the Foreign Supplier Verification Programs (FSVP) Rule for Importers of Food, and (3) the Accredited Third-Party Certification Rule.  

The new rules impact the on-farm production and handling of both international and domestic produce, and establish standards focused on the growing, harvesting, handling, packing and holding of produce.  Key areas included in the rules are agricultural water quality standards and testing, standards for using soil amendments (compost and manure), training of workers, control of domestic and wild animals, cleaning and sanitation of buildings, tools, and equipment, and rules regarding worker health and hygiene.  The new regulations are significant in that the FDA has put in place enforceable standards for produce safety that explicitly articulate on-farm requirements for the safe growing, harvesting, handling, packing and holding of fresh grown foods.

New On-Farm Rules Add Protections for Safeguarding the Food Supply – What you Need to Know:  The Food Safety Modernization Act (FSMA) is the most sweeping reform of our food safety laws in more than 70 years. The law was signed by President Obama on January 4, 2011. It aims to ensure that the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.  In September 2015, the FDA issued the final rule for Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food issued under the Food Safety Modernization Act (Preventative Controls Rule).  Compliance dates for some businesses under the Preventative Controls Rule begin in September 2016.  Covered facilities under the Preventative Controls Rule must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.

On November 13, 2015, the FDA issued three more final rules under the FSMA (scheduled for publication in the Federal Register on November 27, 2015).  The new rules issued by the FDA relate to the regulation of on-farm practices for growing produce.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule):  The Produce Safety Rule applies to both international and domestic produce growers and establishes science-based minimum standards for the growing, harvesting, packing, and holding of produce. The regulation covers most types of produce (fruits and vegetables) including, among others, almonds, apples, pears, blueberries, cantaloupe, grapefruit, lemons, oranges, grapes, green beans, herbs, lettuce, mushrooms, onions, peas, peppers, pineapple, spinach, strawberries, tomatoes, walnuts, and summer squash.  Produce that is not covered by the regulation includes produce that is rarely consumed raw, such as artichokes, asparagus, beets, black-eyed peas, brussel sprouts, cranberries, peanuts, pinto beans, potatoes, pumpkins, sugarbeets, sweet corn, and winter squash.  Produce covered by the rule is eligible for an exemption if the produce receives commercial processing that adequately reduces the presence of microorganisms of public health significance.    However, covered produce that is eligible for an exemption is still subject to on-farm recordkeeping requirements.

The rule provides an exemption for farms or farm mixed-type facilities (an establishment that engages both in activities that are exempt from FDA registration and activities that require registration) with an average annual monetary value of produce sales of $25,000 or less.  There are additional exemptions for smaller farms with food sales of less than $500,000 if the sales are to qualified end-users (consumers or retail food establishments located in the same state or not more than 275 miles away).  The exemptions may be withdrawn if there is an investigation due to foodborne illness linked to an exempt farm, or if the FDA determines it is necessary to protect public health.

All on-farm personnel, including temporary and seasonal workers, who handle covered produce or food-contact surfaces or who are engaged in the supervision of such personnel must receive training to ensure compliance with the rule and its requirements to prevent contamination of produce and food contact surfaces. The rule specifies using hygienic practices (toilet and hand washing facilities) when handling produce and training on the importance of health and hygiene in food safety.  

The new rule also regulates agricultural water and provides that agricultural water (including ice) that contacts produce at any time, is used on food-contact surfaces, or is used for washing hands during or after harvest activities, must comply with the rule and new microbial standards.  

The rule establishes two sets of criteria for microbial water quality, both based on generic E. Coli as the marker for contamination.   The first criteria  states that “no detectable generic E. Coli is allowed for water which is reasonably likely to be transferred to produce through direct or indirect contact (e.g., water for washing hands, waste for food contact surfaces, water used directly on produce during or after harvest).  The rule provides that such water use must be immediately discontinued and corrective actions taken if E. Coli is detected.

The second criteria sets forth a numerical criteria for water that is directly applied to produce during the growing season.  The criteria includes a geometric mean (GM) and a statistical threshold value (STV) for the presence of generic E. Coli.  The GM is a water quality standard where the average of water samples must not exceed 126 colony forming units (CFU) of E. Coli.  The STV reflects a statistical standard in which 90 percent of the water quality samples are below 400 CFU of generic E. Coli.  The GM and STV values will be used as a water management tool.  If water does not meet the criteria, corrective actions will be required.  The FDA intends to roll-out a program for farms to calculate their GM and STV values.

The agriculture water rule requires inspection of the entire agricultural water system at the beginning of a growing season.  A minimum number of test samples is required.  If agricultural water is determined not to be safe and of adequate sanitary quality for its intended use, then the rule requires making necessary changes and re-testing of the water system, including allowing time for dangerous microbes to die off through intervals between irrigation and harvest or treating the water with an EPA-registered antimicrobial pesticide product.

With respect to fertilizer application, the rule regulates biological soil amendments (defined as a material, including manure, that is intentionally added to the soil to improve growing conditions).  The rule sets forth specific requirements for treated and untreated animal waste, including treatment processes (thermal/chemical) and applications that minimize the potential for contact with covered produce during and after application.  There are microbial standards that set limits on detectable amounts of bacteria for processes used to treat biological soil amendments, including the concept of stabilized compost that reduces food safety risks.

There is a separate set of safeguards under the new rule to help prevent contamination of sprouts, which have been frequently associated with foodborne illness. These requirements include preventing contamination of seeds or beans used for sprouting, testing of spent sprout irrigation water from each production batch, testing for Listeria, and taking corrective actions in response to findings of contamination.

If domesticated animals are allowed to graze (or work) in fields in which produce is grown, the regulations encourage (but do not require) farmers to voluntarily apply waiting periods between grazing and harvesting for covered produce. With respect to animal intrusion (such as wild animals), if there is a reasonable probability that animal intrusion will contaminate covered produce, the farmer must monitor those areas for evidence of animal intrusion and evaluate whether the covered produce can be harvested in accordance with the regulations.  Farms are not required to exclude animals from outdoor growing areas, destroy habitat, or clear borders.  The FDA intends to provide additional guidance to prevent animal-based contamination.

Recordkeeping requirements under the regulations require the establishment of written records that identify the farm, actual values and observations obtained during monitoring, a description of the covered produce, and location of the growing area.  The records must be created, dated, and signed by the person who performed the documented activity and also reviewed, dated, and signed by a supervisor or responsible party.  Records must be immediately available to the FDA (or within 24 hours if the records are stored off-site) and must be kept for a period of two years after the record was created (or three years if it’s a record used to qualify for an exemption from the rules).

The effective date of the new rule is 60 days after its publication in the Federal Register.  The actual dates for compliance vary based on the size of the farm and activities.  Here is a compliance date summary:

  • For very small businesses ($25,000-$250,000 in annual produce sales), the compliance dates for addressing certain specified agricultural water is six years;  other requirements are generally four years.
  • For small businesses ($250,000-$500,000 in produce sales), the compliance dates  for addressing certain specified agricultural water is five years; other requirements are generally three years.
  • For all other farms, the compliance dates for addressing certain specified agricultural water is four years; other requirements are generally two years.
  • The compliance dates for covered activities involving sprouts (accelerated compliance date) and for farms eligible for a qualified exemption varies under the rules.

Foreign Supplier Verification Program (FSVP) Rule: The FSVP Rule addresses the safety of imported foods and is closely tied to the Preventive Controls Rule and the Produce Safety Rule. Importers will be required to verify that food imported into the U.S. has been produced to the same food safety standards that are required of U.S. producers. This includes establishing and implementing written procedures (hazard analysis) to ensure that imported foods are safe (evaluated for biological hazards, chemical hazards and physical hazards) and are not being imported from unapproved suppliers.  Food importers will also be required to develop Foreign Supplier Verification Programs that will assure the food they are importing complies with the FSMA Produce Safety Rule and Preventive Controls for Human Food (PCHP) Rule.  The compliance date begins as soon as 18 months after publication of the final FSVP Rule.

Accredited of Third-Party Certification Rule: The Third-Party Certification Rule establishes a voluntary program for accreditation of third party certification bodies (auditors) to conduct food safety audits and issue certifications for foreign facilities and the foods they produce. Foreign entities can use certification for two purposes: (1) certification may be used by importers for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food into the United States; and (2) certification can be used to prevent harmful food from entering the U.S., where food can be accompanied by a certification from the third-party certification body to confirm that the food came from a certified facility.  Although the Foreign Supplier Verification Programs (FSVP) proposal does not require the use of accredited third-party auditors, the FDA anticipates that once the FDA accreditation system is in place, importers may increasingly rely on audits by accredited third parties to meet their supplier verification requirements under FSVP.