Produce Final Rule Goes into Effect

The Food Safety Modernization Act (FSMA) extended FDA’s authority to include produce all the way to the farm level, which put the agency in unfamiliar regulatory territory. To avoid burdening covered facilities with unreasonable compliance demands, the agency proceeded with due caution in developing a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, published November 27, 2015.

That rule, which went into effect on January 26, 2016, applies to both domestic and imported produce and has phased implementation dates, beginning in as little as one year for certain sprout growers.

With the exception of sprouts, the implementation dates are two years after the effective date for covered businesses, three for small businesses and four for very small businesses. Again with the exception of sprout operations, the final rule allows an additional two years to comply with some water quality standards, and testing and recordkeeping provisions.

The produce rule includes requirements for agricultural water quality and testing, manure and compost, and the exclusion of animals from growing areas, as well as hygiene and training requirements for farm workers. It also includes standards related to equipment, tools and buildings, and special testing and other requirements for sprouts.

As a first step, produce facilities should determine if they are covered by the rule. In essence, the rule applies to raw agricultural commodities (RACs). But there are numerous exemptions and opportunities for seeking a variance from one or more requirements.

The rule exempts fruits and vegetables that will go through a pathogen-reducing process such as a microbial “kill step” – provided it is appropriately documented — and food that is rarely consumed raw. Items on the rarely consumed raw list include: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.

The new rule does not apply to food grains, including barley, dent-corn or flint-corn (also known as Indian corn), sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds such as cotton seed, flax seed, rapeseed, soybean, and sunflower seed.

The rule contains modified requirements for certain types of facilities, for example a farm with food sales averaging less than $500,000 per year during the previous 3 years that sell mainly to “qualified end-users.” Qualified end-users can be consumers or restaurants or retail food establishments in the same State.

The agency faced significant challenges in crafting the water quality requirements, which involve two sets of criteria for monitoring microbial water quality, depending on the product involved. The rule prohibits the use of untreated surface water in various situations, including for sprout irrigation, handwashing during and after harvest, washing food-contact surfaces, or for directly contacting produce during or after harvest.

The rule includes a second set of numeric criteria for agricultural water applied directly to growing produce other than sprouts.

The agency anticipates developing an online tool for use by farms to input their water sampling data and calculate the statistical values.

Because this is a whole new regulatory area for the agency, working through the complex compliance issues – especially for the water quality and testing requirements – will be a significant challenge.

Adverse Event Reporting for OTC Drug Products

By EAS Senior Advisor for OTC Drugs and Labeling Susan Crane

The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by consumers when using their products.
Documenting of adverse events has always been part of the record-keeping requirements of the Good Manufacturing Practices (GMP) regulations related to complaint files. However, until passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Actin 2006, the reporting of such events was not required for OTC drug products (unless marketed under NDA or ANDA applications). The FDA subsequently issued two guidance documents to assist firms in complying with the law, the first dealing with reporting requirements and the second addressing labeling.

The law mandates that manufacturers, packers and distributors submit reports of serious adverse events received on their OTC products to the FDA. Serious adverse events are defined as those that:

  • Result in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or
  • Require, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

To facilitate the reporting of these events by consumers, the law requires that OTC drug labeling includes a domestic telephone number or complete domestic address through which a “responsible person” may receive the report. It is essential that this designated person has the necessary training and/or experience. While larger firms often employ health care professionals, this may not be feasible for smaller companies. In these cases, a standardized questionnaire should be developed to ensure that all relevant information is obtained to determine if an event is “serious” and therefore reportable.

In addition, it has become clear through recent FDA warning letters that company and/or product websites are considered an extension of labeling, so firms should monitor posts and comments received through these and other social media platforms. This presents a challenge in that these posts may lack sufficient detail to adequately complete Individual Case Safety Reports (ICSRs) required as part of the submissions – and there may be privacy concerns. However, companies should make good faith efforts to follow-up with the consumer if possible.

As of June 2015, all serious adverse event reports received on OTC drug products must be submitted to the agency through FDA’s Adverse Events Reporting System (FAERS) in electronic format using either a Database to Database Transmission or through the FDA’s Safety Reporting Portal. Additional information is available both on the FAERS website and in a draft guidance document issued in 2014.

When completing the electronic ICSRs, firms should follow good pharmacovigilance practices and include the four basic data elements: information about (1) the patient, (2) the suspected product, (3) the adverse event details and (4) the reporter (if different from patient). The format and content of such reports are completed using the Medical Dictionary for Regulatory Activities (MedDRA), a medical terminology standard developed by the International Council for Harmonization for coding the medical terminology used in the report.

The law requires that serious adverse event reports are submitted to the agency within 15 business days of receipt of the four data elements. The submission should include a copy of the product label, preferably the version associated with the product used by the consumer/patient. In addition, if any new medical information is subsequently received that relates to the initial event, this should also be submitted within 15 days.

With the widespread use of OTC drugs, the reporting of these serious adverse events is a crucial step in monitoring their safety. Manufacturers, packers and distributors should develop procedures and programs to ensure that this regulatory obligation is managed competently and efficiently to assist the FDA in its mission to protect public health.