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NATIONAL POTATO COUNCIL Presented by Edward Ruckert

Produce Safety and the National Bioengineered Food Disclosure Standard

January 2020

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PRODUCE SAFETY I. Background

• The Food and Drug Administration’s (FDA’s) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety regulations, 21 C.F.R. Part 112) apply to produce (most fruits and vegetables) that are raw agricultural commodities.

• Importantly, however, produce that is rarely consumed raw such as potatoes and sweet potatoes are not produce covered by the Produce Safety regulations.

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PRODUCE SAFETY • FDA issued a rule extending, for covered produce other than sprouts, the dates for

compliance with the agricultural water provisions.

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Size of Covered Farm Compliance Period (starting from 1/26/16)

Compliance Date

Very Small Business 8 years January 26, 2024

Small Business 7 years January 26, 2023

All Other Businesses 6 years January 26, 2022

Privileged and Confidential/Attorney-Work Product and Attorney-Client Communication

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PRODUCE SAFETY • While this rule extends the compliance dates for the agricultural water provisions, produce

remains subject to the other provisions of the Produce Safety Rule (as applicable), and the adulteration provisions of the FFD&C Act.

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PRODUCE SAFETY II. Compliance

• The first major compliance date for large farms subject to the Produce Safety Rule, other than sprout operations, arrived on January 26, 2018.

• FDA began routine inspections of large farms other than sprouts operations subject to the Produce Safety Rule, including large produce farms in other countries, in Spring 2019. States were asked to use Spring 2019 as their starting dates for routine inspections of large produce farms.

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PRODUCE SAFETY • Routine inspections of small farms will generally begin in Spring 2020. States may begin

routine inspections as early as January 1, 2020. FDA has directed that States utilizing the earlier date of January 1, 2020 should prioritize completing planned inspections of large farms subject to the rule, prior to inspecting small farms.

• As part of a farm’s Produce Safety compliance, “educate before you regulate,” a team comprised of National Association of State Departments of Agriculture (NASDA), State, FDA, and Cooperative Extension food safety leaders developed the On Farm Readiness Review (OFRR).

• FDA began routine Foreign Supplier Verification Programs inspections of importers of produce from large farms in other countries in Fall 2019.

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PRODUCE SAFETY III. The Inspection

• Scheduling the Inspection– Most often, the agency inspector will call the most responsible person on your farm.

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PRODUCE SAFETY • The inspector will discuss:

– Whether your farm grows covered produce (produce regulated by the rule);– Whether your farm conducts covered activities (growing, harvesting, packing or holding);– Farm size (produce sales and/or food sales) to determine if your farm is not subject to the rule or

meets the requirements for a qualified exemption;– Whether your produce meets the requirements for the commercial processing exemption (e.g.,

subsequent documented “kill step”).

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PRODUCE SAFETY • Announced Inspections

– If your farm is covered by the rule, the inspector will schedule an inspection date that works for both the inspector and the person in charge.

– Have a representative from your farm knowledgeable in the growing, harvesting, packing and holding activities, preferably the person responsible for produce safety, escort the inspection team.

– The inspector or investigator will explain the general flow of the inspection, what the inspection will cover, and records that may be reviewed.

– The inspector or investigator will ask if your farm has any biosecurity practices, hazards, safety protocols, and other requirements that inspectors and investigators need to be aware of and adhere to before the visit.

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PRODUCE SAFETY • Unannounced Inspections

1. If your farm has had produce safety issues in the past and the issues have not been corrected;2. If a follow-up inspection is needed and an unannounced inspection may work best to observe the

necessary changes being made;3. If your farm is unresponsive (no contact within five (5) business days after reasonable contact

attempts have been made) or is unwilling to set a date for the inspection; or4. In response to a complaint, recall, or foodborne outbreak investigation.

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PRODUCE SAFETY • Day of the Inspection

– When an inspector arrives, he or she will ask to speak to the owner or person in charge. The inspector will introduce himself or herself (name, title, agency), provide the reason for the inspection, and show identification.

– Depending upon your state regulations or if FDA conducts the inspection, the inspector may also issue a written Notice of Inspection or similar form.

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PRODUCE SAFETY • Initial Interview

– The inspector will provide a brief description of the reason for and scope of the inspection and activities to be conducted during the inspection.

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PRODUCE SAFETY • Walk-Through of the Farm

– During the inspection, the inspector will observe your farm operation, working with you to coordinate inspection activities with farm operations. He or she will take notes, may take pictures, may collect samples, and will review and may copy records, such as training and biological soil amendment records.

– Throughout the inspection, the inspector will explain what is being looked at and why.

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PRODUCE SAFETY • Exit Interview

– It is preferable if the most responsible person on your farm, such as the farm owner or manager, is available during the exit interview.

– The inspector will go over any regulatory concerns and findings and provide you with information on resources and technical assistance.

– During the exit interview, the inspector or investigator will also identify preventive produce safety practices and conditions on your farm based on the requirements of the Produce Safety Rule. The inspector or investigator will also answer any questions you may have.

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PRODUCE SAFETY

IV. Preventive Controls for Human Food Regulations

• These regulations apply to facilities that must register with FDA.

• A facility must register with FDA if it is engaged in the manufacturing, processing, packing or holding of food for human consumption in the United States unless the facility qualifies for an exemption.

• Farms are among the facilities that are exempted.

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PRODUCE SAFETY • A “farm” is defined as either a “primary production farm” or a “secondary activities farm.”

• A “primary production farm” is – an operation under one management in one general (but not necessarily contiguous) physical location

devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term “farm” includes operations that, in addition to the foregoing activities “pack or hold raw agricultural commodities.”

• A “secondary activities farm” 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.

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PRODUCE SAFETY • As a result of the definition of “farm” and more specifically “secondary activities farm,” many

packing house operations would not qualify as a “farm” and would, therefore, be subject to the Preventive Controls regulations.

• In 2018, however, FDA announced that it was going to exercise enforcement discretion with respect to secondary activities farms and ownership while FDA considers regulatory changes.

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Frank YiannasDeputy Commissioner

Food Policy and Response

Frank YiannasDeputy CommissionerFood Policy and Response

@frankyiannasFDA#smarterfoodsafety

Smarter Food SafetyTogether, a New Era of

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDI. Background

• The National Bioengineered Food Disclosure Standard (“NBFDS” or “Standard”) became law in July 2016.

• It requires food manufacturers, importers, and certain retailers to disclose information concerning whether the labeled food offered for retail sale is bioengineered or uses bioengineered food ingredients.

• The U.S. Department of Agriculture is responsible for developing the Standard and has issued regulations regarding the Standard- 7 C.F.R. Part 66, December 21, 2018.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDII. Applicability of the Standard

• The Standard covers bioengineered food or bioengineered food ingredients.

• Bioengineered foods are those that contain detectible genetic material that have been modified through in vivo recombinant deoxyribonucleic acid (rDNA) techniques and for which modification could not otherwise be obtained through conventional breeding or found in nature.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD• However, a food is not considered to contain modified genetic material if the genetic material

is not detectible in the food.

• A food is not considered to be bioengineered simply because it contains “an incidental addictive present in a food at an insignificant level, and that does not have any technical or functional effect in the food

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD• Covered entities (food manufacturers, importers and certain retailers) are responsible for

meeting the disclosure requirements of the Standard by January 1, 2022. That is called the mandatory compliance date.

• Foods that are in commerce before January 1, 2022 are not required to be recalled or modified.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDIII. Exemptions

• The regulations exempt the following 5 foods/entities from the Standard:– Food served in a restaurant or similar retail food establishment.– Very small food manufacturers, i.e. Annual receipts less than $2,500,000.– A food in which no ingredient intentionally contains a bioengineered substance, with an allowance of

5% for each ingredient for inadvertent or technically unavoidable bioengineered presence.– A food derived from an animal if the sole reason to be considered bioengineered is that the animal

eats feed from a bioengineered source.– A food certified under the National Organic Program.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDIV. List of Bioengineered Foods

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AlfalfaApple (ArticTM varieties)CanolaCornCottonEggplant (BARI Bt Begun varieties)Papaya (ringspot virus-resistant varieties)Pineapple (pink flesh varieties)PotatoSalmon (AquAdvantage®) SoybeanSquash (Summer)Sugarbeet

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDV. Detectability

• The regulations provides a modified genetic material is not detectable if the entity responsible for making the disclosure maintains:– Records to verify the food is sourced from a non-bioengineered crop or source; or– Records to verify the food has been subjected to a refinement process validated to make the genetic

material undetectable in the food; or– Test records such as certificates of analysis confirming the absence of genetic material.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDVI. Responsibility for Disclosure

• For a food packaged prior to receipt by a retailer, the food manufacturers or importer is responsible for ensuring the food label bears the required disclosure.

• If a retailer packages a food or sells food in bulk, the retailer is responsible for the disclosure.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD• There are basically 4 different ways to meet the required disclosure:

– A prescribed statement on the text of a food label– A prescribed symbol on the label– A prescribed electronic or digital link– A prescribed text message.

• For bioengineered foods sold in bulk, the retailer has to use signs or studies, etc. to communicate one of the four described ways.

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NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARDVII. Conclusion

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