#FoodBootCamp

Food Law and Regulation Boot Camp

Justin J. Prochnow – Shareholder, Greenberg Traurig

Mollie Kober – President, MKI Consulting

FDA and USDA Food Safety Regulations 101:

Preventing Adulteration and Contamination

November 15, 2016 – 3:00pm

November 15-16, 2016

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Our eye is on…

• Overview of essential food safety regulations

• Defining “adulteration” and “adulterants” under the FDCA and the Federal Meat Inspection Act

• Update on the Reportable Food Registry

• Differentiating allergens from pathogens

• Update on STECs and E. coli prevention protocols

• How to establish effective food safety guidelines, protocols and screening measures – traceback, HACCP, sanitation SOPs and testing procedures

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Food Safety

• The Food Safety Modernization Act was signed by President Obama on January 4, 2011

• Most sweeping food safety laws in 70 years; concentration on preventing food adulteration as opposed to responding to it

• Five key elements to the FSMA

• Preventative Controls

• Inspection and Compliance

• Imported Food Safety

• Response

• Enhanced Partnerships

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FSMA

• Preventative Controls for Human Food

• Food facilities must have safety plans that set forth how they will identify and minimize hazards (Final Rule: September 10, 2015)

• Preventative Controls for Animal Food

• Current Good Manufacturing Practices and preventative controls for food for animals (Final Rule: September 10, 2015)

• Produce Safety

• Science based standards for growing, harvesting, packing and holding produce on domestic and foreign farms (Final Rule: November 13, 2015)

• Foreign Supplier Verification Program

• Importers must verify that food imported into the US has been produced in the same manner as the required for US producers (Final Rule: November 13 , 2015)

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FSMA (cont.)

• Third Party Certification

• Accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities (Final Rule: November 13, 2015)

• Sanitary Transportation

• Must use sanitary practices to ensure the safety of food (Final Rule: April 5, 2016)

• Intentional Adulteration

• Domestic and foreign facilities must address vulnerable processes in their operations to prevent acts intended to cause large scale harm (Final Rule: May 31, 2016)

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New cGMPs for Foods

• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food (21 CFR Part 117)

• Final rule became effective on November 16, 2015

• Key Requirements:

• Must establish a food safety plan

• Must have a risk based supply chain program for raw materials and other ingredients with a hazard risk

• Must meet CGMPs

• Compliance is staggered

• Businesses other than small or very small – September 19, 2016

• Small businesses - September 18, 2017

• Very small businesses and Grade “A” milk producers – September 17, 2018

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cGMPs for Dietary Supplements

• The major focus of the FDA with respect to dietary supplement companies

• Consistently the most frequent topic of FDA warning letters

• Became final in 2007; 3 year staggered compliance period

• cGMPS include requirements for:

• Maintenance of facilities

• Quality Control procedures

• Testing raw materials and final products

• Handling consumer complaints, returns, and adverse event reports

• Maintaining records

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FDA Definition of “Adulteration”

• “Adulteration” is defined in the Federal Food, Drug and Cosmetic Act at 21 USC 342. Pursuant to 21 USC 342(a) food shall be deemed adulterated if:

• (1) It bears or contains any poisonous or deleterious substance which may render it injurious to health

• but in cases wherein the substance is not an added substance, such food shall not be considered adulterated if the quantity of such substance in such food does not ordinarily render it injurious to health

• (2)(A) It bears or contains a poisonous or deleterious substance which is required for manufacturing but outside the permitted levels (21 USC 346)

• (2)(B) It bears an unapproved food additive (21 USC 346a(a))

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“Adulteration” Defined (cont.)

• Pursuant to 21 USC 342(a) food shall be deemed adulterated if:• (2)(C)(1) It bears an unsafe pesticide chemicals (21 USC 348)

• (2)(C)(2) It bears any unsafe new animal drug (21 USC 360b)

• (2)(C)(3) It bears any putrid, filthy or decomposed substance

• (2)(C)(4) It was prepared or packaged where it might by contaminated with any putrid, filthy or decomposed substance

• (2)(C)(5) It is composed in any part of a diseased animal

• (2)(C)(6) If the packaging is composed of a poisonous or deleterious substance

• (2)(C)(7) If the product has been intentionally exposed to radiation, not in conformance with the regulations

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“Adulteration” Defined (cont.)

• Pursuant to 21 USC 342(b), food shall be deemed adulterated if:

• (1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or

• (2) if any substance has been substituted wholly or in part therefor; or

• (3) if damage or inferiority has been concealed in any manner; or

• (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

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“Adulteration” Defined (cont.)

• Pursuant to 21 USC 342(c), a food shall be deemed adulterated if:

• It contains a color additive deemed unsafe pursuant to 21 USC 379e(a)

• Pursuant to 21 USC 342(d), a food shall be deemed adulterated if:

• It is a confectionary and contains non-nutritive ingredients or alcohol more than .5 percent by volume and not as part of the flavoring

• Pursuant to 21 USC 342(e), a food shall be deemed adulterated if:

• If is butter, oleo, or margarine and contains filthy or putrid ingredients

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“Adulteration” Defined (cont.)

• Pursuant to 21 USC 342(f), a food shall be deemed adulterated if:

• It is a dietary supplement that contains either unsafe directions for use or no directions for use which makes the product unsafe

• It is a new dietary ingredient which has not been established as safe (no NDI notification)

• Pursuant to 21 USC 342(g), a food shall be deemed adulterated if:

• It is not manufactured in accordance with the good manufacturing practices in 21 CFR Part 111

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“Adulteration” Defined (cont.)

• Pursuant to 21 USC 342(h), a food shall be deemed adulterated if:

• It is reoffered for import into the United States if it was previously refused entry, unless compliance is established (21 USC 381(a))

• Pursuant to 21 USC 342(i), a food shall be deemed adulterated if:

• It is not transported under sanitary conditions in compliance with requirements (21 USC 350e)

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Prohibited Acts

• It is a “prohibited act” under the FFDCA to:

• Introduce or deliver for introduction into commerce any product that is adulterated or misbranded (21 USC 331(a)

• Adulterate or misbrand any product (21 USC 331(b)

• Receive any adulterated or misbranded product and then deliver such product into interstate commerce

• Manufacture any adulterated or misbranded product

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Penalties

• The penalties for violating the FFDCA are set out in 21 USC 333 and included:

• (1) Any person who commits a “prohibited act” shall be imprisoned for not more than one year or fined not more than $1,000, or both.

• (2) If any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.

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Regulatory Action (FDA)

• FDA can issue a Warning Letter

• “Encourage” manufacturer or distributor to “encourage” a recall

• FDA Recall Authority• FDA now has mandatory recall authority

when there is the possibility for serious adverse health consequences or death

• Injunction and seizure

• Detain imported product

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USDA Definition of “Adulteration”

• “Adulteration” is also defined in the Federal Poultry Inspection Act (21 USC 453(g)) and the Federal Meat Inspection Act (21 USC 601(m)). Those definitions include many of the same components of “adulterated acts” in the FFDCA, including:

• Poisonous or deleterious ingredients

• Non-permitted pesticides

• Unsafe food additives

• Packed or held in insanitary conditions

• Subjected to radiation not in conformance with the regulations

• Omitted or substituted ingredients

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Regulatory Action (FSIS)

• FSIS can do many of the same things but has certain additional powers as well

• FSIS may suspend or withdraw federal inspection of an official establishment

• Without federal inspection, an establishment may not produce or process meat or poultry products, and therefore must cease operations

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Reportable Food Registry

• The Reportable Food Registry (RFR) was established as part of the FDA Amendments Act in 2010

• The RFR is an online portal for industry to report when there is a reasonable probability of serious adverse health consequences or death

• Companies with registered food facilities that manufacture, process, pack or hold food must make a report to the RFR

• Applies to all food other than infant formulas and dietary supplements

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Reportable Food Registry

• RFR reports must be made with in 24 hours of determining that a food is a “reportable” food

• Company must provide details, investigate root cause, and maintain records for 2 years

• Failure to make a necessary RFR is a “prohibited act” under the FFDCA

• A company is not required to submit an RFR if:

• The adulteration originated with the responsible party; and

• The responsible party detected the adulteration prior to transfer to another company or person; and

• The responsible party corrected the adulteration or caused the destruction of the products

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RFR and Recall Data

• Pathogens Salmonella and Listeria monocytogenesaccount for most recalls

• Undeclared allergens 2nd

leading cause for most recalls in U.S. food supply

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CDC OutbreaksRank of top 8 Pathogens in causing illness, hospitalizations and death in U.S..

Pathogen Illness Hospitalization Death Characteristics

Norovirus 1 2 4 virus

Environment and personnel

Salmonella nontyphodial 2 1 1 bacteria gram +

Environment

Clostridium perfringens 3 bacteria gram + spore former

Intestinal tracts human and animals

Campylobacter spp. 4 3 5 bacteria gram -

Milk, poultry and water

Staphylococcus aureus 5 bacteria gram +

Environment

Toxoplasma gondii 4 2 parasite

Meat, seafood, cat liter

E. Coli(STEC) 0157 5 bacteria gram –

Ruminant animal gut, environment

Listeria monocytogenes 3 bacteria gram +

Environment

Adapted from CDC.gov/foodborneburden 2011

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Aligning Data with Regulations

Food GMPs -- FSMA 21 CFR Part 117 Subpart B • Allergen cited 24 times (Part 110 zero citations)

HACCP (seafood, juice, USDA) and Preventative Controls for Human Food (HARPC 21 CFR Part 117 Subpart C)

• Require understanding of microbiological hazards as it relates to the product, ingredients and processing environment

• Requires understanding and documenting of chemical hazards such as allergens

HARPC Required Preventative Controls

1. Process Controls

2. Sanitation

3. Allergen

4. Supply-chain

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Plant ProtocolsKnow your Product

• Pathogens, allergens known to contain• Ingredients known to contain – control your supply chain

• Probable environmental pathogens

• Process steps involved in getting your product to the consumer• FSMA – requires labeling if Hazard is uncontrolled

• FSMA – requires “written assurances” when Hazard is controlled upstream or downstream

• What controls can be used• Time, Temperature, Water Activity, pH

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Plant ProtocolsAllergen Control

• Required as part of food GMPs

• Undeclared allergens #2 reason for food recalls

• What’s going wrong*? • Wrong packaging

• Terminology incorrect

• No carry-through from ingredient

• Cross-contact

• Ingredient mislabeled from supplier

*Adapted from Gendel and Zhu 2014 “Food Safety Magazine “Learning from FDA” 2014

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Plant ProtocolsAllergen Control

Allergen must be identified as Hazard in HACCP/HARCP Plans and requires a Preventative Control

Food Safety Plans must include control of

1. Labeling • Procedures on label receipt

• Procedures on verification of label against product formulation

• Use of tracking and revision control numbers on labels

• Best Practice -- a two part system to control formulation changes independent of marketing changes

• Procedures and tracking numbers to ensure correct label is issued to job and verification/documentation of label used

• Best Practice procedures to reconcile label use

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Plant ProtocolsAllergen Control

Allergen must be identified as Hazard in HACCP/HARCP Plans and require a Preventative Control

Food Safety Plans must include control of

2. Cross Contact • Sanitation programs must address allergens as a contaminant

• Cleaning effectiveness programs must verify or validate allergen cleans

• Environmental monitoring programs must address airborne allergen cross-contact

• Allergen Matrix used to schedule runs

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Plant ProtocolsAllergen Control

Allergen must be identified as Hazard in HACCP/HARCP Plans and require a Preventative Control

Food Safety Plans must include control of

3. Supply-chain preventative control • Identification of ingredients that contain allergens or “may contain”

• Incoming inspections, appropriate labeling for in house treatment and storage

• Best Practice Required labeling of allergens at supplier level

• Best Practice incoming inspection protocols to verify labeling against specification

• Allergen Matrix used to schedule runs must include ingredient allergens

• Required traceability

• Best Practice Management of Change program that updates with new or changed product; new or changed ingredient; new or changed supplier

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Plant ProtocolsPathogens

• HACCP/HARPC plans must include biological Hazards such as pathogens

• RTE Facilities must have Environmental Monitoring programs as Preventative Control

• Part of this program is increased testing in Zone 1 or product contact areas for environmental indicator organisms

• Ingredient biological Hazards including pathogens must be addressed

• Supply chain applied controls must have written assurances

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Plant ProtocolsSTECs and E. coli prevention

• Recent STEC outbreaks• Flour Recall O121, O26

• Chipotle O26

• STEC outbreaks rank 5th in pathogen related hospitalizations

• Protocols for prevention• HARPC/HACCP plans to include E. coli as a hazard

• Ingredient testing

• Environmental monitoring

• Sanitation practices

• Personnel practices and disease control policies

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Plant ProtocolsSanitation

1 of 4 required Preventative Controls (FSMA HARPC 21 CFR Part 117 Subpart C)

Written Protocols Required

Master Sanitation Plan for facility

Equipment and Process specific protocols• Must include cleaning process, frequency, disassembly instructions• Must include sanitation step(s)• Evaluation of dry vs. wet clean – pros and cons for both• Avoid risky procedures such as pressurized air or water

Starts with design• Flow of people and product

• Best Practice Use of Hygienic Zoning

• Facility• Equipment

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Plant ProtocolsCleaning Effectiveness

• How to assess (cGMPs)• Visual inspection

• Swabbing or testing to release after a clean

• Validation of the cleaning process• Chemical residue

• Microorganisms

• Product residue (including allergens)

• Environmental Monitoring

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Plant ProtocolsEnvironmental Monitoring

• Required verification program for RTE facilities (FSMA HARPC 21 CFR Part 117 Subpart C)

• If pathogens persist in the processing environment, eventually will find their way into the product

• Address Salmonella, Listera, Staph aureus, E. coli

• Must actively be looking for environmental contamination • Address both transient organisms and resident organisms

• Indicator organisms

• Sampling of Zone 1

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Plant ProtocolsEnvironmental Monitoring

• Best Practices• Change sampling sites

• Changes times/shifts/products

• Use a biased sampling approach (look for worse case areas) rather than random

• Address surfaces, air, people

• Include all areas including support areas

• Need to gather baseline data so action and alert levels are appropriate

• Know your products and ingredients, review when these change

• If you aren’t finding anything, it isn’t working

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Plant ProtocolsEnvironmental Monitoring

• Investigations and Trending – Part of Site Goals

• Root cause evaluation

• Documented corrective actions • Ice cream recall – found listeria multiple times, continued to clean and reclean but didn’t

identify the cause

• Reduce risk of test methods and laboratories• Validated methods

• Labs that are accredited for this type of work

• Having a microbiologist on staff/consultation

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Plant ProtocolsTesting

• Product Testing and Ingredient Testing • May be required under FSMA to control certain hazards

UNDERSTANDING THE RISK

• Sampling• Ensure sampling for microorganism contamination is robust and matches risk

• Methods• Only use validated methods

• Use of positive controls to verify method

• Labs• Use accredited labs for requested methodology

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Greenberg Traurig LLP An International Firm of 1900 Attorneys & Government Law & Policy Professionals in

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Legal Disclaimer

• This presentation consists of general legal information. It is not intended to give legal advice about a specific legal problem, nor does it create an attorney-client relationship.

• Due to the importance of individual facts of every situation, the generalization in this presentation may not necessarily be applicable to all situations. Changes in the law could make parts of this presentation obsolete in the future.

• This information is provided with the understanding that if specific legal advice is required, the services of the presenter or another competent attorney should be sought.

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Twitter:

@LawguyJP

Justin J. ProchnowGreenberg Traurig LLP

1200 17th Street, Suite 2400Denver, Colorado 80202

(303) 572-6562prochnowjj@gtlaw.com

Mollie KoberMKI Consulting

3120 W 40th AveDenver, CO, 80211

(720) 263-2654mkober@mkiconsulting.com