Thursday, January 2, 2020

FDA Updates the 2017 Food Code with 2019 Supplement

Every two years, FDA updates the food code either by issuing a new code or by providing a supplement.  On this update, it provides a supplement.  Below are the items FDA viewed as important changes.  We provided a quick assessment and the rule change for ease of seeing these changes.

Item - Allow food establishments in limited circumstances, such as in a restricted office building or break room, that pose minimal risk of causing, or contributing to foodborne illness to operate without a person in charge, as approved by the regulatory authority.
Quick summary/impact - No overall impact except in breakroom applications where food is offered but there is no attendant.  Food offered is viewed as minimal risk.
Section Addition - 2-101.11Assignment.
(C)This section does not apply to certain types of FOOD ESTABLISHMENTS deemed by the REGULATORY AUTHORITY to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and extent of the FOOD preparation.Pf
Application from Annex -  The concept of an unmanned food establishment that is typically located in an office building or restricted break area is a recent innovation. While a wide variety of food items may be provided, these operations are intended to offer packaged TCS and non-TCS food products that are displayed via refrigeration units, food racks, baskets and/or countertop display units. There are a number of state and local agencies that mandate the permit holder be the person in charge or designate a person in charge present at the food establishment during all hours of operation.

Item - “time without temperature control” is used as the public health control for ready-to-eat produce and hermetically sealed food upon cutting, chopping or opening of the hermetically sealed container. This exception allows these foods to begin at 70°F or less and remain at 70°F for a maximum of 4 hours.
Quick Summary/Impact - Once one cuts produce or opens a commercially sealed can, the food becomes a TCS food, and this section provides notice that foods can only be left out at room temperature (no temperature control) for a maximum of 4 hours
Section Addition- 3-501.19 Time as a Public Health Control
(B) If time without temperature control is used as the public health control up to a maximum of 4 hours:
(1) Except as specified in (B)(2), the FOOD shall have an initial temperature of 5ºC (41ºF) or less when removed from cold holding temperature control, or 57°C (135°F) or greater when removed from hot holding temperature control; P
(2) The FOOD may have an initial temperature of 21°C (70°F) or less if;
(a)It is a READY-TO-EAT fruit or vegetable that upon cutting isrendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD as defined in ¶1-201.10(B), or
(b)It is a READY-TO-EAT hermetically sealed FOOD that uponopening is rendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD a defined in ¶1-201.10(B),
(c)The FOOD temperature does not exceed 21°C (70°F)within a maximum time period of 4 hours from the time it was rendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD; and
(d)The FOOD is marked or otherwise identified to indicate the time that is 4 hours past the point in time when the FOOD is rendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD as specified in sub¶¶’s (B)(2)(a) and (b) of this section.
((3)The FOOD shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the FOOD is removed from temperature control; Pf
(4)The FOOD shall be cooked and served, served at any temperature if READY-TO-EAT, or discarded, within 4 hours from the point in time when the FOOD is removed from temperature control; P and
(5)The FOOD in unmarked containers or PACKAGES, or marked to exceed a 4-hour limit shall be discarded. P
Application from Annex - At the 2018 meeting of the CFP it was recommended that Section 3-501.19 be amended to allow raw agricultural commodities (RACs) that are cut on-site (such as tomatoes, melons, or leafy greens) or shelf-stable hermetically sealed containers (such as canned tuna) opened on-site have an initial temperature of 21°C (70°F) or less when time without temperature control is used as a public health control for a maximum of 4 hours. Peer-reviewed scientific literature and the above-mentioned pathogen modeling has shown Salmonella spp. and L. monocytogenes will not exceed a 1-log increase in growth when started and maintained at 21°C (70°F) or less for up to 4 hours.

Item - Remove the allowance for use of chemically treated towelettes for hand washing because the means to wash hands in limited situations is readily available and hand washing has been determined to be effective.
Quick Summary / Impact - The use of chemically treated towelettes was allowed for handwashing stations.  This was dropped, so no longer can be used to fulfill handwashing stations.
Deleted Section - 5-204.11
(C) If APPROVED, when FOOD exposure is limited and HANDWASHING SINKS are not conveniently available, such as in some mobile or TEMPORARY FOOD ESTABLISHMENTS or at some VENDING MACHINE LOCATIONS, EMPLOYEES may use chemically treated towelettes for handwashing.
Item -  Expand and clarify the type of information that should be included when a Hazard Analysis and Critical Control Point Plan is required by a regulatory authority.
Quick Summary/Impact - Adds information on what needs to be required in a HACCP plan.  If one goes through HACCP training, they would know they need to have this.
  • General information on the establishment including name, address, and contact information;
  • The types of foods covered
  • flow diagram or chart for each specific FOOD or category type that identifies each step in the process; those steps that are designated CRITICAL CONTROL POINTS; Pf
  • The ingredients, recipes or formulations, materials and equipment used in the preparation of each specific FOOD or category type and methods and procedural control measures that address the FOOD safety concerns involved; Pf
  • A CRITICAL CONTROL POINTS summary for each specific FOOD or category type that clearly identifies:
    • (1) Each CRITICAL CONTROL POINT, Pf
    • (2) The significant HAZARDS for each CRITICAL CONTROL POINT, Pf
    • (3) The CRITICAL LIMITS for each CRITICAL CONTROL POINT, Pf
    • (4) The monitoring procedure for each CCP including method and frequency as well as designated person
    • (5) Correction Action
    • (6) Verification
    • (7) Record keeping
Item - Added guidance documents for chicken livers and for mail order foods.
Quick Summary / Impact - documents for reference on chicken livers and mail order food.
The mail order document provides good information on those mailing food and is worth reviewing.
Section- Amend 3. Supporting Documents to add the following new sections W and X to read as follows:
W.Minimizing the Risk of Campylobactor and Salmonella Illnesses Associated with Chicken Liver
USDA-FSIS has found that from 2000 to 2015, chicken livers were associated with 22 outbreaks most commonly due to undercooking. USDA-FSIS’ Compliance Guideline, Minimizing the Risk of Campylobacter and Salmonella Illnesses Associated with Chicken Liver provides additional guidance that retailers and others can use to reduce or eliminate pathogens, thereby decreasing the likelihood of foodborne illness outbreaks from this product. The guidance document explains why searing the outside of the liver is not adequate for pathogen elimination in chicken livers and emphasizes appropriate cooking to an internal temperature of 165F to avoid illnesses. Thorough cooking is the only method to eliminate pathogens. This guidance also provides other recommendations to minimize (but not eliminate) pathogen contamination associated with undercooked chicken liver dishes.
This document is available for download at:
https://www.fsis.usda.gov/wps/wcm/connect/b3f4efe7-27d4-4c39-bce7-011b7bbd1e7d/Chicken-Liver-Guidance-July-2018.pdf?MOD=AJPERES

X.Guidance Document for Mail Order Food Companies
This guidance document is intended for retail food establishments delivering perishable foods to the consumer by mail order. The intent of the guide is primarily to provide best practices for preventing biological, physical and chemical contamination, as well as the growth of harmful bacteria and/or the formation of toxins within the food being shipped. Foodborne illness may occur if products are not prepared, packed and shipped using sanitary conditions and proper temperature controls. It is the result of a joint effort by the FDA and the Conference for Food Protection.
This document is available for download at:
http://www.foodprotect.org/media/site/cfp-mail-order-committee-draft-document-per-2018-iii-004.pdf


Retail Food Protection
https://www.fda.gov/retailfoodprotection
FDA Releases Supplement to the 2017 Food Code
December 23, 2019

The U.S. Food and Drug Administration (FDA) has made available the Supplement to the 2017 Food Code. The update addresses recommendations made by regulatory officials, industry, academia, and consumers at the 2018 Biennial Meeting of the Conference for Food Protection.

The Food Code and its Supplement provide government and industry with practical, science-based controls for reducing the risk of foodborne illness in retail and foodservice establishments of all types. The Food Code and the Supplement are joint projects by the FDA, the Centers for Disease Control and Prevention, and the United States Department of Agriculture (USDA) – Food Safety and Inspection Service (FSIS).

The Supplement modifies the 2017 Food Code to, among other things:

• Allow food establishments in limited circumstances, such as in a restricted office building or break room, that pose minimal risk of causing, or contributing to foodborne illness to operate without a person in charge, as approved by the regulatory authority.

• Add a new exception for when “time without temperature control” is used as the public health control for ready-to-eat produce and hermetically sealed food upon cutting, chopping or opening of the hermetically sealed container. This exception allows these foods to begin at 70°F or less and remain at 70°F for a maximum of 4 hours.

• Remove the allowance for use of chemically treated towelettes for hand washing because the means to wash hands in limited situations is readily available and hand washing has been determined to be effective.

• Expand and clarify the type of information that should be included when a Hazard Analysis and Critical Control Point Plan is required by a regulatory authority.

• Include new supporting documents such as the USDA-FSIS Chicken Liver Guidance and the Conference of Food Protection’s Mail Order Food Companies Guidance Document.

The Food Code is the model for retail food regulations in all 50 states, the District of Columbia and other territories. The FDA encourages its state, local, tribal, and territorial partners to adopt the current version of the FDA Food Code, including the Supplement to the 2017 Food Code. The agency’s National Retail Food Team is available to assist regulatory officials, educators, and industry in their efforts to understand, adopt, and implement, the FDA Food Code. Inquiries may be sent to: retailfoodprotectionteam@fda.hhs.gov or directly to a Retail Food Specialist.

The 2017 FDA Food Code and its Supplement is available on the FDA website. The next complete revision of the Food Code will be published in 2021.

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