2018 ACS Body of Knowledge – Domain 1 – Food Safety – Days 5, 6 and 7

Here are the posts for the Food Safety portion of Domain 1 originally posted on the Facebook Cheese Study Group page:

Domain 1 – Food Safety: Federal Regulators and Regulations

Day 5

Today, we are going to discuss the various federal agencies that intersect and oversee our food and set the standards for food safety.

The two primary agencies that govern and regulate our food are the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA).

Food and Drug Administration (FDA):

The FDA inspects all food except meat, poultry and eggs. The agency regulates food transported across state lines. The FDA inspects cheese production facilities and imported cheese, which is often the subject of controversy regarding its decision. Currently, the FDA is questioning the vegetable ashes used in the production of certain cheeses, particularly soft-ripened goat cheeses from France. Many French producers have adjusted their recipes to accommodate the FDA or have ceased to export their cheeses to the US.

Links to articles about the FDA Efforts to Strengthen Oversight of Food Imports:

https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm594524.htm

and Guidance Documents to help Importers and Food Producers meet new requirements:

https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm592386.htm

In addition, the FDA issues the FDA Food Code, including the new Food Safety Modernization Act (FSMA) which is part of the Code of Federal Regulations (CFR). The Food Code is science-based and provides recommendations for food safety regulations. The Food Code was created for city, county, state and tribal agencies. Although the FDA recommends that states adopt its published Food Code, it cannot require it. The FDA also provides technical support and training for industry and regulatory agencies.[1]

Food Safety and Modernization ACT (FSMA):

The FSMA is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.

FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.[2]

The Seven Rules are:

Accredited Third-Party Certification Rule
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Rule
Mitigation Strategies to Protect Food Against Intentional Adulteration Rule
Preventive Controls for Food for Animals Rule
Preventive Controls for Human Food Rule
Sanitary Transportation of Human and Animal Food Rule
Standards for Produce Safety Rule[3]

For more information regarding the FSMA:

https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

You can sign-Up for FSMA Email Updates:

https://www.fda.gov/AboutFDA/ContactFDA/ucm2005606.htm

This link is to an article about the FSMA Preventive Controls Rule for Human Food. It was written for Small Processors in Wisconsin. Other states have adopted this rule:

http://jeniferbuckley.com/wp-content/uploads/FSMA-PC-Rule-Intro-160623.pdf

Another resource is from the National Sustainable Agriculture Coalition:

http://sustainableagriculture.net/fsma/

United States Department of Agriculture (USDA):

The USDA regulates and inspects meat, poultry and eggs. It also regulates food that crosses state boundaries or involves more than one state. In discussions in the Facebook Cheese Study Group, Food Safety Managers at cheese production facilities share that both the FDA and USDA conduct inspections at their facilities. There seems to be a bleed-over between the two agencies regarding cheese production and food safety.

Link to the USDA Website:

https://www.usda.gov/

Centers for Disease Control and Prevention (CDC):

The CDC are agencies of the US Department of Health and Human Services (HHS). They assist the FDA< USDA and state and local regulatory authorities by providing the following services:

Investigating outbreaks of foodborne illnesses
Studying the causes and control of disease
Publishing statistical and case studies
Providing educational services in the field of sanitation
Conducting the Vessel Sanitation Program – an inspection program for cruise ships[4]

Public Health Service (PHS)

Like the CDC, the PHS assists the FDA and USDA and state and local regulatory authorities. The PHS conducts research into the causes of foodborne-illness outbreaks. The PHS also assists in investigating outbreaks.[5]

[1] 7^th Edition ServSafe® Coursebook – National Restaurant Association Solutions (page 14.2)

[2] https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

[3] http://guides.cheesesociety.org/safecheesemakinghub/gettingstarted

[4] 7^th Edition ServSafe® Coursebook – National Restaurant Association Solutions (page 14.2 and 14.3)

[5] 7^th Edition ServSafe® Coursebook – National Restaurant Association Solutions (page 14.3)

Day 6 – State and Local Regulators and Regulations

Today we will look at state and local regulators and regulations.

As stated in the last tutorial the FDA Food Code is recommendations for state and local regulators but is not required. Most states and local jurisdictions adopt the FDA Food Code as is but can make changes. Any changes can only be stricter. (For example, in Portland, Oregon, when I worked there, the temperature danger zone began at 38°F rather than 41°F. This was more restrictive than the FDA Food Code.)

State and local regulatory authority responsibilities include:

Inspection operations
Enforcing regulations
Investigating complaints and illnesses
Issuing licenses and permits
Approving construction
Reviewing and approving HACCP plans

For retailers, onsite inspections will be conducted by local, city or county inspectors. In Georgia, this department is the Division of Environmental Health. Here is a link to their Food Service page:

https://dph.georgia.gov/food-service

Consult your own state for your local rules and regulations.

In metropolitan areas, the city will be responsible for inspections and enforcing regulations. In smaller cities and rural areas, it is more likely to fall under county jurisdiction. Either way, it is your responsibility to know who regulates your operation and what the regulations are.

State and local inspectors who conduct inspections at your operation are trained in food safety, sanitation and public-health principles.

The new FDA regulations in the FSMA take a more proactive than reactive approach to food safety. Preferring to prevent foodborne illness outbreaks than react to outbreaks.

The FDA also recommends that the regulatory authorities use the following three risk designations when evaluating operations:

Priority Items – the most critical actions that prevent, eliminate or reduce hazards.
Priority foundation items – items that support priority items.
Core items – items that relate to general sanitation, the facility, equipment design and general maintenance.

Priority items usually must be corrected within 72 hours and the other two usually within 10 days.

Inspection frequency is based on the following:

Size and complexity of the operation. Larger operations offering many different foods may be inspected more often.
Operations that cater to high-risk populations such as hospitals, nursing facilities and pre-schools may require more inspections.
Inspection history will affect frequency: the less violations, the less often and the more violations, the more inspections.
And sadly, the resources available to the regulatory agency: budget, workload and availability of inspectors.

Quickly, when being inspected, this is the accepted process:

Ask for ID when someone presents themselves as inspector. If you don’t know them or they have no ID deny access. However, if they have proper ID, you must allow them to enter and inspect. Denying access can result in being shut down.
Cooperate with the inspector. Answer their questions and accompany them on the inspection to assist and be available to possibly fix issues immediately and answer any questions they may have. Ask questions respectfully if you don’t understand why the inspector is marking a violation.
Take notes so you can fix issues and share issues with your staff to avoid these issues going forward.
Be polite and friendly. Don’t argue with the inspector; you’re just asking for bigger problems if you do.
Be prepared to provide records that the inspector may request, such as Purchasing records, proof of safety knowledge, temp logs, HACCP plans, training records.
After the inspection, the inspector will discuss the results with you and set a time table for correcting issues. You will be asked to sign the report. This is simply an acknowledgement you received it and does not reflect that you agree. Keep your copy of the report on file.

If the inspector decides that violations pose an imminent health hazard, they may decide to close the operation until corrections are made. These are some reasons they might close the operation:

Significant lack of refrigeration
Backup of sewage into the water supply
Fire or flood
Significant pest infestation
Long interruption of electrical or water service
Clear evidence of a foodborne illness outbreak

(Most of the above is based on information in the 14^th chapter of the 7^th edition ServSafe® Coursebook.)

In chatting with 2017 ACS CCP Exam™, the biggest surprise to many was questions about Wisconsin Licensing of Butter Makers, Cheese Makers and Cheese Graders. I turned to Jane Gau, Food Safety Manager for Sargento in Wisconsin and she directed me to a couple of web pages within the Wisconsin State website.

In addition to the link information she made these comments which I want to share:

“Unlike other states (California and Vermont, etc.) Wisconsin requires persons making cheese for sale hold a cheesemakers license. Persons who affix a grade stamp to cheese also must have a license. In both cases one works under the direction of someone who holds a current license and that person signs the application verifying that the candidate has met the requirements.

There is a State Grader who visits plants that manufacture cheese that is graded and will work with the resident graders to verify that they remain competent. For plants that purchase graded cheese they will also visit and inspect the cheese at that location and verify the grade. The report is retained at the purchasing plant and also is sent to the manufacturing plant.”

Here is the link to the download of Chapter 81 of the Wisconsin Regulations that pertain to Cheese Grading, Packaging and Labeling (Again, remember to view the general requirements and don’t get caught up in the details. There will be only a couple of questions regarding this area.):

C:\Users\marce\Downloads\Wisconsin Legislature Chapter ATCP 81.mht

And this is the download for Wisconsin Regulations that pertain to Butter and Cheese Makers:

C:\Users\marce\Downloads\Wisconsin Legislature Chapter ATCP 69 (4).mht

Day 7 – Third-Party Audits, 3rd Party Advocacy Groups, More miscellaneous Food Safety Information

To prepare for regulatory agency inspections, many operations use regular third-party auditing to ensure the operation is meeting regulations and practicing safe food handling, Good Manufacturing Practices (GMPs) and meeting every safe step in the flow of food. Basically, doing what they profess and promise to be doing to meet all regulations and standards.

A quick google search of “retail consortium” brings up many entities that can assist in 3^rd party audits and understanding what they offer and accomplish.

One I found particularly interesting is “BRC global Standards” and their Food Safety Page:

https://www.brcglobalstandards.com/brc-global-standards/food-safety/

In addition to the FDA, USDA, state and local authorities, many food advocacy groups contribute positively to the safe flow of food in the US.

They include:

Customs and Border Patrol (CBP)
Environmental Protection Agency (EPA)
USDA Certified Organic – National Organic Program (NOP)
Food Alliance
Oregon Tilth
Animal Welfare Approved

National Organic Program website:

https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program

Oregon Tilth:

https://tilth.org/

Food Alliance:

http://foodalliance.org/

Animal Welfare Approved:

https://animalwelfareapproved.us/

These and many other advocacy groups contribute to animal welfare and safe food.

Miscellaneous information covered in Domain 1:

Food Defense Plan:

In addition to a HACCP plan, operations should put a Food Defense Plan in place to protect and minimize exposure to pathogens and deliberate contamination and threats. Not long after 9/11, a representative from Homeland Security came into our facility to talk about the olive bar and possible deliberate contamination. Since that time, many grocers have eliminated open olive bars and salad bars to avoid deliberate contamination. I don’t think a single olive bar is a huge threat, but I have seen customers do some disgusting things that contaminate items. And that is why I never buy food from an open bar.

The FDA created a program to address the points in your operation when food might be at risk. It is based on (yet another) acronym A.L.E.R.T.:

A – Assure: make sure you receive your product from safe producers; supervise your deliveries; use approved suppliers who also practice food defense. You should request that food delivery vehicles be locked or sealed always from source facility to delivery at your facility.
L – Look: Monitor security of products in the facility; limit access to make room, prep room and storage areas; create a system for handling damaged product; store chemicals safely and away from food; Train staff to spot food defense threats.
E – Employees: Know the people in your facility including identifying visitors and their credentials and running background checks on employees.
R – Reports: Keep receiving logs; maintain office files and documents; create staff files and conduct random food defense self-inspections.
T – Threat: Identify what you will do and who you will contact if there is suspicious activity or a threat to your operation. Hold any product that might be contaminated; contact your regulatory authority at once; maintain an emergency contact list.

Most of this information is available on the FDA website. I used the information in Chapter 3 of the 7^th edition of the ServSafe® Courebook.

Product Labeling:

We have already covered Use By, Best By, Sell By and Expiration dating. Also important is information that must be included on labels of food being stored onsite, sold to another party or in the retail setting.

Onsite labeling must include:

Common name of item. (If item is clearly recognizable, then the name is not necessary. But many a time flour and baking powder have been mistaken for each other when not properly identified.)
Use by dates.
Chemicals must be stored away from food, in their original container with the manufacturer’s original label.

Food prepared for re-sale:

Common name of item or a statement that clearly identifies the item.
Quantity of the food.
List of ingredients if more than two in descending order by weight.
List of artificial colors and flavors.
Chemical preservatives.
Source of each major food allergen (referred to as the big 8 in day 4’s tutorial here). This does not apply if the allergen is part of the common name such as milk or peanuts.

Record keeping, in addition to those already covered, should include:

Make process in cheesemaking
Lot coding
Cold chain

More information on Good Manufacturing Practices (GMPs) can be reviewed here:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110&showFR=1

and

https://www.gpo.gov/fdsys/granule/CFR-2016-title21-vol2/CFR-2016-title21-vol2-part117

Review Food Safety Preventive Controls Alliance here (training curriculum as pertains to the FSMA):

https://www.ifsh.iit.edu/fspca

FSMA Final Rule od Foreign Supplier Verification Programs for Importers of Food for Humans and Animals:

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm

FSMA Final Rule on Sanitary Transportation of Human and Animal Rule:

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm

FSMA Final Rule for Preventive Controls for Human Foods:

https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm

We will review Import/Export procedures and food safety later. We will also review registration and licensing later. I am waiting on information from experts in those areas who can assist with pointing us in the right direction.

In addition to being an American Cheese Society Certified Cheese Professional, I am a Certified ServSafe Food Production Manager with certifications that also include ServSafe Certified Instructor and Proctor. I am available for cheese events, cheese program development, cheese training, food safety training and 3rd party food safety auditing. See my About Me and Resume pages for more details or call me at 360 921 9908 to discuss availability.

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2018 ACS Body of Knowledge – Domain 1 – Food Safety – Days 5, 6 and 7

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