Shades of Regulatory Grey

Streamlining the Decision-Making Process

MHOA Educational ConferenceOctober 21, 2015

Presenters

Angelo De Luca, B.A., R.S., Sanitarian, Norwood Health Department

Beth Grossman, B.S., R.D., LDN, d/b/a MA Food Safety Training

Pamela Ross-Kung, M.S., R.S, President, Safe Food Management

What brought us here today?

Objective

Discuss practical ways of determining the proper code reference during an inspection to save time and improve the accuracy of your inspection reports.

Purpose of an Inspection Report

Present a factual record of an inspection Permanent record Addresses pertinent conditions

Communicate results to others Serves as a starting point for next inspection

Support potential enforcement actions

Encourage active managerial control

Help identify trends

Use as a training resource

Importance of accurate reports Establish credibility (inspector should be knowledgeable) Avoid legal roadblocks

History of non-compliance should be based on accurate results - enforcement actions could be impacted

Fairness Court of public opinion Public record (media) Bad publicity Poor scores Improper enforcement taken Variances denied Jobs/bonuses affected Business impacted

Effective Report Writing

Starts with good note taking:

Be as descriptive and specific as possible Identify facility personnel clearly Use dates and times Avoid vague terms Avoid judgmental statements

Keep it simple

Use short, direct sentences

Avoid complicated terms, acronyms, slang, abbreviations (Define any complicated terms that may be unfamiliar to the reader)

Be concise (avoid wordiness)

Stick to the facts

Reports must be entirely objective, unbiased, unemotional

Report your observations

Include direct statements made to you that are relevant to the inspection findings

Be thorough, check every detail

Compare with notes/checklists/resources

What are some challenges to writing a good report?

Challenges to writing a good report

Time constraints Limited knowledge Lack of resources Challenging environment

crampednoisyuncleantoo hot/coldhostile

Others

Decision Making

Determine if the observation is a violation? Some are pretty straight forward. Others are more complicated

If it is, determine the provision in the code Start with the category headings Determine if it’s a red, critical, or non-critical Sometimes it gets complicated May be more than one provision to address a

specific violation We try not to double debit, but sometimes its

necessary

Grey area….

an undefined situation or subject that does not seem  to conform  to  known categories or rules; an intermediate area or topic that is not clearly defined

Let’s take a look a some examples→

Example 1

You observe a facility with an under-counter dish machine, but they do not have a 3-compartment sink. The dish machine was functioning properly.

Should they also have a 3- compartment sink?

Is this a violation?

Response from MDPH

No it is not a violation.

The Food Code does not require the establishment to install both a 3-compartment ware washing sink and a dish machine - as long as the largest piece of equipment fits into the dish machine.

Example 2

You observe foods thawing in a 3-compartment sink that is also used for ware washing.

Is it a violation?

Answer from MDPHBased solely on the observation, it is not a violation.

However, if you ask questions and learn that they did not follow proper procedures before starting the thawing process, you would debit it as follows:

4-501.16(B) (Ware washing sinks, use limitation, which is a non-critical item).If a ware washing sink is used to wash wiping cloths, wash produce, or thaw food, the sink shall be cleaned as specified under under 4-501.14 (cleaning frequency) before and after each time it is used to wash wiping cloths or wash produce or thaw food.

4-702.11 (Sanitizing equipment after washing, which is a red critical item).Sinks used to wash or thaw food shall be sanitized before and after using the sink to wash produce or thaw food.

Example 3

You observe one of your retail establishments making and packaging their own fudge. The packages do not have nutritional labeling.

Is it a violation?

Response from MDPH

No, retail establishments are not required to have nutritional labeling as noted under the Nutritional Labeling and Education Act

EXEMPTIONS AND SPECIAL LABELING PROVISIONS

[21 CFR 101.9(i)5]:

Foods that are not for immediate consumption, that are processed and prepared primarily in a retail establishment and not offered for sale outside that establishment (e.g., bakeries and deli's)[101.9(j)(3)].

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074948.htm#EXEMPTIONS AND SPECIAL

Example 4You are inspecting the produce and meat departments at your local supermarket. While inspecting the misters in over the greens section and in the meat service case, you observe slime and mildew accumulations on the nozzles. Water often drips from these nozzles onto the food product.

Part of the definition of a food contact surface in the Food Code states….a surface of equipment or a utensil from which food may drain, drip, or splash: into a food….

In this situation, are spray misters considered a food contact surface?

Is this a violation?

Answer from MDPH

This is a violation and in this instance, where the water is being sprayed directly onto food, the nozzle would be considered a food contact surface.

This would be marked under #9 4-601.11 Equipment Food Contact Surfaces and Utensils Clean to Sight and Touch

Example 5You observe wiping cloths in a sanitizing solution, but the solution was not at the proper strength.

The code section you looked at was, #24 3-304.14, which is not a critical violation. However that section states that “cloths used for wiping spills shall be wet and cleaned…stored in a chemical sanitizing solution at a concentration specified in 4-501.114 and used for wiping spills…..”

Section #9 4-501.114 Manual and mechanical warewashing equipment, chemical sanitization – temperature, pH, concentration and hardness is a red critical violation.

Which is the correct provision for debiting this violation?

 

Answer from MDPH

This violation would be marked under #24 - FC 3-304.14

It is a non-critical violation because wiping a surface with a wet cloth does not constitute cleaning and sanitizing. The solution needs to be checked periodically and changed since soiled wiping cloths can neutralize the sanitizer.

Example 6

We have a problem establishment that has repeatedly had non-TCS foods with expired sell-by dates.

We use 3-601.12 Honestly Presented at the inspection to debit this practice.

Question is: do local boards of health have the authority to cite 105 CMR 520.00 Labeling?

Should we also include 520.119 (F) as part of the citation?

Response from MDPHYou do have the authority to cite 105 CMR 520.119 (F) under the authority of 105 CMR 590.004 (B) because:

FC 3-201.11(C) Packaged Food, Labeling was stricken and replaced by the following: “Packaged food shall be labeled in accordance with applicable law and as specified under FC 3-202.17 and FC 3-202.18.”

520.119 (F) Sale of Past Date Food Products. No person shall offer for sale in the Commonwealth any food product after the expiration of a "sell by date" or a "best if used by date" unless:

(1) It is wholesome and its sensory physical qualities have not significantly diminished; and, (2) It is segregated from food products which are not "past date"; and, (3) It is clearly and conspicuously marked either on the package or through the use of shelf markers or place cards, as being offered for sale after the recommended last date of sale or best use.

Example 7During an inspection of a local Chinese restaurant, you find that the owner was purchasing ducks from another retail establishment. You are not sure if that retail establishment has a wholesale permit to sell these cooked ducks. You remembered a regulation that retailers are required to buy from licensed wholesalers. However, you can’t find a specific citation for that in the food code or 105 CMR 590.000.  

Is this a violation?

The second issue here was that they could not produce an invoice for the duck in question. If the retailer cannot produce invoices, as proof that they are purchasing from a reputable source.

Is there a citation for that in either the Food Code or 105 CMR 590?  

Answer from MDPH

If the both establishments are not owned by the same entity, then the 1st establishment needs a wholesale food processor license from MDPH Food Protection Program to sell the cooked ducks.

You would then cite #4 3-201.11 (A), since the food is coming from an unapproved source (i.e. unlicensed wholesale food processor).

This establishment would also be required to have invoices available for review, which is required under FC 8-402.11Allowed at Reasonable Times After Due Notice (….PIC provides information and records to the regulatory authority….).

Example 8Picture a muffin pan with 12 cooked muffins inside the pan. They have overflowed onto the pan and now need to be cut to be separated. 

The employee used a knife to cut the muffins. He was not wearing gloves.

The knife has a handle on one end, but no handle on the other end. In order to cut the muffins he had to touch the end without a handle to hold the tip to keep it steady while he’s cutting to separate the muffins. After touching the knife with his bare hands, he wipes his fingers on his apron.

Is this a violation?

Response from MDPH

There is no violation since the employee is meeting the intent of FC 3-301.11 (B) by using the knife to cut the muffins apart.

There is no requirement to wear disposable gloves when using a utensil as a barrier method in order to prevent contamination from hands.

If you did not observe the employee washing his hands that became soiled while completing one task and before moving on to another task then that could be debited under FC 2-301.14 (F) – When to wash hands

ThoughtsOne inspector wanted to debit this under handling foods with bare hands (12  3-101.11).  However, once we saw him touch the knife and started discussing it, he stopped the task. We never actually saw him touch a muffin with his bare hands – only the knife, which was then used to cut the ready to eat muffins. Another inspector thought we should debit it under hand washing because once he touched the knife that was soiled from cutting the muffins, he thought he should have to wash his hands because they had become dirty (10  2-301.14).  However, he was still conducting the same task, so we were questioning whether that would be an appropriate way to debit it.  I was leaning towards debiting it under gloves, use limitation (24  3-301.15), but it didn’t really seem to fit (even though I felt he should be wearing gloves to cut the muffins if he knew he would make contact with the utensil).

Example 9

A retail establishment is stretching curd to make mozzarella cheese at their retail store. Do they need a cheese manufacturing license?

Is this a violation?

Response from MDPH

No, this is not a violation. They do not need a cheese manufacturing license.

The retail establishment is making the cheese balls in a short period of time and the milk used to make the curd is pasteurized (confirmed by letter from the manufacturer of the curd).

Where do you go for help?

If an observation or situation falls into a grey area, or you can’t readily find the answer, what do you do next?

Where do you go for help?

Reaching out…. The 1999 FDA Food Code

105 CMR 590.000 – 595.000 Minimum Standards for Food Establishments State Sanitary Code, Article X

Merged Food Code – Board of Health Rules and Regulations for Food Establishments in Massachusetts – 2011 Edition

Health Inspection Form – front and back

590/1999 Food Code Inspection Guide

Common Violations Sheet (customized to fit your needs)

MA Department of Public Health

FDA

Other regulatory departments in your own city/town - building, electrical, plumbing, fire, etc.)

Other health departments - visit their websites, useful information

Establish your own network of peers

Internet (example: resource handout – build on that over time)

Front of inspection form

Back of inspection form

Inspection GuideUse the headings as a starting point.

Does anybody have their own common violations sheet, commonly referred to as a “cheat sheet”?”

Does it look something like this?

We are going to share ours with you.

Common Violations Sheet

More useful resources….

Will be available online

Make sure you looking a current versions of guidelines/documents.

Narrative Page

Discussion with PIC

“Regulation in practice is hard. There will always be gray areas at the edges.”

unknown

But working together and using the resources can make it all come together more quicklyand accurately.

Questions