52 Paterson Ave Unit#1

Newton, NJ 07860
United States

Environmental Monitoring Program

Purpose

This describes the responsibility and methods used to properly swab equipment and
environmental surfaces as defined in Zones 1 thru 4. This program will enable detection of
potential pathogen harborage areas, pathogens, and organisms that indicate potential presence
in processing environments.

The Pathogen Environmental Monitoring Program will verify the effectiveness of pre-requisite
programs including GMP, Preventative Maintenance, Sanitation, and plant traffic management.

Presently, this program will sample for indicator organisms (Coliform) and Listeria genus.

Policy

A sampling plan has been developed and is documented. Sites have been assigned a unique
identification number. T = Tahini, followed by a 100-199 number which is indicative of a zone 1
site, 200-299 number which is indicative of a zone 2 site, 300-399 number which is indicative of
a zone 3 site, and 400-499 number which is indicative of a zone 4 site. All control swabs are
assigned H000.

Target organisms for zone 1 are coliform and for zones 2-4, coliform & listeria genus.

Frequency of testing is performed on a weekly basis and in accordance with a rotation schedule
to allow all zone 1-3 sites to be tested on an annual basis.

Frequency of zone 4 sites are tested on a monthly basis unless construction activities warrant
an increase of sampling.

Swab locations will be documented internally with a pre-assigned number for the purpose of
being able to cross reference the surface on the Chain of Custody.
Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Swabs shall be obtained at least 3-4 hours after start-up or within the last 4 hours of production
by utilizing the proper sampling swab for the surface sampled.

Note the time the swabs were taken on the chain of custody.

The timeframe for taking swabs should be changed on a periodic basis.

Swab site locations will be audited and changed on a periodic basis.

Protocol for swabbing is outlined in SOP Environmental Swab Procedure

Zones Defined

Zone 1

Sites that are direct or indirect product contact surfaces. Direct product contact surfaces are
surfaces exposed to product during normal equipment operation. Indirect product contact
surfaces are surfaces from which liquids or dust or other material may drain, drop, diffuse, or be
drawn into the product or into the container, and surfaces that touch product contact surfaces or
the container

Examples include but not limited to:

• Inside Tahini Trough

• Inside The Hoppers
• Inside The Mills
• Inside Silo Storage Tank
• Inside Piping
• Gloved hands

Zone 2
Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Sites that are environmental surfaces immediately adjacent to product-contact surfaces. All
surfaces close to product contact surfaces that under normal operating procedures do not
directly contact the product or the product contact surfaces of the container, including the
exterior of processing equipment

Examples include but not limited to:

• Exterior of Tahini Trough

• Control Panels

Zone 3

Sites that are non-product contact; environmental surfaces within the processing room that are
more remote from product contact surfaces.

Examples include but not limited to:

• Hose Nozzles
• Floors
• Walls/Ceiling
• Sesame Seed Hopper
• Underneath Equipment

Zone 4

Sites that are remote from product contact surfaces outside the processing room, but could
impact processing areas through the movement of people, equipment or materials.

Examples include but not limited to:

• Remote from processing

Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

• Warehouse Floors

Testing Laboratories

An accredited pathogen testing laboratory is used to test environmental swabs and their test
methods have been approved.

Action Plan

Currently Listeria testing is not being tested for Zone 1 surfaces.

Coliform - If plan limits exceed <10 cfu/swab in Zone 1, the following action plan may be
followed:

• Review cleaning records and procedural documentation

• Complete an audit of the equipment cleaning procedures.
• Conduct teardown inspections of equipment involved.
• Conduct pre-operational inspections.
• Review environmental data from Zones 2 & 3
• Review environmental data (Zones 1, 2 & 3) from lines feeding product into the line in
question.
• The day after exceeding limits and after completing the above action steps the line shall
be re-swabbed at each site of the original swab. Samples should be taken at pre-op if
available and/or each swabbing time (at least 3-4 hours into the shift) until a minimum of
three consecutive in standard results are obtained. Re-swabs must be completed within
3 weeks.

All corrective action plans shall be documented.

In the event corrective actions do not fix the problem, increased environmental control
procedures and action steps may be required. Examples include:

Quality Assurance Team

Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Reinforce GMP training and provide additional attention sanitation procedures

Observe area during operation for GMP issues/practices
Collect finger swabs from employees on the production line.
Rewrite equipment cleaning protocol
Equipment redesign

After receiving the positive result, corrective actions should be immediately taken. The following
re-sampling shall be taken within a timely basis after receiving the positive result, which allows
time for an investigation and corrective actions to be completed. Re-Sampling shall include a
swab taken after sanitation or pre-operation and a swab taken during the first day of operation.
Wait until the first set of swab results are returned before proceeding on taking swabs for three
operational sampling events or consecutive days of negative results.

If a Listeria genus positive or out of standard Coliform count (>100 cfu/swab) is obtained on a
Zone 2 Swab; the following action plan may include:

Review of cleaning records and procedural documentation.

Audit of Standard Cleaning Methods

Conduct teardown inspections

Conduct pre-operational inspections.

Review environmental data (Zones 1, 2 & 3) from lines feeding product into the line of question.

Review same line environmental data from Zones 1 & 3.

The day after receiving a positive and/or exceeding limit results and after completing that above
action steps, the area shall be re-swabbed to include the positive and/or exceeding limit site and
other vector sites on or near the equipment. Samples must be taken at least 3-4 hours into the
shift for the next three swabbing times until a minimum of three consecutive negatives and in
Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

standard results are obtained. All corrective actions shall be documented in accordance with
the Corrective & Preventative Action Policy. Re-swabs must be completed within 3 weeks.

If a Listeria genus positive is obtained in Zone 3 or 4 or if the Coliform count (>1000 cfu/swab) is
obtained, the site shall be examined and potential causes shall be investigated. Action plans
may be different than Zones 1 & 2 because a Zone 3 positive, in the absence of Zones 1 & 2
positives is an early indicator of a control program that is not robust enough. Action plans are
targeted to GMPs, period cleaning, environmental controls and facility maintenance.

Zone 3 or 4 Listeria positives do not implicate any finished product from the time period (during
swabbing) to receiving results and previous shift can be released for shipment.

In the event corrective actions do not fix the problem, increasing environmental controls
procedures and action steps may be required. Examples include:

• Reinforce employee GMP practices and provide additional attention to sanitation

activities.
• Place foot foamer’s in entryways, seal doors, limit foot traffic.
• Rewrite cleaning protocol and change frequency.
• Examine cleaning of adjacent non-production areas.
• Repair damaged floors
• Restrict fork truck and pallet jack movement.
• Increase cleaning frequency in adjacent Zone 3 & 4 areas.
• Redirect high risk traffic from adjacent areas.
• The day after receiving a positive and/or exceeding limit results and after completing the
above action steps the area shall be re-swabbed to include the positive and/or
exceeding limit site and other vector sites near the Zone 3 & 4 area. Samples will be
taken at least 3-4 hours into the shift for the next three swabbing times until a minimum
of three consecutive negative and/or in standard results are obtained. Re-swabs must be
completed within 3 weeks.

Investigation and Corrective Action Guidelines:

Quality Assurance Team
Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Investigation activities and corrective actions: Investigation of the positive should occur within
24 hours of the positive being reported and corrective action should be taken during the next
scheduled sanitation cycle.

Corrective actions can include tear down cleans, deep cleans and heat treatments. The target
area may encompass a larger area than the original positive site depending on investigative
findings.

All corrective action plans shall be documented as per the Corrective Action Policy.

• Review Data – determine if mapping positives on a layout/schematic drawing would be

beneficial. Are positives repeats from previous 6 weeks? Review clean equipment and
any in-process micro data for trends.
• Review – adjacent area environmental results. Consider traffic flow of employees,
product and materials.
• Was there mechanical intervention? Was there contractor activity that could have
contributed to a positive? PMs up to date with appropriate frequency?
• Are the periodic cleaning and equipment cleaning PMs for the area completed? How
soon before the next scheduled cleaning? Validate by doing a visual inspection of the
area and determine if frequency is adequate.
• Conduct inspection for possible niches.
• Audit cleaning procedures and determine if effective
• List Corrective Actions
• Validation – Schedule follow up observations to reinforce employee behaviors. Audit
procedures for updates and training.
• Summary statement – Source, solution, and validation of Corrective actions for all Zone
1 and 2 Investigations

Plant Construction or New Equipment Installation

Quality Assurance Team

Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

In the event of plant construction and/or new equipment installation in the food processing
areas, increased environmental control is required. Examples of such activities will include:

• Reinforcement of GMP practices and traffic patterns with outside contractors.

• Setting up temporary control barriers within the plant as applicable.
• Increase cleaning frequency of adjacent areas during construction, and/or after
equipment installation and after major repairs are completed.

Sampling for Salmonella shall be performed on construction and adjacent areas during
construction. The frequency of sampling shall be increased after construction, after any
equipment installation, and after major repairs are completed. The sampling sites and swabbing
frequency shall be determined based on a team evaluation of the following:

• Plant location of construction activities

• Type of construction (e.g., installation, demolition, material removal, etc…)
• Time duration of construction activities
• Types of environmental controls implemented

Plant traffic controls, room air pressure, sanitation activities, etc…shall also be assessed during
construction activities.

Roof & Overhead water leaks in exposed product areas & backed up drains in Exposed Ready-
to-Eat Product Areas:

In the event of roof and/or overhead water leaks occurring over direct product contact areas
during operations of exposed product, plant personnel are instructed to report the condition
immediately to the General Manager.

In the event of floor drain backups occurring during operations in product exposure areas, plant
personnel are instructed to report the conditions immediately to the General Manager.

Quality Assurance Team

Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.
 52 Paterson Ave Unit#1
Newton, NJ 07860
United States

Verification

Verification of the requirements in this SOP is accomplished by review of the lab results and
through the internal auditing program and review of pre-requisite programs.

Weekly areas are trended on an excel spreadsheet rotating through the sites in a year. Out of
spec sites are shaded in accordance with the legend on the trend.

PEM Program is reviewed whenever a major change occurs to the process, product or facility,
or minimally every two years.

Responsibility

The General Manager is responsible for the activities in this procedure.

The General Manager is responsible for alerting any private label manufacturers should any
positives or out of range results are found.

Quality Assurance Team

Juan.z@stbquarters.com
This document is a controlled document; downloaded copies are considered uncontrolled. The
above statements are to be used as a guide only. All of the above information is true and
accurate to the best of our knowledge. However, since the conditions of use are beyond our
control, all recommendations or suggestions are made without guarantee, express or implied
on our part. We disclaim all liability in connection with the use of the information contained
herein or otherwise, and all such risks are assumed by the user. Nothing contained herein shall
be construed to infer freedom from patent infringement. We further expressly disclaim all
warranties of merchantability and fitness for a particular purpose.