July-September 2020: Planting to Processing (Formerly West Coast Industrial Solutions Magazine)

July - September 2020
Planting to Processing
In this issue:
Responding to and
Reducing Risk
Formerly
Cultivate Knowledge. Feed the World.

CONTENTS
July - September 2020
PAGE 1
Letter from the Editor
PAGE 3
Innovation: Digital Traceability:
Reducing Risks and
Finding Efficiencies
PAGE 6
Safety: Contents of a Good HACCP Plan
& Manual
PAGE 10
Company Profile: MycoKind LLC
PAGE 12
Ethics: Mitigating Risk through Food
Packaging
PAGE 20
Explore: The Case For a Makerspace in
Downtown Fresno
Advertise with Us!
Contact Information
Tara Sweeney, Marketing Director
tara@wcismag.com
559.999.6637
PO Box 7864, Fresno CA 93747
Staff
Sheri McClure, Content and Sales
Tara Sweeney, Sales and Marketing
Trevor Merrow, Layout and Design
Visit us at wcismag.com

LETTER FROM THE EDITOR
Thank you for reading the July edition of Planting to Processing magazine--
formerly West Coast Industrial Solutions magazine. You voted on our social
media, and we listened; the final votes were 42.1% for “Planting to Processing,”
26.3% for “Cultivate,” 21.1% for “Food & Facilities,” and 10.5% for “Facilities &
Food.”
A
B
C
Now that you have helped us choose a new name, we need your help choosing a new logo! Please vote
through our website or our social media channels to let us know what name you think our logo should be.
The content in the third quarter is focused on risk reduction through: HACCP plans, packaging, and digital
traceability. Along with ways to respond to the changes that the pandemic has made to everyones’ operations:
like Paycheck Protection Program loan forgiveness. You will also meet MycoKind, a group of fungi fun-guys
adapting science and tradition to change the food industry.
We only have to be socially distant with in-person interaction! Feel free to connect with us on social media,
where we give updates on industry events--we attend over 20 trade shows and local events a year! Or browse
our website, where we host these articles as blog posts with more behind the scenes photos and video.
We’re starting an online show through Central Valley Talk and plan to revisit and expand on subjects we have
covered, watch us the first and third Saturday of each month at 11am PST for the live showing or follow us on
social media to stay up to date.
If you missed our past event in October 2019, we will be hosting our second annual trade show: 2020 Safety
Expo in Food & Facilities, May 11th, 2021 at the Clovis Veterans Memorial District in Clovis, CA. Speaking slots
are open if you would like to provide training to industry professionals in agriculture, food and beverage, food
processing, and manufacturing.
Join us as an exhibitor. Contact us today (tara@wcismag.com, (559) 999-6637) if you are interested or browse
our advertising options on our website. wcismag.com/advertise/
-Tara Sweeney
West Coast Industrial Solutions Magazine
West Coast Industrial Solutions Magazine
@wcismag
@wcismag
Planting to Processing | July 2020 1

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2 Planting to Processing | July 2020

Innovation
Digital Traceability: Reducing Risks and
Finding Efficiencies
Written by Alex Lewis, Parity Factory Corp.
The ongoing crisis has shed light on the need for
innovation in the food space, even in the most
fundamental processes.
If someone were to ask you which industries were
most important to our daily lives, what would you say?
Along with things like communications, construction,
and clothing, one of the first things that likely comes
to mind is also one of the most basic: food. The
agricultural and food processing industries provide
for our most key needs and enables our continued
growth. It is unlikely anyone would argue against the
importance of the food and beverage industry to our
society, however 2020 has brought us a loud and
clear reminder of just how crucial it is, in the form of
the COVID-19 pandemic.
In just a few short months, food and beverage
manufacturers saw demand increases that haven’t
been seen in a lifetime. At the time of writing, sectors
of the food industry have experienced spikes in
volume ranging from 32% in milk, 30-47% across
the snack sector, and a staggering 77% increase in
demand for meat, and this trend holds true for nearly
every vertical within the industry.
The stay-at-home orders announced by most
governments have sent consumers rushing to the
store, clearing shelves and placing new strain on food
and beverage processors. As they struggle to keep
up with their order volume, many manufacturers are
looking for new ways to improve their efficiency and
reduce their liabilities. As it turns out, one of the most
effective methods may also be the simplest: digitizing
their lot tracing.
What is digital lot tracing?
All food and beverage manufacturers track their lots.
In fact, it is one of the basic requirements for running a
food processing business, with the specific standards
and protocols defined at the federal level by
organizations such as the FDA. By requiring tracking
of all material that is involved in making a product,
down to the packaging used, it ensures that recalls
can be performed swiftly and protects the health of
the public. Manufacturers manage their tracing using
a variety of methods, from pen and paper, to Microsoft
Excel, to fully integrated traceability software, with
many using a combination of methods. Digital lot
tracing simply means that a company is capturing
Planting to Processing | July 2020 3

and managing their tracing data on a digital platform,
often integrating scanning and barcoding into the
process. This approach has a drastically lower error
rate than more traditional methods and tends to be
significantly more efficient.
Despite tracing being a common daily task that all
processors contend with, there has been surprisingly
little momentum towards automated lot tracing in
food. By some metrics, only 1 in 5 operations have
fully automated their lot data capture, with a bit more
having partially implemented the process. The food
industry has always been slow to adopt new processes,
but as demand and competition skyrockets, many are
finally feeling the need for an upgrade.
The risks of a recall
Executing recalls, specifically executing them quickly
and efficiently, is one of the biggest challenges
that food and beverage manufacturers face.
Under current FDA guidelines, food and beverage
processors need to be able to perform a recall within
four hours. Many of the major retailers demand even
more of their suppliers; if you want your product on
the shelves in a Walmart or Costco, you must be able
to perform the same process in as little as two hours.
The unfortunate reality is that for processors tracing
on paper, particularly those producing at scale, these
targets are difficult to hit. Also, the human element
involved in manual tracing can allow errors to find
their way into data, and this has become especially
true for those who are dramatically increasing their
throughput to keep up with new demand caused by
COVID-19. Without true, reliable data, a recall can
quickly go from difficult to impossible.
The consequences of a botched recall can be dire:
the average recall costs a manufacturer $10 million,
not including possible fines from regulators, or losing
the aforementioned Walmart or Costco contract.
One of the biggest losses is one that may not be
immediately obvious: consumer confidence. Over
half of consumers will quit purchasing a product once
it has been recalled, and studies have shown that a
company’s stock price will typically drop as much as
22% following a major recall. Once that confidence is
gone, it can take months or even years to get it back,
if it can be regained at all.
All these problems can be mitigated, if not
completely prevented, through digital lot tracing.
With a capable solution in place, recall times can
be measured in minutes, not hours, as a few quick
searches replaces shuffling through endless forms to
find the lot in question (if it was recorded correctly at
all). This guarantees compliance with even the most
demanding of rules and regulations and eliminates
all fear when inspectors and auditors show up for
routine recall tests. In addition, the ability to execute
a speedy yet thorough recall when problems arise
minimizes the risk to both consumers, and the
manufacturer’s reputation. The bottom line: most
food manufacturers are going to face a recall at some
point. It is crucial to have the systems in place to react
appropriately when that time comes.
How does it increase efficiency?
Due to the huge importance of lot tracing,
manufacturers using manual systems often have some
of their most competent and experienced employees
devoted to the task. Even if these staff would be better
suited to other areas, it’s just not worth taking the risk
of assigning less experienced employees to the job.
Digital lot tracing solves this by drastically simplifying
the tracing process. Scanning a barcode and letting
software do the rest is far quicker, easier, and less
error-prone than meticulously creating and tracking
hundreds of lot codes by hand. Meaning that you end
up spending less time on tracing, and therefore less
money, while winding up with data that is significantly
more reliable. This both frees up an operation’s most
capable employees to pursue new opportunities and
allows anyone in the operation to take part in the
tracing process. New employees can be trained and
onboarded quickly, which is particularly useful for
processors hiring huge amounts of new labor in the
wake of COVID-19.
All of this allows for greatly increased flexibility
when it comes to staffing, and as COVID-19 turns
the industry on its head the value of that flexibility
has become crystal clear. While many of us have
had the luxury to transition into working from home,
that’s just not an option for many working in the food
space. When employees are unable to attend work,
for example if they are sick, someone else must step
in. This can be a major threat to efficiency when the
few people in your operation qualified to handle lot
tracking are missing. In dealing with turnover and
staff redistribution, there’s tangible benefit to having
a system that allows employees to be effective,
regardless of their experience level.
4 Planting to Processing | July 2020

For those looking to digitize their lot tracing, there
is no shortage of solutions to accomplish that task.
However, a sufficiently robust solution should go
beyond just traceability. If you are tracking each lot as it
moves through your facility, it creates great possibility
to capture additional data such as yields, storage
locations, and quality information. In this way, digital
lot tracing can be viewed as a foundation on which to
build even more extensive efficiency improvements.
These additional features are some of the most
important considerations for any manufacturer to
make when choosing between available systems.
Preparing for an uncertain future
COVID-19 has proven that swift, unpredictable
changes can happen in any industry, even one as
foundational as food and beverage. With new issues
such as shifting demographics, climate change, and
the variable nature of trade on the horizon, it is likely
that changes will become more frequent and even
the smallest efficiencies will be essential to thrive.
Demetrekakes, Pam. “How the Coronavirus Is
Affecting Food Processing.” Foodprocessing.
com, Food Processing Magazine, 2020, www.
foodprocessing.com/articles/2020/how-thecoronavirus-is-affecting-food-processing/.
Lelieveld, H. L. M. Hygiene in Food Processing.
Woodhead, 2017.
Stier, Richard F. “How Food Processors Can Create a
Plan for Traceability and Recalls.” Food Engineering
RSS, Food Engineering, 11 May 2020, www.
foodengineeringmag.com/articles/98026-how-foodprocessors-can-create-a-plan-for-traceability-andrecalls.
Torero, Maximo. “How to Stop a Looming Food
Crisis.” Foreign Policy, 14 Apr. 2020, foreignpolicy.
com/2020/04/14/how-to-stop-food-crisiscoronavirus-economy-trade/.
Customer consciousness is also changing rapidly,
and businesses that want to stay competitive have
no choice but to change with it. As consumers and
regulators demand ever more transparency and
accountability from the food industry, reliable tracing
data is becoming ever more crucial.
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Manufacturers will undoubtedly rise to these new
challenges in the future, just as they are rising to the
challenges of today. And along the way, many will
find a comprehensive digital lot tracing system to be
one of their most valuable tools.
Sources/Further Reading:
Breaux, Randy. “COVID-19 Shows the Need for
Automation.” Foodprocessing.com, Food Processing
Magazine, 2020, www.foodprocessing.com/
articles/2020/power-lunch-covid-19-shows-theneed-for-automation/.
Deloitte. Recall Execution Effectiveness:
Collaborative Approaches to Improving Consumer
Safety and Confidence. 2010.
gos:
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Polyuria Crack Repair
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Planting to Processing | July 2020 5

safety
Contents of a Good HACCP Plan & Manual
Written by Safe Food Alliance Team
Originally Published in Food Safety, HACCP, Starter Series
In today’s food manufacturing environment, basic
food safety principles are no longer enough to meet
customer and regulatory requirements. The rules
have changed, in large part due to the Food Safety
Modernization Act (FSMA). In addition to new laws
from legislators, the standards and demands of
customers now far surpass regulatory requirements.
What this means is there is now an expectation to not
only master Hazard Analysis Critical Control Points
(HACCP) but to go one step further and become
Global Food Safety Initiative (GFSI) certified. To gain
certification with any of these programs, you need to
start in the same place. You start with a HACCP plan.
12 Steps to a Good HACCP Plan
When building out your HACCP plan, follow this
specific methodology involving 12 steps. If you
are having trouble, just reach out to your friendly
neighborhood Safe Food Alliance team.
One thing to remember as you build out your plan
– a HACCP Plan is a living document, and as such,
should be revisited often as your processes change,
your company grows, and you discover better ways
to produce your product. Now that we have that
covered, let’s begin.
1. Assemble the HACCP Team
Your plan will typically include a table where all the
names of the HACCP Team members are written and
signed, and the team leader is clearly designated. The
team functions best when it’s highly cross-functional
and includes members of various departments such
as sanitation, maintenance, production, and quality.
It’s essential to have these varied perspectives and
background knowledge.
In this section, you should include a brief description
of each member’s current position, background,
and experience. You’ll also need to have a copy of
6 Planting to Processing | July 2020

a HACCP formal training certificate for the HACCP
coordinator, from an accredited two-day HACCP
course. There should be some sort of documented
HACCP training for the rest of the team as well,
whether conducted internally or by someone like us.
The more knowledgeable the team, the better the
plan will be.
2. Describe the Product
This section should include a full description of each
product or family of products within the scope of the
plan. Product descriptions should consist of details
that impact the food safety of the product, including
(as applicable):
• the recipe or formulation
• the packing materials and any other information
such as the modified atmosphere
• the conditions in which the product is to be stored
(e.g., temperature, light, humidity)
• the shelf life
• distribution conditions
• any potential for abuse in the distribution chain or
by consumers, which may put the product at risk.
The better you define the product before starting the
hazard analysis, the more thorough the review will be.
3. Identify the Intended Use
The intended use is based on the usual consumption
of the commodity by the final consumer or user. Again,
defining intended use helps ensure a more thorough
hazard analysis later. This section includes both your
company’s intended purpose based on product
design, as well as potential other applications. The
more you know your consumers, the better you can
take care of them. A classic example, in this case, is
cookie dough: it’s a product you typically cook before
consumption, but in some cases, it’s eaten raw. For
this reason, several companies have had recalls on
their cookie dough due to consumer illness.
4. Construct the Flow Diagram
The process flow diagram must be clear and detailed
to describe all process steps. Use this diagram to help
ensure the hazard analysis is thorough and as a visual
reference as your team considers potential hazards
to the consumer. The flow diagram must include
every process step that occurs on-site, from the very
beginning (e.g., receiving and preparing ingredients,
storing packing materials, etc.) to the very end
(shipping, warehousing, etc.) The clearer the diagram
is to the viewer, the easier to understand the process.
Others may also use the table during site visits (e.g.,
customers, auditors, consultants, regulatory officials).
Hence, it’s wise to design it in a way that it’s relatively
clear to others who don’t know the process as well as
you do.
5. On-Site Verification of the Flow Diagram
On-site verification of the diagram helps ensure its
accuracy. Again, the purpose of this is primarily to
ensure a thorough hazard analysis. The site will need
to provide proof that the HACCP Team has verified
the flow diagram. Some companies like to keep the
first version of the diagram with hand-written notes on
it, indicating changes made and initialed and dated
by the participants. Ultimately, however, proof of the
verification is best done with a final, updated copy that
is signed; or meeting minutes indicating approval of
the final version and signatures of participants.
6. Conduct a Hazard Analysis
The hazard analysis is part of the plan that typically
takes the most time to review and update. Here the
team collects and examines all relevant data to the
product’s safety, including process performance,
product defects, customer complaints, results of
internal and third-party audits, and various other
relevant information. The team must take the proper
time to conduct a thorough analysis.
A Hazard analysis can vary in format, but needs to
include these common elements:
• List of all process steps and ingredients
• Identification of potential hazards
• Assessment of each hazard, with consideration of
both severity and likelihood
• Identification of ‘significant’ hazards
• Justification of the assessment (detailed
explanation as to the team’s reasoning)
• Identification of appropriate controls for each
hazard
• Now, under FSMA, the identification of any
Preventive Controls as well. For more information on
this subject, take a look at this article. For training,
refer to the PCQI course.
Planting to Processing | July 2020 7

7. Determine Critical Control Points (CCP’s)
This one is a simple concept. Based on the hazard
analysis described above, you can quickly identify
all significant hazards and CCPs. Critical Control
Points are those essential steps designed to control
a specific hazard so that the product will be safe to
consume. The team should use a decision tree like
this one when determining CCPs.
8. Establish Critical Limits for Each CCP
A critical limit is a critical control point’s “go/no go”
or “acceptable/unacceptable” criteria. For some
processes, such as metal detection, it is as simple
as testing with certified metal test pieces to ensure
proper function. For other types of CCPs, it can be
much more complex and include parameters such as
temperature, humidity, product viscosity, or chemical
concentration. All these variables and values have to
be clearly defined, including both lower and upper
limits, as applicable.
Documents related to the process and relevant
sources used to establish the critical limits must be
available to support the limits. These documents
could be regulatory standards, guidelines, internal or
third-party validation, experimental results, literature
surveys, and expert guidance. The stricter the
validated limits, the higher the potential efficacy.
9. Establish a Monitoring System
This step is where we define the monitoring method
for each CCP. Monitoring is how we ensure the
process has met the critical limit, so the product is
safe. The monitoring procedure should contain the
following:
• What will you monitor?
• How often shall it be monitored?
• Who is responsible for performing the task?
• What instruments will you use?
• How will you monitor? (method)
The clearer the instructions, the fewer chances of
failure.
10. Establish Corrective Actions
Each CCP is required to have predetermined and
documented corrective actions for deviations that may
occur. The corrective actions plan should comprise
at least the following elements: the responsibility
for each action, disposition of the non-complying
product, the correction of the cause of failure, and
recording the event. Keep records of activities readily
available. If you need help with conducting root
cause analysis for your corrective actions, check out
our quick root cause analysis course.
11. Establish Verification Procedures
Much of the discussion in our HACCP courses end up
centering around how to conduct verification in the
context of HACCP properly. Verification procedures
should be activities designed to confirm that the plan
is: 1) being followed; 2) effective for its intended use,
and 3) adequately maintained. We are looking for
defined procedures here, indicating how we conduct
routine verification activities like the sign-off of the
CCP monitoring records, as well as how you complete
the less-frequent validation. The more exhaustive
the verification is, the more confident we can be of
the plan. For more on verification, take a look at our
article “The 6th Principle of HACCP: Verification”.
12. Establish Documentation and Record-keeping
This final step includes establishing both recordkeeping
processes and the company’s documentation
system (establishing defined procedures, the
company’s methods of document control, etc.).
Consider:
• How will you document your system?
• What should you include?
• Who is responsible for doing it?
• How long are you keeping records? Where are you
saving them?
• Who needs to have access to what documents and
how are documents controlled?
A better-documented plan helps ensure better
execution.
As you may realize by now, developing and
documenting an effective HACCP plan is not an easy
task. Training on the methodology, experience, and
technical elements are essential aspects of effective
HACCP Plan implementation. If you need guidance
with training or consultation, Safe Food Alliance is
here to help.
8 Planting to Processing | July 2020

When it comes to food safety,
we’ve got you covered.
Drop in and see us at our Food Safety Center in
Kingsburg, CA or visit us online at safefoodalliance.com
Planting to Processing | July 2020 9

Company profile
MycoKind LLC
MycoKind LLC was incorporated in 2018 when two
PhDs talked about changing the world through
fungi. A food scientist, a plant pathologist, and a
food systems analyst ate dinner over Korean BBQ
and the kindness that grows by culturing community
kickstarted the fungal venture.
They wanted to take a look into changing the food
industry by tapping into novel methods of growing
products. “We are not trying to create new supply
chains or build completely new infrastructures. Rather,
we intend to tap into science and tradition to slightly
adapt something that exists (ie fermentation).”
The most significant milestone up to date was having
a five course four beverage mushroom themed
popup dinner with more than 50 guests and some
VIPs. Some of their favorite accomplishments are
different conversations and interviews among their
colleagues including Daryl of BeerTalkNow, Ilona of
Ktchnrebel, Lichen of Asians in America, Adam of My
Food Job Rocks, Chef Gigi of Sunday Suppers, Lana
of Food Tank, Alex of Cultured Meats and The Future
of Food, and Leneia of Artisan Restaurant Collection.
Each conversation was fun and engaging.
Some challenges that they face are that they “have a
lot of capabilities that are within [their] company and
that means a lot of IP. It is just difficult to figure out
where to start and which idea is fitting for product
market fit.”
Their future plans are to be able to collaborate
with more brands, organizations, institutions, and
communities to increase the accessibility of fungal
knowledge. “Through culturing community, we hope
that our kindness grows too.”
Something they wish more people knew about their
industry: “Fungi have a lot of applications that we
are starting explore in more novel methods. The
possibilities have opened up more discussions on
fermentation, mycoremediation, health and wellness.“
Check them out on social media @mycokindllc on
Facebook or Instagram, @mycokind on Twitter and
LinkedIn, or their website: https://mycokind.com/
as they plan to figure out how to host forays, popup
meals, and classes.
10 Planting to Processing | July 2020

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Planting to Processing | July 2020 11

ethics
Mitigating Risk through Food Packaging
By George G. Misko and Natalie E. Rainer
ethylene scavengers, time-temperature sensors, and
biosensors that can help to prolong shelf life and/
or monitor the condition of food. In fact, it is clear
that over the past 100 years or more, packaging
technology and food processing equipment has
been a major contributor to the manner in which
food products of all sorts safely reach the dinner
tables of Americans and people throughout the
world, while lessening the environmental footprint
of this industry. Indeed, even in these days of the
coronavirus pandemic, the U.S. Food and Drug
Administration (FDA) has stated that “[T]here is no
evidence of food packaging being associated with
the transmission of COVID-19.” 1
Historically, the main function of food packaging
has been to safeguard food by providing a physical
barrier to help maintain food and beverages in a
sanitary condition. Over the years, advances in food
packaging technology have resulted in packaging
that provides additional protection and other
benefits. These more recent innovations include
susceptors to aid in the browning of foods cooked
in microwave ovens, oxygen scavengers/emitters,
The U.S. and other jurisdictions around the world
have implemented food packaging regulations
to assure that packaging materials are safe for
use and that no off-odors or tastes are imparted
from the packaging to food or beverages. And as
technological advances in food packaging provide
improvements in food quality and safety, some of
the regulations governing the composition and use
of food packaging regulations have been changed
to accommodate these advances. This article will
focus on U.S. food laws governing food packaging
materials and revisions to those laws necessitated
by technological advances. First, though, we provide
a brief description of the manner in which food
packaging is regulated in the U.S. and the information
that is required to assure the safety of food contact
materials.
U.S. Food Packaging Laws
The history of formal regulation of food packaging
in the U.S. began with the passage of the Food
Additives Amendment of 1958. Prior to 1958,
customers sometimes insisted on being assured of
1
See the FDA information sheet, titled, “Shopping for Food During the COVID-19 Pandemic – Information for
Consumers.”
12 Planting to Processing | July 2020

a package’s safety and utility by asking to see some
documentation from FDA or the U. S. Department of
Agriculture (USDA) indicating that it had reviewed
and found that the intended use of the materials
would not adulterate food or, put another way, were
safe for their intended use.
The Food Additives Amendment of 1958 added, in
part, a new section to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) that defined the term “food
additive” as “any substance the intended use of which
results or may reasonably be expected to result,
directly or indirectly, in its becoming a component or
otherwise affecting the characteristics of any food”
unless that substance is Generally Recognized as Safe
(GRAS) or subject to one of a number of exceptions
or exclusions listed in the Act.” 2 As a result, all food
contact substances that may reasonably be expected
to migrate to food are regulated as food additives.
Conversely, food packaging substances that are not
reasonably expected to become components of food
are not by definition “food additives” and may be
used without prior authorization or clearance by FDA.
Food contact substances (FCSs) that are considered
food additives must be authorized for use in food
packaging by FDA through a food additive regulation
or a Food Contact Notification (FCN). The food additive
petition process entails clearing food additives
(including food packaging materials that meet the
definition of a food additive) through a notice-andcomment
rulemaking process. Information required
to submit a food additive petition for packaging
materials includes: the identity and composition
of the substance of interest; a description of the
manufacturing process; information on its intended
use (such as food types, temperature conditions at the
time of packaging and during use, and the expected
duration of contact with food); and chemistry and
toxicology data supporting the safety of that food
additive for its intended use. The petition should also
include test methods used to verify specifications
for the raw materials and the finished products.
Finally, the petitioner must include an environmental
assessment to established whether the manufacture
or use of the substance as intended will likely result
in any undue impact that will require further study.
Once a food additive is cleared through this process,
FDA publishes a regulation, which can be relied upon
by the petitioner as well as other manufacturers and
users of the additive provided any limitations and
specifications listed in the regulation are met.
The FCN process largely supplanted the petitioning
process with passage of the FDA Modernization Act
of 1997. Data requirements for an FCN are about the
same as those for a food additive petition with respect
to the need to estimate dietary intake for an additive
and establish safety through the provision of toxicity
data adequate to support the estimated exposure. In
addition, data identifying the FCS, its intended use
manufacturing process and the like are very much
required as in the petition process. The primary
difference between the FCN and FAP process is that
FCNs are proprietary, i.e., they can only be relied upon
by the manufacturer of the FCS identified in the FCN
and by its customers. Third parties who manufacture
the same substance are required to submit their own
FCN to be enabled to reach the same market. The
other major difference is that where it could take
literally years for FDA to grant a petition, an FCN
automatically becomes effective 120 days after it has
been accepted for filing by the Agency, unless FDA
objects in writing prior to the effective date.
Assuring Safety
FDA applies a tiered approach to the toxicity data
needed to support safety of food-contact materials.
That is, the higher the level of estimated dietary intake
to a substance, the greater the toxicity data needed
to support safety.
Another important consideration with respect to
safety is the statutory and regulatory requirement
that food contact materials be manufactured in such
a way as not to result in the adulteration of food,
i.e., be of a purity suitable for the intended use, as
required by FDA’s Good Manufacturing Practices
(GMP) regulation for food packaging materials. 3
The suitable purity requirement dictates that FCSs
may not impart anything to food that may cause it to
be harmful or deleterious to health or result in an offtaste
or -odor in food. To meet this requirement, the
manufacturer must consider the safety of foreseeable
2
See Section 201(s) of the Federal Food, Drug, and Cosmetic Act.
Planting to Processing | July 2020 13

impurities in the FCS, including residual monomers,
starting reactants, catalysts, and reaction byproducts
and degradation products.
New Technologies
As new types of food packaging are developed based
on technological advances, the safety of the materials
used in these packages need to be evaluated. In
some cases, revisions in food packaging regulations
were made to assure the safety of the food in contact
with new technology. We will examine some of these
technologies and what new requirements, if any, were
implemented to assure their safety.
Microwave Susceptors. The introduction of susceptors
in microwave packaging resulted in higher cooking
temperatures, which could be used to crisp and
brown food by cooking it in a microwave oven. FDA
food packaging regulations use the term “Conditions
of Use” to describe the typical temperature conditions
under which food products may be used in contact
with packaging materials or articles intended to
process or hold food. In April 2006, FDA expanded
its list of Conditions of Use to include two additional
categories. One of the new categories, Condition
of Use J (“Cooking at temperatures exceeding
250°F”), is applicable to microwave heat susceptor
materials. The following year, in December 2007, FDA
updated its chemistry guidance for preparing FCN
submissions. The new chemistry guidance includes
specific protocols on testing for dual ovenable,
microwaveable, and microwave heat susceptor
materials.
Antimicrobial Agents. The safety of antimicrobials
used in food packaging is regulated by FDA similar
to other food additives; however, they may also
require registration with the U.S. Environmental
Protection Agency (EPA) under Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Additionally,
antimicrobials used in or on permanent or semipermanent
food contact surfaces, which are not
intended to have an ongoing effect on the food
contact surface, are regulated by FDA as food
additives. If, however, the intended effect is ongoing,
that is, intended to preserve the article from microbes
or the protection of the user, EPA exercises jurisdiction
over the use and food safety issue.
In all cases, except those involving processed food,
the antimicrobial used will be considered a pesticide
for purposes of FIFRA and will require registration with
EPA regardless of FDA’s jurisdiction over the matter.
In addition, antimicrobials added to packaging
materials with the expressed intent of migrating into
the food to increase its shelf life by retarding spoilage
may be considered food preservatives by FDA or
USDA, if meat or poultry, and require labeling of the
food product.
Biobased and Biodegradable Plastics. As interest
in sustainability has increased, the use of biobased
and biodegradable plastics in food packaging is
expanding. “Biobased” means related to or based
out of natural, renewable, or living sources, while
“biodegradable” means capable of being broken
down naturally to basic elemental components (water,
biomass, and gas) with the aid of microorganisms.
“Biobased plastics” are plastics manufactured from
renewable biomass, such as vegetable oil, cornstarch,
pea starch, and microbiota. Biobased plastics can
also be biodegradable.
While biobased plastics are required to comply with
the same regulations with respect to food safety as
fossil-based plastics, there are several regulatory
issues that need to be considered for new biobased
material or new applications for existing materials.
These include determining the appropriate food
simulants to be used to estimate the potential for
migration and demonstrating that the substance
is stable for its intended use. In addition, it may be
necessary to consider the suitable purity of the finished
product with respect to the potential presence of
organic matter, such as cellular debris, and naturally
occurring contaminants (e.g., mycotoxins and algal
biotoxins).
Recycled Materials. The growing interest in
sustainability is also behind recent initiatives by a
number of food companies to increase the use of
recyclable packaging and the use of post-consumer
recycled plastic content in food packaging. Recycled
plastic in food packaging must meet the same safety
standards as virgin plastic.
Companies may independently evaluate the status
and safety of a polymer produced through a recycling
process. However, many companies will submit
3
See Title 21 of the Code of Federal Regulations, Section 174.5.
14 Planting to Processing | July 2020

their determinations to FDA for review through a
voluntary program. If FDA agrees with the company’s
determination that a given recycling process is
adequate to produce suitably pure recycled foodcontact
material, it will issue a no objection letter
(NOL). To assist recyclers, FDA has issued guidance
on recycled plastics for use in food packaging, which
provides information on how to establish the safety of
recycled polymers for food packaging. With respect
to secondary (physical reprocessing) and tertiary
recycling (regeneration of purified starting materials),
FDA stresses the importance of demonstrating
that possible contaminants from prior use of the
plastic are sufficiently removed by the recycling
process. To accomplish this, FDA provides specific
recommendation on contaminant testing.
Conclusion
We have provided several examples of new
innovations incorporated into food packaging. The
use of antimicrobial is just one example of active and
intelligent packaging, or packaging that interacts
with food or its surroundings to prolong shelf life or
monitor the condition of the food, slow the rate of
oxidation, and prevent microbial attack. As advances
in food packaging technology continue, further
regulatory considerations may need to be addressed.
About the Authors:
George Misko is one of Keller and Heckman’s Food
and Drug practice group leaders. Mr. Misko’s practice
focuses on food and drug matters and environmental
concerns, including pesticide regulation, right-toknow
laws, and toxic substance control regulations.
He has extensive experience counseling clients
on regulatory requirements relating to chemical
substances, plastics and food products in the U.S. and
other jurisdictions, including Canada, the European
Union, Latin America, and the Asia-Pacific region. He
also represents trade associations, including acting
as legal counsel to the Global Silicones Council.
Natalie Rainer practices in the area of food and drug
law. She advises clients on regulatory requirements
for foods, dietary supplements, cosmetics, and food
and drug packaging in jurisdictions around the world,
including North America, Latin America, Europe, Asia,
and the Middle East. Ms. Rainer’s practice includes
evaluating the regulatory status of food-contact
materials, food additives, and color additives; advising
companies on advertising and labeling requirements
(including claim substantiation, nutrition labeling,
menu labeling and environmental/green claims); and
counseling clients on the Food Safety Modernization
Act and its regulations.
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Planting to Processing | July 2020 15

finance
Finance: You’ve Received
an SBA Paycheck Protection
Loan: Now What?
Written by Jeffrey Markarian, CPA
Dedekian, George, Small & Markarian
COVID-19 has had a devastating effect on the
American economy, and agriculture has been
especially hard hit. To help provide economic
relief, various federal legislation has been enacted,
including the Coronavirus Aid, Relief and Economic
Security (CARES) Act. As part of the CARES Act, the
Small Business Administration (SBA) received funding
and authority to establish the “Paycheck Protection
Program” (PPP). The PPP is a forgivable loan program
that was established as an incentive for small
businesses to keep their workers on payroll during
this financially difficult time. As of June 5, 2020, the
SBA had received total funding from Congress in the
amount of $659 billion, and had approved 4,525,081
loans totaling approximately $511 billion.
If you are one of the many small business owners in
the agricultural industry that has received a forgivable
PPP loan, you must apply for forgiveness of your
PPP loan by submitting an SBA “Loan Forgiveness
Application” to the lender servicing your PPP loan,
as the loan is not automatically forgiven. As a result,
it is imperative that you plan now to maximize the
forgiveness of your loan.
The SBA has continued to provide additional guidance
throughout the PPP in response to ongoing requests
for assistance and clarity. Also, on June 5, 2020, the
Paycheck Protection Program Flexibility Act (PPPFA)
was enacted, which provides PPP loan recipients with
increased flexibility in utilizing PPP loan proceeds.
Most significantly, The PPPFA has extended the
period to use funds from eight weeks after the date
of receipt of loan proceeds to twenty-four weeks.
Borrowers receiving PPP loan proceeds prior to
June 5, 2020, retain the option to use an eight-week
covered period if desired. Please note that all of the
following information includes the changes resulting
from the PPPFA.
The original intention of the PPP was to keep
employees paid for the eight-week period beginning
with the date loan proceeds are received. As
mentioned above, recent legislation has extended
this to a twenty-four-week period. Expenses to be
paid with loan proceeds include payroll costs and
specific non-payroll costs.
16 Planting to Processing | July 2020

Payroll costs include the following:
• Salary, wages, commissions, or tips (limited
to $15,384.62 per employee for the covered
period)
• Employee benefits (including payments for
vacation, parental, family, medical, or sick leave;
allowance for dismissal or severance pay; group
health care benefits; payment of retirement
benefits; and state and local taxes assessed on
compensation)
Non-payroll costs include the following:
• Interest on mortgage incurred before February
15, 2020
• Rent on lease agreement in force before
February 15, 2020
• Utilities (including electricity, gas, water,
transportation, telephone or internet) for which
service began before February 15, 2020
• To be eligible for full loan forgiveness, at least
60% of the loan must be used for payroll costs
and not more than 40% for allowable non-payroll
costs. If less than 60% of the loan is used for
payroll costs, the borrower is still eligible for
partial loan forgiveness. The first iteration of
the PPP required 75% of the funds to be used
for payroll or only part of the loan would be
forgiven, but the PPPFA decreased the required
percentage.
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What happens if your PPP loan is not forgiven? Any
portion of your PPP loan that is not forgiven will be
required to be paid back over a 2-year period at 1%
interest, with payments deferred for ten months from
the date of the PPP loan disbursement. However, for
PPP loans approved by the SBA on or after June 5,
2020, the PPP loan maturity is increased to 5-years.
On May 15, the SBA released its long-awaited PPP
forgiveness form and instructions for borrowers to
apply for forgiveness (please note that a modified
forgiveness form is pending as a result of the PPPFA).
The form also provides detailed information related
to the documentation required to be provided with
your loan forgiveness application. It is important to
review the documentation requirements; as extensive
documentation may be required to be submitted
depending upon your eligible expenses submitted
for forgiveness. Although the release of the form by
the SBA brought with it significant changes to the
interpretation of some components of forgiveness
that were not previously known, additional guidance
and clarity is still needed on some of the components
of forgiveness. Changes were made to the following
components of the program based on the release of
the form:
Covered payroll periods – Under original guidance,
the covered payroll period began immediately after
loan disbursement and lasted eight weeks. The
PPPFA has increased the covered payroll period to
twenty-four weeks. For those with payroll schedules
that did not align with the disbursement and covered
period, this generated many questions and concerns.
However, this latest guidance indicates that the eightweek
period may begin starting with the borrower’s
first payroll following disbursement, not necessarily
on the day of disbursement. This alternative period
only covers payroll costs, not other allowable
expenses, although adjustments do exist for other
allowable expenses.
Incurred and/or paid expenses – The CARES Act
originally indicated that, for costs to be covered under
PPP, they would need to be incurred and paid during
the eight-week period (increased to twenty-four
weeks by the PPPFA). The latest guidance, however,
forgives costs that are incurred, but not paid, as long
as they are paid on or before regular billing date. This
expansion applies to costs such as mortgage interest,
rent, utilities, and payroll incurred during the loan
period. Payroll costs incurred during the last payroll
Planting to Processing | July 2020 17

period but not paid during the covered or alternative
periods (mentioned above) may be forgiven if those
payroll costs are paid on or before the next regular
payroll date.
Full-time equivalent (FTE) employee counts and
wages – The guidance also included several
clarifications to the FTE employee count and wage
calculations necessary for forgiveness including:
• FTE calculation can be rounded to the nearest
tenth – The formula to calculate an FTE is
average number of hours paid per week per
employee/40, rounded to nearest tenth (differs
from Affordable Care Act calculation).
• Wage reductions must be analyzed on a per
employee annualized basis – Salary or hourly
calculations should be done on an average
annualized basis compared to period of
Jan. 1, 2020, to March 31, 2020. If the average
for the twenty-four week period is 25% less
than first quarter of 2020, loan forgiveness will
be reduced, unless the reduction is restored at
equal to or greater levels by December 31, 2020,
then forgiveness will not be reduced.
• Safe harbor exists for borrowers who rehire lost
employees by December 31, 2020, at the same
level as of Feb. 15, 2020. Forgiveness will not be
reduced.
• Safe harbor exists for borrowers who made
good faith written offer to rehire employees who
then refused. Forgiveness will not be reduced.
• Safe harbor exists for borrowers who fired
employees for cause, voluntarily resigned, or
voluntarily requested and received reduction in
hours. Forgiveness will not be reduced.
Here is a quick rundown of the changes made by the
PPP Flexibility Act. (See table on opposite page)
Also of note:
• *Borrowers may elect to stick with the 8-week
covered period for loans originating prior to
June 5, 2020. However, it is not clear if the June
30, 2020, safe harbor deadline still applies.
• The amount of any Economic Injury Disaster
Loan (EIDL) refinanced will be factored in when
determining the percentage of proceeds for
payroll costs.
• It is unclear whether compensation limits
formerly prorated based on 8 weeks now
prorated based on 24 weeks.
• It is unclear if the covered period may end prior
to 24 weeks if funds have been used.
Further rules and guidance are expected to be
issued from the SBA, including a modified borrower
application form, and a modified loan forgiveness
application that will included the changes resulting
from the recently enacted PPPFA; however, please do
not hesitate to contact us for further assistance with
your PPP loan questions and help maximizing your
loan forgiveness.
Dedekian, George, Small & Markarian
Accountancy Corporation
8080 North Palm Avenue, Suite 201
Fresno, California 93711-5797
P: 559.431.5500
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Criteria Prior Guidance Current Guidance
Covered Period*
Usage of Funds
Extension of Safe Harbor
for Compensation
& FTE Reductions
Deferral of Loan Payments
8 weeks from PPP loan
disbursement
Minimum of 75% of funds
must be used for payroll to
with a maximum of 25% for
non-payroll costs to achieve
forgiveness
Salary or hourly wage
reductions must be reinstated
by June 30, 2020, to avoid
reduced forgiveness
6 months from loan
origination date
The earlier of 24 weeks from
date of loan disbursement
or Dec. 31, 2020.
Minimum of 60% of funds must be
used for payroll with a maximum of
40% used for non-payroll costs to
achieve forgiveness. If 60% of loans
are not used for payroll, forgiveness
is calculated on a sliding scale.
Salary or hourly wage reductions
have until Dec. 31, 2020, to be
restored to avoid reduced
forgiveness
Earlier of 10 months after the last
day of Covered Period or when SBA
remits the loan forgiveness funds to
lender
Loan Maturity
Safe Harbors Based on
Employee Availability,
Rehiring, New Hires
2 years
None
Loans originated after
June 5, 2020:
5 years
Loans originated prior
to June 5, 2020:
Borrowers and lenders may mutually
agree to extend the maturity date of
loans to 5 years
Forgiveness would not be reduced
if borrowers can document in
good faith:
-Inability to rehire individuals
employed on Feb. 15, 2020
-Inability to hire similarly qualified
employees by Dec. 31, 2020
Safe Harbors Based on
Employee Availability in
Compliance with HHS,
CDC, or OSHA guidelines
None
Forgiveness would not be reduced
if borrowers can document in
good faith the inability to return to
same level of business activity as
before Feb. 15, 2020, due to
compliance with requirements
issued by HHS, CDC, OSHA
from the period of March 1, 2020,
to Dec. 31, 2020
Planting to Processing | July 2020 19

explore
The Case For a Makerspace in Downtown
Fresno
Written by Janelle Smith Ozeran
Fresno Ideaworks, established in 2012 in downtown
Fresno, California, is a source of a myriad of tools and
creative opportunities. But, like makers everywhere,
we also value our friendships, collaborative projects,
the comfort of our “third space”, and the therapeutic
value of getting our hands dirty as we mold clay,
wood, metal, textiles, electronics, or plastics into
something new and wonderful.
Over eight years Fresno Ideaworks has grown from
a small group of friendly hackers into a community
workshop full of curious and creative people, eager
to learn and hone new skills and share them with
anyone who comes through our doors. But since the
16th of March 2020 our doors have been closed to all
regular activity - a crushing situation for people who
come to the Shop for any reason, and a threatening
blow to our survival as a non-profit, all-volunteer,
member-driven organization.
We immediately joined the ranks of makerspaces
all over the country, manufacturing PPE for
healthcare professionals and other essential workers.
Collaborating with two other non-profits in Fresno
- Root Access Hackerspace, and Pi Shop Fresno -
we designed, manufactured, and delivered more
20 Planting to Processing | July 2020

than 4000 pieces of PPE by the first week of May to
everyone from hospital nurses to bus drivers, and
from mail carriers to food service workers. We are very
proud of our role in helping protect our neighbors
and caregivers, but we are also very proud of the
collaborative effort. We are already trying to imagine
what new projects we can undertake together when
our spaces are open again!
Meanwhile, we have lost nearly 15% of our
membership, and watching our family shrink is
breaking our hearts. A goal for the immediate future
is to establish a sponsorship fund for those former
members facing financial hardship because of the
COVID-19 experience. Although our membership
fees are among the lowest for similar spaces, they are
suddenly an impossible luxury for some, even though
the emotional health benefits of making and creating
would go a long way to ease the anxiety those same
people are experiencing.
welcome), but opening the whole structure to more
makers will require the help of angels that embrace
our mission. Downtown Fresno, and our Cultural Arts
District neighborhood in particular, have suffered the
adversity of economic downturn for several decades
now. Ideaworks is relentlessly dedicated to being
part of the growth of both the economic health of
the neighborhood, and, through skill-building and
fellowship, part of the economic and emotional wellbeing
of everyone who comes through our doors.
Please help however you can. Donations to
Ideaworks general fund can also be made through
our website at https://ideaworksmakerspaces.
org/Donate, through Venmo at @Fresno-
Ideaworksthrough, or through Givebutter (https://
givebutter.com/KbPYYR). And thank you, in advance,
from all of us at Fresno Ideaworks.
We also have to focus more intently on the facility
upgrades that will enable us to welcome more
members with a greater diversity of skills and abilities
throughout the entire space. Maintaining a historic
building is already a huge challenge (one we makers
Planting to Processing | July 2020 21

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