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The New “Business as Usual” with COVID-19

Written by Tara Sweeney

Food & Facilities Episode on The New “Business as Usual” with COVID-19

The COVID-19 virus is forcing businesses in critical industries, like food processing and manufacturing, to make many changes very quickly. Closures and new operating procedures are popping up throughout all of commerce, and new information is constantly emerging. Updated versions of this article will be available through our website. This article contains current COVID-19 information that will help you and your company adapt to this shifting business landscape. To help you adapt to the temporary, new normal created by the COVID-19 outbreak, this article contains the following: 

  • WHO Symptoms for COVID-19
  • If You Contract COVID-19
  • Facts About COVID-19 that the CDC is Emphasizing
  • FEMA Factchecks
  • How COVID-19 Could Affect Workplaces
  • Jobs and Exposure Risk
  • Federal Critical Infrastructure Sectors
    • Manufacturing
    • Food & Agriculture
  • The Families First Coronavirus Response Act (FFCRA) 
  • Assistance for Small Businesses During the Outbreak

The Coronavirus disease 2019 (COVID-19) is a respiratory illness that spreads from person to person through close contact (within 6 feet) and respiratory droplets from an infected person through coughing or sneezing. The first US case was reported on January 21, 2020.

WHO Symptoms for COVID-19

It is essential to understand that the COVID-19 virus affects different people in different ways.  It is a respiratory disease and most infected people will develop mild to moderate symptoms and recover without requiring special treatment.  However, people who have underlying medical conditions and those over 60 years old have a higher risk of developing severe disease and death. The WHO has outlined what the typical symptoms are, along with additional, less common symptoms.

Common Symptoms Include:

  • fever
  • tiredness
  • dry cough

Other Symptoms Include:

  • shortness of breath
  • aches and pains
  • sore throat
  • and very few people will report diarrhoea, nausea or a runny nose.

Lowering your chances of contracting Covid-19 is simple: avoiding contact with persons who are sick; avoiding touching your face (eyes, nose, mouth); washing your hands frequently with soap and water for at least 20 seconds. However, the CDC has outlined steps to take if you do contract COVID-19 despite taking precautions.

If you contract COVID-19:

  1. People with mild symptoms who are otherwise healthy should self-isolate and contact their medical provider or a COVID-19 information line for advice on testing and referral.
  2. People with fever, cough or difficulty breathing should call their doctor and seek medical attention.
  3. Call ahead before visiting your doctor.
  4. Separate yourself from other people and animals in your home.
  5. Avoid sharing personal household items.
  6. Wear a face mask.
  7. Cover your coughs and sneezes with your elbow.
  8. Wash your hands often, for at least 20 seconds.
  9. Clean all “high-touch” surfaces (phones, doorknobs, steering wheels, etc.) daily.
  10. Monitor your symptoms.

With these precautions if you contract COVID-19, it is also important to recognize misinformation taking footholds during the uncertainty of this crisis. Both the CDC and FEMA have responded to some of the most common misconceptions that have been circulating.

Facts About COVID-19 that the CDC is Emphasizing:

  1. Diseases can make anyone sick, regardless of their race or ethnicity.
  2. Some people are at increased risk of getting COVID-19. (Above 60 years of age and those with pre-existing conditions.)
  3. Someone who has completed quarantine or who has been released from isolation does not pose a risk of infection to other people.
  4. You can help stop COVID-19 by knowing the signs and symptoms.
  5. Using protective precautions to keep yourself and others safe is simple.

Visit the CDC website for the latest information: www.cdc.gov/coronavirus/2019-ncov.

Where the CDC is emphasizing information directly related to the disease outbreak, FEMA has had to rebut disease tangential misinformation. It is important to check your primary information sources credibility and to not assume secondary information sources are factual. During times of uncertainty, it’s more important than ever to verify the source of the information.

FEMA Factchecks

  1. Hantavirus is not a new disease. Transmission from one human to another may occur, but is extremely rare. It is primarily contracted through touching waste products of infected rodents. Visit https://www.cdc.gov/hantavirus for more information.
  2. There is no national lockdown. It is being determined at the state and local levels. The fifteen day shelter in place suggestion is to minimize exposure and prevent the continued spread of the disease. The latest information and resources are available at www.coronavirus.gov
  3. FEMA does not have military assets. Like all emergencies, response is most successful when it is locally executed, state managed and federally supported.  Each state’s governor is responsible for response activities in their state, to include establishing curfews, deploying the National Guard if needed and any other restrictions or safety measures they deem necessary for the health and welfare of their citizens.
  4. Stockpiling groceries and supplies is not suggested. Food supplies are likely to spoil and you want to minimize chances of contact. Demand is high for grocery, household cleaning, and some healthcare products–stores need time to restock.
  5. The U.S. Government is not mailing checks in response to COVID-19 at this time. If you’re contacted about such a check, at the moment, it’s a scam. Keep an eye on the FTC website for more information about this and other common COVID-19 related scams. 
    1. The Coronavirus Aid, Relief, and Economic Security (CARES) Act has passed both the house and Senate and been signed by President Trump on March 27th. Both  CNN and Fortune Magazine report that it could take five to six weeks for the federal government to cut checks and send them out. The $2 trillion package includes a provision to send checks directly to many Americans. The amount is based on annual income: individuals earning up to $75,000 and heads of household up to $112,500 will receive a $1,200 rebate from the federal government. Whereas, couples who earn up to $150,000 will receive $2,400. Above those income levels, the benefits are gradually reduced by $5 for every additional $100 income. This will be capped at $99,000 for individuals, $146,500 for heads of household, and $198,000 for couples. Parents are eligible for a $500 rebate per child.

With these foundational facts on the disease and clearing up tangential misinformation, it is also  imperative to take precautions in the workplace to prevent spreading the virus. OSHA has issued guidelines on how to prepare workplaces for COVID-19. It focuses on the need for employers to implement engineering, administrative, and work practice controls and personal protective equipment (PPE), as well as considerations for doing so. Aside from safety compliance, the outbreak has affected which industries are still running and can affect the operations of those that are.

How COVID-19 Could Affect Workplaces

  • Absenteeism. Workers could be absent for many reasons: they are sick;  they are caregivers for sick family members; they are caregivers for children if schools or daycare centers are closed;  they have family members to at-risk people at home, such as immunocompromised; they are afraid to come to work because of fear of possible exposure.
  • Change in patterns of commerce. Consumer demand for items related to infection prevention (e.g., respirators) is likely to increase significantly, while consumer interest in other goods may decline. Consumers may also change shopping patterns because of a COVID-19 outbreak. Consumers may try to shop at off-peak hours to reduce contact with other people, show increased interest in home delivery services, or prefer other options, such as drive-through service, to reduce person-to-person contact.
  • Interrupted supply/delivery. Shipments of items from geographic areas severely affected by COVID-19 may be delayed or cancelled with or without notification.

The OSHA COVID-19 webpage offers information specifically for workers and employers: www.osha.gov/covid-19.

Jobs and Exposure Risk

OSHA outlines the different job industries and their risk of exposure to the virus by very high, high, medium, and low exposure levels. 

  • Very high exposure risk jobs are those with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem, or laboratory procedures. 
  • High exposure risk jobs are often peripherally related to very high risk exposure jobs. 
  • Workers in the medium exposure risk category may be in contact with the general public (e.g., in schools, high-population-density work environments, and some high-volume retail settings). 
  • Low exposure risk groups do not require contact with people or are infrequently exposed to the general public.

OSHA also outlines five steps employers can take to responsibly prevent their workers from being exposed to COVID-19.

  1. Develop an Infectious Disease Preparedness and Response Plan
  2. Prepare to Implement Basic Infection Prevention Measures
  3. Develop Policies and Procedures for Prompt Identification and Isolation of Sick People, if Appropriate.
  4. Develop, Implement, and Communicate about Workplace Flexibilities and Protections
  5. Implement Workplace Controls
    1. Engineering Controls
    2. Administrative Controls
    3. Safe Work Practices
    4. Personal Protective Equipment (PPE)

Despite the pandemic, many industries are considered too critical to close, and must remain in operation during closures with limitations.

Federal Critical Infrastructure Sectors

The Cybersecurity and Infrastructure Security Agency has comprehensively outlined the specific sectors that the Federal Government has deemed critical. Two such sectors are manufacturing, along with food and agriculture.

Critical Manufacturing Sectors

Critical Manufacturing Industries with Sub Industries

Primary Metals ManufacturingIron/Steel Mills and FerroAlloy

 Alumina and Aluminum Production and Processing

Nonferrous Metal Production and Processing
Machinery ManufacturingEngine and Turbine

Power Transmission Equipment

Earth Moving, Mining, Agricultural, and Construction Equipment
Electrical Equipment, Appliance, and Component ManufacturingElectric Motor

Transformer

Generator
Transportation Equipment ManufacturingVehicles and Commercial Ships

Aerospace Products and Parts

Locomotives, Railroad and Transit Cars, and Rail Track Equipment

Products made by these industries are essential to many other critical infrastructure sectors. The Critical Manufacturing Sector focuses on the identification, assessment, prioritization, and protection of nationally significant manufacturing industries that may be susceptible to manmade and natural disasters. CISA has an existing plan from 2015. For more information, please contact the Sector-Specific Agency at criticalmanufacturing@hq.dhs.gov 

Critical Food and Agriculture Sectors

Homeland Security has recognized Agriculture as a critical industry. As such, these closures do not apply to this sector.  The Food and Agriculture Sector is almost entirely under private ownership and is composed of an estimated 2.1 million farms, 935,000 restaurants, and more than 200,000 registered food manufacturing, processing, and storage facilities. This sector accounts for roughly one-fifth of the nation’s economic activity.

The Food and Agriculture Sector is critically dependent on many sectors, but particularly with the following:

Water and Wastewater SystemsClean Irrigation and Processed Water
Transportation SystemsMovement of Products and Livestock
EnergyPower the Equipment Needed for: Agriculture Production and Food Processing
ChemicalFertilizers and Pesticides Used in the Production of Crops

For resources available to Food and Agriculture Sector partners, visit the Department of Agriculture and the Food and Drug Administration websites.

The Families First Coronavirus Response Act (FFCRA)

The Department of Labor is administering new paid leave requirements effective through December 31, 2020. Each covered employer must post in a conspicuous place on its premises a notice of FFCRA requirements. Employers may not discharge, discipline, or otherwise discriminate against any employee who takes paid sick leave under the FFCRA and files a complaint or institutes a proceeding under or related to the FFCRA. Employers in violation of the first two weeks’ paid sick time or unlawful termination provisions of the FFCRA will be subject to the penalties and enforcement (Sections 16 and 17 of the Fair Labor Standards Act. 29 U.S.C. 216; 217.)

FCRA Coverage and Qualifying for Leave

CoveredNot Covered
Certain public employers, and private employers with fewer than 500 employees.Most Federal employees are not covered by these expanded provisions for family and medical leave, but are covered by paid sick leave. 
Small businesses with fewer than 50 employees may qualify for exemption.

Qualifying for Leave

Full-TimePart-Time
Up to 80 hours paid sick leave.Paid sick leave equal to hours worked on average over a 2-week period.
If Workers are Unable to Work or Telework Due to:
1) Being subject to a Federal, State, or local quarantine or isolation order related to COVID-19;
2) Being advised by a health care provider to self-quarantine related to COVID-19;
3) Experiencing COVID-19 symptoms and is seeking a medical diagnosis;
Employees taking leave shall be paid at either their regular rate or the applicable minimum wage, whichever is higher, up to $511 per day and $5,110 in the aggregate (over a 2-week period).
4) Caring for an individual subject to an order described in (1) or self-quarantine as described in (2);
5) Experiencing any other substantially-similar condition specified by the Secretary of Health and Human Services, in consultation with the Secretaries of Labor and Treasury; or.
Employees taking leave shall be paid at 2/3 their regular rate or 2/3 the applicable minimum wage, whichever is higher, up to $200 per day and $2,000 in the aggregate (over a 2-week period).
6) Caring for a child whose school or place of care is closed (or child care provider is unavailable) for reasons related to COVID-19.,Full-time employees are eligible for up to 12 weeks of leave at 40 hours a week

Part-time employees are eligible for leave for the number of hours that the employee is normally scheduled to work over that period. 

Employees taking leave shall be paid at 2/3 their regular rate or 2/3 the applicable minimum wage, whichever is higher, up to $200 per day and $12,000 in the aggregate (over a 12-week period—two weeks of paid sick leave followed by up to 10 weeks of paid expanded family and medical leave).

Assistance for Small Businesses During the Outbreak

Covered employers qualify for dollar-for-dollar reimbursement through tax credits for all qualifying wages paid under the FFCRA. Qualifying wages are those paid to an employee who takes leave under the Act for a qualifying reason, up to the appropriate per diem and aggregate payment caps. Applicable tax credits also extend to amounts paid or incurred to maintain health insurance coverage. For more information, please see the Department of the Treasury’s website.

Opportunities and resources for emergency funding outside of these tax credits are available through the CalAsian Chamber of Commerce (CACC). Their Business Triage Center has a dedicated team to help small businesses get access to capital by packaging their loans and providing credit enhancement services, supporting applications to Small Business Administration’s (SBA’s) Disaster Loans and the IBank’s Small Business Disaster Relief Loan Guarantee Program. They can also help direct applicants to one of their various lending institution partners.  Additionally, the CACC created a survey to determine how to best assist small businesses statewide. Your input will better enable them to prioritize your business needs during these uncertain times.

CalAsian Chamber of Commerce Business Triage Center contact information.

The U.S. SBA is offering low-interest federal disaster loans for working capital to small businesses in designated states or territories suffering substantial economic injury as a result of the Coronavirus (COVID-19). SBA Disaster Loans are limited to federally declared disaster states or territories. Therefore, your State or Territory may not yet be eligible for assistance. However as of March 17, 2020 they have issued revised criteria that makes more businesses eligible for the loans.

Under newly revised criteria

  • States or territories are only required to certify that at least five small businesses within the state/territory have suffered substantial economic injury, regardless of where those businesses are located.
  • Disaster assistance loans will be available statewide following an economic injury declaration. This will apply to current and future disaster assistance declarations related to Coronavirus.

As of March 20, 2020, all 50 states, the District of Columbia, five territories and one tribe are working directly with FEMA under the Nationwide Emergency Declaration for COVID-19.

The USDA extended the application deadline for the Rural Business Development Grant (RBDG) program and the Rural Energy for America Program (REAP) to no later than April 15, 2020. Contact the Rural Development office for the RBDG deadline in your state. For additional information on the REAP deadline, see page 16925 of the March 25, 2020, Federal Register.

Knowing the symptoms and preventative measures is only the start. Businesses must take responsibility for their employees’ health by adapting their daily operations, and are required to provide sick leave when prevention is not enough. In light of these responsibilities, business owners are not without help: the Federal government will be providing tax breaks to employers for those companies impacted by the outbreak and Chambers of Commerce, like CalAsian Chamber of Commerce, are providing assistance in acquiring additional funding. Be sure to visit our website wcismag.com and social media to read real-time updates to this article, curated content from other industry information leaders, and share how COVID-19 is affecting your business.

Be sure to contact CACC or your local SBA office to see what assistance your company may qualify for. Email CACC with “COVID-19 IMPACT – Technical Assistance Needed” in the subject line. Cha Xiong: 916-389-7489, cxiong@calasiancc.org; Linda Thor: 916-389-7478, lthor@calasiancc.org

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California Shell and Hull Waste to Energy Generating Biomass

California Shell and Hull Waste to Energy Generating Biomass

Written by Dr. Michael Lawrinenko

Our modern society and the conveniences we enjoy comes with a price as demand for energy, food, fiber, and fuel has been met with use of fossil fuels and the development of intense agricultural practices which the use of has generally led to detrimental effects on environmental quality. Landfills and waste yards that hold agricultural and municipal wastes abound our land. Despite some recycling efforts, often it is simply too expensive to eliminate many wastes or open burning is prohibited due to the negative impact on air quality. Trash to steam and co-generation energy plants can mitigate some waste, however it is often economically unfeasible to burn it all: high transportation costs and low-energy values make it too expensive to haul some wastes or even utilize materials that are too wet, do not combust well, and are too far away. As such, land is continually being reappropriated for dumping, substantial amounts of trash are dumped in the oceans, and there continues to be a lack for a sustainable way to manage waste that protects the air that we breathe, the water we drink, and the soil from which we eat.

Pyrolysis is a process in which biomass and wastes such as garbage, agroforestry residuals (wood chip, nut shells, etc.), and even manures are heated under low-oxygen conditions. Biological material is transformed to charcoal and gases. Biochar is charcoal specifically produced from biomass and was originally intended for soil application. However, biochar has many uses and has been developed for water treatment applications, air filtration, and some material production. While there is yet debate about the large-scale production of biochar for specific applications, the pyrolysis process can most definitely condense waste and offer a solution to the growing problem of waste accumulation. Further, the process destroys microbial and viral material-effectively sterilizing the waste as it is converted to charcoal.

The California Almond Board estimates almost 5.6 billion pounds of almond nut shells and hulls. Additionally, there are many other nutshell, pruning wastes, and forestry wastes that require costly grinding equipment and additional fossil fuel usage to operate-just to grind up these materials so they can be land applied. When economical, some of these wastes are burned at co-generation power plants, however the energy value is low (often less than half that of coal) and high transportation costs preclude utility of wastes more than 30 miles from the energy plant. Further, there exist tremendous quantities of non-recyclable paper and plastic wastes that are landfilled. These wastes can be diverted from landfills and from our oceans by converting them into higher energy charcoal with consistent energy value that would be more economical to then ship to co-generation power stations.

Energy values of most biomass are far less than that of coal. Oven dried wood is about two-thirds while fresh wood chips are about a third and baled grasses one fourth to one third that of coal. Charcoal can have energy values up to 90% that of coal. Yield of charcoal can range from 10 to 25%. Therefore, the mass of waste could be realistically reduced to one fourth when converted to charcoal that can be directly fed into co-generation power plants and provide the energy needed to drive these systems. As less mass is transported, the cost to transport charcoal in terms of its energy value would be roughly one fourth to one third that of transporting the biomass which would enable the utilization of biomass and other wastes that are currently too far from the power plant. Thus, using a system that converts wastes to charcoal onsite would create a win-win situation for California in diverting wastes from landfills and increasing green energy production.

Until recently, processes and equipment developed to pyrolyze materials have been costly and consume substantial energy. One of the biggest challenges to economic pyrolysis is moisture content of the feedstock. These challenges have been overcome with the recent development of a system by Dr. Michael Lawrinenko, a soil scientist and expert in biochar. With 450 citations on seven peer-reviewed journal articles, his passion for protecting the environment and deep interest in biochar sparked the interest in developing a pyrolyzer that is economical and robust. His professional work may be found on Google Scholar at https://scholar.google.com/citations?user=HalS7RAAAAAJ&hl=en  While still in development, this system can directly use wet biomass and convert it into biochar. This process is being developed using wood chips; some is fresh and some is compost. This pilot system utilizes a portion of the material for process heat; to drive the drying and pyrolysis of the remaining material. This important breakthrough could potentially be applied to convert agroforestry and other wastes in California for green energy production.

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Company Profile: Raphio Chocolate

Raphio Chocolate

On the southwest corner of First and Barstow, near the center of Fresno, California, you’ll find one of the best little chocolate shops in the state. Look hard, because you might miss it.

Raphio’s Chocolate was started in 2015 by Yohanes Makmur and a business partner, both immigrants from Indonesia. They were both working other jobs at the time but wanted something else. Noticing the craft chocolate market and remembering the cacao beans back home, they were surprised to learn that Indonesian chocolate wasn’t even on the map. Originally, they’d hoped to simply be an importer of cacao beans, but life would take them a different direction—much to the benefit of the rest of us.

The pair reached out to their connections back home and found a farmer they liked working with. The farmer shipped them samples and products that both liked, and they started selling them in the U.S. Hopeful, the pair made a massive order of 1.5 tons… more than their supplier could actually handle, as it turned out. The aesthetic quality didn’t meet U.S. producer’s standards, and Yohanes found himself with 1 and a half tons of cacao beans that he didn’t know what to do with.

That’s when his wife Elisia stepped in. She loved the idea of making chocolate from scratch and took those beans, beginning to experiment with them. While Elisia wasn’t the biggest chocolate fanatic, her husband and children were, and she was making chocolate for them. Her standard was simple: whatever chocolate she made had to be good enough for her kids. Not simply in taste, but in quality. Nothing artificial, nothing she wouldn’t want her kids eating. 

That standard has remained the same, since. And, when Yohanes decided to begin selling this chocolate, he named the shop accordingly: Raphio, after his sons Raphael and Rio. 

Among their greatest challenges, as a microfactory, has been space. It’s obvious when you stand in the front of their store. It’s beautiful and stacked temptingly with cacao beans, cacao tea, chocolates, bonbons, and espresso. You can see the space where they make the chocolate through a small glass window. Speaking as someone who’s been back there for a tour, trust me: there’s not much more space than you can see. As such, they often have to move equipment, clean, and disinfect between tasks, simply because they don’t have the room for a distributed factory space. 

They hope to expand as the Coronavirus pandemic reaches its end, maybe with the hope of two of their most reliable allies. The first is the CMTC, which helped them start operations, offered grants for human resources trainings, and assisted them in marketing through the local advisor, Craig Scharton. This is the same man who connected them to many of their current partners. The second notable partner is the Small Business Development Center, who has offered low-cost and free webinars, teaching them how to run a business and build their brand.

Perhaps this local support—always strong in the Fresno area—is part of the reason that, by Yohanes’s own admission, Raphio’s has a dedicated passion for keeping their partners local. 

Among their first and most notable partners are Enzo’s Olive Oil, who contributes the oil that makes one of their most delectable bars, and local coffee giant Kuppajoy. They consulted with Kuppajoy before building their brand and, since opening, have offered chocolate coffee beans and espresso, both sourced from Kuppajoy. Meanwhile, Kuppajoy is one of the most reliable places to find Raphio’s chocolate bars, lately, they’ve even expanded their local outreach to nearby Madera, where Ficklin Vineyard’s Port Wine plays a crucial part in the making of Raphio’s delicious and hard-to-get bon bons. 

Raphio’s offerings aren’t limited to chocolate. Before the pandemic, they’d also began to focus on education, offering incredibly informative tours of the factory, complete with details about the chocolate harvesting process and life in Indonesia. You’re given a chance to touch the chocolate, taste it, smell it, breathe it. In the future, they hope to grow their educational offerings, maybe making them extracurricular opportunities for local schools and senior homes. Yohanes hopes to use this education to change childrens’ eating habits at a young age, showing them the benefits of dark chocolate and real chocolate, as opposed to the “chocolate-flavored sugar” you’ll find in grocery aisles. 

Likewise, they want a cultural lesson wrapped into the tour, as well. Yohanes would like to teach about the places these cacao beans originate from, possibly partnering with local organizations to bring artifacts to show children. 

But, this comes back to the problem of space. The factory floor is too small for them to offer tours outside of weekends, when schools are closed and people are staying inside, away from the Valley heat. When they expand, they hope to keep this goal of education in mind, researching circulation, space planning, and how people move from one spot to another to expand in a way that allows them to offer tours and increase production without impeding each other.

Yohanes says that, when you pay attention to the ingredients of your food, you shouldn’t simply look at health. You need to pay attention of how it’s made, where, and by who. This chocolate is craft, he says. Its story isn’t limited to Fresno. The farmers back in Indonesia are an integral part of it, and part of the reason for the extra price of the chocolate is that the money goes directly to farmers to better their family’s lives.

One question remains, though: what is Yohanes’s favorite chocolate on offer? He admits that chocolate is an enormous weakness of his, and doesn’t hesitate on his answer: his favorite is the dark chocolate from Tanzania, 72%. It starts like eating honey, and as it melts gives way to flavors of fruits and berries. After you swallow, it lingers on your tongue with a nice tang. Yohanes describes the process of a “rollercoaster of flavors” that is “playing a concert in your mouth.”

It shouldn’t be any surprise that the bar has won competitions in places as far away as London. 

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Cell-Cultured Protein: Regulatory Considerations and Opportunities

Cell-Cultured Protein: Regulatory Considerations and Opportunities

Written By: Eve Pelonis, Natalie Rainer, and Connie Potter; Keller and Heckman, LLP

At the forefront of current food innovation and technology is the “cell-cultured protein” sector (also described as “cultured,” “cell-based,” “cultivated,” “lab-grown,” and “in vitro”). Cell-cultured protein technology essentially entails growing protein cells in a growth medium under controlled conditions. Manufacturers across the globe are rushing to culture proteins that have a taste, texture, and nutrition profile that is indistinguishable from their animal-based counterparts. With products ranging from beef to yellowtail to foie gras to lobster, the cell-cultured protein industry has the potential to revolutionize the food and agriculture industries.

While Singapore has taken an early lead in terms of regulatory approvals by becoming the first nation to approve a cell-based protein, the United States is poised to be a fertile ground for the growth of the cell-cultured protein industry. Below we discuss the future regulation of this industry in the U.S., what information will likely be required to seek regulatory approvals from the relevant regulatory agencies, and issues related to the labeling and marketing of cell-cultured proteins in the U.S.

To set the backdrop for the discussion below, we first discuss the basics of cell-based protein technology: biopsy, cell banking, growth, harvest, and food processing. After collecting a tissue sample from an animal in a biopsy, a laboratory team selects the cells with the most desirable traits and adds them to a cell bank. The selected cells are then multiplied using a bioreactor. The bioreactor uses a growth medium and controlled conditions to create an ideal environment for growing cells, which often grow attached to a scaffold or like structure that helps the cells grow in the proper pattern to create a finished product. Once a sufficient number of cells have accumulated, producers harvest the cells from the growth medium and bioreactor, either detaching the cells from the scaffold structure or removing the cells and scaffold together if the scaffold is edible. The cells are then prepared into a finished food product, often by blending the meat cells with a fat to create, for instance, a ground beef patty or meatball. With this background in mind, we discuss the regulatory framework for evaluating this technology, followed by potential labeling issues, below.

Regulatory Status of Cell-Cultured Protein Products in the United States

As the two agencies that oversee the safety of the U.S. food supply, the U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA) have both asserted regulatory authority over cell-cultured meats. Generally, USDA is responsible for oversight of meat, poultry, processed egg products, and catfish, while FDA oversees virtually all other domestic and imported foods, including all seafood products, sold in the U.S. In 2018, USDA’s Food Safety and Inspection Service (FSIS) and FDA hosted the first of several public meetings on cell-culture technology and discussed potential hazards, oversight considerations, and product labeling.

Following additional public comment periods, the agencies issued a formal interagency agreement in March 2019 that set out their respective roles in the oversight of cell-cultured meat products based on their respective strengths and expertise. Per the formal agreement, FDA will oversee the cell culturing process for meat and poultry products until the harvest stage, including cell collection and the development and maintenance of cell banks, and FDA will retain sole jurisdiction over seafood. Facilities will need to comply with FDA food safety requirements, including food facility registration, hazard analysis and risk-based preventive controls (HARPC), and current Good Manufacturing Practices (GMPs). Following harvest of cells from bioreactors, USDA assumes regulatory authority and is responsible for inspection of the meat cells and finished products derived from livestock and poultry under its authority from the Federal Meat Inspection Act and Poultry Products Inspection Act. FDA and USDA have agreed to collaborate to develop a more detailed joint framework on standard operating procedures, product labeling, and other issues. However, aside from FDA’s issuance of a Request for Information regarding the labeling of foods containing cell-cultured seafood products, as of the date of this publication, neither agency has published further details on these initiatives.

Industry is concerned by the lack of additional action on the part of FDA and USDA. In October 2020, the Alliance for Meat, Poultry, and Seafood Innovation joined the North American Meat Institute in urging FSIS to issue an Advance Notice of Proposed Rulemaking to initiate an

information collection process. The agencies have expressed a great deal of interest in collaborating with cell-cultured meat producers, but companies appear to be reluctant to participate, perhaps given the highly-confidential processes and proprietary information at stake.

Visit CLFP.com or cal (916) 640-8150

Where to Go from Here?

Cell-cultured meat products could pose safety concerns unique from those in traditional meat production. In fact, the technology is so new that it remains unclear just how FDA and USDA will approach the specifics of approving cell-cultured foods. The concerns highlighted in an April 2020 report by the Government Accountability Office (GAO) included the potential use of antibiotics at the cell growth stage and potentially new safety issues unique to this new technology (e.g., residues or constituents not seen in conventional meat or other foods). We expect regulators to evaluate the safety of cell-cultured proteins from all angles: microbial contaminants, cell growth media, scaffolding ingredients, bioreactors, etc. All inputs and impurities of potential concern will be explored.

While industry’s hesitation to be among the first in line to approach regulators is understandable, stakeholders should also recognize that there is an opportunity to be among the first to drive the dialogue, to focus regulators on specific issues, and to be the first entrants into the U.S. market. The more the agencies know about the process, the better they can create a regulatory framework that will most accurately capture the way the industry operates. 

Use of the Term “Meat” and Other Labeling Concerns

Another murky legal and regulatory area facing the cell-cultured protein industry is the marketing of cell-cultured protein products and in particular the naming of such products. Some current contenders for naming cell-cultured products include terms like “clean,” which critics argue reflects a bias for or against other products and affect how they are perceived in the market.

While both USDA and FDA are aware of this labeling question, neither entity has proposed a regulatory solution. Various pieces of legislation have been introduced (but have not passed) in Congress that seek to clarify when a “meat,” “milk” or other traditional term can be used, generally restricting such term to products from traditionally-raised livestock or requiring that non-traditional products use the term “imitation” in their product identity statement. 

Perhaps because of the lack of action by Congress or federal agencies, several states—including Arkansas, Arizona, Louisiana, Mississippi, Missouri, Oklahoma, Nebraska, North Dakota, South Dakota, Texas, and Wyoming—have passed laws restricting use of the term “meat” on cell-cultured meat or plant-based meat alternative products. Many of these laws have been challenged in court by companies in the meat-alternative space that argue the laws violate the First Amendment by limiting speech and are not necessary to protect the public from potentially misleading information in addition to being overbroad and impeding competition in the marketplace. Results of the suits have varied, with some successes for the meat alternative industry. For example, while an Arkansas federal district court granted a preliminary injunction preventing enforcement of a state law that restricted the use of meat claims on plant-based products in 2019—finding that the plaintiffs were likely to prevail on their First Amendment claims, a federal district court in Oklahoma upheld a similar challenge to a state law that required a disclaimer on plant-based foods using a meat term in the product identity statement. 

* * *

Cell-cultured products will be ready to enter the market soon, and USDA and FDA will need to act quickly to create a framework that manufacturers can work with if they want to assert leadership in this space. Even if cell-cultured meat products can overcome regulatory hurdles and enter the market, several recently-published studies show consumers may not yet be willing to embrace cell-cultured meat as an alternative to traditional meat products because of concerns over taste, food safety, and lack of knowledge about the process. Manufacturers will need to focus on consumer outreach and launch education initiatives to garner an understanding of their products to be successful.

(1) Cultured Meat: Shaping the Future of Foods, Keller and Heckman LLP (Feb. 1, 2021), https://www.khlaw.com/insights/cultured-meat-shaping-future-foods. Cell-culturing technology could be an intriguing option for countries like Singapore with limited capabilities for livestock production that seek to produce more food domestically. Other countries have frameworks in place to review cell-cultured products but have not yet approved any. In the European Union, cell-cultured meat products must be assessed as a novel food by the European Food Safety Authority under Regulation (EU) 2015/2283. Australia and New Zealand’s food regulatory agency, Food Standards Australia New Zealand, has a premarket approval system in place that would similarly encompass new cell-cultured products. Cell Based Meat, Food Standards Australia New Zealand https://www.foodstandards.gov.au/consumer/generalissues/Pages/Cell-based-meat.aspx (last visited Feb. 14, 2020).

(2) U.S. Gov’t Accountability Off., GAO-20-325, Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat 9–11 (2020), https://www.gao.gov/assets/710/705768.pdf.

(3) Technology is still improving to create more structured meat products, such as a filet. Aleph Farms, an Israeli start-up, recently announced it had developed a ribeye steak using bioprinting technology. Aleph Farms and The Technion Reveal World’s First Cultivated Ribeye Steak, Cision PR Newswire (Feb. 9, 2021), https://www.prnewswire.com/news-releases/aleph-farms-and-the-technion-reveal-worlds-first-cultivated-ribeye-steak-301224800.html. 

(4) Recordings of each USDA-FDA Joint Public Meetings are linked at FDA’s Food Made with Cultured Animal Cells page, https://www.fda.gov/food/food-ingredients-packaging/food-made-cultured-animal-cells.

(5) Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species, FDA (March 7, 2019), https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell.

(6) See FDA Seeks Input on Labeling of Food Made with Cultured Seafood Cells, FDA (Oct. 6, 2020), https://www.fda.gov/food/cfsan-constituent-updates/fda-seeks-input-labeling-food-made-cultured-seafood-cells. The Senate has twice introduced bills aimed at moving the regulatory process forward by formalizing the USDA/FDA formal agreement and prescribing a timeline for the agencies to promulgate regulations. See Food Safety Modernization for Innovative Technologies Act, S. 3053, 116th Cong. (2019), https://www.congress.gov/bill/116th-congress/senate-bill/3053 (codifying the division of authority for cell-cultured products between USDA and FDA as set forth in their 2019 formal agreement, providing guidelines for inspection of cell-cultured meat production facilities, and creating labeling guidelines specific to cell-cultured meat products); Cell-Cultured Meat and Poultry Regulation Act of 2019, S. 1056, 116th Cong. (2019), https://www.congress.gov/bill/116th-congress/senate-bill/1056 (codifying the USDA/FDA 2019 formal agreement and giving the agencies eighteen months to promulgate regulations regarding inspection frequency of relevant facilities and labeling guidelines).

(7) Meat Institute and AMPS Innovation Send Joint Letter to USDA on Mandatory Labeling for Cell-Based/Cultured Meat & Poultry Products, North American Meat Institute (Oct. 19, 2020), https://www.meatinstitute.org/ht/display/ReleaseDetails/i/180624/pid/287.

(8) U.S. Gov’t Accountability Off., supra note 2, at 8.

(9) See id.

(10) The U.S. Cattlemen’s Association submitted a petition to USDA in February 2018 requesting the agency limit the term “beef” to products from traditionally-harvested livestock, and the petition received over 6000 comments, but USDA has not moved on the issue to date. See Petition for the Imposition of Beef and Meat Labeling Requirements: To Exclude Products Not Derived Directly from Animals Raised and Slaughtered from the Definition of “Beef” and “Meat”, U.S. Cattlemen’s Association (Feb. 9, 2018), https://www.fsis.usda.gov/wps/wcm/connect/e4749f95-e79a-4ba5-883b-394c8bdc97a3/18-01-Petition-US-Cattlement-Association020918.pdf?MOD=AJPERES.

(11) See, e.g., Food Safety Modernization for Innovative Technologies Act, supra note 6; Cell-Cultured Meat and Poultry Regulation Act, supra note 6; Real Marketing Edible Artificials Truthfully Act of 2019, H.R. 4881, 116th Cong., https://www.congress.gov/bill/116th-congress/house-bill/4881/all-info.

(12) Elaine Watson, ‘Highly disingenuous…’ Plant-based labeling battle heats up as more states challenge use of meat, dairy terms, Food Navigator-USA (Feb. 3, 2021), https://www.foodnavigator-usa.com/Article/2021/02/03/Highly-disingenuous-Plant-based-labeling-battle-heats-up-as-more-states-challenge-use-of-meat-dairy-terms?utm_source=newsletter_daily&utm_medium=email&utm_campaign=03-Feb-2021.

(13) Turtle Island Foods SPC v. Soman, 424 F. Supp. 3d 552, 571 (E.D. Ark. 2019) (finding a state law that prohibits plant-based meat alternative products from using terms such as “burger,” “sausage,” and “roast,” even if the product identity statement contains a disclaimer phrase such as “plant-based” or “veggie”).

(14) Upton’s Naturals Co. v. Stitt, No. CIV-20-938-F, slip op. at (W.D. Ok. Nov. 19, 2020) (finding that a law requiring disclaimer terms on plant-based meat alternatives to be at least as equally prominent in size and color as the product name was not unduly burdensome and justified in preventing consumer confusion).

(15) In study published by the University of Sydney and Curtin University, 72% of the 227 surveyed Australian customers in “Generation Z” (born between 1995 and 2010) reported perceptions of uneasiness and discomfort with cultured meat products, even if they thought the product might be a more sustainable food option than traditionally farmed meat. Diana Bogueva & Dora Marinova, Cultured Meat and Australia’s Generation Z, Frontiers in Nutrition, Sept. 2020, at 6, https://doi.org/10.3389/fnut.2020.00148. See also Jo Anderson & Chris Bryant, Messages to Overcome Naturalness Concerns in Clean Meat Acceptance: Primary Findings, Faunalytics, July 2018, Clean-Meat-Acceptance-Primary-Findings.pdf (faunalytics.org) (surveying 1,185 American adults in 2018 and finding that while the majority of those surveyed had not heard of a cell-cultured meat product before, 66% of those surveyed would be willing to try it, but using biased terminology such as “clean meat” that would have legal risk if used in the market); Nearly One in Three Consumers Willing to Eat Lab-Grown Meat, According to New Research, Surveygoo (Jan. 2018), https://surveygoo.com/portfolio/cultured-meat-survey/ (surveying 1,000 U.S. and U.K. consumers and finding 29% would be willing to eat a cell-cultured meat product described as “cultured meat”). 4839-4212-9116, v. 4

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How a Write-Up can Build-Up

How a Write-Up can Build-Up

Written by Tim Nightingale, Nightingale Resolutions

“One of the best write-up experiences I have had in a long time, and the best part was how the employee I wrote-up left the meeting in good spirits.”

Oftentimes, when we read a rule, we think about the dos and don’ts of the equation. But, there is so much more to a rule. Rules are in place for a reason; they are designed to protect us and others from harm. Well written rules, especially ones that are focused on safety, protect employees from physical harm, maintain efficiency and decrease any possible liabilities for the company all the while increasing the quality of food being produced.

Writing an employee up for not adhering to the safety rules is an important and necessary step but comes with no guarantees of changed behavior. 

Daniel shared with me about an upcoming write-up, and I invited him to use a four-step sequence designed to increase the likelihood of a behavioral change. Because of the recent supervision training that Daniel had engaged in, he was ready to grow in his supervisory role and try something different.

Step 1) Prepare a concise list of the ways this choice affects the supervisor, the employee, the other employees, and the company as a whole. When speaking with the employee begin with the following prompt:

This is the way it impacts me and others…

Step 2) Create space to listen to their story without judgment. Use the following prompt:

Can you share with me how this happened?

Step 3) After listening to the story, summarize it and invite the employee to take responsibility using this question:

As you reflect upon it is there anything you would do differently?

Step 4) Thank the employee for recognizing alternative possibilities and complete the four-step sequence with this final invitation:

Knowing how it has impacted me and others is there anything you think could or would do to correct it?

Using these four steps Daniel reported that his relationship with the employee strengthened, that the employee recognized the potential harm that could have come from his shortcuts, committed to changing his behavior, identified ways that it could be done better in the future, gladly accepted the writeup, and even generated ideas for safety practices in other areas. 

If you, or your company, is interested in further exploring the ways that the High-Performing Team Growth Cycle can invite safer, more productive, and higher quality practices with your team please reach out to me at Tim.nightingaledc@gmail.com.

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How to Work with a Food Scientist

How to Work with a Food Scientist

Written by Brian Chau, Principal Advisor at Chau Time

Hiring a food scientist or food product developer can be a daunting challenge. These are the people who transform your food idea into reality. Read more to better understand: how a food scientist within product development operates; how to use a project proposal as a tool to set expectations for your overall vision; and explore the options on how to best collaborate with a food scientist. 

Understand the Framework:

There are a lot of job titles for food scientists including: food technologist, product developer, food specialist, culinologist, culinary developer, formulator, or R&D scientist/chef. For simplicity, food scientist will imply any titles aforementioned. 

When looking for a food scientist, specify that you are looking for someone who can do product development from concept to commercialization. A food scientist with product development experience has the knowledge to help take your idea, create a prototype, and provide a formula that will be commercially viable. Some specialize in product development and not scale-up; that may be fine depending on your needs, but we will focus on a food scientist who can do both. A good food scientist should also be a good product manager, balancing different parameters that affect development from costs to scalability. Their end goal is to deliver a product formulation that is likely to be reproduced at scale while also being food safe. 

What a food scientist will help you do:

  • Make suggestions regarding how to improve the product and provide critical feedback in a very technical and structured approach
  • Tell you that a request is outside the bounds of regulations, food safety, or even scientific principles
  • Assist in the development process
  • Work with an existing manufacturing line

What a food scientist will NOT help you do:

  • Tell you how to reverse engineer intellectual property that a competitor took years to develop
  • Tell you the best flavor (as that is often very subjective and the food scientist may not fit your target audience)
  • Make the final decisions for you and your brand
  • Engineer new equipment for scaling

The first step in working with a food scientist is to co-create a project proposal to set clear expectations and understand how to go through the product development process.

The Project Proposal; Setting Expectations: 

Any good food scientist should best work within the framework you provide them. You provide the guardrails and expectations for your brand. What guides the conversation is understanding that you provide a range of values or priorities that will allow the food scientist to help you better develop the product or inform you about the issues you are to expect on the feasibility of your request. Here is a list of parameters to discuss:

Commercialization: 

Arguably one of the most crucial parameters, and is what differentiates a food scientist from a chef. How you scale up products through equipment is based on your approach and your strategy. Whether you are going to work out of a commercial kitchen or start with a contract manufacturer, a food scientist can guide you through the process. Commercialization goals should often be the first point of discussion as a food scientist will better understand how to scale the product and provide prototypes that have mimicked the commercial processes.

Product Attributes: 

Let the food scientist understand your branding by describing what kind of certifications you expect to have on your package: organic, non-GMO, Kosher, Halal, keto-friendly, high in fiber, no trans-fat, etc. What kind of ingredients do you accept or do not accept and why do you think it is important to the brand?

Packaging: 

Let the food scientist know what is your serving size, number of servings per package, and what type of package you plan to use. If you do not know these parameters, look at analogs in the market and make your best assumption.

Nutritional: 

Although this parameter overlaps with branding, the nutrition panel requires special attention. Offer a range of values for your macronutrients (ex: 8-10 grams of protein per serving size.) Based on your packaging, you can determine if you want vertical, horizontal, or linear labels. Specific nutrition claims and allergen statements will be duly noted.

Cost: 

Your cost of goods sold is important. You want to allow for a range of values here too; be specific on what you are including in your cost of goods sold by mentioning if you are referring to the case, the individual unit, or by the pallet. Look at whether you are referencing minimum order quantity or tiered pricing.

Sensory: 

Determine how many stock keeping units, what flavors, an ideal texture, and ideal look and/or color.

Shelf Life: 

Your suggestions will be an ideal range. The food scientist can tell you what to realistically expect or at least suggest a better range. Be specific on what you are looking for as there are different types of shelf-life studies between sensory, microbiological, and physical and/or chemical. 

Timeline: 

Depending on the product and what stage your business is in; you can have a quick turnaround time or anywhere between 6 and 9 months. Food scientists understand their own timelines and can either fulfill your request or tell you how reasonable or not the timeline is. 

Food scientists are not magicians. They cannot read your mind nor have a product appear out of nowhere. Product development takes time, iteration, and flexibility in making adjustments. The range of values will allow for flexibility in the development process. You don’t want to make the development so difficult that the process stalls out and your launch plans get impacted. Setting expectations allows for dialogue on what is feasible within a timely and structured manner; set priorities between parameters to make decision making easier.

When developing your project proposal, you want to understand what your needs and wants are in the negotiation table as well as the needs and wants of the prospective food scientist. You want to have an idea of how to best communicate with the food scientist and assess if there is synergy with the food scientist. Some food scientists work on a per project proposal which works out best for their project management. Others work on an hourly basis which can be valuable for quick turnaround times. Some food scientists might be open to the idea of equity and turning into a long-time partner of your organization. At the end of the day, a food scientist is a person with a particular skill set of translating science and technology of food and beverage into a commercially viable, food safe, and delicious product. Each food scientist operates under rigorous training in the sciences, but they also have their own personalities that may or may not work well with your brand. Honestly, the same principle applies to anyone you want to hire. Always be open to exploring all options before making a final decision. 

The process of working with a food scientist takes time. In building out these relationships by setting expectations and building dialogue, the path to developing your product will be less stressful. The project proposal is a tool to lay the foundation of how to work with the prospective food scientist. Remember that food scientists are people too and they cannot read your mind; they don’t understand your vision as much as you do and they have their own personalities. By understanding how they operate, you can better manage how to leverage their expertise to grow your business. You can save time in knowing you have someone who can translate the technical information for you to make a final decision. Most importantly, you managed to de-risk a critical component of your business.

Brian Chau: Food Scientist, Fungal Fanatic, and Food Systems Analyst at Chau Time. Brian is the Principal Advisor at Chau Time, his own consultation firm. He is the Co-founder of MycoKind, a food biotech company. He also sits as an advisor to food tech companies. He is working on his first book, How to Work with a Food Scientist, to help founders understand a food scientist’s capabilities and improve the understanding of how to navigate the technical world of food and beverage consumer packaged goods.

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ParityFactory

What exactly does ParityFactory do?  

ParityFactory is a food specific warehouse management (WMS) and production management system. The software is a tool for food and beverage manufacturers to manage the physical operations of their plant, and further, to automate the data management process. This is done through the use of a relatively common technology, although one that is still surprisingly underutilized in the food space: scanning and barcoding. Traditionally, food and beverage manufacturers have managed their tracing data and inventory balances with paper or spreadsheets.  

In a ParityFactory plant, raw materials are tagged with a barcode the moment they enter the facility. With just a simple barcode, the system can track the material at every step of production, whether it’s moved to storage, processed into finished goods, or shipped out. This generates a real-time view of all the inventory on hand, a comprehensive tracing chain, and makes detailed, accurate production planning possible. Customers find they have dramatically reduced inventory variances and a more efficient manufacturing process. 

History 

ParityFactory was founded in Seattle, WA over 30 years ago, but if you took a look at the company today you’d never know it. Despite its long history in food and beverage, the company has more the attitude of a new and growing software firm, and that’s because the last few years have been full of huge changes for the once tiny business. 

Decades ago, the Seattle-based company designed accounting systems for Alaskan fish processors. However, as Tyler Marshall, President at ParityFactory says, “Working in the food and beverage space for so long, we came to realize that there were plenty of companies that were doing accounting well, but very few who offered a comprehensive solution for managing inventory and tracing.” With this realization, the company pivoted towards designing solutions to manage the physical operations on the plant floor roughly 7 years ago. The result was their current offering and namesake of the organization, ParityFactory. 

Growth and Future Plans 

The company’s current CEO, Sean Clemmons, took his position in January 2019 and since then the company has accelerated its growth and added new clients across North America. That growth has brought opportunities to invest in the creation of new and exciting solutions to problems faced in the food and beverage industry. During the two years under Sean’s leadership, ParityFactory has released several extensions to its core platform.  

In 2020 alone, numerous new products have been launched under the ParityFactory brand, including a suite of tools aimed to help manufacturers who work directly with growers receive their product in bulk, automate payment calculation, and get quicker insight into grading and quality data. The company released their latest offering, the ParityFactory inventory Portal, in late 2020. Designed for those who run third-party logistics operations, the Inventory Portal allows users to provide their clients direct access into how much inventory they have stored, with data automatically pulled from the ParityFactory core platform. 

Investment into new products is slated to continue well into 2021 and beyond, as Sean Clemmons puts it, “Many of the challenges processors face are consistent across the industry, but every operation is a little different. With each new client we sign, we discover new problems to solve and new possibilities for innovation.” 
For more information on the ParityFactory platform, visit their website at www.parityfactory.com or reach out to parityfactory@paritycorp.com

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Industry Update: FDA Announces FSMA Food Traceability Proposed Rule

Written by Jon Kimble, Originally Published in Industry Updates

On September 21, 2020, the Food and Drug Administration announced the release of a draft rule for the food industry, “Requirements for Additional Traceability Records for Certain Foods” (also referred to as the Food Traceability Proposed Rule). This is one of the last remaining elements of the FDA’s Food Safety Modernization Act (FSMA), assigned to the FDA by congressional mandate. This draft rule requires that the FDA implement additional traceability expectations for the food industry based on risk.  This new rule is being billed by the FDA as part of its overall “Blueprint for the New Era of Smarter Food Safety”, which outlines several key elements, including enhanced traceability.

Our overall impression is that our customers, such as yourself, are already largely in compliance with the requirements as they’re currently written, perhaps with just a few minor gaps. The FDA has provided more information about the rule on their website. 

7 Key Takeaways Regarding This Rule:

  1. This is a draft rule. Now is the time to submit any feedback or concerns.
  2. Its scope is limited.  It pertains specifically to those who manufacture, process, pack, or hold specific types of foods on the FDA’s “Food Traceability List” (FTL).
  3. It requires tracking specific activities. The FDA refers to these as “Critical Tracking Events” (CTEs), and they include: growing, receiving, transforming, creating, and shipping.
  4. It requires tracking specific data. The FDA calls these “Key Data Elements” (KDEs), and they must be tracked for each Critical Tracking Event.  They include information such as grower location identifier; lot numbers and other traceability identifiers; business names, numbers, and points of contact; quantities and units of measure; and other key elements.
  5. It requires farms to communicate some basic information to customers. This includes location identifiers for the growing area and each location the product was processed or stored at, including business names and key contacts.
  6. The record format is flexible. Under the rule, the FDA allows either paper or electronic records.  However, it’s worth noting that, especially for finished companies who produce ready-to-eat foods, the FDA has made it clear that there is a preference for electronic records, where necessary to facilitate traceability (see the next requirement).
  7. Records must be readily available. The FDA requires that companies be able to provide a sortable electronic spreadsheet to the FDA containing any affected products, within 24 hours of any FDA request, to assist in the investigation of any outbreak or recall. 

If you’d like a member of our team to help you conduct an assessment of your company’s traceability programs, we’re ready to assist you, virtually or on-site! Reach out to us at foodsafety@safefoodalliance.com.

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DOE Revisions to Manufacturing Regulations

DOE Proposes Revisions to Enforcement Regulations for Consumer Products and Commercial and Industrial Equipment

Written by JC Walker of Keller and Heckman, LLP

Date: Sep 10, 2020

In a notice published on August 31, 2020, the U.S. Department of Energy (“DOE” or the “Department”) proposed revisions to its existing enforcement regulations for certain consumer products and commercial and industrial equipment.[1] The proposed revisions are intended to further align the regulations with the Energy Policy and Conservation Act of 1975 (“EPCA”) and provide additional clarity and transparency about DOE’s enforcement process. Manufacturers of covered products should review this proposal very carefully. While certain proposed changes may provide some reduction in administrative overhead, the practical outcome may be to increase a company’s liability exposure during enforcement investigations as we discuss below.

A. Electric Motor Enforcement Procedures

Currently, the enforcement provisions for electric motors are promulgated separately at Part 431, Subpart U. According to DOE, the enforcement process for other covered products at Part 429 is much more developed. Thus, the Department believes that harmonizing electric motor enforcement with the procedures for all other covered products should afford electric motor manufacturers greater clarity. This is by no means an administrative change as the proposal could pose significant liability implications for electric motor manufacturers.

First, enforcement testing for motors could only be conducted by a laboratory that is accredited to the International Organization for Standardization (“ISO”)/International Electrotechnical Commission (“IEC”) standard 17025:2005(E), General requirements for the competence of testing and calibration laboratories. In contrast, Part 431 currently requires testing by National Institute of Standards and Technology/National Voluntary Laboratory Accreditation Program (“NIST/NVLAP”) accredited laboratories.[2] The proposed change should not be significant as NVLAP incorporates the ISO/IEC 17025 standard.[3] As both NVLAP and ISO/IEC 17025 have moved to the most recent version of the standard ISO/IEC 17025:2017, however, it is not clear whether DOE’s prescription of ISO/IEC 17025:2005 narrows the available pool of test laboratories.

More importantly, the proposal would reduce a company’s ability to challenge DOE’s enforcement testing by eliminating 10 C.F.R. § 431.383(f), which allows electric motor manufacturers to request additional DOE testing after DOE makes a noncompliance determination. Under the proposal, it appears that DOE would conduct additional sampling only at its discretion and if a unit in the initial sample is proven to have been defective.

Moving electric motor enforcement to Part 429 will also increase the number of possible causes of action available to DOE, including: failure to test a product in accordance with the applicable test requirements; use of controls or features to circumvent the test procedure and produce test results unrepresentative of the product’s actual energy performance; and knowing misrepresentation by certifying an energy use or efficiency that is not supported by test data.[4]

B. Enforcement of Design Standards

DOE also is proposing to clarify that “design requirements” are energy conservation standards subject to DOE investigation and enforcement, as specified by the EPCA.[5] According to DOE, the evaluation of only a single test unit would be sufficient to demonstrate that basic models in the preceding categories are non-compliant:

DOE’s proposal explicitly states that a test unit of a basic model subject to a design requirement may be selected for enforcement testing or examination. In such an instance, DOE will make a determination of noncompliance for the basic model based on an examination of whether a single unit of the basic model fails to comply with the applicable design requirements, as the standard applies to a design-not the measured performance of individual units-such that one unit can demonstrate noncompliance.[6]

Based on our cursory review, the following covered products are subject to design requirements:

Water boilers                                                  Torchieres

Conventional cooking tops                        Commercial unit heaters

Conventional ovens                                   Walk-in coolers and walk-in freezers

Ceiling fans                                                    Residential boilers

Ceiling fan light kits

Manufacturers of these products would not only be subject to enforcement for noncompliance with the numerical energy performance, but also if a single unit fails to meet an applicable design standard. Examples of such failures could include failing to use a triple pane glass door with either heat-reflective treated glass or gas fill in a walk-in freezer as required by 10 C.F.R. § 431.306(b)(1).

C. Use of Third-Party or Competitor Data for Enforcement

Under its current enforcement regulations, DOE may request any relevant information from manufacturers to assist in determining whether their covered products comply with applicable energy conservation standards.[7] The Department is proposing to allow use of compliance information from other parties, including but not limited to, third-party certification programs or other manufacturers with independent test data, for enforcement purposes. According to the Department:

This proposal ensures that DOE can enforce its regulations in instances where relevant information is retained by parties other than the manufacturer. Parties other than the manufacturer often conduct independent testing to determine compliance with applicable standards. In such instances, DOE’s ability to retrieve that test information could save government testing resources, and ensure that DOE can enforce in a timely manner, which will further DOE’s goals of maintaining a level playing field for all parties and encouraging compliance.[8]

Contrary to DOE’s stated intent, the current proposal may act to chill competitor complaints to the Department. In our experience, manufacturers will often submit test data to DOE to initiate an investigation of a potentially noncompliant competing product. This information is often provided on a confidential basis to avoid commercial disputes with a competitor, because the testing was done in-house rather than by an accredited laboratory, or for a variety of other reasons. The expectation is that DOE will pursue its own testing to support any subsequent enforcement action.

It is difficult to understand, however, how DOE could bring an enforcement action based on confidential information without triggering due process concerns. Thus, any final regulations must address DOE’s procedures for “retrieving” data from third parties; how the Department intends to proceed if complainants request confidentiality; and the likelihood that it will investigate complaints in the absence of such data.

The DOE’s proposal to retrieve test data from third-party certification programs may also raise concerns. Data submitted in support of certification is compliance data and should be available to the DOE. That said, manufacturers should review the terms of their certification program agreements to understand how these organizations will handle their certification data, whether notice will be provided before release to DOE or another agency, and the protections, if any, afforded to non-certification data.

D. Other Changes

The notice proposes several other clarifications and administrative revisions, including:

Adding a process to petition for reexamination of a pending noncompliance determination.[9] As proposed, the process would require that DOE provide the manufacturer with a letter of intent at least 30 days prior to issuing a notice of noncompliance determination. The manufacturer would then have 30 days from the issuance of the letter to file a petition for reexamination that meets certain information requirements (e.g., sets out the material issue(s) with the Department’s assessment or testing, provides complete test reports demonstrating compliance with the applicable standard, etc.). Upon review, DOE may modify or leave its pending determination unchanged.

Providing more specificity and transparency when issuing test notices.[10] In addition to the basic model number, DOE proposes to include characteristics or specifications of subject model(s) (e.g., individual model numbers, serial numbers, manufacturer date ranges or locations) when issuing test notices. The revisions would also require manufacturers to inform the Department if the requested units are unavailable, along with details regarding the unavailability of the units and any similar available units. To that end, the Department proposes to add a provision reserving DOE’s ability to make a noncompliance determination based on a reduced sample size in limited circumstances (e.g., when the basic model is subject to design requirements or test units are unavailable).[11]

Allowing a finding of noncompliance based on a single assessment test where efficiency is at least 25% worse than the applicable standard.[12] According to DOE, the new process would avoid the expenditure of unnecessary resources by foregoing the typical enforcement testing process.

Eliminating the requirement to notify customers of a determination of noncompliance.[13] To reduce the burden on manufacturers, the Department proposes to eliminate the provision at 10 C.F.R. § 429.114(a)(2), which requires that immediate written notice of a determination of noncompliance be provided to all persons to whom the manufacturer has distributed units of the basic model since the last compliance determination.

Comments on the proposal will be accepted until October 30, 2020. For any questions on this notice of proposed rulemaking or energy efficiency requirements in general, please contact us.

[1] Enforcement for Consumer Products and Commercial and Industrial Equipment, 85 Fed. Reg. 53,691 (Aug. 31, 2020).

[2] Or a laboratory accreditation body with a mutual recognition arrangement with NIST/NVLAP; 10 C.F.R. § 431.18.

[3]See generally NIST Handbook 150:2020, NVLAP Procedures and General Requirements, available from https://www.nist.gov/nvlap/publications-and-forms/nvlap-handbooks-and-lab-bulletins.

[4] 85 Fed. Reg. 53,694.

[5] See 42 U.S.C. § 6291(6).

[6] 85 Fed. Reg. 53,694.

[7]10 C.F.R. § 429.106(b). This includes covered products or equipment that are imported into the United States, which are also subject to the applicable provisions of 40 C.F.R. Part 429, 430, and 431. 10 C.F.R. § 429.5.

[8] 85 Fed. Reg. 53,694.

[9]Id. at 53,696.

[10] Id. at 53,694.

[11] See Id. at 53,705 (proposed as 10 C.F.R. § 429.111(a)(8)).

[12] Id. at 53,696.

[13] Id.

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California Manufacturing Technology Consulting (CMTC) California

Written by: Craig Scharton, CMTC Solutions

The first two questions that I am often asked are:

1) What is CMTC?

CMTC is a 501(c)3 nonprofit organization. We are primarily funded through the U.S. Department of Commerce and the State of California. We are part of a national network of organizations (Manufacturing Extension Partnership) that is focused on helping manufacturers. CMTC is the entity that is focused on connecting California’s manufacturers to resources.
President Reagan and Senator Hollings helped to create this network because they found that there were many programs to help the manufacturing sector, but few knew that these programs existed. Just as there are extension agents in agriculture, we are client advisors for small to medium-sized manufacturers.

2) What is a manufacturer?

People often imagine big industrial buildings with welders and conveyor belts. But really, a manufacturer is a business that makes a product. Wineries and breweries are manufacturers. An almond farmer who packages her own seasoned nuts is a manufacturer. We have clients who make a product in their garage or kitchen and we have clients who make parts for fighter jets. Sometimes we even have clients who didn’t know that they were a manufacturer like a restaurant that makes salsa or salad dressing as a side business.
The first thing that I recommend to any manufacturer is to set up an Assessment and a Plan of Action with one of our two incredible, local experts. The assessment takes 1-2 hours of the business’ time and is free. One of our resources has a financial background and the other has an operational background. The manufacturer can choose whichever they think would be the most helpful. Our financial expert is a C.P.A who is also a Chief Financial Officer for several companies. The Operations expert has run manufacturing plants around the world and is a mechanical engineer, with an M.B.A. in Management and is a Black Belt in Lean manufacturing. We are very fortunate to have this level of expertise available to help our local manufacturers.

Regions of Service

My region is the Central Valley, from Tulare County up to San Joaquin County, and over to the Nevada state line. I have experienced colleagues that can help if you are in another part of the state, I’m always happy to make the introduction. It’s a great group of people who, like me, really enjoy helping our businesses.

Beyond the 60+ people who work for CMTC, we also have over 150 trainers and consultants who also help our manufacturing clients. We’ve added quite a few in the Central Valley so that we can pair local professionals with our local businesses. As I look up at my dry erase board, I see local companies who will be using local consultants and trainers to help with: ISO 9001 certification, High Performing Teams training, English as a Second Language, Lean Manufacturing, SQF/HACCP for food safety and audits, SolidWorks training, and forklift safety. Those are just the ones on my current To Do list!

In Fresno County, I work very closely with the Fresno Regional Workforce Development Board (FRWDB). The FRWDB has prioritized training for manufacturing businesses. This business-focused organization works closely with our clients to help their businesses to grow by helping to underwrite the cost of improving the skills of their employees. This is a huge win for our community because the businesses are stronger, and their employees have more skills that can help them to grow in their careers.

CMTC also has formal partnerships with two outstanding local organizations, the San Joaquin Valley Manufacturing Alliance and the Water, Energy, Technology (WET) Center at Fresno State. The SJVMA and WET Center provide many great resources for their respective (and often overlapping) members. We work with many other agencies from EDCs to community colleges, the SBDC and city and county economic development departments.

While I like to find resources to pay for some or all of the training or consulting costs for a client (depending on the business location, size and sector) I often provide other services to help our businesses. I helped one client to find a lender to help them to buy their building. I’ve helped others by connecting them to a consultant to help them get a Research and Development Tax Credit. Often I help by connecting two local manufacturers who can help each other meet supply chain needs locally.

Many manufacturers also use our services as a neutral, third party provider. We can analyze a business’ cyber security needs or which types of technology will help them to become more automated. We often evaluate which type of ERP system a manufacturer needs. Because we aren’t selling a product or software, we can assess a company’s needs and make recommendations and present options.

Love of Local


Hopefully, you can read my enthusiasm for helping our local businesses. It’s been a passion of mine for over three decades. Many of the problems that we face in our region are the result of the disconnection between the resources and the need. Businesses don’t have the time to start calling government agencies to find out which programs might be helpful to them. The programs are often buried deep inside a division within an agency within a department. Even if the business owner managed to find the programs, they wouldn’t know how to find out which was the right one for their needs. This is where I come in. I learn about the resources so a business can find out which programs fit their needs.

Business leaders are often the type of people who like to forge ahead and solve every problem on their own. They often forget to look around to see how many resources there are to help them, their business, and their employees. But it is important to use every resource to help your business to grow. There are many forces making it difficult to operate a business, so it is imperative to take advantage of the programs and services that are here to help. These resources come and go, so stay informed so that you can use them while they are available and find out what the next opportunities are on the horizon.

Finally, local businesses should be supporting other local businesses, if we want our economy to grow. Consider using a local bank. Look around to see if you could source parts or materials in our region. Use a local web designer or mechanical engineer (we have both). Attend some local trade meetings to find out what other manufacturers are doing, so maybe you could connect them to a customer, too. Find local wine or chocolate to give as gifts to your clients. I believe that we have all of the resources that we need, it’s up to us to figure out how to make them work for us effectively.


I’m happy to schedule a zoom meeting with any manufacturers in our region to see if CMTC can be helpful. Please send an email to me at cscharton@cmtc.com

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Managing the Coming Clash Between Solar Development and Environmental Protection

Written by Robert Selna, Selna Partners, LLP

Solar panels continue to drop in price, generate power more efficiently, and attract private developers who consider solar a good investment and pro-environment. As a result, it appears likely that the State of California will reach its goal of generating sixty percent of its electricity with renewable energy sources by 2030. 

It is also clear that large solar projects that generate the most power at the lowest price, require large amounts of flat, undeveloped property proximate to power substations. In California, the property meeting this criteria tends to be agricultural.  This reality sets the stage for conflicts between groups that share similar goals: on one hand are renewable energy proponents hoping to reduce the state’s reliance on greenhouse gas-emitting energy sources; the other is environmentalists and open space advocates, including those concerned about the state’s declining acreage of farmland and the native wildlife habitats and species that live and around it. 

The Nature Conservancy estimates that California will need between 1.6 and 3.1 million acres of solar and wind facilities by 2050 to decarbonize the electricity system and support a complete transition to green energy. The Nature Conservancy has noted that “with so much development on the horizon, it’s imperative that energy planners incorporate impacts to nature when making decisions about a clean energy future.”

Some of California’s local jurisdictions that feature large swaths of agricultural land and open space have started to address the inevitable clash between renewable energy development and nature conservation. They have identified areas for solar development where there is “least conflict” with productive farmland and imperiled plants, animals and natural habitats. For example, Santa Clara and Contra Costa Counites have conducted studies and UC Berkeley completed a similar analysis focused on the San Joaquin Valley. 

The counties that are not working to address the coming conflicts associated with the expected boost in solar development are doing so at their own peril and, instead, may see such disputes resolved by the courts, potentially at a high cost to taxpayers. 

There are a few common sense actions that county governments can take to help avoid clashes, but local government agencies and elected officials must give the actions priority to get them done in a timely fashion, as the demand for solar land rapidly expands. Examples include 1) completing solar mapping studies to understand least conflict areas; 2) executing general plan and zoning code amendments and related environmental reviews to provide solar developers and the public with more certainty about where large solar installations may be sited; and 3) educating agencies and the public about renewable energy, the state’s goals and the best approaches to achieving such aspirations. 

I have seen firsthand how the failure to prepare for the inevitable tension between solar development and land preservation can lead to bad results. My law firm currently represents an association of 250 property owners, cattle ranchers, environmentalist and proponents of good government called Save North Livermore Valley (“SNLV”). 

For more than six months, SNLV has been at odds Alameda County over the County’s decision to process solar development permit in eastern Alameda County. The developer proposes to place approximately 460 acres of ground-mounted solar panel facilities and storage batteries in North Livermore Valley, situated between the City of Livermore and the Altamont Pass. 

Alameda County features hundreds of thousands of agriculture acres on its east side and provides an example of a jurisdiction that has publicly committed to the laudable goal of providing more renewable energy for residents and contributing to the state’s renewable energy goals. Unfortunately, the County essentially ignored the coming battles that pit solar developers against farmers and environmentalists. The county is a cautionary tale for counties that fail to address the tension that occurs when solar companies set their sites on developing ag land and open spaces. 

One County’s Commitment to Renewable Energy 

The tension could have been avoided. A decade ago, Alameda County started down a path to provide clear guidance to solar developers and conservationists, but never completed the work. Now, the 460-acre project, called, Aramis, is causing the very tension the County sought to once avoid. That’s because the project is proposed for North Livermore Valley, which has long been the site of ranchland and is subject to a voter initiative intended to protect agricultural land, wildlife habitats, watersheds, “and the beautiful open space of Alameda County from excessive, badly located and harmful development.” 

The County’s support for solar originated in 2009. That’s when Alameda County Supervisor Scott Haggerty spearheaded the start of East Bay Community Energy (“EBCE”), a non-profit that contracts with clean energy projects to provide more renewable power for residents of the East Bay. Haggerty represents East County, which includes Livermore and is, by far, the County’s most agricultural area. According to County staff reports, “EBCE has brought greater levels of renewable energy at competitive prices to residents of Alameda County….A major goal of the EBCE is to encourage and invest in renewable energy, including solar at the local level.” (citation?)

In East Alameda County between 2008-2012, developers proposed two utility-scale solar projects on land historically used for cattle grazing before the County completed studies on the best locations to site large solar facilities in east county. In 2012, the Supervisors instructed to the County’s planning staff to complete the studies and a general plan amendment before any new large-scale solar projects were approved in east county. Unfortunately, that direction appears to have been ignored. 

Common Sense Steps Can Avoid Conflict

A general plan is county’s most fundamental planning document. In Alameda County, a general plan amendment could have clarified locations where solar installations were allowed and provided a map to reflect the locations. For instance, a general plan might have permitted large solar installations in East County except for in areas identified as scenic routes, or where wineries concentrated vineyard land. 

Zoning divides counties into districts and applies different regulations in each district. Within the districts, zoning dictates the specific uses that are allowed and dictates the scale and scope of those uses. Zoning also includes the uses that are permitted as of right, or conditionally permitted – meaning permitted if they meet certain conditions. In Alameda County, a zoning amendment regarding large-scale solar installations might have limited the contiguous acreage of solar facilities so that they did not occupy a disproportionate amount of land. An amendment also could have dictated that solar projects compensate for any land they occupy by preserving an equal amount of rangeland elsewhere. 

Under the California Environmental Quality Act, general plan and zoning amendments require an environmental impact report (“EIR”). An EIR is intended to help understand the ecological implications of the proposed amendments.  As an example, if a proposed zoning amendment allowed utility-scale solar in an area known for migrating species, the EIR would alert the county and the county might modify the locations to avoid the conflict. 

Mapping studies indicating solar installation locations least likely to impacts the environment have helped counties amend their general plans and zoning districts. In one example, UC Berkeley completed a mapping study throughout the San Joaquin Valley using four mapping components:  1)  Areas that allow for the movement of species; 2) Occupied or potential rare species and communities; 3) Conservation lands that already prevent or restrict development such as dedicated conservation lands and federally-designated critical habitat; and  4) Expertly-identified conservation priority areas.

Finally, given the State of California’s necessary efforts to transition to renewable energy and a corresponding interest from developers to install solar facilities on California ag land, governmental agencies’ decisions must be well-informed. It is not enough for a county agency to know that more solar is needed. A more nuanced understanding is required to evaluate circumstances in which renewable energy development goals conflict with other environmental priorities. 

The Transition to Renewable Energy 

Currently California is transitioning from fossil fuel power sources to renewables including solar, but the transition cannot happen overnight. To be a truly reliable source of energy, solar requires battery storage, otherwise the state’s power grid loses its renewable power at night. Battery storage technology needs more work to work effectively for the grid, but advances are being made. 

Since 2015, California’s solar generation has increased by 350% and accounts for fifty percent of all green energy sources in the state. In recent years, California has actually produced too much solar power during the day and has had to “curtail” the solar power by off-loading it to other states. 

State statistics show that more solar is on the way. According to the California Energy Commission, 9,460 solar facility projects have obtained permits but have not yet completed construction. Many of those are expected to come online in the next five years. As a result, the nascent clash between solar developers and those advocating to preserve agriculture land and open space is only expected to increase. 

County governments can better manage and possibly avoid some of these disputes with timely least-conflict studies and mapping, land use amendments and education. They should not delay!