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CBD in Food and Dietary Supplements: What is the legal status?

Written by Natalie Rainer
Counsel, Keller and Heckman LLP

Interview with Natalie Rainer of Keller and Heckman LLP as a webinar.
Interview with Natalie Rainer of Keller and Heckman LLP as a podcast.
Open in Spotify to listen to the full episode.

Since the Farm Bill of 2018 changed the definition and regulatory status of hemp from an agricultural perspective, confusion and misinformation has been rife on the U.S. Food and Drug Administration (FDA) regulatory status of hemp and its products—including cannabidiol (CBD), a non-psychoactive cannabinoid.  Despite there not being a clear basis for concluding that CBD has an appropriate FDA regulatory status for use in food, CBD has gained mass popularity, and it is not uncommon to see CBD sold in chocolate, oils, and even pet treats in your local stores.  In this article we have summarized the current status of CBD in food and dietary supplements and the hurdles that lie in the path of supporting a suitable FDA status for such uses.

Impact of 2018 Farm Bill

When Congress passed the 2018 Farm Bill (formally known as the Agriculture Improvement Act of 2018), there was widespread misunderstanding that the law legalized substances derived from the Cannabis sativa L. plant, including CBD, for use in food and dietary supplements.  In fact, the relevant provisions of the Farm Bill merely removed hemp from the Controlled Substances Act definition of marijuana.  The 2018 Farm Bill defined “hemp” as Cannabis sativa L. with less than 0.3% tetrahydrocannabinol (THC, a psychoactive component of cannabis) on a dry weight basis (1) and affected the Drug Enforcement Administration’s authority over hemp farming.  The change granted more authority to states to regulate the growth, production, and distribution of hemp products.

The 2018 Farm Bill had no effect on FDA’s authority to regulate CBD or other hemp products; it also did not change the regulatory definitions of “food additive” and “dietary ingredient” to facilitate the use of ingredients like CBD in food and dietary supplements. (2)  FDA continues to have authority to regulate products containing cannabis and cannabis-derived compounds, including those classified as hemp. (3)  Therefore, CBD is subject to the same regulatory requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) as other food additives and new dietary ingredients.  

Current FDA Position on CBD

FDA has consistently taken the position that it is unlawful to sell a food or dietary supplement containing CBD in interstate commerce because CBD is not eligible for use in those products under the FFDCA, as CBD had been studied for possible “drug” uses before it was marketed in foods or dietary supplements.  These clinical studies led to FDA’s 2018 approval of Epidiolex, which contains a purified form of CBD, as a drug for use in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.  Pursuant to Section 301(ll) of the FFDCA, FDA is taking the position that it is unlawful to market foods that contain an added “drug” that has been approved by FDA or “for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”   (While there are exceptions for substances that were in foods before they were approved or studied as drugs, such as caffeine or baking soda, FDA has determined that CBD does not fall under such exceptions.) (4) Likewise, FDA has cited Section 201(ff)(3)(B)(i) of the FFDCA, which explicitly excludes approved drugs or those substances that are the subject of publicly-disclosed clinical studies, from the definition of “dietary ingredients,” as being the basis for CBD not being permitted for use in dietary supplements.  Thus, FDA’s current position is that marketing foods or supplements containing CBD violates the FFDCA and, because of this, that such products are adulterated.  

That said, FDA thus far has taken enforcement action only against foods and supplements containing CBD when such products make drug claims concerning the prevention, diagnosis, mitigation, treatment, or cure of disease.  Specifically, FDA has sent warning letters to a number of companies making claims that CBD can treat conditions such as cancer, Alzheimer’s disease, opioid withdrawal, pain, pet anxiety, arthritis, and other conditions. (5)

In early March 2020, FDA released a Congressionally requested report (6) on the agency’s progress toward developing a regulatory framework to allow CBD in conventional foods and dietary supplements.  To the frustration of many, however, it appears that little actual progress has been made.  The most significant revelation from the report is that FDA is considering developing a risk-based enforcement policy that could clarify FDA’s enforcement priorities.  Given the widespread availability of such products, however, an informal policy of enforcement discretion has essentially been in place for some time.  

Congress Tries to Intervene

FDA has received considerable pressure from Congress, particularly members like Senate Majority Leader Mitch McConnell of Kentucky whose states have invested in hemp agriculture, (7) to permit CBD to be legally sold in foods and supplements.  In September 2019, bipartisan Congress members sent a letter to FDA urging the Agency to provide legal clarity and establish a regulatory pathway for food products containing hemp-derived CBD. (8)  They expressed concern with FDA’s estimate that rulemaking on this topic could take between 3 to 5 years and asked for more expeditious measures, like announcing a policy of enforcement discretion and using an interim rule to establish a regulatory framework.  Several bills have been introduced to create a legislative fix for this issue.  One proposed solution, outlined in a H.R. 5587 introduced by Representative Collin Peterson of Minnesota, would amend Section 201(ff)(3)(B)(i) of the FFDCA (discussed above) to exempt “cannabidiol or a hemp-derived cannabidiol containing substance” from the prohibition on marketing approved drugs as dietary supplements.

Lack of Safety Data

As of yet, there have been no proposed Congressional fixes that address the second hurdle to an appropriate FDA status for CBD:  the definitions of “food additive,” “new dietary ingredient,” and related definitions of adulteration in the FFDCA.  These aspects of the law require FDA to evaluate CBD based on a robust safety data set and do not provide FDA with the authority to authorize CBD for use in food and dietary supplements in the absence of such information.  

“Food additive” is defined under Section 201(s) of the FFDCA as substances that are intended, or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.  While food additives require FDA premarket clearance so as not to be found to adulterate food, there is an exemption from the definition of “food additive” for substances that are “generally recognized as safe” (GRAS) for their intended use.  GRAS status can be supported by either common use in food prior to 1958 (which is not relevant to CBD) or general recognition of safety through scientific procedures—generally requiring the availability of published safety studies in peer-reviewed journals.  Similarly, supplements containing new dietary ingredients are considered adulterated unless they contain only ingredients “present in the food supply as an article used for food in a form in which the food has not been chemically altered” or if, 75 days before marketing, the company submits to FDA evidence to show the dietary ingredient “will reasonably be expected to be safe” for human consumption under labeled conditions of use.  In any case (i.e., to obtain premarket clearance or to support a GRAS position), there must be a robust data set supporting the safety of CBD for use in food.  While FDA has had no questions concerning the use of hulled hemp seeds, hemp seed protein, and hemp seed oil as ingredients for use in human food based on existing safety data (9), to FDA’s knowledge, there are not adequate safety data for CBD.(10)

Setting aside the lack of safety data, FDA is aware of potentially adverse safety data regarding CBD.  FDA has noted that taking CBD may increase or decrease the effects of other medications, as well as the risk of liver injury (a side effect observed in its review of Epidiolex). (11)  Studies performed on laboratory animals found potential male reproductive toxicity concerns (e.g., a decrease in testicular size, inhibition of sperm development, and decreased testosterone). (12) Any safety data developed to support CBD’s safety would also need to adequately address these adverse data to satisfy FDA’s requirements for the safety of food additives and new dietary ingredients.  

The current regulatory framework under the FFDCA does not allow FDA to affirmatively evaluate the safety of CBD for use in foods and supplements, nor does FDA have funding to sponsor the necessary studies to support the safety of CBD.  Rather, FDA is waiting for the necessary safety data to be developed to evaluate CBD’s safety.  While FDA held a public hearing on cannabis in May 2019 and opened a public docket to gather comments and data for FDA review (through which the Agency received approximately 4,500 comments), FDA has yet to receive the necessary safety information to allow it to agree that CBD has a suitable status for use in food and dietary supplements. (13)

What about the States?

For the foreseeable future, it does not appear that CBD will have a suitable FDA status for use in food and supplements, and cannabis containing more than 0.3% THC remains an illegal narcotic under the Controlled Substances Act. (14) But how are states handling this issue?

The legality of cannabis state regulation is varied.  Some states, like California and Colorado, have completely legalized recreational cannabis, which includes CBD products.  Other jurisdictions, such as Vermont and Washington, DC, have legalized marijuana but do not allow sales.  Others have decriminalized it or only allow medical use. (15) A number of states, like Texas and Wisconsin, continue to regulate marijuana as an illegal drug.  Individual states handle issues such as age restrictions, dosage, labelling, testing, and licensing of marijuana differently.  Further complicating matters, individual cities and counties can impose different rules, with some completely banning the growing, manufacturing, and selling of cannabis.  As a result, in many jurisdictions, there is a conflict between the federal government and states that permit the marketing of CBD products.

* * *

Regulations concerning CBD remain in flux.  It remains to be seen how Congress and FDA will address the legality of CBD in food and dietary supplements under the FFDCA.  However, the CBD industry should be aware that robust safety data will most likely be required to ultimately convince FDA to permit CBD in food and dietary supplements.  This endeavor will take a considerable amount of time and financial resources and will need to overcome existing data on adverse health effects.    Despite these issues, we expect to continue to see CBD readily available in food and dietary supplements, provided that such products do not bear drug claims.

The author gratefully acknowledges the assistance of Paula Pastuskovas in the preparation of this article.

1.What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD; FDA (March 5, 2020), available at: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis 

2. Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD; Daily Intake, Keller and Heckman (December 13, 2018), available at: https://www.dailyintakeblog.com/2018/12/contrary-to-popular-reports-farm-bill-will-not-affect-fda-status-of-cbd/

3. Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit; FDA (August 12, 2019), available at:  https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-industrial-hemp-council-2019-hemp-business-summit-08132019 

4.  FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns; FDA (November 25, 2019), available at:  https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

5. Id.  See also FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety (July 23, 2019), available at:  https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer.

6. Report to the U.S. House Committee On Appropriations and the U.S. Senate Committee on Appropriations – Cannabidiol (CBD) – Report in Response to Further Consolidated Appropriations Act, 2020 – U.S. Food and Drug Administration (undated) (public existence disclosed on March 5, 2020), available at: https://hempsupporter.com/assets/uploads/FDA-CBD-Report.pdf.

7. Senator Mitch McConnell, Leader McConnell Discusses Tobacco 21 Legislation, Hemp and CBD with FDA Commissioner Nominee (November 20, 2019), available at:  https://www.republicanleader.senate.gov/newsroom/press-releases/leader-mcconnell-discusses-tobacco-21-legislation-hemp-and-cbd-with-fda-commissioner-nominee.

8. Congress Continues to Seek Regulatory Clarity on CBD from FDA; Daily Intake, Keller and Heckman (September 24, 2019), available at: https://www.dailyintakeblog.com/2019/09/congress-continues-to-seek-regulatory-clarity-on-cbd-from-fda/

9. Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit; FDA (August 12, 2019), available at:   https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-industrial-hemp-council-2019-hemp-business-summit-08132019 

10. FDA, FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) (March 11, 2020), at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd. 

11. What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD; FDA (March 5, 2020), available at:https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis 

12. Id.

13. Id.

14. Cannabis remains a Schedule 1 drug under the Controlled Substances Act. This means that it cannot be used on federal lands within the states as it remains unlawful under federal law.  Let’s Talk Cannabis; California Department of Public Health (November 17, 2017), available at: https://www.cdph.ca.gov/Programs/DO/letstalkcannabis/Pages/legal.aspx.  This is because of the Cole memorandum that was issued in 2013. The memorandum was sent to all United States Attorneys that the Justice Department would not enforce the federal marijuana prohibition on states that legalized marijuana in some form and implemented effective enforcement systems.  Cole Memorandum; U.S. Department of Justice (August 29, 2013), available at: https://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf.  After a brief rescission of the Cole Memorandum by Attorney General Jeff Sessions in 2018, current U.S Attorney General William Barr made a pledge not to go after companies growing or manufacturing marijuana that was in compliance with state laws and with the Cole Memorandum. Cannabis Quick Hits; Daily Intake, Keller and Heckman (February 1, 2019), available at: https://www.dailyintakeblog.com/2019/02/cannabis-quick-hits/.

15. About Marijuana; NORML (last accessed March 11, 2020), available at:  https://norml.org/marijuana 

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California Hemp Farming and Products Start to Take Shape

Written By Robert W. Selna,
Founder Selna Partners Law Firm

Interview with Robert Selna as a webinar.
Listen to the interview with Robert Selna as a podcast episode through Spotify.
Gloved hand holding leaves of five leaved plant, potentially hemp or cannabis.

California hemp cultivation registrations skyrocketed in 2019 and are expected to increase further this year due to federal hemp decriminalization and a perceived demand for hemp-derived CBD and other hemp products. A mature statewide hemp industry is a ways off however, due to unfinished regulations and the on-going effort to overcome a federal ban on food and beverages infused with hemp-derived CBD.  

“Ninety-nine percent of the hemp being grown in California right now is for CBD and, at the moment, the only legal hemp CBD products are topicals and smokable hemp,” said Brian Webster, Founder of CA-Hemp, an advocacy group that supports the growth of the hemp industry. “There needs to be an expansion of the topical and smokable products while the feds and the state issues around hemp CBD in food and beverages get worked out.” 

Hemp is defined as cannabis with extremely low concentrations of THC (not more than 0.3 percent on a dry weight basis). The Food and Drug Administration (FDA) prohibits CBD in food, beverages and cosmetics, regardless of whether the CBD is derived from cannabis that includes THC (the psychoactive constituent of cannabis) or from hemp.

CBD, short for cannabidiol, is a chemical compound from the Cannabis sativa (L.) plant that is widely accepted as exhibiting therapeutic properties, including anti-anxiety and pain-reduction effects. Unlike THC (short of tetrahydrocannabinol), CBD is not psychoactive. 

The U.S. Department of Agriculture (USDA) currently is reviewing public comments submitted in response to its October 2019 draft interim rule for domestic hemp production. The interim rule, which, despite its singular name includes scores of regulations, is a key step to implementing the 2018 Farm Bill. The Farm Bill legalized hemp nationwide after it had been criminalized by Congress in the early 1900s along with marijuana.

The 2018 Farm Bill left it up to states to decide whether to legalize hemp farming within their state’s borders, but required that, at a minimum, cultivated hemp could be freely shipped across all state lines. States that want to permit hemp cultivation either must adopt the federal regulations, or create their own that are consistent with the federal regs. The USDA’s publishing of the first draft of the interim rule has allowed states, including California, to start writing their regulations. 

Federal and State Laws

Outline of west coast states with California highlighted with image of hemp or cannabis filling its shape.

In 2019, as California’s fledgling hemp farmers waited for the federal interim rule to be published, they closely monitored two bills that state legislators introduced to take advantage of a vast new hemp business opportunity created by the 2018 Farm Bill. As the legislative session came to a close last year, results on the bills were mixed.

In mid-October, Governor Gavin Newsom approved SB 153, which provides the funding and timetable for California to draft a state hemp cultivation plan that conforms with the USDA interim rule. That work has started, but can’t be completed until the feds release their final draft.  

In contrast, state lawmakers failed to decide on AB 228, which would have legalized the statewide manufacture and sale of food, beverages and cosmetics that include hemp-derived CBD. The bill died in the Senate Appropriations Committee without a vote.

Following the lead of a handful of other states, including Colorado and Oregon, California Assemblymember Cecilia Aguiar-Curry (D-Winters) tried to address the federal CBD disconnect through AB 228. AB 228 contradicted the FDA, which deems products with CBD as “adulterated,” and prohibits them from being introduced into interstate commerce.

The FDA’s position is based on its decision to approve CBD as an active ingredient in the pharmaceutical drug Epidiolex, which treats a rare form of epilepsy. In turn, the FDA deems CBD to be like all other active drug ingredients, which may not be added to food and dietary supplements. 

Despite seemingly broad support, AB 228 did not make it out of committee by the end of the 2019 legislative session. Aguiar-Curry brought back a new version of AB 228 in January 2020 and hemp industry advocates had hoped the bill would be approved by late March. 

An early 2020 approval timetable proved unrealistic as advocates say that the Governor’s office and legislators still need more education about hemp, a crop that was ubiquitous from the founding of the Nation to the early 1900s, but that had been illegal for more about a century after being lumped together with marijuana. 

Thus far, the California Department of Public Health (CDPH) has followed the FDA’s restrictions on hemp-derived CBD. Meanwhile, one can find hemp-derived CBD wellness products in small health food stores, as well as large chain supermarkets, which has caused confusion among consumers. As noted by CA-Hemp’s Brian Webster, most of the hemp CBD products on those shelves are lotions, creams and other topicals — a type of product the FDA has not regulated.  

The FDA and CDPH prohibition are seen by many as inconsistent with the spirit of the 2018 Farm Bill, which approved the cultivation and sale of hemp, as well as the interstate commercial transfers of hemp and hemp products, including hemp-derived CBD. However, the Farm Bill did explicitly confirm the FDA’s authority to regulate hemp-derivatives in food and beverages. 

Representatives in Congress are starting to awaken to issues surrounding the FDA’s CBD prohibition. Senate Majority Leader Mitch McConnell has taken baby steps to resolve the problem. In mid-September, McConnell introduced a bill that could result in the FDA adopting a more lenient framework for hemp-derived CBD products. Specifically, the legislation directs the FDA to issue “an enforcement discretion policy” that would give the agency latitude and possibly lead to recognition that CBD products are safe.

Industry Growth 

Chart showing change in California Hemp Growers registered with the USDA from 74 in June 2019 to 558 in February of 2020.

Legislative hiccups and regulatory confusion aside, the California hemp industry is gaining momentum. Q4 statistics from the California Department of Food and Agriculture show that the number of registered hemp growers in California increased from 74 in June 2019 to 558 as of February 4, 2020. In addition, there are now at least 1,165 registered hemp cultivation sites and 38,464 acres associated with growers and seed breeders.

Under the 2018 Farm Bill, counties may only allow limited cultivation pilot programs until the USDA confirms that their state’s hemp plan conforms with federal rules. However, until the USDA’s interim rule issuance on Oct. 29, there was a chicken-and-egg problem. California and other states struggled to draft federally compliant hemp plans not knowing exactly what to expect in the interim rule. As a result, at least half of California countries have temporary bans or restrictions on hemp cultivation.

The federal interim rule clarifies states’ hemp regulation responsibilities, including practices for record keeping, methods for testing hemp to ensure that it is below the legal THC limit, and plans for the proper disposal of non-compliant hemp. In addition, the interim rule makes it clear that states and Native American tribes may not prohibit the interstate transport of hemp that has been legally grown under federal and state laws.

California is said to now be working on its hemp conformance plan. SB 153 aids that effort by adding testing, enforcement, and other administrative provisions and providing a deadline for completing a federal hemp conformance plan as May 1, 2020.

California’s nascent hemp industry is incrementally taking shape. 2020 promises to be a big year as federal and state hemp regulations are finalized and the State Legislature debates legalizing hemp-derived CBD products. 

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Innovating Dairy Digester Research

Author: Chris M Brunner
Originally Published on UCANR Food Blog

This episode of Food & Facilities, our host is joined by Chris Brunner and Heather Johnson of Western Institute for Food Safety and Security, and Dr. Pramod Pandey of UC Davis’ School of Veterinary Medicine to discuss innovating dairy digester research.
Open in Spotify to listen.
Dr. Pandey checking samples of biogas collected at UC Davis School of Veterinary Medicine’s lab.
Samples of biogas collected at Dr. Pandey’s lab at the UC Davis School of Veterinary Medicine.

California leads the nation in agricultural production, producing nearly all the nation’s leafy green vegetables, most nut and fruit varieties, and is ranked first in egg and dairy production.

What that means is that California also produces a lot of agricultural waste materials, including lots of manure.

Historically these waste materials have been used as a rich source of compost. However, researchers at UC Cooperative Extension are researching innovative uses for this material. 

Dr. Pramod Pandey, a faculty member and Cooperative Extension specialist at the UC Davis School of Veterinary Medicine, focuses on better ways to manage waste material for both large and small farms. Dr. Pandey researches how to convert the organic matter in manure and other waste materials into a renewable energy source that can be used to power our state.

Converting manure to renewable energy

California gets over 27% of its energy from renewable resources like solar wind, and hydroelectric. Our goal is 50% renewable energy by 2030. California is taking steps towards this goal by building a network of dairy digesters which use bacteria to break down dairy manure and convert it into biogas. Clean burning fuels, such as biogas, are a sustainable source for generating energy because when they are burned, harmful by products are not produced.

California currently gets 27% of its renewable energy from solar, wind, and hydro-electric sources. California hopes to reach 50% renewable energy by the year 2030, and 100% by 2045.

Big bonus

Dr. Pandey holding dry manure material, ready for reuse as fertilizer.

A bonus is that the solid material left after the digesters have done their job is a fertilizer that can be used to grow the fruits, vegetables and nuts that our state is famous for. This type of fertilizer contains nutrients that are more readily available for plants because the digestion process breaks up organic materials more efficiently than traditional composting. The digestion process also helps reduce the number of harmful bacteria found in manure, making it much safer for use on plants grown for human food.

Dr. Pandey and Tim Van Beek (Van Beek Brothers’ Dairy) inspect the contents of a dairy digester together.

California leading in discovery and innovation

When we think about where agriculture has been and where it is going, innovation, efficiency and environmental sustainability are hallmarks of our approach in California. People like Dr. Pandey are driving forward research and technology to minimize the impact of agriculture production on the environment. When we think about where agriculture has been and where it is going, innovation, efficiency and environmental sustainability are hallmarks of our approach in California. His multidisciplinary approach to solving this complex problem of agricultural waste materials and water/air quality helps improve the economic wellbeing of farmers, and benefits Californians by providing nutrients for safe, healthy, and nutritious food.

While the importance of California’s agriculture might be huge, its footprint on the environment doesn’t have to be, and it is researchers like Dr. Pramod Pandey who are ensuring our state leads in discovery and innovation for many harvests to come.

Dr. Pandey and Tim Van Beek stand in front of dairy cows at the Van Beek Brothers’ Dairy.
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Hand Washing: Sanitation That Saves Lives

AnnMargaret Dwyer
Originally Published in Food Safety

We can all agree that handwashing is important. We know that washing your hands prevents you from getting sick, helps prevent the spread of germs, and helps keep our food safe. But time and time again we see people choose to not wash their hands, knowing full well they should be. Why does this happen? It is important to understand why people do not wash their hands, that way more effective techniques can be created to enhance your facility’s handwashing culture.

The Psychology of Not Washing Your Hands

Many people do not wash their hands after they go to the bathroom. But why? Pol Rodellar from VICE chose to ask people why exactly they don’t partake in this sanitary process in the article “People Explain Why They Don’t Wash Their Hands After Peeing”. A few responses to note were:

“People just wash their hands because that’s what they see in films. I sometimes do it in front of people who I saw just washed their hands-I suppose it’s out of respect for others. I guess I don’t do it for myself, but for them.”

Sara, 26

“It’s a fact that washing our hands is just something we do to fit into society. This morning, while I was using the urinal, a colleague who had just finished peeing started thoroughly washing his own hands. So when I finished, I had to do the same so that guy- who continued to wash and dry them as if he had just come out of a mine – didn’t think I was some filthy urchin. So here’s to wasting water and soap and a disposable paper towel just because I can’t be bothered to explain my toilet habits to my colleagues.”

Jordi, 30

“I normally wash my hands before I pee because they’re always dirty due to my job. I only wash my hands afterwards if I splash myself. And to be honest, I’ve stopped worrying about contracting things down there.”

Martin, 28

“I don’t have time to be constantly washing myself. I actually think we all clean ourselves too much – it can’t be good for our skin. Our society is too sterilized and it’s not natural.”

Lucia, 22

But Why?

In a study conducted by scientist Thomas Berry and his colleagues on a university campus, Berry wanted to analyze whether or not gender played a role in handwashing behaviors in the bathroom. The team observed 170 subjects in a public restroom and found that the action of hand washing and for how long were based on the activities the subjects conducted in the restroom. In the study, 91% of women washed their hands. This was attributed to all the women using a cubicle to go to the bathroom. When looking at the men, 87.5% of men washed their hands when using the cubicle but only 59.4% washed their hands when using the urinal. The conclusion was that to the subjects, going to the bathroom in the cubicle warranted more hand washing.

In addition to whether each subject washed their hands, those that did were timed. An important note is that the median time for handwashing showed both men and women washing their hands for less than ten seconds. This is troublesome since the Center for Disease Control (CDC) suggested time for handwashing is 20 seconds. This study shows that if your staff is more likely to use a urinal when going to the bathroom, a greater emphasis on handwashing procedures must be put in place to protect food from being contaminated.

When to Wash Your Hands

The more someone washes their hands, the less likely they are to spread germs and disease. In a manufacturing facility all employees should wash their hands before or after the following:

  • Before beginning work
  • Before preparing food
  • Before handling an injury such as a cut
  • After using the bathroom
  • After sneezing or coughing
  • After touching your hair or face
  • After taking out the trash
  • After using cleaning materials
  • Before changing jobs handling raw and ready to eat food

How to Wash Your Hands

As directed by the Center for Disease Control(CDC):

“Follow these five steps every time.

Wet your hands with clean, running water (warm or cold), turn off the tap, and apply soap.

Lather your hands by rubbing them together with the soap. Lather the backs of your hands, between your fingers, and under your nails.

Scrub your hands for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song from beginning to end twice.

Rinse your hands well under clean, running water.

Dry your hands using a clean towel or air dry them”.

The Science Behind Handwashing

Not washing your hands after going to the bathroom is a leading cause of the spread of infections and diseases. Feces is a common source of Salmonella, E.coli 0157, and norovirus, and can also cause certain respiratory infections. “A single gram of human feces—which is about the weight of a paper clip—can contain one trillion germs”. For this reason, in your facility, it is important to ensure that handwashing practices always remain front of mind by having handwashing diagrams with instructions at every hand washing station.

In addition to germs being spread because hands are not washed after using the bathroom, germs can also spread is animal feces inadvertently on raw meat. Cross-contamination and poor sanitation practices can cause these invisible germs to spread.

The Impact Hand Washing Can Have

“Teaching people about handwashing helps them and their communities stay healthy. Handwashing education in the community:

Reduces the number of people who get sick with diarrhea by 23-40%

Reduces diarrheal illness in people with weakened immune systems by 58%

Reduces respiratory illnesses, like colds, in the general population by 16-21%

Reduces absenteeism due to gastrointestinal illness in schoolchildren by 29-57%

https://www.cdc.gov/handwashing/why-handwashing.html

It is not easy to establish a handwashing program that works. To do so you need an engaged staff who feels a sense of ownership for your company’s food safety culture and understands that they are a determining factor in whether your company produces safe food. Hand washing training and seminars need to be part of your “always-on” food safety program because ultimately your entire staff affects your end product and the bottom-line.

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California League of Food Producers (CLFP) Annual Meeting April 30

News Release

California League of Food Producers

For more information:  Lisa Jager, 916-640-8150, lisa@clfp.com

CLFP Annual Meeting April 30

The California League of Food Producers (CLFP) will hold its 2020 Annual Board of Directors Meeting on April 30 via webinar. The meeting will be presided over by outgoing 2019-20 chair Ross Siragusa, The Kraft Heinz Company. Michael Mariani, Mariani Packing Company, Inc., is expected to be elected and welcomed as the 20-21 chair.

Siragusa is Head of Agriculture & Seed for Kraft Heinz and works out of its Stockton, CA, office. Mariani is a Partner with Mariani Packing, which is based in Vacaville, CA.

Members will hear legislative and regulatory updates from CLFP’s Government Affairs Directors Trudi Hughes and John Larrea, as well as information on how the coronavirus is affecting California’s food
processing industry.

CLFP is an association representing the interests of both large and small food and beverage processors throughout the state. CLFP works to help ensure a favorable and profitable business environment for its members and the food processing industry. The association also has affiliate members that provide a wide variety of products and services to the industry

The Food Processing Expo is produced each February by CLFP, and is the largest event of its kind in California. The 2021 Expo will be held February 9-10 at the Sacramento Convention Center.

For more information, visit CLFP at www.clfp.com and the Expo site at www.foodprocessingexpo.org

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Food Labeling Requirements for Manufacturers and Updated Compliance Dates

By Michael Shabaka, Ph.D., Manex Director of Sales and Innovation Excellence

On May 27, 2016, the U.S. Food and Drug Administration (FDA) published the final rule amending food label requirements.

The final rule amends the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices with a compliance date of July 26, 2018 for manufacturers with $10 million or more in annual food sales, and July 26, 2019 for manufacturers with less than $10 million in annual food sales.

The FDA recently extended these dates to January 2020 and January 2021 respectively. The FDA has created a Small Industry Compliance Guide to help companies better understand who needs to be compliant and how to become compliant. The FDA does not intend for the document to serve as legal advice and refers to this document as recommendations for compliance. Upon review of the 38-page document, it notes that all food, including supplements and infant foods must be compliant with the new labeling requirements, but there are some exceptions.

Under 21 Code of Federal Regulations (CFR) 101.9(j), product exceptions to the new label requirements generally include:

  1. foods offered for sale by a retailer who has annual gross sales made or business done in sales to consumers that is not more than $500,000;
  2. foods offered for sale by a retailer who has annual gross sales made or business done in sales of food to consumers of not more than $50,000;
  3. medical foods; and
  4. foods that contain insignificant amounts of all nutrients (e.g., coffee beans, tea leaves).

If your small business does not manufacture foods that fall within these four exceptions, then you must be fully compliant with the new rules by January 2021.Compliance with the new labeling requirements can be confusing. For example, section V titled: “Which Nutrients Must Newly be Declared, and What Changes Have Been Made to Nutrients Previously Required or Allowed to be Declared?” provides an example of how to address added sugars and what is considered added sugar.

The guideline states that added sugars are defined as sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type, (21 CFR 101.9(c)(6)(iii)). This definition includes single-ingredient foods, such as individually packaged table sugar (see Section V.A.1.(a).(i) and Ref. 1). But there appears to be another twist that can make the new rules confusing and why I believe the FDA is giving smaller manufacturers more time to comply.

For example, the following do not fall under the definition of added sugars. Sugars in fruit or vegetable juice concentrated from 100 percent juices that are sold to consumers (e.g., frozen 100 percent fruit juice concentrate) (21 CFR 101.9(c)(6)(iii)).  Sugars in fruit juice concentrates that are used to formulate the fruit component of jellies, jams, or preserves in accordance with the standards of identities set forth in 21 CFR 150.140 and 150.160 (21 CFR 101.9(c)(6)(iii)). Sugars in the fruit component of fruit spreads (21 CFR 101.9(c)(6)(iii)).  Sugar alcohols and Sugars in juice concentrates that are counted towards percentage juice label declaration under 21 CFR 101.30 for 100 percent juice or 21 CFR 102.33 for juice beverages (21 CFR 101.9(c)(6)(iii)). Sugars in juice concentrates that are used to standardize the Brix values of a single species juice consisting of juice directly expressed from a fruit or vegetable in accordance with 21 CFR 102.33(g)(2) (21 CFR 101.9(c)(6)(iii)). Naturally-occurring sugars found in milk and dairy ingredients, except lactose as defined in 21 CFR 168.122.

The food labeling laws can be a daunting task, especially if there are product changes or reformulations. The additional year that the FDA has provided to ensure manufacturers are compliant can help businesses become fully compliant with the new food label requirements. Does your business understand the new label rules, and will your business be fully compliant with the new food label requirements on January 1, 2021?

About the Author

Michael Shabaka, Ph.D., is the Director of Sales and Innovation Excellence for Manex. He has over 20 years of business development, sales and marketing experience, spanning several industries including biotech, high tech, publishing, environmental lab services, and the non-profit sector. Dr. Shabaka holds a Ph.D. in Organizational Behavior with a concentration in Transformative Learning and Change from the California Institute of Integral Studies, San Francisco. He also holds a Master of Business Administration degree in Marketing and Finance and a Bachelor of Arts degree in International Affairs from Holy Names College, Oakland. He can be reached at mshabaka@manexconsulting.com.

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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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Four Takeaways from the 2019 Safety and Maintenance Expo

On October 22, 2019 West Coast Industrial Solutions hosted the first annual Safety and Maintenance Expo! It was held in Clovis California in the Clovis Veteran’s Memorial District’s state-of-the-art event space. Representatives of industry ranging from food growing and processing, manufacturing, education, utilities, services, and regulatory agencies walked
the trade show floor. Attendees were also able to participate in presentations on Valley Fever training, the FDA’s Food Safety Modernization Act (FSMA), business safety and risk management, and workplace violence prevention and response. Here are the key takeaways from the four presentations made during the expo.

1) Valley Fever training will be required May 1st, 2020.

What is Valley Fever and what are its causes? According to the Mayo Clinic, Valley Fever is a fungal infection caused by spores of coccidioides organisms that can be found in the soil. These spores can be breathed into the lungs after they have been made airborne by any activity that stirs the soil: farming, construction, or strong winds. The first major presenter was Protec Safety Consultants’ Ralph Morales, who provided training for the awareness, prevention, and treatment of Valley Fever. This training was in compliance with California’s Assembly Bill 203 requiring certain construction employers in areas most affected by Valley Fever (including, but not limited to, the counties of Fresno, Kern, Kings, Madera, Merced, Monterey, San Luis Obispo, and Tulare) to provide effective awareness training by May 1st, 2020. This training will be required annually for all employees for professions that participate in digging, grading, or other general earth moving operations; Even if your company is operating vehicles on dirt roads—because the activity can cause the Valley Fever fungus spores to become airborne.

To ensure your company is Valley Fever ready and AB 203 compliant, you can visit protecsafetyinc.com, contact Ralph Morales at ralph@protecsafetyinc.com, or call his office at (559) 900-7471.

2) The FDA’s Food Safety Modernization Act and Changes in Enforcement.

The FDA’s most sweeping reform of U.S. food safety laws in 70 years is the Food Safety Modernization Act (FSMA). The act was meant to address food safety issues and how to prevent them in the U.S. food supply. It was originally signed into law in 2011, with the seven rules being finalized in subsequent years. The second presenter, Safe Food Alliance’s Senior Food Safety Manager, Jon Kimble, explained the FDA’s rules in this law, how they intend to approach addressing these food safety issues, and what is expected of the food industry. These rules include: preventative measures to be implemented in growing and harvesting crops; the proper procedures for processing, transporting, and storing food; the proper importing of food items; and preventing tampering in the food supply. Mr. Kimble punctuated the outlining of these rules with the latest changes the FDA was making to enforce them.

If your company requires food safety training, food safety system development and implementation, root cause analysis, management of internal audits, or advisement on conducting third-party audits, you can contact Jon Kimble at jonk@safefoodalliance.com, or browse Safe Food Alliance’s website safefoodalliance.com/food-safety-training/.

3) Establishing a Safety and Risk Management Plan can Improve Employee Relations and Keep Costs Down

After having over 20 years experience in occupational safety and risk management James G. Parker Insurance Associates’ Vice President, John Cleveland, suggested that the foundation of risk management policies can help businesses have better employee relations and work practices as well as cost savings and mitigation of volatile insurance related expenses. Cleveland outlined the four main rules he has established for businesses to follow and how to apply them. Firstly, he suggested establishing clear expectations, policies, and procedures to ensure peak task performance. Secondly, Cleveland stated employees will generally meet performance expectations and criteria communicated to them. Thirdly, he warned each individual employee comes with their own safety and risk causes that they will bring to the workplace with them. Lastly, the manager working most closely with the employees should be motivating, recognizing, and communicating expectations appropriately.

If your company could benefit from a safety and risk management plan, reach out to James G. Parker Insurance at jgparker.com/ or contact John Cleveland at jrcleveland@jgparker.com.

4) Workplace Violence is Preventable–Know the Signs and How to Respond

Annually, an estimated two million U.S. workers experience violence on the job. Though the warning signs are often overlooked, there are almost always ways to prevent impending violence. Our fourth and final presenter, Alvarez Associates’ President, Hector V. Alvarez, taught a course on Workplace Violence Prevention and Response. He used his over 25 years of experience to craft a course suitable for all staff to learn awareness, tools, and resources to help protect the workplace—and those in it—from the threat of violence. Alvarez covered the dynamics of workplace violence, how to establish personal safety strategies, how to establish workplace safety strategies and resources, how to recognize safety warning signs, and how to form a protocol for properly responding to Active Violence.

If your company requires training in workplace violence prevention and response browse wvpexperts.com/ or contact Hector V. Alvarez at halvarez@wvpexperts.com.

These presenters exhibited alongside our other event participants:

If you missed 2019’s event, don’t worry! The magazine is planning another event on September 17, 2020 at the Clovis Veterans Memorial District. Register for your booth today and you will receive a complimentary business card ad in the July-September 2020 quarterly issue! Final deadline for the booth and advertising space special is May 25, 2020.

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COMPANY PROFILE: United Health Centers of the San Joaquin Valley

United Health Centers of the San Joaquin Valley (UHC) began as a grass roots health care initiative in the early 1970s by Orange Cove and Parlier community members. People who lived and worked in these small rural California cities had to drive over 40 miles to reach the nearest emergency room, and local healthcare resources were few and far between. As a 501(c)(3) non-profit organization and designated as a Federally Qualified Health Center (FQHC), UHC does everything it can to serve everyone, but especially people in underserved populations to receive the quality of healthcare they deserve.

Colleen Curtis, UHC President and CEO

Colleen Curtis has been President and CEO since 2008 and is UHC’s biggest advocate. With the implementation of the Affordable Care Act and effective strategic planning with an all-volunteer Board of Directors, UHC has been able to dramatically expand from only seven health centers in 2010 to seventeen health centers today and have plans for growth to reach twenty-four by the end of 2020. UHC currently has a staff of over 800 employees to deliver care to more than 90,000 patients with 515,000 clinical appointments annually to underserved communities primarily composed of Hispanic farm laborers and agricultural workers.

Through the expansion of health centers located across three Central Valley Counties of Fresno, Tulare and Kings, the UHC mission has remained focused on the underserved:

“We are committed to the lifetime wellness of our communities by providing accessible, comprehensive quality health care to everyone, with compassion and respect,
regardless of ability to pay.”

And in each health center, UHC provides state-of-the-art healthcare in all of its beautifully designed and furnished facilities including those in rural communities like Huron, Mendota, and Earlimart which are among the poorest towns in California.

Each UHC health center offers a combination of comprehensive primary healthcare services
including medical, dental, optometry, integrated behavioral health, chiropractic, prenatal care, as well as, other specialty services, ancillary services including pharmacy, x-ray, and clinical laboratory along with urgent care extended hours on weekends and free patient transportation. UHC also provides free enrollment services to assist patients with medical coverage and has a sliding scale for noninsured patients. The majority of their employees are bilingual, and everyone is incredibly welcoming and provide excellent patient focused services.

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The Basics of Food Tolerances and Maximum Residue Limits

Written by Wiley A. Hall, 4th, Ph.D.
Originally Published in Safe Food Alliance, Testing & Analysis

An MRL (Maximum Residue Limit) or a food tolerance, as it is known in the USA, is the maximum amount of a pesticide residue that can be found in or on food. While any food with a pesticide residue under an MRL should be safe to eat, it is important to remember that an MRL is not a safety limit. That being said, a residue over an MRL is not necessarily a safety hazard, but rather a violation of good agricultural practices (GAP).

If you are growing, packing, importing/exporting, or otherwise involved in the domestic or global trade in agricultural commodities, it is critical that you be aware of any MRLs that may affect your commodity and the regulations around them. This article is meant to give you a basic introduction of pesticides and their limits, but no single article can cover all the complexities and local variations in MRLS. If you have questions about your specific situation, reach out to your PCA, local farm advisor, grower group, or a Safe Food Alliance representative.

Let’s start with some definitions.

Pesticide

A pesticide is defined by the EPA as: “Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”, “Any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant.” or “Any nitrogen stabilizer”.

Active Ingredient

The active ingredient (AI) in a pesticide is the chemical or chemicals that actually have the desired effect and do the heavy lifting (the AI in Round Up is glyphosate). The rest of a pesticide product is the inert ingredients such as solvents (e.g. water) and adjuvants which are additives that improve pesticide performance (spreaders, wetting agents).

Pesticide Residue

A pesticide residue is the trace amount of any pesticide remaining on the crop after treatment
(and any post treatment steps required by the label, such as a reentry period). It is important to note that an MRL may refer to an AI, adjuvant, or any other residue that results from a pesticide application, like metabolites. Remember, all MRLs are specific to a pesticide and crop combination. For example, if you find the fungicide Imazalil on oranges, and the market does not have an MRL for it, then any Imazalil residue found on an orange is illegal (a positive list system or PLS).

Default MRLs

Some markets, like Europe or Japan, have default MRLs where if there’s no specific MRL for a given crop/ pesticide, but the pesticide isn’t specially banned, the MRL defaults to a given value (usually 0.01ppm). These default MRLs are generally set to around the current limit of detection for most pesticides, though, so there’s often little difference between a default MRL and no MRL.

Residue Definition

The last important definition we’ll discuss is the residue definition. The residue definition tells you what chemicals need to be measured to determine if your commodity conforms with the MRL. For example, the residue definition for the herbicide oxyfluorfen is just the chemical oxyfluorfen, but for fosetyl-aluminum both the parent compound, fosetyl-aluminum and the chemical it degrades into in the environment, phosphonic acid, needs to be measured. This can also change based on the commodity and market: the residue definition for glyphosate for wheat in the United States is different than the definition for almonds in Australia.

How are MRLs made?

While an MRL is not a safety limit, the setting of an MRL begins with safety testing.

How It’s Done

  1. The registrant of a pesticide performs animal studies to determine the smallest amount of the active ingredient that the animal can be exposed to before having an adverse reaction. This amount is the no observable adverse effect level or NOAEL.
  2. From there, they take the NOAEL and multiply it 100 times to give a range (Safety Margin) to include as much of the population as possible.
  3. The safety margins and two toxicological values are then applied: the smallest amount that it is acceptable for humans to consume at one sitting (acute reference dose or ARfD) and the smallest amount that it is acceptable for humans to consume on a long-term basis (acceptable daily intake or ADI) are calculated.
  4. The registrant carries out field trials, where the pesticide is applied to the commodity at the highest proposed rate and the crop is then handled according to GAP.
  5. Finally, the MRL is set based on statistical analysis on the range of pesticide residues found on the crop from the field trials, after all applicable harvest activities. What that means is they analyze how much of the crop is left after harvest and measure if it might get people sick.

Following The Directions

Again, while the MRL needs to be at a safe level (all sources of consumption are summed and the MRL is only approved if the public’s estimated consumption is under the ADI and ARfD), it is really a way of ensuring that GAP was followed in the application of the pesticide. If the instructions in the pesticide label are followed, the pesticide residue, by the time the commodity reaches the consumer, should be under the MRL. It is important to follow the label, as an MRL violation is a sign that GAP was not adhered to, possibly risking harm to the environment, workers and those who live nearby the spray site.

How to Stay Informed on MRLs

The world of pesticide regulations is large and constantly changing. Even the basic information
covered in this article may seem like a lot to have to keep track of, without getting into the specifics of how MRLs work in each individual market. Europe alone is worth its own (much longer) article, one that might go out of date in the time between writing and reading. The good news is that all the information you need to stay informed on the state of MRLs is publicly available if you know where to look.

For the most up to date information, make sure to stay in communication with any PCAs, farm advisors, or grower groups who may have firsthand knowledge of your crop, growing methods, and target market.

Second, visit an online database where you can find information on what MRLs there are for your crop and market. Online databases are available for the United States, Europe, Japan, Korea, Canada, for starters, but that can still be a lot to have to keep straight. Bryant Christie Inc. keeps an excellent MRL database that covers over “…1000 pesticides, 875 commodities, and 125 markets”; due to a grant from the federal government. Access is free to users within the United States.

Remember, the key to avoiding pesticide residue issues is to stay informed. By knowing where there may be potential issues ahead of time and testing for residues before you ship your commodity, you can manage your pesticide risk.