“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.email@example.com.
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:
This is a draft rule. Now is the time to submit any feedback or concerns.
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).
It requires tracking specific activities. The FDA refers to these as “Critical Tracking Events” (CTEs), and they include: growing, receiving, transforming, creating, and shipping.
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.
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.
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).
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 firstname.lastname@example.org.
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!
In today’s COVID-19 environment, people may think this isn’t a great statement to make: having safety makes sense. In the safety profession, the following question has always been a challenge: “Why safety?”
There are many reasons why organizations embrace safety, such as complying with OSHA regulations, minimizing the impact of insurance rates, reducing injuries, or minimizing risk exposures. And on the surface, it appears that most companies pay attention to safety to avoid something: recurrence of a recent serious injury; OSHA penalties; high insurance rates. While all of these are good reasons, these actions are reactions: in each case safety isn’t planned, it’s a reaction to something that happens.
In the past, the assumed answer is “because it’s required;” however, today we see safety is all about creating confidence: confidence that our food supply is safe, confidence that our workplaces are safe to work in, and confidence that it’s safe for customers to return. And that confidence comes with success. A safe environment allows customers to feel confident to visit and buy from you, talent to seek employment at your organization and remain, and stability for the organization. Over 30 years of experience has shown that to build this confidence, businesses must follow five steps to embrace safety.
5 Basic Steps to Embrace Safety
Ask yourself “What is of risk to the organization, and how can I possibly control it?” You’d be amazed at all the wasted effort you’ll find if you spend a little time asking these questions. Knowing these risks helps you know how to address them.
OSHA lists absenteeism, change in commerce patterns, and interrupted supply chain are potential risks to businesses from the COVID-19 pandemic. And, if we are to assess for risk, OSHA’s assessment for risk fall into three major categories:
Job duties involving close (within 6 feet), frequent contact with the public, customers or workers, especially contact with infected people or other sources of the virus.
Social conditions in the population area have ongoing transmission.
Traveling to areas that are highly affected by COVID-19.
Considerations would be given to proximity (closeness to others); frequently touched surfaces that may be found in a common area such as a lobby, customer waiting room, breakrooms, restrooms, and time clocks; and layouts such as open spaced work areas and airflow.
Once you know risks you need to address, you can know how you’re going to control them, and you’ll want to put them into a written process. OSHA has outlined a process to reduce exposure risk for employees by addressing both workplace-specific and non-occupational risk factors to determine the best prevention measures for your operation. As always, ensure you are following federal, state, local, tribal and/or territorial recommendations
Applying this to the COVID-19 situation, capturing the efforts you make into a plan ensures your efforts are on track and documented, and that they are working well. The key is to ensure everyone knows who is going to do what by when. Elements of a process would include the following:
Expectations, Better Practices, Application
Responsibilities / Roles
Lists who is responsible for what by when
Who can access the facility / job-site / when (i.e., employees, contractors, visitors), working from home, screenings, PPE and distancing expectations, etc.
How is this done, frequency, what surfaces (hard vs. porous), post-COVID suspected or confirmed, etc.
Social distancing, PPE, washing / sanitizing, staggered shifts and breaks, etc.
If necessary / approved, precautions to take, etc.
Carpooling / Vanpooling / Ridesharing
If necessary, cleaning and disinfecting after each ride, self-screening, barriers / PPE, ventilation
Items the company will provide to employees, customers (within its ability)
For confidence on cleaning, following suspected / confirmed COVID cases, etc.
Educating and including your people in the process, including the risks being controlled and why, will help them engage and contribute to the success, making it more valuable.
Applying this to the COVID-19 situation, education would cover the following elements at a minimum:
What COVID is and How it Transmits: this provides the “why” we are doing what we’re doing.
What to do:
Cover coughs and sneezes
Wear face coverings
Stay home if sick / exposure
What’s changed in the workplace
Your program / what’s expected
Implement the process and watch it take off. For the current COVID-19 pandemic, the Centers for Disease Control (CDC) and OSHA suggest implementing frequent handwashing and shifting policies or practices to include more flexible worksites and work hours. Workplace changes such as workstation distancing or use of barriers, and one single point for entry and a separate single point for exit are also some ideas to consider COVID prevention.
Not everything will be perfect the first time: if something goes wrong, investigate to find out why, then make a change to improve the process.
OSHA uses the following investigation technique for a COVID situation to determine if it is possibly work related or not.
COVID-19 case is likely work-related if:
Several cases develop among workers who work closely together
Contracted shortly after lengthy, close exposure to customer or coworker who has a confirmed case of COVID-19
Job duties include frequent, close exposure to the general public in a locality with ongoing community transmission
COVID-19 case is likely NOT work-related if:
The person is the only worker to contract COVID-19 in vicinity and job duties do not include having frequent contact with the general public, regardless of the rate of community spread.
Outside the workplace, the worker closely and frequently associates with someone who (1) has COVID-19; (2) is not a coworker, and (3) exposes the employee during period in which the individual is likely infectious
The answers to the investigation would trigger immediate actions to do with regard to communication, quarantining and cleaning, and how the process can be improved, if needed.
For additional resources regarding COVID, visit the following links:
These five simple steps will create the confidence needed for success. Contact a safety professional to provide you guidance and support.
About the Author: James Boretti is the President and founder of Boretti, Inc. James has over thirty years of environmental, health and safety management and consultation experience. He is a Certified Safety Professional, a prestigious designation he has held for over 25 years. You can contact him at (559) 372-7545 or email@example.com.
In today’s food manufacturing environment, basic food safety principles are no longer enough to meet customer and regulatory requirements. The rules have changed, in large part due to the Food Safety Modernization Act (FSMA). In addition to new laws from legislators, the standards and demands of customers now far surpass regulatory requirements. What this means is there is now an expectation to not only master Hazard Analysis Critical Control Points (HACCP) but to go one step further and become Global Food Safety Initiative (GFSI) certified. To gain certification with any of these programs, you need to start in the same place. You start with a HACCP plan.
12 Steps to a Good HACCP Plan
When building out your HACCP plan, follow this specific methodology involving 12 steps. If you are having trouble, just reach out to your friendly neighborhood Safe Food Alliance team.
One thing to remember as you build out your plan – a HACCP Plan is a living document, and as such, should be revisited often as your processes change, your company grows, and you discover better ways to produce your product. Now that we have that covered, let’s begin.
1. Assemble the HACCP Team
Your plan will typically include a table where all the names of the HACCP Team members are written and signed, and the team leader is clearly designated. The team functions best when it’s highly cross-functional and includes members of various departments such as sanitation, maintenance, production, and quality. It’s essential to have these varied perspectives and background knowledge.
In this section, you should include a brief description of each member’s current position, background, and experience. You’ll also need to have a copy of a HACCP formal training certificate for the HACCP coordinator, from an accredited two-day HACCP course. There should be some sort of documented HACCP training for the rest of the team as well, whether conducted internally or by someone like us. The more knowledgeable the team, the better the plan will be.
2. Describe the Product
This section should include a full description of each product or family of products within the scope of the plan. Product descriptions should consist of details that impact the food safety of the product, including (as applicable):
the recipe or formulation
the packing materials and any other information such as the modified atmosphere
the conditions in which the product is to be stored (e.g., temperature, light, humidity)
the shelf life
any potential for abuse in the distribution chain or by consumers, which may put the product at risk.
The better you define the product before starting the hazard analysis, the more thorough the review will be.
3. Identify the Intended Use
The intended use is based on the usual consumption of the commodity by the final consumer or user. Again, defining intended use helps ensure a more thorough hazard analysis later. This section includes both your company’s intended purpose based on product design, as well as potential other applications. The more you know your consumers, the better you can take care of them. A classic example, in this case, is cookie dough: it’s a product you typically cook before consumption, but in some cases, it’s eaten raw. For this reason, several companies have had recalls on their cookie dough due to consumer illness.
4. Construct the Flow Diagram
The process flow diagram must be clear and detailed to describe all process steps. Use this diagram to help ensure the hazard analysis is thorough and as a visual reference as your team considers potential hazards to the consumer. The flow diagram must include every process step that occurs on-site, from the very beginning (e.g., receiving and preparing ingredients, storing packing materials, etc.) to the very end (shipping, warehousing, etc.) The clearer the diagram is to the viewer, the easier to understand the process. Others may also use the table during site visits (e.g., customers, auditors, consultants, regulatory officials). Hence, it’s wise to design it in a way that it’s relatively clear to others who don’t know the process as well as you do.
5. On-Site Verification of the Flow Diagram
On-site verification of the diagram helps ensure its accuracy. Again, the purpose of this is primarily to ensure a thorough hazard analysis. The site will need to provide proof that the HACCP Team has verified the flow diagram. Some companies like to keep the first version of the diagram with hand-written notes on it, indicating changes made and initialed and dated by the participants. Ultimately, however, proof of the verification is best done with a final, updated copy that is signed; or meeting minutes indicating approval of the final version and signatures of participants.
6. Conduct a Hazard Analysis
The hazard analysis is part of the plan that typically takes the most time to review and update. Here the team collects and examines all relevant data to the product’s safety, including process performance, product defects, customer complaints, results of internal and third-party audits, and various other relevant information. The team must take the proper time to conduct a thorough analysis.
A Hazard analysis can vary in format, but needs to include these common elements:
List of all process steps and ingredients
Identification of potential hazards
Assessment of each hazard, with consideration of both severity and likelihood
Identification of ‘significant’ hazards
Justification of the assessment (detailed explanation as to the team’s reasoning)
Identification of appropriate controls for each hazard
Now, under FSMA, the identification of any Preventive Controls as well. For more information on this subject, take a look at this article. For training, refer to the PCQI course.
7. Determine Critical Control Points (CCP’s)
This one is a simple concept. Based on the hazard analysis described above, you can quickly identify all significant hazards and CCPs. Critical Control Points are those essential steps designed to control a specific hazard so that the product will be safe to consume. The team should use a decision tree like this one when determining CCPs.
8. Establish Critical Limits for Each CCP
A critical limit is a critical control point’s “go/no go” or “acceptable/unacceptable” criteria. For some processes, such as metal detection, it is as simple as testing with certified metal test pieces to ensure proper function. For other types of CCPs, it can be much more complex and include parameters such as temperature, humidity, product viscosity, or chemical concentration. All these variables and values have to be clearly defined, including both lower and upper limits, as applicable.
Documents related to the process and relevant sources used to establish the critical limits must be available to support the limits. These documents could be regulatory standards, guidelines, internal or third-party validation, experimental results, literature surveys, and expert guidance. The stricter the validated limits, the higher the potential efficacy.
9. Establish a Monitoring System
This step is where we define the monitoring method for each CCP. Monitoring is how we ensure the process has met the critical limit, so the product is safe. The monitoring procedure should contain the following:
What will you monitor?
How often shall it be monitored?
Who is responsible for performing the task?
What instruments will you use?
How will you monitor? (method)
The clearer the instructions, the fewer chances of failure.
10. Establish Corrective Actions
Each CCP is required to have predetermined and documented corrective actions for deviations that may occur. The corrective actions plan should comprise at least the following elements: the responsibility for each action, disposition of the non-complying product, the correction of the cause of failure, and recording the event. Keep records of activities readily available. If you need help with conducting root cause analysis for your corrective actions, check out our quick root cause analysis course.
11. Establish Verification Procedures
Much of the discussion in our HACCP courses end up centering around how to conduct verification in the context of HACCP properly. Verification procedures should be activities designed to confirm that the plan is: 1) being followed; 2) effective for its intended use, and 3) adequately maintained. We are looking for defined procedures here, indicating how we conduct routine verification activities like the sign-off of the CCP monitoring records, as well as how you complete the less-frequent validation. The more exhaustive the verification is, the more confident we can be of the plan. For more on verification, take a look at our article “The 6th Principle of HACCP: Verification”.
12. Establish Documentation and Record-keeping
This final step includes establishing both record-keeping processes and the company’s documentation system (establishing defined procedures, the company’s methods of document control, etc.). Consider:
How will you document your system?
What should you include?
Who is responsible for doing it?
How long are you keeping records? Where are you saving them?
Who needs to have access to what documents and how are documents controlled?
A better-documented plan helps ensure better execution.
As you may realize by now, developing and documenting an effective HACCP plan is not an easy task. Training on the methodology, experience, and technical elements are essential aspects of effective HACCP Plan implementation. If you need guidance with training or consultation, Safe Food Alliance is here to help.
Written by Natalie Rainer Counsel, Keller and Heckman LLP
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.
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
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.
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
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
Author: Chris M Brunner Originally Published on UCANR Food Blog
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.
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.
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.
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.
ThePsychology 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.”
“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.”
“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.”
“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.”
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%
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.
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:
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;
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;
medical foods; and
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 firstname.lastname@example.org.
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.
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 email@example.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.
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.