I left a career as a food scientist and quality control supervisor in 2010. When I entered the tea industry in 2012 I was confident in my ability to navigate USA food regulations and food safety while working directly with tea producers in foreign countries to import and distribute their teas. Much has changed in this time and much more will affect our tea supply within the next few years. On January 4, 2011, in an attempt to further secure the United States food supply, President Obama signed into law the Food Safety Modernization Act (FSMA). This would be the most stringent addition to FDA regulations in the past 70 years.
The FDA took the following five years to develop the regulations that would be enforced with this law, and on September 19, 2016, compliance became necessary for large food companies defined as having more than 500 employees. Tea is probably one of the least regulated industries by the FDA but tea companies in the US will be wise to stay on top of these regulations because these new regulations have put new restrictions on foreign imports and all companies big and small will need to comply by March 18, 2019. As of now, very few tea producers will be in compliance with these new regulations, so much work is necessary.
The five main components of FSMA are preventative controls, inspection and compliance, imported food safety, response, and enhanced partnerships.
Preventative controls mean that tea businesses in the United States will need to have programs in place, such as Good Manufacturing Practices and Hazard Analysis Critical Control Points. Large businesses that are required to comply from September 19, 2016, more than likely already have these programs in place but it is smaller companies that will need to comply by September 19, 2017 (less than 500 employees) or September 19, 2018 (less than $1M in annual sales). Implementing these programs will not put great stress on your operation but a consultant may be required to document and implement these programs.
Inspection and compliance involve more inspections by the FDA to US food facilities. These inspections are risk-based which means that tea facilities will be low on the priority list. This does not mean that tea companies are off the hook. The FDA has the right to inspect at any time and will if they find any reason for threat.
Imported food safety is probably one of the most important sections of the new regulation that will affect the tea industry. The majority of tea consumed in the US originates from other countries. For the most part, the importation and food safety of these products have been beyond the bandwidth of FDA inspections. As of May 30, 2017, large food companies will not only need to trace their food imports to the farm but will also need to verify that the producers of these products in foreign countries have the same preventative controls mentioned above as well as a third-party audit conducted by an FDA-accredited auditor. Smaller tea companies with less than 500 employees will need to be compliant March 19, 2018, and very small companies with less than $1M annual revenue will need to be compliant on March 18, 2019.
Response involves full documentation and traceability of food supplies. This is a program that companies should proactively be doing to prevent the harm of their customers and the potential loss of product on the market due to a full recall. This basically means that if a supplier contacts a food company about a potential contamination of a lot that food company should be able to trace all their products and locations that contain part of the contaminated lot. Without a full traceability program, all products would need to be recalled rather than just a limited amount.
Enhanced partnerships are the FDA’s intention to utilize international networks to facilitate the implementation of these regulations. This includes the accreditation of third party auditors that will facilitate food safety audits at food producers in foreign countries. Compliance with these third party audits will not be begin until May 30, 2017.
The first compliance date for FSMA is September 19, 2016. While no food companies have been shut down by the FDA for being out of compliance the FDA has released a statement that they will guide companies to compliance through education. As other compliance dates approach the FDA will become stricter on the rules. Rules that require documentation are the easiest to regulate, which means the FDA will be able to easily regulate the foreign supplier verification process.
Reading these rules makes it seem like the FDA is further protecting large food companies that have the resources to remain in compliance. Small farmers are at risk of being out of compliance, which is why the FDA has provided exceptions for small farmers that distribute their products within a 275-mile radius. What about tea farmers that need to distribute their products 5,000 miles? These farmers will not be able to afford a third party audit and do not have the knowledge or resources to implement the necessary preventative controls. Even the largest tea estates in India and traditional tea factories in China are not in compliance and will need to invest thousands of dollars retrofitting their facilities to get into compliance. This is the threat to Specialty Tea in the USA.
As an experienced food scientist and activist for small farmers, I have started to turn the wheels of providing consulting and auditing services for tea growers in Tealet’s network. Our company is small, and we do not need to be in compliance until March 2019, so I will use this time to learn the laws and develop a game plan to keep these small growers in compliance so they can continue to share their tea with tea lovers in the United States.
Thanks for this critical information Elyse. It’s pretty obvious what could happen with general food that could be hazardous to ones heatlh. As tea has many antibacterial properties, I’m wondering what potential problems tea can actually run into in theory. I can imagine an excessive amount of pesticides could be discovered in conventionally grown teas but regarding organics, what might be the worst case scenario for example?
Dear Michelle,
I am a small Tea Farmer doing Organic farming here in Assam, India. Producing Organic Tea and manufacturing them organically into finish product may differ in reality. What I mean is, the hazard may evolve during the manufacturing.
With the regulating of tea I don’t think the FDA is too worried about hazards, they are worried about traceability and accountability of the hazard control measures there are on the farm and at the factory. The standard of sanitation is way different in other countries. For instance, at a tea estate in Darjeeling I visited the manager was very proud to show to us the oven they were using to process their teas. The oven was fired by a dried grass they had collected just behind the oven. The grass was a very desirable place for rodents. There was no partition between the grass and the processing facility, so I could only think about the amount of rodent activity in the processing room (where dried tea was stored). The hazard here is rodent dropping making it into the finished dried tea. Another example, in Hangzhou, China tea makers will stay up all night making tea during the season. A common way to stay awake and entertained is to smoke cigarettes. At almost every drying pan we saw there were ashtrays filled with cigarette butts right next to where the farmers are doing the final hand drying of the teas, not even washing hands between smoking and processing tea. Both of these examples would be immediate red flags for the FDA and these producers would not be able to export their products to the US if a third party auditor was to visit. Ask any tea importer of Chinese teas their experience with finding cigarette butts in the received tea and everyone has got at least one story.
China has done a lot to clean up tea making over the last ten years by establishing QS standards. These standards may not be followed by farmers, 5 million in China, but they will be followed by tea makers as opposed to farmers. Farmers in general may be good at farming but they rarely make good quality tea. We have never found a cigarette butt in our tea.
Thanks Elyse, this is essential information for us all. Much appreciated, Kevin.
I’m happy to provide information as it comes. Much work ahead if we are to continue the flow of specialty tea into the US.
Thank you for any future updates.
Shouldn’t speciality coffee shops also be affected by this? Is there any organizing going on against this?
I’m sure coffee is equally affected by this as tea is.
Specialty coffee has been ahead of this curve, and the National Coffee Association strongly advocated for the coffee industry prior to the FDA’s final guidance.
There is one fundamental difference between coffee and tea, though–tea is imported in its final form, while coffee is imported green. Roasting coffee is an important control step in controlling anything hazardous on the beans. Tea does not have a similar control after it arrives in the US.
I believe this is the type of thing Trump was talking about doing away with and people were enraged. I am not a fan of either party, but it looks like, at some point, no one will be able to shoulder the expense of a small business and will get out. The new movement to grow food in public spaces I’m guessing is also on the way to being presented with a ton of problems to deal with. If you haven’t watched Ron Finley on YouTube…see what happened when he grew a garden in a strip alongside his sidewalk. I’ve got to absorb all you’ve put here…it tires me just reading it.
As in the healthcare business, which I have spent my entire professional life, this will take years and years to implement and mostly, the gov’mnt is after the huge importers, the kinds that have massive recalls. My advice is to be aware of what is going on, be as compliant as you can be and keep a low profile.
Thanks for this essential information and discussion Elyse. For businesses large and small, it will be even more important to be in compliance with health and safety regulations, especially as consumers become more aware and require proof or reassurance of the safely of the products they purchase. Keep us posted.
Thank you for the coverage of the FSMA on tea imports. We have been very focused on compliance recently. After months of research we have learned that the FDA is asking us (tea industry people) to create and set our own set of safety standards…we are being tasked with telling the FDA what should be considered safe tea.
I hope this is an opportunity for businesses large and small to shape these rules together. I look forward to the chance to talk about this further with other tea folks.
Thanks Elyse! An eye opener.
We are a small tea garden in Nepal but are organic (certified by IMO) and ISO 22000 certified. Will we be in compliance of the coming rules/laws just by being certified in these two standards? What else do we have to look out for?
Organic certification and ISO certification are completely unrelated. You will need to develop a Good Manufacturing Practices and Hazard Analysis Critical Control Point plans. You will also need to hire a FDA licensed third party audit to inspect your facility to ensure you have these two programs documented and implemented. Your compliance dates are not for another year, so you have time.
Please supply a link that verifies that HACCP plans are required for tea making. There are no critical control points in tea making.
This might be a bit of an over reaction to the FDA taking more care in insuring the safety of our food supply. None of these things are really new or have the potential to have a major impact on the speciality tea, at least for Seven Cups. Having imported tea for more that fifteen years, Seven Cups has a well established relationship with the FDA. They even came to inspect our company a few months ago. We had no trouble passing the inspection. I have to say they have stepped things up, because we have never had a personal inspection before. We, of course are registered with the FDA, and we have registered our suppliers. Seven Cups already has a supply chain that is traceable to the source. This has been the case through our history as an importer.
I set up a HACAP plan for a Chinese RTD company as a consultant, and gained FDA approval for that company. There is nothing about tea production that would require such a plan. These plans are not ok’d by the FDA directly, but by independent labs with FDA authority to evaluate submitted plans. It is a very specialized field, and looks at points in the process where bacteria etc. might be introduced causing food contamination, none of which is relevant to tea production. I understand that Elyse is wanting to set up a consulting business to help companies become compliant with FDA standards. That would be a helpful service for tea companies that are looking at becoming importers. I haven’t experienced FDA safety rules as being draconian as Nigel suggests. Although it can be difficult to find out at times what the exact rule is. I’m sure Elyse would provide a valuable service by learning those rules. Sometimes it’s hard to know how to be compliant until you get caught being out of compliance. Since we work hard at being compliant, none of this is news to us, but some times we have had to learn the hard way. We want our customers to be assured of the safety of our products, so we do our buying due diligence as a part of business best practices, and we know others that do the same. Tea companies may not be familiar with these laws but importers must know them. Sometime the FDA can be a pain to deal with, and slow up the process if they are inspecting a shipment that you are waiting for, but that’s what an importer does. I don’t think the specialty tea industry is going to end up in crisis because they are becoming more vigilant. I have heard that a very large percentage of grocery store products are out of compliance currently. Not a comfortable thought.
It’s not that hard to be compliant with safe food rules, at least where tea is concerned.
The full set of rules of FMSA are yet to go into enforcement. Compliance will be extremely difficult because not only will US tea companies need to have GMP and HACCP plans with documentation of implementation but the foreign suppliers (tea producers) will also need to have these programs as well as an FDA-licensed third party audit to confirm compliance. Even if producers are able to pay off the auditor to approve there are still going to be high costs associated with getting in compliance. It will be very similar to the situation with Organic Certification. It’s going to be very costly for producers to export their products to the US.
Compliance dates for foreign supplier verification are:
March 2017 (large companies with 500+ employees)
May 2018 (companies doing $1M+ per year in sales)
May 2019 (all other small companies)
FDA compliance today is extremely easy and anyone with a little internet savvy can navigate the FDA registration and prior notification process. FDA inspections for the tea industry are low (and will continue to be low even after FMSA) because inspections require much bandwidth and tea is low on the risk list. The foreign supplier verification process will require almost no bandwidth from FDA, which is why I believe it is going to be a very easy thing to regulate. I have seen more rigorous regulations in the prior notification process and have even seen shipments turned back by US customs because the producer did not provide the current PN paperwork. This is what I am afraid will happen to imports that do not have the correct foreign supplier verification documentation.
I don’t believe that is true Elyse, based on my extensive experience with the FDA and third party auditors, in food processing in China. Tea production will never be required to submit GMP or HACCP documentation.
As an importer I take full responsibility for the suppliers I buy from supplying the proper documentation for the FDA, and that my importing paperwork is compliant.
Your belief is not the deciding factor. It seems to me that you have over reacted you what you are interpreting a rather broad presentation of the regulations and stirred up a lot of unnecessary anxiety about the future os specialty tea.
I fully support you studying these regulations over the next three years, and opening up your consulting practice to help tea companies navigate these waters with the FDA, in the mean time people over reacting to rules that will probably be a benefit to the American food chain is un called for.
The idea that these rules will shut down the specialty tea industry really is a big stretch of the imagination.
Thanks Elyse. This is of great help! A lot of systems are in place but still a lot of work to do to prepare ourselves against these non tarif barriers! Keep up the good work!
We are here to help you!
Hello,
If so, what should we do ? while we are just a small cooperative which is a group of Snow Shan tea farmers in the north Vietnam ?
Elyse, thank you so much for providing a place for conversation about this complicated and intimidating stuff!
As importers and blenders, Jasmine Pearl falls under two different but related FSMA rules as a small company: one for importing (FSVP), and one for our food handling operation – blending, packaging, etc. As I understand it, this second rule asks for 7 different programs to be in place, including recall plan, current good manufacturing practice, supplier verification, etc. We already have a recall plan and a HACCP plan implemented so some of the required work has already been done.
My strategy at the moment for writing and reworking plans is to explain everything we do in detail (everything in writing seems to be SUPER important), why we do things the way we do based on our understanding of potential hazards, and also to lean heavily on the “low risk” categorization of tea (herbs are a little less so). Our hazard analysis makes this very clear by referencing FDA docs and European industry guidance that I was able to find online.
Tea is low risk “due to the long history of safe use, low moisture content and the high content of antimicrobial substances”. I’m putting all this in writing to help the FDA understand they shouldn’t be scared of Assam BOP and that the PDF of a scanned phytosanitary certificate we got from the Indian Ministry of Agriculture will be adequate given that it’s tea. We think it should be adequate even if things aren’t done in India the way they would be in the USA.
Justifications like this certainly won’t make us exempt from the rule, but I’m hoping FDA will actually be as “flexible” as they claim in the kinds of verification we can except from tea producing countries.
I’m working on the easy stuff for our “food handling facility” first (current good manufacturing practices, monitoring, and the like) partly to drag my feet on FSVP to give the big guys a minute to help clear the path a little for us (probably wishful thinking). The FDA will have to understand the nature of our product.
As a small business, our company has a little time. I’m not stressing out, but I am being very proactive about FSMA. It’s comforting to know others in our tea universe are talking and worrying as well. Let’s stay in touch!