What is the research behind bee stings for arthritis?

What is the research behind bee stings for arthritis?

Medically reviewed by Stella Bard, MD — Written by Mathieu Rees on December 21, 2021

Bee venom therapy involves injecting a person with honey bee venom or exposing a person to bee stings from live bees. Some evidence suggests this therapy may help people manage joint pain and inflammation associated with inflammatory forms of arthritis.

Bee venom consists of various natural substances that may have beneficial effects on health. Humans have used bee venom as a form of alternative or complementary medicine for thousands of years. However, scientists have only recently begun conducting clinical trials to test the safety and efficacy of bee venom as a treatment for inflammatory arthritis.

This article describes what bee venom therapy is and outlines some of the research into bee venom therapy for arthritis. We also provide information on the safety and side effects of bee venom therapy and list some of the more standard treatment options for arthritis.

What is bee venom therapy?

Honey bees are venomous flying insects that can sting when threatened. A sting transfers venom from the honey bee into its target.

Bee venom therapy refers to any therapy that uses bee venom as a key component. This can involve extracting the bee venom for future use or deliberately provoking live bees to sting a person.

According to a 2018 articleTrusted Source, humans have used bee venom therapy for over 3,000 years. Bee venom contains a variety of chemicals with potential medical applications, including various enzymes, peptides, and amines.

Research behind it
Around 50%Trusted Source of bee venom is a substance called melittin, composed of 26 different amino acids. A 2018 reviewTrusted Source outlines evidence suggesting that bee venom and melittin may have beneficial effects on health. Some important medicinal properties of bee venom and melittin include:

  • antibacterial and antiviral properties
  • anti-inflammatory properties
  • pain-relieving properties
  • anti-cancer properties

As a 2021 reviewTrusted Source explains, arthritis is a chronic condition in which inflammation causes pain, swelling, and stiffness in the joints. Because melittin has pain-relieving and anti-inflammatory properties at lower dosesTrusted Source, some researchers have speculated whether bee venom therapy may help alleviate arthritic joint pain and inflammation.

Animal studies
There is some evidence that bee venom could have anti-inflammatory and anti-arthritic effects in animals.

One 2020 study investigated the efficacy of bee venom in rats with artificially induced rheumatoid arthritis (RA). Researchers divided the rats into four groups: one group received bee venom, a second received the anti-arthritis drug methotrexate, and a third group received saline. The fourth group consisted of rats that did not have RA.

The study found that bee venom and methotrexate were similarly effective in reducing RA symptoms. The researchers concluded that bee venom therapy has the potential to alleviate RA pain and inflammation.

Although the study results are promising, the sample size consisted of only 20 rats. Moreover, because the study involved animals, it is not clear whether and to what extent the findings apply to humans. Indeed, human studies investigating bee venom therapy for arthritis show mixed results.
Human studies

One 2018 studyTrusted Source compared the anti-arthritic effects of bee venom acupuncture with those of the anti-arthritis drugs methotrexate and celecoxib. The study used a relatively large sample of 120 people.

Over the course of 8 weeks, one group received the drug treatment, and the other received 5–15 bee stings every other day. Both groups showed a reduction in their arthritis symptoms, with no significant difference between the groups. Participants in both groups experienced improvements in the following:

Although the above findings are promising, it is important to note that the study was not double-blind and did not compare the treatment effects with those of a placebo. This greatly reduces the reliability of the results.

The results of a 2020 meta-analysis are more promising. This study analyzed the results of several randomized controlled trials investigating bee venom therapy for a range of diseases, including arthritis. The researchers concluded that bee venom therapy might be beneficial in treating inflammatory forms of arthritis.

Conclusion
Bee venom therapy remains an experimental treatment option for arthritis. Although some evidence suggests that bee venom therapy could help manage arthritis, more large-scale, high-quality clinical trials are necessary to confirm its effectiveness.

Bee venom contains many anti-inflammatory and immune-modulating substances, but its clinical effects need further study before people can use it therapeutically. Doctors strongly discourage administration via direct stinging.

Safety
The most obvious safety concern regarding bee venom therapy is the possibility of a serious, life threatening allergic reaction called anaphylaxis. Bee and wasp stings are among the most commonTrusted Source causes of anaphylaxis.

As a 2019 studyTrusted Source explains, allergic reactions to bee stings can lead to the following complications:

  • skin problems, such as localized swelling and hives
  • gastrointestinal symptoms
  • respiratory problems
  • heart problems
  • death

Anyone considering bee venom therapy should first undergo allergy testing to determine whether they are allergic to bee venom. A person can speak with a doctor to get further advice on allergy testing.

Side effects
Bee venom functions to protect the beehive from destruction. Stings deter potential intruders or predators by causing pain and discomfort. Potential adverse effects of bee venom and bee venom therapy includeTrusted Source:

Other treatment options
As a 2021 reviewTrusted Source explains, there is currently no cure for arthritis. However, treatments can help alleviate symptoms and slow the progression of the disease. Treatment options will vary according to various factors, including the type of arthritis a person has. Potential treatment options include:

Summary
Bee venom contains natural substances that may help alleviate joint pain and inflammation associated with arthritis. Bee venom therapy involves extracting bee venom for therapeutic use or exposing a person to bee stings from live bees. It is an ancient practice dating back thousands of years.

Some research suggests that bee venom therapy may be beneficial in treating arthritis. However, further large-scale randomized controlled trials are necessary to confirm these findings.

Anyone considering bee venom therapy should first undergo allergy testing to determine whether they may be allergic to bee stings. Bee venom can cause a serious and potentially life threatening allergic reaction in susceptible individuals. It may also cause more general side effects, such as severe pain, headache, and muscle weakness.

https://www.medicalnewstoday.com/articles/bee-stings-for-arthritis#summary

Parasitic honeybee mite jolts in the hive and uses vibrations to sense where it is

Parasitic honeybee mite jolts in the hive and uses vibrations to sense where it is
by Nottingham Trent University
December 16, 2021

Tiny parasitic mites, which are one the greatest threats to the honeybee, frequently send remarkably strong vibrational pulses into the surface they reside on, a new study has revealed.

Scientists at Nottingham Trent University, which led the work, argue that the vibration could be produced for the purpose of environmental probing, with the mite exploiting the material’s response to the signal to probe its surroundings.

It is hoped that the fundamental discovery could lead to understanding how to manage and possibly even eradicate Varroa destructor mite infestations in the hive.

Using ultra-sensitive accelerometers—which have been able to detect vibrational waveforms originating from one individual mite—the team recorded the repeated knocking of the 1mm creatures, which they do by abruptly jolting their bodies.

The researchers are the first group in the world to capture such vibrational waveform from a mite of any species, which can also be heard as an audio track when driven through speakers.

Varroa mites—which cannot see or hear and weigh about half a milligram—live in honeybee colonies in most parts of the world and feed on adult bees and larvae, passing on a variety of viruses to their hosts and play an important role in the destruction of colonies.

The researchers were looking for vibrational traces coming from honeybees that may be infected but found unexpectedly that the individual mites were providing measurable vibrations of their own.

The vibration that occurs as a result of the mite’s jolting is very short and rapidly produced—taking just 50 to 90 microseconds for the vibration to be transmitted—and the features of the signal vary strongly depending on the material the mite is stood on, providing a ‘signature’ of the substrate.

“It is known in other species, such as the Aye-Aye and some parasitic wasps, that a signal similar to the one we discovered is produced, so that the animal can gather environmental knowledge,” said Harriet Hall, a researcher in Nottingham Trent University’s School of Science and Technology.

She said: “If a mite becomes dislodged from its honeybee host, this could perhaps help it orientate back to a bee, especially as the animal can’t see or hear. The mite jolting is a commonly observed behavior that is energetically demanding to produce—another sign that the mite produces this vibration deliberately, for its own benefit.”

It is widely acknowledged that these mites respond to a variety of sensory stimuli such as temperature and pheromones to orient to bees and to synchronize their offspring development with that of the bee, but little research has been carried out in terms of vibration.

The team is now launching a new branch of investigations to help further clarify the purpose of the vibrations. It is hoped that deeper understanding of the function will enable them to manipulate the behavior to better manage and potentially eradicate the mite from honeybee hives.

It could also have repercussions for the study of other mites and ticks which may use similar signals.

Harriet added: “We could perhaps use the vibrational features of the jolting signal to search for mites in a honeybee colony using our vibration sensing technology, without the need to disturb the bees by physically inspecting the hive. This could lead to a new method of detecting mite infestation early on, enabling beekeepers to medicate their colonies before the mites get out of control or avoid medication altogether, if deemed unnecessary.”

Dr. Martin Bencsik, a physicist at Nottingham Trent University, added: “The vibrational pulse coincides with a mite’s abrupt body motion, which has never been seen before and which we have captured and showcased in our work. We have characterized a new behavior in this species, a discovery so fundamental that it could have numerous and unexpected repercussions.

“For the first time you can see the jolting behavior, the corresponding accelerometer trace, and even hear the repeated ‘knocks’ produced by this organism that weighs as little as a single strand of human hair and is 200 times lighter than a honeybee.

“It is the first study to show that an individual mite is not only a receiver of vibrations, but also a transmitter of vibrations. On the basis of the vast energy spent by the mite to deliver these, they are probably not by-product vibrations of its activity, but deliberately transmitted by the animal for its own benefit.

“The signal is very common in the hive. We found that the animal is capable of slowly winding up energy in some kind of internal ‘spring’ system than it can then suddenly release, providing a super strong, super short vibrational pulse delivery.”

The work is the latest Nottingham Trent University study looking at honeybee communication in the hive. Previous work has found that Queen bees ‘toot’ to instruct the colony to keep them safe, that honeybees drum on the comb to prompt others in the hive to start getting busy, and that surprised honeybees give ‘whooping signal’ in the hive.

The latest research, published in the journal Entomologia Generalis, also involved the University of Warwick.

https://phys.org/news/2021-12-parasitic-honeybee-mite-jolts-hive.html

Bill Baxter to hold position of Acting Chief Apiary Inspector

Bill Baxter will step into familiar shoes once again for the State of Texas, as he fills the position of Acting Chief Apiary Inspector.

Mr. Baxter was employed by the Texas Apiary Inspection Service on June 16, 1977 as a Foulbrood Inspector and on June 1, 2003 was promoted to Assistant Chief Foulbrood Inspector. Mr. Baxter has served in this acting role between two previous Chief Inspectors, Paul Jackson and Mark Dykes.

We’re looking forward to the future and hope that whoever fills the position lives up to the standard that Mary had set. Mary has accomplished so much in her time as Chief that positively affects Texas Beekeepers. From educating legislators at the Texas Capitol to building a foundation for resources and programs that will hopefully continue to grow in her absence. We believe her commitment to educating Texas Master Beekeepers was an efficient and targeted way to expand knowledge within the beekeeping community. This commitment as well as one to consistently learning and staying up to date on the most relevant research studies and industry news will hopefully be a crucial trait for seeking a new Chief.

Whoever fills the position will have big shoes to fill. We will be staying in touch with Texas A&M as they work to fill this position. In the interim, Texas will have Bill Baxter as the Acting Chief Apiary Inspector – providing consistency in the services we expect from the Texas Apiary Inspection Service along with the other inspectors.

Information about the Farm Animal Liability Act

Trace Blair, Jourdanton-based attorney, was interviewed in the Ag Law in the Field podcast. He talked through the three limited liability statutes that exist to protect rural Texas landowners and ag producers. Specifically, this episode offers an update to the details and rules surrounding the Farm Animal Liability Act that went into effect on September 1, 2021. There is also information about the Agritourism, and the required signage.

Links to resources mentioned on the show
Blog post on the Texas Recreational Use statute
Where Can I Find the Agritourism Act Signs?
Texas Farm Animal Liability Act statute
Texas Farm Animal Liability Act FAQs

Listen to the full podcast here:
https://aglaw.libsyn.com/episode-122-trace-blair-texas-limited-liability-statutes-update

Western Honey Bees Most Likely Originated in Asia, Researchers Find

Western Honey Bees Most Likely Originated in Asia, Researchers Find

Cristen Hemingway Jaynes
Dec. 10, 2021 12:13PM EST

For decades, a hot topic in the world of western honey bees has been the question of where these essential crop pollinators and suppliers of most of the world’s honey originated.

The answer was previously believed to be Africa. But a team of scientists led by York University has reached a new conclusion after reconstructing the origin and dispersal pattern of the western honey bees. After sequencing 251 genomes of 18 subspecies from the bees’ native range and analyzing the genetic data, the team determined that the bees most likely originated in Western Asia rather than Africa.

“Our study answered a mystery in bee biology – where did the western honey bee come from? This topic has been intensely debated and recent studies were inconclusive,” said professor Amro Zayed, who teaches biology and serves as York University’s Research Chair in Genomics, in an interview with EcoWatch. “We sequenced the largest number of honeybee subspecies and our analysis indicated that the honey bee originated in Western Asia. We also discovered that the Egyptian honey bee – Apis mellifera lamarckii – is really distinct; its genome differs greatly from honey bees found in [Africa] and the Saudi peninsula.”

According to Zayed and the study’s co-authors, “The genus Apis is composed of 12 extant species that form three distinct groups: giant honeybees, dwarf honeybees, and cavity-nesting honeybees,” as reported by Science News.

“All but one of the extant Apis species are endemic to Asia. The exception, Apis mellifera, is native to Europe, Africa, and Western Asia,” Zayed and his colleagues said.

“By comparing how similar the bee genomes were to each other, the team estimated that the A. mellifera ancestor originated in Asia around 7 million years ago, then spread into both Africa and Europe around 6 million years ago,” Carissa Wong of NewScientist reported.

From its origins in Asia, the western honey bee spread into Africa and Europe, where it created seven distinct lineages that could be traced back to Western Asia, said York University in a press release, as reported by Phys.org. Being native to Africa, Asia and Europe, the honey bee has been able to survive in widely varied climates, from tropical rainforest to regions that are dry, temperate or cold.

“As one of the world’s most important pollinators, it’s essential to know the origin of the western honey bee to understand its evolution, genetics and how it adapted as it spread,” said Zayed, as reported by Phys.org.

“The genetic data allow us to draw an ‘evolutionary’ tree that connects the honey bee populations we see [today] to their ancestors that lived 5 to 10 million years ago before the western honey bee lineage split from its sister species,” Zayed told EcoWatch.

“We use the shape of the tree and the known geographic ranges of modern populations to infer where the ancestors of the western honey bee lived. We then compare the DNA of the different honey bee lineages to discover mutations that are mostly unique to specific lineages – these mutations are more likely to be involved in the adaptation of bee lineages to their local environment,” he added.

The result of the honey bees’ adaptation was the evolution of 27 unique honey bee subspecies. Two separate lineages, one in Egypt and the other in Madagascar, were discovered through the sequencing of the honey bee subspecies.

According to the study, there are “hot spots” in the genome of the honey bees that support their ability to adapt to new areas. Just 145 of the over 12,000 genes in the bee genome had “repeated signatures of adaptation associated with the formation of all major honey bee lineages found today,” according to Phys.org.

“These genes tended to affect development and behaviour, and tended to be expressed in worker bees. This suggests that mutations that affect worker traits and behaviour are key for helping the honey bee adapt to different environments across their vast range,” Zayed told EcoWatch.

The new honey bee data can be used to help protect the species in the future.

“The genomic data generated here can be used to define and protect native honey bee subspecies in Africa, Asia and Europe – some of these subspecies are at a great risk of ‘extinction-via-introgression’; essentially, managed honey bees in most parts of the world are typically a mix of European lineages, which can hybridize with pure subspecies and ‘dilute’ their purity,” remarked Zayed to EcoWatch.

“We can also apply our knowledge of the mutations that allow native bees to adapt to their environment to improve the fitness of managed bees, by – for example – using marker-assisted breeding,” he added.

With the mystery of the origin of the western honey bee solved, the research team hopes that future exploration can examine further how they came to adapt to particular geographic ranges and climates.

“We are in the process of combining our population genomic studies with [quantitative] genetic studies of managed honeybees. We are trying to directly identify mutations that affect the behaviour and health of honey bee colonies to understand the genetic and evolutionary basis of ‘super organismal’ traits,” Zayed told EcoWatch

https://www.ecowatch.com/western-honey-bees-origin-asia-2655985813.html

Honey Bees ‘Scream’ Like Mammals When Attacked by Giant Hornets

Honey Bees ‘Scream’ Like Mammals When Attacked by Giant Hornets

The unique buzzing only happens when giant hornets threaten the hive, showing the complexities of bee communication.
By George Dvorsky
11/10/21 10:41AM

Unsettling and distinctive sounds made by Asian honey bees during attacks of giant hornets might be an alarm signal for the hive to deploy defensive measures.

Attacks by giant hornets (Vespa soror) are existential threats to colonies of honey bees (Apis cerana). Their invasions are brutal and practically identical to those employed by their sister species, Vespa mandarinia, popularly known as murder hornets (the two species are very similar in terms of body shape and behavior, but it’s important to not conflate the two, especially given the invasive potential of V. mandarinia in western North America). Giant hornets, owing to their bulk and ferocity, can devastate an entire bee hive in just a few hours, during which time they kill the defenders, occupy their nest, and—in the ultimate injustice—carry back the defenseless brood as food for their own larvae.

It’s very nasty business, but new research published in Royal Society Open Science shows one potential way in which Asian honey bees have managed to adapt: an alarm call specific to giant hornets.

“It’s alarming to hear!” Heather Mattila, a co-author of the study and a researcher at Wellesley College, told me when I asked her to describe the apparent distress signal. “It’s characterized by rapid bursts of high-pitched sounds that change unpredictably in frequency—they’re quite harsh and noisy.”

Fascinatingly, the alarm shares “acoustic traits with alarm shrieks, fear screams, and panic calls of primates, birds, and meerkats,” according to the study. Mattila said it’s “exciting to learn that the sound properties of the honey bees’ alarm signal are really similar to the properties of signals used by mammals that also live in social groups and share information about danger around them.” Working with local beekeepers in Vietnam, Mattila and her colleagues have spent the better part of seven years studying the various interactions between Asian honey bees and their arch nemesis, the giant hornets. By placing microphones inside of hives, the team amassed over 1,300 minutes of beehive chatter. The newly detected alarm signal, called an “antipredator pipe,” was isolated from other sounds, including other acoustic bee signals, by looking at visual representations of sound known as spectrograms.

“These images show the different properties of the sounds that the bees make, even if they overlapped in time because many bees were signaling at once,” Mattila explained. “We looked through all of our recordings to get good examples of antipredator pipes that were clear of other sounds so that we could characterize their acoustic properties. Then it became easy to recognize them in more chaotic moments, when lots of sounds were being made.”

Read the rest of the article and view the video: https://gizmodo.com/honey-bees-scream-like-mammals-when-attacked-by-giant-1848025762

Pollinator Stewardship Council President’s Letter

A Letter From Our President:

As 2021 draws to a close and 2022 beckons, the Pollinator Stewardship Council (PSC) would like to thank everyone for their support and encouragement over the years.  The Pollinator Stewardship Council remains fully committed to our mission “To defend managed and native pollinators vital to a sustainable food supply, from the adverse impact of pesticides.”

Since 2006 when PSC board member David Hackenberg first drew national attention to the mysterious bee problem now known as CCD, beekeepers and research scientists have worked tirelessly to understand the problem and address the root causes.

The first collaborative effort of the American Beekeeping Federation (ABF) and the American Honey Producers Association (AHPA) was named the Bayer Beekeeper Dialogue Committee (2009-11).  After two years of beekeepers’ good faith efforts with the pesticide industry, we realized that there was no reciprocation. The united effort of the beekeeping organizations continued without Bayer, under the new name of National Honey Bee Advisory Board (2011-14).  Since 2015, the PSC has taken over the mantle.

Good science has always been at the basis of our work, and collaboration with scientists from USDA, EPA, and academia has helped us understand the mysteries of honey bee decline – which we now understand to be a broader insect apocalypse impacting many more species beyond honey bees.

The PSC and our board have been meeting with the EPA and USDA since 2006.  We understand the policy challenges of pollinator protection. Through these years it has always seemed like our efforts were for naught.  Insiders consistently whispered to us that the game was rigged in favor of huge corporations like Monsanto, Ag Chem China, and Bayer.  Today thanks to four brave whistleblowers within EPA and a brilliant piece of investigative journalism, we are learning the extent of that “influence.

A hopeful note is the appointment of Michal Freedhof and Jake Li to the two highest positions within the EPA Office of Pesticide Programs (OPP).  Both are strong people with backgrounds in tackling thorny environmental issues such as PFAS chemicals.Their presence sends a clear signal to staff within the Office of Pesticide Programs.  We are in communication with both directors and feel optimistic that good science and the public’s best interests may finally govern pesticide registration and oversight. At the same time, we remain dedicated to building power outside of the halls of EPA to demand these changes.

The latest example of PSC’s impact in the protection of pollinators is our recent legal victory in California banning the use of the destructive pesticide sulfoxaflor.  With the assistance of our dedicated legal team at Earthjustice, a California Superior court ruled on December 3, 2021, that use of this deadly chemical violated state environmental law.  The members of Pollinator Stewardship Council are committed to the long-haul game of protecting pollinators from pesticides.  This could not have been accomplished without your help and with your continued support we can make real progress in 2022. Your contribution at this critical time will make a difference, and we appreciate your dedication to the protection of our pollinators.  

Steve Ellis, President

Pollinator Stewardship Council

Pesticides Can Affect Multiple Generations of Bees Study Finds Reduced Bee Reproduction Over 2 Years

Pesticides Can Affect Multiple Generations of Bees
Study Finds Reduced Bee Reproduction Over 2 Years
by Amy Quinton
November 29, 2021

A new study from researchers at the University of California, Davis, finds that pesticides not only directly affect bee health, but effects from past exposure can carry over to future generations. The study, published in the journal Proceedings of the National Academy of Sciences, suggests that bees may require multiple generations to recover from even a single application.

Bees play a critical role in agricultural ecosystems, providing pollination for many important crops. In most agricultural areas, bees may be exposed to pesticides multiple times, over multiple years. Studies to date have only looked at exposure to pesticides in one life stage or over one year.

“It was important for us to understand how exposure persists from one generation to the next,” said lead author Clara Stuligross, a Ph.D. candidate in ecology at UC Davis. “Our findings suggest we need to be doing more to help mitigate risks or we limit critical pollination services.”

Reproduction drops
In the study, the blue orchard bee was exposed to imidacloprid — the most commonly used neonicotinoid in California — according to amounts recommended on the label. Neonicotinoids are a class of insecticides chemically related to nicotine. Stuligross said the exposures were similar to what the bees would experience in the field. Female bees that were exposed to the insecticide as larvae had 20% fewer offspring than bees not exposed. Those bees that were exposed as larvae and as adults had 44% fewer offspring.

“We gave them one application in the first year and one in the second — that’s a pretty standard exposure. Even then, we saw strong results that added up, each exposure reducing fertility,” said Stuligross.

Populations affected
Because the impacts of insecticides tend to be additive across life stages, repeated exposure has profound implications for population growth. The research showed that bees exposed to neonicotinoids in both the first and second year resulted in a 72% lower population growth rate compared to bees not exposed at all. Neonicotinoids also persist in the environment long after application.

The study reveals how past pesticide exposure can have lasting impacts, said co-author Neal Williams, professor of entomology at UC Davis. “One could draw parallels to human health where impacts early in development show up much later in life,” he said. “We just didn’t know the same was true for bees. Now we do and we need to continue to manage risks appropriately.”

The study was supported by a UC Davis Jastro Research Award, a UC Davis Ecology Graduate Research Fellowship, a National Science Foundation Graduate Research Fellowship, the National Science Foundation and the UC Davis Department of Entomology through the Harry H. Laidlaw Jr. Bee Research Facility and Laidlaw Endowment.

https://www.ucdavis.edu/climate/news/pesticides-can-affect-multiple-generations-bees

Beekeeping and Agritourism

A new revenue stream is gaining traction with beekeepers, agritourism venues! Clint Walker of Walker Honey Farm talks with our TBA members about the business opportunity of helping connect non-beekeepers to bees. This is a mutually beneficial experience where the guests are able to better understand and appreciate bees. It’s also a great way to raise awareness for your brand and your business. Watch his Texas Beekeepers Association Annual Conference video https://youtu.be/0F9dhNX3UO8
The American Farm Bureau Foundation for Agricultural has created a new app dedicated to connecting these venues and the public. You can sign your agritourism venue up for free on the American Farm Trail app created by the Foundation. Learn more about the app and other resources at https://www.agfoundation.org/news/looking-for-agritourism-operations

FDA Takes Steps to Facilitate the Export of Food under China’s New Facility Registration Requirements – Decree 248

FDA Takes Steps to Facilitate the Export of Food under China’s New Facility Registration Requirements – Decree 248
Constituent Update
December 6, 2021

The FDA is asking establishments currently exporting certain food products to China to voluntarily submit information. We are making this request in response to new facility registration requirements from China. While China has not confirmed that collecting this information is a prerequisite for U.S. establishments to export to China, the FDA is making this request as a precaution against potential trade disruption.  In April 2021, China’s General Administration of Customs (GACC) announced new registration requirements that affect all overseas food manufacturers, processors, and storage facilities of food products exported to China. These requirements are described in China’s Decree 248 and will be in effect on January 1, 2022.

Articles 7 and 8 of the Decree require the exporting countries’ competent authorities to recommend registration of establishments involved in the export to China of certain food categories:

  • Meat and meat products
  • Aquatic products
  • Dairy products
  • Bird nests and bird nest products
  • Casings
  • Bee products
  • Eggs and egg products
  • Edible oils and fats
  • Stuffed wheaten products
  • Edible grains
  • Milled grain industry products and malt
  • Fresh and dehydrated vegetables and dried beans
  • Condiments
  • Nuts and seeds
  • Dried fruits
  • Unroasted coffee beans and cocoa beans
  • Foods for special dietary purposes
  • Functional food

For products that do not fall within the 18 product categories listed in Article 7 and above, the GACC launched a system to facilitate self-registration as indicated in Article 9 of Decree 248. The USDA’s Foreign Agricultural Service (FAS) has published information on the self-registration process.

According to the GACC, it will continue to recognize existing registrations for establishments that export meat and meat products, aquatic products, dairy and infant formula products and bird nests and bird nest products. The FDA currently facilitates the registration of U.S. firms for seafood, dairy, and infant formula products by providing the GACC with documents that identify certified establishments and products that meet applicable U.S. requirements. U.S. firms that have applied in the FDA’s Export Listing Module (ELM) and are currently listed as certified by the GACC to export seafood, dairy, and infant formula products to China do not need to take any action at this time related to registration.

For all other categories of food, the U.S. government interprets the Decree to provide that these products are covered by the existing bilateral agreements with China, such as the Phase One Economic and Trade Agreement, and other bilateral facility registration arrangements. USTR has asked the GACC to confirm its understanding that U.S. establishments that export all other categories of products may self-register. To date the GACC has not confirmed this interpretation of Decree 248 and has failed to provide adequate further guidance for the United States.  While the United States continues to engage with China at multiple levels to ensure minimal new requirements for the United States, the FDA is taking proactive steps to maintain current market access for FDA-regulated firms in the United States that export food to China.

IMPORTANT DATES FOR U.S. ESTABLISHMENTS
As the U.S competent authority for many of the product categories named in Article 7 of Decree 248, the FDA is collecting information in the Export Listing Module (ELM) from U.S. firms that may be needed to facilitate the registration process before the new requirements go into effect on January 1, 2022.

Beginning on December 6, 2021, U.S. establishments that currently produce or store FDA-regulated products for export to China that fall into the product categories 5-18 listed above may submit an application via the FDA’s Export Listing Module (ELM), providing information for products they currently export to China to allow the FDA to facilitate registration of these establishments with China. Step-by-step instructions for using the ELM are available on the FDA’s website.

To ensure that the FDA has the relevant establishment information before the end of the year, any U.S. establishment currently exporting food products in categories 5-18 to China should submit applications to the ELM by December 17, 2021. In addition to meeting U.S. requirements, firms exporting to China are responsible for meeting relevant China regulations and requirements.

Please note that the FDA does not intend to provide a declaration of conformity or other competent authority statement directly to U.S. establishments. In the event it is needed for registration for China, the FDA may provide an attestation directly to GACC for U.S. establishments and their products that comply with applicable U.S. requirements in order to facilitate registration.

For more details on China’s requirements, additional information on the U.S. competent authority for certain products that are under the FDA’s authority or the USDA’s Food Safety and Inspection Service’s authority, or both and for step-by-step instructions on how to apply to the ELM, visit Food Export Library and Online Applications for Export Lists.

For more information, contact the Export Certification Team at CFSANExportCertification@fda.hhs.gov.
https://www.fda.gov/food/cfsan-constituent-updates/fda-takes-steps-facilitate-export-food-under-chinas-new-facility-registration-requirements-decree