News

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention is co-hosting a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) on March 22, 2023. Additionally, EPA is opening a docket for the agencies to receive public comment on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA. The agencies are also announcing the availability of a whitepaper entitled, “Modernizing the Approach to the EPA and FDA Oversight of Certain Products,” which describes the current challenges and highlights the potential benefits of a modernized approach for oversight of these products.

EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s expertise, with the goal of improving protection of human, animal, and environmental health. The purpose of the public comment period and virtual public meeting is to obtain feedback from stakeholders on the whitepaper and ideas for modernizing EPA and FDA’s approach to product oversight.

Currently, EPA and FDA determine regulatory oversight of pesticides and new animal drugs based on the rationale described in a Memorandum of Understanding (MOU) between the agencies signed in 1971 and revised in 1973. Since that time, pesticide and animal drug technologies—and both agencies’ understanding of these technologies—have evolved.
For example, parasite treatment products applied topically to animals (including pets) generally are regulated by EPA if they remain on the skin to control only external parasites (e.g., collars or sprays to control fleas, ticks) and by FDA if they are ingested and absorbed systemically into the bloodstream. The agencies now understand that many of the topically administered products currently regulated by EPA do not remain on the skin and are actually absorbed into the bloodstream, highlighting challenges with the current approach and raising different safety concerns than originally anticipated.

Additionally, genetically engineered (“GE”) pest animals, which are gaining interest as a pest control tool that can reduce the need for conventional pesticides, were not envisioned 50 years ago when the original regulatory approach was developed. As agreed in the 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products (PDF), EPA and FDA have considered how to update their respective responsibilities with the goal of developing an efficient, transparent, and predictable approach for overseeing GE insects. Recently, Executive Order 14081 (PDF), issued September 12, 2022, has further directed the agencies to improve the clarity and efficiency of the regulatory process for biotechnology products, underscoring the need for continued coordination between the agencies on biotechnology. The whitepaper and public meeting only address EPA and FDA oversight.

The agencies’ current approach to determining whether EPA or FDA is the appropriate regulator of certain products does not effectively reflect or accommodate scientific advancement, and it has become clear in some cases that the current approach has resulted in misalignment between product characteristics and the agency better equipped to regulate the product. A modernized approach would ensure that the oversight of these products better aligns with each agency’s expertise, accounts for scientific advancement, avoids redundancy, better protects animal health and safety, and improves regulatory clarity for regulated entities, animal owners, veterinarians, and other stakeholders.

Public Meeting Information
The virtual public meeting will focus on the whitepaper and the following questions. We are not seeking input or comments about any specific products, other federal agencies’ product oversight, or other topics outside the scope of the whitepaper and the questions below. We are particularly interested in receiving comments from the public on the following:
What do you perceive as the strengths and weaknesses of each agency in regulating these types of products?
Are there additional or different challenges that EPA and FDA did not identify in the whitepaper?
How can EPA and FDA communicate with their stakeholders about the regulation of these products in a clearer and more transparent manner?
For regulated entities, how have you historically determined which agency to approach first to bring your product to market?
For consumers, do you know who is regulating the products you use on your animal(s)? If you have a concern or complaint about a specific product, do you know which agency to contact?
How should EPA and FDA modify product oversight to better align with each agency’s mission and expertise?
What difficulties would you envision if EPA and FDA were to modify product oversight to better align with each agency’s mission and expertise, and how could they be mitigated?

Registration
Stakeholders interested in attending the virtual public meeting must register no later than 11:59 p.m. Eastern Time on March 15, 2023. Interested persons should register online at https://www.eventbrite.com/e/547810324427 and will need to provide contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if reasonable accommodations due to a disability are needed. Early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link. Registrants should ensure they retain the webcast link email and should check their “junk mail” folder if they do not receive an automatic confirmation with the webcast link after registering.

Requests for Presenting Oral Comments
During online registration you may indicate if you wish to make oral comments during the virtual public meeting. Registrants requesting to present oral comments should provide information regarding which topics they intend to address at the time of registration. We will do our best to accommodate requests to present oral comments.

Individuals and organizations with common interests are urged to consolidate or coordinate their comments. All requests to make oral comments must be received by March 15, 2023.

We will determine the amount of time allotted to each presenter and notify participants by March 21, 2023. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Submitting Electronic or Written Comments
Comments to the docket and/or presented at the public meeting should be limited to the questions/topics posed in the Federal Register Notice only, as described below.

Public comments will be accepted through 11:59 p.m. Eastern Time at the end of April 24, 2023.

Comments can be submitted electronically via the Federal eRulemaking Portal starting on February 23, 2023. All comment submissions received must reference Docket No. EPA-HQ-OPP-2023-0103. Received comments will be placed in the docket.
Do not electronically submit any information you consider Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional information on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

Following the public meeting and the close of the comment period, the EPA and FDA will consider comments received in determining next steps.

Event Materials
For more information, see the Federal Register Notice.
To submit a comment, visit Docket EPA-HQ-OPP-2023-0103.
WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight (pdf) (264.37 KB, February 17, 2023)

https://www.epa.gov/pesticides/virtual-public-meeting-fda-and-epa-product-oversight-march-22-2023

It’s time again to rally and support the beekeeping community! We are formally requesting the help of every beekeeper: you, your neighbors, your bee club and all the beekeepers you know.

The survey is open and accepting responses from April 1st to April 30th 2023. Please take a moment to submit your response to help us continue to inform beekeepers, researchers, policy makers, and the greater public about impacts to honey bee colony health.

Visit beeinformed.org to join in the effort, learn more, and take the survey!

We rely on word of mouth to reach as many beekeepers as possible. Please share this survey announcement far and wide with your beekeeping friends and local club members!

Friday, March 10th was the final day to file bills for the 2023 Legislative Session. As a TBA Board, we discuss and review potential legislation that may affect beekeepers within the State and have a dedicated Legislative Committee that follows along and meets with legislators as needed. We support some bills and oppose others, as appropriate, in line with TBA’s mission and resolutions.
The TBA Legislative Committee has been diligently tracking the legislative proceedings since last November when the first bee-related bill was filed. The Legislative Committee is currently focused on 9 bills, while another 5 bills are also being watched. These bill are listed on the TBA Legislative page here: https://texasbeekeepers.org/beelaws/
By referencing the TBA Mission and Resolutions to guide our position on each bill, the Legislative Committee strives to represent all beekeepers of Texas.
As we consider each bill, a detailed page is created with information, history and why it matters to the TBA. Please continue to review the 2023 Legislative Session page as it is frequently updated. And if you feel we should include additional bills, or want to share information about a certain bill you can do so with the link at the top of that page.

Did you know that the TBA has a YouTube Channel?? If not, you probably missed our latest post. and if you missed that, you might have also missed the video of Dr. Delaplane from last years summer clinic. That’s right, if you missed out on attending Summer Clinic last year, you can still watch several of the presentations posted on our YouTube Channel for free! Click the link to listen to Dr. Delaplane present on honey bees in Out of Africa or Out of Asia?

There was general talk about using Api-Bioxal in an extended application for the treatment of varroa mites at the ABF Conference last month.

Here is what we have found out about this action so far:

• Three states have an approved 2ee Registration for this use, Vermont, New York and Delaware. Numerous other states are working on it, but, like Texas, many are hesitant to proceed on their own initiative without EPA approval.
• EPA is in the process of responding to the 2ee exemptions. We understand that they expected to release  a letter soon laying out their position.
• According to BetterBee, who now has the right to Api-Bioxal, it’s hard for the
  manufacturer to know which way to go until EPA speaks but they are in the process of discussing several options.

TBA is on the list to receive more information as it becomes available.

Contact: Autumn Canaday
Email: Autumn Canaday
February 15, 2023

U.S. agriculture owes many thanks to the honey bee (Apis mellifera L.), as it plays the crucial role of pollinator within the nation’s food supply. Some of the nation’s food industries rely solely on the honey bee, and it’s estimated that the economic value of its pollination role is worth well over $17 billion each year. With this fact in mind, ARS researchers recently studied the U.S. honey bee’s genetic diversity to ensure that this crucial pollinator insect has sufficient diversity to overcome the growing number of stressors such as parasites, diseases, malnutrition, and climate change.
What they found is alarming: the U.S. honey bee population has low genetic diversity, and this could have a negative impact on future crop pollination and beekeeping sustainability in the country.

The research, recently highlighted in Frontiers, was accomplished by analyzing the genetic diversity of the U.S. honey bee populations through a molecular approach, using two mitochondrial DNA (mtDNA) markers (DNA specifically from a mother). Researchers studied approximately 1,063 bees from hobbyist, and commercial beekeepers in 45 U.S. states, the District of Columbia (D.C.), and two US territories (Guam and Puerto Rico). The data showed that the nation’s managed honey bee populations rely intensively on a single honey bee evolutionary lineage. In fact, 94 percent of U.S. honey bees belonged to the North Mediterranean C lineage. Data reflected that the remainder of genetic diversity belongs to the West Mediterranean M lineage (3%) and the African A lineage (3%).

“It’s important that we have a realistic and accurate estimation of the honey bee’s genetic diversity because this indicates the insect’s ability to respond to disease, adaptation to environment, and productivity,” said ARS Research Entomologist Mohamed Alburaki. “Without this pollinator insect, we will witness a drastic decrease in the quantity and quality of our agricultural products such as almonds, apples, melons, cranberries, pumpkins, broccoli and many other fruits and vegetables that we’re used to purchasing. We can’t wait until a domino effect slowly takes place and affects our food supply.”

93.79 percent of U.S. honey bees belonged to the North Mediterranean C lineage. The percentage of this lineage is displayed for each state

The lack of genetic diversity creates a vulnerability for U.S. honey bees to survive in shifting climates that are now wetter or drier than usual. There is also concern that a honey bee’s inability to fight off disease or parasitic infection could negatively impact beekeeping sustainability. The challenge of U.S. honey bees’ weakened immunity has become an economic burden to bee producers and beekeepers. In the past, U.S. beekeepers suffered less honey bee colony losses and treated against varroa mite (a ferocious honey bee parasite) once per year. In 2023, colony losses and winter mortality are at a high peak and varroa mite requires multiple treatments per year to keep it under control.

“As a honey bee researcher, what worries me the most is that 77 percent of our honey bee populations are represented by only two haplotypes, or maternal DNA, while over hundreds of haplotypes exist in the native range of this species in the Old World, or the honey bees’ native land of evolution,” Alburaki said. “Many of these haplotypes have evolved over millions of years in their native lands, and have developed astonishing adaptation traits that we should consider incorporating in our US honey bee stocks before it is too late.”

These complex factors are driving Alburaki and his ARS research team to develop a solution that’s sustainable for the entire nation. The research team is currently evaluating the paternal diversity of the previously analyzed populations to acquire a full and accurate picture of the overall genetic diversity of the U.S. honeybee populations. Researchers are also interested in the possibility of diversifying breeding stations with honey bee queens from various genetic backgrounds.

Alburaki’s research also identified and named 14 novel haplotypes in the three evolutionary lineages. These haplotypes have never been reported before and can provide new insights into the U.S. honey bee’s evolution since its importation to North America in the 1600s. There is hope that the researchers can use this information to locate and enhance the numbers of these rare and novel US haplotypes, which could speed the process of reaching a healthier diversity within the nation’s honey bee population.

The Agricultural Research Service is the U.S. Department of Agriculture’s chief scientific in-house research agency. Daily, ARS focuses on solutions to agricultural problems affecting America. Each dollar invested in U.S. agricultural research results in $20 of economic impact.

https://www.ars.usda.gov/news-events/news/research-news/2023/dna-research-finds-low-genetic-diversity-among-us-honey-bees/

The Texas Beekeepers Association Legislative Committee has been working hard to follow bills as they are introduced. We will continue to monitor and update this site as new information unfolds. If you see other relevant bills that should receive our attention, please let us know. Please look for the 2023 Legislative Session Updates under the Resources tab under Issues, look for the Legislative Updates box at the bottom, or follow this link. This page will be updated soon with more details on each of the bill we are currently tracking.

Bee-related bills currently following:

• HB 590 – Relating to the labeling and sale of Texas honey.
• HB 1750 – Relating to the applicability of certain city requirements to agricultural operations. (Right to Farm – Burns)
• HB 2271 – Relating to the protection of aquaculture operations. (Right to Farm – Aquaculture – Kacal)
• HB 2308 – Relating to nuisance actions and other actions against agricultural operations. (Right to Farm – Ashby)
• HB 2329 – Relating to honey production operations and the harvesting and packaging of honey and honeycomb. (Clean up bill DSHS – Bailes)
• SB 829 – Relating to cottage food production operations. (Cottage Food –Kolkhorst)