Antimicrobial product label reviews
Bringing an antimicrobial product to market in the US is complex, and there are strict labeling regulations companies must adhere to. Not only will TSG Consulting support your company in complying with federal and state regulations, we can also help develop one label that is suitable for use in all states, thereby streamlining processes and reducing costs.
With offices in Washington, DC and Sacramento, CA, our team of scientific and regulatory experts can help you navigate the intricacies of 40 CFR part 156, as well as the guidance and clarification documents warehoused in various places on EPA and state pesticide websites.
TSG’s labeling service includes:
- A word-for-word commercial label review to ensure adherence to the EPA master label approved for the product
- For subregistered products, a label review for adherence to the requirements of the signed EPA Form 8570-5
- Provision of an electronically annotated PDF of the commercial label, clearly explaining required changes, as well as recommended changes that will facilitate a smooth, swift state registration process
- A second, word-for-word review of the amended label to ensure that only the required amendments were made, and that no other changes were made inadvertently
Why TSG for your antimicrobial label reviews?
We understand antimicrobials – our experts occupy leadership positions in trade associations, and many have held positions within the US Environmental Protection Agency (EPA) and Food & Drug Administration (FDA).
Industry expertise – with many of our experts coming from industry, we understand the marketing and commercialization hurdles facing our clients. This knowledge underpins all of our label review practices.
Front-line knowledge – we conduct label reviews every day for all types of pesticides. Due to the sheer volume of labels we handle on a monthly basis, we have front-line knowledge of changing federal and state guidance. We are also exposed to a variety of label issues, and their eventual solutions, which enables us to efficiently and effectively resolve any challenges that our clients may be facing.
Robust state affairs practice – we are strategically located in Sacramento, California – the most complex state to obtain approval in. Having this large state affairs practice gives us the ability to rotate incoming label reviews. Clients always have refreshed consultants with keen eyes reviewing their labels.
Companies could face difficulties registering cleaners and disinfectants with claims of “long-lasting” effectiveness against C
27 October 2020
USA: EPA temporarily modifies PRN 98-10 to include food contact surface sanitizers that contain isopropyl alcohol
21 May 2020
21 May 2020
Thank you for helping us register our products both federally and in so many states – thanks for making the complex straightforward!
COVID-19 regulatory updates - read our latest advisories from North America and Europe
TSG will keep you up-to-date on changes to antimicrobial, biocide, sanitizer, disinfectant and medical device regulations.
Overcoming the key challenges of FIFRA 25(b) exempt pesticides
Anticipate and prepare for the challenges of state registration early in a product’s lifecycle.
Pesticide devices: how to navigate US regulations and substantiate claims
TSG Consulting’s Abigail Wacek and Dr Christine Greene discuss US regulations for antimicrobial pesticide devices.