The label is the law. How many times have we heard that? Yet all too often, new technicians will question why labels are so complex — and somewhat illogical, from their point of view.
Let’s take a brief walk through the process of how a label is developed in the United States:
When a product that will be sold to the pest control industry is developed with a current active ingredient, meaning the product is using an active ingredient already available, the manufacturer (known as the registrant, because it must register its products) compiles the scientific data requirements on chemistry, toxicology, efficacy and environmental effects. It then develops the various parts of the label.
As appropriate, and based upon science, a signal word is chosen based on the toxicity as sold, not as diluted. Precautionary language is developed. Personal protection equipment is determined. Directions for use then explain how the product is to be used. Where the product can be used is listed. After a few other pieces of information, storage and disposal instructions are listed. Then, the label is submitted to the U.S. Environmental Protection Agency (EPA) for review.
THE EPA’S ROLE
The EPA has 21 days to determine the application is complete. If so, the review begins. Each scientific discipline mentioned is sent to a different group for review. That is, the chemistry teams look at the product chemistry, and so on. The toxicology team looks at the health effects data, and the environmental effects are reviewed.
When each team is satisfied, after months of discussions and any concerns are addressed, the label is ready for final review. It is very common for the EPA to rewrite sections in a manner that can be foreign to our industry. Sometimes, registrants argue certain points. Usually, though, they accept the label language, reserving their challenges for more important issues.
After about a year into the process, the label is returned and accepted. The registrant then develops the actual label to go on the package, based upon the language accepted by the EPA.
The label is then submitted to states for their review. Any objections can derail the process: If a state disagrees with a statement on the EPA-reviewed label, the registrant must go back to the EPA for another change, which usually takes months.
Only after the majority of states register the product can a product move to commerce. The total time from submittal to distribution usually is well over a year, barring any issues.
THE PMP’S ROLE
Pest management professionals (PMPs) commonly ask for label changes. It seems so simple and logical to ask whether the label can just be tweaked to add a new pest, or maybe change some of the language to make it easier to explain to customers. Well, that process is the same. And if no studies must be submitted and reviewed, such as to add a public health pest, a change submitted to the EPA will take about five months to review. If all goes well, the new label would go to market within 12 months.
Why does it take so long? There are many moving parts to getting a label accepted or amended. It is a complex process that can change frequently, thanks to new regulations, policies or notices. Everyone would like to see the process move faster, but the process moves slow for a very good reason: The goal is to embrace sound science and perform a thorough job.
That said, you should never hesitate to contact the manufacturer of a product you use if you have a suggestion. Just be aware that there is a very long and difficult process to simply make a change to a label. Also, suggested changes open the label for a full review, so as the ol’ conventional wisdom goes, “be careful what you wish for.”
With PMPs and manufacturers working together, however, we can have a great supply of good products for years to come. It just takes understanding and patience.
Editor’s Note: On April 1, Pest Management Professional and Control Solutions Inc. presented a free, one-hour webinar that examined how to read and understand pesticide labels. To view the webinar on-demand, please visit MyPMP.net/webinars.
About the Author
Greg Baumann is Vice President, Technical Services & Regulatory Affairs for Nisus Corp.