New Pristine Supplemental Label Explained
by Rose Kachadoorian, Oregon Department of Agriculture
In March of 2012 it came to the attention of both the Oregon Department of Agriculture (ODA) and the Washington State Department of Agriculture (WSDA) that there were EPA approved supplemental pesticide labels with label language that could be very confusing to growers and possibly cause enforcement issues. These supplemental labels stated that they superseded the main container labels.
The new supplemental label for BASF’s Pristine Fungicide (EPA Reg. No. 7969-199) allowed use on blueberries and caneberries, but only if Pristine was not mixed with any other pesticides, adjuvants, fertilizers etc. The problem was that tank mixing was allowed on the main container label (note – there are newer containers of Pristine without blueberries on the label).
In this case, a supplemental label was being used to take away a method (tank mixing) that was allowed on the main container label. Upset growers wanted to know if they tank mixed without knowing about the supplemental label, would they be fined? One frustrated grower exclaimed at a meeting that he wasn’t psychic. They had always been told by ODA to follow the label directions on the container in their possession.
ODA was sympathetic to growers’ concerns and contacted the registrant and EPA. BASF is assessing modifying their label and will work with EPA. EPA realizes that there are potential grower confusion and state enforcement issues. This issue is being discussed within their Labeling Consistency Workgroup to develop a formal policy. ODA is also on the agenda at a national meeting between state agriculture officials and EPA in May to discuss this issue.
Since the issue with Pristine, ODA has found three other supplemental labels with similar problems. One supplemental label was used to extend the Re-entry Interval (REI) that was listed on the main container label.
ODA does not intend to make enforcement of labels with language stating that they supersede the main container labels a regulatory priority. However, if there is an active investigation, the pesticide investigator always asks for a copy of the pesticide records. If a violation of the label is found, enforcement action may take place.
EPA defines supplemental labeling as a “term used to describe labeling which includes newly approved uses, use directions or other instructions which have been added since the last accepted Master label.”
Supplemental labels are most often developed by pesticide companies to add a use site (crop). Proposed federal supplemental labels are submitted to EPA for review and approval.
The most common scenario is that EPA sets a new tolerance for a pesticide on a crop, such as blueberries. The pesticide company adds the crop to their main or master label (EPA, of course, has to approve the new use directions). The company gradually incorporates this new use on its main label. The problem is that the growers and pesticide dealers all have containers with the older label that does not list blueberries. And we all know that you need to have a copy of the pesticide label with use direction for the intended crop in hand prior to use.
The solution is that the company develops a supplemental label describing the use of the pesticide on blueberries. The new federal supplemental label is made available to growers until the new container label is widely available. It is usually a win–win situation.