PRN 91-2: Accuracy of Stated Percentages for Ingredients Statement
May 2, 1991
- Products That Require Efficacy Data
- Compliance Schedule
- For Further Information
The purpose of this notice is to clarify the Office of Pesticide Program's policy with respect to the statement of percentages in a pesticide's label's ingredient statement. Specifically, the amount (percent by weight) of ingredient(s) specified in the ingredient statement on the label must be stated as the nominal concentration of such ingredient(s), as that term is defined in 40 CFR 158.153(i) (1). Accordingly, the Agency has established the nominal concentration as the only acceptable label claim for the amount of active ingredient in the product.
For some time the Agency has accepted two different methods of identifying on the label what percentage is claimed for the ingredient(s) contained in a pesticide. Some applicants claimed a percentage which represented a level between the upper and the lower certified limits. This was referred to as the nominal concentration. Other applicants claimed the lower limit as the percentage of the ingredient(s) that would be expected to be present in their product at the end of the product's shelf-life. Unfortunately, this led to a great deal of confusion among the regulated industry, the regulators, and the consumers as to exactly how much of a given ingredient was in a given product. The Agency has established the nominal concentration as the only acceptable label claim for the amount of active ingredient in the product.
Current regulations require that the percentage listed in the active ingredient statement be as precise as possible reflecting good manufacturing practices 40 CFR 156.10(g)(5) (2). The certified limits required for each active ingredient are intended to encompass any such "good manufacturing practice" variations 40 CFR 158.175(c)(3)
The upper and lower certified limits, which must be proposed in connection with a product's registration, represent the amounts of an ingredient that may legally be present according to 40 CFR 158.175. The lower certified limit is used as the enforceable lower limit for the product composition according to FIFRA section 12(a)(1)(C), while the nominal concentration appearing on the label would be the routinely achieved concentration used for calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest degree of accuracy that is warranted with respect to actual product composition because the nominal concentration would be the amount of active ingredient typically found in the product.
It is important for registrants to note that certified limits for active ingredients are not considered to be trade secret information under FIFRA section 10(b). In this respect the certified limits will be routinely provided by EPA to States for enforcement purposes, since the nominal concentration appearing on the label may not represent the enforceable composition for purposes of section 12(a)(1)(C).
As described below under Unit V. "COMPLIANCE SCHEDULE," all currently registered products as well as all applications for new registration must comply with this Notice by specifying the nominal concentration expressed as a percentage by weight as the label claim in the ingredient(s) statement and equivalence statements if applicable (e.g., elemental arsenic, metallic zinc, salt of an acid). In addition, the requirement for performing sample analyses of five or more representative samples must be fulfilled. Copies of the raw analytical data must be submitted with the nominal ingredient label claim. Further information about the analysis requirement may be found in the 40 CFR 158.170 (4). All products are required to provide certified limits for each active, inert ingredient, impurities of toxicological significance (i.e., upper limit(s) only) and on a case by case basis as specified by EPA. These limits are to be set based on representative sampling and chemical analysis (i.e., quality control) of the product.
The format of the ingredient statement must conform to 40 CFR 156-Labeling Requirements For Pesticides and Devices
After July 1, 1997, all pesticide ingredient statements must be changed to nominal concentration.
All pesticides are required to be efficacious. Therefore, the certified lower limits may not be lower than the minimum level to achieve efficacy. This is extremely important for products which are intended to control pests which threaten the public health, e.g., certain antimicrobial and rodenticide products. Refer to 40 CFR 158.640
In those cases where efficacy limits have been established, the Agency will not accept certified lower limits which are below that level for the shelf life of the product.
As described earlier, the purpose of this Notice is to make the registration process more uniform and more manageable for both the agency and the regulated community. It is the Agency's intention to implement the requirements of this notice as smoothly as possible so as not to disrupt or delay the Agency's high priority programs, i.e., reregistration, new chemical, or fast track (FIFRA section 3(c)3(B). Therefore, applicants/registrants are expected to comply with the requirements of this Notice as follows:
- Beginning July 1, 1991, all new product registrations submitted to the Agency are to comply with the requirements of this Notice.
- Registrants having products subject to reregistration under FIFRA section 4(a) are to comply with the requirements of this Notice when specific products are called in by the Agency under Phase V of the Reregistration Program.
- All other products/applications that are not subject to (1) and (2) above will have until July 1, 1997, to comply with this Notice. Such applications should note "Conversion to Nominal Concentration" on the application form. These types of amendments will not be handled as "Fast Track" applications but will be handled as routine requests.
Anne E. Lindsay