UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 October 9, 1992 PR NOTICE 92-5 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: Persons Responsible for Registration of Pesticides SUBJECT: Product Chemistry Data Requirements for Registration and Reregistration of End-Use Products This notice explains that EPA has waived the submission of certain product chemistry data for end-use products. I. BACKGROUND AND RATIONALE As described in 40 CFR Part 158, color, odor and storage stability data are required to be submitted for registration or reregistration of all pesticide products. However, EPA has reconsidered the need to review this information on a routine basis in registration and reregistration of end-use products. A. Color and Odor In the past, color and odor data were required on the premise that each end-use product has a distinct color and odor which would enable EPA and others in identifying products, particularly in enforcement cases or in medical emergencies. However, because EPA has approved alternate formulations containing substitute colorants and odorants for the same product since 1974, it is nearly impossible for EPA or others to use these characteristics to identify a product. Finally, EPA does not generally need color and odor data to make regulatory judgments about the risks and benefits of end-use products unless the color and odor affect product performance. For these reasons, EPA will waive the requirement that color and odor data be generated or submitted for end-use products unless the color or odor are expected to affect product performance (efficacy). In such cases, EPA reserves the right to request the submission of such data from applicants or registrants in order to make required statutory findings. Because there may be other circumstances that the submission of color and odor data will be necessary, EPA reserves the right to require the generation and submission of color and odor data any time it determines that such data are needed to make required statutory findings. EPA will revise the Part 158 data requirements to reflect this policy. B. Storage Stability The storage stability study provides data on the change in product composition over time. The Pesticide Assessment Guidelines, Subdivision D: Product Chemistry, Series 63-17 storage stability test method describes a study that is conducted for a minimum of one year under either of the following conditions: (i) At 20 or 25 degrees C, and, if the pesticide product packaging is permeable, at a relative humidity of 50%; or (ii) Under warehouse conditions which reflect the expected storage conditions of the commercial product. The utility of this study to provide product composition data on products that may be sold or used more than one year from the date of manufacture is questionable. The Agency is now pursuing alternative test methodologies which will permit the evaluation of pesticide product composition for lengths of time in excess of one year. Until the Series 63-17 guideline can be revised, EPA will waive the requirement that storage stability data be submitted for end-use products unless one of the following conditions are met: 1. The product use pattern is one for which product performance (efficacy) data are required (40 CFR 158.640). 2. The results of the storage stability study indicate that a) the concentration of any active ingredient is not within the certified limits or b) degradates of toxicological significance are detected in the study. 3. Product instability is suspected or incidents of instability are reported. EPA has other requirements which will help assure that the composition of products is acceptable. First, EPA may require that products which change significantly must bear the statement: "Not for sale or use after [date]." Thus, product labeling must bear an expiration date if the active ingredient changes substantially over time. As indicated above, storage stability data are required to be submitted for products which show instability so that a decision can be made about an expiration date or whether to register a product. Second, current regulations require that the percentage listed in the active ingredient statement be as precise as possible reflecting good manufacturing practices [40 CFR 158.10(g)(5)]. 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 submitted for registration, represent the amounts of an ingredient that may legally be present (40 CFR 158.175). The lower certified limit is used as the enforceable lower limit for the product composition, while the nominal concentration appearing on the label would be the amount typically found in the product. Third, EPA has compliance mechanisms, such as sampling and analysis of products found in the marketplace, that are aimed at assuring that products contain amounts of active ingredients which are within the upper and lower certified limits accepted as part of the registration of those products. These regulatory and enforcement efforts will continue to be used to ensure that pesticide products contain what is declared on the labeling. II. POLICY EPA will waive the requirement for color and odor data for registration or reregistration of end-use products, except when color and odor are expected to affect product performance. In such circumstances, EPA reserves the right to request the submission of such data from applicants or registrants in order to make required statutory findings. Registrants must continue to generate storage stability data as required by 40 CFR Part 158. However, these data need not be submitted to the Agency unless the data meet one or more of the following conditions: 1. The product use pattern is one for which product performance data are required (40 CFR 158.640). 2. The results of the storage stability study indicate that a) the concentration of active ingredient(s) is not within the certified limits or b) degradates of toxicological significance are detected. 3. Product instability is suspected or incidents of instability are reported. III. EFFECTIVE DATE This policy is effective immediately. IV. FURTHER INFORMATION If you have questions regarding this policy you may contact Donald Stubbs, Registration Support Branch, Registration Division (703-305-7700). Douglas D. Campt, Director Office of Pesticide Programs ----------------------- CERIS-Net Posting Date: 03.24.93 DISCLAIMER: 1992 PR Notices are sent to CERIS/NPIRS by the U.S. EPA Documents Center in WordPerfect document format. CERIS/NPIRS converts files to ASCII text, with editing to facilitate file transfer, before posting on the CERIS-Net system. This information is available by anonymous FTP from ceris.purdue.edu in the pub/info/prnotice directory. Contact Ed Ramsey of CERIS at 317/494-0442 for access information.