EPA clarifying statement on batch codes
Story Date: 8/12/2013

Source: U.S. Environmental Protection Agency, 8/9/13
 

Following is a clarifying statement developed by EPA in response to a number of inquiries about the batch code requirements.  There appears to be some confusion about the requirements for recording batch codes by bulk repackaging facilities.  The following statement provides clarification about the relevant requirements. This statement focuses on pesticide repackagers, which are pesticide producing establishments that are repackaging a pesticide under contract with the registrant.  These facilities must comply with the repackaging requirements in 40 CFR 165.70 in the pesticide container-containment regulations.  (They may also be subject to the containment regulations in 40 CFR 165.80 – 165.97.)  Because repackaging pesticides is defined as pesticide production, these establishments must also comply with the regulations on the Registration of Pesticide and Active Ingredient Producing Establishments, Submission of Pesticide Reports in 40 CFR Part 167 and the Books and Records of Pesticide Production and Distribution regulations in 40 CFR Part 169. There are two separate requirements in these regulations that address batch codes.  First, §169.2 requires producers – including repackagers – to maintain records of the product name, EPA Registration Number, amounts per batch and batch identification.  Second, §156.140(a) from the pesticide container (label) regulations requires the batch code to be on the label or container for nonrefillable containers.  This is not a requirement for refillable containers.  While each refillable container must be marked in a durable and clearly visible manner with a serial number or other identifying code that will distinguish the individual container from all other containers (40 CFR 165.45(d)), this is not the same as a batch code.  The repackaging regulations require refillers to record three pieces of information each time a pesticide is repackaged into a refillable container: (1) the EPA Registration Number of the pesticide; (2) the date of repackaging; and (3) the serial number or other identifying code of the container.  These records must be kept for three years.
Therefore, a pesticide producing establishment that is repackaging a pesticide under contract with the registrant is required to keep batch codes in their production records.  EPA does not specify the specific format of a batch code or lot code associated with production and the records associated with that production.    However, the batch code is NOT required to be marked on the label or container of a stationary refillable (bulk) container or a portable refillable container. See below for the relevant regulatory text from 40 CFR 156.140(a)(4), 169.1(b) and 169.2(a). § 156.140 Identification of container types.  For products other than plant-incorporated protectants, the following statements, as applicable, must be placed on the label or container.  The information may be located on any part of the container except the closure.  If the statements are placed on the container, they must be durably marked on the container.  Durable marking includes, but is not limited to etching, embossing, ink jetting, stamping, heat stamping, mechanically attaching a plate, molding, or marking with durable ink.   (a) Nonrefillable container.  For nonrefillable containers, the statements in paragraphs (a)(1) through (a)(4) of this section are required except as provided in paragraphs (a)(5), (c), (d) and (e) of this section.  … (4)  Batch code.  A lot number, or other code used by the registrant or producer to identify the batch of the pesticide product which is distributed and sold.   (b)  Refillable container.  For refillable containers, one of the following statements is required except as provided in paragraphs (c), (d) and (e) of this section.  …  (1)  "Refillable Container.  Refill this container with pesticide only.  Do not reuse this container for any other purpose."(2) "Refillable Container.  Refill this container with [common chemical name] only.  Do not reuse this container for any other purpose." § 169.1 Definitions. … (b) Batch.  The term “batch” means a quantity of a pesticide product or active ingredient use in producing a pesticide made in one operation or lot or if made in a continuous or semi-continuous process or cycle, the quantity produced during an interval of time to be specified by the producer. § 169.2 Maintenance of records. All producers of pesticides, devices, or active ingredients used in producing pesticides subject to this Act, including pesticides produced pursuant to an experimental use permit and pesticides, devices, and pesticide active ingredients produced for export, shall maintain the following records:
(a) Records showing the product name, EPA Registration Number, Experimental Permit Number if the pesticide is produced under an Experimental Use Permit, amounts per batch and batch identification (numbers, letters, etc.) of all pesticides produced. In cases where the product is an active ingredient
used in producing a pesticide or where the product is a pesticide which is not registered, is not the subject of an application for registration, or is not produced under an Experimental Use Permit, the records shall also show the complete formula. The batch identification shall appear on all production control records. These records shall be retained for a period of two (2) years























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