OAR 603-025-0275
Producer-Processed Foods Records
(1)
Raw materials, packaging materials, and finished products that are not in compliance with United States Food and Drug Administration (FDA) regulations may be considered adulterated.(2)
Processing and production records for products having a water activity (aw) greater than 0.85 and having been acidified to decrease the equilibrium pH of the food to 4.6 or below will show that the process and product formulations comply with all critical factors mandated by a recognized process.(a)
To demonstrate compliance with acceptable equilibrium pH measurements, batch-by-batch records of pH meter calibration and batch-by-batch records of finished product testing will be maintained.(A)
Finished product testing will be performed following the requirements of the 2010 version of 21 CFR 114.90(a) and (b) (Methodology). A pH meter or potentiometer is the primary instrument used in determining product pH. Colorimetric methods including, but not limited to, indicator solutions and indicator paper may be used if the equilibrium pH of the product is 4.0 or lower.(b)
Processing and production records will be associated with production dates and batches.(c)
Any deviation from an approved process and the corrective action taken to remedy the deviation will be recorded and maintained.(A)
A product produced with a processing deviation will:(i)
Not be sold for human consumption; or,(ii)
Be permitted for sale for human consumption if the product is reprocessed to rectify the deviation in a manner approved by a recognized process authority.(3)
Farm direct marketers will maintain sales records of products subject to OAR 603-025-0235 (Farm Direct Marketer Exemption)(2). Sales records will include, but need not be limited to, the following information:(a)
Product(s) sold;(b)
Price;(c)
Quantity sold;(d)
Current, rolling total of year-to-date sales.(4)
Copies of all records required by these administrative rules (OAR 603-025-0225 (Definitions) through 0275) will be retained at the processing facility or other reasonably accessible location for a period of three years from the date of manufacture.(a)
Records will be made available to the Department upon request.(b)
Failure to provide records to the Department upon request may result in the revocation of the farm direct marketer exemption.
Source:
Rule 603-025-0275 — Producer-Processed Foods Records, https://secure.sos.state.or.us/oard/view.action?ruleNumber=603-025-0275
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