Or. Admin. Code § 603-025-0275

Current through Register Vol. 63, No. 10, October 1, 2024

Section 603-025-0275 - Farm Direct Product 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 must show that the process and product formulations comply with all critical factors mandated by an approved 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 must be maintained.

(A) Finished product testing must 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.

(B) 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 must be associated with production dates and batches.

(c) Any deviation from an approved process and the corrective action taken to remedy the deviation must be recorded and maintained. A product produced with a processing deviation:

(A) Must not be sold for human consumption; or

(B) May be sold for human consumption only if the product is reprocessed to rectify the deviation in a manner approved by a recognized process authority.

(3) Processing and production records for dried or cured fruits, vegetables, edible flowers, herbs or blends of herbs, and herbal tea for which drying or curing is not part of routine post-harvest handling must show that the process ensures the removal of moisture from the food to ensure that the finished product has a water activity of 0.85 or below so bacteria, yeast and molds cannot grow.

(4) Farm direct marketers must maintain sales records of products described in OAR 603-025-0235(2)-(3). Sales records must 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.

(5) Copies of all records required by OAR 603-025-0215 through 603-025-0275 must be retained at the processing facility or other reasonably accessible location for a period of three years from the date of manufacture.

(a) Records must 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.

Or. Admin. Code § 603-025-0275

DOA 14-2012, f. & cert. ef. 6-1-12; DOA 43-2023, amend filed 11/29/2023, effective 11/29/2023

Statutory/Other Authority: ORS 561.190 & 616.686

Statutes/Other Implemented: ORS 616.683