Pennsylvania Code › Title 7 - AGRICULTURE › Part III - Bureau of Food Safety and Laboratory Services › Subpart B - Liquid Foods › Chapter 59a - MILK SANITATION › Subchapter C - PRODUCTION AND PROCESSING OF MILK FOR MANUFACTURING PURPOSES › Section 59a.111 - Drug residue level

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Industry responsibilities.
Manufactured dairy products
					 permitholders shall meet the requirements of this section to confirm their
					 manufactured dairy products are free of violative drug residues.
(1)
Sampling and testing
					 program.
(i) Milk shipped for
					 processing or intended to be processed on the farm where it was produced shall
					 be sampled and tested, prior to processing, for
beta lactam
drug residue. Collection, handling and testing of samples shall be done
					 according to procedures established by the Department in this section, and in
					 accordance with Appendix N of the Grade "A" PMO, regarding drug residue testing
					 and farm surveillance. If a person processes milk on the farm where it was
					 produced and produces that milk in accordance with a written quality control
					 program addressing the use of animal drugs at that dairy operation, that person
					 may request a variance from the testing requirements of this subparagraph. The
					 request shall be in writing and include a copy of the written quality control
					 program. The Department may, on the basis of the request, issue a variance with
					 respect to the requirements of this subparagraph. A variance issued under this
					 subparagraph will be valid for no more than 1 year and may be renewed for
					 additional periods of up to 1 year following the Department's review of the
					 quality control program and any on-farm inspections the Department deems
					 necessary to determine whether a successor variance should be issued.
(ii) When so specified by the FDA, milk
					 shipped for processing, or intended to be processed on the farm where it was
					 produced, shall be sampled and tested, prior to processing, for other drug
					 residues under a random drug sampling program. The random drug sampling program
					 must include at least four samples collected in at least 4 separate months
					 during any consecutive 6-month period.
(iii) When the Commissioner of the FDA
					 determines that a potential problem exists with an animal drug residue or other
					 contaminant in the milk supply, a sampling and testing program shall be
					 conducted, as determined by the FDA. The testing shall continue until the
					 Commissioner of the FDA determines with reasonable assurance that the potential
					 problem has been remedied.
(iv) The
					 dairy industry shall analyze samples for
beta lactams
and
					 other drug residues by methods which have been independently evaluated or
					 evaluated by the FDA and accepted by the FDA as effective to detect drug
					 residues at current safe or tolerance levels. Safe and tolerance levels for
					 particular drugs are established by the FDA.
(v) Sample test results for milk that does
					 not test positive shall be recorded. The test result records shall be retained
					 for 6 months.