The PMO and PC Rule
The PMO, first published as the “Ordinance” has served as the regulatory guidance document for dairy products since 1924, addressing sanitary practices to ensure milk safety from farm to cup. Today, with oversite by FDA and the National Conference on Interstate Milk Shipments (NCIMS), the PMO or equivalent is adopted by all 50 states as regulation for Grade “A” dairy operations. From a food safety perspective, the PMO might be considered as one of the first regulatory “HACCP” programs developed even before HACCP concepts were defined. Vegetative pathogens identified as hazards in raw milk (e.g., a hazard analysis) are controlled by pasteurization developed and validated as an effective CCP, with established critical limits (time and temperature) and monitoring, corrective action, verification and record keeping procedures. The PMO also addresses conditions required to provide for sanitary equipment, procedures and environment essentially providing more detailed GMP guidance and beyond. Now there is the FSMA PC rule. How does the existing Grade “A” milk program fit in? Should PMO regulated plants be exempt? Will dairy plants be regulated under two different systems or one? Will the PMO go away?
Overall, the dairy industry and state regulatory agencies believe the Grade “A” program should continue; converting to just a PC rule based system would be a step backward. FDA agrees and has stated that “we should make use of the existing system of State regulatory oversight for Grade “A” milk and milk products provided through the National Conference on Interstate Milk Shipments (NCIMS) and the food safety requirements of the PMO.” PMO regulated plants were not granted an exemption from the PC rule. So the challenge is in bringing the PMO in line with the final PC rule. The PMO is modified every two years, at the biannual meeting of the NCIMS, where state regulatory agencies, industry and FDA meet to update the PMO and other dairy regulations. The last meeting was in April of 2015 before the final PC rule was published; the next meeting is in May of 2017. It takes several months before changes are finalized and an updated PMO is published, thus the compliance date extension. Based on proposals summited at the 2015 conference, the 2015 PMO was modified in an attempt to make it more PC rule compliant. The added items/modifications were:
- A reference that the PMO shall constitute the facility’s food safety plan aligned with the PC rule and a requirement for a written hazard analysis (PMO, p. 62): The Grade “A” PMO, with Appendices … shall constitute a milk plant’s food safety plan as required by 21 CFR 117.126 to the extent that the procedures address all the hazards identified by the milk plant … A milk plant shall have a written Hazard Analysis for each … milk and/or milk product processed.
- A requirement for a food allergen control plan (PC Rule 117.135; PMO Item 15p, “Protection from Contamination,” p. 81, 89): Milk plants that handle nondairy food allergens shall have a written allergen control plan to protect products from allergen cross-contact, during storage and use, and to ensure proper declaration of allergens on product labeling.
- Requirement for a written recall plan (PC Rule 117.139; PMO Section 2, “Adulterated or Misbranded Milk Products,” p. 15): Milk plants shall establish and maintain a written recall plan for … the recall of adulterated milk products from market when appropriate …
- Requirement for an environmental monitoring program (PC Rule 117.165; PMO Item 15p, p. 90): A milk plant shall have a written environmental monitoring program that is implemented and supported by records for products exposed to the environment when they do not subsequently receive treatment that would significantly minimize the pathogen.
- Requirement for a supply chain program (PC rule Subpart G; PMO Item 15p, p. 90): A milk plant shall have a supplier control program for raw materials and ingredients that is implemented and supported by records to control food safety hazards.
- Changes to the PMO Voluntary HACCP Program (Appendix K) to comply with the PC rule (e.g., as with 2-5 above and additional training requirements).
The modifications to the 2015 PMO are generally in line with the final PC rule. Currently FDA is working with industry and state regulatory agencies to develop proposals for the upcoming NCIMS conference to further fine tune the document so it will be acceptable as an alternative regulatory process for PC rule compliance. Areas that might need further consideration:
- While there is now a requirement for a written hazard analysis, further guidance on hazards identified that need control might be warranted. The PMO addresses potential hazards beyond vegetative pathogens (e.g., excess vitamins, animal drug residues), but there may be others identified that will need to be addressed.
- Environmental monitoring is covered in the PC rule under Verification of Implementation and Effectiveness (117.165) and is not truly Protection from Contamination (PMO, Item 15p), but is verification of sanitation controls designed to minimize the risk of post-pasteurization contamination.
- While cleaning and sanitization is covered in much detail, there were no changes in the 2015 PMO relative to Sanitation Preventive Controls. Illness outbreak have occurred due to recontamination after pasteurization, thus reviewing the PMO in respect to sanitation controls for equipment and the processing environment would be warranted.
- The supply chain program in the PC rule only applies to ingredients that may have hazards that the processor has no control over (e.g., added post-pasteurization; potential allergen cross-contamination). It is also relatively specific in its requirements. This control may need to be expanded on.
- Most requirements of the Voluntary HACCP Program (PMO Appendix K) will for the most part be required of all plants as the PMO becomes PC rule compliant. Currently there are only 10 plants in 7 states that are regulated under Appendix K. The continuation of this as a separate program will need to be addressed.
- The PC rule requires that “PC Qualified Individuals” (through training or experience) be responsible for development and oversite of the Food Safety Plan and other aspects of the PC rule. There are currently no designated responsible persons in the PMO.
- Others …..
As it stands, it looks like the PMO and the Grade “A” milk program will continue and should serve as an alternative regulatory process for enforcing the PC rule. There is still much work to do, including outlining the process for regulatory oversite and enforcement compared to traditional PMO inspections; in reality, there is much work to do in this regard for all food plants. Complicating the issue is that many Grade “A” dairy plants manufacture non-Grade “A” food products as well. All in all, we can rest assured that our dairy products will continue to be safe and wholesome.
FDA. 2015. Pasteurized Milk Ordinance. U.S. Department of Health and Human Services
Public Health Service. Food and Drug Administration.
FDA. 2015. Part 117. Current Good Manufacturing Practice, Hazard Analysis, and Risk–Based Preventive Controls for Human Food. Code of Federal Regulations, Title 21 Part 117. Pages 365-405.
FDA. 2015. Actions of the 2015 National Conference on Interstate Milk Shipments. IMS-a-50. November 16, 2015.
FDA. 2016. Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules. Federal Register Vol. 81, No. 164. Pages 57784-57796.Part 1