FDA Report National Conference on Interstate Milk Shipments May 14, 2017 Nega Beru, Ph. D. Director, Office of Food Safety Center for Food safety and Applied Nutrition Food and Drug Administration

Topics FSMA and the PMO SFTA Waiver FSMA Implementation Automatic Milking Installations Drug Residue Testing Pilot

FSMA and the PMO When Congress enacted the Food Safety Modernization Act (FSMA), it did not exempt Grade “A” milk and milk products or manufacturers of these products from application of the new requirements. Proposals have been submitted to the Conference to amend the PMO to include the requirements of applicable FSMA rules. The reason for these proposals is explained in the preamble to the final rule - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Base Preventive Controls for Human Food

FSMA and the PMO In the preamble to the final rule on preventive controls for human foods, FDA stated: “NCIMS has initiated work to modify the PMO and that work is expected to include all of the requirements in a final human preventive controls rule. FDA has committed resources to work with the appropriate NCIMS Committees to make the necessary changes.”

FSMA and the PMO “…to make use of the existing system of State regulatory oversight for Grade ‘‘A’’ milk and milk products provided through the NCIMS and the food safety requirements of the PMO, we are extending the compliance date for PMO-regulated facilities to comply with the requirements of subparts C and G to September 17, 2018.”

FSMA and the PMO “Doing so is consistent with the request of comments asking us to ‘‘stay’’ the application of the requirements for hazard analysis and risk-based preventive controls to PMO-regulated facilities and work with the NCIMS cooperative program to effect the necessary modifications to the PMO so that it will include all of the requirements in the human preventive controls rule.”

FSMA and the PMO “The extended compliance date is not equivalent to an exemption. Regardless of whether the PMO is modified to include the requirements of a final human preventive controls rule by the extended compliance date, PMO facilities must comply with the human preventive controls rule on September 17, 2018.”

FSMA and the PMO “In establishing a compliance date of September 17, 2018 for PMO facilities, we considered: (1) The extent of revisions that must be made to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO; (2) the process to revise the PMO; and (3) the date at which the necessary revisions to the PMO could begin to be made.”

FSMA and the PMO “We disagree that the necessary revisions to incorporate the requirements of this rule for hazard analysis and risk-based preventive controls into the PMO are ‘‘minor.’’ There are gaps between the requirements of this rule and the current required and voluntary provisions of the PMO (Ref. 49), and gaps such as provisions directed to environmental monitoring, supply-chain controls, and food allergen controls are not ‘‘minor.’’

FSMA and the PMO Consequently, FDA continues to work with the Liaison Committee to arrive at suitable text for proposed amendments to the PMO. We hope that what has been arrived at through that process will ultimately be determined to be acceptable to the state voting delegates at this Conference.

Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule We published the final rule on April 6, 2016 (81 FR 20091), and established an effective date of June 6, 2016, but did not finalize the proposed waivers at that time, stating that we intended to do so prior to the rule’s initial compliance date of April 6, 2017 (81 FR 20091 at 2016).

Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule One year later we published our waivers and relative to the Grade “A” world, FDA granted a waiver for: Businesses subject to the requirements of part 1, subpart O, that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments’ Grade ‘‘A’’ Milk Safety Program, only when engaged in transportation operations involving bulk and finished Grade ‘‘A’’ milk and milk products.

FSMA Implementation FDA has already begun its FSMA rules implementation efforts. An assignment for preventive controls in human food inspection was issued earlier this year. That assignment is for the food industry generally. It will include some dairy facilities. It is not supposed to cover Grade “A” facilities or portions of facilities which are Grade “A”

FSMA Implementation FDA is aware that in the early stages of implementation of this assignment a few Grade “A” facilities were inadvertently visited and inspected FDA has taken steps to prevent recurrences; however, if your Grade “A” facility is visited by FDA investigators wishing to perform a FSMA-rules based inpection, please inform them of your Grade “A” status. You can contact the dairy staff at CFSAN and let them know of any concerns.

Automatic Milking Installations AMI’s have been a subject of significant regulatory interest recently FDA wants to make it very plain that conceptually it does not object to the utilization of AMI’s. FDA welcomes new technologies where they are beneficial to safe production and is interested in working with vendors to assist them with their efforts at complying with PMO sanitary standards and construction design requirements.

Automatic Milking Installations FDA has recently issued two communications relative to robotic milking A letter to GEA stating: FDA did not object to any milk producer utilizing the GEA Monobox as a means of collecting milk. In that letter, however, FDA did also note that certain matters which remain unresolved at present, may result in users of this equipment incurring debits during FDA check-ratings, should such check-ratings occur prior to resolution of the pending matters.

Automatic Milking Installations The second communication we issued recently on this subject is M-I-17-3. In that document we said: “It is our understanding that at this time AMIs do not comply with computer system(s) verification requirements of PMO, Appendix Q, Item 1r, 13r and 14r. FDA has been and will continue to work with AMI manufacturers to bring their computer systems into compliance with PMO, Appendix Q. Until further notice, computer system(s) verification requirements related to Appendix Q, Item 1r, 13, and 14r will not be debited on federal check ratings.”

Automatic Milking Installations FDA is in the process of arranging meetings with the vendors of AMI’s with the view towards ascertaining what the Agency might do to assist them with their efforts at compliance with PMO requirements.

Drug Residues Testing Pilot Program FDA understands that the Pilot Program for screening loads for drug residues families besides beta-lactams, which was approved at the last Conference, has not yet been implemented, but that an implementation date of July 1st of this year has been set. FDA congratulates the Appendix N Modification Study Committee and Chair Roger Hooi on this accomplishment and extends its appreciation to all involved.

Drug Residues Testing Pilot Program FDA strongly encourages all facilities, all States and PR to participate in the Pilot. doing so will strengthen the program and provide an opportunity to provide feedback to the Appendix N Committee on how or whether improvements might be made. FDA considers it is very important to test for drug families other than beta-lactams.

In Closing FDA appreciates the long and productive working relationship it has enjoyed with the states and industry under this cooperative program and looks forward to continuing that relationship. We wish you every success and good luck with your deliberations on the proposals before you this year. Thank you.