FINALIZED ICPPC ANSWERS TO Questions from TPC’s
May 16, 2008
ISSUED 5/19/2006
Q1. Will a Third Party Certifier (TPC) be allowed to certify and list foreign single-service plants?
Yes. The certified rating officer for the TPC will be certified to do this as part of their initial FDA certification (5 plants, 25 farms and 1 SS facility).
Q2. Will a potential TPC Rating Officer (RO), Sampling Surveillance Officer (SSO) or Laboratory Evaluation Officer (LEO) that was previously FDA certified as a State RO, SSO or LEO still be current or will they need to be recertified?
If the SRO's, SSO’s or LEO’s FDA certification is still valid (not expired) and they have conducted state ratings, sampler evaluations or laboratory evaluations, respectively, within the last 18 months, their current certification would be valid through the expiration date. However, if they do not comply with this or their certification has expired, they will be required to be recertified (SRO-5 plants, 25 farms and 1-ss; SSO-5 haulers, 1-plant sampler (raw and pasteurized products and single-service container/caps collection, if applicable; and LEO-1 laboratory).
The above statement would also apply to retired FDA employees (conducting check ratings, Regional Milk Specialist standardization, or laboratory evaluations), which plan to work within the ICPP.
Q3. May a TPC share FDA certified SROs, SSOs or LEOs?
Yes. (Note: This answer was provided prior to the application form being finalized and issued and was based on providing information to potential TPC’s.)
Q4. Does the ICPP preclude a foreign government from applying to be a TPC?
No
ISSUED 11/3/2006
Q5. Are all of the ICPP related documents considered
to be part of M-I-06-17?
· International Certification Pilot Program Committee Cover Letter
· Policies and Procedures Document – National Conference on Interstate Milk Shipments Voluntary International Certification Pilot Program
· Third Party Certifier (TPC) Application for the NCIMS - Voluntary International Certification Pilot Program (ICPP)
· Letter of Understanding Between the National Conference on Interstate Milk Shipments and a Third Party Certifier
· Letter of Intent to Participate in the National Conference on Interstate Milk Shipments Voluntary International Certification Pilot Program
· National Conference on Interstate Milk Shipments Voluntary International Certification Pilot Program Memorandum of Agreement Between a Third party Certifier and a Milk Company
Yes
Q6. The Policies and Procedures document paragraph
6.5.1 requires the routine
regulatory inspectors to be "adequately trained to perform their duties";
what is considered to be "adequately trained"? (We should note the
inspectors may NOT be personnel familiar with NCIMS, PMO or States normal regulatory
procedures.)
Currently, the PMO or other NCIMS documents do not specifically address the issue of educational requirements or training for routine regulatory inspectors. That training is left entirely up to each individual State Regulatory Agency. Within the TPC Application, it asks for the identification of individuals that will conduct the program and their appropriate training, education and experience. As part of the selection process, the International Certification Pilot Program Committee (ICPPC) will consider several factors with respect to personal qualifications including: NCIMS milk program related experience, previous milk program related training, program related certifications, i.e., Rating Officer, Sampling Surveillance Officer, Laboratory Evaluation Officer, etc., technical knowledge (of milk plant and dairy farm operations) training and preparedness of the TPC’s employees to conduct the routine regulatory functions of the program within the guidelines of the program. As the Pilot is up and running, it will work just like it does domestically - the real proof of adequate training will be demonstrated by passing State Ratings and FDA Check Ratings.
Q7. It is stated that the Memorandum of Agreement (MOA) is equivalent to a "permit" or "license". What is the procedure when a producer's or bulk milk hauler/sampler's permit should be suspended? Can there be product stop sale actions?
The same enforcement action(s) that is currently required within the PMO
and the NCIMS Grade “A” Interstate Milk Program will be taken by the TPC. Within
the Pilot the TPC is considered equivalent to a State Regulatory Agency. The
producer or bulk milk hauler/sampler will be notified by the TPC that they are
no longer allowed to ship milk to an IMS Listed Shipper or sample or pick up
milk from a dairy farm, respectively, until the appropriate corrections have
been made. This will occur just like it is taking place now within the program.
Yes, a product stop sale regulatory action may be taken.
Q8. Will Federal Import Milk Act Permits still be required for International Certification Pilot Program (ICPP) Milk Companies (MC's) to import bovine fluid milk into the U.S.?
Yes
Q9. How will import officials be informed of
the ICPP acceptance for a
given product? (Yogurt is okay from company A but not from company B).
Import officials will use the IMS list to identify plants and products that are acceptable to come into the U.S. under this Pilot.
Q10. The following questions related to the Third Party Certifier (TPC) Application for the NCIMS – Voluntary International Certification Pilot Program (ICPP)
a. Page 5, Item I. In addition to the previous answers in the application and the resumes for both partners what are additional ICPPC conflicts of interest policies?
Item I. also requires a copy of the TPC’s written policies and procedures that they have established to ensure that the firm and their employees are free from any conflicts of interest.
Section 8-Code of Ethics of the “Policies and Procedures Document-National Conference on Interstate Milk Shipments Voluntary International Certification Pilot Program” also provides additional information that would be useful in addressing Item I.
Item 6-Third Party Certifier is not to Engage in Conflicting Activities of the example of the “National Conference on Interstate Milk Shipments Voluntary International Certification Pilot Program – Memorandum of Agreement Between a Third Party Certifier and a Milk Company” also provides additional information that would be useful in addressing Item I.
b. Page 5, Item J. After talking to our legal advisers, this is unconscionable and should only be restricted to the TPC negligent involvement with the program, is this the intent?
No, this provision is not limited to only negligent conduct by a TPC.
c. Page 5, Item K. As we both have been involved in the regulatory/consulting areas of the field for so many years we feel our attached resumes and answers to other questions in the application address this section or is there additional material required?
If you feel that your resume and previous answers to other questions adequately cover Item K. then that should be sufficient; however, make sure that they cover the specific factors identified in Item K., especially in relationship to all employees and designated personnel.
d. Page 6. Item L. What is the ICPP Code of Ethics?
It is contained in Section 8-Code of Ethics of the “Policies and Procedures Document-National Conference on Interstate Milk Shipments Voluntary International Certification Pilot Program”.
e. Page 6. Item M. What amount of training is required and the time/expenses involved?
This is difficult to specifically answer. Persons not familiar with or having limited experience in an area of designated work may be required to attend training courses offered by State Regulatory or FDA. All Rating Officers and Laboratory Officers are required to meet the applicable training requirement of the National Conference on Interstate Milk Shipments Grade “A” Milk Safety Program as cited in Section V. Qualifications and Certifications, D. Milk Sanitation Rating Personnel and G. Milk Laboratory Evaluation Personnel and Section VIII. Procedures Governing the Certification of Milk Plant, Receiving Station and Transfer Station NCIMS HACCP Systems for IMS Listed Shippers, E. Qualifications and Certifications, 4. HACCP Listing Personnel and 6. Certification Procedures for SRO’s Who Will Conduct HACCP Listing Audits of the “Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the national Conference on Interstate Milk Shipments.
f. Page 6. Item N. Will the previous answered questions in this application and our attached resumes and training in the field be acceptable for this section?
No. The two specific documents cited in Item N must accompany the submitted application form.
ISSUED 2/14/2007
Q11. Can arrangements be made to notify the TPC’s of training courses and regional seminars?
Yes. The Milk Safety Team (MST) and/or the Regional Milk Specialists can include the TPC’s in any notifications of upcoming training courses and regional milk seminars.
Q12. What products does the Milk Import Act apply to or where can that information be found?
Compliance Policy Guide, Section 560.400 Imported Milk and Cream – Federal Import Milk Act (CPG 7119.05)
http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg560-400.html
Milk and Cream (raw and pasteurized) from domesticated (dairy) cows (genus Bos.)
· Milk, Lowfat Milk, Skim or Nonfat Milk, Fortified Milk, Flavored Milk, Concentrated Milk, and Ultra Filtered Milk.
· Cream, Half-and-Half, Heavy Cream, Light Cream and Light Whipping Cream.
· Does not apply to the following:
Ř Sour Cream, Cultured Milk, Acidified Milk, Yogurt, Cheese, Ice Cream and Eggnog.
Ř Sweetened Condensed Milk, Evaporated Milk, Dried Milk, Nonfat Dry Milk, Nonfat Dry Milk fortified with vitamins A and D, and other dehydrated milk products.
Ř Any of the dairy products for which a permit is otherwise required if they have been processed and packaged in hermetically sealed containers so as to be commercially sterile in accordance with the requirements of 21 CFR 108.35 and 113.
Q13. Does a BTU only, wishing to import raw milk count as one of our milk companies?
This is not provided for in the Pilot. The Pilot as submitted and passed at the 2005 Conference was associated to a milk plant and their associated related BTU(s) that are providing raw milk to the milk plant for the specific production of IMS Listed Grade “A” milk and milk products. The Solution to this Proposal, as passed, states that a TCP is limited to two (2) plants, their servicing laboratories and their related farms. It does not provide for a BTU to be listed for the sole purpose to export raw milk to the U.S.
Q14. A milk company has one main plant that produces products for export to the US. They also have a supply plant that produces condensed and powder for use at the main plant. Can we list both of these plants and call it part of the same milk company for the pilot.
Is the condensed and powder utilized in the production of Grade “A” milk and milk product? If so, is the supply plant in a different physical location?
If it is, I would consider this scenario as two (2) plants under the pilot because both facilities would have to be separately listed in the IMS List. If the facilities are in the same building or location, then they could be listed as one (1) PMO/DMO listing as currently is provided for within the NCIMS program.
Q15. Company A has a milk plant. Coop B has 3 BTU’s shipping milk to this plant. (Part A) Is this one or two milk companies for the purpose of the pilot? (Part B) If it is only one, can the Coop also ship raw milk to a plant in the US and still be part of the original one milk company?
There are two questions being asked and are separated out below:
Q15A:
First of all, these associated related listed BTUs must be shipping raw milk to the milk company for the specific production of IMS Listed Grade “A” milk and milk products of which they wish to export to the U.S. The plant and these associated related listed BTUs would be considered as one plant under the pilot. Under the pilot, BTU’s cannot be formed and listed with the sole intention of exporting raw milk to the U.S.
Q15B:
This is not provided for in the Pilot. The Pilot as submitted and passed at the 2005 Conference was associated to a milk plant and their associated related BTU(s) that are providing raw milk to the milk plant for the specific production of IMS Listed Grade “A” milk and milk products.
Q16. Are all of the Grade A milk program inspections sheets/reports available on the web? If not would it be possible to get a current copy of these.
MST is currently working on getting all of the current forms (10/06 versions) on the FDA web site. Forms that have been finalized (10/06 versions) can be found at the following website:
http://www.fda.gov/opacom/morechoices/fdaforms/default.html.
As the other Forms are finalized, MST will be able to provide these updated versions to the TPCs.
Q17. Are current copies of manuals for the following FDA training course available: Dairy Farm Sanitation and Inspection, Milk Plant Sanitation and Milk Pasteurization Controls and Test, LEO workshop and laboratory workshop?
The training manuals that are utilized in these training courses may be obtained from FDA/ORA/Division of Human Resource Development (DHRD) from Jim Fear at: James.Fear.fda.hhs.gov.
Q18. How does the committee plan to review our records?
On pages 4 and 7 of Proposal 316 Third Party certification Pilot Program (TPCPP) Substitute Solution-2005 NCIMS is states the following:
“The NCIMS Imports Implementation Committee shall assist in the administration of the TPCPP. This Committee’s administrative duties shall include:
7. Other administrative duties during the TPCPP include:
a. Review copies of all regulatory and laboratory records (including results of Appendix N testing) from each TPCPP firm for each dairy facility listed or certified for accuracy and compliance. The TPCPP firm shall submit all regulatory and laboratory records from each dairy facility each quarter during the pilot to the Imports Implementation Committee. If the records are found to be accurate, the Imports Implementation Committee shall provide written documentation of their findings to the TPCPP firm. If the records are found to be incomplete and/or inaccurate, all deficiencies and/or inaccuracies shall be documented and the records returned to the TPCPP firm for correction. If the TPCPP firm’s records indicate non-compliance with the NCIMS Grade “A” PMO and associated documents, the Committee shall immediately inform the TPCPP firm. Furthermore, the Committee shall recommend appropriate action to FDA/MST/LQAT, which may include where appropriate, recommendations for correction, removal of the firm’s IMS listing(s), and/or removal of the TPCPP firm from participation in the TPCPP. The FDA/MST/LQAT shall make the final determination of appropriate action.”
The ICPPC has yet to finalize this review process.
Q19. In light of the Canadian Equivalency Talks, is there any problem with a Canadian Milk Company participating in the International Certification Pilot Program?
No.
Q20. If any personnel changes are made to a TPC application once it has been accepted, is it necessary to notify the ICPPC?
Yes.
ISSUED 3/2/2007
Q21. If any of the existing foreign IMS listed plants and associated foreign IMS Listed BTUs and IMS Listed laboratories want to go Third Party, will all of the current expiration dates for ratings and lab certifications be valid?
This Pilot was not designed or intended to include existing IMS listed plants, located outside the geographic boundaries of the U.S., under the ICPP. It was intended to expand the opportunity to 6 additional plants to become IMS Listed and subsequently their ability to import Grade “A” pasteurized milk and milk products into the U.S. The Pilot provides an additional Option to M-I-00-4. Existing foreign IMS listed plants are utilizing one of the existing Options contained within M-I-00-4 and have successfully done this for a number of years. We do not see the value in including these plants under the pilot, because they already have proven that they can be IMS Listed and are successfully importing Grade “A” pasteurized milk and milk products into the U.S. Also, by taking away one of the spots from additional plants to become IMS Listed, we feel that we would be taking away from the opportunity to provide additional meaningful information related to the objective of the pilot. We are trying to assess how third party certifiers can implement and oversee the NCIMS Grade “A” Milk Safety Program and how foreign plants, BTUs, laboratories and other related NCIMS functions can be complied with.
Q22. A TPC dairy plant receives milk from a receiving plant/transfer station that its company owns and operates, the milk from this facility is shipped to the TPC dairy plant. Would this be one company under the pilot program?
If this receiving/transfer station(s) meets the requirements of the PMO and is utilized in the transfer of Grade “A” raw milk from the IMS Listed BTU(s) that is directly associated with supplying the Grade “A raw milk for the production of exported Grade “A” pasteurized milk and milk products to an IMS Listed plant, then they could be separately IMS listed and would be considered along with the plant IMS Listing as one milk company under the Pilot.
Another acceptable method that could be utilized is for the receiving/transfer station(s) to be listed and included in the Sanitation Compliance Rating of the milk plant listing as indicated on page 53 of the 2005 Revision of the Methods of Making Sanitation Ratings of Milk Shipper. If this method is utilized, they also would be considered as one milk company under the Pilot.
Q23. Where should the Letter of Intent (LOI) and Memorandum of Agreement (MOA) be sent to from the TPCs?
Mr. Leon Townsend
NCIMS Executive Secretary
123 Buena Vista Drive
Frankfort, KY 40601
Q24. Who is responsible to identify the State(s) (Farms, Plants, Labs, etc.) where FDA standardization/certification for State Rating Officer (SRO), State Sampling Surveillance Officer (SSO) and/or Laboratory Evaluation Officer (LEO) will take place?
To adequately evaluate the Pilot, we believe that the TPC is initially responsible to contact and identify a State(s) where such FDA standardization/certification can be conducted. If a TPC is having difficulty in obtaining a State(s) to conduct the standardization/certification, then we would recommend that the TPC contact the ICPPC and ask for assistance.
Q25. Who is responsible to submit the formal written request for FDA standardization/certification as a State Rating Officer (SRO), State Sampling Surveillance Officer (SSO) or Laboratory Evaluation Officer (LEO)?
The identified TPC Owner or President is required to submit the formal written request.
Q25A. Who should the formal written request for FDA standardization/ certification be sent to?
For a LEO, send it to:
Dr. Larry Maturin, Team Leader
Laboratory Proficiency and Evaluation Team
Food and Drug Administration
6502 S. Archer Road, HFH-450
Summit Argo, IL 60501-1957
For a SRO or SSO, send it to:
CAPT Robert Hennes
Dairy and Egg Branch
Food and Drug Administration
5100 Paint Branch Parkway, Room 2C-059
College Park, MD 20740
ISSUED 4/20/2007
Q26. Are all documents, including forms, contracts and written communication between the TPC and regulated Milk Company, that are utilized and exchanged within the NCIMS Voluntary ICPP to be in English or translated into English?
Yes.
Q27. Could an interested party participate on the ICPPC if they have a commercial relationship with a TPC?
No.
Q28. Could an interested party participate on the ICPPC if they do not have any commercial relationship with a TPC?
Yes.
Q29. May an employee of a milk company (MC) or other interested party participate on the ICPPC conference calls with the TPCs?
If acceptable to the TPCs, ICPPC would not have a concern with their participation.
ISSUED 5/16/2008
Q30. Is it acceptable for the regulated dairy plant to pay the Third Party Company (TPC) for the costs of evaluating the commercial laboratory?"
Yes
Note: It is understood that the cost of all regulatory services provided by the Third Party Certifiers will ultimately be borne by the plant or plants benefiting from those services. The preferable solution would be for the TPC to incorporate the cost of laboratory evaluation into the contract with the plant or plants.
Q31. A commercial laboratory certified under the ICPP is IMS listed for the following procedures: #5, #20, #22-Pasteurized Milk Containers. May this commercial laboratory perform official tests outside the scope of the pilot program, i.e., analyze single-service containers and closures from any IMS certified manufacturer?"
No. A laboratory certified under the ICPP is limited to only performing official tests for the facilities operating under the ICPP. However, the ICPP certified commercial laboratory may analyze single service containers and closures from any IMS listed source that are being utilized by a milk plant that is IMS listed under the ICPP.