Section 60-1.13 - Requirements for Participating Infant Formula Suppliers
Effective Date
60-1.13 Requirements for Participating Infant Formula Suppliers
(a) The department shall have the authority to designate approved wholesale suppliers of WIC-approved infant formula, and to limit vendors offering infant formula to wholesale procurements only from approved infant formula suppliers. No wholesale supplier of WIC-approved infant formula products may supply infant formula to a vendor which is eligible for reimbursement from the WIC program unless said infant formula supplier is designated as an approved supplier by the department pursuant to this section. Such designations shall be promulgated on a master list made available on the department’s website and in writing on request, to be updated at least semi-annually.
(b) Applicants for WIC program participation as infant formula suppliers must demonstrate consistency of business integrity. In reaching a determination as to sufficiency of an applicant’s business integrity, the department may rely solely on facts already known to it and representations made by the applicant on its application. The department may not authorize an applicant pursuant to this section if during the last six years the applicant or any of the applicant's current owners, officers, or managers have been convicted of a crime or had a civil judgment entered against them for any activity indicating a lack of business integrity. Activities indicating a lack of business integrity include, but are not limited to, evidence of fraud, antitrust violations, embezzlement, theft, forgery, bribery, falsification or destruction of records, filing a false instrument, making false statements, receiving stolen property, making false claims, and obstruction of justice.
(c) Infant formula suppliers seeking to receive approval from the department to supply infant formula to WIC vendors shall comply with the following requirements:
(1) complete and submit a WIC authorized infant formula supplier application as required by the department;
(2) maintain and be prepared to present to the department on demand proof of a valid food safety license issued by the New York State Department of Agriculture and Markets or a comparable license from another state;
(3) refrain from the sale of any expired food items including infant formula, and be prepared to verify that all infant formula items sold to WIC vendors are in their original manufacturer’s packaging or containers with clearly legible original labeling;
(4) store all WIC-approved infant formula in accordance with manufacturer recommendations;
(5) purchase infant formula only from an infant formula manufacturer or another entity on the New York State approved infant formula supplier list;
(6) present to the department on demand all sales records, invoices and copies of receipts for each delivery of WIC-approved infant formula, including a unique sales identification or invoice number;
(7) whenever infant formula is sold to a vendor, the infant formula supplier shall present to the department on demand the name and address of its infant formula supplier(s), and the date of wholesale purchase from that supplier; name and address of the vendor purchasing the product; records of the month, day and four-digit year of delivery; the specific number of infant formula items purchased, including product name, size of container, stock number or uniform product code; total quantity per item and unit price; and type of payment received;
(8) retain purchase and sale records of all WIC-approved food items sold to WIC vendors for a minimum of three (3) years, and make such records fully available to the department on demand; and
(9) allow the department and its authorized agent(s) unrestricted access to storage facilities and delivery vehicles for inspection purposes during normal business hours. Any business records described in paragraphs (6), (7) and (8) of this subdivision shall be available without restriction to inspectors at such times.
(d) Failure to meet any requirement of this section may be grounds for immediate revocation of an infant formula supplier’s approval to participate in the WIC program, and may be the sole basis for denial of any subsequent application to participate.
(e) An infant formula supplier who has been disqualified pursuant to subdivision (d) of this section shall be entitled to a fair hearing. The infant formula supplier shall be given timely written notice of such action, the reasons therefore, the rules and regulations governing infant formula supplier participation in the WIC program, the right to a fair hearing, and that such hearing may be obtained by the infant formula supplier by following the procedure indicated in the written notice within 15 days from the date the notice of agency action is served. Failure to request a hearing within the required 15-day period will result in a waiver of the infant formula supplier’s right to a hearing.
(f) Written notice of hearing shall be sent by certified mail to the infant formula supplier and other parties involved at least 10 days prior to the scheduled date of the hearing. Such notice shall:
(1) specify the date, time and place of the hearing;
(2) state briefly the issues which are to be the subject of the hearing;
(3) explain the manner in which the fair hearing will be conducted;
(4) apprise the petitioner of its right to be represented by an attorney, to testify, present documentary evidence, produce witnesses, cross-examine adverse witnesses, and to examine prior to and during the hearing the documents and records supporting the action under appeal; and
(5) state that failure to appear at the hearing shall constitute waiver of the petitioner's right to a hearing and that an order will be issued denying or disqualifying the petitioner from participation in the WIC program.
(g) The administrative law judge, in rendering a decision on the infant formula supplier’s eligibility for participation in the WIC program, shall be bound by section 60-1.12 of this Subpart.
(h) The burden of proof of eligibility to participate in the WIC program shall be on the infant formula supplier disqualified for violations of this Subpart.
(i) The provisions of section 60-1.6(d) and (h) of this Subpart concerning hearings, hearing officers, and record of hearings shall apply to fair hearings for infant formula suppliers conducted pursuant to this section.
(j) A copy of the fair hearing decision shall be sent to the petitioner, their attorney, if any, and any other parties involved, within 60 days following the date on which the State agency received the request for a hearing.
(k) Nothing in this section shall prevent the department from immediately disqualifying any infant formula supplier from participating in the WIC program, provided that written notice of disqualification is given to the supplier at least 15 days before the effective date of the disqualification. The disqualification may not be stayed during the pendency of the hearing by the administrative law judge without the consent of the department's representative at the hearing. Disqualification shall remain in effect unless an order is issued at the conclusion of the hearing which reinstates the supplier.
(l) Nothing in this section shall preclude the department from ordering a vendor to immediately cease and desist from transacting for WIC-approved infant formula of any kind with an unapproved or disqualified infant formula supplier. If the department takes such action, it shall immediately notify the vendor. Failure to comply with such an order shall be a violation of WIC program requirements.