RULES AND REGULATIONS
Title 28--HEALTH
AND SAFETY
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 1101, 1103, 1105, 1107
AND 1113]
Supplemental Nutrition Program for Women, Infants and Children (WIC Program)
[30 Pa.B. 6853] A. Scope and Purpose
The Department of Health (Department) adopts amendments to Part VIII (relating to Supplemental Nutrition Program for Women, Infants and Children (WIC Program)) to read as set forth in Annex A. This rulemaking amends Chapters 1101, 1103, 1105, 1107 and 1113, which govern the authorization and management of grocery stores participating in the Department of Health's Special Supplemental Nutrition Program for Women, Infants and Children (WIC Program) and the procedures for administrative appeals of WIC applicants and participants, and local agencies and grocery stores.
The majority of the changes to the Department's regulations are necessitated by recent amendments to the Federal regulations governing the WIC Program found in 7 CFR Part 246 (relating to Special Supplemental Nutrition Program for Women, Infants and Children). The Women, Infants and Children/Food Stamp Program (FSP) Vendor Disqualification Final Rule adopted on March 18, 1999, mandates uniform sanctions for the most serious violations of WIC Program Federal regulations by grocery stores authorized to participate in the WIC Program. The purpose of the Federal amendments, as explained in the preamble to those regulations, is to curb vendor-related fraud and abuse in the WIC Program and to promote coordination between the WIC Program and the Food Stamp Program in the disqualification of stores that violate either WIC Program or Food Stamp Program rules. These regulations reflect the Department's implementation of those changes, as well as several other changes agreed upon after meetings with stakeholders.
B. Comments
Notice of proposed rulemaking was published at 30 Pa.B. 873 (February 19, 2000) with an invitation to submit written comments. In addition to the notice published in the Pennsylvania Bulletin, the Department sent personal notice of the proposed rulemaking by letter dated February 18, 2000, to approximately 1,400 grocery stores which were authorized to participate in the WIC Program.
The Department received no comments within the 30-day comment period.
After the comment period, the Department received comments from the Independent Regulatory Review Commission (IRRC). The Department also received a letter from Senator Vincent Hughes. Although not received within the public comment period, the Department will address the comments expressed by Senator Hughes.
The WIC Program was authorized through an amendment to the Child Nutrition Act of 1966 (42 U.S.C.A. § 1786). Congress authorized the United States Department of Agriculture, Food and Nutrition Services (USDA-FNS), to contract with and make funds available to states to administer the program. In this Commonwealth, the WIC Program receives 100% of its funding from the USDA-FNS. The WIC Program is governed by Federal regulations found in 7 CFR Part 246. The Federal regulations require all aspects of program operation to be included in an annual State Plan of Operations which must be reviewed and approved by the USDA-FNS prior to a state's receipt of funding. See 7 CFR 246.4 (relating to State plan). Because the Department's regulations relate to the operation of the WIC Program under its delegation of authority from the USDA-FNS to operate the WIC Program, the Department was required to submit the proposed regulations to the USDA-FNS for review and approval as an amendment to the State Plan of Operations. See 7 CFR 246.4(c). The Department submitted the regulations to the USDA-FNS. The USDA-FNS notified the Department by letter dated February 25, 2000, that it found the proposed regulations to be in accordance with the WIC Program/Food Stamp Program Vendor Disqualification Final Rule.
Following is a discussion of amendments to the regulations, the comments received by the Department and the Department's response to the comments.
The Department received no comments on the proposed changes to §§ 1103.5, 1103.6, 1105.1, 1105.2, 1105.4 and 1113.2. The Department adopts as final the proposed changes to these sections.
§ 1101.2. Definitions.
The Department received no comments on this section, however, it has made two minor revisions to the definition of ''store slot'' for the purpose of clarification. The Department replaced the words ''particular geographic'' with the word ''trade'' to indicate that store slots are assigned to trade areas. The Department also added the words ''in which the trade area is located'' following the word ''county'' in the second sentence. This is to clarify that the Department's allocation of store slots is based upon the participant density of the specific county in which the store is located.
§ 1103.1. Certification and recertification reviews.
The Department received no comments from IRRC on this section. Senator Hughes did, however, comment on the procedure that the Department uses to certify or recertify stores seeking authorization. He expressed the opinion that the distinction between certification and recertification reviews set forth in § 1103. 1, and monitoring reviews in § 1105.6 (relating to monitoring of WIC authorized stores), was illogical and invalid as a matter of law. Senator Hughes further commented that he had conducted an exhaustive review of relevant Federal regulations and that the regulations do not distinguish between periodic reviews and certification/recertification inspections. He commented that the regulations still fail to correct the problem cited by the Commonwealth Court in Giant Food Stores v. Department of Health (Giant I), 554 A.2d 174 (Pa. Cmwlth. 1989).
In Giant I, the Commonwealth Court held that the finding of the hearing examiner upholding the Department's decision to terminate authorization of a store was not based upon substantial evidence. The decision was based upon the evidence before the Court at that time. In 1989, a store was authorized for a minimum period of 18 months up to a period of 2 years. In Giant 1, the Department conducted a recertification review at the store 14 months into the store's period of authorization. The store failed the review and the Department denied the store's application. The denial of the application was based upon failure to have minimum inventory standards available at the time of the review. The Court found that it was clear from the reading of the contract, that the store's authorization was valid for a period of 2 years (554 A.2d at 176) and that the violation upon which the denial of authorization was based, that is, a shortage of inventory, was such that it would warrant a warning during any other review. The court found that if a single product shortage was not sufficient to justify disqualification during a routine inspection, it was not sufficient to terminate a store from the WIC Program during a recertification inspection. The court determined that there was not substantial evidence upon the record before it to make such a distinction. Therefore, it reversed the Department's decision.
In response to this case, the Department revised its agreement with grocery stores to put a store on notice that its authorization was valid only until such time as the next certification/recertification review was conducted. The duration of certification was codified in the regulations the Department promulgated in 1999 in § 1103.1(c). A store's authorization to participate in the WIC program remains in effect only until such time as ''. . . . its application for recertification is denied or its certification expires if it fails to apply for certification.'' Under both Federal regulations, 7 CFR 246.12(f)(2)(xviii), and State regulations, § 1131.1 (relating to right to appeal), the expiration of a store's authorization is a nonappealable issue and there is no obligation of either party to renew the agreement, 7 CFR 246.12(f)(2)(xvi)).
The certification/recertification reviews are the periodic review of vendor qualifications the State agencies are required to conduct under 7 CFR 246.12(g). The reviews are conducted to determine if stores meet the qualifications necessary to be authorized. The qualifications, called selection and limitation criteria, were established by the Department to further the purpose of the program by ensuring stores are able to meet the needs of participants going to the stores for WIC purchases. For instance, stores are required to maintain minimum inventory of WIC authorized foods to ensure that these foods are available to participants when making purchases. If the stores do not meet the qualifications, they are not authorized. To authorize a store which does not meet the qualifications the Department has established to serve the needs of the WIC participants would not further the purpose of the WIC Program. Section § 1103.1(f) specifically states that the Department, when making a decision on an application for certification or recertification, will deny the application if the criteria for certification or recertification set forth in § 1103.4(a) and (b) are not satisfied, and that there will be no warning or opportunity to correct problems identified during certification or recertification reviews.
In contrast to the certification/recertification reviews which are required by Federal regulation to be conducted at least once every 2 years, 7 CFR 246.12(g), the Department has also implemented a system to monitor stores which have been authorized to participate in the program. State agencies are required to monitor authorized stores under Federal regulation, 7 CFR 246.12(i). The system to monitor stores is set forth under § 1105.6 (relating to monitoring of WIC authorized stores). The purpose of the monitoring is to ensure that once a store has demonstrated that it meets the qualifications necessary to be authorized, the store continues to comply with the program regulations. The purpose of monitoring reviews, as set forth in § 1105.6, is to determine compliance with applicable Federal and State regulations, and to investigate complaints regarding stores. Thus, the purpose of monitoring reviews and certification/recertification reviews are completely different and should be treated differently, regardless of the fact that some of the same factors may be used in conducting the reviews.
The decision issued in Giant I was issued 10 years prior to the publication of the regulations. The issue raised by Senator Hughes had been presented to the Department prior to its initial promulgation of the WIC regulations in 1999. The Department's regulations specifically correct the issue raised by the court in the Giant I case. The regulations clarify that there are different and distinct purposes for the types of reviews Senator Hughes commented on. The Department conducts certification/recertification reviews to determine whether or not a store meets the minimal qualifications necessary to be certified to participate in the WIC Program, while monitoring reviews determine whether a store is complying with regulations during a period of authorization.
In Giant I, as stated previously, the appellate court had no Department regulations before it to distinguish between the two types of reviews. Also, the record before the court did not reflect that the USDA-FNS construed its regulations to embrace such a distinction. Now, however, the USDA-FNS has approved of the regulatory scheme the Department uses for authorization of stores and found it to be in accordance with the authority the Department was delegated by Federal regulation.
Due to moving the criterion contained in § 1103.4(a) (13) to limitation criteria contained in § 1103.4(b) as discussed later herein, the Department citation that appears in subsection (b)(2) for determining whether a store slot is available is incorrect. The Department has revised the proposal to reflect the proper citation. Other than this revision, the Department has made no change to this section.
§ 1103.2. Probationary certification.
IRRC asked for clarification of a citation found in subsection (b)(2). IRRC commented that there appeared to be a typographical error in subsection (b)(2) in the cross reference to inadequate participant access. In the proposed rulemaking, § 1107.3(c)(8) was given as the cite for an explanation of inadequate participant access. The correct citation is § 1103.7(c)(8). The Department has revised the proposal to reflect the proper citation.
§ 1103.3. Authorization of store slots.
Subsection (b) provides that by October 1 of each year the Department will evaluate the WIC participant population to determine the store slot allocation per county for each Federal fiscal year. IRRC asked for an explanation of how the public and the industry will be notified of annual changes to store slots. Upon consideration of this comment, the Department added language to this section to state that the Department will publish the yearly allocations of stores slots in the Pennsylvania Bulletin no later than October 30 of each year, thereby providing notification to the public and industry.
§ 1103.4. Selection and limitation criteria; authorization process.
The Department received no comments on this section, however, it has made a revision for the purpose of clarification. An incorrect citation appears in subsection (a)(2). The Department has replaced the reference to § 1107.1(i) with § 1107.2(j), the proper reference.
The Department had proposed to move the limitation criterion formerly contained in subsection (b)(2) to a selection criteria in subsection (a)(13). This criterion stated that the Department would not authorize a store if it was located within 1 mile of another WIC authorized store unless the Department determined that there was sufficient WIC participant shopping in order to support the authorization of an additional WIC authorized store. In the proposed rulemaking, the Department set forth a new three-tier method for defining ''sufficient participant shopping.'' This method was based upon the proposed method for assigning store slots in § 1103.3 (relating to authorization of store slots). Upon further consideration, the Department has determined that the criterion which appears in the proposed regulations as subsection(a)(13), is, in fact, a limitation criterion. The Department uses this as a limitation criterion in addition to that contained in subsection (b)(1) which requires that a store slot be available in a trade area before authorization of a store. Notwithstanding the fact that a store slot may be open, if a store is located within 1 mile of another store and there is not a sufficient number of WIC participants making their purchases in this area, the store will not be authorized. The purpose of this criterion is to ensure an adequate distribution of WIC authorized stores in a trade area by limiting the authorization of stores to locations within a trade area where participants are shopping. The Department has moved the criterion to subsection (b)(2), and has revised the numbering in subsection (b) to reflect the change. The Department has made additional changes to subsection (c)(1) and (3) to reflect the move of this criterion from a selection criterion to a limitation criterion.
§ 1103.7. Inadequate participant access.
The Department received no comments on this section, however, it has made a revision for the purpose of clarification. In subsection (c)(2), the Department has deleted the words ''according to'' and replaced them with ''in accordance with one of.'' The Department made this change so that the language used in subsection (b)(1), (2) and (3) is consistent.
§ 1105.3. Terms and conditions of participation.
In subsection (a), the Department has corrected the reference to section § 1107.1 (relating to imposition of sanctions).
§ 1105.6. Monitoring of WIC authorized stores.
In subsection (b)(1)(vi), (c)(6) and (d)(6), references are made to the ''disqualification'' of a store based upon violations of statutes and regulations governing the store's participation in the WIC Program detected during compliance investigations, routine reviews and training buys. Due to the changes in the proposed regulations which permit the Department to impose a civil money penalty in lieu of a disqualification if the Department determines that inadequate participant access would result if the store were to be disqualified, the Department has changed the language in these three subsections to reference sanctions under § 1107.1 (relating to imposition of sanctions). The section sets forth the procedure for the Department to use in determining the appropriate sanction to be imposed, whether it be a disqualification or a civil money penalty.
§ 1107.1. Imposition of sanctions.
The Department changed the language in proposed subsection (a) to provide that the Department may choose, in certain circumstances, to not provide a store with a prior warning that program violations were occurring before imposing sanctions. The Department added the words ''in the case of fraud, trafficking, sale of alcohol or alcoholic beverages or tobacco products, and other serious program violations or offenses'' to set forth the circumstances that would guide the Department's determination that no prior warning should be given before imposing the sanction. This change is consistent with 7 CFR 246.12(k)(3) (relating to participant and vendor sanctions), and makes clear that providing a prior warning is an option for the Department only under certain circumstances. As stated in the preamble to the WIC/FSP Vendor Disqualification Final Rule:
The location of this provision (referring to § 246.12(k)(3)) in the final rule clarifies that it applies to both mandatory and State agency-established sanctions. The provision clearly makes the use of prior warning a State agency option. However, the prior warning cannot be provided for trafficking violations or ''the sale of alcohol, alcoholic beverages or tobacco products'' violation because these violations warrant a mandatory sanction for the first offense. Also, while prior warning for other violations may be acceptable for the first incidence, continual use of the warning, undermines the State agency's fraud and abuse investigation and prevention efforts. 64 FR 13314.For clarification, the Department has added the word ''inadequate'' before the words ''participant access'' in the last sentence of subsection (a). This change promotes consistency with the language used throughout the regulations.
New subsections (b) and (c ) both state ''. . . the Department will give the store the option of paying a civil money penalty in lieu of . . . disqualification . . .'' The parallel portions of 7 CFR 246.12(f)(2)(xix) and (xx) provide '' . . . the State agency shall impose a civil money penalty . . . .'' IRRC asked the Department to explain why the language in the proposed amendment differs from the language in the Federal regulation.
The Federal regulations are mandatory for the Department with respect to the options that it may use when imposing sanctions upon stores in certain circumstances. The Federal regulations direct that the Department must impose a civil money penalty in lieu of disqualification in instances of inadequate participant access. Nevertheless, subsections (b) and (c ) are adopted as proposed and provide the option to the store to pay the civil money penalty in lieu of disqualification. This is because the WIC Program is a voluntary program in which vendors choose to participate. The Department can not require the store to pay the civil money penalty, and thus force the continued participation in the WIC Program by the store. The store may make a business decision that it will accept the disqualification for the specified period of time in lieu of payment of the civil money penalty. The USDA-FNS reviewed the proposed regulation and found it to be proper and in accordance with the Final Federal Vendor Disqualification Rule.
§ 1107.1a. Disqualifications.
Under subsection (d)(3), the Department added the language ''on the premises at all times'' to clarify that the store is responsible for always maintaining the minimum inventory required under § 1103.5 (relating to minimum inventory) on the premises. The additional language is consistent with the proposed regulations that permit the store to maintain the inventory on the premises of the store, not the store shelves, as had been the previous requirement.
IRRC had two comments with respect to this section. First, IRRC commented that in subsection (d)(9), the phrase ''or with another WIC check for purchases made with a WIC check'' is unclear, and asked for clarification as to what circumstances the phrase addressed. This phrase addresses a situation in which a store's bank rejects a WIC check that the store improperly accepted and the store then attempts to have the WIC participant reimburse the store for the rejected check with another WIC check or with the participant's own money. No change was made to this proposal.
Secondly, IRRC asked for clarification as to proposed subsection (d)(14), which provides for a 1-year disqualification of a store which fails ''to remit payment of an overcharge within the specified time frame.'' IRRC asked for clarification as to the time frame which the phrase ''within the specified time frame'' referred. To clarify this, the Department added references to §§ 1105.2(f) and (g) and 1105.6(f) (relating to overcharge recovery system; and monitoring of WIC authorized stores) which provides the specific time frames for which remittance is due.
Subsection (h) relates to disqualifications based on an FSP disqualification. The Department has added the words ''WIC Program'' in the last sentence of this subsection to clarify that it is the WIC Program disqualification as a result of a disqualification from the Food Stamp Program that is not subject to administrative or judicial review. The Department has deleted language in subsection (1), which is unnecessary.
§ 1107.2. Civil money penalties.
The Department received no comments on this section, however, it has made a revision for the purpose of clarification. Under subsection (b)(1), the Department removed the proposed language that would require civil money penalties for stores denied recertification to be calculated at 10% of the average monthly sales for the most recent 6-month period. For stores denied recertification for which the option of paying a civil money in lieu of the disqualification is available, the civil money penalty will be calculated on a 5% of the average monthly sales for the most recent 6-month period as set forth in subsection (b)(2).
IRRC noted an inconsistency between proposed subsection (b)(2) and the preamble to the proposed regulations. IRRC commented that proposed subsection (b)(2) begins ''For disqualifications identified in § 1107.1a(d)(2)--(15) . . .'' and the preamble identified this as § 1107.1a(d)(2)--(16). The citation was incorrect in the proposed regulations and is corrected to reflect the proper reference to § 1107.1a(d)(2)--(16).
In subsection (b)(2), the Department also removed the proposed words ''the store shall pay'' to clarify the sentence. These words were inadvertently added in the language of the proposed regulations and the removal of the language does not change the meaning of the subsection.
In subsection (f), the Department has clarified the example provided in the last sentence by explaining that an outstanding financial liability includes overcharges for the ''sale of unauthorized foods'' as opposed to ''the unauthorized sale of foods.'' The word ''unauthorized'' has been deleted before the word ''sale,'' then added after the word ''sale'' to make clear the intent.
§ 1113.1. Right to appeal.
The Department received no comments on this section, however, it has made a revision for the purpose of clarification. In subsection (b)(3), the Department has added the words ''from the WIC Program'' following the first word of the proposed subsection (b)(3) to clarify that a disqualification from the WIC Program as a result of a disqualification from the FSP is the disqualification that is non-appealable. This change is consistent with the Department's clarification made to § 1107.1a(h) set forth previously.
C. Fiscal Impact
The WIC Program is 100% Federally funded. No State dollars are involved in the operation of the WIC Program. The regulatory changes to § 1103.3 (relating to authorization of store slots) that change the method of allocating store slots based upon WIC population density has the potential for increasing by approximately 200 the number of stores authorized to participate in the WIC Program. As a result, the Department anticipates an increase of approximately $96,000 annually in store-related monitoring costs.
D. Paperwork Requirements
The regulations will not increase paperwork for the WIC Program participants or those grocery stores voluntarily participating in the WIC Program. Except to the extent that 200 additional stores will be participating in the WIC Program, the regulations also will not increase paperwork for the Department.
E. Effective Date/Sunset Date
The regulations shall be effective upon publication. The Department will send approximately 1,400 grocery stores currently participating in the WIC Program direct notice of the final regulations upon publication.
These regulations will be monitored continually and will be updated as required by changes in Federal statute or Federal regulations governing the WIC Program. Therefore, no sunset date has been set.
F. Statutory Authority
The WIC Program was authorized through an amendment to the Child Nutrition Act of 1966 (42 U.S.C.A. § 1786). Congress authorized the USDA-FNS to contract with and make funds available to States to administer the program. In this Commonwealth, the WIC Program receives 100% of its funding from the USDA-FNS.
There are no state statutes governing the operation or administration of the WIC Program. There is a State statute found at 62 P. S. § 2951 which authorizes additional State funding for the expansion of the WIC Program. The Commonwealth, however, has not provided funding for the expansion of the program since State Fiscal Year 1996.
The existing State regulations were developed and published in the Pennsylvania Bulletin on July 24, 1999, following the decision of the Commonwealth Court in Giant Food Stores, Inc. v. Commonwealth of Pennsylvania, Department of Health (Giant II), 713 A.2d 177(1998). Giant II held that the Department was required to promulgate regulations governing the selection and management of grocery stores to participate in the WIC Program. The State regulations added Part VIII. The regulations also repealed 28 Pa. Code §§ 8.41--8.74, the Department's then existing regulations pertaining to WIC Program administrative appeals.
The changes to the existing State regulations contained herein are submitted under the Department's general power and duty to protect the health of the people of the Commonwealth (71 P. S. § 532), and under Giant II.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 9, 2000, the Department submitted a copy of a notice of proposed rulemaking, published at 30 Pa.B. 873 to IRRC and to the Chairperson of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare.
In compliance with section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)), the Department submitted a copy of the final-form regulations to IRRC and the Committees on September 18, 2000. In addition, the Department provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available upon request.
In preparing the final-form regulations, the Department has considered all comments it received. The USDA-FNS reviewed and approved these regulations on February 25, 2000.
This final-form regulation was deemed approved by the House Health and Human Services Committee and deemed approved by the Senate Public Health and Welfare Committee. IRRC met on October 19, 2000, and approved the final-form regulations in accordance with section 5.1(e) of the Regulatory Review Act.
H. Contact Person
Questions regarding these regulations may be submitted to Greg Landis, Chief, Grants and Retail Store Management Unit, WIC Program, Room 604, Health and Welfare Building, Harrisburg, PA 17109, (717) 783-1289. Persons with disabilities may submit questions in alternative formats such as by audio tape, braille or by using V/TT: (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
Persons with disabilities who would like to obtain this document in an alternative format (such as, large print, audio tape, braille) should contact Greg Landis so that he may make the necessary arrangements.
I. Findings
The Department finds that:
(1) Public notice of intention to adopt the regulations adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202), and regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and no comments were received.
(3) The adoption of regulations in the manner provided by this order is necessary and appropriate for the compliance with the Federal regulations governing the WIC Program.
J. Order
The Department, acting under the authorizing statute, orders that:
(a) The regulations of the Department, 28 Pa. Code Chapters 1101, 1103, 1105, 1107 and 1113, are amended by adding § 1107.1a and by amending §§ 1101.2, 1103.1--1103.7, 1105.1--1105.4, 1105.6, 1107.1, 1107.2, 1113.1 and 1113.2 to read as set forth in Annex A.
(2) The Secretary of Health shall submit this order and Annex A to the 0ffice of General Counsel and Office of Attorney General for approval as required by law.
(3) The Secretary of Health shall submit this Order, Annex A and a Regulatory Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for their review and action as required by law.
(4) The Secretary of Health shall certify this Order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(5) This order shall take effect immediately upon publication in the Pennsylvania Bulletin.
ROBERT S. ZIMMERMAN, Jr.,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commissin relating to this document, see 30 Pa.B. 5807 (October 14, 2000).)
Fiscal Note: Fiscal Note 10-161 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 28. HEALTH AND SAFETY
PART VIII. SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN (WIC PROGRAM)
CHAPTER 1101. GENERAL PROVISIONS § 1101.2. Definitions.
The following words and terms, when used in this part, have the following meanings, unless the context clearly indicates otherwise:
Allowable foods--Foods and infant formula on the WIC food list. These products meet nutritional standards established by the USDA-FNS and are authorized by the Department for purchase with WIC checks.
Applicant--An individual applying to become a participant.
Authorized representative--For an applicant or participant, an adult applicant or participant, a parent or guardian of an applicant or participant who is an infant or child or an individual designated by that person to represent the applicant or participant in administrative proceedings involving the WIC Program. For a local agency or store, an individual designated by the local agency or store to represent it in administrative proceedings involving the WIC Program.
Breastfeeding woman--A woman, during 1 year postpartum, who is breastfeeding her infant.
Certification--For purposes of Chapters 1101--1109 and 1113, the term means the Department's acceptance of a store, not currently authorized to participate in the WIC Program, as a WIC authorized store. For purposes of Chapter 1111 (relating to applicant and participant appeals), the term means the Department's acceptance of an applicant to participate in the WIC Program as a participant.
Child--A person 1 year of age or older but under 5 years of age.
Clinic--A facility where applicants apply for and participants receive WIC Program services other than food benefits.
Compliance buy--A covert purchase at a WIC authorized store, with a WIC check, conducted to enable the Department to evaluate adherence by a WIC authorized store with this part governing the store's participation in the WIC Program.
Compliance investigation--A series of at least two compliance buys conducted at the same WIC authorized store.
Competent professional authority--An individual on the staff of the local agency authorized to determine nutritional risk and prescribe supplemental foods. The following persons are the only persons the Department will authorize to serve as a competent professional authority: physicians, nutritionists (Bachelor's or Master's Degree in Nutritional Sciences, Community Nutrition, Clinical Nutrition, Dietetics, Public Health Nutrition or Home Economics with emphasis on nutrition), dieticians, registered nurses, physician's assistants (certified by the National Committee on Certification of Physician's Assistants or certified by the State medical certifying authority), or State or local medically trained health officials. The term also applies to an individual who is not on staff at the local agency but who is qualified to provide data upon which nutritional risk determinations are made by a competent professional authority on staff of the local agency.
Department--The Department of Health of the Commonwealth.
Disqualification--For the purposes of Chapters 1101, 1103, 1105, 1107, 1109 and 1113, the term means the action by the Department to end participation of a WIC authorized store in the WIC Program for reasons of fraud, abuse or other violations of this part governing the store's participation in the WIC Program. For purposes of Chapter 1111 (relating to applicant and participant appeals), the term means action by the Department or local agency to end participation of a participant who no longer meets the qualifications necessary to participate in the WIC Program or for reasons of fraud, abuse or violation of standards governing the participant's enrollment in the WIC Program.
Division of WIC--Division of WIC in the Department.
Endorser--The parent or guardian of an infant or child participant who is authorized to use and sign the WIC checks of the infant or child for purchase of allowable foods.
Filing date--The date on which the local agency or the Department receives an appeal.
Food prescription--A designation by a competent professional authority of allowable foods in specified quantities to meet a participant's nutritional needs based upon a determination of nutritional risk.
Health services--Routine pediatric and obstetric care (such as infant and child care and prenatal and postpartum examinations) or referral for treatment.
High risk store--A store identified as a possible perpetrator of fraud or abuse through analysis of redemption patterns of WIC checks or WIC sales, through compliance violations, or by complaints of participants or WIC Program staff.
Infant--A person under 1 year of age.
Inventory audits--A comparison of a WIC authorized store's inventory levels and purchases of a particular WIC product over a specific period of time, to actual WIC purchases of the same product during the same period of time, to determine if the store had adequate product quantities available to satisfy claims made for WIC reimbursement of the product during the same period of time.
Limitation criteria--Criteria in § 1103.4(b) (relating to selection and limitation criteria; authorization process) which the Department has established to limit the number of WIC authorized stores in a particular area to assure that State and local officials can effectively manage, review and monitor WIC authorized stores.
Local agency--A public or private nonprofit health or human service agency with which the Department contracts to provide WIC Program services for a specific geographic area.
Nutritional risk--A determination that one of the following exists:
(i) Detrimental or abnormal nutritional conditions detectable by biochemical or anthropometric measurements.
(ii) Other documented nutritionally related medical conditions.
(iii) Dietary deficiencies that impair or endanger health.
(iv) Conditions that predispose persons to inadequate nutritional patterns or nutritionally related medical conditions.
Onsite review--An overt visit to a store by Federal, Department or local agency personnel to determine if the store meets the selection criteria necessary to be certified or recertified as a WIC authorized store, or a visit to a WIC authorized store after certification or recertification, to determine whether the store is complying with this part governing the store's participation in the WIC Program.
Participant--A pregnant woman, breast-feeding woman, postpartum woman, infant or child enrolled in the WIC Program.
Participant certification period--The period of time during which an individual is authorized to participate in the WIC Program.
Postpartum woman--A woman, during 6 months after termination of pregnancy.
Pregnant woman--A woman determined to have one or more embryos or fetuses in utero.
Premises--The sales floor and storage areas within the building housing the authorized store.
Proxy--A person authorized by the local agency and the participant, or by the participant's parent or guardian if the participant is an infant or child, to pick up or use WIC checks to make purchases for that participant.
Recertification--The Department's authorization of a WIC authorized store, following a review process, to continue as a WIC authorized store.
Redeem--A WIC authorized store submitting a WIC check to its bank for the purpose of securing a money payment for the amount appearing in the ''Pay Exactly'' box on the WIC check.
Sales floor--The display shelving, the floor in the area normally used for retail trade and the area behind the customer service desk, excluding other areas not accessible to the general public.
Sanction--A penalty imposed by the Department upon a WIC authorized store for violation of this part governing the store's participation in the WIC Program. The term does not include a decision to deny certification or recertification following a certification or recertification onsite review process.
Secretary--The Secretary of Health of the Department.
Selection criteria--Criteria in § 1103.4(a) which the Department has established which a store seeking to be certified or recertified is required to satisfy.
Standard formula--Infant formula products that do the following:
(i) Meet the Federal WIC regulatory definition of an iron-fortified formula (7 CFR 246.10(c)(1)(I) (relating to supplemental foods)).
(ii) Comply with the Infant Formula Act of 1980, the act of September 26, 1980 (Pub.L. No. 96-359, 94 Stat. 1190), which amended the Food and Drug Act.
(iii) Meet the requirements of an ''infant formula'' as opposed to an ''exempt infant formula'' or ''medical food'' as determined by the Food and Drug Administration (FDA), United States Department of Health and Human Services.
Stale-dated--After the date imprinted on the product as the recommended last date for sale or use.
Store slot--A slot established by the Department for a WIC authorized store in a trade area. The number of store slots the Department authorizes for a geographic area assigned to a local agency is based on the density of participant population in the county in which the trade area is located and the actual number of participants in the county.
Trade area--A designated geographic area within the geographical area assigned to a local agency, which is organized to serve the participant populations in that designated area through an assigned number of store slots.
Training buy--The presentation of a WIC check by a Federal, Department or local agency representative to purchase foods at a WIC authorized store, which does not result in the actual tender of the WIC check or the purchase of the foods, to evaluate adherence by a WIC authorized store with this part governing the store's participation in the WIC Program.
USDA-FNS--The United States Department of Agriculture, Food and Nutrition Service.
WIC authorized store--A retail food store which is authorized through certification or recertification to provide allowable foods to participants by accepting WIC checks.
WIC check--A negotiable instrument issued to participants to purchase allowable foods at WIC authorized stores.
WIC food list--A list published by the Department in the Pennsylvania Bulletin of foods and infant formula which may be purchased with WIC checks.
WIC identification card--A document issued by the Department to a participant, which is used for identification purposes, signature verification and authorization to purchase allowable foods with WIC checks at a WIC authorized store.
WIC Program--The Special Supplemental Nutrition Program for Women, Infants and Children.
WIC Program benefits--Supplemental foods, nutrition education and referral to health services.
CHAPTER 1103. AUTHORIZATION OF STORES § 1103.1. Certification and recertification reviews.
(a) Qualifying for certification or recertification. To be certified or recertified as a WIC authorized store, a store shall meet the selection criteria in § 1103.4(a) (relating to selection and limitation criteria; authorization process) at the time of the onsite review. If the number of applicants satisfying the selection criteria exceeds the number of stores the Department permits to participate in the WIC Program under the limitation criteria in § 1103.4(b), the Department will determine which store to certify or recertify under the process in § 1103.4(c). The Department will exempt a store from satisfying the selection and limitation criteria only if there is a finding of inadequate participant access, as set forth in § 1103.7 (relating to inadequate participant access).
(b) Certification or recertification review process. The certification or recertification review process is as follows:
(1) A person authorized on behalf of a store to make an application for certification or recertification shall contact the local agency responsible for the county in which the store is located to request an application.
(2) The local agency shall determine if a store slot is available in accordance with § 1103.4(b).
(3) If a store slot is available, the local agency shall send the WIC Program information and an application to the store.
(4) A store that is not certified shall complete the application in accordance with the instructions therein and return it to the local agency. If the local agency is apprised by a certified store that it wants to be recertified, the local agency shall collect the application from the store at the time of the onsite review. The Department will not accept an application for certification or recertification from a store that has been provided notice of disqualification or is disqualified from the WIC Program. The WIC Program disqualification period shall be completed before an application will be accepted by the Department. The Department may deny an application for certification from a new owner of a recently purchased store if the Department determines that the purpose of the sale of the business was a sham transaction to avoid a WIC disqualification.
(5) A person authorized on behalf of a chain of stores to make an application for certification or recertification shall complete a separate application for each store in the chain that seeks certification or recertification.
(6) The local agency shall schedule an onsite review of the store for the purpose of determining if the store meets the selection criteria in § 1103.4(a). The local agency will notify the store of the approximate date of the review.
(7) The local agency shall conduct the onsite review and forward the results to the Department for a decision on the store's application for certification or recertification.
(8) The Department will notify the store of its decision on the store's application for certification or recertification.
(c) Duration of certification or recertification. The certification or recertification of a store shall remain in effect until the store is disqualified, changes ownership, withdraws from the WIC Program, its application for recertification is denied or its certification expires if it fails to apply for recertification. The Department will provide 30 days written notice to the store prior to expiration of WIC certification for any store failing to apply for recertification. Either the Department or the WIC authorized store may terminate the certification for cause after providing at least 30 days advance written notice.
(d) Periodic reviews. At least once every 2 years, the Department will conduct contemporaneous certification and recertification reviews in a trade area for the purpose of filling store slots in that trade area with WIC authorized stores. Both stores that are certified, and stores that are not certified but want to become WIC authorized stores, shall make an application for certification or recertification. The Department will send a notification of the contemporaneous certification/recertification review process to each WIC authorized store and each store on the waiting list. The notice shall include information advising the store of the procedure for being reviewed for the purpose of receiving certification or recertification. The Department will notify a store which fails to seek recertification or is denied recertification under this subsection of the date the store's current certification expires. Expiration of the certification shall be no less than 30 days after the mailing date of the notice.
(e) Moratorium on applications. The Department will not accept applications, or schedule or conduct certification reviews in a trade area 90 days or less prior to the scheduled start date of the contemporaneous certification/recertification reviews in that trade area. The Department will grant an exception to this moratorium only if the Department finds that there would be inadequate participant access, as set forth in § 1103.7, if it does not consider the application. A store granted certification under this exception shall be exempt from the contemporaneous certification/recertification review if it has been certified for less than 60 days prior to the date the contemporaneous reviews begin in the trade area.
(f) No opportunity to correct problems. When the Department is making a decision on an application for certification or recertification, it will deny the application if the criteria for certification or recertification set forth in § 1103.4(a) and (b) are not satisfied. The Department will make its decision on the application without providing a warning or an opportunity to correct problems identified during the certification or recertification review.
(g) Eligibility for stores denied certification or recertification. A store which has been denied certification or recertification shall wait 6 months from the effective date of the Department's decision to reapply, except a store denied certification or recertification under § 1103.4(c)(2) will be placed on a waiting list and will be considered immediately for certification if a store slot becomes open.
§ 1103.2. Probationary certification.
(a) Criteria for probationary certification. If during the certification or recertification review, the store fails to meet one or more of the qualifications in § 1103.4(a) and (b) (relating to selection and limitation criteria; authorization process), the Department may grant probationary certification to the store for a period not to exceed 6 months when either of the following applies:
(1) Inadequate participant access would occur if the store is not certified or recertified.
(2) A store is reviewed prior to opening to the public and the store has not stocked its dairy section or its frozen juice section at the time of the review.
(b) Probationary certification reviews.
(1) If a store receives probationary certification, except in situations of inadequate participant access identified in § 1103.7(c)(8) (relating to inadequate participant access), the Department will conduct an unannounced onsite review during the probationary certification period to determine if regular status should be granted to the store. The Department may rescind probationary certification and deny the store's application to serve as a WIC authorized store if the store fails to meet one or more of the selection criteria during this review.
(2) If a store receives probationary certification due to inadequate participant access as identified in § 1103.7(c)(8), the Department will conduct a certification review of the store and any other stores on the waiting list within the store's trade area. The Department may rescind probationary certification and deny the store's application to serve as a WIC authorized store if the store fails to meet one or more of the selection or limitation criteria during this review.
(c) Extension of probationary certification. If the store fails the review conducted during the probationary certification period, and inadequate participant access exists as determined by the Department, the Department may extend probationary certification for an additional 3 months during which time at least one representative of the store who is responsible for training store personnel on the WIC Program shall attend corrective training.
(d) Extended probationary certification reviews. The Department will conduct an unannounced onsite review during the extended probationary certification period after the store representative has attended corrective training, to determine if certification should be granted to the store. The Department will rescind probationary certification and deny the store's application to serve as a WIC authorized store if the store fails to meet one or more of the selection criteria during this review.
(e) Rescission of probationary certification. If the Department rescinds the probationary or extended probationary certification of a store, the store is not eligible to reapply for certification for 6 months from the date of the Department's rescission of the certification.
§ 1103.3. Authorization of store slots.
(a) Assignment of store slots. The Department will assign store slots based upon WIC participant density according to the following:
(1) In counties with WIC participant density greater than 100 participants per square mile, the Department will assign one store slot for every 175 WIC participants.
(2) In counties with WIC participant density of 25 to 100 participants per square mile, the Department will assign one store slot for every 150 WIC participants.
(3) In counties with WIC participant density less than 25 participants per square mile, the Department will assign one store slot for every 125 WIC participants.
(b) Yearly allocation of store slots. By October 1 of each year, the Department will evaluate WIC participant population to determine store slot allocations per countv for each Federal Fiscal Year. The Department will publish these allocations in the Pennsylvania Bulletin no later than October 30 of each year.
§ 1103.4. Selection and limitation criteria; authorization process.
(a) Selection criteria. The Department will use the following selection criteria to identify stores that meet the operational criteria to serve as a WIC authorized store:
(1) The store shall be located within this Commonwealth.
(2) A store shall serve or reasonably expect to serve at least 25 participants per month.
(i) The Department will provide a store seeking certification which has not been certified previously, an 8-month period to determine if the store is serving 25 participants. The Department may disqualify a store for a period of no less than 6 months in accordance with § 1107.1a(j) (relating to disqualifications) if it is not serving 25 participants at the end of the 8-month period.
(ii) The Department may deny recertification if the store is not serving 25 participants per month in the most recent month for which the Department has participant data at the time the recertification review is conducted.
(3) The store shall have allowable foods properly stored and refrigerated.
(4) The store shall not have stale-dated allowable foods on its sales floor.
(5) The store shall have available on the premises at all times the minimum inventory requirements in § 1103.5 (relating to minimum inventory) of allowable foods.
(6) The store shall have shelf prices less than the maximum allowable cost established by the Department for Food Prescription One and Food Prescription Two. The highest price of each allowable food available at the store, regardless of brand, shall be recorded to determine if the store's prices are within the maximum allowable prices established by the Department. The Department will publish in the Pennsylvania Bulletin, no later than September 15 of each year, the maximum allowable prices for Food Prescription One and Food Prescription Two. Revisions to the maximum allowable prices will be published in the same manner. Food Prescription One and Food Prescription Two are as follows:
(i) Food Prescription One consists of the following:
(A) Eighteen quarts or nine half gallons of milk.
(B) One pound of cheese.
(C) One dozen eggs.
(D) One 15 to 18 ounce container of peanut butter.
(E) One pound of dried beans or peas.
(F) Four 11.5 to 12 ounce containers of frozen concentrated juice or four 46 ounce containers of single strength juice.
(G) Thirty ounces of cereal.
(ii) Food Prescription Two consists of: Thirty-one 13 ounce cans of concentrated contract brand milk or soy based infant formula.
(7) The store shall be open for business at least 8 hours per day, 6 days per week.
(8) The store shall be sanitary. There may not be evidence of unremoved rubbish, vermin, or general lack of cleanliness.
(9) The store shall operate in a permanent fixed location where participants may purchase allowable foods with their WIC checks.
(10) The store may not be currently disqualified from participation in the Food Stamp Program.
(11) The store may not be currently disqualified from the WIC Program or have been denied certification or recertification by the WIC Program within the past 6 months unless the conditions of § 1103.6(a)(2) (relating to waiting list) are met.
(12) The store shall have implemented all required corrective actions resulting from monitoring by the Department, including repayment of any overcharges to the WIC Program, and shall be in compliance with all applicable Federal and State regulations.
(b) Limitation criteria. The Department will use the following criteria to limit the number of WIC authorized stores in a trade area:
(1) A store slot shall be available in the trade area in which the store is located.
(2) The store may not be located within 1 mile of another WIC authorized store within the same trade area unless the Department determines that there is sufficient WIC participant shopping within the 1 mile area to support an additional WIC authorized store. For the purpose of this paragraph, to support the authorization of each additional WIC authorized store within the 1 mile radius, sufficient WIC participant shopping shall be determined by the following:
(i) For counties with WIC participant density greater than 100 participants per square mile, there shall be at least 175 WIC participants shopping within 1 mile of the applying store for each store slot authorized.
(ii) For counties with WIC participant density of 25 to 100 participants per square mile, there shall be at least 150 WIC participants shopping within 1 mile of the applying store for each store slot authorized.
(iii) For counties with WIC participant density less than 25 participants per square mile, there shall be at least 125 WIC participants shopping within 1 mile of the applying store for each store slot authorized.
(c) Authorization process.
(1) If the total number of stores meeting all selection criteria are less than or equal to the total number of store slots assigned to the trade area and there is sufficient WIC participant shopping as defined in subsection (b)(2), all stores meeting the selection criteria shall be authorized to participate in the WIC Program.
(2) If the total number of stores meeting all selection criteria are greater than the total number of store slots assigned to the trade area, the Department will certify or recertify the stores having the lowest weighted prices for the two food prescriptions, until the store slots in the trade area have been filled. For determining the weighted food prices for the two food prescriptions, the Department will add 80% of the total of the store's highest price for Food Prescription One to 20% of the store's highest price for Food Prescription Two.
(3) The criteria in paragraph (2) also apply when more than one store applies for certification or recertification within 1 mile and there is not a sufficient WIC participant shopping as defined in subsection (b)(2) to support an additional WIC authorized store or stores.
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