RULES AND REGULATIONS
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 1101, 1103, 1105, 1107,
1109 AND 1113]
Supplemental Nutrition Program for Women, Infants and Children
[33 Pa.B. 4900]
The Department of Health (Department) adopts amendments to Chapters 1101, 1103, 1105, 1107, 1109 and 1113 to read as set forth in Annex A. This final-form rulemaking governs the authorization, management and appeal rights of stores participating in the Women, Infants and Children (WIC) Program (WIC authorized stores).
A. Purpose and Background
The primary purpose of the final-form rulemaking is to achieve compliance with recent amendments to the Federal regulations governing the WIC Program in 7 CFR Part 246 (relating to supplemental nutrition program for women, infants and children), adopted by the United States Department of Agriculture, Food Nutrition Service (USDA-FNS). The Federal amendments, adopted on December 29, 2000, mandate selection criteria, training requirements, criteria to be used to identify high-risk stores and monitoring requirements, including compliance investigations.
The final-form rulemaking also implements the Department's decision, permitted by Federal regulation, to eliminate the limitation criteria used to limit the number of stores authorized to participate in the WIC Program. Prior to the final-form rulemaking, a store desiring to become a WIC authorized store had to satisfy the selection and limitation criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization). Through the final-form rulemaking, the Department will allow any store that meets the revised selection criteria to participate in the WIC Program. The Department has retained all previous selection criteria with some additions and revisions. The most significant of the revisions is to the manner in which the Department imposes price limitations on foods that may be purchased with WIC checks (allowable foods). Prior to the final-form rulemaking, the Department had maintained limited control on prices for allowable foods by establishing the total maximum allowable cost for two defined ''food prescriptions'' consisting of food items that participants purchase most frequently. The Department has established maximum prices for all allowable foods. Stores are required to have allowable foods available at or below the published prices. Payment by the WIC Program of WIC checks submitted for redemption by WIC authorized stores is limited to no more than the sum total of the maximum prices for each of the WIC food items authorized for purchase on the check.
The Department held a series of meetings for the purpose of soliciting comments from persons affected by the final-form rulemaking. The discretionary changes to the Department's regulations published as proposed rulemaking at 32 Pa.B. 4585 (September 21, 2002) were, to a large measure, the result of the discussions held during these meetings.
The Department's regulations are also a part of the State Plan of Operations required to be submitted to the USDA-FNS under 7 CFR 246.4 (relating to state plan). Therefore, in addition to meeting the Commonwealth's statutory requirements for promulgating regulations, the Department was required to submit changes to its WIC Program regulations to the USDA-FNS for approval. The Department submitted both the proposed and the final-form regulations to the USDA-FNS, which approved the regulations.
The Department published a proposed rulemaking and provided a 30-day public comment period. Additionally, the Department sent out a Retail Store Alert to each local agency WIC director, local agency WIC retail store coordinator and WIC authorized store informing them of the publication of the proposed rulemaking and directing their attention to the revised sections.
The Department received comments to the proposed rulemaking from four commentators. The comments and the Department's responses to the comments appear in the summary of this final-form rulemaking. If a section is not mentioned in the summary, no comments were received on that section and it was adopted as proposed.
One commentator expressed overall support for the stated general purpose of the proposed rulemaking. Additionally, the commentator expressed specific support for the elimination of existing § 1103.4(b) and (c), the imposition of price limitations on all allowable foods in § 1103.4(5), the deletion of references to the appeal rights of local agencies in § 1101.1(b) (relating to background and scope) and Chapter 1113 (relating to store appeals) and the establishment of the Vendor Advisory Workgroup (Workgroup) in § 1101.3(b) (relating to administration).
One commentator expressed agreement with the establishment of the Workgroup in § 1101.3(b) and with § 1103.4(5), which establishes price limitations on WIC allowable foods.
§ 1101.2. Definitions.
One commentator expressed the opinion that all ''onsite reviews'' should be unannounced to achieve the greatest level of compliance with the terms and conditions that govern participation of authorized stores.
The definition of ''onsite review'' states that an onsite review may be announced or unannounced. An onsite review for purposes of store authorization or reauthorization is announced for the reason that the review represents the store's single opportunity to demonstrate understanding and compliance with the criteria governing authorization and reauthorization. Under the final-form rulemaking, failure to demonstrate compliance during the announced onsite review results in denial of the store's application for authorization or reauthorization.
Onsite monitoring reviews are unannounced because the purpose of the monitoring review is to assess compliance with terms and conditions for participation in the WIC Program. If the WIC Program provided notice of the monitoring review, a store routinely not complying with terms and conditions of participation could avoid detection and eventual sanction. For that reason no notice is given. To ensure fairness, the WIC Program does not impose a sanction until at least three monitoring reviews reveal violations of terms and conditions of WIC Program participation. Moreover, the WIC Program notifies the store of the results of each review, gives the store notice that the investigation will continue and imposes training requirements after the second problematic store review. See § 1105.6(b)(3) (relating to monitoring of WIC authorized stores). Unannounced onsite reviews allow the WIC Program to monitor WIC authorized stores for abuse and errors as well as to take corrective action when appropriate as mandated in 7 CFR 246.12(j)(2) (relating to routine monitoring).
§ 1103.4. Selection criteria for authorization and reauthorization.
The Independent Regulatory Review Commission (IRRC) expressed concern that the Department's plan to publish in the Pennsylvania Bulletin the maximum allowable prices for allowable foods quarterly, as provided for under proposed § 1103.4(5), would place an undue burden on stores by requiring them to monitor the Pennsylvania Bulletin to maintain compliance with the WIC Program. IRRC recommended that the information be made available on the Department's website or mailed directly to vendors.
The Department concurs with this suggestion and will inform each WIC authorized store of the maximum allowable prices for WIC allowable foods by mailing the information to the stores prior to publication in the Pennsylvania Bulletin. Section 1103.4(5) has been revised to state that the Department will mail to stores maximum price information for WIC allowable foods.
One commentator expressed concern that an increase in the number of WIC authorized stores as a result of the Department's proposal to eliminate the limitation criteria in § 1103.4(b) and (c), now deleted, would cause an overall increase in the administrative costs associated with mandated onsite reviews. IRRC supported this commentator in its comments and specifically requested that the Department further explain the fiscal impact of this change.
The Department has not revised the final-form rulemaking in response to these comments. The fiscal impact of the increase in store numbers participating in the WIC Program will be neutral for two reasons: (1) while the number of stores participating in the WIC Program and the administrative costs associated with those stores will increase, the total number of onsite store reviews the Department must conduct each year and the costs associated with those reviews will decrease; and (2) the administrative costs associated with the very labor-intensive overcharge recovery system, being replaced by the computer-driven price adjustment system, will be eliminated.
Under prior regulations, WIC authorized stores were reviewed once every 2 years to determine whether the store would continue as a WIC authorized store. Accordingly, the WIC Program conducted onsite reauthorization reviews of 50% of all WIC authorized stores each year. In addition, the WIC Program conducted onsite monitoring reviews in accordance with Federal requirements, of a minimum of 5% of all WIC authorized stores. Therefore, the WIC Program performed onsite reviews of 55% of all WIC authorized stores annually. Under the final-form rulemaking, each WIC authorized store must be reviewed once every 3 years, reducing the number of annual onsite authorization and reauthorization reviews performed by the WIC Program to 34% of all WIC authorized stores. Even considering the Federal monitoring requirement, the overall annual onsite review requirement will be reduced from 55% to 39% of the total number of all WIC authorized stores. The total number of WIC authorized stores would have to increase by 41% before the cost of onsite reviews required under the final-form rulemaking would equal the previous cost of reviews to the WIC Program.
After store reviews, the next highest cost component of the retail store management area of the WIC Program is the overcharge recovery system. Under the overcharge recovery system, all WIC authorized stores are required to submit to the local agency a quarterly price report in which the store lists its highest price during the quarter for each WIC allowable food. WIC Program staff responsible for direct client services have performed the task of manually entering store specific price data, for each WIC authorized store, into the WIC Program's computer data system. The final-form rulemaking replaces the overcharge recovery system with the price adjustment system, which requires no manual input of store specific price data into the computer data system. Therefore, the cost to the Department will remain neutral.
§ 1103.5. Minimum inventory.
The Department has significantly revised proposed § 1103.5. Proposed § 1103.5 listed all foods to which minimum inventory requirements would apply along with exact quantities of the foods that WIC authorized stores would be expected to have on the store premises at all times. Because exact quantities can vary as a result of manufacturer product or packaging changes, the Department determined that the most effective means to identify the minimum inventory requirements of allowable foods adopted by the Department is to publish in the Pennsylvania Bulletin a list of all categories and types of allowable foods for which minimum inventory requirements exist. The list will be published by September 15 of each year and when the Department adopts a revised list. The list will be distributed to all WIC authorized stores at the time of publication of this final-form rulemaking and to any new store when it is authorized to participate in the WIC Program.
The section, as revised, also contains a list of WIC allowable foods for which minimum inventory requirements exist, restricts the minimum inventory requirement of each WIC allowable food to the maximum quantity which could be authorized for one participant for 1 month under 7 CFR 246.10 (relating to supplemental foods), contains a provision for exceptions to the minimum inventory requirements, contains a list of WIC allowable foods for which exceptions may apply and defines when an exception to the minimum inventory requirements expires. Also, as a consequence of the elimination of the list of specific minimum inventory requirements in § 1103.5, the Department has eliminated the reference to the list of minimum inventory requirements in § 1103.4(5).
§ 1103.7. Inadequate participant access.
One commentator expressed concern that the effect of the Department's decision to delete § 1103.7(c)(5)--(7) (relating to inadequate participant access) would be to narrow the definition of ''inadequate participant access'' which might have an adverse impact on participant access to the supplemental foods the WIC Program provides.
Adequate participant access is a fundamental concern for the Department. The purpose of § 1103.7(c)(5)--(7) was to reduce for the WIC Program the administrative burden associated with the transfer of a large number of participants to another store in the context of a denial of reauthorization of a store or a store's disqualification for violation of the terms and conditions that govern participation in the program. Deletion of the paragraphs has no substantive impact on participant access decisions, which are driven by numerous factors. Before denying authorization to a store or disqualifying a store from the WIC Program, the Department gives consideration to availability of public transportation, the proximity of other WIC authorized stores in relation to the number of WIC participants, special dietary needs or ethnicity of participants, existence of physical barriers or other conditions which make access for participants to another WIC authorized store impractical and whether or not there are participants with physical disabilities that cannot be accommodated by another WIC authorized store. By considering all of these factors, and with the increase in the number of WIC authorized stores as a result of the elimination of limitation criteria, the Department is able to ensure adequate participant access to WIC authorized stores that offer a sufficient inventory of fresh WIC allowable foods to meet the nutritional needs of the WIC participants. The Department has not changed the final-form rulemaking in response to this comment.
§ 1107.1. Imposition of sanctions.
Section 1107.1(d)(2), (5), (6), (11) and (12) (relating to imposition of sanctions), as proposed, would have allowed for a 1-year disqualification for the following violations of the terms and conditions governing participation in the WIC Program: providing an allowable food in excess of the amount authorized for purchase on the WIC check (proposed subsection (d)(2)), failing to request a WIC identification card prior to accepting a WIC check (proposed subsection (d)(5)), accepting a WIC check made payable to another store without prior written approval from the Department (proposed subsection (d)(6)), securing the signature of the participant or authorized representative prior to completing the ''Pay Exactly'' box on the WIC check (proposed subsection (d)(11)) or charging the WIC Program sales tax (proposed subsection (d)(12)). The USDA-FNS commented that 7 CFR 246.12(l)(1)(i)(iv) require a state agency to disqualify a store from participation in the WIC Program after a pattern of each of the previous violations of the terms and conditions governing participation in the WIC Program. The Department revised proposed § 1107.1(d)(2), (5), (6), (11) and (12) to require a pattern before the State agency may impose a 1-year term of disqualification. Subsection (d)(2), (5), (6), (11) and (12) now state that the State agency will disqualify a store for having committed two or more incidences of any of the specific violations.
§ 1113.2. Administrative appeal procedures.
The Department has revised proposed § 1113.2 (relating to administrative appeal procedures). Proposed § 1113.2 provided that an administrative appeal had to be filed within 30 days after the effective date of the adverse action. According to 7 CFR 246.18(a)(2) (relating to effective date of adverse actions against vendors), the Department must set the effective date of denials of authorization and disqualifications (other than those imposed under 7 CFR 246.12(l)(1)(i)) no earlier than 15 days and no later than 90 days after the date of the notice of the adverse action.
Additionally, 7 CFR 246.18(b)(2) provides that the Department must give an authorized store or local agency the opportunity to appeal an adverse action within a time period specified by the Department in its notification of the adverse action. Prior to the proposed rulemaking, the Department defined the time period for allowance of appeal of an adverse action as 30 days from the date that the Department mailed the notice of adverse action.
Due to the mandatory time period of at least 15 days between the notice of an adverse action and the effective date of that action required under 7 CFR 246.18(a)(2), the language in the regulations as proposed allowed for, at a minimum, a 45-day time period between the date when the Department mailed a notice of an adverse action and expiration of the 30-day time period allowed for any resulting notice of appeal.
The Department has determined that the long standing time period of 30 days from the date a notice of adverse action is mailed is sufficient for an authorized store or local agency to file an appeal. As a result, in the final-form rulemaking, the Department has revised the language of § 1113.2 to state that an authorized store or local agency may appeal an adverse action within 30 days from the date the Department mailed the notice of the adverse action.
C. Fiscal Impact
The WIC Program is 100% Federally funded. No State dollars are involved in the operation of the WIC Program. The amendment to § 1103.3 (relating to temporary authorization), regarding authorization of stores, eliminating provisions regarding store slots and competition for those slots based upon prices, in and of itself, has the potential for increasing dramatically the number of stores that may be authorized to participate in the WIC Program. Through introduction of provisions regarding maximum allowable prices for all WIC allowable foods, however, the Department hopes to realize two objectives: (1) to keep the number of stores applying for authorization within reasonable limits; and (2) to achieve savings in foods costs that may translate into the additional administrative dollars needed to monitor the additional stores. Other aspects of the final-form rulemaking, such as deletion of the provisions that imposed limitations on the number of store slots available, deletion of the provisions requiring store input and WIC Program collection of quarterly prices from each retail store, as well as the decrease in the annual onsite review requirement will generate program savings. Overall, the Department anticipates the fiscal impact of the final-form rulemaking to be neutral.
D. Paperwork Requirements
The final-form rulemaking will not increase paperwork for WIC Program participants or those grocery stores voluntarily participating in the WIC Program. The increase in the Department's paperwork requirements that will result from the increase in the number of authorized stores will be offset by the decrease in paperwork associated with identifying, based on price calculations, which stores will be awarded available store slots. Paperwork requirements also will decrease as a result of the elimination of the overcharge recovery system and less frequent annual onsite review requirements. Moreover, the Department anticipates fewer appeals by stores denied authorization. Only stores failing to meet selection criteria will be denied authorization and reauthorization and, through temporary authorization, stores may have more than one opportunity to meet selection criteria.
E. Effective Date/Sunset Date
The final-form rulemaking will become effective upon final publication in the Pennsylvania Bulletin. The final-form rulemaking 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 WIC 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. The Women's, Infants' and Children's Nutrition Improvement Act (62 P. S. §§ 2951--2955) 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 State regulations governing the WIC Program were published at 29 Pa.B. 3841 (July 24, 1999), following the decision of the Commonwealth Court in Giant Food Stores, Inc. v. Commonwealth of Pennsylvania, Department of Health, 713 A.2d 177 (Pa. Cmwlth. 1998). The Commonwealth Court 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 (relating to supplemental nutrition program for women, infants and children (WIC program)). The regulations also deleted §§ 8.41--8.74, the Department's then existing regulations pertaining to WIC Program administrative appeals.
The final-form rulemaking is promulgated under section 2102(g) of The Administrative Code of 1929 (code) (71 P. S. § 532(g)), which provides the Department general power to promulgate regulations to carry out its duties. Section 2102(a) of the code gives the Department the authority and duty to protect the health of the people of this Commonwealth and the Giant supra. decision.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on September 11, 2002, the Department submitted a copy of the notice of proposed rulemaking, published at 32 Pa. B. 4585, to IRRC and the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on August 13, 2003, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on August 14, 2003, and approved the final-form rulemaking. The Attorney General approved the final-form rulemaking on September 4, 2003.
H. Contact Person
Questions regarding the final-form rulemaking may be submitted to Greg Landis, Chief, Grants and Retail Store Management Unit, WIC Program, Room 604, Health and Welfare Building, Harrisburg, PA 17108, (717) 783-1289. Persons with a disability may submit questions in alternative formats such as audio tape or Braille or by using V/TT, (717) 783-6514 for speech or hearing impaired persons or the Pennsylvania AT&T Relay Service, (800) 654-5984 (TT). Persons who require an alternative format of this document (that is, large print, audio tape or Braille) should contact Greg Landis at the previous address or telephone numbers to make necessary arrangements.
The Department finds that:
(1) Public notice of the intention to adopt the amendments 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 the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) The adoption of the final-form rulemaking in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutes.
The Department, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 28 Pa. Code Chapters 1101, 1103, 1105, 1107, 1109 and 1113, are amended by amending §§ 1101.1--1101.3, 1103.1--1103.5, 1103.7, 1105.1--1105.6, 1107.1, 1107.1a, 1107.2, 1109.2 and 1113.1--1113.5 and by deleting § 1103.6 to read as set forth in Annex A.
(b) The Secretary shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.
(c) The Secretary 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.
(d) The Secretary shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect upon publication in the Pennsylvania Bulletin.
CALVIN B. JOHNSON, M.D., M.P.H.,
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 33 Pa.B. 4372 (August 30, 2003).)
Fiscal Note: Fiscal Note 10-169 remains valid for the final adoption of the subject regulations.
TITLE 28. HEALTH AND SAFETY
PART VIII. SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN (WIC PROGRAM)
CHAPTER 1101. GENERAL PROVISIONS
§ 1101.1 Background and scope.
(a) Background. Through an amendment to section 17 of the Child Nutrition Act of 1966 (42 U.S.C.A. § 1786), Congress has authorized the USDA-FNS to contract with state agencies for the establishment of the WIC Program. The USDA-FNS contracts with and makes funds available to the Department to administer the WIC Program in this Commonwealth.
(1) The purpose of the WIC Program is to provide allowable foods to income eligible pregnant, breast-feeding or postpartum women, infants and children up to 5 years of age, who are at nutritional risk because of medical problems or poor diets. The WIC Program provides these individuals with nutritious foods to supplement their diets during critical stages of growth and development. These foods are chosen to correct, prevent or minimize health and nutritional problems. The foods are not intended to be a complete diet, but, rather, to supplement other foods available to the participants.
(2) In addition to providing supplemental foods, the WIC Program refers applicants and participants to health services and offers nutrition education so that the food will be properly used and will improve the dietary and health habits of the entire family. The Department uses a retail purchase system to provide the majority of food benefits to participants.
(b) Scope. This part establishes design and operational requirements for the food delivery system for the WIC Program, and prescribes procedures to be used by applicants, participants and stores to appeal actions of the Department and local agencies that may adversely impact upon them.
§ 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.
Authorization--The grant of authority to a store to serve as a WIC authorized store.
(i) For an applicant or participant, a parent or guardian of an applicant or participant who is an infant or child, a proxy or endorser, or an individual designated to represent the applicant or participant in administrative proceedings involving the WIC Program.
(ii) For a store, an individual designated by the store to represent it in administrative proceedings involving the WIC Program.
(iii) For a compliance buy or WIC transaction review, the person conducting the compliance buy or WIC transaction review.
Breastfeeding woman--A woman, during 1 year postpartum, who is breastfeeding her infant.
Certification--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.
Claim--A demand for reimbursement of an overcharge or other improper charge to the WIC Program as a result of a store violation.
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--
(i) 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.
(ii) 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.
Contract brand--The specific manufacturer brand of an allowable food that the Department is contractually bound to prescribe for participants.
Department--The Department of Health of the Commonwealth.
(i) 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.
(ii) For purposes of Chapter 1111, 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, or by complaints of participants or WIC Program staff.
Infant--A person under 1 year of age.
Inventory audit--A comparison of a WIC authorized store's inventory levels of a particular allowable food over a specific period of time, to purchases of the allowable food with WIC checks during the same period of time, to determine if the store had a quantity of the allowable food available for sale during that time sufficient to support its claim for reimbursement for the sale of the allowable food.
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.
Maximum allowable price--The maximum price the Department will pay for an allowable food.
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--A visit to a store by Federal, Department or local agency personnel to determine if the store meets the selection criteria necessary to be a WIC authorized store, or a visit to a WIC authorized store to determine whether the store is complying with this part governing the store's participation in the WIC Program. An onsite review may be announced or unannounced.
Overcharge--A charge by a WIC authorized store to the WIC Program through redemption of a WIC check for an allowable food in excess of the store's shelf price for that food or in excess of the price charged a non-WIC participant for that food.
Overpayment--Payment to a WIC authorized store of a WIC check redeemed by the store in an amount in excess of the amount to which the store was entitled based upon the maximum allowable price of each allowable food authorized for purchase on the WIC check.
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.
Periodic review--Contemporaneous announced onsite reviews of stores in a trade area conducted not less than once every 3 years to select stores for reauthorization.
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 WIC authorized store.
Price adjustment--The retroactive reduction in the amount paid for a redeemed check as a result of a determination of overpayment.
Probationary authorization--The Department's probationary authorization of a WIC authorized store when inadequate participant access would occur if the store were not authorized or reauthorized or when the store is reviewed prior to opening to the public and has not yet stocked its dairy section or its frozen juice section.
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.
Reauthorization--The Department's renewal of authorization.
Redemption--Submission of a WIC check by a WIC authorized store to its bank for the purpose of securing a money payment for the amount appearing in the ''Pay Exactly'' box on the WIC check.
Routine review--An unannounced onsite review of a WIC authorized store to evaluate adherence by the store with the requirements in this part governing the store's participation in the WIC Program.
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.
(i) 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.
(ii) The term does not include a decision to deny authorization or reauthorization following an announced onsite review.
Secretary--The Secretary of the Department.
Selection criteria--Criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization) which the Department has established which a store seeking to be authorized or reauthorized is required to satisfy.
Stale-dated--After the date imprinted on the product as the recommended last date for sale or use.
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.
Store violation--Intentional or unintentional action by the owners, officers, managers, agents or employees of a WIC authorized store that violates the requirements in this part governing the store's participation in the WIC Program and that may result in a claim.
Temporary authorization--The Department's temporary and conditional authorization of a WIC authorized store that fails to meet specified selection criteria during the initial onsite review for purpose of reauthorization.
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.
USDA-FNS--The United States Department of Agriculture, Food and Nutrition Service.
WIC authorized store--A retail food store which is authorized or reauthorized in accordance with § 1103.1 (relating to authorization and reauthorization process and requirements) 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 and verification of eligibility 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.
WIC transaction--The presentation of a WIC check by a participant or authorized representative to a WIC authorized store resulting in the purchase of one or more of the allowable foods designated on the check.
WIC transaction review--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 the requirements in this part governing the store's participation in the WIC Program.
§ 1101.3. Administration.
(a) Department responsibilities. The Department will develop policies and procedures for the operation of the WIC Program, distribute funds to local agencies to assist the Department in operating the WIC Program, authorize stores to participate in the WIC Program, monitor and evaluate WIC Program services provided by WIC authorized stores, maintain fiscal records, submit reports and carry out all other responsibilities delegated to it by the USDA-FNS for the operation of the WIC Program.
(b) Vendor Advisory Workgroup. The Department will form a Vendor Advisory Workgroup with representation from the retail store community, appropriate advocacy groups and associations for retail stores and participants, and from the State and local agencies. The Department will schedule at least two meetings of the Vendor Advisory Workgroup annually to review and discuss retail store and food delivery issues. The Vendor Advisory Workgroup shall function in an advisory capacity only; acceptance of Workgroup recommendations shall be at the discretion of the Department.
(c) Local agency responsibilities. Local agencies shall determine whether participants meet eligibility criteria developed by the Department, develop food prescriptions for participants, provide nutrition education to participants, provide referral information regarding ongoing health services, issue WIC checks to participants to purchase allowable foods and ensure that all participants are served without discrimination. Local agencies shall function as representatives of the Department in conducting onsite reviews, and in monitoring the activities of WIC authorized stores.
CHAPTER 1103. AUTHORIZATION OF STORES
§ 1103.1. Authorization and reauthorization process and requirements.
(a) Duration of authorization or reauthorization. To serve as a WIC authorized store, a store shall be authorized in accordance with subsection (b) or reauthorized in accordance with subsection (c). A store's authorization or reauthorization shall remain in effect until the Department acts on the store's application for reauthorization when the next periodic review is conducted in the trade area in which the store is located, unless terminated earlier in accordance with subsection (d). At least once every 3 years, the Department will conduct a periodic review in each trade area. Failure to submit an application for reauthorization as prescribed under subsection (c) shall result in expiration of the store's authorization or reauthorization. The Department will provide 30 days written notice to the store prior to expiration of authorization or reauthorization for any store failing to submit an application. A store that has received a letter of authorization dated less than 60 days prior to the date of the notice of the periodic review in the store's trade area shall be exempt from the periodic review.
(b) Authorization process.
(1) The store's representative shall contact the local agency responsible for the trade area where the store is located to request an application for authorization. The local agency shall send WIC Program information and an application for authorization to the store. The store shall complete the application for authorization and return it to the local agency.
(2) The Department will refuse to accept an application from a store if the store has been provided notice of disqualification or is disqualified from the WIC Program, if the Department determines that the store relocated or effected a change of ownership to avoid a disqualification, or if the store has been denied authorization or reauthorization and is not eligible to apply for authorization.
(3) The Department will not accept an application for authorization less than 90 days prior to the scheduled start date of the periodic review in that trade area unless the Department finds that there would be inadequate participant access, as set forth in § 1103.7 (relating to inadequate participant access), if it does not consider the application.
(4) If the store's application for authorization is accepted, the local agency shall schedule, as expeditiously as possible, an announced onsite review of the store to determine if the store meets the selection criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization). The local agency shall notify the store in advance of the approximate date of the review.
(5) The local agency shall conduct the onsite review and forward the results to the Department for a decision on the store's application.
(6) The Department will deny the application if the selection criteria in § 1103.4 are not satisfied, unless the Department grants probationary authorization under § 1103.2 (relating to probationary authorization). The Department will notify the store in writing whether the store's application for authorization is granted or denied. If the Department denies the application for authorization, the store shall be eligible to reapply for authorization 6 months after the effective date of the denial.
(c) Reauthorization process.
(1) The Department will include an application for reauthorization with the notice of periodic review it sends to the store. The local agency will collect the application for reauthorization at the time of the announced onsite review of the store to determine if the store meets the selection criteria in § 1103.4. The local agency shall notify the store in advance of the approximate date of the review.
(2) The local agency shall conduct the onsite review and forward the results to the Department for a decision on the store's application.
(3) The Department will deny the application without advance warning if the selection criteria in § 1103.4 are not satisfied, unless the store requests and the Department grants temporary authorization in accordance with § 1103.3 (relating to temporary authorization) or the Department grants probationary authorization in accordance with § 1103.2. The Department will notify the store in writing whether the store's application for reauthorization is granted or denied. If the Department denies the application for reauthorization, the store shall be eligible to apply for authorization 6 months after the effective date of the denial. If the Department grants and later rescinds temporary authorization, the store shall be eligible to apply for authorization 1 year from the date of the first onsite review for reauthorization.
(d) Termination of authorization or reauthorization. The Department will terminate a store's authorization or reauthorization if:
(1) The store has been disqualified.
(2) The store supplied false information in the application for authorization or reauthorization.
(3) The store is not serving at least 25 participants 8 months following authorization.
(4) Ownership of the store changes.
(5) The store relocates in excess of 1 mile of its current location and to a geographical area assigned to another local agency.
(6) The store closes for more than 3 business days and does not notify the Department.
§ 1103.2. Probationary authorization.
(a) Criteria for probationary authorization. If during the onsite review, the store fails to meet selection criteria in § 1103.4(3), (4), (5), (6), (7) or (8) (relating to selection criteria for authorization and reauthorization), the Department will grant probationary authorization 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 authorized or reauthorized.
(2) A store is reviewed prior to opening to the public and the store has not yet stocked its dairy section or its frozen juice section.
(b) Reviews during probationary authorization period. If a store receives probationary authorization, the Department will conduct an unannounced onsite review during the probationary authorization period to determine whether the store is in compliance with selection criteria in § 1103.4 . The Department will rescind probationary authorization 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, unless extension is required under subsection (c). The Department will grant authorization or reauthorization, as applicable, if the store meets all selection criteria during the second onsite review.
(c) Extension of probationary authorization. If the store fails the review conducted during the probationary authorization period, and inadequate participant access exists as determined by the Department, the Department will extend probationary authorization 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 authorization reviews. The Department will conduct an unannounced onsite review during the extended probationary authorization period after the store representative has attended corrective training, to determine whether the store is in compliance with the selection criteria in § 1103.4. The Department will rescind probationary authorization 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. The Department will grant authorization or reauthorization, as applicable, if the store meets all selection criteria during the third and final unannounced onsite review.
(e) Rescission of probationary authorization. If the Department rescinds the probationary or extended probationary authorization of a store, the store is eligible to apply for authorization 6 months from the date of the Department's rescission of probationary or extended probationary authorization.
§ 1103.3. Temporary authorization.
(a) Failure to meet selection criteria during onsite review. If a WIC authorized store that applies for reauthorization fails to meet one or more of the selection criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization) during the announced onsite review, the store may request temporary authorization, except that a store that fails to meet the price and minimum inventory requirements of § 1103.4(5) shall be ineligible for temporary authorization. A store that is a high risk store or the subject of an ongoing compliance investigation also shall be ineligible for temporary authorization.
(b) Conditions of temporary authorization. Temporary authorization shall be conditioned upon the following:
(1) The Department will conduct a second announced onsite review during the temporary authorization period to determine whether the store is in compliance with the selection criteria in § 1103.4. The Department will grant reauthorization if the store meets all selection criteria during this review. The Department will rescind temporary authorization and deny the store's application for reauthorization if the store fails to meet one or more of the selection criteria during the second review.
(2) If the Department rescinds the temporary authorization of a store, the store is eligible to apply for authorization 1 year after the date of the first onsite review that was conducted following the Department's receipt of the store's application for reauthorization.
(3) The Department will reduce by 10% the maximum allowable prices for foods authorized for purchase on WIC checks the store redeems for WIC transactions that occur during the first 90 days of the temporary authorization period.
§ 1103.4. Selection criteria for authorization and reauthorization.
The Department will use the following selection criteria to identify stores that meet the operational criteria to serve as a WIC authorized store:
(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) A store seeking reauthorization shall serve at least 25 participants per month. The Department will deny reauthorization 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 onsite review for reauthorization is conducted.
(3) The store shall have allowable foods properly stored and refrigerated.
(4) The store may 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 of allowable foods as established by the Department under § 1103.5 (relating to minimum inventory) at shelf prices that are equal to or less than the maximum allowable prices for those foods. The Department will publish in the Pennsylvania Bulletin and mail to all WIC authorized stores, quarterly, the maximum allowable prices for allowable foods for the next quarter.
(6) The store shall be open for business and able to serve participants at least 8 hours per day, 6 days per week.
(7) The store shall be sanitary. There may not be unremoved rubbish, vermin, or general lack of cleanliness.
(8) The store shall operate in a permanent fixed location where participants may purchase allowable foods with their WIC checks.
(9) If the store has been denied authorization or reauthorization within the past 12 months, the store must be eligible to apply for authorization under § 1103.1(b) or (c) or § 1103.3(b)(2) (relating to authorization and reauthorization process and requirements; and temporary authorization).
(10) The store may not be currently disqualified from participation in the Food Stamp Program or have been assessed a civil money penalty in lieu of a disqualification from the Food Stamp Program that, had it been imposed, would not yet have expired.
(11) The store may not be currently disqualified from the WIC Program.
(12) The store shall have implemented all required corrective actions resulting from monitoring by the Department, including reimbursement of any overcharges or overpayments, and shall be in compliance with the applicable Federal and State regulations.
(13) None of the store's current owners, officers, or managers shall have been convicted of or had a civil judgment entered against them for conduct demonstrating a lack of business integrity.
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