# COMAR Title 10 — Maryland Department of Health ## Subtitle 54 — Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) ### Chapter 01 — Eligibility, Participation, and Benefits **Authority:** Health-General Article, §18-107(a), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.12 adopted as an emergency provision effective February 21, 1986 (13:6 Md. R. 670); emergency status expired May 31, 1986 **Administrative History:** Regulations .01—.12 adopted as an emergency provision effective June 4, 1986 (13:13 Md. R. 1477); adopted permanently effective October 20, 1986 (13:21 Md. R. 2321) **Administrative History:** Regulation .03 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214) **Administrative History:** Regulation .03B amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .04 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214) **Administrative History:** Regulation .04B amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .06C, E amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .07 amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .09D amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .10 amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulations .01—.12 repealed and Regulations .01—.24 adopted effective March 25, 1996 (23:6 Md. R. 476) **Administrative History:** Regulation .02A amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .03 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 494) **Administrative History:** Regulation .04 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 494); May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .05B amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .06B, C amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .07 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .07D amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Regulation .07E amended effective April 16, 2012 (39:7 Md. R. 494) **Administrative History:** Regulation .08 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .09 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .10 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .10A, B amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .11 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .11 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .12A, G amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .13 amended as an emergency provision effective January 15, 2002 (29:3 Md. R. 214); amended permanently effective May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .13 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .14A, B, C amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .15A amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .16 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .17 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .18 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .19 amended effective March 31, 2014 (41:6 Md. R. 380); May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .20C, D amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .22 amended effective May 18, 2020 (47:10 Md. R. 519) #### Regulation .01 Scope. *COMAR 10.54.01.01* This chapter specifies the eligibility policies and procedures and the benefits available under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC Program or Program) operated by the Maryland Department of Health, with funding substantially provided by the United States Department of Agriculture (USDA) under the Child Nutrition Act of 1966, §17, as amended. #### Regulation .02 Purpose. *COMAR 10.54.01.02* A. The WIC Program provides supplemental foods and nutrition education, including breastfeeding promotion and support: (1) Through local agencies at no cost to eligible individuals; and (2) To pregnant women, postpartum women, breastfeeding women, infants, and children, who are from families with income below a certain established amount and who are determined by a competent professional authority or a competent paraprofessional authority to be at risk with respect to their physical and mental health by reason of inadequate nutrition or health care, or both. B. The WIC Program serves as an adjunct to good health care during critical times of growth and development in order to prevent health problems and improve the health status of participants. #### Regulation .03 Incorporations by Reference. *COMAR 10.54.01.03* In this chapter, the following are incorporated by reference: A. 42 U.S.C. §1786, as amended; B. 7 CFR 246, as amended; and C. 7 CFR 15, 15a, and 15b, as amended. #### Regulation .04 Definitions. *COMAR 10.54.01.04* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who has requested or on whose behalf another person has requested WIC benefits in person, either orally or in writing, under the provisions of this chapter. (2) “Benefits” means the foods prescribed and services provided to a participant by the Program. (3) “Breastfeeding woman” means a woman up to 1 year postpartum who is breastfeeding her infant. (4) “Caretaker” means an individual who is responsible for the care and welfare of a participant. (5) “Caseload” means the participation level that is assigned to a local agency by the State agency. (6) “Certification” means the implementation of criteria and procedures to assess and document an applicant's eligibility for the Program. (7) “Certification period” means the time period for which a participant has been authorized by a local agency as eligible for Program benefits. (8) “Child” means an individual who is 1 year old or older but is younger than 5 years old. (9) “Clinic” means a local agency facility where an applicant is certified. (10) “Competent paraprofessional authority” means an individual who: (a) Does not meet the definition of a competent professional authority; (b) Successfully completes a WIC training program approved by the State agency; and (c) Performs certifications under the supervision of a competent professional authority. (11) Competent Professional Authority. (a) “Competent professional authority” means an individual who is a: (i) Physician; (ii) Nutritionist; (iii) Dietitian; (iv) Registered nurse; (v) Physician's assistant certified by the National Committee on Certification of Physician's Assistants or certified by the State Board of Physician Quality Assurance; or (vi) State or local medically trained health official. (b) “Competent professional authority” includes an individual who is: (i) On the staff of the local agency and authorized by the State agency to serve as a competent professional authority; or (ii) Not on the staff of the local agency, but who is qualified to provide data upon which a nutritional risk determination is made by a competent professional authority on the staff of the local agency. (12) “Complementary feeding process” means a nutrition risk that applies to an infant or a child from 4 through 23 months old who has begun to or is expected to begin to: (a) Consume foods or beverages complementary to breast feeding; (b) Eat independently; (c) Be weaned from breast milk or infant formula; or (d) Transition from a diet specifically intended for infants or toddlers to one based on the Dietary Guidelines for Americans, as updated every 5 years by the United States Department of Agriculture with the United States Department of Health and Human Services under Title III of Public Law 101-445 of the National Nutrition Monitoring and Related Research Act of 1990. (13) “Day” means a calendar day. (14) “Disqualification” means the act of ending the Program participation of a participant, whether as a punitive sanction or for administrative reasons. (15) “Dual participation” means an individual's simultaneous participation in the WIC Program in more than one state, local agency, or clinic, or participation in the WIC Program and in the Commodity Supplemental Food Program funded by the USDA during the same period of time. (16) “Family” means a group of related or nonrelated individuals who are not residents of an institution but who are living together as one economic unit, except that residents of a homeless facility or an institution may not all be considered as members of a single family. (17) “Food delivery system” means the method used by a local agency to provide supplemental foods to a participant. (18) “Food instrument” means an electronic benefits transfer (EBT) card or other document that is used by a participant to obtain supplemental foods. (19) “Health services” means ongoing, routine, pediatric, and obstetric care or referral for treatment. (20) “HHS” means the United States Department of Health and Human Services. (21) Income. (a) “Income” means gross cash income before deductions for: (i) Income taxes; (ii) An employee's Social Security taxes; (iii) Insurance premiums; (iv) Bonds; (v) Housing subsidy in the form of cash or stipend; or (vi) Cash food subsidy. (b) “Income” includes: (i) Monetary compensation for services, including wages, salary, commissions, or fees; (ii) Net income from farm and nonfarm self-employment; (iii) Social Security benefits; (iv) Dividends or interest on savings or bonds, income from estates or trusts, or net rental income; (v) Public assistance or welfare payments; (vi) Unemployment compensation; (vii) Government civilian employee or military retirement pensions, or veterans' payments; (viii) Private pensions or annuities; (ix) Alimony or child support payments; (x) Regular contributions from individuals not living in the household; (xi) Net royalties; (xii) Other cash income, which includes, but is not limited to, cash amounts received or withdrawn from any source including savings, investments, trust accounts, and other resources that are readily available to the applicant or the applicant's family; or (xiii) Cash contributions from others residing in the same living quarters as the applicant. (c) “Income” does not include payments or benefits excluded under 7 CFR §246.7(d)(2)(iv). (22) “Infant” means an individual younger than 1 year old. (23) “Instream migrant” means a migrant farm worker or an individual accompanying a migrant farm worker who is traveling and currently employed or seeking employment in seasonal agricultural work that causes the migrant to move from the migrant's home. (24) “Local agency” means a public or private, nonprofit health or human service agency that provides health services, either directly or through contract. (25) “Migrant farm worker” means an individual: (a) Whose principal employment is in agriculture on a seasonal basis; (b) Who has been employed in agriculture on a seasonal basis within the last 24 months; and (c) Who establishes, for the purpose of employment in agriculture on a seasonal basis, a temporary home. (26) “Nutritional risk” means: (a) Detrimental or abnormal nutritional conditions detectable by biochemical or anthropometric measurements; (b) Other documented nutritionally related medical conditions; (c) Dietary deficiencies that impair or endanger health; (d) Conditions that directly affect the nutritional health of an individual, including alcoholism or drug abuse; or (e) Conditions that predispose individuals to inadequate nutritional patterns or nutritionally related medical conditions, including but not limited to homelessness and migrancy. (27) “Nutrition education” means individual or group education sessions and the provision of information and educational materials designed to improve health status, achieve positive change in dietary and physical activity habits, and emphasize relationships between nutrition, physical activity, and health, all in keeping with the individual's personal and cultural preferences. (28) “Nutritionist” means an individual licensed in Maryland who has a bachelor's or master's degree in nutritional sciences, community nutrition, clinical nutrition, dietetics, public health nutrition, or home economics with an emphasis in nutrition. (29) “Participant” means a pregnant woman, breastfeeding woman, postpartum woman, infant, or child who is receiving benefits under the Program, and the breastfed infant of a breastfeeding woman participant. (30) “Participation” means receiving benefits under the Program. (31) “Participation data” means information concerning the number of: (a) Individuals who received benefits during a reporting period; (b) Infants who received no benefits during a reporting period, but who were breastfed by participant breastfeeding women; and (c) Breastfeeding women who did not receive benefits but whose infant received benefits during the reporting period. (32) “Postpartum woman” means a woman up to 6 months after the termination of her pregnancy. (33) “Poverty income guidelines” means the poverty income guidelines prescribed and adjusted annually by HHS. (34) “Pregnant woman” means a woman who is determined to have one or more embryos or fetuses in utero. (35) “Program” means the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) authorized by 42 U.S.C. §1786, the Child Nutrition Act of 1966, as amended. (36) “Proxy” means an individual who is designated by a participant or a child or infant participant’s parent, guardian, or caretaker to receive food instruments and to redeem food benefits for the participant and whose name is on file at the local agency. (37) “Special nutritional risk applicant” means a migrant farmworker or a migrant farmworker's family, a pregnant woman, or an infant. (38) “State agency” means the Maryland Department of Health's WIC Program. (39) “Supplemental foods" means those foods containing nutrients determined to be beneficial for a pregnant woman, breastfeeding woman, postpartum woman, infant, or child, as prescribed by the Secretary of the USDA under 7 CFR §246.10, which is incorporated by reference in Regulation .03 of this chapter. (40) “USDA” means the United States Department of Agriculture. (41) “Verification of certification” means a document that provides proof of Program eligibility for the participant who is transferring from one WIC agency to another. #### Regulation .05 Eligibility Criteria. *COMAR 10.54.01.05* A. An applicant shall be certified as eligible before participating in the Program. B. To be certified as eligible for the Program, an infant, a child, or a pregnant, postpartum, or breastfeeding woman: (1) Shall reside, without regard to the length of residency, within the jurisdiction of: (a) Maryland, unless a reciprocal agreement has been established with another State agency; and (b) The local agency as defined by the State agency; (2) Shall present documentation of identity for the application for benefits; (3) Shall be determined by the local agency to be income eligible pursuant to the specifications set forth in Regulation .07 of this chapter; (4) Shall be at nutritional risk pursuant to the specifications set forth in Regulation .08 of this chapter; and (5) May not engage in dual participation. #### Regulation .06 Residency Eligibility Determination Process. *COMAR 10.54.01.06* A. In order to be eligible for WIC benefits, an applicant shall provide to a local agency documentation of Maryland residency, or residency in a state having a reciprocal residency agreement with Maryland. B. Documentation. In order to document residency, an applicant shall provide to the local agency one of the following: (1) Dated correspondence documenting the applicant’s home address; (2) Maryland driver's license or identification card; (3) In the case of an applicant who was a prior participant, documentation that the applicant still resides at the same address that is on file with the WIC Program; or (4) Another item that confirms the residency of the applicant. C. Recording of Residency Documentation. A local agency shall document proof of residency. #### Regulation .07 Income Eligibility Determination Process. *COMAR 10.54.01.07* A. Determining Income. (1) In order to determine whether an applicant is income-eligible for Program participation, a local agency shall determine the applicant's income, which is determined pursuant to family size as set forth in §B of this regulation. (2) Subject to the provisions of this regulation, a local agency shall determine an applicant’s income by adding together the sources of income for an applicant and the applicant’s family. (3) In determining an applicant’s family income, a local agency shall consider the family’s income to be the more accurate figure between the family’s income for the previous 12 months or the family’s current rate of income for the last 30 days. (4) If an applicant meets the income eligibility guidelines, a local agency shall declare the applicant income-eligible for WIC benefits based on the applicant's family income. (5) An applicant shall provide to the local agency documentation of the applicant's family income, as set forth in §E of this regulation. B. In order to determine whether an applicant is income-eligible for Program participation, a local agency shall determine the size of the applicant's family according to the following: (1) In the case of a pregnant woman, the unborn child or children are counted only if this action allows the woman to meet income eligibility standards; (2) An infant or child is counted in the family size of the parent, caretaker, or guardian with whom the infant or child resides; (3) An infant, child, or other family member residing in a school or institution is counted in the family size of the parent, caretaker, or guardian who is providing economic support for that infant, child, or family member; (4) An infant or child who is a foster child living with a family, but who remains the legal responsibility of a welfare or other agency, is counted as a family of one and payments made by the agency or other sources to the family for the care of that foster child are the income of that foster child; and (5) An adopted child or individual for whom a family member has accepted legal responsibility is counted in the family size for that family with whom the individual resides. C. Recording of Income Information. (1) A local agency shall document proof of income. (2) If an applicant claims to have no income, the applicant shall complete the form provided by the State agency declaring zero income. D. Determining Income Eligibility. (1) After a local agency has recorded the family size information of an applicant, the local agency shall determine whether the applicant is income-eligible for Program participation. (2) To be considered eligible for the Program, an applicant and the applicant’s family shall have a gross income that is less than or equal to 185 percent of the poverty income guidelines issued by HHS, or shall provide documentation that the applicant is a recipient of: (a) Food stamps under the Food Stamp Act of 1977; (b) Benefits under Maryland's Temporary Cash Assistance program established under Part A of Title IV of the Social Security Act; (c) Medical Assistance Program under Title XIX of the Social Security Act; or (d) Another State-administered program that routinely requires documentation of income, if the program has income eligibility guidelines at or below the WIC Program's income guidelines. (3) A local agency shall determine an applicant to be automatically income-eligible for the WIC Program if a member of the applicant’s family is: (a) Receiving benefits under Maryland's Temporary Cash Assistance program; or (b) A pregnant woman or an infant currently participating in the Medical Assistance Program under Title XIX of the Social Security Act. (4) A local agency shall use the current poverty income guidelines issued by HHS and transmitted by the State agency in determining applicant eligibility. (5) The State agency shall adjust the Program income eligibility guidelines annually at the time the State implements income eligibility guidelines under the Medical Assistance Program. (6) Instream Migrant Farm Worker. A local agency shall consider that: (a) An instream migrant farm worker applicant or the family of an instream migrant farm worker applicant with an expired verification of certification is income-eligible for Program certification if the instream migrant farm worker’s family income was determined at least once within the past 12 months; and (b) A member of an instream migrant farm worker family is income-eligible for Program certification if the income criteria was met either in the migrant's home state before the migrant entered the stream for a particular agricultural season or in an instream area during the agricultural season. E. Documentation of Income. (1) An applicant shall provide to the local agency documentation of the applicant's family income. (2) Except as provided in §E(3) of this regulation, a local agency shall accept any of the following as documentation of income: (a) Pay stubs; (b) Income tax returns; (c) W-2 forms; (d) Forms showing eligibility or benefit levels; and (e) Documents confirming participation in another State-administered program whose income eligibility guidelines are less than or equal to the WIC Program's income eligibility guidelines. (3) If an applicant cannot provide a document cited in §E(2) of this regulation, a local agency may confirm the applicant's participation in another State-administered program by telephoning the appropriate staff person of that program and documenting the telephone contact in the applicant's record. (4) A local agency shall deny Program participation to an applicant who fails to provide income documentation within 30 days of the date that the individual applied for Program benefits. #### Regulation .08 Nutritional Risk Determination Process. *COMAR 10.54.01.08* A. After an applicant is found to meet the Program’s income eligibility standards as specified in Regulation .07 of this chapter, in order for the applicant to receive WIC benefits, the applicant shall be found by the Program to be at nutritional risk. B. In order to determine whether an applicant is at nutritional risk, a competent professional authority or a competent paraprofessional authority on the staff of the local agency shall perform a nutritional assessment based on either information gathered by the local agency or information provided by a competent professional authority not on the staff of the local agency. C. A local agency may not compel an applicant to: (1) Have the nutritional risk assessment completed by a specific medical provider; or (2) Receive ongoing medical care under the local agency. D. In conducting a nutritional risk assessment, a local agency, competent professional authority, or competent paraprofessional authority shall assess each applicant’s height (or length) and weight measurements at the time of certification by: (1) Performing the measurements on each applicant; (2) Requiring documentation of each applicant's measurements from a health care provider; or (3) In its discretion, both §D(1) and (2) of this regulation. E. Hematological Tests. (1) In addition to the assessments set forth in §D of this regulation, a local agency, competent professional authority, or competent paraprofessional authority shall: (a) Perform a hematological test for anemia such as a hemoglobin or hematocrit; (b) Require documentation of the test from a health care provider at the time of certification for applicants with no other nutritional risk factor present; or (c) In its discretion, both §E(1)(a) and (b) of this regulation. (2) For applicants with a qualifying nutritional risk factor present at certification, a local agency, competent professional authority, or competent paraprofessional authority shall within 90 days of the certification: (a) Perform a hematological test; (b) Require documentation of the test from a health care provider; or (c) In its discretion, both §E(2)(a) and (b) of this regulation. (3) The local agency, competent professional authority, or competent paraprofessional authority shall perform or require documentation of the hematological test as follows: (a) For a pregnant woman, during pregnancy; (b) For a breastfeeding or postpartum woman, after the termination of pregnancy; (c) For a breastfeeding woman 6—12 months postpartum, if a test was not performed after the termination of pregnancy or whose test result after pregnancy was below normal range; (d) For an infant, 9—12 months old; (e) For a child 12—24 months old, any time during that period, but, if possible, at 6 months after the infant test; (f) For a child 2 years old or older, whose test result at the child's last certification is within the normal range, at least once every 12 months; and (g) For a child 2 years old or older whose test result at the child’s last certification is below normal range, at 6 month intervals until the result is within normal range. F. The local agency, competent professional authority, or competent paraprofessional authority shall obtain a nutrition history for each applicant. G. Using the information gathered pursuant to §§D—F of this regulation, a competent professional authority or competent paraprofessional authority shall use the nutritional risk criteria found in Charts A and B in Regulation .11 of this chapter to determine if the applicant is at nutritional risk pursuant to the priority levels set forth in Regulation .09 of this chapter, and thus eligible for the Program. H. A local agency: (1) May determine a breastfeeding woman to be at nutritional risk if her breastfed infant has been determined to be at nutritional risk; (2) May certify a breastfed infant to be at nutritional risk if the infant's mother is determined to be at nutritional risk; (3) Shall place a breastfeeding mother and her infant in the highest priority level for which either is qualified; (4) Shall place an applicant exhibiting more than one risk factor in the highest applicable priority level; and (5) May not place an individual in successive certification periods whose only identified risk factor is possibility of regression of nutritional status. #### Regulation .09 Priority Levels of Nutritional Risk. *COMAR 10.54.01.09* A. A local agency shall classify applicants according to priority levels of nutritional risk. B. Priority Levels of Nutritional Risk. (1) Priority I. Priority I is a pregnant woman, a breastfeeding woman, or an infant at nutritional risk because of: (a) Detrimental or abnormal nutritional conditions detected by biochemical or anthropometric measurements; (b) Other documented nutritionally related medical conditions; or (c) Conditions that directly affect the nutritional health of an individual, including depression, smoking, alcoholism, or drug abuse. (2) Priority II. Except for an infant who qualifies for Priority I, Priority II is: (a) An infant younger than 6 months old born to a woman who was a Program participant during her pregnancy; (b) An infant younger than 6 months old born to a woman who was not a Program participant during pregnancy but whose medical records document that the woman was at nutritional risk during the pregnancy due to nutrition conditions detectable by biochemical or anthropometric measurements or other documented, nutritionally related medical conditions that demonstrated the individual’s need for supplemental foods; or (c) A breastfeeding mother of a breastfed infant who has been certified in the Program as Priority II. (3) Priority III. Priority III is a child or postpartum woman at nutritional risk because of: (a) Detrimental or abnormal nutritional conditions detected by biochemical or anthropometric measurements; (b) Other documented nutritionally related medical conditions; or (c) Conditions that directly affect the nutritional health of an individual, including depression, smoking, alcoholism, or drug abuse. (4) Priority IV. Priority IV is a: (a) Pregnant woman, a breastfeeding woman, or an infant at nutritional risk because of: (i) Dietary deficiencies that impair or endanger health; or (ii) Conditions that predispose the individual to inadequate nutritional patterns, including homelessness or migrancy; and (b) Breastfeeding woman or an infant at nutritional risk because of possibility of regression of nutritional status. (5) Priority V. Priority V is a child at nutritional risk because of: (a) Dietary deficiencies that impair or endanger health; (b) Conditions that predispose the child to inadequate nutritional patterns, including homelessness or migrancy; or (c) Possibility of regression of nutritional status. (6) Priority VI. Priority VI is a postpartum woman at nutritional risk because of: (a) Dietary deficiencies that impair or endanger health; (b) Conditions that predispose the individual to inadequate nutritional patterns, including homelessness or migrancy; or (c) Possibility of regression of nutritional status. #### Regulation .10 Priority Waiting List. *COMAR 10.54.01.10* A. When it is serving its maximum caseload, a local agency shall maintain a priority waiting list of individuals seeking Program benefits. B. In order to be placed on the priority waiting list, an individual shall be certified as eligible to participate in the Program. C. A local agency shall place an individual on a priority waiting list according to the priority levels set forth in Regulation .09 of this chapter, as follows: (1) To be placed on the priority waiting list in Priority levels I—V, an individual shall seek certification and be successfully certified by the local agency as eligible for Program benefits; and (2) To be placed on the priority waiting list in Priority level VI, an individual may request to be on the waiting list over the telephone, unless the individual's postpartum status is at issue, in which case the local agency shall place the individual on the waiting list only after the individual receives a personal assessment at the local agency. D. The State agency may advise the local agency that one or more priority levels may be excluded from consideration for the waiting list if it is not possible for those priority levels to be placed on the Program in the foreseeable future. However, if an applicant meets the requirements for one of the priority levels and requests placement on a priority waiting list, the applicant may not be denied inclusion. E. An individual on the waiting list shall be selected for Program participation as soon as services become available. An individual in the highest priority level of the waiting list shall receive services before an individual in the next highest priority level on the waiting list receives services. Within a priority group, an applicant shall receive services on a first-come, first-served basis. F. A local agency shall notify an individual of placement on the waiting list within 20 days of the date that the individual applies for Program benefits, or in the case of an infant or pregnant woman, within 10 days of the date that the application for benefits was made. #### Regulation .11 Nutritional Risk Factors. *COMAR 10.54.01.11* A. For purposes of the WIC Program, to be considered at nutritional risk: (1) A woman shall exhibit one or, where specified, two of the nutritional risk factors listed in Chart A, as shown in §B of this regulation; and (2) An infant or child shall exhibit one or, where specified, two of the nutritional risk factors listed in Chart B, as shown in §B of this regulation. B. Explanation of Charts. C. Chart A. D. Chart B. #### Regulation .12 Application Processing Procedures. *COMAR 10.54.01.12* A. A local agency shall perform the certification process at no cost to the applicant. B. To lend administrative efficiency and participant convenience to the certification process, a local agency shall, whenever possible, use intake procedures for processing applications that are combined with intake procedures for other health programs or services administered by the local agency. These procedures may include: (1) Verification procedures; (2) Certification interviews; and (3) Income computations. C. When a local agency is not serving its maximum case load, the local agency shall: (1) Accept an application; (2) Arrive at an eligibility determination; (3) Notify the applicant of the decision made; and (4) Issue food instruments pursuant to the terms set forth in §E of this regulation. D. To ensure that accurate records are kept of the date of an application, the local agency shall, at the time of each visit record the: (1) Applicant's name; (2) Applicant's address; and (3) Date of the visit. E. Time Frames. (1) A local agency shall notify a special nutritional risk applicant of an eligibility or ineligibility determination within 10 days of the date of the application for Program benefits, except that the State agency may provide an extension of the notification period to a maximum of 15 days for the local agency that makes a written request which includes a justification of the need for an extension; or (2) A local agency shall notify other applicants of their eligibility or ineligibility within 20 days of the date of the application for Program benefits. F. If, during a certification visit, a local agency determines that an applicant is ineligible for the Program, the local agency shall: (1) Inform the special nutritional risk applicant within 10 days of the certification visit, and other applicants within 20 days of the certification visit, of the: (a) Applicant's ineligibility; (b) Reason for ineligibility; and (c) Applicant's right to a fair hearing on the ineligibility determination; (2) Document the reasons for ineligibility; and (3) Retain this information on file at the local agency. G. At the same time an applicant completes the certification process and the local agency determines the applicant to be eligible for Program benefits, the local agency shall issue benefits for up to 90 days. #### Regulation .13 Certification Periods. *COMAR 10.54.01.13* A. A local agency shall certify an applicant for Program benefits for the following time periods: (1) A pregnant woman for the duration of her pregnancy and up to the last day of the month in which the infant turns 6 weeks old or the pregnancy ends; (2) A postpartum woman up to the last day of the 6th month after the infant is born or the pregnancy ends; (3) A breastfeeding woman up to the last day of the month of the breastfed infant’s first birthday as long as the woman is breastfeeding; (4) An infant younger than 6 months old up to the last day of the month of the infant’s first birthday; (5) An infant from 6 months old to 1 year old up to the last day of the 6th month from the date of certification; and (6) A child 1 year old or older up to the last day of the month 1 year from the date of the certification or the month in which the child turns 5 years old. B. When there is difficulty in appointment scheduling for participants referred to in §A(4)—(6) of this regulation, a local agency may shorten or extend the certification period by not more than 30 days on a case-by-case basis. C. A local agency may use anthropometric data for a nutrition risk determination that precedes the date of certification by up to 60 days and bloodwork data following U.S. Centers for Disease Control and Prevention recommendations with no reduction in the length of certification. D. Anthropometric data for an individual certified as a pregnant woman shall be collected during the pregnancy, and data for an individual certified as a postpartum or a breastfeeding woman shall be collected after the termination of the pregnancy. E. Not less than 15 days before the expiration of a certification period, the Program shall notify a participant, or a child or infant participant's parent, guardian, or caretaker that the participant's certification period for the Program is about to expire. F. A participant, or a child or infant participant's parent, guardian, or caretaker shall apply in person for benefits for the next certification period. #### Regulation .14 Action Affecting Participation During a Certification Period. *COMAR 10.54.01.14* A. A local agency may disqualify a participant in the middle of a certification period for Program abuse, which includes but is not limited to: (1) The sale or exchange of food instruments or food obtained with a food instrument; (2) Dual participation; (3) Making false or misleading statements or intentionally misrepresenting, concealing, or withholding information in order to obtain benefits; (4) Verbal or physical abuse of or threat of physical abuse to Program or vendor staff; (5) Receipt from food vendors of cash or credit toward the purchase of unauthorized food or other items of value instead of authorized supplemental foods; and (6) Failure to pick up food benefits for 2 consecutive issue months. B. Funding Shortages. (1) If the State agency experiences funding shortages, it may discontinue Program benefits to participants, but only after exploring alternative actions. (2) The State agency may discontinue benefits by: (a) Disqualifying a priority level of participants; or (b) Withholding benefits to a priority level with the expectation of providing benefits again when funds are available. (3) When the State agency elects to restrict benefits to a priority level of participants due to insufficient funds for a period of time: (a) The State agency shall discontinue benefits for: (i) The least possible number of participants; (ii) Those participants whose nutritional and health status would be least impaired by the discontinuation of Program benefits; and (b) A local agency may not enroll new participants in restricted priority levels during this period. C. Ineligibility. A local agency shall disqualify a participant in the middle of a certification period if, on the basis of a reassessment of Program eligibility status, the individual is determined ineligible for Program benefits. #### Regulation .15 Dual Participation. *COMAR 10.54.01.15* A. A participant may not engage in dual participation. B. The State agency in conjunction with the local agency is responsible for the detection and prevention within its program of dual participation. C. The local agency shall take immediate actions to investigate and resolve all incidents of suspected Program abuse involving dual participation. D. In order to prevent possible dual participation by an applicant, at certification the local agency shall verify the identity of each applicant and shall use the following to establish the identity of the infant or child applicant: (1) Immunization record; (2) Birth certificate; or (3) Other record that the local agency considers adequate to establish the identity of an infant or child applicant. #### Regulation .16 Applicant and Participant Rights and Responsibilities in the Certification Process. *COMAR 10.54.01.16* A. At the time of certification, a local agency shall inform an applicant or the parent, guardian, or caretaker of a child or infant applicant, of the following: (1) The applicant may not engage in dual participation; (2) The Program violations and the sanctions applicable to a participant, a child or infant participant's parent, guardian, or caretaker, or proxy for committing those violations; (3) The importance of regularly picking up food benefits and food; (4) The disqualification policy for failure to pick up food benefits and the number of months of nonparticipation resulting from the disqualification; (5) The policy of not providing notification of disqualification to the participant when the participant fails to pick up food benefits; (6) The right to a fair hearing if the participant does not agree with the disqualification for failure to pick up food benefits; (7) How the local agency food delivery system operates and a list of authorized stores where food benefits may be redeemed; (8) The available health services, where they are located, how they may be obtained, and why they may be useful; (9) A participant or a child or infant participant’s parent, guardian, or caretaker shall notify the local agency of any change in life circumstances that would have an impact on Program eligibility; and (10) A participant or a child or infant participant’s parent, guardian, or caretaker shall advise any designated proxy of the proxy’s obligations under the Program, Program violations, participant and proxy sanctions, and the authorized food stores. B. At the time of certification, the Program applicant or a child or infant applicant’s parent, guardian, or caretaker shall read, or the Program representative or a local agency staff person shall read to the individual, the following: (1) “The rules for applying for WIC are the same for everyone;” (2) “I can ask a WIC employee for a fair hearing if someone tells me I cannot be on WIC and I do not agree;” and (3) “I will get information about healthy eating and active living. WIC will help and support me with breastfeeding. I will get information about immunizations and other services I might need.” C. After advising the applicant, or the child or infant applicant’s parent, guardian, or caretaker of the rights and responsibilities set forth in this regulation, the applicant or the child or infant applicant’s parent, guardian, or caretaker, shall read, or a Program representative shall read to the applicant, or the child or infant applicant’s parent, guardian, or caretaker, the following statements: (1) “I understand what my rights and responsibilities are;” (2) “I agree to follow the rules below. I will:(i) not sell, give away or trade my eWIC card, foods, or formula for money, credit, rain checks or other items. If I have WIC items I can’t use, I will return them to the clinic; (ii) not post WIC items for sale or trade on the internet; (iii) not swear, yell, harass, threaten, physically harm WIC or store staff, or damage WIC or store property; (iv) not enroll a child who is not in my legal or designated care; and (v) not enroll in WIC in more than one state or get benefits from more than one WIC clinic each month;” (3) “The information I have provided for eligibility determination is correct, to the best of my knowledge;” (4) “The information that I provide to the WIC Program is being submitted in connection with the receipt of federal assistance;” (5) “Program officials may verify information provided to them;” (6) “I understand and agree that intentionally making a false or misleading statement or misrepresenting, hiding, or withholding facts may result in my having to pay the WIC Program, in cash, the value of the food benefits improperly issued to me and may subject me to civil or criminal prosecution under State and federal law and disqualification from the WIC Program;” and (7) “I agree to give true and complete information about changes in my life circumstances that would have an impact on my eligibility for WIC benefits (for example, I will notify WIC if I have changes in my income or family size or if I move).” D. The applicant or the child or infant applicant’s parent, guardian, or caretaker, shall acknowledge the reading of the statements enumerated in §C of this regulation by signing the Rights and Responsibilities form provided by the State agency. #### Regulation .17 Transfer of Certification. *COMAR 10.54.01.17* A. A local agency shall: (1) Issue a verification of certification to a participant who: (a) Is a member of a family in which there is a migrant farm worker; or (b) Advises the local agency that the participant's family is likely to be relocating outside of Maryland during the certification period; (2) Ensure that each verification of certification contains the following: (a) Name of the participant; (b) Date the certification was performed; (c) Date the income eligibility was last determined; (d) Nutritional risk condition of the participant; (e) Date the certification expires; (f) Signature and printed or typed name of the local agency official who issued the verification of certification; (g) The name and address of the certifying local agency; and (h) An identification number for the verification of certification or some other means of accountability; (3) Accept a valid verification of certification from a participant of a WIC Program whether within or outside of Maryland; and (4) Accept the verification of certification or the copy of the State-approved certification form as proof of eligibility for WIC Program benefits until the participant’s certification period expires. B. A local agency may not: (1) Issue a verification of certification to an individual placed on the waiting list; or (2) Deny participation in the Maryland WIC Program to an individual with a valid verification of certification because of a difference between another state’s and Maryland’s eligibility criteria. C. A local agency may use the verification of certification as verification of income eligibility for the family of a migrant farm worker if the migrant farm worker is currently away from the migrant farm worker’s home jurisdiction, and if the migrant farm worker’s family income has been determined within the last 12 months. D. A local agency having a waiting list for participation that receives a transferring participant shall place the transferring participant ahead of waiting applicants without regard to priority level. #### Regulation .18 Receipt of Benefits. *COMAR 10.54.01.18* A. Nutrition Benefits. A local agency shall: (1) Ensure that nutrition education is offered every 3 months to the participant or the parent, proxy, guardian, or caretaker of an infant or child participant during each certification period; (2) Provide a nutrition care plan to the participant, based on the need for this plan as determined by a competent professional authority, and to a participant, parent, proxy, guardian, or caretaker who requests a nutrition care plan; (3) Ensure that a competent professional authority or competent paraprofessional authority determines the selection of the food package according to the category and nutritional need of the participant; and (4) Ensure that the food package is consistent with foods allowed under the provisions of 7 CFR §246.10, which is incorporated by reference in Regulation .03 of this chapter. B. Proxies. (1) If a participant or a child or infant participant’s parent, guardian, or caretaker is unable to pick up or redeem WIC benefits, the participant or the child or infant participant’s parent, guardian, or caretaker may name a proxy to pick up benefits, redeem them, or both. (2) A participant or a child or infant participant's parent, guardian, or caretaker shall register the name of the proxy with the local agency before the proxy may perform any WIC-related activity. (3) The Program may remove an individual who violates Program standards from serving as a proxy. (4) A participant or a child or infant participant's parent, guardian, or caretaker may replace a proxy with another individual. (5) A participant or a child or infant participant's parent, guardian, or caretaker shall advise a proxy of the: (a) Proxy's obligations under the Program; (b) Program violations; (c) Participant and proxy sanctions; and (d) Authorized food stores. C. Receipt of Food Benefits. (1) Except as provided in §B(3) and (4) of this regulation, a participant or the participant’s proxy shall report to a designated site at designated times to receive food benefits prepared for that participant and to acknowledge receipt of the benefits. (2) When distributing food benefits, a local agency shall check a participant’s identification. (3) A local agency may mail or otherwise deliver food benefits to participants on a local agency-wide basis if the State agency approves this action on the basis of a hardship that may be encountered by the target population, such as seasonally inclement weather. (4) A local agency may mail or otherwise deliver food benefits to the participant or the participant’s parent, guardian, or caretaker who in writing requests this delivery and explains why it is necessary if a participant and the participant’s proxy are unable to report to the designated site to receive food benefits due to a hardship, including, but not limited to: (a) Illness; (b) Handicap; (c) Imminent childbirth; or (d) Difficulty of access to the site. (5) If the hardship cited in §C(4) of this regulation does not allow time for a written request to be made, a local agency may act on a verbal request for the upcoming benefit distribution period only and shall follow the procedure set forth in §C(4) of this regulation if the hardship continues. (6) When the hardship is resolved, a local agency shall continue with normal benefit issuance procedure. D. Receipt and Consumption of Food. (1) To obtain WIC-authorized foods, a participant or proxy shall complete transactions at WIC-authorized vendors. (2) Only the participant for whom the food package was prescribed shall consume food obtained with a WIC food instrument. #### Regulation .19 Sanctions. *COMAR 10.54.01.19* A. The Program may sanction a participant or proxy in the Program, in addition to seeking criminal or civil sanctions or other remedies that may be applicable under federal, State, or local law. B. If a participant or a child or infant participant’s parent, guardian, or caretaker, has deliberately misrepresented the participant’s income, residence, family size, health status, medical data, or date of birth, the: (1) Program shall disqualify the participant from the program for 1 year; and (2) Offending party shall pay to the State agency, in cash, the value of food benefits improperly received. C. If a participant or a child or infant participant’s parent, guardian, caretaker, or proxy obtains or attempts to obtain food benefits to which the participant is not entitled, sanctions shall be applied according to the following: (1) If the offending party is a participant or a child or infant participant's parent, guardian, or caretaker: (a) For the first offense, the Program shall counsel the individual and issue a warning letter; (b) For a subsequent offense, the Program shall disqualify the participant from the Program for: (i) 3 months; or (ii) 1 year if the State agency assesses a monetary claim of $100 or more; and (c) In either case in §C(1)(a) and (b) of this regulation, the offending party shall pay to the State agency, in cash, the value of the food benefits obtained; or (2) If the offending party is a proxy, the: (a) Program shall remove the proxy; and (b) Proxy shall pay to the State agency, in cash, the value of the food benefits obtained. D. If a participant engages in dual participation as defined in Regulation .04B of this chapter: (1) The Program shall counsel the participant or a child or infant participant’s parent, guardian, or caretaker, and disqualify the participant for 1 year; and (2) The offending party shall pay to the State agency, in cash, the monetary value of the items received. E. If a participant or a child or infant participant’s parent, guardian or caretaker, or a proxy physically abuses or threatens abuse of WIC or vendor staff, the Program shall: (1) Report the incident to the police; (2) Disqualify the participant from the Program for 1 year if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker; and (3) Remove the proxy if the offending party is a proxy. F. If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy verbally abuses or harasses WIC or vendor staff, or disrupts the peaceful and orderly conduct of business at a WIC or vendor facility, the Program shall: (1) For the first offense, disqualify the participant from the Program for 6 months; (2) Remove the proxy if the offending party is a proxy; and (3) For a subsequent offense, disqualify the participant from the Program for 1 year. G. If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy sells or exchanges supplemental food purchased with a food instrument or sells a food instrument to another individual or entity, the: (1) Program shall: (a) Disqualify the participant for 3 months if the offending party is a participant or a child or infant participant's parent, guardian, or caretaker; or (b) For a subsequent offense, disqualify the participant from the Program for 6 months if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker; (c) Disqualify the offending party for 1 year if the State agency assesses a monetary claim of $100 or more; or (d) Remove the proxy if the offending party is a proxy; and (2) Offending party shall pay to the State agency, in cash, the monetary value of food or food instruments sold or exchanged. H. If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy attempts to redeem or redeems a food instrument for unauthorized foods or for quantities of food in excess of that indicated on the food instrument, if the offending party is a: (1) Participant or a child or infant participant’s parent, guardian, or caretaker: (a) For the first offense, the Program shall counsel the individual and issue a warning letter; (b) For a subsequent offense, the Program shall disqualify: (i) The participant from the Program for 3 months; or (ii) The offending party from the Program for 1 year if the State agency assesses a monetary claim of $100 or more; and (c) In either case in §H(1)(a) and (b) of this regulation, the offending party shall pay to the State agency, in cash, the value of the food benefits obtained; or (2) Proxy, the: (a) Program shall remove the proxy; and (b) Proxy shall pay to the State agency, in cash, the value of the food benefits obtained. I. If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy receives cash or credit toward the purchase of unauthorized food or other items of value instead of or in addition to authorized supplemental foods or exchanges, or attempts to exchange or returns or attempts to return authorized WIC food to the vendor for cash or non-WIC items, the: (1) Program shall: (a) Disqualify the participant from the Program for 3 months if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker; (b) For a subsequent offense, disqualify the participant from the Program for 6 months if the offending party is a participant or a child or infant participant’s parent, guardian, or caretaker; or (c) Disqualify the offending party for 1 year if the State agency assesses a monetary claim of $100 or more; (2) Program shall remove the proxy if the offending party is a proxy; and (3) Offending party shall pay to the State agency, in cash, the amount indicated on the food instrument with which the items were initially obtained, if the items were obtained. J. If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy allows an unauthorized individual to use the Maryland WIC participant identification folder, if the offending party is a: (1) Participant or a child or infant participant’s parent, guardian, or caretaker: (a) For the first offense, the Program shall counsel the individual and issue a warning letter; and (b) For a subsequent offense, the Program shall disqualify the participant from the Program for 3 months; or (2) Proxy, the Program shall remove the proxy. K. If a participant or a child or infant participant’s parent, guardian, or caretaker, or a proxy fails to pay a monetary penalty imposed by the Program for redeeming food benefits, if the offending party is a: (1) Participant or a child or infant participant’s parent, guardian, or caretaker, the Program shall disqualify the participant from the Program for 1 year; or (2) Proxy, the Program shall remove the proxy. L. Failure to Return Breast Pump. (1) If a participant fails to return a hospital grade breast pump, the Program shall issue a warning letter to the participant. (2) If a participant fails to return a hospital grade breast pump after receipt of a warning letter, the participant shall pay to the State agency, in cash, the monetary value of the breast pump. #### Regulation .20 Local and State Agency Sanction Responsibilities. *COMAR 10.54.01.20* A. A local agency shall implement participant and proxy sanctions and notify the State agency of the action taken. B. The State agency may also initiate participant and proxy sanctions and other acts based on information available to the State agency. C. Except for a participant the State agency disqualifies for failure to pick up food benefits, the State agency shall, not less than 15 days before disqualification, advise the participant in writing of the reasons for the disqualification and of the right to a fair hearing on the disqualification. D. When the State agency pursues collection of a claim against a participant who has been improperly issued food benefits, it shall advise the participant in writing of: (1) The reasons for the claim; (2) The value of the improperly issued benefits to be repaid to the Program; (3) That the participant shall pay to the State agency, in cash, the value of the improperly issued benefits; and (4) The participant's right to a fair hearing on the claim. #### Regulation .21 Appeal Procedures. *COMAR 10.54.01.21* A. Applicants and participants may appeal certain State or local agency actions. B. An applicant or participant: (1) May appeal a State or local agency action resulting in the individual's being: (a) Denied participation in the WIC Program; (b) Instructed to repay the cash value of improperly issued benefits; or (c) Disqualified from the Program; and (2) Shall appeal the action in accordance with COMAR 10.01.06. #### Regulation .22 Nondiscrimination. *COMAR 10.54.01.22* A. Civil Rights Requirements. (1) To ensure that an individual may not, on the grounds of race, color, national origin, age, sex, or handicap, be excluded from participation in, be denied benefits of, or be otherwise subjected to discrimination under the Program, a local agency shall comply with the requirements of: (a) Title VI of the Civil Rights Act of 1964 as incorporated by reference in Regulation .03C of this chapter; (b) Title IX of the Education Amendments of 1972 as incorporated by reference in Regulation .03C of this chapter; (c) §504 of the Rehabilitation Act of 1973 as incorporated by reference in Regulation .03C of this chapter; (d) The Age Discrimination Act of 1975 as incorporated by reference in Regulation .03C of this chapter; (e) USDA Food and Nutrition Service instructions issued by the Program to the local agencies; and (f) USDA regulations on nondiscrimination as incorporated by reference in Regulation .03C of this chapter. (2) A local agency shall: (a) Notify the public of the nondiscrimination policy and complaint rights of a participant and an applicant as set forth in §B of this regulation; (b) Review and monitor its activities to ensure Program compliance with the nondiscrimination laws and regulations; and (c) Collect and report racial and ethnic participation data as required by Title VI of the Civil Rights Act of 1964, which prohibits discrimination in federally assisted programs on the basis of race, color, or national origin. B. Complaints. (1) An individual may submit to a local agency a complaint that alleges an incident of discrimination pursuant to §A of this regulation. (2) The local agency shall forward to the State agency, within 10 days, the complaint which alleges discrimination. (3) The State agency shall refer the complaint, including a complaint based on sex or handicap, to the USDA for investigation and necessary action. #### Regulation .23 Non-English Materials. *COMAR 10.54.01.23* A. The Program shall accommodate the non-English-speaking individuals in the population eligible to be served as set forth in this chapter. B. When the population eligible to be served needs services or information in a language other than English in order to be informed of or to participate in the Program, the local agency shall: (1) Take reasonable steps to provide Program information in the appropriate language; and (2) Ensure that the rights and responsibilities listed on the certification form are read to the applicant in the appropriate language. #### Regulation .24 Conflict of Laws and Regulations. *COMAR 10.54.01.24* If the provisions of this chapter conflict with federal statutes and regulations, including the provisions incorporated by reference in Regulation .03 of this chapter, the federal statutes and regulations prevail. ### Chapter 02 — Local Agency **Authority:** Health-General Article, §§18-107(a) and 18-108, Annotated Code of Maryland **Administrative History:** Effective date: March 30, 1992 (19:6 Md. R. 674) **Administrative History:** Regulation .01 amended as an emergency provision effective July 8, 1993 (20:15 Md. R. 1219); amended permanently effective January 9, 1994 (20:20 Md. R. 1572) **Administrative History:** Regulation .02 amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 473); amended permanently effective June 3, 1996 (23:11 Md. R. 810) **Administrative History:** Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulations .04, .10, .14, .17, and .18 amended as an emergency provision effective June 29, 1996 (23:15 Md. R. 1083); amended permanently effective October 21, 1996 (23:21 Md. R. 1468) **Administrative History:** Regulation .05B, C amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .06 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulations .07F, .10A, .14A, and .18C amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1532) **Administrative History:** Regulation .08A amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .09 repealed and new Regulation .09 adopted effective April 16, 2012 (39:7 Md. R. 494) **Administrative History:** Regulation .10A amended effective April 16, 2012 (39:7 Md. R. 494) **Administrative History:** Regulation .10A, C amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .11D amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .14A amended effective April 16, 2012 (39:7 Md. R. 494) **Administrative History:** Regulation .14C amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .17A, B amended effective May 18, 2020 (47:10 Md. R. 519) **Administrative History:** Regulation .18 adopted as an emergency provision effective July 8, 1993 (20:15 Md. R. 1219); adopted permanently effective January 9, 1994 (20:20 Md. R. 1572) **Administrative History:** Regulation .18 amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 473); amended permanently effective June 3, 1996 (23:11 Md. R. 810) **Administrative History:** Regulation .18 amended as an emergency provision effective August 26, 1999 (26:19 Md. R. 1446); amended permanently effective November 15, 1999 (26:23 Md. R. 1777) **Administrative History:** Regulation .18 amended effective November 13, 2000 (27:22 Md. R. 2060) **Administrative History:** Regulation .18 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1685) **Administrative History:** Regulation .18 amended as an emergency provision effective July 1, 2010 (37:16 Md. R. 1058); amended permanently effective October 4, 2010 (37:20 Md. R. 1394) **Administrative History:** Regulation .18 amended as an emergency provision effective July 1, 2012 (39:17 Md. R. 1145); amended permanently effective October 15, 2012 (39:20 Md. R. 1306) **Administrative History:** Regulation .18 amended as an emergency provision effective July 19, 2013 (40:17 Md. R. 1418); emergency status extended to February 3, 2014 (41:2 Md. R. 89); amended permanently effective January 6, 2014 (40:26 Md. R. 2164) **Administrative History:** Regulation .18 amended as an emergency provision effective August 28, 2014 (41:19 Md. R. 1075); amended permanently effective November 10, 2014 (41:22 Md. R. 1319); December 8, 2016 (43:24 Md. R. 1350) **Administrative History:** Regulation .18 amended effective March 26, 2018 (45:6 Md. R. 321) **Administrative History:** Regulation .18B amended as an emergency provision effective July 1, 1994 (21:16 Md. R. 1380); amended permanently effective October 24, 1994 (21:21 Md. R. 1814) **Administrative History:** Regulation .18B amended as an emergency provision effective July 1, 1997 (24:15 Md. R. 1060); amended permanently effective October 20, 1997 (24:21 Md. R. 1451) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1116); amended permanently effective October 9, 1995 (22:20 Md. R. 1543) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective December 22, 2003 (30:25 Md. R. 1848) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1252); amended permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2005 (32:15 Md. R. 1314); amended permanently effective October 10, 2005 (32:20 Md. R. 1656) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1150); amended permanently effective August 27, 2007 (34:17 Md. R. 1509) **Administrative History:** Regulation .18B, C amended as an emergency provision effective June 26, 2008 (35:15 Md. R. 1345); amended permanently effective October 6, 2008 (35:20 Md. R. 1776) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2009 (36:15 Md. R. 1164); amended permanently effective September 7, 2009 (36:18 Md. R. 1382) **Administrative History:** Regulation .18B, C amended as an emergency provision effective July 1, 2011 (38:19 Md. R. 1146); amended permanently effective October 17, 2011 (38:21 Md. R. 1279) **Administrative History:** Regulation .18B, C amended as an emergency provision effective August 6, 2015 (42:18 Md. R. 1173); amended permanently effective October 26, 2015 (42:21 Md. R. 1302) **Administrative History:** Regulation .18E adopted as an emergency provision effective August 6, 2015 (42:18 Md. R. 1173); adopted permanently effective October 26, 2015 (42:21 Md. R. 1302) #### Regulation .01 Scope. *COMAR 10.54.02.01* These regulations are promulgated to specify the selection and the responsibilities of a local agency, and the rate of payment to a local agency in the administration of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC Program or Program), operated by the Maryland Department of Health with funding substantially provided by the U.S. Department of Agriculture under §17 of the Child Nutrition Act of 1966, 42 U.S.C. §1786. #### Regulation .02 Definitions. *COMAR 10.54.02.02* The terms defined in COMAR 10.54.01.04 also apply to this chapter. #### Regulation .03 Selection of a Local Agency. *COMAR 10.54.02.03* The State agency shall select a local agency in accordance with the following priorities: A. First consideration shall be given to a public or a private nonprofit health agency that will provide ongoing, routine pediatric and obstetric care and administrative services; B. Second consideration shall be given to a public or private nonprofit health or human service agency that will enter into a written agreement with another agency for either ongoing, routine pediatric and obstetric care or administrative services; C. Third consideration shall be given to a public or private nonprofit health agency that will enter into a written agreement with private physicians licensed by the State in order to provide ongoing, routine pediatric and obstetric care to a specific category of participants (women, infants, or children); D. Fourth consideration shall be given to a public or private nonprofit human service agency that will enter into a written agreement with private physicians licensed by the State to provide ongoing, routine pediatric and obstetric care; and E. Fifth consideration shall be given to a public or private nonprofit health or human service agency that will provide ongoing, routine pediatric and obstetric care through referral to a health care provider. #### Regulation .04 Duties and Responsibilities. *COMAR 10.54.02.04* To participate in the Program, a local agency shall: A. Comply with the fiscal and operational requirements prescribed by the State agency or the federal government in: (1) This chapter; (2) COMAR 10.54.01; (3) 7 CFR Part 3015; (4) 7 CFR Part 3016; and (5) 7 CFR Part 246; B. Maintain the caseload within the prescribed performance standards of the State-assigned level over a prescribed time period as specified in the written agreement between the State agency and the local agency; C. Inform the State agency on a timely basis of clinic sites and hours of operation; D. Make available, contract to make available, or provide by referral, appropriate health services to participants and inform applicants of the health services which are available; E. Devise and implement a plan to make health services available to participants at the clinic or through written agreements with health care providers when health services are provided through referral; F. Provide Program benefits to the participant at no cost; G. Perform the certification procedure at no cost to the applicant; H. Have on its staff a competent professional authority as defined at COMAR 10.54.01.04; I. Maintain on file and have available for review, audit, and evaluation all criteria used for certification, including information on the: (1) Area served; (2) Income standards used; and (3) Specific criteria used to determine nutritional risk; J. Provide nutrition education services to participants, in compliance with all State and federal statutes and regulations including: (1) Regulation .06 of this chapter; (2) 7 CFR 246; and (3) COMAR 10.54.01; K. Implement and operate a food delivery system prescribed by the State agency pursuant to these regulations and approved by the Food and Nutrition Service of the U.S. Department of Agriculture; L. Maintain complete, accurate, documented, and current accounting of all Program funds received and expended; M. Establish an internal monitoring system to review local agency operations and its associated clinics or contractors; N. Provide orientation and ongoing in-service training for staff; O. Inform the State agency of the content and schedule of training activities; P. Make staff available to attend training sessions offered by the State agency; and Q. Compile data, maintain records, and submit reports as required to permit effective enforcement of nondiscrimination laws and regulations. #### Regulation .05 Certification Process. *COMAR 10.54.02.05* A local agency shall: A. Certify an applicant as eligible for the Program according to the policies and procedures prescribed in COMAR 10.54.01; B. Inform an applicant or participant, or a parent or caretaker, of the participant’s rights and responsibilities and the Program benefits as prescribed in COMAR 10.54.01.16 and .18; and C. Maintain historical participant case files which shall include at least the following information obtained at each certification: (1) Information regarding income documentation as required by COMAR 10.54.01.07; (2) Anthropometric measurements of height and weight; (3) A hematological test result as required by COMAR 10.54.01.08E; (4) The local agency copy of the form developed by the Department outlining the rights and responsibilities of the applicant or participant and the form signed by the: (a) Applicant; (b) Parent; or (c) Caretaker; and (5) Documentation of the nutrition education contacts, including the: (a) Date; and (b) Nutrition education content. #### Regulation .06 Nutrition Education. *COMAR 10.54.02.06* A. A local agency shall provide nutrition education or a local agency shall enter into an agreement with another agency to provide nutrition education. B. If nutrition education is provided by another agency, then the local agency shall: (1) Acknowledge the nutrition education agreement in the nutrition education plan to the State agency; (2) Ensure proper training to the individual or individuals rendering the services; and (3) Monitor the services rendered. C. A local agency shall ensure that nutrition education is: (1) Made available at no cost to the participant; (2) Practical and relevant to the participant's individual needs; and (3) Integrated into: (a) Participant health care plans; (b) The delivery of supplemental foods; and (c) Other Program operations. D. To carry out the nutrition education responsibilities, a local agency shall: (1) Develop and submit for State agency approval an annual nutrition education plan; (2) Make available at reasonable times and locations during each 1-year certification period at least four opportunities for nutrition education for the: (a) Adult participant; (b) Parent or caretaker of an infant or child participant; and (c) Child participant whenever possible; (3) Document in each participant’s file, at the time of certification or recertification, all nutrition education sessions given to the participant, parent, caretaker, or child; (4) Document the participant’s, parent’s, caretaker’s, or child’s refusal or inability to attend or participate in nutrition education for purposes of further education efforts and monitoring as specified by the State agency; and (5) Provide an individual care plan for a participant when the need for a plan is determined by a competent professional authority or when a participant, parent, or caretaker requests an individual care plan. #### Regulation .07 Food Delivery. *COMAR 10.54.02.07* A. General Provisions. A local agency shall: (1) Implement and operate a food delivery system according to the local agency's agreement with the State agency; (2) Ensure that the food delivery system's operation is compatible with the delivery of health and nutrition education services; (3) Inform a participant or the parent or caretaker of an infant or child participant of the authorized vendors within the local agency service area; (4) Issue food instruments to participants or the participant's parent, caretaker, or proxy in accordance with COMAR 10.54.01; and (5) Ensure that a participant or the participant’s parent, caretaker, or proxy signs for receipt of food instruments. B. Vendor Authorization. The State agency, in conjunction with a local agency, shall: (1) Determine the appropriate number and distribution of vendors needed to serve the participants within the area served by the local agency; and (2) Conduct and provide documentation of on-site visits to an applicant vendor. C. Vendor Agreements. A local agency shall abide by the vendor agreement or agreements authorized for use in the local agency by the State agency. D. Vendor Training. A local agency shall provide training to a vendor when required by the State agency. E. Vendor Monitoring. A local agency, in conjunction with the State agency, shall: (1) Conduct on-site monitoring visits to at least 10 percent of the authorized vendors per year, selected on a representative basis, and submit to the State agency a summary of the results; (2) Identify and monitor vendors who present the potential for abuse of the Program and submit to the State agency a summary of the results; (3) Ensure investigation of suspected fraud and abuse and of complaints against participants as well as complaints by participants; and (4) Recommend sanctioning of vendors as prescribed at COMAR 10.54.03.16. F. Food Instruments Accountability. A local agency shall control and provide accountability for the receipt and issuance of food instruments. G. Conflict of Interest. A local agency shall notify the State agency if any conflict of interest appears to exist between the local agency or a member of its staff and a vendor within its jurisdiction. #### Regulation .08 Financial Management System. *COMAR 10.54.02.08* A local agency shall: A. Maintain records that identify the source and use of funds expended for Program activities and which contain information pertaining to: (1) Authorization; (2) Receipt of funds; (3) Obligations; (4) Unobligated balances; (5) Assets; (6) Liabilities; (7) Outlays; and (8) Income; and B. Implement procedures which ensure prompt and accurate payment of allowable costs. #### Regulation .09 Program Costs — General. *COMAR 10.54.02.09* A local agency may have the following administrative and program services costs: A. Direct costs, as allowed under 7 CFR Part 3016, which are identifiable costs incurred exclusively for the purpose of the Program; and B. Indirect costs, as allowed by 7 CFR Part 3016, which are those costs incurred for a common purpose benefitting more than one program. #### Regulation .10 Allowable Administrative and Program Service Costs. *COMAR 10.54.02.10* A. Expenditures for Nutrition Education. (1) During each federal fiscal year, a local agency shall use for nutrition education an amount equal to at least 20 percent of the administrative award set forth in §B of this regulation. (2) A local agency may not apply the cost of dietary assessments for purposes of certification and the cost of prescribing and issuing supplemental foods to the 20 percent minimum amount required to be spent on nutrition education. (3) A local agency may apply the following to the 20 percent minimum amount required to be spent on nutrition education: (a) Salary and other costs for time spent on nutrition education consultation, whether with an individual or group; (b) The cost of procuring, producing, and distributing nutrition education materials including the cost of: (i) Handouts; (ii) Flip charts; (iii) Videos; (iv) Food models or other teaching aids; and (v) Mailing nutrition education material to participants; (c) Salary and other costs incurred in developing the local agency's annual nutrition education plan; and (d) Other costs that can be justified by the local agency to the State agency as related to nutrition education. B. Expenditures for Administrative Costs. A local agency may incur costs for the following administrative services: (1) Outreach; (2) Interpreters; (3) Translators; and (4) Fair hearings including the cost of an independent medical assessment of an appellant, when ordered by an administrative law judge. C. The Cost of Program Certification Procedures. A local agency may incur the following program certification costs: (1) Laboratory fees for tests conducted to determine whether an individual is at nutritional risk; (2) The cost of expendable medical supplies necessary to determine whether an individual is at nutritional risk; (3) The cost of medical equipment used in connection with a nutritional risk determination to take anthropometric measurements, such as scales, measuring boards, and medical equipment used for analysis to detect anemia; and (4) Salary and other costs for time spent on certification. D. Prior Approved Costs. A local agency may incur the following allowable costs only with prior approval from the State agency: (1) Data processing costs which are required by the local agency, except for those used in general management and payroll, including acquisition of automatic data processing hardware or software whether by outright purchase, retail purchase agreement, or other method of acquisition; (2) Capital expenditures over $5,000, such as the cost of facilities, equipment, including medical equipment, other capital assets, and any repairs that materially increase the value or useful life of capital assets; and (3) Management studies performed by an agency, or department other than the local agency, or those performed by an outside consultant under contract with the local agency. #### Regulation .11 Monitoring and Review. *COMAR 10.54.02.11* A. Management Evaluation and Reviews. Every 2 years the State agency shall conduct a monitoring review of each local agency, including an on-site review of a minimum of 20 percent of the clinics in a local agency or one clinic, whichever is greater. This review shall encompass, but not be limited to, the evaluation of: (1) Management; (2) Certification; (3) Nutrition education; (4) Civil rights compliance; (5) Accountability; (6) Financial management systems; and (7) Food delivery systems. B. Periodic Review of a Local Agency's Qualifications. (1) The State agency may conduct periodic reviews of the qualifications of an authorized local agency. (2) Based upon the results of the reviews in §B(1) of this regulation, the State agency may take appropriate action, including the disqualification of a local agency. C. Investigations. The State agency shall investigate any allegation of a local agency's noncompliance with State and federal Program statutes and regulations. D. Local Agency Audits. (1) The Department may arrange for an audit by an entity independent from the Department. (2) The audit in §D(1) of this regulation may go beyond the management evaluation of the financial operation of a local agency. #### Regulation .12 Disqualification of a Local Agency. *COMAR 10.54.02.12* The State agency may disqualify a local agency when the: A. State agency determines a local agency's noncompliance with Program regulations; B. State's Program funds are insufficient to support the continued operation of the Program's existing local agencies at the agencies' current participation level; or C. State agency determines, following a review of local agency credentials in accordance with Regulation .11B of this chapter, that another local agency can operate the Program more effectively and efficiently. #### Regulation .13 Claims and Penalties. *COMAR 10.54.02.13* A. If the State agency determines through a review of a local agency's reports, program or financial analysis, monitoring, audit, or other means, that Program funds provided to a local agency for administrative and program services purposes were, through the local agency's negligence or fraud, misused or otherwise diverted from Program purposes, the State agency shall make a claim against the local agency. B. The local agency shall pay the State agency a sum equal to the amount of misused or diverted administrative and program services funds and the face value of food misused or diverted instruments, or both. #### Regulation .14 Records and Reports. *COMAR 10.54.02.14* A. A local agency shall: (1) Maintain full and complete records concerning Program operations; (2) Establish and maintain records concerning: (a) Financial operations; (b) Food delivery systems; (c) Food instrument issuance; (d) Equipment purchases; (e) Inventory; (f) Certification; (g) Nutrition education; (h) Civil rights; (i) Fair hearing procedures; and (j) Other information as specified by the State agency; (3) Retain all records for a minimum of 4 years following the date of submission of the final expenditure report for the period to which the report pertains; (4) Except for medical case records of individual participants, unless they are the only source of certification data, make available for review, audit, or copying during normal business hours, records for: (a) Representatives of the Comptroller General of the United States, U.S. Department of Agriculture's Office of the Inspector General, Food and Consumer Service (FCS) of the U.S. Department of Agriculture; and (b) State-authorized personnel; (5) Submit a quarterly expenditure report on a form specified by the Department within 30 days after the end of the quarter being reported; (6) Ensure that, for the purposes of an audit, the quarterly expenditure report is documented so that it can be traced to its source; and (7) Designate a person who shall certify the quarterly expenditure report as to its completeness and accuracy. B. A local agency may not divulge individual names in any report issued. C. The State agency or a local agency shall: (1) Forward Program records to the Food and Nutrition Service of the U.S. Department of Agriculture whenever either agency is disposing of them, if the Food and Nutrition Service of the U.S. Department of Agriculture considers any of the records to be of historical interest; and (2) Retain a record for nonexpendable property acquired in whole or in part with Program funds for 3 years after final disposition of the property. D. If any litigation, claim, negotiation, audit, or other action involving the records specified in §A(2) of this regulation has been started before the end of the 3-year period, a local agency shall keep the records until all issues are resolved, or until the end of the regular 3-year period, whichever is later. #### Regulation .15 Appeal Procedures. *COMAR 10.54.02.15* A local agency filing an appeal from an administrative decision made in connection with these regulations shall do so in accordance with COMAR 10.01.06. #### Regulation .16 Conflict of State and Federal Law and Regulation. *COMAR 10.54.02.16* If a provision of this chapter conflicts with a federal statute or regulation, the federal statute or regulation prevails. #### Regulation .17 Program Information Disclosure. *COMAR 10.54.02.17* A. The Food and Nutrition Service of the U.S. Department of Agriculture and the State agency reserve the right to use information obtained under the Program in a summary, statistical, or other form which does not identify an individual client. B. The Food and Nutrition Service of the U.S. Department of Agriculture and the State agency may require the local agency to supply medical data and other information collected under the Program, in a form that does not identify individual clients, to enable the United States Department of Agriculture or the State agency to evaluate the effect of food intervention upon low income individuals determined to be at nutritional risk. C. A local agency shall protect the confidentiality of information obtained from a Program applicant or participant and shall disclose this information only to: (1) An individual directly connected with the administration or enforcement of the Program, including an individual investigating or prosecuting violations in the WIC Program under federal, State, or local authority; (2) A representative of a public organization with whom the State agency has executed a written agreement pursuant to 7 CFR §246.26; and (3) The Comptroller General of the United States for audit and examination authorized by law. #### Regulation .18 Payment to a Local Agency. *COMAR 10.54.02.18* A. The funds awarded by the Department to a local agency are based on the caseload to be served and are subject to the availability of federal funds. B. Funding rates will be updated annually and available from the Department. ### Chapter 03 — Retail Food and Pharmacy Vendors **Authority:** Health-General Article, §§2-104(b), 18-107(a), and 18-108, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.21 adopted as an emergency provision effective November 1, 1995 (22:22 Md. R. 1655 and 22:23 Md. R. 1796); emergency status expired May 1, 1996 **Administrative History:** Regulations .01—.21 adopted effective May 2, 1996 (23:6 Md. R. 476) **Administrative History:** Regulations .03, .04, .07, and .10—.16 amended as an emergency provision effective November 1, 1996 (23:24 Md. R. 1679); amended permanently effective February 24, 1997 (24:4 Md. R. 292) **Administrative History:** Regulation .13 amended as an emergency provision effective July 1, 1998 (25:14 Md. R. 1128); amended permanently effective October 5, 1998 (25:20 Md. R. 1532) **Administrative History:** Chapter revised effective September 18, 2000 (27:18 Md. R. 1665) **Administrative History:** Regulations .02—.04, .06, .07, .09, .10—.13, .15, .16, .18, and .19 amended as an emergency provision effective October 1, 2002 (29:23 Md. R. 1807); amended permanently effective March 31, 2003 (30:6 Md. R. 421) **Administrative History:** Regulations .02—.04, .06, .07, .10, .11, and .14—.16 amended as an emergency provision effective December 15, 2006 (34:1 Md. R. 29); amended permanently effective April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .03B amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875); June 13, 2022 (49:12 Md. R. 640) **Administrative History:** Regulations .03B, .04C, F, .06, .10, .11, .13, .14A, .15, and .16G amended as an emergency provision effective December 22, 2004 (32:1 Md. R. 25); amended permanently effective March 14, 2005 (32:5 Md. R. 581) **Administrative History:** Regulations .03B, .04G, .09, .09-1, .10H, .11A, C, .13, .14A, and .15B, C amended as an emergency provision effective November 3, 2008 (35:24 Md. R. 2069); amended permanently effective February 9, 2009 (36:3 Md. R. 209) **Administrative History:** Regulation .03B, .09-1, .10, .13, .14A, .15B, C, .16A, B amended as an emergency provision effective October 5, 2011 (38:23 Md. R. 1416); amended permanently effective December 26, 2011 (38:26 Md. R. 1697) **Administrative History:** Regulation .04 amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875); June 13, 2022 (49:12 Md. R. 640) **Administrative History:** Regulations .04, .09-1, .10, .11A, .13, .14A, .15B, C, .16, and .19E amended as an emergency provision effective October 1, 2012 (39:22 Md. R. 1427); amended permanently effective March 4, 2013 (40:4 Md. R. 347) **Administrative History:** Regulation .04E, H amended effective April 13, 2015 (42:7 Md. R. 570) **Administrative History:** Regulation .05B amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .06 amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulations .06A, .13, .14A, .15B, C, .16B, .18E, and .19E amended as an emergency provision effective September 16, 2009 (36:21 Md. R. 1587); amended permanently effective December 14, 2009 (36:25 Md. R. 1955) **Administrative History:** Regulation .06E adopted effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .07 amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .07B, C amended effective March 13, 2017 (44:5 Md. R. 293) **Administrative History:** Regulation .07C amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .08B amended effective March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .09C amended effective March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .09E adopted effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .09-1 adopted as an emergency provision effective October 1, 2002 (29:23 Md. R. 1807); adopted permanently effective March 31, 2003 (30:6 Md. R. 421) **Administrative History:** Regulation .09-1A amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .10 amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .11 amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .11A amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); **Administrative History:** Regulation .12 repealed and new Regulation .12 adopted as an emergency provision effective December 22, 2004 (32:1 Md. R. 25); adopted permanently effective March 14, 2005 (32:5 Md. R. 581) **Administrative History:** Regulation .12A amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .13 amended effective May 12, 2014 (41:9 Md. R. 521); April 13, 2015 (42:7 Md. R. 570) **Administrative History:** Regulation .13 repealed and new Regulation .13 adopted effective March 13, 2017 (44:5 Md. R. 293) **Administrative History:** Regulation .13 amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .14 amended effective March 13, 2017 (44:5 Md. R. 293); June 13, 2022 (49:12 Md. R. 640) **Administrative History:** Regulation .14A amended effective May 12, 2014 (41:9 Md. R. 521); April 13, 2015 (42:7 Md. R. 570); October 5, 2020 (47:20 Md. October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .15 amended effective March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .15B amended effective May 12, 2014 (41:9 Md. R. 521); June 13, 2022 (49:12 Md. R. 640) **Administrative History:** Regulation .15D amended effective June 13, 2022 (49:12 Md. R. 640) **Administrative History:** Regulation .16 amended effective May 12, 2014 (41:9 Md. R. 521); March 13, 2017 (44:5 Md. R. 293); October 5, 2020 (47:20 Md. R. 875); June 13, 2022 (49:12 Md. R. 640) **Administrative History:** Regulation .18B, E amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .18C, E amended effective March 13, 2017 (44:5 Md. R. 293) **Administrative History:** Regulation .18E amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .19 amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .19A amended effective March 13, 2017 (44:5 Md. R. 293); June 13, 2022 (49:12 Md. R. 640) #### Regulation .01 Scope. *COMAR 10.54.03.01* This chapter specifies the policies and procedures for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to authorize vendors to redeem WIC food instruments and provide foods to WIC participants. #### Regulation .02 Incorporations by Reference. *COMAR 10.54.03.02* In this chapter, the following documents are incorporated by reference: A. 42 U.S.C. §1786, as amended; and B. 7 CFR 15-15b and 246, as amended. #### Regulation .03 Definitions. *COMAR 10.54.03.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Above 50 percent vendor” means a vendor that derives or will derive after commencement of business more than 50 percent of the vendor's annual eligible food sales revenue from WIC food instruments. (2) “Accounting records” means: (a) Legible records that show actual numbers of eligible food sales from the vendor and not an estimated number or percentage of eligible food sales; and (b) Actual WIC sales for each individual day. (3) “Approved foods” means the types and brands of foods: (a) Approved by the State agency for use by Program participants; (b) Included on the Maryland WIC Authorized Foods List; and (c) Included in the Approved Product List (APL). (4-1) “Approved Product List (APL)” means the electronic list of approved foods maintained by the State agency. (4-2) “Authorization” means approval by the State agency for a food store, pharmacy only, food store/pharmacy combination, or a military commissary to redeem WIC food instruments as a vendor. (4-3) “Benefits” means the foods prescribed and services provided to a participant by the Program. (5) “Change in ownership” means the transfer of majority control or ownership of a store. (6) “Compliance buy” means a covert, on-site investigation in which a representative of the Program: (a) Poses as a: (i) Participant; (ii) Parent, guardian, or caretaker of an infant or child participant; or (iii) Proxy; (b) Presents one or more food instruments to be redeemed for food; and (c) Does not reveal during the visit that the individual is a Program representative. (7) “Day” means a calendar day. (8) “Disqualification” means revocation of a vendor's WIC authorization for a specified period of time as prescribed in Regulation .16 of this chapter. (9) “Excess charges” means the amount above the maximum price payable for the food benefits charged by a vendor to the Program. (10) “Exempt infant formulas” means those infant formulas available, which are not categorized as either contract or noncontract, standard infant formulas. (11) “Food instrument” means an electronic benefits issuance card or other document that is used to obtain supplemental foods. (12) “Food package” means a grouping of specified types and amounts of foods, as set forth in Regulation .06A of this chapter, used for the purpose of evaluating vendor prices. (13) “Food sales” means sales of all SNAP eligible foods intended for home preparation and consumption, as set forth in 7 CFR §246.2. (14) “Food store” means a grocery or supermarket licensed under COMAR 10.15.03 that ordinarily has, for sale to the public, authorized foods and does not have a pharmacy under the same ownership on its premises. (15) “Food store/pharmacy combination” means a food store and a pharmacy under the same ownership on the same premises. (16) “High risk” means a vendor has been determined by the State agency to have a high probability of violating program requirements. (17) “Inventory audit” means an audit conducted over a specific period of time in order to determine whether a vendor’s claimed reimbursement for the sale of an amount of a specific food item exceeds the vendor’s documented inventory of that item. (18) “Inventory invoices” mean sales receipts for WIC food purchased by the vendor for resale by the vendor, from a supplier which can be a wholesaler, distributor, manufacturer, or other retailer. (19) “Maximum price payable” means the maximum amount of money the Program will pay a vendor for the WIC food items on the food instrument. (20) “Medical foods” means WIC-eligible formula authorized for children and women with special dietary needs. (21) “Minimum required stock” means the specific types and amounts of WIC-authorized foods that shall be in a vendor's store during business hours. (22) “Monitoring” means assessing vendor compliance with program requirements. (23) “Nonprofit entity” means a vendor applicant or vendor whose business has been granted a 26 U.S.C. §501(c)(3) federal income tax exemption by the United States Internal Revenue Service. (24) “On-site review” means an inspection of a vendor applicant's premises by a Program representative to ensure that requirements for authorization are met. (25) “Participant” means a pregnant woman, a breastfeeding woman, a postpartum woman, an infant, a breastfed infant of a participant breastfeeding woman, or a child receiving supplemental foods or food benefits from the Program. (26) “Pattern” means two or more vendor violations of the same provision. (27) “Peer group” means a grouping of stores with similar characteristics and business practices that correlate to food costs. (28) “Peer group average” means the arithmetic mean of prices charged by vendors within a peer group for food items. (29) “Pharmacy only” means an establishment that: (a) Has been issued a permit to operate by the State Board of Pharmacy; and (b) Does not have a food store under the same ownership on its premises. (29-1) “PIN” means a personal identification number used to securely access benefits on the food instrument. (30) “Program” means the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) authorized by 42 U.S.C. §1786, the Child Nutrition Act of 1966, as amended, including the local, State, and federal entities that administer it. (31) “Proxy” means an individual who is designated by a participant or a child, or infant participant’s parent, guardian, or caretaker to receive food instruments and to redeem food benefits for the participant and whose name is on file at a local agency. (32) “Region” means a designated area of the State for administration of the WIC Program including vendor selection and peer group designation. (33) “Standard infant formulas” means nutritionally complete infant formulas which do not require the addition of any ingredient other than water before being served in a liquid state and which supply at least 10 milligrams of iron per liter at standard dilution and approximately 20 kilocalories per fluid ounce at standard dilution. (34) “State agency” means the Maryland Department of Health's WIC Program. (35) “Store” means a food store, pharmacy, food store/pharmacy combination, or military commissary. (36) “Supplemental Nutrition Assistance Program (SNAP)” means the federal program administered by the United States Department of Agriculture that provides financial assistance for purchasing food. (37) “Traffic” means to buy or sell a food instrument or benefits for cash. (38) “Universal Product Code (UPC)” means a unique barcode assigned to a trade item and used to track items for sale in stores, such as food. (39) “USDA” means the United States Department of Agriculture. (40) “Vendor” means a sole proprietorship, partnership, cooperative association, corporation, or other business entity operating one or more stores authorized by the State agency to provide authorized supplemental foods to participants under a retail food delivery system. (41) “Vendor agreement” means a written agreement between the State agency and a vendor concerning the duties and responsibilities of the vendor and the State agency with respect to a vendor's participation in the WIC Program. (42) “Vendor applicant” means a sole proprietorship, partnership, cooperative association, corporation, or other business entity operating one or more stores that has applied to the State agency for WIC authorization. (43) “Vendor price list form” means the form used by the State agency to collect a vendor's shelf prices for WIC food items. (44) “Vendor’s price” means the cost of a food package listed in Regulation .06A of this chapter as calculated from actual lowest shelf prices collected by the State agency during an on-site visit. (45) “WIC” means the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) as authorized by 42 U.S.C. §1786, the Child Nutrition Act of 1966, as amended. (46) “WIC-authorized foods list” means a list of foods authorized by the Maryland WIC program for purchase by Maryland WIC participants. (47) “WIC Management Information System” means the WIC Program's software application, which provides: (a) Client services; (b) Financial management; and (c) Vendor compliance oversight. #### Regulation .04 Authorization Requirements. *COMAR 10.54.03.04* A. A store shall obtain authorization to operate as a WIC vendor from the State agency before redeeming food benefits. B. A store: (1) May not redeem WIC food benefits unless the store is authorized as a WIC vendor by the State agency; (2) Constitutes a separate vendor and shall be authorized separately from other stores operated by the same business entity; and (3) Shall have a single, fixed location. C. In order to receive authorization from the State agency, a vendor shall: (1) Submit a completed vendor application package as set forth in Regulation .07 of this chapter to the State agency; (2) Have in its store from the time of application the minimum required stock as set forth in Regulation .14 of this chapter; (3) Post shelf prices for all WIC-approved foods at, on, or near the food items; (4) Comply with applicable federal and State laws and regulations; (5) Maintain the store premises in a sanitary condition with no evidence of: (a) Excess trash; (b) Vermin; or (c) General lack of cleanliness; (6) Be accessible to persons with disabilities; (7) Successfully complete an on-site review as set forth in Regulation .08 of this chapter; (8) Have a management representative attend a training session offered by the State agency; (9) Be authorized by SNAP; and (10) Be in good standing with SNAP and have not: (a) Been disqualified; (b) Been suspended; (c) Been issued a charge or adverse action letter; (d) Filed an appeal; or (e) Been assessed a civil money penalty within the 24 months prior to the date of application. D. In order to receive authorization from the State agency, a vendor applicant may not: (1) Have owners, officers, or managers that have been indicted for, convicted of, or have had a civil judgment entered against them for any activity indicating a lack of business integrity; (2) Currently be under disqualification by the State agency; (3) Owe money to the State agency; or (4) Derive or derive after commencement of business more than 50 percent of the vendor’s or applicant’s annual eligible food sales revenue from food purchased with WIC food instruments, with the exception of: (a) A nonprofit entity; or (b) An above 50 percent vendor the State agency has authorized for participant access reasons. E. Pursuant to Regulation .19 of this chapter, if the State agency determines that a participant hardship exists, where access to special infant formula and WIC-eligible medical foods are not available through a food/pharmacy combination store, the State agency, at its sole discretion, may authorize a pharmacy only vendor that shall: (1) Adhere to the requirements set forth in §C(1) and (3)—(8) of this regulation; (2) Hold a current permit to operate as a pharmacy issued by the State Board of Pharmacy; (3) Only accept WIC food instruments prescribing exempt infant formula and WIC-eligible medical foods; and (4) Upon request by a participant, provide exempt infant formulas and WIC-eligible medical foods within 48 hours, excluding weekends and holidays. F. Except for a pharmacy only or military commissary, a vendor applicant shall have actual lowest current shelf prices that are less than or equal to 125 percent of the peer group average in the vendor applicant’s region during the month of application, as determined by the State agency for each of the food packages set forth in Regulation .06A of this chapter. G. A vendor applicant may not apply for authorization in order to circumvent sanctions imposed by SNAP or the State agency on a previous vendor. H. The vendor applicant shall provide to the State agency documents that demonstrate the vendor applicant has submitted the application in good faith including but not limited to: (1) A copy of the sales agreement including but not limited to the sales price; (2) Names and addresses of the owners, directors, managers, and other decision makers of the store, including whether any of these people are related to the vendor who has been sanctioned; and (3) A copy of the lease or deed for the store. I. In order to determine whether the vendor applicant seeks authorization in order to circumvent sanctions imposed on a vendor by the State agency, the State agency shall review the totality of the circumstances and may consider whether the: (1) Vendor applicant is related to the former vendor; (2) Former vendor or a relative of the former vendor is involved in the operation of the store; (3) Former vendor or a relative of the former vendor is a director, officer, or otherwise part of the entity that will own the store; and (4) Business was sold for fair market value. J. A store can be reassessed at any time during the authorization period to ensure that it meets the current vendor authorization requirements as set forth in this regulation. K. A vendor applicant denied authorization three times in a 12-month period may not reapply until after 12 months have passed since the last denial date. #### Regulation .05 Requirements for Military Commissaries. *COMAR 10.54.03.05* A. The State agency shall authorize a military commissary vendor applicant that complies with the requirements of §B of this regulation. B. To become an authorized WIC vendor, a military commissary shall complete and sign a vendor agreement based on the memorandum of understanding jointly prepared by the USDA and the United States Department of Defense, in place of the vendor agreement defined in Regulation .03B of this chapter. #### Regulation .06 Food Packages for Peer Group Price Calculation. *COMAR 10.54.03.06* A. The State agency shall group the food items on the vendor price list form into the following food packages: (1) Foods for an infant 4 months old or older but younger than 13 months old: (a) 31 13-fluid-ounce cans of concentrated liquid infant formula with iron as specified in the WIC infant formula rebate contract; (b) 24 ounces of dry infant cereal; and (c) 128 ounces of infant vegetables and fruit; (2) Foods for a child 1 year old or older but younger than 5 years old: (a) 3 gallons and 1 quart of fluid milk; (b) 1 dozen large eggs; (c) 36 ounces of dry cereal; (d) 128 fluid ounces of single-strength canned juice; (e) 18 ounces of peanut butter; (f) 1 pound of cheese; and (g) 2 pounds of whole wheat bread, brown rice, or soft corn tortillas; (3) Foods for a breastfeeding woman: (a) 5 gallons and 1 quart of fluid milk; (b) 2 dozen large eggs; (c) 36 ounces of dry cereal; (d) 36 ounces frozen juice concentrate; (e) 18 ounces of peanut butter; (f) 2 pounds of cheese; (g) 30 ounces of tuna, salmon, or sardines; and (h) 16 ounces of dried beans; and (4) Foods for a nonbreastfeeding, postpartum woman: (a) 3 gallons and 1 quart of fluid milk; (b) 1 dozen large eggs; (c) 36 ounces of dry cereal; (d) 24 fluid ounces of single-strength frozen juice concentrate; and (e) 1 pound of cheese. B. The State agency shall calculate monthly the peer group average in Peer Groups 1—18 for each food package set forth in §A of this regulation by adding together the average food instrument price and average cost of food items that make up a food package and dividing that sum by the total number of food store and food store/pharmacy combination vendors in the region. C. The State agency shall provide, upon request, the current peer group average in Peer Groups 1—19 for each food package in §A of this regulation. D. The State agency shall compile the peer group averages for the food packages in §A of this regulation based upon redemption data provided by the WIC Management Information System. #### Regulation .07 Vendor Application Package and Dates. *COMAR 10.54.03.07* A. The State agency shall provide an application package to a vendor that requests it. B. The application package shall consist of the following: (1) An overview of the WIC Program; (2) The minimum requirements for authorization; (3) The WIC Authorized Foods List; (4) The Minimum Required Stock List; (5) The Application Checklist; (6) The eWIC Readiness Assessment; (7) The Vendor Application Price List; (8) The Authorized Infant Formula and Medical Foods Supplier Directory; (9) Instructions for completing the application for vendor authorization; (10) An application for vendor authorization; and (11) Two vendor agreements. #### Regulation .08 On-Site Review of Vendor Applicants. *COMAR 10.54.03.08* A. A military commissary is exempt from State on-site reviews. B. Except as provided in §A of this regulation, the State agency shall conduct an unscheduled on-site review of a vendor applicant’s store within 60 days of receipt of an application to ensure that the store meets the requirements for authorization as set forth in Regulation .04C(1)—(6) and .04D of this chapter. #### Regulation .09 Grant, Retention, and Denial of Authorization. *COMAR 10.54.03.09* A. The State agency shall grant or deny authorization to a vendor applicant within 60 days of receipt of an application. B. Authorization Granted. The State agency shall grant authorization if the vendor applicant's store meets the requirements for authorization as set forth in Regulation .04 of this chapter. C. Authorization Retained. A vendor retains its authorization until the: (1) Vendor’s authorization is terminated as a sanction for a Program violation in accordance with this chapter; (2) State agency terminates the vendor's authorization in accordance with the provisions of the vendor agreement; (3) Vendor notifies the State agency it wishes to cease operation as a WIC vendor; (4) Authorization period as contained in the vendor agreement has expired; or (5) Vendor is determined, in accordance with Regulation .10H of this chapter, to derive more than 50 percent of its eligible food sales from the redemption of WIC food benefits. D. Authorization Denied. (1) The State agency shall deny authorization if a vendor applicant's store does not meet the minimum requirements for authorization as set forth in Regulation .04 of this chapter. (2) Upon denial of an application, the State agency shall notify a vendor applicant: (a) In writing of the reason for denial of its application; and (b) Of its right to request a hearing on the denial as set forth in Regulation .18 of this chapter. E. Authorization Period. (1) The State agency, in accordance with 7 CFR 246.12, may not authorize a vendor for a period exceeding 3 years. (2) The State Agency, at its discretion, may authorize a vendor for a period less than 3 years. #### Regulation .09-1 Price Determinations. *COMAR 10.54.03.09-1* A. The WIC Program shall calculate peer group averages according to the peer groups set forth in Regulation .03B(33)—(38) of this chapter. B. The WIC Program may implement price determinations that are applicable statewide, or to specific peer groups, provided that vendors receive 30 days notice of the intended determination. #### Regulation .10 Food Package Prices After Authorization. *COMAR 10.54.03.10* A. After authorization, a vendor, other than a pharmacy only or military commissary, shall maintain prices for each of the food packages set forth in Regulation .06A of this chapter that are less than or equal to 125 percent of the peer group average for each food package. B. Upon request of the State agency, a vendor, other than a pharmacy or military commissary, shall submit on the vendor price list form its lowest shelf prices for WIC-authorized foods to the State agency. C. The State agency shall notify a vendor, other than a pharmacy only or a military commissary, that fails to submit its prices on the vendor price list form when requested to do so that, if the price list form is not received by the Program within 10 business days of the State agency’s request, the vendor’s authorization shall be terminated for 12 months from the date of disqualification. D. If a vendor, other than a military commissary, submits prices on the vendor price list form that make its food package price more than 125 percent of the peer group average for that food package, or the food package prices are determined by the WIC Management Information System calculation to exceed 125 percent of the peer group average, the State agency shall notify the vendor that: (1) Its price submission or food package price calculation is unacceptable; (2) It shall lower its actual lowest shelf prices for the WIC foods and resubmit the vendor price list form to the State agency within 10 days following the notification; and (3) If the vendor’s resubmitted prices indicate that a food package will cost the Program more than 125 percent of the peer group average for that food package, the State agency may disqualify the vendor for 12 months from the date of disqualification. E. If, at any time, a vendor, other than a military commissary, has actual lowest shelf prices that make any food package price more than 125 percent of the peer group average, the State agency shall notify the vendor that: (1) The vendor shall lower its actual lowest shelf prices for the WIC foods within 10 days; and (2) If the vendor’s prices remain so that a food package will cost the Program more than 125 percent of the peer group average, the vendor’s authorization shall be terminated for 12 months from the date of disqualification. F. If, in 2 consecutive reporting months, a vendor, other than a pharmacy only or a military commissary, is determined by the WIC Management Information System calculation to have food package prices that exceed 125 percent of the peer group average, the vendor’s authorization shall be terminated for 12 months from the date of disqualification. G. The State agency may request that a vendor, other than a pharmacy only or a military commissary, submit semi-annual price lists at the State agency’s sole discretion and may use these price lists and the WIC Management Information System for calculation of excess charges if it is determined that excess charges have occurred. H. For the purpose of cost containment, the State agency shall assign to an above 50 percent vendor peer group a vendor that is determined by the State agency, through a comparison of the vendor's gross annual sales, SNAP eligible sales, and WIC redemptions, to derive more than 50 percent of the vendor's eligible food sales revenue from the redemption of WIC food instruments. I. A vendor that has been determined to derive more than 50 percent of its eligible food sales revenue from the redemption of WIC food instruments will only be paid at the statewide average of all other non-above 50 percent vendors. J. For the purpose of cost containment, the State agency: (1) Shall use the methodology provided by the U.S. Department of Agriculture, Food Nutrition Service to ascertain whether or not the vendor derives more than 50 percent of the vendor’s eligible food sales revenue from the redemption of WIC food instruments; and (2) May reject information submitted by a vendor to demonstrate that it does not derive more than 50 percent of the vendor’s eligible food sales revenue from the redemption of WIC food instruments. #### Regulation .11 Maximum Reimbursement to Vendors. *COMAR 10.54.03.11* A. Food Store, Food Store/Pharmacy Combination, and Pharmacy Only Vendors. The State agency shall establish a maximum price payable for each WIC-approved food item, which shall be calculated as follows: (1) Based on the WIC Management Information System calculation, the State agency shall determine every month the peer group average for each WIC-approved food item; and (2) Except as provided in §C of this regulation, the maximum price payable for a food instrument prescribing infant formula shall be: (a) Equal to 125 percent of the peer group averages as determined by the WIC Management Information System calculation for the individual food items on the food instrument; or (b) Limited to an amount determined by the Program. B. Military Commissaries. The maximum price payable by the State agency for a food item redeemed by a military commissary is the price charged by the military commissary. C. The maximum price payable to vendors that are determined to derive more than 50 percent of their annual sales revenue from the redemption of WIC food benefits may not exceed the Statewide average price per food item paid to all other vendors. #### Regulation .12 Recovery of Excess Charges. *COMAR 10.54.03.12* A. The State agency, through prepayment and post payment edit review of WIC redemptions, shall ensure that excess charges do not occur. B. If the State agency determines that excess charges have occurred as a result of software, bank, or other error, the State agency reserves the right to bill a vendor for excess charges. C. The State agency may not bill a vendor if the vendor's excess charges total $25 or less. #### Regulation .13 WIC-Authorized Foods. *COMAR 10.54.03.13* A. The State agency shall: (1) Maintain the WIC-authorized foods list; (2) Make the list available to all participants and authorized WIC vendors; and (3) Maintain the APL. B. A vendor shall keep a copy of the Program’s current WIC-authorized foods list: (1) At each cash register where WIC transactions are handled; and (2) On-site at the authorized vendor location along with the vendor manual. C. The WIC-authorized foods list shall be used in conjunction with the APL to identify foods items that are eligible for purchase using WIC food instruments. D. Food instruments may require that program participants purchase specific manufacturers or brands that are not included in the WIC-authorized foods list. E. Authorized vendors shall sell WIC-approved brands for food categories identified in the WIC-authorized foods list and the APL. #### Regulation .14 Minimum Required Stock. *COMAR 10.54.03.14* A. A food store or food store/pharmacy combination vendor with four or more cash registers shall maintain on the store premises, available for immediate purchase by a WIC participant during regular business hours, the following minimum required stock: (1) Fluid milk: (a) 4 gallons whole; and (b) 6 gallons 1-percent or fat-free; (2) 6 dozen medium or large white or brown eggs; (3) Domestic cheese: (a) Four varieties; (b) A total of 6 pounds; (c) 8 or 16-ounce packages only; and (d) Block, shredded, stick, string, cubed, cracker cuts, or sliced; (4) Unsweetened 100-percent juice: (a) Two varieties; and (b) Six 64-ounce containers; (5) Frozen concentrate unsweetened 100-percent fruit juice: (a) Two varieties; and (b) Six 11.5—12-ounce cans or 48-ounce containers; (6) 32 total infant fruits and vegetables: (a) Two varieties of each; (b) 16 4-ounce containers of each; and (c) Plain, a combination of fruits, a combination of vegetables, or a combination of fruits and vegetables; (7) Infant meats: (a) Six 2.5-ounce jars; and (b) One variety of plain meat; (8) Dry cereal: (a) Corn, wheat, oats, or rice: (i) Six 12-ounce or larger containers; and (ii) Two varieties; (b) Whole grain wheat or oats: (i) Six 12-ounce or larger containers; and (ii) Two varieties; and (c) At least one hot cereal in an 11.8-ounce container or larger; (9) Infant cereal: (a) Six 8-ounce or 16-ounce containers dry; (b) Two varieties; and (c) At least one variety of rice; (10) Peanut butter: (a) One brand; and (b) Six 16—18-ounce containers; (11) Beans: (a) Three 1-pound bags dry type in two varieties; and (b) 12 15—16-ounce packed in water cans in three varieties; (12) Canned fish: (a) 30-ounces total and packed in water; and (b) Two varieties of: (i) Canned chunk light tuna in 5—6-ounce cans; (ii) Pink salmon in 5—7.5-ounce or 14.75-ounce cans; and (iii) Sardines in 3.75-ounce cans; (13) Fruits and vegetables: (a) A total value of $32; (b) Two varieties of fruits, fresh, whole or cut, loose or prepackaged, frozen or canned; and (c) Two varieties of vegetables, fresh, whole or cut, loose or prepackaged, frozen or canned; (14) Bread, rolls, tortillas, pasta, rice, and oats in two varieties and a total of 4 pounds: (a) 100 percent whole grain or whole wheat bread, 16-ounce packages; (b) 100 percent whole grain or whole wheat rolls, 15—16-ounce packages; (c) Dry, plain brown rice, 16-ounce packages; (d) Soft corn or whole wheat tortillas, 16-ounce packages; (e) Whole grain or whole wheat pasta, 16-ounce packages; or (f) 100-percent oats, 16-ounce packages; and (15) Infant formula: (a) 15 12.4-ounce containers, or containers of the currently authorized size, of powdered infant formula as specified by the WIC infant formula rebate contract; and (b) Four 12.4-ounce containers, or containers of the currently authorized size, of soy-based powdered infant formula as specified by the WIC infant formula rebate contract. B. A food store or food store/pharmacy combination vendor with one to three cash registers shall maintain on the store premises, available for immediate purchase by a WIC participant during regular business hours, the following minimum required stock: (1) Fluid milk: (a) 2 gallons whole; and (b) 3 gallons 1-percent or fat-free; (2) 6 dozen medium or large white or brown eggs; (3) Domestic cheese: (a) Two varieties; (b) A total of 3 pounds; (c) 8 or 16-ounce packages only; and (d) Block, shredded, stick, string, cubed, cracker cuts, or sliced; (4) Unsweetened 100-percent fruit juice: (a) Two varieties; and (b) Three 64-ounce containers; (5) Frozen concentrate unsweetened 100-percent juice: (a) One variety; and (b) Three 11.5—12-ounce cans or three 48-ounce containers; (6) 20 total infant fruits and vegetables: (a) Two varieties of each; (b) 10 4-ounce containers of each; and (c) Plain, a combination of fruits, a combination of vegetables, or a combination of fruits and vegetables; (7) Dry cereal: (a) Corn, wheat, oats, or rice: (i) Three 12-ounce or larger containers; and (ii) One variety; (b) Whole grain wheat or oats: (i) Three 12-ounce or larger containers; and (ii) One variety; (8) Infant cereal: (a) Three 8-ounce or 16-ounce containers dry; and (b) One variety; (9) Peanut butter: (a) One brand; and (b) Three 16—18-ounce containers; (10) Beans. Two varieties of five 15—16-ounce cans packed in water; (11) Canned fish: (a) 15 ounces total and packed in water; and (b) One variety of: (i) Canned chunk light tuna in 5—6-ounce cans; (ii) Pink salmon in 5—7.5-ounce or 14.75-ounce cans; and (iii) Sardines in 3.75-ounce cans; (12) Fruits and vegetables: (a) A total value of $16; (b) One variety of fruits, fresh, whole or cut, loose or prepackaged, frozen or canned; and (c) One variety of vegetables, fresh, whole or cut, loose or prepackaged, frozen or canned; (13) Bread, rolls, tortillas, pasta, rice and oats in two varieties and a total of two pounds: (a) 100-percent whole grain or whole wheat bread, 16-ounce packages; (b) 100-percent whole grain or whole wheat rolls, 15—16-ounce packages; (c) Dry, plain brown rice, 16-ounce packages; (d) Soft corn or whole wheat tortillas, 16-ounce packages; (e) Whole grain or whole wheat pasta, 16-ounce packages; or (f) 100-percent oats, 16-ounce packages; and (14) Infant Formula. Seven 12.4-ounce containers, or containers of the currently authorized size, of powdered infant formula as specified by the WIC infant formula rebate contract. C. A pharmacy only or food store/pharmacy combination vendor shall provide exempt formulas, or WIC-eligible medical foods within 48 hours, excluding weekends and holidays, for a request by a participant or the Program. #### Regulation .15 Required Vendor Practices. *COMAR 10.54.03.15* A. The State agency or its representative shall conduct inventory audits, compliance buys, and monitoring to ensure that authorized vendors comply with required vendor practices. B. General Requirements. (1) A vendor shall: (a) Maintain on the store premises, available for immediate purchase by a WIC participant during regular business hours, the minimum required stock; (b) Post the State agency’s WIC sign at the front of the store or in a conspicuous place on the store premises and use other materials provided or approved by the WIC program; (c) Maintain the vendor premises in a sanitary condition with no evidence of: (i) Excess trash; (ii) Vermin; or (iii) General lack of cleanliness; (d) Display a current food service facility license, issued by the local health department or department of environment, or if a pharmacy only or a food store/pharmacy combination, a pharmacy permit issued by the State Board of Pharmacy, in a location visible to Program representatives; (e) Train vendor personnel in WIC policies and procedures; (f) Display the shelf price of a WIC food at, on, or near the item; (g) Treat individuals redeeming food instruments the same as other customers; (h) Submit information requested by the State agency by the date requested; (i) Attend a WIC training that has been required by the Program for a vendor with a high rate of: (i) Errors; (ii) Rejected transactions; (iii) Complaints; or (iv) Other minor violations; (j) Provide WIC foods in a store at a fixed location; (k) If a pharmacy only or a food store/pharmacy combination: (i) Upon request by a participant or the Program, provide infant formulas and medical foods within 48 hours, excluding weekends and holidays; (ii) Only accept the food instrument after obtaining the requested formula; and (iii) If a pharmacy only vendor, only accept food instruments prescribing infant formula and WIC-eligible medical foods; (l) Maintain accounting records that are relevant to the vendor’s performance under the vendor agreement for 3 years, for review at reasonable times by State agency representatives or other authorized State or federal officials; (m) If a SNAP vendor, remain in good standing and not: (i) Be disqualified; (ii) Be suspended; (iii) Have been issued a charge or adverse action letter; (iv) Have filed an appeal; or (v) Have been assessed a civil money penalty; (n) Give 30 days notice to the State agency of the store's closing, relocation, or change in ownership; (o) Pay, by the date due, money penalties imposed by the State agency and overcharges; (p) Submit the vendor price list form when requested to do so by the State agency; (q) For the food packages set forth in Regulation .06A of this chapter, maintain prices that are less than or equal to 125 percent of the peer group average as determined by the WIC Management Information System calculation for each food package; (r) Have a representative attend and participate in an annual vendor training session once every 12 months, if the State agency: (i) Gives the vendor 14 days notice of a scheduled training session; and (ii) Holds the training session in the vendor’s region or offers the training session virtually; (s) If more than 30 days are needed to reopen the vendor’s business in the same location, reapply for authorization and be approved as a WIC vendor in order to obtain authorization to operate as a WIC Vendor; and (t) Maintain an active email account that is monitored no less than once a week. (2) A vendor may not: (a) Charge WIC participants a higher price for food than other customers; (b) Violate the nondiscrimination provisions of federal regulations in 7 CFR 15, 15a, and 15b, as incorporated by reference in Regulation .02 of this chapter; (c) Provide false information to the Program; (d) Except for a pharmacy or military commissary, process fewer than 25 WIC transactions in a consecutive 3-month period; (e) Intentionally submit false prices on the vendor price list form; (f) Use the WIC acronym or WIC logo, or close facsimiles, in the name of the vendor or in advertising or other promotional materials; (g) Apply stickers, tags, or labels that have the WIC acronym or logo on WIC-approved foods; (h) Use manufacturer supplied shelf tags, talkers, or labels that make unauthorized use of the WIC acronym or logo; (i) Apply WIC-approved shelf tags to nonapproved foods; or (j) Derive more than 50 percent of its annual SNAP eligible foods sales from WIC food benefits. (3) Accounting Records. Accounting records shall include, but are not limited to: (a) Sales and use tax returns; (b) U.S. individual or business tax returns; (c) Daily sales journals or daily ledgers; (d) Sales receipts or register tape; (e) Inventory invoices; and (f) A breakdown of sales between SNAP eligible foods and non-eligible foods. (4) Inventory Invoices. (a) Inventory invoices shall include the: (i) Name and address of the supplier; (ii) Date of purchase; (iii) Description of the exact food items purchased, including size, stock number, and UPC code if available; (iv) Unit price of the food items; (v) Total quantity purchased; and (vi) If inventory invoices do not completely describe the actual food item, verifiable computer codes for the item. (b) Inventory invoices or purchase receipts for infant formula shall only be accepted from those wholesalers, distributors, and manufacturers listed on Maryland’s Authorized Infant Formula and Medical Foods Supplier Directory. (5) A vendor who violates the provisions set forth in this section is subject to the sanctions in Regulation .16 of this chapter. C. Transactional Requirements. (1) A vendor shall: (a) Provide authorized foods to an individual redeeming food benefits only upon presentation of a valid food instrument; (b) Accept the WIC food instrument with a valid PIN as identification without requiring another form of identification; (c) At the time of purchase, give a participant a receipt indicating the store name, date of transaction, and total dollar amount for items purchased with a food instrument and that the sale was a WIC transaction; (d) Provide the WIC participant with a shopping list of remaining benefits upon request; (e) Accept a food instrument only for authorized food brands, quantities, and types and as prescribed on the food instrument; (f) Accept cents-off coupons from an individual redeeming WIC food instruments for prescribed approved foods and deduct savings from the purchase price; (g) Allow the use of bonus or club cards, buy one, get one free, and any other promotion offered to store customers that does not involve cash back; (h) Accept a valid food instrument as payment in full for the prescribed WIC foods purchased; (i) Allow participants and proxies authorized to redeem food benefits a choice of the WIC-approved foods in the participant’s benefits balance; (j) Allow the purchase of the full amount or less than the full amount of food on a food instrument; (k) Redeem valid food instruments presented by a participant or proxy; (l) Scan the actual UPC code that is affixed to the item being purchased by the WIC participant; (m) Allow the participant to pay the difference when a fruit and vegetable purchase exceeds the value of the cash value benefit; and (n) Obtain infant formula only from manufacturers, distributors, and wholesalers listed on Maryland’s Authorized Infant Formula and Medical Foods Supplier Directory, as available on the Program’s website. (2) A vendor may not: (a) Ask a participant or proxy for the PIN securing their food instrument; (b) Redeem food benefits for spoiled or out-of-date food; (c) Redeem food benefits in whole or in part for a non-food item or credit; (d) Issue a rain check that would allow an individual redeeming a food benefit to get, at a later date, an item the vendor does not have at the time the food instrument is presented; (e) Transfer cash in the form of change from the food benefit to an individual redeeming a food instrument; (f) Collect sales tax on WIC food purchases; (g) Traffic in WIC food instruments or benefits; (h) Sell alcohol, alcoholic beverages, or tobacco products in exchange for a food instrument or benefits; (i) Accept a food instrument or benefits in exchange for: (i) Ammunition; (ii) A firearm; (iii) An explosive; or (iv) A controlled substance as defined by 21 U.S.C. §802; (j) Manually key in a food instrument number without an actual food instrument being presented; or (k) Scan UPC codes from: (i) Codebooks; (ii) Reference sheets; or (iii) Lists. (3) A vendor may not provide solely to participants incentive items or other free merchandise, including food. (4) A vendor who violates the provisions of this section is subject to the sanctions in Regulation .16 of this chapter. D. Post-Transactional Requirements. (1) A vendor shall: (a) Notify the Program of attempted or actual misuse of WIC food instruments by a participant or other individual; (b) Receive reimbursement only for approved benefits redeemed at the vendor’s store; (c) Charge the State agency only for approved food received by a participant; (d) Reimburse the Program for the loss sustained by the Program due to theft, fraud, or improper handling of food instruments by vendor personnel or agents; and (e) Surrender lost or stolen food instruments to WIC representatives upon request. (2) A vendor may not: (a) Permit the return of food purchased with a food instrument in exchange for cash or another item; (b) Claim reimbursement for the sale of an amount of a specific food item that exceeds the vendor’s documented inventory of that item for a specific period of time; or (c) Claim reimbursement for vendor bank fees. (3) A vendor who violates the provisions of this section is subject to the sanctions in Regulation .16 of this chapter. #### Regulation .16 Vendor Sanctions. *COMAR 10.54.03.16* A. The Program may sanction a vendor that fails to comply with a required practice in Regulation .15B(1)(a)—(l), (n)—(q), and (t) and (2)(b) and (e)—(i), C(1)(a)—(n), (2)(a), (b), (d)—(f), (j), and (k), and (3), and D(1)(a) and (e) and (2)(a) and (c) of this chapter as follows: (1) Written warning following each violation; and (2) Disqualification for 1 year for a pattern of violations of the same provisions within a 12-month period. B. The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15C(2)(h) of this chapter by disqualifying the vendor for 3 years. C. The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15C(2)(g) or(i) of this chapter by disqualifying the vendor for 6 years. D. The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15C(2)(g) or(i) of this chapter by permanent disqualification if the vendor is convicted in a criminal court of charges stemming from those violations. E. The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15B(2)(a), C(2)(c) or (f), or D(1)(b) or (c) or (2)(b) of this chapter by: (1) A written warning if one violation is detected in any 12-month period; or (2) Disqualifying the vendor for 3 years for two or more violations of the same provision in any 12-month period. F. When a vendor that has previously received a sanction for violation of the provisions of Regulation .15B(2)(a), C(2)(c) or (f), or D(1)(b) or (c) or (2)(b) of this chapter, the Program shall impose a 6-year disqualification for violation of the same provision. G. Disqualification. (1) Except in circumstances described in §G(2) of this regulation, the Program shall disqualify a vendor that has been disqualified by SNAP in violation of Regulation .15B(1)(m) of this chapter for the same length of time as SNAP disqualification. (2) If disqualification of the vendor will result in inadequate participant access in accordance with Regulation .19 of this chapter, the State agency shall impose a civil money penalty in lieu of disqualification. (3) Except in circumstances described in §G(4) of this regulation, the Program shall disqualify a vendor that has been assessed a civil money penalty for hardship by SNAP instead of disqualification by SNAP in violation of Regulation .15B(1)(m) of this chapter, for the same period for which the vendor would otherwise have been disqualified by SNAP. (4) If disqualification of a vendor that has been assessed a civil money penalty for hardship by SNAP instead of disqualification by SNAP would result in inadequate participant access in accordance with Regulation .19 of this chapter, the Department may not: (a) Disqualify the vendor; or (b) Impose a civil money penalty in lieu of disqualification. H. The Program may not accept a vendor's voluntary cancellation of the vendor's authorization in lieu of a disqualification. I. The Program shall sanction a vendor that fails to comply with a required practice in Regulation .15B(1)(r) or (s) or (2)(c), (d), or (j) or D(1)(d) of this chapter by terminating the vendor agreement. J. The State agency shall notify the USDA of a disqualification or money penalty: (1) Within 15 days after the vendor's opportunity to request an administrative appeal has expired; or (2) After the vendor's administrative appeals have been exhausted. K. If a vendor is disqualified or has been assessed a money penalty because of multiple violations in a single investigation, the Program shall: (1) Sanction the vendor for the single most serious violation; and (2) Include the following in its notice to USDA: (a) The vendor's: (i) Name; (ii) Address; and (iii) Identification number; (b) The length of any disqualification; (c) The specific violations charged; and (d) The amount of any money penalty. L. Upon completion of the period of disqualification a vendor shall regain authorization after successfully completing the authorization process as set forth in Regulation .04 of this chapter. M. Military Commissaries. The Program: (1) May not sanction military commissaries for Program violations; and (2) Shall report a sanctionable offense committed by a military commissary to the commanding officer of the installation and, if the commanding officer takes no action to ensure the violation does not recur, to the USDA. N. Any adverse action taken by SNAP will be reciprocated by the Program to include disqualification and if applicable, imposing a civil money penalty. #### Regulation .17 Additional Penalties for Program Violations. *COMAR 10.54.03.17* In addition to the State agency sanctions set forth in Regulation .16 of this chapter, and pursuant to 7 CFR §§246.12(f)(xiv) and 246.23(d), a vendor that commits fraud and abuse of the Program may be liable to prosecution under federal, State, and local laws. #### Regulation .18 Vendor Appeals. *COMAR 10.54.03.18* A. Except as otherwise provided in this regulation, the procedures set forth in COMAR 10.01.03, and not the procedures set forth in COMAR 10.01.06, govern appeals by vendors and vendor applicants. B. Notice. (1) Not less than 15 days in advance of the effective date of the proposed Program action, the Program shall provide notice to a vendor applicant, or vendor whose application is proposed to be denied or authorization is proposed to be disqualified, on the right to a hearing on the proposed denial or disqualification. (2) The Program shall provide notice that complies with the requirements set forth in COMAR 10.01.03. C. Request for Hearing. (1) A vendor or vendor applicant shall preserve the right to a hearing, if a hearing is desired, by filing a written request for a hearing with the Director of the Program within 10 days of the receipt of the notice of proposed disqualification or denial. (2) The Program shall consider a request for a hearing filed on the earlier of the dates it is: (a) Received by the Program; or (b) Postmarked by the United States Postal Service. D. Hearings. (1) The Office of Administrative Hearings shall have jurisdiction over the hearings provided in this regulation. (2) If a hearing is requested, the agency shall hold the hearing pursuant to: (a) Health-General Article, §§18-107(a) and 18-108, Annotated Code of Maryland; (b) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (c) COMAR 10.01.03; (d) COMAR 28.02.01; and (e) This chapter. E. A vendor may not appeal the following actions: (1) Disqualification from WIC resulting from a violation of Regulation .15B(1)(m) of this chapter; (2) The State agency's decision as to whether a participant hardship exists; (3) The expiration of a vendor agreement; (4) The State agency's determination to include or exclude an infant formula manufacturer, wholesaler, distributor, or retailer from the required list of infant formula suppliers; (5) The validity or appropriateness of the State agency’s prohibition of incentive items and the State agency’s denial of an above 50 percent vendor’s request to provide an incentive item; (6) The State agency's determination whether to notify a vendor in writing when an investigation reveals an initial violation for which a pattern of violations must be established in order to impose a sanction; (7) The validity or appropriateness of the State agency’s selection criteria for competitive price, including, but not limited to, vendor peer group criteria and the criteria used to identify vendors that are above 50 percent vendors or comparable to above 50 percent vendors; (8) The State agency's determination whether a vendor had an effective policy and program in effect to prevent trafficking and that the ownership of the vendor was not aware of, did not approve of, and was not involved in the conduct of the violation; (9) Disputes regarding payments and vendor claims, not including the opportunity to justify or correct a vendor overcharge or other error; or (10) The validity or appropriateness of the State agency's vendor selection criteria. #### Regulation .19 Participant Hardship. *COMAR 10.54.03.19* A. Except for the sanction prescribed in Regulation .16D of this chapter, the State agency may determine that a participant hardship would exist if a vendor is disqualified and one of the following conditions would result: (1) At least ten participants have to travel more than 2 miles to reach a vendor; (2) A physical barrier or condition exists that would make normal travel to another vendor impossible; or (3) Ten or more participants can only be served properly by a particular vendor because of a language barrier, religious dietary needs, access to exempt infant formula, or access to WIC-eligible medical foods. B. If the State agency determines that a participant hardship would exist if a vendor is disqualified, the State agency, in its sole discretion, may impose a money penalty instead of disqualification if the vendor: (1) Provides to the State agency documentation that the violations that led to the sanction have been corrected; and (2) Owes no payments to the State agency. C. If the State agency determines to impose a money penalty, the State agency shall calculate the amount of the money penalty for each violation by multiplying 10 percent of the vendor's average monthly food instrument redemptions by the number of months the disqualification would have been in effect. D. The State agency shall calculate the average monthly redemption by using: (1) The 6 months immediately preceding notice to the vendor of the disqualification; or (2) Up to 6 months' data if the vendor has not redeemed food instruments for a full 6 months before notice of the disqualification. E. The maximum money penalty for each: (1) Violation that would have resulted in a disqualification is $11,000; and (2) Investigation that detected violations that would have resulted in disqualification is $49,000. F. Vendor Money Payment. (1) A vendor that owes a money penalty pursuant to §C of this regulation shall pay the money penalty either in a lump sum within 1 month from the date of billing by the State agency, or in installments. (2) The State agency shall calculate the number of installment payments by dividing the amount due by 1/2 the number of months the disqualification would have been in effect. (3) The vendor shall pay the: (a) First installment not later than the date the disqualification would have been effective had there been no participant hardship; and (b) Remaining payments on the first day of each succeeding month. G. If a vendor fails to pay the money penalty in accordance with the payment schedule as provided in §F of this regulation, the State agency shall disqualify the vendor's authorization for the full period of the sanction and may not refund any partial payments. #### Regulation .20 Conflict of Documents. *COMAR 10.54.03.20* If the provisions of this chapter conflict with the WIC State plan or other policies of the Program, the provisions of this chapter prevail. #### Regulation .21 Conflict of Laws. *COMAR 10.54.03.21* If the provisions of this chapter conflict with federal statutes and regulations, including those incorporated by reference in Regulation .02 of this chapter, the federal statutes and regulations prevail.