7 Draft Agreement Appendix A_Federal Regulations.pdf

NEW ENGLAND AND TRIBAL ORGANIZATIONS (NEATO)

WIC RETAIL INFANT FORMULA REBATE AGREEMENT

ITB Draft Agreement Appendix A

Federal Regulations

7 CFR Ch. II Part §246

7 CFR Ch. II (1–1–20 Edition) Pt. 246

[72 FR 68985, Dec. 6, 2007, as amended at 73 FR 11312, Mar. 3, 2008. Redesignated at 78 FR 12230, Feb. 22, 2013, and further redesignated at 79 FR 7054, Feb. 6, 2014]

PART 246—SPECIAL SUPPLEMENTAL

NUTRITION PROGRAM FOR

WOMEN, INFANTS AND CHIL-

DREN

Subpart A—General

Sec.

246.1 General purpose and scope.

246.2 Definitions.

246.3 Administration.

Subpart B—State and Local Agency Eligibility

246.4 State plan.

246.5 Selection of local agencies.

246.6 Agreements with local agencies.

Subpart C—Participant Eligibility

246.7 Certification of participants.

246.8 Nondiscrimination.

246.9 Fair hearing procedures for partici-

pants.

Subpart D—Participant Benefits

246.10 Supplemental foods.

246.11 Nutrition education.

Subpart E—State Agency Provisions

246.12 Food delivery methods.

246.13 Financial management system.

246.14 Program costs.

246.15 Program income other than grants.

246.16 Distribution of funds.

246.16a Infant formula and authorized foods cost containment.

246.17 Closeout procedures.

246.18 Administrative appeal of State agen-

cy actions.

Subpart F—Monitoring and Review

246.19 Management evaluation and moni-

toring reviews.

246.20 Audits.

246.21 Investigations.

Subpart G—Miscellaneous Provisions

246.22 Administrative appeal of FNS deci-

sions.

246.23 Claims and penalties.

246.24 Procurement and property manage-

ment.

246.25 Records and reports.

246.26 Other provisions.

246.27 Program information.

246.28 OMB control numbers.

AUTHORITY: 42 U.S.C. 1786.

SOURCE: 50 FR 6121, Feb. 13, 1985, unless otherwise noted.

EDITORIAL NOTE: Nomenclature changes to part 246 appear at 76 FR 35097, June 16, 2011.

Subpart A—General

§ 246.1 General purpose and scope.

This part announces regulations under which the Secretary of Agri-culture shall carry out the Special Supplemental Nutrition Program for Women, Infants and Children (WIC Pro-gram). Section 17 of the Child Nutri-tion Act of 1966, as amended, states in part that the Congress finds that sub-stantial numbers of pregnant, postpartum and breastfeeding women, infants and young children from fami-lies with inadequate income are at spe-cial risk with respect to their physical and mental health by reason of inad-equate nutrition or health care, or both. The purpose of the Program is to provide supplemental foods and nutri-tion education, including breastfeeding promotion and support, through pay-ment of cash grants to State agencies which administer the Program through local agencies at no cost to eligible persons. The Program shall serve as an adjunct to good health care during critical times of growth and develop-ment, in order to prevent the occur-rence of health problems, including drug and other harmful substance abuse, and to improve the health sta-tus of these persons. The program shall be supplementary to SNAP; any pro-gram under which foods are distributed to needy families in lieu of SNAP bene-fits; and receipt of food or meals from soup kitchens, or shelters, or other forms of emergency food assistance.

[50 FR 6121, Feb. 13, 1985, as amended at 54 FR 51294, Dec. 14, 1989; 58 FR 11506, Feb. 26, 1993; 76 FR 59888, Sept. 28, 2011]

§ 246.2 Definitions.

For the purpose of this part and all contracts, guidelines, instructions, forms and other documents related hereto, the term:

2 CFR part 200, means the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards published by OMB. The

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00364 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

JO

B

Food and Nutrition Service, USDA § 246.2 part reference covers applicable: Acro-nyms and Definitions (subpart A), Gen-eral Provisions (subpart B), Post Fed-eral Award Requirements (subpart D), Cost Principles (subpart E), and Audit Requirements (subpart F). (NOTE: Pre- Federal Award Requirements and Con-tents of Federal Awards (subpart C) does not apply to the National School Lunch Program).

Above-50-percent vendors means ven-dors that derive more than 50 percent of their annual food sales revenue from WIC food instruments, and new vendor applicants expected to meet this cri-terion under guidelines approved by

FNS.

Affirmative Action Plan means that portion of the State Plan which de-scribes how the Program will be initi-ated and expanded within the State’s jurisdiction in accordance with § 246.4(a).

A–130 means Office of Management and Budget Circular A–130, which pro-vides guidance for the coordinated de-velopment and operation of informa-tion systems.

Applicants means pregnant women, breastfeeding women, postpartum women, infants, and children who are applying to receive WIC benefits, and the breastfed infants of applicant breastfeeding women. Applicants in-clude individuals who are currently participating in the program but are re-applying because their certification period is about to expire.

Authorized supplemental foods means those supplemental foods authorized by the State or local agency for issuance to a particular participant.

Breastfeeding means the practice of feeding a mother’s breastmilk to her infant(s) on the average of at least once a day.

Breastfeeding women means women up to one year postpartum who are breastfeeding their infants.

Cash-value voucher means a fixed-dol-lar amount check, voucher, electronic benefit transfer (EBT) card or other document which is used by a partici-pant to obtain authorized fruits and vegetables. Cash-value voucher is also known as cash-value benefit (CVB) in an EBT environment.

Categorical eligibility means persons who meet the definitions of pregnant women, breastfeeding women, postpartum women, or infants or chil-dren.

Certification means the implementa-tion of criteria and procedures to as-sess and document each applicant’s eli-gibility for the Program.

Children means persons who have had their first birthday but have not yet attained their fifth birthday.

Clinic means a facility where appli-cants are certified.

Competent professional authority means an individual on the staff of the local agency authorized to determine nutritional risk and prescribe supple-mental foods. The following persons are the only persons the State agency may authorize to serve as a competent professional authority: Physicians, nu-tritionists (bachelor’s or master’s de-gree in Nutritional Sciences, Commu-nity Nutrition, Clinical Nutrition, Di-etetics, Public Health Nutrition or Home Economics with emphasis in Nu-trition), dieticians, registered nurses, physician’s assistants (certified by the National Committee on Certification of Physician’s Assistants or certified by the State medical certifying author-ity), or State or local medically trained health officials. This definition also applies to an individual who is not on the staff of the local agency but who is qualified to provide data upon which nutritional risk determinations are made by a competent professional au-thority on the staff of the local agency.

Competitive bidding means a procure-ment process under which FNS or the State agency selects a single source (such as a single infant formula manu-facturer offering the lowest price), as determined by the submission of sealed bids, for a product for which bids are sought for use in the Program.

Compliance buy means a covert, on-site investigation in which a represent-ative of the Program poses as a partici-pant, parent or caretaker of an infant or child participant, or proxy, trans-acts one or more food instruments or cash-value vouchers, and does not re-veal during the visit that he or she is a program representative.

Contract brand infant formula means all infant formulas (except exempt in-fant formulas) produced by the manu-facturer awarded the infant formula

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00365 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

7 CFR Ch. II (1–1–20 Edition) § 246.2 cost containment contract. If under a single solicitation the manufacturer subcontracts for soy-based infant for-mula, then all soy-based infant for-mulas covered by the subcontract are also considered contract brand infant formulas (see § 246.16a(c)(1)(i)). If a State agency elects to solicit separate bids for milk-based and soy-based in-fant formulas, all infant formulas issued under each contract are consid-ered the contract brand infant formula (see § 246.16a(c)(1)(ii)). For example, all of the milk-based infant formulas issued by a State agency that are pro-duced by the manufacturer that was awarded the milk-based contract are considered contract brand infant for-mulas. Similarly, all of the soy-based infant formulas issued by a State agen-cy that are produced by the manufac-turer that was awarded the soy-based contract are also considered to be con-tract brand infant formulas. Contract brand infant formulas also include all infant formulas (except exempt infant formulas) introduced after the contract is awarded.

Cost containment measure means a competitive bidding, rebate, direct dis-tribution, or home delivery system im-plemented by a State agency as de-scribed in its approved State Plan of operation and administration.

CSFP means the Commodity Supple-mental Food Program administered by the Department, authorized by section 5 of the Agriculture and Consumer Pro-tection Act of 1973, as amended, and governed by part 247 of this title.

Days means calendar days.

Department means the U.S. Depart-ment of Agriculture.

Discount means, with respect to a

State agency that provides Program foods to participants without the use of retail grocery stores (such as a State agency that provides for the home de-livery or direct distribution of supple-mental food), the amount of the price reduction or other price concession provided to any State agency by the manufacturer or supplier of the par-ticular food product as the result of the purchase of Program food by each such State agency, or its representative, from the manufacturer or supplier.

Disqualification means the act of end-ing the Program participation of a par-ticipant, authorized food vendor, or au-thorized State or local agency, whether as a punitive sanction or for adminis-trative reasons.

Documentation means the presen-tation of written documents which sub-stantiate statements made by an appli-cant or participant or a person apply-ing on behalf of an applicant.

Drug means:

(a) A beverage containing alcohol;

(b) A controlled substance (having the meaning given it in section 102(6) of the Controlled Substance Act (21 U.S.C.

802(6)); or

(c) A controlled substance analogue (having the meaning given it in section 102(32) of the Controlled Substance Act (21 U.S.C. 802(32)).

Dual participation means simulta-neous participation in the Program in one or more than one WIC clinic, or participation in the Program and in the CSFP during the same period of time.

EBT Capable means the WIC vendor demonstrates their cash register sys-tem or payment device can accurately and securely obtain WIC food balances associated with an EBT card, maintain the necessary files such as the author-ized product list, hot card file and claim file and successfully complete WIC EBT purchases.

Electronic Benefit Transfer (EBT) means a method that permits elec-tronic access to WIC food benefits using a card or other access device ap-proved by the Secretary.

Electronic signature means an elec-tronic sound, symbol, or process, at-tached to or associated with an appli-cation or other record and executed and or adopted by a person with the in-tent to sign the record.

Employee fraud and abuse means the intentional conduct of a State, local agency or clinic employee which vio-lates program regulations, policies, or procedures, including, but not limited to, misappropriating or altering food instruments or cash-value vouchers, entering false or misleading informa-tion in case records, or creating case records for fictitious participants.

Exempt infant formula means an in-fant formula that meets the require-ments for an exempt infant formula under section 412(h) of the Federal

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00366 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

Food, Drug, and Cosmetic Act (21 U.S.C. 350a(h)) and the regulations at 21 CFR parts 106 and 107.

Family means a group of related or nonrelated individuals who are living together as one economic unit, except that residents of a homeless facility or an institution shall not all be consid-ered as members of a single family.

Farmer means an individual author-ized by the State agency to sell eligible fruits and vegetables to participants at a farmers’ market or roadside stands.

Individuals who exclusively sell produce grown by someone else, such as wholesale distributors, cannot be authorized.

Farmers’ market means an association of local farmers who assemble at a de-fined location for the purpose of selling their produce directly to consumers.

Fiscal year means the period of 12 cal-endar months beginning October 1 of any calendar year and ending Sep-tember 30 of the following calendar year.

FNS means the Food and Nutrition Service of the U.S. Department of Agri-culture.

Food costs means the costs of supple-mental foods, determined in accord-ance with § 246.14(b).

Food delivery system means the meth-od used by State and local agencies to provide supplemental foods to partici-pants.

Food instrument means a voucher, check, electronic benefits transfer card (EBT), coupon or other document which is used by a participant to ob-tain supplemental foods.

Food sales means sales of all SNAP el-igible foods intended for home prepara-tion and consumption, including meat, fish, and poultry; bread and cereal products; dairy products; fruits and vegetables. Food items such as con-diments and spices, coffee, tea, cocoa, and carbonated and noncarbonated drinks may be included in food sales when offered for sale along with foods in the categories identified above. Food sales do not include sales of any items that cannot be purchased with SNAP benefits, such as hot foods or food that will be eaten in the store.

Full nutrition benefit means the min-imum amount of reconstituted fluid ounces of liquid concentrate infant for-mula as specified in Table 1 of § 246.10(e)(9) for each food package cat-egory and infant feeding variation (e.g., Food Package IA fully formula fed, IA–FF).

Health services means ongoing, rou-tine pediatric and obstetric care (such as infant and child care and prenatal and postpartum examinations) or refer-ral for treatment.

High-risk vendor means a vendor iden-tified as having a high probability of committing a vendor violation through application of the criteria established in § 246.12(j)(3) and any additional cri-teria established by the State agency.

Home food delivery contractor means a sole proprietorship, partnership, coop-erative association, corporation, or other business entity that contracts with a State agency to deliver author-ized supplemental foods to the resi-dences of participants under a home food delivery system.

Homeless facility means the following types of facilities which provide meal service. A supervised publicly or pri-vately operated shelter (including a welfare hotel or congregate shelter) de-signed to provide temporary living ac-commodations; a facility that provides a temporary residence for individuals intended to be institutionalized; or a public or private place not designed for, or normally used as, a regular sleeping accommodation for human beings.

Homeless individual means a woman, infant or child:

(a) Who lacks a fixed and regular nighttime residence; or

(b) Whose primary nighttime resi-dence is:

(1) A supervised publicly or privately operated shelter (including a welfare hotel, a congregate shelter, or a shelter for victims of domestic violence) des-ignated to provide temporary living ac-commodation;

(2) An institution that provides a temporary residence for individuals in-tended to be institutionalized;

(3) A temporary accommodation of not more than 365 days in the residence of another individual; or

(4) A public or private place not de-signed for, or ordinarily used as, a reg-ular sleeping accommodation for human beings.

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00367 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

IHS means the Indian Health Service of the U.S. Department of Health and Human Services.

Individual with disabilities means a handicapped person as defined in 7 CFR 15b.3.

Infant formula means a food that meets the definition of an infant for-mula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and that meets the re-quirements for an infant formula under section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107.

Institution means any residential ac-commodation which provides meal service, except private residences and homeless facilities.

Infants means persons under one year of age.

Inventory audit means the examina-tion of food invoices or other proofs of purchase to determine whether a ven-dor has purchased sufficient quantities of supplemental foods to provide par-ticipants the quantities specified on food instruments redeemed by the ven-dor during a given period of time.

Local agency means: (a) A public or private, nonprofit health or human service agency which provides health services, either directly or through contract, in accordance with § 246.5; (b) an IHS service unit; (c) an Indian tribe, band or group recognized by the De-partment of the Interior which oper-ates a health clinic or is provided health services by an IHS service unit;

or (d) an intertribal council or group that is an authorized representative of Indian tribes, bands or groups recog-nized by the Department of the Inte-rior, which operates a health clinic or is provided health services by an IHS service unit.

Members of populations means persons with a common special need who do not necessarily reside in a specific geo-graphic area, such as off-reservation Indians or migrant farmworkers and their families.

Migrant farmworker means an indi-vidual whose principal employment is in agriculture on a seasonal basis, who has been so employed within the last 24 months, and who establishes, for the purposes of such employment, a tem-porary abode.

Multi-function equipment means Point-of-Sale equipment obtained by a WIC vendor through commercial sup-pliers, which is capable of supporting WIC EBT and other payment tender types.

Net price means the difference be-tween an infant formula manufactur-er’s lowest national wholesale price per unit for a full truckload of infant for-mula and the rebate level or the dis-count offered or provided by the manu-facturer under an infant formula cost containment contract.

Non-contract brand infant formula means all infant formula, including ex-empt infant formula, that is not cov-ered by an infant formula cost contain-ment contract awarded by that State agency.

Nonprofit agency means a private agency which is exempt from income tax under the Internal Revenue Code of 1954, as amended.

Nutrition education means individual and group sessions and the provision of materials that are designed to improve health status and achieve positive change in dietary and physical activity habits, and that emphasize the rela-tionship between nutrition, physical activity, and health, all in keeping with the personal and cultural pref-erences of the individual.

Nutrition Services and Administration (NSA) Costs means those direct and in-direct costs, exclusive of food costs, as defined in § 246.14(c), which State and local agencies determine to be nec-essary to support Program operations.

Costs include, but are not limited to, the costs of Program administration, start-up, monitoring, auditing, the de-velopment of and accountability for food delivery systems, nutrition edu-cation and breastfeeding promotion and support, outreach, certification, and developing and printing food in-struments and cash-value vouchers.

Nutritional risk means: (a) Detri-mental or abnormal nutritional condi-tions detectable by biochemical or an-thropometric measurements; (b) Other documented nutritionally related med-ical conditions; (c) Dietary deficiencies that impair or endanger health; (d)

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00368 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

Conditions that directly affect the nu-tritional health of a person, including alcoholism or drug abuse; or (e) Condi-tions that predispose persons to inad-equate nutritional patterns or nutri-tionally related medical conditions, in-cluding, but not limited to, homeless-ness and migrancy.

OIG means the Department’s Office of the Inspector General.

Other harmful substances means other substances such as tobacco, prescrip-tion drugs and over-the-counter medi-cations that can be harmful to the health of the WIC population, espe-cially the pregnant woman and her fetus.

Partially-redeemed food instrument means a paper food instrument which is redeemed for less than all of the sup-plemental foods authorized for that food instrument.

Participant violation means any delib-erate action of a participant, parent or caretaker of an infant or child partici-pant, or proxy that violates Federal or State statutes, regulations, policies, or procedures governing the Program.

Participant violations include, but are not limited to, deliberately making false or misleading statements or de-liberately misrepresenting, concealing, or withholding facts, to obtain bene-fits; selling or offering to sell WIC ben-efits, including cash-value vouchers, food instruments, EBT cards, or sup-plemental foods in person, in print, or online; exchanging or attempting to exchange WIC benefits, including cash-value vouchers, food instruments, EBT cards, or supplemental foods for cash, credit, services, non-food items, or un-authorized food items, including sup-plemental foods in excess of those list-ed on the participant’s food instru-ment; threatening to harm or phys-ically harming clinic, farmer, or ven-dor staff; and dual participation.

Participants means pregnant women, breastfeeding women, postpartum women, infants and children who are receiving supplemental foods or food instruments or cash-value vouchers under the Program, and the breastfed infants of participant breastfeeding women.

Participation means the sum of:

(1) The number of persons who re-ceived supplemental foods or food in-struments during the reporting period;

(2) The number of infants who did not receive supplemental foods or food in-struments but whose breastfeeding mother received supplemental foods or food instruments during the report pe-riod; and

(3) The number of breastfeeding women who did not receive supple-mental foods or food instruments but whose infant received supplemental foods or food instruments during the report period.

Postpartum women means women up to six months after termination of pregnancy.

Poverty income guidelines means the poverty income guidelines prescribed by the Department of Health and Human Services. These guidelines are adjusted annually by the Department of Health and Human Services, with each annual adjustment effective July 1 of each year. The poverty income guidelines prescribed by the Depart-ment of Health and Human Services shall be used for all States, as defined in this section, except for Alaska and Hawaii. Separate poverty income guidelines are prescribed for Alaska and Hawaii.

Pregnant women means women deter-mined to have one or more embryos or fetuses in utero.

Price adjustment means an adjustment made by the State agency, in accord-ance with the vendor agreement, to the purchase price on a food instrument after it has been submitted by a vendor for redemption to ensure that the pay-ment to the vendor for the food instru-ment complies with the State agency’s price limitations.

Primary contract infant formula means the specific infant formula for which manufacturers submit a bid to a State agency in response to a rebate solicita-tion and for which a contract is award-ed by the State agency as a result of that bid.

Program means the Special Supple-mental Nutrition Program for Women, Infants and Children (WIC) authorized by section 17 of the Child Nutrition Act of 1966, as amended.

Proxy means any person designated by a woman participant, or by a parent

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00369 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith or caretaker of an infant or child par-ticipant, to obtain and transact food instruments or cash-value vouchers or to obtain supplemental foods on behalf of a participant. The proxy must be designated consistent with the State agency’s procedures established pursu-ant to § 246.12(r)(1). Parents or care-takers applying on behalf of child and infant participants are not proxies.

Rebate means the amount of money refunded under cost containment pro-cedures to any State agency from the manufacturer of the particular food product as the result of the purchase of the supplemental food with a voucher or other purchase instrument by a par-ticipant in each State agency’s pro-gram. Such rebates shall be payments made subsequent to the exchange of a food instrument for food.

Remote Indian or Native village means an Indian or Native village that is lo-cated in a rural area, has a population of less than 5,000 inhabitants, and is not accessible year-round by means of a public road (as defined in 23 U.S.C.

101).

Routine monitoring means overt, on-site monitoring during which program representatives identify themselves to vendor personnel.

Secretary means the Secretary of Ag-riculture.

SFPD means the Supplemental Food Programs Division of the Food and Nu-trition Service of the U.S. Department of Agriculture.

Sign or signature means a handwritten signature on paper or an electronic sig-nature. If the State agency chooses to use electronic signatures, the State agency must ensure the reliability and integrity of the technology used and the security and confidentiality of electronic signatures collected in ac-cordance with sound management prac-tices, and applicable Federal law and policy, and the confidentiality require-ments in § 246.26.

Single-function equipment means Point-of-Sale equipment, such as barcode scanners, card readers, PIN pads and printers, provided to an au-thorized WIC vendor solely for use with the WIC Program.

State means any of the fifty States, the District of Columbia, the Common-wealth of Puerto Rico, the Virgin Is-lands, Guam, American Samoa, or the Commonwealth of the Northern Mar-iana Islands.

State agency means the health depart-ment or comparable agency of each State; an Indian tribe, band or group recognized by the Department of the Interior; an intertribal council or group which is an authorized represent-ative of Indian tribes, bands or groups recognized by the Department of the Interior and which has an ongoing rela-tionship with such tribes, bands or groups for other purposes and has con-tracted with them to administer the Program; or the appropriate area office of the IHS.

State alliance means two or more State agencies that join together for the purpose of procuring infant for-mula under the Program by soliciting competitive bids for infant formula.

State Plan means a plan of Program operation and administration that de-scribes the manner in which the State agency intends to implement and oper-ate all aspects of Program administra-tion within its jurisdiction in accord-ance with § 246.4.

Statewide EBT means the State agen-cy has converted all WIC clinics to an EBT delivery method and all author-ized vendors are capable of transacting EBT purchases.

Supplemental foods means those foods containing nutrients determined by nu-tritional research to be lacking in the diets of pregnant, breastfeeding and postpartum women, infants, and chil-dren, and foods that promote the health of the population served by the WIC Program as indicated by relevant nutrition science, public health con-cerns, and cultural eating patterns, as prescribed by the Secretary in § 246.10.

Supplemental Nutrition Assistance Pro-gram (SNAP), formerly known as the Food Stamp Program, is the program authorized by the Food and Nutrition Act of 2008 (7 U.S.C. 2011, et. seq.), in which eligible households receive bene-fits that can be used to purchase food items from authorized retail stores and farmers’ markets.

USDA implementing regulations in-clude the following: 2 CFR part 400, Uniform Administrative Requirements, Cost Principles, and Audit Require-ments for Federal Awards; 2 CFR part

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00370 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

Food and Nutrition Service, USDA § 246.3

415, General Program Administrative Regulations; 2 CFR part 416, General Program Administrative Regulations for Grants and Cooperative Agreements to State and Local Governments; and 2 CFR part 418, New Restrictions on Lob-bying.

Vendor means a sole proprietorship, partnership, cooperative association, corporation, or other business entity operating one or more stores author-ized by the State agency to provide au-thorized supplemental foods to partici-pants under a retail food delivery sys-tem. Each store operated by a business entity constitutes a separate vendor and must be authorized separately from other stores operated by the busi-ness entity. Each store must have a single, fixed location, except when the authorization of mobile stores is nec-essary to meet the special needs de-scribed in the State agency’s State Plan in accordance with § 246.4(a)(14)(xiv).

Vendor authorization means the proc-ess by which the State agency assesses, selects, and enters into agreements with stores that apply or subsequently reapply to be authorized as vendors.

Vendor limiting criteria means criteria established by the State agency to de-termine the maximum number and dis-tribution of vendors it authorizes pur-suant to § 246.12(g)(2).

Vendor overcharge means inten-tionally or unintentionally charging the State agency more for authorized supplemental foods than is permitted under the vendor agreement. It is not a vendor overcharge when a vendor sub-mits a food instrument for redemption and the State agency makes a price ad-justment to the food instrument.

Vendor peer group system means a classification of authorized vendors into groups based on common charac-teristics or criteria that affect food prices, for the purpose of applying ap-propriate competitive price criteria to vendors at authorization and limiting payments for food to competitive lev-els.

Vendor selection criteria means the cri-teria established by the State agency to select individual vendors for author-ization consistent with the require-ments in § 246.12(g)(3) and (g)(4).

Vendor violation means any inten-tional or unintentional action of a ven-dor’s current owners, officers, man-agers, agents, or employees (with or without the knowledge of manage-ment) that violates the vendor agree-ment or Federal or State statutes, reg-ulations, policies, or procedures gov-erning the Program.

WIC means the Special Supplemental Nutrition Program for Women, Infants and Children authorized by section 17 of the Child Nutrition Act of 1966, 42 U.S.C. 1786.

WIC-eligible nutritionals for partici-pants with qualifying conditions (here-after referred to as ‘‘WIC-eligible nutritionals) means certain enteral products that are specifically formu-lated to provide nutritional support for individuals with a qualifying condi-tion, when the use of conventional foods is precluded, restricted, or inad-equate. Such WIC-eligible nutritionals must serve the purpose of a food, meal or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and may not be a conventional food, drug, flavoring, or enzyme. WIC-eligible nutritionals in-clude many, but not all, products that meet the definition of medical food in Section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)).

[50 FR 6121, Feb. 13, 1985; 50 FR 8098, Feb. 28, 1985]

EDITORIAL NOTE: For FEDERAL REGISTER ci-tations affecting § 246.2, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 246.3 Administration.

(a) Delegation to FNS. Within the De-partment, FNS shall act on behalf of the Department in the administration of the Program. Within FNS, SFPD and the Regional Offices are respon-sible for Program administration. FNS shall provide assistance to State and local agencies and evaluate all levels of Program operations to ensure that the goals of the Program are achieved in the most effective and efficient manner possible.

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00371 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

7 CFR Ch. II (1–1–20 Edition) § 246.3

(b) Delegation to the State agency. The State agency is responsible for the ef-fective and efficient administration of the Program in accordance with the re-quirements of this part; the Depart-ment’s regulations governing non-discrimination (7 CFR parts 15, 15a, and 15b); governing administration of grants (2 CFR part 200, subparts A through F and USDA implementing regulations 2 CFR part 400 and part 415); governing non-procurement debar-ment/suspension (2 CFR part 180, OMB Guidelines to Agencies on Government-wide Debarment and Suspension and USDA implementing regulations 2 CFR part 417); governing restrictions on lob-bying (2 CFR part 200, subpart E and USDA implementing regulations 2 CFR part 400, part 415, and part 418); and governing the drug-free workplace re-quirements (2 CFR part 182, Govern-ment-wide Requirements for Drug-Free Workplace); FNS guidelines; and, in-structions issued under the FNS Direc-tives Management System. The State agency shall provide guidance to local agencies on all aspects of Program op-erations.

(c) Agreement and State Plan. (1) Each State agency desiring to administer the Program shall annually submit a State Plan and enter into a written agreement with the Department for ad-ministration of the Program in the ju-risdiction of the State agency in ac-cordance with the provisions of this part.

(2) The written agreement shall in-clude a certification regarding lob-bying and, if applicable, a disclosure of lobbying activities, as required by 2 CFR part 200, subpart E and USDA im-plementing regulations 2 CFR part 400, part 415, and part 418.

(3) The written agreement must in-clude a statement that supports full use of Federal funds provided to State agencies for the administration of the WIC Program, and excludes such funds from State budget restrictions or limi-tations including hiring freezes, work furloughs, and travel restrictions.

(d) State agency eligibility. A State agency shall be ineligible to partici-pate in the WIC Program if State or local sales tax is collected on WIC food purchases in the area in which it ad-ministers the program, except that, if sales tax is collected on WIC food pur-chases by sovereign Indian entities which are not State agencies, the State agency shall remain eligible if any ven-dors collecting such tax are disquali-fied.

(e) State staffing standards. Each State agency shall ensure that suffi-cient staff is available to administer an efficient and effective Program includ-ing, but not limited to, the functions of nutrition education, breastfeeding pro-motion and support, certification, food delivery, fiscal reporting, monitoring, and training. Based on the June par-ticipation of the previous fiscal year, each State agency, as a minimum, shall employ the following staff:

(1) A full-time or equivalent adminis-trator when the monthly participation level exceeds 1,500, or a half-time or equivalent administrator when the monthly participation exceeds 500.

(2) At least one full-time or equiva-lent Program specialist for each 10,000 participants above 1,500, but the State agency need not employ more than eight Program specialists unless the State agency considers it necessary.

Program specialists should be utilized for providing fiscal management and technical assistance, monitoring ven-dors, reviewing local agencies, train-ing, and nutritional services, or other Program duties as assigned by the State agency.

(3) For nutrition-related services, one full-time or equivalent nutritionist when the monthly participation is above 1,500, or a half-time or equiva-lent nutritionist when the monthly participation exceeds 500. The nutri-tionist shall be named State WIC Nu-trition Coordinator and shall meet State personnel standards and quali-fications in paragraphs (e)(3) (i), (ii), (iii), (iv), or (v) of this section and have the qualifications in paragraph (e)(3)(vi) of this section. Upon request, an exception to these qualifications may be granted by FNS. The State WIC Nutrition Coordinator shall—

(i) Hold a Master’s degree with em-phasis in food and nutrition, commu-nity nutrition, public health nutrition, nutrition education, human nutrition, nutrition science or equivalent and have at least two years responsible ex-perience as a nutritionist in education, VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00372 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

Food and Nutrition Service, USDA § 246.4 social service, maternal and child health, public health, nutrition, or di-etetics; or

(ii) Be registered or eligible for reg-istration with the American Dietetic Association and have at least two years experience; or

(iii) Have at least a Bachelor of Science or Bachelor of Arts degree, from an accredited four-year institu-tion, with emphasis in food and nutri-tion, community nutrition, public health nutrition, nutrition education, human nutrition, nutrition science or equivalent and have at least three years of responsible experience as a nu-tritionist in education, social service, maternal and child health, public health nutrition, or dietetics; or

(iv) Be qualified as a Senior Public Health Nutritionist under the Depart-ment of Health and Human Services guidelines; or

(v) Meet the IHS standards for a Pub-lic Health Nutritionist; and

(vi) Have at least one of the fol-lowing: Program development skills, education background and experience in the development of educational and training resource materials, commu-nity action experience, counseling skills or experience in participant ad-vocacy.

(4) A designated breastfeeding pro-motion coordinator, to coordinate breastfeeding promotion efforts identi-fied in the State plan in accordance with the requirement of § 246.4(a)(9) of this part. The person to whom the State agency assigns this responsi-bility may perform other duties as well.

(5) A staff person designated for food delivery system management. The per-son to whom the State agency assigns this responsibility may perform other duties as well.

(6) The State agency shall enforce hiring practices which comply with the nondiscrimination criteria set forth in § 246.8. The hiring of minority staff is encouraged.

(f) Delegation to local agency. The local agency shall provide Program benefits to participants in the most ef-fective and efficient manner, and shall comply with this part, the Depart-ment’s regulations governing non-discrimination (7 CFR parts 15, 15a, 15b), the regulations governing the ad-ministration of grants (2 CFR part 200, subpart A–F and USDA implementing regulations 2 CFR part 400 and part 415), Office of Management and Budget Circular A–130, and State agency and FNS guidelines and instructions.

[50 FR 6121, Feb. 13, 1985; 50 FR 8098, Feb. 28, 1985, as amended at 52 FR 21236, June 4, 1987;

59 FR 11499, Mar. 11, 1994; 65 FR 83277, Dec. 29, 2000; 71 FR 56728, Sept. 27, 2006; 76 FR 37983, June 29, 2011; 76 FR 59888, Sept. 28, 2011; 81 FR 10449, Mar. 1, 2016; 81 FR 66494, 66495, Sept. 28, 2016]

Subpart B—State and Local Agency Eligibility

§ 246.4 State plan.

(a) Requirements. By August 15 of each year, each State agency shall submit to FNS for approval a State Plan for the following fiscal year as a pre-requisite to receiving funds under this section. The State agency may submit the State Plan in the format provided by FNS guidance. Alternatively, the State agency may submit the Plan in combination with other federally re-quired planning documents or develop its own format, provided that the infor-mation required below is included. FNS requests advance notification that a State agency intends to use an alter-native format. The State Plan shall be signed by the State designated official responsible for ensuring that the Pro-gram is operated in accordance with the State Plan. FNS will provide writ-ten approval or denial of a completed State Plan or amendment within 30 days of receipt. Within 15 days after FNS receives an incomplete Plan, FNS will notify the State agency that addi-tional information is needed to com-plete the Plan. Any disapproval will be accompanied by a statement of the rea-sons for the disapproval. After receiv-ing approval of the State Plan, each State agency shall only submit to FNS for approval substantive changes in the State Plan. A complete and approved Plan shall include:

(1) An outline of the State agency’s goals and objectives for improving Pro-gram operations, to include EBT and/or EBT implementation.

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00373 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

7 CFR Ch. II (1–1–20 Edition) § 246.4

(2) A budget for nutrition services and administration funds, and an esti-mate of food expenditures.

(3) An estimate of Statewide partici-pation for the coming fiscal year by category of women, infants and chil-dren.

(4) The State agency staffing pattern.

(5) An Affirmative Action Plan which includes—

(i) A list of all areas and special pop-ulations, in priority order based on rel-ative need, within the jurisdiction of the State agency, the State agency’s plans to initiate or expand operations under the Program in areas most in need of supplemental foods, including plans to inform nonparticipating local agencies of the availability and bene-fits of the Program and the availability of technical assistance in imple-menting the Program, and a descrip-tion of how the State agency will take all reasonable actions to identify po-tential local agencies and encourage agencies to implement or expand oper-ations under the Program within the following year in the neediest one-third of all areas unserved or partially served;

(ii) An estimate of the number of po-tentially eligible persons in each area and a list of the areas in the Affirma-tive Action Plan which are currently operating the Program and their cur-rent participation, which participant priority levels as specified in § 246.7 are being reached in each of these areas, and which areas in the Affirmative Ac-tion Plan are currently operating CSFP and their current participation;

and

(iii) A list of the names and addresses of all local agencies.

(6) Plans to provide program benefits to eligible migrant farmworkers and their families, to Indians, and to home-less individuals.

(7) The State agency’s plans, to be conducted in cooperation with local agencies, for informing eligible persons of the availability of Program benefits, including the eligibility criteria for participation, the location of local agencies operating the Program, and the institutional conditions of § 246.7(n)(1)(i) of this part, with empha-sis on reaching and enrolling eligible women in the early months of preg-nancy and migrants. Such information shall be publicly announced by the State agency and by local agencies at least annually. Such information shall also be distributed to offices and orga-nizations that deal with significant numbers of potentially eligible per-sons, including health and medical or-ganizations, hospitals and clinics, wel-fare and unemployment offices, social service agencies, farmworker organiza-tions, Indian tribal organizations, or-ganizations and agencies serving home-less individuals, and religious and com-munity organizations in low-income areas.

(8) A description of how the State agency plans to coordinate program op-erations with other services or pro-grams that may benefit participants in, or applicants for, the program.

(9) The State agency’s nutrition edu-cation goals and action plans to in-clude:

(i) A description of the methods that will be used to provide drug and other harmful substance abuse information, to promote and support breastfeeding, and to meet the special nutrition edu-cation needs of migrant farmworkers and their families, Indians, and home-less persons.

(ii) State agencies have the option to provide nutrition education materials to institutions participating in the CACFP at no cost, as long as a written agreement for sharing such materials is in place between the relevant WIC and CACFP entities. State agencies may initiate a sharing agreement with their State-level CACFP counterparts that would apply statewide, or may au-thorize their local agencies or clinics to initiate a sharing agreement at the local level with their local level CACFP counterparts.

(10) For Indian State or local agen-cies that wish to apply for the alter-nate income determination procedure in accordance with § 246.7(d)(2)(vii), documentation that the majority of In-dian household members have incomes below eligibility criteria.

(11) A copy of the procedure manual developed by the State agency for guid-ance to local agencies in operating the Program. The manual shall include—

(i) Certification procedures, includ-ing:

VerDate Sep<11>2014 13:08 Mar 05, 2020 Jkt 250015 PO 00000 Frm 00374 Fmt 8010 Sfmt 8010 Q:\07\7V4.TXT PC31kp ay ne o n V

M O

F R

W

IN

w ith

(A) A list of the specific nutritional risk criteria by priority level which ex-plains how a person’s nutritional risk is determined;

(B) Hematological data requirements including timeframes for the collection of such data;

(C) The procedures for requiring proof of pregnancy, consistent with § 246.7(c)(2)(ii), if the State agency chooses to require such proof;

(D) The State agency’s income guide-lines for Program eligibility;

(E) Adjustments to the participant priority system (see § 246.7(e)(4)) to ac-commodate high-risk postpartum women or the addition of Priority VII;

and,

(F) Alternate language for the state-ment of rights and responsibilities which is provided to applicants, par-ents, or caretakers when applying for benefits as outlined in § 246.7(i)(10) and (j)(2)(i) through (j)(2)(iii). This alter-nate language must be approved by FNS before it can be used in the re-quired statement.

(ii) Methods for providing nutrition education, including breastfeeding pro-motion and support, to participants.

Nutrition education will include infor-mation on drug abuse and other harm-ful substances. Participants will in-clude homeless individuals.

(iii) Instructions concerning all food delivery operations performed at the local level, including the list of accept-able foods and their maximum monthly quantities as required by § 246.10(b)(2)(i).

(iv) Instructions for providing all records and reports which the State agency requires local agencies to main-tain and submit; and

(v) Instructions on coordinating oper-ations under the program with drug and other harmful substance abuse counseling and treatment services.

(12) A description of the State agen-cy’s financial management system.

(13) A description of how the State agency will distribute nutrition serv-ices and administration funds, includ-ing start-up funds, to local agencies op-erating under the Program.

(14) A description of the food delivery system as it operates at the State agency level, including—

(i) Type of system. All food delivery systems in use within the State agen-cy’s jurisdiction;

(ii) Vendor limiting and selection cri-teria. Vendor limiting criteria, if used by the State agency, and the vendor se-lection criteria established by the State agency consistent with the re-quirements in § 246.12(g)(3) and (g)(4);

(iii) A sample vendor, farmer and/or farmers’ market, if applicable, agreement.

The sample vendor agreement must in-clude the sanction schedule, the proc-ess for notification of violations in ac-cordance with § 246.12(l)(3), and the State agency’s policies and procedures on incentive items in accordance with § 246.12(g)(3)(iv), which may be incor-porated as attachments or, if the sanc-tion schedule, the process for notifica-tion of violations, or policies on incen-tive items are in the State agency’s regulations, through citations to the regulations. State agencies that intend to delegate signing of vendor, farmer and/or farmers’ market agreements to local agencies must describe the State agency supervision and instruction that will be provided to ensure the uni-formity and quality of local agency ac-tivities;

(iv) Vendor monitoring. The system for monitoring vendors to ensure compli-ance and prevent fraud, waste, and pro-gram noncompliance, and the State agency’s plans for improvement in the coming year in accordance with § 246.12(j). The State agency must also include the criteria it will use to deter-mine which vendors will receive rou-tine monitoring visits. State agencies that intend to delegate any aspect of vendor monitoring responsibilities to a local agency or contractor must de-scribe the State agency supervision and instruction that will be provided to ensure the uniformity and quality of vendor monitoring;

(v) Farmer monitoring. The system for monitoring farmers and/or farmers’ markets within its jurisdiction, if ap-plicable, for compliance with program requirements;

(vi) Options regarding trafficking con-victions.