[Code of Federal Regulations]
[Title 7, Volume 4]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR246.2]

[Page 309-315]
 
                          TITLE 7--AGRICULTURE
 
    CHAPTER II--FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE
 
PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN--Table of Contents
 
                           Subpart A--General
 
Sec. 246.2  Definitions.

    For the purpose of this part and all contracts, guidelines, 
instructions, forms and other documents related hereto, the term:
    Affirmative Action Plan means that portion of the State Plan which 
describes how the Program will be initiated and expanded within the 
State's jurisdiction in accordance with Sec. 246.4(a).
    A-130 means Office of Management and Budget Circular A-130, which 
provides guidance for the coordinated development and operation of 
information 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 
include 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.

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    Categorical eligibility means persons who meet the definitions of 
pregnant women, breastfeeding women, postpartum women, or infants or 
children.
    Certification means the implementation of criteria and procedures to 
assess and document each applicant's eligibility 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 applicants are certified.
    Competent professional authority means an individual on the staff of 
the local agency authorized to determine nutritional risk and prescribe 
supplemental foods. The following persons are the only persons the State 
agency may authorize to serve as a competent professional authority: 
Physicians, nutritionists (bachelor's or master's degree in Nutritional 
Sciences, Community Nutrition, Clinical Nutrition, Dietetics, Public 
Health Nutrition or Home Economics with emphasis in Nutrition), 
dieticians, registered nurses, physician's assistants (certified by the 
National Committee on Certification of Physician's Assistants or 
certified by the State medical certifying authority), or State or local 
medically trained health officials. 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 authority on the staff of the local 
agency.
    Competitive bidding means a procurement process under which FNS or 
the State agency selects a single source (such as a single infant 
formula manufacturer 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 
representative of the Program poses as a participant, parent or 
caretaker of an infant or child participant, or proxy, transacts one or 
more food instruments, and does not reveal during the visit that he or 
she is a program representative.
    Contract brand infant formula means all infant formulas (except 
exempt infant formulas) produced by the manufacturer awarded the infant 
formula cost containment contract. If under a single solicitation the 
manufacturer subcontracts for soy-based infant formula, then all soy-
based infant formulas covered by the subcontract are also considered 
contract brand infant formulas (see Sec. 246.16a(c)(1)(i)). If a State 
agency elects to solicit separate bids for milk-based and soy-based 
infant formulas, all infant formulas issued under each contract are 
considered the contract brand infant formula (see 
Sec. 246.16a(c)(1)(ii)). For example, all of the milk-based infant 
formulas issued by a State agency that are produced by the manufacturer 
that was awarded the milk-based contract are considered contract brand 
infant formulas. Similarly, all of the soy-based infant formulas issued 
by a State agency that are produced by the manufacturer that was awarded 
the soy-based contract are also considered to be contract 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 
distribution, or home delivery system implemented by a State agency as 
described in its approved State Plan of operation and administration.
    CSFP means the Commodity Supplemental Food Program administered by 
the Department, authorized by section 5 of the Agriculture and Consumer 
Protection Act of 1973, as amended, and governed by part 247 of this 
title.
    Days means calendar days.
    Department means the U.S. Department 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 delivery or direct 
distribution of supplemental food), the amount of the price reduction or 
other price concession provided to any State agency by the manufacturer 
or supplier of the particular food product as the result of the purchase 
of Program food by each such State agency, or its representative, from 
the manufacturer or supplier.

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    Disqualification means the act of ending the Program participation 
of a participant, authorized food vendor, or authorized State or local 
agency, whether as a punitive sanction or for administrative reasons.
    Documentation means the presentation of written documents which 
substantiate statements made by an applicant or participant or a person 
applying 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 simultaneous 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.
    Exempt infant formula means an infant formula that meets the 
requirements for an exempt infant formula under section 412(h) of the 
Federal 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 considered as 
members of a single family.
    Fiscal year means the period of 12 calendar months beginning October 
1 of any calendar year and ending September 30 of the following calendar 
year.
    FNS means the Food and Nutrition Service of the U.S. Department of 
Agriculture.
    Food costs means the costs of supplemental foods, determined in 
accordance with Sec. 246.14(b).
    Food delivery system means the method used by State and local 
agencies to provide supplemental foods to participants.
    Food instrument means a voucher, check, electronic benefits transfer 
card (EBT), coupon or other document which is used by a participant to 
obtain supplemental foods.
    Health services means ongoing, routine pediatric and obstetric care 
(such as infant and child care and prenatal and postpartum examinations) 
or referral for treatment.
    High-risk vendor means a vendor identified as having a high 
probability of committing a vendor violation through application of the 
criteria established in Sec. 246.12(j)(3) and any additional criteria 
established by the State agency.
    Home food delivery contractor means a sole proprietorship, 
partnership, cooperative association, corporation, or other business 
entity that contracts with a State agency to deliver authorized 
supplemental foods to the residences of participants under a home food 
delivery system.
    Homeless facility means the following types of facilities which 
provide meal service. A supervised publicly or privately operated 
shelter (including a welfare hotel or congregate shelter) designed to 
provide temporary living accommodations; 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 residence is:
    (1) A supervised publicly or privately operated shelter (including a 
welfare hotel, a congregate shelter, or a shelter for victims of 
domestic violence) designated to provide temporary living accommodation;
    (2) An institution that provides a temporary residence for 
individuals intended 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 designed for, or ordinarily used 
as, a regular sleeping accommodation for human beings.
    IHS means the Indian Health Service of the U.S. Department of Health 
and Human Services.

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    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 
formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(z)) and that meets the requirements 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 accommodation which provides meal 
service, except private residences and homeless facilities.
    Infants means persons under one year of age.
    Inventory audit means the examination of food invoices or other 
proofs of purchase to determine whether a vendor has purchased 
sufficient quantities of supplemental foods to provide participants the 
quantities specified on food instruments redeemed by the vendor 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 Sec. 246.5; (b) an IHS service 
unit; (c) an Indian tribe, band or group recognized by the Department of 
the Interior which operates 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 
recognized by the Department of the Interior, 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 geographic area, such as off-
reservation Indians or migrant farmworkers and their families.
    Migrant farmworker means an individual 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 temporary abode.
    Net price means the difference between an infant formula 
manufacturer's lowest national wholesale price per unit for a full 
truckload of infant formula and the rebate level or the discount offered 
or provided by the manufacturer under an infant formula cost containment 
contract.
    Non-contract brand infant formula means all infant formula, 
including exempt infant formula, that is not covered by an infant 
formula cost containment 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 or group education sessions and 
the provision of information and educational materials designed to 
improve health status, achieve positive change in dietary habits, and 
emphasize relationships between nutrition and health, all in keeping 
with the individual's personal, cultural, and socioeconomic preferences.
    Nutrition Services and Administration (NSA) Costs means those direct 
and indirect costs, exclusive of food costs, as defined in 
Sec. 246.14(c), which State and local agencies determine to be necessary 
to support Program operations. Costs include, but are not limited to, 
the costs of Program administration, start-up, monitoring, auditing, the 
development of and accountability for food delivery systems, nutrition 
education and breastfeeding promotion and support, outreach, 
certification, and developing and printing food instruments.
    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 a person, including alcoholism 
or drug abuse; or (e) Conditions that predispose persons to inadequate 
nutritional patterns or nutritionally related medical conditions, 
including, but not limited to, homelessness and migrancy.
    OIG means the Department's Office of the Inspector General.

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    Other harmful substances means other substances such as tobacco, 
prescription drugs and over-the-counter medications that can be harmful 
to the health of the WIC population, especially the pregnant woman and 
her fetus.
    Participants means pregnant women, breastfeeding women, postpartum 
women, infants and children who are receiving supplemental foods or food 
instruments under the Program, and the breastfed infants of participant 
breastfeeding women.
    Participant violation means any intentional action of a participant, 
parent or caretaker of an infant or child participant, or proxy that 
violates Federal or State statutes, regulations, policies, or procedures 
governing the Program. Participant violations include intentionally 
making false or misleading statements or intentionally misrepresenting, 
concealing, or withholding facts to obtain benefits; exchanging food 
instruments or supplemental foods for cash, credit, non-food items, or 
unauthorized food items, including supplemental foods in excess of those 
listed on the participant's food instrument; threatening to harm or 
physically harming clinic or vendor staff; and dual participation.
    Participation means the sum of the number of persons who have 
received supplemental foods or food instruments during the reporting 
period and the number of infants breastfed by participant breastfeeding 
women (and receiving no supplemental foods or food instruments) during 
the reporting 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 Department 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 determined to have one or more embryos or 
fetuses in utero.
    Price adjustment means an adjustment made by the State agency, in 
accordance 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 payment to the vendor for the food instrument complies 
with the State agency's price limitations.
    Program means the Special Supplemental 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 or caretaker of an infant or child participant, to obtain and 
transact food instruments or to obtain supplemental foods on behalf of a 
participant. The proxy must be designated consistent with the State 
agency's procedures established pursuant to Sec. 246.12(r)(1). Parents 
or caretakers applying on behalf of child and infant participants are 
not proxies.
    Rebate means the amount of money refunded under cost containment 
procedures 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 participant in each State 
agency's program. 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 located 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 Agriculture.
    SFPD means the Supplemental Food Programs Division of the Food and 
Nutrition Service of the U.S. Department of Agriculture.
    7 CFR part 3016 means the Department's Uniform Federal Assistance

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Regulations. Part 3016 implements the policies established by the Office 
of Management and Budget (OMB) in Circulars A-21, A-87, A-102, A-110, 
and A-122, as well as OMB Guidance on Implementation of the Federal 
Grant and Cooperative Agreement Act of 1977.
    7 CFR part 3017 means the Department's Common Rule regarding 
Governmentwide Debarment and Suspension (Non-procurement) and 
Governmentwide Requirements for Drug-Free Workplace. Part 3017 
implements the requirements established by Executive Order 12549 
(February 18, 1986) and sections 5151-5160 of the Drug-Free Workplace 
Act of 1988 (Pub. L. 100-690).
    7 CFR part 3018 means the Department's Common Rule regarding 
Governmentwide New Restrictions on Lobbying. Part 3018 implements the 
requirements established by section 319 of the 1990 Appropriations Act 
for the Department of Interior and Related Agencies (Pub. L. 101-121).
    State means any of the 50 States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, 
the Northern Marianas Islands, and the Trust Territory of the Pacific 
Islands.
    State agency means the health department 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 
representative of Indian tribes, bands or groups recognized by the 
Department of the Interior and which has an ongoing relationship with 
such tribes, bands or groups for other purposes and has contracted with 
them to administer the Program; or the appropriate area office of the 
IHS.
    State Plan means a plan of Program operation and administration that 
describes the manner in which the State agency intends to implement and 
operate all aspects of Program administration within its jurisdiction in 
accordance with Sec. 246.4.
    Supplemental foods means those foods containing nutrients determined 
to be beneficial for pregnant, breastfeeding, and postpartum women, 
infants and children, as prescribed by the Secretary in Sec. 246.10.
    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. Each store 
operated by a business entity constitutes a separate vendor and must be 
authorized separately from other stores operated by the business entity. 
Each store must have a single, fixed location, except when the 
authorization of mobile stores is necessary to meet the special needs 
described in the State agency's State Plan in accordance with 
Sec. 246.4(a)(14)(xiv).
    Vendor authorization means the process 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 determine the maximum number and distribution of vendors it 
authorizes pursuant to Sec. 246.12(g)(2).
    Vendor overcharge means intentionally 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 submits a food instrument for redemption and the State agency 
makes a price adjustment to the food instrument.
    Vendor selection criteria means the criteria established by the 
State agency to select individual vendors for authorization consistent 
with the requirements in Sec. 246.12(g)(3).
    Vendor violation means any intentional or unintentional action of a 
vendor's current owners, officers, managers, agents, or employees (with 
or without the knowledge of management) that violates the vendor 
agreement or Federal or State statutes, regulations, policies, or 
procedures governing 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 medical foods means certain enteral products that are 
specifically formulated to provide nutritional

[[Page 315]]

support for individuals with a diagnosed medical condition, when the use 
of conventional foods is precluded, restricted, or inadequate. Such WIC-
eligible medical foods may be nutritionally complete or incomplete, but 
they must serve the purpose of a food, provide a source of calories and 
one or more nutrients, and be designed for enteral digestion via an oral 
or tube feeding. WIC-eligible medical foods include 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, as amended at 52 
FR 25189, July 2, 1987; 54 FR 51294, Dec. 14, 1989; 55 FR 9717, Mar. 15, 
1990; 58 FR 11506, Feb. 26, 1993; 58 FR 47022, Sept. 7, 1993; 59 FR 
11498, Mar. 11, 1994; 63 FR 63973, Nov. 18, 1998; 64 FR 13322, Mar. 18, 
1999; 64 FR 56674, Oct. 21, 1999; 65 FR 3378, Jan. 21, 2000; 65 FR 
53527, Sept. 5, 2000; 65 FR 51222, Aug. 23, 2000; 65 FR 77249, Dec. 11, 
2000; 65 FR 83277, Dec. 29, 2000]