Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Bloodwork Requirements

DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

7 CFR Part 246

RIN 0584-AC30

Special Supplemental Nutrition Program for Women, Infants, and

Children (WIC): Bloodwork Requirements

AGENCY: Food and Nutrition Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends regulations governing the Special

Supplemental Nutrition Program for Women, Infants, and Children (WIC)

to allow State agencies the option to defer the collection of blood

test data for up to 90 days after the date of certification, so long as

the applicant is determined to have at least one qualifying nutrition

risk factor at the time of certification. In addition, this final rule

will expand the current regulatory standard of the maximum age of blood

test data used to assess nutritional risk for WIC certification.

Although blood tests may no longer be a mandatory part of each WIC

applicant's certification intake process, such tests are still required

for the purposes of assessing nutritional status, nutrition

surveillance, providing nutrition education, further tailoring food

packages to meet nutritional needs, and referring to appropriate health

and social services in the community.

EFFECTIVE DATE: January 18, 2000.

FOR FURTHER INFORMATION CONTACT: Debbie Whitford at (703) 305-2730

during regular business hours (8:30 a.m. to 5:00 p.m.) Monday through

Friday.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

This rule has been determined to be not significant for purposes of

Executive Order 12866 and, therefore, has not been reviewed by the

Office of Management and Budget.

Regulatory Flexibility Act

This rule has been reviewed with regard to the requirements of the

Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612). Samuel Chambers,

Jr., Administrator of the Food and Nutrition Service, has certified

that this rule will not have a significant impact on a substantial

number of small entities. This rule provides State and local agencies

with increased flexibility in meeting certification requirements for

the Program. Participants and applicants are also affected by changes

in the certification process which should result in expedited receipt

of program services.

Paperwork Reduction Act

This rule imposes no new reporting or recordkeeping requirements.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.

3507), current reporting and recordkeeping requirements for Part 246

were approved by the Office of Management and Budget under Control

Number 0584-0043.

Executive Order 12372

The Special Supplemental Nutrition Program for Women, Infants and

Children (WIC) is listed in the Catalog of Federal Domestic Assistance

Programs under No. 10.557. For reasons set forth in the final rule in 7

CFR Part 3015, Subpart V, and related Notice (48 FR 29115), this

program is included in the scope of Executive Order 12372 which

requires intergovernmental consultation with State and local officials.

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil

Justice Reform. This rule is intended to have preemptive effect with

respect to any State or local laws, regulations or policies which

conflict with its provisions or which would otherwise impede its full

implementation. This rule is not intended to have retroactive effect

unless so specified in the EFFECTIVE DATE paragraph of this preamble.

Prior to any judicial challenge to the application of the provisions of

this rule, all applicable administrative procedures must be exhausted.

Public Law 104-4

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.

L. 104-4, establishes requirements for Federal agencies to assess the

effects of their regulatory actions on State, local and tribal

governments and the private sector. Under section 202 of the UMRA, the

Food and Nutrition Service generally must prepare a written statement,

including a cost-benefit analysis, for proposed and final rules with

``Federal mandates'' that may result in expenditures to State, local or

tribal governments, in the aggregate, or the private sector, of $100

million or more in any one year. When such a statement is required

under section 202 of the UMRA, section 205 generally requires the Food

and Nutrition Service to identify and consider a reasonable number of

regulatory alternatives and adopt the least costly, most cost-effective

or least burdensome alternative that achieves the objective of the

rule.

This rule contains no Federal mandates (under the regulatory

provisions of Title II of the UMRA) for State, local and tribal

governments or the private sector of $100 million or more in any one

year. Thus, this rule is not subject to the requirements of sections

202 and 205 of the UMRA.

Background

On November 19, 1998, the Department published a proposal at 63 FR

64211 regarding changes in bloodwork requirements for the WIC Program.

Three specific concerns compelled the Department to reassess the blood

testing requirements.

First, current WIC blood test requirements do not generally

correspond with State, local, and generally accepted periodicity

schedules and guidelines. Second, the move towards managed care

programs as the primary source of health care has affected the ability

of WIC local agencies to obtain hematological referral data in a

timeframe that coincides with WIC certification periods. The source of

health care for WIC participants and others has been shifting in many

States from local health department clinics, many of which collected

bloodwork to meet WIC's needs on site at the WIC clinic, to managed

care settings in which blood tests are performed off site from the WIC

clinic and thus provided to WIC on a referral basis. Third,

[[Page 70174]]

bloodwork data obtained from referral sources is becoming more

frequently the norm in WIC because of Federal, State and local policies

limiting blood handling only to persons or laboratories with specified

medical credentials, thereby precluding some WIC local agencies from

collecting or analyzing blood samples.

A total of one hundred comment letters were received during the

comment period, which ended on January 19, 1999. The Department has

given all comments careful consideration in the development of this

final rule and would like to thank all commenters who responded to the

proposal. Following is a discussion of each provision, as proposed,

comments received, and an explanation of the provisions set forth in

this final rule.

1. Hematological Tests for Anemia (Sec. 246.7(e), (e)(1), and

(e)(1)(i)-(ii))

The vast majority of commenters supported the Department's proposal

to no longer require a blood test at the time of each WIC applicant's

certification intake process as long as at least one qualifying

nutrition risk factor is present for the applicant. Such tests must,

however, be collected within 90 days of the certification date. Several

commenters wrote that this provision will remove a barrier to service

that many applicants experience. As one commenter wrote, ``While these

changes will certainly be appreciated by WIC Programs and

practitioners, the main beneficiaries will be the families

themselves.''

Given the importance of anemia testing in WIC's target population

and WIC's long and successful track record in reducing national rates

of anemia, Sec. 246.7(e)(1)(i) continues to require a blood test but

will permit its completion within 90 days of the date of certification,

except as noted for infants (discussed later in this preamble). The

test data will be used for the critical purposes of appropriately

assessing an applicant's nutritional status, nutrition surveillance,

providing nutrition education, tailoring food packages and referring to

health care or social services. Although the Department considers the

collection of blood test data at certification as optimal to assist

with performing the most timely and complete nutrition assessment and

providing appropriate nutrition education and referrals, this rule

addresses the practical realities faced by State agencies and the

difficulties some participants encounter obtaining blood tests at the

time of, or previous to, the certification intake process. The

Department believes that this provision, if implemented with the proper

controls, will provide greater flexibility and reduce barriers to

service without lessening program quality. State agencies will,

however, be required to provide for blood tests at certification for

income eligible applicants with no other documented risk condition

(with the exception of presumptively eligible pregnant women as

discussed below) in order to determine if the applicant is at

nutritional risk due to anemia.

2. Timing of Nutritional Risk Data (Sec. 246.7(e), (e)(1), and

(e)(1)(i)-(ii))

Timing of Bloodwork

The proposed rule was intended to allow sufficient flexibility to

State agencies to accommodate generally accepted recommendations of

maternal and child health and medical experts. In April 1998, the

Centers for Disease Control and Prevention (CDC) issued a document

titled, ``Recommendations to Prevent and Control Iron Deficiency in the

United States.'' These recommendations are intended to guide primary

health care providers in preventing and controlling iron deficiency in

infants, preschool children, and women of childbearing age,

particularly pregnant women--populations served by the WIC Program

which are at high risk for iron-deficiency anemia. Another recognized

organization, the American Academy of Pediatrics (AAP), also provides

guidance for anemia screening in their publication ``Recommendations

for Preventive Pediatric Health Care.'' However, these recommendations

are for children not at risk or who ``* * * have no manifestations of

any important health problems, and are growing and developing in

satisfactory fashion.'' Taking into consideration that the CDC

``Universal Screening'' recommendations specifically address the WIC

target population, they were adopted as the basis for the periodicity

of anemia screening outlined in the proposed rule. Commenters generally

supported the anemia screening provisions outlined in the proposal. As

such, they have been adopted as final at Sec. 246.7(e)(1)(ii)(B). The

screening timeframes are discussed below.

Women

For pregnant, breastfeeding (those being certified at 0-6 months

postpartum), and other postpartum women, results of a hematological

test for anemia must be obtained at certification or within 90 days of

the date of certification (when the applicant has at least one

qualifying nutritional risk present at certification). Such test may be

performed by the WIC agency or test results may be obtained from a

referral source. The CDC recommends that anemia screening be done at

the earliest opportunity during pregnancy and at 4 to 6 weeks after

delivery for postpartum and breastfeeding women. Blood test results

must be reflective of women applicants' categories, meaning that the

test must have been taken for pregnant women during pregnancy and for

postpartum or breastfeeding women following termination of pregnancy.

For breastfeeding women who are 6-12 months postpartum, no additional

blood test is necessary if a test was performed after the termination

of their pregnancy.

Regarding pregnant women, current WIC regulations at Section

246.7(e)(1)(iii), provide State agencies additional flexibility by

allowing them to presume that income-eligible pregnant women are

nutritionally at risk and thus eligible to participate in the program.

Presumptively eligible women can be certified immediately and can

receive program benefits for 60 days from the date they were certified,

by which time a nutrition assessment must be conducted to establish

nutritional risk. If the subsequent assessment determines that the

woman does not meet qualifying nutritional risk criteria, the

certification terminates on the date of the determination, or 60 days

after the participant was presumptively certified, whichever is sooner.

This final rule defers the bloodwork requirement at certification or

within the 60-day presumptive certification period for these women, for

up to 90 days after the certification date. However, if the nutrition

assessment performed during the 60-day period does not include anemia

testing and does not identify any other qualifying risk factor, a blood

test must be performed or obtained from referral sources before that

60-day period elapses to permit continuity of service for women found

to be anemic. This requirement enables such pregnant women to have the

temporary presumptive certification extended to a full certification

period without disruption to continued receipt of WIC benefits, should

they be found anemic.

Infants

Consistent with the 1998 CDC recommendations Section 246.7

(e)(1)(ii)(B) requires all infants 9 months of age or older to have a

hematological test for anemia between 9 and 12 months of age. Such test

may be performed by the WIC agency or test results may be obtained from

a referral source. A blood test taken between 6 and 9 months of age may

be used to meet the test requirement, however

[[Page 70175]]

State agencies are encouraged to obtain blood test data between 9 and

12 months of age as recommended by CDC. In addition, recognizing that

the CDC guidelines state that blood tests for anemia for infants under

6 months of age may be appropriate for preterm infants and low

birthweight infants who were not fed iron-fortified formula, this final

rule permits, but does not require, blood tests for such infants.

The Department also wishes to clarify that in cases where the State

agency has opted to certify infants under 6 months of age up to their

first birthday, as permitted in Section 246.7(g)(1)(iv), such infants

must receive a blood test between 9 and 12 months of age. The extension

of the certification period up to the first birthday is only permitted

provided the quality and accessibility of health care services are not

diminished. A blood test for anemia is considered a critical component

of health care services and thus, must be performed or obtained from

referral services. The CDC recommendations identify the period between

9 and 12 months as the optimal timeframe for anemia testing for

infants. Also considered as a critical component of health care

services during the one-year period, is securing current length and

weight measurements in order to assess the infant's growth.

State agencies that certify infants at 6 month intervals must

ensure that infants 9 months of age or older receive a blood test. If a

blood test is taken at the 6 month certification, such test can be used

to meet the infant bloodwork requirement.

Children

For children, a hematological test for anemia must be obtained at

certification or within 90 days of the date of certification (when the

applicant has at least one qualifying nutritional risk). Such test may

be performed by the WIC agency or test results may be obtained from a

referral source. State agencies must perform a blood test for children

between 12 and 24 months of age and at least annually for children over

the age of 2 years.

For children over 1 year, CDC recommends that children have a blood

test 6 months after the infant test, i.e., around 15 to 18 months of

age, and annually thereafter from ages 2 to 5 years. The provision

requiring a blood test between 12 and 24 months allows the State Agency

flexibility in accommodating the CDC recommended 6-month follow-up to

the infant bloodwork. While for most children, this would fall between

15 and 18 months of age, this final rule expands the allowable

timeframe to accommodate practical logistical difficulties and

circumstances. For example, if there is no bloodwork done during

infancy, or it is taken during infancy at a time other than the

recommended 9 to 12-month period, or there are other logistical

complications, it could be impractical to obtain bloodwork during the

optimal 15 to 18-month period. Nevertheless, because pediatric health

authorities generally recommend that children have a blood test during

the most vulnerable period of 15 to 18 months, when anemia is more

likely to become manifest, State agencies are expected to make every

effort to coordinate the scheduling of bloodwork for children between

12 and 24 months old within the recommended 15 to 18 month timeframe.

The Department also wishes to clarify that although bloodwork data

obtained when an infant was between 9 and 12 months old may be used to

certify a 12-month old as a child, such data cannot be used to fulfill

the blood test that is required between 12 and 24 months. Children who

had an inadequate iron intake during infancy are at greatest risk of

developing anemia between 12 and 24 months of age. Thus, for example, a

child who is first certified for WIC and first tested at or before 12

months of age, must have a follow-up test by 24 months of age and

preferably at 18 months of age (as recommended by CDC and which

coincides with WIC 6 month certification periods). As such, the

provision at Section 246.7(e)(1) which allowed the blood test for

children to be waived, has been modified to state that for children

ages two and older who were determined to be within the normal range at

their last certification, the blood test may be waived, provided that a

blood test is performed at least once every 12 months. For those

children ages two and older with a positive anemia screening result at

their last certification a blood test is required at six-month

intervals.

The following table summarizes the anemia screening requirements as

set for in this rule:

Bloodwork Requirements for WIC Certification

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Category Anemia screening schedule

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Women...........................

Pregnant........................ During their current pregnancy.

Postpartum...................... After the termination of their

pregnancy.

Breastfeeding................... After the termination of their

pregnancy.*

Infants......................... Once between the ages of 9-12 months.*

*

Children........................ Once between the ages of 12-24

months.* * * (One blood test at or

before 12 months cannot fulfill the

requirement for the infant and the 12-

24 month child screening)

Annually between the ages of 24-60

months.****

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* For Breastfeeding women 6-12 months postpartum, no additional blood

test is necessary if a blood test was obtained after the termination

of pregnancy.

** A blood test taken between 6-9 months of age can be used to meet this

screening requirement.

*** A blood test is recommended 6 months after the infant test, at

around 15 to 18 months of age.

**** Children ages 24-60 months with a positive anemia screening result

require a follow-up blood test at 6 month intervals.

Age of Bloodwork

As a result of comments received on the proposed rule and to be

more consistent with CDC guidelines, the Department has revised its

position with regard to the age of hematological referral data. Under

the proposal, hematological referral data could not be more than 90

days old. Commenters questioned why the 90-day time frame was necessary

given the specifics of the CDC guidelines we were proposing to adopt.

Commenters viewed the 90-day limit as an unnecessary administrative

barrier to coordination with other health providers. In response to

commenter concerns, the Department has determined there is no longer a

need to establish a maximum allowable age of referral hematological

data. Instead, referral hematological data must meet the following

conditions regardless of the age of such data:

(1) must be reflective of a woman applicant's category, meaning the

test must have been taken for pregnant

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women during pregnancy and for postpartum or breastfeeding women

following termination of pregnancy;

(2) must conform to the anemia screening schedule for infants and

children as outlined in the above table; and

(3) the date and results of the anemia screening must be obtained

and recorded on the certification form as currently required in Section

246.7(i)(4).

This decision recognizes that if blood test results are within

normal limits and meet the conditions as stated above, a WIC agency

need not perform an additional anemia screening.

Failure to Provide Bloodwork Data Within 90 Days

Many commenters requested clarification for situations when a

participant fails to provide referral bloodwork data within 90 days

following certification. The Department would like to emphasize that if

a State agency chooses to implement the option to obtain blood test

data within 90 days of certification, the State agency must put into

place procedures to ensure receipt of the data. Examples of appropriate

procedures may include reminders and/or instituting monthly food

instrument pick-up for participants who have not provided the test

data. Because the participant has a risk condition that makes the

individual eligible for participation, the Department does not believe

it would be appropriate to impose sanctions on the participant for

failure to provide the referral data. However, recognizing WIC's

important role in anemia screening, it is important that blood test

data be obtained. Therefore, the Department reserves the right to

disallow this option for those State agencies that exhibit poor

performance in obtaining the referral data. (Poor performance would

include, for example, if a management evaluation indicates that

bloodwork data for participants are frequently not collected within 90

days after certification.) A State agency exercising the option to

allow data up to 90 days after the date of certification may in turn

disallow this provision in a local agency that has exhibited poor

performance in obtaining referral data. The Department believes that

this approach fairly balances the need for accountability and State

flexibility.

Weight and Height or Length

The Department considers the effort at certification to measure and

record height or length and weight and collect dietary and other

medical data for all applicants to be minimal but necessary during the

intake process, and not subject to the difficulties related to

bloodwork assessment. These timely measurements and data are

fundamental to the accuracy of nutritional risk assessment for all

categories of applicants, but especially for infant and pregnant women

applicants. Using weight and length data that were taken at 2 months of

age as a basis to certify that same infant at 4 months of age

represents questionable nutrition services standards. However, almost

all who commented on this provision requested that the acceptable age

of anthropometric data remain at 60 days. Many commented that the

common use of referral data for WIC certification necessitates

flexibility in terms of age of data and that reducing the allowable age

of data could result in a barrier to service for the participant. In

recognition of these comments, the Department has left this provision

unchanged. State agencies have the option to use anthropometric data up

to 60 days old. However, the Department is concerned about current

State agency practice regarding the measurement of weight and height or

length. Analysis of the participant characteristics data indicates

that, as of April 1996, approximately 5 percent of all enrollees for

whom data were submitted had anthropometric measurements that were more

than 60 days old at certification. By State agency, the range was from

0 to 20 percent. However, 61 out of 88 State agencies had rates of less

than 1 percent. Applicants not providing appropriate referral data are

expected to be weighed and measured at certification. Current

regulations do not allow for deferring the measurement of weight and

height or length beyond the date of certification.

The Department wishes to stress that anthropometric data must

reflect current health and categorical status. Therefore, although data

may be up to 60 days old, such data may not be appropriate for pregnant

women, or infants and children during critical periods of growth. As

such, State agencies should use appropriate judgment in applying this

option. The Department will continue to monitor, via management

evaluations, the appropriate use of this provision to ensure the

integrity of nutrition assessment in the WIC Program.

State Agency Options for Implementation

Many commenters requested clarification on a State's option to

implement the various provisions outlined in the proposal. A State

agency may choose to implement some, none or all of the options

contained in this final rule. For example,

a State agency may choose to allow the use of referral

bloodwork data [as long as it meets the conditions described in Section

246.7 (e)(1)(i)], and not implement the option that permits bloodwork

data to be collected up to 90 days after certification.

a State agency may choose to establish a more restrictive

timeframe for the collection of bloodwork data, e.g., 45 days prior to

or after certification date, rather than 90 days as allowed in this

rule.

a State agency may allow local agency variations to

accommodate differences in local health care delivery systems.

a State agency may choose to collect weight and height or

length data at certification, but allow the use of referral bloodwork

data [as long as it meets the conditions described in Section

246.7(e)(1)(i)] or the collection of bloodwork data within 90 days of

certification.

3. Allowable Costs for Anemia Tests (Sec. 246.14 (c)(2)(i)-(iv))

The proposal would have allowed State agencies to perform one

additional hematological test as medically necessary in follow-up to a

finding of anemia within a certification period. This follow-up test

would be an allowable WIC cost for nutrition assessment purposes when

deemed necessary for health monitoring as determined by the WIC

competent professional authority (CPA). Commenters generally supported

this provision, but expressed concern that WIC could experience

increased pressure from Health Departments to perform such tests. The

Department has retained in this final rule at Sec. 246.14(c)(2)(i) the

option to perform the follow-up test. The Department wishes to

emphasize that while this rule would permit WIC to pay for one follow-

up test, State agencies are encouraged to weigh the cost effectiveness

of WIC expenditures for such purposes against other competing and

critical WIC needs. The Department generally believes that follow up

monitoring of blood values of persons with anemia is largely the

responsibility of health care providers, and should be treated as a

medical, rather than solely a nutritional, concern. As such, the

Department encourages State agencies to explore other locally available

sources for ongoing health care and assessments for WIC participants

with anemia.

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4. State Plan (Sec. 246.4 (a)(11)(i))

The proposal would have required State agencies to incorporate

their blood test data requirements and timeframes in detail in the

``Certification Procedures'' section of their State Plan Procedure

Manual. Commenters supported this provision and it has been adopted in

this final rule at Sec. 246.4(a)(11)(i). The Department wishes to point

out that given the new flexibility regarding the timeframe for the

collection of bloodwork data, it is important to document the date of

the bloodwork results on certification forms, as required in Section

246.7(i)(4). The recording of the date is important especially in the

context of nutrition surveillance and participant characteristic

information that is collected at periodic intervals and provides

invaluable information. Appropriate procedures that must be followed

when blood test data are obtained include: (1) make notations in the

participant's file with respect to nutrition risk factors listed and

priority as appropriate; (2) document the date the nutrition risk data

were taken if different from the date of certification; (3)inform the

woman or parent/guardian of the outcome and meaning of the blood test

if the results show anemia; (4) provide follow-up nutrition education,

if appropriate; (5) make adjustments in the food package, as

appropriate; and (6) make referrals to health care or social services,

as appropriate.

List of Subjects in 7 CFR Part 246

Administrative practice and procedure, Civil rights, Food

assistance programs, Food and Nutrition Service, Food donations, Grant

programs--health, Grant programs--social programs, Indians, Infants and

children, Maternal and child health, Nutrition, Nutrition education,

Penalties, Reporting and recordkeeping requirements, Public assistance

programs, WIC, Women.

For the reasons set forth in the preamble, 7 CFR Part 246 is

amended as follows:

PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS

AND CHILDREN

1. The authority citation for part 246 continues to read as

follows:

Authority: 42 U.S.C. 1786.

2. In Sec. 246.4, paragraph (a)(11)(i) is revised to read as

follows:

Sec. 246.4 State plan.

(a) * * *

(11) * * *

(i) Certification procedures, including a list of the specific

nutritional risk criteria by priority level which cites conditions and

indices to be used to determine a person's nutritional risk,

hematological data requirements including timeframes for the collection

of such data, the State agency's income guidelines for Program

eligibility, and any adjustments to the participant priority system

made pursuant to Sec. 246.7(e)(4) to accommodate high-risk postpartum

women or the addition of Priority VII;

* * * * *

3. In Sec. 246.7:

a. The introductory text of paragraph (e) is revised;

b. The introductory text of paragraph (e)(1) is removed;

c. Paragraphs (e)(1)(i), (e)(1)(ii), (e)(1)(iii), and (e)(1)(iv)

are redesignated as paragraphs (e)(1)(iii), (e)(1)(iv), (e)(1)(v), and

(e)(1)(vi) respectively;

d. New paragraphs (e)(1)(i) and (e)(1)(ii) are added; and

e. A heading is added to newly redesignated paragraphs (e)(1)(iii),

(e)(1)(iv), and (e)(1)(vi).

f. Newly redesignated paragraph (e)(1)(v) is revised.

The revisions and additions read as follows:

Sec. 246.7 Certification of participants.

* * * * *

(e) Nutritional risk. To be certified as eligible for the Program,

applicants who meet the Program's eligibility standards specified in

paragraph (c) of this section must be determined to be at nutritional

risk. A competent professional authority on the staff of the local

agency shall determine if a person is at nutritional risk through a

medical and/or nutritional assessment. This determination may be based

on referral data submitted by a competent professional authority not on

the staff of the local agency. Nutritional risk data shall be

documented in the participant's file and shall be used to assess an

applicant's nutritional status and risk, tailor the food package to

address nutritional needs, design appropriate nutrition education, and

make referrals to health and social services for follow-up, as

necessary and appropriate.

Except as stated in paragraph (e)(1)(v) of this section, at least

one determination of nutritional risk must be documented at the time of

certification in order for an income eligible applicant to receive WIC

benefits.

(1) Determination of nutritional risk. (i) Required nutritional

risk data. (A) At a minimum, height or length and weight measurements

shall be performed and/or documented in the applicant's file at the

time of certification. In addition, a hematological test for anemia

such as a hemoglobin, hematocrit, or free erythrocyte protoporphyrin

test shall be performed and/or documented at certification for

applicants with no other nutritional risk factor present. For

applicants with a qualifying nutritional risk factor present at

certification, such test shall be performed and/or documented within 90

days of the date of certification. However, for breastfeeding women 6-

12 months postpartum, such hematological tests are not required if a

test was performed after the termination of their pregnancy. In

addition, such hematological tests are not required, but are permitted,

for infants under nine months of age. All infants nine months of age

and older (who have not already had a hematological test performed or

obtained, between the ages of six and nine months), shall have a

hematological test performed between nine and twelve months of age or

obtained from referral sources. This hematological test does not have

to occur within 90 days of the date of certification. Only one test is

required for children between 12 and 24 months of age, and this test

should be done 6 months after the infant test, if possible. At the

State or local agency's discretion, the hematological test is not

required for children ages two and older who were determined to be

within the normal range at their last certification. However, the

hematological test shall be performed on such children at least once

every 12 months. Hematological test data submitted by a competent

professional authority not on the staff of the local agency may be used

to establish nutritional risk. However, such referral hematological

data must:

(1) Be reflective of a woman applicant's category, meaning the test

must have been taken for pregnant women during pregnancy and for

postpartum or breastfeeding women following termination of pregnancy;

(2) Conform to the anemia screening schedule for infants and

children as outlined in paragraph (e)(1)(ii)(B) of this section; and

(3) Conform to recordkeeping requirements as outlined in paragraph

(i)(4) of this section.

(B) Height or length and weight measurements and, with the

exceptions specified in paragraph (e)(1)(v) of this section,

hematological tests, shall be obtained for all participants, including

those who are determined at nutritional risk based solely on the

established nutritional risk status of another person,

[[Page 70178]]

as provided in paragraphs (e)(1)(iv) and (e)(1)(v) of this section.

(ii) Timing of nutritional risk data. (A) Weight and height or

length. Weight and height or length shall be measured not more than 60

days prior to certification for program participation.

(B) Hematological test for anemia. (1) For pregnant, breastfeeding,

and postpartum women, and child applicants, the hematological test for

anemia shall be performed or obtained from referral sources at the time

of certification or within 90 days of the date of certification. The

hematological test for anemia may be deferred for up to 90 days from

the time of certification for applicants who have at least one

qualifying nutritional risk factor present at the time of

certification. If no qualifying risk factor is identified, a

hematological test for anemia must be performed or obtained from

referral sources (with the exception of presumptively eligible pregnant

women).

(2) Infants nine months of age and older (who have not already had

a hematological test performed, between six and nine months of age, by

a competent professional authority or obtained from referral sources),

shall between nine and twelve months of age have a hematological test

performed or obtained from referral sources. Such a test may be

performed more than 90 days after the date of certification.

(3) For pregnant women, the hematological test for anemia shall be

performed during their pregnancy. For persons certified as postpartum

or breastfeeding women, the hematological test for anemia shall be

performed after the termination of their pregnancy. For breastfeeding

women who are 6-12 months postpartum, no additional blood test is

necessary if a test was performed after the termination of their

pregnancy. The participant or parent/guardian shall be informed of the

test results when there is a finding of anemia, and notations

reflecting the outcome of the tests shall be made in the participant's

file. Nutrition education, food package tailoring, and referral

services shall be provided to the participant or parent/guardian, as

necessary and appropriate.

(iii) Breastfeeding dyads. * * *

(iv) Infants born to WIC mothers or women who were eligible to

participate in WIC. * * *

(v) Presumptive eligibility for pregnant women. A pregnant woman

who meets the income eligibility standards may be considered

presumptively eligible to participate in the program, and may be

certified immediately without an evaluation of nutritional risk for a

period up to 60 days. A nutritional risk evaluation of such woman shall

be completed not later than 60 days after the woman is certified for

participation. A hematological test for anemia is not required to be

performed within the 60-day period, but rather within 90 days, unless

the nutritional risk evaluation performed does not identify a

qualifying risk factor. If no qualifying risk factor is identified, a

hematological test for anemia must be performed or obtained from

referral sources before the 60-day period elapses. Under the subsequent

determination process, if the woman does not meet any qualifying

nutritional risk criteria, including anemia criteria, the woman shall

be determined ineligible and may not participate in the program for the

reference pregnancy after the date of the determination. Said applicant

may subsequently reapply for program benefits and if found to be both

income eligible and at qualifying nutritional risk may participate in

the program. Persons found ineligible to participate in the program

under this paragraph shall be advised in writing of the ineligibility,

of the reasons for the ineligibility, and of the right to a fair

hearing. The reasons for the ineligibility shall be properly documented

and shall be retained on file at the local agency. In addition, if the

nutritional risk evaluation is not completed within the 60-day

timeframe, the woman shall be determined ineligible.

(vi) Regression. * * *

* * * * *

4. In Sec. 246.14, paragraph (c)(2) is revised to read as follows:

Sec. 246.14 Program costs.

* * * * *

(c) * * *

(2) The cost of Program certification, nutrition assessment and

procedures and equipment used to determine nutritional risk, including

the following:

(i) Laboratory fees incurred for up to two hematological tests for

anemia per individual per certification period. The first test shall be

to determine anemia status. The second test may be performed only in

follow up to a finding of anemia when deemed necessary for health

monitoring as determined by the WIC State agency;

(ii) Expendable medical supplies;

(iii) Medical equipment used for taking anthropometric

measurements, such as scales, measuring boards, and skin fold calipers;

and for blood analysis to detect anemia, such as spectrophotometers,

hematofluorometers and centrifuges; and

(iv) Salary and other costs for time spent on nutrition assessment

and certification.

* * * * *

Dated: December 10, 1999.

Samuel Chambers, Jr.,

Administrator, Food and Nutrition Service.

[FR Doc. 99-32586 Filed 12-15-99; 8:45 am]

BILLING CODE 3410-30-P