[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Proposed Rules]
[Pages 64211-64215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30917]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 63, No. 223 / Thursday, November 19, 1998 / 
Proposed Rules  

[[Page 64211]]


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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: Proposed rule.

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SUMMARY: This proposed rule would amend regulations governing the 
Special Supplemental Nutrition Program for Women, Infants, and Children 
(WIC) to provide that hematological tests for anemia no longer be a 
mandatory part of each WIC applicant's certification intake process, so 
long as at least one nutrition risk factor is present for the 
applicant. This proposed rule would allow the State agency the 
discretion to obtain such tests at certification or within 90 days of 
the date of certification. Such tests would be used for the purposes of 
assessing nutritional status, providing nutrition education, further 
tailoring food packages to meet nutritional needs, and referring to 
appropriate health and social services in the community. The proposed 
revisions to current WIC Program regulations will accommodate a 
changing health care environment; facilitate improved coordination with 
other health programs serving WIC applicants; minimize potentially 
repetitive, costly, and invasive blood testing procedures; reduce 
inconvenience to applicants, and expedite services to needy individuals 
applying for WIC Program benefits.

DATES: To be assured of consideration, comments must be postmarked on 
or before January 19, 1999.

ADDRESSES: Comments should be sent to Ronald J. Vogel, Acting Director, 
Supplemental Food Programs Division, Food and Nutrition Service, USDA, 
3101 Park Center Drive, Room 540, Alexandria, Virginia 22302, (703) 
305-2730. All written comments will be available for public inspection 
during regular business hours (8:30 a.m. to 5 p.m., Monday through 
Friday) at the above-noted address.

FOR FURTHER INFORMATION CONTACT: Barbara Hallman at (703) 305-2730 
during regular business hours (8:30 a.m. to 5 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 (5 U.S.C. 601-612). Pursuant to that review, 
Samuel Chambers, Jr., Acting 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. State and local 
agencies and participants would be most affected by this proposed rule. 
This proposal would provide State and local agencies with increased 
flexibility in meeting certification requirements for the Program. 
Participants and applicants would also be affected by changes in the 
certification process which should result in expedited receipt of 
program services.

Paperwork Reduction Act

    This proposed rule imposes no new reporting or recordkeeping 
requirements which are subject to review by the Office of Management 
and Budget (OMB) in accordance with the Paperwork Reduction Act of 
1995.

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 12998

    This proposed rule has been reviewed under Executive Order 12998, 
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

    The Department reassesses WIC Program regulations and operations on 
an ongoing basis to ensure the continuing efficiency and effectiveness 
of the program. The subject of blood testing requirements has 
repeatedly been identified as warranting consideration for change based 
on frequent expressions of concern from the WIC community, including 
health

[[Page 64212]]

and medical officials at both the State and local levels. Numerous 
concerns have been brought to the Department's attention on the WIC 
Program's current blood test requirements, which may have the 
consequences of delaying enrollment of WIC applicants, duplicating 
effort, and creating unnecessary administrative expense, and hardship 
to applicants.
    Three specific concerns regarding changes in the delivery and 
operation of health care also compel the Department's reassessment of 
the blood testing requirements. First, WIC blood tests coincide with 
WIC certification periods, thus, the schedule of blood tests required 
at WIC certification does not generally correspond with State, local, 
and generally accepted periodicity schedules and guidelines. The 
Department has been informed that many health programs, as cost 
containment measures, are commonly limiting blood test screening to a 
specified minimum seen as medically necessary, consistent with State, 
local, and generally accepted guidelines and other auxiliary health 
programs such as lead poisoning prevention programs or Early and 
Periodic, Screening, Diagnosis and Treatment programs. Health care 
providers have expressed concerns to the Department that the WIC 
Program's certification schedule, of which blood testing is a mandatory 
part, is creating a barrier to public health care coordination by 
artificially dictating periodicity for hematological testing, rather 
than conforming to standard clinical practice used by the State and 
local health care system.
    Second, the move towards managed care programs as the primary 
source of health care has affected the ability of WIC local agencies to 
obtain blood test 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, 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.

The Proposal

    In response to these major concerns, the Department is proposing 
changes in the timing of anemia tests, extending the age of the data 
that may be used, clarifying allowable costs for anemia tests, and 
making corresponding changes to State Plan requirements.
    These topics are discussed in greater detail below.

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

    Given the logistical difficulties of current bloodwork requirements 
described above, the Department is proposing that hematological tests 
for anemia no longer be a mandatory part of each WIC applicant's 
certification intake process as long as at least one nutrition risk 
factor is present for the applicant. However, given the importance of 
anemia testing in the target population and WIC's long and successful 
track record in reducing national rates of anemia, this rule proposes 
to require such a test but would permit its completion within 90 days 
of the date of certification, except as noted for infants as discussed 
later in this preamble. The test data would be used for the critical 
purposes of appropriately assessing an applicant's nutritional status, 
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 proposal 
addresses the practical realities faced by State agencies by providing 
flexibility to obtain this data up to 90 days after the certification 
intake process. State agencies would, however, be required to provide 
for blood tests at certification for income eligible applicants with no 
other documented risk conditions (with the exception of presumptively 
eligible pregnant women as discussed below) in order to determine if 
they are at nutritional risk due to anemia.

2. Timing of Hematological Tests (Sec. 246.7 (e), (e)(1), and (e)(1) 
(i)-(ii))

Age of Bloodwork Data
    The Department has received comments from State agencies that the 
allowable age for bloodwork data limits local agency flexibility to 
coordinate with other health care programs. To address the concerns 
with the age of bloodwork data, this proposed rulemaking would expand 
the current regulatory standard from 60 days to 90 days as the maximum 
age of bloodwork data used to assess nutritional risk. The proposed 90-
day limit should allow additional flexibility to coordinate referral 
data with other health care programs, yet at the same time assure that 
the data accurately represent the applicant's health status. This 
rulemaking would assist in assuring this by continuing to require that 
such data are reflective of the categorical nutritional status/risk of 
women applicants. Thus, for a pregnant woman the test must be conducted 
during pregnancy, and for a breastfeeding or a postpartum woman the 
test must be conducted after the termination of their pregnancy.
    The categorical restrictions do not apply to infants and children. 
As such, State agencies may use bloodwork data obtained from an infant 
to certify a child applicant, provided such data is not more than 90 
days old. For example, bloodwork data obtained when the infant was 10 
months old may be used to certify a 13-month old child.
Timing of Bloodwork
    This proposed rule is intended to allow sufficient flexibility to 
States 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. As such, the CDC 
recommendations stipulate that blood test results should be obtained at 
the earliest opportunity during pregnancy, from 4 to 6 weeks after 
delivery for postpartum and breastfeeding women, between 9 and 12 
months of age for infants, and 6 months later (15-18 months) and 
annually from ages 2 to 5 years for children. This rule would provide 
States with the flexibility to conform to these recommendations to 
better assure that WIC staff have blood test data reflecting current 
status at appropriate times during the certification period yet provide 
that WIC participants receive timely nutrition care and referral during 
their certification periods.
    For pregnant, breastfeeding, and postpartum women, a hematological 
test for anemia must be performed at

[[Page 64213]]

certification or within 90 days of the date of certification. The test 
may be from a referral source or may be conducted by WIC. The referral 
data may be up to 90 days old, so long as it is reflective of women 
applicants' categories, meaning the test must have been taken for 
pregnant women during pregnancy and for postpartum or breastfeeding 
women following termination of pregnancy.
    Regarding pregnant women, current regulations at 
Sec. 246.7(e)(1)(iii), which reflect WIC legislation, provide State 
agencies an 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 up until 
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 
nutritional risk criteria, the certification terminates on the date of 
the determination, or 60 days after the participant was certified, 
whichever is sooner. This proposed rule would eliminate the bloodwork 
requirement at certification or within the 60-day presumptive 
certification period for these women, further easing burden. However, 
under this proposal, 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.
    Consistent with the new CDC recommendations, all infants 9 months 
of age or older must have a hematological test for anemia between 9 and 
12 months of age. Such test may be performed by the WIC agency or 
obtained from referral data. A blood test taken between 6 and 9 months 
of age may be used to meet the test requirement, however 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 proposal would permit, but 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 Sec. 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. As stated earlier in this preamble, 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. A 
blood test taken at 6 months of age may be used to meet the infant 
blood test requirement, because such data would fall within the 90-day 
age of bloodwork data timeframe.
    For children, current provisions at Section 246.7(e)(1) allow State 
and local agency discretion to waive the blood test for children who 
were determined to be within the normal range at their last 
certification period, provided that such test is performed at least 
once every 12 months. The new CDC guidelines recommend a blood test 
between 9 and 12 months of age, 6 months thereafter (around 15 to 18 
months of age), and annually thereafter for each year from ages 2 to 5 
years of age. Thus, this rule proposes that State agencies perform a 
blood test between 12 and 24 months of age to permit them full 
flexibility to accommodate arrangements for bloodwork for these 
children within the CDC recommended 6-month timeframe following their 
infant bloodwork. While for most children, this would fall between 15 
and 18 months of age, this proposal would expand the allowable 
timeframe to accommodate practical logistical difficulties and 
circumstances where, for example, there was no previous bloodwork 
during infancy, it was taken during infancy at a time other than the 
recommended 9 to 12 month period, or other logistical complications 
which made bloodwork during the optimal 15 to 18 month period 
infeasible. 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.
    As for women, the referral bloodwork data allowed to be used to 
certify children and infants can be up to 90 days old. However, 
although bloodwork data obtained when an infant was between 9 and 12 
months old may be used to certify a 12-month old child, such data 
cannot be used to fulfill the blood test that is required between 12 
and 24 months of age nor can it be used to waive a blood test. Children 
who had an inadequate iron intake during infancy are at greatest risk 
of developing anemia between 12 and 24 months of age. Thus, it is 
critical that children receive a blood test for anemia during the 
period of 12-24 months of age. As such, the current provision at 
Sec. 245.7(e) 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.
Other Nutrition Assessment Data
    The Department again emphasizes that this proposal provides for 
flexibility only in the timing of the collection and age of anemia 
blood test data: If not completed at certification (using current data, 
or data up to 90 days old), it must be completed within 90 days of 
certification except as noted for infants as discussed earlier in this 
preamble. All other nutrition assessment data, e.g., height and weight, 
and dietary and medical assessment data, must be collected as currently 
required; namely: It must be collected at certification for 
breastfeeding and postpartum women, infants and children, and, for 
pregnant women unless the State agency has opted to implement 
presumptive eligibility for pregnant women. State agencies implementing 
presumptive eligibility must still collect height, weight and dietary 
and medical assessment data for pregnant women within 60 days of 
certification to determine eligibility. 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

[[Page 64214]]

assessment. These timely measurements and data are fundamental to the 
assessment of nutritional risk of all categories of applicants.

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

    Current WIC Program regulations (Sec. 246.14(c)(2) (i)-(iv)) 
stipulate that fees, equipment, salary and other costs associated with 
the collection of hematological data to test for anemia for 
certification purposes are allowable Program costs. This proposed rule 
would specify that collection of hematological data is not only for 
certification purposes, but also for health assessment and monitoring 
purposes. This proposal would also allow State agencies to perform one 
additional hematological test as medically necessary in follow-up to a 
finding of anemia within a certification period. The Department 
proposes changes in Sec. 246.14(c)(2) and (c)(2) (i)-(iv) to clarify 
that this follow-up test for nutrition assessment purposes is an 
allowable WIC cost when deemed necessary for health monitoring as 
determined by the WIC competent professional authority (CPA).
    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.

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

    State agencies must incorporate their blood test data requirements 
and timeframes in detail in the ``Certification Procedures'' section of 
their State Plan Procedure Manual.
    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) inform the woman or parent/guardian of the outcome and meaning of 
the blood test if the results show anemia; (3) provide follow-up 
nutrition education, if appropriate; (4) make adjustments in the food 
package, as appropriate; and (5) 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 
proposed to be 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;
* * * * *
    2. 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;
    e. Newly redesignated paragraphs (e)(1)(iii), (e)(1)(iv) and 
(e)(1)(vi) are amended by adding a heading; and
    f. Newly redesignated paragraphs (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 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. At a minimum, height or length and weight shall be measured 
and 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 
at certification or within 90 days of the date of certification. 
However, 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, by a competent 
professional authority), shall between nine and twelve months of age 
have a hematological test performed 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. 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. Height or 
length and weight measurements and, with the exceptions specified in 
this paragraph, hematological tests, shall be obtained for all 
participants, including those who are determined at nutritional

[[Page 64215]]

risk based solely on the established nutritional risk status of another 
person, 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 for program participation at the time of certification.
    (B) Hematological test for anemia. 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. 
However, a State agency cannot use hematological data obtained from 
referral sources that is taken more than 90 days prior to the date of 
certification for program participation.
    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. 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. 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 unless the nutrition risk evaluation 
performed does not identify a risk factor. If no 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 
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, unless she 
subsequently reapplies for program benefits and is found to be both 
income eligible and at nutritional risk. Notification of the 
ineligibility determination shall be given in accordance with paragraph 
(j)(5) of this section. In addition, if the nutritional risk evaluation 
is not completed within the 60-day timeframe, the woman's participation 
shall end. As set forth in paragraph (j)(8) of this section, 
notification must be given prior to expiration of the certification 
period.
    (vi) Regression. * * *
* * * * *
    3. 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 and nutrition assessment 
procedures, including the following:
    (i) Laboratory fees incurred for up to two hematological tests for 
anemia per individual per certification period conducted to assess 
nutritional status and determine whether such individual is at 
nutritional risk. 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 necessary to assess nutritional 
status and to determine whether persons are at nutritional risk;
    (iii) In connection with nutrition assessment and nutritional risk 
determinations, 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: October 2, 1998.
Samuel Chambers, Jr.,
Acting Administrator, Food and Nutrition Service.
[FR Doc. 98-30917 Filed 11-18-98; 8:45 am]
BILLING CODE 3410-30-U