[Federal Register Volume 64, Number 241 (Thursday, December 16, 1999)]
[Rules and Regulations]
[Pages 70173-70178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32586]



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  Federal Register / Vol. 64, No. 241 / Thursday, December 16, 1999 / 
Rules and Regulations  

[[Page 70173]]


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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: Final rule.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
            Category                     Anemia screening schedule
------------------------------------------------------------------------
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.****
------------------------------------------------------------------------
* 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

[[Page 70176]]

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.

[[Page 70177]]

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