Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Miscellaneous Vendor-Related Provisions, 21807-21811 [E8-8767]
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21807
Rules and Regulations
Federal Register
Vol. 73, No. 79
Wednesday, April 23, 2008
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
Implementation Date: State agencies
must implement the provisions of this
rule no later than October 23, 2008.
FOR FURTHER INFORMATION CONTACT:
Debra R. Whitford, Chief, Policy and
Program Development Branch,
Supplemental Food Programs Division,
Food and Nutrition Service, 3101 Park
Center Drive, Room 522, Alexandria,
Virginia 22302, (703) 305–2746.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF AGRICULTURE
Executive Order 12866
Food and Nutrition Service
This rule has been determined to be
non-significant and was not reviewed by
the Office of Management and Budget in
conformance with Executive Order
12866.
7 CFR Part 246
[FNS–2007–0041]
Regulatory Flexibility Act
RIN 0584–AD36
Special Supplemental Nutrition
Program for Women, Infants and
Children (WIC): Miscellaneous VendorRelated Provisions
Food and Nutrition Service
(FNS), USDA.
ACTION: Final rule.
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AGENCY:
SUMMARY: This final rule amends the
regulations governing the WIC Program
to clarify issues that have arisen
subsequent to the publication of the
WIC Food Delivery Systems Final Rule
on December 29, 2000, and to
strengthen further the requirements for
State vendor management and infant
formula cost-containment systems. This
rule contains provisions that would
prohibit a State agency from requiring
an infant formula manufacturer to
provide free infant formula or other
items in its infant formula rebate bid
solicitation and contract; require that a
State agency provide an abbreviated
administrative review when a vendor
receives a WIC civil money penalty
(CMP) as a result of a Food Stamp
Program (FSP) disqualification; and
expand the types of vendor information
that a State agency may release for
general program purposes. Technical
changes were also made to 7 CFR
246.16a due to revisions made to the
WIC Food Packages, published in the
Federal Register December 6, 2007. This
rule updates regulatory citations
contained in 7 CFR 246.16a that refer to
7 CFR 246.10.
DATES: Effective Date: This rule is
effective June 23, 2008.
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This rule has been reviewed with
regard to the requirements of the
Regulatory Flexibility Act of 1980 (5
U.S.C. 601–612). The Administrator,
Food and Nutrition Service, has
certified that this rule will not have a
significant impact on a substantial
number of small entities. This rule
modifies language used in WIC infant
formula rebate solicitations and
contracts, as well as in vendor
agreements. The effect of these changes
would fall primarily on State agencies.
Vendors authorized by the WIC Program
to provide supplemental foods, some of
which are small entities, could also be
affected. However, the impact on small
entities is expected to be minimal.
Unfunded Mandates Reform Act
Title II of the 1995 (UMRA), Public
Law 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 Department 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
to the private sector, of $100 million or
more in any one year. When such a
statement is needed for a rule, section
205 of the UMRA generally requires the
Department to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
more cost-effective or least burdensome
alternative that achieves the objectives
of the rule.
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This rule contains no Federal
mandates (under the regulatory
provisions of Title II of the UMRA) that
impose costs on State, local, or tribal
governments or to the private sector of
$100 million or more in any one year.
This rule is, therefore, not subject to the
requirements of sections 202 and 205 of
the UMRA.
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 29114), this program is included in
the scope of Executive Order 12372 that
requires intergovernmental consultation
with State and local officials.
Federalism Summary Impact Statement
Executive Order 13132 requires
Federal agencies to consider the impact
of their regulatory actions on State and
local governments. Where such actions
have federalism implications, agencies
are directed to provide a statement for
inclusion in the preamble to the
regulations describing the agency’s
considerations in terms of the three
categories called for under section
(6)(b)(2)(B) of Executive Order 13121.
Prior Consultation With State Officials
Prior to drafting the final rule, a
comment period was provided to permit
State and local agencies and the general
public the opportunity to comment on
the proposed changes. Further, because
the WIC Program is a Stateadministered, federally funded program,
FNS regional offices have formal and
informal discussions with State and
local officials on an ongoing basis
regarding program and policy issues.
This arrangement allows State and local
agencies to provide comments that form
the basis for many discretionary
decisions in this and other WIC Program
rules. We have also received oral and
written requests for policy guidance on
the implications of the Food Delivery
Systems Final Rule from State agencies
that deliver WIC services.
Nature of Concerns and the Need To
Issue This Rule
This rule addresses the need to assure
the soundness of infant formula rebate
solicitations and contracts. With limited
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exceptions, as provided for at 42 U.S.C.
1786(h)(8) and WIC regulations at 7 CFR
246.16a(a), all State agencies must
continuously operate a cost containment
system for infant formula. Some also
have rebates for other supplemental
foods, such as infant juice and cereal.
As a result, in Fiscal Year 2006, State
agencies received approximately $1.7
billion in rebates on infant formula and
other supplemental foods purchased by
WIC participants. The rebates that State
agencies receive allow the WIC Program
to serve an estimated 2 million
additional participants annually.
Infant formula manufacturers have
questioned the inclusion of
requirements to provide free infant
formula and other items in infant
formula rebate bid solicitations. Receipt
of free infant formula reduces the
amount of formula that the State agency
potentially could purchase under rebate
contracts and may lower the level of
rebate bids received. A lower rebate
could lead to a reduction in the number
of eligible persons that the WIC Program
is able to serve. This rule modifies the
requirements for rebate solicitations and
contracts to address this issue and
thereby helps to maintain sound infant
formula cost containment systems.
Technical changes were made to 7
CFR 246.16a due to revisions made to
the WIC Food Packages, published in
the Federal Register December 6, 2007.
This rule updates regulatory citations
contained in 7 CFR 246.16a that refer to
7 CFR 246.10.
The rule also addresses two issues
affecting WIC vendors. First, State
agencies have questioned the need to
offer a full administrative review to
vendors who receive a WIC civil money
penalty as a result of FSP
disqualification. State agencies are
required to impose a civil money
penalty when they determine that an
authorized vendor that has been
disqualified from the FSP is needed to
ensure participant access to
supplemental foods. In responding to
this issue, the rule seeks to assure a
vendor’s right to due process while
encouraging the most cost-effective use
of State agency resources.
In addition, while implementing the
WIC Food Delivery Systems Final Rule,
State agencies have sought approval to
release basic vendor information that
the rule designates as confidential. This
rule seeks to accommodate State agency
requests to release such information,
while preserving the overall
confidentiality of vendor information.
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Extent To Which Those Concerns Have
Been Met
The rule would substantially resolve
the vendor management problems State
agencies have identified. It increases a
State agency’s flexibility in conducting
appeals of a civil money penalty
imposed in lieu of reciprocal
disqualification from the WIC Program,
and in disclosing vendor information as
part of sound program management. It
also supports the integrity of State
agency infant formula rebate systems by
prohibiting gratis provision
requirements in infant formula rebate
solicitations and contracts.
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. Prior to any judicial challenge to
the provisions of this rule or the
application of its provisions, all
applicable administrative procedures
must be exhausted.
Civil Rights Impact Analysis
FNS has reviewed this final rule in
accordance with Departmental
Regulation 4300–4, ‘‘Civil Rights Impact
Analysis,’’ to identify and address any
major civil rights impacts this rule
might have on minorities, women, and
persons with disabilities. All data
available to FNS indicate that protected
individuals have the same opportunity
to participate in the WIC Program as
non-protected individuals. FNS
specifically prohibits State and local
government agencies that administer the
WIC Program from engaging in actions
that discriminate against any individual
in any of the protected classes; see 7
CFR 246.8(a) for the non-discrimination
policy of the WIC Program. Where State
agencies have options, and they choose
to implement a certain provision, they
must implement it in such a way that it
complies with the regulations at 7 CFR
246.8.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995
(44 U.S.C. Chap. 35; see 5 CFR 1320)
requires that the Office of Management
and Budget (OMB) approve all
collections of information by a Federal
agency before they can be implemented.
Respondents are not required to respond
to any collection of information unless
it displays a current valid OMB control
number. This rule does not contain
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information collection requirements
subject to approval by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995.
E-Government Act Compliance
FNS is committed to complying with
the E-Government Act, to promote the
use of the Internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
Background
On July 27, 2005, the Department
published a proposed rule at 70 FR
43332, concerning revisions of
miscellaneous vendor-related provisions
of the WIC Program regulations. The
comment period ended on November
25, 2005. Thirteen comment documents
were submitted to the Department to
provide comments on the proposed
revisions. We greatly appreciate these
comments, all of which were carefully
considered in the development of this
final rule. Following is a discussion of
each provision as proposed, the
comments received, and an explanation
of the provisions set forth in this final
rule.
1. Gratis Provisions in Infant Formula
Rebate Solicitations and Contracts (7
CFR 246.16a(j)(4))
The Department proposed prohibiting
the requirement of gratis infant formula
or other items in infant formula rebate
solicitations and contracts. The receipt
of free infant formula or other items by
the State agency from the manufacturer
may lower the level of rebate bids
received. Therefore, the Department
proposed to amend 7 CFR 246.16a(j), by
adding to a list of provisions that are
prohibited to be included in cost
containment contracts the requirement
for gratis infant formula and other items.
All but one of the comment letters
received supported this proposal. Some
of the comment letters supporting the
provision also recommended allowing:
(1) Exceptions from the gratis
prohibition for labels and other
inexpensive educational materials that
are germane to the contract; (2) gratis
provisions only for new brands of infant
formula introduced to participants as a
result of the bid process; (3) State
agencies that choose to provide sample
infant formula to pay for it at the net
contract price; (4) capping the purchase
amount of infant formula samples to no
more than one percent of the previous
year’s volume of infant formula; and (5)
gratis provisions as voluntary
components of bids which would not be
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used in evaluating the bidder’s
qualifications, or economics of the bid.
One commenter opposing the
provision agreed that the elimination of
sample or gratis formula would result in
lower cost to the manufacturer, more
favorable bids, and ultimately lower
WIC food costs. However, the
commenter stated that formula is
needed by clinics for formula challenges
and substitutions for a different type of
formula when an infant cannot tolerate
the formula initially issued. This
commenter requested that the
Department require State agencies to
evaluate the levels and uses of gratis
infant formulas to ensure cost
effectiveness and to ensure the needs of
infant participants are addressed. The
Department has considered these
recommendations and discuses them
below.
One commenter requested State
agencies be allowed to purchase limited
quantities of sample infant formula.
Currently, WIC State agencies are
allowed to pay for sample infant
formula for clinics to use for formula
challenges and substitutions. Contracts
can include a provision to allow a State
agency to purchase sample formulas at
the same net cost as other contract
infant formulas. WIC Program funds
may not be used to purchase formula for
applicants or other individuals who are
not WIC participants (7 CFR
246.14(b)(1)(i)). Therefore, State
agencies that choose to purchase sample
infant formula would be expected to
ensure that such formula is issued to a
WIC participant only.
Commenters also suggested State
agencies be given the authority to
request the manufacturer provide labels
and mixing instructions for safe
handling and safe storage of its
products. It is not the intent of this
regulation to prohibit such practices by
State agencies; however, such items may
not be included as a required provision
in an infant formula rebate solicitation
and contract.
Several commenters suggested State
agencies be required to limit the
purchase amount of infant formula
samples. If a State agency purchases
infant formula to be distributed as
samples, or receives sample infant
formula voluntarily from an infant
formula manufacturer, State agencies
may want, as a prudent business
decision, to consider capping the
amount of sample infant formula that is
issued, or to establish other procedures
for the control and issuance of sample
infant formula. However, no changes
will be added to this rule requiring such
a cap.
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FNS continues to believe that contract
solicitations should not require any
gratis infant formulas, even if these
gratis formulas are not included as part
of the bid evaluation. Such provisions
are considered inappropriate and could
have the effect of reducing rebate
savings not only to individual State
agencies, but also to the WIC Program
nationally.
Accordingly, after careful
consideration of the comments received,
7 CFR 246.16a(j)(4) in this final rule
remains as proposed.
2. Abbreviated Administrative Reviews
(7 CFR 246.18(a)(1)(ii))
The Department proposed to require a
State agency to offer an abbreviated
administrative review when a vendor
appeals a WIC CMP imposed in lieu of
a disqualification that stems from an
FSP disqualification unless, as in the
case of all adverse actions subject to
abbreviated administrative review, the
State agency decides to provide a full
administrative review. As a result of the
WIC/FSP Vendor Disqualification Rule,
64 FR 13311, March 18, 1999, a
reciprocal disqualification imposed by a
WIC State agency, i.e., a disqualification
based on an FSP disqualification, is not
currently subject to administrative or
judicial review under the WIC Program.
However, if the State agency determines
that the vendor is needed to ensure
participant access to supplemental
foods, the State agency must impose a
CMP in lieu of a disqualification as
provided in 7 CFR 246.12(l)(1)(ix);
under 7 CFR 246.18(a)(1)(i), the
imposition of a CMP in lieu of
disqualification is subject to a full
administrative review.
The Department took the position that
a CMP imposed in lieu of a reciprocal
disqualification does not warrant a full
administrative review, and instead
should be subject to an abbreviated
administrative review, because at issue
are two factual questions only, namely,
whether the vendor has been
disqualified from FSP and whether the
State agency correctly calculated the
amount of the CMP. Answers to these
questions can easily be established
within the context of an abbreviated
review; an abbreviated review would be
the more cost-effective means of
honoring the vendor’s due process
protections. This would be consistent
with the adverse actions for which WIC
Program regulations currently allow
abbreviated reviews.
All commenters supported the
proposal, although one commenter
recommended that adverse actions for
two other reasons also be made subject
to abbreviated administrative review,
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including denial of authorization based
on an absence of FSP authorization and
disqualification resulting from failure to
pay a CMP.
The Department agrees that denial of
authorization based on an absence of
FSP authorization should also be subject
to an abbreviated administrative review.
Like termination based on change of
location, or denial of an application
submitted outside of the timeframe for
submitting applications, which are
subject to abbreviated administrative
review under the current regulations,
determination of whether an applicant
vendor is currently FSP-authorized is
also a narrow factual determination.
Many WIC State agencies require FSP
authorization as a selection criterion for
WIC authorization. Although not a
mandatory selection criterion, requiring
FSP authorization as a selection
criterion for WIC authorization helps
the WIC State agency to screen vendor
applicants regarding common
requirements of the two programs such
as business integrity and valid
documentation of ownership.
However, unlike the absence of FSP
authorization, failure to pay a CMP may
involve issues that are beyond a narrow
factual determination. Therefore, the
Department will consider seeking public
comment on whether an abbreviated
administrative review rather than a full
administrative review should be
provided for failure to pay a CMP in a
future rulemaking.
Accordingly, 7 CFR 246.18(a)(1)(ii) in
this final rule remains as proposed
except that denial of authorization
based on an absence of FSP
authorization will be included as an
additional adverse action which is
subject to an abbreviated administrative
review.
3. Confidentiality of Vendor Information
(7 CFR 246.26(e))
The current 7 CFR 246.26(e) restricts
the use or disclosure of information that
individually identifies a vendor, except
for the vendor’s name, address and
authorization status, to persons directly
connected with the administration or
enforcement of WIC or FSP; persons
directly connected with the
administration or enforcement of any
Federal or State law; or vendors who are
subject to an adverse action.
The Department proposed to amend 7
CFR 246.26(e) to expand the types of
vendor information allowed for general
release and thus not be subject to
confidentiality restrictions, including
the vendor’s telephone number, Web
site and e-mail address, WIC
identification number, and store type.
The term ‘‘store type’’ refers to ordinary
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terms for retail food stores, such as
‘‘grocery store,’’ ‘‘chain store,’’ and
‘‘convenience store,’’ but not to
specialized regulatory terms such as
‘‘above-50-percent vendor’’ or ‘‘WIConly store’’. ‘‘Store type’’ was included
in the preamble of the proposed rule,
but inadvertently omitted from the
proposed rule itself. The Department
believed that this increased information
would allow WIC State agencies to
provide participants with vendors’
telephone numbers and Web sites and/
or e-mail addresses to assist them with
locating authorized vendors in their
neighborhood or local service area, and
that knowing a vendor’s store type also
would help participants to determine
where to transact their food
instruments. Further, the Department
proposed to allow WIC State agencies to
issue public notices of vendor
disqualifications (including the length
of disqualification and the reason for the
disqualification) and to provide this
information to authorized vendors and
program participants; the Department
believed that issuing public notices of
WIC vendor disqualifications would
deter vendor fraud and abuse in the WIC
Program.
The comments were generally
supportive, but requested several
clarifications and revisions. Many of the
commenters objected to release of the
vendor identification number,
contending that this would not assist
the participants or public, and may lead
to fraud, e.g., creation of a counterfeit
vendor stamp. Also, one of the
commenters asserted that knowing the
store type of a vendor would not help
participants to choose where to shop.
Finally, one of the commenters stated
that the name of the owner should be
released, since this would assist the
State health licensing process. The
Department agrees that the vendor
identification number would be of little
value, and that making WIC vendor
identification numbers public could
lead to fraud.
However, the Department cannot
consider making the name of the owner
available to the general public in this
final rule, since the name of the owner
was not specified in 7 CFR 246.26(e) of
the proposed rule. Removing the
confidentiality of such personal
information should not be undertaken
without an opportunity for comment.
Also, the Department disagrees that the
store type should not be made available
to the general public, since, unlike the
name of the owner, there is no privacy
issued involved. Accordingly, the
vendor identification number and the
name of the owner are not included in
7 CFR 246.26(e) of this final rule, while
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the store type of the vendor is included
in 7 CFR 246.26(e).
One of the commenters recommended
that 7 CFR 246.26(e)(2) should be
revised to include local ordinances as
well as Federal and State laws regarding
the persons directly connected with
administration or enforcement, because
a city may be responsible for licensing
grocery stores, and also because the WIC
State agency could benefit by having
another source of information on
ownership. Another commenter asserted
that FNS should clarify that infant
formula manufacturers participating in
the cost containment process are
persons directly connected with the
administration or enforcement of the
WIC Program in 7 CFR 246.26(e)(1).
This commenter pointed out that these
companies play a unique and important
role regarding WIC, and thus need to
know how the retail presence of their
products will be impacted by the
acceptance of a bid in order to reduce
uncertainties which might impede
aggressive bidding, and also need to
ensure that participants have access to
infant formula when a State agency
transitions to a new contractor or during
periods of inventory shortages. The
information of interest includes only the
names of the top 20 retailers and their
associated percentage of WIC volume.
The Department agrees that the State
agency should be able to share
confidential vendor information with
persons who are directly connected
with the administration or enforcement
of local laws or ordinances on such
matters as licensing grocery stores,
under agreement with the State agency
restricting third party disclosure.
Accordingly, 7 CFR 246.26(e)(2) of this
final rule includes the reference to local
laws and ordinances as well as Federal
and State laws. However, the
Department does not agree that infant
formula manufacturers are persons
directly connected with the
administration or enforcement of the
WIC Program within the meaning of 7
CFR 246.26(e)(1). Although infant
formula manufacturers have a unique
and important role regarding the WIC
Program, these manufacturers do not
administer or enforce the Federal, State,
or local laws, rules, regulations, or
ordinances which govern the WIC
Program. Their contracts with WIC State
agencies do not include responsibilities
for such programmatic activities as the
certification of participants, the
authorization of vendors, the operation
of State agency Management
Information Systems, the conducting of
audits or investigations on behalf of
State agencies, or any other activities
applying the Federal WIC-related laws,
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rules, and regulations, or for such
responsibilities related to State or local
laws or ordinances. The redemption
volume of individual WIC vendors is
confidential vendor information under 7
CFR 246.26(e), and thus may not be
disclosed by WIC State agencies to
infant formula manufacturers under 7
CFR 246.26(e)(1) because infant formula
manufacturers are not persons directly
connected with the administration or
enforcement of the WIC Program.
Finally, several commenters
expressed reservations or recommended
restrictions regarding State agencies
issuing public notices of WIC vendor
disqualifications. One of the
commenters objected to release of the
disqualification information because the
proposed provision is so broad that it
could compromise investigative
techniques and lead to release of
investigative reports, and that release of
derogatory information could unfairly
damage the reputation of a vendor who
later prevails on appeal. One commenter
objected to release of the
disqualification information because
this may be used to justify an expansive
discovery process in legal proceedings
regarding information on vendors other
than the vendor seeking discovery,
recommending that the proposed
provision needs to be more specific and
should cover CMPs as well as
disqualifications. Another commenter
asserted that there should be equal
treatment for participants and program
officials, i.e., public notification of
participants and program officials found
guilty of fraud; this commenter also
asserted that such notification should
only occur after due process has been
exhausted.
The Department agrees with many of
these concerns. To accommodate all of
these issues, disqualification
information is addressed by a new 7
CFR 246.26(e)(4) in this final rule. This
new provision explicitly provides that a
State agency may release such
information at its discretion, that the
imposition of CMPs may be included as
well as disqualifications, and that State
agencies are only permitted to release
the vendor’s name, address, length of
the disqualification or amount of the
CMP, and a summary of the reason(s) for
such sanction provided in the notice of
adverse action. Further, the new
provision provides that such
information may not be disclosed unless
the vendor’s right to appeal through the
judicial as well as administrative review
procedures has been exhausted. Finally,
under this new provision, this
information may only be disclosed to
other authorized vendors or vendor
applicants, since such disclosure is
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intended to deter vendor violations, not
the violations of participants or program
officials. If a State agency does not view
this revised language as meeting all of
its concerns, then the State agency may
exercise its discretion to not issue such
notices.
List of Subjects in 7 CFR Part 246
Food assistance programs, Food
donations, Grant programs—social
programs, Indians, Infants and children,
Maternal and child health, Nutrition,
Nutrition education, Public assistance
programs, WIC, Women.
Accordingly, 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
§ 246.26
Other provisions.
*
1. The authority citation for part 246
continues to read as follows:
I
Authority: 42 U.S.C. 1786.
2. In § 246.16a:
a. Amend paragraph (c)(3)(i),
(c)(3)(ii)(A) and (B) by removing the
reference ‘‘§ 246.10(c)(1)(i)’’ wherever it
appears and replacing it with
‘‘§ 246.10(e)(1)(iii) and
§ 246.10(e)(2)(iii)’’.
I b. Amend paragraph (c)(4)(i) by
removing the reference
‘‘§ 246.10(c)(1)(vi)’’ and replacing it
with ‘‘§ 246.10(e)(9)(Table1))’’.
I c. Amend paragraph (e) by removing
the reference ‘‘§ 246.4(a)(14)(xi)’’ and
replacing it with ‘‘§ 246.4(a)(14)(x)’’.
I d. Amend paragraph (j)(2) by
removing the reference ‘‘§ 246.10(f); or’’
and replacing it with ‘‘§ 246.10(g);’’.
I e. Amend paragraph (j)(3) by
removing the period at the end of the
paragraph and adding in its place a
semicolon followed by the word ‘‘or’’;
and
I f. Add paragraph (j)(4) to read as
follows:
I
I
§ 246.16a
Stamp Program disqualification under
§ 246.12(l)(1)(vii) and,
(J) Denial of an application based on
a determination of whether an applicant
vendor is currently authorized by the
Food Stamp Program.
*
*
*
*
*
I 4. In § 246.26:
I a. Amend the first sentence of the
introductory text of paragraph (e) by
removing the words ‘‘and authorization
status’’ and by adding, in their place,
the words ‘‘, telephone number, Web
site/e-mail address, store type, and
authorization status’’;
I b. Amend paragraph (e)(2) by adding
the words ‘‘or local law or ordinance’’
at the end of the first sentence; and,
I c. Add a new paragraph (e)(4) to read
as follows:
Infant formula cost containment.
Dated: April 10, 2008.
Roberto Salazar,
Administrator, Food and Nutrition Service.
[FR Doc. E8–8767 Filed 4–22–08; 8:45 am]
BILLING CODE 3410–30–P
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2008–0411; Directorate
Identifier 2008–NM–061–AD; Amendment
39–15488; AD 2008–09–07]
RIN 2120–AA64
§ 246.18 Administrative review of State
agency actions.
(a) * * *
(1) * * *
(ii) * * *
(I) A civil money penalty imposed in
lieu of disqualification based on a Food
VerDate Aug<31>2005
15:54 Apr 22, 2008
Jkt 214001
Final rule; request for
comments.
ACTION:
SUMMARY: We are adopting a new
airworthiness directive (AD) for all
Boeing Model 757 airplanes and Model
767–200, 767–300, and 767–300F series
airplanes. This AD requires revising the
Limitations section of the airplane flight
manual to advise the flight crew of
procedures to follow to ensure that a
fuel filter impending bypass condition
due to gross fuel contamination is
detected in a timely manner. This AD
was prompted by an error in the
operating program software (OPS) of the
engine indication and crew alerting
system (EICAS). The error prevents the
display of an advisory message to the
flight crew of a left engine fuel filter
contamination and imminent bypass
condition, which may indicate an
imminent multiple engine thrust loss or
engine malfunction event due to fuel
contamination. We are issuing this AD
to prevent malfunction and thrust loss
on both engines, which could result in
a forced off-airport landing.
DATES: This AD is effective May 8, 2008.
We must receive comments on this
AD by June 23, 2008.
ADDRESSES: You may send comments by
any of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.
• Hand Delivery: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
Examining the AD Docket
DEPARTMENT OF TRANSPORTATION
*
mstockstill on PROD1PC66 with RULES
*
*
*
*
(j) * * *
I (4) Require infant formula
manufacturers to provide gratis infant
formula or other items.
*
*
*
*
*
I 3. In § 246.18, add new paragraphs
(a)(1)(ii)(I) and (a)(1)(ii)(J) to read as
follows:
*
*
*
*
(e) * * *
I (4) At the discretion of the State
agency, all authorized vendors and
vendor applicants regarding vendor
sanctions which have been imposed,
identifying only the vendor’s name,
address, length of the disqualification or
amount of the civil money penalty, and
a summary of the reason(s) for such
sanction provided in the notice of
adverse action. Such information may
be disclosed only following the
exhaustion of all administrative and
judicial review, in which the State
agency has prevailed, regarding the
sanction imposed on the subject vendor,
or the time period for requesting such
review has expired.
*
*
*
*
*
21811
Airworthiness Directives; Boeing
Model 757 Airplanes and Model 767–
200, 767–300, and 767–300F Series
Airplanes
Federal Aviation
Administration (FAA), DOT.
AGENCY:
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
You may examine the AD docket on
the Internet at https://
www.regulations.gov; or in person at the
Docket Management Facility between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD
docket contains this AD, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Office (telephone 800–647–
5527) is in the ADDRESSES section.
Comments will be available in the AD
docket shortly after receipt.
FOR FURTHER INFORMATION CONTACT: Judy
Coyle, Aerospace Engineer, Propulsion
Branch, ANM–140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind
E:\FR\FM\23APR1.SGM
23APR1
Agencies
[Federal Register Volume 73, Number 79 (Wednesday, April 23, 2008)]
[Rules and Regulations]
[Pages 21807-21811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8767]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 73, No. 79 / Wednesday, April 23, 2008 /
Rules and Regulations
[[Page 21807]]
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
7 CFR Part 246
[FNS-2007-0041]
RIN 0584-AD36
Special Supplemental Nutrition Program for Women, Infants and
Children (WIC): Miscellaneous Vendor-Related Provisions
AGENCY: Food and Nutrition Service (FNS), USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends the regulations governing the WIC
Program to clarify issues that have arisen subsequent to the
publication of the WIC Food Delivery Systems Final Rule on December 29,
2000, and to strengthen further the requirements for State vendor
management and infant formula cost-containment systems. This rule
contains provisions that would prohibit a State agency from requiring
an infant formula manufacturer to provide free infant formula or other
items in its infant formula rebate bid solicitation and contract;
require that a State agency provide an abbreviated administrative
review when a vendor receives a WIC civil money penalty (CMP) as a
result of a Food Stamp Program (FSP) disqualification; and expand the
types of vendor information that a State agency may release for general
program purposes. Technical changes were also made to 7 CFR 246.16a due
to revisions made to the WIC Food Packages, published in the Federal
Register December 6, 2007. This rule updates regulatory citations
contained in 7 CFR 246.16a that refer to 7 CFR 246.10.
DATES: Effective Date: This rule is effective June 23, 2008.
Implementation Date: State agencies must implement the provisions
of this rule no later than October 23, 2008.
FOR FURTHER INFORMATION CONTACT: Debra R. Whitford, Chief, Policy and
Program Development Branch, Supplemental Food Programs Division, Food
and Nutrition Service, 3101 Park Center Drive, Room 522, Alexandria,
Virginia 22302, (703) 305-2746.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This rule has been determined to be non-significant and was not
reviewed by the Office of Management and Budget in conformance with
Executive Order 12866.
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). The
Administrator, Food and Nutrition Service, has certified that this rule
will not have a significant impact on a substantial number of small
entities. This rule modifies language used in WIC infant formula rebate
solicitations and contracts, as well as in vendor agreements. The
effect of these changes would fall primarily on State agencies. Vendors
authorized by the WIC Program to provide supplemental foods, some of
which are small entities, could also be affected. However, the impact
on small entities is expected to be minimal.
Unfunded Mandates Reform Act
Title II of the 1995 (UMRA), Public Law 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 Department 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 to the private sector, of $100 million or more in any one
year. When such a statement is needed for a rule, section 205 of the
UMRA generally requires the Department to identify and consider a
reasonable number of regulatory alternatives and adopt the least
costly, more cost-effective or least burdensome alternative that
achieves the objectives of the rule.
This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) that impose costs on State, local,
or tribal governments or to the private sector of $100 million or more
in any one year. This rule is, therefore, not subject to the
requirements of sections 202 and 205 of the UMRA.
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 29114), this
program is included in the scope of Executive Order 12372 that requires
intergovernmental consultation with State and local officials.
Federalism Summary Impact Statement
Executive Order 13132 requires Federal agencies to consider the
impact of their regulatory actions on State and local governments.
Where such actions have federalism implications, agencies are directed
to provide a statement for inclusion in the preamble to the regulations
describing the agency's considerations in terms of the three categories
called for under section (6)(b)(2)(B) of Executive Order 13121.
Prior Consultation With State Officials
Prior to drafting the final rule, a comment period was provided to
permit State and local agencies and the general public the opportunity
to comment on the proposed changes. Further, because the WIC Program is
a State-administered, federally funded program, FNS regional offices
have formal and informal discussions with State and local officials on
an ongoing basis regarding program and policy issues. This arrangement
allows State and local agencies to provide comments that form the basis
for many discretionary decisions in this and other WIC Program rules.
We have also received oral and written requests for policy guidance on
the implications of the Food Delivery Systems Final Rule from State
agencies that deliver WIC services.
Nature of Concerns and the Need To Issue This Rule
This rule addresses the need to assure the soundness of infant
formula rebate solicitations and contracts. With limited
[[Page 21808]]
exceptions, as provided for at 42 U.S.C. 1786(h)(8) and WIC regulations
at 7 CFR 246.16a(a), all State agencies must continuously operate a
cost containment system for infant formula. Some also have rebates for
other supplemental foods, such as infant juice and cereal. As a result,
in Fiscal Year 2006, State agencies received approximately $1.7 billion
in rebates on infant formula and other supplemental foods purchased by
WIC participants. The rebates that State agencies receive allow the WIC
Program to serve an estimated 2 million additional participants
annually.
Infant formula manufacturers have questioned the inclusion of
requirements to provide free infant formula and other items in infant
formula rebate bid solicitations. Receipt of free infant formula
reduces the amount of formula that the State agency potentially could
purchase under rebate contracts and may lower the level of rebate bids
received. A lower rebate could lead to a reduction in the number of
eligible persons that the WIC Program is able to serve. This rule
modifies the requirements for rebate solicitations and contracts to
address this issue and thereby helps to maintain sound infant formula
cost containment systems.
Technical changes were made to 7 CFR 246.16a due to revisions made
to the WIC Food Packages, published in the Federal Register December 6,
2007. This rule updates regulatory citations contained in 7 CFR 246.16a
that refer to 7 CFR 246.10.
The rule also addresses two issues affecting WIC vendors. First,
State agencies have questioned the need to offer a full administrative
review to vendors who receive a WIC civil money penalty as a result of
FSP disqualification. State agencies are required to impose a civil
money penalty when they determine that an authorized vendor that has
been disqualified from the FSP is needed to ensure participant access
to supplemental foods. In responding to this issue, the rule seeks to
assure a vendor's right to due process while encouraging the most cost-
effective use of State agency resources.
In addition, while implementing the WIC Food Delivery Systems Final
Rule, State agencies have sought approval to release basic vendor
information that the rule designates as confidential. This rule seeks
to accommodate State agency requests to release such information, while
preserving the overall confidentiality of vendor information.
Extent To Which Those Concerns Have Been Met
The rule would substantially resolve the vendor management problems
State agencies have identified. It increases a State agency's
flexibility in conducting appeals of a civil money penalty imposed in
lieu of reciprocal disqualification from the WIC Program, and in
disclosing vendor information as part of sound program management. It
also supports the integrity of State agency infant formula rebate
systems by prohibiting gratis provision requirements in infant formula
rebate solicitations and contracts.
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.
Prior to any judicial challenge to the provisions of this rule or the
application of its provisions, all applicable administrative procedures
must be exhausted.
Civil Rights Impact Analysis
FNS has reviewed this final rule in accordance with Departmental
Regulation 4300-4, ``Civil Rights Impact Analysis,'' to identify and
address any major civil rights impacts this rule might have on
minorities, women, and persons with disabilities. All data available to
FNS indicate that protected individuals have the same opportunity to
participate in the WIC Program as non-protected individuals. FNS
specifically prohibits State and local government agencies that
administer the WIC Program from engaging in actions that discriminate
against any individual in any of the protected classes; see 7 CFR
246.8(a) for the non-discrimination policy of the WIC Program. Where
State agencies have options, and they choose to implement a certain
provision, they must implement it in such a way that it complies with
the regulations at 7 CFR 246.8.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR
1320) requires that the Office of Management and Budget (OMB) approve
all collections of information by a Federal agency before they can be
implemented. Respondents are not required to respond to any collection
of information unless it displays a current valid OMB control number.
This rule does not contain information collection requirements subject
to approval by the Office of Management and Budget under the Paperwork
Reduction Act of 1995.
E-Government Act Compliance
FNS is committed to complying with the E-Government Act, to promote
the use of the Internet and other information technologies to provide
increased opportunities for citizen access to Government information
and services, and for other purposes.
Background
On July 27, 2005, the Department published a proposed rule at 70 FR
43332, concerning revisions of miscellaneous vendor-related provisions
of the WIC Program regulations. The comment period ended on November
25, 2005. Thirteen comment documents were submitted to the Department
to provide comments on the proposed revisions. We greatly appreciate
these comments, all of which were carefully considered in the
development of this final rule. Following is a discussion of each
provision as proposed, the comments received, and an explanation of the
provisions set forth in this final rule.
1. Gratis Provisions in Infant Formula Rebate Solicitations and
Contracts (7 CFR 246.16a(j)(4))
The Department proposed prohibiting the requirement of gratis
infant formula or other items in infant formula rebate solicitations
and contracts. The receipt of free infant formula or other items by the
State agency from the manufacturer may lower the level of rebate bids
received. Therefore, the Department proposed to amend 7 CFR 246.16a(j),
by adding to a list of provisions that are prohibited to be included in
cost containment contracts the requirement for gratis infant formula
and other items.
All but one of the comment letters received supported this
proposal. Some of the comment letters supporting the provision also
recommended allowing: (1) Exceptions from the gratis prohibition for
labels and other inexpensive educational materials that are germane to
the contract; (2) gratis provisions only for new brands of infant
formula introduced to participants as a result of the bid process; (3)
State agencies that choose to provide sample infant formula to pay for
it at the net contract price; (4) capping the purchase amount of infant
formula samples to no more than one percent of the previous year's
volume of infant formula; and (5) gratis provisions as voluntary
components of bids which would not be
[[Page 21809]]
used in evaluating the bidder's qualifications, or economics of the
bid.
One commenter opposing the provision agreed that the elimination of
sample or gratis formula would result in lower cost to the
manufacturer, more favorable bids, and ultimately lower WIC food costs.
However, the commenter stated that formula is needed by clinics for
formula challenges and substitutions for a different type of formula
when an infant cannot tolerate the formula initially issued. This
commenter requested that the Department require State agencies to
evaluate the levels and uses of gratis infant formulas to ensure cost
effectiveness and to ensure the needs of infant participants are
addressed. The Department has considered these recommendations and
discuses them below.
One commenter requested State agencies be allowed to purchase
limited quantities of sample infant formula. Currently, WIC State
agencies are allowed to pay for sample infant formula for clinics to
use for formula challenges and substitutions. Contracts can include a
provision to allow a State agency to purchase sample formulas at the
same net cost as other contract infant formulas. WIC Program funds may
not be used to purchase formula for applicants or other individuals who
are not WIC participants (7 CFR 246.14(b)(1)(i)). Therefore, State
agencies that choose to purchase sample infant formula would be
expected to ensure that such formula is issued to a WIC participant
only.
Commenters also suggested State agencies be given the authority to
request the manufacturer provide labels and mixing instructions for
safe handling and safe storage of its products. It is not the intent of
this regulation to prohibit such practices by State agencies; however,
such items may not be included as a required provision in an infant
formula rebate solicitation and contract.
Several commenters suggested State agencies be required to limit
the purchase amount of infant formula samples. If a State agency
purchases infant formula to be distributed as samples, or receives
sample infant formula voluntarily from an infant formula manufacturer,
State agencies may want, as a prudent business decision, to consider
capping the amount of sample infant formula that is issued, or to
establish other procedures for the control and issuance of sample
infant formula. However, no changes will be added to this rule
requiring such a cap.
FNS continues to believe that contract solicitations should not
require any gratis infant formulas, even if these gratis formulas are
not included as part of the bid evaluation. Such provisions are
considered inappropriate and could have the effect of reducing rebate
savings not only to individual State agencies, but also to the WIC
Program nationally.
Accordingly, after careful consideration of the comments received,
7 CFR 246.16a(j)(4) in this final rule remains as proposed.
2. Abbreviated Administrative Reviews (7 CFR 246.18(a)(1)(ii))
The Department proposed to require a State agency to offer an
abbreviated administrative review when a vendor appeals a WIC CMP
imposed in lieu of a disqualification that stems from an FSP
disqualification unless, as in the case of all adverse actions subject
to abbreviated administrative review, the State agency decides to
provide a full administrative review. As a result of the WIC/FSP Vendor
Disqualification Rule, 64 FR 13311, March 18, 1999, a reciprocal
disqualification imposed by a WIC State agency, i.e., a
disqualification based on an FSP disqualification, is not currently
subject to administrative or judicial review under the WIC Program.
However, if the State agency determines that the vendor is needed to
ensure participant access to supplemental foods, the State agency must
impose a CMP in lieu of a disqualification as provided in 7 CFR
246.12(l)(1)(ix); under 7 CFR 246.18(a)(1)(i), the imposition of a CMP
in lieu of disqualification is subject to a full administrative review.
The Department took the position that a CMP imposed in lieu of a
reciprocal disqualification does not warrant a full administrative
review, and instead should be subject to an abbreviated administrative
review, because at issue are two factual questions only, namely,
whether the vendor has been disqualified from FSP and whether the State
agency correctly calculated the amount of the CMP. Answers to these
questions can easily be established within the context of an
abbreviated review; an abbreviated review would be the more cost-
effective means of honoring the vendor's due process protections. This
would be consistent with the adverse actions for which WIC Program
regulations currently allow abbreviated reviews.
All commenters supported the proposal, although one commenter
recommended that adverse actions for two other reasons also be made
subject to abbreviated administrative review, including denial of
authorization based on an absence of FSP authorization and
disqualification resulting from failure to pay a CMP.
The Department agrees that denial of authorization based on an
absence of FSP authorization should also be subject to an abbreviated
administrative review. Like termination based on change of location, or
denial of an application submitted outside of the timeframe for
submitting applications, which are subject to abbreviated
administrative review under the current regulations, determination of
whether an applicant vendor is currently FSP-authorized is also a
narrow factual determination. Many WIC State agencies require FSP
authorization as a selection criterion for WIC authorization. Although
not a mandatory selection criterion, requiring FSP authorization as a
selection criterion for WIC authorization helps the WIC State agency to
screen vendor applicants regarding common requirements of the two
programs such as business integrity and valid documentation of
ownership.
However, unlike the absence of FSP authorization, failure to pay a
CMP may involve issues that are beyond a narrow factual determination.
Therefore, the Department will consider seeking public comment on
whether an abbreviated administrative review rather than a full
administrative review should be provided for failure to pay a CMP in a
future rulemaking.
Accordingly, 7 CFR 246.18(a)(1)(ii) in this final rule remains as
proposed except that denial of authorization based on an absence of FSP
authorization will be included as an additional adverse action which is
subject to an abbreviated administrative review.
3. Confidentiality of Vendor Information (7 CFR 246.26(e))
The current 7 CFR 246.26(e) restricts the use or disclosure of
information that individually identifies a vendor, except for the
vendor's name, address and authorization status, to persons directly
connected with the administration or enforcement of WIC or FSP; persons
directly connected with the administration or enforcement of any
Federal or State law; or vendors who are subject to an adverse action.
The Department proposed to amend 7 CFR 246.26(e) to expand the
types of vendor information allowed for general release and thus not be
subject to confidentiality restrictions, including the vendor's
telephone number, Web site and e-mail address, WIC identification
number, and store type. The term ``store type'' refers to ordinary
[[Page 21810]]
terms for retail food stores, such as ``grocery store,'' ``chain
store,'' and ``convenience store,'' but not to specialized regulatory
terms such as ``above-50-percent vendor'' or ``WIC-only store''.
``Store type'' was included in the preamble of the proposed rule, but
inadvertently omitted from the proposed rule itself. The Department
believed that this increased information would allow WIC State agencies
to provide participants with vendors' telephone numbers and Web sites
and/or e-mail addresses to assist them with locating authorized vendors
in their neighborhood or local service area, and that knowing a
vendor's store type also would help participants to determine where to
transact their food instruments. Further, the Department proposed to
allow WIC State agencies to issue public notices of vendor
disqualifications (including the length of disqualification and the
reason for the disqualification) and to provide this information to
authorized vendors and program participants; the Department believed
that issuing public notices of WIC vendor disqualifications would deter
vendor fraud and abuse in the WIC Program.
The comments were generally supportive, but requested several
clarifications and revisions. Many of the commenters objected to
release of the vendor identification number, contending that this would
not assist the participants or public, and may lead to fraud, e.g.,
creation of a counterfeit vendor stamp. Also, one of the commenters
asserted that knowing the store type of a vendor would not help
participants to choose where to shop. Finally, one of the commenters
stated that the name of the owner should be released, since this would
assist the State health licensing process. The Department agrees that
the vendor identification number would be of little value, and that
making WIC vendor identification numbers public could lead to fraud.
However, the Department cannot consider making the name of the
owner available to the general public in this final rule, since the
name of the owner was not specified in 7 CFR 246.26(e) of the proposed
rule. Removing the confidentiality of such personal information should
not be undertaken without an opportunity for comment. Also, the
Department disagrees that the store type should not be made available
to the general public, since, unlike the name of the owner, there is no
privacy issued involved. Accordingly, the vendor identification number
and the name of the owner are not included in 7 CFR 246.26(e) of this
final rule, while the store type of the vendor is included in 7 CFR
246.26(e).
One of the commenters recommended that 7 CFR 246.26(e)(2) should be
revised to include local ordinances as well as Federal and State laws
regarding the persons directly connected with administration or
enforcement, because a city may be responsible for licensing grocery
stores, and also because the WIC State agency could benefit by having
another source of information on ownership. Another commenter asserted
that FNS should clarify that infant formula manufacturers participating
in the cost containment process are persons directly connected with the
administration or enforcement of the WIC Program in 7 CFR 246.26(e)(1).
This commenter pointed out that these companies play a unique and
important role regarding WIC, and thus need to know how the retail
presence of their products will be impacted by the acceptance of a bid
in order to reduce uncertainties which might impede aggressive bidding,
and also need to ensure that participants have access to infant formula
when a State agency transitions to a new contractor or during periods
of inventory shortages. The information of interest includes only the
names of the top 20 retailers and their associated percentage of WIC
volume.
The Department agrees that the State agency should be able to share
confidential vendor information with persons who are directly connected
with the administration or enforcement of local laws or ordinances on
such matters as licensing grocery stores, under agreement with the
State agency restricting third party disclosure. Accordingly, 7 CFR
246.26(e)(2) of this final rule includes the reference to local laws
and ordinances as well as Federal and State laws. However, the
Department does not agree that infant formula manufacturers are persons
directly connected with the administration or enforcement of the WIC
Program within the meaning of 7 CFR 246.26(e)(1). Although infant
formula manufacturers have a unique and important role regarding the
WIC Program, these manufacturers do not administer or enforce the
Federal, State, or local laws, rules, regulations, or ordinances which
govern the WIC Program. Their contracts with WIC State agencies do not
include responsibilities for such programmatic activities as the
certification of participants, the authorization of vendors, the
operation of State agency Management Information Systems, the
conducting of audits or investigations on behalf of State agencies, or
any other activities applying the Federal WIC-related laws, rules, and
regulations, or for such responsibilities related to State or local
laws or ordinances. The redemption volume of individual WIC vendors is
confidential vendor information under 7 CFR 246.26(e), and thus may not
be disclosed by WIC State agencies to infant formula manufacturers
under 7 CFR 246.26(e)(1) because infant formula manufacturers are not
persons directly connected with the administration or enforcement of
the WIC Program.
Finally, several commenters expressed reservations or recommended
restrictions regarding State agencies issuing public notices of WIC
vendor disqualifications. One of the commenters objected to release of
the disqualification information because the proposed provision is so
broad that it could compromise investigative techniques and lead to
release of investigative reports, and that release of derogatory
information could unfairly damage the reputation of a vendor who later
prevails on appeal. One commenter objected to release of the
disqualification information because this may be used to justify an
expansive discovery process in legal proceedings regarding information
on vendors other than the vendor seeking discovery, recommending that
the proposed provision needs to be more specific and should cover CMPs
as well as disqualifications. Another commenter asserted that there
should be equal treatment for participants and program officials, i.e.,
public notification of participants and program officials found guilty
of fraud; this commenter also asserted that such notification should
only occur after due process has been exhausted.
The Department agrees with many of these concerns. To accommodate
all of these issues, disqualification information is addressed by a new
7 CFR 246.26(e)(4) in this final rule. This new provision explicitly
provides that a State agency may release such information at its
discretion, that the imposition of CMPs may be included as well as
disqualifications, and that State agencies are only permitted to
release the vendor's name, address, length of the disqualification or
amount of the CMP, and a summary of the reason(s) for such sanction
provided in the notice of adverse action. Further, the new provision
provides that such information may not be disclosed unless the vendor's
right to appeal through the judicial as well as administrative review
procedures has been exhausted. Finally, under this new provision, this
information may only be disclosed to other authorized vendors or vendor
applicants, since such disclosure is
[[Page 21811]]
intended to deter vendor violations, not the violations of participants
or program officials. If a State agency does not view this revised
language as meeting all of its concerns, then the State agency may
exercise its discretion to not issue such notices.
List of Subjects in 7 CFR Part 246
Food assistance programs, Food donations, Grant programs--social
programs, Indians, Infants and children, Maternal and child health,
Nutrition, Nutrition education, Public assistance programs, WIC, Women.
Accordingly, 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
0
1. The authority citation for part 246 continues to read as follows:
Authority: 42 U.S.C. 1786.
0
2. In Sec. 246.16a:
0
a. Amend paragraph (c)(3)(i), (c)(3)(ii)(A) and (B) by removing the
reference ``Sec. 246.10(c)(1)(i)'' wherever it appears and replacing
it with ``Sec. 246.10(e)(1)(iii) and Sec. 246.10(e)(2)(iii)''.
0
b. Amend paragraph (c)(4)(i) by removing the reference ``Sec.
246.10(c)(1)(vi)'' and replacing it with ``Sec.
246.10(e)(9)(Table1))''.
0
c. Amend paragraph (e) by removing the reference ``Sec.
246.4(a)(14)(xi)'' and replacing it with ``Sec. 246.4(a)(14)(x)''.
0
d. Amend paragraph (j)(2) by removing the reference ``Sec. 246.10(f);
or'' and replacing it with ``Sec. 246.10(g);''.
0
e. Amend paragraph (j)(3) by removing the period at the end of the
paragraph and adding in its place a semicolon followed by the word
``or''; and
0
f. Add paragraph (j)(4) to read as follows:
Sec. 246.16a Infant formula cost containment.
* * * * *
(j) * * *
0
(4) Require infant formula manufacturers to provide gratis infant
formula or other items.
* * * * *
0
3. In Sec. 246.18, add new paragraphs (a)(1)(ii)(I) and (a)(1)(ii)(J)
to read as follows:
Sec. 246.18 Administrative review of State agency actions.
(a) * * *
(1) * * *
(ii) * * *
(I) A civil money penalty imposed in lieu of disqualification based
on a Food Stamp Program disqualification under Sec. 246.12(l)(1)(vii)
and,
(J) Denial of an application based on a determination of whether an
applicant vendor is currently authorized by the Food Stamp Program.
* * * * *
0
4. In Sec. 246.26:
0
a. Amend the first sentence of the introductory text of paragraph (e)
by removing the words ``and authorization status'' and by adding, in
their place, the words ``, telephone number, Web site/e-mail address,
store type, and authorization status'';
0
b. Amend paragraph (e)(2) by adding the words ``or local law or
ordinance'' at the end of the first sentence; and,
0
c. Add a new paragraph (e)(4) to read as follows:
Sec. 246.26 Other provisions.
* * * * *
(e) * * *
0
(4) At the discretion of the State agency, all authorized vendors and
vendor applicants regarding vendor sanctions which have been imposed,
identifying only the vendor's name, address, length of the
disqualification or amount of the civil money penalty, and a summary of
the reason(s) for such sanction provided in the notice of adverse
action. Such information may be disclosed only following the exhaustion
of all administrative and judicial review, in which the State agency
has prevailed, regarding the sanction imposed on the subject vendor, or
the time period for requesting such review has expired.
* * * * *
Dated: April 10, 2008.
Roberto Salazar,
Administrator, Food and Nutrition Service.
[FR Doc. E8-8767 Filed 4-22-08; 8:45 am]
BILLING CODE 3410-30-P