[Federal Register Volume 74, Number 239 (Tuesday, December 15, 2009)]
[Rules and Regulations]
[Pages 66213-66217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29799]



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 Rules and Regulations
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  Federal Register / Vol. 74, No. 239 / Tuesday, December 15, 2009 / 
Rules and Regulations  

[[Page 66213]]



DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

7 CFR Parts 210 and 220

[FNS-2008-0033]
RIN 0584-AD65


School Food Safety Program Based on Hazard Analysis and Critical 
Control Point Principles

AGENCY: Food and Nutrition Service (FNS), USDA.

ACTION: Final rule.

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

SUMMARY: This final rule implements a legislative provision which 
requires school food authorities participating in the National School 
Lunch Program (NSLP) or the School Breakfast Program (SBP) to develop a 
school food safety program for the preparation and service of school 
meals served to children. The school food safety program must be based 
on the hazard analysis and critical control point (HACCP) system 
established by the Secretary of Agriculture. The food safety program 
will enable schools to take systematic action to prevent or minimize 
the risk of foodborne illness among children participating in the NSLP 
and SBP.

DATES: This final rule is effective January 14, 2010.

FOR FURTHER INFORMATION CONTACT: William Wagoner or Marisol Benesch, 
Policy and Program Development Branch, Child Nutrition Division, Food 
and Nutrition Service at (703) 305-2590.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 111 of the Child Nutrition and WIC Reauthorization Act of 
2004 (Pub. L. 108-265; June 30, 2004) amended section 9(h) of the 
Richard B. Russell National School Lunch Act (NSLA) (42 U.S.C. 1758(h)) 
by adding the requirement that school food authorities (SFAs) implement 
a food safety program at each food preparation and service facility 
participating in the NSLP or the SBP. The food safety program, which 
became a requirement in the school year beginning July 1, 2005, must be 
based on the HACCP system established by the Secretary of Agriculture. 
A HACCP-based food safety program should enable SFAs to identify 
potential food hazards, identify critical points where hazards can be 
controlled or minimized through control measures, and establish 
monitoring procedures and corrective action.
    Prior to Public Law 108-265, there was no federal requirement for a 
HACCP-based food safety program for SFAs participating in the NSLP and 
SBP. Program regulations only required SFAs to follow State and local 
sanitation and health standards. SFAs were expected to check food 
temperatures per State and local regulations, but were not required to 
follow a systematic food safety program.
    To provide guidance and help SFAs implement the required food 
safety program in School Year 2005-2006, FNS issued two memoranda in 
January 2005 and July 2006, as well as ``Guidance for School Food 
Authorities: Developing a School Food Safety Program Based on the 
Process Approach to HACCP Principles'' in June 2005, http://www.fns.usda.gov/cnd/CNlabeling/Food-Safety/HACCPGuidance.pdf. This 
practical guidance was followed by a proposed rule published in the 
Federal Register on August 5, 2008 (73 FR 45359). The FNS guidance and 
the proposed rule recommend the Process Approach because it is 
considered easier to implement than the traditional HACCP method. The 
Process Approach, developed by the Food and Drug Administration, 
simplifies traditional HACCP by grouping foods according to preparation 
process and applying the same control measures to all menu items within 
a group, instead of developing a HACCP plan for each item. The proposed 
rule also gave SFAs the option to implement traditional HACCP.
    This final rule codifies the requirements set forth in the proposed 
rule. The statutory requirement has already been implemented by program 
operators with the assistance of guidance, technical assistance, and 
training from FNS and the National Food Service Management Institute 
(NFSMI).

II. Discussion of Public Comments

    The comment period for the proposed rule ended September 19, 2008 
(73 FR 45359). FNS received seven public comments: one from an 
advocate, one from a State Agency, three from school districts, and two 
from individuals. The comments addressed the following areas:

Food Safety Program Based on HACCP

    A program advocate would like assurances that the HACCP-based food 
safety programs SFAs had in place prior to this rule would be 
considered acceptable. The commenter asked the Department to emphasize 
that SFAs have discretion to follow traditional HACCP or the Process 
Approach to HACCP.
    FNS stated in the proposed rule that SFAs may keep an existing food 
safety program if it reflects all the HACCP principles described in the 
rule. SFAs may follow traditional HACCP or the Process Approach to 
HACCP.
    A large school district commented that the Process Approach only 
saved minimum time, and recommended the Department allow 18-24 months 
for phased-in implementation to give program operators sufficient time 
to design/implement the program and train the food service staff. The 
commenter also expressed concern about the potential cost of equipment 
for the food safety program and stated that it spent $50,000 in 
specialized thermometers for all its SFA sites. Another commenter 
recommended that SFAs be allowed flexibility to develop cost-effective 
and unique systems that reflect the HACCP principles.
    Public Law 108-265 established July 1, 2005 as the effective date 
for the food safety program requirement. The Department identified 
school year 2005-2006 as the implementation period for the food safety 
program, as required by statute, and provided SFAs practical guidance 
and training in collaboration with NFSMI. Several years have passed 
since the implementation date established by law; therefore, phased-in 
implementation is not an option. By now, SFAs should be working on 
reviewing and improving their established HACCP-based food safety 
program.

[[Page 66214]]

    Implementation of this legislative requirement is not expected to 
result in major equipment expenses for program operators. SFAs 
operating the NSLP and SBP should already have thermometers and other 
basic equipment necessary to prepare, serve, and store meals safely in 
compliance with State and local public health standards, as previously 
required by the NSLP and SBP regulations.
    With regard to ease of implementation and flexibility, the 
Department wishes to emphasize that the practical guidance and training 
provided to SFAs presented a simplified version of the Process Approach 
adapted for school food service operations. The Process Approach is 
less complex than traditional HACCP and is inherently flexible because 
it gives each SFA the ability to tailor the food safety program to each 
site. Furthermore, SFAs have discretion to follow either the Process 
Approach or traditional HACCP.

Monitoring and Recording Food Temperature Daily

    A large school food authority commented that developing and 
monitoring the HACCP-based food safety program is time consuming. One 
commenter asked that schools be allowed to maintain electronic records, 
and another recommended the Department issue schedules for food safety 
inspections and temperature monitoring.
    While the food safety program must reflect all HACCP principles 
discussed in the FNS guidance, it does not have to be elaborate or 
extremely time consuming. A number of resources were developed to 
facilitate implementation of the school food safety program. NFSMI 
produced templates and other materials to help SFAs implement a basic 
HACCP-based food safety program in School Year 2005-2006. In addition, 
NFSMI provided technical assistance and training to SFAs upon request 
from the State Agencies. These resources continue to be available to 
SFAs to enhance their current HACCP-based food safety program.
    FNS encourages the use of technology to reduce burden when 
possible. This final rule allows SFAs to maintain electronic records as 
long as they can be retrieved. FNS does not consider it necessary to 
set a schedule for temperature checking and recording because HACCP 
already identifies the critical control points for temperature 
monitoring and the timing is defined by the food preparation process. 
The schedule for food safety inspections is determined by the State or 
local agency in charge of inspections. The food safety inspection 
requirement is discussed in a separate rule.

Recordkeeping Period

    Commenters in general recommended that recordkeeping requirements 
be based on the incubation period for a likely pathogen or communicable 
disease and not exceed 1 year. As suggested by several commenters, the 
proposed recordkeeping period will be changed to six months following 
each month's temperature records. FNS believes this recordkeeping 
requirement will not be an unnecessary burden on schools and will allow 
schools to document their efforts to comply with the food safety 
program requirement and to prevent foodborne illness.

Miscellaneous Comments

    Commenters would like funding for training and program 
implementation, as well as additional guidance and training activities. 
A commenter requested refresher training on the Process Approach and 
regular updates to the FNS practical guidance. Another commenter asked 
FNS to explicitly state that State Administrative Expense Funds can be 
used for food safety purposes.
    NFSMI continues to offer training to support the implementation of 
school food safety programs. In addition, FNS continues to serve as an 
information resource for SFAs and assesses the need for additional 
training and technical assistance resources on a regular basis.
    With regard to funding, State Administrative Expense funds are 
available to support food safety training and technical assistance 
activities sponsored by the State agency.

III. Conclusion

    This final rule amends 7 CFR 210.9 to incorporate the food safety 
program in the provisions covered by the SA agreement, 7 CFR 210.13 to 
add a new paragraph on the food safety program requirement based on 
HACCP, 7 CFR 210.15 to address the recordkeeping requirement, 7 CFR 
210.18 to include the food safety program as part of the administrative 
reviews, and 7 CFR 220.7 to extend the food safety program requirement 
to the SBP.

IV. Procedural Matters

Executive Order 12866

    This rule has been determined to be significant and was reviewed by 
the Office Management and Budget in conformance with Executive Order 
12866.

Regulatory Impact Analysis

Need for Action
    This action is needed to formally implement the food safety program 
requirement established by Public Law 108-265. More than 101,000 
schools participate in the NSLP and SBP and serve over 38 million meals 
daily in a variety of settings. Although school meals are generally 
safe, it is essential that SFAs follow a systematic food safety program 
to safeguard the health of children.
Benefits
    HACCP is considered an effective method to attain control of 
foodborne illness risk factors. As a result of this rule, SFAs will 
implement a HACCP-based food safety program in their preparation and 
service sites to prevent or minimize the risk of foodborne illness.
Costs
    The Regulatory Impact Analysis estimates that the total cost 
associated with implementing a HACCP-based food safety program at $46 
million in the first year of implementation. FNS expects that the 
subsequent annual costs associated with this proposal would decline as 
one-time program development efforts are completed, with 5 year costs 
totaling approximately $116 million.

Regulatory Flexibility Act

    This final rule has been reviewed with regard to the requirements 
of the Regulatory Flexibility Act (5 U.S.C. 601-612). Implementation of 
this rule is not expected to impose a significant economic impact on a 
substantial number of small entities. Existing program regulations in 
Sec.  210.13(a) require that SFAs follow proper sanitation and health 
standards established under State and local law. Many SFAs have 
Standard Operating Procedures in place to comply with State and local 
public health regulations, or have already implemented a food safety 
program as a result of the statutory requirement, subsequent FNS 
guidance and NFSMI training available since 2005.

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 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/

[[Page 66215]]

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 1 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 1 year. Program operators already have basic equipment and 
standard operating procedures in place to prepare meals that comply 
with sanitation and health standards established under State and local 
law. This rule is, therefore, not subject to the requirements of 
sections 202 and 205 of the UMRA.

Executive Order 12372

    The NSLP is listed in the Catalog of Federal Domestic Assistance 
under No. 10.555 and the SBP is listed under No. 10.553. For the 
reasons set forth in the final rule in 7 CFR part 3015, Subpart V and 
related Notice [48 FR 29115, June 24, 1983], these Programs are 
included in the scope of Executive Order 12372, which requires 
intergovernmental consultation with State and local officials.
    Since the NSLP and SBP are federally funded programs administered 
at the State level, FNS headquarters and regional office staff have 
ongoing formal and informal discussions with State and local officials 
regarding operational issues. This arrangement allows State and local 
agencies to provide feedback that forms the basis for any discretionary 
decisions made in this and other rules.

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 13132.
Prior Consultation With State and Local Officials
    Shortly after passage of the Child Nutrition and WIC 
Reauthorization Act of 2004, FNS met with officials from State 
education agencies to discuss the new school food safety requirements 
and to hear their concerns. FNS also solicited input from the Food 
Safety and Inspection Service, Food and Drug Administration, National 
Food Service Management Institute, Centers for Disease Control and 
Prevention, School Nutrition Association, National Environmental Health 
Association, and State and local public health agencies. Furthermore, 
the Department published a proposed rule on August 5, 2008 to solicit 
public comments, which have been addressed in the preamble.
Nature of Concerns and Need To Issue This Rule
    During the public comment period, some State and local officials 
raised concerns that school food service personnel may lack the 
expertise and time to properly implement a HACCP-based food safety 
program. Others expressed concern that the proposed requirement will 
increase the workload of school foodservice personnel.
    This rule establishes in regulation the requirement that SFAs 
follow food safety procedures that are generally regarded as essential 
in institutional food service operations. Implementation of this 
requirement also supports the food safety recommendations in the 2005 
Dietary Guidelines for Americans.
Extent to Which FNS Meets Those Concerns
    To address the stakeholders' concerns, FNS offered the Process 
Approach to HACCP, which is considered an easier method than 
traditional HACCP. FNS adapted the Process Approach to fit the school 
food service operation, issued practical guidance in 2005, and worked 
with NFSMI to develop training materials for program operators. The 
guidance and training materials provide step-by-step instructions for 
implementing the food safety program and examples. FNS will assess the 
need for additional training and technical assistance resources as we 
continue to learn about program experience at the State and local 
levels.

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 
under Sec.  210.18(q) or Sec.  235.11(f) must be exhausted.

Civil Rights Impact Analysis

    FNS has reviewed this final rule in accordance with the Department 
Regulation 4300-4, ``Civil Rights Impact Analysis,'' to identify any 
major civil rights impacts the rule might have on children on the basis 
of age, race, color, national origin, sex or disability. After a 
careful review of the rule's intent and provisions, FNS has determined 
that this rule does not affect the participation of protected 
individuals in the NSLP and SBP.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35, see 5 CFR 
1320) requires that OMB approve all collections of information by a 
Federal agency from the public 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. Once 
OMB approves the information collection, FNS will merge these burden 
hours into National School Lunch Program, OMB  0584-0006, 
expiration date 5/31/2012. A 60-day notice was published in the Federal 
Register at 70 FR 45359 on August 5, 2008, which provided the public an 
opportunity to submit comments on the information collection burden 
resulting from this rule. FNS will publish a document in the Federal 
Register once these requirements have been approved. FNS is increasing 
the burden hours from 1,938,870, which was the total burden hours 
published in the proposed rule on August 5, 2008, to 2,248,284. The 
increase is due to the increase in program participants in school food 
authorities and schools. The 2,248,284 takes into account the increase 
from 20,710 to 20,858 school food authorities and an increase from 
100,398 to 101,705 schools that participate in the NSLP and the 81,517 
schools that participate in the SBP.

[[Page 66216]]



                                             Estimated Annual Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of        Annual      Average burden   Annual burden
                                     Section        respondents      frequency     per  response       hours
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
State agency shall confirm      7 CFR                         57              61            1              3,477
 that each school food           210.18(h)(6).
 authority has a food safety
 program based on HACCP
 principles. New Burden.
SFA must implement a food       7 CFR 210.13(c).          20,858               1           76          1,585,208
 safety program based on HACCP
 principles for each food
 preparation and service
 facility under its
 jurisdiction. New burden.
                               ---------------------------------------------------------------------------------
    Total New Reporting.......  ................  ..............  ..............  ..............       1,588,685
----------------------------------------------------------------------------------------------------------------
                                                  Recordkeeping
----------------------------------------------------------------------------------------------------------------
Schools record and maintain     7 CFR                    101,705             180             .02         366,138
 NSLP records from food safety   210.15(b)(5).
 program. New Burden.
Schools record and maintain     7 CFR 220.7.....          81,517             180             .02         293,461
 SBP records from food safety
 program.
                               ---------------------------------------------------------------------------------
    Total New Recordkeeping...  ................  ..............  ..............  ..............         659,599
                               ---------------------------------------------------------------------------------
        Total Burden Requested  ................  ..............  ..............  ..............       2,248,284
----------------------------------------------------------------------------------------------------------------

E-Government Act Compliance

    FNS is committed to complying with the E-Government Act 2002, 44 
U.S.C. 3601, et seq. 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.

List of Subjects

7 CFR Part 210

    Grant programs--education, Grant programs--health, Infants and 
children, Nutrition, Penalties, Reporting and recordkeeping 
requirements, School breakfast and lunch programs, Surplus agricultural 
commodities.

7 CFR Part 220

    Grant programs--education, Grant programs--health, Infants and 
children, Nutrition, Reporting and recordkeeping requirements, School 
breakfast and lunch programs.


0
Accordingly, 7 CFR parts 210 and 220 are amended as follows:

PART 210--NATIONAL SCHOOL LUNCH PROGRAM

0
1. The authority citation for 7 CFR part 210 continues to read as 
follows:

    Authority:  42 U.S.C. 1751-1760, 1779.


0
2. In Sec.  210.9, revise paragraph (b)(14) to read as follows:


Sec.  210.9  Agreement with State agency.

* * * * *
    (b) * * *
    (14) Maintain, in the storage, preparation and service of food, 
proper sanitation and health standards in conformance with all 
applicable State and local laws and regulations, and comply with the 
food safety requirements of Sec.  210.13;
* * * * *

0
3. In Sec.  210.13, redesignate paragraph (c) as paragraph (d), and add 
a new paragraph (c) to read as follows:


Sec.  210.13  Facilities management.

* * * * *
    (c) Food safety program. The school food authority must develop a 
written food safety program for each of its food preparation and 
service facilities that meets the requirements in paragraph (c)(1) or 
paragraph (c)(2) of this section.
    (1) A school food authority with a food safety program based on 
traditional hazard analysis and critical control point (HACCP) 
principles must:
    (i) Perform a hazard analysis;
    (ii) Decide on critical control points;
    (iii) Determine the critical limits;
    (iv) Establish procedures to monitor critical control points;
    (v) Establish corrective actions;
    (vi) Establish verification procedures; and
    (vii) Establish a recordkeeping system.
    (2) A school food authority with a food safety program based on the 
process approach to HACCP must ensure that its program includes:
    (i) Standard operating procedures to provide a food safety 
foundation;
    (ii) Menu items grouped according to process categories;
    (iii) Critical control points and critical limits;
    (iv) Monitoring procedures;
    (v) Corrective action procedures;
    (vi) Recordkeeping procedures; and
    (vii) Periodic program review and revision.
* * * * *

0
4. In Sec.  210.15,
0
a. Revise the introductory text in paragraph (b); and
0
b. Revise paragraph (b)(5).
    The revisions read as follows:


Sec.  210.15  Reporting and recordkeeping.

* * * * *
    (b) Recordkeeping summary. In order to participate in the Program, 
a school food authority or a school, as applicable, must maintain 
records to demonstrate compliance with Program requirements. These 
records include but are not limited to:
* * * * *
    (5) Records from the food safety program for a period of six months 
following a month's temperature records to demonstrate compliance with 
Sec.  210.13(c), and records from the most recent food safety 
inspection to demonstrate compliance with Sec.  210.13(b).
0
5. In Sec.  210.18, add a new paragraph (h)(6) to read as follows:


Sec.  210.18  Administrative reviews.

* * * * *
    (h) * * *
    (6) Food safety. The State Agency must examine records to confirm 
that each school food authority under its

[[Page 66217]]

jurisdiction meets the food safety requirements of Sec.  210.13.
* * * * *

PART 220--SCHOOL BREAKFAST PROGRAM

0
6. The authority citation for 7 CFR part 220 continues to read as 
follows:

    Authority:  42 U.S.C. 1773, 1779, unless otherwise noted.


0
7. In Sec.  220.7:
0
a. Add a new paragraph (a)(3); and
0
b. Revise paragraph (e)(8).
    The addition and revision read as follows:


Sec.  220.7  Requirements for participation.

    (a) * * *
    (3) A school food authority must implement a food safety program 
meeting the requirements of Sec.  210.13(c) and Sec.  210.15(b)(5) of 
this chapter at each of the food preparation and service facilities 
under its jurisdiction serving breakfasts.
* * * * *
    (e) * * *
    (8) Maintain, in the storage, preparation and service of food, 
proper sanitation and health standards in conformance with all 
applicable State and local laws and regulations, and comply with the 
food safety requirements in paragraph (a)(2) and paragraph (a)(3) of 
this section;
* * * * *

    Dated: December 4, 2009.
Kevin W. Concannon,
Under Secretary, Food, Nutrition, and Consumer Services.
[FR Doc. E9-29799 Filed 12-14-09; 8:45 am]
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