Change in Accredited Laboratory Fees, 56235-56238 [2014-22208]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Rules and Regulations]
[Pages 56235-56238]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22208]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 391

[Docket No. FSIS-2014-0026]
RIN 0583-AD


Change in Accredited Laboratory Fees

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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[[Page 56236]]

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
regulations to change the fees it charges for the accreditation and the 
maintenance of accreditation of non-Federal laboratories for the FSIS 
Accredited Lab Program (ALP). The fees in this final rule will be 
applied on the effective date.

DATES: This final rule is effective November 18, 2014.

FOR FURTHER INFORMATION CONTACT: Charles Williams, Room 6065, South 
Agriculture Building, 1400 Independence Ave. SW., Washington, DC 20250-
0235, Phone: (202) 720-5627, Email: charles.williams@fsis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    FSIS has been delegated the authority to exercise the functions of 
the Secretary of Agriculture (7 CFR 2.18, 2.53) as specified in the 
Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.) and the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.). FSIS 
protects the public by verifying that meat and poultry products are 
wholesome, not adulterated, and properly marked, labeled, and packaged.
    In addition, under the Food, Agriculture, Conservation, and Trade 
Act of 1990, as amended (7 U.S.C. 138-138i), FSIS has authority to 
accredit non-Federal laboratories. The accreditation allows non-Federal 
laboratories to conduct analyses of official regulatory meat and 
poultry samples. One provision (7 U.S.C. 138f) requires that a 
laboratory seeking accreditation under the 1990 Act or under the FMIA 
or PPIA pay a non-refundable accreditation fee to cover the costs of 
the Accredited Laboratory Program.

Proposed and Final Rules

    On April 21, 2014, FSIS published a proposed rule to amend 9 CFR 
391.5(a) to change the fee structure for the accreditation and the 
maintenance of the accreditation of laboratories for the FSIS 
Accredited Laboratory Program (ALP) (79 FR 22052). FSIS did not receive 
any comment on the proposed rule. Hence, it is adopting the proposed 
rule in its entirety as its final rule.
    FSIS explained in the proposed rule that under the regulations 
currently in effect, FSIS charges each laboratory a flat annual fee of 
$5,000 per accreditation or maintenance of accreditation. FSIS further 
explained that a laboratory may apply for FSIS accreditation and 
maintenance of accreditation in one to six analyte classes: Food 
Chemistry, chlorinated hydrocarbons (CHCs), polychlorinated biphenyls 
(PCBs), arsenic, nitrosamines, and sulfonamides. Under the regulations 
currently in effect, FSIS charges laboratories the flat rate of $5,000 
for each accreditation obtained regardless of the type or the number of 
accreditations. A laboratory accredited for all six analyte classes is 
charged a total fee of $30,000. FSIS bills annually for the costs of 
the services it provides the laboratories, including the cost of FSIS 
auditing non-Federal laboratories, conducting periodic proficiency test 
sample studies, conducting on-site reviews, and maintaining 
accreditation (includes analyzing proficiency test results and 
documentation).
    FSIS explained that the costs to the ALP can be reduced when 
laboratories apply for multiple accreditations, because most of the 
cost to the Agency in conducting the ALP is in travel and administering 
sample studies to determine laboratory proficiency.
    Therefore, as proposed, FSIS is amending the regulations to include 
a sliding scale for accreditations and the maintenance of 
accreditations after payment of the base fee of $5,000 for the first 
accreditation that a laboratory receives. Under the final rule, FSIS 
will charge laboratories $5,000 per year for the first analyte class 
accreditation or maintenance of accreditation, $2,900 per year for the 
second, and $2,100 per year for each additional analyte class 
accreditation or maintenance of accreditation.
    As FSIS proposed, the final rule includes a fee of $2,900 \1\ for 
the second accreditation because FSIS staff can review multiple 
accreditations (different analyte classes) for the same laboratory in 
one trip. Under the final rule, FSIS will charge $2,100 \2\ each for 
the third, fourth, fifth, and sixth accreditations, because, when a 
laboratory has three or more accreditations, some of the instrument 
types and chemical processes are similar from analysis to analysis. 
This fact means that the review will be less labor-intensive. FSIS 
determined that costs to participants in the accredited laboratory 
program will cover the cost to the Agency for the administration of the 
program. The costs are included below in Table 1 and are based on 
available FSIS laboratory and personnel cost data.
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    \1\ Source: FSIS, OPHS, LQAS, Accredited Laboratory Program.
    \2\ Ibid.

                        Table 1--ALP Fee Schedule
------------------------------------------------------------------------
                                               Accreditations
               Item               --------------------------------------
                                        1            2           3-6
------------------------------------------------------------------------
Auditing of non-Federal                 $2,546         $816         $408
 Laboratories....................
Proficiency Tests................        1,237        1,237        1,237
Maintenance of Accreditation.....          918          536          153
Additional Costs.................          347          347          347
                                  --------------------------------------
    Total........................        5,048        2,936        2,145
                                  --------------------------------------
    Rounded Total................        5,000        2,900        2,100
------------------------------------------------------------------------

Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This final rule has been designated a ``non-significant'' 
regulatory action under section 3(f) of Executive Order (E.O.) 12866. 
Accordingly, the rule has not

[[Page 56237]]

been reviewed by the Office of Management and Budget under E.O. 12866.

Baseline

    The FSIS Accredited Laboratory Program, (ALP) is voluntary and 
charges a non-refundable accreditation fee. Currently, the annual fee 
is $5,000 per accreditation (Table 2). As discussed above, FSIS is 
reducing the fees after the first accreditation. Table 2 below compares 
current fees to proposed fees.

        Table 2--Current and Proposed Accreditation Fee Schedule
------------------------------------------------------------------------
                                           Current             New
            Accreditation               accreditation     accreditation
                                           lab fee           lab fee
------------------------------------------------------------------------
First...............................            $5,000            $5,000
Second..............................             5,000             2,900
Third-Sixth.........................             5,000             2,100
------------------------------------------------------------------------

    Currently, there are 53 laboratories accredited for 60 
activities.\3\ Most (42 out of 53) laboratories are accredited for food 
chemistry. There are 13 laboratories accredited for CHCs and five 
laboratories for PCBs. Only five of the 53 laboratories are accredited 
for more than one analyte. These laboratories are accredited for 2-3 
analytes. The analysis below assumes laboratories will keep the same 
number of accreditations under the new fee structure.
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    \3\ FSIS, OPHS, LQAS, Accredited Laboratory Program.
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Expected Cost of the Final Rule

    For the purposes of this analysis, FSIS considered the pre- and 
post-rule cost to the industry; they are shown in Table 3 below. The 
cost to the industry will fall from $300,000 per year to $283,700 per 
year.

                                    Table 3--Annual Costs Pre- and Post-Rule
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                                                                      Pre-rule                  Post-rule
                                                             ---------------------------------------------------
                 Number of  analyte  classes                                 Industry                  Industry
                                                              Number labs      cost     Number labs      cost
----------------------------------------------------------------------------------------------------------------
1...........................................................           48     $240,000           48     $240,000
2...........................................................            3   \4\ 30,000            3   \5\ 23,700
3...........................................................            2       30,000            2       20,000
                                                             ---------------------------------------------------
                                                                       53      300,000           53      283,700
----------------------------------------------------------------------------------------------------------------

Expected Benefits of the Final Rule

    The benefit accrued to the industry is equivalent to current 
accreditation costs minus the new accreditation costs which incorporate 
the efficiencies outlined in the preamble.
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    \4\ Calculation--Total Cost = (Accreditation 1 Cost * Number of 
Laboratories) + (Accreditation 2 Cost * Number of Laboratories) = 
($5,000 * 3) + ($5,000 * 3).
    \5\ Calculation--Total Cost = (Accreditation 1 Cost * Number of 
Laboratories) + (Accreditation 2 Cost * Number of Laboratories) = 
($5,000 * 3) + ($2,900 * 3).
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    The final rule will benefit the lab industry by offering a sliding 
accreditation fee schedule. The lower cost is a result of leveraging 
efficiencies in the current accreditation process that will allow the 
industry to realize cost savings if they increase the number of 
accreditations. Under the current accreditation fee schedule, the total 
industry cost is estimated as $300,000 ($300,000 = 60 Accreditations x 
$5,000) (Table 3). Therefore, the total industry cost is $283,700, a 
net benefit of $16,300 ($300,000 - $283,700 = $16,300). If the total 
number of accreditations remains unchanged, the present value of total 
industry net benefit due to the final rule (Table 4), adjusted with 3% 
inflation rate for 10 years is $139,000, resulting in an annualized 
expected benefit of $16,295.

                 Table 4--Summary of Costs and Benefits
------------------------------------------------------------------------
  Current  costs    Proposed  costs       Proposed        Net Benefits
      (FY13)             (FY14)           benefits       (10 years, 3%)
------------------------------------------------------------------------
       $300,000           $283,700            $16,300          $139,000
------------------------------------------------------------------------

Final Regulatory Flexibility Analysis

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the final rule will 
not have a significant economic impact on a substantial number of small 
entities in the United States.

Paperwork Reduction Act

    This rule does not contain any new information collection or 
recordkeeping requirements that are subject to the Office of Management 
and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.)

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et

[[Page 56238]]

seq.) by, among other things, promoting the use of the Internet and 
other information technologies and providing increased opportunities 
for citizen access to Government information and services, and for 
other purposes.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
retroactive proceedings will be required before parties may file suit 
in court challenging this rule.

Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

Additional Public Notification

    FSIS will announce this notice online through the FSIS Web page 
located at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register.
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at https://www.fsis.usda.gov/wps/portal/fsis/programs-and-services/email-subscription-service. Options range from recalls to export information 
to regulations, directives, and notices. Customers can add or delete 
subscriptions themselves, and have the option to password protect their 
accounts.

USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at https://
www.ocio.usda.gov/sites/default/files/docs/2012/
Complaincombined6812.pdf, or write 
a letter signed by you or your authorized representative. Send your 
completed complaint form or letter to USDA by mail, fax, or email:

Mail: U.S. Department of Agriculture Director, Office of Adjudication, 
1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: program.intake@usda.gov.

    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

List of Subjects in 9 CFR Part 391

    Fees and charges.

    For the reasons discussed in the preamble, FSIS amends 9 CFR 
Chapter III as follows:

PART 391--FEES AND CHARGES FOR INSPECTION AND LABORATORY 
ACCREDITATION

0
1. The authority citation for part 391 continues to read as follows:

    Authority: 7 U.S.C. 138d, 7 U.S.C. 1622, 1627, and 2219a; 21 
U.S.C. 451 et seq.; 21 U.S.C. 601-695.


0
2. Revise paragraph (a) of Sec.  391.5 to read as follows:


Sec.  391.5  Laboratory accreditation fee.

    (a) The annual fee for the accreditation and maintenance of 
accreditation provided pursuant to Sec.  439.5 of this chapter shall be 
$5,000 for the first analyte class, $2,900 for the second analyte 
class, and $2,100 for each additional analyte class.
* * * * *

    Done at Washington, DC, on September 11, 2014.
Alfred Almanza,
Administrator.
[FR Doc. 2014-22208 Filed 9-18-14; 8:45 am]
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