[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Proposed Rules]
[Pages 22052-22054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08962]



[[Page 22052]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 391

[Docket No. FSIS-2013-0022]
RIN 0583-AD


Change in Accredited Laboratory Fees

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend 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). Currently, the 
Agency charges a flat annual fee of $5,000 for each accreditation or 
maintenance of accreditation. Laboratories that participate in FSIS' 
ALP can receive accreditation in one to six analyte classes. FSIS is 
proposing to charge laboratories $5,000 per year for the first analyte 
class accreditation or maintenance (as it currently does), but to 
reduce the charges to $2,900 per year for the second, and $2,100 per 
year for each additional analyte class accreditation or maintenance of 
accreditation.

DATES: Submit comments on or before June 20, 2014.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Room 
Manager, U.S. Department of Agriculture, Food Safety and Inspection 
Service, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, 
Room 8-163B, Washington, DC 20250-3700.
     Hand- or courier-delivered submittals: Deliver to Docket 
Room Manager, Patriots Plaza 3, 355 E. Street SW., Room 8-163B, 
Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2013-0022. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Charles Williams, Room 6065, South 
Building, 1400 Independence Avenue SW., Washington, DC 20250; Phone: 
(202) 720-5627, Email: [email protected].

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.

Laboratory Accreditation Fees

    FSIS is proposing 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).
    Currently, FSIS charges each laboratory a flat annual fee of $5,000 
per accreditation or maintenance of accreditation. 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. 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 services it 
provides the laboratories, which includes the cost of FSIS auditing 
non-Federal laboratories, conducting periodic proficiency test sample 
studies, on-site review, maintenance of accreditation (includes 
analyzing proficiency test results and documentation) and other 
additional costs.
    The Agency has determined that the costs to the Accredited 
Laboratory Program can be reduced when laboratories apply for multiple 
accreditations. Most of the cost to the Agency in conducting the ALP is 
in travel and administering sample studies to determine laboratory 
proficiency.
    FSIS is proposing 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 
proposal, the Agency would 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.
    The Agency is proposing 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. FSIS 
is proposing $2,100 \2\ 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. This fact means that the review will be less labor intensive. 
FSIS has determined that the proposed costs to participants in the 
accredited laboratory program will cover the cost to the Agency for the 
administration of the program. The proposed 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.

[[Page 22053]]



                                       Table 1--Proposed ALP Fee Schedule
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                                                                                  Accreditations
                              Item                               -----------------------------------------------
                                                                         1               2              3-6
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Auditing of non-Federal Laboratories............................          $2,546            $816            $408
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
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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 proposed rule has been designated a ``non-
significant'' regulatory action under section 3(f) of Executive Order 
(E.O.) 12866. Accordingly, the rule has not 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 
proposing to reduce fees after the first accreditation. Table 2 below 
compares current fees to proposed fees.

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

    For the purposes of this analysis, FSIS considers 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--Expected 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
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1...........................................................           48     $240,000           48     $240,000
2...........................................................            3   \4\ 30,000            3   \5\ 23,700
3...........................................................            2       30,000            2       20,000
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½             --------------------------------------
                                                                       53      300,000           53      283,700
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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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Expected Benefits of the Proposed Rule

    The benefit accrued to the industry is equivalent to current 
accreditation costs minus the proposed accreditation costs which 
incorporate the proposed efficiencies outlined in the preamble.

[[Page 22054]]

    The proposed 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). Should the proposed rule be 
finalized, the total industry cost would be $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 proposed 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
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                                                                Proposed costs      Proposed       Net benefits
                    Current costs  (FY13)                           (FY14)          benefits      (10 years, 3%)
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$ 300,000....................................................        $283,700          $16,300         $139,000
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Regulatory Flexibility Analysis

    The FSIS Administrator has made a preliminary determination that 
this proposed rule would not have a significant economic impact on a 
substantial number of small entities in the United States, as defined 
by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

Paperwork Reduction Act

    FSIS has reviewed this rule under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3520) and has determined that there is no 
information collection related to this proposed rule.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et 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 proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this proposed 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 proposed 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 proposed 
regulation will not have substantial and direct effects on Tribal 
governments and will not have significant Tribal implications.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.)
    Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, audiotape, 
etc.) should contact USDA's Target Center at (202) 720-2600 (voice and 
TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY).

Additional Public Notification

    FSIS will announce this proposed rule online through the FSIS Web 
page located at http://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 http://www.fsis.usda.gov/subscribe. 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.

List of Subjects in 9 CFR Part 391

    Fees and charges.

    For the reasons discussed in the preamble, FSIS is proposing to 
amend 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. 138f, 7 U.S.C. 1622, 1627, and 2219a; 21 
U.S.C. 451 et seq.; 21 U.S.C. 601-695; 7 CFR 2.18 and 2.53.
0
2. In Sec.  391.5 revise paragraph (a) to read as follows:


Sec.  391.5  Laboratory accreditation fee.

0
(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: March 24, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-08962 Filed 4-18-14; 8:45 am]
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