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

Download as PDF asabaliauskas on DSK5VPTVN1PROD with RULES Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Rules and Regulations and inspect lots not designated by the electronic inspection system. * * * * * (e) All products, required by this part to be inspected, shall be inspected only at an official establishment or at an official import inspection establishment approved by the Administrator as provided in this section. Such approved official import inspection establishments will be listed in the Meat, Poultry and Egg Product Inspection Directory, published by the Food Safety and Inspection Service. The listing will categorize the kind or kinds of product which may be inspected at each official import inspection establishment, based on the adequacy of the facilities for making such inspections and handling such products in a sanitary manner. (f) Owners or operators of establishments, other than official establishments, who want to have import inspections made at their establishments, shall apply to the Administrator for approval of their establishments for such purpose. Application shall be made on a form furnished by the Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC, and shall include all information called for by that form. (g) Approval for Federal import inspection shall be in accordance with subpart D of this part. (h) Owners or operators of establishments at which import inspections of product are to be made shall furnish adequate sanitary facilities and equipment for examination of such product. The requirements of §§ 381.21 and 381.36, and part 416 of this chapter shall apply as conditions for approval of establishments as official import inspection establishments to the same extent and in the same manner as they apply with respect to official establishments. (i) The Administrator is authorized to approve any establishment as an official import inspection establishment provided that an application has been filed and drawings have been submitted in accordance with the requirements of paragraphs (c) and (d) of this section and he determines that such establishment meets the requirements under paragraph (e) of this section. Any application for inspection under this section may be denied or refused in accordance with the rules of practice in part 500 of this chapter. (j) Approval of an official import inspection establishment may be withdrawn in accordance with applicable rules of practice if it is VerDate Sep<11>2014 17:48 Sep 18, 2014 Jkt 232001 determined that the sanitary conditions are such that the product is rendered adulterated, that such action is authorized by section 21(b) of the Federal Water Pollution Control Act, as amended (84 Stat. 91), or that the requirements of paragraph (e) of this section were not complied with. Approval may also be withdrawn in accordance with section 401 of the Act and applicable rules of practice. (k) A special official number shall be assigned to each official import inspection establishment. Such number shall be used to identify all products inspected and passed for entry at the establishment. PART 590—INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) 17. The authority citation for part 590 continues to read as follows: ■ Authority: 21 U.S.C. 1031–1056. 18. Revise § 590.915 to read as follows: ■ § 590.915 Foreign inspection certificate requirements. (a) Except as provided in § 590.960, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product. (b) An official of the foreign government agency must certify that any product described on any official certificate was produced in accordance with the regulatory requirements § 590.910. (c) The electronic foreign inspection certification must be in English, be transmitted directly to FSIS before the product’s arrival at the official import inspection establishment, and be available to import inspection personnel. (d) The paper foreign inspection certificate must accompany each consignment; be submitted to import inspection personnel at the official import inspection establishment; be in English; and bear the official seal of the foreign government responsible for the inspection of the product, and the name, title, and signature of the official authorized to issue the inspection certificates for products imported into the United States. (e) The electronic foreign inspection certification and paper foreign inspection certificate must contain: (1) The date; PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 56235 (2) The foreign country of export and the producing foreign establishment number; (3) The species used to produce the product and the source country and foreign establishment number, if the source materials originate from a country other than the exporting country; (4) The product’s description including the process category, the product category, and the product group; (5) The name and address of the importer or consignee; (6) The name and address of the exporter or consignor; (7) The number of units (pieces or containers) and the shipping or identification mark on the units; (8) The net weight of each lot; and (9) Any additional information the Administrator requests to determine whether the product is eligible to be imported into the United States. ■ 19. Revise § 590.920 to read as follows: § 590.920 Import inspection application. (a) Applicants must submit an import inspection application to apply for the inspection of any product offered for entry. Applicants may apply for inspection using a paper or electronic application form. (b) Import inspection applications for each consignment must be submitted (electronically or on paper) to FSIS in advance of the shipment’s arrival at the official import establishment where the product will be reinspected, but no later than when the entry is filed with U.S. Customs and Border Protection. (c) The provisions of this section do not apply to products that are exempted from inspection by §§ 590.960 and 590.965. Done at Washington, DC, on September 11, 2014. Alfred V. Almanza, Administrator. [FR Doc. 2014–22206 Filed 9–18–14; 8:45 am] BILLING CODE 3410–DM–P 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 Food Safety and Inspection Service, USDA. ACTION: Final rule. AGENCY: E:\FR\FM\19SER1.SGM 19SER1 56236 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Rules and Regulations 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 nonFederal 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: SUMMARY: 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. TABLE 1—ALP FEE SCHEDULE Accreditations Item 1 2 3–6 $2,546 1,237 918 347 $816 1,237 536 347 $408 1,237 153 347 Total .................................................................................................................................................. 5,048 2,936 2,145 Rounded Total .................................................................................................................................. asabaliauskas on DSK5VPTVN1PROD with RULES Auditing of non-Federal Laboratories ...................................................................................................... Proficiency Tests ..................................................................................................................................... Maintenance of Accreditation .................................................................................................................. Additional Costs ....................................................................................................................................... 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 1 Source: FSIS, OPHS, LQAS, Accredited Laboratory Program. VerDate Sep<11>2014 17:48 Sep 18, 2014 Jkt 232001 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 ‘‘nonsignificant’’ regulatory action under section 3(f) of Executive Order (E.O.) 12866. Accordingly, the rule has not 2 Ibid. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\19SER1.SGM 19SER1 56237 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Rules and Regulations been reviewed by the Office of Management and Budget under E.O. 12866. Baseline 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. The FSIS Accredited Laboratory Program, (ALP) is voluntary and charges a non-refundable accreditation fee. TABLE 2—CURRENT AND PROPOSED ACCREDITATION FEE SCHEDULE Current accreditation lab fee Accreditation First .................................................................................................................................................................. Second ............................................................................................................................................................. Third–Sixth ....................................................................................................................................................... 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. New accreditation lab fee $5,000 5,000 5,000 $5,000 2,900 2,100 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 Pre-rule Number of analyte classes Number labs 1 ....................................................................................................................................... 2 ....................................................................................................................................... 3 ....................................................................................................................................... Post-rule Industry cost Number labs Industry cost 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 × $5,000) (Table 3). Therefore, the total industry $240,000 4 30,000 30,000 48 3 2 $240,000 5 23,700 20,000 53 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. The final rule will benefit the lab industry by offering a sliding accreditation fee schedule. The lower 48 3 2 300,000 53 283,700 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 (FY13) Proposed costs (FY14) Proposed benefits Net Benefits (10 years, 3%) $300,000 $283,700 $16,300 $139,000 asabaliauskas on DSK5VPTVN1PROD with RULES 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 3 FSIS, OPHS, LQAS, Accredited Laboratory Program. 4 Calculation—Total Cost = (Accreditation 1 Cost * Number of Laboratories) + (Accreditation 2 Cost VerDate Sep<11>2014 17:48 Sep 18, 2014 Jkt 232001 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 * Number of Laboratories) = ($5,000 * 3) + ($5,000 * 3). 5 Calculation—Total Cost = (Accreditation 1 Cost * Number of Laboratories) + (Accreditation 2 Cost PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 (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 EGovernment Act (44 U.S.C. 3601, et * Number of Laboratories) = ($5,000 * 3) + ($2,900 * 3). E:\FR\FM\19SER1.SGM 19SER1 56238 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Rules and Regulations 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. asabaliauskas on DSK5VPTVN1PROD with RULES Additional Public Notification FSIS will announce this notice 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/wps/portal/ fsis/programs-and-services/emailsubscription-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. VerDate Sep<11>2014 17:48 Sep 18, 2014 Jkt 232001 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. Done at Washington, DC, on September 11, 2014. Alfred Almanza, Administrator. [FR Doc. 2014–22208 Filed 9–18–14; 8:45 am] BILLING CODE 3410–DM–P NUCLEAR REGULATORY COMMISSION 10 CFR Part 51 [NRC–2012–0246] How To File a Complaint of Discrimination RIN 3150–AJ20 To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http:// www.ocio.usda.gov/sites/default/files/ docs/2012/ Complain_combined_6_8_12.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). Continued Storage of Spent Nuclear Fuel 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 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. 2. Revise paragraph (a) of § 391.5 to read as follows: ■ § 391.5 Laboratory accreditation fee. (a) The annual fee for the accreditation and maintenance of accreditation provided pursuant to § 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. * * * * * PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Nuclear Regulatory Commission. ACTION: Final rule. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is revising its generic determination regarding the environmental impacts of the continued storage of spent nuclear fuel beyond a reactor’s licensed life for operation and prior to ultimate disposal. The NRC prepared a final generic environmental impact statement that provides a regulatory basis for this final rule. The Commission concludes that the generic environmental impact statement generically determines the environmental impacts of continued storage of spent nuclear fuel beyond the licensed life for operation of a reactor. The final rule also clarifies that the generic determination applies to license renewal for an independent spent fuel storage installation (ISFSI), reactor construction permits, and early site permits. The final rule clarifies how the generic determination will be used in future NRC environmental reviews, and makes changes to improve readability. Finally, the final rule makes conforming amendments to the determinations on the environmental effects of renewing the operating license of a nuclear power plant to address issues related to the onsite storage of spent nuclear fuel and offsite radiological impacts of spent nuclear fuel and high-level waste disposal. SUMMARY: This final rule is effective on October 20, 2014. ADDRESSES: Please refer to Docket ID NRC–2012–0246 when contacting the NRC about the availability of information for this final rule. You may access publicly-available information related to this final rule by any of the following methods: • Federal Rulemaking Web site: Go to http://www.regulations.gov and search DATES: E:\FR\FM\19SER1.SGM 19SER1

Agencies

[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]


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

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.

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

[[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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \3\ FSIS, OPHS, LQAS, Accredited Laboratory Program.
---------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                      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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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 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/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 http://
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]
BILLING CODE 3410-DM-P