United States
Environmental Protection
Agency

Office of Chemical Safety and Pollution Prevention
(7503P)
	EPA XXX-X-XX-XXX
                                                                    	April 2015
	Product Performance Test Guidelines

		OCSPP 810.2200:
            Disinfectants for Use on Hard Surfaces - Efficacy Data Recommendations

                                     NOTICE

  This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS). To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number. Any test guideline developed after April 22, 2010 will use the new acronym (OCSPP) in their title.

  	The OCSPP test guidelines serve as a compendium of accepted standardized methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public, and companies that are subject to data submission requirements under TSCA, FIFRA and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice. At places in this guidance, the Agency uses the word "should."  In this guidance, use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.

  	For additional information about these test guidelines and to access the guidelines electronically, please go to http://www.epa.gov/ocspp and select the topic entitled, "Test Methods and Guidelines." You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

  DRAFT DOCUMENT DISCLAIMER:  This draft document is distributed solely for the purpose of external review. It has not been formally disseminated by the EPA and should not be construed to represent any Agency determination or policy. The information correction process under the Agency's Information Quality Guidelines does not apply until this document is formally disseminated by the EPA in its final form. This draft document should only be cited or quoted in the context of providing comments.

OCSPP 810.2200: Disinfectants for use on hard surfaces - efficacy data recommendations

(a) Scope.

      (1) Applicability. This guideline describes test methods that EPA believes will generally satisfy testing requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)(7U.S.C. 136, et seq.) and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). It addresses testing to demonstrate the effectiveness of antimicrobial pesticides bearing claims as disinfectants, fungicides, virucides, and tuberculocides. Refer to OCSPP 810.2000: General Considerations for Public Health Uses of Antimicrobial Agents for guidance.

      (2) Background. The source materials used in developing this OCSPP test guideline are OPP guidelines 91-2: Products for use on hard surfaces and 91-30: Acceptable methods (Pesticide Assessment Guidelines, Subdivision G, Product Performance. EPA report 540/9-82-026, October 1982).

(b) Purpose. This guideline addresses efficacy testing for antimicrobial pesticides intended to be used on hard surfaces, namely disinfectants, fungicides, virucides, and tuberculocides in a variety of product types (water-soluble powders, liquids, sprays, towelettes, etc.).

(c) General considerations

      (1) Efficacy claims. This guideline provides guidance for developing data solely for the purpose of supporting the following claims for hard surface disinfectants (limited spectrum disinfectants, general or broad spectrum disinfectants, hospital or healthcare disinfectants) and additional claims (internal toilet and urinal bowl surface disinfectants, and disinfectants with fungicidal, virucidal, and/or tuberculocidal claims). Refer to OCSPP Test Guideline 810.2000 for general testing recommendations prior to testing. See Tables 1 and 2 for a summary of the efficacy claims and recommendations for testing.

      (2) Test Methods. Refer to Tables 1 and 2 for information on efficacy test methods recommended to support disinfectant and additional label claims, respectively. The Agency recommends the use of the most recently published version of the standard methods (e.g., AOAC International [AOAC], ASTM). See standard methods for control carrier counts (mean number of viable microbes per carrier) and other method associated information. Agency Standard Operating Procedures for many of the test procedures referenced in the tables are available online at: http://www.epa.gov/pesticides/methods/atmpa2z.htm. Information regarding specifics such as the number of batches to test, performance standards, and control carrier counts is provided in the description for each type of label claim.

      (3) Spray products. Spray products referenced in Table 1 include aerosol, trigger, and pump dispensers.

      (4) Towelette products. For products formulated as impregnated wipes or towelettes, refer to Table 1. For evaluation of efficacy, the Agency recommends the use of a modified AOAC Method 961.02 (Germicidal Spray Products as Disinfectants test) or ASTM E2362 (Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection). Instead of spraying the inoculated surface of the carriers, the product should be tested by wiping the surface of the carriers with the saturated towelette, and then sub-culturing the carriers after the specified holding time. The towelette should be removed from its container and handled with sterile gloves. One towelette should be used to wipe 10 inoculated carriers (e.g., use 1 towelette for 10 carriers or 6 towelettes for 60 carriers). For each carrier, an unused area of the towelette should be used for wiping. Also, see section (j) of this document on bridging for cases where an applicant formulates a disinfectant towelette using an existing EPA-registered bulk liquid formulation. Note: A detailed description of the wiping procedure, including the towelette folding and rotation process should be included in the test protocol and documented in the raw data and final report.

      (5) Product batches. Refer to the claim-specific sections below to identify the type and number of batches to be evaluated for efficacy. Depending on the claim, testing will be conducted on batches (two or three) at or below the lower certified limit(s) (LCL) listed on the confidential statement of formula (CSF) of the product, or at the nominal concentration.

      (6) Soil load. If a product is intended to be effective in the presence of organic soil (i.e., a one-step disinfectant product), an appropriate organic soil, such as 5 percent blood serum, should be added to the inoculum prior to carrier inoculation.

      (7) Neutralization confirmation. Testing to verify the effectiveness of the neutralizer should be conducted in advance or concurrently with the efficacy test. The procedure should include conditions relevant to the efficacy test (e.g., growth medium, product dilution and contact time, neutralizer, and microbe).

      (8) Confirmatory data. Refer to OCSPP 810.2000: General Considerations for Public Health Uses of Antimicrobial Agents, section (b)(7) for situations (i.e., duplicated product formulations and minor formulation changes in a registered product) requiring confirmatory data. Specific information related to confirmatory data is provided in the description for each label claim. For pressurized spray products, certification should be furnished specifying that all parts and materials used in manufacturing the container for pressurized spray disinfectants are identical to those specified by the basic manufacturer.

      (9) Additional microorganisms. For efficacy testing requirements related to broad-spectrum or hospital disinfectants which bear label claims against bacteria other than Salmonella enterica (ATCC10708), Staphylococcus aureus (ATCC 6538), or Pseudomonas aeruginosa (ATCC 15442), see section (d)(6).

      (10) Contact Time. All products should meet the performance standard associated with the method and microbe at <=10 minutes of contact.

Table 1.  Summary of Testing for Disinfectant Claims
                                     Claim
                           Formulation/Test Methods
                                Test Organisms
                            No. of Batches/Carriers
Limited spectrum disinfectant/hard non-porous surfaces
Water soluble powders/liquids
AOAC Use-Dilution Method (ref. 1)
Staphylococcus aureus (ATCC 6538) or Salmonella enterica (ATCC 10708)

Three batches at LCL; 60 carriers against either organism (180 total carriers)

Spray products
AOAC Germicidal Spray Products as Disinfectants Test (ref. 2)

Towelettes
AOAC Germicidal Spray Products as Disinfectants Test modified for towelettes or ASTM E2362 (ref. 3)

Broad-spectrum disinfectant/hard non-porous surfaces
Water soluble powders/liquids
AOAC Use-Dilution Method
Staphylococcus aureus (ATCC 6538) and Salmonella enterica (ATCC 10708)
Three batches at LCL; 60 carriers against each organism (360 total carriers)

Spray products
AOAC Germicidal Spray Products as Disinfectants Test

Towelettes
AOAC Germicidal Spray Products as Disinfectants Test modified for towelettes or ASTM E2362

Hospital or healthcare disinfectant/hard non-porous surfaces
Water soluble powders/liquids
AOAC Use-Dilution Method
Staphylococcus aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 15442)
Three batches at LCL: 60 carriers against each organism (360 total carriers)

Spray products
AOAC Germicidal Spray Products as Disinfectants Test

Towelettes
AOAC Germicidal Spray Products as Disinfectants Test modified for towelettes or ASTM E2362

Table 2.  Summary of Testing for Additional Label Claims
                                     Claim
                           Formulation/Test Methods
                                Test Organisms
                            No. of Batches/Carriers
Fungicidal disinfectant/hard non-porous surfaces
Water soluble powders/liquids
AOAC Use-Dilution Test modified for fungi or
AOAC Fungicidal Test (ref. 4)
Trichophyton mentagrophytes (ATCC 9533)
Two batches at the LCL; 10 carriers per batch (20 total carriers) for carrier-based methods. Two batches for the AOAC Fungicidal Test.

Spray products
AOAC Germicidal Spray Products as Disinfectants Test modified for fungi

Towelettes
AOAC  Germicidal Spray Products as Disinfectants Test modified for towelettes or ASTM E2362

Virucidal disinfectant/hard non-porous surfaces
Water soluble powders/liquids
ASTM E1053 (ref. 5)
Virus claimed on the label or approved surrogate
Two batches at the nominal concentration; 10 carriers per batch. For non-surrogates, test one surface per batch; for surrogates, test two surfaces per batch.

Towelettes
AOAC Germicidal Spray Products as Disinfectants Test modified for towelettes or ASTM E2362

Tuberculocidal disinfectant/hard non-porous surfaces.
Water soluble powders/liquids
AOAC Tuberculocidal Activity of Disinfectants (ref. 8), Quantitative Tuberculocidal Activity Test (ref. 9)
Mycobacterium bovis BCG
Two batches at the LCL; 10 carriers per batch.

Spray products
AOAC Germicidal Spray Products Test modified for tuberculocidal activity

Two batches at the LCL;  10 carriers per batch

Towelettes
AOAC  Germicidal Spray Products as Disinfectants Test modified for towelettes or ASTM E2362

Two batches at the LCL; 10 carriers per batch
Additional bacteria /hard non-porous surfaces.
Water soluble powders/liquids
AOAC Use-Dilution Test
Additional bacteria claimed on the label
Two batches at the nominal concentration; 10 carriers for each batch.
Internal toilet and urinal bowl surfaces above and below the water line
Water-soluble powders and non-volatile liquid products
AOAC Use-Dilution Test modified to include a 5% organic soil challenge added to the bacterial inoculum.
S. enterica (ATCC 10708) or S. aureus (ATCC 6538) for limited disinfectant products; S. enterica and S. aureus for broad-spectrum disinfectant products; S. aureus and P. aeruginosa (ATCC 15442) for hospital disinfectants
Test sixty carriers against each of three batches of the product at the LCL

(d) Disinfectants

      (1) Limited spectrum products. This section addresses efficacy testing for disinfectant products with limited efficacy (effective against Gram-negative or Gram-positive bacteria, but not both). Refer to Table 1 for test methods. Conduct the following:

            (i) Test organism. To demonstrate efficacy, testing should be conducted against Salmonella enterica (S. enterica), formerly designated as Salmonella choleraesuis, American Type Culture Collection (ATCC) 10708 for effectiveness against Gram-negative bacteria, or Staphylococcus aureus (S. aureus) (ATCC 6538) for effectiveness against Gram-positive bacteria.

            (ii) Batches/number of carriers. Test three batches of the product at the LCL. For each batch, test using sixty carriers.

            (iii) Control carrier counts for AOAC Use-Dilution Methods (ref. 1). For the AOAC Use-Dilution Methods, the mean log density for S. enterica is to be at least 5.0 (corresponding to a geometric mean density of 1.0 x 10[5]) and not above 6.0 (corresponding to a geometric mean density of 1.0 x 10[6]). A mean log density <5.0 or >6.0 invalidates the test. The mean log density for S. aureus is to be at least 6.0 (corresponding to a geometric mean density of 1.0 x 10[6]) and not above 7.0 (corresponding to a geometric mean density of 1.0 x 10[7]). A mean log density <6.0 or >7.0 invalidates the test.

            (iv) Control carrier counts for spray products and single-use towelettes. The mean log density for S. enterica is to be at least 4.0 (corresponding to a geometric mean density of 1.0 x 10[4]) and not above 5.5 (corresponding to a geometric mean density of 3.2 x 10[5]). A mean log density <4.0 or >5.5 invalidates the test. The mean log density for S. aureus is to be at least 5.0 (corresponding to a geometric mean density of 1.0 x 10[5]) and not above 6.5 (corresponding to a geometric mean density of 3.2 x 10[6]). A mean log density <5.0 or >6.5 invalidates the test.

            (v) Performance measure.

                  (A) For the AOAC Use-Dilution Methods, conduct three independent tests (i.e., three batches tested once on three different test days) against the test microbe at the LCL. The performance standard for S. aureus is 0-3 positive carriers out of sixty. The performance standard for S. enterica is 0-1 positive carriers out of sixty. Contamination of one carrier (culture tube) is allowed per 60-carrier set; occurrence of more than one contaminated carrier invalidates the test results.

                  (B) For the AOAC Germicidal Spray Products as Disinfectants test and towelette methods, the product should kill the test microorganisms on 59 out of each set of 60 carriers/slides. Contamination of only one carrier (culture tube) is allowed per 60-carrier set; occurrence of more than one contaminated carrier invalidates the test results.

            (vi) Confirmatory testing for limited spectrum products. For confirmatory testing, follow the above testing guidance in sections (c) and (d)(1), with the exception that ten carriers for each of two different batches of product should be tested against S. aureus (ATCC 6538) or S. enterica (ATCC 10708). For all methods, the product should kill all the test microorganisms on all carriers. Control carrier counts specifications should be met. For a valid test, no contamination of any carrier is allowed.

      (2) General or broad spectrum efficacy products. For disinfectants with label claims against both Gram-negative and Gram-positive bacteria, the product is considered a general or broad spectrum disinfectant. Refer to Table 1 for test methods. Conduct the following:

            (i) Test organism. To demonstrate efficacy, testing should be conducted against both S. enterica (ATCC 10708) and S. aureus (ATCC 6538.

            (ii) Batches/number of carriers. For each organism, test sixty carriers against each of three batches of the product at the LCL.

            (iii) Control carrier counts for AOAC Use-Dilution Methods. For the AOAC Use-Dilution Methods, the mean log density for S. enterica is to be at least 5.0 (corresponding to a geometric mean density of 1.0 x 10[5]) and not above 6.0 (corresponding to a geometric mean density of 1.0 x 10[6]). A mean log density <5.0 or >6.0 invalidates the test. The mean log density for S. aureus is to be at least 6.0 (corresponding to a geometric mean density of 1.0 x 10[6]) and not above 7.0 (corresponding to a geometric mean density of 1.0 x 10[7]). A mean log density <6.0 or >7.0 invalidates the test.

            (iv) Control carrier counts for spray products and towelettes. The mean log density for S. enterica is to be at least 4.0 (corresponding to a geometric mean density of 1.0 x 10[4]) and not above 5.5 (corresponding to a geometric mean density of 3.2 x 10[5]). A mean log density <4.0 or >5.5 invalidates the test. The mean log density for S. aureus is to be at least 5.0 (corresponding to a geometric mean density of 1.0 x 10[5]) and not above 6.5 (corresponding to a geometric mean density of 3.2 x 10[6]). A mean log density <5.0 or >6.5 invalidates the test.
            (v) Performance measure.

                  (A) For the AOAC Use-Dilution Methods, conduct three independent tests (i.e., three batches tested at the LCL on three different test days) against the test microbe. The performance standard for S. aureus is 0-3 positive carriers out of sixty. The performance standard for S. enterica is 0-1 positive carriers out of sixty. Contamination of only one carrier (culture tube) is allowed per 60-carrier set; occurrence of more than one contaminated carrier invalidates the test results.

                  (B) For the AOAC Germicidal Spray Products as Disinfectants test and towelette methods, the product should kill the test microorganisms on 59 out of each set of 60 carriers/slides. Contamination of only one carrier (culture tube) is allowed per 60-carrier set; occurrence of more than one contaminated carrier invalidates the test results.

            (vi) Confirmatory testing for general or broad spectrum products. For confirmatory testing, follow the above testing guidance in sections (c) and (d) (2), with the exception that ten carriers for each of two different batches of product (within the CSF) should be tested against S. aureus (ATCC 6538) and S. enterica (ATCC 10708). For all methods, the product should kill all the test microorganisms on all carriers. Control carrier counts specifications should be met. For a valid test, no contamination of any carrier is allowed.

      (3) Hospital or healthcare disinfectants. This section addresses efficacy testing for products recommended for use in hospitals, clinics, dental offices, nursing homes, sickrooms, or any other healthcare-related facility. Refer to Table 1 for test methods. Conduct the following:

            (i) Test organism. To demonstrate efficacy, testing should be conducted against S. aureus (ATCC 6538) and Pseudomonas aeruginosa (ATCC 15442).

            (ii) Batches/number of carriers. For each organism, test sixty carriers against each of three batches of the product at the LCL.

            (iii) Control carrier counts for AOAC Use-Dilution Methods. For the Use-Dilution Methods, the mean log density for S. aureus and P. aeruginosa is to be at least 6.0 (corresponding to a geometric mean density of 1.0 x 10[6]) and not above 7.0 (corresponding to a geometric mean density of 1.0 x 10[7]). A mean log density <6.0 or >7.0 invalidates the test.

            (iv) Control carrier counts for spray products and towelettes. The mean log density for both S. aureus and P. aeruginosa is to be at least 5.0 (corresponding to a geometric mean density of 1.0 x 10[5]) and not above 6.5 (corresponding to a geometric mean density of 3.2 x 10[6]). A mean log density <5.0 or >6.5 invalidates the test.

            (v) Performance measure.

                  (A) For the AOAC Use-Dilution Methods, conduct three independent tests (i.e., three batches at the LCL tested on three different test days) against the test microbe. The performance standard for S. aureus is 0-3 positive carriers out of sixty. The performance standard for P. aeruginosa is 0-6 positive carriers out of sixty. Contamination of only one carrier (culture tube) is allowed per 60-carrier set; occurrence of more than one contaminated carrier invalidates the test results.

                  (B) For the AOAC Germicidal Spray Products as Disinfectants test and towelette methods, the product should kill the test microorganisms on 59 out of each set of 60 carriers/slides. Contamination of only one carrier (culture tube) is allowed per 60-carrier set; occurrence of more than one contaminated carrier invalidates the test results.

            (vi) Confirmatory testing for products with hospital or healthcare disinfectant claim. For confirmatory testing, follow the above testing guidance in sections (c) and (d) (3), with the exception that ten carriers for each of two different batches of product (within the CSF) should be tested against S. aureus (ATCC 6538) and P. aeruginosa (ATCC 15442). For all methods, the product should kill all the test microorganisms on all carriers. Control carrier counts specifications should be met. For a valid test, no contamination of any carrier is allowed.

      (4) Disinfectants for internal toilet and urinal bowl surfaces above and below the water line. To add claims to existing limited, broad-spectrum, or hospital products for internal toilet and urinal bowl surfaces, conduct the following:

            (i) Test method. Regarding water-soluble powders and non-volatile liquid products test procedure, the Agency recommends the use of the AOAC Use-Dilution Methods modified to include a 5% organic soil challenge added to the bacterial inoculum.

                  (A) The contained bowl water (96 fl oz of 200-400 ppm hard water, which represents traditional high volume toilets) should be used to calculate the appropriate use dilution for testing. The contained bowl water for low volume toilets should be measured and used to calculate the appropriate use dilution using 200-400 ppm hard water for testing.

            (ii) Test organisms. Test against S. enterica (ATCC 10708) or S. aureus (ATCC 6538), for limited disinfectant products; S. enterica and S. aureus, for broad-spectrum disinfectant products; and S. aureus and P. aeruginosa (ATCC 15442), for hospital disinfectant products. Follow the testing recommendations (i.e., control carrier counts, and performance measure) specified for limited, broad-spectrum, and hospital disinfectant claims.

            (iii) Batches/number of carriers. Test sixty carriers against each of three batches of the product at the LCL.

            (iv) Performance Measure. Meet the performance measures specified for each claim (e.g., hospital claim) and specified microbe(s).

      (5) Additional microorganisms. Label claims for additional microbes other than the designated test microorganism(s) is permitted, provided that the target microbe is likely to be present in or on the recommended use areas and surfaces. This section addresses efficacy testing for limited, broad-spectrum or hospital disinfectants which bear label claims against bacteria other than S. enterica (ATCC 10708), S. aureus (ATCC 6538) or P. aeruginosa (ATCC 15442). Following recommendations for test methods, per the product formulation as provided in Table 1, conduct additional testing as described below:

            (i) Test organism. To demonstrate efficacy, testing should be conducted against each specific bacterium to be claimed on the label.

            (ii) Batches/number of carriers. Test ten carriers against each of two batches of the product at the nominal concentration.

            (iii) Control carrier counts for all methods. The minimum carrier count for a valid test should be a mean of 1 x 10[4] CFU/carrier.

            (iv) Performance measure. The product should kill all the test microorganisms on all ten carriers. For a valid test, no contamination of any carrier is allowed.

(e) Fungicidal claims. A fungicidal claim may be added to an existing broad-spectrum or hospital disinfectant product. Refer to Table 2 for test methods. Conduct the following:

      (1) Test organism. To demonstrate efficacy, testing should be conducted against Trichophyton mentagrophytes (ATCC 9533).

      (2) Batches/number of carriers.

            (i) For AOAC Fungicidal Activity of Disinfectants Test. Two batches of product at the LCL should be evaluated for efficacy at 5, 10, and 15 minute exposure times. The method is a suspension test.

            (ii) For AOAC Use-Dilution Method, AOAC Germicidal Spray Products as Disinfectants Test, and towelettes. Tests may be modified to conform to appropriate elements (e.g., media, growth conditions) in the AOAC Fungicidal Activity of Disinfectants test. Test ten carriers against each of two batches of product at the LCL.

      (3) Titer of conidial suspension/control counts.

            (i) AOAC Fungicidal Activity of Disinfectants test. The inoculum employed should provide a concentration of >= 5 x 10[6] conidia/mL.

            (ii) AOAC Use-Dilution Method, AOAC Germicidal Spray Products as Disinfectants Test, and single-use towelettes. The inoculum employed should provide a concentration of 1 x 10[4]  -  1 x 10[5] conidia per carrier.

      (4) Performance measure.
            (i) AOAC International Fungicidal Activity of Disinfectants test. All fungal spores at 10 and 15 minutes should be killed (no positive carriers).

            (ii) AOAC Use-Dilution Method, AOAC Germicidal Spray Products as Disinfectants Test, and towelettes. All fungal spores on all 10 carriers should be killed (no positive carriers).

(f) Virucidal claims. Virucidal claims may be added to existing broad-spectrum or hospital disinfectant products (liquids, sprays, towelettes). Virucidal products are intended for use on dry inanimate surfaces; therefore, data are developed using carrier-based methods. To simulate in-use conditions, the specific virus to be treated (or surrogate) should be inoculated onto hard surfaces (e.g., Petri dishes, glass carriers, or other appropriate test surface), allowed to dry, and then treated with the product according to the directions for use on the product label. Refer to Table 2 for test methods. Conduct the following:

      (1) Test organism. Each specific virus listed on the label should be tested, unless there is an acceptable surrogate for the virus. For example, label claims against Hepatitis B virus, Hepatitis C virus, and Norovirus, the Duck Hepatitis B virus, Bovine Viral Diarrhea virus, and Feline Calicivirus, respectively, are considered acceptable surrogates for testing. Additional guidance and protocols for surrogate virus testing can be found at http://www.epa.gov/oppad001/regpolicy.htm.

      (2) In limited situations such as towelette bridging and confirmatory testing, the Agency will allow testing of the most resistant virus on the label based on disinfection hierarchy. The categories and the presumed levels of resistance are provided below:

            (i) Small non-enveloped viruses (most resistant viruses). For label claims to inactivate small non-enveloped viruses such as members of the Picornaviridae family (e.g., poliovirus, enterovirus, hepatitis A virus, rhinovirus), and the Caliciviridae family (e.g., parvovirus) select the most resistant representative virus (or acceptable surrogate) such as Feline calicivirus for testing.

            (ii) Large non-enveloped viruses (intermediate resistant viruses). For label claims to inactivate large non-enveloped viruses such as members of the members of the Adenoviridae family (e.g., adenovirus), Reoviridae family (e.g., rotavirus), and Papillomaviridae family (e.g., papillomavirus), select the most resistant representative virus (or acceptable surrogate) such as Adenovirus for testing.

            (iii) Enveloped viruses (least resistant viruses). For label claims to inactivate enveloped viruses such as members of the Coronaviridae family (e.g., coronavirus), Flaviviridae family (e.g., hepatitis C virus), Herpesviridae family (e.g., herpes virus), Poxviridae family (e.g., vaccinia), Hepadnaviridae family (e.g., hepatitis B virus), Orthomyxoviridae family (e.g., Influenza), Paramyxoviridae family (e.g., parainfluenza) and Retroviridae family (e.g., human immunodeficiency virus), select the most resistant representative virus (or acceptable surrogate) for testing.

      (3) Soil load. If the product is intended to be represented as virucidal in the presence of organic soil (one-step), an appropriate organic soil, such as 5 percent blood serum, should be included with the viral inoculum. When viral suspensions are grown in the presence of at least 5% serum, addition of serum to the inoculum is not expected as part of a study to support a one-step label claim.

      (4) Number of batches. Test two batches of product at the nominal concentration.

      (5) Surfaces. For non-surrogates, test one surface per batch; for surrogates, test two surfaces per batch.

      (6) Viral concentration. Test each batch against a recoverable virus end point titer of >=10[4] viable viral particles from the test surface for a specified exposure period.

      (7) Performance measure. Following treatment of the test virus with the disinfectant product, the presence of remaining viable virus should then be assayed using an appropriate virological technique (e.g., cytopathogenic effect, fluorescent antibody, plaque count, or animal response). The protocol for the viral assay should provide the information identified below.

            (i) The virus recovery (control carrier counts) should include a minimum of four determinations (i.e., four replications) per each dilution in the assay system (e.g., tissue culture, embryonated egg, animal infection, etc.).

            (ii) Cytotoxicity control. The effect of the disinfectant (with addition of the neutralizer) on the viral assay system should include a minimum of four determinations (i.e., four replications) per each dilution. Note:  Level of cytotoxicity may be determined in advance or for one test and is not required to be performed with each test.

            (iii) The activity of the disinfectant (treated carriers) against the test virus should include a minimum of four determinations (i.e., four replications) per dilution in the assay system.

            (iv) Neutralization control. Neutralization controls should be performed (Ref. 6) and should include a minimum of four determinations (i.e., four replications) per each dilution. The neutralizer control may be determined in advance or for one test and is not required to be performed with each test.

            (v) Any special methods (e.g., use of columns) which are used to increase the virus titer and to detoxify the residual disinfectant should be described in the protocol.

            (vi) The ID50 values (control carrier counts) calculated for each assay should be provided.

            (vii) The test results should be reported as the log reduction of the virus (ID50 of the virus control carriers less the ID50 of the test carriers) as calculated by an appropriate statistical method (e.g., Reed and Munch, Most Probable Number, Spearman-Karber).

            (viii) The product should demonstrate complete inactivation of the virus at all dilutions.

            (ix) If cytotoxicity is present, the virus control titer should be increased to demonstrate a >=3 log10 reduction in viral titer beyond the cytotoxic level.

            (x) A laboratory report of a single test with one virus  involving a tissue culture assay system should include the details of the methods employed; see examples of information in Tables 2-1, 2-2 and 2-3:

                  (A) Performance measure. The product should demonstrate complete inactivation of the virus at all dilutions. If cytotoxicity is present, a >= 3-log reduction in viral titer should be demonstrated beyond the cytotoxic level recovered from the carrier surface.

  Table 2-1: Example of Virucidal Test Results for One Test
                               Dilution of Virus
                             Virus - Disinfectant*
                              (treated carriers)
                               Virus - Control*
                              (control carriers)
     Cytotoxicity  -  Control
(disinfectant and neutralizer without virus)
10[-1]
T  T  T  T
+  +  +  +
T  T  T  T
10[-2]
T  T  T  T
+  +  +  +
T  T  T  T
10[-3]
T  0  0  0
+  +  +  +
T  0  0  0
10[-4]
0  0  0  0
+  +  +  +
0  0  0  0
10[-5]
0  0  0  0
+  +  +  +
0  0  0  0
10[-6]
0  0  0  0
+  +  +  0
0  0  0  0
10[-7]
0  0  0  0
+  0  0  0
0  0  0  0
10[-8]
0  0  0  0
0  0  0  0
0  0  0  0
	Note:  T = toxic to cell line; + = virus recovered; 0 = no virus recovered
	*Recovery of virus from surfaces.

  Table 2-2: Example Calculation (Spearman-Karber) of the Tissue Culture Infective Dose 50 (TCID50)  -  for the Control Counts
                                    Values
                              Accumulated Values
                           Virus Dilution Inoculated
                         No. Infected/ No. Inoculated
                                 No. Infected
                               No. not Infected
                                 No. Infected
                               No. not Infected
                         No. Infected/ No. Inoculated
                                  % Infected
10[-1]
4/4
4
0
24
0
24/24
100
10[-2]
4/4
4
0
20
0
20/20
100
10[-3]
4/4
4
0
16
0
16/16
100
10[-4]
4/4
4
0
12
0
12/12
100
10[-5]
4/4
4
0
8
0
8/8
100
10[-6]
3/4
3
1
4
1
4/5
80
10[-7]
1/4
1
3
1
4
1/5
20
10[-8]
0/4
0
4
0
8
0/8
0
  TCID50 = 10[6.5] (6.5 logs)

  Table 2-3: Example Calculation (Spearman-Karber) of the Tissue Culture Lethal Dose 50 (TCLD50)  -  for the Treated Carriers
                                    Values
                              Accumulated Values
                           Virus Dilution Inoculated
                           No. Toxic/ No. Inoculated
                                   No. Toxic
                                 No. not Toxic
                                   No. Toxic
                                 No. not Toxic
                           No. Toxic/ No. Inoculated
                                    % Toxic
10[-1]
4/4
4
0
9
0
9/9
100
10[-2]
4/4
4
0
5
0
5/5
100
10[-3]
1/4
1
3
1
3
1/4
25
10[-4]
0/4
0
4
0
7
0/7
0
10[-5]
0/4
0
4
0
11
0/11
0
10[-6]
0/4
0
4
0
15
0/15
0
10[-7]
0/4
0
4
0
19
0/19
0
10[-8]
0/4
0
4
0
23
0/23
0
 TCLD50 = 10[2.7] Therefore: Virus inactivation = TCID50 - TCLD50 = 10[3.8] log[10] (a log reduction of 3.8)

(g) Tuberculocidal claims. Tuberculocidal claims may be added to broad-spectrum or hospital disinfectant products. In the Agency's "Data Call-In Notice for Tuberculocidal Effectiveness for All Antimicrobial Pesticides with Tuberculocidal Claims," dated June 13, 1986 (Ref. 7), applicants were given the option of choosing from one of three test methods (AOAC Tuberculocidal Activity of Disinfectants test, a modified AOAC Tuberculocidal Activity of Disinfectants test, or the Quantitative Tuberculocidal Activity Test) for conducting tuberculocidal efficacy tests. Based on experience since 1986, the Agency does not recommend the use of the Quantitative Tuberculocidal Activity Test (a suspension test) for testing disinfectant formulations for use on hard surfaces. An exception to this is for glutaraldehyde-based products, which have not been validated in the AOAC Tuberculocidal Activity of Disinfectants test (a carrier based test). Therefore, the Quantitative Tuberculocidal Activity Test should only be used for glutaraldehyde-based products. The Agency strongly recommends for all other liquid formulations, use of the carrier-based AOAC Tuberculocidal Activity of Disinfectants test. Refer to Table 2 for recommendations per formulation type. Conduct the following:

      (1) Test organism. To demonstrate efficacy, testing should be conducted against Mycobacterium bovis (BCG) (M. bovis).  Test cultures of M. bovis (BCG) may be grown using agitation; consult with EPA regarding the methodology for producing these cultures.

      (2) Batches/number of carriers. Test ten carriers against each of two different batches of product at the LCL.

      (3) Control carrier counts for AOAC Tuberculocidal Activity of Disinfectants test and AOAC Tuberculocidal Activity of Disinfectants test with modifications. Per the 2012 revisions for the AOAC Tuberculocidal Activity of Disinfectants test, the mean log density is to be at least 4.0 (corresponding to a geometric mean density of 1.0 x 10[4]) and not above 6.0 (corresponding to a geometric mean density of 1.0 x 10[6]). A mean log density < 4.0 or > 6.0 invalidates the test.

      (4) Control carrier counts for AOAC Germicidal Spray Products as Disinfectants test and towelettes. The log density of M. bovis should be >= 4.0 (corresponding to a geometric mean density of >=1.0 x 10[4] CFU/carrier) a mean log density of <4.0 invalidates the test.

            (i) Evaluate the product against M. bovis BCG for the label recommended contact time.

      (5) Performance Measure. Mycobacterium on all carriers (in primary subculture medium) should be killed (no positive carriers), and there should be no growth in any of the associated subculture media. For a valid test, no contamination of any carrier or secondary subculture medium is allowed.

      (6) The spray and towelette tests should be modified to conform to appropriate elements (e.g., media, growth conditions, etc.) as in the AOAC Tuberculocidal Activity of Disinfectants test.

      (7) Media Performance. The performance of the subculture media should be confirmed in advance or concurrently with testing. The results should be submitted with the product performance data.

(h) Glutaraldehyde formulations

      (1) Test Procedure. For glutaraldehyde formulations, the Agency recommends the Quantitative Tuberculocidal Activity Test. This test has been referenced in the Agency's  "Data Call-In Notice for Tuberculocidal Effectiveness for All Antimicrobial Pesticides with Tuberculocidal Claims," dated June 13, 1986 (Ref. 7). Two samples, representing two different batches of the product should each be uti - lized in at least four separate studies (a total of at least eight studies), against M. bovis, so that upper 95 percent confidence limits can be determined for each point on the survival curve. If the product is intended to be represented as tuberculocidal in the presence of organic soil (one-step), an appropriate organic soil, such as 5 percent blood serum, should be included with the bacterial inoculum.

      (2) Performance measure. For the Quantitative Tuberculocidal Activity Method, survival curves should be constructed from the average of four separate replicates so that the upper 95% Confidence Limit can be determined for each point on the curve. The minimum time claimed for efficacy is determined by finding the point where the average survival curve intersects the probability of one survivor. If the data show a four-log reduction, but the survivor curve does not intersect the one-survivor line, the minimal time is found by extrapolating the upper 95% confidence limit curve such that the value where it intersects the one survivor line is not 50% greater than when the survivor curve intersects the one survivor line. The test substance should demonstrate >1.0 x 10[4] CFU kill of the test organism at the stated contact time (i.e., a >4 log10 reduction of the test organism).

      (3) The organism titer should be > 1 x 107 CFU/ml.

(i) Validation testing for Quaternary Ammonium Compounds. Products formulated solely with quaternary ammonium compounds as the active ingredient(s) should be supported with validation testing to confirm their tuberculocidal label claim. One additional product sample should be tested in a different laboratory from the original one, or in the same laboratory using different study director, technical staff and quality assurance unit, using the same test procedure and conditions as used in the first laboratory test.

(j) Bridging for EPA-registered liquids and disinfectant towelettes. In cases where an applicant formulates a disinfectant towelette using an existing EPA-registered bulk liquid formulation, the following chemistry and efficacy studies should be conducted and submitted to EPA for review.

      (1) Bridging: Chemical Analysis.

            (i) All active ingredients in the expressed liquid should evaluated for concentration and must be within the certified limits of the Confidential Statement of Formula of the liquid formula being referenced (bridged).

            (ii) The disinfectant towelettes package should be filled according to the manufacturing specifications. Excess liquid in the bulk towelettes containers is not to be poured off for use in the chemical testing for data bridging, rather the liquid used in the chemical testing should only be that expressed from the towelettes.

            (iii) Two batches (expressed liquid) of the towelette should be tested.

            (iv) Analytical data for the active ingredients in the expressed liquid should be submitted for review.

            (v) The means used to express the liquid should be included in the study protocol.

      (2) Bridging: Efficacy Testing. Efficacy testing should be conducted under the same testing conditions (e.g. soil load, contact time, temperature) on two or three batches (depending on claim) as used for the bulk liquid testing. A detailed description of the wiping procedure, including the towelette folding and rotation process should be included in the test protocol and documented in the raw data and final report. All testing requirements for controls, control carrier counts and performance standards should be followed for each test method/microbe combination. For each type of claim, see specific details below:

            (i) Limited, broad-spectrum and hospital disinfectants. The Agency recommends the use of the AOAC Germicidal Spray Products as Disinfectants test modified for towelettes, using the test organisms (and control count requirements for a valid test) specified for the primary claim. Test sixty carriers against each of three batches of the product at the nominal concentration. The product should kill the test microorganisms on 59 out of each set of 60 carriers/slides. This testing is intended to support bridging of all remaining vegetative bacteria listed (with the exception of the tuberculocidal claim) on the EPA registered liquid disinfectant used to saturate the towelette to the EPA registered towelette product.

            (ii) Fungicidal claims. The Agency recommends the use of the AOAC Germicidal Spray Products as Disinfectants test modified for fungicidal towelette testing. The test should be modified to conform to appropriate elements (e.g., media, growth conditions) in the AOAC International Fungicidal Activity of Disinfectants test. Evaluate the product against T. mentagrophytes (ATCC 9533) for the label recommended contact time. Test ten carriers against each of two batches of product at the nominal concentration. The product should kill (no positive carriers) the test organism on all 10 carriers. This testing is intended to support bridging of all remaining fungi listed on the EPA registered liquid disinfectant used to saturate the towelette to the EPA registered towelette product.

            (iii) Tuberculocidal Claims. Bridging of data for towelettes is not allowed for tuberculocidal claims.

            (iv) Virus Claims. Based on the bulk liquid label, claims for small non-enveloped, large non-enveloped and enveloped viruses can be supported by selecting the most resistant virus on the existing label -  all other viruses on the label will be supported by this testing. Test ten carriers for each of two batches of the product at the nominal concentration on one surface type. The product should demonstrate complete inactivation of the virus at all dilutions. If cytotoxicity is present, a >= 3-log reduction in viral titer should be demonstrated beyond the cytotoxic level recovered from the carrier surface.

(k) Data collection and reporting.

Refer to OCSPP 810.2000: General Considerations for Public Health Uses of Antimicrobial Agents for guidance. The applicant is encouraged to use the EPA's standard efficacy report format, which may be found at http://www.epa.gov/oppad001/efficacystudystandards.htm.

(l) References. The references in this paragraph may be consulted for additional background information:

      (1) Official Methods of Analysis of the AOAC International, Chapter 6, Disinfectants, Use-Dilution Methods (955.14, 955.15, & 964.02).  Current edition. AOAC International, Suite 500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.\

      (2) Official Methods of Analysis of the AOAC International, Chapter 6, Disinfectants, Official Method 961.02 Germicidal Spray Products as Disinfectants. Current edition. AOAC International, Suite 500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.

      (3) Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection, ASTM Designation E2362. Current edition. ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

      (4) Official Methods of Analysis of the AOAC International, Chapter 6, Disinfectants, Official Method 955.17 Fungicidal Activity of Disinfectants. Current edition. AOAC International, Suite 500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.

      (5) Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces, ASTM Designation E1053., Current edition.  ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

      (6) Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations, ASTM Designation E1483.Current edition.  ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

      (7) Environmental Protection Agency, Data Call-in Notice for Tuberculocidal Effectiveness Data for All Antimicrobial Pesticides with Tuberculocidal Claims (Registration Division, Office of Pesticide Pro - grams, June 13, 1986).

      (8) Official Methods of Analysis of the AOAC International, Chapter 6, Disinfectants, Official Method 965.12 Tuberculocidal Activity of Dis - infectants. Current edition. AOAC International, Suite 500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.

      (9) Ascenzi, J.M., et al., A More Accurate Method for Measurement of Tuberculocidal Activity of Disinfectants. Applied Environmental Microbiology, Vol. 53, No. 9, 1987, pp. 2189-2192. (Suspension-based assay).


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Page 30124]
[FR Doc No: 2023-09974]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-1773-000]

Pomona Energy Storage 2 LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Pomona Energy Storage 2 LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 22, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: May 2, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-09974 Filed 5-9-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65198-65199]
[FR Doc No: 2023-20404]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0043]

TUV SUD America, Inc.: Grant of Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for TUV SUD America, Inc., as a Nationally
Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
September 21, 2023.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2300 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition for TUV SUD America, Inc. (TUVAM) as a NRTL. TUVAM's
expansion covers the addition of nine test sites to the NRTL scope of
recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition. Each NRTL's scope of recognition includes (1) the
type of products the NRTL may test, with each type specified by the
applicable test standard and (2) the recognized site(s) that has/have
the technical capability to perform the product-testing and product-
certification activities for test standards within the NRTL's scope.
Recognition is not a delegation or grant of government authority;
however, recognition enables employers to use products approved by the
NRTL to meet OSHA standards that require product testing and
certification.
    The agency processes applications by a NRTL for initial
recognition, as well as for an expansion or renewal of recognition,
following requirements in Appendix A to 29 CFR 1910.7. This appendix
requires that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides the preliminary finding. In the second notice,
the agency provides the final decision on the application. These
notices set forth the NRTL's scope of recognition or modifications of
that scope. OSHA maintains an informational web page for each NRTL,
including TUVAM, which details that NRTL's scope of recognition. These
pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    TUVAM submitted an application, dated January 24, 2021 (OSHA-2007-
0043-0045), requesting the conversion of ten existing Satellite
Notification Acceptance Program (SNAP) sites to recognized sites under
the NRTL Policy for Transitioning to Satellite Notification and
Acceptance Program Termination (SNAP Transition Policy) published in
the Federal Register on November 24, 2020 (85 FR 75042), as amended by
a June 22, 2022 Memorandum from James S. Frederick, Deputy Assistant
Secretary for Occupational Safety and Health, to Regional
Administrators and Executive Staff, titled ``Second Revision to the
Nationally Recognized Testing Laboratory (NRTL) Policy for
Transitioning to Satellite Notification and Acceptance Program (SNAP)
Termination.'' TUVAM amended their application on December 10, 2021
(OSHA-2007-0043-0046), to remove one site from the original request,
leaving nine sites to be considered in the expansion request.
    OSHA published the preliminary notice announcing TUVAM's expansion
application in the Federal Register on August 15, 2023 (88 FR 55478).
The agency requested comments by August 30, 2023, but it received no
comments in response to this notice. OSHA is now proceeding with this
final grant of expansion of TUVAM's NRTL recognition.
    To obtain or review copies of all public documents pertaining to
the TUVAM application, go to http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor. Docket No. OSHA-2007-0043 contains all materials
in the record concerning TUVAM's recognition. All submissions,
including copyrighted material, are available for inspection through
the OSHA Docket Office. Contact the OSHA Docket Office at (202) 693-
2350 for assistance in locating docket submissions.

II. Final Decision and Order

    OSHA staff examined TUVAM's expansion application, its capability
to meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that
TUVAM meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the specified limitations and condition. OSHA
limits the expansion of TUVAM's recognition to include the nine sites
listed in Table 1, below. This limitation is consistent with the
recognition that OSHA grants to other NRTLs that operate multiple
sites.

   Table 1--List of Test Sites for Inclusion in TUVAM's NRTL Scope of
                               Recognition
------------------------------------------------------------------------
        TUVAM site name                 Address              Country
------------------------------------------------------------------------
Shenzhen......................  Building 6, 12 & 13,    China.
                                 Zhiheng Wisdomeland
                                 Business Park, Nantou
                                 Checkpoint Road 2,
                                 518052, Shenzhen,
                                 Guangdong Province.
Gormley.......................  11 Gordon Collins       Canada.
                                 Drive, Gormley,
                                 Ontario L0H 1G0.

Fareham.......................  Octagon House,          United Kingdom.
                                 Concorde Way,
                                 Segensworth North,
                                 Fareham, Hampshire,
                                 PO15 5RL.
Seoul.........................  10, Gukjegumyung-ro,    Korea.
                                 Yeongdeungpo-gu,
                                 Seoul.
Tampa.........................  5610 West Sligh         United States.
                                 Avenue, Suite 100,
                                 Tampa, Florida.
Tokyo.........................  Sumitmo Fudosan, Nishi- Japan.
                                 shinjuku Bldg. No 4
                                 8F 4-33-4, Nishi-
                                 Shinjuku, Sjinjuku-
                                 ku, Tokyo, 160-0023.
Taipei........................  7F, No 37, Section 2,   Taiwan.
                                 Zhongyang, South
                                 Road, Beitou
                                 District, 11270
                                 Taipei City.
Singapore.....................  No. 15 International    Singapore.
                                 Business Park 609937.
Guangzhou.....................  5F/8F (East),           China.
                                 Communication
                                 Building, 163 Pingyun
                                 Road, Huangpu Avenue
                                 West Guangzhou,
                                 510656, Guangdong
                                 Province.
------------------------------------------------------------------------

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
TUVAM must abide by the following conditions of the recognition:
    1. TUVAM must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. TUVAM must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. TUVAM must continue to meet the requirements for recognition,
including all previously published conditions on TUVAM's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of TUVAM as a NRTL, subject to the limitations and
conditions specified above.

III. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. Accordingly, the agency is issuing this notice pursuant to 29
U.S.C. 657(g)(2), Secretary of Labor's Order No. 8-2020 (85 FR 58393,
Sept. 18, 2020), and 29 CFR 1910.7.

    Signed at Washington, DC.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-20404 Filed 9-20-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Rules and Regulations]
[Pages 51333-51335]
[FR Doc No: 2020-17732]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31325 Amdt. No. 3917]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective August 20, 2020. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of August 20, 2020.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC, 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg 29, Room 104, Oklahoma
City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the

airport and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPS as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866;(2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and
(3)does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal.
    For the same reason, the FAA certifies that this amendment will not
have a significant economic impact on a substantial number of small
entities under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97:

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on August 7, 2020.
Wade E.K. Terrell,
Manager, Flight Procedures & Airspace Group.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 10 September 2020

Aniak, AK, Aniak, Takeoff Minimums and Obstacle DP, Amdt 4
Bethel, AK, Bethel, ILS Y OR LOC Y RWY 19R, Orig-E
Bethel, AK, Bethel, ILS Z OR LOC Z RWY 19R, Amdt 7G
Bethel, AK, Bethel, RNAV (GPS) RWY 1R, Amdt 1A
Bethel, AK, Bethel, VOR RWY 1L, Amdt 2D
Cold Bay, AK, Cold Bay, ILS OR LOC RWY 15, Amdt 19
Cold Bay, AK, Cold Bay, LOC BC RWY 33, Amdt 11
Cold Bay, AK, Cold Bay, RNAV (GPS) RWY 15, Amdt 3
Cold Bay, AK, Cold Bay, RNAV (GPS) RWY 33, Amdt 3
Cold Bay, AK, Cold Bay, Takeoff Minimums and Obstacle DP, Amdt 9
Dillingham, AK, Dillingham, RNAV (GPS) RWY 1, Amdt 3
Mekoryuk, AK, Mekoryuk, NDB-B, Orig, CANCELLED
Mekoryuk, AK, Mekoryuk, NDB/DME-A, Amdt 4, CANCELLED
Evergreen, AL, Evergreen Rgnl/Middleton Field, RNAV (GPS) RWY 10,
Amdt 1D
Guntersville, AL, Guntersville Muni--Joe Starnes Field, RNAV (GPS)
RWY 7, Orig-B
Guntersville, AL, Guntersville Muni--Joe Starnes Field, RNAV (GPS)
RWY 25, Orig-A
Huntsville, AR, Huntsville Muni, VOR/DME RWY 12, Amdt 2A, CANCELLED
Rogers, AR, Rogers Muni-Carter Field, VOR RWY 2. Amdt 13E, CANCELLED
Grass Valley, CA, Nevada County, VOR OR GPS-A, Amdt 1C, CANCELLED
Hemet, CA, Hemet-Ryan, RNAV (GPS) RWY 5, Orig-D
San Jose, CA, Reid-Hillview Of Santa Clara County, RNAV (GPS) RWY
13L, Amdt 1
San Jose, CA, Reid-Hillview Of Santa Clara County, RNAV (GPS) Y RWY
31R, Amdt 1
San Jose, CA, Reid-Hillview Of Santa Clara County, RNAV (GPS) Z RWY
31R, Amdt 2
St Petersburg-Clearwater, FL, St Pete-Clearwater Intl, ILS OR LOC
RWY 18, ILS RWY 18 (SA CAT I), ILS RWY 18 (SA CAT II), Orig-A
Webster City, IA, Webster City Muni, NDB RWY 32, Amdt 8A, CANCELLED
Boise, ID, Boise Air Terminal/Gowen Fld, RNAV (RNP) Z RWY 28L, Amdt
2
Boise, ID, Boise Air Terminal/Gowen Fld, RNAV (RNP) Z RWY 28R, Amdt
2
Kankakee, IL, Greater Kankakee, ILS OR LOC RWY 4, Amdt 8
Kankakee, IL, Greater Kankakee, RNAV (GPS) RWY 4, Amdt 2
Kankakee, IL, Greater Kankakee, RNAV (GPS) RWY 16, Amdt 1B
Kankakee, IL, Greater Kankakee, RNAV (GPS) RWY 22, Amdt 1B
Kankakee, IL, Greater Kankakee, RNAV (GPS) RWY 34, Amdt 1B
Lincoln, IL, Logan County, NDB RWY 21, Amdt 2A, CANCELLED
Brazil, IN, Brazil Clay County, VOR RWY 9, Amdt 7B. CANCELLED
Cambridge, MD, Cambridge-Dorchester Rgnl, RNAV (GPS)-A, Orig-A
Augusta, ME, Augusta State, RNAV (GPS) RWY 35, Orig-C
Bay City, MI, James Clements Muni, VOR-A, Amdt 12B, CANCELLED
Cassville, MO, Cassville Muni, VOR RWY 9, Amdt 2B, CANCELLED
Eldon, MO, Eldon Model Airpark, Takeoff Minimums and Obstacle DP,
Orig-B
Binghamton, NY, Greater Binghamton/Edwin A Link Field, ILS OR LOC
RWY 16, Amdt 7
Binghamton, NY, Greater Binghamton/Edwin A Link Field, ILS OR LOC
RWY 34, Amdt 5
Binghamton, NY, Greater Binghamton/Edwin A Link Field, RNAV (GPS)
RWY 10, Amdt 1
Binghamton, NY, Greater Binghamton/Edwin A Link Field, RNAV (GPS)
RWY 16, Amdt 2
Binghamton, NY, Greater Binghamton/Edwin A Link Field, RNAV (GPS)
RWY 28, Amdt 3
Southampton, NY, Southampton, COPTER RNAV (GPS) 190, Orig-B
East Liverpool, OH, Columbiana County, VOR RWY 25, Amdt 5, CANCELLED
Tulsa, OK, Tulsa Intl, ILS OR LOC RWY 36R, ILS RWY 36R (SA CAT I),
ILS RWY 36R (CAT II), Amdt 29H
Bradford, PA, Bradford Rgnl, ILS OR LOC RWY 32, Amdt 13

Nacogdoches, TX, Nacogdoches A L Mangham Jr Rgnl, NDB RWY 18, Amdt
1C, CANCELLED
Richmond, VA, Richmond Intl, ILS OR LOC RWY 2, Amdt 2C
Richmond, VA, Richmond Intl, VOR RWY 20, Amdt 1D
Bennington, VT, William H. Morse State, VOR RWY 13, Amdt 1B,
CANCELLED
Springfield, VT, Hartness State (Springfield), Takeoff Minimums and
Obstacle DP, Amdt 3A
Charleston, WV, Yeager, ILS OR LOC RWY 23, Amdt 31A
Powell, WY, Powell Muni, NDB RWY 31, Amdt 2C, CANCELLED

    Rescinded: On July 13, 2020 (85 FR 41912), the FAA published an
Amendment in Docket No. 31319 Amdt No. 3911, to Part 97 of the
Federal Aviation Regulations under sections 97.37. The following
entry for Jaffrey, NH effective September 10, 2020, is hereby
rescinded in its entirety:

Jaffrey, NH, Jaffrey Airfield-Silver Ranch, Takeoff Minimums and
Obstacle DP, Amdt 1A

    Rescinded: On August 6, 2020 (85 FR 47643), the FAA published an
Amendment in Docket No. 31323 Amdt No. 3915, to Part 97 of the
Federal Aviation Regulations under sections 97.29, and 97.33. The
following entries for El Paso, TX effective September 10, 2020, are
hereby rescinded in their entirety:

El Paso, TX, El Paso Intl, ILS OR LOC RWY 22, Amdt 32E
El Paso, TX, El Paso Intl, RNAV (GPS) Y RWY 22, Orig-F
El Paso, TX, El Paso Intl, RNAV (RNP) Z RWY 22, Amdt 1B

[FR Doc. 2020-17732 Filed 8-19-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)]
[Notices]
[Pages 30180-30182]
[FR Doc No: 2018-13831]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2381]

The Food and Drug Administration's Comprehensive, Multi-Year
Nutrition Innovation Strategy; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meeting entitled ``FDA's Comprehensive, Multi-Year
Nutrition Innovation Strategy.'' The purpose of the public meeting is
to give interested persons an opportunity to discuss FDA's nutrition
innovation strategy, including: A standard icon or symbol for the claim
``healthy''; a more efficient review strategy for evaluating qualified
health claims; statements or claims that could facilitate innovation to
promote healthful eating patterns; approaches for modernizing standards
of identity; possible changes that could make ingredient information
more consumer friendly; and FDA's educational campaign for consumers
about the updated Nutrition Facts Label that consumers will be seeing
in the marketplace.

DATES: The public meeting will be held on July 26, 2018, from 8:30 a.m.
until 5:30 p.m. Eastern Time. Submit either electronic or written
comments on this public meeting by August 27, 2018. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public meeting will be held at the Hilton Washington DC/
Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. For more
information on the hotel see http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered.

Electronic comments must be submitted on or before August 27, 2018. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of August 27, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2381 for ``FDA's Comprehensive, Multi-Year Nutrition
Innovation Strategy.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    For questions about registering for the meeting or to register by
phone: Melissa Schroeder, SIDEM, 1775 Eye St, NW, Suite 1150,
Washington, DC 20006,<PHONE_NUMBER>, [email protected].
    For general questions about the meeting or for special
accommodations due to a disability: Juanita Yates, Center for Food
Safety and Applied Nutrition (HFS-009), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA plays a critical role in promoting public health by, among
other things, ensuring that food labeling provides consumers with
reliable, evidence-based information so that they can make informed
choices about the foods they purchase in order to maintain and improve
their health through diet and nutrition. On January 11, 2018, FDA
released its 2018 Strategic Policy Roadmap (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm591993.htm), which focuses, in
part, on efforts to empower consumers to make better and more informed
decisions about their diets and health, foster the development of
healthier food options, and expand the opportunities to use nutrition
to reduce morbidity and mortality due to chronic disease. The roadmap
highlights FDA's commitment to finding approaches to advance policies
that better achieve these goals.
    On March 29, 2018, FDA Commissioner Dr. Scott Gottlieb, M.D.
announced a comprehensive, multi-year FDA Nutrition Innovation Strategy
(hereinafter the ``FDA Nutrition Innovation Strategy'') (to access the
speech, visit https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm).
The Nutrition Innovation Strategy seeks to promote public health
through improved nutrition, encourage industry innovation to create
healthy products that consumers seek, and address ways for consumers to
identify those products. In implementing the Nutrition Innovation
Strategy, FDA is committed to providing opportunities for public input
to help with these initiatives. Early and active engagement from
stakeholders and the public will help to inform FDA's thinking and
policy actions.

II. Topics for Discussion at the Public Meeting

    FDA will host a 1-day meeting to provide stakeholders and other
interested persons an opportunity to have an in-depth discussion on
various aspects of the FDA Nutrition Innovation Strategy and to provide
input on ways to modernize FDA's approach to better protect public
health while removing barriers to industry innovation. FDA expects that
the topics addressed at the meeting will include the following (a more
detailed agenda will be made available prior to the meeting):
     Considering using a standard icon to denote the claim
``healthy'' on food labels.

     Creating a more efficient review strategy for evaluating
qualified health claims on food labels.
     Discussing new or enhanced labeling statements or claims
that could facilitate innovation to produce more healthful foods and
more healthful consumer food choices.
     Modernizing the standards of identity to provide more
flexibility for the development of healthier products, while making
sure consumers have accurate information about these food products.
     Providing opportunities to make ingredient information
more helpful to consumers.
     FDA's educational campaign for consumers about the updated
Nutrition Facts Label.
    We invite interested parties to provide information on the above
and other topics related to the FDA Nutrition Innovation Strategy.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by July 19, 2018, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted.
    If you need special accommodations due to a disability, please
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later
than July 12, 2018.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments and requests to participate in the focused sessions.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the focused sessions. All requests to make oral
presentations must be received by July 12, 2018, midnight Eastern Time.
We will determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin, and will select
and notify participants by July 16, 2018. Speakers will be limited to
making oral remarks; there will not be an opportunity to display
materials such as slide shows, videos, or other media during the
meeting. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Webcast participants are asked to preregister at
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Other Issues for Consideration: A summary of key information on
participating in the meeting follows:

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Submit either
              Date                      Address           Preregister     Electronic address  Request to make an        Special          electronic or
                                                                                oral presentation    accommodations     written comments
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 26, 2018 from 8:30 a.m.      Hilton Washington   July 19, 2018:      https://            July 12, 2018.....  July 12, 2018:      Submit Comments
 until 5:30 p.m. EDT.              DC/Rockville        Closing date for    www.fda.gov/Food/                       closing date to     to: https://
                                   Hotel, 1750         registration.       NewsEvents/                             request special     www.regulations.g
                                   Rockville Pike,                         WorkshopsMeetings                       accommodations      ov, or Dockets
                                   Rockville, MD                           Conferences/                            due to a            Management Staff
                                   20852.                                  default.htm.                            disability.         (HFA-305), Food
                                                                                and Drug
                                                                                Administration,
                                                                                5630 Fishers
                                                                                Lane, Rm. 1061,
                                                                                Rockville, MD
                                                                                20852.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: June 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13831 Filed 6-26-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 67 (Tuesday, April 8, 2014)]
[Notices]
[Page 19407]
[FR Doc No: C1-2014-07353]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71818; File No. SR-NYSEARCA-2014-27]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Rule 6.62
To Specifically Address the Number and Size of Contra-Parties to a
Qualified Contingent Cross Order

March 27, 2014.

Correction

    In notice document 2014-07353 appearing on pages 18599-18601 in the
issue of April 2, 2014, make the following correction:
    On page 18599, in the second column, the date in the heading which
was inadvertently omitted is corrected to read as set forth above.

[FR Doc. C1-2014-07353 Filed 4-7-14; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Page 29081]
[FR Doc No: 2017-13446]

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ENVIRONMENTAL PROTECTION AGENCY

[9961-61-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, Territory of U.S. Virgin Islands

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's approval of the Territory of U.S.
Virgin Islands' request to revise/modify its EPA Administered Permit
Programs: The National Pollutant Discharge Elimination System EPA-
authorized program to allow electronic reporting.

DATES: EPA's approval is effective June 27, 2017.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On April 25, 2017, the U.S. Virgin Islands Department of Planning &
Natural Resources (VI DPNR) submitted an application titled ``National
Network Discharge Monitoring Report System'' for revision to its EPA-
approved program under title 40 CFR to allow new electronic reporting.
EPA reviewed VI DPNR's request to revise its EPA-authorized Part 123--
EPA Administered Permit Programs: The National Pollutant Discharge
Elimination System program and, based on this review, EPA determined
that the application met the standards for approval of authorized
program revision set out in 40 CFR part 3, subpart D. In accordance
with 40 CFR 3.1000(d), this notice of EPA's decision to approve U.S.
Virgin Islands' request to revise its Part 123--EPA Administered Permit
Programs: The National Pollutant Discharge Elimination System program
to allow electronic reporting under 40 CFR part 122 is being published
in the Federal Register.
    VI DPNR was notified of EPA's determination to approve its
application with respect to the authorized program listed above.

Matthew Leopard,
Director, Office of Information Management.
[FR Doc. 2017-13446 Filed 6-26-17; 8:45 am]
BILLING CODE 6560-50-P