§ 80.585 - What is the process for approval of a test method for determining the sulfur content of diesel or ECA marine fuel?

§ 80.585 What is the process for approval of a test method for determining the sulfur content of diesel or ECA marine fuel?

(a)

(1) Approval of test methods approved by voluntary consensus-based standards bodies. Through December 31, 2015, for such a method to be approved, the following information must be submitted to the Administrator by each test facility for each test method that it wishes to have approved: Any test method approved by a voluntary consensus-based standards body, such as ASTM International or the International Organization for Standardization (ISO), shall be approved as a test method for determining the sulfur content of diesel fuel if it meets the applicable accuracy and precision criteria under § 80.584. The approval of a test method is limited to the single test facility that performed the testing for accuracy and precision. The individual facility must submit the accuracy and precision results for each method, including information on the date and time of each test measurement used to demonstrate precision, following procedures established by the Administrator.

(2) Approval of test methods approved by voluntary consensus-based standards bodies. Beginning January 1, 2016, any test method approved by a voluntary consensus-based standards body, such as the ASTM International or the International Organization for Standardization (ISO), shall be approved as a test method for determining the sulfur content of diesel fuel if it meets the applicable accuracy and precision criteria under § 80.584. These records must be kept by the facility for a period of five years.

(b) Approval of test methods not approved by a voluntary consensus-based standards body. For such a method to be approved, the following information must be submitted to the Administrator by each test facility for each test method that it wishes to have approved:

(1) Full test method documentation, including a description of the technology and/or instrumentation that makes the method functional.

(2) Information demonstrating that the test method meets the applicable accuracy and precision criteria of § 80.584, including information on the date and time of each test measurement used to demonstrate precision.

(3) If requested by the Administrator, test results from use of the method to analyze samples of commercially available fuel provided by EPA.

(4) Any additional information requested by the Administrator and necessary to render a decision as to approval of the test method.

(c) Sample retention. Samples used for precision and accuracy determination must be retained for 90 days.

(d) EPA approval.

(1) Within 90 days of receipt of all materials required to be submitted under paragraph (b) of this section, the Administrator shall determine whether the test method is approved under this section.

(2) If the Administrator denies approval of the test method, within 90 days of receipt of all materials required to be submitted under paragraph (b) of this section, the Administrator will notify the applicant of the reasons for not approving the method. If the Administrator does not notify the applicant within 90 days of receipt of the application, that the test method is not approved, then the test method shall be deemed approved.

(3) If the Administrator finds that an individual test facility has provided false or inaccurate information under this section, upon notice from the Administrator the approval shall be void ab initio.

(4) The approval of any test method under paragraph (b) of this section shall be valid from the date of approval from the Administrator.

(e) Quality assurance procedures for sulfur measurement instrumentation. A test shall not be considered a test using an approved test method unless the following quality control procedures are performed separately for each instrument used to make measurements:

(1) Follow all mandatory provisions of ASTM D6299 and construct control charts from the mandatory quality control testing prescribed in paragraph 7.1 of the reference method, following guidelines under A 1.5.1 for individual observation charts and A 1.5.4 for moving range charts.

(2) Follow paragraph 7.3.1 of ASTM D6299 to check standards using a reference material at least monthly or following any major change to the laboratory equipment or test procedure. Any deviation from the accepted reference value of a check standard greater than 1.44 ppm (for diesel fuel subject to the 15 ppm sulfur standard), 19.36 ppm (for diesel fuel subject to the 500 ppm sulfur standard), or 36.14 ppm (for ECA marine fuel subject to the 1,000 ppm sulfur standard must be investigated.

(3) Samples of tested batches must be retained for 30 days or the period equal to the interval between quality control sample tests, whichever is longer.

(4) Upon discovery of any quality control testing violation of paragraph A 1.5.1.3 for individual observation charts or A1.5.4.1 and A1.5.4.2 for moving range charts of ASTM D6299, or any check standard deviation greater than 1.44 ppm (for diesel fuel subject to the 15 ppm sulfur standard), 19.36 ppm (for diesel fuel subject to the 500 ppm sulfur standard), or 36.14 ppm (for ECA marine fuel subject to the 1,000 ppm sulfur standard), conduct an investigation into the cause of such violation or deviation and, after restoring method performance to statistical control, retest retained samples from batches originally tested since the last satisfactory quality control material or check standard testing occasion.

(f) Materials incorporated by reference. The published materials identified in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, a document must be published in the Federal Register and the material must be available to the public. All approved materials are available for inspection at the Air and Radiation Docket and Information Center (Air Docket) in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the Air Docket is [phone]. These approved materials are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call [phone] or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. In addition, these materials are available from the sources listed below.

(1) ASTM International material. The following standards are available from ASTM International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, (877) 909-ASTM, or http://www.astm.org:

(i) ASTM D6299-13, Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance, approved October 1, 2013 (“ASTM D6299”).

(ii) [Reserved]

(2) [Reserved]

[69 FR 39187, June 29, 2004, as amended at 75 FR 22972, Apr. 30, 2010; 79 FR 23654, Apr. 28, 2014; 80 FR 9097, Feb. 19, 2015; 85 FR 7073, Feb. 6, 2020]