Notice of New Streamlined Approval Process for Non-Regulatory Methods in SW-846

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA or Agency) is providing notice of a new streamlined approval process for non-regulatory methods in the “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods” manual, also known as SW-846. This new process will employ the use of Web site postings and an extensive email list to notify the SW-846 scientific community of methods being released for public comment, which differs from the traditional Federal Register publication. All methods beginning with Update VI to SW-846 will utilize the new process. This new process only applies to SW-846 methods published as guidance, where there are no changes to the hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA). The process for updating or publishing SW-846 analytical methods that are required in the RCRA regulations (referred to as Method Defined Parameters or MDPs) will not change. EPA is not requesting public comment on this notice.

FOR FURTHER INFORMATION CONTACT:

Christina Langlois-Miller, Office of Resource Conservation and Recovery (5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460-0002; telephone number: 703-308-0744; email address: Langlois-Miller.Christina@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

This notice is directed to the public in general. It may, however, be of particular interest to those conducting waste sampling and analysis for RCRA-related activities. This universe might include any entity that generates, treats, stores, or disposes of hazardous or non-hazardous solid waste and might also include any laboratory that conducts waste sampling and analyses for such entities.

B. How can I get additional information about the new process?

You may access this Federal Register document electronically from the Government Printing Office under the “Federal Register” listings at FDSys ( http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR ) or at the SW-846 Methods Web site ( https://www.epa.gov/hw-sw846/epas-streamlined-procedure-publishing-non-regulatory-sw-846-methods ).

II. What is the subject and purpose of this notice?

The Agency is announcing a new streamlined process for adding non-regulatory methods to “Test Methods for Evaluating Solid Waste, Physical/Chemical Methods,” EPA publication SW-846. The SW-846 compendium consists of over 200 analytical methods for sampling and analyzing waste and other matrices. Most methods are intended as guidance (i.e., non-regulatory methods) with the exception of what EPA refers to as “method defined parameters” or MDPs, that are required in the RCRA regulations for compliance purposes. In the interest of releasing new and updated SW-846 methods more quickly in order to respond to emergencies and issues such as emerging contaminants and keeping up with the speed of scientific advancements, EPA will be using a new process to release validated non-regulatory methods for public comment and to incorporate these methods into the official SW-846 compendium. This notice serves to notify the public of the new process, which EPA will begin using for its next set of updates to SW-846. Under the new process, EPA will no longer employ the Federal Register as a vehicle for adding non-regulatory methods and guidance to SW-846. However, the Agency will continue to use the regulatory development process for adding MDP methods to SW-846 (see https://www.epa.gov/hw-sw846/final-rule-methods-innovation-rule-mir#mdp for a list of MDPs). Non-regulatory methods and guidance will be released using EPA's SW-846 Web site, which can be found at https://www.epa.gov/hw-sw846,, and a dedicated SW-846 electronic mailing list.

III. Background

Over the years, the regulated community has expressed concern that the Agency has not made available in a timely manner the use of analytical methods that take advantage of technological advancements. In an attempt to address the public's concern, the Agency published the Methods Innovation Rule (MIR), on June 14, 2005 (see 70 FR 34538-34592 or https://www.gpo.gov/fdsys/pkg/FR-2005-06-14/pdf/05-10197.pdf ), which provided flexibility to laboratories regarding method selection for waste characterization in support of RCRA, as appropriate. In addition, the rule allowed modification to most SW-846 methods and substitution of non-SW-846 methods, provided the modified or substituted method meets the defined quality assurance/quality control (QA/QC) parameters established in the method or defined for the project and falls within EPA's mission to protect human health and the environment.

Since most SW-846 methods are guidance and not required by the RCRA regulations, EPA sought a more efficient approach to announce the availability of methods for public use and to solicit comment prior to incorporating new or revised methods in the SW-846 compendium.

IV. What is the new process?

EPA receives requests to add or update SW-846 methods from various sources (e.g., EPA Regions, other federal and state government agencies, analytical method developers, commercial laboratories, and other scientific groups). These requests are considered if the new method or revision:

• Addresses a national emergency (e.g., oil spill);
• Is essential for continuing the EPA mission (e.g., regulatory change);
• Is needed by EPA Regions/program offices (e.g., bioavailability of lead)
• Addresses an emerging environmental contaminant (e.g., perfluorinated compounds)
• Makes available a new or updated technology (e.g., collision cell mass spectrometry)
• Is a collaborative effort with other federal agencies (e.g., DOD, USGS, FDA)
• Provides an opportunity for greener chemistry or increased safety (e.g., decreased solvent use)

Once EPA selects a method for possible revision or inclusion in SW-846, the method will be sent to the SW-846 method workgroup, made up of chemists and technical experts with knowledge of and experience with the specific methodology and/or technology, for further evaluation.

Listed below are the new steps that EPA will follow for publication of non-regulatory SW-846 methods, beginning with final review from the SW-846 method workgroup. EPA will:

1. Obtain Agency organic and/or inorganic workgroup approval of new and/or revised methods.

a. Agency workgroups consist of EPA scientists from the Regions and program offices.

2. Post methods on the “Validated Methods” Web page at https://www.epa.gov/hw-sw846/validated-test-methods-recommended-waste-testing and link to the Hazardous Waste Test Methods landing page, at https://www.epa.gov/hw-sw846.

3. Notify the SW-846 analytical community via emails and web posting of the comment-period initiation date. The comment period will be set for a minimum of 30 days, depending on the number and complexity of methods.

a. The Web pages will also indicate that the methods are drafts and that comments are being accepted until the end date of the comment period.

4. Catalog and respond to public comments in a “Response to Comments” document.

5. Revise methods based on EPA's review of comments.

6. Post the new and/or revised methods, the “Response to Comments” background document(s), and other supporting documents permanently on the “SW-846 Compendium” Web page at https://www.epa.gov/hw-sw846/sw-846-compendium.

7. Email the SW-846 mailing list, notifying all entities of the incorporation of the new additions to the SW-846 compendium.

V. How can I sign up for the SW-846 mailing list?

If you would like to receive information regarding new policies, guidance related to SW-846 methods, announcements of open comment periods, and final changes or updates to methods in SW-846, it is important to sign up for the SW-846 mailing list. The form to sign up for the SW-846 mailing list is located at https://www.epa.gov/hw-sw846/forms/contact-us-about-hazardous-waste-test-methods. To sign up, fill out the form at the bottom of the page, including the “Name” and “Email Address” sections, and click the “Yes” button for Email List Sign-up before submitting.

The Agency also plans to find the email addresses of previous commenters on Updates to SW-846 to notify them of the new process and to see if they would like to be placed on the SW-846 mailing list.

VI. Summary

This new approach to announcing SW-846 methods for public comment will allow EPA to make available new advancements in technologies in a timely manner and provide increased accessibility to analytical procedures, guidance, and Updates to SW-846, while still employing a mechanism to request public comment and incorporate comments into the final methods. In addition, the new process will result in a cost savings for the Agency since it removes the burden of unnecessary steps in releasing guidance to the public while retaining the appropriate steps to ensure EPA's standard of quality and integrity.