                          RCRA REVISION CHECKLIST 231
                   Hazardous Waste Electronic Manifest Rule
                              79 FR 7518  -  7563
                               February 7, 2014
                        (RCRA Cluster XXIII, Non-HSWA)

Name of State:	Virginia
State Statutory Authority:	§ 10.1-1402 of the Code of Virginia
Title of Regulations: 	Virginia Hazardous Waste Management Regulations, 9VAC20-60
Effective Date:  Annual Update 2014 effective April 8, 2015 (VA.R., Volume 31, Issue 14, March 9, 2015)
Date Checklist Completed: 	February 27, 2015

                             FEDERAL REQUIREMENTS
                             FEDERAL RCRA CITATION
                           ANALOGOUS STATE CITATION
                               STATE ANALOG IS:

                                  EQUIV-ALENT
LESS STRIN-GENT
                                MORE STRIN-GENT
                               BROADER IN SCOPE
            PART 260  -  HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL
                             SUBPART A -- GENERAL
ANY INFORMATION PROVIDED TO EPA UNDER PARTS 260 THROUGH 266 AND 268 OF THIS CHAPTER WILL BE MADE AVAILABLE TO THE PUBLIC TO THE EXTENT AND IN THE MANNER AUTHORIZED BY THE FREEDOM OF INFORMATION ACT, 5 U.S.C. SECTION 552, SECTION 3007(B) OF RCRA AND EPA REGULATIONS IMPLEMENTING THE FREEDOM OF INFORMATION ACT AND SECTION 3007(B), AND PART 2 OF THIS CHAPTER, AS APPLICABLE.
260.2(A)
See Endnote 1.

§260.2 not incorporated by reference (IBR) in 9VAC20-60-260A per 9VAC20-60-260 B.10.

                                      N/A
EXCEPT AS PROVIDED UNDER PARAGRAPH (C) OF THIS SECTION, ANY PERSON WHO SUBMITS INFORMATION TO EPA IN ACCORDANCE WITH PARTS 260 THROUGH 266 AND 268 OF THIS CHAPTER MAY ASSERT A CLAIM OF BUSINESS CONFIDENTIALITY COVERING PART OR ALL OF THAT INFORMATION BY FOLLOWING THE PROCEDURES SET FORTH IN § 2.203(b) of this chapter.  Information covered by such a claim will be disclosed by EPA only to the extent, and by means of the procedures, set forth in part 2, Subpart B, of this chapter except that information required by § 262.53(a) and § 262.83 that is submitted in a notification of intent to export a hazardous waste will be provided to the U.S. Department of State and the appropriate authorities in the transit and receiving or importing countries regardless of any claims of confidentiality.  However, if no such claim accompanies the information when it is received by EPA, it may be made available to the public without further notice to the person submitting it.
260.2(B)
See Endnote 1.

           §260.2 not IBR in 9VAC20-60-260A per 9VAC20-60-260 B.10.

                                      N/A
AFTER August 6, 2014, no claim of business confidentiality may be asserted by any person with respect to information entered on a Hazardous Waste Manifest (EPA Form 8700-22), a Hazardous Waste Manifest Continuation Sheet (EPA Form 8700-22A), or an electronic manifest format that may be prepared and used in accordance with
§ 262.20(A)(3) of this chapter.
260.2(c)(1)
SEE ENDNOTE 1.

           §260.2 not IBR in 9VAC20-60-260A per 9VAC20-60-260 B.10.

                                      N/A
EPA WILL MAKE ANY ELECTRONIC MANIFEST THAT IS PREPARED AND USED IN ACCORDANCE WITH § 262.20(A)(3), or any paper manifest that is submitted to the system under §§ 264.71(a)(6) or 265.71(a)(6) of this chapter available to the public under this section when the electronic or paper manifest is a complete and final document.  Electronic manifests and paper manifests submitted to the system are considered by EPA to be complete and final documents and publicly available information after 90 days have passed since the delivery to the designated facility of the hazardous waste shipment identified in the manifest.
260.2(C)(2)
See Endnotes 1 and 2*.

           §260.2 not IBR in 9VAC20-60-260A per 9VAC20-60-260 B.10.

                                      N/A
                           SUBPART B -- DEFINITIONS
DEFINITIONS
Electronic manifest (or e-Manifest) means the electronic format of the hazardous waste manifest that is obtained from EPA's national e-Manifest system and transmitted electronically to the system, and that is the legal equivalent of EPA Forms 8700-22 (Manifest) and 8700-22A (Continuation Sheet).
260.10
States cannot receive authorization to implement EPA's national e-Manifest system.  Therefore, States must not replace language referring to "EPA" with State terms.

                                 9VAC20-60-18.
                IBR in 9VAC20-60-260A (see 9VAC20-60-260 B 3).
                                       X

Electronic Manifest System (or e-Manifest System) means EPA's national information technology system through which the electronic manifest may be obtained, completed, transmitted, and distributed to users of the electronic manifest and to regulatory agencies.
260.10
States cannot receive authorization to implement EPA's national e-Manifest system.  Therefore, States must not replace language referring to "EPA" with State terms.

                                 9VAC20-60-18.
                IBR in 9VAC20-60-260A (see 9VAC20-60-260 B 3).
                                       X

Manifest means the shipping document EPA Form 8700-22 (including, if necessary, EPA Form 8700-22A), or the electronic manifest, originated and signed in accordance with the applicable requirements of parts 262 through 265.
260.10
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-260A.
                                       X

User of the electronic manifest system means a hazardous waste generator, a hazardous waste transporter, an owner or operator of a hazardous waste treatment, storage, recycling, or disposal facility, or any other person that:
(1) Is required to use a manifest to comply with:
(i) Any federal or state requirement to track the shipment, transportation, and receipt of hazardous waste or other waste material that is shipped from the site of generation to an off-site designated facility for treatment, storage, recycling, or disposal; or
(ii) Any federal or state requirement to track the shipment, transportation, and receipt of rejected wastes or regulated container residues that are shipped from a designated facility to an alternative facility, or returned to the generator; and
(2) Elects to use the system to obtain, complete and transmit an electronic manifest format supplied by the EPA electronic manifest system, or
(3) Elects to use the paper manifest form and submits to the system for data processing purposes a paper copy of the manifest (or data from such a paper copy), in accordance with § 264.71(a)(2)(v) or § 265.71(a)(2)(v) of this chapter.  These paper copies are submitted for data exchange purposes only and are not the official copies of record for legal purposes.
260.10
States cannot receive authorization to implement EPA's national e-Manifest system. Therefore, States must not replace language referring to "EPA" with State terms in provision (2) within this definition.  Also see Endnote 2.

                                 9VAC20-60-18.
                IBR in 9VAC20-60-260A (see 9VAC20-60-260 B 3).
                                       X

      PART 262  -  STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE
                          SUBPART B  -  THE MANIFEST
Electronic manifest.  In lieu of using the manifest form specified in paragraph (a)(1) of this section, a person required to prepare a manifest under paragraph (a)(1) of this section may prepare and use an electronic manifest, provided that the person:
262.20(a)(3)

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Complies with the requirements in § 262.24 of this part for use of electronic manifests, and
262.20(a)(3)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Complies with the requirements of 40 CFR § 3.10 for the reporting of electronic documents to EPA.
262.20(a)(3)(ii)
States must retain the citation to 40 CFR § 3.10.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

                                       X

USE OF THE ELECTRONIC MANIFEST
Use of the electronic manifest.
262.24
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Legal equivalence to paper manifests.  Electronic manifests that are obtained, completed, and transmitted in accordance with §262.20(a)(3), and used in accordance with this section in lieu of EPA Forms 8700-22 and 8700-22A are the legal equivalent of paper manifest forms bearing handwritten signatures, and satisfy for all purposes any requirement in these regulations to obtain, complete, sign,  provide, use, or retain a manifest.
262.24(a)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Any requirement in these regulations to sign a manifest or manifest certification by hand, or to obtain a handwritten signature, is satisfied by signing with or obtaining a valid and enforceable electronic signature within the meaning of § 262.25(a) of this Part.
262.24(a)(1)
States must retain the citation to 40 CFR 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Any requirement in these regulations to give, provide, send, forward, or return to another person a copy of the manifest is satisfied when an electronic manifest is transmitted to the other person by submission to the system.
262.24(a)(2)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

                            *see 9VAC20-60-262 B 9.
                                       X

Any requirement in these regulations for a generator to keep or retain a copy of each manifest is satisfied by retention of a signed electronic manifest in the generator's account on the national e-Manifest system, provided that such copies are readily available for viewing and production if requested by any EPA or authorized state inspector.
262.24(a)(3)
See Endnote 3.**

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

                           **see 9VAC20-60-262 B 7.
                                       X

No generator may be held liable for the inability to produce an electronic manifest for inspection under this section if the generator can demonstrate that the inability to produce the electronic manifest is due exclusively to a technical difficulty with the electronic manifest system for which the generator bears no responsibility.
262.24(a)(4)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

                            *see 9VAC20-60-262 B 9.
                                       X

A generator may participate in the electronic manifest system either by accessing the electronic manifest system from its own electronic equipment, or by accessing the electronic manifest system from portable equipment brought to the generator's site by the transporter who accepts the hazardous waste shipment from the generator for off-site transportation.
262.24(b)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

*see 9VAC20-60-262 B 9.
                                       X

Restriction on use of electronic manifests.  A generator may prepare an electronic manifest for the tracking of hazardous waste shipments involving any RCRA hazardous waste only if it is known at the time the manifest is originated that all waste handlers named on the manifest participate in the electronic manifest system.
262.24(c)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

*see 9VAC20-60-262 B 9.
                                       X

Requirement for one printed copy.  To the extent the Hazardous Materials regulation on shipping papers for carriage by public highway requires shippers of hazardous materials to supply a paper document for compliance with 49 CFR § 177.817, a generator originating an electronic manifest must also provide the initial transporter with one printed copy of the electronic manifest.
262.24(d)
States must retain the citation to 49 CFR § 177.817.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Special procedures when electronic manifest is unavailable. If a generator has prepared an electronic manifest for a hazardous waste shipment, but the electronic manifest system becomes unavailable for any reason prior to the time that the initial transporter has signed electronically to acknowledge the receipt of the hazardous waste from the generator, then the generator must obtain and complete a paper manifest and if necessary, a continuation sheet (EPA Forms 8700-22 and 8700-22A) in accordance with the manifest instructions in the appendix to this part, and use these paper forms from this point forward in accordance with the requirements of 40 CFR § 262.23.
262.24(e)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.

                            *see 9VAC20-60-262 B 9.
                                       X

Special procedures for electronic signature methods undergoing tests.  If a generator has prepared an electronic manifest for a hazardous waste shipment, and signs this manifest electronically using an electronic signature method which is undergoing pilot or demonstration tests aimed at demonstrating the practicality or legal dependability of the signature method, then the generator shall also sign with an ink signature the generator/offeror certification on the printed copy of the manifest provided under paragraph (d) of this section.
262.24(f)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-262A.
                                       X

Imposition of user fee.  A generator who is a user of the electronic manifest may be assessed a user fee by EPA for the origination of each electronic manifest.  EPA shall maintain and update from time-to-time the current schedule of electronic manifest user fees, which shall be determined based on current and projected system costs and level of use of the electronic manifest system.  The current schedule of electronic manifest user fees shall be published as an appendix to this part.
262.24(g)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."  Also see Endnote 2.

                  §262.24(g) not IBR per 9VAC20-60-262 B 10.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.

N/A

ELECTRONIC MANIFEST SIGNATURES   (All 9VAC20-60-18 IBR in 9VAC20-60-262A - See Subdivision B.7)
Electronic manifest signatures.
262.25
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."
                                       X

Electronic signature methods for the e-Manifest system shall:
262.25(a)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."
                                       X

Be a legally valid and enforceable signature under applicable EPA and other Federal requirements pertaining to electronic signatures; and
262.25(a)(1)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."
                                       X

Be a method that is designed and implemented in a manner that EPA considers to be as cost-effective and practical as possible for the users of the manifest.
262.25(a)(2)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."
                                       X

     PART 263  -  STANDARDS APPLICABLE TO TRANSPORTERS OF HAZARDOUS WASTE
      SUBPART B -- COMPLIANCE WITH THE MANIFEST SYSTEM AND RECORDKEEPING
THE MANIFEST SYSTEM
Manifest requirement.  A transporter may not accept hazardous waste from a generator unless the transporter is also provided with a manifest signed in accordance with requirements of 262.23.
263.20(a)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Exports.  In the case of exports other than those subject to Subpart H of 40 CFR part 262, a transporter may not accept such waste from a primary exporter or other person if he knows the shipment does not conform to the EPA Acknowledgment of Consent; and unless, in addition to a manifest signed by the generator in accordance with this section, the transporter shall also be provided with an EPA Acknowledgment of Consent which, except for shipments by rail, is attached to the manifest (or shipping paper for exports by water (bulk shipment)).  For exports of hazardous waste subject to the requirements of subpart H of 40 CFR part 262, a transporter may not accept hazardous waste without a tracking document that includes all information required by 40 CFR § 262.84.
263.20(a)(2)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."

                9VAC20-60-18. IBR in 9VAC2-60-263 A. 9VAC20-60-
                      263 B 3 retains the term "EPA."
                                       X

Compliance Date for Form Revisions.  The revised Manifest form and procedures in 40 CFR §§ 260.10, 261.7, 263.20, and 263.21, had an effective date of September 5, 2006.  The Manifest form and procedures in 40 CFR §§ 260.10, 261.7, 263.20, and 263.21, contained in the 40 CFR, parts 260 to 265, edition revised as of July 1, 2004, were applicable until September 5, 2006.
263.20(a)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Use of electronic manifest -- legal equivalence to paper forms for participating transporters.  Electronic manifests that are obtained, completed, and transmitted in accordance with § 262.20(a)(3) of part 262, and used in accordance with this section in lieu of EPA Forms 8700-22 and 8700-22A, are the legal equivalent of paper manifest forms bearing handwritten signatures, and satisfy for all purposes any requirement in these regulations to obtain, complete, sign, carry, provide, give, use, or retain a manifest.
263.20(a)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Any requirement in these regulations to sign a manifest or manifest certification by hand, or to obtain a handwritten signature, is satisfied by signing with or obtaining a valid and enforceable electronic signature within the meaning of  40 C.F.R. § 262.25(a).
263.20(a)(4)(i)
States must retain the citation to 40 C.F.R. 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Any requirement in these regulations to give, provide, send, forward, or return to another person a copy of the manifest is satisfied when a copy of an electronic manifest is transmitted to the other person by submission to the system.
263.20(a)(4)(ii)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.

                            *see 9VAC20-60-262 B 3.
                                       X

Any requirement in these regulations for a manifest to accompany a hazardous waste shipment is satisfied when a copy of an electronic manifest is accessible during transportation and forwarded to the person or persons who are scheduled to receive delivery of the waste shipment, except that to the extent that the Hazardous Materials regulation on shipping papers for carriage by public highway requires transporters of hazardous materials to carry a paper document to comply with 49 CFR § 177.817, a hazardous waste transporter must carry one printed copy of the electronic manifest on the transport vehicle.
263.20(a)(4)(iii)
States must retain the citation to 49 CFR § 177.817.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Any requirement in these regulations for a transporter to keep or retain a copy of a manifest is satisfied by the retention of an electronic manifest in the transporter's account on the e-Manifest system, provided that such copies are readily available for viewing and production if requested by any EPA or authorized state inspector.
263.20(a)(4)(iv)
See Endnotes 2 and 3.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.

                            *see 9VAC20-60-262 B 3.
                                       X

No transporter may be held liable for the inability to produce an electronic manifest for inspection under this section if that transporter can demonstrate that the inability to produce the electronic manifest is exclusively due to a technical difficulty with the EPA system for which the transporter bears no responsibility.
263.20(a)(4)(v)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.

                            *see 9VAC20-60-262 B 3.
                                       X

A transporter may participate in the electronic manifest system either by accessing the electronic manifest system from the transporter's own electronic equipment, or by accessing the electronic manifest system from the equipment provided by a participating generator, by another transporter, or by a designated facility.
263.20(a)(5)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.

                            *see 9VAC20-60-262 B 3.
                                       X

Special procedures when electronic manifest is not available.  If after a manifest has been originated electronically and signed electronically by the initial transporter, and the electronic manifest system should become unavailable for any reason, then:
263.20(a)(6)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.

                            *see 9VAC20-60-262 B 3.
                                       X

The transporter in possession of the hazardous waste when the electronic manifest becomes unavailable shall reproduce sufficient copies of the printed manifest that is carried on the transport vehicle pursuant to paragraph (a)(4)(iii)(A) of this section, or obtain and complete another paper manifest for this purpose.  The transporter shall reproduce sufficient copies to provide the transporter and all subsequent waste handlers with a copy for their files, plus two additional copies that will be delivered to the designated facility with the hazardous waste.
263.20(a)(6)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

On each printed copy, the transporter shall include a notation in the Special Handling and Additional Description space (Item 14) that the paper manifest is a replacement manifest for a manifest originated in the electronic manifest system, shall include (if not pre-printed on the replacement manifest) the manifest tracking number of the electronic manifest that is replaced by the paper manifest, and shall also include a brief explanation why the electronic manifest was not available for completing the tracking of the shipment electronically.
263.20(a)(6)(ii)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.

                            *see 9VAC20-60-262 B 3.
                                       X

A transporter signing a replacement manifest to acknowledge receipt of the hazardous waste must ensure that each paper copy is individually signed and that a legible handwritten signature appears on each copy.
263.20(a)(6)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

From the point at which the electronic manifest is no longer available for tracking the waste shipment, the paper replacement manifest copies shall be carried, signed, retained as records, and given to a subsequent transporter or to the designated facility, following the instructions, procedures, and requirements that apply to the use of all other paper manifests.
263.20(a)(6)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Special procedures for electronic signature methods undergoing tests.  If a transporter using an electronic manifest signs this manifest electronically using an electronic signature method which is undergoing pilot or demonstration tests aimed at demonstrating the practicality or legal dependability of the signature method, then the transporter shall sign the electronic manifest electronically and also sign with an ink signature the transporter acknowledgement of receipt of materials on the printed copy of the manifest that is carried on the vehicle in accordance with paragraph (a)(4)(iii)(A) of this section.  This printed copy bearing the generator's and transporter's ink signatures shall also be presented by the transporter to the designated facility to sign in ink to indicate the receipt of the waste materials or to indicate discrepancies.  After the owner/operator of the designated facility has signed this printed manifest copy with its ink signature, the printed manifest copy shall be delivered to the designated facility with the waste materials.
263.20(a)(7)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Imposition of user fee for electronic manifest use.  A transporter who is a user of the electronic manifest may be assessed a user fee by EPA for the origination or processing of each electronic manifest.  EPA shall maintain and update from time-to-time the current schedule of electronic manifest user fees, which shall be determined based on current and projected system costs and level of use of the electronic manifest system.  The current schedule of electronic manifest user fees shall be published as an appendix to Part 262 of this Chapter.
263.20(a)(8)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."  Also see Endnote 2.

§263(a)(8) not IBR per 9VAC20-60-263 B.4.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
N/A

Electronic Manifest Signatures.
263.25
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

Electronic manifest signatures shall meet the criteria described in §262.25(a) of this Chapter
263.25(a)
States must retain the citation to 40 C.F.R. 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-263A.
                                       X

PART 264  -  STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES
          SUBPART E  -  MANIFEST SYSTEM, RECORDKEEPING, AND REPORTING
USE OF MANIFEST SYSTEM
If the facility receives a hazardous waste shipment accompanied by a manifest, the owner, operator, or his agent must:
264.71(a)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Sign and date, by hand, each copy of the manifest;
264.71(a)(2)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Note any discrepancies (as defined in § 264.72(a)) on each copy of the manifest;
264.71(a)(2)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Immediately give the transporter at least one copy of the manifest;
264.71(a)(2)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Within 30 days of delivery, send a copy (Page 3) of the manifest to the generator,
264.71(a)(2)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Within 30 days of delivery, send the top copy (Page 1) of the Manifest to the e-Manifest system for purposes of data entry and processing.  In lieu of mailing this paper copy to EPA, the owner or operator may transmit to the EPA system an image file of Page 1 of the manifest, or both a data string file and the image file corresponding to Page 1 of the manifest.  Any data or image files transmitted to EPA under this paragraph must be submitted in data file and image file formats that are acceptable to EPA and that are supported by EPA's electronic reporting requirements and by the electronic manifest system.
264.71(a)(2)(v)
States must retain the term "EPA" within this provision.  Also see Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.

                           *see 9VAC20-60-264 B 32.
                                       X

Retain at the facility a copy of each manifest for at least three years from the date of delivery.
264.71(a)(2)(vi)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Legal equivalence to paper manifests.  Electronic manifests that are obtained, completed, and transmitted in accordance with § 262.20(a)(3), and used in accordance with this section in lieu of the paper manifest form are the legal equivalent of paper manifest forms bearing handwritten signatures, and satisfy for all purposes any requirement in these regulations to obtain, complete, sign,  provide, use, or retain a manifest.
264.71(f)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Any requirement in these regulations for the owner or operator of a facility to sign a manifest or manifest certification by hand, or to obtain a handwritten signature, is satisfied by signing with or obtaining a valid and enforceable electronic signature within the meaning of 40 C.F.R.
§ 262.25(a).
264.71(f)(1)
States must retain the citation to 40 C.F.R. 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Any requirement in these regulations to give, provide, send, forward, or to return to another person a copy of the manifest is satisfied when a copy of an electronic manifest is transmitted to the other person.
264.71(f)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Any requirement in these regulations for a manifest to accompany a hazardous waste shipment is satisfied when a copy of an electronic manifest is accessible during transportation and forwarded to the person or persons who are scheduled to receive delivery of the waste shipment.
264.71(f)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Any requirement in these regulations for an owner or operator to keep or retain a copy of each manifest is satisfied by the retention of the facility's electronic manifest copies in its account on the e-Manifest system, provided that such copies are readily available for viewing and production if requested by any EPA or authorized state inspector.
264.71(f)(4)
See Endnotes 2 and 3.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.

*see 9VAC20-60-264 B 32.
                                       X

No owner or operator may be held liable for the inability to produce an electronic manifest for inspection under this section if the owner or operator can demonstrate that the inability to produce the electronic manifest is due exclusively to a technical difficulty with the electronic manifest system for which the owner or operator bears no responsibility.
264.71(f)(5)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.

                           *see 9VAC20-60-264 B 32.
                                       X

An owner or operator may participate in the electronic manifest system either by accessing the electronic manifest system from the owner's or operator's electronic equipment, or by accessing the electronic manifest system from portable equipment brought to the owner's or operator's site by the transporter who delivers the waste shipment to the facility.
264.71(g)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.

                           *see 9VAC20-60-264 B 32.
                                       X

Special procedures applicable to replacement manifests.  If a facility receives hazardous waste that is accompanied by a paper replacement manifest for a manifest that was originated electronically, the following procedures apply to the delivery of the hazardous waste by the final transporter:
264.71(h)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Upon delivery of the hazardous waste to the designated facility, the owner or operator must sign and date each copy of the paper replacement manifest by hand in Item 20 (Designated Facility Certification of Receipt) and note any discrepancies in Item 18 (Discrepancy Indication Space) of the paper replacement manifest,
264.71(h)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

The owner or operator of the facility must give back to the final transporter one copy of the paper replacement manifest,
264.71(h)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Within 30 days of delivery of the waste to the designated facility, the owner or operator of the facility must send one signed and dated copy of the paper replacement manifest to the generator, and send an additional signed and dated copy of the paper replacement manifest to the electronic manifest system, and
264.71(h)(3)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.

                           *see 9VAC20-60-264 B 32.
                                       X

The owner or operator of the facility must retain at the facility one copy of the paper replacement manifest for at least three years from the date of delivery.
264.71(h)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Special procedures applicable to electronic signature methods undergoing tests.  If an owner or operator using an electronic manifest signs this manifest electronically using an electronic signature method which is undergoing pilot or demonstration tests aimed at demonstrating the practicality or legal dependability of the signature method, then the owner or operator shall also sign with an ink signature the facility's certification of receipt or discrepancies on the printed copy of the manifest provided by the transporter.  Upon executing its ink signature on this printed copy, the owner or operator shall retain this original copy among its records for at least 3 years from the date of delivery of the waste.
264.71(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Imposition of user fee for electronic manifest use.  An owner or operator who is a user of the electronic manifest format may be assessed a user fee by EPA for the origination or processing of each electronic manifest.  An owner or operator may also be assessed a user fee by EPA for the collection and processing of paper manifest copies that owners or operators must submit to the electronic manifest system operator under § 264.71(a)(2)(v) of this part. EPA shall maintain and update from time-to-time the current schedule of electronic manifest system user fees, which shall be determined based on current and projected system costs and level of use of the electronic manifest system.  The current schedule of electronic manifest user fees shall be published as an appendix to Part 262 of this Chapter.
264.71(j)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."  Also see Endnote 2.

DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
§DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
264.71(j) not IBR per 9VAC20-60-264 B 33.N/A

Electronic Manifest Signatures.
264.71(k)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

Electronic manifest signatures shall meet the criteria described in § 262.25(a) of this Chapter.
264.71(k)(1)
States must retain the citation to 40 C.F.R. 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-264A.
                                       X

PART 265  -  INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE, TREATMENT, STORAGE, AND DISPOSAL FACILITIES
          SUBPART E  -  MANIFEST SYSTEM, RECORDKEEPING, AND REPORTING
If the facility receives a hazardous waste shipment accompanied by a manifest, the owner, operator, or his agent must:
265.71(a)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Sign and date, by hand, each copy of the manifest;
265.71(a)(2)(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Note any discrepancies (as defined in § 265.72(a) on each copy of the manifest;
265.71(a)(2)(ii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Immediately give the transporter at least one copy of the manifest;
265.71(a)(2)(iii)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Within 30 days of delivery, send a copy (Page 3) of the manifest to the generator,
265.71(a)(2)(iv)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Within 30 days of delivery, send the top copy (Page 1) of the Manifest to the electronic manifest system for purposes of data entry and processing.  In lieu of mailing this paper copy to the electronic manifest system operator, the owner or operator may transmit to the system operator an image file of Page 1 of the manifest, or both a data string file and the image file corresponding to Page 1 of the manifest.  Any data or image files transmitted to EPA under this paragraph must be submitted in data file and image file formats that are acceptable to EPA and that are supported by EPA's electronic reporting requirements and by the electronic manifest system.
265.71(a)(2)(v)
States must retain the term "EPA" within this provision.  Also see Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.

                           *see 9VAC20-60-265 B 19.

                                       X

Retain at the facility a copy of each manifest for at least three years from the date of delivery.
265.71(a)(2)(vi)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Legal equivalence to paper manifests.  Electronic manifests that are obtained, completed, and transmitted in accordance with § 262.20(a)(3), and used in accordance with this section in lieu of the paper manifest form are the legal equivalent of paper manifest forms bearing handwritten signatures, and satisfy for all purposes any requirement in these regulations to obtain, complete, sign,  provide, use, or retain a manifest.
265.71(f)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Any requirement in these regulations for the owner or operator of a facility to sign a manifest or manifest certification by hand, or to obtain a handwritten signature, is satisfied by signing with or obtaining a valid and enforceable electronic signature within the meaning of 40 C.F.R.
§ 262.25(a).
265.71(f)(1)
States must retain the citation to 40 C.F.R. 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Any requirement in these regulations to give, provide, send, forward, or to return to another person a copy of the manifest is satisfied when a copy of an electronic manifest is transmitted to the other person.
265.71(f)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Any requirement in these regulations for a manifest to accompany a hazardous waste shipment is satisfied when a copy of an electronic manifest is accessible during transportation and forwarded to the person or persons who are scheduled to receive delivery of the waste shipment.
265.71(f)(3)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Any requirement in these regulations for an owner or operator to keep or retain a copy of each manifest is satisfied by the retention of the facility's electronic manifest copies in its account on the e-Manifest system, provided that such copies are readily available for viewing and production if requested by any EPA or authorized state inspector.
265.71(f)(4)
See Endnotes 2 and 3.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.

                           *see 9VAC20-60-265 B 19.

                                       X

No owner or operator may be held liable for the inability to produce an electronic manifest for inspection under this section if the owner or operator can demonstrate that the inability to produce the electronic manifest is due exclusively to a technical difficulty with the electronic manifest system for which the owner or operator bears no responsibility.
265.71(f)(5)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.

                           *see 9VAC20-60-265 B 19.

                                       X

An owner or operator may participate in the electronic manifest system either by accessing the electronic manifest system from the owner's or operator's electronic equipment, or by accessing the electronic manifest system from portable equipment brought to the owner's or operator's site by the transporter who delivers the waste shipment to the facility.
265.71(g)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.

                           *see 9VAC20-60-265 B 19.

                                       X

Special procedures applicable to replacement manifests.  If a facility receives hazardous waste that is accompanied by a paper replacement manifest for a manifest that was originated electronically, the following procedures apply to the delivery of the hazardous waste by the final transporter:
265.71(h)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Upon delivery of the hazardous waste to the designated facility, the owner or operator must sign and date each copy of the paper replacement manifest by hand in Item 20 (Designated Facility Certification of Receipt) and note any discrepancies in Item 18 (Discrepancy Indication Space) of the paper replacement manifest,
265.71(h)(1)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

The owner or operator of the facility must give back to the final transporter one copy of the paper replacement manifest,
265.71(h)(2)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Within 30 days of delivery of the waste to the designated facility, the owner or operator of the facility must send one signed and dated copy of the paper replacement manifest to the generator, and send an additional signed and dated copy of the paper replacement manifest to the electronic manifest system, and
265.71(h)(3)
See Endnote 2.*

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.

                           *see 9VAC20-60-265 B 19.

                                       X

The owner or operator of the facility must retain at the facility one copy of the paper replacement manifest for at least three years from the date of delivery.
265.71(h)(4)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Special procedures applicable to electronic signature methods undergoing tests.  If an owner or operator using an electronic manifest signs this manifest electronically using an electronic signature method which is undergoing pilot or demonstration tests aimed at demonstrating the practicality or legal dependability of the signature method, then the owner or operator shall also sign with an ink signature the facility's certification of receipt or discrepancies on the printed copy of the manifest provided by the transporter.  Upon executing its ink signature on this printed copy, the owner or operator shall retain this original copy among its records for at least 3 years from the date of delivery of the waste.
265.71(i)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Imposition of user fee for electronic manifest use.  An owner or operator who is a user of the electronic manifest format may be assessed a user fee by EPA for the origination or processing of each electronic manifest.  An owner or operator may also be assessed a user fee by EPA for the collection and processing of paper manifest copies that owners or operators must submit to the electronic manifest system operator under § 265.71(a)(2)(v) of this part. EPA shall maintain and update from time-to-time the current schedule of electronic manifest system user fees, which shall be determined based on current and projected system costs and level of use of the electronic manifest system.  The current schedule of electronic manifest user fees shall be published as an appendix to Part 262 of this Chapter.
265.71(j)
States cannot receive authorization for this provision, but should adopt it while retaining the term "EPA."  Also see Endnote 2.

                  §265.71(j) not IBR per 9VAC20-60-265 B 20.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
DID NOT ADOPT

Annual Update 2014 did not incorporate the subdivisions of the e-Manifest Rule which impose a possible fee that may be collected by EPA for use of the manifest system. EPA has indicated that they will promulgate a subsequent rule which will provide the user fee schedule and compliance date for use of the e-manifest system which is still in development. Therefore, this regulatory action did not include the provisions for imposition of a user fee by EPA.
N/A

Electronic Manifest Signatures.
265.71(k)
                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Electronic manifest signatures shall meet the criteria described in § 262.25(a) of this Chapter.
265.71(k)(1)
States must retain the citation to 40 C.F.R. 262.25(a), and cannot insert a citation to a state provision.

                                 9VAC20-60-18.
                            IBR in 9VAC20-60-265A.
                                       X

Endnotes:

1	40 CFR 260.2 is not required for authorization; therefore, States do not have to include 40 CFR 260.2 in 	their adoption of the Federal regulations by reference.  The requirements for Availability of Information 	are found on the "Availability of Information" checklist for RCRA section 3006(f), but 40 CFR 260.2 	is not included on that checklist.

2.	Within this provision, the reference to "system" means the EPA national electronic manifest system.  	See the definition in 40 C.F.R. 260.10.

3.	States should retain the term "EPA" within this provision and may change "state" to the name of the 	state.


[Federal Register: July 2, 2009 (Volume 74, Number 126)]
[Notices]
[Page 31730-31732]
[DOCID:fr02jy09-50]

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

ENVIRONMENTAL PROTECTION AGENCY

[Docket ID Numbers EPA-HQ-OECA-2009-0280; FRL-8925-3]

Agency Information Collection Activities: Request for Comments on
Proposed Information Collection Request (ICR) for Annual Public Water
Systems Compliance Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that EPA is planning to submit the
following existing, approved, continuing Information Collection Request
(ICR) to the Office of Management and Budget (OMB) for the purpose of
renewing the ICRs. Before submitting the ICRs to OMB for review and
approval, EPA is soliciting comments on specific aspects of the
information collections as described below in SUPPLEMENTARY
INFORMATION.

DATES: Comments must be submitted on or before August 31, 2009.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier service. Follow the detailed instructions
as provided under SUPPLEMENTARY INFORMATION, section A.

FOR FURTHER INFORMATION CONTACT: The contact individual for the ICR is
listed under SUPPLEMENTARY INFORMATION, section II.C.

SUPPLEMENTARY INFORMATION:

A. How Can I Access the Docket and/or Submit Comments?

1. Docket Access Instructions

    EPA has established a public docket for the ICRs listed in the
SUPPLEMENTARY INFORMATION, section II.B. The docket is available for
online viewing at http://www.regulations.gov, or in person viewing at
the Enforcement and Compliance Docket and Information Center (ECDIC),
in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue, NW., Washington, DC. The EPA/DC Public Reading
Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is (202) 566-
1744, and the telephone number for the Enforcement and Compliance
Docket and Information Center (ECDIC) docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft
collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. When
in the system, select ``search,'' then key in the docket ID number
identified in this document.

2. Instructions for submitting comments. Submit your comments by one of
the following methods:

    1. Electronic Submission: Access http://www.regulations.gov and
follow the online instructions for submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Enforcement and Compliance Docket and Information Center
(ECDIC), Environmental Protection Agency, EPA Docket Center (EPA/DC),
Mailcode: 2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
    5. Hand Delivery: Enforcement and Compliance Docket and Information
Center (ECDIC), Environmental Protection Agency, EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW.,
Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. Deliveries are
only accepted

during the Docket Center's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Direct your comments to the specific docket listed in SUPPLEMENTARY
INFORMATION, section II.B, and reference the OMB Control Number for the
ICR. It is EPA's policy that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.

B. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act
(PRA), EPA is soliciting comments and information to enable it to:
    (1) Evaluate whether the proposed collections of information are
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    (2) Evaluate the accuracy of the Agency's estimates of the burdens
of the proposed collections of information.
    (3) Enhance the quality, utility, and clarity of the information to
be collected.
    (4) Minimize the burden of the collections of information on those
who are to respond, including through the use of appropriate automated
or electronic collection technologies or other forms of information
technology, e.g., permitting electronic submission of responses.

C. What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

II. ICR To Be Renewed

A. For All ICR

    The Agency computed the burden for each of the recordkeeping and
reporting requirements applicable to the industry for the currently
approved ICR listed in this notice. Where applicable, the Agency
identified specific tasks and made assumptions, while being consistent
with the concept of the PRA.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions to; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements which have subsequently changed; train personnel to be
able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.
    The listed ICR addresses Safe Drinking Water Act information
collection requirements which have mandatory reporting requirements.
The requirements are mandated under Section 1414(c)(3)(A) of the Safe
Drinking Water Act.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information, unless the Agency displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations under Title 40 of the Code of Federal Regulations are
published in the Federal Register, or on the related collection
instrument or form. The display of OMB control numbers for certain EPA
regulations is consolidated at 40 CFR part 9.

B. What Information Collection Activity or ICR Does This Apply to?

    In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et
seq.), this notice announces that EPA is planning to submit a
continuing Information Collection Request (ICR) to the Office of
Management and Budget (OMB):
    (1) Docket ID Number: EPA-HQ-OECA-2009-0280.
    Title: Annual Public Water Systems Compliance Report.
    ICR Number: EPA ICR Number 1812.04, OMB Control Number 2020-0020.
    ICR Status: This ICR is scheduled to expire on June 30, 2008.

C. Contact Individuals for ICR

    (1) Annual Public Water Systems Compliance Report; Joyce Chandler
of the Office of Compliance at<PHONE_NUMBER>; or via E-mail to:
<EMAIL_ADDRESS>EPA ICR Number 1812.04; OMB Control Number
2020-0020; expiration date June 30, 2008.

D. Information for Individual ICR

    (1) Annual Public Water Systems Compliance Report; Docket ID Number
EPA-HQ-OECA-2009-0280, EPA ICR Number 1812.04; OMB Control Number 2020-
0020; expiration date June 30, 2008.
    Affected Entities: Fifty-six states (including Puerto Rico, the
Virgin Islands, American Samoa, Guam, the Commonwealth of the Northern
Mariana Islands, and Navajo Nation) currently have primary enforcement
authority under the Safe Drinking Water Act. The State of Wyoming and
the District of Columbia neither currently have primary enforcement
authority nor are currently seeking primary authority, so the number of
56 states is unlikely to change during the next three years.

    Abstract: Section 1414(c)(3)(A) of the Safe Drinking Water Act
requires that each state (a term that includes states, commonwealths
and territories) that has primary enforcement authority under the Act
shall prepare, make readily available to the public, and submit to the
Administrator of EPA, an annual report of violations of national
primary drinking water regulations in the State. These Annual State
Public Water System Compliance Reports are to include violations of
maximum contaminant levels, treatment requirements, variances and
exemptions, and monitoring requirements determined to be significant by
the Administrator after consultation with the states. To minimize a
state's burden in preparing its annual statutorily-required report, EPA
issued guidance that explains what Section 1414(c)(3)(A) requires and
provides model language and reporting templates. EPA also annually
makes available to the states a computer query that generates for each
state (from information states are already separately required to
submit to EPA's national database on a quarterly basis) the required
violations information in a table consistent with the reporting
template in EPA's guidance.
    Affected Entities: Entities potentially affected by this action are
states, tribes, and territories that have primary enforcement authority
and meet the definition of ``state'' under the Safe Drinking Water Act
(Act).
    Estimated Number of Respondents: 56.
    Frequency of Response: Annually.
    Estimated Total Annual Hour Burden: 4,480 hours.
    Estimated Total Annual Cost: $280,000. This includes an estimated
burden cost of $280,000 and an estimated cost of $0 for capital
investment or maintenance and operational costs.
    Changes in the Estimates: There is a decrease of 80 hours in the
total estimated hour burden currently identified in the OMB inventory
of Approved ICR Burden. This is due to the fact that the number of
respondents included in the current approved ICR incorrectly counted
the burden of the District of Columbia as a respondent, when that
burden is done by EPA, not the District of Columbia. The hour burden
for each respondent is estimated as 80 hours.
    EPA will consider any comments received and may amend any of the
above ICR, as appropriate. Then the final ICR packages will be
submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At
that time, EPA will issue one Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR(s) to OMB and
the opportunity to submit additional comments to OMB. If you have any
questions about any of the above or the approval process, please
contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: June 23, 2009.
Lisa C. Lund,
Director, Office of Compliance.
[FR Doc. E9-15683 Filed 7-1-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Page 46508]
[FR Doc No: 2019-19040]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER02-1695-000]

Cabazon Wind Partners, 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 Cabazon Wind
Partners, 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 September 4, 2019.
    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 should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: August 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19040 Filed 9-3-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 106-109]
[FR Doc No: 2020-29058]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1825 and FDA-2020-D-1138]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on January 4, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) 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,<PHONE_NUMBER>.
     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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidances.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, or Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services (HHS), pursuant to
the authority under section 319 of the Public Health Service Act (42
U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed
since January 27, 2020, nationwide.\1\ On March 13, 2020, President
Donald J. Trump declared that the COVID-19 outbreak in the United
States constitutes a national emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ Secretary of Health and Human Services Alex M. Azar, II,
``Determination that a Public Health Emergency Exists'' (originally
issued on January 31, 2020, and subsequently renewed), available at:
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 371(h)(1)(C)) and Sec.  10.115(g)(2)). The guidances are
available on FDA's web pages entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders'' (available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and ``Search for FDA Guidance Documents'' (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

   Table 1--Guidances Related to the COVID-19 Public Health Emergency
------------------------------------------------------------------------
                                                             Contact
                                            Title of      information to
       Docket No.            Center         guidance      request single
                                                              copies
------------------------------------------------------------------------
FDA-2020-D-1825.........  CBER........  Investigational  Office of
                                         COVID-19         Communication,
                                         Convalescent     Outreach and
                                         Plasma           Development,
                                         (Updated         10903 New
                                         November 2020).  Hampshire
                                                          Ave., Bldg.
                                                          71, Rm. 3128,
                                                          Silver Spring,
                                                          MD 20993-0002;
                                                          1-800-835-4709
                                                          or 240-402-
                                                          8010; email
<EMAIL_ADDRESS>FDA-2020-D-1138.........  CDRH........  Notifying CDRH   CDRH-
                                         of a Permanent   [email protected]
                                         Discontinuance   hs.gov. Please
                                         or               include the
                                         Interruption     document
                                         in               number 20032-
                                         Manufacturing    R2 and
                                         of a Device      complete title
                                         Under Section    of the
                                         506J of the      guidance in
                                         FD&C Act         the request.
                                         During the
                                         COVID-19
                                         Public Health
                                         Emergency
                                         (Revised)
                                         (November
                                         2020).
FDA-2020-D-1138.........  CDRH........  Enforcement      CDRH-
                                         Policy for       [email protected]
                                         Bioburden        hs.gov. Please
                                         Reduction        include the
                                         Systems Using    document
                                         Dry Heat to      number 20044
                                         Support Single-  and complete
                                         User Reuse of    title of the
                                         Certain          guidance in
                                         Filtering        the request.
                                         Facepiece
                                         Respirators
                                         During the
                                         Coronavirus
                                         Disease 2019
                                         (COVID-19)
                                         Public Health
                                         Emergency
                                         (November
                                         2020).
FDA-2020-D-1138.........  CDRH........  Enforcement      CDRH-
                                         Policy for the   [email protected]
                                         Quality          hs.gov. Please
                                         Standards of     include the
                                         the              document
                                         Mammography      number 20047
                                         Quality          and complete
                                         Standards Act    title of the
                                         During the       guidance in
                                         COVID-19         the request.
                                         Public Health
                                         Emergency
                                         (December
                                         2020).
------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER Guidance

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

                                     Table 2--CBER Guidance and Collections
----------------------------------------------------------------------------------------------------------------
                                        CFR cite referenced in        Another guidance title        OMB control
      COVID-19 guidance title             COVID-19 guidance           referenced in COVID-19          No(s).
-----------------------------------------------------------------------------guidance---------------------------
Investigational COVID-19             21 CFR part 312............  ..............................       0910-0014
 Convalescent Plasma (Updated        21 CFR parts 610, 606, and   ..............................       0910-0116
 November 2020).                      630.
                                                                  Form FDA 3926.................       0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidances

    While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for these guidances. These previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA statutory
provision, regulations and guidances have been approved by OMB as
listed in the following table. These guidances also contain a
collection of information that has been granted a PHE waiver from the
PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 3--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                                          Another guidance                      New collection
     COVID-19 guidance title       Citation referenced  referenced in COVID-   OMB control    covered by PHE PRA
                                       in COVID-19          19 guidance          No(s).             waiver
-----------------------------------------guidance---------------------------------------------------------------
Notifying CDRH of a Permanent      Section 506J (21     ...................       0910-0491
 Discontinuance or Interruption     U.S.C.356j) of the
 in Manufacturing of a Device       FD&C Act.
 Under Section 506J of the FD&C
 Act During the COVID-19 Public
 Health Emergency (Revised)
 (November 2020).
                                   21 CFR Part 807,     ...................       0910-0625
                                    subparts A through
                                    D.

                                                        Emergency Use             0910-0595
                                                         Authorization of
                                                         Medical Products
                                                         and Related
                                                         Authorities;
                                                         Guidance for
                                                         Industry and Other
                                                         Stakeholders.
                                                                                Updates to FDA
                                                                                every 6 weeks
                                                                                after initial
                                                                                notification on
                                                                                the shortage
                                                                                situation.
                                                                                Voluntary
                                                                                submission of
                                                                                other information.
Enforcement Policy for Bioburden   ...................  Emergency Use             0910-0595
 Reduction Systems Using Dry Heat                        Authorization of
 to Support Single-User Reuse of                         Medical Products
 Certain Filtering Facepiece                             and Related
 Respirators During the                                  Authorities;
 Coronavirus Disease 2019 (COVID-                        Guidance for
 19) Public Health Emergency                             Industry and Other
 (November 2020).                                        Stakeholders.
                                                                                Labeling of the
                                                                                bioburden
                                                                                reduction system.
Enforcement Policy for the         21 CFR Part 900....  ...................       0910-0309
 Quality Standards of the
 Mammography Quality Standards
 Act [MQSA] During the COVID-19
 Public Health Emergency
 (December 2020).
                                                                                Document the time
                                                                                period that the
                                                                                facility was
                                                                                temporarily closed
                                                                                and present
                                                                                information during
                                                                                the facility's
                                                                                MQSA inspection.
                                                                                Document and
                                                                                provide the
                                                                                circumstances re:
                                                                                lack of medical
                                                                                physicist survey
                                                                                within 14 months
                                                                                of the last annual
                                                                                survey.
                                                                                Information on
                                                                                inability to meet
                                                                                the survey
                                                                                timeframes
                                                                                described in the
                                                                                guidance.
                                                                                Provide
                                                                                documentation of
                                                                                the dates and
                                                                                events that led to
                                                                                noncompliance and
                                                                                that facility will
                                                                                ensure compliance
                                                                                as soon as
                                                                                possible after
                                                                                COVID-19
                                                                                restrictions are
                                                                                lifted.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29058 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P