N.H. Admin. Code § Env-Hw 1302.02

Current through Register No. 50, December 12, 2024

Section Env-Hw 1302.02 - Amendments to Incorporated Federal Requirements

The following amendments shall apply to the incorporated requirements:

(a) Amend 40 CFR 266.500 by:

(1) Deleting the definition of "household waste pharmaceutical" and replacing it with "Household waste pharmaceutical means a pharmaceutical that is a household waste and is excluded from regulation as a hazardous waste pursuant to RSA 147-A:2, VII(b)."; and

(2) Deleting the definition of "non-pharmaceutical hazardous waste" and replacing it with "Non-pharmaceutical hazardous waste means a hazardous waste that is not a pharmaceutical.";

(b) Amend 40 CFR 266.501 as follows:

(1) Amend 40 CFR 266.501(a) and (b) to read as follows:

(a)" A healthcare facility that is a small quantity generator when counting all of the hazardous waste it generates and accumulates in a calendar month, including both its hazardous waste pharmaceuticals and its non- pharmaceutical hazardous waste, remains subject to Env-Hw 500 and is not subject to this subpart, except for §§ 266.505 and 266.507 and the optional provisions of § 266.504.

(b) A healthcare facility that is a small quantity generator when counting all of the hazardous waste it generates and accumulates in a calendar month, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, has the option of complying with § 266.501(d) for the management of its hazardous waste pharmaceuticals as an alternative to complying with Env-Hw 500 and the optional provisions of § 266.504.";

(2) Amend 40 CFR 266.501(d) introductory language and (e) by replacing "parts 262 through 265" and with "Env-Hw 500 through Env-Hw 700";

(3) Amend 40 CFR 266.501(f) by replacing " 40 CFR part 262 " with "Env-Hw 500"; and

(4) Amend 40 CFR 266.501(g) introductory language by replacing "40 CFR parts 260 through 273" and with "the hazardous waste rules";

(c) Amend 40 CFR 266.502 as follows:

(1) Amend 40 CFR 266.502(a) to read as follows:

(a)" Notification and withdrawal from this subpart for healthcare facilities managing hazardous waste pharmaceuticals-

(1) Notification. A healthcare facility shall notify the department that it is a healthcare facility operating under this subpart, by completing and submitting to the department a notification form obtained from the department that includes the information specified in Env-Hw 504.02(a), as applicable. When completing item 10 of the notification form, in lieu of providing a narrative description, EPA and state hazardous waste numbers, and estimated quantity generated per month for its hazardous waste pharmaceuticals, a healthcare facility shall enter the word"pharmaceuticals". A healthcare facility shall submit a separate notification form for each site or EPA identification number.

(i) A healthcare facility that already has an EPA identification number shall notify the department, using the notification form, that it is a healthcare facility within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.

(ii) A healthcare facility that does not have an EPA identification number shall obtain one by notifying the department, using the notification form, that it is a healthcare facility within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.

(iii) A healthcare facility shall keep a copy of its notification on file for as long as the healthcare facility is subject to this subpart.

(2) Withdrawal. A healthcare facility that operated under this subpart but is no longer subject to this subpart, because it is a small quantity generator under Env-Hw 500 when counting all its hazardous waste, and elects to withdraw from this subpart, shall notify the department using the notification form identified in Env-Hw 504.02(a), that it is no longer operating under this subpart. A healthcare facility that is withdrawing from this subpart shall provide all applicable EPA and state hazardous waste numbers for its hazardous waste pharmaceuticals in item 10 of the notification form. A healthcare facility shall submit a separate notification form for each EPA identification number.

(i) A healthcare facility shall submit the notification form notifying that it is withdrawing from this subpart before it begins operating under Env-Hw 500.

(ii) A healthcare facility shall keep a copy of its withdrawal on file for three years from the date of signature on the notification of its withdrawal.";

(2) Amend 40 CFR 266.502(g) by adding after " 40 CFR part 268 " the following: ", incorporated by reference in Env-Hw 1202";

(3) Amend 40 CFR 266.502(h) by adding the following:

(5)" If a returned shipment is accompanied by a paper manifest or an electronic manifest that was printed for the healthcare facility's signature, submit a copy of the signed manifest to the department within 5 days of receipt of the returned shipment.";

(4) Amend 40 CFR 266.502(i) by adding the following:

(4)" A healthcare facility shall be subject to the quarterly reporting requirements of Env-Hw 512.02 with respect to non-creditable hazardous waste pharmaceuticals.";

(5) Amend 40 CFR 266.502(j)(1) to read as follows:

(1)" A healthcare facility shall keep a copy of each manifest signed in accordance with Env-Hw 510.02 and each signed copy from the designated facility that received the non-creditable hazardous waste pharmaceuticals for three years from the date of signature by the healthcare facility. A healthcare facility may rely on the electronic manifest system to satisfy manifest recordkeeping requirements only if the healthcare facility has registered in the electronic manifest system and has established access to manifest records stored therein, except as follows:

(i) For shipments using an electronic manifest that was printed for the healthcare facility's signature, the healthcare facility shall retain the paper copy of the electronic manifest with the healthcare facility's signature for three years from the date of signature by the healthcare facility.

(ii) For shipments using a paper manifest, a healthcare facility who has registered in the electronic manifest system shall retain the copy of the manifest signed in accordance with Env-Hw 510.02 until such time as the healthcare facility verifies, in the electronic manifest system, receipt of the shipment by the designated facility.";

(6) Amend 40 CFR 266.502(j)(3) by replacing "§ 262.11(f)" with "Env-Hw 502.01";

(7) Amend 40 CFR 266.502(l) paragraph heading by replacing "very small quantity generator" with "small quantity generator";

(8) Amend 40 CFR 266.502(l) introductory language by replacing "very small quantity generator under § 262.14" with "small quantity generator under Env-Hw 500"; and

(9) Amend 40 CFR 266.502(l)(1) by:

a. Replacing "(as defined in § 260.10)" with "(as defined in Env-Hw 104)";

b. Replacing "very small quantity generator" with "small quantity generator"; and

c. Replacing "§ 260.10 of this chapter" with "Env-Hw 104";

(d) Amend 40 CFR 266.503 as follows:

(1) Amend 40 CFR 266.503(b) paragraph heading by replacing "very small quantity generator" with "small quantity generator";

(2) Amend 40 CFR 266.503(b) introductory language by replacing "very small quantity generator under § 262.14" with "small quantity generator under Env-Hw 500"; and

(3) Amend 40 CFR 266.503(b)(1) by:

a. Replacing "§ 260.10" with "Env-Hw 104"; and

b. Replacing "very small quantity generator" with "small quantity generator";

(e) Amend 40 CFR 266.504 as follows:

(1) Amend 40 CFR 266.504 section heading by replacing "very small quantity generators" with "small quantity generators";

(2) Amend 40 CFR 266.504(a), (b) paragraph heading, and (b) introductory language by replacing "very small quantity generator" with "small quantity generator";

(3) Amend 40 CFR 266.504(b)(2) to read as follows:

(2)" The small quantity generator healthcare facility meets the conditions of Env-Hw 501.02(c)(1) and the receiving full quantity generator meets the conditions in Env-Hw 504.01(f), Env-Hw 504.02(a)(15), and Env-Hw 509.02(l)";

(4) Amend 40 CFR 266.504(c) paragraph heading by replacing "very small quantity generators" with "small quantity generators";

(5) Amend 40 CFR 266.504(c) by replacing "very small quantity generator" with "small quantity generator"; and

(6) Amend 40 CFR 266.504(d) to read as follows:

(d)" Long-term care facilities with 20 beds or fewer. A long-term care facility with 20 beds or fewer shall determine the applicability of 40 CFR 266 Subpart P in accordance with 40 CFR 266.501, as amended by Env-Hw 1302.02(b).";

(f) Amend 40 CFR 266.505 by replacing "very small quantity generators operating under § 262.14" with "small quantity generators operating under Env-Hw 500";

(g) Amend 40 CFR 266.506(a) introductory language by replacing "40 CFR parts 262 through 273" with "Env-Hw 300 and Env-Hw 500 through Env-Hw 1300";

(h) Amend 40 CFR 266.507 as follows:

(1) Amend 40 CFR 266.507(c) by replacing "defined in § 261.7(b)(1)" with "specified in Env-Hw 401.03(d)(1)"; and

(2) Amend 40 CFR 266.507(d) by replacing "defined in § 261.7(b)(1) or (2)" with "specified in Env-Hw 401.03(d)(1) or (2), as applicable";

(i) Amend 40 CFR 266.508 as follows:

(1) Amend 40 CFR 266.508(a)(2) by replacing " 40 CFR part 262 subpart B" with "Env-Hw 510, Env-Hw 511.02, and Env-Hw 512.01(a)(1) and (d) through (f)";

(2) Amend 40 CFR 266.508(a)(2)(i) by replacing "EPA Form 8700-22" with "the manifest"; and

(3) Amend 40 CFR 266.508(a)(2)(ii) by replacing "write the word "PHARMS" in Item 13 of EPA Form 8700-22" with "write the word "PHARMS" or "PHRM" in item 13 of the manifest"; and

(j) Amend 40 CFR 266.510 as follows:

(1) Amend 40 CFR 266.510(a)(1) to read as follows:

(1)" Notification. A reverse distributor shall notify the department that it is a reverse distributer operating under this subpart, by completing and submitting to the department a notification form obtained from the department that includes the information specified in Env-Hw 504.02(a), as applicable.

(i) A reverse distributor that already has an EPA identification number shall notify the department, using a notification form, that it is a reverse distributor, as defined in § 266.500, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.

(ii) A reverse distributor that does not have an EPA identification number shall obtain one by notifying the department, using a notification form, that it is a reverse distributor, as defined in § 266.500, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.";

(2) Amend 40 CFR 266.510(a)(7) by replacing " 40 CFR part 262 subpart M" with "Env-Hw 509.02(a)(4) and (a) (5)";

(3) Amend 40 CFR 266.510(a)(8) by replacing "§ 262.17(a)(8)(ii) and (iii)" with "Env-Hw 505.04 and Env-Hw 506";

(4) Amend 40 CFR 266.510(c)(3) by replacing "§ 262.17(a)(7)" with "Env-Hw 509.02(a)(2)";

(5) Amend 40 CFR 266.510(c)(7) by adding the following: "(v) If a returned shipment is accompanied by a paper manifest or an electronic manifest that was printed for the reverse distributor's signature, submit a copy of the signed manifest to the department within 5 days of receipt of the returned shipment.";

(6) Amend 40 CFR 266.510(c)(8) by adding after " 40 CFR part 268 " the following words: ", incorporated by reference in Env-Hw 1202";

(7) Amend 40 CFR 266.510(c)(9) by adding the following: "(iii) A reverse distributor shall be subject to the quarterly reporting requirements of Env-Hw 512.02 with respect to evaluated hazardous waste pharmaceuticals.";

(8) Amend 40 CFR 266.510(c)(10)(ii) to read as follows: "(ii) A reverse distributor shall keep a copy of each manifest signed in accordance with Env-Hw 510.02 and each signed copy from the designated facility that received the evaluated hazardous waste pharmaceuticals for 3 years from the date of signature by the reverse distributor. A reverse distributor may rely on the electronic manifest system to satisfy manifest recordkeeping requirements only if the reverse distributor has registered in the electronic manifest system and has established access to manifest records stored therein, except as follows:

(A) For shipments using an electronic manifest that was printed for the reverse distributor's signature, the reverse distributor shall retain the paper copy of the electronic manifest with the reverse distributor's signature for 3 years from the date of signature by the reverse distributor.

(B) For shipments using a paper manifest, a reverse distributor who has registered in the electronic manifest system shall retain the copy of the manifest with the reverse distributor's signature until such time as the reverse distributor verifies, in the electronic manifest system, receipt of the shipment by the designated facility.";

(9) Amend 40 CFR 266.510(c)(10)(v) by replacing "§ 262.17(a)(7)(iv)" with "Env-Hw 509.02(a)(2)"; and

(10) Amend 40 CFR 266.510(d) introductory language by replacing "40 CFR parts 264, 265, and 267 and the permit requirements of 40 CFR part 270 " with "Env-Hw 700 and the permit requirements of Env-Hw 300".

N.H. Admin. Code § Env-Hw 1302.02

Derived from Volume XLII Number 32, Filed August 11, 2022, Proposed by #13406, Effective 7/23/2022, Expires 7/23/2032