42 U.S.C. § 6992b — Tracking of medical waste

Page 7040 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 6992 1 So in original. Probably should be ‘‘exudates’’. SUBCHAPTER X—DEMONSTRATION MEDICAL WASTE TRACKING PROGRAM § 6992. Scope of demonstration program for med- ical waste (a) Covered States The States within the demonstration program established under this subchapter for tracking medical wastes shall be New York, New Jersey, Connecticut, the States contiguous to the Great Lakes and any State included in the program through the petition procedure described in sub- section (c), except for any of such States in which the Governor notifies the Administrator under subsection (b) that such State shall not be covered by the program. (b) Opt out (1) If the Governor of any State covered under subsection (a) which is not contiguous to the At- lantic Ocean notifies the Administrator that such State elects not to participate in the dem- onstration program, the Administrator shall re- move such State from the program. (2) If the Governor of any other State covered under subsection (a) notifies the Administrator that such State has implemented a medical waste tracking program that is no less stringent than the demonstration program under this sub- chapter and that such State elects not to par- ticipate in the demonstration program, the Ad- ministrator shall, if the Administrator deter- mines that such State program is no less strin- gent than the demonstration program under this subchapter, remove such State from the dem- onstration program. (3) Notifications under paragraphs (1) or (2) shall be submitted to the Administrator no later than 30 days after the promulgation of regula- tions implementing the demonstration program under this subchapter. (c) Petition in The Governor of any State may petition the Administrator to be included in the demonstra- tion program and the Administrator may, in his discretion, include any such State. Such peti- tion may not be made later than 30 days after promulgation of regulations establishing the demonstration program under this subchapter, and the Administrator shall determine whether to include the State within 30 days after receipt of the State’s petition. (d) Expiration of demonstration program The demonstration program shall expire on the date 24 months after the effective date of the regulations under this subchapter. (Pub. L. 89–272, title II, § 11001, as added Pub. L. 100–582, § 2(a), Nov. 1, 1988, 102 Stat. 2950.) § 6992a. Listing of medical wastes (a) List Not later than 6 months after November 1, 1988, the Administrator shall promulgate regula- tions listing the types of medical waste to be tracked under the demonstration program. Ex- cept as provided in subsection (b), such list shall include, but need not be limited to, each of the following types of solid waste: (1) Cultures and stocks of infectious agents and associated biologicals, including cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures. (2) Pathological wastes, including tissues, organs, and body parts that are removed dur- ing surgery or autopsy. (3) Waste human blood and products of blood, including serum, plasma, and other blood components. (4) Sharps that have been used in patient care or in medical, research, or industrial lab- oratories, including hypodermic needles, sy- ringes, pasteur pipettes, broken glass, and scalpel blades. (5) Contaminated animal carcasses, body parts, and bedding of animals that were ex- posed to infectious agents during research, production of biologicals, or testing of phar- maceuticals. (6) Wastes from surgery or autopsy that were in contact with infectious agents, including soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, and surgical gloves. (7) Laboratory wastes from medical, patho- logical, pharmaceutical, or other research, commercial, or industrial laboratories that were in contact with infectious agents, includ- ing slides and cover slips, disposable gloves, laboratory coats, and aprons. (8) Dialysis wastes that were in contact with the blood of patients undergoing hemodialysis, including contaminated disposable equipment and supplies such as tubing, filters, disposable sheets, towels, gloves, aprons, and laboratory coats. (9) Discarded medical equipment and parts that were in contact with infectious agents. (10) Biological waste and discarded materials contaminated with blood, excretion, excudates 1 or secretion from human beings or animals who are isolated to protect others from communicable diseases. (11) Such other waste material that results from the administration of medical care to a patient by a health care provider and is found by the Administrator to pose a threat to human health or the environment. (b) Exclusions from list The Administrator may exclude from the list under this section any categories or items de- scribed in paragraphs (6) through (10) of sub- section (a) which he determines do not pose a substantial present or potential hazard to human health or the environment when improp- erly treated, stored, transported, disposed of, or otherwise managed. (Pub. L. 89–272, title II, § 11002, as added Pub. L. 100–582, § 2(a), Nov. 1, 1988, 102 Stat. 2951.) § 6992b. Tracking of medical waste (a) Demonstration program Not later than 6 months after November 1, 1988, the Administrator shall promulgate regula- Page 7041 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 6992d tions establishing a program for the tracking of the medical waste listed in section 6992a of this title which is generated in a State subject to the demonstration program. The program shall (1) provide for tracking of the transportation of the waste from the generator to the disposal facil- ity, except that waste that is incinerated need not be tracked after incineration, (2) include a system for providing the generator of the waste with assurance that the waste is received by the disposal facility, (3) use a uniform form for tracking in each of the demonstration States, and (4) include the following requirements: (A) A requirement for segregation of the waste at the point of generation where prac- ticable. (B) A requirement for placement of the waste in containers that will protect waste handlers and the public from exposure. (C) A requirement for appropriate labeling of containers of the waste. (b) Small quantities In the program under subsection (a), the Ad- ministrator may establish an exemption for gen- erators of small quantities of medical waste list- ed under section 6992a of this title, except that the Administrator may not exempt from the program any person who, or facility that, gen- erates 50 pounds or more of such waste in any calendar month. (c) On-site incinerators Concurrently with the promulgation of regula- tions under subsection (a), the Administrator shall promulgate a recordkeeping and reporting requirement for any generator in a demonstra- tion State of medical waste listed in section 6992a of this title that (1) incinerates medical waste listed in section 6992a of this title on site and (2) does not track such waste under the reg- ulations promulgated under subsection (a). Such requirement shall require the generator to re- port to the Administrator on the volume and types of medical waste listed in section 6992a of this title that the generator incinerated on site during the 6 months following the effective date of the requirements of this subsection. (d) Type of medical waste and types of genera- tors For each of the requirements of this section, the regulations may vary for different types of medical waste and for different types of medical waste generators. (Pub. L. 89–272, title II, § 11003, as added Pub. L. 100–582, § 2(a), Nov. 1, 1988, 102 Stat. 2952.) § 6992c. Inspections (a) Requirements for access For purposes of developing or assisting in the development of any regulation or report under this subchapter or enforcing any provision of this subchapter, any person who generates, stores, treats, transports, disposes of, or other- wise handles or has handled medical waste shall, upon request of any officer, employee, or rep- resentative of the Environmental Protection Agency duly designated by the Administrator, furnish information relating to such waste, in- cluding any tracking forms required to be main- tained under section 6992b of this title, conduct monitoring or testing, and permit such person at all reasonable times to have access to, and to copy, all records relating to such waste. For such purposes, such officers, employees, or rep- resentatives are authorized to— (1) enter at reasonable times any establish- ment or other place where medical wastes are or have been generated, stored, treated, dis- posed of, or transported from; (2) conduct monitoring or testing; and (3) inspect and obtain samples from any per- son of any such wastes and samples of any containers or labeling for such wastes. (b) Procedures Each inspection under this section shall be commenced and completed with reasonable promptness. If the officer, employee, or rep- resentative obtains any samples, prior to leav- ing the premises he shall give to the owner, op- erator, or agent in charge a receipt describing the sample obtained and, if requested, a portion of each such sample equal in volume or weight to the portion retained if giving such an equal portion is feasible. If any analysis is made of such samples, a copy of the results of such anal- ysis shall be furnished promptly to the owner, operator, or agent in charge of the premises con- cerned. (c) Availability to public The provisions of section 6927(b) of this title shall apply to records, reports, and information obtained under this section in the same manner and to the same extent as such provisions apply to records, reports, and information obtained under section 6927 of this title. (Pub. L. 89–272, title II, § 11004, as added Pub. L. 100–582, § 2(a), Nov. 1, 1988, 102 Stat. 2952.) § 6992d. Enforcement (a) Compliance orders (1) Violations Whenever on the basis of any information the Administrator determines that any person has violated, or is in violation of, any require- ment or prohibition in effect under this sub- chapter (including any requirement or prohibi- tion in effect under regulations under this sub- chapter) (A) the Administrator may issue an order (i) assessing a civil penalty for any past or current violation, (ii) requiring compliance immediately or within a specified time period, or (iii) both, or (B) the Administrator may commence a civil action in the United States district court in the district in which the vio- lation occurred for appropriate relief, includ- ing a temporary or permanent injunction. Any order issued pursuant to this subsection shall state with reasonable specificity the nature of the violation. (2) Orders assessing penalties Any penalty assessed in an order under this subsection shall not exceed $25,000 per day of noncompliance for each violation of a require- ment or prohibition in effect under this sub- chapter. In assessing such a penalty, the Ad- ministrator shall take into account the seri- ousness of the violation and any good faith ef- forts to comply with applicable requirements.