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PA Bulletin, Doc. No. 96-956

PROPOSED RULEMAKING

ENVIRONMENTAL
QUALITY BOARD

[25 PA. CODE CH. 285]

Marking of Infectious Waste Containers

[26 Pa.B. 2790]

   The Environmental Quality Board (Board) proposes to amend Chapter 285 (relating to storage, collection and transportation of municipal waste) to read as set forth in Annex A.

   This proposal was adopted by the Board at its regular meeting on April 16, 1996.

A.  Effective Date

   These proposed amendments will go into effect immediately upon publication in the Pennsylvania Bulletin as final rulemaking.

B.  Contact Persons

   For further information, contact Ronald C. Hassinger, Chief, General Permits/Beneficial Use Section, Bureau of Land Recycling and Waste Management, Rachel Carson State Office Building, 14th Floor, 400 Market Street, P. O. Box 8472, Harrisburg, PA 17105-8472, telephone: (717) 787-7381, or Marc A. Roda, Assistant Counsel, Bureau of Regulatory Counsel, Rachel Carson State Office Building, 9th Floor, 400 Market Street, P. O. Box 8464, Harrisburg, PA 17105-8464, telephone (717) 787-7060. Information regarding submitting comments on this proposal appears in Section I of this Preamble. These proposed amendments are available electronically through the Department of Environmental Protection (Department) Web site (http://www.dep.state.pa.us).

C.  Statutory Authority

   This proposal is being made under the provisions of sections 105 and 201 of the Solid Waste Management Act (35 P. S. §§ 6018.105 and 6018.201); sections 1 and 4 of the Infectious and Chemotherapeutic Waste Disposal Act (35 P. S. §§ 6019.1 and 6019.4); and section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20). Under sections 105 and 201 of the Solid Waste Management Act and sections 1 and 4 of the Infectious and Chemotherapeutic Waste Disposal Act, the Board has the power and duty to adopt rules and regulations concerning the storage, treatment, disposal and transportation of infectious and chemotherapeutic waste as are necessary to protect the public's health, safety and welfare, as well as protect the environmental resources of the Commonwealth. Section 1920-A of The Administrative Code of 1929 grants the Board the authority to promulgate rules and regulations that are necessary for the proper work of the Department.

D.  Background and Purpose of the Proposed Rulemaking

   The purpose of this proposed amendment is to provide greater flexibility in the Department's regulations pertaining to the marking and labeling of containers holding infectious and chemotherapeutic waste (ICW). Currently, generators and transporters of ICW must both color code (red for infectious and yellow for chemotherapeutic) and label. These amendments will allow color coding or labeling to be alternative methods of identifying the container. This proposed rulemaking is in response to a petition by DeRoyal Industries Incorporated (DeRoyal) to amend § 285.147(d) (relating to marking of containers) to allow an alternative to the requirement that ICW containers must be red or yellow in color.

   On August 1, 1995, DeRoyal submitted to the Board a petition to amend § 285.147(d) to allow an alternative to the requirement that ICW containers used for storage and transportation be red or yellow in color. DeRoyal has submitted this petition to facilitate the sale of its product the ''TraceCart.'' The TraceCart is a medical product and ICW storage and transportation container. The TraceCart is blue in color with a red lid and is designed to have labels attached which appropriately describe the nature of the container's contents.

   The TraceCart is marketed Nationally. According to DeRoyal, the mandatory color coding requirements of § 285.147 are unique to the Commonwealth. Furthermore, this unique color coding requirement makes it more expensive to manufacture the TraceCart for sale in this Commonwealth.

   At its March 14, 1996, meeting, the Department's Solid Waste Advisory Committee (Committee) voted to recommend the Department proceed with the draft regulations as they pertain to rigid containers.

   Section 285.146 (relating to storage containers) requires that bags used as ICW containers be color coded, red for infectious and yellow for chemotherapeutic waste. The Department had proposed to the Committee to amend § 285.146(d) to allow as an alternative to the container color coding, labeling the containers with the universal biological hazard symbol and the words ''infectious and chemotherapeutic waste'', as described in § 285.147(c). The Committee voted to recommend deletion of the draft language that would have changed this requirement.

   This proposed rulemaking reflects the recommendations of the Committee as made in their March 14, 1996, meeting. The Department wishes to solicit additional comment through this notice on § 285.146(d) as described in this Preamble.

E.  Summary of Proposed Rulemaking

   When the Department's container color coding requirements were first promulgated in 1988, those requirements were consistent with industry practice at that time. However, since 1988 several changes have taken place at the Federal level, including rule changes at the United States Department of Labor's Occupational Safety and Health Administration (OSHA) and the United States Department of Transportation (USDOT).

   Currently, the Department's container color coding requirements for ICW containers are more stringent then what is required by Federal law. OSHA is responsible for promulgating regulations setting standards for the protection of workers. Under OSHA's Bloodborne Pathogen Rule (29 CFR Part 1910.1030), infectious waste containers must either be labeled with the universal biological hazard symbol or colored red. USDOT is responsible for promulgating regulations establishing standards for the safe transportation of hazardous materials. USDOT recently amended 49 CFR Parts 171--173 which in part applied OSHA's labeling requirements to the packaging requirements for shipments of infectious materials.

   The Department's container color coding requirements are also more stringent then the practices recommended by the United States Environmental Protection Agency (USEPA). USEPA is responsible for promulgating standards for the storage and transportation of hazardous wastes. USEPA does not currently have regulations addressing infectious or chemotherapeutic wastes. However, their guidelines recommend using either the universal biological hazard symbol as described in the OSHA regulations, color coding or clearly labeled (EPA Guide for Infectious Waste Management (May, 1986)).

   There are no legal requirements or environmental or public health reasons mandating that the Department maintain its dual labeling and color coding requirements for infectious and chemotherapeutic wastes. Allowing either labeling or color coding as alternative methods of identifying containers of infectious and chemotherapeutic waste is reasonable and appropriate and is consistent with the Department's commitment to adopt environmental regulations that are no more stringent than Federal requirements when there is no purpose served by being more stringent.

   The existing requirements at § 285.147(d) and (e) require that all containers be color coded as well as labeled with the biological hazard symbol. The Board proposes to amend § 285.147(d) and (e) to allow color coding as an alternative to the labeling requirements.

F.  Benefits and Costs

   Executive Order 1996-1 requires a cost/benefit analysis of the proposed amendment.

Benefits

   By amending § 285.147, companies that manufacture and Nationally market containers for the storage and transportation of ICW will be able to market the same container in this Commonwealth. This should reduce the cost of the containers in this Commonwealth.

Costs

   If adopted, this proposed amendment will not impose any new costs on individuals managing infectious and chemotherapeutic wastes.

G.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Department submitted a copy of the proposed amendment on June 4, 1996, to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. In addition to submitting the proposed amendment, the Department has provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the agency in compliance with Executive Order 1996-1. A copy of this material is available to the public upon request.

   If IRRC has objections to any portion of the proposed amendment, it will notify the Department within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review, prior to the final publication of the amendments, by the Department, the General Assembly and the Governor of objections raised.

H.  Sunset Review

   This regulation will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulation effectively fulfills the goals for which it was intended.

I.  Public Comments.

   Written Comments--Interested persons are invited to submit written comments, suggestions or objections regarding the proposal to the Environmental Quality Board, P. O. Box 8477, Harrisburg, PA 17105-8477 (express mail:  Environmental Quality Board, 15th Floor, Rachel Carson State Office Building, 400 Market Street, Harrisburg, PA 17105-8477). Comments received by facsimile will not be accepted. Comments, suggestions or objections must be received by the EQB by July 15, 1996, within 30 days of publication in the Pennsylvania Bulletin. Interested persons may also submit a summary of their comments to the Board. The summary will be provided to each member of the Board in the agenda packet distributed prior to the meeting at which final regulations will be considered. The summary shall not exceed one page in length and must be received by July 15, 1996.

   Electronic Comments--Comments may be submitted electronically to the Board at RegComments@A1.dep.state.pa.us. A subject heading of the proposal and a return name and address must be included in each transmission. Comments submitted electronically must also be received by the Board by July 15, 1996.

   Persons with a disability who require an accommodation to comment on these proposed regulations should contact the Department at (717) 787-4526 to discuss how we may best accommodate their needs. If necessary, use the AT&T Relay Service by calling 1 (800) 654-5984 (TDD users) or 1 (800) 654-5988 (voice users) and request that they relay the call to Sharon Freeman at (717) 787-4526.

JAMES M. SEIF,   
Chairperson

   Fiscal Note:  7-298. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 25.  ENVIRONMENTAL PROTECTION

PART I.  DEPARTMENT OF
ENVIRONMENTAL PROTECTION

Subpart C.  PROTECTION OF
NATURAL RESOURCES

ARTICLE VIII.  MUNICIPAL WASTE

CHAPTER 285.  STORAGE, COLLECTION AND TRANSPORTATION OF MUNICIPAL WASTE

Subchapter A.  STORAGE OF MUNICIPAL WASTE

§ 285.147.  Marking of containers.

*      *      *      *      *

   (c)  The following information shall be printed on the outermost container for each package of infectious or chemotherapeutic waste for either onsite movement or offsite transportation:

   (1)  The words ''infectious waste'' or ''chemotherapeutic waste,'' whichever is applicable.

   (2)  The universal biohazard symbol that conforms to the design shown in regulations of the United States Occupational Safety and Health Administration at 29 CFR 1910.145(f)(8)(ii) (relating to specifications for accident prevention signs and tags).

   (d)  [Except for sharps containers used in patient or examination rooms, for corrugated fiberboard boxes, or for stationary waste storage containers, the color of the outermost container for each package of infectious or chemotherapeutic waste shall be as follows:

   (1)  Red for infectious waste.

   (2)  Yellow for chemotherapeutic waste.]

   The labeling information specified in subsection (c) shall be fluorescent orange or orange-red in color, or predominately so, with a background of a contrasting color for infectious waste, and yellow in color, or predominately so, with a background of a contrasting color for chemotherapeutic waste.

   (e)  Red bags or red containers for infectious waste and yellow bags or yellow containers for chemotherapeutic waste may be substituted for the marking requirements in subsection (c).

   [(e)] (f)  ***

[Pa.B. Doc. No. 96-956. Filed for public inspection June 14, 1996, 9:00 a.m.]



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