RULES AND REGULATIONS
Title 25--ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[25 PA. CODE CH. 285]
Marking of ICW Containers
[27 Pa.B. 1794] The Environmental Quality Board (Board) by this order amends the Department of Environmental Protection's (Department's) regulations governing municipal waste management, particularly infectious and chemotherapeutic waste, by amending Chapter 285 (relating to storage, collection and transportation of municipal waste). These amendments are set forth in Annex A.
This order was adopted by the Board at its meeting of December 17, 1996.
A. Effective Date
These amendments are effective 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. Persons with a disability may use the AT&T Relay Service by calling (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This final rulemaking is available electronically through the Department's Website (http://www.dep.state.pa.us).
C. Statutory Authority
The final rulemaking is being made under the authority 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 this 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 Summary
This final rulemaking revises the Department's regulations pertaining to marking and labeling of containers holding infectious and chemotherapeutic waste (ICW). Previously, generators and transporters of ICW had to mark containers, except for rigid fiberboard containers, by labeling and color coding (red for infectious and yellow for chemotherapeutic). Under these amendments rigid containers, whether or not made out of fiberboard, only have to be labeled. Nonrigid containers, that is bags, must still be color coded as well as labeled.
This rulemaking is in response to DeRoyal Industries Incorporated's (DeRoyal) August 1, 1995, petition to the Board. DeRoyal petitioned the Board 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. DeRoyal manufactures a product, a rigid-plastic container, which can be used for storing or transporting ICW. This product is marketed Nationally. DeRoyal contends that specially manufacturing containers to meet the Commonwealth's unique color coding requirements unnecessarily increases the cost of manufacturing the containers.
The Department is aware of another company that manufactures reusable, rigid nonfiberboard containers for storing and transporting ICW. This company also markets the containers Nationally. As a result, this company also has a similar problem of increased manufacturing costs due to compliance with the mandatory color coding requirements of § 285.147.
In addition to the business issues raised by the petition, the Department's ICW marking requirements have become more stringent than Federal requirements. 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). The regulations promulgated by these agencies are less stringent than the Department's regulations requiring color coding and labeling of ICW containers. OSHA is responsible for promulgating regulations setting standards for the protection of workers. Under OSHA's Bloodborne Pathogen Rule (29 CFR 1910.1030), infectious waste containers must either be labeled with the universal biological hazard symbol or colored red. The USDOT is responsible for promulgating regulations establishing standards for the safe transportation of hazardous materials. Under the USDOT regulations (49 CFR Part 173) containers of infectious substances to be transported must be marked with either an infectious substances label or, if the infectious material is a regulated medical waste, a biological hazard symbol. There is no requirement that the container be color coded.
In addition to the consistency issue, the Department's existing regulations concerning the marking of ICW containers have been in part preempted by the USDOT regulations. The USDOT regulations are promulgated under the Hazardous Materials Transportation Act (HMTA). The HMTA preempts State laws that are not substantively equivalent to USDOT regulations concerning the marking or labeling of containers. See 49 U.S.C.A. §§ 5101--5127.
As stated previously, the USDOT has promulgated standards for containers used to transport infectious substances, including regulated medical wastes. The USDOT's definition of infectious substance includes materials the Department defines as infectious waste. Both the USDOT and the Department require that infectious waste be transported in rigid containers. Since the USDOT's regulations do not require these containers to be color coded, the Department's existing regulations requiring rigid nonfiber board containers to be color coded are preempted.
Due to the foregoing concerns, the Department developed a proposed rulemaking that would have made color coding and labeling alternative methods of marking containers. This proposed rulemaking called for amending § 285.146(d) (relating to storage containers) to allow labeling as an alternative to color coding the container. The label will be the universal biological hazard symbol and the words ''infectious and chemotherapeutic waste,'' as described in § 285.147(c).
This proposed rulemaking was submitted to the Solid Waste Advisory Committee (Committee) at its March 14, 1996, meeting. The Committee voted to recommend approval of the proposed amendments as they pertain to rigid containers. However, it was recommended that the regulations should continue to require that bags containing ICW be both color coded and labeled.
The Committee's recommendations are incorporated into the final rulemaking. Section 285.146 (relating to storage containers) is amended to make it clear that bags used as ICW containers be labeled and color coded, red for infectious and yellow for chemotherapeutic waste. The final-form regulations still authorize labeling of rigid containers which is substantially the same as Federal requirements. As a result, the Committee, at its September 12, 1996, meeting voted for the Department to proceed with the final rulemaking.
E. Summary of Comments and Responses on the Proposed Rulemaking
Notice of proposed rulemaking was published at 26 Pa.B. 2790 (June 15, 1996) and was followed by a 30-day public comment period. No public meetings or hearings were held.
Five persons and organizations commented on the proposed amendments during the comment period. The Independent Regulatory Commission (IRRC) also submitted comments.
The Department has prepared a ''Comment and Response Document'' summarizing and responding to the comments received by the Board. This document is available for review upon request from the contact persons identified in Section B of this Preamble.
Three of the six commentators strongly urged that color coded bags and containers should also be labeled according to the type of waste they hold. The commentators expressed concerns relative to the possible confusion that may arise when ICW containers/bags are only color coded. As an example, because some institutions utilize yellow colored bags/containers for radioactive waste, yellow bags/containers containing chemotherapeutic waste that are not also labeled may be mistaken for radioactive waste and managed improperly.
The Department agrees with the commentators. The final rulemaking leaves intact the current regulatory requirement of both color coding and labeling of bags used for infectious or chemotherapeutic waste storage. Section 285.146 is amended by adding a cross reference to the marking requirements in § 285.147.
The final rulemaking requires all rigid containers to be labeled. Color coding will not be an acceptable method of identifying these containers. This labeling requirement is being adopted in part to address the USDOT preemption issue previously discussed. Furthermore, the Department believes that requiring rigid containers to be labeled will ensure that the ICW will be properly managed.
The Department's previous regulations already exempted fiberboard boxes from the requirement to be color coded. The Department is not aware of any significant instances where fiberboard ICW containers were mishandled.
Two of the commentators were confused by the meaning of ''(f)***'' at the end of the proposed rulemaking. The Department's response explained that the use of the three asterisks is the designation used by the Legislative Reference Bureau to signify that no changes have been proposed to the existing regulatory language.
One commentator recommended that to ensure that the ICW was not disposed in a municipal landfill, that the ICW containers be color coded and labeled. For the reasons stated previously, the Department believes that the best approach is to require ICW bags to be color coded and only require labeling for rigid ICW containers.
The petitioner, DeRoyal, submitted comments supportive of the proposed amendments. The Department believes that the final rulemaking continues to satisfy the petitioner's objectives.
Finally, IRRC submitted a recommendation that the final-form regulations should make color coding an allowable supplemental method of identifying the ICW containers. This recommendation was based upon the fact that four commentators were concerned about making color coding an alternative to labeling.
The Department does not believe that IRRC's recommendation addresses the commentator's concerns. The Department agrees with the other commentators that ICW bags should be color coded as well as labeled. With respect to rigid containers, nothing in the final-form regulations prohibits the use of color coding in addition to labeling. However, given the USDOT preemption issue, the Department believes it is advisable to state that possibility in the final rule.
F. Benefits, Costs and Compliance
Executive Order 1996-1 requires a cost/benefit analysis of the final-form rulemaking.
Benefits By amending §§ 285.146 and 285.147, companies that manufacture and Nationally market rigid 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 these containers in this Commonwealth.
Compliance Costs These final amendments will not impose any new costs on individuals managing infectious and chemotherapeutic wastes.
Compliance Assistance Plan The Department will provide compliance assistance by providing written notice to Pennsylvania licensed infectious and chemotherapeutic waste transporters and by providing notice to professional organizations including: The Hospital Association of Pennsylvania, Pennsylvania Veterinary Medical Association, Pennsylvania Medical Society and the Pennsylvania Dental Association.
Paperwork Requirements No additional paperwork will be required as a result of this final rulemaking.
G. Sunset Review
These final-form regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on June 4, 1996, the Department submitted a copy of the proposed amendments to IRRC and to the Chairpersons of the House and Senate Environmental Resources and Energy Committees. In compliance with section 5(b.1) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of the comments, as well as other documentation.
In preparing these final-form regulations, the Department has considered the comments received from IRRC and the public. These comments are addressed in the comment and response document and Section E of this Preamble. The Committees did not provide comments on the proposed rulemaking.
The final-form regulations were deemed approved by the House Environmental Resources and Energy Committee on February 24, 1997, and were deemed approved by the Senate Environmental Resources and Energy Committee on February 24, 1997. IRRC met on March 6, 1997, and approved the amendments in accordance with section 5(c) of the Regulatory Review Act.
I. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) These amendments do not enlarge the purpose of the proposal published at 26 Pa.B. 2790.
(4) These amendments are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this Preamble.
J. Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapter 285, are amended by amending §§ 285.146 and 285.147 to read as set forth in Annex A.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form as required by law.
(c) The Chairperson shall submit this order and Annex A to IRRC and the Senate and House Environmental Resources and Energy Committees as required by the Regulatory Review Act.
(d) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect immediately upon publication.
(Editor's Note: The amendment of § 285.146, amended in this document, was not included in the proposal at 26 Pa.B. 2790).)
JAMES M. SEIF,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 27 Pa.B. 1519 (March 22, 1997).)
Fiscal Note: Fiscal Note 7-298 remains valid for the final adoption of the subject regulations.
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 § 285.146. Storage containers.
(a) Infectious and chemotherapeutic waste shall be placed in containers that are:
(1) Leakproof.
(2) Impervious to moisture.
(3) Sufficient in strength to prevent puncturing, tearing or bursting during storage.
(b) In addition to the requirements of subsection (a), used sharps shall be stored in containers that are:
(1) Rigid.
(2) Tightly lidded.
(3) Puncture resistant.
(c) In addition to the requirements of subsection (a), infectious waste fluids--quantities greater than 20 cubic centimeters--and chemotherapeutic waste fluids shall be stored in containers that are:
(1) Break resistant.
(2) Tightly lidded or tightly stoppered.
(d) When bags are used as the only storage container, double or multiple bagging shall be employed and the following requirements shall be met:
(1) Upon packaging, the bags shall be securely tied.
(2) The bag shall be constructed of material of sufficient single thickness strength to meet the following:
(i) The ASTM standard D1709-91, Test Method for Impact Resistance of Polyethylene Film by the Free Falling Dart Method, with an impact resistance of 165 grams or greater (Method A).
(ii) The ASTM standard D1922-89, Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method, with a tearing resistance, parallel and perpendicular to the length of the bag, of 480 grams.
(iii) If the standards in subparagraphs (i) and (ii) are modified by ASTM, the standard that is in effect on the date of manufacture of the bags shall be applied.
(3) Bags shall include one of the following certifications indicating that the ASTM standards have been met:
(i) Each bag shall contain a printed certification by the manufacturer.
(ii) The manufacturer may issue a certification letter to the infectious or chemotherapeutic waste generator and print a certification on each packaged lot of the bags.
(4) Bags used as containers shall have sufficient seam strength that is at least equal in resistance to tearing and equally impermeable as the other portions of the bag.
(5) Bags used as containers shall be yellow in color for each package of chemotherapeutic waste and red in color for each package of infectious waste and shall be labeled in accordance with § 285.147(c) (relating to marking of containers).
(e) Red or yellow containers shall contain colorants which are organic pigments with no heavy metal content.
(f) With the exception of persons who work at a small quantity generator's operation, where less than 220 pounds of infectious and chemotherapeutic waste is generated per month, persons packaging infectious or chemotherapeutic waste for offsite transportation shall wear:
(1) Protective overalls.
(2) Heavy gloves of neoprene or equivalent materials.
§ 285.147. Marking of containers.
(a) The outermost container for each package of infectious or chemotherapeutic waste for offsite transportation shall be labeled immediately after packing. The label shall be securely attached and shall be clearly legible. Indelible ink shall be used to complete the information on the label, and the label shall be at least 3 inches by 5 inches in dimension.
(b) The following information shall be included on the label:
(1) The name, address and telephone number of the generator.
(2) The date the waste was generated.
(3) The name of the transporter and, if applicable, Department-issued infectious and chemotherapeutic waste transporter license number.
(c) The following information shall be printed on the outermost container or bag 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) 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) Stationary waste storage containers shall be lined with the appropriate colored bag for infectious or chemotherapeutic waste.
[Pa.B. Doc. No. 97-550. Filed for public inspection April 11, 1997, 9:00 a.m.]
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