RESPONSE TO COMMENTS DOCUMENT

STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE; SUBPART K –
STANDARDS APPLICABLE TO ACADEMIC LABORATORIES; PROPOSED RULE

PUBLISHED ON MAY 23, 2006

November 12, 2008

TABLE OF CONTENTS

  TOC \o "1-3" \h \z    HYPERLINK \l "_Toc214262106"  BACKGROUND AND
PURPOSE OF DOCUMENT	  PAGEREF _Toc214262106 \h  1

  HYPERLINK \l "_Toc214262107"  Background	  PAGEREF _Toc214262107 \h  1

  HYPERLINK \l "_Toc214262108"  Purpose of Document	  PAGEREF
_Toc214262108 \h  1

  HYPERLINK \l "_Toc214262109"  SUMMARY OF PUBLIC COMMENTS AND AGENCY
RESPONSE:S ON PROPOSED STANDARDS APPLICABLE TO ACADEMIC LABORATORIES
PAGEREF _Toc214262109 \h  3

  HYPERLINK \l "_Toc214262110"  1.0	General	  PAGEREF _Toc214262110 \h
3

  HYPERLINK \l "_Toc214262111"  1.1	Overarching Support for Proposed
Rule	  PAGEREF _Toc214262111 \h  3

  HYPERLINK \l "_Toc214262112"  1.2	Overarching Opposition to Proposed
Rule	  PAGEREF _Toc214262112 \h  3

  HYPERLINK \l "_Toc214262113"  1.3	Performance-Based Versus
Prescriptive Requirements	  PAGEREF _Toc214262113 \h  5

  HYPERLINK \l "_Toc214262114"  1.4	Other	  PAGEREF _Toc214262114 \h  7

  HYPERLINK \l "_Toc214262115"  2.0 	Applicability of Subpart K
PAGEREF _Toc214262115 \h  8

  HYPERLINK \l "_Toc214262116"  2.1	General	  PAGEREF _Toc214262116 \h
8

  HYPERLINK \l "_Toc214262117"  2.2	Laboratories in Teaching Hospitals
PAGEREF _Toc214262117 \h  10

  HYPERLINK \l "_Toc214262118"  2.3	Laboratories in Non-profit Research
Institutes	  PAGEREF _Toc214262118 \h  12

  HYPERLINK \l "_Toc214262119"  2.4	Conditionally Exempt Small Quantity
Generators	  PAGEREF _Toc214262119 \h  14

  HYPERLINK \l "_Toc214262120"  2.5	Facilities with Laboratories not
Eligible to Participate in Subpart K	  PAGEREF _Toc214262120 \h  15

  HYPERLINK \l "_Toc214262121"  2.5.1	Government Research Laboratories
PAGEREF _Toc214262121 \h  17

  HYPERLINK \l "_Toc214262122"  2.5.2	Commercial R&D Laboratories and
Others	  PAGEREF _Toc214262122 \h  18

  HYPERLINK \l "_Toc214262123"  2.6	Broadening Subpart K to
Non-Laboratory Facilities	  PAGEREF _Toc214262123 \h  19

  HYPERLINK \l "_Toc214262124"  3.0	Definitions	  PAGEREF _Toc214262124
\h  20

  HYPERLINK \l "_Toc214262125"  3.1	Definition of Central Accumulation
Area	  PAGEREF _Toc214262125 \h  20

  HYPERLINK \l "_Toc214262126"  3.1	Definition of Central Accumulation
Area	  PAGEREF _Toc214262126 \h  20

  HYPERLINK \l "_Toc214262127"  3.2	Definition of College or University
 PAGEREF _Toc214262127 \h  21

  HYPERLINK \l "_Toc214262128"  3.2.1	General Support	  PAGEREF
_Toc214262128 \h  21

  HYPERLINK \l "_Toc214262129"  3.2.2	Concerns and Questions	  PAGEREF
_Toc214262129 \h  22

  HYPERLINK \l "_Toc214262130"  3.3	Definition of Laboratory	  PAGEREF
_Toc214262130 \h  23

  HYPERLINK \l "_Toc214262131"  3.3.1	General	  PAGEREF _Toc214262131 \h
 23

  HYPERLINK \l "_Toc214262132"  3.3.2	Expanding the Definition of
Laboratory	  PAGEREF _Toc214262132 \h  28

  HYPERLINK \l "_Toc214262133"  3.4	Definition of Laboratory Clean-out
PAGEREF _Toc214262133 \h  33

  HYPERLINK \l "_Toc214262134"  3.5	Definition of Laboratory Worker
PAGEREF _Toc214262134 \h  36

  HYPERLINK \l "_Toc214262135"  3.6	Definition of RCRA-Trained
Individual	  PAGEREF _Toc214262135 \h  39

  HYPERLINK \l "_Toc214262136"  3.7	Definition of Reactive Acutely
Hazardous Unwanted Material	  PAGEREF _Toc214262136 \h  42

  HYPERLINK \l "_Toc214262137"  3.8	Definition of Unwanted Material
PAGEREF _Toc214262137 \h  46

  HYPERLINK \l "_Toc214262138"  4.0 	Notification	  PAGEREF
_Toc214262138 \h  49

  HYPERLINK \l "_Toc214262139"  5.0 	Labeling Containers of Unwanted
Material	  PAGEREF _Toc214262139 \h  53

  HYPERLINK \l "_Toc214262140"  5.1	General	  PAGEREF _Toc214262140 \h
53

  HYPERLINK \l "_Toc214262141"  5.2	The Term “Unwanted Material”
PAGEREF _Toc214262141 \h  57

  HYPERLINK \l "_Toc214262142"  5.3	Emergency Response Information
PAGEREF _Toc214262142 \h  58

  HYPERLINK \l "_Toc214262143"  5.4	Accumulation Start Date	  PAGEREF
_Toc214262143 \h  61

  HYPERLINK \l "_Toc214262144"  5.5	Information for Hazardous Waste
Determination	  PAGEREF _Toc214262144 \h  64

  HYPERLINK \l "_Toc214262145"  6.0 	Managing Containers of Unwanted
Material	  PAGEREF _Toc214262145 \h  65

  HYPERLINK \l "_Toc214262146"  6.1	General	  PAGEREF _Toc214262146 \h
65

  HYPERLINK \l "_Toc214262147"  6.2	Working Containers	  PAGEREF
_Toc214262147 \h  68

  HYPERLINK \l "_Toc214262148"  7.0 	Training	  PAGEREF _Toc214262148 \h
 75

  HYPERLINK \l "_Toc214262149"  7.1	General	  PAGEREF _Toc214262149 \h
75

  HYPERLINK \l "_Toc214262150"  7.2	Commensurate with Duties	  PAGEREF
_Toc214262150 \h  80

  HYPERLINK \l "_Toc214262151"  7.3	Training of Personnel Conducting
On-site Transfers	  PAGEREF _Toc214262151 \h  81

  HYPERLINK \l "_Toc214262152"  7.4	Other Trainings Provided to
Laboratory Personnel	  PAGEREF _Toc214262152 \h  82

  HYPERLINK \l "_Toc214262153"  8.0 	Removal Frequency for Unwanted
Materials	  PAGEREF _Toc214262153 \h  84

  HYPERLINK \l "_Toc214262154"  8.1	General	  PAGEREF _Toc214262154 \h
84

  HYPERLINK \l "_Toc214262155"  8.2	Regularly Scheduled Removals of
Unwanted Material	  PAGEREF _Toc214262155 \h  86

  HYPERLINK \l "_Toc214262156"  8.3	Removal of Unwanted Material when
Volumes are Exceeded	  PAGEREF _Toc214262156 \h  89

  HYPERLINK \l "_Toc214262157"  9.0	On-site Transfers of Unwanted
Material Outside the Laboratory	  PAGEREF _Toc214262157 \h  94

  HYPERLINK \l "_Toc214262158"  9.1	General	  PAGEREF _Toc214262158 \h
94

  HYPERLINK \l "_Toc214262159"  9.2	Comments on “Directly”	  PAGEREF
_Toc214262159 \h  94

  HYPERLINK \l "_Toc214262160"  10. 0	On-site Consolidation Areas
PAGEREF _Toc214262160 \h  97

  HYPERLINK \l "_Toc214262161"  11.0 	Hazardous Waste Determinations
PAGEREF _Toc214262161 \h  104

  HYPERLINK \l "_Toc214262162"  11.1	General	  PAGEREF _Toc214262162 \h
104

  HYPERLINK \l "_Toc214262163"  11.2	Assignment of Hazardous Waste Codes
  PAGEREF _Toc214262163 \h  109

  HYPERLINK \l "_Toc214262164"  11.3	Four-Day Limit for Hazardous Waste
Determination	  PAGEREF _Toc214262164 \h  112

  HYPERLINK \l "_Toc214262165"  12.0 	Laboratory Clean-outs	  PAGEREF
_Toc214262165 \h  116

  HYPERLINK \l "_Toc214262166"  12.1	General	  PAGEREF _Toc214262166 \h
116

  HYPERLINK \l "_Toc214262167"  12.2	Incentives to Conduct Clean-outs
PAGEREF _Toc214262167 \h  121

  HYPERLINK \l "_Toc214262168"  12.2.1	 30-Day Limit for Laboratory
Clean-outs	  PAGEREF _Toc214262168 \h  123

  HYPERLINK \l "_Toc214262169"  12.2.2	 Not Counting Hazardous Wastes
from Laboratory Clean-outs	  PAGEREF _Toc214262169 \h  125

  HYPERLINK \l "_Toc214262170"  12.2.3	 Expanding Laboratory Clean-out
Incentives	  PAGEREF _Toc214262170 \h  130

  HYPERLINK \l "_Toc214262171"  12.3	12-Month Interval Between
Laboratory Clean-outs	  PAGEREF _Toc214262171 \h  132

  HYPERLINK \l "_Toc214262172"  12.4	Compulsory Laboratory Clean-outs
PAGEREF _Toc214262172 \h  134

  HYPERLINK \l "_Toc214262173"  13.0	Laboratory Management Plan
PAGEREF _Toc214262173 \h  136

  HYPERLINK \l "_Toc214262174"  13.1	General	  PAGEREF _Toc214262174 \h
136

  HYPERLINK \l "_Toc214262175"  13.2	Enforceability of LMP	  PAGEREF
_Toc214262175 \h  143

  HYPERLINK \l "_Toc214262176"  13.3	Adding an Element to the LMP about
Procedures for Unknowns	  PAGEREF _Toc214262176 \h  145

  HYPERLINK \l "_Toc214262177"  14.0	Recordkeeping Requirements
PAGEREF _Toc214262177 \h  147

  HYPERLINK \l "_Toc214262178"  14.1	Retention of Label Information
PAGEREF _Toc214262178 \h  148

  HYPERLINK \l "_Toc214262179"  14.2	Training Records	  PAGEREF
_Toc214262179 \h  148

  HYPERLINK \l "_Toc214262180"  15.0	Enforcement and Compliance under
Proposed Rule	  PAGEREF _Toc214262180 \h  151

  HYPERLINK \l "_Toc214262181"  16.0	Issues that are Outside the Purview
of this Rulemaking	  PAGEREF _Toc214262181 \h  153

  HYPERLINK \l "_Toc214262182"  16.1	Treatment in Labs	  PAGEREF
_Toc214262182 \h  153

  HYPERLINK \l "_Toc214262183"  16.2	One EPA ID Number per Campus
PAGEREF _Toc214262183 \h  155

  HYPERLINK \l "_Toc214262184"  16.3	Eliminate Acutely Hazardous Waste
PAGEREF _Toc214262184 \h  155

  HYPERLINK \l "_Toc214262185"  16.4	Other Issues that are Outside the
Purview of this Rulemaking	  PAGEREF _Toc214262185 \h  156

  HYPERLINK \l "_Toc214262186"  17.0	Miscellaneous Comments	  PAGEREF
_Toc214262186 \h  159

  HYPERLINK \l "_Toc214262187"  Appendix I: Organizations Commenting on
Proposed Rule	  PAGEREF _Toc214262187 \h  165

  HYPERLINK \l "_Toc214262188"  Appendix II:  Organizations Whose
Comments Received Support from Other Organizations	  PAGEREF
_Toc214262188 \h  170

 BACKGROUND AND PURPOSE OF DOCUMENT

Background

On May 23, 2006, the U.S. Environmental Protection Agency (EPA) proposed
alternative generator requirements applicable to college and university
laboratories as defined in the proposed rule (71 FR 29712).  The
proposed rule provided a flexible and protective set of regulations that
address the specific nature of hazardous waste generation and
accumulation in laboratories at colleges and universities.  The
flexibility in the proposed rule would allow colleges and universities
the discretion to determine the most appropriate and effective method f
compliance with the proposed requirements.  Additionally, the proposed
rule is optional and colleges and universities have the choice of
managing their hazardous wastes in accordance with the new alternative
regulations or remaining subject to the existing generator regulations.

	The comment period for the proposed rule was originally due to close on
August 21, 2006.  However, EPA received a request from the National
Association of College and University Business Officers (NACUBO), on
behalf of the American Council on Education (ACE), the Campus Safety
Health and Environmental Management Association (CSHEMA), and the Campus
Consortium for Environmental Excellence (C2E2) to extend the comment
period for 45 days.  On August 21, 2006, EPA extended the public comment
period by 30 days (see 71 FR 48500).  The comment period for the
proposed rule closed on September 20, 2006.

EPA received 111 sets of comments in response to the proposal.

Purpose of Document

This document presents a summary of the public comments received in
response to the proposed rule.  The public comments (e.g., suggestions,
concerns, questions) are summarized according to specific issues related
to the proposed rule and preamble.

In each summary, we indicate the number of organizations whose comments
are reflected in it.  We also identify the organizations.  To do so, we
assigned each organization a unique commenter number.  We then prepared
the summaries and inserted commenter numbers into each summary to
identify the organizations whose comments are reflected in it.  Appendix
I of this document includes a table identifying each organization that
commented on the proposed rule and its commenter and document ID
numbers.

In addition, a number of commenters expressed general support for the
comments submitted by another organization.  Appendix II identifies
these commenters and the organizations whose comments they
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The public can view the comment letters in their entirety at the EPA
Docket Center.  It is located at the EPA Headquarters West Building,
Room 3334, 1301 Constitution Avenue, NW, Washington D.C.  Comment
letters are also available electronically at the following website:
www.regulations.gov.  The docket identification number for the proposed
rule is EPA-HQ-RCRA-2003-0012.

SUMMARY OF PUBLIC COMMENTS AND AGENCY RESPONSES ON PROPOSED STANDARDS
APPLICABLE TO ACADEMIC LABORATORIES

1.0	General

	1.1	Overarching Support for Proposed Rule

Comment:  We heard from 90 commenters that indicated general support for
EPA’s efforts to modify the hazardous waste regulations for
laboratories (Commenter Nos. 2, 3, 4, 5, 7, 8, 9, 10, 11, 13, 14, 15,
16, 17, 18, 19, 20, 21, 22, 23, 25, 29, 30, 31, 32, 33, 34, 35, 36, 37,
39, 42, 44, 45, 46, 48, 49, 51, 52, 53, 54, 57, 59, 60, 61, 62, 64, 65,
67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 83, 84, 85,
86, 87, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 104,
106, 107, 108, 109, 110, 111, and 112).  Note that many of these
commenters expressed concerns about the rule and suggested further
modifications.  Please refer to other sections of this document for
these comments and the Agency’s responses.

Response:  EPA thanks the commenters for their support and took into
account their specific comments in finalizing Subpart K.

1.2	Overarching Opposition to Proposed Rule

Comment:  We heard from three commenters expressing concern about
extending regulatory relief to a specific segment of the regulated
community, as this could be problematic (e.g., it would place increased
demands on regulators in compliance/enforcement, and create a
“slippery slope” for other regulated entities seeking relief)
(Commenter Nos. 40, 41, 56).  And, we heard from one commenter stating
that it views the proposed rule as generally unnecessary (Commenter No.
58).  The commenter views the addition of regulations specifically for
college or university labs as unsupported by the rationale provided in
the proposed rule.  The commenter disagrees with the Agency’s
arguments that colleges and universities face unique and overly
challenging compliance problems under RCRA.

Response:  EPA disagrees with the commenters’ assessment of Subpart K.
 We have a long history of working with the academic sector.  This
rulemaking is a culmination of many years of investigation and
participation by EPA in efforts designed to better understand the
challenges that the academic community faces when managing hazardous
wastes generated in laboratories under the hazardous waste regulations.
As discussed at length in the preamble to the proposed rule (see 71 FR
29715), these efforts include two Reports to Congress; a project under
EPA’s eXcellence and Leadership program (Project XL) with three
colleges and universities in New England; a pilot project led by the
Howard Hughes Medical Institute (HHMI) to develop and implement a
performance-based approach to the management of laboratory waste at ten
colleges and universities; and a public meeting on June 18, 2003,
sponsored by EPA to discuss the management of hazardous waste in
research and/or academic laboratories. (See the announcement of the
public meeting at 68 FR 33121, June 3, 2003.  The comments submitted to
EPA in response to the public meeting are included in the docket for
today’s rulemaking.)  All of these efforts and comments from colleges
and universities and their trade associations on the proposed rule
confirm EPA’s conclusion that differences in hazardous waste
generation and management activities at laboratories at academic
institutions warrant this alternative set of requirements.

Comment:  We heard from one commenter that the proposed rule provides
remedies to specific problems encountered by college or university
laboratories, but it does not recognize the basic differences between
college or university laboratory operation and the paradigm that
underlies the current regulations (Commenter No. 43).  The commenter
stated that the proposed rule offers "work-a-rounds" for some selected
items but leaves a large number of unresolved issues.  The commenter
suggested that the proposed provisions could make an excellent outline
for a “best practices” document.

Response:   EPA disagrees with the commenter.  Specifically in the
development of Subpart K, the Agency identified how the hazardous waste
generation and management practices at college and university
laboratories differ from both industrial production and industrial
laboratory operations in four meaningful ways.  These differences, which
were confirmed by many of the commenters, provide the rationale for
today’s final rule.  Further, throughout the years of working with
academic institutions, EPA has heard consistently that the greatest
challenge that academic institutions face in managing their laboratory
hazardous wastes under the existing generator regulations is making the
RCRA hazardous waste determination at the point of generation pursuant
to 40 CFR 262.11 (i.e., determining whether their solid waste is
hazardous waste and assigning the proper hazardous waste code(s) in the
laboratory at the time the hazardous waste is generated).  This is
largely because the individuals in the laboratory generating the
hazardous waste and other materials are students, who are often not
trained to make a hazardous waste determination.  We, therefore,
proposed and finalized removing the responsibility for the hazardous
waste determination from the students in the laboratory and place it in
the hands of trained environmental health and safety (EH&S)
professionals.  While this rulemaking could not address every issue the
academic sector has with the SAA regulations, due to our history of
working with the academic sector and taking their many comments on the
rule into account, we believe that the final rule creates a laboratory
hazardous waste management system that better fits the hazardous waste
generation pattern in academic laboratories.

Comment:  We heard from two commenters stating that EPA consider
revising and clarifying the satellite accumulation provision for all
generators, instead of creating a unique rule for just university and
college laboratories (Commenter Nos. 56 and 88).  One of the commenters
stated that this suggestion would address the problems cited by EPA more
broadly, as it appears that the proposed rule is the result of
unsupported interpretations of the SAA provisions (Commenter No. 88).

Response:  EPA intended to promulgate a rule to address specific
hazardous waste determination issues for laboratories at eligible
academic entities and in doing so, addressed various SAA issues related
to these types of laboratories.  It did not intend to promulgate a rule
on SAA issues in general and thus did not propose revising the SAA
regulations for all generators.  Thus, this comment is out of the scope
of this rulemaking.

Comment:  We heard from one commenter stating that, in the long run, it
is more advantageous to human health and safety and the environment to
leave academic laboratories subject to the present RCRA generator
requirements (Commenter No. 115).  The commenter does not agree that it
is onerous to educate students, researchers and others generating
hazardous waste in academic laboratories about proper hazardous waste
management.

Response:  The Agency disagrees with the commenter.  EPA believes that
today's rule will lead to the safe management of unwanted materials and
greater environmental protection by requiring that RCRA hazardous waste
determinations be performed by trained personnel, rather than by
untrained students.  We also believe that today's final rule will
promote the protection of human health and the environment by ensuring
that all unwanted materials which may, in whole or in part, be RCRA
hazardous wastes, are safely managed while in the laboratory prior to
the time that the hazardous waste determination is made.  In addition,
EPA believes that the requirement to develop and implement an LMP will
improve the coordination and integration of hazardous waste management
procedures and enhance environmental awareness among researchers and
students at eligible academic entities, leading to a transfer of good
environmental management practices to the larger community.

Comment:  Three commenters stated that it is advantageous to teach
students environmental protection and hazardous waste regulation before
they enter the workforce and that the proposed rule may not achieve this
effectively (Commenter Nos. 40, 41, 115).  One of the commenters stated
that many of the students and staff are likely to continue to work in
various laboratory settings throughout their careers and that exposing
them to the hazardous waste management standards will improve compliance
and provide greater protection of the public health and the environment
(Commenter 115).

Response:  EPA agrees that it is important to teach students and staff
how to manage hazardous waste in the laboratory to the level needed to
perform their duties in the laboratory.  There are many students at a
college or university taking science classes who will not go on to work
in a laboratory in the future, however.  Thus, Subpart K requires that
eligible academic entities train their laboratory workers and students.
And, the training must provide sufficient information so that laboratory
workers and students can understand and implement the requirements of
Subpart K, commensurate with their duties.

1.3	Performance-Based Versus Prescriptive Requirements

Comment: We heard from 28 commenters that Subpart K should be a
performance-based regulation (Commenter Nos. 7, 8, 10, 11, 14, 20, 25,
30, 53, 54, 60, 61, 62, 68, 75, 77, 80, 87, 89, 93, 95, 96, 97, 98, 99,
107, 108, 110).  These commenters stated that performance-based
regulations encourage colleges and universities to achieve better
performance because they allow for tailored approaches to specific needs
and encourage college or university participation under Subpart K.

Response:  EPA thanks the commenters for their support.  We reiterate
the statements we made in the preamble to the proposed rule that Subpart
K pairs a performance-based approach for management of unwanted
materials in the laboratory with a requirement for the eligible academic
entity to develop and implement an LMP.  We agree with the commenters
that a performance-based approach will allow eligible academic entities
greater flexibility by allowing them to tailor their laboratory waste
management program with respect to container labeling, container
management, and training, while ensuring better environmental results.

Comment:  We heard from four commenters that the proposed
performance-based regulations would place an increased burden on states
in compliance monitoring and enforcement (Commenter Nos. 41, 56, 58,
66).  The commenters stated that the proposed rule would require
additional resources by state compliance and enforcement personnel to
review college or university-specific practices (e.g., because the rule
is not prescriptive and focuses on a subset of the regulatory
community).  One commenter expressed concern about the proposed rule’s
apparent lack of balance between flexibility for the regulated community
and practical ability of the regulatory agencies to ensure protection
for human health and the environment through inspections (Commenter No.
41).  The commenter stated that regulating agencies must simultaneously
determine whether the laboratory is maintaining compliance with its own
specified methods and whether those methods would even meet the
performance-based standards if fully complied with.  Another commenter
stated that flexible regulations are unenforceable in the “real
world,” and that the rule would place an “unfunded mandate” on
regulators who would need to review individual elements of a LMP
(Commenter No. 58).  One commenter expressed its strong preference for
straightforward, specific requirements and stated its belief that the
proposed regulation may not be protective of human health and the
environment (Commenter No. 66).

Response:  Subpart K is an optional rule meaning that states have the
option  to adopt the rule or not.  Like any new regulation, it takes
time for state inspectors to learn the new rules and provisions.  In the
Economic Analysis for the final Subpart K regulation, the main areas
analyzed for impacts on state governments are reviewing notifications,
inspector training, and increased duration of inspections.  The
commenters are correct in that it will take some extra time for
inspectors; however the aggregate costs of this burden assuming 100%
adoption is not considered an unfunded mandate under the Unfunded
Mandates Reform Act of 1995 because Subpart K does not contain a federal
mandate that would result in expenditures of $100 million or more for
State, local, and tribal governments, in the aggregate, or the private
sector in any one year.  Further, EPA believes that the flexibility in
Subpart K is balanced with the required planning document, the LMP, and
we anticipate that participation in Subpart K will increase compliance
and management of hazardous laboratory waste because of this balance.
As we stated in the preamble of the proposed rule, we recognize that
performance-based standards inherently lack specificity.  However, this
is the reason we added a requirement to develop an LMP, a planning
component to ensure that an eligible academic entity thoroughly
considers its specific circumstances, and provides the detail needed to
ensure safe management of its unwanted materials.

Comment:  One commenter stated that EPA should make every effort to use
clear terminology in the preamble and regulatory text (Commenter No.
55).  The commenter stated that the wording "standard" or "standards'
should be avoided.  The commenter stated that the term can be
misinterpreted and encouraged EPA to use alternative words (e.g.,
“requirement”).

Response:  EPA believes that we used clear and concise terminology in
the preamble and regulatory text.  In fact, we did not use the word
standard or standards in the regulatory text of the final rule
addressing the commenters concern.  However in the preamble, there are
certain phrases used such as performance-based standard that continues
to the use the word standard.  We believe that this terminology in the
preamble is clearly a synonym for requirements or provisions and would
not likely be misinterpreted.

1.4	Other

Comment:  We heard from eight commenters expressing concern about
EPA’s estimate that approximately nine percent of college or
university hazardous waste is from their laboratories (Commenter Nos. 7,
11, 25, 29, 76, 86, 91, 101).  These commenters stated that, in their
experience, laboratory waste represents significantly more of a college
or university’s total waste stream and provided estimates ranging from
60 percent to 95 percent.

Response:  Based on these comments, the Agency sent follow-up letters to
several commenters requesting additional information in support of their
comments.  In response to our inquiries, many of the commenters supplied
detailed information about their hazardous waste generation and one
commenter provided a detailed analysis of our methodology for
determining the percentage of laboratory hazardous waste, including
specific suggestions on how to improve the methodology for the final
rule.  As a result of these comments, EPA has significantly revised the
methodology used in the proposal to determine the total quantity of
hazardous waste and laboratory hazardous waste.  Specifically, in the
proposal, we used key-word searches of the description field on Biennial
Report (BR) forms to identify laboratory hazardous waste as a percent of
the total hazardous waste generated.  Our revised methodology uses three
source codes from the BR to identify which hazardous wastes are from
laboratories:

G11 - Discarding off-specification or out-of-date chemicals or products
(unused chemicals or products – corresponds to P and U hazardous waste
codes);

G22 – Laboratory analytical wastes (used chemicals from laboratory
operations), and

G09 - Other production or service-related processes from which the waste
is a direct outflow or result.

Because hazardous waste from the source code G09 could also be generated
in non-laboratory operations, these wastes were only considered
laboratory wastes if the waste form codes indicated it was shipped in a
lab pack (i.e., waste form codes W001 or W004).

Additional laboratory wastes were identified using key-word searches of
the description field.  This revised method resulted in a much higher
estimate for laboratory hazardous waste as a percent of total hazardous
waste at colleges and universities – 73% under the revised
methodology, compared to 9% under the original methodology used in the
proposed rule.  This revised methodology was used to calculate the
amount of laboratory hazardous waste generated as a percent of the total
hazardous waste generated for colleges and universities, as well as for
other types of facilities with laboratories that we considered including
in today’s final rule:  teaching hospitals, non-profit research
institutes, governmental research laboratories, and commercial R&D
laboratories.  For a full explanation of the methodology used to
determine the amounts of total hazardous waste and laboratory hazardous
waste generated at colleges and universities, teaching hospitals, and
non-profit research institutes, see the memo entitled, Lab Rule Data
Analyses, from ICF International to Patricia Mercer, May 1, 2008; and
for hazardous waste information for LQG government research laboratories
and LQG commercial R&D laboratories see the memo entitled, Final
Analyses of College and University Laboratory Hazardous Waste, from ICF
International to Patricia Mercer, August 17, 2007.  Copies of both memos
are in today’s docket.  Using the revised methodology, we now estimate
that for college and university LQGs, 73% of their total hazardous waste
is from laboratories.  The percent of hazardous waste coming from
laboratories at teaching hospitals and non-profit research institutes is
even higher – 81% and 92%, respectively.  Further, with all three
types of eligible academic entities, nearly all LQGs generate laboratory
hazardous waste.

Comment: We heard from eight commenters asking EPA to work with the
states to encourage them to adopt the final rule so that colleges and
universities can participate under the proposed provisions at the
earliest practicable time (Commenter Nos. 10, 23, 31, 62, 64, 78, 95,
112).  One commenter stated that EPA should allow individual states to
adopt the rule in a manner that is consistent across borders and is
consistent with EPA’s intent of the rule (Commenter No. 10).

Response:  EPA plans to work with the states to encourage them to adopt
the rule quickly.  We’re hoping to provide training sessions on the
final rule in the regions and will encourage states to attend.

2.0 	Applicability of Subpart K

2.1	General

Comment:  We heard from 26 commenters suggesting that the scope of the
rule be broadened to include laboratories in the non-academic sector
(Commenter Nos.  3, 4, 5, 7, 13, 14, 24, 33, 38, 39, 44, 47, 51, 57, 60,
62, 67, 82, 86, 87, 89, 94, 95, 99, 107, 112).  These commenters stated
that many non-academic laboratories are comparable to labs eligible for
the rule (e.g., in regard to waste generation, operations) and would
benefit from the rule’s performance-based approach.  Refer to the
comments below for additional information on their suggestions.

Response:  EPA thanks the commenters for their suggestion of broadening
the scope of the rule.  Based on the comments above and below and
additional research by EPA regarding the presence of students in
laboratories at institutions other than colleges and universities, we
have expanded the scope of the final rule to include specific additional
entities that fit all aspects of the rationale for this rule such as a
hazardous waste generation pattern that is similar to that found at
college and university laboratories and a significant student
population.  EPA did not expand the scope of the final rule to include
certain entities because they did not fit all aspects of the rationale
for this rule such as government research laboratories and commercial
R&D laboratories (for more on these two types of facilities see below).
Therefore, today’s final rule allows colleges and universities,
teaching hospitals that are owned by or have a formal written
affiliation agreement with a college or university, and non-profit
research institutes that are owned by or have a formal written
affiliation agreement with a college or university, to opt into Subpart
K.  This expansion includes laboratories at facilities that we and many
commenters believe are closely integrated with laboratories at colleges
and universities.  Collectively, we are calling the entities that are
eligible to opt into today’s final rule, “eligible academic
entities.”

Comment:  We heard from twelve commenters to extend the rule to labs in
all sectors (Commenter Nos. 4, 7, 13, 24, 38, 39, 51, 67, 86, 89, 99,
107).  Five commenters indicated that any workplace (e.g., academic,
government, industry) potentially covered under the OSHA Lab Standard
should be covered under the rule (Commenter No. 4, 7, 39, 67, 86).   Two
commenters stated that the rule should be extended to all institutional
research organizations (Commenter Nos. 51, 99).

Response:  EPA thanks the commenters for their suggestion of broadening
the scope of the rule to labs in all sectors/workplace or to all
institutional research organizations.  Based on the comments above and
below and additional research by EPA regarding the presence of students
in laboratories at institutions other than colleges and universities, we
have expanded the scope of the final rule to include specific additional
entities that fit all aspects of the rationale for this rule such as a
hazardous waste generation pattern that is similar to that found at
college and university laboratories and a significant student
population.  EPA researched the sectors suggested above: academic,
government, and industry to determine if their research laboratories fit
the rationale of having a significant student presence.  Based on our
findings, EPA did not expand the scope of the final rule to include
government research laboratories (at this time) and commercial R&D
laboratories because they did not seem to have a significant student
presence (for more on these two types of facilities see below).  Through
our research, we concluded that laboratories at teaching hospitals that
are owned by or have a formal written affiliation agreement with a
college or university and non-profit research institutes that are owned
by or have a formal written affiliation agreement with a college or
university have a significant student presence and thus fit all aspects
of the rationale of Subpart K.  Therefore, today’s final rule allows
colleges and universities, teaching hospitals that are owned by or have
a formal written affiliation agreement with a college or university, and
non-profit research institutes that are owned by or have a formal
written affiliation agreement with a college or university, to opt into
Subpart K.  This expansion includes laboratories at facilities that we
and many commenters believe are closely integrated with laboratories at
colleges and universities.  Collectively, we are calling the entities
that are eligible to opt into today’s final rule, “eligible academic
entities.”

Comment:  We heard from three commenters that stated that the proposed
rule should not be extended to non-college or university laboratories
(Commenter Nos. 74, 84, 102).  The commenters stated that college or
university labs face unique challenges (e.g., transient student
populations), which need to be addressed.

Response:  EPA agrees that challenges with transient students in terms
of training them and having them make hazardous waste determinations are
unique to academic laboratories and this factor sets them apart from
industrial research laboratories.  However, based on the comments above
and below and additional research by EPA regarding the presence of
students in laboratories at institutions other than colleges and
universities, we have expanded the scope of the final rule to include
specific additional entities that fit all aspects of the rationale for
this rule, including having transient students.  EPA agrees that the
rule should not be extended to those types of facilities for which EPA
did not find a significant student presence in their laboratories.
Therefore, Subpart K allows colleges and universities, teaching
hospitals that are owned by or have a formal written affiliation
agreement with a college or university, and non-profit research
institutes that are owned by or have a formal written affiliation
agreement with a college or university, to opt into Subpart K.

2.2	Laboratories in Teaching Hospitals

Comment:  We heard from 37 commenters stating that the definition of lab
should include laboratories in hospitals (e.g., clinical and/or research
labs) and related medical units (e.g., dental offices) that are
affiliated with colleges and universities or that the scope should be
expanded to include teaching hospitals, and affiliated hospitals
(Commenter Nos. 2, 3, 7, 8, 11, 13, 14, 22, 25, 28, 30, 32, 34, 38, 47,
54, 57, 60, 61, 62, 65, 68, 74, 76, 77, 78, 79, 81, 83, 86, 88, 90, 93,
100, 108, 110, 112).  The commenters stated these labs are comparable to
college or university laboratories eligible for the rule (e.g., they
have comparable waste generation patterns), and the labs share faculty
and equipment with eligible labs, creating a possibly difficult
compliance situation under dual regulation. The commenter stated that
there is not information about turnover rates of staff in research
enterprises at hospitals.  The commenter stated that EPA’s working
groups used to frame the discussion and proposed rule did not include
any experts from hospital research enterprises. One commenter stated
that teaching hospitals contain many laboratories that act as chemistry
laboratories and the amount of time a student spends at a teaching
hospital is comparable to that of a graduate student in another
laboratory discipline (Commenter No. 7).  Another commenter asked the
Agency to include laboratories at college and university affiliated
hospitals and other similar locations (i.e., dental colleges or clinics
and associated laboratories).  This commenter asserted that these
laboratories are used by a large number of students; they are used for
instructional and research purposes; while some processes are status and
predictable, others are not; large numbers of different waste streams
are produced, but in relatively small quantities (Commenter No. 8).  One
commenter states that personnel, including students, faculty, and
researchers routinely move between the teaching hospital and other
academic facilities in the course of their work, and the waste streams
are often quite diverse at teaching hospitals not unlike those from
other research endeavors (Commenter No. 30).  Two commenters suggested
that the rule be extended to affiliated hospitals (Commenter Nos. 3 and
57).

Response:  EPA agrees with the commenters based on our additional
research into the hazardous waste generation pattern and the presence of
students in teaching hospitals.

Based on EPA’s observations, as well as comments that we have received
and given the nature of teaching and research, activities conducted at
teaching and research laboratories in colleges, universities, teaching
hospitals, and non-profit research institutes are comparable and
therefore share similar hazardous waste generation patterns.  Given that
these types of organizations with research and teaching laboratories
share similar hazardous waste generation patterns, we focused on the
extent to which these entities had a significant student presence, which
is a very important basis of today’s rule.  Because students are
inherently transient, and generally have less accountability than
professionals employed in laboratories, it is unlikely that they will
make a proper hazardous waste determination which requires detailed
knowledge of RCRA.

In terms of the transient students, EPA has learned from its research
that teaching hospitals instruct a variety of students -- interns,
residents, nursing students, laboratory technicians, and more, in the
hospital.  Instruction of these students includes work in the
laboratories to learn about the processes and tests conducted there,
introducing similar difficulties as those encountered at colleges and
universities in teaching and training transient students and making the
hazardous waste determination.  Also, medical research at a college and
university oftentimes is shared between the college and university
laboratories and teaching hospital laboratories.

EPA recognizes that a teaching hospital that is owned by a college or
university will instruct students from its medical school.  However, due
to the complex healthcare system, many times medical students or
residents from a medical school will train in a teaching hospital that
is affiliated with a college or university, but not owned by the college
or university.  We do not want to preclude these teaching hospitals that
are training students and have a significant transient student
population from participating in Subpart K.  Therefore, EPA looked for a
way to define the concept of “affiliated teaching hospital.”  We
discovered that the Accreditation Council for Graduate Medical Education
(ACGME) defines two types of agreements between a medical school and a
teaching hospital:  a master affiliation agreement and a program letter
of agreement.  EPA has determined that the presence of these agreements
indicates that a teaching hospital is formally affiliated with a college
or university.

Based on the evidence provided by commenters and additional EPA
research, we have concluded that teaching hospitals owned by or formally
affiliated with a college or university fit within all aspects of the
rationale of today’s final rule:  many hazardous wastes that vary over
time are generated in small quantities at many points of generation, and
there is a significant and transient student population that is not
familiar with the RCRA hazardous waste requirements.  Therefore, EPA is
allowing teaching hospitals, as defined in this final rule that are
either owned by or have a formal written affiliation agreement with a
college or university, to opt into Subpart K for their laboratories

2.3	Laboratories in Non-profit Research Institutes

Comment:  We heard from 11 commenters to extend the rule to labs in the
non-profit sector (Commenter Nos. 4, 13, 57, 60, 62, 67, 81, 82, 94, 95,
112).  Two of the commenters stated that the rule should be extended to
non-production, non-diagnostic labs with similar waste generation
patterns at non-commercial, non-profit research organizations (Commenter
No. 62, 112).  One commenter stated that they collaborate with the local
university on projects and many of its investigators hold positions at
the university, and because of this collaborative relationship, their
hazardous waste practices are similar (Commenter No. 67).  One of the
commenters stated that it is not uncommon for individuals who are
faculty members at a college or university to be assigned space to
perform their research at an affiliated hospital or research foundation
(Commenter No. 57). One commenter stated that their university is
affiliated with laboratories which currently would not be covered under
the scope of the rule and that this would make it difficult to train
laboratory personnel and faculty in two different laboratory
requirements (Commenter No. 81).  The commenter stated that this would
affect situations involving a privately funded research laboratory on
the university’s property.

Response:  In response to these comments, EPA conducted additional
research and identified from the BR information housed in the RCRAInfo
database, nine non-profit research institutes that are LQGs (see Section
III.A.1 for information on their hazardous waste generation).  For all
nine LGG non-profit research institutes, we were able to obtain readily
available information on student populations and programs, as well as
substantial evidence that non-profit research institutes are similar to
colleges and universities in that they sometimes grant degrees of their
own, co-sponsor degrees with colleges and universities, teach classes,
and share faculty, funding sources, and laboratory space with colleges
and universities.  We determined that the information obtained is
generally representative of the universe of laboratories at non-profit
research institutes, because among the non-profits we researched, we
found that their hazardous waste generation patterns and student
programs were remarkably homogenous. We also determined that a research
laboratory at a non-profit research institute that is owned by or has a
formal written affiliation agreement with a college or university shares
the same hazardous waste generation pattern rationale identified in the
rule

As EPA conducted additional study into non-profit research institutes,
it was difficult for the Agency to draw a hard line between college and
universities and non-profit research institutes.  For example, Memorial
Sloan-Kettering Cancer Center (MSKCC) is a non-profit cancer research
institute, a teaching hospital, a graduate school in biomedical
sciences, and is in partnership with the Weill Cornell Graduate School
of Medical Sciences and Cornell University to train students in research
and patient care.  MSKCC also partners with New York-Presbyterian
Hospital, the Hospital for Special Surgery, and the Rockefeller
University.  Via these partnerships, the majority of the faculty of the
Weill Cornell Medical Graduate School of Medical Sciences has their
research laboratories and other facilities located within the Weill
Cornell Medical College-New York-Presbyterian Hospital Complex and the
MSKCC’s research laboratory buildings.  Another outgrowth of this
partnership is that MSKCC jointly administers a Ph.D. program with
Cornell and Weill Medical College in computational biology and medicine.
 Finally, besides its own graduate school of biomedical sciences, MSKCC
offers two certificate programs for students to learn cytotechnology and
radiation therapy.

As shown in the example above, a non-profit research institute owned or
formally affiliated with a college or university may be so closely
associated with the college and university that excluding them will
prevent colleges and universities from establishing one laboratory waste
management system, introducing confusion among researchers working in
laboratories at both institutions.  In this situation, such non-profit
research institutes are virtually identical to a college and university
and their hazardous waste generation patterns and student presence fit
within the rationale of this rule.  This information made it clear to us
that non-profit research institutes often are “academic” and should
be eligible to opt into today’s final rule, when they are owned by or
formally affiliated with a college or university.

One of the commenters above recommended that EPA expand the scope of the
rule to any institution that has a formal affiliation with a college or
university.  While the Agency does not believe it should expand the
scope of the rule to all institutions that have any kind of an
affiliation with a college or university, we do believe it is
appropriate to allow those non-profit research institutes that have a
formal written affiliation agreement with a college or university to opt
into Subpart K.  And, in order to ensure that the formal written
affiliation agreement between the two entities represents an affiliation
that is longstanding, we believe that the affiliation must be at the
institutional level, as opposed to an agreement between staff or
professors at the two eligible academic entities.  Of the nine
non-profit research institutes that are identified as LQGs in the BR, we
determined that eight had formal affiliations with colleges and
universities on an institutional level.  For example, the Burnham
Institute not only administers its own graduate program, it also has an
institutional affiliation with the University of California at San Diego
by participating in a joint graduate training program in molecular
pathology (where approximately 30 graduate students a year obtain their
primary scientific training at the Institute).

The reason we are requiring a formal written affiliation agreement at
the institutional level is because having a formal affiliation at the
institutional level with a college or university seemed to increase the
likelihood that the non-profit research institutes would have students
in their laboratories.  And, the presence of a significant transient
student presence is an important part of the rationale for today’s
rule.  Typically, a formal affiliation at the institutional level allows
students at a college or university to conduct thesis research at the
non-profit research institute, use non-profit researchers as mentors,
and at times take some of their degree classes at the non-profit
research institute.  Further, requiring a formal written affiliation
agreement between the non-profit research institute and a college or
university will assist the implementing agency verify that an
affiliation at the institutional level exists.  Thus, for these reasons,
we decided to limit today’s rule to those non-profit research
institutes that have a formal written affiliation at the institutional
level with a college or university.

2.4	Conditionally Exempt Small Quantity Generators

Comment:  We heard from 27 commenters that conditionally exempt small
quantity generators (CESQGs) should be allowed to opt into the Subpart K
regulations (Commenter Nos. 7, 8, 10, 11, 25, 29, 30, 37, 49, 53, 54,
60, 61, 64, 65 71, 73, 74, 76, 81, 85, 89, 91, 96, 100, 101, 109).  The
commenters generally noted that many colleges and universities have
large quantity generator (LQG) and/or small quantity generator (SQG)
sites and that extending the rule to CESQGs will assist these colleges
and universities in managing all of their college or university lab
waste in a uniform manner.

Response:  In light of the comments received, EPA agrees that it makes
sense that at least some CESQGs would want to opt into Subpart K.  EPA
recognizes that laboratories at eligible academic entities that are
CESQGs share the same hazardous waste generation patterns as
laboratories at larger generators, except the eligible academic entities
that are CESQGs generate smaller quantities of hazardous waste.
However, while laboratories at CESQGs fit within the rationale used to
define the scope of this rule, the proposal did not allow them to opt
in.  At the time of the proposal, we had thought CESQGs would not want
to opt into Subpart K since they currently are not subject to the
controls that apply to satellite accumulation areas (SAAs) and do not
have to comply with most of the other requirements that apply to LQGs
and SQGs.  In fact, many of the provisions in today’s final rule would
be more stringent than those to which they are currently subject under
§ 261.5.  However, as illustrated above, numerous commenters indicated
that we should provide CESQGs with the same opportunity as SQGs and LQGs
to assess which set of generator regulations is most appropriate for
their laboratories and that we should not prohibit them from opting into
Subpart K.  EPA also agrees with the commenters who noted that one
campus can potentially include many separate generator sites, some LQGs,
some SQGs, and some CESQGs.  And this issue is particularly pertinent
for urban college and university campuses that are divided by public
roads.  Thus, EPA is allowing eligible academic entities to opt into
Subpart K for their CESQG sites and is allowing stand-alone CESQGs to
opt into Subpart K, as well.  CESQG sites at an eligible academic entity
may include field laboratories and small laboratories separated from the
main campus by public roadways.  In addition, we expect that some
eligible academic entities that are themselves CESQGs (i.e., stand-alone
CESQGs), such as small non-profit research institutes, may choose to opt
into the rule to take advantage of the clean-out provisions.

Comment:  We heard from 24 commenters stating that the rule’s
clean-out incentives should be extended to CESQGs (Commenter Nos. 6, 7,
8, 10, 11, 25, 30, 37, 53, 54, 61, 64, 70, 73, 74, 76, 78, 81, 85, 97,
100, 101, 108, and 109).  These commenters generally stated that the
proposed incentives would relieve CESQGs from a change in generator
status due to a clean-out and encourage them to clean out their labs.
Fifteen commenters stated that CESQGs should be allowed to adopt the
clean-out provisions without adopting the entire Subpart K regulation
(Commenter Nos. 11, 25, 30, 54, 61, 64, 70, 73, 74, 76, 78, 85, 100,
108, and 109).

Response:  EPA agrees that stand-alone CESQGs and CESQG sites that are
part of a larger eligible academic entity will benefit by removing
legacy chemicals from the laboratory by taking advantage of the
clean-out incentives of today’s rule.  However, EPA is not allowing a
stand-alone eligible academic entity or a CESQG site that is part of a
larger eligible academic entity to partake only in the laboratory
clean-out provisions and not the other Subpart K requirements because
this would prevent CESQGs from taking advantage of the two main benefits
of today’s final rule.  That is, if a CESQG site only participated in
the laboratory clean-out provisions, it would not be able to take
advantage of the flexibility in where and when to make the hazardous
waste determination.  Second, if a CESQG site that is part of a larger
eligible academic entity only participated in the laboratory clean-out
provisions, it would be unable to establish one hazardous waste
management system in all the laboratories at the eligible academic
entity.  The ability to establish a unified hazardous waste management
system for all laboratories is one of the priorities cited by academic
commenters.  Therefore, in order for a CESQG site at an eligible
academic entity or an eligible academic entity that is itself a CESQG,
to take part in the laboratory clean-out incentives, the eligible
academic entity must opt into Subpart K in its entirety and follow the
management standards for unwanted materials in the laboratories.

2.5	Facilities with Laboratories not Eligible to Participate in Subpart
K

Comment:  We heard from two commenters stating that government and
private labs are often located and/or operated in conjunction with
college or university labs (Commenter Nos. 81, 83).  One commenter
stated that EPA should allow these labs to use Subpart K when working at
a college or university lab, to prevent dual regulation.  The other
commenter stated that these laboratories are essentially
indistinguishable from the University’s labs and the federal
researchers are courtesy, associate, or adjunct faculty of the
University.

Response:  While the instance where a government research laboratory or
a commercial private laboratory are located on a college or university
campus can create a complicated situation, EPA has never proposed basing
the applicability of  Subpart K on location.  Rather, the applicability
of Subpart K is based on how entities fit the rationale of the rule. EPA
has determined that, at this time, laboratories at government research
and commercial R&D facilities are not eligible to participate in Subpart
K.  Thus, regardless of where government research and commercial R&D
facilities are located, they are not eligible to participate in Subpart
K.   Finally, only eligible academic entities can participate under
Subpart K for the laboratories they own.  See below for more information
about government research and commercial R&D laboratories.

Comment:  Two commenters suggested that the Agency expand the scope to
institutions affiliated with colleges and universities (Commenter Nos.
60, 90).  One commenter recommended that EPA expand the scope of Subpart
K to include those institutions that have a formal affiliation with a
college or university but are not themselves a college or university
(Commenter No. 60).  The commenter also recommended that EPA establish a
mechanism whereby non-college or university institutions with no
affiliations with a college or university but with research laboratories
with characteristics and hazardous waste generation patterns similar to
a college or university, can petition to be regulated under Subpart K.
Another commenter suggested that the definition of laboratory should
include other teaching and research “laboratories” affiliated with
the college or university (Commenter No. 90).

Response:  The Agency does not believe it should expand the scope of the
rule to all institutions that have any kind of an affiliation with a
college or university.  We did expand the scope of the rule to include
institutions that fully fit the rationale of the rule.  Therefore,
today’s final rule allows colleges and universities, teaching
hospitals that are owned by or have a formal written affiliation
agreement with a college or university, and non-profit research
institutes that are owned by or have a formal written affiliation
agreement with a college or university, to opt into Subpart K.  We do
believe it is appropriate to allow those non-profit research institutes
that have a formal written affiliation agreement with a college or
university and those teaching hospitals that have a formal written
affiliation agreement with a college or university to opt into Subpart
K.

Comment:  We heard from three commenters that stated that the definition
should be broadened to include academic laboratories at secondary
educational institutions (Commenter Nos. 40, 41, 45).  The commenters
stated that one of the primary purposes of the rule is to address the
difficulty of colleges and universities in training its students on RCRA
compliance.  These commenters stated that this same concern is present
at secondary institutions.  Two of the commenters stated that the rule
should not be expanded to include other types of organizations than
secondary and post-secondary institutions (Commenter Nos. 40, 41).  The
commenters do not believe that other organizations face the same level
of difficulties in regard to training of students.

Response:  While these commenters are asking for secondary educational
institutions to be included, none of the commenters are secondary
educational institutions nor do they represent secondary educational
institutions.  EPA believes that is may be inappropriate to allow
secondary educational institutions to opt into Subpart K because they do
not operate with a centralized Environmental Health and Safety
department similar to eligible academic entities.  Subpart K is designed
so that trained professions, aka EH&S staff, make the hazardous waste
determination or transport laboratory hazardous waste to central
accumulation areas.  This type of management scheme does not exist at
secondary educational institutions rendering Subpart K inappropriate for
these types of facilities.   Further, EPA already has a program called
the Schools Chemical Clean-out Campaign (SC3) whose mission “aims to
ensure that all schools are free from hazards associated with mismanaged
chemicals. SC3 gives K-12 schools information and tools to responsibly
manage chemicals.”

2.5.1	Government Research Laboratories

Comment:  We heard from 12 commenters to extend the rule to labs in the
public sector (Commenter No. 4, 5, 13, 14, 33, 44, 62, 67, 82, 107, 112,
116).  One commenter stated that its government research laboratories
meet the essential criteria for eligibility under the rule, such as
similar waste accumulation practices, multiple points of waste
generation, student populations, and highly variable waste streams
(Commenter No. 33).  The commenter pointed out areas of the proposed
regulatory text that could be modified to accommodate this suggestion.
One commenter stated that Federal government biomedical research
laboratories meet all aspects of the proposed definition of lab, except
for accreditation (Commenter No. 14).  Another commenter stated that
government labs could benefit particularly from the clean-out provisions
(Commenter No. 44). Finally one commenter asked EPA to include
flexibility in the hazardous waste management at government research
facilities (Commenter No. 116).

Response:  In addition to the public comments above, EPA collected
readily available information on hazardous waste generation patterns and
student presence in government research laboratories.  From EPA’s BR
on hazardous waste generated by LQGs, we identified 39 LQG government
research laboratories.  Overall, from the information available at this
time, it appears that laboratories at government research laboratories
have hazardous waste generation patterns similar to laboratories at
colleges and universities—i.e., generating small quantities of many
types of waste that vary over time at many points of generation—since
they are research laboratories. In addition, one commenter above, a
Federal agency, provided student numbers for ten of its laboratories,
three of which we have identified as LQGs.  We also acquired aggregated
student numbers or estimates for three other Federal agencies.  We were
unable to obtain student population data at laboratories at the
remaining government research laboratories, including State and Local
governmental laboratories.  Based on this lack of available information
about the other key aspect of the rationale for today’s rule, that is,
significant student presence, EPA has decided to defer our decision on
government research laboratories.  Therefore, government research
laboratories are not included in this final rulemaking.  Rather, in
2009, EPA expects to prepare a Federal Register Notice soliciting
additional information about government research laboratories,
particularly the presence of students at such research laboratories in
order to make a more informed decision regarding whether or not to allow
them to opt into Subpart K in the future.

2.5.2	Commercial R&D Laboratories and Others

Comment:  We heard from 13 commenters to extend the rule to commercial
or for-profit laboratories (Commenter Nos. 4, 13, 33, 38, 39, 47, 51,
62, 67, 82, 87, 99, 111).  One commenter expressed support for
sector-based strategies and urged EPA to expand the rule to research and
development laboratories in the specialty batch chemical manufacturing
sector (Commenter No. 87).  One commenter stated that the problems
confronted by academic laboratories as cited in the rule are symptomatic
of most if not all laboratories, including low-level production
laboratories such as a clinical laboratory or an environmental chemistry
laboratory (Commenter No. 38).  The commenter goes on to say that
non-academic laboratories should be covered under Subpart K because they
are indistinguishable from research labs at academic institutions, not
withstanding the student factor.  Another commenter stated that the
definition of laboratory should be changed to include research
laboratories in the private sector that engage in essentially the same
type of work; i.e., use of relatively small quantities of a wide variety
of materials for research purposes (not production or pilot scale)
(Commenter No. 47).

Response:  Based on these comments and responses to follow-up letters to
commercial research and development laboratories (copies of which are in
today’s docket), it appears that there is a similar hazardous waste
generation pattern (i.e., small amounts of many different types of waste
generated at multiple points of generation) as at laboratories at
colleges and universities.  However, there is little evidence of student
presence in these laboratories as indicated in the comments above and in
follow-up responses from commenters and EPA’s own research.  Without
the presence of students, commercial R&D laboratories do not have the
same challenges in making hazardous waste determinations for their
laboratory hazardous wastes and in training their laboratory personnel.
Having similar hazardous waste generation patterns is only one element
in determining which entities should be eligible to opt into Subpart K.
EPA believes that having a significant student presence in the
laboratories (which increases the difficulty in training and in making
hazardous waste determinations) is extremely important.  Therefore,
without meeting the rationale that a significant number of students must
be present, EPA has decided not to allow commercial R&D laboratories to
opt into Subpart K.

Comment:  One commenter recommended that the Agency extend portions of
the rule to commercial industrial labs (Commenter No. 84). The commenter
stated that commercial and industrial labs have personnel to make the
RCRA characterization whereas colleges and universities do not.
However, the commenter recommended that the performance standards of the
working container, Laboratory Management Plan, clean-out proposals add
to environmental protection if applied to commercial and industrial
laboratories.

Response:  EPA did not take comment on whether to apply only certain
provisions of Subpart K to the commercial research and development
laboratories.  Therefore the commenter’s request is out the scope of
this rulemaking.

2.6	Broadening Subpart K to Non-Laboratory Facilities

Comment:  We heard from 13 commenters stating that the definition of lab
should include machine shops, maintenance shops, motor vehicle stations,
and/or fabrication units, mechanic units (Commenter Nos. 10, 11, 13, 25,
29, 31, 37, 54, 70, 79, 80, 91, 104). We also heard from 18 commenters
that expressed concern about dual regulation at colleges and
universities as a result of Subpart K, i.e., for college or university
lab unwanted material and all other RCRA hazardous waste at the college
or university campus and indicated that EPA should extend Subpart K to
the entire campus (Commenter Nos. 13, 19, 29, 31, 43, 48, 54, 70, 76,
77, 81, 83, 90, 91, 92, 104, 107, 108).  These commenters stated that a
dual system is burdensome and inefficient, would create compliance
problems, and would discourage participation under Subpart K

Response:  While the Agency understands the concerns raised by the
commenters, we also believe that the Subpart K requirements were
developed to address specific concerns raised by the academic community
as they related to hazardous wastes generated in their
laboratories—that is, the situations and challenges that exist in
teaching and research laboratories are unique (e.g., having to identify
which of the potentially hundreds of different wastestreams meet the
definition of hazardous waste).  The academic community has not raised
such concerns about the hazardous wastes generated outside of the
laboratories.  For this reason, we believe it is inappropriate to expand
the scope of the rule beyond laboratories at eligible academic entities.

Comment:  We heard from one commenter stating that, if EPA does not
broaden Subpart K to the entire college or university campus, it should
allow colleges and universities to select specific labs on a campus to
participate in Subpart K (i.e., labs large enough to benefit from the
rule) while the others do not (Commenter No. 48).

Response:  EPA understands the commenter’s suggestion but disagrees
with the concept and did not change Subpart K to allow this practice.
Under Subpart K, all laboratories owned by the eligible academic entity
within one EPA Identification Number must comply with the same set of
regulations.  In other words, the alternative approach can not be
applied to only one or a few laboratories within that EPA Identification
Number, but rather must apply to all laboratories or no laboratories.
The reason for this is that EPA believes it would be difficult for an
eligible academic entity to keep track of which set of generator
regulations apply to which laboratory or group of laboratories.
Moreover, it would be extremely difficult, if not impossible, for the
States or Regions to keep track of the applicable set of regulations if,
within a single EPA Identification Number, different laboratories were
choosing to be regulated under different requirements.  No mechanism
currently exists at EPA or the States to track such distinctions.

Comment:  We heard from one commenter that stated that EPA should not
expand Subpart K to non-labs at colleges and universities (Commenter No.
74).  The commenter supports EPA's efforts in providing specialized
regulations to laboratories based upon the unique challenges involved.
The commenter noted that colleges and universities have the option of
remaining under existing RCRA regulations if Subpart K is not desired.

Response:  EPA thanks the commenter for its support and we maintain that
Subpart K only applies to laboratories that fit the definition of
laboratory at eligible academic entities.

3.0	Definitions

	3.1	Definition of Central Accumulation Area

Comment:  We heard from one commenter that suggested that the definition
of “Central Accumulation Area” should not require compliance with
section 262.211 for “unwanted material” for which a hazardous waste
determination has not been made and which may not even be a solid waste
(Commenter No. 79).  This commenter stated that the provision requires
personnel to unnecessarily add additional labeling to and manage
materials that may not be waste.

Response:  We disagree with the commenter.  The rule provides
flexibility with regard to where and when the hazardous waste
determination is made for unwanted materials generated in the laboratory
– in the laboratory, before the unwanted materials are removed from
the laboratory; or within four days of arriving at an on-site central
accumulation area or on-site treatment, storage or disposal facility.
Section 262.211 contains the requirements for making the hazardous waste
determination in an on-site central accumulation area.  If the eligible
academic entity chooses to make the hazardous waste determination in its
on-site central accumulation area, then it will be subjecting those
unwanted materials to regulation under § 262.211, even though some of
those unwanted materials may turn out not to be solid or hazardous
waste.  The extra labeling would be limited to dating the container upon
arrival.  The date on the container is for  calculating whether the
hazardous waste determination is made within four calendar days and for
calculating the maximum accumulation time (i.e., 90, 180 or 270 days).
If, when the hazardous determination is made, it turns out that an
unwanted material is not a solid waste, then it is not subject to Part
262 Subpart K, or to the RCRA hazardous waste regulations.  If it turns
out to be a solid waste, but not a hazardous waste, then it is not
subject to Part 262 Subpart K, but must be managed in compliance with
any other applicable regulations and/or conditions.

Comment:  We heard from one commenter asking that college and university
central accumulation areas be exempt from the special requirements for
ignitable or reactive waste at 40 CFR 264.176 (Commenter No. 81).  The
commenter stated that college and university waste streams are typically
small in quantity and the total volumes of flammable and reactive
chemical wastes present in its central accumulation areas present a
lower risk than volumes of like hazardous wastes produced in industry
and production facilities.  The commenter stated that, if proper
pollution prevention and preparedness measures are established to
minimize releases to the environment, the 50-foot property line safe
distance requirements for flammable and reactive wastes can be overly
restrictive.

Response:  Under existing generator regulations small quantity
generators that store containers of hazardous waste in what is commonly
referred to as a <180-day area in compliance with 262.34(d) are not
subject to 40 CFR 265.176 (see 40 CFR 262.34(d)(2)).  However, large
quantity generators that store containers of hazardous waste in what is
commonly referred to as a <90-day area in compliance with 262.34(a) are
subject to 40 CFR 265.176 for the storage of ignitable or reactive
hazardous wastes.  When codifying the term “central accumulation
area,” the Agency did not propose to change the regulations for the
management of hazardous waste at such areas.  The intent was merely to
develop a term to refer easily to these types of areas collectively.

3.2	Definition of College or University

3.2.1	General Support

Comment:  We heard from ten commenters expressing general support for
EPA’s definition of “College/University” (Commenter Nos. 7, 8, 11,
30, 47, 59, 66, 74, 90, and 98).  Two of the commenters stated that
broadening the definition to include institutions that offer
certificates but not degrees probably would not have an appreciable
impact because such institutions do not typically engage in research or
have a significant number of teaching laboratories (Commenter Nos. 11
and 30).

Response:  We agree with the commenter.  Broadening the definition of
college or university to include institutions that offer certificates is
not necessary.  These institutions are unlikely to engage in research of
have a significant number of teaching laboratories, and therefore have
no need to be eligible to opt into today’s rule.

Comment:  We heard from one commenter expressing support for the
rule’s definition, except that it does not support the exception of
the limiting language of “accredited by an accrediting agency listed
annually by the U.S. Department of Education (Commenter No. 8).

Response:  We disagree with the commenter.  The Agency is requiring that
a college or university must be accredited in order to provide some
assurance that an institution of higher education that is opting into
Subpart K is a legitimate college or university, as determined by a
recognized organization.

Comment:  We heard from five commenters expressing general support to
limit the definition to accredited colleges and universities (Commenter
Nos. 11, 25, 30, 59, 74).  Four of these commenters expressed their
belief that accreditation is a sound quality control measure (Commenter
Nos. 11, 25, 30, 59).  One of the commenters recommended that criteria
for the definition include either accreditation by one of the eight U.S.
regional higher education accrediting organizations, or listing in the
Carnegie Foundation for the Advancement of Teaching higher education
database (Commenter No. 25).  The commenter stated that inclusion in the
Carnegie Foundation database as an alternative to accreditation assures
inclusion of institutions such as some faith-based institutions (e.g.,
Bob Jones University) that decline accreditation on principle.

Response:   The Agency proposed to limit Subpart K to those colleges and
universities that are accredited by an accrediting agency listed
annually by the U.S. Department of Education.  The Agency has decided
against changing the definition of college or university to include
colleges and universities accredited by other accrediting agencies.  The
U.S. Department of Education must publish its list of accrediting
agencies annually in the Federal Register.  This process provides an
opportunity for regular revisions and public input, while ensuring
accountability for the list of accrediting agencies.

	3.2.2	Concerns and Questions

Comment:  We heard from one commenter that stated its belief that EPA
should reconsider the college or university definition because it may be
too broad (Commenter No. 25).  The commenter stated that the proposed
rule’s definition would result in approximately 6,900 institutions
being eligible for Subpart K.  This would include some institutions that
should be excluded from Subpart K participation (e.g., institutions that
do not, as a minimum, grant degrees at the Associate level).

Response:  The Agency disagrees with the commenter.  We proposed that a
college or university must be a private or public, post-secondary
academic institution that grants degrees.  The final rule retains the
requirement that a college or university must grant degrees to be
eligible to opt into Subpart K.  Therefore, we estimate that the number
of colleges and universities that generate laboratory hazardous waste
that would be eligible to opt into Subpart K would be 1,256.

Comment:  We heard from one commenter asking for clarification of the
college or university definition (Commenter No. 20).  The commenter
stated that its college or university has several outreach programs that
are associated with two-year technical schools; in some cases, these
institutions grant certificates of completion, rather than degrees. The
commenter believes it would be appropriate for these institutions’
unwanted materials to be included in the rule.

Response:  The Agency has retained the requirement for a college or
university to grant degrees in order to be eligible to opt into Subpart
K.  Although it is difficult to obtain hazardous waste data that
distinguish between institutions of higher education based on whether
the institution grants degrees or certificates, the Agency has assumed,
and commenters have confirmed that institutions that grant certificates
are unlikely to generate much laboratory hazardous waste and therefore,
it is not necessary to revise the definition of college or university to
include them.

Comment:  We heard from one commenter asking EPA to broaden the
definition of college or university to include more post-secondary
educational institutions (Commenter No. 83).  The commenter is
particularly interested in extending the rule to facilities that may not
be associated with a post-secondary institution, such as art studios. In
addition, the commenter believes additional outreach to art studios that
may be SQGs is needed because they may not be aware of the applicable
requirements.

Response:  As we discussed in the preamble to the proposed rule, art
studios are considered laboratories (we have included this concept in
the definition of laboratory in the final rule).  Therefore, art studios
that are at an eligible academic entity, such as a college or
university, would be eligible to participate in Subpart K, if the
college or university that owns the art studios opts into Subpart K.
However, art studios that are not part of an eligible academic entity
would not be eligible to participate in Subpart K.  One main goal of the
rule is to remove the responsibility for the hazardous waste
determination from untrained students and place it in the hands of
professional EH&S staff.  The Agency doubts that the type of art studio
to which the commenter refers would have professional EH&S staff.

3.3	Definition of Laboratory

	3.3.1	General

Comment:  We heard from 17 commenters expressing concern with the
definition's last sentence: "An area where the same hazardous wastes are
routinely generated…is not a laboratory" (Commenter Nos. 7, 11, 25,
29, 49, 53, 54, 60, 61, 68, 73, 76, 77, 79, 81, 96, 114).  These
commenters stated that many laboratory areas covered under the rule
repeat the same analytical processes during a span of time (e.g., a
month, semester, or years) and routinely generate the same waste types.
Refer to Section 3.3.2 of this document for additional comments asking
for inclusion of photo labs in the definition.

Response:  We agree with the commenters.  We have deleted the last
sentence from the proposed definition of laboratory:  “An area where
the same hazardous wastes are routinely generated, such as photo
processing, is not a laboratory.”  The reason the Agency originally
included this statement in the proposed definition is that part of our
basis for proposing this rule is that laboratories at colleges and
universities, unlike other types of hazardous waste generators, generate
many different types of wastes that vary over time.  However, based on
comments received, we believe it is no longer appropriate to include
this sentence for the following reasons.  First, comments indicated that
some photo laboratories do, in fact, generate many wastestreams that
vary over time – this is especially true when the photo laboratories
are art studios where students may be experimenting with different
photographic techniques, such as daguerreotype and calotype finishing.

Second, commenters pointed out that is it not unusual for an individual
research laboratory to generate the same hazardous waste routinely for
lengthy periods of time, as it focuses on a single area of research.
Additionally, commenters pointed out that teaching laboratories can have
an experiment that is part of the ongoing curriculum and that generates
the same hazardous wastes each semester.  We did not intend to create a
system whereby some laboratories at the eligible academic entity would
be eligible and some would not, based on the hazardous waste generation
pattern of each individual laboratory.  To the contrary, for ease of
implementation and enforcement, if the eligible academic entity chooses
to be subject to Subpart K, the Agency is requiring that all
laboratories covered under an individual EPA Identification Number must
operate under those provisions.  Therefore, we believe that it is
sufficient that an eligible academic entity’s laboratories, as a
category, rather than each laboratory, generate many different wastes
every day.

Third, based on comments and follow-up discussion, we now understand
that in many cased photo processing takes place alongside teaching and
research and that it would be difficult to regulate differently the
various laboratory operations, as the same students and laboratory
workers operate in both areas.  Therefore, we have not only removed the
last sentence of the proposed definition of laboratory, we have revised
the definition of laboratory to include photo laboratories.

Comment:  We heard from two commenters asking EPA to clarify that
several "laboratories" may be present in the same physical space
(Commenter Nos. 11, 25).

Response:  The definition of laboratory does not include a description
of the size of area that would be considered one laboratory versus more
than one laboratory.  We realize that some laboratories are very large
rooms, with multiple work stations.  Under Subpart K, there is a shift
toward regularly scheduled pick-ups of unwanted materials, with volume
limits per laboratory kept as a back-up.  We anticipate that this will
reduce the need to distinguish what is one laboratory versus multiple
laboratories.  In cases where it is necessary to distinguish between
what is one laboratory versus multiple laboratories, we will defer to
the State or Region to make such decisions.  It is not possible for EPA
to anticipate all site-specific situations and include them in a
definition.

Comment:  We heard from one commenter suggesting that EPA revise the
“Applicability” section of the rule (262.201) to provide a
comprehensive list of all types of areas/locations that fall under the
rule (e.g., college or university labs, stockrooms, photo labs, etc.
(Commenter No. 100).

Response:  We agree with the commenter.  However, the applicability
section of the rule is intended to identify the types of institutions
that may opt into Subpart K for their laboratories.  It is not intended
to exhaustively and inclusively enumerate all areas or locations that
fall under the rule.  Therefore, instead we have revised the definition
of laboratory in the final rule to make our intent clearer, and we
provide examples of certain areas that would be considered laboratories.
 It now reads:

an area owned by an eligible academic entity where relatively small
quantities of chemicals and other substances are used on a
non-production basis for teaching or research (or diagnostic purposes at
a teaching hospital) and are stored in containers that are easily
manipulated by one person.  Photo laboratories, art studios, and field
laboratories are considered laboratories.  Areas such as chemical
stockrooms and preparatory laboratories that provide a support function
to teaching and research laboratories (or diagnostic laboratories at
teaching hospitals) are also considered laboratories.

Comment:  We heard from one commenter that EPA should address the
dilemma of a single area that both meets and fails the laboratory
definition (Commenter No. 54).  The commenter provided an example of
college and university laboratory workers that work side-by-side with
workers employed by the state or Federal government, private research
institutions and medical centers.  The laboratory will typically have
students and varied waste streams, and be serviced by the college or
university's hazardous waste program.  The commenter believes such
scenarios need to be clarified.

Response:  The Agency agrees with the commenter.  The definition of
laboratory has been revised to clarify that a laboratory must be owned
by an eligible academic entity to participate under Subpart K.

To be eligible to opt into Subpart K, an institution first must meet the
definition of “eligible academic entity.”  That is it must be a
college or university, or a non-profit research institute or teaching
hospital that is owned by or has a formal written affiliation agreement
with a college or university, as these terms are defined in the final
rule.  Second, an eligible academic entity may opt into Subpart K for
the laboratories that it owns.  Therefore, government facilities with
laboratories that are operated by colleges and universities (such as
many of the Department of Energy’s laboratories) would not be eligible
to opt into Subpart K, because the government facility is not an
eligible academic entity and the laboratories are not owned by an
eligible academic entity.

Any laboratory workers, students, guest researchers, interns, etc., that
work in a laboratory at an eligible academic entity that opts into
Subpart K must comply with Subpart K while teaching or conducting
research in the laboratories at the eligible academic entity, regardless
of whether the researcher is an employee of the eligible academic
entity.

Comment:  We heard from one commenter that took issue with descriptions
used in the definition to define a college or university laboratory
(e.g., “high turnover rate,” “non-production basis) (Commenter No.
76).  The commenter expressed concern that these terms are not clearly
defined and are open to different interpretations.  The commenter
suggested that, if EPA is using these words to restrict the definition
from non-academic, commercial laboratories, the Agency should use these
words specifically.

Response:  EPA elected to use the term “non-production basis” within
the definition of laboratory, because it was used by OSHA in its
Laboratory Standard (see 29 CFR 1920.1450) and we had been told by
stakeholders that they would prefer us to use existing terminology when
possible.  It is intended to distinguish research and teaching
laboratories from pilot and production laboratories.

The term “high turnover rate” is not used in the definition of
laboratory, although it is used in the preamble when discussing the part
of the rationale for the rule that concerns students.

Comment:  We heard from one commenter that noted that EPA states that
“laboratories not located at colleges or universities would not be
covered” (Commenter No. 83).  The commenter asked for clarification
whether the definition includes such facilities such as remote
university research stations, farms or other university leased, owned or
operated facilities.

Response:  The applicability of the final rule has been expanded to
include colleges and universities, as well as teaching hospitals and
non-profit research institutes that are owned by or have a written
affiliation agreement with a college or university.  A laboratory must
be owned by an eligible academic entity in order to operate under
Subpart K.  If a remote research station or farm is owned by an eligible
academic entity, and otherwise meets the definition of a laboratory,
then it would be able to operate under Subpart K.

Comment:  We heard from one commenter that the definition of a
laboratory, as written in the proposed rule, does not take into
consideration the diverse nature of research (Commenter No. 29).  The
commenter stated that labs may be located on or off campus on property
that is owned, leased or even borrowed.

Response:  The applicability of the final rule has been expanded to
include colleges and universities, as well as teaching hospitals and
non-profit research institutes that are owned by or have a written
affiliation agreement with a college or university.  A laboratory must
be owned by an eligible academic entity in order to operate under
Subpart K.  If a laboratory is off campus, is owned by an eligible
academic entity, and otherwise meets the definition of a laboratory,
then it would be able to operate under Subpart K.

Comment:  We heard from one commenter that the definition could be read
to infer a laboratory with more than one person is not a laboratory
(Commenter No. 52).  The commenter stated that there is normally more
than one person in most laboratories and the chemicals handled in these
laboratories are of such size that one person can easily handle them.
The commenter asked EPA to consider rewording the definition.

Response:  The Agency did not intend to infer that a laboratory with
more than one person could not operate under Subpart K.  To the
contrary, EPA intends for a laboratory with more than one person to be
able to operate under Subpart K if it otherwise meets the definition of
“laboratory.” In the definition of laboratory, we elected to use the
phrase “stored and used in containers that are easily manipulated by
one person,” because it was used by OSHA in its Laboratory Standard
(see 29 CFR 1920.XXX) and we had been told by stakeholders that they
would prefer us to use existing terminology when possible.  The phrase
is intended to describe the types of containers that are typically used
in teaching and research laboratories on a non-production basis.  This
is to distinguish teaching and research laboratories from pilot and
production laboratories where larger containers, such as vats, or tanks
are used which can not be manipulated by one person without the aid of
equipment or machinery.

Comment:  We heard from one commenter that that some college or
university laboratories have dual roles (e.g., academic and commercial
components); this could create confusion under the current definition
(Commenter No. 8).

Response:  We realize that some laboratories owned by eligible academic
entities may have contracts to perform research or analyses for
non-eligible academic entities.  If the laboratory is owned by an
eligible academic entity, it may operate under Subpart K, provided the
laboratory otherwise meets the definition of laboratory.  That is, as
long as such a laboratory is used for teaching or research on a
non-production basis, it would be allowed to operate under Subpart K.
If the laboratory were manufacturing products for commercial use,
however, it would not be considered a laboratory.

Comment:  We heard from one commenter that the definition and
applicability criteria may be better served if the requirements were
based on laboratory workers and their waste operations/management and
training requirements, rather than on specific operations (Commenter No.
81).  The commenter stated that this would relieve colleges and
universities from having to train the same lab workers on two different
waste management procedures and requirements for lab and non-lab
settings.

Response:  We recognize that there will be some personnel at an eligible
academic entity that will have to be familiar with two sets of hazardous
waste regulations – those for laboratories and those for
non-laboratories.  We anticipate that those personnel will be limited to
EH&S professionals or others fulfilling that role, because they
typically provide services to the entire eligible academic entity’s
campus.  We have not been told of situations in which personnel, such as
students, researchers, or other laboratory workers, perform additional
duties that would require them to learn hazardous waste regulations
other than those for the laboratory.

Comment:  We heard from one commenter stating that an art studio should
not be included in the definition of laboratory (Commenter No. 24).  The
commenter stated that, since the proposed rule is mainly geared to those
locations familiarly known as "laboratories," it believes the definition
of "laboratory" should ensure there is a relatively bright line to
describe whether a location is or is not included.  It believes this
will greatly assist the regulated community in determining whether a
particular location is a "laboratory" and will ensure greater
consistency when applying the rule nationwide.

Response:  We disagree with the commenter.  We have heard from many
stakeholders and commenters that art studios share the same hazardous
waste generation patterns as areas that are typically referred to as
laboratories.  That is, they generate many wastestreams in small
quantities that vary over time.  Art students are taught and experiment
in art studios much the same way that chemistry and biology students use
their laboratories.  Therefore, as we discussed in the preamble to the
proposed rule, although art studios are rarely referred to as
laboratories, we will continue to consider them laboratories, provided
they are owned by an eligible academic entity and they otherwise meet
the definition of laboratory.  We have revised the definition of
laboratory in the final rule to state that art studios are considered
laboratories.

Comment:  We heard from one commenter stating that its university hosts
Federal laboratory research and Federally funded labs; as the rule is
currently written, these laboratories would not be eligible for the rule
even though they essentially are indistinguishable from the university
labs (Commenter No. 81).

Response:  Under the final rule, if the laboratories that host the
federally funded research are owned by an eligible academic entity, the
laboratories would be allowed to operate under Subpart K.  If, however,
the laboratories that host the federally funded research are owned by an
institution that does not meet the definition of “eligible academic
entity,” they would not be allowed to operate under Subpart K.

Comment:  We heard from one commenter stating that government and
private labs are often located and/or operated in conjunction with
college or university labs (Commenter No. 83).  The commenter stated
that EPA should allow these labs to use Subpart K when working at a
college or university lab, to prevent dual regulation.

Response:  Under the final rule, if the laboratories are owned by an
eligible academic entity, the laboratories would be allowed to operate
under Subpart K.  If, however, the laboratories are owned by a
governmental or private entity that does not meet the definition of
“eligible academic entity,” they would not be allowed to operate
under Subpart K.

	3.3.2	Expanding the Definition of Laboratory

Comment:  We heard from 66 commenters expressing a general and/or
specific desire that EPA broaden the scope of the lab definition to
include additional types of labs at colleges and universities (Commenter
Nos. 2, 3, 4, 7, 8, 10, 11, 13, 14, 19, 20, 22, 24, 25, 29, 30, 31, 32,
36, 34, 37, 39, 43, 47, 48, 49, 53, 54, 57, 60, 61, 62, 64, 65, 66, 67,
68, 69, 70, 72, 73, 74, 76, 77, 78, 79, 80, 81, 83, 84, 86, 88, 90, 91,
92, 93, 96, 98, 100, 102, 104, 107, 108, 110, 111, 112).  The commenters
generally believe that other types of labs qualify for the proposed rule
(e.g., based on their staffing/waste operations), and that a broader
definition would encourage more protective waste management (e.g., by
obviating the need for dual regulations, simplifying compliance) and
encourage greater participation in Subpart K.  Refer to the comments
below for additional information on their suggestions.

Response:  In the final rule, we have revised the definition of
laboratory to include additional types of areas.  Specifically, the
definition of laboratory now includes photo laboratories, art studios,
and field laboratories.  Additionally, areas such as chemical stockrooms
and preparatory laboratories that provide a support function to teaching
and research laboratories (or diagnostic laboratories at teaching
hospitals) are also considered laboratories.

Comment:  We heard from five commenters suggesting that the proposed
rule defer to the OSHA definition of "laboratories" promulgated in 29
CFR 1910.1450 (Commenter Nos. 4, 7, 39, 67, 86).  One of the commenters
stated that this change would target equivalent risk groups, while
promoting a level of regulatory harmony between OSHA and EPA regulations
which impact the same user community (Commenter No. 4).

Response:  Under 29 CFR 1910.1450, OSHA defines “laboratory” as,
“a facility where the “laboratory use of hazardous chemicals”
occurs.  It is a workplace where relatively small quantities of
chemicals are used on a non-production basis.”  In addition, OSHA
defines “laboratory scale” as, “work with substances in which the
containers used for reactions, transfers, and other handling of
substances are designed to be easily and safely manipulated by one
person.  “Laboratory scale” excludes those workplaces whose function
is to produce commercial quantities of materials.”

Under 40 CFR 262.200, “laboratory” is defined as, “an area owned
by an eligible academic entity where relatively small quantities of
chemicals and other substances are used on a non-production basis for
teaching or research (or diagnostic purposes at a teaching hospital) and
are stored and used in containers that are easily manipulated by one
person.  Photo laboratories, art studios, and field laboratories are
considered laboratories.  Areas such as chemical stockrooms and
preparatory laboratories that provide a support function to teaching or
research laboratories (or diagnostic laboratories at teaching hospitals)
are also considered laboratories.”

At the suggestion of many stakeholders, the Agency used several phrases
from OSHA’s definitions that were useful and relevant, such as
“relatively small quantities of chemicals,” “used on a
non-production basis,” and “containers that are easily manipulated
by one person,” and combined them into a single definition.  However,
it is important to point out that although the definitions share many
similarities, EPA chose not to defer completely to the OSHA definition
and that the applicability of EPA’s and OSHA’s laboratory rules are
different.  Under EPA’s rule, only laboratories that are owned by an
eligible academic entity may choose to operate its laboratories under
Subpart K.

Comment:  We heard from 21 commenters that the definition of a
laboratory be revised to read, "Laboratory means an area under the
administrative or managerial control of a college or university where
relatively small quantities of chemicals and other substances are used
on a non-production basis for teaching or research purposes and are
stored and used in containers that are easily manipulated by one
person”  (Commenter Nos. 11, 25, 34, 37, 49, 54, 60, 61, 64, 69, 70,
73, 77, 78, 79, 91, 96, 98, 100, 108, 110).  These commenters generally
stated their belief that the administrative or managerial control of a
college or university laboratory is more appropriate than its location
(e.g., a college or university's research and teaching laboratories may
be in various locations).

Response:  We agree with the commenters, in principle.  However, the
terminology, “under the administrative or managerial control” is not
currently used or defined under RCRA.  The Agency agrees that the
definition of laboratory should be revised so that the location of the
laboratory is not pertinent and we have incorporated into the final
definition of laboratory a similar concept as suggested by the
commenters.  However, we have relied on terminology that is already used
and defined n RCRA.  Specifically, under the final rule, a laboratory is
“an area that is owned by and eligible academic entity…”

Comment:  We heard from one commenter suggesting that the definition of
laboratory should be:  “An area where small quantities of chemicals
and other substances are used on a non-production basis for teaching
and/or research purposes and are stored and used in containers that are
easily manipulated by one person.  Laboratory associated wastes include
areas generating unwanted materials or wastes in small quantities in
support of laboratory operations, including
maintenance/heating/wastewater facilities, photographic laboratories,
and computer laboratories” (Commenter No. 107).

Response:  We have revised the definition of laboratory to include some
areas that provide a support function to laboratories.  This includes
chemical stockrooms and preparatory laboratories, because these areas
are well integrated with the operation of the laboratories.  That is
they are often in close proximity to laboratories, and share laboratory
personnel, and thus should properly be viewed as part of the laboratory.
 However, this revision would not include maintenance, heating and
wastewater facilities because they typically provide support functions
for an entire campus and not just the laboratories.

Comment:  We heard from one commenter that items such as exclusion of
photographic operations, "easily manipulated by one person", and
restrictions on anything even resembling a commercial operation do not
lend themselves to a clear delineation of who's in and who's out of the
rule (Commenter No. 43).  The commenter suggested that the proposal be
made applicable to "administrative sub units (colleges, schools,
departments, etc. whose primary function is instruction and/or
research."

Response:   EPA has revised the applicability of the rule from what was
proposed.  We believe that the final rule is clear as to who is eligible
to participate under this rule.  To be eligible to opt into Subpart K,
an institution first must meet the definition of “eligible academic
entity.”  That is, it must be a college or university, or a non-profit
research institute or teaching hospital that is owned by or has a formal
written affiliation agreement with a college or university, as these
terms are defined in today’s rule.  Second, an eligible academic
entity may opt into Subpart K for the laboratories that it owns.  We
have revised the definition of laboratory to include photographic
laboratories (as discussed below in detail).  However, in response to
other commenters, we have retained several phrases from OSHA’s
definitions, such as “relatively small quantities of chemicals,”
“used on a non-production basis,” and “containers that are easily
manipulated by one person.”  These phrases have been in use by OSHA
for nearly 20 years and therefore the regulated community is already
familiar with them.

Comment:  We heard from one commenter suggesting that the definition is
too restrictive and recommending that EPA base the definition on the
laboratory type operations conducted as opposed to the wastes generated
(Commenter No. 68).  The commenter stated that providing a list of
examples tends to add confusion when contained in a regulatory
definition. The commenter stated that, by necessity, no list of examples
can be complete.  Instead, the preamble should discuss the intent of the
definition as written, and include some examples of covered operations
for illustrative purposes, but the examples should be annotated by
“such as, but not limited to” to avoid later confusion. The
commenter asked EPA to revise the definition of lab to read:
“Laboratory means an area owned/operated by or affiliated with a
college or university where relatively small quantities of chemicals and
other substances are used on a non-production basis for teaching or
research purposes and are stored and used in containers that are easily
manipulated by one person.”

Response:  We disagree with the commenter.  Many other commenters
requested that we explicitly include types of laboratories that we
intend to be included in the definition of laboratory.  We included many
of the types of laboratories that commenters suggested because we
believe that including these examples in the definition of laboratory
provides clarity for both implementers and enforcers. We do not intend
to suggest, and believe that the language in the definition does not
suggest, that the list of examples is exhaustive or all-inclusive.

Comment:  We heard from one commenter stating that the definition of lab
should include recreation department studios (Commenter No. 102).  The
commenter stated its support for the inclusion of art studios in the
definition of laboratory and recommended adding the non-instructional
art studios commonly operated by the recreation departments of many
schools.  The commenter stated that these student workshops generate
much the same waste as instructional studios, and in much the same
quantities. The commenter also stated that frequently, institutions with
small or nonexistent art departments, such as engineering schools, will
have substantial generation of paint, solvent, and ceramics waste from
these recreational studios.  The commenter suggested an addition
specifically including recreation department studios.

Response:  Based on this one comment, we do not believe that we have
enough information to make a determination about whether it is
appropriate to include recreation department studios in the definition
of laboratory and therefore we have not made the suggested addition.

Comment:  We heard from 13 commenters stating that the definition of lab
should include machine shops, maintenance shops, motor vehicle stations,
and/or fabrication units, mechanic units (Commenter Nos. 10, 11, 13, 25,
29, 31, 37, 54, 70, 79, 80, 91, 104).

Response:  We disagree with the commenters.  The hazardous waste
generation pattern in laboratories is different than in other parts of
an eligible academic entity.  Laboratories tend to generate relatively
small volumes of many different hazardous wastes that vary over time.
In addition, the personnel that generate hazardous waste in laboratories
are often students who lack accountability and are inherently transient,
and therefore are difficult to train.  This combination of the hazardous
waste generation pattern and students in laboratories makes accurate
hazardous waste determinations particularly difficult.  In contract,
machine shops, maintenance shops, motor vehicle stations, etc., tend to
generate relatively large volumes of a few, predictable hazardous
wastes.  The personnel that generate hazardous waste in these
non-laboratory areas tend to be employees and therefore are expected to
have lower turnover and more accountability than students.  Since these
non-laboratory areas do not share the hazardous waste generation pattern
or have students generating hazardous waste, we do not believe it is
appropriate for the definition of laboratory to include these areas.

Comment:  We heard from 22 commenters stating that the definition of lab
should include chemical stockrooms and other areas ancillary to the
laboratory (Commenter Nos. 2, 8, 11, 25, 30, 31, 37, 54, 61, 62, 68, 69,
70, 72, 76, 77, 78, 79, 91, 100, 111, 112).  The commenters stated that
these areas are comparable to college or university labs eligible for
the rule and often share a physical proximity.

Response:  We agree with the commenters and have revised the definition
of laboratory to include chemical stockrooms, preparatory laboratories
and other areas that perform a support function to teaching or research
laboratories (or diagnostic laboratories at teaching hospitals).  The
reason for this change is that the operation of these areas is well
integrated with the operation of the laboratories; that is, they are
often in close proximity to laboratories, and share laboratory
personnel, and thus should properly be viewed as part of the laboratory.
 Chemical stockrooms that are not associated with laboratory operations
would not however, be eligible to operate under Subpart K.  For example,
a chemical stockroom that stores cleaning chemicals or pesticides for
maintenance at the facility would not be providing a support function to
a laboratory and would not be considered a laboratory that is allowed to
operate under Subpart K.

Comment:  We heard from 19 commenters stating that the definition of lab
should include field laboratories (Commenter Nos. 8, 11, 20, 25, 31, 37,
47, 54, 61, 66, 68, 77, 79, 90, 91, 96, 100, 102, 110).  The commenters
stated that many colleges and universities operate field laboratories
that entail similar operations as college or university labs eligible
for the rule and involve faculty and students working in both settings
that should not be subject to dual regulation.

Response:  We agree with the commenters that field laboratories should
be considered laboratories because we agree that field laboratories,
like other laboratories under this rule, exhibit similar hazardous waste
generation patterns.  By considering field laboratories as laboratories,
laboratory personnel would thus only need to operate under one set of
hazardous waste regulations.

Comment:  We heard from 40 commenters stating that the definition of lab
should include photo labs/dark rooms (Commenter Nos. 2, 7, 8, 10, 11,
13, 14, 20, 25, 29, 30, 31, 32, 36, 37, 43, 47, 48, 53, 54, 61, 68, 69,
70, 72, 73, 76, 77, 79, 80, 81, 83, 86, 90, 91, 96, 100, 108, 110, 112).
 The commenters stated that many of their laboratories or lab buildings
include photo processing areas that should be eligible for the rule to
avoid dual regulation.

Response:  We agree with the commenters and in response we have deleted
the last sentence from the proposed definition of laboratory:  “An
area where the same hazardous wastes are routinely generated, such as
photo processing, is not a laboratory.”   The reason the Agency
originally included this statement in the proposed definition is that
part of our basis for proposing this rule is that laboratories at
colleges and universities, unlike other types of hazardous waste
generators, generate many different types of wastes that vary over time.
 However, based on the comments received, we believe it is no longer
appropriate to include this sentence for the following reasons.  First,
comments indicated that some photo laboratories do, in fact, generate
many wastestreams that vary over time - this is especially true when the
photo laboratories are art studios where students may be experimenting
with different photographic techniques, such as daguerreotype and
calotype finishing.

Second, commenters pointed out that it is not unusual for an individual
research laboratory to generate the same hazardous waste routinely for
lengthy periods of time, as it focuses on a single area of research.
Additionally, commenters pointed out that teaching laboratories can have
an experiment that is part of the ongoing curriculum and that generates
the same hazardous wastes each semester.  We did not intend to create a
system whereby some laboratories at the eligible academic entity would
be eligible and some would not, based on the hazardous waste generation
pattern of each individual laboratory.  To the contrary, for ease of
implementation and enforcement, if the eligible academic entity chooses
to be subject to Subpart K, the Agency is requiring that all
laboratories covered under an individual EPA Identification Number must
operate under those provisions.  Therefore, we believe that it is
sufficient that an eligible academic entity’s laboratories, as a
category, rather than each individual laboratory, generate many
different wastes every day.

Third, based on comments and follow-up discussion, we now understand
that in many cases photo processing takes place alongside teaching and
research and that it would be difficult to regulate differently the
various laboratory operations, as the same students and laboratory
workers operate in both areas.  Therefore, we have revised the
definition of laboratory to include photo laboratories.

	3.4	Definition of Laboratory Clean-out

Comment:  We heard from three commenters for EPA to delete reference to
“or that have expired” (Commenter Nos. 11, 60, and 91).  One
commenter stated that expired material is not necessarily unwanted and
that, in most laboratories, only the laboratory worker is capable of
deciding that an expired material is unwanted (Commenter No. 11).
Because this has caused misunderstandings in the past, the commenter
requests deletion of "or that have expired."  Another commenter stated
that “expired materials” is a subjective concept (Commenter No. 60).
 Two commenters offered an alternative definition and suggested that the
colleges and universities describe in the Laboratory Management Plan the
procedure used by the college or university to address expired materials
(Commenter Nos. 11 and 60).

Response:  We disagree with the commenters and have left the phrase
“or that have expired” in the definition of laboratory clean-out to
describe one situation in which is might be appropriate for a chemical
to be removed from a laboratory during a laboratory clean-out.  We are
not suggesting that every chemical that has expired is an unwanted
material and should be removed during a laboratory clean-out.  But the
expiration date of a chemical should certainly be one factor in deciding
whether or not a chemical should be removed during a laboratory
clean-out.  We agree with the commenter that the LMP should include
procedures for identifying and disposing of chemicals that can become
more dangerous when they exceed their expiration date.  Therefore, in
Part II of the LMP, we have added such a requirement. [See Section 13.0
of this document for more detail on the requirements of the LMP].

Comment:  We heard from three commenters suggesting alternate
definitions of laboratory clean-out (Commenter Nos. 60, 76, 107):

One commenter suggested revising the definition of Laboratory Clean-out
to read: “Laboratory Clean-out means an evaluation of the inventory of
chemicals and other materials in a laboratory that are no longer needed
and the subsequent removal of those chemicals or other unwanted
chemicals from the laboratory.  A clean-out may occur for several
reasons.  It may be on a routine basis (e.g., at the end of a semester
or academic year) or as a result of a renovation, relocation, or change
in laboratory supervisor/occupant.  A regular removal of unwanted
chemicals as required by section 262.208 does not qualify as a
laboratory clean-out” (Commenter No. 60).

One commenter stated that it would be more useful for the definition to
read:  “Laboratory clean-out means an evaluation of an inventory of
chemicals in a work area that is no longer used or needed by the space
occupant and ….” (Commenter No. 76).  The commenter stated that each
college or university should define the procedure for that determination
in its performance-based Laboratory Management Plan.

One commenter suggested that the definition be revised to say that a
clean out  “means an evaluation of the inventory of chemicals and
other materials in a laboratory, stock room, product storage area….”
(Commenter No. 107).

Response:  We disagree with commenters because we believe our definition
best captures EPA’s intent, and, therefore, the definition of
laboratory clean-out remains unchanged from the proposal.  However, we
agree that an eligible academic entity should include in Part II of its
LMP, procedures for conducting and documenting laboratory clean-outs.
In addition, the definition of laboratory has been revised to include
additional areas, such as chemical stockrooms, and therefore, such
ancillary support areas are also able to conduct laboratory clean-outs
under 40 CFR 262.213

Comment:  We heard from one commenter that the definition should be
clarified to allow the removal of unwanted material associated with a
laboratory clean out to qualify as a regularly scheduled removal to
allow smaller facilities to coordinate their waste management activities
(Commenter No. 77).

Response:  We view laboratory clean-outs to be distinct from routine,
regularly scheduled removals of unwanted materials.  In the course of
normal laboratory operations, many chemicals are used and will become
unwanted materials and ultimately may be determined to be hazardous
wastes.  This can occur as a result of teaching or research activities
or, in the case of teaching hospitals, as a result of clinical or
diagnostic activities.  We expect that these routinely generated
wastestreams will comprise the bulk of the unwanted materials that are
removed from the laboratory during regularly scheduled removals.  On the
other hand, a laboratory often can accrue a large number of unused
chemicals in its inventory, some of which can become dangerous over
time, developing the potential to cause significant harm.  It has been
our observation that it is unusual for laboratories to remove unused
chemicals from their inventories on any regular basis.   Therefore, a
regularly scheduled removal of unwanted material does not qualify as a
laboratory clean-out.  Nor does a laboratory clean-out qualify as a
regularly scheduled removal.  However, nothing prohibits these two
events from happening concurrently in order to coordinate waste
management activities.

Comment:  We heard from one commenter that there are inconsistencies in
the definition of laboratory clean-out as it relates to discussions in
the preamble and rule (Commenter No. 114).  The commenter noted that EPA
says that it envisions laboratory clean-outs as more comprehensive than
the regularly scheduled removals of unwanted material.  It also notes
that the Agency discusses past inspections and enforcement cases that
have revealed used and unused chemicals at college or university labs
that have remained for long periods of time, and it discusses the
hazards of these chemicals but it does not equate the hazards with
quantity of the chemicals found.  The commenter also pointed out that
the definition of a laboratory clean-out includes language referring to
the “subsequent removal of those chemicals or other unwanted materials
from the laboratory.”  The commenter pointed out, however, that, under
the current proposal, if at the conclusion of a laboratory clean-out the
total volume of unwanted materials in the laboratory does not exceed 55
gallons (or 1 quart of reactive acutely hazardous waste), the materials
may remain in the laboratory until the next regularly scheduled removal
of the unwanted material.  The commenter stated its belief that, if the
used and unused chemicals (along with other unwanted materials) are not
removed after a clean-out, then there would appear to be no immediate
benefit or incentive for a safer laboratory environment and better waste
management and timely removal and disposal of these materials.  The
commenter expressed concern that a clean-out could conclude without the
unwanted materials being removed promptly from the laboratory.  The
commenter stated that, if the definition does not mean that materials
must be removed at the conclusion, regardless of quantity, then the name
and definition should more appropriately reflect this.

Response:  We agree with the commenter that the preamble and the
regulatory text of the proposed rule are somewhat inconsistent, as
described.  In the final rule, we have retained the proposed regulatory
text.  Therefore, 40 CFR 262.213(a)(1) requires that an “eligible
academic entity must remove all unwanted materials from the laboratory
within 30 calendar days from the start of the laboratory clean-out.”
The discussion in the preamble to the proposed rule to which the
commenter refers should no longer be considered relevant.  We agree with
the commenter that the timely removal and disposal of the laboratory
clean-out chemicals is the main goal of conducting laboratory clean-outs
and to let the chemicals remain in the laboratory at the conclusion of
the laboratory clean-out is counter-intuitive.  Therefore, regardless of
the quantity of unwanted materials generated during a laboratory
clean-out, all unwanted materials must be removed at the conclusion of
the laboratory clean-out.

	3.5	Definition of Laboratory Worker

Comment:  We heard from nine commenters that expressed general support
for the proposed definition of laboratory worker (Commenter No. 7, 8,
11, 25, 54, 71, 73, 79, 86).  One of the commenters stated that, if a
more detailed description is necessary, it will vary from campus to
campus and it is most appropriately written into the LMP (Commenter No.
7).

Response:  We don’t expect that eligible academic entities will have a
need to provide a more detailed description of laboratory worker, beyond
what is provided.  But, if the need arises, the eligible academic entity
could write it into Part II of its LMP, such as under the element
describing intended best practices for training.

Comment:  We heard from one commenter stating that, if EPA broadens the
rule to include non-college or university labs, EPA should broaden the
definition of “lab worker” to address workers in non-college or
university lab settings (Commenter No. 14).   It suggested that, at
non-academic institutions, the transient workforce that would be allowed
to receive instruction, in lieu of training, be limited to individuals
who do not perform independent research tasks (i.e., are under direct
supervision of a trained laboratory worker) and are serving in
appointments of one year or less.

Response:  Under the final rule, the distinction between training for
laboratory workers and instruction for students has been eliminated.
Now both students and laboratory workers must be trained commensurate
with duties.  Therefore, the comment is now moot.

Comment:  We heard from one commenter that many students will be present
in a laboratory, but may not fulfill the true definition of a laboratory
worker; therefore, they may not need to meet the training requirements
specified in the rule (Commenter No. 80).  The commenter suggested the
differentiation of a laboratory worker and student worker, or use of
discretion of lab supervisors when the determination of training needs
is made.

Response:  Under the final rule, the distinction between training for
laboratory workers and instruction for students has been eliminated.
Now both students and laboratory workers must be trained commensurate
with duties.  Therefore, the comment is now moot.

Comment:  We heard from one commenter that the definition should be
revised to include the phrase “contractors or vendors” after the
word “technician” (Commenter No. 84).  The commenter stated that
contractors and vendors are commonly used by colleges and universities.

Response:  We realize that contractors and vendors are commonly used by
eligible academic entities to make or verify hazardous waste
determinations.  Contractors and vendors used in this capacity should
have the appropriate RCRA training.  However, while it is the
responsibility of the eligible academic entity to provide training to
laboratory workers, it is not the responsibility of the eligible
academic entity to provide the required training to a contractor or
vendor.  Therefore, we have not included contractors or vendors in the
definition of laboratory worker.

Comment:  We heard from one commenter that suggested adding a definition
for “student” that allows undergraduate students, including paid
temporary students that conduct research or teach, not to be considered
laboratory workers (Commenter No. 107).  The commenter also suggested
revising the definition of laboratory worker to include: “…but is
not limited to faculty, staff, post-doctoral fellows, visiting
scientists/researchers, interns, researchers….”

Response:  The definition of “laboratory worker” in the preamble to
the proposed rule differed slightly from the definition in the proposed
regulatory text.  In the definition included the regulatory text, the
last sentence of the definition included the words “Undergraduate and
graduate” when referring to students.  However, the definition
included in the preamble discussion omitted the words “Undergraduate
and graduate.”  Today, we are finalizing the definition in the
regulatory text, as it was proposed, so that the final sentence reads,
“Undergraduate and graduate students in a supervised classroom setting
are not laboratory workers.”

However, contrary to the commenter’s suggestion EPA would consider
undergraduate or graduate students in an unsupervised research setting
or in a supervisory role, such as teaching, to be laboratory workers.
Additionally, any student performing duties of a trained professional,
such as transferring unwanted materials and hazardous wastes outside of
a laboratory, would be considered a trained professional, rather than a
student.

Our list of examples of types of laboratory personnel that could be
considered laboratory workers is not exhaustive.  And, as the commenter
suggests, visiting scientists or researchers could also be considered
laboratory workers.

Comment:  We heard from one commenter that offered the following revised
definition: “Laboratory Worker means a person who handles chemicals or
unwanted chemicals in a laboratory and may include, but is not limited
to faculty, staff, post-doctoral fellows, interns, researchers,
technicians, supervisors, managers, and principal investigators.  A
person does not need to be paid or otherwise compensated for his/her
work in the laboratory to be considered a laboratory worker.
Undergraduate and graduate students in an instructional or teaching
setting are not laboratory workers” (Commenter No. 60).  Specifically,
the commenter suggested replacing the current language “in a
supervised classroom setting” with “in an instructional or teaching
setting.”

Response:  We believe that the phrase “in a supervised classroom
setting” more accurately conveys our meaning and is therefore less
confusing than the phrase “in an instructional or teaching setting.”
 EPA expects that students in a classroom setting will be under the
direct supervision of an instructor or professor who would be considered
a laboratory worker.   If we were to use the commenter’s suggested
phrase we would be concerned that students in an unsupervised research
setting could be interpreted as being in an instructional or teaching
setting.

Comment:  We heard from one commenter that the definition’s last
sentence, beginning "(u)ndergraduate and graduate students in a
supervised classroom . . ." seems to leave a loophole, in that those
students in an unsupervised classroom setting would be classified as
laboratory workers (Commenter No. 102).  The commenter suggested that,
if this person is an unsupervised student, he or she should be subject
to the same requirements as any faculty, staff, or other person handling
chemicals.  The commenter asked EPA to clarify that undergraduate and
graduate students in a supervised classroom are included as laboratory
workers.

Response:  Undergraduate and graduate students in a supervised classroom