April 27, 2005

MEMORANDUM

TO:		Patricia Mercer, EPA

FROM:	Maribelle Rodríguez, Mike Hartley, and Earl Harris

SUBJECT:	College and University Large Quantity Generators in 2001;

Work Assignment Number 3-33, Contract Number 68-W-02-006

Under the referenced work assignment, ICF identified college and
university (C/U) large quantity generators (LQGs) in 2001 and estimated
the quantity of hazardous waste generated by these sites.  Section 1 of
this memorandum describes the methodology used to identify and collect
data on C/U LQGs.  Section 2 summarizes information on the number of C/U
LQGs and the quantity of hazardous waste generated by these sites.

Please do not hesitate to contact Maribelle at<PHONE_NUMBER> with
questions or comments.

1.	Methodology

To identify C/U LQGs in 2001 and estimate the quantity of hazardous
waste generated by these sites, ICF undertook the following steps:

Step 1:  Identify C/U LQGs in 2001

To identify C/U LQGs in 2001, ICF referred to the Site Identification
(ID) Forms of the 2001 Biennial Report (BR).  The Site ID Form contains
basic waste handler information (e.g., EPA ID number, site name, Federal
generator status).

Based on Federal generator status information reported in the Site ID
Forms, we identified all LQGs in 2001.  For these sites, we extracted
the following information from the Site ID Forms and used it to create a
2001 C/U LQG database:

EPA ID number;

Site name;

Address;

EPA Region;

·	Primary North American Industrial Classification System (NAICS) code;

·	Secondary NAICS code(s);

Federal generator status (i.e., LQG); and

·	Indicator of whether the site treats, stores, or disposes of
hazardous waste.

Sites represented by primary NAICS codes 6112 through 6116 were
categorized as four-year, two-year, or vocational schools.  Sites
represented by primary NAICS code 622 were categorized as hospitals.
Sites represented by any other primary NAICS code were excluded from the
rest of the analysis.

Exhibit 1 provides a description of the NAICS codes used in this
analysis, as well as the corresponding SIC codes.  The exhibit also
indicates how the NAICS codes were used to categorize LQGs by type of
institution.

Exhibit 1

NAICS/SIC Codes and Types of Institution Included in this Analysis

NAICS

Code

SIC

Code(s)

Industry Sector

Type of Institution

61131	8221	Colleges, Universities, and Professional Schools	Four-Year
School

61121	8222	Junior Colleges	Two-Year School

6114	8243, 8244, 8299	Business Schools and Computer and Management
Training	Vocational School

611519	8243, 8249, 8299	Other Technical and Trade Schools

	61161	7911, 8299	Fine Arts Schools

	611699	7999, 8299	All Other Miscellaneous Schools and Instruction

	62211	8062, 8069	General Medical and Surgical Hospitals	Hospital

62231	8069	Specialty (except Psychiatric and Substance Abuse) Hospitals

For sites categorized as four-year, two-year, or vocational schools, ICF
reviewed the list of site names to identify C/Us that have an art
program and/or a medical school.  In conducting this review, ICF
referred to the following two references:

The Art School and Program Directory, which was developed by
ArtSchools.com; and

List of Medical Schools of the U.S. and Canada, which was developed by
the Association of American Medical Colleges.

For sites categorized as hospitals, ICF reviewed the list of site names
to identify hospitals affiliated with a C/U.  If a hospital is
affiliated with a C/U (e.g., Howard University Hospital), the site was
considered a C/U LQG.  If a hospital is not affiliated with a C/U (e.g.,
Kaiser Permanente Medical Center), the site was excluded from the rest
of this analysis.  Note that, in determining whether a hospital is
affiliated with a C/U, we referred to List of Medical Schools of the
U.S. and Canada, which was developed by the Association of American
Medical Colleges.  If this reference did not address our need, we made a
determination based on information obtained through minimal research
(i.e., a simple Web search) or used our own judgment.

Step 2:  Compile Information on Hazardous Waste Generated by C/U LQGs in
2001

Once the C/U LQGs were identified, ICF compiled waste stream data
reported in Generation and Management (GM) Forms of the 2001 BR.  The GM
Form includes information on hazardous waste streams generated and
managed on site or sent off site for management.

For each hazardous waste stream generated by a C/U LQG, we compiled the
following information:

Quantity of waste generated;

Form code;

Source code;

RCRA radioactive mixed;

EPA hazardous waste codes representing the hazardous waste;

Waste type;

Waste description;

Indicator of whether the waste is a laboratory waste;

EPA ID of the facility managing the waste stream;

Name of the facility managing the waste stream;

Code of management method used; and

Quantity of waste managed using management method code.

The above data were included in the 2001 C/U LQG database developed
under Step 1.

Waste types were assigned to each waste stream based on the EPA
hazardous waste codes representing it.  For information on the waste
stream classification scheme used in this analysis, refer to Attachment
A.

ICF notes that, for purposes of this analysis, a waste was considered a
laboratory waste if the BR waste description contained the word
“lab.”

Step 3: Eliminate Remediation Waste Streams from the 2001 C/U LQG
Database

After compiling the waste stream information, ICF identified and
eliminated remediation waste streams from the 2001 C/U LQG database.
For purposes of this analysis, a waste was considered a remediation
waste if it was represented by the BR source code G41-G49, or the BR
waste description contained the word “remediation.”

Step 4:  Estimate Quantity of Hazardous Waste Generated by C/U LQGs in
2001

To estimate the total quantity of hazardous waste generated by C/U LQGs
in 2001, ICF added up the quantity of hazardous waste generated by each
of these sites in 2001.

2.	Data Summaries

Exhibit 2 shows the number of C/U LQGs and the quantity of hazardous
waste generated by these LQGs in 2001, by type of institution (e.g.,
four-year school), industry sector, and waste type.  It also shows the
total number of LQGs (i.e., 365) and the quantity of hazardous waste
generated by these LQGs in 2001 (i.e., 34,563 tons).

Exhibit 3 shows the number of C/U LQGs that generated laboratory waste
in 2001 and the quantity of laboratory waste generated by these LQGs, by
type of institution, industry sector, and waste type.  It also shows the
total number of LQGs (i.e., 266) and the quantity of laboratory waste
generated by these LQGs in 2001 (i.e., 3,109 tons).  ICF notes that, for
purposes of this analysis, a waste was considered a laboratory waste if
the BR waste description contained the word “lab.”

Exhibit 4 shows the number of LQGs at C/Us with art programs and the
quantity of hazardous waste generated by these LQGs in 2001, by type of
institution, industry sector, and waste type.  It also shows the total
number of LQGs (i.e., 239) and the quantity of hazardous waste generated
by these LQGs in 2001 (i.e., 7,167 tons).  ICF notes that the BR does
not contain a data element that indicates positively whether a hazardous
waste stream was generated as a result of art-related activities.  Thus,
the exhibit shows data for all hazardous waste generated by LQGs at C/Us
with art programs.  The reader should not assume, however, that all of
this waste quantity is related to art activities.  In fact, some
percentage of this waste might come from LQGs within the art programs.

Exhibit 5 shows the number of LQGs at C/Us with medical schools and the
quantity of hazardous waste generated by these LQGs in 2001, by type of
institution, industry sector, and waste type.  It also shows the total
number of LQGs (i.e., 66) and the quantity of hazardous waste generated
by these LQGs in 2001 (i.e., 1,475 tons).  ICF notes that the BR does
not contain a data element that indicates positively whether a hazardous
waste stream was generated as a result of medical school activities.
Thus, the exhibit shows data for LQGs whose site names refer to a
medical school or to a hospital affiliated with a C/U (i.e., a
university hospital).

Exhibit 2

Number of C/U LQGs and Quantity of Hazardous Waste Generated by These
LQGs in 2001,

by Type of Institution, Industry Sector and Waste Type a

Industry Sector	NAICS

Code	SIC

Code	Waste Type	Number of LQGs 	Gen Tons	% of Total Gen Tons c

4-Year Schools

Colleges, Universities, and Professional Schools	61131	8221	Dioxin
pesticide wastes	27	2.30	0.01%

Colleges, Universities, and Professional Schools	61131	8221	Heavy metal
and cyanide wastes	1	3.49	0.01%

Colleges, Universities, and Professional Schools	61131	8221	Ignitable,
corrosive, and/or reactive characteristic wastes	249	925.44	2.68%

Colleges, Universities, and Professional Schools	61131	8221	Inorganic
(metal) wastes	268	3,157.27	9.13%

Colleges, Universities, and Professional Schools	61131	8221	Lab packs
130	758.54	2.19%

Colleges, Universities, and Professional Schools	61131	8221	Listed
discarded chemical products (i.e., 'P' and/or 'U' code wastes)	206
216.95	0.63%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
hazardous wastes from non-specific sources (i.e., mixture of 'F' code
wastes)	7	23.87	0.07%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
toxic characteristic wastes (i.e., mixture of 'D' code wastes)	61	168.24
0.49%

Colleges, Universities, and Professional Schools	61131	8221	Organic
wastes	112	220.55	0.64%

Colleges, Universities, and Professional Schools	61131	8221	Pesticide
wastes	17	5.99	0.02%

Colleges, Universities, and Professional Schools	61131	8221	Spent
solvents	239	2,982.97	8.63%

Colleges, Universities, and Professional Schools	61131	8221	Unknown	34
159.19	0.46%

Subtotal	314 b	8,625	24.95%

2-Year Schools

Junior Colleges	61121	8222	Ignitable, corrosive, and/or reactive
characteristic wastes	8	8.39	0.02%

Junior Colleges	61121	8222	Inorganic (metal) wastes	8	28.72	0.08%

Junior Colleges	61121	8222	Lab packs	3	4.75	0.01%

Junior Colleges	61121	8222	Listed discarded chemical products (i.e., 'P'
and/or 'U' code wastes)	8	4.53	0.01%

Junior Colleges	61121	8222	Mixture of toxic characteristic wastes (i.e.,
mixture of 'D' code wastes)	2	4.13	0.01%

Junior Colleges	61121	8222	Organic wastes	8	9.28	0.03%

Junior Colleges	61121	8222	Spent solvents	7	22.73	0.07%

Subtotal	13 b	83	0.24%

Vocational Schools

All Other Miscellaneous Schools and Instruction	611699	7999, 8299
Ignitable, corrosive, and/or reactive characteristic wastes	1	0.08	0.00%

All Other Miscellaneous Schools and Instruction	611699	7999, 8299
Inorganic (metal) wastes	1	25,016.09	72.38%

All Other Miscellaneous Schools and Instruction	611699	7999, 8299	Listed
discarded chemical products (i.e., 'P' and/or 'U' code wastes)	1	0.08
0.00%

All Other Miscellaneous Schools and Instruction	611699	7999, 8299
Organic wastes	1	0.65	0.00%

All Other Miscellaneous Schools and Instruction	611699	7999, 8299	Spent
solvents	1	0.87	0.00%

Fine Arts Schools	61161	7911, 8299	Ignitable, corrosive, and/or reactive
characteristic wastes	2	1.28	0.00%

Fine Arts Schools	61161	7911, 8299	Inorganic (metal) wastes	2	11.06
0.03%

Fine Arts Schools	61161	7911, 8299	Listed discarded chemical products
(i.e., 'P' and/or 'U' code wastes)	2	2.43	0.01%

Fine Arts Schools	61161	7911, 8299	Mixture of toxic characteristic
wastes (i.e., mixture of 'D' code wastes)	1	0.81	0.00%

Fine Arts Schools	61161	7911, 8299	Organic wastes	2	3.20	0.01%

Fine Arts Schools	61161	7911, 8299	Spent solvents	1	1.09	0.00%

Fine Arts Schools	61161	7911, 8299	Unknown	1	1.20	0.00%

Other Technical and Trade Schools	611519	8243, 8249, 8299	Ignitable,
corrosive, and/or reactive characteristic wastes	1	9.99	0.03%

Other Technical and Trade Schools	611519	8243, 8249, 8299	Inorganic
(metal) wastes	2	32.21	0.09%

Other Technical and Trade Schools	611519	8243, 8249, 8299	Spent solvents
1	0.15	0.00%

Subtotal	6 b	25,081	72.57%

University Hospitals

General Medical and Surgical Hospitals	62211	8062, 8069	Ignitable,
corrosive, and/or reactive characteristic wastes	20	41.71	0.12%

General Medical and Surgical Hospitals	62211	8062, 8069	Inorganic
(metal) wastes	27	278.42	0.81%

General Medical and Surgical Hospitals	62211	8062, 8069	Lab packs	10
74.98	0.22%

General Medical and Surgical Hospitals	62211	8062, 8069	Listed discarded
chemical products (i.e., 'P' and/or 'U' code wastes)	21	22.15	0.06%

General Medical and Surgical Hospitals	62211	8062, 8069	Mixture of toxic
characteristic wastes (i.e., mixture of 'D' code wastes)	4	1.28	0.00%

General Medical and Surgical Hospitals	62211	8062, 8069	Organic wastes	6
1.06	0.00%

General Medical and Surgical Hospitals	62211	8062, 8069	Spent solvents
26	317.06	0.92%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Ignitable, corrosive, and/or reactive characteristic wastes	1	1.89	0.01%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Inorganic (metal) wastes	1	0.30	0.00%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Listed discarded chemical products (i.e., 'P' and/or 'U' code wastes)	1
3.50	0.01%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Spent solvents	1	32.30	0.09%

Subtotal	32 b	775	2.24%

Total	365	34,563	100.00%

a  Exhibit does not include data on remediation wastes.  For purposes of
this analysis, a waste was considered a remediation waste if it was
represented by the Biennial Report source code G41-G49, or the Biennial
Report waste description contained the word “remediation.”

b  An LQG may generate more than one type of waste.  Thus, the number of
LQGs is not additive.

c  Based on total quantity of waste generated by C/U LQGs in 2001, i.e.,
34,563 tons.

Exhibit 3

Number of C/U LQGs that Generated Laboratory Waste in 2001 and Quantity
of Laboratory Waste Generated

by These LQGs, by Type of Institution, Industry Sector and Waste Type a,
b

Industry Sector	NAICS

Code	SIC

Code	Waste Type	Number of LQGs 	Gen Tons	% of Total Gen Tons d

4-Year Schools

Colleges, Universities, and Professional Schools	61131	8221	Dioxin
pesticide wastes	10	1.70	0.00%

Colleges, Universities, and Professional Schools	61131	8221	Ignitable,
corrosive, and/or reactive characteristic wastes	107	244.60	0.71%

Colleges, Universities, and Professional Schools	61131	8221	Inorganic
(metal) wastes	112	328.65	0.95%

Colleges, Universities, and Professional Schools	61131	8221	Lab packs
114	653.99	1.89%

Colleges, Universities, and Professional Schools	61131	8221	Listed
discarded chemical products (i.e., 'P' and/or 'U' code wastes)	120
121.05	0.35%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
hazardous wastes from non-specific sources (i.e., mixture of 'F' code
wastes)	5	14.10	0.04%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
toxic characteristic wastes (i.e., mixture of 'D' code wastes)	28	45.18
0.13%

Colleges, Universities, and Professional Schools	61131	8221	Organic
wastes	26	22.82	0.07%

Colleges, Universities, and Professional Schools	61131	8221	Pesticide
wastes	5	0.51	0.00%

Colleges, Universities, and Professional Schools	61131	8221	Spent
solvents	137	1,484.21	4.29%

Colleges, Universities, and Professional Schools	61131	8221	Unknown	4
2.98	0.01%

Subtotal	235 c	2,920	8.45%

2-Year Schools

Junior Colleges	61121	8222	Ignitable, corrosive, and/or reactive
characteristic wastes	3	1.60	0.00%

Junior Colleges	61121	8222	Inorganic (metal) wastes	3	0.18	0.00%

Junior Colleges	61121	8222	Lab packs	3	4.68	0.01%

Junior Colleges	61121	8222	Listed discarded chemical products (i.e., 'P'
and/or 'U' code wastes)	5	2.12	0.01%

Junior Colleges	61121	8222	Spent solvents	4	6.48	0.02%

Subtotal	8 c	15	0.04%

Vocational Schools

All Other Miscellaneous Schools and Instruction	611699	7999, 8299
Ignitable, corrosive, and/or reactive characteristic wastes	1	0.08	0.00%

All Other Miscellaneous Schools and Instruction	611699	7999, 8299
Inorganic (metal) wastes	1	0.09	0.00%

All Other Miscellaneous Schools and Instruction	611699	7999, 8299	Listed
discarded chemical products (i.e., 'P' and/or 'U' code wastes)	1	0.08
0.00%

Fine Arts Schools	61161	7911, 8299	Inorganic (metal) wastes	1	3.58	0.01%

Fine Arts Schools	61161	7911, 8299	Listed discarded chemical products
(i.e., 'P' and/or 'U' code wastes)	2	0.54	0.00%

Subtotal	3 c	4	0.01%

University Hospitals

General Medical and Surgical Hospitals	62211	8062, 8069	Ignitable,
corrosive, and/or reactive characteristic wastes	10	20.94	0.06%

General Medical and Surgical Hospitals	62211	8062, 8069	Inorganic
(metal) wastes	10	2.37	0.01%

General Medical and Surgical Hospitals	62211	8062, 8069	Lab packs	6
27.91	0.08%

General Medical and Surgical Hospitals	62211	8062, 8069	Listed discarded
chemical products (i.e., 'P' and/or 'U' code wastes)	12	8.50	0.02%

General Medical and Surgical Hospitals	62211	8062, 8069	Mixture of toxic
characteristic wastes (i.e., mixture of 'D' code wastes)	2	0.79	0.00%

General Medical and Surgical Hospitals	62211	8062, 8069	Organic wastes	2
0.04	0.00%

General Medical and Surgical Hospitals	62211	8062, 8069	Spent solvents
10	71.84	0.21%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Ignitable, corrosive, and/or reactive characteristic wastes	1	1.69	0.00%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Inorganic (metal) wastes	1	0.22	0.00%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Listed discarded chemical products (i.e., 'P' and/or 'U' code wastes)	1
3.42	0.01%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Spent solvents	1	32.30	0.09%

Subtotal	20 c	170	0.49%

Total	266	3,109	9.00%

a  For purposes of this analysis, a waste was considered a laboratory
waste if the Biennial Report waste description contained the word
“lab.”

b  Exhibit does not include data on remediation wastes.  For purposes of
this analysis, a waste was considered a remediation waste if it was
represented by the Biennial Report source code G41-G49, or the Biennial
Report waste description contained the word “remediation.”

c  An LQG may generate more than one type of waste.  Thus, the number of
LQGs is not additive.

d  Based on total quantity of waste generated by C/U LQGs in 2001, i.e.,
34,563 tons.

Exhibit 4

Number of LQGs at C/Us with Art Programs and Quantity of Hazardous Waste
Generated

by These LQGs in 2001, by Type of Institution, Industry Sector, and
Waste Type a, b

Industry Sector	NAICS

Code	SIC

Code	Waste Type	Number of LQGs 	Gen Tons	% of Total Gen Tons d

4-Year Schools

Colleges, Universities, and Professional Schools	61131	8221	Dioxin
pesticide wastes	22	1.92	0.01%

Colleges, Universities, and Professional Schools	61131	8221	Heavy metal
and cyanide wastes	1	3.49	0.01%

Colleges, Universities, and Professional Schools	61131	8221	Ignitable,
corrosive, and/or reactive characteristic wastes	190	771.26	2.23%

Colleges, Universities, and Professional Schools	61131	8221	Inorganic
(metal) wastes	200	2,814.82	8.14%

Colleges, Universities, and Professional Schools	61131	8221	Lab packs	99
589.90	1.71%

Colleges, Universities, and Professional Schools	61131	8221	Listed
discarded chemical products (i.e., 'P' and/or 'U' code wastes)	150
181.43	0.52%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
hazardous wastes from non-specific sources (i.e., mixture of 'F' code
wastes)	7	23.87	0.07%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
toxic characteristic wastes (i.e., mixture of 'D' code wastes)	44	138.96
0.40%

Colleges, Universities, and Professional Schools	61131	8221	Organic
wastes	73	100.13	0.29%

Colleges, Universities, and Professional Schools	61131	8221	Pesticide
wastes	9	1.37	0.00%

Colleges, Universities, and Professional Schools	61131	8221	Spent
solvents	180	2,370.39	6.86%

Colleges, Universities, and Professional Schools	61131	8221	Unknown	28
129.55	0.37%

Subtotal	235 c	7,127	20.62%

2-Year Schools

Junior Colleges	61121	8222	Ignitable, corrosive, and/or reactive
characteristic wastes	1	0.09	0.00%

Junior Colleges	61121	8222	Inorganic (metal) wastes	2	16.96	0.05%

Junior Colleges	61121	8222	Listed discarded chemical products (i.e., 'P'
and/or 'U' code wastes)	1	1.59	0.00%

Subtotal	2 c	19	0.05%

Vocational Schools

Fine Arts Schools	61161	7911, 8299	Ignitable, corrosive, and/or reactive
characteristic wastes	2	1.28	0.00%

Fine Arts Schools	61161	7911, 8299	Inorganic (metal) wastes	2	11.06
0.03%

Fine Arts Schools	61161	7911, 8299	Listed discarded chemical products
(i.e., 'P' and/or 'U' code wastes)	2	2.43	0.01%

Fine Arts Schools	61161	7911, 8299	Mixture of toxic characteristic
wastes (i.e., mixture of 'D' code wastes)	1	0.81	0.00%

Fine Arts Schools	61161	7911, 8299	Organic wastes	2	3.20	0.01%

Fine Arts Schools	61161	7911, 8299	Spent solvents	1	1.09	0.00%

Fine Arts Schools	61161	7911, 8299	Unknown	1	1.20	0.00%

Subtotal	2 c	21	0.06%

Total	239	7,167	20.74%

a  The Biennial Report does not contain a data element that indicates
positively whether a hazardous waste stream was generated as a result of
art-related activities.  Thus, the exhibit shows data for all hazardous
waste generated by LQGs at C/Us with art programs.  It should not be
assumed, however, that all of this waste quantity is related to art
activities.  In fact, some percentage of this waste might come from LQGs
within the art programs.

b  Exhibit does not include data on remediation wastes.  For purposes of
this analysis, a waste was considered a remediation waste if it was
represented by the Biennial Report source code G41-G49, or the Biennial
Report waste description contained the word “remediation.”

c  An LQG may generate more than one type of waste.  Thus, the number of
LQGs is not additive.

d  Based on total quantity of waste generated by C/U LQGs in 2001, i.e.,
34,563 tons.

Exhibit 5

Number of LQGs at C/Us with Medical Schools and Quantity of Hazardous
Waste Generated

by These LQGs in 2001, by Type of Institution, Industry Sector and Waste
Type a, b

Industry Sector	NAICS

Code	SIC

Code	Waste Type	Number of LQGs 	Gen Tons	% of Total Gen Tons d

4-Year Schools

Colleges, Universities, and Professional Schools	61131	8221	Dioxin
pesticide wastes	1	0.25	0.00%

Colleges, Universities, and Professional Schools	61131	8221	Ignitable,
corrosive, and/or reactive characteristic wastes	19	55.52	0.16%

Colleges, Universities, and Professional Schools	61131	8221	Inorganic
(metal) wastes	25	114.99	0.33%

Colleges, Universities, and Professional Schools	61131	8221	Lab packs	13
46.65	0.13%

Colleges, Universities, and Professional Schools	61131	8221	Listed
discarded chemical products (i.e., 'P' and/or 'U' code wastes)	23	34.17
0.10%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
hazardous wastes from non-specific sources (i.e., mixture of 'F' code
wastes)	1	5.17	0.01%

Colleges, Universities, and Professional Schools	61131	8221	Mixture of
toxic characteristic wastes (i.e., mixture of 'D' code wastes)	5	4.56
0.01%

Colleges, Universities, and Professional Schools	61131	8221	Organic
wastes	8	7.78	0.02%

Colleges, Universities, and Professional Schools	61131	8221	Pesticide
wastes	1	0.06	0.00%

Colleges, Universities, and Professional Schools	61131	8221	Spent
solvents	30	431.15	1.25%

Colleges, Universities, and Professional Schools	61131	8221	Unknown	1
0.32	0.00%

Subtotal	34 c	701	2.03%

University Hospitals

General Medical and Surgical Hospitals	62211	8062, 8069	Ignitable,
corrosive, and/or reactive characteristic wastes	20	41.71	0.12%

General Medical and Surgical Hospitals	62211	8062, 8069	Inorganic
(metal) wastes	27	278.42	0.81%

General Medical and Surgical Hospitals	62211	8062, 8069	Lab packs	10
74.98	0.22%

General Medical and Surgical Hospitals	62211	8062, 8069	Listed discarded
chemical products (i.e., 'P' and/or 'U' code wastes)	21	22.15	0.06%

General Medical and Surgical Hospitals	62211	8062, 8069	Mixture of toxic
characteristic wastes (i.e., mixture of 'D' code wastes)	4	1.28	0.00%

General Medical and Surgical Hospitals	62211	8062, 8069	Organic wastes	6
1.06	0.00%

General Medical and Surgical Hospitals	62211	8062, 8069	Spent solvents
26	317.06	0.92%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Ignitable, corrosive, and/or reactive characteristic wastes	1	1.89	0.01%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Inorganic (metal) wastes	1	0.30	0.00%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Listed discarded chemical products (i.e., 'P' and/or 'U' code wastes)	1
3.50	0.01%

Specialty (except Psychiatric and Substance Abuse) Hospitals	62231	8069
Spent solvents	1	32.30	0.09%

Subtotal	32 c	775	2.24%

Total	66	1,475	4.27%

a  The Biennial Report does not contain a data element that indicates
positively whether a hazardous waste stream was generated as a result of
medical school activities.  Thus, the exhibit shows data for LQGs whose
site names refer to a medical school or to a hospital affiliated with a
C/U (i.e., a university hospital).

b  Exhibit does not include data on remediation wastes.  For purposes of
this analysis, a waste was considered a remediation waste if it was
represented by the Biennial Report source code G41-G49, or the Biennial
Report waste description contained the word “remediation.”

c  An LQG may generate more than one type of waste.  Thus, the number of
LQGs is not additive.

d  Based on total quantity of waste generated by C/U LQGs in 2001, i.e.,
34,563 tons.

Attachment A

Waste Stream Classification

Waste Stream Classification

As described in Step 2 of this memorandum, ICF has attempted to describe
the waste streams of C/U LQGs based on their waste codes.  If one waste
code was reported for a given waste stream, ICF relied on that code to
describe the waste (e.g., a waste stream with only a D004 waste code was
described as “inorganic (metal) waste”).

Note that many hazardous waste streams include two or more waste codes.
For these waste streams, ICF developed a simplifying approach for
describing them.  Specifically, ICF used the classification scheme in
Exhibit A-1 to classify waste codes as either “primary” or
“secondary” codes.  Primary waste codes are codes that, in ICF’s
professional judgment, more accurately describe the type of waste in
comparison with secondary codes.

ICF used primary codes to describe waste streams with two or more waste
codes.  For example, as shown in the exhibit, a waste stream containing
F001 and D001 waste codes was described in this memorandum as a “spent
solvent.”

Exhibit A-1

Waste Stream Classification Scheme

EPA Hazardous Waste Code(s) Representing the Waste Streams

Waste Type

Primary Waste Code(s)

Secondary Waste Code (s)

One or more D001-D003 code

None

Ignitable, corrosive, and/or reactive characteristic wastes

One or more D004-D011 code

None

One or more D001-D003 code

Inorganic (metal) wastes

One or more D012-D017 code

None

One or more D001-D003 code

Pesticide wastes

One or more D018-D043 code

None

One or more D001-D003 code

Organic wastes

Any other D mixtures

None

Mixture of toxic characteristic wastes (i.e., mixture of “D” code
wastes)

One or more F001-F005 code

Any P, U, or D codes

Spent solvents

One or more F006-F012, F019 code

Any P, U, or D codes

Heavy metal and cyanide wastes

One or more F020-F028 code

Any P, U, or D codes

Dioxin pesticide wastes

One or more F032, F034-F035 code

Any P, U, or D codes

Wood preserving wastes

One or more F037-F038 code

Any P, U, or D codes

Petroleum refining sludges

F039

Any other code

Multi-source leachates

Any other F mixtures

Any P, U, or D codes

Mixture of hazardous wastes from non-specific sources (i.e., mixture of
“F” code wastes)

K001

Any other non-K codes

Wood preserving wastes

One K002-K008 code

Any other non-K codes

Inorganic pigment production wastes

One K009-K011, K013-K030, K083, K085, K093-K096, K103-K105, K107-K118,
K136, K149-K151, K156-K159, K161 code

Any other non-K codes

Organic chemical production wastes

One K031-K043, K097-K099, K123-K126, K131-K132 code

Any other non-K codes

Pesticide production wastes

One K044-K047 code

Any other non-K codes

Explosive manufacturing wastes

One or more K048-K052 code

Any other non-K codes

Petroleum refining wastes

One K060, K087, K141-K145, K147-K148 code

Any other non-K codes

Coking operation wastes

One K061-K062 code

Any other non-K codes

Iron and steel production wastes

K064

Any other non-K codes

Primary copper production wastes

K065

Any other non-K codes

Primary lead production wastes

K066

Any other non-K codes

Primary zinc production wastes

One K069, K100 code

Any other non-K codes

Secondary lead smelting wastes

One K071, K073, K106 code

Any other non-K codes

Inorganic chemical production wastes

One K084, K101-K102 code

Any other non-K codes

Veterinary pharmaceutical production wastes

K086

Any other non-K codes

Ink formulation wastes

K088

Any other non-K codes

Primary aluminum production wastes

One K090-K091 code

Any other non-K codes

Ferroalloy production wastes

Any other K mixtures (i.e., any non K048-K052 code combination)

Any other non-K codes

Mixture of hazardous wastes from specific sources (i.e., mixture of
“K” code wastes)

One or more P or U code

Listed discarded chemical products (i.e., “P” and/or “U” code
wastes)

Lab packs with no identified code

(i.e., “LABP”)

Any other code

Lab packs

  SIC codes are not reported in the Site ID Form.  ICF referred to the
U.S. Census Bureau’s 1997 NAICS and 1987 SIC Correspondence Tables
(available at http://www.census.gov) to identify the SIC code(s)
associated with the primary NAICS code reported in the Site ID Forms.

  Available at: http://www.artschools.com/.

  Available at:  http://www.aamc.org/members/listings/msalphaae.htm.

  Available at:  http://www.aamc.org/members/listings/msalphaae.htm.

  Based on technical direction provided by the EPA WAM on February 8,
2005.

  Based on technical direction provided by the EPA WAM on April 26,
2005.

Page  PAGE  2

Exhibit 2 (continued)

Number of C/U LQGs and Quantity of Hazardous Waste Generated by These
LQGs in 2001,

by Type of Institution, Industry Sector and Waste Type a

Exhibit 4 (continued)

Number of LQGs at C/Us with Art Programs and Quantity of Hazardous Waste
Generated

by These LQGs in 2001, by Type of Institution, Industry Sector, and
Waste Type a, b

Exhibit 5 (continued)

Number of LQGs at C/Us with Medical Schools and Quantity of Hazardous
Waste Generated

by These LQGs in 2001, by Type of Institution, Industry Sector and Waste
Type a, b

Exhibit A-1 (continued)

Waste Stream Classification Scheme

Page A- PAGE  1


[Federal Register: October 9, 2009 (Volume 74, Number 195)]
[Notices]
[Page 52244-52245]
[DOCID:fr09oc09-73]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0118]

Guidances for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Documents: Respiratory Viral Panel
Multiplex Nucleic Acid Assay; and Testing for Human Metapneumovirus
Using Nucleic Acid Assays; and Testing for Detection and
Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic
Acid Assays; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the special controls guidance document entitled ``Class
II Special Controls Guidance Document: Respiratory Viral Panel
Multiplex Nucleic Acid Assay,'' and two companion special controls
guidance documents entitled ``Class II Special Controls Guidance
Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid
Assays'' and ``Class II Special Controls Guidance Document: Testing for
Detection and Differentiation of Influenza A Virus Subtypes Using
Multiplex Nucleic Acid Assays.'' These guidance documents describe a
means by which respiratory viral panel multiplex nucleic acid assays
may comply with the requirement of special controls for class II
devices. The guidance documents include recommendations for performance
evaluation, labeling, and measures to address the effects of ancillary
reagents (specific reagents required under instructions for use of the
assay but not provided) on safety and effectiveness of the device.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule codifying the classification of the respiratory viral panel
multiplex nucleic acid assay into class II (special controls), and
establishing these guidance documents as the special controls for those
devices.

DATES:  Submit written or electronic comments on the guidances at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES:  Submit written requests for single copies of the guidance
documents entitled ``Class II Special Controls Guidance Document:
Respiratory Viral Panel Multiplex Nucleic Acid Assay,'' ``Class II
Special Controls Guidance Document: Testing for Human Metapneumovirus
(hMPV) Using Nucleic Acid Assays,'' or ``Class II Special Controls
Guidance Document: Testing for Detection and Differentiation of
Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assay'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993. Send one self-addressed adhesive label to assist that
office in processing your request, or fax your request to<PHONE_NUMBER>.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
    Submit written comments concerning these guidances to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5550, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule codifying the classification of the respiratory viral
panel multiplex nucleic acid assay into class II (special controls)
under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360c(f)(2)), and establishing these guidance
documents as the special controls for respiratory viral panel multiplex
nucleic acid assay devices classified under that regulation. Section
513(f)(2) of the act provides that any person who submits a premarket
notification under section 510(k) of the act (21 U.S.C. 360(k)) for a
device that has not previously been classified may, within 30 days
after receiving an order classifying the device in class III under
section 513(f)(1), request FDA to classify the device under the
criteria set forth in section 513(a)(1). FDA shall, within 60 days of
receiving such a request, classify the device by written order. This
classification shall be the initial classification of the device.
Within 30 days after the issuance of an order classifying the device,
FDA must publish a notice in the Federal Register announcing such
classification.
    Under this authority, on January 3, 2008, FDA by order classified
into class II, subject to these special control guidance documents, the
Luminex Molecular Diagnostics, Inc., xTAG\TM\ RVP (Respiratory Viral
Panel).

II. Significance of Special Controls Guidance Documents

    FDA believes that adherence to the recommendations described in
these guidance documents, in addition to the general controls, will
provide reasonable assurance of the safety and effectiveness of
respiratory viral panel multiplex nucleic acid assays classified under
Sec.  866.3080. In order to be classified as a class II device under
Sec.  866.3080, an RVP device must comply with the requirement of
special controls; manufacturers must address the issues requiring
special controls as identified in the guidance documents, either by
following the recommendations in the guidance documents or by some
other means that provides equivalent assurances of safety and
effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of any of the guidance
documents may do so by using the Internet. To receive ``Class II
Special Controls Guidance Document: Respiratory Viral Panel Multiplex
Nucleic Acid Assay,'' (document number 1669); ``Class II Special
Controls Guidance Document: Testing for Human Metapneumovirus (hMPV)
Using Nucleic Acid Assays,'' (document number 1673); or ``Class II
Special Controls Guidance Document: Testing for Detection and
Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic
Acid Assays,'' (document number 1672); you may either send an e-mail
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document, or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document numbers shown in parentheses in the previous
sentence to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information.

The CDRH Web site may be accessed at http://www.fda.gov/MedicalDevices/
default.htm. A search capability for all CDRH guidance documents is
available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available on the Division of Dockets Management
Internet site at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule establishing as special controls for the respiratory viral
panel multiplex nucleic acid assay the three guidance documents that
are the subject of this notice. The preamble to that rule addresses the
application of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520) to the information collection provisions referenced in these
guidance documents.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Revised comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: October 1, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24431 Filed 10-8-09; 8:45 am]

BILLING CODE 4160-01-S


The Honorable Sandra Keo Chairwoman Sac & Fox Tribe of Missouri 305 North Main Street Reserve, KS 66434 Dear Chairwoman Keo:

On July 18, 1997, the Environmental Protection Agency ( EPA) promulgated the National Ambient Air Quality Standard ( NAAQS) for fine particulate matter or PM 2.5. This standard addresses particulate matter less than 2.5 microns in diameter and was based on EPA's review of a number of health studies which indicate that exposure to fine particulate matter is correlated with increased mortality and serious health affects such as aggravation of lung disease, asthma attacks, and heart problems.

As a first step in the process towards implementing this new fine particulate matter standard, the EPA requests that you submit recommended designation and documentation in accordance with section 107( d)( 1)( A) of the Clean Air Act to us by February 15, 2004. Your Tribe's participation in this process is optional. The recommended area designation should be based on quality assured air quality monitoring data for calendar years 2000 to 2002. EPA may make modifications to these designations as it deems necessary. If EPA determines that a modification to a Tribe's recommendation is necessary, the EPA will notify the Tribe no later than 120 days prior to promulgating the designations. This will provide the Tribe an opportunity to demonstrate why the EPA's modification is not appropriate. EPA intends to promulgate final designations by December 15, 2004, based on the most recent available data.

We will consult with your Environmental Director in this process and offer the EPA's assistance so that their office might advise you on the designation of your reservation. We are also available to meet with you at your request. A copy of the guidance and a Fact Sheet are enclosed. The documents may also be found at the following webpage: http:// www. epa. gov/ ttn/ naaqs/ pm/ pm25_ index. html We will keep your tribe informed of any additional guidance and other support activities. Should you have any questions regarding this matter, please contact Art Spratlin, Director of the Air, RCRA, and Toxics Division, who may be contacted at ( 913) 551 7401.

Sincerely,

James B. Gulliford Regional Administrator Enclosures cc: Ms. Gina Kneib Environmental Director ARTD/ APDB: cas: c:/ JROBINSON/ KEO. WPD/ 062403 APDB APDB CNSL ARTD OEP RGAD Robinson Tapp Patrick Spratlin Bustos Guilliford 06/ / 03 06/ / 03 06/ / 03 06/ / 03 06/ / 03 06/ / 03