As a general matter, in manufacturing processes the determination of when a material becomes a 

solid waste is made after the material is removed from the “manufacturing process unit” 

[40 CFR 261.4(c)]. DOE suggests that this concept also be applied to laboratory environments so 

that chemicals would not be considered solid waste until they have been removed from the 

laboratory process unit (i.e., an area in which an experimental, analytical, or instructional process 

involving the use of chemicals at one or more stations takes place under the supervision of a 

qualified person, such as a principal investigator, research director, laboratory manager, or other 

technically qualified individual). Under this approach, chemicals would be allowed to 

accumulate in the laboratory process unit indefinitely without making a hazardous waste 

determination until a specified quantity, such as 55 gallons (or one quart for acutely hazardous 

material), has been collected. More chemicals might be allowed a higher limit, such as 110 

gallons (or two quarts for acutely hazardous material), if secondary containment were provided 

and operations were governed by an environmental management system (EMS). Within a 

specified time after reaching applicable threshold (e.g., 10 days), the container(s) would need to be 

dated and excess material would then be moved to a central waste collection area. Waste 

generation from the laboratory process unit would be defined to occur when the dated containers 

were transferred to the central waste accumulation area from the laboratory process unit. At the 

central waste accumulation area, a qualified environmental professional would determine whether 

accumulated chemicals must be managed as hazardous waste or could be reused or recycled. 

Such a determination would be required to occur within a specified time (e.g., 30 days) after the 

date on the accumulation container. 

Also, within the same specified time, chemicals determined to be hazardous waste would need to 

be transferred to either an on-site 90-day hazardous waste storage facility or a permitted on-site or 

off-site hazardous waste treatment, storage, or disposal facility. A maximum capacity could be 

established for accumulation of hazardous wastes within the central waste accumulation area.

Inherent in this approach is the reality that laboratory operations occur by or under the supervision 

of a principal investigator, research director, laboratory manager, or other technically qualified 

person, and occur within an area assigned to that person. Activities not occurring within such an 

area, or outside the scope of supervision by such a responsible person, would not be considered to 

occur within a laboratory process unit. Prior to the time chemicals are moved to the central 

collection area from the laboratory process unit, the chemicals would be subject to the applicable 

laboratory practice regulations promulgated under the Occupational Health and Safety Act (see 29 

CFR 1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories”).

Incorporating this laboratory process unit approach into the generator regulations would be 

a more workable system than the existing satellite accumulation area system as it has been 

applied to some laboratory settings. Specifically, the existing provisions in 40 CFR 

262.34(c)(1), which allow a generator without a permit or interim status to accumulate 

limited quantities of hazardous waste “in containers at or near any point of generation 

where wastes initially accumulate that is under the control of the operator of the process 

generating the waste,” have been interpreted in the ways listed below when applied to some 

laboratories. 

In certain cases, each experiment/research station in a laboratory has been interpreted to be a 

“process generating the waste.”
 Similarly, each experiment/research station has sometimes been interpreted to be “the 

point of generation where wastes initially accumulate.” Under this interpretation, a 

separate waste accumulation container must be placed at or near each experiment 

station.

 In some cases, the individual researcher at each experiment/research station has been 

interpreted to be “the operator of the process generating the waste.” Hence, each 

researcher has been required to maintain control of the waste accumulation container 

near his/her experiment station. Furthermore, “control” has been interpreted to mean 

that, because individual researchers cannot be present to monitor their waste 

accumulation containers at all times, locking devices must be used. Restricting 

building access has been determined to be insufficient for meeting this requirement. 

Overall, these interpretations result in a very narrow definition of “operator of the 

process,” which appears to be inconsistent with the definitions of “generator,” 

“person,” and “operator,” in 40 CFR 260.10, and EPA guidance [EPA, “Hazardous 

Waste Generated in Laboratories,” Memorandum from E. Cotsworth to RCRA Senior 

Policy Advisors in EPA Regions I – X, Faxback #14618, August 16, 2002]. 

 Individual researchers have been required to characterize wastes accumulated in 

containers and assign Land Disposal Restrictions (LDR) treatment standards codes 

before transfer of the containers to a central accumulation area.

DOE believes that the interpretations listed above may cause the undesirable 

outcomes listed below, which would be alleviated with no adverse effect on 

personnel safety, human health, or the environment if the suggested laboratory 

process unit approach were adopted and implemented. 

 Requiring a separate waste container for each experiment/research station 

significantly increases the number of waste containers in a laboratory, which 

increases the potential for accidental spills and releases of potentially hazardous 

chemicals. 

 Requiring that hazardous waste determinations be made at each experiment/research 

station significantly reduces the opportunity for reuse and recycle of surplus chemicals, 

because individual researchers are not necessarily aware of reuse and recycle 

opportunities throughout the laboratory facility. 

 Requiring researchers to make hazardous waste determinations and assign LDR 

treatment standards codes significantly increases the number of persons requiring 

training. In addition, it may result in waste characterizations being made by personnel 

that are less qualified than an environmental professional who would routinely perform 

this task at a central accumulation area. 

DOE notes that compliance with 40 CFR 262.34(c)(1) was not as significant an issue before 

regulations implementing the LDR program were promulgated. However, for the purpose of 

identifying the point at which materials become subject to the LDR treatment standards, the EPA 

has articulated certain interpretations of the meaning of the term “point of generation.” As a 
result, regulatory inspectors are now interpreting the term “point of generation” as having the same 

meaning for purposes of evaluating compliance with satellite accumulation area requirements as 

for LDR program purposes. In some cases, this has resulted in a determination that the point of 

generation for laboratory wastes is located upstream of the container in which waste accumulates, 

because the waste leaves the “process” prior to placement in the container. DOE submits that it is 

impractical to expect that full waste designation for newly generated laboratory wastes can be 

made before they have been accumulated in containers, collected, and evaluated in the context of 

other laboratory wastes generated at the same facility. Accordingly, DOE suggests that the point 

of generation at which laboratory waste should be characterized is the point at which the 

accumulation container exits the laboratory process unit and is placed in a central accumulation 

area. This regulatory approach would allow trained environmental professionals to fully

designate waste after accumulation in order to provide for full evaluation of reuse and recycling 

opportunities at the laboratory facility, LDR compliance, and proper disposal, while assuring safe

management during waste accumulation periods.

(b) If the EPA decides not to adopt the laboratory process unit approach suggested in Specific 

Comment IV.2, item 1(a), DOE suggests that the Agency (either in guidance or the preamble to an 

NPRM or final rule) explicitly interpret certain laboratory processes as being subject to the 

manufacturing process unit approach [40 CFR 261.4(c)]. For example, High Pressure Liquid 

Chromatography (HPLC) equipment uses solvents to carry chemical samples into the HPLC unit. 

Within the unit, the carrier solvent containing the chemical sample is pumped through a column 

that separates the chemical from the solvent. The carrier solvent exits the column and is collected 

in a small container. The solvent enters the container through a tube that penetrates the top of the 

container. DOE suggests that the container into which the solvent is conveyed be considered part 

of the HPLC unit and that the whole HPLC, including the container, be considered a 

manufacturing process unit. If this approach were adopted, then pursuant to 40 CFR 261.4(c), the 

solvent collected in the container would not become solid or hazardous waste until it has been 

removed from the unit. In addition, there would be no further need to debate whether, due to the 

tube penetration at the top, the container complies the requirement in 40 CFR 265.173(a) that 

storage containers be closed unless waste is being added or removed. 

(c) If the EPA decides not to adopt the laboratory process unit approach suggested in Specific 

Comment IV.2, item 1(a), DOE also suggests that EPA consider modifying 40 CFR 262.34(c) by

creating a new type of generator accumulation area. This would be a central accumulation area 

for short-term aggregation (or staging) of hazardous wastes as they are being moved from satellite 

accumulation areas to on-site 90-day storage facilities or permitted treatment, storage, or disposal 

facilities located either on site or off site. The concept would be similar to the “transfer facility” 

concept that already exists for hazardous waste transporters in 40 CFR 263.12. Specifically, 

DOE suggests modifying 40 CFR 262.34(c) by adding the following provisions in an appropriate 

location: 

A generator may accumulate hazardous wastes without a permit or interim status and without 

complying with the requirements in 40 CFR 262.34(a) (applicable to generator storage up to 90 

days) at a central location near the point of generation for the purpose of sorting, consolidating, or 

repackaging the wastes provided that: (i) the wastes are in containers; (ii) no waste remains in the 

central area longer than 10 days; and (iii) the generator complies with the hazardous waste 
container requirements in 40 CFR 265.171, 265.172, and 265.173.

In the approach suggested here, the accumulation of hazardous waste laboratory chemicals in 

containers at or near their point of generation would remain subject to the existing requirements 

applicable to satellite accumulation areas [40 CFR 262.34(c)]. However, the generator would not 

necessarily be required to transfer excess accumulated hazardous wastes within 3 days directly

from the satellite accumulation area to either on-site 90-day storage units or permitted on-site or 

off-site treatment, storage, or disposal units. Instead, the generator would have the option to 

transfer excess wastes to the new central accumulation unit instead, where the waste could be held 

in containers for up to 10 days without a permit. During the 10 days, the waste could be sorted, 

consolidated, or repackaged prior to being transferred to either on-site 90-day storage units or 

permitted on-site or off-site treatment, storage, or disposal units.

2. Although 40 CFR 262.34(a)(2) does not state that tanks are subject to its date marking 

requirement, EPA guidance indicates that the Agency intended for both tanks and containers to be 

marked with accumulation start dates [see 51 FR 10146, 10160 (March 24, 1986); EPA, “RCRA, 

Superfund, and EPCRA Call Center Monthly Report,” EPA530-R-03-002f, Faxback #14683, June 

2003]. DOE suggests that the EPA modify 40 CFR 262.34 to clarify the requirement for marking 

the accumulation start date on a hazardous waste tank. 

3. DOE suggests that the EPA consider the following other clarifications in 40 CFR 

262.34(c), if the laboratory process unit approach is not adopted:

 40 CFR 262.34(c)(1) allows a generator to accumulate hazardous waste without a permit in 

containers “at or near any point of generation.” The definition of the phrase “at or near,” 

as used in this section, is not clear. As a result, the question of proper location for a 

satellite accumulation area has frequently been raised during regulatory inspections at 

DOE facilities. DOE believes the confusion would be lessened if guidance on this point 

were available. DOE would appreciate having such guidance structured to also address a 

related issue concerning accumulation of flammable or reactive materials that must be 

stored in accordance with the Uniform Fire Code (UFC). It is not always possible to 

provide UFC-compliant accumulation “at or near” the point of generation. Hence, DOE 

encourages the EPA to consider issuing an interpretation of the phrase “at or near the point 

of generation” that would provide sufficient flexibility to accommodate the safety 

requirements for storage/accumulation of hazardous wastes imposed by other applicable 

regulations (such as the UFC).

DOE suggests that the EPA consider modifying 40 CFR 262.34 to explicitly authorize generators 

to treat hazardous wastes without a permit or interim status in accumulation areas located near the 

point of generation, if such treatment is performed in a tank or container that complies with the 

technical standards in 40 CFR 265, subpart I or subpart J, as appropriate. In addition, the EPA 

should consider specifying in 40 CFR 262.34 that, while the treatment cannot involve incineration, 

burning, or other thermal treatment, any other treatment technology protective of human health 

and environment and that can be safely performed in a tank or container would be acceptable.

4. Another aspect of 40 CFR part 262, subpart J, “University Laboratories XL 

Project—Laboratory Environmental Management Standard” [see 40 CFR 262.104], that DOE 

believes should be made available to all laboratories is allowing containers too small to be labeled 
(e.g., vials, test tubes, and other glass waste) to be placed into secondary containers for labeling.

5. 5. DOE supports finalization of the changes to the Uniform Hazardous Waste Manifest 

program proposed in the Federal Register on May 22, 2001 [66 FR 28239-28318]. In 

particular (consistent with the Department’s comments submitted October 4, 2001, Docket 

Number F-2000-UWMP-FFFFF), DOE encourages the EPA to move toward use of a 

single, easily acquired manifest form while retaining origination and/or destination States’ 

ability to require additional information on the form. DOE also supports the development 

of an electronic manifest system that would simplify the task of preparation and tracking of 

these important documents.

6. 6. DOE suggests that the EPA add a definition for “empty tank” to the regulations, 

including delineation of the status of the residue in an empty tank, similar to 40 CFR 261.7 

(Residues of hazardous Waste in Empty Containers).

7. 40 CFR Section 262.34(a) requires generators who accumulate hazardous waste for less 

than 90 days to comply with the requirements in 40 CFR 265, subpart D with respect to their 

90-day storage units. Subpart D requires that the owner/operator file a written report to the 

Regional Administrator within 15 days after an incident occurs that requires implementing the 

contingency plan [40 CFR 265.56(j)]. DOE suggests that the EPA consider clarifying the 

meaning of the phrase “implementing the contingency plan” in this requirement, at least with 

respect to 90-day storage units. Specifically, DOE suggests that a written report be required only 

if the contingency plan was implemented in response to an event that could threaten human health 

or the environment.

8. 8. 40 CFR Section 262.34(b) allows generators to request an extension of up to 30 days to the 

90-day accumulation time. The EPA Regional Administrator may grant such an 

extension on a case-by-case basis if the need for the extension arises due to unforeseen, 

temporary, and uncontrollable circumstances. DOE suggests that the EPA consider 

providing a self-implementing provision for extensions of the type described in 40 CFR 

262.34(b) if secondary containment for the affected storage unit has been provided. The 

generator could still be required to establish and document that the circumstances requiring 

the extension were unforeseen, temporary, and uncontrollable. However, instead of 

submitting such documentation to the Regional Administrator, it would be available in the 

generator’s records for review by the EPA (and authorized State representatives) at any

time.