Summary of Stakeholder Comments By Topic 

(Waste Determinations)

Stakeholder: Rutgers University Topic: Move waste determination to CAA

Comment: Current regulation states, the hazardous waste determination must be made by the 

person generating the waste (40 CFR 262.1 1). Currently at many research locations the 

researchers and scientists are the individuals generating the waste. Although these individuals are 

familiar with the chemical constituents and the properties of these chemicals, they are not familiar 

with the RCRA regulations and waste classification.

The generator program would be improved if the waste could be collected, and later 

classified by a more experienced person. The facility Environmental Health and Safety (EHS) 

professionals are typically have more expertise with the RCRA regulations and hazardous waste 

classification. The researcher would be responsible to collect the waste at the point of 

generation and list the constituents of the waste on the container, but not determine if it is a 

R C M regulated waste. The waste materials can then be classified and appropriately labeled 

prior to being brought to a central collection point by the EHS staff. This would eliminate 

improper waste classifications (over and under classification) and many of the labeling mishaps in 

research laboratories.

Stakeholder: Northeastern University Topic: Move waste determination to CAA

Comment: Hazardous Waste Determination. There needs to be more flexibility in the 

hazardous waste determination rule. Colleges and universities frequently have faculty and 

researchers that leave

or retire; making it necessary to clean out the laboratory they work in. By providing flexibility for 

making waste determinations in cases such as this, materials that would frequently be managed as 

wastes can be recycled and reused at the institution. This can be accomplished by delaying the 

waste determination until the material is brought into the main accumulation room or until an 

appropriately trained person designated by the institution reviews the material in the laboratory. A

time limit such as 30 days could be established for the material awaiting determinations.

Stakeholder: Tennessee Valley

Authority

Topic: Maintain current rules for waste 

determinations

Comment: The requirements for waste determinations as found in Part 262.11 are reasonable and 

valid. This rule allowing for generator knowledge and/or testing as a waste determination is a good 

rule that has proven to be effective and should be maintained.

Stakeholder: Pacific NW National 

Laboratory

Topic: Move waste determination to CAA
Comment: 262.11: The timing of a waste determination is problematical for waste streams 

that vary somewhat. The interpretation of when to designate a waste varies widely in EPA

guidance and stems from point of generation issues. From a practical standpoint, 

determination of waste characteristics for laboratory waste streams and remediation wastes 

at the exact point and time of generation is infeasible, as the waste characteristics vary as the 

waste is generated. Further, as noted in the Howard Hughes Medical Institute report2 of October 

2001, it is not practical or productive to expect laboratory staffs to acquire the level of expertise 

necessary to correctly designate wastes. Flexibility is needed in order to allow for accurate, 

complete designation of waste. We suggest EPA clarify that designation, at least for laboratory

waste and remediation waste, be accomplished when a given quantity of waste is accumulated.

Stakeholder: Pacific NW National 

Laboratory

Topic: Point of Generation -262.34(c)(1)

Comment: 262.34(c)(1): The use of the term “point of generation” is frequently questioned in 

this context. This requirement was not a source of significant compliance issues prior to the 

promulgation of the Land Disposal Restrictions (LDRs.) Now that EPA has defined the point of 

generation for purposes of identifying waste subject to the LDRs, this requirement is being 

interpreted by regulatory inspectors in the same light. In some cases, the point of generation is 

being interpreted as being upstream of the accumulation container in which the waste accumulates, 

since the waste has already left the process prior to placement in the container. Inspectors are now 

expecting that waste designation requirements apply at the point of generation.

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

made at the point of generation, as that term is currently defined as “the point at which a waste 

exits the unit in which it was generated”. [40 CFR 261.4(c)] Natural variation occurs in laboratory 

waste streams due to changes made during experimental processes, the variation in inputs to waste 

streams (e.g. samples being analyzed), and changes that can occur upon exiting a process (e.g. 

degradation of organic substances.) To require full designation at the point and time of generation 

would require research and/or support staff to continually re-evaluate waste being accumulated in 

the light of additions to the satellite accumulation container. For automated analytical instruments, 

for instance, wastes might have to be re-analyzed frequently to determine levels of metals in the 

waste until accumulation of a given quantity was completed. Indeed, PNNL has received 

indications that the exit point from the process, not the accumulation container, is the true point of 

generation where waste must be fully characterized. This is clearly impractical for small volume, 

variable waste streams, especially if analysis is necessary for full designation.

We do not believe EPA intended this situation to occur. On the contrary, EPA intended for waste 

to accumulate at or near the point of generation in a satellite area prior to its movement to a 90-day 

accumulation area or TSD under reduced requirements, and stated that such accumulation did not 

present a threat to human health and the environment if it followed those requirements, i.e. 40 CFR 

262.34. [49 FR 49568 (12/20/84).] The

present situation has arisen as a result of the further definition of “point of generation” necessary

for proper implementation of land disposal restrictions requirements. We also do not believe EPA 

intended that any staff member responsible for a process that generates waste collected at a 

satellite accumulation point be trained in waste designation or detailed waste management 
requirements. We do not believe this is practiced in

general industry and should not be expected at laboratory facilities. In addition, as stated in the 

Howard Hughes Medical Institute study, “Requiring laboratory staff to acquire this level of 

expertise is not practical or productive.”6

The current regulatory scheme does not support a flexible approach, and has resulted in an 

expectation for full designation at the point of generation. Proper waste designation is more 

important than ever due to the land disposal restrictions requirements. We urge EPA to craft the 

regulatory approach to allow trained research support staff to fully designate waste after 

accumulation in order to provide for full LDR compliance and proper disposal while assuring safe 

management during waste accumulation periods.

Stakeholder: Pacific NW National 

Laboratory

Topic: Inconsistent interpretation : solid waste vs. 

HW and associated recordkeeping requirements

262.40(c): The requirement to maintain documentation of waste determinations is applied 

inconsistently in the field and interpreted variably by EPA in different documents. The 

regulation itself indicates that records of any determination made pursuant to 262.11 must be 

retained. 262.11 indicates that determinations must be made for all solid waste. EPA guidance 

indicates that information on determinations must “clearly demonstrate that the 

information relied upon is sufficient to identify the waste accurately and completely.”11 By 

contrast, 262.10 states that 40 CFR 262 applies to generators of hazardous waste. EPA has 

previously indicated that the requirement for recordkeeping for waste determinations only 

applies to hazardous waste.12 To the extent that EPA and the authorized states believe that 

the recordkeeping requirements apply to determinations that a waste is non-hazardous, the 

requirement is burdensome and is a prime candidate for reduction.

Stakeholder: PhRMA Topic: Clarify the requirement to allow any

qualified individual within a corporation to 

complete the hazardous waste determination 

process

Comment: 262.11 – Even though the definition of “person” in 260.10 includes a corporation, 

certain state regulators view the opening statement in 262.11 to require the individual, whose 

actions generates a solid waste, to complete the hazardous waste determination process specified 

in 262.11(a) through (d). PhRMA requests that EPA clarify this requirement to allow any 

qualified individual within a corporation to complete the hazardous waste determination 

process.

Stakeholder: PhRMA Topic: Point of Generation

Comment: Point-of-Generation - PhRMA recommends that discharges from High Pressure Liquid 

Chromatography (HPLC) instrumentation and other similar analytical equipment, including Gas 

Chromatographs (GC) and Mass Spectrometers (MS), be considered RCRA solid wastes only after 
the waste collection container is physically disconnected from the instrumentation. EPA 

guidance issued on March 17, 2004, (Frequently Asked Questions about Satellite Accumulation 

Areas) indicated that containers to equipment to collect waste must comply with the satellite 

accumulation area requirements. There are three key reasons for requesting this change: (1) the 

collection container is an integral part of the process as the system can not run without the 

collection container; (2) there is little or no environmental risk associated with the container as the 

volume is typically very small and the laboratory equipment is always operated within a building 

where spills can be cleaned up before they reach the environment; and (3) the container is under 

the control of the generator and when it is removed, it is managed as a RCRA container. 

Stakeholder: State of Florida Topic: Clarify under what conditions “generator 

knowledge” acceptable

Comment: Hazardous Waste Determination: 262.11. This section should specify under what 

conditions “generator knowledge” is considered acceptable without supporting analyses. 

What type of “knowledge” is required? Can the generator rely on false or misleading 

representations by a vendor as “knowledge”? If not, the regulation should clarify this. FDEP 

requests that EPA clarify whether “applying knowledge” means that the generator is in 

violation of the regulations when he has not made and documented an overt act of 

determination. 

Analytical testing is always better than generator knowledge, which works only when based 

on a clear understanding of the nature of waste generation. For example: an auto body facility

may have looked at MSDSs for its paints and found none listed any metals of concern. Based on 

that data, the facility determines that its spray-paint booth filters are not hazardous waste. This 

would be appropriate, and the determination should be signed, dated and otherwise documented. 

However, cars being sanded down will be coated with different paints. Therefore, a separate 

determination should be made on the sand-blast grit. Unfortunately, MSDS information will not 

show whether toxicity characteristic constituents are present in a commercial chemical

product at levels which could make the discarded material a hazardous waste. MSDSs only 

list constituents present at 1% or 0.1% for carcinogens.

A grab sample of a continuously-generated HW would probably be as efficient in determining its 

strength or toxicity as several samples over a period of time of the same continuous operation. A 

composite sample might be more appropriate if the strength or toxicity of the generated material 

changes through time. One sample would not be

sufficient in making an adequate determination if a waste determination is made initially 

and the waste is then put in a pile or a large tank. If a generator has no process knowledge of 

the origin of containers of waste, composite samples should not be allowed.

The generator’s method of waste characterization should be on the “hazardous waste profile form” 

that FDEP proposes (see below - Not Included in data base) especially when the determination is 

made by means of product and process knowledge. The specifications for counting wastes to 

determine generator status, which now appears in 261.5, appropriately belong in or near 

262.11.
Stakeholder: State of Florida Topic: Adopt an official “hazardous waste profile 

form” (HWPF)

Comment: Proposed Hazardous Waste Profile Form for Hazardous Waste Identification, Waste 

Analysis Plans, and LDR certification: 262.11, 262.20. 264.13, 265.13, 268.7, and 268.9.

FDEP proposes that EPA adopt an official “hazardous waste profile form” (HWPF). This 

form would fulfill the generator requirement in 262.11 to make a hazardous waste determination, 

and should be attached to or referenced in all manifests used pursuant to 262.20. The HWPF 

should be signed by both the generator and the TSDF. The TSDF's signature on the HWPF 

would constitute the required notice under 264.12(b) that the

facility had the proper permit to treat the generator's waste. The HWPF would standardize the 

various individual formats currently used by TSDFs/interim status facilities to fulfill their 

obligations under 264.13/265.13. TSDF approval of a generator’s HWPF should expire and be 

renewed periodically (at least every five years and when the generator’s process changes.) The 

HWPF could be used in lieu of the land disposal notification and certification forms 

currently required by 268.7. In addition, the HWP form could be used by off-site solid waste 

facilities for purposes of compliance with NPDES, NESHAP and TRI requirements. Generators 

who treat hazardous waste on-site to decharacterize the waste or to meet LDR treatment 

standards should be required to keep copies of the HWP form on-site instead of the records 

currently required by 40 CFR 268.7 & 9. 

Generators should keep HWP forms three years from the date any waste was last shipped 

to the receiving facility. TSDFs should maintain the information on the HWP forms in their 

operating record. Electronic versions of the HWP form would be acceptable. Generators should be 

subject to civil and/or criminal penalties for shipping material that does not conform to statements 

and descriptions on the HWPF.

Stakeholder: Alcoa Topic: Minimize duplication between 40 CFR 

262.11 and waste characterization requirements 

in §268 and RCRA treatment storage and 

disposal facility (TSDF) waste analysis 

requirements in §265.13.

Comment: § 262.11 – HAZARDOUS WASTE DETERMINATION. In many ways, the 

hazardous waste determination requirements at 40 CFR 262.11 overlap with waste 

characterization requirements in §268 and RCRA treatment storage and disposal facility 

(TSDF) waste analysis requirements in §264.13 and §265.13. These often overlapping 

requirements result in duplication, added costs and re-work. These requirements should be 

streamlined to minimize duplication.

Stakeholder: American Petroleum 

Institute (API) 

Topic: Address inconsistencies between EPA’s 

“Waste Management System; Testing and 

Monitoring Activities; Proposed Rule: Methods 

Innovation Rule,” and the associated “RCRA Waste 
Sampling Draft Technical Guidance,” EPA 

document number EPA530-D-02-002, (EPA’s 

Proposed Technical Guidance or TG)

Comment: Requirements found in §262.11(c)(1) and (2) address generator requirements to 

determine if a solid waste is a hazardous waste. Sampling and analytical methods used to meet 

these requirements have been the subject of Agency guidance and extensive generator experience. 

The most recent Agency effort, addressed in EPA’s “Waste Management System; Testing and 

Monitoring Activities; Proposed Rule: Methods Innovation Rule,” and the associated “RCRA 

Waste Sampling Draft Technical Guidance,” EPA document number EPA530-D-02-002, (EPA’s 

Proposed Technical Guidance or TG), lead to API filling comments to EPA Docket No. RCRA–

2002-0025 on February 28, 2003.

One major concern addressed in API’s comments to the draft TG is an incorrect regulatory

interpretation expressed throughout the document. The TG describes the toxicity characteristic 

(TC) threshold limits at 40 CFR 261.24 as single sample, never-to-be-exceeded limits. This is not 

the case, as is clear from reviewing the technical basis for the TC limits in the rulemaking record. 

The TC limits are based on average concentrations in a waste that is disposed of in a manner that 

potentially subjects off-site populations to a long-term (lifetime) exposure to the TC constituents 

through the ground water pathway. 

The regulation (§261.24) describes the TC limits as the maximum concentration in a 

representative sample of waste, as the term “representative sample” is defined in 40 CFR 260.10. 

The definition of representative sample in 40 CFR 260.10 clearly states that such a sample 

represents the average properties of the waste. This concept is firmly embedded in 

technical guidance previously issued by EPA (SW-846, Chapter Nine). The incorrect 

interpretation in the draft TG contradicts the SW-846 guidance, and its application would 

result in different conclusions (false identification of a waste as hazardous) for many wastes, 

with the effect of greatly increasing the cost of compliance for the regulated community.

API requests EPA review the comments received or withdraw the draft TG. Issuing a draft itself 

has provided less clarity as to the requirements on generators as they comply with the requirements 

of §262.11.

Stakeholder: EIA Topic: Clarify reactivity characteristic

Comment: EIA also believes that it is often difficult to determine definitively if a waste is or 

is not a “reactive” waste using just the narrative description at 40 C.F.R. § 261.23(a). An 

example of this is with aerosol cans, which EIA believes should not be characterized as a 

“reactive” hazardous waste. Nonetheless, some EPA guidance suggests that aerosol cans are 

reactive because they are pressurized. However, if this is the case, there are many other pressurized 

vessels that arguably also could be considered “reactive.” In fact, any sealed container that is 

exposed to heat will generate some level of internal pressure. As a result, EIA requests that EPA 

clarify the reactivity standard and that EPA consider whether it is advisable use of one or 

more testing protocols to help define the reactivity characteristic.
Stakeholder: American Airlines Topic: Clarify under what conditions “generator 

knowledge” acceptable

Comment: Waste Characterization. American believes EPA should clarify when it is 

appropriate to use generator knowledge instead of analytical sampling for waste 

characterization. It is the generator’s responsibility to know if each particular waste steam is 

hazardous. Unfortunately, many characteristically hazardous waste streams vary in composition 

from one day to the next. Such variability often makes it difficult to appropriately characterize 

each container of waste and apply the correct waste codes to such material. In general, American 

believes that periodic testing is appropriate to determine whether a material is a 

characteristically hazardous waste and why. However, at large manufacturing facilities 

which may generate hundreds of containers of waste per year, it may be impractical to 

sample each and every container of waste to determine the appropriate waste codes. As 

such, American believes that EPA should clarify that it is appropriate to utilize laboratory 

testing to determine in the first instance (and periodically thereafter) whether a waste is 

characteristically hazardous and which characteristics are present. Once such a 

determination is made, the generator should be allowed to use the results of that testing along with 

knowledge of process (i.e. what goes into the process that generates the waste) to determine the 

appropriate waste codes. 

An example of the above would be generator with a waste that testing showed to 

becharacteristically hazardous for cadmium (D006), chromium (D007) and lead (D008). Based on 

its knowledge of the process that generates the waste, the generator also knows that these are the 

only hazardous waste codes potentially applicable to the waste. However, the generator also 

knows from prior analysis that the waste does not always exhibit the D008 characteristic. Based on 

this knowledge, and without testing every container of waste, the generator should be allowed to 

classify the waste as D006, D007 and D008 even though, in some instances, the D008 

characteristic is not present. In other words, generators should not be subject to penalties for 

reasonably relying on initial/periodic waste analysis combined with knowledge of process to 

consistently classify characteristically hazardous waste streams in which there is some variation –

provided the most conservative approach is utilized – i.e. all potential waste codes are applied.

Stakeholder: American Ref-Fuel Topic: Representative sampling should always be 

required

Comment: 1. Program Improvements: Sampling. Ref-Fuel is concerned by an example cited by the 

EPA in the ANPR as indicative of the type of improvement suggested by stakeholders in the past. 

The example is:

“When is the use of grab sampling more appropriate than representative sampling?”.

Ref-Fuel believes that the regulation should remain clear that “representative sampling” is a 

fundamental basis of RCRA sampling, and that it is always required. “Grab sampling” 

should only be valid if the generator can prove conclusively that the waste is completely 
homogeneous, meaning that every grab sample would yield identical analytical results. One 

could presumably prove this only after a rigorous testing program of grab samples over a 

suitably long period of time, and comparing these to composite samples. This standard must 

likewise apply to enforcement officials. In its August 2002 “RCRA Waste Sampling Draft 

Technical Guidance”, which was the subject of EPA Docket RCRA-2002-0025, the EPA stated 

that: “[A]n enforcement official, when conducting a compliance sampling inspection to evaluate a 

waste handler’s compliance with a ‘do not exceed’ standard, take only one sample. Such a sample 

may be purposively selected based on professional judgement. This is because all the enforcement 

official need to observe – for example to determine that a waste is hazardous – is a single 

exceedance of the standard.” (See page 11 of the Guidance)

Ref-Fuel’s industry expressed its disagreement with this concept as part of that docket in a 

comment letter submitted by the Integrated Waste Services Association (IWSA). We feel 

compelled to express our disagreement with the concept again as part of this docket because it 

appears to be still under consideration by EPA in one form or another.

Representative composite sampling must remain the fundamental basis of all RCRA 

sampling. Grab sampling is only appropriate, and should only be approved, after the 

generator proves that the waste is completely homogeneous across a broad time frame. We 

believe that this is sound policy for all wastes, and we also have an interest specific to our 

industry. Municipal waste combustion ash residue is similar to the municipal waste from which it 

is derived with regards to the fact that it is not homogeneous. EPA expects that generators of solid 

waste will examine a “representative sample” of the waste to determine whether the waste is 

hazardous. According to 40 CFR 260.10, a “representative sample” is one that “can be 

expected to exhibit the average properties of the universe or whole.” Further, as SW-846 has 

long recognized, consistent with accepted statistical methods, test programs to determine 

whether or not a particular waste stream is a “hazardous waste” are developed taking into 

account the need to take a sufficient number of samples (typically, multiple samples) of a 

waste to establish a level of confidence that the testing results accurately characterize the 

waste. The desired level of confidence requires a statistical evaluation of the sampling results 

from multiple samples. A single sample, taken out of the statistical context, is meaningless.

Stakeholder: ASTSWMO Topic: Clarify that the option for classification of 

hazardous waste based upon generator knowledge 

does not apply to facilities that receive the waste 

from other generators. 

Comment: EPA needs to clarify that the option for classification of hazardous waste based upon 

generator knowledge does not apply to facilities that receive the waste from other generators. 

Regarding the U and P lists, States were under the impression that EPA was going to finish 

rulemaking for these lists for mixtures. We disagree with use of the “sole active ingredient” 

rationale to consider these materials and listed wastes - particularly when it comes to the cleanup 

of mixtures.
Stakeholder: Pacific NW National 

Laboratory

Topic: Clarify that generator knowledge is adequate 

to designate waste

Comment: 262.11(c)(2): The use of generator knowledge to designate waste seems to be 

questioned by regulators. EPA allows use of generator knowledge to designate waste, and wastes 

are routinely designated on this basis alone. However, EPA seems to be ambivalent as to 

whether it is truly adequate. For instance, EPA states in guidance that “Compliance is best 

ensured through sampling and analysis.”3 Due to this attitude and to the definitions of “acceptable 

knowledge” given in other EPA guidance4 referencing analytical data, questions may be raised 

as to the adequacy of generator knowledge in many cases. This position also conflicts with 

the joint EPA/NRC guidance5 to generators of mixed radioactive and hazardous waste 

(such as PNNL) which encourages the use of generator knowledge to designate waste. EPA 

should clarify that generator knowledge is adequate to designate waste. Criteria could be 

offered to specify how knowledge could be used properly.

14 commenters; 17 comments