**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 b y the person generating the waste (40 CFR 262.1 1). Currentl y 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 ty

pically 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 appropriatel y 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 freq uently 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 appropriatel y trained person designated b y 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: Th e 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.
Stakehol der: P acific NW National Laboratory Topic: M ove waste determination to CAAComment: 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 characteristi**  **cs 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 correctl y designate wastes. Fl exibility 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: P oint of Generation

- 262.34(c)(1)

Comment: 2 62.34(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 issu es 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 b y regulatory

inspectors in the same light. Insome 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 newl y generated laboratory wastes can be made at the point of generation, as that term is currently defined as “the point at whic h 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 anal yz ed), and chang es 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 o f additions to the satellite accumulation container. For automated analy tical instruments, for instance, wastes might have to be re

- analyzed frequentl y 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 clearl y impractical for small volume, variable waste streams, especially i f anal ys is is necessary

for full designation.
We do not believe EPA intended this situation to occur. On the contrary , EPA intended f or 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 managementrequirements. 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 Hu ghes 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 accumulatio n in order to provide for full LDR compliance and proper disposal while assuring safe management during waste accumulation periods.
Stakeholder: P acific 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 demo**  **nstrate 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 recordkeep ing 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). **PhR MA requests that EPA clarify this requirement to allow any**  **qualified individual within a corporation to complete the hazardous waste determination process.** 
Stakeholder: PhRMA Topic: P oint of Generation
Comment: Point

- of

- Generation

- PhRMA recommends that discharges from High Pressure Liquid Chromatography (HP LC ) instrumentation and other similar anal ytical equipment, including Gas Chromatographs (GC) and Mass Spectrometers (MS), be considered RCRA solid wastes only a fterthe waste collection container is phy sicall y disconnected from the instrumentation. E PA

guidance issued on March 17, 2004, (Frequentl y Asked Questions about Satellite Accumulation Areas) indicated that containers to equipment to collect waste must comply with the satellite accumulatio n area requirements. There are three key reasons for requesting this change: (1) the collection container is an integral part of the process as the sy stem can not run without the collection container; (2) there is little or no environmental risk associate d with the container as the volume is ty

picall y very small and the laboratory equipment is alway s 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 rel y on false or misleading representations by

a vendor as “knowledge”? I f 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 a ct 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 foun d 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 be ing 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 probabl y be as efficient in determining its strength or to xicity

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 adequ**  **ate 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)** especiall y when the determination is made b y means of product and process knowledge. **The specifications for counting waste s 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 Analy sis 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 264.13/2 65.13.**  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 re quired 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 TRIrequirements. **Generators who treat hazardous waste on** 
**- site to decharacterize the waste or to meet LDR treatmen**  **t 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**  **s hipped**  **to the receiving facility** . TSDFs sh ould 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: M **inimize duplication** between **40 CFR 262.11**  and **waste characterization requirements in §268 and RCRA**  **t reatment 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**  **t reatment storage and disposal facility**  **(TSDF) waste analysis require ments 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 E PA’s “Waste Management Sy stem; Testing and Monitoring Activities; Proposed Rule: Methods Innovation Rule,” and the associated “RCRA WasteSampling Draft Technical Guidance,” EPA document number EPA530

- D

- 02

- 002, (EPA’s Proposed Tec hnical 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 anal ytical 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 Sy stem; 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 inco rrect 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 clearl y states **that such a sample represents the average properties of the waste.**  **T his concept is firmly embedded in**  **technical guidance previously issued by EPA (SW**
**- 846, Chapter Nine).**  **T he incorrect**  **interpretation in the draft TG contradi cts 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 greatl y increasing the cost of compliance for the regulated community

. APIrequests EPA review the comments received or withdraw the draft TG. I ssuing a draft itself has provided less clarity as to the requirements on generators as they c omply w ith the requirements of § 262.11.
Stakeholder: EIA Topic: Clarify reactivity

characteristic
Co mment: **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 o ther pressurized vessels that arguabl y also could be considered “reactive.” In fact, any s ealed container that is exposed to heat will generate some level of internal pressure. **As a result,**  **EIA requests that**  **EP A**  **clarify the reactivity standard and that EPA consider whether it is advisable use of one or mo**  **re testin g 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 appl y 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 periodi**  **cally 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 anal ys is that the waste does not always e xhibit 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. Inother words, generators should not be subject to penalties for reasonabl y rel ying on initial/periodic waste analy sis combined with knowledge of process to consistently

classify characteristicall y 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 alway s 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 b y 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 homogeneo**  **us, 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 insp ection to evaluate a waste handler’s compliance with a ‘do not exceed’ standard, take onl y on e sample. Such a sample may be purposivel y s elected 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 Serv ices 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 b y EPA in one form or another. **Representative composite sampling must remain the fundam ental 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 als o 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 “r epresentative 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 reco**  **gnized, 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 s tatistical**  **evaluation of**  **the sampling**  **results from multiple samples. A single sample, taken out of the st**  **atistical 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

- particularl y when it comes to the cleanup of mixtures.Stakeholder: Pacific NW **Nati onal** 

**Laboratory** Topic: Clarify that generator knowledge is adequate to designate waste

Comment: 2 62.11(c)(2): **The use of generator knowledge** to designate waste seems to be questioned b y r egulators. EPA allows use of generator knowledge to designate w aste, and wastes are routinel y 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 anal ys is.”3 Due to this attitu de and to the definitions of “acceptable knowledge” given in other EPA guidance4 referencing anal ytical 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 know ledge could be used properly.**  14 commenters; 17 comments