46126 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Proposed Rules 

approved under OMB control number 

0910–0139. 

VIII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in E.O. 13132. We have 

determined that this proposed rule does 

not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the E.O. and, 

consequently, a federalism summary 

impact statement is not required. 

IX. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in E.O. 13175. We have tentatively 

determined that the rule does not 

contain policies that would have a 

substantial direct effect on one or more 

Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

The Agency solicits comments from 

tribal officials on any potential impact 

on Indian Tribes from this proposed 

action. 

X. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Jacobs, G., ‘‘Validation of the Radiation 

Sterilization of Pharmaceuticals.’’ In: J. 

Agalloco and F. J. Carleton (eds.), 

Validation of Pharmaceutical Processes 

(3rd Ed.) Informa USA, New York, 2007. 

2. Microbiology Sub-Committee, Radiation 

Sterilization Task Force, Parenteral Drug 

Association, Technical Report No. 11, 

‘‘Sterilization of Parenterals by Gamma 

Radiation,’’ Journal of Parenteral Science 

and Technology, 42 (3S), 1988, available 

at: https://store.pda.org/ProductCatalog/ 

Product.aspx?ID=1170. 

3. United States Pharmacopeial Convention 

(USP 40), Radiation Sterilization 

<1229.10>, 2017. 

4. United States Pharmacopeial Convention 

(USP 40), Sterilization of Compendial 

Articles <1229>, 2017. 

5. FDA Guidance for Industry on ‘‘Sterile 

Drug Products Produced by Aseptic 

Processing—Current Good 

Manufacturing Practice,’’ September 

2004; available at https://www.fda.gov/ 

downloads/drugs/guidance

complianceregulatoryinformation/ 

guidances/ucm070342.pdf. 

6. United States Pharmacopeial Convention 

(USP 40), Sterilization and Sterility 

Assurance of Compendial Articles 

<1211>, 2017. 

7. FDA Drug Safety Communication, ‘‘FDA 

Requests Label Changes and Single-Use 

Packaging for Some Over-the-Counter 

Topical Antiseptic Products to Decrease 

Risk of Infection,’’ November 13, 2013; 

available at https://www.fda.gov/Drugs/ 

DrugSafety/ucm374711.htm. 

8. FDA Preliminary Regulatory Impact 

Analysis, Repeal of Regulation Requiring 

an Approved New Drug Application for 

Drugs Sterilized by Irradiation; https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 

List of Subjects in 21 CFR Part 310 

Administrative practice and 

procedure, Drugs, Labeling, Medical 

devices, Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act and under authority 

delegated to the Commissioner of Food 

and Drugs, it is proposed that 21 CFR 

part 310 be amended as follows: 

PART 310—NEW DRUGS 

■ 1. The authority citation for part 310 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360b–360f, 360j, 360hh–360ss, 

361(a), 371, 374, 375, 379e, 379k–1; 42 U.S.C. 

216, 241, 242(a), 262. 

■ 2. In § 310.502, revise paragraph (a) 

introductory text and remove and 

reserve paragraph (a)(11) to read as 

follows: 

§ 310.502 Certain drugs accorded new 

drug status through rulemaking 

procedures. 

(a) The drugs listed in this paragraph 

have been determined by rulemaking 

procedures to be new drugs within the 

meaning of section 201(p) of the Federal 

Food, Drug, and Cosmetic Act. An 

approved new drug application under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act and part 314 of this 

chapter is required for marketing the 

following drugs: 

* * * * * 

(11) [Reserved] 

* * * * * 

Dated: September 7, 2018. 

Scott Gottlieb, 

Commissioner of Food and Drugs. 

[FR Doc. 2018–19845 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 261 

[EPA–R10–RCRA–2018–0538; SW–FRL– 

9982–05—Region 10] 

Hazardous Waste Management 

System; Proposed Exclusion for 

Identifying and Listing Hazardous 

Waste 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule and request for 

comment. 

SUMMARY: The Environmental Protection 

Agency (also, ‘‘the Agency’’ or ‘‘we’’ in 

this preamble) is proposing to grant a 

petition submitted by Sandvik Special 

Metals (Sandvik), in Kennewick, 

Washington to exclude (or ‘‘delist’’) up 

to 1,500 cubic yards of F006 wastewater 

treatment sludge per year from the list 

of federal hazardous wastes. 

The Agency is proposing to grant the 

petition based on an evaluation of 

waste-specific information provided by 

Sandvik. This proposed decision, if 

finalized, conditionally excludes the 

petitioned waste from the requirements 

of hazardous waste regulations under 

the Resource Conservation and 

Recovery Act. 

We conclude that Sandvik’s 

petitioned waste is nonhazardous with 

respect to the original federal listing 

criteria and that there are no other 

factors (including additional 

constituents) other than those for which 

the waste was listed that would warrant 

retaining the waste as a hazardous 

waste. Subject to state-only 

requirements within the state of 

Washington, or federally-authorized or 

state-only requirements in other states 

where the subject wastes may be 

disposed of, Sandvik’s petitioned waste 

may be disposed of in a Subtitle D 

landfill which is permitted, licensed, or 

registered by a State to manage 

industrial solid waste. 

DATES: Comments must be received on 

or before October 12, 2018. Requests for 

an informal hearing must reach the EPA 

by September 27, 2018. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R10– 

RCRA–2018–0538 by one of the 

following methods: 


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• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• Mail: To Dr. David Bartus, Office of 

Air and Waste, EPA, Region 10, 1200 

6th Avenue, Suite 155, OAW–150, 

Seattle, Washington 98101. 

• Hand Delivery: To Dr. David Bartus, 

Office of Air and Waste, EPA, Region 

10, 1200 6th Avenue, Suite 155, OAW– 

150, Seattle, Washington 98101. Such 

deliveries are only accepted during 

normal hours of operation. Please 

contact David Bartus at (206) 553–2804. 

Instructions: Direct your comments to 

Docket ID No. EPA–R10–RCRA–2018– 

0538. The EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov 

website is an ‘‘anonymous access’’ 

system, which means the EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

email comment directly to the EPA 

without going through 

www.regulations.gov your email address 

will be automatically captured and 

included as part of the comment that is 

placed in the public docket and made 

available on the internet. If you submit 

an electronic comment, the EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

physical media you submit. If the EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, the EPA may not 

be able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Any person may request an informal 

hearing on this proposed decision by 

filing a request with Timothy Hamlin, 

Director, Office of Air and Waste, EPA, 

Region 10, 1200 6th Ave., Suite 155, 

OAW–150, Seattle, Washington 98101. 

The request must contain the 

information prescribed in 40 Code of 

Federal Regulations CFR 260.20(d). 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information may not be publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the RCRA Records Center, 16th floor, 

U.S. EPA, Region 10, 1200 6th Avenue, 

Suite 155, OAW–150, Seattle, 

Washington 98101. This facility is open 

from 8:30 a.m. to 4:00 p.m., Monday 

through Friday, excluding legal 

holidays. We recommend you telephone 

David Bartus at (206) 553–2804 before 

visiting the Region 10 office. The public 

may copy material from the regulatory 

docket at 15 cents per page. 

FOR FURTHER INFORMATION, CONTACT: Dr. 

David Bartus, EPA, Region 10, 1200 6th 

Avenue, Suite 155, OAW–150, Seattle, 

Washington 98070; telephone number: 

(206) 553–2804; fax number (206) 553– 

8509; email address: bartus.dave@

epa.gov. 

As discussed in Section V below, the 

Washington State Department of 

Ecology is evaluating Sandvik’s petition 

under state authority. Information on 

Ecology’s action may be found at 

https://fortress.wa.gov/ecy/publications/ 

SummaryPages/1804023.html. 

SUPPLEMENTARY INFORMATION: The 

information in this section is organized 

as follows: 

I. Overview Information 

II. Background 

A. What is a listed waste? 

B. What is a delisting petition? 

C. What factors must the EPA consider in 

deciding whether to grant a delisting 

petition? 

III. EPA’s Evaluation of the Waste 

Information and Data 

A. What waste did Sandvik petition EPA 

to delist? 

B. How does Sandvik generate the waste? 

C. How did Sandvik sample and analyze 

the waste? 

D. What were the results of Sandvik’s 

analysis of the waste? 

E. How did the EPA evaluate the risk of 

delisting this waste? 

F. What did the EPA conclude about 

Sandvik’s waste? 

IV. Conditions for Exclusion 

A. When would the EPA finalize the 

proposed delisting exclusion? 

B. How will Sandvik manage the waste if 

it is delisted? 

C. What are the maximum allowable 

concentrations of hazardous constituents 

in the waste? 

D. How frequently must Sandvik test the 

waste? 

E. What data must Sandvik submit? 

F. What happens if Sandvik’s waste fails to 

meet the conditions of the exclusion? 

G. What must Sandvik do if the process 

changes? 

V. How would this action affect states? 

VI. Statutory and Executive Order Reviews 

I. Overview Information 

The EPA is proposing to grant the 

petition submitted by Sandvik Special 

Metals (Sandvik) located in Kennewick, 

Washington to exclude or delist an 

annual volume of up to 1,500 cubic 

yards of F006 wastewater treatment 

sludge from the lists of hazardous waste 

set forth in 40 Code of Federal 

Regulations CFR 261.31. Sandvik claims 

that the petitioned waste does not meet 

the criteria for which the EPA listed it, 

and that there are no additional 

constituents or factors which could 

cause the waste to be hazardous. 

Based on our review described in 

section III, we agree with the petitioner 

that the waste is nonhazardous. We 

reviewed the description of the process 

which generates the waste and the 

analytical data submitted by Sandvik. 

We believe that the petitioned waste 

does not meet the criteria for which the 

waste was listed, and that there are no 

other factors which might cause the 

waste to be hazardous. 

II. Background 

A. What is a listed waste? 

The EPA published an amended list 

of hazardous wastes from nonspecific 

and specific sources on January 16, 

1981, as part of its final and interim 

final regulations implementing § 3001 of 

Resource Conservation and Recovery 

Act (RCRA). The EPA has amended this 

list several times and published it in 40 

CFR 261.31 and 261.32. 

We list these wastes as hazardous 

because: (1) They typically and 

frequently exhibit one or more of the 

characteristics of hazardous wastes 

identified in subpart C of part 261 (that 

is, ignitability, corrosivity, reactivity, 

and toxicity) or (2) they meet the criteria 

for listing contained in § 261.11(a)(2) or 

(3). 

B. What is a delisting petition? 

Individual waste streams may vary 

depending on raw materials, industrial 

processes, and other factors. Thus, 

while a waste described in the 

regulations generally is hazardous, a 

specific waste from an individual 

facility meeting the listing description 

may not be hazardous. 

A procedure to exclude or delist a 

waste is provided in 40 CFR 260.20 and 

260.22 which allows a person or a 

facility to submit a petition to the EPA 

or to an authorized state demonstrating 


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1Washington State has promulgated regulations 

at WAC 173–303–910(3) corresponding to the cited 

federal regulation. However, Washington State has 

not received final authorization to implement these 

regulations in lieu of the federal program. As such, 

they are effective concurrent with 40 CFR 260.20 

and 260.22 on a state-only basis. 

that a specific waste from a particular 

generating facility is not hazardous.1

In a delisting petition, the petitioner 

must show that a waste does not meet 

any of the criteria for listed wastes in 40 

CFR 261.11 and that the waste does not 

exhibit any of the hazardous waste 

characteristics of ignitability, reactivity, 

corrosivity, or toxicity. The petitioner 

must present sufficient information for 

us to decide whether any factors in 

addition to those for which the waste 

was listed warrant retaining it as a 

hazardous waste. (See § 260.22, 42 

U.S.C. 6921(f) and the background 

documents for the listed wastes.) 

If a delisting petition is granted, the 

generator remains obligated under 

RCRA to confirm that the waste remains 

nonhazardous according to the 

conditions of the delisting. 

C. What factors must EPA consider in 

deciding whether to grant a delisting 

petition? 

In reviewing this petition, we 

considered the original listing criteria 

and the additional factors required by 

the Hazardous and Solid Waste 

Amendments of 1984 (HSWA). See 

§ 222 of HSWA, 42 U.S.C. 6921(f), and 

40 CFR 260.22(d)(2)–(4). We evaluated 

the petitioned waste against the listing 

criteria and factors cited in 

§ 261.11(a)(2) and (3). 

Besides considering the criteria in 40 

CFR 260.22(a), 261.11(a)(2) and (3), 42 

U.S.C. 6921(f), and in the background 

documents for the listed wastes, the 

EPA must consider any factors 

(including additional constituents) other 

than those for which we listed the waste 

if these additional factors could cause 

the waste to be hazardous. 

Our proposed decision to grant the 

petition to delist the waste from 

Sandvik’s Kennewick, Washington 

facility is based on our evaluation of the 

waste for factors or criteria which could 

cause the waste to be hazardous. These 

factors included: (1) Whether the waste 

is considered acutely toxic; (2) the 

toxicity of the constituents; (3) the 

concentration of the constituents in the 

waste; (4) the tendency of the 

constituents to migrate and to 

bioaccumulate; (5) the persistence in the 

environment of any constituents once 

released from the waste; (6) plausible 

and specific types of management of the 

petitioned waste; (7) the quantity of 

waste produced; and (8) waste 

variability. 

The EPA must also consider as 

hazardous wastes mixtures containing 

listed hazardous wastes and wastes 

derived from treating, storing, or 

disposing of listed hazardous waste. See 

40 CFR 261.3(a)(2)(iv) and (c)(2)(i), 

called the ‘‘mixture’’ and ‘‘derivedfrom’’ rules, respectively. Mixture and 

derived-from wastes are also eligible for 

exclusion but remain hazardous until 

excluded. 

III. EPA’s Evaluation of the Waste 

Information and Data 

A. What waste did Sandvik petition the 

EPA to delist? 

On April 27, 2018, Sandvik petitioned 

the EPA to exclude an annual volume of 

up to 1,500 cubic yards of F006 

wastewater treatment sludges generated 

at its facility located in Kennewick, 

Washington from the list of hazardous 

wastes contained in 40 CFR 261.31. 

F006 is defined in § 261.31 as 

‘‘Wastewater treatment sludges from 

electroplating operations . . .’’ Sandvik 

claims that the petitioned waste does 

not meet the criteria for which F006 was 

listed (i.e., cadmium, hexavalent 

chromium, nickel and complexed 

cyanide) and that there are no other 

factors which would cause the waste to 

be hazardous. 

B. How does Sandvik generate the 

waste? 

Sandvik Special Metals fabricates 

specialty titanium and zirconium tubing 

for the aeronautical, medical and 

nuclear industries. The filter cake waste 

material that is the subject of this 

delisting action is the combined end 

waste from the wastewater treatment 

facility (WWTF) that manages F006 

chemical etching wastes, and a separate 

coolant process waste stream associated 

with Sandvik’s manufacturing process. 

A detailed description of the processes 

which contribute to the filter cake, 

including the wastewater treatment and 

the manufacturing processes, associated 

alloys and process materials, is 

provided below. 

Titanium and zirconium alloys are the 

main raw materials for the 

manufacturing process, with titanium 

being used for most products and 

zirconium being used only on special 

orders for the nuclear industry. In recent 

years, zirconium accounted for less than 

one percent of the total production, 

however, zirconium has accounted for 

up to 10 to 20 percent of the production 

volume historically. The manufacturing 

processes meet strict industry standards 

for Sandvik customers and are 

consistent at the Kennewick facility. 

The standard tube making process for 

titanium (Ti) and zirconium (Zr) alloyed 

tubing includes three main steps. See 

Figure 1 in Sandvik’s delisting petition. 

The alloys used in the process arrive at 

the Kennewick facility in the form of 

large diameter rough tubing (either 

extrusions or Trex [which is an 

extrusion that has been reduced once]) 

from one of two suppliers, Sandvik SZ 

in Sweden or ATI in Oregon. In the first 

tube-making process, the extrusions or 

Trex go through multiple cold pilger 

steps to reduce the diameter size of the 

tubing into seamless hollow metal 

tubing. The cold pilgering process uses 

roll dies (presses) and a tapered mandrel 

(the rod that supports the inside of the 

tube during formation) to reduce the 

size of the tubing cross section. A fatty 

acid coolant/lubricant is used to manage 

heat generation during the process. The 

number of cold pilgering steps is 

dependent on the available starting 

materials and final tube size. After each 

cold pilger step, the interior of the tube 

is cleaned in a hot alkaline solution to 

remove the fatty acid coolant/lubricant 

used in the forming process, resulting in 

the generation of an alkaline rinsing 

solution that is discharged to the WWTF 

and a small amount of used fatty acid 

coolant/lubricant, which is pumped to 

an underground storage tank and then 

batch transferred to the WWTF. 

The second step in the tube forming 

process is a high temperature anneal 

step performed to relieve stress on the 

metal that can make it brittle after cold 

forming. Annealing also improves the 

homogeneity of the metal and can 

improve the ductile and toughness 

properties. No waste is generated during 

the annealing process. 

During the third step, after annealing, 

the hollows, or final tubes are rotary 

straightened and cleaned in the hot 

alkaline solution again to remove the 

straightening lubrication. The cleaned 

hollows are open dip etched in an 

acidic solution to remove a small 

amount of metal from both the outer 

diameter (OD) and inner diameter (ID) 

surfaces. The acidic waste and rinse 

water from the hollow etch process is 

discharged to the WWTF. This acid etch 

step is the basis for application of the 

F006 listing to Sandvik’s WWTF sludge, 

as discussed in the following section. 

If the next pass is to produce a smaller 

OD or thinner wall hollow, the above 

three-step process is repeated until the 

desired sizing is accomplished resulting 

in a final tube. 


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2SDS constituent reporting requirements are 

typically ingredients which have been determined 

to be health hazards, and which comprise 1% or 

greater of the composition, except chemicals 

identified as carcinogens which are listed if the 

concentrations are 0.1% or greater. In addition, 

chemicals <1% (<0.1% for carcinogens) are 

reported if they could be released from the product 

at a concentration that would exceed an established 

Occupational Safety and Health Administration 

(OHSA) exposure limit. SDSs are prepared in 

accordance with OHSA (29 CFR 1910.1200(g)) and 

the Global Harmonization System. 

3Fluoride does not meet the criteria set forth in 

Section 3.1 but is included in the final list of COPCs 

as requested by the EPA during a 17 April 2017 

teleconference. 

4This sampling requirement is in place to satisfy 

state-only requirements of Ecology’s dangerous 

waste program. This requirement is considered 

broader in scope than the federally authorized 

program. 

C. How is Sandvik’s waste captured by 

the F006 listing definition? 

The listing definition for F006 waste 

at 40 CFR 261.31 states that the source 

definition of F006 wastes include: 

Wastewater treatment sludges from 

electroplating operations except from 

the following processes: (1) Sulfuric 

acid anodizing of aluminum; (2) tin 

plating on carbon steel; (3) zinc plating 

(segregated basis) on carbon steel; (4) 

aluminum or zinc-aluminum plating on 

carbon steel; (5) cleaning/stripping 

associated with tin, zinc and aluminum 

plating on carbon steel; and (6) chemical 

etching and milling of aluminum. 

The EPA promulgated an interpretive 

rule (51 FR 43350 (December 2, 1986)) 

clarifying the scope of the EPA 

Hazardous Waste No. F006 contained in 

the list of hazardous wastes from nonspecific sources of Subpart D of Part 

261. This interpretive rule established 

that: 

The F006 listing is (and always has 

been) therefore, inclusive of wastewater 

treatment sludges from only the 

following processes: (1) Common and 

precious metals electroplating, except 

tin, zinc (segregated basis), aluminum, 

and zinc-aluminum plating on carbon 

steel; (2) anodizing, except sulfuric acid 

anodizing of aluminum; (3) chemical 

etching and milling, except when 

performed on aluminum; and (4) 

cleaning and stripping, except when 

associated with tin, zinc, and aluminum 

plating on carbon steel. 

Because the Sandvik production 

process that results in generation of the 

candidate WWTF sludge includes 

chemical etching other than that 

performed on aluminum, Sandvik’s 

WWTF sludge meets the definition of 

F006 listed waste. 

D. How did Sandvik sample and 

analyze the petitioned waste? 

Sandvik conducted a detailed 

chemical analysis of their WWTF sludge 

according to a written sampling and 

analysis plan (SAP), provided as 

Attachment 2 to the delisting petition. 

This SAP included the following key 

elements: 

• A description of the manufacturing 

and wastewater treatment processes 

relevant to the petitioned waste; 

• An initial identification of 

Constituents of Potential Concern 

(COPCs) potentially present in the 

petitioned waste based on 

manufacturing and wastewater 

treatment processes; 

• Development of sampling strategies 

to address variations and periodic 

fluctuations in the manufacturing and 

wastewater treatment processes, 

including obtaining representative 

samples to account for variations of 

alloys used in the manufacturing 

process and addition of coolant/ 

lubricant into the filter cake. 

• The proposed methodology for 

evaluating the resulting data with 

respect to anticipated delisting decision 

criteria; and 

• A Quality Assurance Project Plan 

(QAPP) documenting the required 

quality and quantity of the data 

necessary for decisions based on them 

to be within an acceptable degree of 

uncertainty. 

Sandvik’s SAP identified an initial 

list of COPCs based on a consideration 

of constituents included in the F006 

hazardous waste listing and present in 

the manufacturing and wastewater 

treatment materials and processes. See 

Section 2 and Table 5 of Attachment 2 

in Sandvik’s delisting petition. 

Additionally, the list of COPCs included 

impurities and other constituents listed 

in the alloys and in the process and 

wastewater treatment chemical Safety 

Data Sheets (SDS).2 Constituents were 

then evaluated based on historical 

detections in the filter cake waste and 

compared to constituents listed in the 

following RCRA regulations, as 

applicable to the Kennewick facility and 

this specific filter cake waste: 

• Constituent for which F006 was 

listed (40 CFR part 261 Appendix VII; 

WAC 173–303–082) or listed as a Land 

Disposal Restriction (LDR) constituent 

subject to treatment for F006 or 

identified as a constituent for which an 

LDR Universal Treatment Standard has 

been established (40 CFR 268.40 and 

268.48; WAC 173–303–140) with the 

exception of cyanide. Cyanide was not 

retained as a COPC because there is no 

documented use of cyanide at the 

Kennewick facility and it was not 

detected in historical filter cake 

samples. 

• Constituent has been historically 

detected in filter cake and was present 

on the Toxicity Characteristics List (40 

CFR 261.24; WAC 173–303–090 Part 8), 

Hazardous Constituents List (40 CFR 

part 261 Appendix VIII; WAC 173–303– 

9905), and/or Groundwater Monitoring 

List (40 CFR part 264 Appendix IX; 

WAC 173–303–110(7)). 

• According to the alloy composition, 

constituent could potentially be present 

in the filter cake and is listed on the 

Toxicity Characteristics List (40 CFR 

261.24; WAC 173–303–090(8)), 

Hazardous Constituents List (40 CFR 

part 261 Appendix VIII; WAC 173–303– 

9905), and/or the Groundwater 

Monitoring List (40 CFR part 264 

Appendix IX; WAC 173–303–110 Part 

7). 

A constituent was not retained as a 

COPC if it was not: 

• Listed on potentially relevant 

regulatory lists; or 

• There was no documented 

Kennewick facility use of the 

constituent, or it was a minor 

constituent in wastewater treatment 

material, not detected in historical filter 

cake samples, or converted to another 

COPC in the wastewater treatment 

process (i.e., hydrofluoric acid is 

present as fluoride in the filter cake). 

Based on this analysis, Sandvik’s SAP 

proposed the following list of COPCs: 

Arsenic; Barium; Cadmium; Chromium 

(including hexavalent chromium); 

Cobalt; Copper; Fluoride; 3 Lead; Nickel; 

Silver; Tin; Vanadium; and Zinc. Details 

of Sandvik’s identification of COPCs can 

be found in Table 5 in Attachment 2 to 

the delisting petition. 

The objectives of the waste 

characterization sampling conducted by 

Sandvik were as follows: 

• To supplement the existing 

historical data set with total and TCLP 

data for the identified COPCs; 

• To collect samples that are 

representative of process variations that 

include processing of two different alloy 

materials (titanium and zirconium) and 

the periodic addition of the waste 

coolant/lubricant to the filter cake 

waste; 

• To assess acute toxicity effects of 

wastes in accordance with the 

Washington State Department of 

Ecology’s 80–12, Part A protocol,4 and 

• To generate a representative data set 

that can be used in the Delisting Risk 

Assessment Software (DRAS) modeling. 

To achieve these objectives, Sandvik 

collected six (6) representative samples 

over three (3) sampling events that 

included the following scope of work: 

• Each event included the collection 

of one filter cake sample with the used 


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5The zirconium product requirements are more 

sensitive to contamination. As such, the tanks and 

mills are flushed prior to zirconium production. 

The titanium product requirements are not as 

sensitive; therefore, following zirconium 

production, the same acids and coolant/lubricants 

are used during titanium production. 

coolant/lubricant waste stream and one 

filter cake sample without the used 

coolant/lubricant waste stream; 

• Since titanium raw materials are 

present at higher weight composition 

percentages than zirconium, four filter 

cake samples (two with coolant and two 

without coolant) events were obtained 

when only titanium alloys were being 

run in the manufacturing process; and 

• To account for the use of zirconium, 

two samples (one with coolant and one 

without coolant) were obtained while 

zirconium alloys were also being run in 

the manufacturing process in addition 

to titanium alloys.5

All samples were analyzed for total 

and TCLP COPCs, where applicable. If 

chromium was detected at a 

concentration above the laboratory 

practical quantitation limit (PQL), a 

sample from the same sampling event 

was analyzed for hexavalent chromium. 

If chromium was not detected above the 

PQL, no additional testing was 

performed. This approach to sampling 

for chromium was used for both total 

and TCLP sampling. 

One sample with the coolant/ 

lubricant and one sample without the 

coolant/lubricant was analyzed to assess 

acute toxicity via bioassay as part of the 

first titanium-only sampling events. 

This combination of the filter cake 

production characteristics is expected to 

be the most conservative choice for 

bioassay testing, given the higher 

number of impurities in the titanium 

alloy. Additional details of Sandvik’s 

waste characterization sampling 

activities are provided in Attachment 2 

to the delisting petition. 

D. What were the results of Sandvik’s 

analysis of its waste? 

Sandvik provided results of their 

waste characterization activities in 

Attachment 3 to the delisting petition 

entitled ‘‘Sampling Results and Data 

Evaluation Report.’’ As part of its 

overall delisting petition submission, 

Sandvik submitted a signed statement 

certifying that information in the 

petition, including their submission of 

waste characterization data and 

description of the associated sampling 

and analysis activities, is true, accurate 

and complete, and the responsibilities 

of the signatory of the delisting petition. 

See 40 CFR 260.22(i)(12). 

Sandvik conducted its first sampling 

event on July 31, 2017, followed by two 

additional sampling events on August 

31 and September 25, 2017. Two 

representative samples of the WWTF 

filter cake were collected during each 

event, one with the used coolant/ 

lubricant waste stream and one without, 

for a total of six filter cake samples. Of 

these six samples, four were collected 

when only titanium alloys were being 

run in the manufacturing process, and 

two when zirconium was also being run. 

Each sample was a composite sample 

collected from four separate locations 

within each filter cake collection bin 

used to collect the filter cake following 

the filter press. Sandvik’s delisting 

petition states that according to facility 

representatives, the filter cake 

generation durations and resulting 

volumes within the filter press during 

each sampling event were typical for 

facility operations. Additional details of 

Sandvik’s waste characterization 

sampling activities can be found in 

Section 3 of the SAP (Attachment 2 of 

the delisting petition). 

Sandvik performed a quality 

assurance/quality control review of each 

laboratory report, with complete results 

of the data validation review detailed in 

Appendix C of the SAP. While this 

review identified one constituent 

(arsenic) from one sampling round 

where the data do not fully satisfy the 

data quality objectives set forth in 

Sandvik’s quality control standards, 

Sandvik concludes that the data are 

nevertheless generally suitable for their 

intended decision-making function. 

This constituent and sampling round 

are discussed further below. 

Based on the results of filter cake 

characterization sampling, Sandvik 

concluded that all constituents other 

than hexavalent chromium should be 

retained as constituents of concern for 

further evaluation. Sandvik’s deletion of 

hexavalent chromium from the list of 

COPCs is based on hexavalent 

chromium not being detected in any of 

the filter cake total or TCLP analysis 

according to the sampling methodology 

described above. 

Sandvik compared their 2017 waste 

characterization sampling results to 

historical total and TCLP results 

available for several of the COPCs. The 

range of recent COPC results was 

consistent with historical results except 

for fluoride. Historical total fluoride 

concentrations of 67,500 mg/kg and 

42,000 mg/kg from 1991 and 1997, 

respectively, were several orders of 

magnitude higher than recent 

concentrations; the highest recent 

concentration was 907 mg/kg. Sandvik 

indicates that it has progressively 

reduced the amount of etching in its 

process at the Kennewick facility, which 

would result in a decline in 

hydrofluoric acid use and fluoride in 

the filter cake. In addition, the 

collection method of the historical 

samples as well as the production and 

wastewater treatment system operations 

at the time of historical sampling are 

unknown. As a result, the 2017 samples 

are considered to be more representative 

of typical conditions for fluoride for 

current and future operations at the 

Kennewick facility. 

Overall, totals concentrations from the 

three 2017 sampling events were within 

the range of historical results. In 

addition to fluoride, as discussed in the 

previous paragraph, one 2017 maximum 

nickel sample (425 mg/kg) exceeded the 

historical maximum nickel sample of 

392 mg/kg. The 2017 totals samples also 

exceeded historical maximum 

concentrations for arsenic, barium, 

chromium, and silver, but none of these 

constituents had a difference of more 

than one order of magnitude between 

the 2017 and historic samples. Because 

most historical concentrations are from 

20 or more years ago and production 

and collection methods are unknown, 

the 2017 COPC results obtained from 

implementation of the SAP were 

considered more reliable and used for 

the subsequent data evaluation. 

Sandvik also compared the 2017 

waste characterization sampling result 

to the toxicity characteristic (TC) 

regulatory standard for those waste 

constituents for which regulatory 

standards have been established. Based 

on this comparison, Sandvik concluded 

that the candidate wastes do not exhibit 

the toxicity characteristic. Although 

Sandvik did not explicitly evaluate their 

candidate wastes for the characteristics 

of ignitability, reactivity or corrosivity, 

the EPA agrees that process knowledge 

provides an adequate demonstration 

that the wastes in question do not 

exhibit the enumerated characteristics. 

E. How did the EPA evaluate the risk of 

delisting this waste? 

For this delisting determination, we 

assumed that the waste would be 

disposed in a Subtitle D landfill and we 

considered transport of waste 

constituents through ground water, 

surface water and air. We evaluated 

Sandvik’s analysis of petitioned waste 

using the Agency’s Delisting Risk 

Assessment Software (DRAS) to predict 

the concentration of hazardous 

constituents that might be released from 

the petitioned waste and to determine if 

the waste would pose a threat to human 

health and the environment. The DRAS 

software and associated documentation 

can be found at www.epa.gov/hw/ 


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hazardous-waste-delisting-riskassessment-software-dras. 

To predict the potential for release to 

groundwater from landfilled wastes and 

subsequent routes of exposure to a 

receptor, the DRAS uses dilution 

attenuation factors derived from the 

EPA’s Composite Model for leachate 

migration with Transformation 

Products. From a release to ground 

water, the DRAS considers routes of 

exposure to a human receptor of 

ingestion of contaminated groundwater, 

inhalation from groundwater while 

showering and dermal contact from 

groundwater while bathing. 

From a release to surface water by 

erosion of waste from an open landfill 

into storm water run-off, DRAS 

evaluates the exposure to a human 

receptor by fish ingestion and ingestion 

of drinking water. From a release of 

waste particles and volatile emissions to 

air from the surface of an open landfill, 

DRAS considers routes of exposure of 

inhalation of volatile constituents, 

inhalation of particles, and air 

deposition of particles on residential 

soil and subsequent ingestion of the 

contaminated soil by a child. The 

technical support document and the 

user’s guide to DRAS are included in 

the docket. 

Sandvik documented the input 

parameters used in their DRAS analysis, 

as summarized below: 

TABLE 1—SANDVIK DELISTING DRAS INPUT

DRAS input parameter Value Assumptions 

Waste Management Unit Type ....... Landfill ........................................... Waste planned for disposal in the Finley Buttes Municipal Landfill, 

Boardman, Oregon. 

Waste Volume—annual generation 1,500 cubic yards/year .................. Conservative estimation value based on facility-specific information. 

Waste Management Unit Active Life 20 years ......................................... Selected based on the DRAS default value. 

Target risk—carcinogenic risk level 1×10¥5 .......................................... Based on risk ranges in the EPA’s RCRA Delisting Technical Support 

Document (2008). 

Target risk—health quotient ............ 1.0 .................................................. Based on risk ranges in the EPA’s RCRA Delisting Technical Support 

Document (2008). 

At a target cancer risk of 1×10¥5 and 

a target hazard quotient of 1.0, the 

DRAS program determined maximum 

allowable concentrations for each 

constituent in both the waste and the 

leachate at an annual waste volume of 

1,500 cubic yards. Sandvik used the 

maximum estimated annual waste 

volume and the maximum reported total 

and estimated leachate concentrations 

as inputs to estimate the constituent 

concentrations in the ground water, soil, 

surface water or air. The following table 

documents the constituent-specific 

maximum total and TCLP sample 

results used as input to the DRAS 

analysis, and the resulting modeling 

results from DRAS. The EPA notes that 

it has independently conducted its own 

DRAS modeling run, and has verified 

the modeling results documented by 

Sandvik in its delisting petition. 

TABLE 2—SAMPLING DATA AND DRAS MODELING RESULTS

Constituent of 

concern 

Maximum observed 

concentration 1

Modeling results 

Total 1

(mg/kg) 

TCLP 

(mg/L) 4

Total concentrations TCLP concentration 

Limiting 

concentration 

(mg/kg) 2

Limiting pathway 3

Limiting 

concentration 

(mg/L) 2

Limiting pathway 3

Arsenic .................. 4.77 0.05 U 9,840 Fish Ingestion .............. 0.042 GW Ingestion. 

Barium .................. 24.1 0.05 U 21,300,000 Fish Ingestion .............. 176 MCL. 

Cadmium .............. 15.0 0.05 U 37,100 Fish Ingestion .............. 0.451 MCL. 

Chromium ............. 44.3 0.05 U 77,500 Air Particulate Inhalation.9.54 MCL. 

Cobalt ................... 291 0.255 103,000 Air Particulate Inhalation.1.06 GW Ingestion. 

Copper .................. 26.2 0.057 3,790,000 Fish Ingestion .............. 120 MCL. 

Fluoride ................. 907 114 1,490,000,000 Soil .............................. 194 GW Ingestion. 

Lead ...................... 11.1 0.05 U 8,870,000 Air Particulate Inhalation.2.95 MCL. 

Nickel .................... 425 0.466 3,870,000 Air Particulate Inhalation.66.4 GW Ingestion. 

Silver ..................... 5.76 0.05 U 3,830,000 Fish Ingestion .............. 38.8 GW Ingestion. 

Tin ......................... 268 0.05 U 14,900,000,000 Soil .............................. 192,000,000 GW Ingestion. 

Vanadium ............. 1,500 0.05 U 124,000,000 Soil .............................. 16.9 GW Ingestion. 

Zinc ....................... 69.4 0.233 9,810,000 Fish ingestion .............. 992 GW Ingestion. 

1 Maximum concentration obtained during implementation of the 2017 Sampling and Analysis Plan (Geosyntec, 2017). 

2The Limiting Concentration is the lowest risk-based concentration developed in DRAS for the potential receptor pathways and specified target 

risk levels. See text in Section IV.C for the EPA’s consideration of limiting concentrations exceeding 1,000,000 mg/kg for total concentrations or 

1,000,000 mg/L for TCLP concentrations. 3The Limiting Pathway is the corresponding potential receptor pathway for the Limiting Concentration. 

4For detected constituents, the maximum analytical result was used. For non-detect constituents (annotated with a ‘‘U’’), the practical quantitation limit (PQL) was used. 5 Note: Italicized cells indicate exceedance of COPC Concentration Input over the Limiting Concentration in the DRAS modeling. 


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F. What did the EPA conclude about 

Sandvik’s waste? 

The maximum reported 

concentrations of the hazardous 

constituents found in this waste are 

presented in the table above. The table 

also presents the maximum allowable 

concentrations. Except for the 

groundwater pathway for arsenic, the 

concentrations of all constituents in 

both the waste and the leachate are 

below the allowable concentrations. 

For arsenic, the maximum reported 

concentration was undetected at a value 

of 0.05 mg/L, a value slightly higher 

than the maximum allowable TCLP 

concentration of 0.042 mg/L. The EPA’s 

review of the corresponding laboratory 

reports indicate that the laboratory 

reported sample results from the July 

31, 2017 characterization sampling 

round as non-detect based on a practical 

quantitation limit of 0.05 mg/L. 

Subsequent laboratory reports for the 

August 31, 2017 and October 4, 2017 

characterization rounds, however, 

reported TCLP arsenic results as nondetect at a level of 0.001 mg/L, based on 

a lower method detection limit rather a 

practical quantitation limit. Since the 

total arsenic results for all 

characterization samples are both low 

and consistent, ranging from 2.02 to 

4.77 mg/kg, the EPA believes that the 

TCLP arsenic results for the July 31, 

2017 results are not likely to be 

materially different than lower nondetect results for the August 31, 2017 

and October 4, 2017 sample results. 

Also, based on the difference in arsenic 

concentrations from the totals analysis 

(detected at low levels) and the TCLP 

samples (non-detect), arsenic appears to 

be relatively immobile in the filter cake. 

Therefore, the EPA concludes that even 

though the TCLP arsenic data from the 

August 31, 2017, laboratory report does 

not explicitly document satisfaction of 

the 0.042 mg/L TCLP arsenic delisting 

criterion, the overall data set clearly 

supports a conclusion that the TCLP 

arsenic results do not exceed the 

maximum allowable concentration of 

0.042 mg/L from any of the 

characterization sampling rounds, and 

that this arsenic data quality issue is not 

a sufficient basis to disqualify Sandvik’s 

waste from being delisted. If the EPA 

approves Sandvik’s delisting petition, 

Sandvik must ensure that any required 

periodic verification sampling and 

analysis meet appropriate data quality 

standards to address this issue. 

We, therefore, conclude that 

Sandvik’s wastewater treatment sludge 

is not a substantial or potential hazard 

to human health and the environment 

when disposed of in a Subtitle D 

landfill. Further, the data presented by 

Sandvik in their petition supports the 

EPA’s conclusion that the petitioned 

waste does not exhibit any hazardous 

characteristic, and that there are no 

other factors that would warrant 

retaining the waste as hazardous. On 

this basis, we propose to grant the 

Sandvik’s petition to delist this waste. If 

this exclusion is finalized, and subject 

to the conditions of the final delisting, 

Sandvik must dispose of this waste in 

a Subtitle D landfill permitted or 

licensed by a state and will remain 

obligated to verify that the waste 

continues to meet the allowable 

concentrations set forth here. Sandvik 

must also continue to demonstrate that 

the waste does not exhibit any 

hazardous characteristics pursuant to 40 

CFR part 261 Subpart C. 

IV. Conditions for Exclusion 

A. When would the EPA finalize the 

proposed delisting exclusion? 

HSWA specifically requires the EPA 

to provide notice and an opportunity for 

comment before granting or denying a 

final exclusion. Thus, EPA will not 

make a final decision or grant an 

exclusion until it has addressed all 

timely public comments on today’s 

proposal, including any at public 

hearings. 

Since this rule would reduce the 

existing requirements for persons 

generating hazardous wastes, the 

regulated community does not need a 

six-month period to come into 

compliance in accordance with § 3010 

of RCRA as amended by HSWA. 

B. How will Sandvik manage the waste 

if it is delisted? 

If the petitioned waste is delisted, 

Sandvik must dispose of it in a Subtitle 

D landfill which is permitted, licensed, 

or registered by a state to manage 

industrial waste. 

C. What are the maximum allowable 

concentrations of hazardous 

constituents in the waste? 

Concentrations measured in the waste 

of the following constituents must not 

exceed the concentrations in Table 3 

below. The EPA notes that for barium, 

chromium, and silver, the DRAS model 

output predicts a maximum 

concentration in an extract of the waste 

that exceeds the toxicity characteristic 

regulatory designation level (TC Limit) 

for that constituent. Since wastes that 

are a candidate for delisting cannot 

exhibit a characteristic, the fourth 

column in Table 3 caps the maximum 

TCLP concentration of the waste at the 

toxicity characteristic regulatory level 

for barium, chromium and silver. These 

capped levels for the maximum TCLP 

concentration are the enforceable 

decision criteria for demonstrating that 

the waste meets delisting criteria. 

TABLE 3—VERIFICATION CONSTITUENTS AND COMPLIANCE CONCENTRATIONS

Constituent 

Total 

concentration 

DRAS model 

(mg/kg) 

TCLP 

concentration 

DRAS model 

(mg/l) 

TCLP 

concentration 

DRAS model 

capped at TC 

limit 

(mg/l) 

Arsenic ......................................................................................................................................... 9,840 0.042 0.042 

Barium .......................................................................................................................................... N/A 176 100 

Cadmium ...................................................................................................................................... 37,100 0.451 0.451 

Chromium .................................................................................................................................... 77,500 9.54 5.00 

Cobalt ........................................................................................................................................... 103,000 1.06 1.06 

Copper ......................................................................................................................................... N/A 120 120 

Fluoride ........................................................................................................................................ N/A 194 194 

Lead ............................................................................................................................................. N/A 2.95 2.95 

Nickel ........................................................................................................................................... N/A 66.4 66.4 

Silver ............................................................................................................................................ N/A 38.8 5.00 

Vanadium ..................................................................................................................................... N/A 16.9 16.9 

Zinc .............................................................................................................................................. N/A 992 992 


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The EPA notes that in multiple 

instances the maximum allowable total 

constituent concentrations provided by 

the DRAS model exceed 100% of the 

waste—these DRAS results are an 

artifact of the risk calculations that do 

not have physical meaning. In instances 

where DRAS predicts a maximum 

constituent greater than 100 percent of 

the waste (that is, greater than 1,000,000 

mg/kg or mg/L, respectively, for total 

and TCLP concentrations), the EPA is 

not requiring Sandvik to perform 

sampling and analysis for that 

constituent and sampling type (total or 

TCLP). In these instances, the 

corresponding entry in Table 3 above is 

‘‘N/A.’’ 

D. How frequently must Sandvik test the 

waste? 

Sandvik must analyze a representative 

sample of the wastewater treatment 

sludges on an annual basis to 

demonstrate that the constituents of 

concern in the petitioned waste do not 

exceed the concentrations of concern in 

section IV.C above. Sandvik must use 

methods with sufficient analytical 

sensitivity and appropriate quality 

control procedures. SW–846 Method 

1311 must be used for generation of the 

leachate extract used in the testing of 

the subject waste. SW–846 Method 1311 

is incorporated by reference in 40 CFR 

260.11. 

A total analysis of the waste 

(accounting for any filterable liquids 

and the dilution factor inherent in the 

TCLP method) may be used to estimate 

the TCLP concentration as provided for 

in section 1.2 of Method 1311. The EPA 

is not requiring Sandvik to use Method 

1330 for extraction of wastes, since 

Method 1330 is applicable to API 

separator sludges, rag oils, slop oil 

emulsions, and other oil wastes derived 

from petroleum refining, which are 

fundamentally different wastes than 

those proposed by Sandvik for delisting. 

E. What data must Sandvik submit? 

Sandvik must submit the data 

obtained through annual verification 

testing to U.S. EPA Region 10, Office of 

Air and Waste, 1200 6th Avenue, Suite 

155, OAW–150, Seattle, Washington 

98101 upon each anniversary of the 

effective date of this exclusion. Sandvik 

must submit sampling data from both 

titanium and zirconium manufacturing 

processes provided both of these 

materials have been in production and 

contributed to candidate wastes within 

the three (3) month period prior to each 

anniversary of the effective date of this 

delisting. If both materials are not in 

production with the specified threemonth period, then only data from that 

material in production need be 

submitted. 

Sandvik must compile, summarize, 

and maintain on-site for a minimum of 

five years, records of analytical data 

required by this rule, and operating 

conditions relevant to those data 

analytical data. Sandvik must make 

those records available for inspection. 

All data must be accompanied by a 

signed copy of the certification 

statement in 40 CFR 260.22(i)(12). 

F. What happens if Sandvik fails to meet 

the conditions of the exclusion? 

If Sandvik violates the terms and 

conditions established in the exclusion, 

the Agency may start procedures to 

withdraw the exclusion. 

If the verification testing of the waste 

does not demonstrate compliance with 

the delisting concentrations described 

in section IV.C above, or other data 

(including but not limited to leachate 

data or groundwater monitoring data 

from the final land disposal facility) 

relevant to the delisted waste indicates 

that any constituent is at a 

concentration in waste above specified 

delisting verification concentrations in 

Table 3, Sandvik must notify the 

Agency within 10 days of first 

possessing or being made aware of the 

data. The exclusion will be suspended 

and the waste managed as hazardous 

until Sandvik has received written 

approval from the EPA to continue the 

exclusion. Sandvik may provide 

sampling results which support the 

continuation of the delisting exclusion. 

The EPA has the authority under 

RCRA and the Administrative 

Procedures Act, 5 U.S.C. 551 (1978) et 

seq. to reopen a delisting decision if we 

receive new information indicating that 

the conditions of this exclusion have 

been violated, or are otherwise not being 

met. 

G. What must Sandvik do if the process 

changes? 

If Sandvik significantly changes the 

manufacturing or treatment process or 

the chemicals used in the 

manufacturing or treatment process, 

Sandvik may not handle the wastewater 

treatment sludge generated from the 

new process under this exclusion until 

it has demonstrated to the EPA that the 

waste meets the concentrations set forth 

in section IV.C and that no new 

hazardous constituents listed in 

Appendix VIII of 40 CFR part 261 have 

been introduced. Sandvik must manage 

wastes generated after the process 

change as hazardous waste until 

Sandvik has received written notice 

from the EPA that the demonstration 

has been accepted. 

V. How would this action affect the 

states? 

Because the EPA is proposing to issue 

this exclusion under the federal RCRA 

delisting regulations, only states subject 

to federal RCRA delisting provisions 

will be affected. This exclusion may not 

be effective in states which have 

received authorization from the EPA to 

make their own delisting decisions. 

The EPA allows states to impose their 

own non-RCRA regulatory requirements 

that are more stringent than the EPA’s, 

under § 3009 of RCRA. These more 

stringent requirements may include a 

provision that prohibits a federally 

issued exclusion from taking effect in 

the state. We urge petitioners to contact 

the state regulatory authority to 

establish the status of their wastes under 

the state law. 

The EPA has also authorized some 

states to administer a delisting program 

in place of the federal program, that is, 

to make state delisting decisions. 

Therefore, this exclusion does not apply 

in those authorized states. If Sandvik 

manages the waste in any state with 

delisting authorization, Sandvik must 

obtain delisting authorization or other 

determination from the receiving state 

before it can manage the waste as 

nonhazardous in that state. 

While Washington State has received 

final authorization to implement most of 

its dangerous waste program regulations 

in lieu of the federal program, including 

the listing and identification of F006 

wastes (See 51 FR 3782 (January 30, 

1986), it has not been authorized to 

implement its delisting regulations 

program in lieu of the federal program. 

The EPA notes that Washington State 

has provisions in the Washington 

Administrative Code (WAC) 173–303– 

910(3) similar to the federal provisions 

upon which this delisting is based. 

These provisions are in effect as a 

matter of state law. Thus, Sandvik must 

seek approval from Washington State at 

the state level in addition to this 

proposed delisting. 

VI. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This proposed action is exempt from 

review by the Office of Management and 

Budget because it is a rule of particular 

applicability, not general applicability. 


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The proposed action approves a 

delisting petition under RCRA for the 

petitioned waste at a particular facility. 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

This proposed action is not an 

Executive Order 13771 regulatory action 

because actions such as approval of 

delisting petitions under RCRA are 

exempted under Executive Order 12866. 

C. Paperwork Reduction Act 

This proposed action does not impose 

an information collection burden under 

the provisions of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.) because it only applies to a 

particular facility. 

D. Regulatory Flexibility Act 

E. Because this rule is of particular 

applicability relating to a particular 

facility, it is not subject to the regulatory 

flexibility provision of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.). 

F. Unfunded Mandates Reform Act 

This proposed action does not contain 

any unfunded mandate as described in 

the Unfunded Mandates Reform Act (2 

U.S.C. 1531–1538) and does not 

significantly or uniquely affect small 

governments. The action imposes no 

new enforceable duty on any state, 

local, or tribal governments or the 

private sector. 

G. Executive Order 13132: Federalism 

This proposed action does not have 

federalism implications. It will not have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

H. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed action does not have 

tribal implications as specified in 

Executive Order 13175. This proposed 

action applies only to a particular 

facility on non-tribal land. Thus, 

Executive Order 13175 does not apply 

to this action. 

I. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This proposed action is not subject to 

Executive Order 13045 because it is not 

economically significant as defined in 

Executive Order 12866, and because the 

EPA does not believe the environmental 

health or safety risks addressed by this 

action present a disproportionate risk to 

children. This proposed action’s health 

and risk assessments using the Agency’s 

Delisting Risk Assessment Software 

(DRAS), which considers health and 

safety risks to children, are described in 

section III.E above. The technical 

support document and the user’s guide 

for DRAS are included in the docket. 

J. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

This proposed action is not subject to 

Executive Order 13211, because it is not 

a significant regulatory action under 

Executive Order 12866. 

K. National Technology Transfer and 

Advancement Act 

This proposed action does not involve 

technical standards as described by the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note). 

L. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this proposed 

action does not have disproportionately 

high and adverse human health or 

environmental effects on minority 

populations, low-income populations, 

and/or indigenous peoples. The EPA 

has determined that this proposed 

action will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. The Agency’s risk 

assessment, as described in section III.E 

above, did not identify risks from 

management of this material in an 

authorized, solid waste landfill (e.g. 

RCRA Subtitle D landfill, commercial/ 

industrial solid waste landfill, etc.). 

Therefore, the EPA believes that any 

populations in proximity of the landfills 

used by this facility should not be 

adversely affected by common waste 

management practices for this delisted 

waste. 

M. Congressional Review Act 

This proposed action is exempt from 

the Congressional Review Act (5 U.S.C. 

801 et seq.) because it is a rule of 

particular applicability. 

List of Subjects in 40 CFR Part 261 

Environmental protection, Hazardous 

waste, Recycling, and Reporting and 

recordkeeping requirements. 

Dated: August 21, 2018. 

Jan Hastings, 

Deputy Director, Office of Air and Waste. 

For the reasons set out in the 

preamble, the EPA proposes to amend 

40 CFR part 261 as follows: 

PART 261—IDENTIFICATION AND 

LISTING OF HAZARDOUS WASTE 

■ 1. The authority citation for part 261 

continues to read as follows: 

Authority: 42 U.S.C. 6905, 6912(a), 6921, 

6922, 6924(y) and 6938. 

■ 2. Amend Table 1 of Appendix IX to 

Part 261 by adding the following waste 

stream entry ‘‘Sandvik Special Metals’’ 

in alphabetical order to read as follows: 

Appendix IX to Part 261—Wastes 

Excluded Under §§ 260.20 and 260.22 

TABLE 1—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES

Facility Address Waste description 

*******

Sandvik Special 

Metals.

Kennewick, Washington.Wastewater treatment sludges, F006, generated at Sandvik Special Metals (Sandvik) facility in 

Kennewick, Washington at a maximum annual rate of 1,500 cubic yards per year. The sludge 

must be disposed of in a Subtitle D landfill which is licensed, permitted, or otherwise authorized 

by a state to accept the delisted wastewater treatment sludge. The exclusion becomes effective 

as of [the date of final publication]. 

1. Delisting Levels: (A) The constituent concentrations in a representative sample of the waste must 

not exceed the following levels: Total concentrations (mg/kg): Arsenic—9,840; Cadmium—37,100; 

Chromium—77,500; Cobalt—103,000. TCLP Concentrations (mg/l in the waste extract): Arsenic— 

0.042; Barium—100; Cadmium—0.451; Chromium—5.00; Cobalt—1.06; Copper—120; Fluoride— 

194; Lead—2.95; Nickel—66.4; Silver—5.00; Vanadium—16.9; Zinc—992. 


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Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Proposed Rules 46135 

TABLE 1—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES—Continued 

Facility Address Waste description 

2. Annual Verification Testing: To verify that the waste does not exceed the delisting concentrations 

specified in Section 1.A, Sandvik must collect and analyze one representative waste sample with 

coolant on an annual basis no later than each anniversary of the effective date of this delisting 

using methods with appropriate detection concentrations and elements of quality control. If both titanium and zirconium products have been in production and contributed to candidate wastes within the three-month period prior to each anniversary of the effective date of this delisting, samples 

of waste from both manufacturing processes must be collected for that reporting cycle. Otherwise, 

sampling only of that material in production within the specified three-month period is required. 

Sampling data must be provided to the EPA no later 60 days following each anniversary of the effective date of this delisting, or such later date as the EPA may agree to in writing. Sandvik must 

conduct all verification sampling according to a written sampling plan and associated quality assurance project plan that ensures analytical data are suitable for their intended use, which must 

be made available to the EPA upon request. Sandvik’s annual submission must also include a 

certification that all wastes satisfying the delisting concentrations in Condition 1.A have been disposed of in a Subtitle D landfill which is licensed, permitted, or otherwise authorized by a state to 

accept the delisted wastewater treatment sludge. 

3. Changes in Operating Conditions: Sandvik must notify the EPA in writing if it significantly 

changes the manufacturing process, the chemicals used in the manufacturing process, the treatment process, or the chemicals used in the treatment process. Sandvik must handle wastes generated after the process change as hazardous until it has demonstrated that the wastes continue 

to meet the delisting concentrations in section 1.C, demonstrated that no new hazardous constituents listed in 40 CFR part 261 Appendix VIII have been introduced into the manufacturing process or waste treatment process, and it has received written approval from the EPA that it may 

continue to manage the waste as non-hazardous. 

4. Data Submittals: Sandvik must submit the data obtained through verification testing or as required by other conditions of this rule to the Director, Office of Air and Waste, U.S. EPA Region 

10, 1200 6th Avenue Suite 155, OAW–150, Seattle, Washington, 98070 or his or her equivalent. 

The annual verification data and certification of proper disposal must be submitted within 60 days 

after each anniversary of the effective date of this delisting exclusion, or such later date as the 

EPA may agree to in writing. Sandvik must compile, summarize, and maintain on-site for a minimum of five years, records of analytical data required by this rule, and operating conditions relevant to those data. Sandvik must make these records available for inspection. All data must be 

accompanied by a signed copy of the certification statement in 40 CFR 260.22(i)(12). If Sandvik 

fails to submit the required data within the specified time or maintain the required records on-site 

for the specified time, the EPA may, at its discretion, consider such failure a sufficient basis to reopen the exclusion as described in paragraph 5. 

5. Reopener Language—(A) If, any time after disposal of the delisted waste, Sandvik possesses or 

is otherwise made aware of any data relevant to the delisted waste indicating that any constituent 

is at a higher than the specified delisting concentration, then Sandvik must report such data, in 

writing, to the Director, Office of Air and Waste, EPA, Region 10, or his or her equivalent, within 

10 days of first possessing or being made aware of that data. (B) Based on the information described in paragraph (A) and any other information received from any source, the EPA will make 

a preliminary determination as to whether the reported information requires Agency action to protect human health or the environment. Further action may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment. 

(C) If the EPA determines that the reported information does require Agency action, the EPA will 

notify Sandvik in writing of the actions it believes are necessary to protect human health and the 

environment. The notice shall include a statement of the proposed action and a statement providing Sandvik with an opportunity to present information as to why the proposed Agency action 

is not necessary or to suggest an alternative action. Sandvik shall have 30 days from the date of 

the EPA’s notice to present the information. (D) If after 30 days Sandvik presents no further information or after a review of any submitted information, the EPA will issue a final written determination describing the Agency actions that are necessary to protect human health or the environment. Any required action described in the EPA’s determination shall become effective immediately, unless the EPA provides otherwise. 

*******

[FR Doc. 2018–19595 Filed 9–11–18; 8:45 am] 

BILLING CODE 6560–50–P 


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