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Attachment 1 

ENVIRONMENTAL PROTECTION AGENCY 

40 CFR Parts 261, 268 and 302 

[EPA-HQ-RCRA-2010-XXXX, FRL_XXXX-X] 

RIN 2050-AG55 

Hazardous Waste Management System; Identification and Listing of Hazardous Waste; 

Removal of Saccharin and Its Salts from the Lists of Hazardous Constituents, Hazardous 

Wastes, and Hazardous Substances 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Proposed Rule. 

SUMMARY: The Environmental Protection Agency (EPA or the Agency) is proposing to 

amend its regulations under the Resource Conservation and Recovery Act (RCRA) to remove 

saccharin and its salts from the lists of hazardous constituents and commercial chemical products 

which are hazardous wastes when discarded or intended to be discarded. EPA is also proposing 

to amend the regulations under the Comprehensive Environmental Response, Compensation, and 

Liability Act (CERCLA) to remove saccharin and its salts from the list of hazardous substances. 

This proposed rule is in response to a petition submitted to EPA by the Calorie Control Council 

(CCC), to remove saccharin and its salts from the above lists. EPA is proposing to grant CCC’s 

petition based on a review of the evaluations conducted by key public health agencies concerning 

the carcinogenic and other potential toxicological effects of saccharin and its salts, as well as 
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EPA’s own assessment of the waste generation and management information for saccharin and 

its salts, which demonstrate that saccharin and its salts do not meet the criteria in the hazardous 

waste regulations for remaining on EPA’s lists of hazardous constituents, hazardous wastes, and 

hazardous substances. 

DATES: Comments must be received on or before [INSERT 60 DAYS FROM DATE OF 

FEDERAL REGISTER PUBLICATION]. 

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-RCRA-2009-

0310 by one of the following methods: 

• www.regulations.gov: Follow the on-line instructions for submitting comments. 

E-mail: Comments may be sent by electronic mail (e-mail) to 

rcra.docket@epamail.epa.gov, Attention Docket ID No. EPA-HQ-RCRA-2009-

0310. 

Mail: Comments may be submitted by mail to: OSWER Docket, Office of Resource 

Conservation and Recovery, U.S. Environmental Protection Agency, Mailcode: 

5305T, 1200 Pennsylvania Avenue, NW, Washington, DC 20460, Attention 

Docket ID No. EPA-HQ-RCRA-2009-0310. Please include a total of two copies 

of your comments. 

Hand Delivery: Deliver your comments to: EPA Docket Center, Public Reading 

Room, Room 3334, EPA West Building, 1301 Constitution Avenue, NW, 

Washington, DC 20460, Attention Docket ID No. EPA-HQ-RCRA-2009-0310. 

Such deliveries are only accepted during the Docket’s normal hours of operation 
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(8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays) and 

special arrangements should be made for deliveries of boxed information. 

Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-2009-0310. 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 

e-mail. The www.regulations.gov website is an “anonymous access” system, which means EPA 

will not know your identity or contact information unless you provide it in the body of your 

comment. If you send an e-mail comment directly to EPA without going through 

www.regulations.gov, your e-mail address will be automatically captured and included as a part 

of the comment that is placed in the public docket and made available on the Internet. If you 

submit an electronic comment, EPA recommends that you include your name and other contact 

information in the body of your comment and with any disk or CD ROM you submit. If EPA 

cannot read your comment due to technical difficulties and cannot contact you for clarification, 

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. For additional 

information about EPA’s public docket, visit the EPA Docket Center homepage at 

http://www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket are listed in www.regulations.gov index. Although listed 

in the index, some information is not publicly available, i.e., CBI or other information whose 

disclosure is restricted by statute. Certain other material, such as copyrighted material, will be 
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publicly available only in hard copy. Publicly available docket materials are available either 

electronically in www.regulations.gov or in hard copy at the OSWER Docket in the EPA Docket 

Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, DC 

20460. The Public Meeting Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone number for the OSWER Docket and the Public Reading 

Room is (202) 566-1744. 

FOR FURTHER INFORMATION CONTACT: Mr. Narendra Chaudhari, Office of Resource 

Conservation and Recovery (5304W), U.S. Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW, Washington, DC 20460; telephone number: 703-308-0454; e-mail 

address: chaudhari.narendra@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this Action Apply to Me? 

This proposed rule could directly affect businesses that generate or manage unused 

commercial products that contain saccharin or its salts as the sole active ingredient. The wastes 

affected by this proposed rule are listed as EPA Hazardous Waste No. U202 (see 40 CFR 

261.33(f)). If finalized, these wastes will no longer be listed hazardous wastes. This action may 

also affect entities that need to respond to releases of these wastes as CERCLA hazardous 

substances, since saccharin and its salts will no longer be CERCLA hazardous substances. 

Persons in charge of vessels or facilities from which saccharin or its salts are released will no 

longer be required to immediately notify the National Response Center of the release under 
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section 103 of CERCLA and will not be subject to the liability provisions under section 103 of 

CERCLA. The table below provides a guide for readers regarding entities that likely would be 

directly or indirectly affected by this action, based on the information available from the 2007 

Biennial Report.1

 Industry Sectors Potentially Affected by the Proposed Rule 

NAICS Code Industry Description for NAICS Code 

5417 Scientific Research and Development Services 

31193 Flavoring Syrup and Concentrate Manufacturing 

32541 Pharmaceutical and Medicine Manufacturing 

32562 Toilet Preparation Manufacturing2

54171 

Research and Development in the Physical, 

Engineering, and Life Sciences 

49311 General Warehousing and Storage 

61131 Colleges, Universities, and Professional Schools 

312111 Soft Drink Manufacturing 

325411 Medicinal and Botanical Manufacturing 

325412 Pharmaceutical Preparation Manufacturing 

325199 

All Other Basic Organic Chemical Manufacturing 

[manufacturers of saccharin] 

 This action, however, may affect other entities not listed in the table. To determine 

whether your facility is affected by this action, you should examine 40 CFR parts 261, 268 and 

 

1

 EPA, in partnership with the States, biennially collects information regarding the generation, management, and 

final disposition of hazardous wastes regulated under RCRA. See the 2007 Biennial Report on the EPA web site 

http://www.epa.gov/epawaste/inforesources/data/index.htm

2

 Saccharin and its salts are used in personal-care products such as mouthwash, dental cleaners, and lipstick, which 

come under Toilet Preparation Manufacturing (NAICS Code 32562).
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302 carefully, along with the final regulatory language amending Chapter I of the Code of 

Federal Regulations (CFR). This language is found at the end of this Federal Register notice. If 

you have questions regarding the applicability of this action to a particular entity, consult the 

person listed in the preceding section entitled FOR FURTHER INFORMATION CONTACT. 

B. What Should I Consider as I Prepare My Comments for EPA?

 1. Submitting CBI. Do not submit this information to EPA through www.regulations.gov

or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI 

information submitted on a disk or CD ROM that you mail to EPA, mark the outside of the disk 

or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific 

information that is claimed as CBI. In addition to one complete version of the comment that 

includes information claimed as CBI, a copy of the comment that does not contain the 

information claimed as CBI must be submitted for inclusion in the public docket. Information so 

marked will not be disclosed except in accordance with the procedures set forth in 40 CFR 

part 2. For further information on the procedures for submitting CBI data, contact Ms. LaShan 

Haynes (5305W), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, 

Washington, DC 20460, (e-mail address and telephone number: haynes.lashan@epa.gov, (703) 

605-0516). 

2. Tips for Preparing your Comments. When submitting comments, remember to: 

• Identify the rulemaking by docket number and other identifying information 

(subject heading, Federal Register date and page number). 

• Follow directions - The agency may ask you to respond to specific questions or 

organize comments by referencing a Code of Federal Regulations (CFR) part or 

section number. 
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• Explain why you agree or disagree; suggest alternative and substitute language 

for your requested changes. 

• Describe any assumptions that you used and provide any technical information 

and/or data that you used. 

• If you estimate potential burden or costs, explain how you arrived at your 

estimate in sufficient detail to allow for it to be reproduced. 

• Provide specific examples to illustrate your concerns and suggest alternatives. 

• Explain your views as clearly as possible, avoiding the use of profanity or 

personal threats. 

• Make sure to submit your comments by the comment period deadline identified. 

Preamble Outline 

I. Statutory Authority 

II. List of Abbreviations and Acronyms 

III. Overview 

A. What is EPA Proposing in This Rule? 

B. Why is EPA Proposing This Rule? 

C. What Information Did EPA Consider in Its Decision to Propose This Rule? 

IV. Background 

A. How Does EPA Identify a Chemical Substance as a Hazardous Constituent, 

Hazardous Waste, or Hazardous Substance? 

B. What is the History of the Listings for Saccharin and Its Salts? 
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C. Who Submitted a Petition to the EPA and What Do They Seek? 

V. EPA’s Evaluation of the Petition Based on the Available Toxicological Information and 

Waste Generation and Management Information for Saccharin and Its Salts 

A. Evaluation of Toxicological Information for Saccharin and Its Salts to Assess the 

Petition 

1. Evaluation of Information on the Carcinogenicity of Saccharin and Its Salts by NTP 

and IARC 

2. Evaluation of Information on Other Toxicological Effects of Saccharin and Its Salts by 

NTP and IARC 

B. Evaluation of Waste Generation and Management Information for Saccharin and 

Its Salts to Assess the Petition 

1. Quantity and Types of Wastes Generated 

2. Factors Considered for Waste Listing 

VI. EPA’s Conclusions and Rationale for Proposing to Grant the Petition 

VII. Status of Land Disposal Restrictions for U202 Listed Wastes 

VIII. State Authorization 

A. Applicability of the Rule in Authorized States 

B. Effect on State Authorization 

IX. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) 

Designation and List of Hazardous Substances and Reportable Quantities 

X. Relationship to Other Rules 

XI. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory Planning and Review 
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B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation and Coordination with Indian Tribal 

Governments 

G. Executive Order 13045: Protection of Children from Environmental Health and 

Safety Risks 

H. Executive Order 13211: Actions that Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and Advancement Act 

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations 

I. Statutory Authority 

EPA proposes these regulations under the authority of §§1006, 2002(a), 3001 and 3002 

of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act 

(RCRA), as amended, by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 

U.S.C. 6905, 6912(a), 6921 and 6922. These statutes combined are commonly referred to as the 

“Resource Conservation and Recovery Act” (RCRA) and will be referred to as such for the 

remainder of this action. 
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Section 102 of the Comprehensive Environmental Response, Compensation, and 

Liability Act of 1980 (CERCLA), 42 U.S.C. 9602, is the authority under which the CERCLA 

aspects of this rule are promulgated. 

II. List of Abbreviations and Acronyms 

BRS Biennial Reporting System 

CAG Carcinogen Assessment Group 

CBI Confidential Business Information 

CCC Calorie Control Council 

CERCLA Comprehensive Environmental Response, Compensation, and Liability Act 

CFR Code of Federal Regulations 

DHHS Department of Health and Human Services 

EPA U.S. Environmental Protection Agency 

EPCRA Emergency Planning and Community Right-to-Know Act of 1986 

FDA Food and Drug Administration 

HSWA Hazardous and Solid Waste Amendments of 1984 

IARC International Agency for Research on Cancer 

LC 50 Lethal Concentration 50% 

LD 50 Lethal Dose 50% 

LDRS Land Disposal Restrictions 

NAICS North American Industrial Classification System 

NOEL No Effect Level 

NTP National Toxicology Program 

OMB Office of Management and Budget 

ROC Report on Carcinogens 

RQ Reportable Quantity 

WHO World Health Organization 

III. Overview 

A. What is EPA Proposing in This Rule? 

EPA is proposing to grant a petition submitted by the Calorie Control Council (CCC) 

under 40 CFR 260.20 to remove saccharin and its salts from the lists of hazardous constituents 

(40 CFR part 261, Appendix VIII), hazardous wastes (40 CFR 261.33(f)), and hazardous 

substances (40 CFR 302.4).
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B. Why is EPA Proposing This Rule? 

 Under §260.20, any person may petition the EPA Administrator to modify or revoke any 

provision in Parts 260 through 266, 267, 268, and 273 of 40 CFR. The CCC argued in a petition 

it submitted to EPA (which is included in the docket for this proposed rule) that the current 

scientific evidence, as viewed by key public health agencies, such as the National Toxicology 

Program (NTP) and the International Agency for Research on Cancer (IARC), does not support 

classifying saccharin as a potential human carcinogen, which was EPA’s original basis for 

placing saccharin and its salts on its lists. EPA’s evaluation of this petition considered the 

original basis for the listing, NTP’s and IARC’s more recent conclusions about the risk of 

carcinogenicity of saccharin and its salts, and other factors or criteria required for making a 

listing determination. Based on this evaluation, EPA has determined that saccharin and its salts 

do not present any significant risk to human health or the environment. Therefore, EPA is 

proposing to grant CCC’s petition by proposing to remove saccharin and its salts from the lists of 

hazardous constituents (40 CFR part 261, Appendix VIII), hazardous wastes (40 CFR 261.33(f)), 

and hazardous substances (40 CFR 302.4). 

C. What Information Did EPA Consider in Its Decision to Propose This Rule? 

 EPA’s analysis of whether or not to remove saccharin and its salts from its lists began 

with a review of the information in CCC’s petition. This was followed by a review of the 

supporting information referred to in CCC’s petition. The key supporting information for 

assessing the potential health risks from saccharin and its salts came from NTP and IARC. The 

NTP and IARC recently re-evaluated the available scientific evidence for saccharin and its salts 

and provided their findings on the carcinogenicity of these substances. (See Section V.A.). 

Since EPA originally listed saccharin based solely upon the evidence that it is a potential human 

Deleted: for removing saccharin and 

its salts from the lists of hazardous 

constituents, hazardous wastes, and 

hazardous substances
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carcinogen, it was important to consider the recent findings of NTP and IARC. In addition, EPA 

considered all other factors that could cause it to list saccharin and its salts as hazardous wastes, 

as well as hazardous constituents (Appendix VIII of Part 261) and hazardous substances (Part 

302). 

IV. Background

A. How Does EPA Identify a Chemical Substance as a Hazardous Constituent, Hazardous 

Waste, or Hazardous Substance? 

 EPA’s regulations establish two ways of identifying solid wastes as hazardous wastes 

under RCRA. A waste may be considered hazardous if it exhibits certain hazardous properties 

(“characteristics”) or if it is included on a specific list of wastes that EPA has determined are 

hazardous (“listing” a waste as hazardous) because the Agency has concluded that they may pose 

a substantial present or potential hazard to human health or the environment if improperly 

managed. EPA’s regulations in the Code of Federal Regulations (40 CFR) define four hazardous 

waste characteristic properties: ignitability, corrosivity, reactivity, and toxicity (see 40 CFR 

261.21 - 261.24). As a generator, you must determine whether or not a waste exhibits any of 

these characteristics by testing, or by using your knowledge of the process that generated the 

waste (see §262.11(c)). 

 EPA “lists” wastes as hazardous if they meet the criteria set out in 40 CFR 261.11. The 

regulations at 40 CFR 261.31 through 261.33 contain the various hazardous wastes the Agency 

has listed to date. Under §§261.33(e) and (f), the Agency includes two lists of commercial 

chemical products or manufacturing chemical intermediates, or off-specification commercial 

chemical products or manufacturing chemical intermediates, that are hazardous wastes if and 
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when they are discarded or intended to be discarded. The phrase “commercial chemical product 

or manufacturing chemical intermediate” refers to a chemical substance that is manufactured or 

formulated for commercial or manufacturing use, and consists of the commercially pure grade of 

the chemical, any technical grades of the chemical that are produced or marketed, and all 

formulations in which the chemical is the sole active ingredient. 

 The Agency lists a chemical in §261.33(e) as an acutely hazardous waste if it meets the 

criteria in §261.11(a)(2), which state that the waste “has been found to be fatal to humans in low 

doses or, in the absence of data on human toxicity, it has been shown in studies to have an oral 

LD 50 toxicity (rat) of less than 50 milligrams per kilogram, an inhalation LC 50 toxicity (rat) of 

less than 2 milligrams per liter, or a dermal LD 50 toxicity (rabbit) of less than 200 milligrams 

per kilogram or is otherwise capable of causing or significantly contributing to an increase in 

serious irreversible, or incapacitating reversible, illness.” 

 The Agency lists a chemical in §261.33(f) as a hazardous waste if it meets the criteria in 

§261.11(a)(1) and/or §261.11(a)(3). Section 261.11(a)(1) requires that the waste “exhibits any of 

the characteristics of hazardous waste identified in subpart C.” Section 261.11(a)(3) requires 

that the waste contains hazardous constituents identified in 40 CFR part 261, Appendix VIII, and 

after considering a number of factors, “. . . the Administrator concludes that the waste is capable 

of posing a substantial present or potential hazard to human health or the environment when 

improperly treated, stored, transported, or disposed of, or otherwise managed.” EPA places 

chemicals on the list of hazardous constituents in Appendix VIII “if they have been shown in 

scientific studies to have toxic, carcinogenic, mutagenic or teratogenic effects on humans or 

other life forms.” 
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 Whenever a hazardous waste or waste stream is identified or listed as hazardous under 

§3001 of RCRA, it automatically becomes a hazardous substance under the statutory provisions 

of §101(14) of CERCLA. 

B. What is the History of the Listings for Saccharin and Its Salts? 

 In 1980, as part of its final and interim final regulations implementing §3001 of RCRA, 

EPA promulgated the lists of hazardous constituents (40 CFR part 261, Appendix VIII) and 

commercial chemical products or manufacturing chemical intermediates identified as hazardous 

wastes (40 CFR 261.33(f)) that included saccharin and its salts (45 FR 33084, May 19, 1980 and 

45 FR 78532, November 25, 1980). The hazardous constituents listed in Appendix VIII were 

those which had been shown in scientific studies to have toxic, carcinogenic, mutagenic, or 

teratogenic effects on humans or other life forms, and included substances that had been 

identified by the Agency’s Carcinogen Assessment Group (CAG). Saccharin was one of the 

constituents identified by CAG as a potential human carcinogen. The identification of saccharin 

by CAG, which lead to its inclusion in Appendix VIII of Part 261, is the sole reason the Agency 

listed saccharin as EPA Hazardous Waste No. U202 in 40 CFR 261.33(f). The Agency added 

“and salts” to the saccharin listing in the November 25, 1980 rulemaking, since normal 

commercial use includes both forms. The substances listed on 40 CFR 261.33(f) are commercial 

chemical products, manufacturing chemical intermediates, or off-specification commercial 

chemical products that are hazardous wastes if and when they are discarded or intended to be 

discarded. 

 Saccharin and its salts are included in 40 CFR 302.4 and designated as hazardous 

substances under §102(a) of CERCLA, if they are listed under §3001 of RCRA. 

Deleted: reputable 
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C. Who Submitted a Petition to the EPA and What Do They Seek? 

 On April 30, 2003, the CCC submitted a rulemaking petition to EPA, under 40 CFR 

260.20, seeking removal of saccharin and its salts from the lists of hazardous constituents (40 

CFR part 261, Appendix VIII), hazardous wastes (40 CFR 261.33(f)), and hazardous substances 

(40 CFR 302.4). In the petition, CCC argued that the key public health agencies, such as NTP 

and IARC had recently concluded, based on the current scientific evidence, that saccharin is not 

a potential human carcinogen. CCC also argued that, since EPA listed saccharin and its salts on 

the lists of hazardous constituents, hazardous wastes, and hazardous substances based solely on 

their potential as human carcinogens, there is no longer any basis for EPA to continue to include 

saccharin and its salts on these lists, and, therefore, believe that they should be removed from 

these lists. To examine CCC’s complete petition, see the docket for this proposed rule. 

V. EPA’s Evaluation of the Petition Based on the Available Toxicological Information 

and Waste Generation and Management Information for Saccharin and Its Salts

 Saccharin is a white crystalline powder which is about 300 times sweeter than sucrose. It 

is typically available commercially either in the acid form (saccharin) or as salts (sodium 

saccharin or calcium saccharin). The use of the name saccharin has been applied to all three 

forms of this chemical. Saccharin and its salts are used primarily as non-nutritive sweeteners. 

The most common uses are in diet soft drinks, as a table-top sweetener, and in products, such as 

juices, sweets, chewing gum and jellies. They are also used in cosmetics (e.g., toothpaste, 

mouthwash, and lipstick), pharmaceuticals (e.g., for coatings on pills), and electroplating (e.g., as 

a brightener in nickel-plating baths). 

Deleted: have
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 EPA listed saccharin and its salts on the lists of hazardous constituents (40 CFR part 261, 

Appendix VIII), hazardous wastes (40 CFR 261.33(f)), and hazardous substances (40 CFR 

302.4) based solely upon the evidence that it is a potential human carcinogen. EPA’s evaluation 

of CCC’s petition includes consideration of the original basis for the listings in light of the most 

recent scientific evidence about the risk of carcinogenicity of saccharin and its salts. However, 

EPA has also evaluated the petitioner’s requests against the listing criteria and factors that would 

need to be considered today under the regulations. 

A. Evaluation of Toxicological Information for Saccharin and Its Salts to Assess the 

Petition 

There have been numerous scientific studies conducted over the past several decades for 

the purpose of determining the toxicological effects, in particular carcinogenic effects, from the 

use of saccharin and its salts. The NTP and IARC have recently re-evaluated the available 

scientific information on saccharin and its salts relevant to its carcinogenic and other 

toxicological effects. In 1996, CCC submitted a nomination to (or petitioned) the NTP to 

consider removing saccharin from its Report on Carcinogens (ROC) “based upon mechanistic 

data related to development of urinary bladder cancers in rats.” NTP re-evaluated the available 

scientific information for saccharin and published its decision on CCC’s petition in 2000, as part 

of its 9th ROC. In 1999, IARC published the results of its latest re-evaluation of the available 

scientific information for saccharin and its salts. The evaluations on the carcinogenicity and 

other toxicological effects of saccharin and its salts by NTP and IARC are summarized below. 

See the “NTP Report on Carcinogens Background Document for Saccharin” (which will now be 

referred to as NTP’s Background Document) and part of the IARC Monographs Volume 73 

concerning saccharin and its salts, which are included in the docket for this rulemaking. EPA 
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believes it is appropriate to accept the saccharin evaluations performed by NTP and IARC. The 

NTP decision to delist saccharin from the ROC included scientific peer reviews, as well as public 

comment. IARC’s evaluation on the carcinogenicity of saccharin and its salts provides 

additional support in EPA’s assessment of CCC’s petition. 

1. Evaluation of Information on the Carcinogenicity of Saccharin and Its Salts by 

NTP and IARC 

 NTP initially listed saccharin as “reasonably anticipated to be a human carcinogen” in its 

2nd ROC, published in 1981, based on sufficient evidence, at that time, of carcinogenicity in 

experimental animals. Specifically, the listing was based on increased incidence of bladder 

tumors in experimental animals, especially male rats, when they were fed sodium saccharin. 

However, saccharin was removed, or delisted, by NTP in its 9th ROC, published in 2000. The 

delisting decision for saccharin was made on the basis of a formal review process adopted by 

NTP, which included two Federal and one non-government scientific peer review and public 

comment and review. 

 In the ROC and its background document, NTP summarized its evaluation supporting the 

decision to remove saccharin as “reasonably anticipated to be a human carcinogen” as follows: 

 “There is evidence of the carcinogenicity of saccharin in rats but less convincing 

evidence in mice. Mechanistic studies indicate that the observed urinary bladder cancers 

in rat studies are related to urinary pH, osmolality, volume, presence of precipitate and 

urothelial damage with attendant hyperplasia following dietary concentrations of 3% or 

higher with inconsistent findings at lower dietary concentrations. The factors thought to 

contribute to tumor induction by sodium saccharin in rats would not be expected to occur 

in humans. The mouse data are inconsistent and require verification by additional 

studies. Results of several epidemiology studies indicate no clear association between 

saccharin consumption and urinary bladder cancer. Although it is impossible to 

absolutely conclude that it poses no threat to human health, sodium saccharin is not 

reasonably anticipated to be a human carcinogen under conditions of general usage as an 

artificial sweetner.” 

Deleted: , an interagency program 

headquartered in the Department of 

Health and Human Services (DHHS) for 

toxicological assessment of chemicals 

within the Federal government that 

includes EPA and the Food and Drug 

Administration (FDA) on its executive 

committee,

Deleted: , a part of the World Health 

Organization (WHO), for assessing the 

potential toxicological effects to humans 

or other life forms from the use of 

saccharin and its salts

Deleted: , following a delisting petition 

from the CCC
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The available epidemiology studies, according to NTP, mostly examined associations between 

urinary bladder cancer and artificial sweetners, rather than saccharin per se. The time trend data 

for bladder cancer from these studies were thought to be essentially noninformative with no clear 

indication that the increased use of saccharin or artificial sweetners, beginning in the 1940’s, was 

associated with any general increase in bladder cancer when controlled for confounding factors, 

mainly smoking. NTP’s decision to delist saccharin, as stated in the ROC, was as follows: 

“Saccharin will be delisted from the Report on Carcinogens, because the rodent cancer 

data are not sufficient to meet the current criteria to list this chemical as reasonably 

anticipated to be a human carcinogen. This is based on the perception that the observed 

bladder tumors in rats arise by mechanisms not relevant to humans, and the lack of data 

in humans suggesting a carcinogenic hazard.” 

IARC first evaluated saccharin in 1980 and concluded the following: 

“There is sufficient evidence that saccharin alone, given at high doses, produces tumours 

of the urinary tract in male rats ...” (IARC, 1980). 

In 1999, IARC presented its last re-evaluation, taking into consideration all new data on 

saccharin and its salts. It found that, based on a review of human studies on the carcinogenicity 

of artificial sweetners, that there is “no consistent pattern of dose-response relationship between 

use of artificial sweetners and cancers of the urinary bladder or lower urinary tract is apparent in 

the available literature.” The animal studies in rats with sodium saccharin did show urinary 

bladder tumors in the 2-generation studies. However, the incidence of bladder tumors was 

significant only at higher doses (greater than 3% of the diet). Based on this re-evaluation, IARC 

concluded the following: 

“There is inadequate evidence in humans for the carcinogenicity of saccharin salts used 

as sweetners.” 

“There is sufficient evidence in experimental animals for the carcinogenicity of sodium 

saccharin.” 

Deleted: 
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“There is inadequate evidence in experimental animals for the carcinogenicity of 

saccharin (acid form) and calcium saccharin.” 

In making its overall evaluation of the carcinogenic risk from saccharin and its salts, IARC stated 

the following: 

“In making its evaluation, the Working Group concluded that sodium saccharin produces 

urothelial bladder tumours in rats by a non-DNA-reactive mechanism that involves the 

formation of urinary calcium phosphate-containing precipitate, cytotoxicity and enhanced 

cell proliferation. This mechanism is not relevant to humans because of critical 

interspecies differences in urine composition.” 

“Saccharin and its salts are not classifiable as to their carcinogenicity to humans (Group 

3).” 

2. Evaluation of Information on Other Toxicological Effects of Saccharin and Its 

Salts by NTP and IARC 

 In addition to the evaluation of information on saccharin’s carcinogenicity, NTP’s 

Background Document and IARC’s 1999 re-evaluation (as presented in IARC Monograph 

Volume 73) included information and analysis on other toxicological effects of saccharin and its 

salts. Specifically, saccharin, in the form of sodium saccharin, has generally been tested in rats 

by feeding the rats diets containing specified amounts of sodium saccharin. It has not been 

found to be acutely toxic in rats based on the criterion for listing hazardous wastes under 

§261.11(a)(2). The LD 50 values for sodium saccharin by oral administration in rats ranged 

from 14 g/kg (14,000 mg/kg) to 17 g/kg (17,000 mg/kg) of body weight, which is significantly 

higher than the oral LD 50 value for rats of less than 50 mg/kg specified under the listing 

criterion. A 2-generation feeding study in rats that were given 1% to 7.5% sodium saccharin in 

their diet indicated that a 1% dietary level (500 mg/kg of body weight) of sodium saccharin 

represented a no-effect level (NOEL). There was also no significant increase in the incidence of 

urinary bladder tumors at the 3% dietary level of sodium saccharin. Generally, the studies on 
Draft/Deliberative Document- Do Not Distribute Page 20 of 37

mutagenicity, genotoxicity, developmental and reproductive toxicity using saccharin and sodium 

saccharin have shown negative results. For more detailed information and analysis on other 

toxicological effects of saccharin and its salts, see NTP’s Background Document and IARC’s 

1999 re-evaluation in the docket for this proposed rule. 

B. Evaluation of Waste Generation and Management Information for Saccharin and Its 

Salts to Assess the Petition 

1. Quantity and Types of Wastes Generated 

 Saccharin and its salts are listed hazardous wastes, if the waste arises from the discard of 

a commercial chemical product, manufacturing chemical intermediate, or off-specification 

material (EPA Hazardous Waste No. U202 in 40 CFR 261.33(f)). The U-waste code applies 

only if the chemical is present in a pure or technical grade form, or is the sole active ingredient in 

the chemical formulation; in addition, the chemical must be unused. 

 The U202 listing is narrow and does not apply to other discarded materials that merely 

contain saccharin or its salts, e.g., discarded products that contain saccharin as a sweetening 

agent. Nor does the listing apply to manufacturing process wastes that may contain saccharin or 

its salts, except for unused or off-specification saccharin or its salts that are discarded. 

Therefore, U202 is primarily generated by companies that manufacture saccharin or its salts, use 

saccharin or its salts in product formulations (e.g., soft drinks, cosmetics, pharmaceuticals), and 

by companies that are discarding small quantities of unused or off-specification saccharin or its 

salts, such as some laboratories. 

 Facilities are required by EPA to report the amount of hazardous waste, including U202 

generated biennially (every two years) as part of the Biennial Report System, or BRS. Based on 

the information available from the BRS for the years 2001, 2003, 2005, and 2007, generators 
Draft/Deliberative Document- Do Not Distribute Page 21 of 37

reported a total of 123 specific wastes listed as U202 during this time period (some generators 

reported multiple U202 wastes over the years in question). The total amount of U202 waste 

generated over these four years was 20 tons for all industries/NAIC Codes; for 2007, there were 

4.1 tons of U202 reported for 29 separate wastes. 

 Most of the U202 wastes appear to be discarded unused or off specification material and 

“lab packs,” which package hazardous items for shipping and disposal. A limited number of 

other wastes are also reported, including contaminated debris/soil, organic and aqueous liquids, 

and other unidentified material. Although wastes were reported as “generated” by hazardous 

waste treatment, storage, and disposal facilities, the BRS data indicate that nearly all of these 

wastes were not generated onsite, but rather were received from offsite for storage/packing and 

subsequent transfer for treatment or disposal. To avoid counting wastes twice (i.e., the reported 

wastes from the generator and again from the waste facility packing/transferring the waste), one 

can subtract out the amounts of waste reported by hazardous waste collection and treatment 

facilities. Removing the U202 wastes generated at these hazardous waste handling facilities 

gives a total of 14.7 tons generated from 2001 through 2007, and a total of 2.9 tons for 2007 

alone. Therefore, the total quantity of U202 generated is quite small compared to the total 

volume of hazardous waste generated, both on an annual basis and over the course of four 

reporting years.3 

2. Factors Considered for Waste Listing 

 Saccharin and its salts were listed as hazardous waste under the criterion for listing given 

in 40 CFR 261.11(a)(3). Under this criterion, the Agency can list a waste if it contains any of the 

 

3

 For comparison, BRS shows that approximately 47 million tons of hazardous waste was generated in 2007 (see 

http://www.epa.gov/osw/inforesources/data/br07/national07.pdf). Also in 2007, approximately 137 million tons of 

municipal waste went to landfills and other disposal (see http://www.epa.gov/epawaste/nonhaz/municipal/msw99.htm).
Draft/Deliberative Document- Do Not Distribute Page 22 of 37

toxic constituents identified in 40 CFR part 261, Appendix VIII and, after considering a number 

of factors, the Agency concludes that the waste poses a “substantial present or potential hazard to 

human health or the environment” when improperly managed. The nature of the toxicity of a 

chemical contained in a waste is one of the factors to be considered in listing a waste as “toxic” 

(see §261.11(a)(3)(i)). The Agency cited toxicity as the “decisive” factor in listing commercial 

chemical products under §261.33(f), because the waste is typically the chemical itself (see EPA’s 

Background Document for §261.33, April 1981). Saccharin and its salts were listed as toxic 

constituents on Appendix VIII and subsequently identified as hazardous wastes in §261.33(f) 

based solely on their potential for carcinogenic effect in humans. Therefore, if the toxicological 

basis for listing saccharin and its salts on Appendix VIII of Part 261 is removed, then the basis 

for listing in §261.33(f) no longer exists. 

 Other factors considered in listing a waste under §261.11(a)(3) are related to the potential 

of the chemical to migrate if improperly managed, and include the chemical’s persistence and 

accumulation potential. However, these other factors are not critical in a listing evaluation for 

commercial chemical products containing saccharin and its salts, because the low toxicity of 

these chemicals revealed in scientific studies, including a lack of potential carcinogenic effect in 

humans, means that any risk from a plausible management scenario (e. g., disposal in a landfill) 

would not be sufficient to cause a substantial present or potential hazard. In addition, the 

quantity of waste generated from the discard of saccharin and its salts by individual facilities and 

on a nationwide basis (§261.11(a)(3)(viii)) is relatively small, as described previously, which 

further reduces any potential hazard that might arise from disposal of the waste. The generators 

are distributed across the nation, located in 42 different counties according to the BRS data, 

reducing the likelihood of significant codisposal in the same landfill. 
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 Additionally, one of the other factors for EPA to consider is action taken by other 

governmental agencies and regulatory programs (§261.11(a)(3)(x)). These actions also 

demonstrate that saccharin and its salts do not present a substantial hazard. These actions 

include: (1) the determinations by NTP and IARC that saccharin is not a potential human 

carcinogen, as discussed previously; (2) the State of California’s removal of saccharin and its 

salts from its list of chemicals known to cause cancer or reproductive toxicity (under its Safe 

Drinking Water and Toxic Enforcement Act of 1986, known as “proposition 65”)4

; and (3) the 

FDA’s approval of a variety of uses of saccharin in food, cosmetics, and drugs, and elimination 

of the warning label on food containing saccharin.5 Saccharin and its salts continue to be used 

widely as a non-nutritive sweetener in food products and are also used in products, such as 

toothpaste, mouthwash, chewing gum, confections, and pharmaceuticals. 

 Furthermore, as noted previously in section V.A.2., the information reviewed indicates 

that saccharin and its salts are not acutely toxic, and as such, they would not meet the criterion 

for listing hazardous wastes under §261.11(a)(2). Moreover, saccharin and its salts do not meet 

the criterion under §261.11(a)(1), because saccharin and its salts are not expected to exhibit any 

of the characteristics of hazardous waste, i.e., the ignitability, corrosivity, reactivity, and toxicity, 

as described in 40 CFR 261.21 through 261.24. 

 Finally, the Agency needed to consider only one factor in listing saccharin and its salts as 

hazardous substances under CERCLA. Under the statutory provisions of §101(14) of CERCLA, 

a hazardous waste that exhibits one or more of the hazardous waste characteristics or specifically 

 

4

 California EPA, Office of Environmental Health Hazard Assessment, Notice to Interested Parties for Chemical 

Delisted Effective April 6, 2001 and Notice to Interested Parties for Chemical Delisted Effective January 17, 2003 

(available in the docket for this proposed rulemaking). 

5 Section 517, Title V, Appendix A, Consolidated Appropriations Act of 2001 (Pub. L. 106-554, 114 Stat. 2763), 

repealed 21 U.S.C. 343(o), the saccharin warning statement requirement. 
Draft/Deliberative Document- Do Not Distribute Page 24 of 37

is listed as a hazardous waste under RCRA becomes a hazardous substance under CERCLA.6

 

As a result, saccharin and its salts were listed in 40 CFR 302.4 and designated as hazardous 

substances under §102(a) of CERCLA. Therefore, if the U202 hazardous waste listing under 

RCRA is removed, there would be no basis for listing saccharin and its salts as hazardous 

substances under CERCLA. 

VI. EPA’s Conclusions and Rationale for Proposing to Grant the Petition 

EPA believes that saccharin and its salts, based on the results of the latest reviews of the 

available scientific information performed by NTP and IARC, do not pose a present or potential 

risk of causing toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life 

forms. This is because saccharin and its salts: (1) are not found to be highly toxic in scientific 

studies; (2) are not reasonably expected to have carcinogenic effects in humans and carcinogenic 

effects in experimental animals (i.e., rats) have been observed mainly at higher doses (greater 

than 3% of the diet) that cannot reasonably be expected to be available in the environment 

outside of laboratory conditions; and (3) are not reasonably expected to be mutagenic or 

teratogenic. Therefore, there is no basis for retaining saccharin and its salts as a hazardous 

constituent listed on Appendix VIII of Part 261. 

EPA also believes that saccharin and its salts, based on a review of the evaluations 

conducted by NTP and IARC concerning the carcinogenic and other potential toxicological 

 

6

 In addition, hazardous substances include: (1) any substance designated pursuant to section 311(b)(2)(A) of the 

Federal Water Pollution Control Act; (2) any element, compound, mixture, solution, or substance designated 

pursuant to section 102 of the Comprehensive Emergency Response, Compensation, and Liability Act; (3) any toxic 

pollutant listed under section 307(a) of the Federal Water Pollution Control Act; (4) any hazardous air pollutant 

listed under section 112 of the Clean Air Act; and (5) any imminently hazardous chemical substance or mixture with 

respect to which the Administrator has taken action pursuant to section 7 of the Toxic Substances Control Act. 

Saccharin and its salts are not included on any of these lists. 
Draft/Deliberative Document- Do Not Distribute Page 25 of 37

effects of saccharin and its salts, as well as EPA’s own assessment of the waste generation and 

management information for saccharin and its salts, do not meet the criteria for listing them as 

hazardous wastes under 40 CFR 261.11. This is because saccharin and its salts: (1) are not 

known to exhibit any of the characteristics of hazardous wastes identified in 40 CFR 261.21 

through 261.24; (2) are not found to be acutely toxic in studies with animals; (3) are not found to 

be highly toxic in non-acute (longer-term) scientific studies; (4) are not discarded annually in a 

quantity which could reasonably be considered to pose a “substantial present or potential hazard 

to human health or the environment” when improperly treated, stored, transported, or disposed 

of, or otherwise managed; and (5) are not considered hazardous by other government agencies 

and regulatory programs. Therefore, there is no basis for retaining the listing for saccharin and 

its salts as a hazardous waste under 40 CFR 261.33(f). 

EPA’s listing of saccharin and its salts as hazardous substances under CERCLA (40 CFR 

302.4) was based solely upon these substances being listed as U202 hazardous wastes under 

RCRA (40 CFR 261.33(f)). Therefore, since the Agency is proposing to remove saccharin and 

its salts as U202 listed hazardous wastes and saccharin and its salts are not designated or listed as 

hazardous substances on any of the other environmental statutes identified in §101(14) of 

CERCLA that defines the term “hazardous substance,” there exists no basis for retaining 

saccharin and its salts on CERCLA’s list of hazardous substances (40 CFR 302.4). Based on the 

above conclusions, EPA is proposing to grant CCC’s petition to remove saccharin and its salts 

from the lists of hazardous constituents (40 CFR part 261, Appendix VIII), hazardous wastes (40 

CFR 261.33(f)), and hazardous substances (40 CFR 302.4). 
Draft/Deliberative Document- Do Not Distribute Page 26 of 37

VII. Status of Land Disposal Restrictions for U202 Listed Wastes 

 As discussed in the previous section, the Agency is proposing to remove saccharin and its 

salts from the list of commercial chemical products which are hazardous wastes when discarded 

or intended to be discarded (40 CFR 261.33(f)). These chemicals are specifically listed as 

RCRA Hazardous Waste No. U202 under 40 CFR 261.33(f). The regulations under 40 CFR part 

268, prohibit the land disposal of RCRA hazardous waste unless they meet a certain level or 

have been treated by a technology specified by EPA prior to land disposal. See the table 

“Treatment Standards for Hazardous Wastes” in §268.40. The land disposal restrictions (LDRs) 

only apply to solid wastes that are RCRA hazardous wastes. Therefore, if saccharin and its salts 

are removed from the list of hazardous wastes based on this proposal, they would not be subject 

to the LDRs. Therefore, EPA is also proposing to remove saccharin and its salts from the table 

“Treatment Standards for Hazardous Wastes” in §268.40. 

VIII. State Authorization 

A. Applicability of the Rule in Authorized States 

Under §3006 of RCRA, EPA may authorize a qualified State to administer and enforce a 

hazardous waste program within the State in lieu of the Federal program, and to issue and 

enforce permits in the State. Following authorization, EPA retains enforcement authority under 

§§3008, 3013, and 7003 of RCRA, although authorized States have primary enforcement 

responsibility. The standards and requirements for State authorization are found at 40 CFR part 

271. 

Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a 

State with final RCRA authorization administered its hazardous waste program entirely in lieu of 
Draft/Deliberative Document- Do Not Distribute Page 27 of 37

EPA administering the Federal program in that State. The Federal requirements no longer 

applied in the authorized State, and EPA could not issue permits for any facilities in that State, 

since only the State was authorized to issue RCRA permits. When new, more stringent Federal 

requirements were promulgated, the State is obligated to enact equivalent authorities within 

specified timeframes. However, the new Federal requirements do not take effect in an 

authorized State until the State adopted the Federal requirements as State law. 

In contrast, under RCRA §3006(g), (42 U.S.C. 6926(g)), new Federal requirements and 

prohibitions imposed pursuant to HSWA authority take effect in authorized States at the same 

time that they take effect in unauthorized States. Although authorized States still are required to 

update their hazardous waste programs to remain equivalent to the Federal program, EPA is 

directed by the statute to implement the requirements and prohibitions in authorized States, 

including the issuance of new permits implementing those requirements, until EPA authorizes 

the State to do so. 

Authorized States are required to modify their programs only when EPA promulgates 

Federal requirements that are more stringent or broader in scope than existing Federal 

requirements. RCRA §3009 allows the States to impose standards more stringent than those in 

the Federal program. See also 40 CFR 271.1(i). Therefore, authorized States may, but are not 

required to adopt Federal regulations, both HSWA or non-HSWA, that are considered less 

stringent than previous Federal requirements. 

B. Effect on State Authorization 

This rule is promulgated pursuant to non-HSWA authority. The changes in this rule are 

less stringent than the current Federal requirements. Therefore, States will not be required to 

adopt and seek authorization for these changes. EPA will implement the changes to the 

Deleted: not proposed under the

Deleted: of HSWA. Thus, the 

proposed rule, if finalized, would be 

applicable on the effective date only in 

those States that do not have final RCRA 

authorization. Moreover, authorized 

States are required to modify their 

program only when EPA promulgates 

Federal regulations that are more 

stringent or broader in scope than the 

authorized State regulations. This is a 

result of §3009 of RCRA, which allows 

States to impose more stringent 

regulations than the Federal program. 

This proposed rule is considered to be 

Deleted: regulations.

Deleted: authorized 

Deleted: are

Deleted: the proposed
Draft/Deliberative Document- Do Not Distribute Page 28 of 37

exemptions only in those States which are not authorized for the RCRA program. Nevertheless, 

EPA believes that this rule has considerable merit, and the Agency thus strongly encourages 

States to amend their programs and become Federally-authorized to implement these rules. 

IX. Comprehensive Environmental Response, Compensation, and Liability Act 

(CERCLA) Designation and List of Hazardous Substances and Reportable 

Quantities 

Section 101(14) of CERCLA defines the term “hazardous substance” as those substances 

designated or listed under several other environmental statutes and those substances designated 

by EPA as hazardous under CERCLA §102(a). In particular, CERCLA §101(14)(C) 

incorporates by reference any hazardous waste having the characteristics identified under or 

listed pursuant to §3001 of the Solid Waste Disposal Act. CERCLA §102(a) authorizes EPA to 

designate as hazardous those substances that, when released into the environment, may present 

substantial danger to the public health, welfare or the environment, and to establish the 

reportable quantity (RQ) for all CERCLA hazardous substances. CERCLA §102(b) sets a RQ of 

one pound (statutory RQ) for hazardous substances, except those for which RQs have been 

established pursuant to §311(b)(4) of the Clean Water Act (CWA). A list of CERCLA 

hazardous substances with their corresponding RQs is provided in Table 302.4 at 40 CFR part 

302. CERCLA section 103 requires any person who releases a CERCLA hazardous substance in 

an amount equal to or greater than its RQ to report the release immediately to the National 

Response Center. 

 On April 4, 1985, EPA issued a final rule, “Notification Requirements, Reportable 

Quantity Adjustments; Final Rule and Proposed Rule” (see 50 FR 13456). The final rule 

Formatted: Font: Not Bold

Deleted: proposed rulemaking 

Deleted: EPA

Deleted: , if they become final
Draft/Deliberative Document- Do Not Distribute Page 29 of 37

retained the statutory RQ of one pound for saccharin and its salts with a note that the final RQ is 

subject to change when the assessment of potential carcinogenicity and/or chronic toxicity is 

completed. 

 On March 16, 1987, EPA proposed to adjust the statutory RQ for saccharin and its salts 

to 100 pounds (45.5 kg) (see 52 FR 8140), which EPA finalized on August 14, 1989 (see 54 FR 

33418). Saccharin and its salts, at the time of RQ adjustment, were classified as weight of 

evidence Group C,7 potency Group 38 substances and received a “low” hazard ranking. 

 In this proposal, the Agency is proposing to remove saccharin and its salts from the list of 

CERCLA hazardous substances in conjunction with the removal of saccharin and its salts from 

the list of hazardous constituents (40 CFR part 261, Appendix VIII) and the list of commercial 

chemical products deemed hazardous waste (40 CFR 261.33(f)). With removal of the RCRA 

hazardous waste listing, the Agency does not have an independent basis upon which to retain 

saccharin and salts as CERCLA hazardous substances. That is, the Agency’s designation of 

saccharin and its salts under §102(a) was based solely upon its inclusion as a hazardous 

substance under §101(14)(C) of CERCLA. 

X. Relationship to Other Rules 

This action is not intended, and should not be inferred to affect the status of saccharin 

under any statute or program other than RCRA and CERCLA. The granting of CCC’s petition 

does not remove saccharin from the EPCRA §313 list, which requires annual reporting of 

environmental releases of toxic chemicals. 

 

7

 Group C (possible human carcinogen) includes hazardous substances with “limited” evidence of carcinogenicity in 

animals and “inadequate evidence,” “no data,” or “no evidence” from human epidemiologic studies. 

8 Group 3 – “low” hazard category. RQ levels are assigned to the hazard rankings as follows: high (one pound RQ), 

medium (10 pound RQ), and low (100 pound RQ). 

Deleted: is a

Deleted: substance
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XI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review 

 Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a 

"significant regulatory action.” Pursuant to the terms of Executive Order 12866, although the 

annual effect of this proposed rule is expected to be less than $100 million, the Agency has 

determined that this proposed rule is a significant regulatory action because it contains novel 

policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget 

(OMB) for review under EO 12866 and any changes made in response to OMB 

recommendations have been documented in the docket for this action. 

B. Paperwork Reduction Act 

This action does not impose an information collection burden under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). In 

fact, EPA expects that the total annual respondent burden from this proposed rule would result in 

a net reduction in national annual paperwork burden to the affected facilities because of 

elimination of hazardous waste, and CERCLA hazardous substance reporting requirements. 

EPA also expects this rule to result in net annual cost savings to these same facilities from 

reduced waste management costs, by the expected shift of waste management from RCRA 

Subtitle C hazardous waste management, to RCRA Subtitle D nonhazardous waste management. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a 

regulatory flexibility analysis of any rule subject to notice and comment rulemaking 

requirements under the Administrative Procedure Act or any other statute, unless the agency 
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certifies that the rule will not have a significant economic impact on a substantial number of 

small entities. Small entities include small businesses, small organizations, and small 

governmental jurisdictions. 

For purposes of assessing the impacts of today’s rule on small entities, small entity is 

defined as: (1) a small business as defined by the Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201;” (2) a small governmental jurisdiction that is a government of a 

city, county, town, school district or special district with a population of less than 50,000; and (3) 

a small organization that is any not-for-profit enterprise which is independently owned and 

operated and is not dominant in its field. 

After considering the economic impacts of today’s proposed rule on small entities, I 

certify that this action will not have a significant economic impact on a substantial number of 

small entities. In determining whether a rule has a significant economic impact on a substantial 

number of small entities, the impact of concern is any significant adverse economic impact on 

small entities, since the primary purpose of the regulatory flexibility analyses is to identify and 

address regulatory alternatives “which minimize any significant economic impact of the 

proposed rule on small entities” (5 U.S.C. sections 603 and 604). Thus, an agency may certify 

that a rule will not have a significant economic impact on a substantial number of small entities 

if the rule relieves regulatory burden, or otherwise has a positive economic effect on small 

entities subject to the rule.

Because this action is designed to lower the cost of waste management for these 

industries, we have therefore concluded that today’s proposed rule will relieve regulatory burden 

for all affected small entities. The Agency continues to be interested in the potential impacts of 

the proposed rule on small entities and welcomes comments on issues related to such impacts. 
Draft/Deliberative Document- Do Not Distribute Page 32 of 37

D. Unfunded Mandates Reform Act 

This action contains no Federal mandates under the provisions of Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal 

governments or the private sector. This is because this proposed rule imposes no enforceable duty 

on any State, local, or tribal governments or the private sector. Therefore, this action is not subject 

to the requirements of sections 202 or 205 of the UMRA. 

 This action is also not subject to the requirements of section 203 of UMRA because it 

contains no regulatory requirements that might significantly or uniquely affect small 

governments. 

E. Executive Order 13132: Federalism 

 This 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, as 

specified in Executive Order 13132. This proposed rule primarily affects generators of certain 

hazardous wastes from the discard of unused commercial products that contain saccharin and its 

salts. There are no State and local government bodies that incur direct compliance costs by this 

rulemaking. State and local government implementation expenditures are expected to be less 

than $500,000 in any one year. Thus, Executive Order 13132 does not apply to this action. 

In the spirit of Executive Order 13132, and consistent with EPA policy to promote 

communications between EPA and State and local governments, EPA specifically solicits 

comment on this proposed rule from State and local officials. 
Draft/Deliberative Document- Do Not Distribute Page 33 of 37

F. Executive Order 13175: Consultation and Coordination with Indian Tribal 

Governments 

This action does not have tribal implications, as specified in Executive Order 13175 (65 

FR 67249, November 9, 2000). This proposed rule does not significantly or uniquely affect the 

communities of Indian tribal governments, nor would it impose substantial direct compliance 

costs on them. Thus, Executive Order 13175 does not apply to this rule. 

G. Executive Order 13045: Protection of Children from Environmental Risks and Safety 

Risks 

 This action is not subject to EO 13045 (62 FR 19885, April 23, 1997) because it is not 

economically significant as defined in EO 12866, and because the Agency does not believe the 

environmental health or safety risks addressed by this action present a disproportionate risk to 

children.

H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution 

or Use 

This proposed rule is not a "significant energy action" as defined in Executive Order 

13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect 

on the supply, distribution, or use of energy. This proposed rule reduces regulatory burden and 

should not adversely affect energy supply, distribution or use.

I. National Technology Transfer and Advancement Act 

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 

(“NTTAA”), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use 

voluntary consensus standards in its regulatory activities, unless to do so would be inconsistent 

with applicable law or otherwise impractical. Voluntary consensus standards are technical 
Draft/Deliberative Document- Do Not Distribute Page 34 of 37

standards (e.g., materials specifications, test methods, sampling procedures, and business 

practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA 

directs EPA to provide Congress, through OMB, explanations when the Agency decides not to 

use available and applicable voluntary consensus standards. 

 This proposed rulemaking does not involve technical standards. Therefore, EPA is not 

considering the use of any voluntary consensus standards. 

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations 

Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive 

policy on environmental justice. Its main provision directs Federal agencies, to the greatest 

extent practicable and permitted by law, to make environmental justice part of their mission by 

identifying and addressing, as appropriate, disproportionately high and adverse human health or 

environmental effects of their programs, policies, and activities on minority populations and lowincome populations in the United States. 

EPA has determined that this proposed rule 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. EPA is 

committed to addressing environmental justice concerns and has assumed a leadership role in 

environmental justice initiatives to enhance environmental quality for all citizens of the United 

States. The Agency’s goals are to ensure that no segment of the population, regardless of race, 

color, national origin, income, or net worth bears disproportionately high and adverse human 

health and environmental impacts as a result of EPA’s policies, programs, and activities. Our 

goal is to ensure that all citizens live in clean and sustainable communities. In response to 
Draft/Deliberative Document- Do Not Distribute Page 35 of 37

Executive Order 12898, and to concerns voiced by many groups outside the Agency, EPA’s 

Office of Solid Waste and Emergency Response (OSWER) formed an Environmental Justice 

Task Force to analyze the array of environmental justice issues specific to waste programs and to 

develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3-

17). 

The Agency’s assessment, based on the small quantity of saccharin and its salts that are 

estimated to be discarded by affected facilities and their relatively low toxicity, is that there is no 

significant risk to human health or the environment from managing saccharin and its salts in 

nonhazardous waste landfills (the plausible management scenario). As noted previously in 

section V.B.2., the facilities that generate these small quantities of waste are distributed across 

the nation, which makes it unlikely that any one segment of the population would be impacted 

disproportionately from management of this nonhazardous waste. However, the Agency 

continues to be interested in any potential environmental justice concerns as a result of this 

proposed rule and welcomes comments on issues related to such concerns. 

List of Subjects

40 CFR Part 261

Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping 

requirements 

40 CFR Part 268

Environmental protection, Hazardous waste, Reporting and recordkeeping requirements 
Draft/Deliberative Document- Do Not Distribute Page 36 of 37

40 CFR Part 302 

Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous 

waste, Intergovernmental relations, Natural resources, Reporting and record keeping 

requirements, Superfund, Water pollution control, Water supply 

Dated: 

_______________________________________________ 

Lisa P. Jackson, 

Administrator. 

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is 

proposed to be amended as follows: 

PART 261—IDENTIFICATION AND LISTING OF HAZARDOUS WASTE 

1. The authority citation for part 261 continues to read as follows: Authority: Sections 

1006, 2002(a), 3001, and 3002 of the Solid Waste Disposal Act, as amended by the 

Resource Conservation and Recovery Act of 1976, as amended (42 U.S.C. 6905, 6912(a), 

6921, 6922). 

2. Section 261.33 is amended by removing the entries for the U202 hazardous waste in the 

table under paragraph (f) with the following substance names: “1,2-Benzisothiazol3(2H)-one, 1,1-dioxide, & salts” and “Saccharin, & salts.” 
Draft/Deliberative Document- Do Not Distribute Page 37 of 37

3. Appendix VIII is amended by removing the entries for: “Saccharin...1,2-Benzisothiazol3(2H)-one, 1,1-dioxide...81-07-2...U202” and “Saccharin salts...U202.” 

PART 268—LAND DISPOSAL RESTRICTIONS 

4. The authority citation for part 268 continues to read as follows: Authority: 42 U.S.C. 

6905, 6912(a), 6921, and 6924. 

5. Section 268.40 is amended by removing the entry for waste code U202 from the table 

“Treatment Standards for Hazardous Wastes.” 

6. Appendix VII is amended by removing the entry for waste code U202 from Table 1, 

“Effective Dates of Surface Disposed Wastes (Non-Soil and Debris) Regulated in the 

LDRs – Comprehensive List.” 

PART 302—DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION 

7. The authority citation for part 302 continues to read as follows: Authority: 42 U.S.C. 

9602, 9603, and 9604; 33 U.S.C. 1321 and 1361. 

8. Section 302.4 is amended by removing the entry for “Saccharin, & salts” from table 

302.4.