20942 Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 

attend the hearing, see the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel, Procedure and Administration. 

[FR Doc. 2010–9338 Filed 4–21–10; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R06–OAR–2005–NM–0007; FRL– 

9140–1] 

Approval and Promulgation of Air 

Quality Implementation Plans; New 

Mexico; Transportation Conformity 

Requirement for Bernalillo County 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

a revision to the New Mexico State 

Implementation Plan (SIP) at New 

Mexico Administrative Code 20.11.3, 

concerning transportation conformity 

rules for Bernalillo County, New 

Mexico. The plan revision is intended to 

ensure consistency with amendments to 

the federal Transportation Conformity 

Rule. These plan revisions meet 

statutory and regulatory requirements, 

and are consistent with EPA’s guidance. 

DATES: Written comments should be 

received on or before May 24, 2010. 

ADDRESSES: Please see the related direct 

final rule, which is located in the ‘‘Rules 

and Regulations’’ section of this Federal 

Register, for detailed instructions on 

how to submit comments. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Riley, Air Planning Section 

(6PD–L), Environmental Protection 

Agency, Region 6, 1445 Ross Avenue, 

Suite 700, Dallas, Texas 75202–2733, 

telephone 214–665–8542; fax number 

214–665–7263; e-mail address 

riley.jeffrey@epa.gov. 

SUPPLEMENTARY INFORMATION: This 

document proposes to take action on 

SIP revisions submitted by the Governor 

of New Mexico on behalf of the 

Albuquerque Environmental Health 

Department. We have published a direct 

final rule approving the State’s SIP 

revisions in the ‘‘Rules and Regulations’’ 

section of this Federal Register because 

we view this as a noncontroversial 

action and anticipate no adverse 

comment. We have explained our 

reasons for this action in the preamble 

to the direct final rule. 

If we receive no adverse comment, we 

will not take further action on this 

proposed rule. If we receive adverse 

comment, we will withdraw the direct 

final rule and it will not take effect. We 

would address all public comments in 

any subsequent final rule based upon 

this proposed rule. 

We do not intend to institute a second 

comment period on this action. Any 

parties interested in commenting must 

do so at this time. For further 

information, please see the information 

provided in the ADDRESSES section of 

this document. 

Dated: April 9, 2010. 

Lawrence E. Starfield, 

Acting Regional Administrator, Region 6. 

[FR Doc. 2010–9197 Filed 4–21–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 261, 268 and 302 

[EPA–HQ–RCRA–2010–0310, FRL–9140–3] 

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 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 June 21, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

RCRA–2009–0310 by one of the 

following methods: 

• http://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: 28221T, 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 (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 http:// 

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 http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site 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 http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as a part of the comment 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 20943 

1EPA, 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. 

2Saccharin 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). 

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 http://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 publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in http:// 

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 section 103 of CERCLA 

and will not be subject to the liability 

provisions under section 107 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 Manufacturing.2

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 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 http://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. 

• 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. 

• 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? 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
20944 Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 

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? 

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 

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. 

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). 

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 

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, 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 20945 

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 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 states 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.’’ 

Whenever a hazardous waste or waste 

stream is identified or listed as 

hazardous under section 3001 of RCRA, 

it automatically becomes a hazardous 

substance under the statutory provisions 

of section 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 section 

102(a) of CERCLA, if they are listed 

under section 3001 of RCRA. 

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). 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
20946 Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 

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 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 sweetener. 

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 reevaluation, 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. 

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 reevaluation (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 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 20947 

3For 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). 

4California 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). 

5Section 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. 

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 offspecification 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 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 this time 

period 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 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 of 

part 261 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. 

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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
20948 Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 

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. 

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., 

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 section 101(14) 

of CERCLA, a hazardous waste that 

exhibits one or more of the hazardous 

waste characteristics or specifically 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 section 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 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 

section 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). 

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 section 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 sections 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 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 section 

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. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 20949 

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). 

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 section 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 nonHSWA, 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 

proposed 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 in this rule 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 Federallyauthorized to implement this rule once 

it becomes final. 

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 section 

102(a). In particular, CERCLA section 

101(14)(C) incorporates by reference any 

hazardous waste having the 

characteristics identified under or listed 

pursuant to section 3001 of the Solid 

Waste Disposal Act. CERCLA section 

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 section 102(b) sets a RQ of one 

pound (statutory RQ) for hazardous 

substances, except those for which RQs 

have been established pursuant to 

section 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 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 3 8

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 section 102(a) was 

based solely upon its inclusion as a 

hazardous substance under section 

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. 

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 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
20950 Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 

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. 

This action is designed to lower the 

cost of waste management for affected 

entities, by removing 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 under RCRA and from the list 

of hazardous substances under CERCLA. 

We have therefore concluded that 

today’s proposed rule will relieve 

regulatory burden for all affected small 

entities. We continue to be interested in 

the potential impacts of the proposed 

rule on small entities and welcome 

comments on issues related to such 

impacts. 

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. 

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 Health 

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 

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 

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 low-income 

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 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 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 75, No. 77 / Thursday, April 22, 2010 / Proposed Rules 20951 

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. 

40 CFR Part 302 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

substances, Hazardous waste, 

Intergovernmental relations, Natural 

resources, Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply. 

Dated: April 15, 2010. 

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

6922, 6924(y) and 6938. 

§ 261.33 [Amended] 

2. Section 261.33 is amended by 

removing the entries for the U202 

hazardous waste in the table under 

paragraph (f). 

Appendix VIII [Amended] 

3. Appendix VIII to part 261 is 

amended by removing the entries for 

‘‘Saccharin’’ and ‘‘Saccharin salts’’ from 

the table ‘‘Hazardous Constituants.’’ 

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. 

§ 268.40 [Amended] 

5. Section 268.40 is amended by 

removing the entry for waste code U202 

from the table ‘‘Treatment Standards for 

Hazardous Wastes.’’ 

Appendix VII [Amended] 

6. Appendix VII to part 268 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. 

§ 302.4 [Amended] 

8. In § 302.4, the table is amended by 

removing the entry for ‘‘Saccharin, & 

salts.’’ 

[FR Doc. 2010–9167 Filed 4–21–10; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 97 

[WP Docket No. 10–72; FCC 10–45] 

Amendment of the Commission’s 

Rules Regarding Amateur Radio 

Service Communications During 

Government Disaster Drills 

AGENCY: Federal Communications 

Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: In this document, the 

Commission adopted a document 

seeking comment on its proposal to 

amend the Commission’s amateur radio 

service rules with respect to amateur 

radio operations during governmentsponsored emergency preparedness and 

disaster readiness drills and tests. 

Specifically, the Commission proposes 

to amend the rules to provide that, 

under certain limited conditions, 

amateur radio operators may transmit 

messages during emergency and disaster 

preparedness drills, regardless of 

whether the operators are employees of 

entities participating in the drill. 

DATES: Comments are due on or before 

May 24, 2010 and reply comments are 

due on or before June 7, 2010. 

ADDRESSES: You may submit comments, 

identified by WP Docket No. 10–72 by 

any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Federal Communications 

Commission’s Web Site: http:// 

www.fcc.gov/cgb/ecfs/. Follow the 

instructions for submitting comments. 

• Mail: Filings can be sent by hand or 

messenger delivery, by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail 

(although the Commission continues to 

experience delays in receiving U.S. 

Postal Service mail). All filings must be 

addressed to the Commission’s 

Secretary, Office of the Secretary, 

Federal Communications Commission. 

• People With Disabilities: Contact 

the Commission to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by e-mail: FCC504@fcc.gov 

or phone: 202–418–0530 or TTY: 202– 

418–0432. For detailed instructions for 

submitting comments and additional 

information on the rulemaking process, 

see the SUPPLEMENTARY INFORMATION

section of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Cohen, Senior Legal Counsel, 

Public Safety and Homeland Security 

Bureau, at (202) 418–0799, or by e-mail 

at Jeff.Cohen@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Federal Communication 

Commission’s Notice of Proposed 

Rulemaking (NPRM) in WP Docket No. 

10–72, FCC 10–45, adopted on March 

18, 2010, and released on March 24, 

2010. This document is available to the 

public at http://hraunfoss.fcc.gov/ 

edocs_public/attachmatch/FCC-10- 

45A1.doc. 

Synopsis of the NPRM 

1. In this NPRM, the Commission 

proposes to amend its amateur radio 

service rules with respect to amateur 

radio operations during governmentsponsored emergency preparedness and 

disaster readiness drills and tests. 

Although public safety land mobile 

radio systems are the primary means of 

radio-based communications for 

emergency responders, experience has 

shown that amateur radio has played an 

important role in preparation for, 

during, and in the aftermath of, natural 

and man-made emergencies and 

disasters. Current rules provide for 

amateur radio use during emergencies. 

At the same time, the rules prohibit 


emcdonald on DSK2BSOYB1PROD with PROPOSALS