78918 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Rules and Regulations 

EPA has no authority to disapprove a 

111(d)/129 plan submission for failure 

to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a 111(d)/129 plan 

submission, to use VCS in place of a 

111(d)/129 plan submission that 

otherwise satisfies the provisions of the 

Clean Air Act. Thus, the requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) do not 

apply. This rule does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

B. Submission to Congress and the 

Comptroller General 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This rule is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

C. Petitions for Judicial Review 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by February 15, 

2011. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this rule for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action approving the 

Commonwealth of Virginia section 

111(d)/129 negative declaration and 

request for EPA withdrawal of the 

HMIWI plan approval may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 62 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Aluminum, 

Fertilizers, Fluoride, Intergovernmental 

relations, Paper and paper products 

industry, Phosphate, Reporting and 

recordkeeping requirements, Sulfur 

oxides, Sulfur acid plants, Waste 

treatment and disposal. 

Dated: December 2, 2010. 

W.C. Early, 

Acting Regional Administrator, Region III. 

■ 40 CFR Part 62, Subpart VV, is 

amended as follows: 

PART 62—[AMENDED] 

■ 1. The authority citation for part 62 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart VV—Virginia 

■ 2. Section 62.11625 is amended by 

revising the section heading, 

designating the existing paragraph as (a) 

and adding paragraph (b) to read as 

follows: 

§ 62.11625 Identification of plan—negative 

declaration. 

* * * * * 

(b) On September 13, 2010, the 

Commonwealth of Virginia, Department 

of Environmental Protection, submitted 

a negative declaration, and request for 

withdrawal of EPA’s plan approval 

under paragraph (a). 

■ 3. Section 62.11626 is removed. 

■ 4. Section 62.11627 is revised to read 

as follows: 

§ 62.11627 Effective date. 

The effective date of the negative 

declaration and EPA withdrawal of the 

plan approval is February 15, 2011. 

[FR Doc. 2010–31741 Filed 12–16–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 261, 268, and 302 

[EPA–HQ–RCRA–2009–0310, FRL–9239–8] 

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: Final Rule. 

SUMMARY: The Environmental Protection 

Agency (EPA or the Agency) is 

amending 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 amending 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 final 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 granting 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. This review/ 

assessment demonstrates 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: This final rule is effective on 

January 18, 2011. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–RCRA–2009–0310. All 

documents in the docket are listed in 

the http://www.regulations.gov index. 

Certain 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: For 

general information, review our Web 

site at http://www.epa.gov/epaoswer/ 

hazwaste. For information on specific 

aspects of the rule, contact Narendra 

Chaudhari of the Office of Resource 

Conservation and Recovery (5304P), 

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. Who is potentially affected by this 

final rule? 

This final rule could directly affect 

businesses that generate or manage 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Rules and Regulations 78919 

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). 

unused commercial products that 

contain saccharin or its salts. 

Specifically, the wastes affected by this 

final rule are unused commercial 

chemical products, manufacturing 

chemical intermediates, 

off-specification material, container 

residues, and spill residues that contain 

saccharin or its salts in a pure or 

technical grade form, or as the sole 

active ingredient and are listed as EPA 

Hazardous Waste No. U202 (see 40 CFR 

261.33(f)). These wastes will no longer 

be subject to the U202 listing, provided 

the States adopt and seek authorization 

for this final rule. 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 FINAL RULE

NAICS code Industry description for NAICS code 

31193 .............................................. Flavoring Syrup and Concentrate Manufacturing. 

312111 ............................................ Soft Drink Manufacturing. 

325199 ............................................ All Other Basic Organic Chemical Manufacturing [manufacturers of saccharin]. 

32541 .............................................. Pharmaceutical and Medicine Manufacturing. 

325411 ............................................ Medicinal and Botanical Manufacturing. 

325412 ............................................ Pharmaceutical Preparation Manufacturing. 

32562 .............................................. Toilet Preparation Manufacturing.2

49311 .............................................. General Warehousing and Storage. 

5417 ................................................ Scientific Research and Development Services. 

54171 .............................................. Research and Development in the Physical, Engineering, and Life Sciences. 

61131 .............................................. Colleges, Universities, and Professional Schools. 

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. 

Preamble Outline 

I. Statutory Authority 

II. List of Abbreviations and Acronyms 

III. Summary of This Action 

IV. Summary of the Proposed Action 

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. Response to Comments and Rationale for 

the Final Rule 

A. Response to Comments 

B. EPA’s Rationale for Granting 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. 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 

K. Congressional Review Act 

I. Statutory Authority 

These regulations are being 

promulgated under the authority of 

sections 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, 6922, 6924, 

6924(y), and 6938. 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, as amended, 

is the authority under which the 

CERCLA aspects of this rule are 

promulgated. 

II. List of Abbreviations and Acronyms 

BRS Biennial Reporting System 

CCC Calorie Control Council 

CERCLA Comprehensive Environmental 

Response, Compensation, and Liability Act 

CFR Code of Federal Regulations 

EPA Environmental Protection Agency 

EPCRA Emergency Planning and 

Community Right-to-Know Act 

FDA Food and Drug Administration 

HSWA Hazardous and Solid Waste 

Amendments of 1984 


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78920 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Rules and Regulations 

3The regulations proposed by EPA on April 22, 

2010 did not remove the chemical name of 

saccharin and its salts (1, 2-Benzisothiazol-3(2H)- 

one, 1, 1-dioxide, & salts) from 40 CFR 302.4. The 

final regulatory text corrects that inadvertent 

omission. 

4To examine CCC’s complete petition, see the 

docket for this final rule. 

IARC International Agency for Research on 

Cancer 

LD50 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 

III. Summary of This Action 

In this notice, EPA is finalizing 

regulations to remove saccharin and its 

salts from the lists of hazardous 

constituents (40 CFR part 261, 

Appendix VIII) and hazardous wastes 

(40 CFR 261.33 (f)) under RCRA and 

from the list of hazardous substances 

(40 CFR 302.4) under CERCLA. These 

final regulations are substantively the 

same as those that EPA proposed on 

April 22, 2010 (75 FR 20942).3 This 

final rule is in response to a petition 

submitted to EPA by the Calorie Control 

Council (CCC),4 under 40 CFR 260.20, to 

remove saccharin and its salts from its 

lists of hazardous constituents and 

hazardous wastes. In the same petition, 

CCC also requested removal of saccharin 

and its salts from the list of hazardous 

substances. EPA is granting 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. This review/assessment 

demonstrates 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. 

IV. Summary of the Proposed Action 

On April 22, 2010, EPA issued a 

proposed rule (75 FR 20942) that would 

grant a petition submitted by CCC 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). 

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 its petition 

(which is included in the docket for this 

final 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 and only basis for placing 

saccharin and its salts on its lists of 

hazardous constituents, hazardous 

wastes, and hazardous substances. 

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, as well as other factors or criteria 

required for making a listing 

determination. Based on this evaluation, 

EPA determined that saccharin and its 

salts do not present a significant risk to 

human health or the environment. 

Therefore, EPA proposed 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). 

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. The chemical name for 

saccharin and its salts is ‘‘1,2- 

Benzisothiazol-3(2H)-one, 1,1-dioxide & 

salts.’’ 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). 

As discussed in the proposed rule, 

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 (75 FR 

20945, April 22, 2010). 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 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 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 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Rules and Regulations 78921 

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-governmental 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 sweeteners, 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 sweeteners, 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 sweeteners, that there is ‘‘no 

consistent pattern of dose-response 

relationship between use of artificial 

sweeteners 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 sweeteners.’’ 

‘‘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 LD50 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 LD50 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 and IARC’s 1999 

re-evaluation in the docket for this final 

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 commercial 

chemical products, manufacturing 

chemical intermediates, offspecification material, container 

residues or spill residues (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 


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78922 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Rules and Regulations 

5For 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). 

6California 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). 

7Section 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. 

8 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 Environmental 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. 

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 on-site, but rather were 

received from off-site for storage/ 

packing and subsequent transfer for 

treatment or disposal. To avoid counting 

these 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 from the 20 

tons reported for all industries/NAIC 

Codes noted previously gives a total of 

14.7 tons generated from 2001 through 

2007; similarly, removing the double 

counting in the 2007 data from the 4.1 

tons of U202 reported for all NAIC 

Codes gives 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.5

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 to human health or the 

environment. 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 BRS data, reducing the 

likelihood of significant co-disposal 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 to human health or 

the environment. 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’’); 6 and (3) the FDA’s 

approval of a variety of uses of 

saccharin in food, cosmetics, and drugs, 

and the elimination of the warning label 

on food containing saccharin.7

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., 

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)(C) 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.8 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. The Agency no longer has an 

independent basis upon which to retain 

saccharin and its salts as CERCLA 

hazardous substances and is taking 

action to remove saccharin and its salts 


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from the list of CERCLA hazardous 

substances. 

VI. Response to Comments and 

Rationale for the Final Rule 

A. Response to Comments 

EPA received comments from the CCC 

and the New York State Department of 

Environmental Conservation (NYSDEC) 

in response to the proposed rule. The 

CCC supported EPA’s proposal, which 

responded to CCC’s April 30, 2003 

petition, to remove saccharin and its 

salts from the lists of hazardous 

constituents, hazardous wastes and 

hazardous substances. In its comments, 

CCC stated that the current scientific 

evidence for saccharin and EPA’s own 

assessment supports the Agency’s 

proposed decision to remove saccharin 

and its salts from its lists. NYSDEC’s 

comments do not present any concerns 

about EPA’s proposal to remove 

saccharin and its salts from its lists. 

Instead, NYSDEC’s comments request 

clarification regarding the regulatory 

status of a discarded unused chemical 

product containing multiple ingredients 

(i.e., saccharin-containing nicotine gum) 

under 40 CFR 261.33. Since EPA’s 

proposal was for removing saccharin 

and its salts from its lists, the Agency 

does not consider NYSDEC’s comments 

to be within the scope of the rule and 

therefore, not relevant to its decision on 

finalizing the proposal. The entire 

comments submitted by CCC and 

NYSDEC in response to the proposed 

rule are available in the docket for this 

rulemaking. 

B. EPA’s Rationale for Granting the 

Petition 

In summary, the comments on the 

proposed rule were either supportive or 

requested clarification on an issue that 

is not relevant to EPA’s proposed 

decision; the Agency received no 

comments that disagreed with EPA’s 

proposal 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). 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) and effect mechanisms that 

are not relevant to humans; 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 waste generation and 

management information for saccharin 

and its salts, do not meet the criteria for 

listing 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 removing 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 independent basis for retaining 

saccharin and its salts on CERCLA’s list 

of hazardous substances (40 CFR 302.4). 

Based on the above conclusions, EPA 

has decided to finalize the proposed 

rule granting CCC’s petition without any 

substantive changes. 

VII. Status of Land Disposal 

Restrictions for U202 Listed Wastes 

As discussed in the previous section, 

the Agency is removing saccharin and 

its salts from the list of unused 

commercial chemical products, 

manufacturing chemical intermediates, 

off-specification material, container 

residues, and spill residues 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. Because 

saccharin and its salts are being 

removed from the list of hazardous 

wastes based on this final rule, they 

would not be subject to the LDRs. 

Therefore, EPA is also removing 

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 


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9 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. 

10 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). 

11The Agency is also removing the chemical 

name for saccharin and its salts, 1,2-Benzisothiazol3(2H)-one, 1,1-dioxide, & salts which appears as a 

separate entry on the list of CERCLA hazardous 

substances. 

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 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 

included 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. 

IX. 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,9 potency Group 3 10

substances and received a ‘‘low’’ hazard 

ranking. 

In this rule, the Agency is removing 

saccharin and its salts 11 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 its 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 and its salts under 

any statute or program other than RCRA 

and CERCLA. The granting of CCC’s 

petition does not remove saccharin from 

the EPCRA section 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 

This action is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order (EO) 12866 (58 FR 

51735, October 4, 1993) and is therefore 

not subject to review under the EO. 

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 final 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 final rule on small 

entities, I certify that this action will not 


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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 final 

rule on small entities’’ (5 U.S.C. 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 final rule will relieve regulatory 

burden for all affected small entities. 

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 final 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 final 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. Thus, 

Executive Order 13132 does not apply 

to this action. 

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 final 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 action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not a significant 

regulatory action under Executive Order 

12866. 

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. NTTAA directs EPA 

to provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. 

This action 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 final 

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 

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. 


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78926 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Rules and Regulations 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each house of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). This 

rule will be effective on January 18, 

2011. 

List of Subjects 

40 CFR Part 261 

Hazardous waste, Recycling, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 268 

Hazardous waste, Reporting and 

recordkeeping requirements. 

40 CFR Part 302 

Air pollution control, Chemicals, 

Hazardous substances, Hazardous 

waste, Intergovernmental relations, 

Natural resources, Reporting and record 

keeping requirements, Superfund, Water 

pollution control, Water supply. 

Dated: December 13, 2010. 

Lisa P. Jackson, 

Administrator. 

■ For the reasons set out in the 

preamble, title 40, chapter I of the Code 

of Federal Regulations is 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 Constituents.’’ 

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. Section 302.4 is amended as 

follows: 

■ a. By removing the entry for ‘‘1,2- 

Benzisothiazol-3(2H)-one, 1,1-dioxide, & 

salts’’ from Table 302.4. 

■ b. By removing the entry for 

‘‘Saccharin, & salts’’ from Table 302.4. 

■ c. By removing the entry for ‘‘81072 

Saccharin, & salts. 1,2-Benzisothiazol3(2H)-one, 1,1-dioxide, & salts’’ from 

Appendix A to § 302.4. 

[FR Doc. 2010–31773 Filed 12–16–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2010–0003] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) luis.

rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Federal 

Insurance and Mitigation Administrator 

has resolved any appeals resulting from 

this notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

Interested lessees and owners of real 

property are encouraged to review the 

proof Flood Insurance Study and FIRM 

available at the address cited below for 

each community. The BFEs and 

modified BFEs are made final in the 

communities listed below. Elevations at 

selected locations in each community 

are shown. 

National Environmental Policy Act. 

This final rule is categorically excluded 

from the requirements of 44 CFR part 

10, Environmental Consideration. An 

environmental impact assessment has 

not been prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This final 

rule is not a significant regulatory action 


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