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, 20942-20951 [2010-9167]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Proposed Rules]
[Pages 20942-20951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9167]


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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.

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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:
     https://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 
https://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 https://www.regulations.gov or e-mail. The https://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 https://www.regulations.gov, your e-mail address will be 
automatically captured and included as a part of the comment

[[Page 20943]]

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 https://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in https://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 https://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\
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    \1\ EPA, in partnership with the States, biennially collects 
information regarding the generation, management, and final 
disposition of hazardous wastes regulated under RCRA. See the 2007 
Biennial Report on the EPA Web site https://www.epa.gov/epawaste/inforesources/data/index.htm.
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 Industry Sectors Potentially Affected by the Proposed Rule

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                                        Industry description for  NAICS
             NAICS Code                              Code
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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].
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    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.
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    \2\ Saccharin and its salts are used in personal-care products 
such as mouthwash, dental cleaners, and lipstick, which come under 
Toilet Preparation Manufacturing (NAICS Code 32562).
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B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI
    Do not submit this information to EPA through https://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?

[[Page 20944]]

    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 Sec. Sec.  
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 Sec.  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,

[[Page 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 Sec.  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 Sec.  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 Sec.  261.33(e) as an acutely 
hazardous waste if it meets the criteria in Sec.  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 Sec.  261.33(f) as a hazardous waste 
if it meets the criteria in Sec.  261.11(a)(1) and/or Sec.  
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 Sec.  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

[[Page 20946]]

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 re-evaluation, taking into 
consideration all new data on saccharin and its salts. It found that, 
based on a review of human studies on the carcinogenicity of artificial 
sweetners, that there is ``no consistent pattern of dose-response 
relationship between use of artificial sweetners and cancers of the 
urinary bladder or lower urinary tract is apparent in the available 
literature.'' The animal studies in rats with sodium saccharin did show 
urinary bladder tumors in the 2-generation studies. However, the 
incidence of bladder tumors was significant only at higher doses 
(greater than 3% of the diet). Based on this re-evaluation, IARC 
concluded the following:

    There is inadequate evidence in humans for the carcinogenicity 
of saccharin salts used as sweetners.
    There is sufficient evidence in experimental animals for the 
carcinogenicity of sodium saccharin.
    There is inadequate evidence in experimental animals for the 
carcinogenicity of saccharin (acid form) and calcium saccharin.

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

    In making its evaluation, the Working Group concluded that 
sodium saccharin produces urothelial bladder tumours in rats by a 
non-DNA-reactive mechanism that involves the formation of urinary 
calcium phosphate-containing precipitate, cytotoxicity and enhanced 
cell proliferation. This mechanism is not relevant to humans because 
of critical interspecies differences in urine composition.
    Saccharin and its salts are not classifiable as to their 
carcinogenicity to humans (Group 3).

2. Evaluation of Information on Other Toxicological Effects of 
Saccharin and Its Salts by NTP and IARC
    In addition to the evaluation of information on saccharin's 
carcinogenicity, NTP's Background Document and IARC's 1999 re-
evaluation (as presented in IARC Monograph Volume 73) included 
information and analysis on other toxicological effects of saccharin 
and its salts. Specifically, saccharin, in the form of sodium 
saccharin, has generally been tested in rats by feeding the rats diets 
containing specified amounts of sodium saccharin. It has not been found 
to be acutely toxic in rats based on the criterion for listing 
hazardous wastes under Sec.  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

[[Page 20947]]

and IARC's 1999 re-evaluation in the docket for this proposed rule.

B. Evaluation of Waste Generation and Management Information for 
Saccharin and Its Salts To Assess the Petition

1. Quantity and Types of Wastes Generated
    Saccharin and its salts are listed hazardous wastes, if the waste 
arises from the discard of a commercial chemical product, manufacturing 
chemical intermediate, or off-specification material (EPA Hazardous 
Waste No. U202 in 40 CFR 261.33(f)). The U-waste code applies only if 
the chemical is present in a pure or technical grade form, or is the 
sole active ingredient in the chemical formulation; in addition, the 
chemical must be unused.
    The U202 listing is narrow and does not apply to other discarded 
materials that merely contain saccharin or its salts, e.g., discarded 
products that contain saccharin as a sweetening agent. Nor does the 
listing apply to manufacturing process wastes that may contain 
saccharin or its salts, except for unused or off-specification 
saccharin or its salts that are discarded. Therefore, U202 is primarily 
generated by companies that manufacture saccharin or its salts, use 
saccharin or its salts in product formulations (e.g., soft drinks, 
cosmetics, pharmaceuticals), and by companies that are discarding small 
quantities of unused or off-specification saccharin or its salts, such 
as some laboratories.
    Facilities are required by EPA to report the amount of hazardous 
waste, including U202 generated biennially (every two years) as part of 
the Biennial Report System, or BRS. Based on the information available 
from the BRS for the years 2001, 2003, 2005, and 2007, generators 
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\
---------------------------------------------------------------------------

    \3\ For comparison, BRS shows that approximately 47 million tons 
of hazardous waste was generated in 2007 (see https://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 https://www.epa.gov/epawaste/nonhaz/municipal/msw99.htm).
---------------------------------------------------------------------------

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 Sec.  261.11(a)(3)(i)). 
The Agency cited toxicity as the ``decisive'' factor in listing 
commercial chemical products under Sec.  261.33(f), because the waste 
is typically the chemical itself (see EPA's Background Document for 
Sec.  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 Sec.  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 Sec.  261.33(f) no longer 
exists.
    Other factors considered in listing a waste under Sec.  
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 (Sec.  
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 
(Sec.  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.
---------------------------------------------------------------------------

    \4\ California EPA, Office of Environmental Health Hazard 
Assessment, Notice to Interested Parties for Chemical Delisted 
Effective April 6, 2001 and Notice to Interested Parties for 
Chemical Delisted Effective January 17, 2003 (available in the 
docket for this proposed rulemaking).
    \5\ Section 517, Title V, Appendix A, Consolidated 
Appropriations Act of 2001 (Pub. L. 106-554, 114 Stat. 2763), 
repealed 21 U.S.C. 343(o), the saccharin warning statement 
requirement.
---------------------------------------------------------------------------

    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 Sec.  261.11(a)(2). Moreover, saccharin and its salts do 
not

[[Page 20948]]

meet the criterion under Sec.  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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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 Sec.  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 Sec.  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.

[[Page 20949]]

    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 non-
HSWA, that are considered less stringent than previous Federal 
requirements.

B. Effect on State Authorization

    This rule is promulgated pursuant to non-HSWA authority. The 
changes 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 Federally-authorized 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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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 Sec.  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

[[Page 20950]]

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,