[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Rules and Regulations]
[Pages 78918-78926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31773]


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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.

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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: 
[email protected].

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

[[Page 78919]]

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\
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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 http://www.epa.gov/epawaste/inforesources/data/index.htm.
    \2\ Saccharin and its salts are used in personal-care products, 
such as mouthwash, dental cleaners, and lipstick, which come under 
Toilet Preparation Manufacturing (NAICS Code 32562).

         Industry Sectors Potentially Affected by the Final Rule
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            NAICS code               Industry description for NAICS code
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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.
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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.

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

[[Page 78920]]

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.
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    \3\ The 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.
    \4\ To examine CCC's complete petition, see the docket for this 
final rule.
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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 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 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

[[Page 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 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 
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 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 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, off-specification 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

[[Page 78922]]

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\
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    \5\ For comparison, BRS shows that approximately 47 million tons 
of hazardous waste was generated in 2007 (see http://www.epa.gov/osw/inforesources/data/br07/national07.pdf). Also in 2007, 
approximately 137 million tons of municipal waste went to landfills 
and other disposal (see http://www.epa.gov/epawaste/nonhaz/municipal/msw99.htm).
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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 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 (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 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 
(Sec.  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.
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    \6\ 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).
    \7\ 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.
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    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 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)(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

[[Page 78923]]

from the list of CERCLA hazardous substances.
---------------------------------------------------------------------------

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

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 Sec.  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 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

[[Page 78924]]

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 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 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 Federally-authorized 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.
---------------------------------------------------------------------------

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

    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.
---------------------------------------------------------------------------

    \11\ The Agency is also removing the chemical name for saccharin 
and its salts, 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, & salts 
which appears as a separate entry on the list of CERCLA hazardous 
substances.
---------------------------------------------------------------------------

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

[[Page 78925]]

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.

[[Page 78926]]

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.

0
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

0
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.

Sec.  261.33  [Amended]

0
2. Section 261.33 is amended by removing the entries for the U202 
hazardous waste in the table under paragraph (f).

Appendix VIII [Amended]

0
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

0
4. The authority citation for part 268 continues to read as follows:

    Authority:  42 U.S.C. 6905, 6912(a), 6921, and 6924.

Sec.  268.40  [Amended]

0
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]

0
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

0
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.

Sec.  302.4  [Amended]

0
8. Section 302.4 is amended as follows:
0
a. By removing the entry for ``1,2-Benzisothiazol-3(2H)-one, 1,1-
dioxide, & salts'' from Table 302.4.
0
b. By removing the entry for ``Saccharin, & salts'' from Table 302.4.
0
c. By removing the entry for ``81072 Saccharin, & salts. 1,2-
Benzisothiazol-3(2H)-one, 1,1-dioxide, & salts'' from Appendix A to 
Sec.  302.4.

[FR Doc. 2010-31773 Filed 12-16-10; 8:45 am]
BILLING CODE 6560-50-P