labeled for Category 3 operations pursuant to paragraph (b) of this
section;
    (2) Must not operate the small unmanned aircraft over open air
assemblies of human beings; and
    (3) May only operate the small unmanned aircraft above any human
being if the operation meets one of the following conditions:
    (i) The operation is within or over a closed- or restricted-access
site, and any human being located within the closed- or restricted-
access site is on notice that a small unmanned aircraft may fly over
them; or
    (ii) The small unmanned aircraft does not maintain sustained flight
over any human being not directly participating in the operation of the
small unmanned aircraft or located under a covered structure or inside
a stationary vehicle that can provide reasonable protection from a
falling small unmanned aircraft.
    (b) Eligibility. To be qualified to conduct Category 3 operations,
the small unmanned aircraft system must:
    (1) Be designed, produced, or modified such that it:
    (i) Will not cause injury to a human being that is equivalent to or
greater than the severity of the injury caused by a transfer of 25
foot-pounds of kinetic energy upon impact from a rigid object;
    (ii) Does not contain any exposed rotating parts that could
lacerate human skin upon impact with a human being; and
    (iii) Does not contain any safety defects identified by the
Administrator.
    (2) Display a label indicating eligibility to conduct Category 3
operations. The label must be in English and be legible, prominent, and
permanently affixed to the small unmanned aircraft.
    (3) Have current remote pilot operating instructions that apply to
the operation of the small unmanned aircraft system. The person who
designed, produced, or modified the small unmanned aircraft system must
make available the instructions upon sale, transfer, or use of the
aircraft by someone other than the person who designed, produced, or
modified the small unmanned aircraft system. Such instructions must
address, at a minimum:
    (i) A system description that includes the required small unmanned
aircraft system components, any system limitations, and the declared
category or categories of operation;
    (ii) Modifications that will not change the ability of the small
unmanned aircraft system to meet the requirements for the category or
categories of operation the small unmanned aircraft system is eligible
to conduct; and
    (iii) Instructions for how to verify and change the mode or
configuration of the small unmanned aircraft system, if they are
variable.
    (4) Be subject to a product support and notification process.
Anyone who designs, produces, or modifies a small unmanned aircraft
system under this paragraph (b) must maintain product support and
notification procedures to notify the public and the FAA of:
    (i) Any defect or condition that causes the small unmanned aircraft
system to no longer meet the requirements of this subpart; and
    (ii) Any identified safety defect that causes the small unmanned
aircraft system to exceed a low probability of fatality.
    (5) Operate only after the person who designed, produced, or
modified the small unmanned aircraft system has received notification
that the FAA has accepted a Declaration of Compliance for that small
unmanned aircraft system in accordance with Sec.  107.135.

Sec.  107.125  Means of compliance.

    (a) To meet the requirements of Sec.  107.115(b)(1) for operations
in Category 2, or the requirements of Sec.  107.120(b)(1) for
operations in Category 3, the means of compliance must consist of test,
analysis, or inspection that the Administrator has determined is
acceptable. The means of compliance may include consensus standards.
    (b) An applicant requesting FAA acceptance of a means of compliance
must submit the following information to the FAA in a manner specified
by the Administrator:
    (1) Detailed description of the means of compliance; and
    (2) Justification, including any substantiating material, showing
the means of compliance establishes achievement of or equivalency to
the safety level identified in Sec. Sec.  107.115(b)(1) and
107.120(b)(1).

Sec.  107.130  Variable mode and variable configuration of small
unmanned aircraft systems.

    A small unmanned aircraft system may be eligible for one or more
categories of operation over human beings under this subpart, as long
as a remote pilot in command cannot inadvertently switch between modes
or configurations.

Sec.  107.135  Declaration of Compliance.

    (a) Required information. Prior to declaring a small unmanned
aircraft system to be compliant with the requirements of this subpart
for Category 2 or 3 operations, an applicant must submit a Declaration
of Compliance for acceptance by the FAA, in a manner specified by the
Administrator, that includes the following information:
    (1) Applicant's name;
    (2) Applicant's physical address;
    (3) Applicant's email address;
    (4) The small unmanned aircraft system make and model name;
    (5) The small unmanned aircraft system serial number or range of
serial numbers that are the subject of the Declaration of Compliance;
    (6) Whether the Declaration of Compliance is an initial declaration
or an amended declaration;
    (7) If the Declaration of Compliance is an amended declaration, the
reason for the re-submittal;
    (8) Certification that the applicant:
    (i) Has demonstrated that the small unmanned aircraft, or specific

configurations of that aircraft, satisfies Sec.  107.115(b)(1)(i) and
(ii), or Sec.  107.120(b)(1)(i) and (ii), or both, through an accepted
means of compliance;
    (ii) Has satisfied Sec.  107.115(b)(4) or Sec.  107.120(b)(4), or
both; and
    (iii) Will, upon request, allow the Administrator to inspect its
facilities, technical data, and any manufactured small unmanned
aircraft system and witness any tests necessary to determine compliance
with this subpart; and
    (9) Other information as required by the Administrator.
    (b) FAA acceptance. If the FAA determines the applicant has
demonstrated compliance with the requirements of this subpart, it will
notify the applicant that it has accepted the Declaration of
Compliance. If the FAA determines the applicant has not provided
sufficient evidence to demonstrate compliance, the FAA will notify the
applicant that it has not accepted the Declaration of Compliance.
    (c) Notification of a safety issue. Prior to initiating rescission
proceedings pursuant to paragraphs (d)(1) through (3) of this section,
the FAA will notify the applicant if a safety issue has been identified
for the Declaration of Compliance.
    (d) Rescission. (1) No person may operate a small unmanned aircraft
system identified on a Declaration of Compliance that the FAA has
rescinded pursuant to this subpart while that Declaration of Compliance
is rescinded.
    (2) The FAA may rescind a Declaration of Compliance if any of the
following conditions occur:
    (i) A small unmanned aircraft system for which a Declaration of
Compliance was accepted no longer complies with Sec.  107.115(b)(1) or
Sec.  107.120(b)(1);
    (ii) The FAA finds a Declaration of Compliance is in violation of
Sec.  107.5(a); or
    (iii) The Administrator determines an emergency exists related to
safety in accordance with the authority in 49 U.S.C. 46105.
    (3) If a safety issue identified under paragraph (c) of this
section has not been resolved, the FAA may rescind the Declaration of
Compliance as follows:
    (i) The FAA will issue a notice proposing to rescind the
Declaration of Compliance. The notice will set forth the agency's basis
for the proposed rescission and provide the holder of the Declaration
of Compliance with 10 business days from the date of issuance of the
proposed notice to submit evidentiary information to refute the
proposed notice.
    (ii) The holder of the Declaration of Compliance must submit
information demonstrating how the small unmanned aircraft system meets
the requirements of this subpart within 10 business days from the date
of issuance of the proposed notice.
    (iii) If the FAA does not receive the information required by
paragraph (d)(3)(ii) of this section within 10 business days from the
date of the issuance of the proposed notice, the FAA will issue a
notice rescinding the Declaration of Compliance.
    (4) If the Administrator determines that an emergency exists in
accordance with paragraph (d)(2)(iii) of this section, the FAA will
exercise its authority under 49 U.S.C. 46105(c) to issue an order
rescinding a Declaration of Compliance without initiating the process
in paragraph (d)(3) of this section.
    (e) Petition to reconsider the rescission of a Declaration of
Compliance. A person subject to an order of rescission under paragraph
(d)(3) of this section may petition the FAA to reconsider the
rescission of a Declaration of Compliance by submitting a request to
the FAA in a manner specified by the Administrator within 60 days of
the date of issuance of the rescission.
    (1) A petition to reconsider the rescission of a Declaration of
Compliance must demonstrate at least one of the following:
    (i) A material fact that was not present in the original response
to the notification of the safety issue and an explanation for why it
was not present in the original response;
    (ii) The FAA made a material factual error in the decision to
rescind the Declaration of Compliance; or
    (iii) The FAA did not correctly interpret a law, regulation, or
precedent.
    (2) Upon consideration of the information submitted under paragraph
(e)(1) of this section, the FAA will issue a notice either affirming
the rescission or withdrawing the rescission.
    (f) Inapplicability of part 13, subpart D, of this chapter. Title
14 CFR part 13, subpart D, does not apply to the procedures of
paragraphs (d) and (e) of this section.

Sec.  107.140  Previously manufactured small unmanned aircraft systems.

    A remote pilot in command may operate a small unmanned aircraft
system manufactured prior to [the effective date of a subsequent final
rule] over human beings under the following circumstances:
    (a) Category 1 operations. The small unmanned aircraft weighs 0.55
pounds or less on takeoff, including everything that is on board or
otherwise attached to the aircraft; or
    (b) Category 2 and 3 operations. (1) The FAA has accepted a
Declaration of Compliance in accordance with Sec.  107.135; and
    (2) The small unmanned aircraft is labeled for the appropriate
category of operations in English such that the label is legible,
prominent, and permanently affixed to the small unmanned aircraft.

Sec.  107.145  Record retention.

    A person who submits a Declaration of Compliance or means of
compliance under this subpart must retain the following substantiating
data:
    (a)(1) For the Declaration of Compliance, the holder of the
Declaration of Compliance must store the detailed description of the
means of compliance and justification, including any substantiating
material, for two years after the cessation of production of the small
unmanned aircraft system to support the Declaration of Compliance; and
    (2) Any accompanying data must contain detailed information on the
type of means of compliance and the results or justification used to
demonstrate the small unmanned aircraft system meets Sec. Sec.
107.115(b) and 107.120(b), as applicable.
    (b)(1) For a means of compliance, the information described in
paragraph (a) of this section must be stored for as long as the means
of compliance is accepted by the FAA; and
    (2) Accompanying data or information must contain:
    (i) Test procedures that outline the test methodology, if
applicable; and
    (ii) Justification, including any substantiating material, showing
the means of compliance establishes achievement of or equivalency to
the safety level identified in Sec. Sec.  107.115(b)(1) and
107.120(b)(1), as applicable.

Sec.  107.150  Relabeling by remote pilot in command for Category 2 and
3 operations.

    If a Category 2 or Category 3 label affixed to a small unmanned
aircraft is damaged or destroyed such that it is no longer legible, a
remote pilot in command must relabel the aircraft in English such that
the label is legible, prominent, and will remain on the small unmanned
aircraft for the duration of the operation before conducting operations
over human beings. The label must correctly identify the category or
categories of operation over human beings that the small unmanned
aircraft is qualified to conduct in accordance with this subpart.

0
17. Amend Sec.  107.205 by revising paragraph (b) and adding paragraph
(j) to read as follows:

Sec.  107.205   List of regulations subject to waiver.

* * * * *
    (b) Section 107.29(a)(2) and (b)--Anti-collision light required for
operations at night and during periods of civil twilight.
* * * * *
    (j) Section 107.105--Prohibition on operations over moving
vehicles.

    Issued under the authority provided by 49 U.S.C. 106(f), 40101
note; and 44807, in Washington, DC on January 29, 2019.
Elaine L. Chao,
Secretary, Department of Transportation.
Daniel K. Elwell,
Acting Administrator, Federal Aviation Administration.
[FR Doc. 2019-00732 Filed 2-12-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: April 22, 2010 (Volume 75, Number 77)]
[Proposed Rules]
[Page 20942-20951]
[DOCID:fr22ap10-17]

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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.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
proposing to amend its regulations under the Resource Conservation and
Recovery Act (RCRA) to remove saccharin and its salts from the lists of
hazardous constituents and commercial chemical products which are
hazardous wastes when discarded or intended to be discarded. EPA is
also proposing to amend the regulations under the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) to
remove saccharin and its salts from the list of hazardous substances.
This proposed rule is in response to a petition submitted to EPA by the
Calorie Control Council (CCC), to remove saccharin and its salts from
the above lists. EPA is proposing to grant CCC's petition based on a
review of the evaluations conducted by key public health agencies
concerning the carcinogenic and other potential toxicological effects
of saccharin and its salts, as well as EPA's own assessment of the
waste generation and management information for saccharin and its
salts, which demonstrate that saccharin and its salts do not meet the
criteria in the hazardous waste regulations for remaining on EPA's
lists of hazardous constituents, hazardous wastes, and hazardous
substances.

DATES: Comments must be received on or before June 21, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2009-0310 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail: Comments may be sent by electronic mail (e-mail)
to<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-RCRA-
2009-0310.
     Mail: Comments may be submitted by mail to: OSWER Docket,
Office of Resource Conservation and Recovery, U.S. Environmental
Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460, Attention Docket ID No. EPA-HQ-RCRA-2009-0310.
Please include a total of two copies of your comments.
     Hand Delivery: Deliver your comments to: EPA Docket
Center, Public Reading Room, Room 3334, EPA West Building, 1301
Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID No.
EPA-HQ-RCRA-2009-0310. Such deliveries are only accepted during the
Docket's normal hours of operation (8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays) and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2009-0310. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as a part of the comment

that is placed in the public docket and made available on the Internet.
If you submit an electronic comment, EPA recommends that you include
your name and other contact information in the body of your comment and
with any disk or CD-ROM you submit. If EPA cannot read your comment due
to technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OSWER Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Avenue, NW., Washington, DC 20460. The Public Meeting Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the OSWER Docket and the Public
Reading Room is<PHONE_NUMBER>.

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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
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\
---------------------------------------------------------------------------

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

 Industry Sectors Potentially Affected by the Proposed Rule

------------------------------------------------------------------------
                                        Industry description for  NAICS
             NAICS Code                              Code
------------------------------------------------------------------------
5417................................  Scientific Research and
                                       Development Services.
31193...............................  Flavoring Syrup and Concentrate
                                       Manufacturing.
32541...............................  Pharmaceutical and Medicine
                                       Manufacturing.
32562...............................  Toilet Preparation
                                       Manufacturing.\2\
54171...............................  Research and Development in the
                                       Physical, Engineering, and Life
                                       Sciences.
49311...............................  General Warehousing and Storage.
61131...............................  Colleges, Universities, and
                                       Professional Schools.
312111..............................  Soft Drink Manufacturing.
325411..............................  Medicinal and Botanical
                                       Manufacturing.
325412..............................  Pharmaceutical Preparation
                                       Manufacturing.
325199..............................  All Other Basic Organic Chemical
                                       Manufacturing [manufacturers of
                                       saccharin].
------------------------------------------------------------------------

    This action, however, may affect other entities not listed in the
table. To determine whether your facility is affected by this action,
you should examine 40 CFR parts 261, 268 and 302 carefully, along with
the final regulatory language amending Chapter I of the Code of Federal
Regulations (CFR). This language is found at the end of this Federal
Register notice. If you have questions regarding the applicability of
this action to a particular entity, consult the person listed in the
preceding section entitled FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------

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

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

1. Submitting CBI
    Do not submit this information to EPA through http://
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information submitted on
a disk or CD-ROM that you mail to EPA, mark the outside of the disk or
CD-ROM as CBI and then identify electronically within the disk or CD-
ROM the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
the procedures set forth in 40 CFR part 2. For further information on
the procedures for submitting CBI data, contact Ms. LaShan Haynes
(5305W), U.S. Environmental Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460, (e-mail address and telephone
number<EMAIL_ADDRESS>(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?

    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,

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

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

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 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).
---------------------------------------------------------------------------

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

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.

    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

impact on a substantial number of small entities. In determining
whether a rule has a significant economic impact on a substantial
number of small entities, the impact of concern is any significant
adverse economic impact on small entities, since the primary purpose of
the regulatory flexibility analyses is to identify and address
regulatory alternatives ``which minimize any significant economic
impact of the proposed rule on small entities'' (5 U.S.C. sections 603
and 604). Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on small entities subject to the rule.
    This action is designed to lower the cost of waste management for
affected entities, by removing saccharin and its salts from the lists
of hazardous constituents and commercial chemical products which are
hazardous wastes when discarded or intended to be discarded under RCRA
and from the list of hazardous substances under CERCLA. We have
therefore concluded that today's proposed rule will relieve regulatory
burden for all affected small entities. We continue to be interested in
the potential impacts of the proposed rule on small entities and
welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or Tribal governments or the private
sector. This is because this proposed rule imposes no enforceable duty
on any State, local, or Tribal governments or the private sector.
Therefore, this action is not subject to the requirements of sections
202 or 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This proposed rule primarily
affects generators of certain hazardous wastes from the discard of
unused commercial products that contain saccharin and its salts. There
are no State and local government bodies that incur direct compliance
costs by this rulemaking. State and local government implementation
expenditures are expected to be less than $500,000 in any one year.
Thus, Executive Order 13132 does not apply to this action.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have Tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This proposed
rule does not significantly or uniquely affect the communities of
Indian Tribal governments, nor would it impose substantial direct
compliance costs on them. Thus, Executive Order 13175 does not apply to
this rule.

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

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not a ``significant energy action'' as
defined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because
it is not likely to have a significant adverse effect on the supply,
distribution, or use of energy. This proposed rule reduces regulatory
burden and should not adversely affect energy supply, distribution or
use.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities, unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. EPA is committed to addressing environmental justice
concerns and has assumed a leadership role in environmental justice
initiatives to enhance environmental quality for all citizens of the
United States. The Agency's goals are to ensure that no segment of the
population, regardless of race, color, national origin, income, or net
worth bears disproportionately high and adverse human health and
environmental impacts as a result of EPA's policies, programs, and
activities. Our goal is to ensure that all citizens live in clean and
sustainable communities. In response to Executive Order 12898, and to
concerns voiced by many groups outside the Agency, EPA's Office of
Solid Waste and Emergency Response (OSWER) formed an Environmental
Justice Task Force to analyze the array of environmental justice issues
specific to waste programs and to develop an overall strategy to
identify and address these issues (OSWER Directive No. 9200.3-17).
    The Agency's assessment, based on the small quantity of saccharin
and its salts that are estimated to be discarded by affected facilities
and their relatively

low toxicity, is that there is no significant risk to human health or
the environment from managing saccharin and its salts in nonhazardous
waste landfills (the plausible management scenario). As noted
previously in section V.B.2., the facilities that generate these small
quantities of waste are distributed across the nation, which makes it
unlikely that any one segment of the population would be impacted
disproportionately from management of this nonhazardous waste. However,
the Agency continues to be interested in any potential environmental
justice concerns as a result of this proposed rule and welcomes
comments on issues related to such concerns.

List of Subjects

40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.

40 CFR Part 268

    Environmental protection, Hazardous waste, Reporting and
recordkeeping requirements.

40 CFR Part 302

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Reporting and recordkeeping requirements, Superfund,
Water pollution control, Water supply.

    Dated: April 15, 2010.
Lisa P. Jackson,
Administrator.

    For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

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

    Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and
6938.

Sec.  261.33  [Amended]

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

Appendix VIII [Amended]

    3. Appendix VIII to part 261 is amended by removing the entries for
``Saccharin'' and ``Saccharin salts'' from the table ``Hazardous
Constituants.''

PART 268--LAND DISPOSAL RESTRICTIONS

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

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

Sec.  268.40  [Amended]

    5. Section 268.40 is amended by removing the entry for waste code
U202 from the table ``Treatment Standards for Hazardous Wastes.''

Appendix VII [Amended]

    6. Appendix VII to part 268 is amended by removing the entry for
waste code U202 from Table 1, ``Effective Dates of Surface Disposed
Wastes (Non-Soil and Debris) Regulated in the LDRs--Comprehensive
List.''

PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION

    7. The authority citation for part 302 continues to read as
follows:

    Authority: 42 U.S.C. 9602, 9603, and 9604; 33 U.S.C. 1321 and
1361.

Sec.  302.4  [Amended]

    8. In Sec.  302.4, the table is amended by removing the entry for
``Saccharin, & salts.''

[FR Doc. 2010-9167 Filed 4-21-10; 8:45 am]
BILLING CODE 6560-50-P