of 40 CFR part 266, subpart G, or State requirements analogous to the
export requirements in 40 CFR part 266, subpart G.
    (1) For the purposes of subpart H, the designated OECD Member
countries consist of Australia, Austria, Belgium, the Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Poland,
Portugal, the Republic of Korea, the Slovak Republic, Spain, Sweden,
Switzerland, Turkey, the United Kingdom, and the United States.
    (2) For the purposes of subpart H of this part, Canada and Mexico
are considered OECD Member countries only for the purpose of transit.
    (b) Any person who exports hazardous waste to or imports hazardous
waste from: A designated OECD Member country for purposes other than
recovery (e.g., incineration, disposal), Mexico (for any purpose), or
Canada (for any purpose) remains subject to the requirements of
subparts E and F of this part, and is not subject to the requirements
of subpart H of this part.

0
5. Subpart H is revised to read as follows:
Subpart H--Transboundary Movements of Hazardous Waste for Recovery
Within the OECD
Sec.
262.80 Applicability.
262.81 Definitions.
262.82 General conditions.
262.83 Notification and consent.
262.84 Movement document.
262.85 Contracts.
262.86 Provisions relating to recognized traders.
262.87 Reporting and recordkeeping.
262.88 Pre-approval for U.S. recovery facilities [Reserved].
262.89 OECD waste lists.

Subpart H--Transboundary Movements of Hazardous Waste for Recovery
Within the OECD

Sec.  262.80  Applicability.

    (a) The requirements of this subpart apply to imports and exports
of wastes that are considered hazardous under U.S. national procedures
and are destined for recovery operations in the countries listed in
Sec.  262.58(a)(1). A waste is considered hazardous under U.S. national
procedures if the waste:
    (1) Meets the Federal definition of hazardous waste in 40 CFR
261.3; and
    (2) Is subject to either the Federal RCRA manifesting requirements
at 40 CFR part 262, subpart B, the universal waste management standards
of 40 CFR part 273, State requirements analogous to 40 CFR part 273,
the export requirements in the spent lead-acid battery management
standards of 40 CFR part 266, subpart G, or State requirements
analogous to the export requirements in 40 CFR part 266, subpart G.
    (b) Any person (exporter, importer, or recovery facility operator)
who mixes two or more wastes (including hazardous and non-hazardous
wastes) or otherwise subjects two or more wastes (including hazardous
and non-hazardous wastes) to physical or chemical transformation
operations, and thereby creates a new hazardous waste,

becomes a generator and assumes all subsequent generator duties under
RCRA and any exporter duties, if applicable, under this subpart.

Sec.  262.81  Definitions.

    The following definitions apply to this subpart.
    Competent authority means the regulatory authority or authorities
of concerned countries having jurisdiction over transboundary movements
of wastes destined for recovery operations.
    Countries concerned means the OECD Member countries of export or
import and any OECD Member countries of transit.
    Country of export means any designated OECD Member country listed
in Sec.  262.58(a)(1) from which a transboundary movement of hazardous
wastes is planned to be initiated or is initiated.
    Country of import means any designated OECD Member country listed
in Sec.  262.58(a)(1) to which a transboundary movement of hazardous
wastes is planned or takes place for the purpose of submitting the
wastes to recovery operations therein.
    Country of transit means any designated OECD Member country listed
in Sec.  262.58(a)(1) and (a)(2) other than the country of export or
country of import across which a transboundary movement of hazardous
wastes is planned or takes place.
    Exporter means the person under the jurisdiction of the country of
export who has, or will have at the time the planned transboundary
movement commences, possession or other forms of legal control of the
wastes and who proposes transboundary movement of the hazardous wastes
for the ultimate purpose of submitting them to recovery operations.
When the United States (U.S.) is the country of export, exporter is
interpreted to mean a person domiciled in the United States.
    Importer means the person to whom possession or other form of legal
control of the waste is assigned at the time the waste is received in
the country of import.
    OECD area means all land or marine areas under the national
jurisdiction of any OECD Member country listed in Sec.  262.58. When
the regulations refer to shipments to or from an OECD Member country,
this means OECD area.
    OECD means the Organization for Economic Cooperation and
Development.
    Recognized trader means a person who, with appropriate
authorization of countries concerned, acts in the role of principal to
purchase and subsequently sell wastes; this person has legal control of
such wastes from time of purchase to time of sale; such a person may
act to arrange and facilitate transboundary movements of wastes
destined for recovery operations.
    Recovery facility means a facility which, under applicable domestic
law, is operating or is authorized to operate in the country of import
to receive wastes and to perform recovery operations on them.
    Recovery operations means activities leading to resource recovery,
recycling, reclamation, direct re-use or alternative uses, which
include:

R1 Use as a fuel (other than in direct incineration) or other means to
generate energy.
R2 Solvent reclamation/regeneration.
R3 Recycling/reclamation of organic substances which are not used as
solvents.
R4 Recycling/reclamation of metals and metal compounds.
R5 Recycling/reclamation of other inorganic materials.
R6 Regeneration of acids or bases.
R7 Recovery of components used for pollution abatement.
R8 Recovery of components used from catalysts.
R9 Used oil re-refining or other reuses of previously used oil.
R10 Land treatment resulting in benefit to agriculture or ecological
improvement.
R11 Uses of residual materials obtained from any of the operations
numbered R1-R10.
R12 Exchange of wastes for submission to any of the operations numbered
R1-R11.
R13 Accumulation of material intended for any operation numbered R1-
R12.

    Transboundary movement means any movement of wastes from an area
under the national jurisdiction of one OECD Member country to an area
under the national jurisdiction of another OECD Member country.

Sec.  262.82  General conditions.

    (a) Scope. The level of control for exports and imports of waste is
indicated by assignment of the waste to either a list of wastes subject
to the Green control procedures or a list of wastes subject to the
Amber control procedures and by the national procedures of the United
States, as defined in Sec.  262.80(a). The OECD Green and Amber lists
are incorporated by reference in Sec.  262.89(d).
    (1) Listed wastes subject to the Green control procedures.
    (i) Green wastes that are not considered hazardous under U.S.
national procedures as defined in Sec.  262.80(a) are subject to
existing controls normally applied to commercial transactions.
    (ii) Green wastes that are considered hazardous under U.S. national
procedures as defined in Sec.  262.80(a) are subject to the Amber
control procedures set forth in this subpart.
    (2) Listed wastes subject to the Amber control procedures.
    (i) Amber wastes that are considered hazardous under U.S. national
procedures as defined in Sec.  262.80(a) are subject to the Amber
control procedures set forth in this subpart.
    (ii) Amber wastes that are considered hazardous under U.S. national
procedures as defined in Sec.  262.80(a), are subject to the Amber
control procedures in the United States, even if they are imported to
or exported from a designated OECD Member country listed in Sec.
262.58(a)(1) that does not consider the waste to be hazardous. In such
an event, the responsibilities of the Amber control procedures shift as
provided:
    (A) For U.S. exports, the United States shall issue an
acknowledgement of receipt and assume other responsibilities of the
competent authority of the country of import.
    (B) For U.S. imports, the U.S. recovery facility/importer and the
United States shall assume the obligations associated with the Amber
control procedures that normally apply to the exporter and country of
export, respectively.
    (iii) Amber wastes that are not considered hazardous under U.S.
national procedures as defined in Sec.  262.80(a), but are considered
hazardous by an OECD Member country are subject to the Amber control
procedures in the OECD Member country that considers the waste
hazardous. All responsibilities of the U.S. importer/exporter shift to
the importer/exporter of the OECD Member country that considers the
waste hazardous unless the parties make other arrangements through
contracts.

    Note to Paragraph (a)(2): Some wastes subject to the Amber
control procedures are not listed or otherwise identified as
hazardous under RCRA, and therefore are not subject to the Amber
control procedures of this subpart. Regardless of the status of the
waste under RCRA, however, other Federal environmental statutes
(e.g., the Toxic Substances Control Act) restrict certain waste
imports or exports. Such restrictions continue to apply with regard
to this subpart.

    (3) Procedures for mixtures of wastes.
    (i) A Green waste that is mixed with one or more other Green wastes
such that the resulting mixture is not considered hazardous under U.S.

national procedures as defined in Sec.  262.80(a) shall be subject to
the Green control procedures, provided the composition of this mixture
does not impair its environmentally sound recovery.

    Note to Paragraph (a)(3)(i): The regulated community should note
that some OECD Member countries may require, by domestic law, that
mixtures of different Green wastes be subject to the Amber control
procedures.

    (ii) A Green waste that is mixed with one or more Amber wastes, in
any amount, de minimis or otherwise, or a mixture of two or more Amber
wastes, such that the resulting waste mixture is considered hazardous
under U.S. national procedures as defined in Sec.  262.80(a) are
subject to the Amber control procedures, provided the composition of
this mixture does not impair its environmentally sound recovery.

    Note to Paragraph (a)(3)(ii): The regulated community should
note that some OECD Member countries may require, by domestic law,
that a mixture of a Green waste and more than a de minimis amount of
an Amber waste or a mixture of two or more Amber wastes be subject
to the Amber control procedures.

    (4) Wastes not yet assigned to an OECD waste list are eligible for
transboundary movements, as follows:
    (i) If such wastes are considered hazardous under U.S. national
procedures as defined in Sec.  262.80(a), such wastes are subject to
the Amber control procedures.
    (ii) If such wastes are not considered hazardous under U.S.
national procedures as defined in Sec.  262.80(a), such wastes are
subject to the Green control procedures.
    (b) General conditions applicable to transboundary movements of
hazardous waste: (1) The waste must be destined for recovery operations
at a facility that, under applicable domestic law, is operating or is
authorized to operate in the importing country;
    (2) The transboundary movement must be in compliance with
applicable international transport agreements; and

    Note to Paragraph (b)(2): These international agreements
include, but are not limited to, the Chicago Convention (1944), ADR
(1957), ADNR (1970), MARPOL Convention (1973/1978), SOLAS Convention
(1974), IMDG Code (1985), COTIF (1985), and RID (1985).

    (3) Any transit of waste through a non-OECD Member country must be
conducted in compliance with all applicable international and national
laws and regulations.
    (c) Provisions relating to re-export for recovery to a third
country: (1) Re-export of wastes subject to the Amber control
procedures from the United States, as the country of import, to a third
country listed in Sec.  262.58(a)(1) may occur only after an exporter
in the United States provides notification to and obtains consent from
the competent authorities in the third country, the original country of
export, and any transit countries. The notification must comply with
the notice and consent procedures in Sec.  262.83 for all countries
concerned and the original country of export. The competent authorities
of the original country of export, as well as the competent authorities
of all other countries concerned have thirty (30) days to object to the
proposed movement.
    (i) The thirty (30) day period begins once the competent
authorities of both the initial country of export and new country of
import issue Acknowledgements of Receipt of the notification.
    (ii) The transboundary movement may commence if no objection has
been lodged after the thirty (30) day period has passed or immediately
after written consent is received from all relevant OECD importing and
transit countries.
    (2) In the case of re-export of Amber wastes to a country other
than those listed in Sec.  262.58(a)(1), notification to and consent of
the competent authorities of the original OECD Member country of export
and any OECD Member countries of transit is required as specified in
paragraph (c)(1) of this section, in addition to compliance with all
international agreements and arrangements to which the first importing
OECD Member country is a party and all applicable regulatory
requirements for exports from the first country of import.
    (d) Duty to return or re-export wastes subject to the Amber control
procedures. When a transboundary movement of wastes subject to the
Amber control procedures cannot be completed in accordance with the
terms of the contract or the consent(s) and alternative arrangements
cannot be made to recover the waste in an environmentally sound manner
in the country of import, the waste must be returned to the country of
export or re-exported to a third country. The provisions of paragraph
(c) of this section apply to any shipments to be re-exported to a third
country. The following provisions apply to shipments to be returned to
the country of export as appropriate:
    (1) Return from the United States to the country of export: The
U.S. importer must inform EPA at the specified address in Sec.
262.83(b)(1)(i) of the need to return the shipment. EPA will then
inform the competent authorities of the countries of export and
transit, citing the reason(s) for returning the waste. The U.S.
importer must complete the return within ninety (90) days from the time
EPA informs the country of export of the need to return the waste,
unless informed in writing by EPA of another timeframe agreed to by the
concerned Member countries. If the return shipment will cross any
transit country, the return shipment may only occur after EPA provides
notification to and obtains consent from the competent authority of the
country of transit, and provides a copy of that consent to the U.S.
importer.
    (2) Return from the country of import to the United States: The
U.S. exporter must provide for the return of the hazardous waste
shipment within ninety (90) days from the time the country of import
informs EPA of the need to return the waste or such other period of
time as the concerned Member countries agree. The U.S. exporter must
submit an exception report to EPA in accordance with Sec.  262.87(b).
    (e) Duty to return wastes subject to the Amber control procedures
from a country of transit. When a transboundary movement of wastes
subject to the Amber control procedures does not comply with the
requirements of the notification and movement documents or otherwise
constitutes illegal shipment, and if alternative arrangements cannot be
made to recover these wastes in an environmentally sound manner, the
waste must be returned to the country of export. The following
provisions apply as appropriate:
    (1) Return from the United States (as country of transit) to the
country of export: The U.S. transporter must inform EPA at the
specified address in Sec.  262.83(b)(1)(i) of the need to return the
shipment. EPA will then inform the competent authority of the country
of export, citing the reason(s) for returning the waste. The U.S.
transporter must complete the return within ninety (90) days from the
time EPA informs the country of export of the need to return the waste,
unless informed in writing by EPA of another timeframe agreed to by the
concerned Member countries.
    (2) Return from the country of transit to the United States (as
country of export): The U.S. exporter must provide for the return of
the hazardous waste shipment within ninety (90) days from the time the
competent authority of the country of transit informs EPA of the need
to return the waste or such other period of time as the concerned
Member countries agree. The U.S. exporter must

submit an exception report to EPA in accordance with Sec.  262.87(b).
    (f) Requirements for wastes destined for and received by R12 and
R13 facilities. The transboundary movement of wastes destined for R12
and R13 operations must comply with all Amber control procedures for
notification and consent as set forth in Sec.  262.83 and for the
movement document as set forth in Sec.  262.84. Additional
responsibilities of R12/R13 facilities include:
    (1) Indicating in the notification document the foreseen recovery
facility or facilities where the subsequent R1-R11 recovery operation
takes place or may take place.
    (2) Within three (3) days of the receipt of the wastes by the R12/
R13 recovery facility or facilities, the facility(ies) shall return a
signed copy of the movement document to the exporter and to the
competent authorities of the countries of export and import. The
facility(ies) shall retain the original of the movement document for
three (3) years.
    (3) As soon as possible, but no later than thirty (30) days after
the completion of the R12/R13 recovery operation and no later than one
(1) calendar year following the receipt of the waste, the R12 or R13
facility(ies) shall send a certificate of recovery to the foreign
exporter and to the competent authority of the country of export and to
the Office of Enforcement and Compliance Assurance, Office of Federal
Activities, International Compliance Assurance Division (2254A),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.
Washington, DC 20460, by mail, e-mail without digital signature
followed by mail, or fax followed by mail.
    (4) When an R12/R13 recovery facility delivers wastes for recovery
to an R1-R11 recovery facility located in the country of import, it
shall obtain as soon as possible, but no later than one (1) calendar
year following delivery of the waste, a certification from the R1-R11
facility that recovery of the wastes at that facility has been
completed. The R12/R13 facility must promptly transmit the applicable
certification to the competent authorities of the countries of import
and export, identifying the transboundary movements to which the
certification pertain.
    (5) When an R12/R13 recovery facility delivers wastes for recovery
to an R1-R11 recovery facility located:
    (i) In the initial country of export, Amber control procedures
apply, including a new notification;
    (ii) In a third country other than the initial country of export,
Amber control procedures apply, with the additional provision that the
competent authority of the initial country of export shall also be
notified of the transboundary movement.
    (g) Laboratory analysis exemption. The transboundary movement of an
Amber waste is exempt from the Amber control procedures if it is in
certain quantities and destined for laboratory analysis to assess its
physical or chemical characteristics, or to determine its suitability
for recovery operations. The quantity of such waste shall be determined
by the minimum quantity reasonably needed to perform the analysis in
each particular case adequately, but in no case exceed twenty-five
kilograms (25 kg). Waste destined for laboratory analysis must still be
appropriately packaged and labeled.

Sec.  262.83  Notification and consent.

    (a) Applicability. Consent must be obtained from the competent
authorities of the relevant OECD countries of import and transit prior
to exporting hazardous waste destined for recovery operations subject
to this subpart. Hazardous wastes subject to the Amber control
procedures are subject to the requirements of paragraph (b) of this
section; and wastes not identified on any list are subject to the
requirements of paragraph (c) of this section.
    (b) Amber wastes. Exports of hazardous wastes from the United
States as described in Sec.  262.80(a) that are subject to the Amber
control procedures are prohibited unless the notification and consent
requirements of paragraph (b)(1) or paragraph (b)(2) of this section
are met.
    (1) Transactions requiring specific consent:
    (i) Notification. At least forty-five (45) days prior to
commencement of each transboundary movement, the exporter must provide
written notification in English of the proposed transboundary movement
to the Office of Enforcement and Compliance Assurance, Office of
Federal Activities, International Compliance Assurance Division
(2254A), Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460, with the words ``Attention: OECD Export
Notification'' prominently displayed on the envelope. This notification
must include all of the information identified in paragraph (d) of this
section. In cases where wastes having similar physical and chemical
characteristics, the same United Nations classification, the same RCRA
waste codes, and are to be sent periodically to the same recovery
facility by the same exporter, the exporter may submit one general
notification of intent to export these wastes in multiple shipments
during a period of up to one (1) year. Even when a general notification
is used for multiple shipments, each shipment still must be accompanied
by its own movement document pursuant to Sec.  262.84.
    (ii) Tacit consent. If no objection has been lodged by any
countries concerned (i.e., exporting, importing, or transit) to a
notification provided pursuant to paragraph (b)(1)(i) of this section
within thirty (30) days after the date of issuance of the
Acknowledgement of Receipt of notification by the competent authority
of the country of import, the transboundary movement may commence.
Tacit consent expires one (1) calendar year after the close of the
thirty (30) day period; renotification and renewal of all consents is
required for exports after that date.
    (iii) Written consent. If the competent authorities of all the
relevant OECD importing and transit countries provide written consent
in a period less than thirty (30) days, the transboundary movement may
commence immediately after all necessary consents are received. Written
consent expires for each relevant OECD importing and transit country
one (1) calendar year after the date of that country's consent unless
otherwise specified; renotification and renewal of each expired consent
is required for exports after that date.
    (2) Transboundary movements to facilities pre-approved by the
competent authorities of the importing countries to accept specific
wastes for recovery:
    (i) Notification. The exporter must provide EPA a notification that
contains all the information identified in paragraph (d) of this
section in English, at least ten (10) days in advance of commencing
shipment to a pre-approved facility. The notification must indicate
that the recovery facility is pre-approved, and may apply to a single
specific shipment or to multiple shipments as described in paragraph
(b)(1)(i) of this section. This information must be sent to the Office
of Enforcement and Compliance Assurance, Office of Federal Activities,
International Compliance Assurance Division (2254A), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460,
with the words ``OECD Export Notification--Pre-approved Facility''
prominently displayed on the envelope. General notifications that cover
multiple shipments as described in paragraph (b)(1)(i) of this section
may cover a period of up to three (3) years. Even when a general
notification is used for multiple shipments, each shipment still must
be accompanied by its own

movement document pursuant to Sec.  262.84.
    (ii) Exports to pre-approved facilities may take place after the
elapse of seven (7) working days from the issuance of an
Acknowledgement of Receipt of the notification by the competent
authority of the country of import unless the exporter has received
information indicating that the competent authority of any countries
concerned objects to the shipment.
    (c) Wastes not covered in the OECD Green and Amber lists. Wastes
destined for recovery operations, that have not been assigned to the
OECD Green and Amber lists, incorporated by reference in Sec.
262.89(d), but which are considered hazardous under U.S. national
procedures as defined in Sec.  262.80(a), are subject to the
notification and consent requirements established for the Amber control
procedures in accordance with paragraph (b) of this section. Wastes
destined for recovery operations, that have not been assigned to the
OECD Green and Amber lists incorporated by reference in Sec.
262.89(d), and are not considered hazardous under U.S. national
procedures as defined by Sec.  262.80(a) are subject to the Green
control procedures.
    (d) Notifications submitted under this section must include the
information specified in paragraphs (d)(1) through (d)(14) of this
section: (1) Serial number or other accepted identifier of the
notification document;
    (2) Exporter name and EPA identification number (if applicable),
address, telephone, fax numbers, and e-mail address;
    (3) Importing recovery facility name, address, telephone, fax
numbers, e-mail address, and technologies employed;
    (4) Importer name (if not the owner or operator of the recovery
facility), address, telephone, fax numbers, and e-mail address; whether
the importer will engage in waste exchange recovery operation R12 or
waste accumulation recovery operation R13 prior to delivering the waste
to the final recovery facility and identification of recovery
operations to be employed at the final recovery facility;
    (5) Intended transporter(s) and/or their agent(s); address,
telephone, fax, and e-mail address;
    (6) Country of export and relevant competent authority, and point
of departure;
    (7) Countries of transit and relevant competent authorities and
points of entry and departure;
    (8) Country of import and relevant competent authority, and point
of entry;
    (9) Statement of whether the notification is a single notification
or a general notification. If general, include period of validity
requested;
    (10) Date(s) foreseen for commencement of transboundary
movement(s);
    (11) Means of transport envisaged;
    (12) Designation of waste type(s) from the appropriate OECD list
incorporated by reference in Sec.  262.89(d), description(s) of each
waste type, estimated total quantity of each, RCRA waste code, and the
United Nations number for each waste type;
    (13) Specification of the recovery operation(s) as defined in Sec.
262.81.
    (14) Certification/Declaration signed by the exporter that states:

    I certify that the above information is complete and correct to
the best of my knowledge. I also certify that legally-enforceable
written contractual obligations have been entered into, and that any
applicable insurance or other financial guarantees are or shall be
in force covering the transboundary movement.
Name:------------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------

    Note to Paragraph (d)(14): The United States does not currently
require financial assurance for these waste shipments. However, U.S.
exporters may be asked by other governments to provide and certify
to such assurance as a condition of obtaining consent to a proposed
movement.

    (e) Certificate of Recovery. As soon as possible, but no later than
thirty (30) days after the completion of recovery and no later than one
(1) calendar year following receipt of the waste, the U.S. recovery
facility shall send a certificate of recovery to the exporter and to
the competent authorities of the countries of export and import by
mail, e-mail without a digital signature followed by mail, or fax
followed by mail. The certificate of recovery shall include a signed,
written and dated statement that affirms that the waste materials were
recovered in the manner agreed to by the parties to the contract
required under Sec.  262.85.

Sec.  262.84  Movement document.

    (a) All U.S. parties subject to the contract provisions of Sec.
262.85 must ensure that a movement document meeting the conditions of
paragraph (b) of this section accompanies each transboundary movement
of wastes subject to the Amber control procedures from the initiation
of the shipment until it reaches the final recovery facility, including
cases in which the waste is stored and/or sorted by the importer prior
to shipment to the final recovery facility, except as provided in
paragraphs (a)(1) and (2) of this section.
    (1) For shipments of hazardous waste within the United States
solely by water (bulk shipments only), the generator must forward the
movement document with the manifest to the last water (bulk shipment)
transporter to handle the waste in the United States if exported by
water, (in accordance with the manifest routing procedures at Sec.
262.23(c)).
    (2) For rail shipments of hazardous waste within the United States
which originate at the site of generation, the generator must forward
the movement document with the manifest (in accordance with the routing
procedures for the manifest in Sec.  262.23(d)) to the next non-rail
transporter, if any, or the last rail transporter to handle the waste
in the United States if exported by rail.
    (b) The movement document must include all information required
under Sec.  262.83 (for notification), as well as the following
paragraphs (b)(1) through (b)(7) of this section:
    (1) Date movement commenced;
    (2) Name (if not exporter), address, telephone, fax numbers, and e-
mail of primary exporter;
    (3) Company name and EPA ID number of all transporters;
    (4) Identification (license, registered name or registration
number) of means of transport, including types of packaging envisaged;
    (5) Any special precautions to be taken by transporter(s);
    (6) Certification/declaration signed by the exporter that no
objection to the shipment has been lodged, as follows:

    I certify that the above information is complete and correct to
the best of my knowledge. I also certify that legally-enforceable
written contractual obligations have been entered into, that any
applicable insurance or other financial guarantees are or shall be
in force covering the transboundary movement, and that:
    1. All necessary consents have been received; OR
    2. The shipment is directed to a recovery facility within the
OECD area and no objection has been received from any of the
countries concerned within the thirty (30) day tacit consent period;
OR
    3. The shipment is directed to a recovery facility pre-approved
for that type of waste within the OECD area; such an authorization
has not been revoked, and no objection has been received from any of
the countries concerned.

(Delete sentences that are not applicable)

Name:------------------------------------------------------------------
Signature:-------------------------------------------------------------
Date:------------------------------------------------------------------

    (7) Appropriate signatures for each custody transfer (e.g.,
transporter, importer, and owner or operator of the recovery facility).
    (c) Exporters also must comply with the special manifest
requirements of 40 CFR 262.54(a), (b), (c), (e), and (i) and importers
must comply with the import

requirements of 40 CFR part 262, subpart F.
    (d) Each U.S. person that has physical custody of the waste from
the time the movement commences until it arrives at the recovery
facility must sign the movement document (e.g., transporter, importer,
and owner or operator of the recovery facility).
    (e) Within three (3) working days of the receipt of imports subject
to this subpart, the owner or operator of the U.S. recovery facility
must send signed copies of the movement document to the exporter, to
the Office of Enforcement and Compliance Assurance, Office of Federal
Activities, International Compliance Assurance Division (2254A),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460, and to the competent authorities of the countries
of export and transit. If the concerned U.S. recovery facility is a
R12/R13 recovery facility as defined under Sec.  262.81, the facility
shall retain the original of the movement document for three (3) years.

Sec.  262.85  Contracts.

    (a) Transboundary movements of hazardous wastes subject to the
Amber control procedures are prohibited unless they occur under the
terms of a valid written contract, chain of contracts, or equivalent
arrangements (when the movement occurs between parties controlled by
the same corporate or legal entity). Such contracts or equivalent
arrangements must be executed by the exporter and the owner or operator
of the recovery facility, and must specify responsibilities for each.
Contracts or equivalent arrangements are valid for the purposes of this
section only if persons assuming obligations under the contracts or
equivalent arrangements have appropriate legal status to conduct the
operations specified in the contract or equivalent arrangements.
    (b) Contracts or equivalent arrangements must specify the name and
EPA ID number, where available, of paragraph (b)(1) through (b)(4) of
this section:
    (1) The generator of each type of waste;
    (2) Each person who will have physical custody of the wastes;
    (3) Each person who will have legal control of the wastes; and
    (4) The recovery facility.
    (c) Contracts or equivalent arrangements must specify which party
to the contract will assume responsibility for alternate management of
the wastes if their disposition cannot be carried out as described in
the notification of intent to export. In such cases, contracts must
specify that:
    (1) The person having actual possession or physical control over
the wastes will immediately inform the exporter and the competent
authorities of the countries of export and import and, if the wastes
are located in a country of transit, the competent authorities of that
country; and
    (2) The person specified in the contract will assume responsibility
for the adequate management of the wastes in compliance with applicable
laws and regulations including, if necessary, arranging the return of
wastes and, as the case may be, shall provide the notification for re-
export.
    (d) Contracts must specify that the importer will provide the
notification required in Sec.  262.82(c) prior to the re-export of
controlled wastes to a third country.
    (e) Contracts or equivalent arrangements must include provisions
for financial guarantees, if required by the competent authorities of
any countries concerned, in accordance with applicable national or
international law requirements.

    Note to Paragraph (e): Financial guarantees so required are
intended to provide for alternate recycling, disposal or other means
of sound management of the wastes in cases where arrangements for
the shipment and the recovery operations cannot be carried out as
foreseen. The United States does not require such financial
guarantees at this time; however, some OECD Member countries do. It
is the responsibility of the exporter to ascertain and comply with
such requirements; in some cases, transporters or importers may
refuse to enter into the necessary contracts absent specific
references or certifications to financial guarantees.

    (f) Contracts or equivalent arrangements must contain provisions
requiring each contracting party to comply with all applicable
requirements of this subpart.
    (g) Upon request by EPA, U.S. exporters, importers, or recovery
facilities must submit to EPA copies of contracts, chain of contracts,
or equivalent arrangements (when the movement occurs between parties
controlled by the same corporate or legal entity). Information
contained in the contracts or equivalent arrangements for which a claim
of confidentiality is asserted in accordance with 40 CFR 2.203(b) will
be treated as confidential and will be disclosed by EPA only as
provided in 40 CFR 260.2.

    Note to Paragraph (g): Although the United States does not
require routine submission of contracts at this time, the OECD
Decision allows Member countries to impose such requirements. When
other OECD Member countries require submission of partial or
complete copies of the contract as a condition to granting consent
to proposed movements, EPA will request the required information;
absent submission of such information, some OECD Member countries
may deny consent for the proposed movement.

Sec.  262.86  Provisions relating to recognized traders.

    (a) A recognized trader who takes physical custody of a waste and
conducts recovery operations (including storage prior to recovery) is
acting as the owner or operator of a recovery facility and must be so
authorized in accordance with all applicable Federal laws.
    (b) A recognized trader acting as an exporter or importer for
transboundary shipments of waste must comply with all the requirements
of this subpart associated with being an exporter or importer.

Sec.  262.87  Reporting and recordkeeping.

    (a) Annual reports. For all waste movements subject to this
subpart, persons (e.g., exporters, recognized traders) who meet the
definition of primary exporter in Sec.  262.51 or who initiate the
movement documentation under Sec.  262.84 shall file an annual report
with the Office of Enforcement and Compliance Assurance, Office of
Federal Activities, International Compliance Assurance Division
(2254A), Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460, no later than March 1 of each year
summarizing the types, quantities, frequency, and ultimate destination
of all such hazardous waste exported during the previous calendar year.
(If the primary exporter or the person who initiates the movement
document under Sec.  262.84 is required to file an annual report for
waste exports that are not covered under this subpart, he may include
all export information in one report provided the following information
on exports of waste destined for recovery within the designated OECD
Member countries is contained in a separate section.) Such reports
shall include all of the following paragraphs (a)(1) through (a)(6) of
this section specified as follows:
    (1) The EPA identification number, name, and mailing and site
address of the exporter filing the report;
    (2) The calendar year covered by the report;
    (3) The name and site address of each final recovery facility;
    (4) By final recovery facility, for each hazardous waste exported,
a description of the hazardous waste, the EPA hazardous waste number
(from 40 CFR

part 261, subpart C or D), designation of waste type(s) and applicable
waste code(s) from the appropriate OECD waste list incorporated by
reference in Sec.  262.89(d), DOT hazard class, the name and U.S. EPA
identification number (where applicable) for each transporter used, the
total amount of hazardous waste shipped pursuant to this subpart, and
number of shipments pursuant to each notification;
    (5) In even numbered years, for each hazardous waste exported,
except for hazardous waste produced by exporters of greater than 100kg
but less than 1,000kg in a calendar month, and except for hazardous
waste for which information was already provided pursuant to Sec.
262.41:
    (i) A description of the efforts undertaken during the year to
reduce the volume and toxicity of the waste generated; and
    (ii) A description of the changes in volume and toxicity of the
waste actually achieved during the year in comparison to previous years
to the extent such information is available for years prior to 1984;
and
    (6) A certification signed by the person acting as primary exporter
or initiator of the movement document under Sec.  262.84 that states:

    I certify under penalty of law that I have personally examined
and am familiar with the information submitted in this and all
attached documents, and that based on my inquiry of those
individuals immediately responsible for obtaining the information, I
believe that the submitted information is true, accurate, and
complete. I am aware that there are significant penalties for
submitting false information including the possibility of fine and
imprisonment.

    (b) Exception reports. Any person who meets the definition of
primary exporter in Sec.  262.51 or who initiates the movement document
under Sec.  262.84 must file an exception report in lieu of the
requirements of Sec.  262.42 (if applicable) with the Office of
Enforcement and Compliance Assurance, Office of Federal Activities,
International Compliance Assurance Division (2254A), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460,
if any of the following occurs:
    (1) He has not received a copy of the RCRA hazardous waste manifest
(if applicable) signed by the transporter identifying the point of
departure of the waste from the United States, within forty-five (45)
days from the date it was accepted by the initial transporter;
    (2) Within ninety (90) days from the date the waste was accepted by
the initial transporter, the exporter has not received written
confirmation from the recovery facility that the hazardous waste was
received;
    (3) The waste is returned to the United States.
    (c) Recordkeeping. (1) Persons who meet the definition of primary
exporter in Sec.  262.51 or who initiate the movement document under
Sec.  262.84 shall keep the following records in paragraphs (c)(1)(i)
through (c)(1)(iv) of this section:
    (i) A copy of each notification of intent to export and all written
consents obtained from the competent authorities of countries concerned
for a period of at least three (3) years from the date the hazardous
waste was accepted by the initial transporter;
    (ii) A copy of each annual report for a period of at least three
(3) years from the due date of the report;
    (iii) A copy of any exception reports and a copy of each
confirmation of delivery (i.e., movement document) sent by the recovery
facility to the exporter for at least three (3) years from the date the
hazardous waste was accepted by the initial transporter or received by
the recovery facility, whichever is applicable; and
    (iv) A copy of each certificate of recovery sent by the recovery
facility to the exporter for at least three (3) years from the date
that the recovery facility completed processing the waste shipment.
    (2) The periods of retention referred to in this section are
extended automatically during the course of any unresolved enforcement
action regarding the regulated activity or as requested by the
Administrator.

Sec.  262.88  Pre-approval for U.S. recovery facilities [Reserved].

Sec.  262.89  OECD waste lists.

    (a) General. For the purposes of this subpart, a waste is
considered hazardous under U.S. national procedures, and hence subject
to this subpart, if the waste:
    (1) Meets the Federal definition of hazardous waste in 40 CFR
261.3; and
    (2) Is subject to either the Federal RCRA manifesting requirements
at 40 CFR part 262, subpart B, the universal waste management standards
of 40 CFR part 273, State requirements analogous to 40 CFR part 273,
the export requirements in the spent lead-acid battery management
standards of 40 CFR part 266, subpart G, or State requirements
analogous to the export requirements in 40 CFR part 266, subpart G.
    (b) If a waste is hazardous under paragraph (a) of this section, it
is subject to the Amber control procedures, regardless of whether it
appears in Appendix 4 of the OECD Decision, as defined in Sec.  262.81.
    (c) The appropriate control procedures for hazardous wastes and
hazardous waste mixtures are addressed in Sec.  262.82.
    (d) The OECD waste lists, as set forth in Annex B (``Green List'')
and Annex C (``Amber List'') (collectively ``OECD waste lists'') of the
2009 ``Guidance Manual for the Implementation of Council Decision
C(2001)107/FINAL, as Amended, on the Control of Transboundary Movements
of Wastes Destined for Recovery Operations,'' are incorporated by
reference. This incorporation by reference was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. This material is incorporated as it exists on the date of the
approval and a notice of any change in these materials will be
published in the Federal Register. The materials are available for
inspection at: the U.S. Environmental Protection Agency, Docket Center
Public Reading Room, EPA West, Room 3334, 1301 Constitution Avenue NW.,
Washington, DC 20004 (Docket  EPA-HQ-RCRA-2005-0018) or at the
National Archives and Records Administration (NARA), and may be
obtained from the Organization for Economic Cooperation and
Development, Environment Directorate, 2 rue Andr[eacute] Pascal, F-
75775 Paris Cedex 16, France. For information on the availability of
this material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. To contact
the EPA Docket Center Public Reading Room, call<PHONE_NUMBER>. To
contact the OECD, call +33 (0) 1 45 24 81 67.

PART 263--STANDARDS APPLICABLE TO TRANSPORTERS OF HAZARDOUS WASTE

0
The authority citation for part 263 continues to read as follows:

    Authority: 42 U.S.C. 6906, 6912, 6922-6925, 6937, and 6938.

0
Section 263.10(d) is amended by revising paragraph (d) to read as
follows:

Sec.  263.10  Scope.

* * * * *
    (d) A transporter of hazardous waste subject to the Federal
manifesting requirements of 40 CFR part 262, or subject to the waste
management standards of 40 CFR part 273, or subject to State
requirements analogous to 40 CFR part 273, that is being imported

from or exported to any of the countries listed in 40 CFR 262.58(a)(1)
for purposes of recovery is subject to this Subpart and to all other
relevant requirements of subpart H of 40 CFR part 262, including, but
not limited to, 40 CFR 262.84 for movement documents.
* * * * *

PART 264--STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE
TREATMENT, STORAGE, AND DISPOSAL FACILITIES

0
8. The authority citation for part 264 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6924, and 6925.

0
9. Section 264.12 is amended by revising paragraph (a)(2) to read as
follows:

Sec.  264.12  Required notices.

    (a) * * *
    (2) The owner or operator of a recovery facility that has arranged
to receive hazardous waste subject to 40 CFR part 262, subpart H must
provide a copy of the movement document bearing all required signatures
to the foreign exporter; to the Office of Enforcement and Compliance
Assurance, Office of Federal Activities, International Compliance
Assurance Division (2254A), Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; and to the competent
authorities of all other countries concerned within three (3) working
days of receipt of the shipment. The original of the signed movement
document must be maintained at the facility for at least three (3)
years. In addition, such owner or operator shall, as soon as possible,
but no later than thirty (30) days after the completion of recovery and
no later than one (1) calendar year following the receipt of the
hazardous waste, send a certificate of recovery to the foreign exporter
and to the competent authority of the country of export and to EPA's
Office of Enforcement and Compliance Assurance at the above address by
mail, e-mail without a digital signature followed by mail, or fax
followed by mail.
* * * * *

0
10. Section 264.71 is amended by revising paragraphs (a)(3) and (d) to
read as follows:

Sec.  264.71  Use of manifest system.

    (a) * * *
    (3) If a facility receives hazardous waste imported from a foreign
source, the receiving facility must mail a copy of the manifest and
documentation confirming EPA's consent to the import of hazardous waste
to the following address within thirty (30) days of delivery: Office of
Enforcement and Compliance Assurance, Office of Federal Activities,
International Compliance Assurance Division (2254A), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
* * * * *
    (d) Within three (3) working days of the receipt of a shipment
subject to 40 CFR part 262, subpart H, the owner or operator of a
facility must provide a copy of the movement document bearing all
required signatures to the exporter, to the Office of Enforcement and
Compliance Assurance, Office of Federal Activities, International
Compliance Assurance Division (2254A), Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460, and to competent
authorities of all other concerned countries. The original copy of the
movement document must be maintained at the facility for at least three
(3) years from the date of signature.
* * * * *

PART 265--INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF
HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES

0
11. The authority citation for part 265 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6906, 6912, 6922, 6923, 6924, 6925,
6935, 6936, and 6937.

0
12. Section 265.12 is amended by revising paragraph (a)(2) to read as
follows:

Sec.  265.12  Required notices.

    (a) * * *
    (2) The owner or operator of a recovery facility that has arranged
to receive hazardous waste subject to 40 CFR part 262, subpart H must
provide a copy of the movement document bearing all required signatures
to the foreign exporter; to the Office of Enforcement and Compliance
Assurance, Office of Federal Activities, International Compliance
Assurance Division (2254A), Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460; and to the competent
authorities of all other countries concerned within three (3) working
days of receipt of the shipment. The original of the signed movement
document must be maintained at the facility for at least three (3)
years. In addition, such owner or operator shall, as soon as possible,
but no later than thirty (30) days after the completion of recovery and
no later than one (1) calendar year following the receipt of the
hazardous waste, send a certificate of recovery to the foreign exporter
and to the competent authority of the country of export and to EPA's
Office of Enforcement and Compliance Assurance at the above address by
mail, e-mail without a digital signature followed by mail, or fax
followed by mail.
* * * * *

0
13. Section 265.71 is amended by revising paragraphs (a)(3) and (d) to
read as follows:

Sec.  265.71  Use of manifest system.

    (a) * * *
    (3) If a facility receives hazardous waste imported from a foreign
source, the receiving facility must mail a copy of the manifest and
documentation confirming EPA's consent to the import of hazardous waste
to the following address within thirty (30) days of delivery: Office of
Enforcement and Compliance Assurance, Office of Federal Activities,
International Compliance Assurance Division (2254A), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
* * * * *
    (d) Within three (3) working days of the receipt of a shipment
subject to 40 CFR part 262, subpart H, the owner or operator of a
facility must provide a copy of the movement document bearing all
required signatures to the exporter, to the Office of Enforcement and
Compliance Assurance, Office of Federal Activities, International
Compliance Assurance Division (2254A), Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460, and to competent
authorities of all other countries concerned. The original copy of the
movement document must be maintained at the facility for at least three
(3) years from the date of signature.
* * * * *

PART 266--STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES
AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES

0
14. The authority citation for part 266 is revised to read as follows:

    Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905,
6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.

0
15. In Sec.  266.80(a) the table is revised to read as follows:

Sec.  266.80  Applicability and requirements.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
       If your batteries . . .             And if you . . .          Then you . . .           And you . . .
----------------------------------------------------------------------------------------------------------------
(1) Will be reclaimed through          .......................  are exempt from 40 CFR   are subject to 40 CFR
 regeneration (such as by electrolyte                            parts 262 (except for    parts 261 and Sec.
 replacement).                                                   Sec.   262.11), 263,     262.11 of this
                                                                 264, 265, 266, 268,      chapter.
                                                                 270, 124 of this
                                                                 chapter, and the
                                                                 notification
                                                                 requirements at
                                                                 section 3010 of RCRA.
(2) Will be reclaimed other than       generate, collect, and/  are exempt from 40 CFR   are subject to 40 CFR
 through regeneration.                  or transport these       parts 262 (except for    parts 261 and Sec.
                                        batteries.               Sec.   262.11), 263,     262.11, and applicable
                                                                 264, 265, 266, 270,      provisions under part
                                                                 124 of this chapter,     268.
                                                                 and the notification
                                                                 requirements at
                                                                 section 3010 of RCRA.
(3) Will be reclaimed other than       store these batteries    are exempt from 40 CFR   are subject to 40 CFR
 through regeneration.                  but you aren't the       parts 262 (except for    parts 261, Sec.
                                        reclaimer.               Sec.   262.11), 263,     262.11, and applicable
                                                                 264, 265, 266, 270,      provisions under part
                                                                 124 of this chapter,     268.
                                                                 and the notification
                                                                 requirements at
                                                                 section 3010 of RCRA.
(4) Will be reclaimed other than       store these batteries    must comply with 40 CFR  are subject to 40 CFR
 through regeneration.                  before you reclaim       266.80(b) and as         parts 261, Sec.
                                        them.                    appropriate other        262.11, and applicable
                                                                 regulatory provisions    provisions under part
                                                                 described in 266.80(b).  268.
(5) Will be reclaimed other than       don't store these        are exempt from 40 CFR   are subject to 40 CFR
 through regeneration.                  batteries before you     parts 262 (except for    parts 261, Sec.
                                        reclaim them.            Sec.   262.11), 263,     262.11, and applicable
                                                                 264, 265, 266, 270,      provisions under part
                                                                 124 of this chapter,     268.
                                                                 and the notification
                                                                 requirements at
                                                                 section 3010 of RCRA.
(6) Will be reclaimed through          export these batteries   are exempt from 40 CFR   are subject to 40 CFR
 regeneration or any other means.       for reclamation in a     parts 263, 264, 265,     part 261 and Sec.
                                        foreign country.         266, 268, 270, 124 of    262.11, and either
                                                                 this chapter, and the    must comply with 40
                                                                 notification             CFR part 262, subpart
                                                                 requirements at          H (if shipping to one
                                                                 section 3010 of RCRA.    of the OECD countries
                                                                 You are also exempt      specified in 40 CFR
                                                                 from part 262, except    262.58(a)(1)), or
                                                                 for 262.11, and except   must:
                                                                 for the applicable      (a) Comply with the
                                                                 requirements in          requirements
                                                                 either: (1) 40 CFR       applicable to a
                                                                 part 262 subpart H; or   primary exporter in 40
                                                                 (2) 262.53               CFR 262.53, 262.56(a)
                                                                 ``Notification of        (1) through (4), (6),
                                                                 Intent to Export,        and (b) and 262.57;
                                                                 262.56(a)(1) through     and
                                                                 (4)(6) and (b)          (b) Export these
                                                                 ``Annual Reports,''      batteries only upon
                                                                 and 262.57               consent of the
                                                                 ``Recordkeeping''.       receiving country and
                                                                                in conformance with
                                                                                the EPA
                                                                                Acknowledgement of
                                                                                Consent as defined in
                                                                                subpart E of part 262
                                                                                of this chapter; and
                                                                                (c) Provide a copy
                                                                                of the EPA
                                                                                Acknowledgment of
                                                                                Consent for the
                                                                                shipment to the
                                                                                transporter
                                                                                transporting the
                                                                                shipment for
                                                                                export.
(7) Will be reclaimed through          Transport these          are exempt from 40 CFR   must comply with
 regeneration or any other means.       batteries in the U.S.    parts 263, 264, 265,     applicable
                                        to export them for       266, 268, 270, 124 of    requirements in 40 CFR
                                        reclamation in a         this chapter, and the    part 262, subpart H
                                        foreign country.         notification             (if shipping to one of
                                                                 requirements at          the OECD countries
                                                                 section 3010 of RCRA.    specified in 40 CFR
                                                                                262.58(a)(1)), or must
                                                                                comply with the
                                                                                following:
                                                                                (a) you may not
                                                                                accept a shipment
                                                                                if you know the
                                                                                shipment does not
                                                                                conform to the EPA
                                                                                Acknowledgment of
                                                                                Consent;
                                                                                (b) you must ensure
                                                                                that a copy of the
                                                                                EPA Acknowledgment
                                                                                of Consent
                                                                                accompanies the
                                                                                shipment; and

                                                                                (c) you must ensure
                                                                                that the shipment
                                                                                is delivered to the
                                                                                facility designated
                                                                                by the person
                                                                                initiating the
                                                                                shipment.
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 271--REQUIREMENTS FOR AUTHORIZATION OF STATE HAZARDOUS WASTE
PROGRAMS

0
16. The authority citation for part 271 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), and 6926.

0
17. Section 271.1(j) is amended by adding the following entry to Table
1 and Table 2 in chronological order by date of publication in the
Federal Register, to read as follows:

Sec.  271.1  Purpose and scope.

* * * * *
    (j) * * *

               Table 1--Regulations Implementing the Hazardous and Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
                                                                   Federal Register
          Promulgation date             Title of regulation           reference              Effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Jan. 8, 2010........................  Exports of hazardous     [Insert FR page          July 7, 2010.
                                       waste.                   numbers].
----------------------------------------------------------------------------------------------------------------

* * * * *

            Table 2--Self-Implementing Provisions of the Hazardous and Solid Waste Amendments of 1984
----------------------------------------------------------------------------------------------------------------
                                                                            RCRA
              Effective date               Self-implementing provision    citation    Federal Register reference
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
July 7, 2010.............................  Exports of hazardous waste.      3017(a)  [Insert Federal Register
                                                                                reference for publication
                                                                                of final rule].
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-31081 Filed 1-7-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Pages 66566-66567]
[FR Doc No: 2021-25589]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0405]

Maytee Lledo: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring Maytee Lledo from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this order on a finding that Ms. Lledo was convicted of a felony
under Federal law for conduct that relates to the development or
approval, including the process for development or approval, of any
drug product under the FD&C Act. Ms. Lledo was given notice of the
proposed permanent debarment and an opportunity to request a hearing to
show why she should not be debarred within the timeframe prescribed by
regulation. Ms. Lledo has not responded to the notice. Ms. Lledo's
failure to respond and request a hearing within the prescribed
timeframe constitutes a waiver of her right to a hearing concerning
this action.

DATES: This order is applicable November 23, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the development or
approval, including the process for development or approval, of any
drug product under the FD&C Act. On April 16, 2021, in the U.S.
District Court for the Southern District of Florida, Miami Division, a
judgment of conviction was entered against Ms. Maytee Lledo, after her
plea of guilty to one count of Conspiracy to Commit Wire Fraud in
violation of 18 U.S.C. 1349, a felony offense under Federal law.
    The factual basis for this conviction is as follows: As contained
in the Information, entered into the docket on August 31, 2020, and the
Factual Proffer in Support of Ms. Lledo's guilty plea, entered into the
docket on February 5, 2021, both from her case, Ms. Lledo was a
receptionist at Sacred Heart Medical Office P.A., a private medical
practice, in Florida. That medical practice primarily served a
pediatric population. From about September 2013 through June 2016, Ms.
Lledo and others conspired to unlawfully enrich themselves by making
materially false representations about clinical trials, fabricating
data and the participation of subjects in those clinical trials,
concealing from FDA, sponsors, and contract research organizations the
fact that the data and participation of subjects had been fabricated,
and inducing sponsors and contract research organizations to pay money
for Ms. Lledo and her co-conspirators' own benefit. Specifically, one
of Ms. Lledo's co-conspirators entered into a contract with a Contract
Research Organization (CRO) retained by a drug manufacturer (Sponsor)
to hire clinical investigators and to manage clinical trials. Ms.
Lledo's co-conspirator entered into a contract with the CRO to conduct
a study at Unlimited Medical Research site in return for payment. The
study was for an investigational drug intended to treat pediatric
asthma in children between the ages of 4 and 11 years. Her co-
conspirators were responsible for complying with the study protocol,
including administering study drug to subjects in the study and
preparing written records, known as case histories, which documented
the participation of subjects in the study.
    Ms. Lledo participated in a scheme to defraud the Sponsor by
fabricating the data and participation of subjects in the clinical
trial in a variety of ways. Ms. Lledo and her co-conspirators falsified
medical records to portray persons as legitimate study subjects when
they were not. In addition, her co-conspirators made it appear as
though pediatric subjects made scheduled visits to Unlimited Medical
Research when they had not; made it appear as though subjects had taken
the study drug as required when they had not; and made it appear that
the study subjects had received checks as payment when they had not. In
addition, study subjects were required to make daily phone calls to an
``e-diary'' system and report their daily drug usage and experience
with the study drug. As part of the conspiracy, Ms. Lledo placed
thousands of telephone calls to the e-diary system, using falsely
obtained PIN numbers to access the system, for purposes of reporting
fabricated data on behalf of purportedly legitimate study subjects. Ms.
Lledo entered this fabricated information in the e-diary system for at
least 11 study subjects.
    Based on this conviction, FDA sent Ms. Lledo by certified mail on
July 27, 2021, a notice proposing to permanently debar her from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(A) of the FD&C Act, that Ms. Lledo was
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the development or
approval, including the process for development or approval, of a drug
product under the FD&C Act. The proposal also offered Ms. Lledo an
opportunity to request a hearing, providing her 30 days from the date
of receipt of the letter in which to file the request, and advised her
that failure to file a timely request for a hearing would constitute an
election not to use the opportunity for a hearing and a waiver of any
contentions concerning this action. Ms. Lledo received the proposal on
August 2, 2021. She did not request a hearing within the timeframe
prescribed by regulation and has, therefore, waived her opportunity for
a hearing and any contentions concerning her debarment (21 CFR part
12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(A) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms. Lledo
has been convicted of a felony under Federal law for conduct relating
to the development or approval, including the process for development
or approval, of a drug product under the FD&C Act.
    As a result of the foregoing finding, Ms. Lledo is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(A) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Ms. Lledo during her
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Lledo provides services
in any capacity to a person with an approved or pending drug product
application during her period of debarment she will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA
will not accept or review any abbreviated new drug application from Ms.
Lledo during her period of debarment, other than in connection with an
audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the
FD&C Act). Note that, for purposes of sections 306 and 307 of the FD&C
Act, a ``drug product'' is defined as a drug subject to regulation
under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or
382) or under section 351 of the Public Health Service Act (42 U.S.C.
262) (section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).
    Any application by Ms. Lledo for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2021-N-0405 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25589 Filed 11-22-21; 8:45 am]
BILLING CODE 4164-01-P