Iranian Transactions and Sanctions Regulations, 18990-18995 [2014-07572]
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Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Rules and Regulations
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[FR Doc. 2014–07326 Filed 4–4–14; 8:45 am]
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in the Federal Register of February 27,
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BILLING CODE 4160–01–P
BILLING CODE 4910–13–P
DEPARTMENT OF THE TREASURY
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Foreign Assets Control
Food and Drug Administration
31 CFR Part 560
21 CFR Parts 556 and 558
Iranian Transactions and Sanctions
Regulations
[Docket No. FDA–2014–N–0002]
Office of Foreign Assets
Control, Treasury.
ACTION: Final rule.
AGENCY:
Zoetis Inc., et al.; Withdrawal of
Approval of New Animal Drug
Applications for Combination Drug
Medicated Feeds Containing an
Arsenical Drug; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notification of withdrawal of
approval; correction.
ACTION:
The Food and Drug
Administration (FDA) published a
document in the Federal Register of
February 27, 2014, concerning the
voluntary withdrawal of approval of
new animal drug applications (NADAs).
The document contained an incorrect
list of NADAs.
DATES: This correction is effective April
7, 2014.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
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SUMMARY:
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The Department of the
Treasury’s Office of Foreign Assets
Control (‘‘OFAC’’) is adopting a final
rule amending the Iranian Transactions
and Sanctions Regulations (‘‘ITSR’’) by
expanding an existing general license
that authorizes the exportation or
reexportation of food to individuals and
entities in Iran to include the broader
category of agricultural commodities.
The rule also clarifies and adds certain
definitions in OFAC regulations.
Finally, the rule adds a new general
license that authorizes the exportation
or reexportation of certain replacement
parts for certain medical devices.
DATES: Effective: April 7, 2014.
FOR FURTHER INFORMATION CONTACT:
Assistant Director for Licensing, tel.:
202/622–2480, Assistant Director for
SUMMARY:
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Policy, tel.: 202/622–2746, Assistant
Director for Regulatory Affairs, tel.: 202/
622–4855, Assistant Director for
Sanctions Compliance and Evaluation,
tel.: 202/622–2490, Office of Foreign
Assets Control, or Chief Counsel
(Foreign Assets Control), tel.: 202/622–
2410, Office of the General Counsel,
Department of the Treasury (not toll free
numbers).
SUPPLEMENTARY INFORMATION: OFAC is
adopting a final rule amending the ITSR
by expanding an existing general license
that authorizes the exportation or
reexportation of food to individuals and
entities in Iran to include the broader
category of agricultural commodities.
Exports of certain specified items, as
well as exports to certain persons, are
excluded from the general license.
Additionally, OFAC is clarifying, for
purposes of the general licenses in ITSR
§ 560.530, that the definitions of the
terms agricultural commodities,
medicine, and medical device include,
in the case of items subject to the Export
Administration Regulations, 15 CFR
Part 730 et seq. (‘‘EAR’’), items that are
designated as EAR99 and, in the case of
items that are not subject to the EAR,
items that would be designated as
EAR99 if they were located in the
United States.
Furthermore, this rule adds a
definition of ‘‘covered person,’’ which,
with respect to the exportation or
reexportation of items subject to the
EAR, is a U.S. person or a non-U.S.
person, and for purposes of items not
subject to the EAR, is a U.S. person,
wherever located, or an entity owned or
controlled by a U.S. person and
established or maintained outside the
United States (a ‘‘U.S.-owned or
-controlled foreign entity’’). This
amendment clarifies that, for purposes
of the exportation or reexportation of
items that are not subject to the EAR,
and consistent with 31 CFR 560.556, the
general licenses set forth in § 560.530
apply to any U.S. person, wherever
located, or any U.S.-owned or
-controlled foreign entity.
Finally, OFAC is adding a new
general license that authorizes the
exportation or reexportation of
replacement parts for certain medical
devices to individuals and entities in
Iran provided that the replacement parts
are designated under the EAR as EAR99,
or would be designated as EAR99 if they
were located in the United States, and
limited to a one-for-one export or
reexport basis. This rule also updates
the definition of ‘‘basic medical
supplies’’ to exclude the word ‘‘basic’’
and make related conforming changes.
Accordingly, the ‘‘List of Basic Medical
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Supplies’’ published on the OFAC Web
site and in the Federal Register will
now be called the ‘‘List of Medical
Supplies.’’
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Electronic and Facsimile Availability
This document and additional
information concerning OFAC are
available from OFAC’s Web site
(www.treasury.gov/ofac). Certain general
information pertaining to OFAC’s
sanctions programs is also available via
facsimile through a 24-hour fax-ondemand service, tel.: 202/622–0077.
Background
OFAC is adopting a final rule
amending the ITSR, 31 CFR Part 560, by
expanding the general license set forth
in § 560.530(a)(2) that authorizes the
exportation or reexportation of food to
Iran to include the broader category of
agricultural commodities. Exports of
certain specified items, as well as
exports to certain persons, are excluded
from the general license. Additionally,
OFAC is clarifying, for purposes of the
general licenses in ITSR § 560.530, the
definitions of the terms agricultural
commodities, medicine, and medical
device, as set forth in more detail below.
Finally, OFAC is adding a new general
license that authorizes the exportation
or reexportation of replacement parts for
certain medical devices to individuals
and entities in Iran provided that the
replacement parts are designated as
EAR99, or would be designated as
EAR99 if they were located in the
United States, and further provided that
the replacement parts are limited to a
one-for-one export or reexport basis.
Today’s amendments also update the
definition of ‘‘basic medical supplies’’
to exclude the word ‘‘basic’’ and make
related conforming changes.
Accordingly, the ‘‘List of Basic Medical
Supplies’’ published on the OFAC Web
site and in the Federal Register will
now be called the ‘‘List of Medical
Supplies.’’
The Trade Sanctions Reform and
Export Enhancement Act of 2000, as
amended (22 U.S.C. 7201 et seq.)
(‘‘TSRA’’), provides that, with certain
exceptions, the President may not
impose a unilateral agricultural sanction
or unilateral medical sanction against a
foreign country or foreign entity unless,
at least 60 days before imposing such a
sanction, the President submits a report
to Congress describing the proposed
sanction and the reasons for it and
Congress enacts a joint resolution
approving the report. See 22 U.S.C.
7202. Section 906 of TSRA, however,
requires in pertinent part that the export
of agricultural commodities, medicine,
or medical devices to the government of
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a country that has been determined by
the Secretary of State, pursuant to, inter
alia, section 6(j) of the Export
Administration Act of 1979 (50 U.S.C.
App. 2405(j)), to have repeatedly
provided support for acts of
international terrorism,1 or to any entity
in such a country, shall be made
pursuant to one-year licenses issued by
the United States Government, except
that the requirements of such one-year
licenses shall be no more restrictive
than general licenses administered by
the Department of the Treasury. See 22
U.S.C. 7205(a)(1). Section 906 also
specifies that procedures be in place to
deny licenses for exports of agricultural
commodities, medicine, or medical
devices to any entity within such
country promoting international
terrorism.
Moreover, as provided in section 221
of the USA PATRIOT Act (Pub. L. 107–
56) (codified at 22 U.S.C. 7210), nothing
in TSRA shall limit the application or
scope of any law, including any
Executive order or regulation
promulgated pursuant to such law,
establishing criminal or civil penalties
for the unlawful export of any
agricultural commodity, medicine, or
medical device to a Foreign Terrorist
Organization; a foreign organization,
group, or person designated pursuant to
Executive Orders 12947 or 13224
(sanctions on terrorists and certain
supporters of terrorism); weapons of
mass destruction or missile
proliferators; or designated narcotics
trafficking entities. In addition, TSRA
itself provides in section 904(2) that the
restrictions on the imposition of
unilateral agricultural sanctions or
unilateral medical sanctions shall not
affect any authority or requirement to
impose a sanction to the extent such
sanction applies to any agricultural
commodity, medicine, or medical
device that is (A) controlled on the
United States Munitions List (the
‘‘USML’’), (B) controlled on any control
list established under the Export
Administration Act of 1979 or any
successor statute, or (C) used to
facilitate the design, development, or
production of chemical or biological
weapons, missiles, or weapons of mass
destruction. See 22 U.S.C. 7203(2).
On October 12, 2011, OFAC adopted
a final rule issuing a general license set
forth in the ITSR § 560.530(a)(2)
authorizing the exportation or
reexportation of food (as defined in the
general license), including bulk
agricultural commodities listed in
appendix B to the ITSR, to the
1 The Secretary of State has made such a
determination with respect to Iran.
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18991
Government of Iran, to any individual or
entity in Iran, or to persons in third
countries purchasing specifically for
resale to any of the foregoing, and the
conduct of related transactions (see 76
FR 63191). Separately, OFAC has
routinely issued specific licenses
authorizing the exportation or
reexportation of agricultural
commodities (other than food items as
previously defined in ITSR section
560.530(a)(2)) to the Government of
Iran, individuals or entities in Iran, or
persons in third countries purchasing
specifically for resale to any of the
foregoing, and the conduct of related
transactions. In addition, OFAC has
continued to review its TSRA licensing
procedures, particularly the procedures
for licensing exports of agricultural
commodities.
As a result of this review, OFAC today
is further expanding the general license
set forth at ITSR § 560.530(a)(2), which,
prior to today’s amendment, authorized
the exportation and reexportation of
food (including bulk agricultural
commodities listed on appendix B to the
ITSR), to authorize the exportation or
reexportation of the broader category of
agricultural commodities, with certain
specified exceptions, to the Government
of Iran, to individuals or entities in Iran,
or to persons in third countries
purchasing specifically for resale to any
of the foregoing, and the conduct of
related transactions. Activities
authorized pursuant to ITSR
§ 560.530(a)(2), as amended today, are
subject to the proviso that, unless
otherwise authorized by specific
license, payment terms and financing
for sales pursuant to the general license
are limited to, and consistent with,
those authorized by ITSR § 560.532, and
the further proviso that all such exports
or reexports must be shipped within the
12-month period beginning on the date
of the signing of the contract for export
or reexport. All food items authorized
by the general license prior to today’s
amendment continue to be authorized
under the general license, as amended.
Each year, OFAC will determine
whether to revoke this general license.
Unless revoked, this general license will
remain in effect.
OFAC has determined that the
exportation or reexportation of a small
number of specified agricultural
commodities to the Government of Iran,
to any individual or entity in Iran, or to
persons in third countries purchasing
specifically for resale to any of the
foregoing, as well as the exportation or
reexportation of agricultural
commodities to military or law
enforcement purchasers or importers,
continue to require the level of review
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Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Rules and Regulations
afforded by specific licensing. As a
result, the general license set forth at
ITSR § 560.530(a)(2), as amended today,
does not authorize the exportation or
reexportation to Iran of castor beans,
castor bean seeds, certified pathogenfree eggs (unfertilized or fertilized),
dried egg albumin, live animals
(excluding live cattle), embryos
(excluding cattle embryos), Rosary/
Jequirity peas, non-food-grade gelatin
powder, peptones and their derivatives,
super absorbent polymers, western red
cedar, or all fertilizers. (See ITSR
§ 560.530(a)(2)(ii) for the exclusion of
these items.) Similarly, the general
license, as amended today, does not
authorize the exportation or
reexportation of agricultural
commodities to military or law
enforcement purchasers or importers.
(See ITSR § 560.530(a)(2)(iii) for the
exclusion of these persons.) The general
license, as amended today, also does not
authorize any transaction or dealing
with a person whose property and
interests in property are blocked under,
or who is designated or otherwise
subject to any sanction under, inter alia,
the terrorism, proliferation of weapons
of mass destruction, or narcotics
trafficking programs administered by
OFAC. (See ITSR § 560.530(d)(5).)
Additionally, OFAC is clarifying, for
purposes of the general licenses in ITSR
§ 560.530, that the definitions of the
terms agricultural commodities,
medicine, and medical device include,
in the case of items subject to the Export
Administration Regulations, 15 CFR
Part 730 et seq. (‘‘EAR’’), items that are
designated as EAR99 and, in the case of
items that are not subject to the EAR,
items that would be designated as
EAR99 if they were located in the
United States. (See ITSR § 560.530(e).)
For example, a company located in the
United States may be authorized under
the general license set forth at
§ 560.530(a)(2) to arrange for the export
from a third country to Iran of
agricultural commodities produced in
the third country if those commodities
would be designated as EAR99 if they
were located in the United States.
Furthermore, this rule adds a
definition of covered person, which,
with respect to the exportation or
reexportation of items subject to the
EAR, is a U.S. person or a non-U.S.
person, and for purposes of items not
subject to the EAR, a U.S. person,
wherever located, or an entity owned or
controlled by a U.S. person and
established or maintained outside the
United States (a ‘‘U.S.-owned or
-controlled foreign entity’’). This
amendment clarifies that, for purposes
of the exportation or reexportation of
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items that are not subject to the EAR,
and consistent with 31 CFR 560.556, the
general licenses set forth in § 560.530
apply to any U.S. person, wherever
located, or any U.S.-owned or
-controlled foreign entity. For example,
a U.S.-owned or -controlled foreign
entity may be authorized under the
general license set forth at
§ 560.530(a)(2) to arrange for the
reexport to Iran of EAR99 medicines, as
well as the export to Iran of medicines
not subject to the EAR (e.g., medicines
produced outside the U.S. by a non-U.S.
person with no controlled U.S. content)
that would be designated as EAR99 if
they were located in the United States.
The general licenses set forth at ITSR
§ 560.530(a)(2) through (4) do not
authorize, and specific licenses are
therefore still required for, the
exportation or reexportation of the
following to the Government of Iran
(wherever located), to any individual or
entity in Iran, or to persons in third
countries purchasing specifically for
resale to any of the foregoing, and for
the conduct of related transactions:
—the excluded agricultural
commodities specified in ITSR
§ 560.530(a)(2)(ii);
—the excluded medicines specified in
ITSR § 560.530(a)(3)(iii);
—medical devices other than medical
supplies as defined in
§ 560.530(a)(3)(ii); or
—agricultural commodities, medicine,
or medical supplies to military or law
enforcement purchasers or importers.
In the course of continually reviewing
its TSRA licensing procedures, OFAC
also adopted a final rule on October 22,
2012, issuing a new general license set
forth at ITSR § 560.530(a)(3) authorizing
the exportation or reexportation to Iran
of medicine and basic medical supplies
(as defined in the general license and
included in a List of Basic Medical
Supplies posted to OFAC’s Web site)
(see 77 FR 64664). The definition of
basic medical supplies as originally
published on October 22, 2012,
specifically excluded replacement parts.
On July 25, 2013, OFAC updated the
List of Basic Medical Supplies to
include additional items. This update
added to the list, among other items,
certain EAR99-designated accessories,
components, and optional equipment
for use with medical devices included
elsewhere on the list, which are distinct
from replacement parts.
OFAC has now determined, however,
that the export or reexport of
replacement parts for certain medical
devices should be authorized, provided
that the replacement parts are
designated as EAR99 or, in the case of
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replacement parts that are not subject to
the EAR, would be designated as EAR99
if they were located in the United
States, and further provided that the
replacement parts are limited to a onefor-one basis (i.e., only one replacement
part can be exported or reexported to
replace a broken or non-operational
component). Accordingly, OFAC today
is issuing a new general license set forth
at ITSR § 560.530(a)(4) authorizing the
exportation or reexportation of
replacement parts that are designated as
EAR99, or that would be designated as
EAR99 if they were located in the
United States, for medical devices on a
one-for-one basis and with certain
exceptions, to the Government of Iran,
to individuals or entities in Iran, or to
persons in third countries purchasing
specifically for resale to any of the
foregoing, and the conduct of related
transactions. Each year, OFAC will
determine whether to revoke this
general license. Unless revoked, this
general license will remain in effect.
Public Participation
Because the amendment of 31 CFR
Part 560 involves a foreign affairs
function, the provisions of Executive
Order 12866 of September 30, 1993, and
the Administrative Procedure Act (5
U.S.C. 553), requiring notice of
proposed rulemaking, opportunity for
public participation, and delay in
effective date, are inapplicable. Because
no notice of proposed rulemaking is
required for this rule, the Regulatory
Flexibility Act (5 U.S.C. 601–612) does
not apply.
Paperwork Reduction Act
The collections of information related
to the Regulations are contained in 31
CFR Part 501 (the ‘‘Reporting,
Procedures and Penalties Regulations’’).
Pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3507), those
collections of information have been
approved by the Office of Management
and Budget under control number 1505–
0164. An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless the collection of information
displays a valid control number.
List of Subjects in 31 CFR Part 560
Administrative practice and
procedure, Agricultural commodities,
Banks, Banking, Blocking of assets,
Drugs, Exports, Food, Foreign trade,
Humanitarian aid, Investments, Iran,
Loans, Medical devices, Medicine,
Penalties, Services, Specially designated
nationals, Terrorism, Transportation,
Weapons of mass destruction.
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Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Rules and Regulations
§ 560.530 Commercial sales, exportation,
and reexportation of agricultural
commodities, medicine, and medical
devices.
For the reasons set forth in the
preamble, the Department of the
Treasury’s Office of Foreign Assets
Control amends 31 CFR Part 560 as
follows:
PART 560—IRANIAN TRANSACTIONS
AND SANCTIONS REGULATIONS
1. The authority citation for part 560
is revised to read as follows:
■
Authority: 3 U.S.C. 301; 18 U.S.C. 2339B,
2332d; 22 U.S.C. 2349aa–9; 22 U.S.C. 7201–
7211; 31 U.S.C. 321(b); 50 U.S.C. 1601–1651,
1701–1706; Pub. L. 101–410, 104 Stat. 890
(28 U.S.C. 2461 note); Pub. L. 110–96, 121
Stat. 1011 (50 U.S.C. 1705 note); Pub. L. 111–
195, 124 Stat. 1312 (22 U.S.C. 8501–8551);
Pub. L. 112–81, 125 Stat. 1298 (22 U.S.C.
8513a); Pub. L. 112–158, 126 Stat. 1214 (22
U.S.C. 8701–8795); E.O. 12613, 52 FR 41940,
3 CFR, 1987 Comp., p. 256; E.O. 12957, 60
FR 14615, 3 CFR, 1995 Comp., p. 332; E.O.
12959, 60 FR 24757, 3 CFR, 1995 Comp., p.
356; E.O. 13059, 62 FR 44531, 3 CFR, 1997
Comp., p. 217; E.O. 13599, 77 FR 6659,
February 8, 2012; E.O. 13622, 77 FR 45897,
August 2, 2012; E.O. 13628, 77 FR 62139,
October 12, 2012.
Subpart D—Interpretations
2. Amend § 560.405 by revising the
note to paragraph (e) to read as follows:
■
§ 560.405 Transactions ordinarily incident
to a licensed transaction authorized.
*
*
*
*
*
Note to Paragraph (e) of § 560.405: See
§ 560.530(a)(2) through (4) for general
licenses authorizing, with certain exceptions,
the exportation or reexportation of
agricultural commodities, medicine, medical
supplies, and replacement parts for certain
medical devices to the Government of Iran,
individuals or entities in Iran, or persons in
third countries purchasing specifically for
resale to any of the foregoing. These general
licenses also authorize the conduct of related
transactions, including, but not limited to,
financing and payment, provided that
payment terms and financing are limited to,
and consistent with, § 560.532, which sets
forth payment terms for sales authorized by
one of the general licenses set forth in
paragraphs (a)(2) through (4) of § 560.530 or
by a specific license issued pursuant to
paragraph (a)(1) of the same section.
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Subpart E—Licenses, Authorizations
and Statements of Licensing Policy
3. Amend § 560.530 by revising
paragraphs (a), (b), (c) introductory text,
(c)(4) and (5), adding paragraph (d)(6),
revising paragraphs (e)(1)(i), (e)(1)(ii)
introductory text, (e)(2) introductory
text, and (e)(3), and adding paragraph
(e)(4) to read as follows:
■
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(a)(1) One-year license requirement.
(i) The exportation or reexportation of
agricultural commodities, medicine, and
medical devices that are not covered by
the general licenses in paragraphs (a)(2)
through (4) of this section (as set forth
in paragraph (a)(1)(ii) of this section) to
the Government of Iran, to any
individual or entity in Iran, or to
persons in third countries purchasing
specifically for resale to any of the
foregoing, shall only be made pursuant
to a one-year specific license issued by
the Office of Foreign Assets Control
(‘‘OFAC’’) for contracts entered into
during the one year period of the license
and shipped within the 12-month
period beginning on the date of the
signing of the contract. No specific
license will be granted for the
exportation or reexportation of the items
set forth in paragraph (a)(1)(ii) of this
section to any entity or individual in
Iran promoting international terrorism,
to any individual or entity designated
pursuant to Executive Order 12947 (60
FR 5079, 3 CFR, 1995 Comp., p. 356),
Executive Order 13224 (66 FR 49079, 3
CFR, 2001 Comp., p. 786), or Public Law
104–132, to any narcotics trafficking
entity designated pursuant to Executive
Order 12978 of October 21, 1995 (60 FR
54579, 3 CFR, 1995 Comp., p. 415) or
the Foreign Narcotics Kingpin
Designation Act (21 U.S.C. 1901–1908),
or to any foreign organization, group, or
persons subject to any restriction for its
or their involvement in weapons of
mass destruction or missile
proliferation. Executory contracts
entered into pursuant to paragraph
(b)(2) of this section prior to the
issuance of a one-year license described
in this paragraph shall be deemed to
have been signed on the date of issuance
of that one-year license (and, therefore,
the exporter is authorized to make
shipments under that contract within
the 12-month period beginning on the
date of issuance of the one-year license).
(ii) For the purposes of this part,
‘‘agricultural commodities, medicine,
and medical devices that are not
covered by the general licenses in
paragraphs (a)(2) through (4) of this
section’’ are:
(A) The excluded agricultural
commodities specified in paragraph
(a)(2)(ii) of this section;
(B) The excluded medicines specified
in paragraph (a)(3)(iii) of this section;
(C) Medical devices (as defined in
paragraph (e)(3) of this section) other
than medical supplies (as defined in
paragraph (a)(3)(ii) of this section); and
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18993
(D) Agricultural commodities (as
defined in paragraph (e)(1) of this
section), medicine (as defined in
paragraph (e)(2) of this section), and
medical supplies (as defined in
paragraph (a)(3)(ii) of this section) to
military or law enforcement purchasers
or importers.
(2)(i) General license for the
exportation or reexportation of
agricultural commodities. Except as
provided in paragraphs (a)(2)(ii) and (iii)
of this section, the exportation or
reexportation by a covered person (as
defined in paragraph (e)(4) of this
section) of agricultural commodities (as
defined in paragraph (e)(1) of this
section) (including bulk agricultural
commodities listed in appendix B to
this part) to the Government of Iran, to
any individual or entity in Iran, or to
persons in third countries purchasing
specifically for resale to any of the
foregoing, and the conduct of related
transactions, including, but not limited
to, the making of shipping and cargo
inspection arrangements, the obtaining
of insurance, the arrangement of
financing and payment, shipping of the
goods, receipt of payment, and the entry
into contracts (including executory
contracts), are hereby authorized,
provided that, unless otherwise
authorized by specific license, payment
terms and financing for sales pursuant
to this general license are limited to,
and consistent with, those authorized by
§ 560.532 of this part; and further
provided that all such exports and
reexports are shipped within the 12month period beginning on the date of
the signing of the contract for export or
reexport.
(ii) Excluded agricultural
commodities. Paragraph (a)(2)(i) of this
section does not authorize the
exportation or reexportation of the
following items: castor beans, castor
bean seeds, certified pathogen-free eggs
(unfertilized or fertilized), dried egg
albumin, live animals (excluding live
cattle), embryos (excluding cattle
embryos), Rosary/Jequirity peas, nonfood-grade gelatin powder, peptones
and their derivatives, super absorbent
polymers, western red cedar, or all
fertilizers.
(iii) Excluded persons. Paragraph
(a)(2)(i) of this section does not
authorize the exportation or
reexportation of agricultural
commodities to military or law
enforcement purchasers or importers.
Note to Paragraph (a)(2) of § 560.530:
Consistent with section 906(a)(1) of the Trade
Sanctions Reform and Export Enhancement
Act of 2000 (22 U.S.C. 7205), each year OFAC
will determine whether to revoke this general
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07APR1
18994
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Rules and Regulations
license. Unless revoked, the general license
will remain in effect.
(3)(i) General license for the
exportation or reexportation of
medicine and medical supplies. Except
as provided in paragraphs (a)(3)(iii) and
(iv) of this section, the exportation or
reexportation by a covered person (as
defined in paragraph (e)(4) of this
section) of medicine (as defined in
paragraph (e)(2) of this section) and
medical supplies (as defined in
paragraph (a)(3)(ii) of this section) to the
Government of Iran, to any individual or
entity in Iran, or to persons in third
countries purchasing specifically for
resale to any of the foregoing, and the
conduct of related transactions,
including, but not limited to, the
making of shipping and cargo
inspection arrangements, the obtaining
of insurance, the arrangement of
financing and payment, shipping of the
goods, receipt of payment, and the entry
into contracts (including executory
contracts), are hereby authorized,
provided that, unless otherwise
authorized by specific license, payment
terms and financing for sales pursuant
to this general license are limited to,
and consistent with, those authorized by
§ 560.532 of this part; and further
provided that all such exports or
reexports are shipped within the 12month period beginning on the date of
the signing of the contract for export or
reexport.
(ii) Definition of medical supplies. For
purposes of this general license, the
term medical supplies means those
medical devices, as defined in
paragraph (e)(3) of this section, that are
included on the List of Medical
Supplies on OFAC’s Web site
(www.treasury.gov/ofac) on the Iran
Sanctions page.
ehiers on DSK2VPTVN1PROD with RULES
Note to Paragraph (a)(3)(ii) of § 560.530:
The List of Medical Supplies is maintained
on OFAC’s Web site (www.treasury.gov/ofac)
on the Iran Sanctions page. The list also will
be published in the Federal Register, as will
any changes to the list. The List of Medical
Supplies contains those medical devices for
which OFAC previously did not require an
Official Commodity Classification of EAR99
issued by the Department of Commerce’s
Bureau of Industry and Security to be
submitted with a specific license application
and which are now generally licensed.
(iii) Excluded medicines. Paragraph
(a)(3)(i) of this section does not
authorize the exportation or
reexportation of the following
medicines: non-NSAID analgesics,
cholinergics, anticholinergics, opioids,
narcotics, benzodiazapenes, and
bioactive peptides.
(iv) Excluded persons. Paragraph
(a)(3)(i) of this section does not
VerDate Mar<15>2010
14:32 Apr 04, 2014
Jkt 232001
authorize the exportation or
reexportation of medicine or medical
supplies to military or law enforcement
purchasers or importers.
Note to Paragraph (a)(3) of § 560.530:
Consistent with section 906(a)(1) of the Trade
Sanctions Reform and Export Enhancement
Act of 2000 (22 U.S.C. 7205), each year,
OFAC will determine whether to revoke this
general license. Unless revoked, the general
license will remain in effect.
(4) General license for the exportation
or reexportation of replacement parts
for certain medical devices. (i) The
exportation or reexportation by a
covered person (as defined in paragraph
(e)(4) of this section) of replacement
parts for medical devices (as defined in
paragraph (e)(3) of this section) exported
or reexported pursuant to paragraphs
(a)(1) or (a)(3)(i) of this section to the
Government of Iran, to any individual or
entity in Iran, or to persons in third
countries purchasing specifically for
resale to any of the foregoing, and the
conduct of related transactions,
including, but not limited to, the
making of shipping and cargo
inspection arrangements, the obtaining
of insurance, the arrangement of
financing and payment, shipping of the
goods, receipt of payment, and the entry
into contracts (including executory
contracts), are hereby authorized,
provided that, unless otherwise
authorized by specific license, payment
terms and financing for sales pursuant
to this general license are limited to,
and consistent with, those authorized by
§ 560.532 of this part; provided that
such replacement parts are designated
as EAR99, or, in the case of replacement
parts that are not subject to the Export
Administration Regulations, 15 CFR
parts 730 et seq. (‘‘EAR’’), would be
designated as EAR99 if they were
located in the United States; and further
provided that such replacement parts
are limited to a one-for-one export or
reexport basis (i.e., only one
replacement part can be exported or
reexported to replace a broken or nonoperational component).
(ii) Excluded persons. Paragraph
(a)(4)(i) of this section does not
authorize the exportation or
reexportation of replacement parts for
medical devices to military or law
enforcement purchasers or importers.
Note to Paragraph (a)(4) of § 560.530:
Consistent with section 906(a)(1) of the Trade
Sanctions Reform and Export Enhancement
Act of 2000 (22 U.S.C. 7205), each year,
OFAC will determine whether to revoke this
general license. Unless revoked, the general
license will remain in effect.
(b) General license for arrangement of
exportation and reexportation of
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Fmt 4700
Sfmt 4700
covered products that require a specific
license. (1) With respect to sales
authorized pursuant to paragraph
(a)(1)(i) of this section, the making of
shipping arrangements, cargo
inspections, obtaining of insurance, and
arrangement of financing (consistent
with § 560.532) for the exportation or
reexportation of agricultural
commodities, medicine, and medical
devices that are not covered by the
general licenses in paragraphs (a)(2)
through (4) of this section (as set forth
in paragraph (a)(1)(ii) of this section) to
the Government of Iran, to any
individual or entity in Iran, or to
persons in third countries purchasing
specifically for resale to any of the
foregoing, are authorized.
(2) Entry into executory contracts
(including executory pro forma
invoices, agreements in principle, or
executory offers capable of acceptance
such as bids in response to public
tenders) for the exportation or
reexportation of agricultural
commodities, medicine, and medical
devices that are not covered by the
general licenses in paragraphs (a)(2)
through (4) of this section (as set forth
in paragraph (a)(1)(ii) of this section) to
the Government of Iran, to any
individual or entity in Iran, or to
persons in third countries purchasing
specifically for resale to any of the
foregoing, is authorized, provided that
the performance of an executory
contract is expressly made contingent
upon the prior issuance of a one-year
specific license described in paragraph
(a)(1)(i) of this section.
(c) Instructions for obtaining one-year
licenses. In order to obtain the one-year
specific license described in paragraph
(a)(1)(i) of this section, the exporter
must provide to OFAC:
*
*
*
*
*
(4) A description of all items to be
exported or reexported pursuant to the
requested one-year license, including a
statement that the items are designated
as EAR99, or would be designated as
EAR99 if they were located in the
United States, and, if necessary,
documentation sufficient to verify that
the items to be exported or reexported
are designated as EAR99, or would be
designated as EAR99 if they were
located in the United States, and do not
fall within any of the limitations
contained in paragraph (d) of this
section; and
(5) For items subject to the EAR, an
Official Commodity Classification of
EAR99 issued by the Department of
Commerce’s Bureau of Industry and
Security (‘‘BIS’’), certifying that the
product is designated as EAR99, is
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07APR1
ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Rules and Regulations
required to be submitted to OFAC with
the request for a license authorizing the
exportation or reexportation of all
fertilizers, live horses, western red
cedar, or medical devices other than
medical supplies (as defined in
§ 560.530(a)(3)(ii)). See 15 CFR 745.3 for
instructions for obtaining an Official
Commodity Classification of EAR99
from BIS.
(d) * * *
(6) Nothing in this section or in any
general or specific license set forth in or
issued pursuant to paragraph (a) of this
section authorizes the exportation or
reexportation of any agricultural
commodity, medicine, or medical
device that is not designated as EAR99
or, in the case of any agricultural
commodity, medicine, or medical
device not subject to the EAR, would
not be designated as EAR99 if it were
located in the United States.
(e) * * *
(1) * * *
(i) In the case of products subject to
the EAR, 15 CFR part 774, products that
are designated as EAR99, and, in the
case of products not subject to the EAR,
products that would be designated as
EAR99 under the EAR if they were
located in the United States, in each
case that fall within the term
‘‘agricultural commodity’’ as defined in
section 102 of the Agricultural Trade
Act of 1978 (7 U.S.C. 5602); and
(ii) In the case of products subject to
the EAR, products that are designated as
EAR99, and in the case of products not
subject to the EAR, products that would
be designated as EAR99 if they were
located in the United States, in each
case that are intended for ultimate use
in Iran as:
*
*
*
*
*
(2) Medicine. For the purposes of this
part, medicine is an item that falls
within the definition of the term ‘‘drug’’
in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321)
and that, in the case of an item subject
to the EAR, is designated as EAR99 or,
in the case of an item not subject to the
EAR, that would be designated as
EAR99, if it were located in the United
States.
*
*
*
*
*
(3) Medical device. For the purposes
of this part, a medical device is an item
that falls within the definition of
‘‘device’’ in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
321) and that, in the case of an item
subject to the EAR, is designated as
EAR99, or in the case of an item not
subject to the EAR, that would be
designated as EAR99 if it were located
in the United States.
VerDate Mar<15>2010
14:32 Apr 04, 2014
Jkt 232001
(4) Covered person. For purposes of
this part, a covered person is, with
respect to the exportation or
reexportation of items subject to the
EAR, a U.S. person or a non-U.S.
person, and for purposes of items not
subject to the EAR, a U.S. person,
wherever located, or an entity owned or
controlled by a U.S. person and
established or maintained outside the
United States.
*
*
*
*
*
4. Amend § 560.533 by revising
paragraphs (a) and (b) to read as follows:
■
§ 560.533 Brokering sales of agricultural
commodities, medicine, and medical
devices.
(a) General license for brokering sales
by U.S. persons. United States persons
are authorized to provide brokerage
services on behalf of U.S. persons for
the sale and exportation or
reexportation by U.S. persons of
agricultural commodities, medicine, and
medical devices, provided that the sale
and exportation or reexportation is
authorized, as applicable, by a one-year
specific license issued pursuant to
paragraph (a)(1)(i) of § 560.530 or by one
of the general licenses set forth in
paragraphs (a)(2), (a)(3), and (a)(4) of
§ 560.530.
(b) Specific licensing for brokering
sales by non-U.S. persons of agricultural
commodities. Specific licenses may be
issued on a case-by-case basis to permit
U.S. persons to provide brokerage
services on behalf of non-U.S., nonIranian persons for the sale and
exportation or reexportation of
agricultural commodities to the
Government of Iran, entities in Iran, or
individuals in Iran. Specific licenses
issued pursuant to this section will
authorize the brokering only of sales
that are to purchasers permitted
pursuant to § 560.530.
Note To Paragraph (b) of § 560.533:
Requests for specific licenses to provide
brokerage services under this paragraph must
include all of the information described in
§ 560.530(c).
*
*
*
*
*
Dated: March 31, 2014.
Adam J. Szubin,
Director, Office of Foreign Assets Control.
[FR Doc. 2014–07572 Filed 4–4–14; 8:45 am]
BILLING CODE P
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18995
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2014–0113]
Special Local Regulation; Annual
Marine Events on the Colorado River,
Between Davis Dam (Bullhead City,
Arizona) and Headgate Dam (Parker,
Arizona) Within the San Diego Captain
of the Port Zone
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
the 2014 Lake Havasu Desert Storm
marine event special local regulations
on April 26, 2014. This annual marine
event occurs on the navigable waters of
the Colorado River in Lake Havasu,
Arizona. This action is necessary to
provide for the safety of the
participants, crew, spectators, safety
vessels, and general users of the
waterway. During the enforcement
period, persons and vessels are
prohibited from entering into, transiting
through, or anchoring within this
regulated area unless authorized by the
Captain of the Port, or his designated
representative.
SUMMARY:
This rule is effective from 8 a.m.
to 2 p.m. April 26, 2014. If the event is
delayed by inclement weather, these
regulations will also be enforced on
April 27, 2014, from 8 a.m. to 2 p.m.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this notice, call
or email Lieutenant Commander John
Bannon, Waterways Management, U.S.
Coast Guard Sector San Diego, CA;
telephone 619–278–7261, email
John.E.Bannon@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Special Local
Regulations in Lake Havasu for the 2014
Desert Storm Shootout in 33 CFR
100.1102, Table 1, Item 4 from 8 a.m. to
2 p.m. on April 26, 2014. If the event is
delayed by inclement weather, these
regulations will also be enforced on
April 27, 2014, from 8 a.m. to 2 p.m.
Under provisions of 33 CFR 100.1102,
persons and vessels are prohibited from
entering into, transiting through, or
anchoring within the regulated area,
unless authorized by the Coast Guard
Captain of the Port or his designated
representative. Persons or vessels
desiring to enter into or pass through
the special local regulations may request
permission from the Captain of the Port
or a designated representative. If
DATES:
E:\FR\FM\07APR1.SGM
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Agencies
[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Rules and Regulations]
[Pages 18990-18995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07572]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 560
Iranian Transactions and Sanctions Regulations
AGENCY: Office of Foreign Assets Control, Treasury.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of the Treasury's Office of Foreign Assets
Control (``OFAC'') is adopting a final rule amending the Iranian
Transactions and Sanctions Regulations (``ITSR'') by expanding an
existing general license that authorizes the exportation or
reexportation of food to individuals and entities in Iran to include
the broader category of agricultural commodities. The rule also
clarifies and adds certain definitions in OFAC regulations. Finally,
the rule adds a new general license that authorizes the exportation or
reexportation of certain replacement parts for certain medical devices.
DATES: Effective: April 7, 2014.
FOR FURTHER INFORMATION CONTACT: Assistant Director for Licensing,
tel.: 202/622-2480, Assistant Director for Policy, tel.: 202/622-2746,
Assistant Director for Regulatory Affairs, tel.: 202/622-4855,
Assistant Director for Sanctions Compliance and Evaluation, tel.: 202/
622-2490, Office of Foreign Assets Control, or Chief Counsel (Foreign
Assets Control), tel.: 202/622-2410, Office of the General Counsel,
Department of the Treasury (not toll free numbers).
SUPPLEMENTARY INFORMATION: OFAC is adopting a final rule amending the
ITSR by expanding an existing general license that authorizes the
exportation or reexportation of food to individuals and entities in
Iran to include the broader category of agricultural commodities.
Exports of certain specified items, as well as exports to certain
persons, are excluded from the general license.
Additionally, OFAC is clarifying, for purposes of the general
licenses in ITSR Sec. 560.530, that the definitions of the terms
agricultural commodities, medicine, and medical device include, in the
case of items subject to the Export Administration Regulations, 15 CFR
Part 730 et seq. (``EAR''), items that are designated as EAR99 and, in
the case of items that are not subject to the EAR, items that would be
designated as EAR99 if they were located in the United States.
Furthermore, this rule adds a definition of ``covered person,''
which, with respect to the exportation or reexportation of items
subject to the EAR, is a U.S. person or a non-U.S. person, and for
purposes of items not subject to the EAR, is a U.S. person, wherever
located, or an entity owned or controlled by a U.S. person and
established or maintained outside the United States (a ``U.S.-owned or
-controlled foreign entity''). This amendment clarifies that, for
purposes of the exportation or reexportation of items that are not
subject to the EAR, and consistent with 31 CFR 560.556, the general
licenses set forth in Sec. 560.530 apply to any U.S. person, wherever
located, or any U.S.-owned or -controlled foreign entity.
Finally, OFAC is adding a new general license that authorizes the
exportation or reexportation of replacement parts for certain medical
devices to individuals and entities in Iran provided that the
replacement parts are designated under the EAR as EAR99, or would be
designated as EAR99 if they were located in the United States, and
limited to a one-for-one export or reexport basis. This rule also
updates the definition of ``basic medical supplies'' to exclude the
word ``basic'' and make related conforming changes. Accordingly, the
``List of Basic Medical
[[Page 18991]]
Supplies'' published on the OFAC Web site and in the Federal Register
will now be called the ``List of Medical Supplies.''
Electronic and Facsimile Availability
This document and additional information concerning OFAC are
available from OFAC's Web site (www.treasury.gov/ofac). Certain general
information pertaining to OFAC's sanctions programs is also available
via facsimile through a 24-hour fax-on-demand service, tel.: 202/622-
0077.
Background
OFAC is adopting a final rule amending the ITSR, 31 CFR Part 560,
by expanding the general license set forth in Sec. 560.530(a)(2) that
authorizes the exportation or reexportation of food to Iran to include
the broader category of agricultural commodities. Exports of certain
specified items, as well as exports to certain persons, are excluded
from the general license. Additionally, OFAC is clarifying, for
purposes of the general licenses in ITSR Sec. 560.530, the definitions
of the terms agricultural commodities, medicine, and medical device, as
set forth in more detail below. Finally, OFAC is adding a new general
license that authorizes the exportation or reexportation of replacement
parts for certain medical devices to individuals and entities in Iran
provided that the replacement parts are designated as EAR99, or would
be designated as EAR99 if they were located in the United States, and
further provided that the replacement parts are limited to a one-for-
one export or reexport basis. Today's amendments also update the
definition of ``basic medical supplies'' to exclude the word ``basic''
and make related conforming changes. Accordingly, the ``List of Basic
Medical Supplies'' published on the OFAC Web site and in the Federal
Register will now be called the ``List of Medical Supplies.''
The Trade Sanctions Reform and Export Enhancement Act of 2000, as
amended (22 U.S.C. 7201 et seq.) (``TSRA''), provides that, with
certain exceptions, the President may not impose a unilateral
agricultural sanction or unilateral medical sanction against a foreign
country or foreign entity unless, at least 60 days before imposing such
a sanction, the President submits a report to Congress describing the
proposed sanction and the reasons for it and Congress enacts a joint
resolution approving the report. See 22 U.S.C. 7202. Section 906 of
TSRA, however, requires in pertinent part that the export of
agricultural commodities, medicine, or medical devices to the
government of a country that has been determined by the Secretary of
State, pursuant to, inter alia, section 6(j) of the Export
Administration Act of 1979 (50 U.S.C. App. 2405(j)), to have repeatedly
provided support for acts of international terrorism,\1\ or to any
entity in such a country, shall be made pursuant to one-year licenses
issued by the United States Government, except that the requirements of
such one-year licenses shall be no more restrictive than general
licenses administered by the Department of the Treasury. See 22 U.S.C.
7205(a)(1). Section 906 also specifies that procedures be in place to
deny licenses for exports of agricultural commodities, medicine, or
medical devices to any entity within such country promoting
international terrorism.
---------------------------------------------------------------------------
\1\ The Secretary of State has made such a determination with
respect to Iran.
---------------------------------------------------------------------------
Moreover, as provided in section 221 of the USA PATRIOT Act (Pub.
L. 107-56) (codified at 22 U.S.C. 7210), nothing in TSRA shall limit
the application or scope of any law, including any Executive order or
regulation promulgated pursuant to such law, establishing criminal or
civil penalties for the unlawful export of any agricultural commodity,
medicine, or medical device to a Foreign Terrorist Organization; a
foreign organization, group, or person designated pursuant to Executive
Orders 12947 or 13224 (sanctions on terrorists and certain supporters
of terrorism); weapons of mass destruction or missile proliferators; or
designated narcotics trafficking entities. In addition, TSRA itself
provides in section 904(2) that the restrictions on the imposition of
unilateral agricultural sanctions or unilateral medical sanctions shall
not affect any authority or requirement to impose a sanction to the
extent such sanction applies to any agricultural commodity, medicine,
or medical device that is (A) controlled on the United States Munitions
List (the ``USML''), (B) controlled on any control list established
under the Export Administration Act of 1979 or any successor statute,
or (C) used to facilitate the design, development, or production of
chemical or biological weapons, missiles, or weapons of mass
destruction. See 22 U.S.C. 7203(2).
On October 12, 2011, OFAC adopted a final rule issuing a general
license set forth in the ITSR Sec. 560.530(a)(2) authorizing the
exportation or reexportation of food (as defined in the general
license), including bulk agricultural commodities listed in appendix B
to the ITSR, to the Government of Iran, to any individual or entity in
Iran, or to persons in third countries purchasing specifically for
resale to any of the foregoing, and the conduct of related transactions
(see 76 FR 63191). Separately, OFAC has routinely issued specific
licenses authorizing the exportation or reexportation of agricultural
commodities (other than food items as previously defined in ITSR
section 560.530(a)(2)) to the Government of Iran, individuals or
entities in Iran, or persons in third countries purchasing specifically
for resale to any of the foregoing, and the conduct of related
transactions. In addition, OFAC has continued to review its TSRA
licensing procedures, particularly the procedures for licensing exports
of agricultural commodities.
As a result of this review, OFAC today is further expanding the
general license set forth at ITSR Sec. 560.530(a)(2), which, prior to
today's amendment, authorized the exportation and reexportation of food
(including bulk agricultural commodities listed on appendix B to the
ITSR), to authorize the exportation or reexportation of the broader
category of agricultural commodities, with certain specified
exceptions, to the Government of Iran, to individuals or entities in
Iran, or to persons in third countries purchasing specifically for
resale to any of the foregoing, and the conduct of related
transactions. Activities authorized pursuant to ITSR Sec.
560.530(a)(2), as amended today, are subject to the proviso that,
unless otherwise authorized by specific license, payment terms and
financing for sales pursuant to the general license are limited to, and
consistent with, those authorized by ITSR Sec. 560.532, and the
further proviso that all such exports or reexports must be shipped
within the 12-month period beginning on the date of the signing of the
contract for export or reexport. All food items authorized by the
general license prior to today's amendment continue to be authorized
under the general license, as amended. Each year, OFAC will determine
whether to revoke this general license. Unless revoked, this general
license will remain in effect.
OFAC has determined that the exportation or reexportation of a
small number of specified agricultural commodities to the Government of
Iran, to any individual or entity in Iran, or to persons in third
countries purchasing specifically for resale to any of the foregoing,
as well as the exportation or reexportation of agricultural commodities
to military or law enforcement purchasers or importers, continue to
require the level of review
[[Page 18992]]
afforded by specific licensing. As a result, the general license set
forth at ITSR Sec. 560.530(a)(2), as amended today, does not authorize
the exportation or reexportation to Iran of castor beans, castor bean
seeds, certified pathogen-free eggs (unfertilized or fertilized), dried
egg albumin, live animals (excluding live cattle), embryos (excluding
cattle embryos), Rosary/Jequirity peas, non-food-grade gelatin powder,
peptones and their derivatives, super absorbent polymers, western red
cedar, or all fertilizers. (See ITSR Sec. 560.530(a)(2)(ii) for the
exclusion of these items.) Similarly, the general license, as amended
today, does not authorize the exportation or reexportation of
agricultural commodities to military or law enforcement purchasers or
importers. (See ITSR Sec. 560.530(a)(2)(iii) for the exclusion of
these persons.) The general license, as amended today, also does not
authorize any transaction or dealing with a person whose property and
interests in property are blocked under, or who is designated or
otherwise subject to any sanction under, inter alia, the terrorism,
proliferation of weapons of mass destruction, or narcotics trafficking
programs administered by OFAC. (See ITSR Sec. 560.530(d)(5).)
Additionally, OFAC is clarifying, for purposes of the general
licenses in ITSR Sec. 560.530, that the definitions of the terms
agricultural commodities, medicine, and medical device include, in the
case of items subject to the Export Administration Regulations, 15 CFR
Part 730 et seq. (``EAR''), items that are designated as EAR99 and, in
the case of items that are not subject to the EAR, items that would be
designated as EAR99 if they were located in the United States. (See
ITSR Sec. 560.530(e).) For example, a company located in the United
States may be authorized under the general license set forth at Sec.
560.530(a)(2) to arrange for the export from a third country to Iran of
agricultural commodities produced in the third country if those
commodities would be designated as EAR99 if they were located in the
United States.
Furthermore, this rule adds a definition of covered person, which,
with respect to the exportation or reexportation of items subject to
the EAR, is a U.S. person or a non-U.S. person, and for purposes of
items not subject to the EAR, a U.S. person, wherever located, or an
entity owned or controlled by a U.S. person and established or
maintained outside the United States (a ``U.S.-owned or -controlled
foreign entity''). This amendment clarifies that, for purposes of the
exportation or reexportation of items that are not subject to the EAR,
and consistent with 31 CFR 560.556, the general licenses set forth in
Sec. 560.530 apply to any U.S. person, wherever located, or any U.S.-
owned or -controlled foreign entity. For example, a U.S.-owned or -
controlled foreign entity may be authorized under the general license
set forth at Sec. 560.530(a)(2) to arrange for the reexport to Iran of
EAR99 medicines, as well as the export to Iran of medicines not subject
to the EAR (e.g., medicines produced outside the U.S. by a non-U.S.
person with no controlled U.S. content) that would be designated as
EAR99 if they were located in the United States.
The general licenses set forth at ITSR Sec. 560.530(a)(2) through
(4) do not authorize, and specific licenses are therefore still
required for, the exportation or reexportation of the following to the
Government of Iran (wherever located), to any individual or entity in
Iran, or to persons in third countries purchasing specifically for
resale to any of the foregoing, and for the conduct of related
transactions:
--the excluded agricultural commodities specified in ITSR Sec.
560.530(a)(2)(ii);
--the excluded medicines specified in ITSR Sec. 560.530(a)(3)(iii);
--medical devices other than medical supplies as defined in Sec.
560.530(a)(3)(ii); or
--agricultural commodities, medicine, or medical supplies to military
or law enforcement purchasers or importers.
In the course of continually reviewing its TSRA licensing
procedures, OFAC also adopted a final rule on October 22, 2012, issuing
a new general license set forth at ITSR Sec. 560.530(a)(3) authorizing
the exportation or reexportation to Iran of medicine and basic medical
supplies (as defined in the general license and included in a List of
Basic Medical Supplies posted to OFAC's Web site) (see 77 FR 64664).
The definition of basic medical supplies as originally published on
October 22, 2012, specifically excluded replacement parts. On July 25,
2013, OFAC updated the List of Basic Medical Supplies to include
additional items. This update added to the list, among other items,
certain EAR99-designated accessories, components, and optional
equipment for use with medical devices included elsewhere on the list,
which are distinct from replacement parts.
OFAC has now determined, however, that the export or reexport of
replacement parts for certain medical devices should be authorized,
provided that the replacement parts are designated as EAR99 or, in the
case of replacement parts that are not subject to the EAR, would be
designated as EAR99 if they were located in the United States, and
further provided that the replacement parts are limited to a one-for-
one basis (i.e., only one replacement part can be exported or
reexported to replace a broken or non-operational component).
Accordingly, OFAC today is issuing a new general license set forth at
ITSR Sec. 560.530(a)(4) authorizing the exportation or reexportation
of replacement parts that are designated as EAR99, or that would be
designated as EAR99 if they were located in the United States, for
medical devices on a one-for-one basis and with certain exceptions, to
the Government of Iran, to individuals or entities in Iran, or to
persons in third countries purchasing specifically for resale to any of
the foregoing, and the conduct of related transactions. Each year, OFAC
will determine whether to revoke this general license. Unless revoked,
this general license will remain in effect.
Public Participation
Because the amendment of 31 CFR Part 560 involves a foreign affairs
function, the provisions of Executive Order 12866 of September 30,
1993, and the Administrative Procedure Act (5 U.S.C. 553), requiring
notice of proposed rulemaking, opportunity for public participation,
and delay in effective date, are inapplicable. Because no notice of
proposed rulemaking is required for this rule, the Regulatory
Flexibility Act (5 U.S.C. 601-612) does not apply.
Paperwork Reduction Act
The collections of information related to the Regulations are
contained in 31 CFR Part 501 (the ``Reporting, Procedures and Penalties
Regulations''). Pursuant to the Paperwork Reduction Act of 1995 (44
U.S.C. 3507), those collections of information have been approved by
the Office of Management and Budget under control number 1505-0164. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless the collection of
information displays a valid control number.
List of Subjects in 31 CFR Part 560
Administrative practice and procedure, Agricultural commodities,
Banks, Banking, Blocking of assets, Drugs, Exports, Food, Foreign
trade, Humanitarian aid, Investments, Iran, Loans, Medical devices,
Medicine, Penalties, Services, Specially designated nationals,
Terrorism, Transportation, Weapons of mass destruction.
[[Page 18993]]
For the reasons set forth in the preamble, the Department of the
Treasury's Office of Foreign Assets Control amends 31 CFR Part 560 as
follows:
PART 560--IRANIAN TRANSACTIONS AND SANCTIONS REGULATIONS
0
1. The authority citation for part 560 is revised to read as follows:
Authority: 3 U.S.C. 301; 18 U.S.C. 2339B, 2332d; 22 U.S.C.
2349aa-9; 22 U.S.C. 7201-7211; 31 U.S.C. 321(b); 50 U.S.C. 1601-
1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461
note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); Pub. L.
111-195, 124 Stat. 1312 (22 U.S.C. 8501-8551); Pub. L. 112-81, 125
Stat. 1298 (22 U.S.C. 8513a); Pub. L. 112-158, 126 Stat. 1214 (22
U.S.C. 8701-8795); E.O. 12613, 52 FR 41940, 3 CFR, 1987 Comp., p.
256; E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 12959,
60 FR 24757, 3 CFR, 1995 Comp., p. 356; E.O. 13059, 62 FR 44531, 3
CFR, 1997 Comp., p. 217; E.O. 13599, 77 FR 6659, February 8, 2012;
E.O. 13622, 77 FR 45897, August 2, 2012; E.O. 13628, 77 FR 62139,
October 12, 2012.
Subpart D--Interpretations
0
2. Amend Sec. 560.405 by revising the note to paragraph (e) to read as
follows:
Sec. 560.405 Transactions ordinarily incident to a licensed
transaction authorized.
* * * * *
Note to Paragraph (e) of Sec. 560.405: See Sec. 560.530(a)(2)
through (4) for general licenses authorizing, with certain
exceptions, the exportation or reexportation of agricultural
commodities, medicine, medical supplies, and replacement parts for
certain medical devices to the Government of Iran, individuals or
entities in Iran, or persons in third countries purchasing
specifically for resale to any of the foregoing. These general
licenses also authorize the conduct of related transactions,
including, but not limited to, financing and payment, provided that
payment terms and financing are limited to, and consistent with,
Sec. 560.532, which sets forth payment terms for sales authorized
by one of the general licenses set forth in paragraphs (a)(2)
through (4) of Sec. 560.530 or by a specific license issued
pursuant to paragraph (a)(1) of the same section.
Subpart E--Licenses, Authorizations and Statements of Licensing
Policy
0
3. Amend Sec. 560.530 by revising paragraphs (a), (b), (c)
introductory text, (c)(4) and (5), adding paragraph (d)(6), revising
paragraphs (e)(1)(i), (e)(1)(ii) introductory text, (e)(2) introductory
text, and (e)(3), and adding paragraph (e)(4) to read as follows:
Sec. 560.530 Commercial sales, exportation, and reexportation of
agricultural commodities, medicine, and medical devices.
(a)(1) One-year license requirement. (i) The exportation or
reexportation of agricultural commodities, medicine, and medical
devices that are not covered by the general licenses in paragraphs
(a)(2) through (4) of this section (as set forth in paragraph
(a)(1)(ii) of this section) to the Government of Iran, to any
individual or entity in Iran, or to persons in third countries
purchasing specifically for resale to any of the foregoing, shall only
be made pursuant to a one-year specific license issued by the Office of
Foreign Assets Control (``OFAC'') for contracts entered into during the
one year period of the license and shipped within the 12-month period
beginning on the date of the signing of the contract. No specific
license will be granted for the exportation or reexportation of the
items set forth in paragraph (a)(1)(ii) of this section to any entity
or individual in Iran promoting international terrorism, to any
individual or entity designated pursuant to Executive Order 12947 (60
FR 5079, 3 CFR, 1995 Comp., p. 356), Executive Order 13224 (66 FR
49079, 3 CFR, 2001 Comp., p. 786), or Public Law 104-132, to any
narcotics trafficking entity designated pursuant to Executive Order
12978 of October 21, 1995 (60 FR 54579, 3 CFR, 1995 Comp., p. 415) or
the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1901-1908), or
to any foreign organization, group, or persons subject to any
restriction for its or their involvement in weapons of mass destruction
or missile proliferation. Executory contracts entered into pursuant to
paragraph (b)(2) of this section prior to the issuance of a one-year
license described in this paragraph shall be deemed to have been signed
on the date of issuance of that one-year license (and, therefore, the
exporter is authorized to make shipments under that contract within the
12-month period beginning on the date of issuance of the one-year
license).
(ii) For the purposes of this part, ``agricultural commodities,
medicine, and medical devices that are not covered by the general
licenses in paragraphs (a)(2) through (4) of this section'' are:
(A) The excluded agricultural commodities specified in paragraph
(a)(2)(ii) of this section;
(B) The excluded medicines specified in paragraph (a)(3)(iii) of
this section;
(C) Medical devices (as defined in paragraph (e)(3) of this
section) other than medical supplies (as defined in paragraph
(a)(3)(ii) of this section); and
(D) Agricultural commodities (as defined in paragraph (e)(1) of
this section), medicine (as defined in paragraph (e)(2) of this
section), and medical supplies (as defined in paragraph (a)(3)(ii) of
this section) to military or law enforcement purchasers or importers.
(2)(i) General license for the exportation or reexportation of
agricultural commodities. Except as provided in paragraphs (a)(2)(ii)
and (iii) of this section, the exportation or reexportation by a
covered person (as defined in paragraph (e)(4) of this section) of
agricultural commodities (as defined in paragraph (e)(1) of this
section) (including bulk agricultural commodities listed in appendix B
to this part) to the Government of Iran, to any individual or entity in
Iran, or to persons in third countries purchasing specifically for
resale to any of the foregoing, and the conduct of related
transactions, including, but not limited to, the making of shipping and
cargo inspection arrangements, the obtaining of insurance, the
arrangement of financing and payment, shipping of the goods, receipt of
payment, and the entry into contracts (including executory contracts),
are hereby authorized, provided that, unless otherwise authorized by
specific license, payment terms and financing for sales pursuant to
this general license are limited to, and consistent with, those
authorized by Sec. 560.532 of this part; and further provided that all
such exports and reexports are shipped within the 12-month period
beginning on the date of the signing of the contract for export or
reexport.
(ii) Excluded agricultural commodities. Paragraph (a)(2)(i) of this
section does not authorize the exportation or reexportation of the
following items: castor beans, castor bean seeds, certified pathogen-
free eggs (unfertilized or fertilized), dried egg albumin, live animals
(excluding live cattle), embryos (excluding cattle embryos), Rosary/
Jequirity peas, non-food-grade gelatin powder, peptones and their
derivatives, super absorbent polymers, western red cedar, or all
fertilizers.
(iii) Excluded persons. Paragraph (a)(2)(i) of this section does
not authorize the exportation or reexportation of agricultural
commodities to military or law enforcement purchasers or importers.
Note to Paragraph (a)(2) of Sec. 560.530: Consistent with
section 906(a)(1) of the Trade Sanctions Reform and Export
Enhancement Act of 2000 (22 U.S.C. 7205), each year OFAC will
determine whether to revoke this general
[[Page 18994]]
license. Unless revoked, the general license will remain in effect.
(3)(i) General license for the exportation or reexportation of
medicine and medical supplies. Except as provided in paragraphs
(a)(3)(iii) and (iv) of this section, the exportation or reexportation
by a covered person (as defined in paragraph (e)(4) of this section) of
medicine (as defined in paragraph (e)(2) of this section) and medical
supplies (as defined in paragraph (a)(3)(ii) of this section) to the
Government of Iran, to any individual or entity in Iran, or to persons
in third countries purchasing specifically for resale to any of the
foregoing, and the conduct of related transactions, including, but not
limited to, the making of shipping and cargo inspection arrangements,
the obtaining of insurance, the arrangement of financing and payment,
shipping of the goods, receipt of payment, and the entry into contracts
(including executory contracts), are hereby authorized, provided that,
unless otherwise authorized by specific license, payment terms and
financing for sales pursuant to this general license are limited to,
and consistent with, those authorized by Sec. 560.532 of this part;
and further provided that all such exports or reexports are shipped
within the 12-month period beginning on the date of the signing of the
contract for export or reexport.
(ii) Definition of medical supplies. For purposes of this general
license, the term medical supplies means those medical devices, as
defined in paragraph (e)(3) of this section, that are included on the
List of Medical Supplies on OFAC's Web site (www.treasury.gov/ofac) on
the Iran Sanctions page.
Note to Paragraph (a)(3)(ii) of Sec. 560.530: The List of
Medical Supplies is maintained on OFAC's Web site (www.treasury.gov/ofac) on the Iran Sanctions page. The list also will be published in
the Federal Register, as will any changes to the list. The List of
Medical Supplies contains those medical devices for which OFAC
previously did not require an Official Commodity Classification of
EAR99 issued by the Department of Commerce's Bureau of Industry and
Security to be submitted with a specific license application and
which are now generally licensed.
(iii) Excluded medicines. Paragraph (a)(3)(i) of this section does
not authorize the exportation or reexportation of the following
medicines: non-NSAID analgesics, cholinergics, anticholinergics,
opioids, narcotics, benzodiazapenes, and bioactive peptides.
(iv) Excluded persons. Paragraph (a)(3)(i) of this section does not
authorize the exportation or reexportation of medicine or medical
supplies to military or law enforcement purchasers or importers.
Note to Paragraph (a)(3) of Sec. 560.530: Consistent with
section 906(a)(1) of the Trade Sanctions Reform and Export
Enhancement Act of 2000 (22 U.S.C. 7205), each year, OFAC will
determine whether to revoke this general license. Unless revoked,
the general license will remain in effect.
(4) General license for the exportation or reexportation of
replacement parts for certain medical devices. (i) The exportation or
reexportation by a covered person (as defined in paragraph (e)(4) of
this section) of replacement parts for medical devices (as defined in
paragraph (e)(3) of this section) exported or reexported pursuant to
paragraphs (a)(1) or (a)(3)(i) of this section to the Government of
Iran, to any individual or entity in Iran, or to persons in third
countries purchasing specifically for resale to any of the foregoing,
and the conduct of related transactions, including, but not limited to,
the making of shipping and cargo inspection arrangements, the obtaining
of insurance, the arrangement of financing and payment, shipping of the
goods, receipt of payment, and the entry into contracts (including
executory contracts), are hereby authorized, provided that, unless
otherwise authorized by specific license, payment terms and financing
for sales pursuant to this general license are limited to, and
consistent with, those authorized by Sec. 560.532 of this part;
provided that such replacement parts are designated as EAR99, or, in
the case of replacement parts that are not subject to the Export
Administration Regulations, 15 CFR parts 730 et seq. (``EAR''), would
be designated as EAR99 if they were located in the United States; and
further provided that such replacement parts are limited to a one-for-
one export or reexport basis (i.e., only one replacement part can be
exported or reexported to replace a broken or non-operational
component).
(ii) Excluded persons. Paragraph (a)(4)(i) of this section does not
authorize the exportation or reexportation of replacement parts for
medical devices to military or law enforcement purchasers or importers.
Note to Paragraph (a)(4) of Sec. 560.530: Consistent with
section 906(a)(1) of the Trade Sanctions Reform and Export
Enhancement Act of 2000 (22 U.S.C. 7205), each year, OFAC will
determine whether to revoke this general license. Unless revoked,
the general license will remain in effect.
(b) General license for arrangement of exportation and
reexportation of covered products that require a specific license. (1)
With respect to sales authorized pursuant to paragraph (a)(1)(i) of
this section, the making of shipping arrangements, cargo inspections,
obtaining of insurance, and arrangement of financing (consistent with
Sec. 560.532) for the exportation or reexportation of agricultural
commodities, medicine, and medical devices that are not covered by the
general licenses in paragraphs (a)(2) through (4) of this section (as
set forth in paragraph (a)(1)(ii) of this section) to the Government of
Iran, to any individual or entity in Iran, or to persons in third
countries purchasing specifically for resale to any of the foregoing,
are authorized.
(2) Entry into executory contracts (including executory pro forma
invoices, agreements in principle, or executory offers capable of
acceptance such as bids in response to public tenders) for the
exportation or reexportation of agricultural commodities, medicine, and
medical devices that are not covered by the general licenses in
paragraphs (a)(2) through (4) of this section (as set forth in
paragraph (a)(1)(ii) of this section) to the Government of Iran, to any
individual or entity in Iran, or to persons in third countries
purchasing specifically for resale to any of the foregoing, is
authorized, provided that the performance of an executory contract is
expressly made contingent upon the prior issuance of a one-year
specific license described in paragraph (a)(1)(i) of this section.
(c) Instructions for obtaining one-year licenses. In order to
obtain the one-year specific license described in paragraph (a)(1)(i)
of this section, the exporter must provide to OFAC:
* * * * *
(4) A description of all items to be exported or reexported
pursuant to the requested one-year license, including a statement that
the items are designated as EAR99, or would be designated as EAR99 if
they were located in the United States, and, if necessary,
documentation sufficient to verify that the items to be exported or
reexported are designated as EAR99, or would be designated as EAR99 if
they were located in the United States, and do not fall within any of
the limitations contained in paragraph (d) of this section; and
(5) For items subject to the EAR, an Official Commodity
Classification of EAR99 issued by the Department of Commerce's Bureau
of Industry and Security (``BIS''), certifying that the product is
designated as EAR99, is
[[Page 18995]]
required to be submitted to OFAC with the request for a license
authorizing the exportation or reexportation of all fertilizers, live
horses, western red cedar, or medical devices other than medical
supplies (as defined in Sec. 560.530(a)(3)(ii)). See 15 CFR 745.3 for
instructions for obtaining an Official Commodity Classification of
EAR99 from BIS.
(d) * * *
(6) Nothing in this section or in any general or specific license
set forth in or issued pursuant to paragraph (a) of this section
authorizes the exportation or reexportation of any agricultural
commodity, medicine, or medical device that is not designated as EAR99
or, in the case of any agricultural commodity, medicine, or medical
device not subject to the EAR, would not be designated as EAR99 if it
were located in the United States.
(e) * * *
(1) * * *
(i) In the case of products subject to the EAR, 15 CFR part 774,
products that are designated as EAR99, and, in the case of products not
subject to the EAR, products that would be designated as EAR99 under
the EAR if they were located in the United States, in each case that
fall within the term ``agricultural commodity'' as defined in section
102 of the Agricultural Trade Act of 1978 (7 U.S.C. 5602); and
(ii) In the case of products subject to the EAR, products that are
designated as EAR99, and in the case of products not subject to the
EAR, products that would be designated as EAR99 if they were located in
the United States, in each case that are intended for ultimate use in
Iran as:
* * * * *
(2) Medicine. For the purposes of this part, medicine is an item
that falls within the definition of the term ``drug'' in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and that, in
the case of an item subject to the EAR, is designated as EAR99 or, in
the case of an item not subject to the EAR, that would be designated as
EAR99, if it were located in the United States.
* * * * *
(3) Medical device. For the purposes of this part, a medical device
is an item that falls within the definition of ``device'' in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and
that, in the case of an item subject to the EAR, is designated as
EAR99, or in the case of an item not subject to the EAR, that would be
designated as EAR99 if it were located in the United States.
(4) Covered person. For purposes of this part, a covered person is,
with respect to the exportation or reexportation of items subject to
the EAR, a U.S. person or a non-U.S. person, and for purposes of items
not subject to the EAR, a U.S. person, wherever located, or an entity
owned or controlled by a U.S. person and established or maintained
outside the United States.
* * * * *
0
4. Amend Sec. 560.533 by revising paragraphs (a) and (b) to read as
follows:
Sec. 560.533 Brokering sales of agricultural commodities, medicine,
and medical devices.
(a) General license for brokering sales by U.S. persons. United
States persons are authorized to provide brokerage services on behalf
of U.S. persons for the sale and exportation or reexportation by U.S.
persons of agricultural commodities, medicine, and medical devices,
provided that the sale and exportation or reexportation is authorized,
as applicable, by a one-year specific license issued pursuant to
paragraph (a)(1)(i) of Sec. 560.530 or by one of the general licenses
set forth in paragraphs (a)(2), (a)(3), and (a)(4) of Sec. 560.530.
(b) Specific licensing for brokering sales by non-U.S. persons of
agricultural commodities. Specific licenses may be issued on a case-by-
case basis to permit U.S. persons to provide brokerage services on
behalf of non-U.S., non-Iranian persons for the sale and exportation or
reexportation of agricultural commodities to the Government of Iran,
entities in Iran, or individuals in Iran. Specific licenses issued
pursuant to this section will authorize the brokering only of sales
that are to purchasers permitted pursuant to Sec. 560.530.
Note To Paragraph (b) of Sec. 560.533: Requests for specific
licenses to provide brokerage services under this paragraph must
include all of the information described in Sec. 560.530(c).
* * * * *
Dated: March 31, 2014.
Adam J. Szubin,
Director, Office of Foreign Assets Control.
[FR Doc. 2014-07572 Filed 4-4-14; 8:45 am]
BILLING CODE P