Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations 58911

conspicuous means in a reasonably

understandable form and readily noticeable

to the consumer. As to type size, disclosures

in 12-point type are deemed to be readily

noticeable for purposes of § 226.5a.

Disclosures printed in less than 12-point type

do not automatically violate the standard;

however, disclosures in less than 8-point

type would likely be too small to satisfy the

standard. Disclosures that are transmitted by

electronic communication are judged for

purposes of the clear and conspicuous

standard based on the form in which they are

provided even though they may be viewed by

the consumer in a different form.

2. Prominent location. i. Generally. Certain

of the required disclosures provided on or

with an application or solicitation must be

prominently located. Disclosures are deemed

to be prominently located, for example, if the

disclosures are on the same page as an

application or solicitation reply form. If the

disclosures appear elsewhere, they are

deemed to be prominently located if the

application or solicitation reply form

contains a clear and conspicuous reference to

the location of the disclosures and indicates

that they contain rate, fee, and other cost

information, as applicable. Disclosures

required by § 226.5a(b) that are placed

outside the table must begin on the same

page as the table but need not end on the

same page.

ii. Electronic disclosures. Electronic

disclosures are deemed to be prominently

located if:

A. They are posted on a web site and the

application or solicitation reply form is

linked to the disclosures in a manner that

prevents the consumer from by-passing the

disclosures before submitting the application

or reply form; or

B. They are located on the same page as an

application or solicitation reply form, that

contains a clear and conspicuous reference to

the location of the disclosures and indicates

that they contain rate, fee, and other cost

information, as applicable.

* * * * *

5a(b) Required Disclosures

5a(b)(1) Annual Percentage Rate

* * * * *

6. Introductory rates—premium rates. If the

initial rate is temporary and is higher than

the permanently applicable rate, the card

issuer must disclose the initial rate in the

table. The initial rate must be in at least 18-

point type unless the issuer also discloses in

the table the permanently applicable rate.

The issuer may disclose in the table the

permanently applicable rate that would

otherwise apply if the issuer also discloses

the time period during which the initial rate

will remain in effect. In that case, the

permanently applicable rate must be in at

least 18-point type.

7. Increased penalty rates. If the initial rate

may increase upon the occurrence of one or

more specific events, such as a late payment

or an extension of credit that exceeds the

credit limit, the card issuer must disclose in

the table the initial rate and the increased

penalty rate that may apply. If the penalty

rate is based on an index and an increased

margin, the issuer must also disclose in the

table the index and the margin as well as the

specific event or events that may result in the

increased rate, such as ‘‘applies to accounts

60 days late.’’ If the penalty rate cannot be

determined at the time disclosures are given,

the issuer must provide an explanation of the

specific event or events that may result in

imposing an increased rate. In describing the

specific event or events that may result in an

increased rate, issuers need not be as detailed

as for the disclosures required under

§ 226.6(a)(2). For issuers using a tabular

format, the specific event or events must be

placed outside the table and an asterisk or

other means shall be used to direct the

consumer to the additional information. At

its option, the issuer may include in the

explanation of the penalty rate the period for

which the increased rate will remain in

effect, such as ‘‘until you make three timely

payments.’’ The issuer need not disclose an

increased rate that is imposed when credit

privileges are permanently terminated.

* * * * *

Appendices G and H—Open-End and

Closed-End Model Forms and Clauses

1. Permissible changes. * * * (But see

Appendix G comment 5 for special rules

concerning certain disclosures required

under § 226.5a for credit and charge card

applications and solicitations). * * *

* * * * *

APPENDIX G—OPEN-END MODEL FORMS

AND CLAUSES

* * * * *

5. Model G–10(A), Sample G–10(B) and

Model G–10(C). i. Model G–10(A) and

Sample G–10(B) illustrate, in the tabular

format, all of the disclosures required under

§ 226.5a for applications and solicitations for

credit cards other than charge cards. Model

G–10(B) is a sample disclosure illustrating an

account with a lower introductory rate and

penalty rate. Model G–10(C) illustrates the

tabular format disclosure for charge card

applications and solicitations and reflects all

of the disclosures in the table.

ii. Except as otherwise permitted,

disclosures must be substantially similar in

sequence and format to model forms G–10(A)

and (C). The disclosures may, however, be

arranged vertically or horizontally and need

not be highlighted aside from being included

in the table. While proper use of the model

forms will be deemed in compliance with the

regulation, card issuers are permitted to use

headings and disclosures other than those in

the forms (with an exception relating to the

use of ‘‘grace period’’) if they are clear and

concise and are substantially similar to the

headings and disclosures contained in model

forms. For further discussion of requirements

relating to form, see the commentary to

§ 226.5a(a)(2).

* * * * *

By order of the Board of Governors of the

Federal Reserve System, September 27, 2000.

Jennifer J. Johnson,

Secretary of the Board.

[FR Doc. 00–25316 Filed 10–2–00; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Parts 742 and 774

[Docket No. 000920265–0265–01]

RIN 0694–AC13

Revisions and Clarifications to the

Commerce Control List; Chemical and

Biological Weapons Controls;

Australia Group

AGENCY: Bureau of Export

Administration, Commerce.

ACTION: Final rule.

SUMMARY: This final rule amends the

Commerce Control List (CCL) of the

Export Administration Regulations to

implement an October 1999 Australia

Group agreement to clarify the scope of

controls on saxitoxin, toxic gas

monitoring systems, and cross-flow

filtration equipment, as well as

clarifying the application of the rule for

mixtures containing Australia Group

(AG) chemicals that are also identified

as Schedule 1 chemicals under the

Chemical Weapons Convention. The

final rule also amends the CCL to

authorize, without a license, exports of

certain medical products containing

botulinum toxin, and certain diagnostic

and food testing kits that contain AGcontrolled toxins. Finally, this final rule

amends the CCL to add titanium carbide

and silicon carbide to the list of

construction materials for heat

exchangers. Restrictions on chemicals

and toxins that are also controlled for

CW (Chemical Weapons Convention)

purposes continue to apply. This rule

will result in an overall decreased

licensing burden on U.S. industry.

EFFECTIVE DATE: This rule is effective:

October 3, 2000.

FOR FURTHER INFORMATION CONTACT:

James Seevaratnam, Director, Chemical

and Biological Controls Division,

Bureau of Export Administration, (202)

501–7900.

SUPPLEMENTARY INFORMATION:

Background

On October 7, 1999, the Bureau of

Export Administration (BXA) published

a final rule amending the Export

Administration Regulations (EAR) to

implement the October 1998 Australia

Group agreement to amend controls on

toxic gas monitoring systems and to

amend the CCL to authorize, without a

license, exports of medical products

containing controlled biological toxins

that are developed, packaged and sold

for medical treatment.

58912 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations

The Australia Group (AG), a

multilateral forum that coordinates

export controls to curtail the

proliferation of chemical and biological

weapons, held its annual consultations

in Paris, October 4–8, 1999. The 30 AG

participating countries agreed to

maintain export controls on a list of

chemicals, biological agents, relevant

equipment and technology that could be

used in the production of chemical or

biological weapons. The AG reviews

items on its control list periodically to

enhance the effectiveness and achieve

greater harmonization of participating

governments’ national controls.

At the October 1999 Australia Group

consultations, participants agreed to

further revise the control list entry for

toxic gas monitoring systems to clarify

the scope of controls. To implement this

agreement, this final rule amends the

Commerce Control List (CCL) of the

Export Administration Regulations

(EAR) by revising Export Control

Classification Number (ECCN) 2B351.

Specifically, this rule clarifies that the

control of toxic gas monitoring systems

under ECCN 2B351 applies only to such

systems that operate on line without any

requirement for human intervention.

The AG agreed that the intent of this

control is to control systems capable of

detecting toxic gases in environments

such as a chemical plant rather than

batch-mode operation equipment that is

normally used in a laboratory. While not

changing the scope of the control in any

way, this rule also clarifies the

description of cross-flow filtration

equipment in ECCN 2B352 by

describing it as cross (tangential) flow

filtration equipment. In an expansion of

controls, the Australia Group agreed to

add titanium carbide and silicon carbide

to the list of materials describing heat

exchangers subject to control in ECCN

2B350.

The Department of Commerce also

maintains controls on exports of

biological agents that could be used in

the production of biological weapons.

These materials require a license under

ECCN 1C351 for export and reexport for

CB (chemical and biological weapons)

reasons to all destinations, except

Canada. These controls are

implemented in accordance with the

export control provisions of the

Australia Group. Note that two

biological agents, ricin and saxitoxin,

classified as ECCN 1C351.d.5 and .d.6,

respectively, are Schedule 1 chemicals

under the Chemical Weapons

Convention and are also controlled for

CW reasons to all destinations,

including Canada.

As agreed by the AG, medical

products that contain the AG-controlled

botulinum toxin that are pharmaceutical

formulations designed for human

administration in the treatment of

medical conditions have broad medical

applications while posing no significant

proliferation concerns. Such products

are controlled under ECCN 1C991 and

may be exported and reexported

without a license to all destinations and

entities, except terrorist supporting

countries (Cuba, Iran, Iraq, Libya, North

Korea, Sudan, Syria) and Serbia, and

except as provided in Parts 736 and 744

of the EAR. This further liberalization of

licensing requirements for the

botulinum toxin does not apply if the

botulinum toxin is to be exported in any

other configuration, including bulk

shipments, or for any other end-uses, in

which case it is still controlled under

ECCN 1C351.

In addition, this final rule further

amends ECCN 1C991 to clarify the

criteria for defining an item containing

botulinum toxin as a medical product

when approved by the Food and Drug

Administration (FDA) for distribution in

interstate commerce as a medical

product. Specifically, the medical

product must be: (1) Pharmaceutical

formulations designed for human

administration in the treatment of

medical conditions; (2) prepackaged for

distribution as medical products; and,

(3) approved by the Food and Drug

Administration to be marketed as

medical products.

Further, this rule removes controls on

certain diagnostic and food testing kits

that contain toxins controlled by the

AG. Specifically, this final rule amends

ECCN 1C991 to include diagnostic and

food testing kits containing AGcontrolled toxins controlled under

ECCN 1C351. Such testing kits may be

exported and reexported without a

license to all destinations and entities,

except to terrorist supporting countries

and Serbia, and except as provided in

Parts 736 and 744 of the EAR, when the

kits are specifically developed,

packaged, and marketed for diagnostic

or public health purposes. Diagnostic

and food testing kits containing CWcontrolled toxins continue to be

controlled under ECCN 1C351 to all

destinations, including Canada.

This rule clarifies that the scope of

AG-controls on saxitoxin under

1C351.d.6 applies only to saxitoxin and

not the entire family of paralytic

shellfish poisons (e.g., neosaxitoxin)

which, other than saxitoxin, are

classified under EAR99. This rule also

clarifies the forms of saxitoxin and ricin

that are controlled for CW reasons under

ECCN 1C351.

Finally, the AG agreed to the

development of a rounding rule for

mixtures that contain trace and

unintended quantities of AG-controlled

chemicals that are also on CWC

Schedule 1 listed in ECCN 1C350. The

United States is providing a ‘‘round to

zero’’ rule for Schedule 1 chemicals

similar to that agreed by the AG. This

rule, currently set forth in section 712.1

of the Chemical Weapons Convention

Regulations, is now added to the note

under 1C350 on mixtures. The licensing

requirements do not apply to mixtures

containing less than 0.5% aggregate

quantities of Schedule 1 chemicals as

unavoidable by-products or impurities,

and the Schedule 1 chemicals are not

intentionally produced or added.

Exporters are reminded that although

license requirements have been

removed for shipments of the medical

products and test kits for CB reasons as

described above, these items continue to

require a license under 1C991 for export

or reexport to terrorist supporting and

embargoed destinations and entities.

Exporters may also need to consult with

the Department of the Treasury’s Office

of Foreign Assets Control, which

administers economic sanctions against

certain countries and entities, including

the Taliban controlled areas of

Afghanistan.

Although the EAA expired on August

20, 1994, the President invoked the

International Emergency Economic

Powers Act and continued in effect the

Export Administration Regulations and,

to the extent permitted by law, the

provisions of the EAA in Executive

Order 12924 of August 19, 1994, as

extended by the President’s notices of

August 15, 1995 (60 FR 42767), August

14, 1996 (61 FR 42527), August 13, 1997

(62 FR 43629), August 13, 1998 (63 FR

44121), August 10, 1999 (64 FR 44101)

and August 8, 2000 (65 FR 48347).

Rulemaking Requirements

1. This final rule has been determined

to be not significant for purposes of

Executive Order 12866.

2. Notwithstanding any other

provision of law, no person is required

to respond to, nor shall any person be

subject to a penalty for failure to comply

with a collection of information, subject

to the requirements of the Paperwork

Reduction Act, unless that collection of

information displays a currently valid

Office of Management and Budget

Control Number. This rule involves a

collection of information subject to the

Paperwork Reduction Act of 1980 (44

U.S.C. 3501 et seq.). This collection has

been approved by the Office of

Management and Budget under control

numbers 0694–0088, ‘‘Multi-Purpose

Application,’’ which carries a burden

hour estimate of 45 minutes for a

Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations 58913

manual submission and 40 minutes for

an electronic submission.

3. This rule does not contain policies

with Federalism implications sufficient

to warrant preparation of a Federalism

assessment under Executive Order

13132.

4. The provisions of the

Administrative Procedure Act (5 U.S.C.

553) requiring notice of proposed

rulemaking, the opportunity for public

participation, and a delay in effective

date, are inapplicable because this

regulation involves a military and

foreign affairs function of the United

States (5 U.S.C. 553(a)(1)). Further, no

other law requires that a notice of

proposed rulemaking and an

opportunity for public comment be

given for this final rule. Because a

notice of proposed rulemaking and an

opportunity for public comment are not

required to be given for this rule under

the Administrative Procedure Act or by

any other law, the analytical

requirements of the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.) are

not applicable. Therefore, this

regulation is issued in final form.

Although there is no formal comment

period, public comments on this

regulation are welcome on a continuing

basis. Comments should be submitted to

Kirsten Mortimer, Office of Exporter

Services, Bureau of Export

Administration, Department of

Commerce, P.O. Box 273, Washington,

DC 20044.

List of Subjects in 15 CFR Parts 742 and

774

Exports, foreign trade.

Accordingly, 15 CFR Chapter 7,

Subchapter C, is amended as follows:

1. The authority citation for 15 CFR

part 742 is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50

U.S.C. 1701 et seq.; 18 U.S.C. 2510 et seq.;

22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; E.O.

12058, 43 FR 20947, 3 CFR, 1978 Comp., p.

179; E.O. 12851, 58 FR 33181, 3 CFR, 1993

Comp., p. 608; E.O. 12924, 59 FR 43437, 3

CFR, 1994 Comp., p. 917; E.O. 12938, 59 FR

59099, 3 CFR, 1994 Comp., p. 950; E.O.

13026, 61 FR 58767, 3 CFR, 1996 Comp., p.

228; Notice of November 12, 1998, 63 FR

63589, 3 CFR, 1998 Comp., p. 305; Notice of

August 3, 2000 (65 FR 48347, August 8,

2000).

2. The authority citation for 15 CFR

part 774 is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.

7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C.

287c, 22 U.S.C. 3201 et seq., 22 U.S.C. 6004;

30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42

U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app.

466c; 50 U.S.C. app. 5; E.O. 12924, 59 FR

43437, 3 CFR, 1994 Comp., p. 917; E.O.

13026, 61 FR 58767, 3 CFR, 1996 Comp., p.

228; Notice of August 3, 2000 (65 FR 48347,

August 8, 2000).

PART 742—[AMENDED]

3. Section 742.18 is amended by

revising paragraph (a)(1) as follows:

§ 742.18 Chemical Weapons Convention

(CWC or Convention)

* * * * *

(a) * * *

(1) Schedule 1 chemicals identified in

ECCNs 1C350 and 1C351. A license is

required for CW reasons for exports and

reexports of Schedule 1 chemicals

identified under ECCN 1C350.a.20, a.24,

and a.31 and ECCN 1C351.d.5 and d.6

to all destinations including Canada.

CW applies to 1C351.d.5 for ricin in the

form of Ricinus Communis Agglutinin II

(RCA II), also known as ricin D or

Ricinus Communis Lectin III (RCL III);

and Ricinus Communis Lectin IV

(RCL IV), also known as ricin E. CW

applies to 1C351.d.6 for saxitoxin

identified by C.A.S. #35523–89–8. Also

see the advance notification procedures

and annual reporting requirements

described in § 745.1 of the EAR.

* * * * *

PART 774—[AMENDED]

4. In Supplement No. 1 to part 774

(the Commerce Control List), Category

1—Materials, Chemicals,

‘‘Microorganisms,’’ and ‘‘Toxins’’,

Export Control Classification Numbers

(ECCNs) are amended:

a. By revising the License

Requirements section for ECCN 1C350;

b. By revising ECCN 1C351; and

c. By revising ECCN 1C991, as

follows:

1C350 Chemicals, that may be used as

precursors for toxic chemical agents.

License Requirements

Reason for Control: CB, CW, AT

Control(s) Country chart

CB applies to entire entry .. CB Column 2

CW applies to 1C350.a.2, a.3, a.5, a.6,

a.7, a.8, a.10, a.11, a.12, a.13, a.15, a.16,

a.17, a.20, a.21, a.22, a.23, a.24, a.28,

a.29, a.30, a.31, a.32, a.33, a.35, a.37,

a.41, a.47, a.48, a.49, a.50, a.51, a.53, or

a.54. For 1C350.a.20, a.24 and a.31, a

license is required for CW reasons for all

destinations, including Canada. For all

other chemicals controlled for CW

reasons, a license is a required for

export to countries not listed in

Supplement No. 2 to part 745, except for

Schedule 3 chemicals which do not

require a license for CW reasons if an

End-Use Certificate has been obtained

from the government of the importing

country. See § 742.18 of the EAR. Also,

see § 745.2 of the EAR for End-Use

Certificate requirements. The Commerce

Country Chart is not designed to

determine licensing requirements for

items controlled for CW reasons.

AT applies to entire entry ..... AT Column

1

License Requirement Notes:

1. SAMPLE SHIPMENTS: Certain

sample shipments of chemicals

controlled under ECCN 1C350 may be

made without a license, as provided by

the following:

a. Chemicals Not Eligible: No CWC

Schedule 1 chemical is eligible for

sample shipment without a license.

Therefore, the following chemicals are

not eligible for sample shipments: 0-

Ethyl-2-diisopropylaminoethyl

methylphosphonite (QL) (C.A.S.

#57856–11–8), Ethylphosphonyl

difluoride (C.A.S. #753–98–0), and

Methylphosphonyl difluoride (C.A.S.

#676–99–3).

b. Countries Not Eligible: The

following countries are not eligible to

receive any sample shipments: Cuba,

Iran, Iraq, Libya, North Korea, Sudan,

Syria.

c. Sample Shipments: A license is not

required for sample shipments when the

cumulative total of these shipments

does not exceed a 55-gallon container or

200 kg of each chemical to any one

consignee per calendar year. Multiple

sample shipments, in any quantity, not

exceeding the totals indicated in this

paragraph may be exported without a

license, in accordance with the

provisions of this Note 1. A consignee

that receives a sample shipment under

this exclusion may not resell, transfer,

or reexport the sample shipment, but

may use the sample shipment for any

other legal purpose unrelated to

chemical weapons. However, a sample

shipment exported and received under

this exclusion remains subject to all

General Prohibitions including the enduse restriction described in § 744.4 of

the EAR. Sample shipments of

chemicals included in CWC Schedule 2

and controlled for CW reasons to nonCWC States Parties (destinations not

listed in Supplement No. 2 to part 745

of the EAR) may not be made without

a license. Sample shipments of

chemicals listed in Schedule 3 and

controlled for CW reasons to non-States

Parties may not be made without first

obtaining an End-Use Certificate, as

described in § 745.2 of the EAR. If no

End-Use Certificate is obtained pursuant

to § 745.2 of the EAR, a license is

required for sample shipments to nonVerDate 11<MAY>2000 17:36 Oct 02, 2000 Jkt 194001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\03OCR1.SGM pfrm04 PsN: 03OCR1
58914 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations

CWC States Parties of Schedule 3

chemicals controlled under ECCN

1C350 for CW reasons.

d. The exporter is required to submit

a quarterly written report for shipments

of samples made under this Note 1. The

report must be on company letterhead

stationery (titled ‘‘Report of Sample

Shipments of Chemical Precursors’’ at

the top of the first page) and identify the

chemical(s), Chemical Abstract Service

Registry (C.A.S.) number(s),

quantity(ies), the ultimate consignee’s

name and address, and the date

exported. The report must be sent to the

U.S. Department of Commerce, Bureau

of Export Administration, P.O. Box 273,

Washington, DC 20044, Attn: ‘‘Report of

Sample Shipments of Chemical

Precursors’’.

2. MIXTURES: Mixtures controlled by

this entry that contain certain

concentrations of precursor and

intermediate chemicals are subject to

the following licensing requirements:

a. A license is required, regardless of

the concentrations in the mixture, for

the following chemicals: 0-Ethyl-2-

diisopropylaminoethyl

methylphosphonite (QL)

(C.A.S.#57856–11–8),

Ethylphosphonyl difluoride

(C.A.S.#753–98–0) and

Methylphosphonyl difluoride

(C.A.S.#676–99–3), unless the

mixture contains less than 0.5%

aggregate quantities of Schedule 1

chemicals as unavoidable by-products

or impurities, and the Schedule 1

chemicals are not intentionally

produced or added.

b. A license is required when at least

one of the following chemicals

constitutes more than 10 percent of the

weight of the mixture: Arsenic

trichloride (C.A.S.#7784–34–1),

Benzilic acid (C.A.S.#76–93–7),

Diethyl ethylphosphonate

(C.A.S.#78–38–6), Diethyl

methylphosphonite

(C.A.S.#15715–41–0),Diethyl-N,Ndimethylphosphoroamidate

(C.A.S.#2404–03–7), N,NDiisopropyl-beta-aminoethane thiol

(C.A.S.#5842–07–9), N,NDiisopropyl-2-aminoethyl chloride

hydrochloride (C.A.S.#4261–68–

1), N,N-Diisopropyl-beta-aminoethanol

(C.A.S.#96–80–0), N,NDiisopropyl-beta-aminoethyl chloride

(C.A.S.#96–79–7), Dimethyl

ethylphosphonate (C.A.S.#6163–

75–3), Dimethyl methylphosphonate

(C.A.S.#756–79–6),

Ethylphosphonous dichloride

[Ethylphosphinyl dichloride]

(C.A.S.#1498–40–4),

Ethylphosphonus difluoride

[Ethylphosphinyl difluoride]

(C.A.S.#430–78–4),

Ethylphosphonyl dichloride

(C.A.S.#1066–50–8),

Methylphosphonous dichloride

[Methylphosphinyl dichloride]

(C.A.S.#676–83–5),

Methylphosphonous difluoride

[Methylphosphinyl difluoride]

(C.A.S.#753–59–3),

Methylphosphonyl dichloride

(C.A.S.#676–97–1), Pinacolyl

alcohol (C.A.S.#464–07–3), 3-

Quinuclidinol (C.A.S.#1619–34–

7), and Thiodiglycol (C.A.S.#111–

48–8) (Related ECCN: 1C995);

c. A license is required when at least

one of all other chemicals in the List of

Items Controlled under ECCN 1C350

constitutes more than 25 percent of the

weight of the mixture (related ECCN:

1C995); and

d. A license is not required under this

entry for mixtures when the controlled

chemical is a normal ingredient in

consumer goods packaged for retail sale

for personal use. Such consumer goods

are classified as EAR99.

Note to Mixtures: Calculation of

concentrations of AG-controlled

chemicals:

a. Exclusion. No chemical may be

added to the mixture (solution) for the

sole purpose of circumventing the

Export Administration Regulations;

b. Absolute Weight Calculation. When

calculating the percentage, by weight, of

components in a chemical mixture,

include all components of the mixture,

including those that act as solvents;

c. Example.

11% chemical listed in paragraph b. of

Note 2.

39% chemical not listed in Note 2

50% Solvent

100% Mixture

11/100=11% chemical listed in

paragraph b. of Note 2.

In this example, a license is required

because a chemical listed in paragraph

b. of Note 2 constitutes more than 10

percent of the weight of the mixture.

3. COMPOUNDS. A license is not

required under this entry for chemical

compounds created with any chemicals

identified in this entry, unless those

compounds are also identified in this

entry.

Technical Notes: 1. For purposes of

this entry, a ‘‘mixture’’ is defined as a

solid, liquid or gaseous product made

up of two or more components that do

not react together under normal storage

conditions.

2. The scope of this control applicable

to Hydrogen Fluoride (Item 25 in List of

Items Controlled) includes its liquid,

gaseous, and aqueous phases, and

hydrates.

LIST OF ITEMS CONTROLLED

* * * * *

1C351 Human pathogens, zoonoses, and

‘‘toxins’’, as follows (see List of Items

Controlled).

License Requirements

Reason for Control: CB, CW, AT

Control(s) Country chart

CB applies to entire entry .. CB Column 1

CW applies to 1C351.d.5 and d.6 and

a license is required for CW reasons for

all destinations, including Canada, as

follows: CW applies to 1C351.d.5 for

ricin in the form of (1) Ricinus

Communis AgglutininII (RCAII), also

known as ricin D or Ricinus Communis

LectinIII (RCLIII); and (2) Ricinus

Communis LectinIV (RCLIV), also known

as ricin E. CW applies to 1C351d.6 for

saxitoxin identified by C.A.S. #35523–

89–8. See § 742.18 of the EAR for

licensing information pertaining to

chemicals subject to restriction pursuant

to the Chemical Weapons Convention

(CWC). The Commerce Country Chart is

not designed to determine licensing

requirements for items controlled for

CW reasons.

AT applies to entire

entry.

AT Column 1

License Exceptions

LVS: N/A

GBS: N/A

CIV: N/A

List of Items Controlled

Unit: $ value.

Related Controls: Certain forms of

ricin and saxitoxin in 1C351.d.5. and

d.6 are CWC Schedule 1 chemicals (see

§ 742.18 of the EAR). The U.S.

Government must provide advance

notification and annual reports to the

OPCW of all exports of Schedule 1

chemicals. See § 745.1 of the EAR for

notification procedures. See 22 CFR part

121, Category XIV and § 121.7 for

additional CWC Schedule 1 chemicals

controlled by the Department of State.

All vaccines and ‘‘immunotoxins’’ are

excluded from the scope of this entry.

Certain medical products and diagnostic

and food testing kits that contain

biological toxins controlled under

paragraph (d) of this entry, with the

exception of toxins controlled for CW

reasons under d.5 and d.6, are excluded

from the scope of this entry. Vaccines,

‘‘immunotoxins’’, certain medical

products, and diagnostic and food

testing kits excluded from the scope of

this entry are controlled under ECCN

1C991. For the purposes of this entry,

only saxitoxin is controlled under

Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations 58915

paragraph d.6; other members of the

paralytic shellfish poison family (e.g.

neosaxitoxin) are classified as EAR99.

Related Definitions:(1) For the

purposes of this entry ‘‘immunotoxin’’

is defined as an antibody-toxin

conjugate intended to destroy specific

target cells (e.g., tumor cells) that bear

antigens homologous to the antibody.

(2) For the purposes of this entry

‘‘subunit’’ is defined as a portion of the

‘‘toxin’’.

Items:

a. Viruses, as follows:

a.1. Chikungunya virus;

a.2. Congo-Crimean haemorrhagic

fever virus;

a.3. Dengue fever virus;

a.4. Eastern equine encephalitis virus;

a.5. Ebola virus;

a.6. Hantaan virus;

a.7. Japanese encephalitis virus;

a.8. Junin virus;

a.9. Lassa fever virus

a.10. Lymphocytic choriomeningitis

virus;

a.11. Machupo virus;

a.12. Marburg virus;

a.13. Monkey pox virus;

a.14. Rift Valley fever virus;

a.15. Tick-borne encephalitis virus

(Russian Spring-Summer encephalitis

virus);

a.16. Variola virus;

a.17. Venezuelan equine encephalitis

virus;

a.18. Western equine encephalitis

virus;

a.19. White pox; or

a.20. Yellow fever virus.

b. Rickettsiae, as follows:

b.1. Bartonella quintana (Rochalimea

quintana, Rickettsia quintana);

b.2. Coxiella burnetii;

b.3. Rickettsia prowasecki; or

b.4. Rickettsia rickettsii.

c. Bacteria, as follows:

c.1. Bacillus anthracis;

c.2. Brucella abortus;

c.3. Brucella melitensis;

c.4. Brucella suis;

c.5. Burkholderia mallei

(Pseudomonas mallei);

c.6. Burkholderia pseudomallei

(Pseudomonas pseudomallei);

c.7. Chlamydia psittaci;

c.8. Clostridium botulinum;

c.9. Francisella tularensis;

c.10. Salmonella typhi;

c.11. Shigella dysenteriae;

c.12. Vibrio cholerae;

c.13. Yersinia pestis.

d. ‘‘Toxins’’, as follows: and

‘‘subunits’’ thereof:

d.1. Botulinum toxins;

d.2. Clostridium perfringens toxins;

d.3. Conotoxin;

d.4. Microcystin (cyanginosin);

d.5. Ricin;

d.6. Saxitoxin;

d.7. Shiga toxin;

d.8. Staphylococcus aureus toxins;

d.9. Tetrodotoxin;

d.10. Verotoxin; or

d.11. Aflatoxins.

1C991 Vaccines, immunotoxins, medical

products, diagnostic and food testing kits,

as follows (see List of Items controlled).

License Requirements

Reason for Control: CB, AT.

Control(s) Country Chart

CB applies to 1C991.d ...... CB Column 3

AT applies to entire entry .. AT Column 1

License Exceptions

LVS: N/A

GBS: N/A

CIV: N/A

List of Items Controlled

Unit: $ value.

Related Controls: Medical products

containing ricin in the form of (1)

Ricinus Communis AgglutininII (RCAII),

also known as ricin D or Ricinus

Communis LectinIII (RCLIII); and (2)

Ricinus Communis LectinIV (RCLIV),

also known as ricin E; and saxitoxin

identified by C.A.S. #35523–89–8, are

controlled for CW reasons under 1C351.

Related Definitions: For the purpose

of this entry ‘‘immunotoxin’’ is defined

as an antibody-toxin conjugate intended

to destroy specific target cells (e.g.,

tumor cells) that bear antigens

homologous to the antibody. For the

purpose of this entry ‘‘medical

products’’ are: (1) Pharmaceutical

formulations designed for human

administration in the treatment of

medical conditions; (2) prepackaged for

distribution as medical products; and,

(3) approved by the Food and Drug

Administration to be marketed as

medical products. For the purpose of

this entry, ‘‘diagnostic and food testing

kits’’ are specifically developed,

packaged and marketed for diagnostic or

public health purposes. Biological

toxins in any other configuration,

including bulk shipments, or for any

other end-uses are controlled by ECCN

1C351.

Items:

a. Vaccines containing items

controlled by ECCNs 1C351, 1C352,

1C353 and 1C354;

b. Immunotoxins;

c. Medical products containing

botulinum toxins controlled by ECCN

1C351.d.1;

d. Medical products containing

biological toxins controlled by ECCN

1C351.d.2 through d.11, except

biological toxins controlled for CW

reasons under 1C351.d.5 and d.6; and

e. Diagnostic and food testing kits

containing biological toxins controlled

by ECCN 1C351.d, except biological

toxins controlled for CW reasons under

ECCN 1C351.d.5 and d.6.

5. In Supplement No. 1 to part 774

(the Commerce Control List), Category

2—Materials Processing, Export Control

Classification Numbers (ECCNs) are

amended:

a. By revising the List of Items

Controlled section for 2B350;

b. By revising the entry heading and

List of Items Controlled section for

ECCN 2B351; and

c. By revising the List of Items

Controlled section for ECCN 2B352, as

follows:

2B350 Chemical manufacturing facilities

and equipment, as follows (see List of Items

Controlled).

* * * * *

List of Items Controlled

Unit: Equipment in number.

Related Controls: The controls in this

entry do not apply to equipment that is:

(a) specially designed for use in civil

applications (e.g., food processing, pulp

and paper processing, or water

purification); AND (b) inappropriate, by

the nature of its design, for use in

storing, processing, producing or

conducting and controlling the flow of

chemical weapons precursors controlled

by 1C350.

Related Definitions: For purposes of

this entry the term ‘‘chemical warfare

agents’’ are those agents subject to the

export licensing authority of the U.S.

Department of State, Office of Defense

Trade Controls. (See 22 CFR part 121)

Items:

a. Reaction vessels or reactors, with or

without agitators, with total internal

(geometric) volume greater than 0.1 m 3

(100 liters) and less than 20 m 3 (20,000

liters), where all surfaces that come in

direct contact with the chemical(s)

being processed or contained are made

from any of the following materials:

a.1. Alloys with more than 25%

nickel and 20% chromium by weight;

a.2. Fluoropolymers;

a.3. Glass (including vitrified or

enamelled coating or glass lining);

a.4. Nickel or alloys with more than

40% nickel by weight;

a.5. Tantalum or tantalum alloys;

a.6. Titanium or titanium alloys; or

a.7. Zirconium or zirconium alloys;

b. Agitators for use in reaction vessels

or reactors where all surfaces of the

agitator that come in direct contact with

the chemical(s) being processed or

contained are made from any of the

following materials:

58916 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations

b.1. Alloys with more than 25%

nickel and 20% chromium by weight;

b.2. Fluoropolymers;

b.3. Glass (including vitrified or

enamelled coatings or glass lining);

b.4. Nickel or alloys with more than

40% nickel by weight;

b.5. Tantalum or tantalum alloys;

b.6. Titanium or titanium alloys; or

b.7. Zirconium or zirconium alloys;

c. Storage tanks, containers or

receivers with a total internal

(geometric) volume greater than 0.1 m3

(100 liters) where all surfaces that come

in direct contact with the chemical(s)

being processed or contained are made

from any of the following materials:

c.1. Alloys with more than 25%

nickel and 20% chromium by weight;

c.2. Fluoropolymers;

c.3. Glass (including vitrified or

enamelled coatings or glass lining);

c.4. Nickel or alloys with more than

40% nickel by weight;

c.5. Tantalum or tantalum alloys;

c.6. Titanium or titanium alloys; or

c.7. Zirconium or zirconium alloys;

d. Heat exchangers or condensers

with a heat transfer surface area of less

than 20 m2, where all surfaces that come

in direct contact with the chemical(s)

being processed are made from any of

the following materials:

d.1. Alloys with more than 25%

nickel and 20% chromium by weight;

d.2. Fluoropolymers;

d.3. Glass (including vitrified or

enamelled coatings or glass lining);

d.4. Graphite;

d.5. Nickel or alloys with more than

40% nickel by weight;

d.6. Silicon carbide;

d.7. Tantalum or tantalum alloys;

d.8. Titanium or titanium alloys;

d.9. Titanium carbide; or

d.10. Zirconium or zirconium alloys

e. Distillation or absorption columns

of internal diameter greater than 0.1 m,

where all surfaces that come in direct

contact with the chemical(s) being

processed are made from any of the

following materials:

e.1. Alloys with more than 25%

nickel and 20% chromium by weight;

e.2. Fluoropolymers;

e.3. Glass (including vitrified or

enamelled coatings or glass lining);

e.4. Graphite;

e.5. Nickel or alloys with more than

40% nickel by weight;

e.6. Tantalum or tantalum alloys;

e.7. Titanium or titanium alloys; or

e.8. Zirconium or zirconium alloys;

f. Remotely operated filling

equipment in which all surfaces that

come in direct contact with the

chemical(s) being processed are made

from any of the following materials:

f.1. Alloys with more than 25% nickel

and 20% chromium by weight; or

f.2. Nickel or alloys with more than

40% nickel by weight;

g. Multiple seal valves incorporating a

leak detection port, bellows-seal valves,

non-return (check) valves or diaphragm

valves, in which all surfaces that come

into direct contact with the chemical(s)

being processed or contained are made

from any of the following materials:

g.1. Alloys with more than 25%

nickel and 20% chromium by weight;

g.2. Fluoropolymers;

g.3. Glass (including vitrified or

enamelled coatings or glass lining);

g.4. Nickel or alloys with more than

40% nickel by weight;

g.5. Tantalum or tantalum alloys;

g.6. Titanium or titanium alloys; or

g.7. Zirconium or zirconium alloys;

h. Multi-walled piping incorporating

a leak detection port, in which all

surfaces that come in direct contact with

the chemical(s) being processed or

contained are made from any of the

following materials:

h.1. Alloys with more than 25%

nickel and 20% chromium by weight;

h.2. Fluoropolymers;

h.3. Glass (including vitrified or

enamelled coatings or glass lining);

h.4. Graphite;

h.5. Nickel or alloys with more than

40% nickel by weight;

h.6. Tantalum or tantalum alloys;

h.7. Titanium or titanium alloys; or

h.8. Zirconium or zirconium alloys;

i. Multiple-seal, canned drive,

magnetic drive, bellows or diaphragm

pumps, with manufacturer’s specified

maximum flow-rate greater than 0.6 m3/

hour, or vacuum pumps with

manufacturer’s specified maximum

flow-rate greater than 5 m3/hour (under

standard temperature (273 K (0° C)) and

pressure (101.3 kPa) conditions), in

which all surfaces that come into direct

contact with the chemical(s) being

processed are made from any of the of

the following materials:

i.1. Alloys with more than 25% nickel

and 20% chromium by weight;

i.2. Ceramics;

i.3. Ferrosilicon;

i.4. Fluoropolymers;

i.5. Glass (including vitrified or

enamelled coatings or glass lining);

i.6. Graphite;

i.7. Nickel or alloys with more than

40% nickel by weight;

i.8. Tantalum or tantalum alloys;

i.9. Titanium or titanium alloys, or

i.10. Zirconium or zirconium alloys;

j. Incinerators designed to destroy

chemical warfare agents, or chemical

weapons precursors controlled by

1C350, having specially designed waste

supply systems, special handling

facilities and an average combustion

chamber temperature greater than 1000°

C in which all surfaces in the waste

supply system that come into direct

contact with the waste products are

made from or lined with any of the

following materials:

j.1. Alloys with more than 25% nickel

and 20% chromium by weight;

j.2. Ceramics; or

j.3. Nickel or alloys with more than

40% nickel by weight.

2B351 Toxic gas monitoring systems that

operate on-line and dedicated detectors

therefor.

* * * * *

List of Items Controlled

Unit: Equipment in number.

Related Controls: N/A.

Related Definitions: For the purposes

of this entry, the term ‘‘continuous

operation’’ describes the capability of

the equipment to operate on line

without human intervention. The intent

of this entry is to control toxic gas

monitoring systems capable of

collection and detection of samples in

environments such as chemical plants,

rather than those used for batch-mode

operation in laboratories.

Items:

a. Designed for continuous operation

and usable for the detection of chemical

warfare agents or chemicals controlled

by 1C350 at concentrations of less than

0.3mg/m3 (see technical note below); or

b. Designed for the detection of

cholinesterase-inhibiting activity.

Technical Note: Toxic Gas Monitoring

Systems, controlled under 2B351.a., include

those with detection capability for chemicals

containing phosphorus, sulfur, fluorine or

chlorine, other than those specified in 1C350.

2B352 Equipment capable of use in

handling biological materials, as follows

(see List of Items Controlled).

* * * * *

List of Items Controlled

Unit: Equipment in number.

Related Controls: N/A.

Related Definitions: For purposes of

this entry, isolators include flexible

isolators, dry boxes, anaerobic chambers

and glove boxes.

Items:

a. Complete containment facilities at

P3 or P4 containment level;

Technical Note: P3 or P4 (BL3, BL4, L3,

L4) containment levels are as specified in the

WHO Laboratory Biosafety Manual (Geneva,

1983).

b. Fermenters capable of cultivation of

pathogenic microorganisms, viruses, or

for toxin production, without the

propagation of aerosols, having a

capacity equal to or greater than 100

liters.

Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations 58917

1 In its original health claim evaluation, FDA used

the term ‘‘folic acid’’ to describe this B vitamin.

Later, the agency decided that the broader term

‘‘folate’’ was more scientifically accurate because

that term encompasses both synthetic and naturally

occurring forms of the vitamin, whereas folic acid

refers only to the synthetic form (see 58 FR 53254

at 53257 through 53258 and 53280, October 14,

1993). Accordingly, this rule uses the term ‘‘folate.’’

The two terms may be used interchangeably in food

labeling.

2Neural tube defects are birth defects of the brain

or spinal cord. Spina bifida and anencephaly are

the most common types of neural tube defects.

Technical Note: Fermenters include

bioreactors, chemostats, and continuous-flow

systems.

c. Centrifugal separators capable of

the continuous separation of pathogenic

microorganisms, without the

propagation of aerosols, and having all

of the following characteristics:

c.1. A flow rate greater than 100 liters

per hour;

c.2. Components of polished stainless

steel or titanium;

c.3. Double or multiple sealing joints

within the steam containment area; and

c.4. Capable of in situ steam

sterilization in a closed state.

Technical Note: Centrifugal separators

include decanters.

d. Cross (tangential) flow filtration

equipment capable of continuous

separation of pathogenic

microorganisms, viruses, toxins, and

cell cultures without the propagation of

aerosols, having all of the following

characteristics:

d.1. Equal to or greater than 5 square

meters;

d.2. Capable of in situ sterilization.

e. Steam sterilizable freeze-drying

equipment with a condenser capacity

greater than 50 kgs of ice in 24 hours but

less than 1,000 kgs;

f. Equipment that incorporates or is

contained in P3 or P4 containment

housing, as follows:

f.1. Independently ventilated

protective full or half suits;

f.2. Class III biological safety cabinets

or isolators with similar performance

standards;

g. Chambers designed for aerosol

challenge testing with microorganisms,

viruses, or toxins and having a capacity

of 1 m3 or greater.

Dated: September 22, 2000.

R. Roger Majak,

Assistant Secretary for Export

Administration.

[FR Doc. 00–25068 Filed 10–2–00; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 91N–0101, 91N–0098, 91N–

0103, and 91N–100H]

RIN 0910–AA19

Food Labeling: Health Claims and

Labeling Statements; Dietary Fiber and

Cancer; Antioxidant Vitamins and

Cancer; Omega-3 Fatty Acids and

Coronary Heart Disease; Folate and

Neural Tube Defects; Revocation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking its

regulations codifying the agency’s

decision not to authorize the use of

health claims for four substance-disease

relationships in the labeling of foods,

including dietary supplements: Dietary

fiber and cancer, antioxidant vitamins

and cancer, omega-3 fatty acids and

coronary heart disease, and the claim

that 0.8 milligram (mg) of folate in

dietary supplement form is more

effective in reducing the risk of neural

tube defects than a lower amount in

conventional food. This action is being

taken in response to a decision of the

U.S. Court of Appeals for the D.C.

Circuit invalidating these regulations

and directing FDA to reconsider

whether to authorize the four health

claims. This action will result in the

removal of the regulations but does not

constitute FDA authorization of the four

claims. FDA is completing its

reconsideration of the claims and

expects to issue decisions on all four

claims by October 10, 2000.

DATES: This rule is effective October 3,

2000.

FOR FURTHER INFORMATION CONTACT:

James E. Hoadley, Center for Food

Safety and Applied Nutrition (HFS–

832), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–5429.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 6,

1993, FDA issued final rules

announcing its decision not to authorize

the use of health claims for four

substance-disease relationships in the

labeling of conventional foods. (See 58

FR 2537 (dietary fiber and cancer); 58

FR 2622 (antioxidant vitamins and

cancer); 58 FR 2682 (omega-3 fatty acids

and coronary heart disease); and 58 FR

2606 (folic acid 1 and neural tube

defects2)). Soon after, FDA proposed in

the Federal Register of October 14, 1993

(58 FR 53296), not to authorize use of

three of the four claims in the labeling

of dietary supplements. In October

1993, after further review of evidence on

the relationship between folate and

reduced risk of neural tube defects, FDA

proposed to authorize a health claim for

this relationship (58 FR 53254, October

14, 1993); however, the agency

proposed not to allow such claims to

include a statement that folate from one

source is more effective in reducing the

risk of neural tube defects than folate

from another source. Both proposals

became final by operation of law on

December 31, 1993. (See 59 FR 395,

January 4, 1994 (dietary fiber and

cancer, antioxidant vitamins and cancer,

and omega-3 fatty acids and coronary

heart disease); 59 FR 433, January 4,

1994 (folate and neural tube defects).)

FDA’s decisions not to authorize these

four claims are codified in § 101.71(a)

(21 CFR 101.71(a)) (dietary fiber and

cancer); § 101.71(c) (antioxidant

vitamins and cancer); § 101.71(e)

(omega-3 fatty acids and coronary heart

disease); and § 101.79(c)(2)(i)(G) (21

CFR 101.79(c)(2)(i)(G)) (claims

comparing effectiveness of folate from

different sources).

Several dietary supplement marketers

and nonprofit organizations that had

submitted comments during FDA’s

health claims rulemakings filed suit in

Federal district court on constitutional

and statutory grounds seeking, among

other things, authorization to make the

following health claims for use in the

labeling of dietary supplements:

‘‘Consumption of fiber may reduce the

risk of colorectal cancer,’’

‘‘Consumption of antioxidant vitamins

may reduce the risk of certain kinds of

cancer,’’ ‘‘Consumption of omega-3 fatty

acids may reduce the risk of coronary

heart disease,’’ and ‘‘0.8 mg of folic acid

in a dietary supplement is more

effective in reducing the risk of neural

tube defects than a lower amount in

foods in common form.’’ The district

court ruled for FDA in all respects