DEPARTMENT OF HEALTH & HUMAN SERVlCES Public Health Serv~ce 

Fwd and Drug Administration 

Rockville MD 20857 

TO: All Foreign Hanufacturers and Importers of Electronic 

Products for Which Applicable FIX Performance Standards 

Exist 

F'E4 district offices handle the day-to-day responsibilities for 

control of the imprtation of electronic products to which E'DA 

radiation performance standards apply. Before these producl can 

be permitted to enter the U.S., manufacturers and impxters are 

required to suit with each shipment certain required entry 

papers through the District Director, U.S. Gustorns Service to the 

appropriate FDA district office. This letter provides importers 

with guidance on their responsibilities, including the requesting 

of exemptions from certification and the submitting of getitions 

to bring products into compliance, - All required information must 

be satisfactorily suhnitted before these products can be 

permitted to enter the U.S. 

Enclosures 

we are enclosing a copy of the following items: 

1. The Radiation Control for Health and Safety Act of 1968. - Your special attention is called to the provisions of Section 360 

entitled "Imports", 

2, A compilation of the FW.i regulations published 

pursuant to the Act. Note particularly the provisions of 21 CFR 

1005 entitled "Importation of Electronic ProductsY. 

3. HEW Publication (FDA) 77-8008 a brochure titled Hlmports 

Radiation - Producing Electronic Products" which contains a list 

of FDA district offices. The import officers of these districts 

should be contacted by importers and import brokers regarding 

local procedures for importation of electronic products at the 

specific ports of entry within their jurisdiction, All 

comnunications relating to specific shipments of electronic 

products including details on the completion and suhission of 

FDA fonns and other entry papers are to be handled directly with 

the local FDA office, (Witional copies of the FDA forms listed 

in this letter are available from the FDA district office). 

Where necessary the field offices will forward special cases to 

the Bureau for consideration. 

[The FDA Form FD 701 has been discontinued. Use Customs Entry Forms CF 3461 or CF 3461 ALT] 
5. FDA Form 766 entitled "Application for Authorization to 

Relabel or to Perform Other Action". This form is to be filled 

out for all noncompliant products which are either to be brought 

into compliance, or for which an exemption will be requested by 

the importer. This form 766 must be sutmitted to the local E'DA 

office. 

6. Department of Treasury Regulations, 19 CFR 12, Sections 

12-90 and 12.91. 

7. U.S. Customs Service Circular, RES-2-O:D:C, 

XENT-l-O:D:C, dated June 5, 1974. This circular presents 

guidelines to be used in processing importations subfect to the 

Radiation Control for Health and Safety Act of 1968, 

8. E'DA Form 2877 entitled @&laration tor Products Subject 

to Radiation Control Standardsn. This form must be completed and 

submitted to the U.S. Customs Service when you import products 

for which performance standards are in effect, The Form FD 2877 

provides information necessary to identify the electronic product 

being imported, its manufacturer, the importer, the port of 

entry, and, most significantly, the compliance status of the 

products. The importer is required to describe his product in 

accordance with one of four possible compliance categories. He 

must affirm that the product: 

A, Has been manufactured prior 

the standard. 

Product 

Television Receivers 

Cold Cathode Gas Discharge Tubes 

Microwave Ovens 

Diagnostic X-ray Equipment 

Cabinet X-ray (Baggage Inspection 

Systems) 

Cabinet X-ray (all other systems) 

Lasers and Laser Products 

Ultrasonic Therapy Products 

High Intensity Mercury Vapor 

Discharge Lamps 

Sunlamps and Sunlamp Products 

to the effective date of 

Effective Date 

January 15, 1970 

May 19, 1970 

October 6, 1971 

August 1, 1974 

April 25, 1974 

April 10, 1975 

August 2,. 1976 

February 17, 1979 

March 7, 1980 

May 7, 1980 
B. Complies with the performance standard and is 

appropriately labeled, or, 

C. Does not amply with the performance standard, but 

is being imported only for purpose of research, investigation, 

studies, demonstrations, or training, or, 

D. Does not canply with the performance standard, but 

will be brought into compliance. 

Conditions for Product Entry 

When Affirmation A is made the importer must supply the E'U 

district office with evidence, such as a notarized statement (or 

foreign equivalent), from the actual fabricating manufacturer 

that the equipnent was indeed manufactured prior to the date of 

the appropriate standard. The product may enter the country 

without bond after confirmation by the FDA that the statement is 

correct, 

When Affirmation 8 is made the product will be permitted to enter 

the country without bond, if FDA is satisfied that all reporting 

(21 CFR 1002) , performance (21 CFR Parts 1020, 1030 and lo#), 

and labeling requirements (21 CEi Part 1010) have been 

satisfactorily met. 

In cases where Affirmation C is made, the product will be 

detained and an application for exemption from certification 

under Section 360B(b) of the Radiation Control for Health and 

Safety Act must be suhnitted to and approved by the FDA district . off ice before the product can be permitted entry for the purpose \ 

of research, investigations, studies, demonstrations or training. 

It may be possible to obtain an exemption in advance of the 

expected date of importation. In order to apply for an exemption 

the imprter must complete and suhit forms E'D 766 and 2877 along 

with other information, to the District Director of the E'DA 

district responsible for the port where the product will enter. 

The Form FD 766 and appended information should fully describe 

the product or component being imported, the purpose for which it 

is being imported, the specific purpose (e-g., research, studies, 

demonstration), where it will be located, the time period the 

importer intends to keep it in this country and the name of the 

individual responsible for the control of the product. If the 

exemption has not been obtained prior to the time of importation, 
a request for such an exemption must be made at the time of 

entry. When the exemption has been granted by the l?DA district 

office, the uncertified or noncompliant product will be permitted 

to enter the country under a U.S. Customs Service Temporary 

Import Bond. These products shall then be used only in 

accordance with the conditions stated in the approved FD 766. No 

exempt products may be introduced in comnerce. Uncertified or 

noncompliant medical or dental device for which there is an 

applicable performance standard (e.g,, diagnostic x-ray, medical 

laser, etc.) may not normally be used on human subjects and may 

never be so used without written authorization of the-Director, 

Bureau of Radiological Health. 

In cases where Affirmation D has been made, the product will be 

detained and the importer must subnit to the FDA district office, 

a petition to bring the product into compliance. This petition 

shall state that the importer intends to: (1) bring the product 

into compliance with the performance standard in accordance with 

a corrective action plan approved by the BRH and/or (2) fulfill 

certification requirements by suhitting an initial report or a 

model change report and by affixiq a certification label. This 

petition is to be subnitted on, or as an attachment to, a Form FD 

766. The proposed corrective action plan of the importer must be 

submitted through the district to the BRH within 10 days. If 

this petition is approved, the importer must, within 180 days of 

the conditional release of his product from Customs custody, 

either bring his product into compliance with the performance 

standard, export it from the United States, or destroy it,. 

Importers may also bring electronic products into compliance with 

the standard under Affirmation D based on the results of 

research, demonstration, investigation, etc. conducted under an 

exemption received in accordance with Section 3W(b) of the 

Radiation Control for Health and Safety Act. To choose this 

option under Affirmation D, the importer must check Affirmation D 

on the FD 2877 Declaration and apply for an exemption under 

Section 3608(b) of the Act. This exemption request shall include 

that information required above for products being imported under 

Affirmation C plus all of the requirements for an exemption under 

Affirmation D. 

As in the case under Affirmation C, no imported electronic 

product that is a noncompliant medical or dental device for which 

there is an applicable performance standard may normally be used 
on human subjects until it is brought into compliance with the 

performance standard and may never be so used without written 

authorization of the Director, Bureau of Radiological Health. 

All Affirmation D entries shall be U.S, Customs Service 

consumption entries . X-ray Product Identification 

In order to insure accurate and expeditious processing of all 

import declarations and to process the entry of x-ray'products 

with a minimum of delay, the importer must employ uniform 

nomenclature in identifying various x-ray systems and components. 

It is therefore requested that manufacturers and/or importers 

identify their products in accordance with the categories listed 

in 21 CFR 1020,30(a) (1). These categories are as follows: 

Diagnostic x-ray systems 

Tube housing assemblies 

X-ray controls 

X-ray high voltage generators 

Tables 

Cradles 

Film changers 

Cassette holders 

Beam-limiting devices 

Spot-film devices 

Image intensifiers 

Imaqe receptor support devices for mamnoqraphic 

x-ray systems manufactured after September 5, 1978 

Cephalometric devices manufactured after February 25, 

1978 

The &ove categories will need to be included on the FD 2877 

Declaration in addition to a more general description of the 

product, (i.e., diagnostic x-ray component or diagnostic x-ray 

subsystem) . Completion of Import Forms 

Failure to complete the importation forms and declarations 

satisfactorily, or failure to describe the electronic product 

imprted, may result in the rejection of the import papers or the 

detention of the shipnent at the port of entry until the 
necessry information has been suhnitted and has been found to be 

satisfactory by the FDA district office. 

You should be aware that additional requirements may apply to 

manufacturers and importers of medical devices, pertaining to 

manufacturer or distributor registration, product testing and 

sutmission of premarket notification. More detailed information 

may be obtained from the FDA local district office. 

If you have any questions about these requirements, please do not 

hesitate to contact the E'DA District Import Officer. 

Sincerely yours, 

Acting Director 

Division of Compliance 

Bureau of Radiological Health 
Figure 10 

ENTRY AND IMMEDIATE DELIVERY 

(CF 3461) 

DEPARTMENT OF THE TREASURY 

UNITED STATES CUSTOMS SERVICE 

ENTRYhMMEDIATE DELIVERY 

Form Approved 

OM8 No. 1515-0069 

!:,'c,, 12 ITIILIAW NO. 13 MANIFEST WANTITV 

I I I 

I9CFR 14Z.l.111.I6. 141.1Z141.l4 e 

27. CERTIFICATION 

I herebv mate application lor entry/irnmediate delivery. 1 cntifv 

that the above information is accur8t~. the bond is sufficient. valid. 

and current. and that all requirements of 19 CFR Part 142 have been 

met. 

SIGNATURE OF APPLICA'IT 

1 

29. BROKER OR OTHER GOVT. AGENCY USE 

4 E'ITRV NUMBER 

24. TSUSA NUMBER 1% &-zq-' 1 X. UANWACTURER NO. 

1. ENTRV TVPE COOEiNAXE I. ARRIVAL DATE 

s . 28. CUSTOMS USE ONLY 

1. ELECTED E'ITRV DATE 

OTHER AGENCY ACTION REQUIRED. NAMELY: 

I I I. 8ROIE~IIM.MITED FILE WEE* 

I 9 IUW~~ER %UMBER 

I 

I 5. PORT 

I 

0 ENTRY REJECTED. BECAUSE: 

I 6.mNGLE TRAUS. EDNO 

I 

e. CONSIGNEE NuMOER 

I 

DELIVERY S1GN4TunE DATE 

AUTHORIZED: 

10. uLT.UATE COWIGNEE NAME ! 'I IUPORTER OF OECORO NAME I 

th* 

Customs Form 3461 11 12085) 

11. CACRlER CODE 

I 

I 10 DESCRIPTION OF MERCUANOISE 

13 VOVAGEIFLIGHTITRIP 

I 14. LOCATION 06 COWS-COIEISI.UAME1Sl 

15. VESSEL C0OE:LAML 

I 16. US PORT O* UNLADING 11 YANIF EST WBER 

I I I 

II. G 0 NUMOEI 

I 

I9 TOTAL VALUE 

I 
Figure 11 

ENTRY AND IMMEDIATE DELIVERY (ALTERNATE) (CF 3461 ALT) 

ENTRYIIMMEDIATE DELIVERY 

1) p(I 142.S. 142.11 142.22 142.24 

I; 

4 

Go 

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WfURE OF APPLICANT DATE Y 

X rn d 
SUBMIT IN TRIPLICATE (Submrt rn QUADRUPLICATE if you desire copy returned to you) 

Public reporting burden for this collection of information ts est~mated to average 25 hours per response, ~nclud~n the t~me for revlewtng ~nstruct~ons, 

searchmg ewrst~ng data sources, gatherm and malnta~n~ng the data needed, and completlng revlewlng the collec?~on of ~nforrnat~on Send comments 

regard~ng th~s burden estlmate or any otger aspect of th~r collen~on of ~nforrnat~on, lcludmg suggest~onr for reducmg th~s burden to: 

APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION 

OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS 

Re orts Clearance Off~cer PHS and to Off~ce of Mana ement and Bud et 

~u\ert H Humphre BUII~I~ Room 721-B Paperwork ~e3ct1on Project (0g10-0025) 200 Independence Jvenue, ?h Washmgton, DC 20503 

Wash~ngton, DC 20201 Ann PRA 

Date Sample No. 

To DIRECTOR, District, Food and Drug Administration. 

form Approved; OM8 No. 09 10-M25 

Expiration Dater November 30, 1991 

Application is hereby made for authorization to bring the merchandise below into compliance with the Act. 

Product Entry No, and Date 

Carrier Amount and Marks 

Redelivery bond has been posted by the applicant. The merchandise will be kept apart from all other merchandise and will 

be available for inspection at all reasonable times. The operations, ifauthorized, will be carried out at 

and will require about days to complete. A detailed description of the method by which the merchandise will be 

brought into compliance is given in the space below: 

We will pay all supervisory costs in accordance with current regulations. 

Firm Name and Address 

Applicant's signature 

ACTION ON APPLICATION 

To: Date 

(Name and Address) 

Your application has been denied 

aproved with tire lbllowing conditions 

Time limit within which to complete authorized uperations 

When the authorized operations are completed, fill in the importer's certificate on the reverse side and return this notice to 

this ofice. 

ORM FDA 766 (1 1/89) 

Ilirector, District 

SEE OTHER SIDE 
IM I'OHTER'S CERTIFICATE 

Place ,19- 

1 certify that the worh tu be performed under the authorization has been completed and the goods are now ready for 

inspection at 

The rejected portion is ready for destruction under Customs' supervision and is held at 

, Applicant 

HEPORT OF INVESTIGATOR / INSPECTOR 

TO THE PORT DIRECTOR OR DISTRICT DIRECTOR: 

I have examined the with~n-described goods and find them to be the identical goods described herein, and that they 

have been on ,I9 

as authorized except 

DATA ON CLEANED GOODS: 

Good Portion 

Rejections 

Loss (if any) 

Did importer clean entire shipment? 

Time and cost of supervlslon 

Inspechng Officer 

DIRECTOR OF DISTRICT. 

Disposed of as noted above 
197

United States Customs Service, Treasury § 12.91

not redelivered within 5 days following

the date required by paragraph (e)(2) of

this section, liquidated damages shall

be assessed in the full amount of the

bond if it is a single entry bond, or if a

continuous bond is used, the amount

that would have been taken under a

single entry bond.

(f) Products refused entry. If a product

is denied entry under the provisions of

this section, the port director shall

refuse to release the product for entry

into the United States and shall issue a

notice of the refusal to the importer or

consignee.

(g) Disposition of products refused entry

into the United States; redelivered products. Products which are denied entry

under paragraph (b) of this section, or

which are redelivered in accordance

with paragraph (e)(2) of this section,

and which are not exported under Customs supervision within 90 days from

the date of notice of refusal of admission or date of redelivery, shall be disposed of under Customs laws and regulations. However, no such disposition

shall result in an introduction into the

United States of a product in violation

of the Federal Boat Safety Act of 1971

(46 U.S.C. 1451–1489).

[T.D. 76–166, 41 FR 23398, June 10, 1976, as

amended by T.D. 82–220, 47 FR 52138, Nov. 19,

1982; T.D. 84–213, 49 FR 41168, Oct. 19, 1984;

T.D. 86–203, 51 FR 42997, Nov. 28, 1986]

ELECTRONIC PRODUCTS

§ 12.90 Definitions.

As used in §§ 12.90 and 12.91, the term

‘‘the Act’’ shall mean the Public

Health Service Act (42 U.S.C. 201 et

seq.), as amended by the Radiation Control for Health and Safety Act of 1968

(42 U.S.C. 263b et seq.), and as further

amended from time to time.

[T.D. 83–235, 48 FR 52436, Nov. 18, 1983]

§ 12.91 Electronic products offered for

importation under the Act.

(a) Standards prescribed by the Department of Health and Human Services.

Electronic products offered for importation into the customs territory of

the United States are subject to standards prescribed under section 358 of the

Act (42 U.S.C. 263f) unless intended

solely for export. Prescribed standards

shall not apply to any electronic product intended solely for export if:

(1) Such product and the outside of

any shipping container used in the export of such product are labeled or

tagged to show that it is intended for

export, and

(2) Such product meets all the applicable requirements of the country to

which it is intended for export.

(See 21 CFR, chapter I, subchapter J.)

(b) Requirements for entry and release.

Electronic products subject to standards in effect under section 358 of the

Act (42 U.S.C. 263f), when offered for

importation into the customs territory

of the United States, shall be refused

entry unless there is filed with the

entry, in duplicate, a declaration (FDA

Form FD 2877) verified by the importer

of record which identifies the products

and affirms:

(1) That the electronic products were

manufactured before the date of any

applicable electronic product performance standard (the date of manufacture

shall be specified); or

(2) That the electronic products comply with all standards in effect under

section 358 of the Act (42 U.S.C. 263f),

and chapter I, subchapter J, title 21,

Code of Federal Regulations (21 CFR,

chapter I, subchapter J), and that the

certification required by section 360 of

the Act (42 U.S.C. 263h) in the form of

a label or tag is attached to the product; or

(3)(i) That the electronic products do

not comply with all standards in effect

under section 358 of the Act (42 U.S.C.

263f), and chapter I, subchapter J, title

21, Code of Federal Regulations (21

CFR, chapter I, subchapter J), but are

being imported for the purpose of research, investigations, studied, demonstrations, or training, (ii) that the

products will not be introduced into

commerce and when the use for which

they were imported is completed they

will be destroyed or exported under

Customs supervision, and (iii) that an

exemption for these products has been

or will be requested from the National

Center for Devices and Radiological

Health, Food and Drug Administration,

in accordance with section 360B(b) of

the Act (42 U.S.C. 263j); or
198

§ 12.91 19 CFR Ch. I (4–1–97 Edition)

(4) That the electronic products do

not comply with all standards in effect

under section 358 of the Act (42 U.S.C.

263f) and chapter I, subchapter J, Code

of Federal Regulations (21 CFR, chapter I, subchapter J), but that a timely

and adequate petition for permission to

bring the products into compliance

with applicable standards has been or

will be filed with the Secretary of

Health and Human Services in accordance with section 360 of the Public

Health Service Act, as amended, and as

implemented by 21 CFR 1005.21.

(c) Notice of sampling. When a sampling of a product offered for importation has been requested by the Secretary of Health and Human Services,

as provided for in 21 CFR 1005.10, the

port director having jurisdiction over

the shipment from which the sample is

procured shall give to its owner or importer of record prompt notice of delivery of, or intention to deliver, the sample. If the notice so requires, the owner

or importer of record shall hold the

shipment of which the sample is typical and not release the shipment until

notice of the results of the tests of the

sample from the Secretary of Health

and Human Services stating the product fulfills the requirements of the Act.

(d) Release under bond. If a declaration filed in accordance with paragraph

(b) of this section states that the entry

is being made under circumstances described in paragraph (b)(4) of this section, the entry shall be accepted only if

the owner or importer of record gives a

bond on Customs Form 301, containing

the bond conditions set forth in § 113.62

of this chapter, for the production of a

notification from the Secretary of

Health and Human Services or his designee, in accordance with 21 CFR

1005.23, that the electronic product described in the declaration filed by the

importer of record is in compliance

with the applicable standards. The

bond shall be in an amount deemed appropriate by the port director. Within

180 days after the entry of such additional period as the port director may

allow for good cause shown, the importer of record shall take any action

necessary to insure delivery to the port

director of the notification described in

this paragraph. If the notification is

not delivered to the director of the port

of entry of the electronic products

within 180 days of the date of entry or

such additional period as may be allowed by the port director, for good

cause shown, the importer of record

shall deliver or cause to be delivered to

the port director those electronic products which were released. In the event

that any electronic products are not

redelivered to Customs custody or exported under Customs supervision

within the period allowed by the port

director in the Notice of Redelivery

(Customs Form 4647), liquidated damages shall be assessed in the full

amount of a bond if it is a single entry

bond, or if a continuous bond is used,

the amount that would have been

taken under a single entry bond.

(e) Release without bond—special exemptions. For certain electronic products the Director, National Center for

Devices and Radiological Health, has

granted special exemptions from the

otherwise applicable standards under

the Act. Such exempted products may

be imported and released without bond

if they meet all the criteria of the special exemption. If a special exemption

is granted after the product has been

imported under bond in accordance

with paragraph (d) of this section, the

bond conditions pertaining to the notification of compliance from the Secretary of Health and Human Services

shall be deemed to have been satisfied.

(f) Merchandise refused entry. If electronic products are denied entry under

any provision of this section, the port

director shall refuse to release the

merchandise for entry into the United

States.

(g) Disposition of merchandise refused

entry into the United States; redelivered

merchandise. Electronic products which

are denied entry under paragraph (b) of

this section, or which are redelivered

in accordance with paragraph (d) of

this section, and which are not exported under Customs supervision

within 90 days from the date of notice

of refusal of admission or date of redelivery, shall be disposed of under Customs laws and regulations. However,

no such disposition shall result in an

introduction into the United States of
199

United States Customs Service, Treasury § 12.97

an electronic product in violation of

the Act (42 U.S.C. 263f, 263h).

[T.D. 83–235, 48 FR 52436, Nov. 18, 1983, as

amended by T.D. 84–213, 49 FR 41168, Oct. 19,

1984]

SWITCHBLADE KNIVES

§ 12.95 Definitions.

Terms as used in §§ 12.96 through

12.103 of this part are defined as follows:

(a) Switchblade knife. ‘‘Switchblade

knife’’ means any imported knife, or

components thereof, or any class of imported knife, including ‘‘switchblade’’,

‘‘Balisong’’, ‘‘butterfly’’, ‘‘gravity’’ or

‘‘ballistic’’ knives, which has one or

more of the following characteristics

or identities:

(1) A blade which opens automatically by hand pressure applied to a button or device in the handle of the knife,

or any knife with a blade which opens

automatically by operation of inertia,

gravity, or both;

(2) Knives which, by insignificant

preliminary preparation, as described

in paragraph (b) of this section, can be

altered or converted so as to open automatically by hand pressure applied to a

button or device in the handle of the

knife or by operation of inertia, gravity, or both;

(3) Unassembled knife kits or knife

handles without blades which, when

fully assembled with added blades,

springs, or other parts, are knives

which open automatically by hand

pressure applied to a button or device

in the handle of the knife or by operation of inertia, gravity, or both; or

(4) Knives with a detachable blade

that is propelled by a spring-operated

mechanism, and components thereof.

(b) Insignificant preliminary preparation. ‘‘Insignificant preliminary preparation’’ means preparation with the

use of ordinarily available tools, instruments, devices, and materials by

one having no special manual training

or skill for the purpose of modifying

blade heels, relieving binding parts, altering spring restraints, or making

similar minor alterations which can be

accomplished in a relatively short period of time.

(c) Utilitarian use. ‘‘Utilitarian use’’

includes but is not necessarily limited

to use:

(1) For a customary household purpose;

(2) For usual personal convenience,

including grooming;

(3) In the practice of a profession,

trade, or commercial or employment

activity;

(4) In the performance of a craft or

hobby;

(5) In the course of such outdoor pursuits as hunting and fishing; and

(6) In scouting activities.

[T.D. 71–243, 36 FR 18859, Sept. 23, 1971, as

amended by T.D. 90–50, 55 FR 28192, July 10,

1990]

§ 12.96 Imports unrestricted under the

Act.

(a) Common and special purpose knives.

Imported knives with a blade style designed for a primary utilitarian use, as

defined in § 12.95(c), shall be admitted

to unrestricted entry provided that in

condition as entered the imported

knife is not a switchblade knife as defined in § 12.95(a)(1). Among admissible

common and special purpose knives are

jackknives and similar standard pocketknives, special purpose knives, scout

knives, and other knives equipped with

one or more blades of such single edge

nonweapon styles as clip, skinner,

pruner, sheep foot, spey, coping, razor,

pen, and cuticle.

(b) Weapons with fixed blades. Importations of certain articles having a

fixed unexposed or exposed blade are

not within the prohibition of 15 U.S.C.

1241 through 1245. However, upon release by Customs, possession of these

admissible articles which include such

weapons as sword canes, camel whips,

swords, sheath knives, machetes and

similar devices that may be capable of

use as weapons may be in violation of

State or municipal laws.

[T.D. 71–243, 36 FR 18860, Sept. 23, 1971, as

amended by T.D. 90–50, 55 FR 28192, July 10,

1990]

§ 12.97 Importations contrary to law.

Importations of switchblade knives,

except as permitted by 15 U.S.C. 1244,

are importations contrary to law and
DEPARTMENT OF THE TREASURY 

U.S. CUSTOMS SERVICE 

WASHINGTON 

CIRCULAR: RES-2-O:D:C 

xENT-L4:D:C 

DATE: JUN 5 1974 

Subject : Importations of electronic products subject to radiation 

emission standards established by the Department of Health, 

Education, and Welfare 

Reference : Radiation Control for Health and Safety Act of 1968; 

42 U.S.C. 26% et. seq.; Subchapter J, Parts 1000-1030; 

21 CFR, Chapter 1, fonnerly 21 CFR 278 and 42 CPR, 

Part 78, Subpart G; 19 CFR 12.90 and 12.91; Customs 

Service Circulars ENT-1-R:E:R dated Maxyh 2, 1973; 

ENT-1-AC dated July 25, 1972, April 11, 1972, and 

October 15, 1970. 

1. PURPOSE 

a. To implement procedural changes and increase the enforcement of the 

Radiation Control for Health and Safety Act of 1968. 

b. To advise Customs officers of the recodification of Health, Education, 

and Welfare regulations. 

c. To consolidate, update, and supersede previous instructions. 

2. BACKGROUND 

a. The Bureau of Radiological Health of the Food and Drug Administration 

has requested the assistance of the U. S. Customs Service in effecting a 

greater degree of enforcement of the above referenced "Act .ll As a result, 

a Memorandum of Understanding between the two agencies was concluded on 

March 20, 1974. 

b. Food and Drug will be taking a more active role in screening declarations, s;unpling,and making determinations at the local level. While 

Customs ~sponsibilities will remain unchanged, certain procedural changes 

will be mquired. Simultaneous instmctians in the form of an FDA . 

Compliance Program Guidance Manual have been prepared by Food and Drug and 

are being issued to local Food and Drmg offices. 
c. For the information and guidance of Customs officers, the Food and 

Drug Administration is in the process of recodifying regulations. . 

Health, Education, and Welfare regulations, applicable to the above noted 

"Act," were recodified as (21 CFR, Chapter 1, Subchapter J, Parts 1000-1030), 

and published in Federal Register Volume 38, Number 198, Part 111, dated 

October 15, 1973. 

3. ACTION 

Effective upon receipt of this circular, the following guidelines shall 

be utilized in processing importations subject to the ihdiation Control 

for Health and Safety Act of 1968. 

a. The regulatory requirements involving importations subject to the 

"Actt1 are set forth in 19 CFR 12.90 and 12.91. No changes are immediately 

contemplated to these regulations. 

b. As of this date, performance standards have been established for the 

following products and necessitate thesubmission of the required declaration 

with I.D. and entry: 

1. Television receivers 

2. Cold cathode gas discharge tubes 

3. Microwave ovens 

4. Cabinet and diagnostic X-ray apparatus (effective August 1, 1974) 

c. District Directors shall ensure that all importations subject to the 

"Act" are brought to the attention of the local Food and Drug office. 

d. With the exception of the use of the declaration, the same local 

procedures (notification , inspect ion, sampling, release, etc . which 

apply to other imported products subject to Food and Drug inspection, 

should be utilized in processing importations subject to the "Act." 

e. Customs will discontinue transmitting the copy of the required 

declaration to the Bureau of Radiological Health at Rockville, Maryland. 

It is to be fwnished or transmitted to the local Food and Drug office. 

f. District Directors shall establish procedures to ensure that the 

local Food and Drug office receives the duplicate copy of the declaration; 

either by accompanying any import documents submitted to Food and Drug 

and to be returned to ~'bstoms for normal processing of the importation, 

or as a direct mailing where local Food and Drug offices are not readily 

available. The original shall conrinue to be a part of the entry package. 
g. As with other Food &d Drug importations, Custons and the importer/ 

broke? are to be notified by Food and Drug of any action necessitated on 

each hportation subject to the "Act. " This does not preclude any 

statutory or regulatory Customs processing of the importation. 

h. Any questions ~egarding importations subject to the "~ct" should 

now be di~ected to the local or jurisdictional Food and Drug office. 

Operational matters requiring Headquarters assistance should be 

directed to the Compliance Branch, Duty Assessment Division, Office of 

Operations, FTS (202) 964-8651, 

i. A sam?le declaration format reflecting appropriate changes is 

attached. 

a. Headquarters Circular EXT-1-R:E:R dated March 2, 1973. 

b. Headquarrers Circular ENT-1-AC dated April 11, 1972. 

c. Hezdquarters Circul= EN'-1-AC dated October 15, 1970. 

File: RES-2-0:D:C F 

A~NG ASS istant Commissioner (Operat ions ) 

Att achnent 

Distrfiution : A, 3, C 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

PUBLIC HEALTH SERVICE 

FOOD AND DRUG ADMINISTRATION 

Form Approved OMB No 09 10-0025 

Expiration Date: June 30, 1994 

INSTRUCTIONS 

I I 

PRODUCT IDENTIFICATION 

YAME AND ADDRESS OF MANUFACTURER 

DECLARATloN SUBJECT To 

RADIATION CONTROL STANDARDS 

UAME AND ADDRESS OF IMPORTER OF RECORD 

1 Type or prtnt w11h ball punt pen 

2 Subm~t one copy wcth U S Customs Serwe Entr Papers ,, 3 Attach two coptes to Form FDA 701 .'Importer i!ntry Nottce 

ULTIMATE CONSIGNEE (If not Importer of Record) 

DISTRICTIPORT DIRECTOR OF CUSTOMS 

PORT OF ENTRY ENTRY NO 1 DATE 

AFFIRMATION (Check ao~roortate statement andstan) 

jUANTlTY 

IlWe hereby declare. 

0 A. That the &itruntt products cdrntlfced above were manufactured prcor to the dati! uf any applccable electrontc product performance 

standard 

FOR X-RAY. LIST APPROPRIATE SYSTEM OR COMPONENT CATEGORY 

TYPE 

Date of Mdrcufacture 

BRAND NAME MODEL NO 

a B Thdt rt~t elrctrotr~c products tdenttflid above comply wcth the pertormdnce standards prescrcbed tn Food and Dtug Admcnstratton Rules 21 

CFR 1010 whtcn are appltcable at date of manufacture and that a cert~fccate In the form of a tag or label to th~s etfect IS affcxed to each 

produrt 

C That tlae electron~c products cdentcf~ed above do no1 comply w~th the performance standards prescrtbed In Food and Drug Admcncstratcon 

Rules 21 CFR 1010 but are becng cmported fur the purpose of research, cnvesttyrtcons, studtes, demonstrattons, or tralntng An exemptton for 

thrsi p~~ducts hasbeen or wtll be requested ut tilt: hector uf the FDA Center fur Devtres and Rad~ologccdl Health In dcrordance wcrh 

Secttun 538 (21 U 5 C 36000) of the Rad~dt~olc iuntrc~l for Hedlrh and Saftey Act They wcll not be mtroduced Into commerce. and when 

thetr m~sscorl IS completed they will be de>ttoyeJ uc exported under the Untted States Custums Srrvtce supervlslon 

0 D That the electrcjncc products ~dentcfttd above d" rlut cumply wcth the performance standards prescrcbed cn Food and Drug Admcntstratcon 

Rules 21 CFR 1010 but that a ttmely and adequate petltton for permcsston to brtng the product Into compliance wtth the applccable standard 

has bettn or wdl be fded w~th the Food and Drug Adm~ncstratcon In accordance w~th 21 CFR 1005 21 There products wtll rematn under bond 

and no1 be tntruduced into commerce unttl notcf~catcun Is rececved from the Food and Drug Admcncrtratton, that the products are tn 

compltan~e w~th applc~able standards 

Slgnature of Imponer of Returd 

Facrtmcle of scgnature not acceptable 

Ublic reporting burden for this collection of information Is esttmated to average 16 hours per response, tncludtng the tune for revcewcng tnstructtons, 

earchtngextsttng data sources. gathermy and malntamng the data needed, and completing and revcewmg thecollectlon of tnformatcon Send 

omments regardrng thts burden esttmate or any other aspect of thcscollecr~on of ~nformatcon, ~ncludcng suggestcons for reductng thts burden to. 

Lepons Cleararm Off~cer. PHS and t~. Offtce of Management and Budget 

lubtrt ti Humpl~~cy bu~ldlng Hoom 721-8 Pdperworh Reductcon Protect (0910 0025) 

'00 Independence Avenue S vV Washington, DC 20503 

Yashtngt~n. DC 20201 

inn. PRA 

Please DO NOT HE TURN thts form to ecther of these addresses 

IRM F DA 2877 (8193) PREVIOUS EDITION IS OBSOLETE PAGE 1 OF ? PAGES 
INSTRUCnONS TO IMPORTERYBROKERS OF ELECTRONIC PRODUCTS 

The following information is provided to assist in completing the FDA 2877 Declaration 

In those cases where Affirmation C is made on Form FDA 2877 stating that the product(s) does not comply with the 

applicable performance standard, the product(s) may only be imported for purposes of research, investigations, studies, 

demonstrations, or training (See CP Circular, 7382.007A regarding certain shipments of television receivers, microwave 

ovens and certain Class I laser products). The product(s) will then be detained by the District Food and Drug ~dministration 

Office, and before the product(s) is allowed to be used for its intended purpose (research, investigations, studies, 

demonstrations or training) an exemption from certification must be submitted to the District Office for approval. Such 

requests must include the following: 

1. A full description for the subject electronic product(s). 

2. The purpose for which the product(s) is being imported. 

3. How the product(s) will be used. 

4. Where the product(s) will be located. c 

5. The approximate length of time the product(s) will be in this country. 

The request for exemption from certification may be made on the FDA 766 form or it may be presented as an attachment to 

the Form FDA 766. Since products for which "C' Affirmations are made will be under a Temporary Import Bond, ultimate 

disposition is limited to export or destruction under U.S. Customs supervision when the purpose has been achieved or the 

time limit of the exemption has expired. 

In those cases where Affirmation D is made on Form FDA 2877 stating that the product(s) does not comply with the 

applicable performance standard but will be brought into compliance, a statement as to how the product will be brought 

into compliance is required. (Affirmation D is also made for failure to provide reports, failure to certify, etc.) The product(s) 

will be detained by the District Office; and the importer/broker must file a statement with the FDA 766, or as an attachment 

to it, indicating the procedure intended to bring the product into compliance. This documentation must be submitted to 

the District Office for approval before permission will be granted to modify the product as described in the application. 

The Form FDA 766 must include a statement that the product will be brought into compliance by the submission of a 

satisfactory corrective action plan and/or an initial or model change report. The FDA Form 766 must also include: 

1. A full description of the electronic product(s). 

2. The purpose for which the product(s) is being imported. 

3. How the product(s) will be used. 

4. Where the product(s) will be located. 

5. The approximate length of time necessary to bring the product(s) into compliance. 

If an importerJbroker of diagnostic x-ray equipment intends to import uncertified x-ray equipment into the United States 

for purposes of research, investigation, studies, demonstrations, or training but also wishes to retain the option of bringing 

the product into compliance with the performance standard, check Affirmations C and D on the FDA 2877 and insert the 

word "or" between the Affirmations. Note: The US. Customs Service will treat this entry as a "D" Affirmation for purposes 

of duty. 

This option is only available for uncertified diagnostic equipment manufactured after August 1, 1974. Such requests must 

include the following: 

1. A full description of the subject electronic product(s). 

2. A statement of the need to use the option "C' or "D" Affirmation. 

3. A description of how the product(s) will be used under Affirmation C. 

4. Astatement of how the product(s) will be brought into compliance under Affirmation D. 

5. Where the product(s) will be located. 

6. The approximate length of time necessary to evaluate or demonstrate the product(s) and the time necessary to bring 

the product(s) into compliance (both actions must be accomplished within the period of time granted by FDA). 

Ultimately, the product(s) must be brought into compliance with the applicable standard in accordance with a corrective 

action plan which has been approved by the FDA or the submission of an initial or model change report which assures that 

the product is in compliance with the performance standard. If the produa(s) are not brought into compliance within the 

allotted time frame of the approved application and an extension is not requested of, or granted by the FDA, the District 

Office shall refuse entry on the shipment and require the product(s) to be either exported or destroyed under US. Customs 

supervision. 

FORM FDA 2877 (8193) 

C. 

PAGE 2 OF 2 PAGES