
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360nn]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
              Part C--Electronic Product Radiation Control
 
Sec. 360nn. Inspection, records, and reports


(a) Inspection of premises

    If the Secretary finds for good cause that the methods, tests, or 
programs related to electronic product radiation safety in a particular 
factory, warehouse, or establishment in which electronic products are 
manufactured or held, may not be adequate or reliable, officers or 
employees duly designated by the Secretary, upon presenting appropriate 
credentials and a written notice to the owner, operator, or agent in 
charge, are thereafter authorized (1) to enter, at reasonable times, any 
area in such factory, warehouse, or establishment in which the 
manufacturer's tests (or testing programs) required by section 360kk(h) 
of this title are carried out, and (2) to inspect, at reasonable times 
and within reasonable limits and in a reasonable manner, the facilities 
and procedures within such area which are related to electronic product 
radiation safety. Each such inspection shall be commenced and completed 
with reasonable promptness. In addition to other grounds upon which good 
cause may be found for purposes of this subsection, good cause will be 
considered to exist in any case where the manufacturer has introduced 
into commerce any electronic product which does not comply with an 
applicable standard prescribed under this part and with respect to which 
no exemption from the notification requirements has been granted by the 
Secretary under section 360ll(a)(2) or 360ll(e) of this title.

(b) Record keeping

    Every manufacturer of electronic products shall establish and 
maintain such records (including testing records), make such reports, 
and provide such information, as the Secretary may reasonably require to 
enable him to determine whether such manufacturer has acted or is acting 
in compliance with this part and standards prescribed pursuant to this 
part and shall, upon request of an officer or employee duly designated 
by the Secretary, permit such officer or employee to inspect appropriate 
books, papers, records, and documents relevant to determining whether 
such manufacturer has acted or is acting in compliance with standards 
prescribed pursuant to this part.

(c) Disclosure of technical data

    Every manufacturer of electronic products shall provide to the 
Secretary such performance data and other technical data related to 
safety as may be required to carry out the purposes of this part. The 
Secretary is authorized to require the manufacturer to give such 
notification of such performance and technical data at the time of 
original purchase to the ultimate purchaser of the electronic product, 
as he determines necessary to carry out the purposes of this part after 
consulting with the affected industry.

(d) Public nature of reports

    Accident and investigation reports made under this part by any 
officer, employee, or agent of the Secretary shall be available for use 
in any civil, criminal, or other judicial proceeding arising out of such 
accident. Any such officer, employee, or agent may be required to 
testify in such proceedings as to the facts developed in such 
investigations. Any such report shall be made available to the public in 
a manner which need not identify individuals. All reports on research 
projects, demonstration projects, and other related activities shall be 
public information.

(e) Trade secrets

    The Secretary or his representative shall not disclose any 
information reported to or otherwise obtained by him, pursuant to 
subsection (a) or (b) of this section, which concerns any information 
which contains or relates to a trade secret or other matter referred to 
in section 1905 of title 18, except that such information may be 
disclosed to other officers or employees of the Department and of other 
agencies concerned with carrying out this part or when relevant in any 
proceeding under this part. Nothing in this section shall authorize the 
withholding of information by the Secretary, or by any officers or 
employees under his control, from the duly authorized committees of the 
Congress.

(f) Information required to identify and locate first purchasers of 
        electronic products

    The Secretary may by regulation (1) require dealers and distributors 
of electronic products, to which there are applicable standards 
prescribed under this part and the retail prices of which is not less 
than $50, to furnish manufacturers of such products such information as 
may be necessary to identify and locate, for purposes of section 360ll 
of this title, the first purchasers of such products for purposes other 
than resale, and (2) require manufacturers to preserve such information. 
Any regulation establishing a requirement pursuant to clause (1) of the 
preceding sentence shall (A) authorize such dealers and distributors to 
elect, in lieu of immediately furnishing such information to the 
manufacturer, to hold and preserve such information until advised by the 
manufacturer or Secretary that such information is needed by the 
manufacturer for purposes of section 360ll of this title, and (B) 
provide that the dealer or distributor shall, upon making such election, 
give prompt notice of such election (together with information 
identifying the notifier and the product) to the manufacturer and shall, 
when advised by the manufacturer or Secretary, of the need therefor for 
the purposes of section 360ll of this title, immediately furnish the 
manufacturer with the required information. If a dealer or distributor 
discontinues the dealing in or distribution of electronic products, he 
shall turn the information over to the manufacturer. Any manufacturer 
receiving information pursuant to this subsection concerning first 
purchasers of products for purposes other than resale shall treat it as 
confidential and may use it only if necessary for the purpose of 
notifying persons pursuant to section 360ll(a) of this title.

(June 25, 1938, ch. 675, Sec. 537, formerly act July 1, 1944, ch. 373, 
title III, Sec. 537, formerly Sec. 360A, as added Pub. L. 90-602, 
Sec. 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered Sec. 537 and amended 
Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E), (3), (4), Nov. 28, 1990, 104 
Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat. 
779.)

                          Codification

    Section was classified to section 263i of Title 42, The Public 
Health and Welfare, prior to renumbering by Pub. L. 101-629.


                               Amendments

    1993--Pub. L. 103-80 amended directory language of Pub. L. 101-629, 
Sec. 19(a)(4), which renumbered section 263i of Title 42, The Public 
Health and Welfare, as this section.
    1990--Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E), 
substituted ``section 360kk(h)'' for ``section 263f(h)'', ``this part'' 
for ``this subpart'', and ``section 360ll(a)(2) or 360ll(e)'' for 
``section 263g(a)(2) or 263g(e)''.
    Subsecs. (b) to (e). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted 
``this part'' for ``this subpart'' wherever appearing.
    Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E)(ii), 
substituted ``this part'' for ``this subpart'', ``section 360ll'' for 
``section 263g'' in three places, and ``section 360ll(a)'' for ``section 
263g(a)''.


               Noninterference With Other Federal Agencies

    Enactment of this section not to be construed to supersede or limit 
the functions under any other provision of law of any officer or agency 
of the United States, see section 4 of Pub. L. 90-602, set out as a note 
under section 360hh of this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 360ll, 360oo of this title.
