21 U.S.C. § 350c : US Code - Section 350C: Maintenance and inspection of records

Search 21 U.S.C. § 350c : US Code - Section 350C: Maintenance and inspection of records

(a) Records inspection
If the Secretary has a reasonable belief that an article of food
is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals, each person (excluding
farms and restaurants) who manufactures, processes, packs,
distributes, receives, holds, or imports such article shall, at the
request of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of appropriate
credentials and a written notice to such person, at reasonable
times and within reasonable limits and in a reasonable manner, to
have access to and copy all records relating to such article that
are needed to assist the Secretary in determining whether the food
is adulterated and presents a threat of serious adverse health
consequences or death to humans or animals. The requirement under
the preceding sentence applies to all records relating to the
manufacture, processing, packing, distribution, receipt, holding,
or importation of such article maintained by or on behalf of such
person in any format (including paper and electronic formats) and
at any location.
(b) Regulations concerning recordkeeping
The Secretary, in consultation and coordination, as appropriate,
with other Federal departments and agencies with responsibilities
for regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for not
longer than two years, of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport, distribute,
receive, hold, or import food, which records are needed by the
Secretary for inspection to allow the Secretary to identify the
immediate previous sources and the immediate subsequent recipients
of food, including its packaging, in order to address credible
threats of serious adverse health consequences or death to humans
or animals. The Secretary shall take into account the size of a
business in promulgating regulations under this section.
(c) Protection of sensitive information
The Secretary shall take appropriate measures to ensure that
there are in effect effective procedures to prevent the
unauthorized disclosure of any trade secret or confidential
information that is obtained by the Secretary pursuant to this
section.
(d) Limitations
This section shall not be construed -
(1) to limit the authority of the Secretary to inspect records
or to require establishment and maintenance of records under any
other provision of this chapter;
(2) to authorize the Secretary to impose any requirements with
respect to a food to the extent that it is within the exclusive
jurisdiction of the Secretary of Agriculture pursuant to the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.);
(3) to have any legal effect on section 552 of title 5 or
section 1905 of title 18; or
(4) to extend to recipes for food, financial data, pricing
data, personnel data, research data, or sales data (other than
shipment data regarding sales).