21 USC 350d(a)(4): Food Registration Documents

          
Sec. 350d. Registration of food facilities


(a) Registration

                           (1) In general

        The Secretary shall by regulation require that any facility 
    engaged in manufacturing, processing, packing, or holding food for 
    consumption in the United States be registered with the Secretary. 
    To be registered--
            (A) for a domestic facility, the owner, operator, or agent 
        in charge of the facility shall submit a registration to the 
        Secretary; and
            (B) for a foreign facility, the owner, operator, or agent in 
        charge of the facility shall submit a registration to the 
        Secretary and shall include with the registration the name of 
        the United States agent for the facility.

                          (2) Registration

        An entity (referred to in this section as the ``registrant'') 
    shall submit a registration under paragraph (1) to the Secretary 
    containing information necessary to notify the Secretary of the name 
    and address of each facility at which, and all trade names under 
    which, the registrant conducts business and, when determined 
    necessary by the Secretary through guidance, the general food 
    category (as identified under section 170.3 of title 21, Code of 
    Federal Regulations) of any food manufactured, processed, packed, or 
    held at such facility. The registrant shall notify the Secretary in 
    a timely manner of changes to such information.

                            (3) Procedure

        Upon receipt of a completed registration described in paragraph 
    (1), the Secretary shall
    notify the registrant of the receipt of such registration and assign 
    a registration number to each registered facility.

        

            
 
          

                              (4) List

        The Secretary shall compile and maintain an up-to-date list of 
    facilities that are registered under this section. Such list and any 
    registration documents submitted pursuant to this subsection shall 
    not be subject to disclosure under section 552 of title 5. 
    Information derived from such list or registration documents shall 
    not be subject to disclosure under section 552 of title 5 to the 
    extent that it discloses the identity or location of a specific 
    registered person.

(b) Facility

    For purposes of this section:
        (1) The term ``facility'' includes any factory, warehouse, or 
    establishment (including a factory, warehouse, or establishment of 
    an importer) that manufactures, processes, packs, or holds food. 
    Such term does not include farms; restaurants; other retail food 
    establishments; nonprofit food establishments in which food is 
    prepared for or served directly to the consumer; or fishing vessels 
    (except such vessels engaged in processing as defined in section 
    123.3(k) of title 21, Code of Federal Regulations).
        (2) The term ``domestic facility'' means a facility located in 
    any of the States or Territories.
        (3)(A) The term ``foreign facility'' means a facility that 
    manufacturers, processes, packs, or holds food, but only if food 
    from such facility is exported to the United States without further 
    processing or packaging outside the United States.
        (B) A food may not be considered to have undergone further 
    processing or packaging for purposes of subparagraph (A) solely on 
    the basis that labeling was added or that any similar activity of a 
    de minimis nature was carried out with respect to the food.

(c) Rule of construction

    Nothing in this section shall be construed to authorize the 
Secretary to require an application, review, or licensing process.

(June 25, 1938, ch. 675, Sec. 415, as added Pub. L. 107-188, title III, 
Sec. 305(a), June 12, 2002, 116 Stat. 667.)
                               Regulations

    Pub. L. 107-188, title III, Sec. 305(e), June 12, 2002, 116 Stat. 
669, provided that: ``Not later than 18 months after the date of the 
enactment of this Act [June 12, 2002], the Secretary of Health and Human 
Services shall promulgate proposed and final regulations for the 
requirement of registration under section 415 of the Federal Food, Drug, 
and Cosmetic Act [21 U.S.C. 350d] (as added by subsection (a) of this 
section). Such requirement of registration takes effect--
        ``(1) upon the effective date of such final regulations; or
        ``(2) upon the expiration of such 18-month period if the final 
    regulations have not been made effective as of the expiration of 
    such period, subject to compliance with the final regulations when 
    the final regulations are made effective.''
                            Electronic Filing

    Pub. L. 107-188, title III, Sec. 305(d), June 12, 2002, 116 Stat. 
668, provided that: ``For the purpose of reducing paperwork and 
reporting burdens, the Secretary of Health and Human Services may 
provide for, and encourage the use of, electronic methods of submitting 
to the Secretary registrations required pursuant to this section 
[enacting this section, amending sections 331 and 381 of this title, and 
enacting provisions set out as a note under this section]. In providing 
for the electronic submission of such registrations, the Secretary shall 
ensure adequate authentication protocols are used to enable 
identification of the registrant and validation of the data as 
appropriate.''