
[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Rules and Regulations]
[Pages 15627-15630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-N-0011]


Requirements To Submit Prior Notice of Imported Food; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
prior notice of imported food regulations to reflect a change in the 
electronic data interchange system and its expanded capabilities, to 
correct inaccurate number designations in section headings, and to 
reflect a change in an office's name. This action is ministerial or 
editorial in nature.

DATES: This rule is effective March 30, 2017.

FOR FURTHER INFORMATION CONTACT: Jennifer Thomas, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2094.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 801(m) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 381(m)) requires that FDA establish regulations 
requiring that those persons importing articles of food or offering 
articles of food for import into the United States submit certain 
information about imported foods before the products' arrival in the 
United States. We have established the regulations at title 21, Code of 
Federal Regulations (CFR) part 1, subpart I (21 CFR 1.276 to 1.285). 
Section 801(m) of the FD&C Act also provides that an article of food 
imported or offered for import is subject to refusal of admission into 
the United States if adequate prior notice has not been provided to 
FDA. Our regulations in 21 CFR part 1, subpart I, include information 
on when to submit prior notice, how to submit prior notice, and what 
information is required in a prior notice.

II. Description of the Technical Amendments

    We are making technical amendments in our prior notice regulations 
in part 1, subpart I (Sec. Sec.  1.276 to 1.285), to:
     Reflect the change in an electronic data interchange 
system and its expanded capabilities;
     correct paragraph number designations in certain 
introductory text paragraphs; and
     revise the name of an FDA office receiving certain 
information.
    The technical amendments are ministerial or editorial in nature and 
are not intended to modify any substantive requirements.

A. Revising an Electronic Data Interchange System and Recognizing Its 
Expanded Capabilities

    Our current regulations, at Sec. Sec.  1.279, 1.280, 1.281, and 
1.282, refer to the ``Automated Broker Interface/Automated Commercial 
System (ABI/ACS)'' or ``Automated Broker Interface of the Automated 
Commercial System (ABI/ACS).'' We are amending these regulations to 
reflect the change of the electronic data interchange system from 
``Automated Broker Interface/Automated Commercial System (ABI/ACS)'' or 
``Automated Broker Interface of the Automated Commercial System (ABI/
ACS)'' to ``Automated Broker Interface/Automated Commercial 
Environment/International Trade Data System (ABI/ACE/ITDS).'' In the 
Federal Register of May 16, 2016 (81 FR 30320), the Department of 
Homeland Security's U.S. Customs and Border Protection (CBP) issued a 
notice

[[Page 15628]]

announcing that the Automated Commercial Environment (ACE) will be the 
sole electronic data interchange (EDI) system authorized by the 
Commissioner of CBP for processing electronic entries and entry 
summaries associated with the entry types specified in the notice, for 
merchandise that is subject to our import requirements. The notice also 
announced that the Automated Commercial System (ACS) will no longer be 
a CBP-authorized EDI system for purposes of processing these electronic 
filings. Therefore, we are revising our regulations at Sec. Sec.  
1.279, 1.280, 1.281, and 1.282 by replacing all references to the 
``Automated Broker Interface/Automated Commercial System (ABI/ACS)'' 
and ``Automated Broker Interface of the Automated Commercial System 
(ABI/ACS)'' with ``Automated Broker Interface/Automated Commercial 
Environment/International Trade Data System (ABI/ACE/ITDS)'' to 
accurately identify the current EDI system. We note, however, that 
there is no change in the FDA Prior Notice System Interface (FDA PNSI).
    Additionally, current Sec.  1.280 states that, for purposes of 
submitting prior notice, prior notice for articles that have been 
refused under section 801(m)(1) of the FD&C Act and our regulations 
must be submitted through the FDA PNSI until such time as we and CBP 
issue a determination that ACS or its successor system can accommodate 
such transactions. In addition, current Sec.  1.281 describes what 
information must be provided in the prior notice and states that, until 
such time as we and CBP issue a determination that ACS can accommodate 
such transactions, the tracking number may not be submitted in lieu of 
other certain information if the prior notice is submitted via ABI/ACS. 
Furthermore, if an article of food is arriving by express consignment 
operator or carrier, our current regulations state that the tracking 
number can only be submitted in certain circumstances when neither the 
submitter nor transmitter is the express consignment operator or 
carrier, and the prior notice is submitted via the FDA PNSI. We are 
revising the regulations to remove these limitations because the new 
ACE EDI system can accommodate such transactions. These faster, 
streamlined, and automated processes allow traders to submit tracking 
numbers much more easily. Therefore, we are removing the limitation 
that the tracking number may not be submitted in lieu of certain other 
information throughout the prior notice regulations.
    Furthermore, with the tracking number, we can learn the information 
we need to make entry determinations, such as port, date and time of 
arrival, airway bill, bill of lading, and vessel name and voyage or 
flight number. Removing the condition that the transmitter or submitter 
cannot be the operator or carrier gives submitters more options for 
providing the information we require. Accordingly, the technical 
amendment provides greater flexibility to industry while also allowing 
us to screen imported food articles adequately.
    These changes are deregulatory in nature because they lessen the 
burden imposed on traders without impairing our ability to ensure the 
safety of imported food. The expanded capabilities of the new ACE EDI 
system allow for additional flexibility in submitting certain 
information. Because of technical limitations of the former system, in 
certain cases the prior notice information could be submitted only via 
FDA PNSI because ACS could not accommodate such transactions. For 
example, ACS could not accept the tracking number in lieu of other 
certain information such as port, date and time of arrival, airway 
bill, bill of lading, vessel name, and voyage or flight number.
    The new ACE EDI system can accommodate these transactions, which 
results in additional flexibility to industry. Some filers no longer 
have to use two systems to file prior notice information for the same 
food import line. In addition, FDA staff will be able to more 
efficiently process import entry submissions and more quickly make the 
initial import entry determination for food imports, in furtherance of 
our goal to ensure the safety of imported food.

B. Correcting Number Designations in Headings and Changing an FDA 
Office's Title

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) was 
signed into law on January 4, 2011. Section 304 of FSMA amended section 
801(m)(1) of the FD&C Act to require that a person submitting prior 
notice of imported food, in addition to other information already 
required, report ``any country to which the article has been refused 
entry.'' On May 5, 2011, we issued an interim final rule (2011 IFR) (76 
FR 25542) implementing section 304 of FSMA. Specifically, the 2011 IFR 
amended Sec.  1.281 by adding a new requirement to paragraphs (a), (b), 
and (c) that any person submitting prior notice of imported food report 
the name of any country to which the article has been refused entry. 
However, the 2011 IFR neglected to make corresponding edits to change 
the paragraph number designations in the introductory text for 
paragraphs (a), (b), and (c) in Sec.  1.281 to reflect the additional 
data element as added by the 2011 IFR and affirmed in a final rule 
published on May 30, 2013 (78 FR 32359). The technical amendment 
corrects those designations.
    Furthermore, current Sec.  1.285(i)(2) refers to the ``FDA Prior 
Notice Center.'' The office is now named the ``FDA Division of Food 
Defense Targeting,'' so we are amending Sec.  1.285(i)(2) accordingly.

III. The Administrative Procedure Act

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553). 
Under 5 U.S.C. 553(b)(3)(B) of the APA, an Agency may, for good cause, 
find (and incorporate the finding and a brief statement of reasons in 
the rules issued) that notice and public comment procedure on a rule is 
impracticable, unnecessary, or contrary to the public interest. We have 
determined that notice and public comment are unnecessary because these 
amendments only make technical or non-substantive, ministerial changes 
to reflect the change in an electronic data interchange system and its 
expanded capabilities, correct number designations in headings as a 
result of the FSMA amendments to prior notice, and amend the name of an 
FDA office. For these reasons we have determined that publishing a 
notice of proposed rulemaking and providing opportunity for public 
comment is unnecessary.
    In addition, we find good cause for these amendments to become 
effective on the date of publication of this action. The APA allows an 
effective date less than 30 days after publication as ``provided by the 
agency for good cause found and published with the rule'' (5 U.S.C. 
553(d)(3)). A delayed effective date is unnecessary in this case 
because the amendments do not impose any new regulatory requirements on 
affected parties. As a result, affected parties do not need time to 
prepare before the rule takes effect. Therefore, we find good cause for 
this correction to become effective on the date of publication of this 
action.

IV. Paperwork Reduction Act of 1995

    This final rule refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 1, subpart I, have been 
approved under OMB control number 0910-0520.

[[Page 15629]]

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.


0
2. Amend Sec.  1.279 by revising paragraph (b)(1) to read as follows:


Sec.  1.279  When must prior notice be submitted to FDA?

* * * * *
    (b) * * *
    (1) If prior notice is submitted via the Automated Broker 
Interface/Automated Commercial Environment/International Trade Data 
System (ABI/ACE/ITDS), you may not submit prior notice more than 30-
calendar days before the anticipated date of arrival.
* * * * *

0
3. Amend Sec.  1.280 by revising paragraphs (a)(1) and (2) and (b) to 
read as follows:


Sec.  1.280  How must you submit prior notice?

    (a) * * *
    (1) The U.S. Customs and Border Protection (CBP) Automated Broker 
Interface/Automated Commercial Environment/International Trade Data 
System (ABI/ACE/ITDS); or
    (2) The FDA PNSI at https://www.access.fda.gov/. You must submit 
prior notice through the FDA Prior Notice System Interface (FDA PNSI) 
for articles of food imported or offered for import by international 
mail, and other transaction types that cannot be made through ABI/ACE/
ITDS.
    (b) If a customhouse broker's or self-filer's system is not working 
or if the ABI/ACE/ITDS interface is not working, prior notice must be 
submitted through the FDA PNSI.
* * * * *

0
4. Amend Sec.  1.281 by revising paragraphs (a) introductory text, 
(a)(11)(iv), (a)(17)(i) and (iii), (b) introductory text, (c) 
introductory text, (c)(11)(iii), and (c)(17)(i) and (iii) to read as 
follows:


Sec.  1.281  What information must be in a prior notice?

    (a) General. For each article of food that is imported or offered 
for import into the United States, except by international mail, you 
must submit the information for the article that is required in 
paragraphs (a)(1) through (18) of this section:
* * * * *
    (11) * * *
    (iv) Notwithstanding paragraphs (a)(11) introductory text and 
(a)(11)(i) through (iii) of this section, if the article of food is 
arriving by express consignment operator or carrier, the express 
consignment operator or carrier tracking number may be submitted in 
lieu of the information required in paragraphs (a)(11) introductory 
text and (a)(11)(i) through (iii) of this section.
* * * * *
    (17) * * *
    (i) The Airway Bill number(s) or Bill of Lading number(s), as 
applicable. This information is not required for an article of food 
when carried by or otherwise accompanying an individual when entering 
the United States. If the article of food is arriving by express 
consignment operator or carrier, the express consignment operator or 
carrier tracking number may by submitted in lieu of the Airway Bill 
number(s) or Bill of Lading number(s), as applicable;
* * * * *
    (iii) For food arriving by air carrier, the flight number. If the 
article of food is arriving by express consignment operator or carrier, 
the express consignment operator or carrier tracking number may be 
submitted in lieu of the flight number;
* * * * *
    (b) Articles arriving by international mail. For each article of 
food that is imported or offered for import into the United States by 
international mail, you must submit the information for the article 
that is required in paragraphs (b)(1) through (12) of this section:
* * * * *
    (c) Refused articles. If the article of food has been refused under 
section 801(m)(1) of the act and under this subpart, you must submit 
the information for the article that is required in paragraphs (c)(1) 
through (19) of this section. However, if the refusal is based on Sec.  
1.283(a)(1)(iii) (Untimely Prior Notice), you do not have to resubmit 
any information previously submitted unless it has changed or the 
article has been exported and the original prior notice was submitted 
through ABI/ACE/ITDS. If the refusal is based on Sec.  1.283(a)(1)(ii), 
you should cancel the previous submission per Sec.  1.282(b) and (c).
* * * * *
    (11) * * *
    (iii) Notwithstanding paragraphs (c)(11) introductory text and 
(c)(11)(i) and (ii) of this section, if the article of food arrived by 
express consignment operator or carrier, the express consignment 
operator or carrier tracking number may be submitted in lieu of the 
information required in paragraphs (c)(11) introductory text and 
(c)(11)(i) and (ii) of this section.
* * * * *
    (17) * * *
    (i) The Airway Bill number(s) or Bill of Lading number(s), as 
applicable; however, this information is not required for an article of 
food when carried by or otherwise accompanying an individual when 
entering the United States. If the article of food arrived by express 
consignment operator or carrier, the express consignment operator or 
carrier tracking number may be submitted in lieu of the Airway Bill 
number(s) or Bill of Lading number(s), as applicable;
* * * * *
    (iii) For food that arrived by air carrier, the flight number. If 
the article of food arrived by express consignment operator or carrier, 
the express consignment operator or carrier tracking number may be 
submitted in lieu of the flight number;
* * * * *

0
5. Amend Sec.  1.282 by revising paragraph (c) to read as follows:


Sec.  1.282  What must you do if information changes after you have 
received confirmation of a prior notice from FDA?

* * * * *
    (c) If you submitted the prior notice via ABI/ACE/ITDS, you should 
cancel the prior notice via ACE by requesting that CBP cancel the 
entry.

0
6. Amend Sec.  1.285 by revising the first sentence in paragraph (i)(2) 
to read as follows:


Sec.  1.285  What happens to food that is imported or offered for 
import from unregistered facilities that are required to register under 
subpart H of this part?

* * * * *
    (i) * * *
    (2) The FDA Division of Food Defense Targeting must be notified of 
the applicable registration number in writing.* * *
* * * * *


[[Page 15630]]


    Dated: March 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06201 Filed 3-29-17; 8:45 am]
 BILLING CODE 4164-01-P


