FDA ACE External Outreach - Human and Animal Food

FDA US Food and Drug Administration

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Making ACE Work for You: Importing FDA Regulated Products
Office of Enforcement and Import Operations and Office of Information Systems Management ··· US Food and Drug Administration October 2019

Agenda

Overview: ACE and FDA
· What is ACE? · How ACE Works for FDA · FDA Current Status · Most Common CBP and
FDA Rejections · Common Data Errors · FDA Flags · FDA ACE Final Rule
Changes

Commodity Specific Information

Information and Resources for All FDA
Regulated Products

· Know the Product Being · Avoiding Delays with FDA

Imported

· Use the Supplemental

· Information Needed for

Guide

Submission

· Summary

· Common Reasons for

· Frequently Asked

Commodity Specific Entry Questions

Processing Delays

· Resources

· Commodity Specific

· FDA Points of Contact for

Resources

Imports

2

Making ACE Work for You: Importing FDA Regulated Products
OVERVIEW: ACE AND FDA
3

What is ACE?
The Automated Commercial Environment is a centralized system for all transactions related to imports and exports. Filers electronically submit all information related to an inbound shipment and the government processes the
transaction systematically and sends status updates.
4

How ACE & PREDICT Work for FDA

Industry
1
Filer accesses ACE through the Automated Broker Interface, submits PGA Message Set to CBP

CBP
2 CBP conducts a syntax
validation to ensure all mandatory data is populated; if PGA
Message Set is complete, CBP will send to FDA for
further processing. Entries with missing data
will prompt an error message back to the filer.
5
CBP sends the message back to the filer

FDA
3
Data is stored in and processed by OASIS, screened by PREDICT (PN screening if required)

4
FDA generates a cargo disposition message and
sends to CBP *

* Data that is electronically

validated may be automatically

"May Proceeded"

5

FDA Current Status
· ACE became mandatory in June 2016 · Final Rule issued in November 2016 · FDA Supplemental Guide version 2.5.1 released April 2018 · FDA continues to work closely with importers, brokers, and
software developers to ensure understanding and compliance of the ACE process · FDA also continues to collaborate with CBP to troubleshoot issues and make system enhancements
6

FDA Current Status
· Automated May Proceeds have increased in ACE, and the percentage of lines requiring manual review have decreased.
­ In 2014, only 26% of (ACS) lines were Automated May Proceeds.
­ In 2018, 70% of lines were Automated May Proceeds.
7

FDA Current Status
· In ACE, FDA requests less documents.
­ In 2014, approximately 3% of (ACS) lines needed additional information to make an admissibility decision (Documents Required).
­ In 2018, approximately 2% of (ACE) lines needed additional information to make an admissibility decision (Documents Required).
8

Most Common CBP & FDA Rejects

CBP Rejects
Jan ­ Sep 2019
· Missing or Invalid Affirmations of Compliance
· Missing or Invalid Entities
· Missing or Invalid PG21 Record or Individual Qualifier Code

FDA Rejects
Jan ­ Sep 2019
· Invalid Product Code
· Cancelled Food Facility Registration
· Invalid State/Zip Combination

· Missing or Invalid Entity ID Code for FEI or DUNS

· Food Facility Registration Not on File

· Missing or Invalid FEI or DUNS Number

· Food Facility Registration Invalidated by PGA

· Only Mandatory Entities Allowed

· Mismatch Between Food Facility Registration and Manufacturer

9

Common Data Errors
Areas for Improvement
· Must know the Intended Use Code of the product prior to transmitting entry data (foods do not require an IUC)
· Know required Entities and Affirmation of Compliance (AoC) Codes for commodity type
· Other than the few repeatable AoC codes listed in the SG, do not submit the same AoC code more than once per line
· Submit correct entity addresses and DUNS or FEI number
10

Common Data Errors
Consumer Use is different than Personal Use
­ Base Code 130 For Consumer Use as a Non-Food Product
­ Base Code 100 For Personal Use as a Non-Food Product
­ Base Code 210 For Personal Use as Human Food
11

FD Flags
· FD1 ­ Indicates that the article may be subject to FDA jurisdiction, including FDA review under 801(a) of the FD&C Act. For products not subject to FDA jurisdiction, a filer can "Disclaim" product from FDA notification requirements.
· FD2 ­ Indicates that the article is under FDA jurisdiction and review of entry information by FDA under section 801(a) will take place. However, the article is not "food" for which prior notice information is required.
· FD3 ­ Indicates that the article may be subject to prior notice under section 801(m) of the FD&C Act and 21 CFR Part1, subpart I. , e.g., the article has both food and non-food uses.
· FD4 ­ Indicates that the article is "food" for which prior notice is required under section 801(m) of the FD&C Act and 21 CFR Part1, subpart I.
12

Final Rule
The Final Rule for submission of information to the Automated Commercial Environment (ACE) was published in the Federal Register on November 29, 2016.
13

Reminders
· Optional ­ Line Value · Optional ­ Quantity and Unit of Measure
­ Except for Radiation Emitting Products subject to a Form FDA 2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards
­ Prior Notice datasets
· Mandatory ­ Importer of Record contact information is required for all non-food lines
· Although data elements may be optional, transmitting them may expedite processing ·
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Making ACE Work for You: Importing FDA Regulated Products
HUMAN AND ANIMAL FOOD
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Submitting Human and Animal Food Entries in ACE
· Know the Product Being Imported · Information Needed for Submission · Common Reasons for Food Entry Processing
Delays · Additional Resources
16

Know the Product Being Imported
The term "food" means
­ Articles used for food or drink for man or other animals
­ Chewing gum ­ Articles used for components of any such article
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Know the Product Being Imported
Examples of food products
· Fruits and vegetables · Seafood · Bottle water · Dietary supplements · Pet food · Animal feed
18

Overview: Products Requiring Prior Notice
· Human and animal food products requiring Prior Notice include:
­ Food imported for use, storage, or distribution in the United States
­ Food transshipped through the United States to another country
­ Food imported for future export ­ Food for use in a Foreign Trade Zone (FTZ) ­ Food for Trade Shows ­ Food to be sold in Duty Free Shops
19

Options for Submitting Human and Animal Food Entries in ACE
· Stand Alone Prior Notice Submission [PN Standalone]
· Food Commodity Combined Entry Submission [PN + 801(a)]
· Non-PN Food Commodity or PN Requirements Previously Met [Non-PN and PN Previously Met]
20

Information Needed for Submission
Program & Processing Codes
Program Code for all food commodities is FOO.

The Processing Code will be determined by the commodity sub-type:

PG01 Government Agency Code
FDA FDA
FDA
FDA FDA
FDA

Commodity Type
Food Food Food Food Food Food

PG01 Government
Agency Program Code
FOO FOO
FOO
FOO FOO
FOO

Commodity Sub-Type
Natural State Food Processed Food Animal Food (includes pet food, medicated feed and feeds) Additives and Colors Dietary Supplements Ceramicware or Food Contact Substance

PG01 Government
Agency Processing Code
NSF PRO
FEE
ADD DSU
CCW
21

Information Needed for Submission
Product Code Overview

Position Name

Structure of the FDA Product Code

1-2

3

4

5

Industry Code (N)

Class Code (A)

Sub Class Code
(A or "-")

Process Identification Code ­ PIC
(A or "-")

Legend: N ­ Numeric; A ­ Alphabetic; AN - Alphanumeric

6-7
Product (AN)

· FDA Product Code errors are among the most common reasons for FDA Entry Rejections.
· Use a valid FDA Product Code per the FDA Product Code Builder.
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Information Needed for Submission
Product Codes
· Product code is mandatory.

PG01: Program Code & Commodity

PG01: Processing Code & Commodity Subtype

PG02: Industry Code

FOO ­ Food*

NSF - Natural State Food PRO - Processed Food FEE - Animal Feed DSU - Dietary Supplement ADD - Additives and Colors CCW - Ceramicware or Food Contact Substance

01-46, 48, 49, 50, 52, 54, 69, 70, 71 or 72
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LACF and Acidified
· LACF Industry Codes: 02-39, 41, 71, & 72 with PIC: F (Aseptic) and E (Commercially Sterile)
· AF Industry Codes: 02-39, 41, 71, & 72 with PIC: I (Acidified)

23

Information Needed for Submission
Packaging and Condition

Data Element Quantity Unit of Measure Lot Number Information PGA Line Value

PN Standalone

PN+801(a)

Non-PN and PN Previously Met

Mandatory

Mandatory

Optional but highly encouraged

Mandatory
Mandatory for Infant formula, Acidified Foods,
and LACF products Optional but highly
encouraged

Mandatory
Mandatory for Infant formula, Acidified Foods,
and LACF products Optional but highly
encouraged

Mandatory if Quantity is entered
Optional but highly encouraged

* See FDA Supplemental Guide for ACE for valid units of measure for Human and Animal Food Packaging Containers.

24

Information Needed for Submission
Intended Use Codes

· Intended Use Code is not required for foods, food contact surfaces, and prior notice.
· If providing an Intended Use code, the following are applicable options:

CFSAN Regulated Products Import Scenario
For Research Use as Human Food For Research Use as an Animal Food Personal Importation

Intended Use Code

CBP Intended Use Name

260.000 015.000 210.000

For Research Use as Human Food For Research Use as an Animal Food For Personal Use as Human Food

25

Information Needed for Submission

Entities

Entity Data Requirement

PN Standalone

PN+801(a)

Prior Notice Submitter (PNS) Prior Notice Transmitter (PNT) Manufacturer (MF) or FDA Consolidator (FDC) or Grower (DFI) Shipper (DEQ) FDA Importer (FD1)
Ultimate Consignee (UC)
Owner (DFP)
Location of Goods (LG)
Foreign Supplier Verification Program Importer (FSV) Delivered to Party (DP) Broker/Filer Point of Contact (PK)

Mandatory Mandatory
Mandatory
Mandatory Mandatory (Except for T&E entries) Mandatory (Except for T&E entries) Mandatory (Except for T&E entries) Mandatory when the article of food/feed was refused for inadequate PN and moved under CBP Supervision
Optional but highly encouraged

Mandatory Mandatory
Mandatory Mandatory Mandatory
Mandatory
Mandatory Mandatory when the article of food/feed was refused for inadequate PN and moved
under CBP Supervision Mandatory beginning May
30, 2017
Optional but highly encouraged

Non-PN and PN Previously Met
Mandatory (Only MF allowed)
Mandatory Mandatory
Mandatory beginning May 30, 2017 Mandatory
Optional but highly encouraged 26

FSVP Reminders
· FSVP Data Elements:
­ Firm name ­ Firm address ­ Email Address ­ Duns # ­ Individual's name and phone # (optional)
· FSVP Exemptions:
­ Affirmations of Compliance
· Research and Evaluation (RNE) · FSVP Exempt (FSX)
· CSMS message #17-000314 titled DA Foreign Supplier Verification Programs (FSVP) Initial Compliance Date: https://apps.cbp.gov/csms/viewmssg.asp?Recid=22717&page=&srch_argv=17-000314&srchtype=all&btype=&sortby=&sby
· Infographic depicting who is subject to FSVP Requirements: https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf
· For regulatory, technical, and policy questions that are not already addressed online or internally about FSVP (and Preventive controls), the Technical Assistance Network (TAN): https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
27

Information Needed for Submission

Affirmations of Compliance

Required Affirmation of Compliance Codes
PFR or CFR or GFR or FME RNO Required for Rail or Containerized Rail CAN Required if using PG13 or if SCAT or IATA not provided VFT Required for Air, Rail, Truck, or Ocean VES Required for Ocean FCE Required for LACF and AF products SID Required for LACF and AF products VOL Required for LACF and AF products if container dimensions not provided FSX Required if applicable beginning May 30, 2017 RNE Required if applicable beginning May 30, 2017

PN Standalone
Mandatory Conditional Conditional Conditional Conditional

PN+801(a)
Mandatory Conditional Conditional Conditional Conditional Conditional Conditional
Conditional
Conditional Conditional

Non-PN and PN Previously Met
Conditional Conditional Conditional Conditional Conditional

PN Standalone PN+801(a)
Non PN & PN Prev. Met

Optional Affirmation of Compliance Codes (O for Optional)

S U I T O S C G L CC E F F I I P AJ SV F F FF R R F F F C I R A C BF K I I I Q R R RRNN R R RCNR P C PE C NFF I
O O OOOOOOO

O O OOOOOOO OOO O OO O OOOO

OOOO O OO O OOOO

28

Information Needed for Submission

Origin, Shipment, and Arrival

Data Element
Country of Production or Place of Growth Country of Shipment
Country of Refusal

PN Standalone
Mandatory Mandatory
Mandatory if refused by other country(-ies)

PN+801(a)
Mandatory Mandatory
Mandatory if refused by other country(-ies)

Non-PN and PN Previously Met
Mandatory
Mandatory if refused by other country(-ies)

Container Number Express Courier Tracking Number

Mandatory if containerized cargo by water, air, rail, or land
Mandatory for mail/express courier in lieu of AWB/BOL/Flight #

Mandatory if containerized cargo by water, air, rail, or land
Mandatory for mail/express courier in lieu of AWB/BOL/Flight #

Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Arrival Anticipated Port of Entry

Mandatory Mandatory Mandatory

Mandatory Mandatory Mandatory

Mandatory Mandatory
Optional
29

Summary
· Know the product being imported and associated requirements
· Understand the data elements · Provided correct and accurate information · Give Entry Filers the information they need · Obtain all necessary information from the Importer
NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA's review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information.
30

Common Reasons for Food Entry Processing Delays
Low Acid and Acidified Foods · Failure to provide: FCE and SID; Container
Dimensions or Volume; Lot Number · Firm and/or Product incorrectly provided
31

Additional Resources
· For more information about Human and Animal Foods, visit http://www.fda.gov/Food/default.htm
· For more information about Registration of Food Facilities, visit https://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htm
· For Prior Notice Q&As, visit https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm2 006836.htm
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Making ACE Work for You: Importing FDA Regulated Products
INFORMATION AND RESOURCES FOR ALL FDA REGULATED PRODUCTS
33

Avoiding Delays with FDA
· Delays occur when:
­ Inaccurate information such as incorrect product code are submitted
­ Intended Use Code qualifier "UNK" (Unknown)
· To expedite FDA review:
­ All information provided should be complete and accurate ­ Provide conditional data elements if applicable to the
product being declared ­ Provide optional data elements such as:
· FEI and/or DUNS · Quantity and Unit of Measure
34

Use the FDA Supplemental Guide
· Review each of the PG records until all required information is understood and has been provided by the importer
· Each section identifies:
­ mandatory, optional, and conditional data elements ­ codes and code descriptions ­ length/class (syntax) for data element types
· Follow any instructions provided by your software vendor to ensure all data elements are entered for transmission.
35

Summary
· Know the product being imported and associated requirements
· Understand the data elements · Provided correct and accurate information · Give Entry Filers the information they need · Obtain all necessary information from the
Importer
36

Frequently Asked Question
Q: If I transmit an FDA entry, does ACE allow me to correct the data if I realize I made a mistake?
A: When CBP receives an entry, it will automatically send the entry to FDA to process in real time if the entry is within five days of arrival. Unless CBP or FDA rejected the entry, no corrections can be made. If CBP or FDA did reject your entry, work with your ABI representative to send a correction.
37

Frequently Asked Question
Q: When does FDA receive the entry data from CBP? I have had an "FDA Review Message" for several days.
A: Once the entry is accepted by CBP, CBP sends out a generic message that says "DATA UNDER PGA REVIEW." This is not a confirmation that the data was sent to FDA. CBP will only send the entry to FDA, if the transmitted arrival date is within five days. If it is more than five days out, CBP will wait until it is within that timeframe to send it to FDA.
If it is within five days of arrival and you have not received any FDA response within your usual turnaround time, contact FDA's ACE Help Desk at ACE_Support@fda.hhs.gov and your CBP Client Representative.
38

Frequently Asked Question
Q: Does FDA prefer DUNS or FEI numbers for entity identification codes (PG19)?
A: FEI and DUNS are optional, but encouraged.
Note: As of 5/30/2017, the DUNS will be required for the FSVP importer for each line entry of food, unless they are subject to exemption and/or modified requirements. For additional information, visit
https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm549668.htm.
39

Frequently Asked Questions
Q: Is the Drug Registration number an FEI number?
A: The Drug Registration Number (REG) is the 9-digit DUNS number the firm has on file with FDA Center for Drugs, Evaluation, and Research (CDER) Drug Registration (eDRLS). Only those DUNS numbers on file with eDRLS are Drug Registration Numbers (REG).
These can be found at on the Drug Firm Registration Lookup webpage:
http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
40

Frequently Asked Question
Q: Why can't I see the status of my entry in ITACS? Why does it say "FDA entry status information is not available pending receipt of conveyance arrival notification" when the shipment has arrived?
A: CBP is not consistently sending arrival notifications to FDA upon arrival of a shipment. Without receipt of that notification, ITACS will display the above message. This does not affect the ability to submit documents, submit availability information, or FDA's ability to review the entry.
Reference: CSMS #16-001003
41

Frequently Asked Question
Q: What are the lessons learned for how ACE changed filing for FDA?
A: Communicate early and often about FDA requirements. (Importer, Broker, and Software Vendor).
Delays and rejects occur when inaccurate information is provided, such as invalid product code or an unknown intended use code.
Use FDA as a resource. Attend webinars or request a training session. We are here to help.
42

Frequently Asked Questions
Q: Is "UNK" (Unknown) still allowed as an Intended Use Code?
A: UNK is still allowed as an Intended Use Code when the IUC is mandatory. If "UNK" is declared, CBP will not reject the entry if Affirmations of Compliance are not provided.
FDA highly encourages the transmission of complete data, including the correct Intended Use Code and Affirmations of Compliance. Refer to the FDA Supplemental Guide for a full list of requirements based on the import scenario.
UNK should only be used if information is not able to be obtained. Utilizing this code may lead to manual reviews and delayed processing by FDA.
43

Resources
· CSMS #16-000557, FDA ACE Entries: Common Errors https://csms.cbp.gov/viewmssg.asp?Recid=21913&page=&srch_argv= 16-000557&srchtype=&btype=&sortby=&sby=
· CSMS #16-000741, FDA ACE Reject Document Posted to FDA.gov https://csms.cbp.gov/viewmssg.asp?Recid=22092&page=&srch_argv= 16-000741&srchtype=&btype=&sortby=&sby=
44

Resources Available Online
· FDA ACE Affirmations of Compliance and Affirmations of Compliance Quick Reference at http://www.fda.gov/forindustry/importprogram/entryprocess/entrysubmissionprocess/ucm461234.htm
· FDA ACE/ITDS Webpage (including FDA Supplemental Guide) at https://www.fda.gov/industry/import-systems/automated-commercial-environmentinternational-tradedata-system-aceitds
· FDA DUNS Portal at https://fda.dnb.com/FDAUI/login.aspx and FDA Guide at https://www.fda.gov/media/95828/download
· Product Code Builder Tool and Tutorial at https://www.accessdata.fda.gov/scripts/ora/pcb/index.cfm
· For more information about FDA's Import Program, visit http://www.fda.gov/forindustry/importprogram/default.htm
· For information about ACE Quantity Data Instructions, visit https://www.fda.gov/downloads/ForIndustry/ImportProgram/EntryProcess/ImportSystems/UCM48725 6.pdf
45

Resources
Contact the FDA Imports Inquiry Team for questions regarding FDA import operations and policy, product coding,
FD flags associated with HTS codes, entry declaration requirements for determining admissibility, if a product is
regulated by FDA and other general import questions.
FDAImportsInquiry@fda.hhs.gov 301-796-0356
46

Resources
Contact FDA ACE Support Center for technical questions related to the FDA Supplemental Guide, required data elements, ACE entries, rejects, and errors.
ACE_Support@fda.hhs.gov 877-345-1101 (domestic toll-free) 571-620-7320 (local or international)
CSMS #17-000162: The ACE Support Center operates from 6 a.m. to 10 p.m. EST seven days per week.
Always keep your CBP Client Representative on all ACE-related email traffic
47

FDA Points of Contact for Imports

FDA Unit
ACE Support Center
FDA Imports Inquiry
Local FDA Office
Division of Food Defense Targeting

Contact Information

Areas of Focus

ACE_Support@fda.hhs.gov

Technical issues related to the FDA

Toll Free: 877-345-1101

supplemental guide, required data elements,

Local/International: 571-620-

and general ACE submission questions,

7320

including entry submissions rejected by FDA.

FDAImportsInquiry@fda.hhs.gov 301-796-0356

General questions regarding FDA import operations and policy, including product classification (program, processing, product

and HTS codes) and declaration

First-line support for product coding and

http://www.fda.gov/ForIndustry/I mportProgram/ucm319216.htm

entry-specific questions, including working through the FDA entry admissibility process, once the entry is successfully transmitted to

FDA and accepted

Prior.Notice@fda.hhs.gov

866-521-2297 http://www.fda.gov/Food/Guidanc eRegulation/ImportsExports/Impo

General questions regarding Prior Notice for food shipments

rting/ucm2006836.htm

48

Questions
49