Contains Nonbinding Recommendations 
 
Establishing and Maintaining a List of 
U.S. Dairy Product 
Manufacturers/Processors with Interest 
in Exporting to Chile: Guidance for 
Industry and FDA 
 
 
Additional copies are available from: 
Office of Food Safety 
Division of Dairy, Egg and Meat Safety HFS-306 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
  College Park, MD  20740   
(Tel) 240-402-1485  
 
 
You may submit written comments regarding this guidance at any time.  Submit written 
comments on the guidance to Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should 
be identified with the title of the guidance document.   
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
May 2003; Revised June 22, 2005 and November 2018 
 
OMB Control No. 0910-0509 
Expiration Date: 11/30/2020 
*See additional PRA statements in Section III of this guidance 
  Contains Nonbinding Recommendations 
 
Table of Contents  
 
I.  Introduction 
 
II.  Discussion 
 
III.  Paperwork Reduction Act of 1995 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
 
Establishing and Maintaining a List of 
U.S. Dairy Product 
Manufacturers/Processors with Interest 
in Exporting to Chile: Guidance for 
 1
Industry and FDA   
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page. 
 
I.  Introduction 
This guidance document is being published to notify the public of FDA's efforts to assist U.S. 
manufacturers/processors (hereinafter referred to as firms) that wish to export dairy products to 
Chile.  FDA took this action in response to discussions with Chile that were adjunct to the 
negotiations of the United States-Chile Free Trade Agreement.  As a result of those discussions, 
Chile recognized FDA as the competent food safety authority in the United States to identify 
U.S. dairy product manufacturers and processors eligible to export to Chile and concluded that it 
will not conduct individual inspections of U.S. firms identified on a list established by the FDA 
as eligible to export to Chile.  The list identifies U.S. firms that have expressed interest to FDA 
in exporting dairy products to Chile, that are subject to FDA jurisdiction, and that are not the 
subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending 
warning letter.  The List of U.S. Dairy Product Manufacturers/Processors with Interest in 
Exporting to Chile established by FDA is posted on FDA's Internet site and shared with Chile.  
Every two years, Chile passes an authorizing resolution accepting this list and provides the list to 
their ports of entry to facilitate the importation of U.S. dairy products.  Chile has requested that 
this list be updated every two years at the expiration of the current authorizing resolution.  
Therefore, FDA intends to contact the U.S. firms that are on the list every two years to verify 
that the information they have provided to FDA is still valid.  FDA intends to report this updated 
list to Chile so that Chile can reauthorize its resolution for another two-year period. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
                                                
1 This guidance has been prepared by the Office of Food Safety, Division of Dairy, Egg and Meat Safety in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.   Contains Nonbinding Recommendations 
 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required. 
This is a revision of the second edition of this guidance, which FDA issued in June 2005.  This 
guidance revises the procedures firms should use to be included on FDAs list of dairy exporters 
to Chile. 
II. Discussion   
 
A.  Establishment of a List of U.S. Dairy Product Manufacturers/Processors 
FDA has established and is maintaining a list identifying U.S. firms that have expressed to FDA 
their interest in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the 
subject of a pending judicial enforcement action (e.g., an injunction or seizure) or a pending 
warning letter.  The list is sent to responsible authorities in Chile, and is posted on FDA's 
Internet site at: 
https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm120245.htm. 
Subsequent to the publication of the second edition of the guidance, FDA launched an electronic 
system for receiving and processing requests for inclusion on this list.  Consequently, FDA is 
revising the guidance to explain how firms should request to be listed and how to update current 
listing information. Application for inclusion on this list is voluntary.  However, Chile has 
advised that dairy products from firms not on this list could be prevented by Chilean authorities 
from entering commerce in Chile.  The term "dairy products" for purposes of this list is not 
intended to cover the raw agricultural commodity raw milk. 
FDA requests that all firms wishing to be included on the Chile dairy export list or to update 
their listing information indicate their interest by submitting an application to be listed via the 
FDA Unified Registration and Listing Systems (FURLS) Export Listing Module (ELM) found at 
https://www.access.fda.gov/.  The ELM facilitates the collection of firm and product information 
that FDA will use to determine eligibility for placement on the export lists.  Respondents who 
need help completing applications online or who need to submit applications through other 
means may contact the Center for Food Safety and Applied Nutrition (CFSAN) directly by mail 
using the address on the cover page of this guidance, by email 
(CFSANExportCertification@fda.hhs.gov) or telephone (240-402-2307). 
The list on FDA's Internet site and the information shared with Chile, some or all of which may 
be posted on Chile's website, includes the plant numbers; names, telephone numbers, and e-mail 
addresses of the contact persons; and lists of products being exported to Chile, in addition to the 
names and addresses of the firms' manufacturing and processing plants.  The information 
identified above for submission to FDA is intended to assist FDA in establishing and maintaining 
the list.  We consider the information on this list, which is provided voluntarily with the 
understanding that it will be communicated to Chile and posted on the Internet, to be information 
that is not protected from disclosure under 5 U.S.C.  552(b)(4).  Contains Nonbinding Recommendations 
 
B.  Inclusion on the List 
For each firm that submits an application, FDA intends to review the applicant's recent 
inspection history, including FDA or other Federal or State agency inspections. FDA intends to 
place the names and addresses of firms that are not the subject of a pending judicial enforcement 
action (e.g., injunction or seizure) or a pending warning letter on the list. FDA intends to deny 
listing a firm if the firm is the subject of a pending judicial enforcement action or a pending 
warning letter. 
FDA intends to send a confirmation e-mail or letter to the applicants to notify them of FDA's 
decision with respect to their eligibility or ineligibility for inclusion on the list.  Every two years, 
FDA also intends to send a letter to firms that are currently listed, requesting that they update the 
information they initially provided and indicate whether they wish to continue being listed. 
C.  Updating the List 
FDA intends to provide Chilean authorities with an updated list of firms on a quarterly basis.  
The quarterly update will list any additional firms that have applied to FDA within the previous 
three-month period and have been determined by FDA to meet the criteria for inclusion on the 
list.  FDA also intends to delete from the list on a quarterly basis those firms that FDA has 
determined (either by notice from the firm or by FDA inspection) have gone out of business or 
have indicated to FDA in writing that they no longer intend to export dairy products to Chile.  
FDA also intends to remove from the list any firms that do not respond to FDA's request every 
two years for updated information.  The quarterly update schedule along with the two-year 
request for updated information is intended to provide FDA and dairy firms with a structured and 
predictable schedule for updating the list and to provide FDA with sufficient time to determine 
the eligibility or ineligibility of firms applying for placement on the list. 
If a listed firm subsequently becomes the subject of a pending judicial enforcement action or a 
pending warning letter, FDA intends to remove that firm from the list posted on the Internet and 
to send a revised list to Chilean authorities as soon as possible after the firm becomes the subject 
of the pending judicial enforcement action or pending warning letter, usually within 48-72 hours 
after the relevant FDA action.  Since a pending judicial enforcement action or a pending warning 
letter, if associated with a food safety concern, necessitates a more expedient process to protect 
public health, FDA intends to remove such a firm from the list as soon as possible, rather than to 
wait for the quarterly update described above. 
FDA intends for each issuance of the list, whether issued as a result of a scheduled quarterly 
update or as a result of removal of a firm due to a pending judicial enforcement action or a 
pending warning letter, to be numbered sequentially and dated to indicate the date of the most 
recent update. 
 
  Contains Nonbinding Recommendations 
 
III.  Paperwork Reduction Act of 1995  
 
This guidance contains information collections that 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 time required to complete this information collection is estimated to average 60 minutes per 
response and 30 minutes per update every two years, including the time to review instructions, 
search existing data resources, gather the data needed, and complete and review the information 
collection.  Send comments regarding this burden estimate or suggestions for reducing this 
burden to: 
 
FDA PRA Staff, Office of Operations 
Food and Drug Administration 
Three White Flint North, 10A-12M 
11601 Landsdown St. 
North Bethesda, MD 20852 
PRAStaff@fda.hhs.gov 
 
 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
 
collection of information unless it displays a currently valid OMB control number.  
 
The OMB control number for this information collection is 0910-0509 (expires 
 
11/30/2020).