0509 - Chile guidance

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
Industry and FDA 1
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 FDA’s 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. 35013520).
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).