January 27, 2014 Division of Dockets Management (HFA

January 27, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Docket No. FDA-2011-N-0143
Foreign Supplier Verification Programs for
Importers of Food for Humans and
Animals and Hazard Analysis and
Risk-Based Preventive Controls for
Human Food
Docket No. FDA-2022-N-0146
Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food Safety
Audits and to Issue Certifications
Submitted via eRulemaking Portal: http://www.regulations.gov
Dear Sir or Madam:
The National Coffee Association (NCA) appreciates the opportunity to submit comments on the
above referenced proposed rules consistent with the notices published in the Federal Register
(78 FR 45730-45779 and 78 FR 45782-45839).
NCA represents the U.S. coffee industry, which generates $36 billion annually in retail and
foodservice sales, and conducts over $5 billion in trade with 50 countries from Africa, Asia,
and Latin America. In addition to the 2,300 roasters and importers, the industry is comprised
of nearly 28,000 coffee cafés employing persons in every state and region. Through retail,
restaurant and coffee café sales, the industry serves approximately 175 million consumers
annually.
NCA membership, which includes roasters, coffee growers, importers and exporters
domiciled within and beyond the borders of the United States, will be impacted by rules
proposed under The FDA Food Safety Modernization Act of 2011 (FSMA) that relate to the
statute’s provisions regarding Foreign Supplier Verification Programs for Importers (FSVP)
and Accreditation of Third-Party Auditors/Certification Bodies to conduct food safety audits for
some aspects of FSMA compliance.
NCA appreciates the fact that the U.S. Food and Drug Administration (FDA) continues to
develop rules to implement this important legislation. NCA supports the paramount importance
of preventing contamination and health safety risks throughout the U.S. food chain through a
system that is based on risk-based assessments and sound risk management practice. NCA
particularly favors the approach taken in the legislation, and reflected in the regulatory construct,
to focus on prevention rather than remediation.
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
Page Two
Introduction
Supporting the approach and intent of FSMA, the FSVP essentially extends the reach of the
statute’s regulatory focus on the prevention of foodborne illness beyond the borders of the
United States. Parallel in many ways to the supplier verification required of domestic facilities
under the Hazard Analysis (HA) and Preventive Controls (PC) regulation, the FSVP aims to
ensure that the statute’s strict regimen of protective measures are also securely applied by
suppliers of imported foods before they reach U.S. shores.
However, several of the FSVP provisions and procedures proposed by FDA extend regulatory
measures beyond the legislative intent and pose compliance burdens that will result in
unnecessary logistical and financial burdens without providing corresponding food safety
benefits – as well as counteracting existing policies and protocols that currently serve to ensure
food safety and effectively propel the legislative intent of FSMA. The fact that green coffee
beans, caffeinated or decaffeinated (hereafter referred to as “coffee”), are nearly always
imported but also always are a low risk commodity means that FDA’s proposed foreign supplier
verification requirements, as applied to imported coffee, must be commensurate with those risks
and with the nature of the supply chain so that the agency does not impose unnecessary
burdens on our importers.
Executive Summary: Imported Coffee is a Low-Risk Commingled Raw Agricultural
Commodity for which Foreign Supplier Verification Requirements Should Be
Correspondingly Limited
FDA should recognize in the preamble to the final rule the unique attributes of imported coffee:
i.e., that imported coffee is a low-risk commingled raw agricultural commodity for which foreign
supplier verification requirements should be correspondingly limited. First, coffee is inherently
low risk and not associated with the types of microbial or food allergen concerns that would
normally present a potential Class I recall-level risk. This fact by itself justifies a proportionately
limited set of supplier verification demands. Second, imported coffee is virtually always roasted
in the United States, and the foreign supplier is not relied upon to control the hazards. Indeed,
the foreign source of coffee is simply the supplier of a commingled raw agricultural commodity
that is further processed in the United States. This reinforces the conclusion that foreign
supplier verification is not needed from a hazard control standpoint. Third, to the extent that
coffee is considered “produce” it would be exempt from the requirements under FDA’s proposed
rule for fresh produce safety due to subsequent commercial processing. This means there are
no FDA on-farm regulations for imported coffee against which verifications of compliance would
be needed. Finally, the unique nature of the raw coffee bean supply chain makes a “one step
back” verification process an absolute necessity.
Taken together, it is clear that imported coffee should only be subject to limited foreign supplier
verification requirements. FDA should clarify that, for imported coffee, the importer must only
look “one step back” in the supply chain to assure that the coffee exporter is taking reasonable
steps to assure that the commingled raw agricultural commodity is not adulterated under U.S.
law. Coffee importers should be given broad flexibility on how to accomplish that goal.
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
Page Three
To the extent that coffee importers wish to avail themselves of audits conducted by FDAaccredited third-party auditors to meet their foreign supplier verification obligations, supplier
verification audits should not be subject to the requirements in FSMA Section 307 that the
statute reserves for the Mandatory Import Certification (MIC) program and the Voluntary
Qualified Importer Program (VQIP). We believe this approach fully meets both the letter and the
spirit of FSMA and provides complete protection for the U.S. consumer. We elaborate on these
key points below.
Coffee is a Low-Risk Product
FSMA hinges on the concept of protecting the U.S. food supply. Throughout the rulemaking
process, the FDA has recognized and deployed the statute’s legislative intent. In so doing, the
coffee industry has consistently encouraged the agency to adopt a non-prescriptive approach,
built on the statute’s basic premise of a risk-based structure, incorporating the risk level
associated with each type of food into the regulatory framework set forth. The agency has
generally acknowledged food industry comments to keep the proposed rules flexible rather than
prescriptive. This flexibility enables companies to apply the new rules in a risk-based way,
consistent with the type of food and extent of controls used at a given facility. This risk-based
approach is consistent with the fundamental approach of FSMA, which pervades many of the
statute’s provisions.
In that regard, coffee should be recognized for its low-risk nature with regard to potential food
contamination. Risk generally enters the food chain through spoilage, improper holding
temperature or storage conditions, or importation from sources known to lack adequate safety
controls. Coffee is a low-risk food on several levels. First, coffee is a dry commodity in its green
state and is not susceptible to spoilage. As such, coffee is inherently a low-risk, commingled raw
agricultural commodity, marginalizing any concerns about contamination due to inadequate
safety controls at origin nations. Further, coffee cannot be consumed without roasting at high
temperatures followed by brewing. This extensive treatment addresses any of the few food
safety concerns that could exist for the raw product. While not raised in the current proposed
rules, intentional contamination is also amply addressed through coffee industry participation in
the Customs-Trade Partnership Against Terrorism program (C-TPAT), the voluntary supply
chain safety program conducted by the U.S. Customs & Border Protection (CBP) agency of the
Department of Homeland Security (DHS).
Therefore, adequate recognition should be given to the low-risk nature of coffee. In turn, the
proposed regulatory design should incorporate adequate flexibility to afford levels of scrutiny in
proportion to the level of risk proposed by a given food. For coffee, that would be an
appropriately lower level of scrutiny which, given the nature of the commodity, preserves the
same high level of safety assurance. Coffee should not be subject to the same supplier
verification requirements as higher risk commingled raw agricultural commodities.
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
Page Four
Coffee is Exempt from the Product Safety Requirements: Therefore, No Foreign Supplier
Verification is Needed to Assure Compliance with that Rule
For raw agricultural commodities that are fruits or vegetables, importers must also verify
compliance with FSMA’s produce safety rules. Under FSMA’s produce safety proposed rule,
produce is explicitly excluded under two circumstances: 1) specified produce commodities that
are rarely consumed raw; and 2) produce subject to a kill step through commercial processing.
Conceptually, coffee qualifies for the anticipated exemption under both conditions.
Notably, coffee is not referenced directly in the produce safety rules. However, there are several
ways, whether by design or accident, that coffee may be construed as within its purview. First,
the definition of “produce” is not represented to be exhaustive, and so despite the absence of
direct reference, coffee could be included by default. Moreover, under the preventive controls
rule, coffee is within the sphere of “fruit or vegetable,” whereupon it would fall within the
definition of “produce.” In addition, coffee is not on the produce safety rules’ specified list of
“produce that is typically not consumed raw.”
Coffee is not a fruit, vegetable or produce. In its green state, coffee is a dried seed that is not
consumable without roasting and brewing at high temperatures. Coffee is not similar to any
other listed item of produce and so should not be regarded as “produce.” As such, it falls outside
of the produce anticipated for scrutiny by FSMA and the proposed rules.
For argument sake, even if coffee were considered as “produce,” it is never consumed raw.
Therefore, coffee should be added without question to the list of “produce that is typically not
consumed raw.” Moreover, to be consumable, coffee must be roasted at high temperatures,
after which the ground beans must be brewed. High-temperature roasting sanitizes coffee of
microorganisms and is an established “kill step” as referenced in the proposed rules.
Since coffee qualifies for both criteria, either of which alone would qualify it for exemption from
the produce safety rules, NCA maintains that coffee should enjoy a blanket exemption. That
exemption eliminates further need for individual clarifications to the definitions of “fruit or
vegetable,” or “produce” and/or the list of “produce that is typically not consumed raw.”
Accordingly, as the agency’s product safety regulation does not apply to coffee, there are no
regulatory requirements for on-farm activities against which compliance by foreign growers
needs to be verified.
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
Page Five
FDA Should Clarify the Meaning of “Adequate Assurances”
Fundamental to FSVP is the concept of providing “adequate assurances” that food is accorded
“at least the same level of public health protection” as FSMA’s HA and PC requirements. Since
virtually all coffee must be imported into the U.S., the focus on imported foods through the
FSVP elevates the potential impact and burden on the U.S. coffee industry.
The need to provide “adequate assurances” about compliance with the HA/PC standards in the
context of FSVP also elevates the importance of a clear definition of those standards.
“Adequate assurances” – regardless of the FSVP measures set forth to secure them – cannot
attain a reliable level of certainty when FSVP introduces a loose definition of their application. In
other words, applying a FSVP standard of “at least the same level of public health protection” 1)
leaves open the application of standards other than HA/PC, 2) incorporates by reference the
uncertainties built into the HA/PC standards and, moreover, 3) raises questions about the
practicality of application of HA/PC standards where the facilities which need to have adequate
controls in place are outside of U.S. jurisdiction, U.S. traditions of food safety protocols (such as
HACCP plans), and direct control by U.S. importers/exporters.
Despite the importance of the standard to the structure of FSVP, the proposed rule offers no
further explanation of the meaning of “same level of public health protection.” While there is a
presumption that the standard engages HA/PC rules, there is no clear defining language.
Because of additional issues raised by the application of HA/PC rules in the international
context, as outlined below, NCA strongly recommends that a flexible approach be adopted to
meeting the FSVP standard of “at least the same level of public health protection.” Given that
the FSVP proposed rule appears to contemplate that other standards may provide the same
level of public health protection, a flexible approach should comport with the proposed rule’s
anticipated application.
Should the intent be to incorporate HA/PC standards, FSVP would in turn incorporate remaining
uncertainties in HA/PC standards. More significantly, the application of HA/PC standards in a
trans-national setting under FSVP may prove difficult, if not untenable, in several ways.
Under HA/PC, each facility that manufactures, processes, packs or holds food for sale in the
U.S. must identify and evaluate known or reasonably foreseeable hazards for each type of food
and, in turn, each facility must identify and implement preventive controls for those hazards.
Under FSVP, the food safety systems in place at foreign suppliers’ facilities are effectively
guaranteed only through the legal responsibility assigned to importers.
When considering whether “adequate assurances” exist, importers should consider issues such
as: Do the foreign supplier’s facilities have adequate, written food safety plans in place? Have
they accounted for all hazards “reasonably likely to occur”? Are they keeping compliant
records?
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
Page Six
Supplier Verification Requirements for Coffee Should be Flexible and Limited
Pervading all of the compliance measures specified under FSVP should be coffee’s inherent
low-risk status. On the most basic level, requirements for importers’ development of an FSVP
are specific to “each type of food,” and for coffee the construct should take into account coffee’s
low level of risk. In fact, the low-risk nature of coffee should cascade up the regulatory pyramid
on which FSVP is built – namely, the assessment of hazards that are “reasonably likely to
occur” under HA/PC, which impacts foreign suppliers’ bar in meeting the standard of “at least
the same level of public health protection,” and which in turn triggers the compliance parameters
for providing for “adequate assurances” with their programs. That is, because all of the
“reasonably likely to occur” hazards in coffee are controlled domestically, no verification of
foreign suppliers should be required.
Coffee’s low-risk nature stems from several immutable steps in its manufacture. Coffee is unfit
for consumption without roasting at high temperatures. That process involves application of
above-threshold temperatures and duration to eliminate any microorganisms that may, however
unlikely, be present on the green coffee bean. The roasted bean must also be further
processed, as well as brewed before consumption.
As part of the FSVP, importers are required to complete a review of the compliance status of
foreign suppliers, including Warning Letters, Import Alerts and mandatory certification orders.
While aimed at the noble goal of assessing the regulatory compliance of the supplier, we are
concerned that the benefits of this requirement would be stymied by practical application
challenges. Particularly with foreign suppliers, the availability of the documents that FDA wants
importers to review is sketchy at best. There is a very low likelihood that the extensive search
required for each foreign supplier would result in any responsive information – givern the unique
nature of our industry, as FDA understandably does not place a high priority on inspecting
exporters of low-risk products. Therefore, this requirement would establish a commercial burden
that, because of the scarce availability of these documents for foreign suppliers, would
effectively serve no public health benefit. In addition, being subject to an FDA compliance action
would likely not disqualify the supplier automatically, further divorcing the burden of compliance
from any direct public benefit. That is, simply because responsive information is identified, this
does not necessarily mean that the supplier is not able to supply food that is safe for its
intended purpose. A requirement to engage in a compliance status review also seems
unnecessary when the importer or the importer’s customer is controlling the hazards in the food.
What matters most for supplier verification purposes is the inherent risk of the product (for which
coffee is inherently low) and the risk of the supplier (largely determined by the importer’s
historical track record with that supplier). Accordingly, FDA should reduce or eliminate the focus
on FDA compliance history.
FDA Should Simplify Documentation of Importer Status for Importers of Coffee
Verification activities are put in the hands of importers under the premise that the responsible
party – or “importer” – as defined in the statute – is the owner of the food when it crosses the
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
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U.S. border, denoting a financial interest in assuring its safety and the likely capacity to conduct
FSVP activities. Accordingly, the rule defines “importer” as a “person in the U.S. who has
purchased an article of food that is offered for entry into the U.S.” However, if the food is not
already sold at the time of entry, the “importer” becomes the person in the U.S. to whom the
article has been consigned at the time of entry. If there is no U.S. owner or consignee, then the
“importer” would be the U.S. Agent or representative of the foreign owner or consignee at the
time of entry.
The circumstances surrounding the importation of coffee make the designation of importer and
imposition of related food safety responsibility more complex. As a commingled raw agricultural
commodity, coffee must be further processed, with hazards controlled by the processor in the
U.S. that often is the importer’s customer. The proposed rule exempts importers from supplier
verification activities if they can document annually that their customer controls the hazards. We
think this kind of documentation requirement is unnecessary for a food like coffee where it is
obvious that the food will be adequately processed before consumption (because otherwise it is
inedible). FDA should reconsider this requirement so that it is not mandatory for importers of
products where their customers necessarily will control the hazards.
Additionally, with a supply chain that includes an array of buyers, traders and brokers in the
U.S., the processor with control over the hazards will not always be regarded as the “importer.”
In this scenario, the processor can sometimes be the importer and other times not, and yet the
processor is ultimately controlling the hazards. One notable example is the occasional “foreign
importer of record,” who imports, warehouses and even lists coffee on the commodities
exchange without a U.S. connection. This scenario would allow responsibility to devolve down
to the warehouse as the consignee, while it would be inappropriate to assign responsibility for
food safety to a warehouse. Rather than allowing this default to the ultimate consignee, NCA
recommends that FSVP make specific provision for the engagement of an independent
sampler.
FDA Should Clarify “Foreign Supplier” as Applied to Imported Coffee
For coffee, the identification of the “foreign supplier” is also of particular concern. The proposed
rule defines the foreign supplier as the foreign farm that harvested the crop or the last foreign
establishment that manufactured/processed the food in more than a de minimis way. Coffee
generally moves from the farm to a mill, where the bean is extracted from the cherry by means
of fermentation, washing and/or drying. This step likely qualifies as processing that is more than
de minimis, making the mill the “foreign supplier.” However, further clarification is needed on the
de minimis standard and/or its application in the context of the coffee supply chain. Activities
that could use clarification confirming compliance under the de minimis standard include mixing,
processing and packing of food into primary contact containers.
Confirmation that processing at the mill exceeds de minimis processing standard would align
with the FDA’s definition of the “exporter” which is required to register with the agency, namely
the last foreign establishment that manufactured/processed the food in more than a de minimis
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
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way. This alignment would serve to clarify the identity of the foreign supplier as well as add a
further layer of security within the coffee supply chain.
Another way to say this is that FDA should rely on the “one-back” rule adopted for records
traceability under the Bioterrorism Act of 2002. This rule would limit the identification of the
“foreign supplier” to the last party in possession of the coffee before it sets sail for the U.S. The
“one-back” rule, moreover, aligns nicely with the FDA’s definition of the “exporter” who is
required to register with the agency. Moreover, as a commingled raw agricultural commodity
that is not a fruit or vegetable, coffee qualifies for the specific provision in FSMA that limits
traceability to one step back. If FDA requires suppliers to be verified more than one step back
on the chain, this would exceed legal authority for traceability. Additionally, the coffee industry
has consistently encouraged the FDA to align definitions, wherever feasible, among rules
affecting food imports, be they stipulated under FSMA, Bioterrorism or other statutes.
Verification Activities Should Be Flexible
Which party is controlling the hazards triggers different requirements under FSVP. Where the
importer controls the hazards, it must document at least annually that it has established and is
following procedures that adequately control the hazard and, similarly, the importer must obtain
at least annual assurance from a customer who controls the hazard. If these criteria are met,
there is no further need for the importer to conduct a foreign supplier verification activity
regarding the hazard. As discussed above, we are concerned about the documentation
requirement when an importer’s customer controls the hazards.
However, where the hazard is controlled by the foreign supplier, the FDA presents two
alternative proposals for verification requirements and is requesting public comment on which it
should apply. Option 1, focusing on hazards that pose a reasonable probability of serious harm
to public health (i.e., hazards that could cause a Class I recall), would require the importer to
conduct an initial on-site audit and at least annual subsequent audits for suppliers that control
these most serious hazards, with the on-site audits conducted either by the importer or a third
party. Specifically, on-site auditing would be required for microbiological hazards in raw
agricultural commodities like coffee if the supplier controls these hazards. Option 2, which would
apply the same approach for all hazards, offers more flexibility, allowing the importer to choose
the activity that would adequately verify that the hazard managed by the supplier has been
adequately controlled.
NCA strongly recommends the adoption of Option 2 to comply with supplier verification
requirements. For coffee, Option 1 would not apply regardless of the FDA’s choice because, as
a low-risk commodity, foreign suppliers are not controlling any hazards that pose a reasonable
probability of serious harm. Moreover, the flexibility reflected in Option 2, which embraces a
menu of options such as periodic auditing, testing, records review and other procedures
established to be appropriate, is in line with the safety procedures and protocols already in
place throughout the coffee supply chain. Thus, it builds on well-established, effective practices
that the industry already uses today. Option 2 also presents the flexibility to respond to future
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
Page Nine
hazards that the industry may not be able to anticipate at this time. Examples include new
hazards that may arise along the supply chain, changing verification activities, such as
technologies that alter processing at mills, and electronic versus paper recordkeeping.
Third-Party Audits May Be Used, But Not Required, for Imported Coffee
Since coffee is a low-risk food, we urge FDA not to require an MIC for coffee, which would
trigger the Third-Party Certification mandate for a certification by an FDA-accredited auditor to
accompany foods offered for import. However, it is important to note that the requirements for
FDA-accredited third-party auditors should not apply if an importer chooses to use an FDAaccredited auditor for audits under their FSVP. Such a requirement contradicts FSMA, which
limits any requirements for third-party auditors to only “regulatory audits” (MIC and VQIP) –
which do not encompass the FSVP
It is possible that the best supplier verification audits will come from audits conducted by FDAaccredited third parties. Industry should be able to take advantage of this valuable resource
without the consequence of having the resulting audit reported directly to the FDA, having direct
reporting to FDA of serious problems, or laboratory testing results directly reported. Industry’s
alternative might be to retain other third-party auditors which may not have the desired expertise
in our field, which will not serve public interest in ensuring food safety.
Furthermore, regardless of who conducts the audit, FDA should not be given access to audit
reports for supplier verification audits. It is clear from prior rules regarding infant formula and
medical devices that it is against public policy for the agency to access an audit report during a
routine inspection. FDA should interpret the third-party certification construct so that any audits
completed by an accredited auditor or certification body would not be sent automatically to the
agency. It is burdensome enough for high-risk foods and certainly should not be extended to
low-risk foods like coffee. This is another reason why FDA-accredited auditors should be able to
conduct FSVP audits without application of the same requirements that would apply if they
conduct audits for certification purposes for MIC or VQIP.
Foreign manufacturers routinely conduct consultative audits to test and improve their food
safety controls. Subjecting these audits to automatic FDA reporting for instances of serious
public health risks would have a dissuasive effect on this important self-directed and effective
audit measure. Because the purpose of the audit is self-improvement, such reporting would be
irrelevant and misleading if delivered to FDA – and also would be out of the context of its
application as part of the overall food safety design of the supplier’s facility, the reason for the
consultative audit, and the changes made as a result of the audit. Also, it will also be of great
benefit to food safety along the supply chain to be able to secure the best possible auditing
knowledge in a consultative manner.
January 27, 2014
FSMA FSVP and Third-Party Certification Comments
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FDA Should Reexamine Aspects of Its Proposed Records-Related Requirements
The proposed rule would require documents to be provided to FDA electronically upon request
and would require all FSVP records to be maintained in English. First, this “remote access”
requirement (perhaps through online submission) opens the door to the potential for these
documents to get into unintended hands via passive technical errors or deliberate hacking.
Revelation of data specific to the facility in question could identify them to those who may have
intent to interfere with safety.
This scenario not only threatens to undermine the integrity and security of the individual facility’s
safety control system, but also creates an avenue by which detailed information about safety
procedures and protocols can end up in the hands of those who might try to introduce
adulteration, such as through a potential act of terrorism. Moreover, such a requirement is
clearly beyond FDA’s express statutory authority and also is not necessary to effectuate the
goals of the Act.
Regarding the English language requirement, we are concerned that the importers, who
themselves may not speak English as their first language, are required to maintain the records
that they create in English. This imposes an unnecessary translation burden and could be bad
for food safety if the translation causes confusion, as is quite possible. Moreover, for coffee,
virtually every origin nation has a predominant language other than English. This means that a
lot of translation will be needed for records created by a foreign supplier and sent to an importer
as a verification activity. Therefore, the accuracy and utility of providing “adequate assurances”
would be best served by allowing documents to be created and maintained in the importer’s
native language and the native languages of the origin nations. For the coffee supply chain, that
would mean that, at a minimum, allowed languages for FSVP documents should be specified to
include English, Spanish, Portuguese, Indonesian, Vietnamese, Oromigna and Amharic. We
support a requirement to translate documents for the FDA, upon request.
Summary
In summary, connecting all of the observations and recommendations discussed above is the
basic, underlying purpose and legislative design of FSMA. Aimed at protecting the U.S. food
supply, it adopts an approach that is based most fundamentally on identifying risks and
addressing them in a manner commensurate with the nature and level of the risk posed by
individual foods. Coffee is an inherently low-risk food that should, in line with statutory intent and
purpose, be accorded appropriately non-prescriptive treatment, as discussed above, which
comports with its innate and exceedingly low risk level.
Respectfully submitted,
The National Coffee Association

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