\"Third-Party Certification Programs for Foods and Feeds; Request for
Comments\"\
April 1, 2008 FDA Prepublication Federal Register Notice\
[http://edocket.access.gpo.gov/2008/E8-6705.htm](https://delusawas.webmail.ec.europa.eu/exchweb/bin/redir.asp?URL=http://edocket.access.gpo.gov/2008/E8-6705.htm)

Request for Information\
\
FDA is seeking information on the use of third-party certification
programs. In addition to general information, we are posing several
specific questions related to these types of programs.\
\
*1. What domestic and foreign third-party certification programs for
suppliers are currently in use by U.S. companies?*

*2. Do the current third-party certification programs ensure compliance
with FDA requirements?*

3\. What are the obstacles to private sector participation in these
third-party certification programs?

4\. What incentives would increase participation in these third-party
certification programs?

**[Comment:]{.underline}**

The EU Commission has no exact information available to which extent
private, voluntary standards are used in primary production and food
industry. However, the web sites of the Global Food Safety Initiative,
Safe Quality Food, British Retail Consortium, International Food
Standard, and GlobalGAP claim a significant number of subscribers:
Around 100.000 producers of fruit, vegetables and aquaculture products
in 80 countries operate under GlobalGap-accredited production standards
and about 60 retail chains, namely in Europe, source only from certified
suppliers. According to informed sources, some US retail chains are
considering to join the consortium.

The protection of public health is a major field of governmental
activity and food safety forms an integral and essential part of it. The
definition and enforcement of food safety standards, which are essential
to defend the public's health can, therefore, not be left to the private
sector alone. Legal standards adopted through democratically legitimated
processes include a mix of measures, including pre-marketing
authorizations (e.g. for pesticides, additives and colorants) and post
marketing surveillance according to science-based thresholds (e.g.
enforcement of tolerances for chemical or microbial contaminants), which
are deemed necessary to protect food safety. Multilateral standard
setting bodies, namely the CODEX Alimentarius, provide a forum for
global harmonization.

Private voluntary standards currently established in the food chain
frequently aim at ensuring compliance with legal requirements, but in
many cases the provisions go beyond what is legally prescribed to cover
issues of labor and social rights, production methods or environmental
protection and sustainability. For example, driven by considerations of
public opinion and image rather than sustainable pest management,
private standards of individual retail chains may prescribe a narrow
selection of acceptable pesticides and private tolerances far below
legal limits.

This poses a fundamental dilemma for governmental endorsement of
private, voluntary standards: If the hazard addressed and the measure
prescribed in the private standard are essential for public health
protection, the standard should be made a legal requirement. But if
compliance is not essential, the standard cannot justify governmental
intervention in private businesses.

Generally speaking, adherence to private, voluntary standards may lead
to products in compliance with legal requirements. But they may go
beyond that essential threshold. If these standards then provide a basis
of governmental decisions (about inspection at the port of entry or
about the allocation of resources for domestic controls) they become
quasi endorsed without having undergone democratic processes of
regulatory policy making.

Clearly, third party certification may provide an important route
towards expanding the capacity of governmental agents to enforce
compliance with legal standards. But legal standards have to be defined
by the public sector in the first place. As private standards may go
beyond legal obligations, they cannot readily be endorsed by the
government.

Private bodies such as the Global Food Safety Initiative or the British
Retailer Consortium may develop programs to certify compliance with US
regulatory standards, which may be based on available guidance and legal
provisions issued by FDA. But it would be a different situation if FDA
accepts GSFI or BRC standards *in lieu of* certification of compliance
with US legal provisions. Such an endorsement would give these private
initiatives a quasi-legal status. This in turn could be interpreted as
bringing such standards within the scope of the world trade rules and
the Agreement on Saniatry and Phytosanitary Measures -- namely its
Articles 2.1[^1], 5.6[^2] and especially Article 13[^3], as it would
give them an \"official\" status.

The EU hygiene legislation (Regulation 852/2004) provides that food
producers must implement quality control systems based on HACCP and that
all farmers must use Good Agricultural Practices. Adherence to these
obligations is verified by local authorities and auditing systems at
county, state and country level. For high risk foods, namely foods of
animal origin, compliance with these requirements may be documented via
official certification by the exporting government. Under certain
conditions, the authorities of the exporting country may delegate the
inspection and certification to third parties (c.f. Article 5 of
Regulation 882/2004 on official food and feed controls). However, under
the EU rules of verification (1) the government of the importing country
clearly defines the minimum standards of safety and quality control and
(2) although the competent authority of the exporting country may
delegate the task of inspection and certification to a third party, it
remains ultimately responsible. To date, there have been no instances of
a third country wishing to avail of this possibility.

[^1]: Members shall ensure that any sanitary or phytosanitary measure is
    applied only to the extent necessary to protect human, animal or
    plant life or health...

[^2]: Members shall ensure that such measures are not more
    trade-restrictive than required to achieve their appropriate level
    of sanitary or phytosanitary protection, taking into account
    technical and economic feasibility.

[^3]: Members shall ensure that they rely on the services of
    non-governmental entities for implementing sanitary or phytosanitary
    measures only if these entities comply with the provisions of this
    Agreement.