PUBLIC SUBMISSION | As of: February 15, 2009 Tracking No. 806f144a Comments Due: January 01, 0001 Late comments are accepted |
Docket: FDA-2008-D-0381
Draft Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds; Availability
Comment On: FDA-2008-D-0381-0001
Draft Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds; Availability
Document: FDA-2008-D-0381-0005
Anonymous - Comment
Dear Sir/Madam:
The United States Pharmacopeial Convention (USP) thanks the US Food and
Drug Administration (FDA) for the opportunity to comment on the FDA’s draft
Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and
Feeds [Note 1].
We are supportive of this effort, and pleased that the draft guidance implicitly
recognizes the role and importance of standards and other safeguards in helping
to ensure safe imports. We believe that third-party certification programs, along
with Good Manufacturing Practices (GMPs) and other measures, could play an
important role in promoting food security and safety.
We note that the draft guidance mirrors in some key respects the verification
programs developed and launched by USP for dietary supplements, dietary
supplement ingredients, drug substances, and excipients [Note 2]. Many
elements of USP’s current verification programs -- GMP audit, document review,
testing for conformity assessments, certification, surveillance testing, and
decertification --- are attributes of third party certification programs sought by the
FDA in the draft guidance. Thus, USP’s programs may serve as helpful examples
to the FDA in its efforts to encourage certification efforts in the area of foods and
feeds.
In USP’s programs, GMP audits play an important role, since quality cannot be
assured solely by testing. For example, in USP’s programs, inspection reports
identify major and minor deficiencies noted in the manufacturing process and until
corrective actions for major deficiencies are implemented, certification letters are
withheld. One of the important requirements of these programs relates to change
control, and mandates that USP be notified of all major and moderate changes (as
defined in USP manuals), prior to implementation. This helps ensure consistency
in the quality and safety of the products/ingredients certified.
We also strongly believe in the role and importance of public standards in
advancing verification programs and other food protection efforts. Measures of
quality, purity, and identity for preservatives, antioxidants, colors, and other
substances used as components of food can provide an established standard to
which to verify and test food and food ingredients, making available to all- industry,
consumers, and government – an accepted measure, thereby creating public
confidence in products and their ingredients, and promoting the movement of such
goods in international commerce.
Public standards are established to protect the public health, thwarting intentional
adulteration and counterfeiting, by allowing rapid updating of monographs to
address new threats. This was recently demonstrated with the recent USP-FDA
cooperation on heparin and glycerin monographs, and is potentially equally as
valuable in the area of foods and feeds. We would therefore be appreciative of an
opportunity to work with FDA to augment standards-setting efforts in the foods
area.
While USP is best known for setting quality standards for drugs, drug products,
dietary supplements, excipients and biologicals in the USP-NF, it also now sets
standards for food ingredients, using the same open and participatory science-
based processes used to establish its drug standards. The food ingredient
standards are published in the Food Chemicals Codex (FCC), which USP recently
acquired from the Institute of Medicine (IOM) and has since updated and
republished in its 6th edition.
At present, a limited number of FCC standards are incorporated into specific FDA
regulations approving particular food additives, but unlike the drug standards in the
USP-NF, FCC food ingredient standards do not have broad legal recognition in the
United States. Although the Secretary has the current authority under the Food,
Drug, and Cosmetic Act to set food ingredient standards, and does so as
evidenced in 21 CFR Parts 172-189, many of the established food ingredient
criteria are now outdated or lacking in the necessary detail to provide adequate
guidance to the food industry or confidence in the consumer. We would therefore
request that FDA work to find ways to update and enhance recognition of
standards in this area, and as noted, we think that would also benefit certification
programs.
We thank FDA again for the opportunity to comment. We would be very pleased
to share with you our experiences and expertise in developing and conducting
verification programs during the past seven years, our more recent experience with
FCC, and our related expertise and partnership with FDA in advancing public
standards over the last century, and to discuss how this knowledge might be
helpful in developing verification programs for foods and feeds.
Sincerely,
The United States Pharmacopeial Convention
For additional information, please contact:
V. Srini Srinivasan, Ph.D.
Vice President, Verification Programs
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
P (301) 816-8334
VS@USP.org
Ben A. Firschein, J.D.
Director, Government Affairs
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
P (301) 816-8235
F (301) 998-6798
baf@usp.org
Notes:
[1] http://www.fda.gov/oc/guidance/thirdpartycert.html.
[2] See http://www.usp.org/USPVerified/. USP verification programs relating to
drug substances, excipients, and dietary ingredients are global in nature, and
manufacturers from China, India, Canada, Argentina, Peru, and other countries are
taking part in these programs. FDA’s draft guidance notes that "recommendation
2 of the [President's] Action Plan is to 'verify compliance of foreign producers with
U.S. safety and security standards through certification,'" and that the Food
Protection Plan "emphasizes certification as a way to help verify the safety of
[food] products." (See, page 4). Additionally the draft guidance provides
that "inspectors should determine if an establishment has an effective,
documented program to verify product safety using scientifically sound methods."
(See, page 12).