NAMA Comments
Re:
Docket No. 02N-0277, Proposed Rulemaking
“Establishment and Maintenance of Records Under
the Public Health Security and Bioterrorism
Preparedness and
Response Act of 2002”
July 8, 2003
Dockets Management
Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
To Whom It May Concern:
The North American Millers' Association (NAMA) appreciates the opportunity to comment on the Food and Drug Administration's (FDA) proposed regulation on the establishment and maintenance of records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (a.k.a. The Bioterrorism Act). The tragic events of September 11, 2001 demonstrated the need to protect the U.S. public from the threat of terrorist attacks, and the FDA plays an important part by ensuring the security of the U.S. food supply. NAMA supports the increased focus on security and the efforts of Congress and the FDA to improve current food chain practices to help guard against potential attacks.
As the national association representing 46 milling companies and over 95% of the U.S. milling capacity for wheat, corn, oats and rye, NAMA and its members have a vested interest in maintaining a safe food supply. To help maintain a safe food supply NAMA members work diligently to comply with all U.S. regulations governing food safety and plant security. In addition, NAMA members often set higher internal standards in order to ensure the products a mill is processing are of the highest possible quality.
Since NAMA members firmly believe in the need for a safe food, NAMA members support the concept of enhanced record maintenance that FDA has proposed.
However, as members of the entire food chain and companies in the business of providing food to U.S. and foreign customers, NAMA wants to emphasize several points that the FDA should clarify and address in its final regulations.
Clarification
of Reasonably Available
In section 1.337(a), FDA is proposing to require that
anyone governed by the regulation “include
information reasonably available to you to identify
the specific source of each ingredient that was used
to make every lot of finished product, so that
incoming ingredients can be linked to the outgoing
finished products.” The proposed regulation
continues by recognizing that many companies in the
food industry rely on multiple sources of ingredients
and commonly commingle those ingredients to produce a
finished product. While NAMA appreciates FDA's
recognition of the commingling of ingredients, NAMA
is concerned that the regulations do not properly
clarify what will satisfy the requirement of
“reasonably available” to effectively avoid
failing to comply.
FDA officials have verbally expressed their willingness to be flexible regarding what information is reasonably available to the food industry given their standard practices as long as the basic information requirements are met. NAMA believes that a written definition of what is meant by “reasonably available” and some criteria by which this definition can be objectively determined by an FDA official would give industry a better guideline and avoid possible disputes.
Maintain
Flexibility
NAMA wants to commend the FDA for providing
flexibility in its regulations on records by allowing
for the use of existing records to meet these
requirements. Many millers already request and keep
much of the information the FDA is proposing to
require. However, NAMA cautions against using any
“one size fits all” generic form as an
example or requirement. Example forms can become
informal requirements out in the field though
originally only meant as a guide. Providing further
example scenarios where records would be in
compliance and non-compliance within the final
regulations may solve this problem.
NAMA also encourages FDA to maintain its flexibility regarding the exact type of information that is available to the food industry. Not all companies require or need the same type of identification as other members in the food chain, i.e. lot numbers and identity preserved ingredients. Recognizing this fact, the FDA should not define rigid identification requirements. By keeping this flexibility, the FDA can preserve the intent of the Bioterrorism Act and still avoid dramatic changes to what are currently efficient and effective business practices.
Protection of
Trade Secrets and
Confidential Information
NAMA desires the addition of explicit procedures that
the Secretary plans to implement to prevent the
unauthorized disclosure of any trade secrets or
confidential information. The level of document
access granted to FDA officials under the
Bioterrorism Act should require an equally high level
of protection of sensitive information. Reemphasizing
the importance of current protections and legal
requirements during FDA instruction will not suffice.
Documents deemed confidential or trade secrets by a
company should not be subject to the Freedom of
Information Act (FOIA) and should only be accessed by
appropriate FDA officials if deemed critical to an
ongoing investigation. These safeguards need to be
specifically addressed in the final regulation.
Compliance
Assistance
The FDA should recognize that not all companies in
the food chain and, not even all companies in a
specific sector of the food chain, have the same
capability to understand or comply with the proposed
requirements. The additional time FDA provides for
small businesses to comply with the regulation is
necessary and correct. NAMA encourages FDA to also
provide all businesses, upon request, additional
assistance in order to ensure proper compliance by
the respective deadlines. The assistance will help
small or conservatively staffed companies better
understand how they might comply with the regulations
using existing information and what new information
might need to be collected. Compliance assistance
will help to assure that the food industry is meeting
requirements and that food security is not
jeopardized due to an inability to fully comply.
Possible
Impact on International Trade
NAMA is concerned that the proposed regulations may
lead to unintended consequences to the regulation of
U.S. goods in foreign trade. The system that FDA is
proposing provides for the establishment and
maintenance of records identifying the previous and
subsequent source for all food articles. This system,
while conceived solely as a mechanism to secure the
U.S. food supply, also establishes a precedent for
government regulated traceability of food articles.
Though this system has substantial flexibility and
the process of tracking food back to its source is
currently conducted by government agencies, the
codification and regulation of such a process is new.
FDA should work with other government agencies to
demonstrate the differences between this proposed
system and a system of traceability and identity
preservation proposed by many foreign countries for
use with genetically modified crops. Without
collaboration and careful planning, this proposed
regulation could be used to legitimize foreign trade
proposals detrimental to U.S. trade interests.
Thank you for the opportunity to provide comment on this proposed regulation. NAMA looks forward to working with the FDA on these and other regulations to help ensure the security of the U.S. food supply. If you have any questions please contact me at 202/484-2200, ext. 104 or at bfaga@namamillers.org.
Sincerely,
Betsy Faga
President
Read more:
NAMA comments on the Food and Drug Administration's proposed rulemaking “Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002”. July 8, 2003
NAMA Urges FDA to Increase Food Security Without Sacrificing Foreign Trade, April 9, 2003
NAMA comments on the Food and Drug Administration's proposed regulation on prior notice of imported food under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
NAMA's comments on FDA's proposed regulation on registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
last updated July 30, 2003
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