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Disagreements Over Disclosability: FDA Should Contact FCN Submitters Before Releasing Information Claimed as Confidential

By Keller and Heckman LLP’s Packaging Practice Group

The legislative history behind the Food Additives Amendment of 19581 (and the amendments made thereto since 1958) leave no doubt that the purpose of the law was to assure a safe food supply by providing for the pre-clearance of any chemicals added to foods that might be ingested, i.e., that might reasonably be expected to become components of food.

By definition, the goal of the Federal Food, Drug, and Cosmetic Act was to assure the safety of the food supply and to make any findings attendant thereto transparent so the public will know how the safety of the food supply has been evaluated and determined. It has always been understood that certain data -- including the chemical identity of added substances, analytical methodology, estimated daily intakes, and available toxicology to support the safety showing or conclusion -- should be disclosed or disclosable.

At the same time, there has always been a general understanding that the U.S. Food and Drug Administration (FDA) should not disclose trade secrets regarding manufacturing methods, processing chemicals that are part of the manufacturing method and are not intended to have a technical effect in the finished product, anticipated sales volumes or marketing plans or the like unless, in some unusual circumstance, these elements have a direct bearing on safety and the ability of the scientific community to evaluate it.

Nothing in the Freedom of Information Act (FOIA) of 1966,2 has changed these fundamental premises and, therefore, it is incumbent upon FDA to consult with one who submits information to support a Food Additive Petition (FAP) or Food Contact Notification (FCN) before the agency divulges any trade secret information labeled "confidential" unless the information in question clearly must be disclosed to permit a safety evaluation by the public, including other scientists.3

For companies that file Food Additive Petitions or Food Contact Notifications, one of the most important aspects of making a regulatory submission to FDA is the confidentiality afforded to the information that is submitted. As any manufacturer or supplier understands, one's trade secrets are one's trade; to compromise the proprietary nature of some of the information contained in FDA submissions is to put the business itself at risk. Consequently, submitters of information to FDA rely on the agency to protect confidential information from public disclosure, even when such information is requested quite formally under the Freedom of Information Act.4 Under FOIA and its published rules, FDA is required to make certain records available to the public for inspection and copying. The law, however, protects several categories of records against forced disclosure, including "trade secrets and commercial or financial information" that is "privileged and confidential."5 The implementing regulations of FDA for FOIA are found at 21 C.F.R. Part 20 ("Public Information"). The regulation at 21 C.F.R. § 20.61 reiterates the FOIA exemption for trade secrets and confidential or privileged commercial or financial information.

With the implementation early in 2000 of the 1997 Food and Drug Modernization Act's (FDAMA's) Food Contact Notification (FCN) system, which allows manufacturers of food- contact substances to seek FDA clearance for their products by proprietary notifications, FOIA requests have increased so that asserting confidentiality for information submitted as part of an FCN can be quite crucial.

In addition, so-called "me-too" notifications for identical or nearly identical substances intended to be used in the same or similar applications may be submitted to FDA; thus, the protection of confidential information often becomes an important business consideration. It is commonplace for a company to submit a FOIA request for an FCN to obtain the data submitted by an earlier filer and then prepare its own notification for the identical substance so that it can go on the market as a competitor. Clearly, the materials sought through FDA's FOIA office can be extremely valuable from a marketing standpoint -- and highly sensitive from a confidential trade secret standpoint. This has led to much recent discussion regarding the way in which FDA treats material that is submitted in regulatory filings, as a part of FCNs in particular, when such material is claimed to be confidential.

FDA to Filers: Notice Isn't Required

Information disclosure was a topic of some controversy during FDA's Stakeholders' Workshop on the Food-Contact Notification Process, held Oct. 15, 2002. During the meeting, agency leaders and industry representatives discussed the types of information considered exempt from public disclosure under FDA's public information regulations, 21 C.F.R. § 20.61 ("Trade secrets and commercial or financial information which is privileged or confidential").

It is quite commonplace for notifiers to mark trade secret information as "confidential" in FCN submissions, and also to provide a "sanitized" version of the FCN to assist the agency in responding to any FOIA requests it may receive once the notification becomes effective. In fact, FDA recommends in its administrative guidance that notifiers submit such a sanitized version.6 According to the regulation, FDA may disagree with the claim of confidentiality. Specifically, Section 20.61(e) provides that, "When the Food and Drug Administration receives a request for [trade secrets, etc., to be kept confidential] and determines that disclosure may be required, the Food and Drug Administration will make reasonable efforts to notify the submitter about these facts." The submitter then has five working days from receipt of notice to object to the disclosure.

During the stakeholders' meeting, however, it was brought to light that, on occasion, FDA has released information without first contacting the submitter when it disagrees with a claim of confidentiality. From a notifier's standpoint, this practice is troubling, and raises the possibility of public disclosures that could be very detrimental to a notifier's business interests.7

The position advanced by some at FDA is that the agency is not obligated to provide notice if it disagrees with a notifier's claim of confidentiality. In support of this position, they point to an exception to the Section 20.61(e) notice procedure when

[d]isclosure is required by a regulation issued after notice and opportunity for public comment that specifies narrow categories of records that are to be disclosed under the Freedom of Information Act, but in this case a submitter may still designate records as described in paragraph (d) of this section as exempt from disclosure, and in exceptional cases, the Food and Drug Administration may, at its discretion, follow the notice procedures in paragraph (e) of this section.8

FDA has not identified the specific regulation describing the disclosability of information on which the agency is relying, but we believe that the only possible candidates are the regulations that discuss the public disclosure (and non-disclosure) of information provided in Food Additive Petitions (see 21 C.F.R. § 171.1(h)) and FCNs (see 21 C.F.R. § 170.102(e)). As described in the Food Contact Notification proposed rule (65 Fed. Reg. 43269 (July 13, 2000)), the types of information in an FCN that will be disclosable upon its effectiveness are comparable to those listed under Section 171.1(h), a long-standing provision that has been applied in the case of Food Additive Petitions. Thus, we will review the language in Part 171 for our discussion.

Specifically, Section 171.1(h)(1) identifies the following categories of information in a Food Additive Petition "as available for public disclosure unless extraordinary circumstances are shown" [emphasis added]:

  • (i) all safety and functionality data and information;

    (ii) a protocol for a test or study;

    (iii) adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of names and information that would identify the person using the report or any third party involved with the report;

    (iv) a list of all ingredients contained in a food additive; and

    (v) an assay method or other analytical method.

With respect to three of these five categories of ordinarily "disclosable" information (items (ii), (iv), and (v)), however, the regulation provides that the information is not disclosable if it is covered by the exemption for trade secrets and confidential commercial information in 21 C.F.R. § 20.61. Section 171.1(h)(2) then goes on to list the following as not typically disclosable:

  • (i) manufacturing methods or processes, including quality control procedures,

    (ii) production, sales, distribution, and similar data and information, and

    (iii) quantitative or semi quantitative formulas.

It is our opinion that the identification in Section 171.1(h)(1) of certain information in Food Additive Petitions (and, therefore, in Food-Contact Notifications) as presumptively disclosable does not constitute the specification of "narrow categories of records that are to be disclosed under [FOIA]." Nevertheless, it is this interpretation that FDA apparently is using to invoke the exception in Section 20.61(f)(3), thus relieving the agency of the obligation to notify submitters of information claimed as confidential prior to its release.

Section 20.61(f)(3) clearly is intended to apply only when a regulation provides such definite identification of disclosable information that there can be little, if any, chance for a mistake by FDA as to whether the information may be released. That is simply not the case with Section 171.1(h)(1). Three of the five categories of possibly disclosable information contain exceptions for trade secrets and confidential commercial information covered by 21 C.F.R. § 20.61. Therefore, FDA personnel are still left with the dilemma of determining whether information claimed as confidential by the submitter, but falling within one of these categories, is disclosable under Section 171.1(h) or protected by Section 20.61.

Furthermore, Section 171.1(h)(2) states that information on a manufacturing process is not disclosable. Yet the determination of what information falls within this classification (such as impurity data, which FDA has generally withheld from disclosure -- properly in our view) is frequently not clear-cut. For all of these reasons, Section 171.1(h) leaves far too much to the judgment of FDA personnel for the regulation to justify FDA in not notifying submitters prior to releasing information that has been claimed as confidential if it is even arguably protected under Section 20.61 or under Section 171.1(h)(2).

While one must empathize with the fact that the agency would find it burdensome to contact all notifiers when there is disagreement about confidentiality, it seems clear that this is a burden that should be borne when there is any question regarding the proper treatment of the information. Mistaken disclosures can be devastating to a manufacturer and could even be legally actionable by the company. Such action could lead to civil penalties in the form of injunctive relief and/or compensatory monetary relief (see 5 U.S.C. § 552a(g)) and criminal penalties in the form of misdemeanor charges and fines (see 5 U.S.C. § 552a(i)(1)) against the agency and its officers. It seems imprudent for FDA to claim total discretion as to whether or not to notify a submitter of an FCN concerning the proposed disclosure of information claimed as confidential.

In light of the currently competitive business climate, and the need to sustain trust and cooperation between the agency and regulated industry, it seems the wiser course for FDA to re- examine its procedures for notifying submitters of confidential information when there is disagreement over disclosability. The risks attendant to agency releases of confidential information, for both submitters and FDA, compel the development of a notification procedure that is feasible, and that can be consistently applied by agency personnel. As with many agency programs, this issue may be best resolved with input from both the regulators and the companies that are regulated.


1See Pub. L. 85-929 (Sept. 6, 1958).

2See 5 U.S.C. § 552 (1966).

3While not particularly relevant here, other than to show that FDA does treat company confidential information with great respect, it is interesting to note that the agency has persistently refused to divulge toxicological data submitted in the course of drug Generally Recognized as Safe and Effective (GRASE) proceedings prior to the time a decision has been made on a proposed monograph even where a docket on a particular class of drugs has been in pending status for as long as 10 years. The fact that the parties submitting information for such dockets asked that their safety data, not the sort of commercial information cited above, be kept confidential has been enough to convince FDA to withhold the information and fervently defend its right to do so.

4See Title 5 of the U.S. Code (5 U.S.C. § 552) ("Public information; agency rules, opinions, orders, records, and proceedings").

521 U.S.C. § 552(b)(4).

6SeeSection V of FDA's Guidance for Industry -- Preparation of Food Contact Notifications: Administrative (May 2002): "FDA recommends that a notifier submit an additional copy of its notification identifying those portions that the notifier considers to be trade secret or confidential business information (i.e., a redacted version of the notification). FDA may not agree that all identified information is protected from disclosure under 21 CFR Part 20."

7A tangential side-effect of this sort of occurrence can be some reluctance on the part of the manufacturer to submit complete and desirably candid notifications. The U.S. District Court for the District of Columbia, in Public Citizen v. FDA, 539 F. Supp. 1320 (May 11, 1982), based its decision on the confidential nature of information on a two-pronged test: (1) would disclosure of the information impair the government's ability to obtain necessary information in the future, and (2) would the disclosure cause substantial harm to the competitive position of the person who submitted the information. The same court, in Public Citizen v. FDA, 964 F. Supp. 413 (Feb. 24, 1997), used the same two-pronged test to make a determination that information was privileged and not to be disclosed under FOIA. In both cases, Public Citizen was seeking test data that was developed to support a drug or medical device innovation.

821 C.F.R. § 20.61(f)(3).