Date: Dec 15, 1997
The first step on the road to recovery from any malady is to recognize and accept the fact that there is a malfunction. Where such recognition is allowed to occur, experience teaches that the road to recovery has been paved. My hope today is that I can increase your recognition of the fact that some of the main world regulatory systems for food contact substances have not been working and are in need of thoughtful reevaluation and attention.
For the past 40 years, I have been a practitioner of food and drug law who has specialized in packaging and other food contact materials regulation. In all of this time, and with intensifying frustration, it has become increasingly clear to me that (1) packaging materials and other food contact substances present an inconsequential risk at most, and have never given rise to public health problem; (2) despite this fact, unconscionable amounts of scarce human and financial resources are being spent on creating and complying with arcanely complex regulations to deal with this "nonproblem," and (3) the regulatory techniques developed in most countries for the handling of this"nonproblem" are fundamentally inapt and have little practical value. You may feel this is an unduly harsh analysis,so let's check by looking at how the two best-known regulatory systems for food contact substances in the world function and what they have produced.
Since the passage of the Food Additives Amendment of 1958, the United States has been regulating what have generally been called"indirect food additives," and what I believe are more accurately referred to as "food contact substances"since the substances in question are never deliberately added to foods. As a result of the unfortunate way in which the 1958 law was written, the United States' Food and Drug Administration has regulated these food contact substances in the same way it regulates additives intentionally added to food like aspartame,sucrose polyesters (Olestra), and other micro- and macro-nutrients. It is my personal view that the regulatory system is fatally faulty, even for direct additives, but it has been a monumental failure as far as indirect additives are concerned.
With respect to any given food contact substance, unless one can reach a sound conclusion that his product is exempt from the general requirements of the statute, or can determine that the existing regulations already cover the component of interest, what is mandated under the 1958 Act is that someone file a Food Additive Petition seeking a regulation that will permit the use of the component under specified conditions. Once a regulation issues--usually in two to four years, unless the situation is unusually simple--it constitutes an authorization for anyone to make the component and sell it or use it in the packaging applications that the regulation covers, subject, of course, to any applicable patent protection the proponent of the regulation might have. Originally, it was theorized that having generic authorizations by way of regulations, instead of"licensing" specific uses, would save government and industry time and effort--a laudable objective, but one that has not been achieved, even minimally, in the 40 years of the Food Additives Amendment's existence.
The regulations covering "indirect food additives"occupy more than 265 pages in the Code of Federal Regulations.This is the first place most companies and other agencies in the United States look when they want to determine if a chemical they want to buy (or produce) is properly covered for food contact applications. Sound good? A "one book" reference to see if you are in compliance with the food law requirements or not?No way. The problem is that the FDA regulations in Parts 175 through 179 of Volume 21 of the Code of Federal Regulations are not conventional regulations prescribing a course of action or set of legal requirements, and are certainly not codified if consistency and orderliness are the earmark of codification. What these regulations are is a partial listing of substances that can be used in food contact applications, a partial statement of the permitted uses of such substances, and a set of customized specifications that constitute definitions of what the cleared substances are. They are remarkable for the fact that there is little or no consistency of treatment for the variety of substances, nor has any effort ever been made to avoid over lap and even duplication.4
The food additive regulations in the United States cannot be readily classified or characterized. They can only be understood if one accepts the fact that there is no stereotypical regulation; in truth, each regulation is essentially a unique set of specifications designed to accommodate the needs of the government and a petitioner at a given point in time. It is, in my opinion, to the credit of the Food and Drug Administration that it recognized early on that it had been given an unwieldy task where packaging materials were concerned, and that it decided it could and would regulate different usage areas with some measure of creativity and flexibility. As I began saying in print in 1966, what FDA should have done was to go back to Congress and tell the legislators that they had enacted a regulatory scheme that the Agency advocated in 1957 but that was proving to be inappropriate because it did not accommodate the needs of industry or the government.5 Instead, it stretched the regulatory girdle to adopt regulations that were somewhere between licenses and regulations, but had the virtues of neither.
Thus, we have regulations that govern specific polymers or copolymers and set forth varying levels and types of specifications and limitations for each such substance. Then we have regulations that are lists of adjuvants that may be used in conjunction with polymers, or other base materials. There are also separate regulations for some such adjuvants. But whether the release agents, stabilizers, or antioxidants are grouped in a list or covered by separate regulations, the criteria that characterize them as acceptable or not are in the nature of specifications that cannot be checked in the marketplace so that compliance is more an honor system than an enforceable. In addition, there are what were originally called "omnibus regulations" that contain long lists of substances that can be mixed and matched, and reacted to form can enamels, paper coatings, adhesives, and rubber articles for repeated use. If this sounds like a complicated and confusing hodgepodge of disconnected provisions unlike anything else you have encountered, you understand the situation perfectly.
Again, to FDA's credit, what I think it did, consciously or not,was to decide soon after 1958 that "indirect additives"presented no real public health threat, so maximum flexibility could be employed in developing unrelated formats for food additive regulations so long as the Agency's toxicologists were satisfied that a proposed use would be safe. Stated another way,over all of these 40 years, FDA has been developing regulations that have to be tailored to provide some assurance that an unknown user or alternate manufacturer will not do anything that will give rise to a safety problem, and, at the same time, write a provision that will satisfy the legitimate needs of the petitioner with whom it is dealing. Moreover, once a regulation is drafted by the Office of Premarket Approval at FDA, since a formal rule of general application is to be published in the Federal Register, there must be "sign off " by a variety of other reviewers in the Center for Food Safety and Nutrition,the Office of the General Counsel, and the Commissioner's Office.Is it any wonder that the time between the filing of a petition and its publication averages between two and four years, with many taking much more time.6
Would it not be easier and more sensible to review a petitioner's or applicant's product, evaluate it in the light of the specifically stated proposed intended use, and then indicate quite simply whether that narrow proposed use by a known applicant is safe in the eyes of the government? Would it not be even simpler to review premarket notifications proposing a given set of uses, and then let them become effective unless a potential safety problem seems likely, or some other problem of substance needs resolution? Of course it would, but this would require a change in the law.
Since seeking a change in the law apparently had no appeal or seemed infeasible to the Agency until very recently, but in recognition of the fact that the petition backlog was attaining the status of a serious embarrassment that would eventually even get Congressional attention,7 FDA moved to try to set up what you might call a scientifically grounded track system designed to allow faster clearances for selected cases. In furtherance of this aim, it has implemented such procedural devices as the granting of exemptions from obtaining regulations for substances shown to present exposure potential below a threshold of concern, and by setting up a special review cadre to deal with petitions where the exposure might exceed the threshold deemed of no concern but which otherwise lend themselves to less time-consuming review. The first faster track plan for issuing exemptions is known as the Threshold of Regulation procedure and is detailed in section 170.39 of the regulations. The second procedural nuance is called the Special Project Team process; it has been set up as an internal administrative mechanism within the Office of Premarket Approval and has been described in various FDA staff speeches, no rulemaking being necessary here.8
While the Threshold of Regulation technique might eventually have proven reasonably efficient, since it is a case-by-case treatment, obtaining a "no objection" letter from FDA under this plan is now requiring more than six months; about 19 have issued since the new rules became effective in August 1995.The Special Project Team (SPT) treatment of selected petitions has also expedited handling a bit; but the pattern here is mixed and uncertain, primarily because FDA's decisions on what substances and exposures will qualify for SPT treatment is ad hoc and, therefore, unpredictable.
So much for the United States. Discussion of the European Union's regulatory system requires first that I express proper trepidation and humility about characterizing the process as I see it, especially in this forum where all of you undoubtedly understand the fine points much better than I. However, since my thesis demands an analysis of both the U.S. and EU systems to make my main point, and making a "macro" analysis does not require dealing with all of the fine points, I will ask your indulgence while I tell you how this foreigner sees the European Union (EU) approach.
We are, of course, well aware of the fact that talking about Europe and the European system would normally require much more than making reference to the EU directives, especially since so much in the realm of packaging regulation is left, even today, to the national authorities of the member countries. Also, we certainly know that the EU member states, as well as the European countries that are not yet part of the Union, have differing regulatory approaches. Again, however, for the purposes of this paper, I am focusing only on the basic EU strategy since it is premised, like the soon-to-be reformed United States system, on the theory that the way to regulate food contact materials is by general directives that clear substances on a generic basis with limitations or specifications that are published in directives intended to apply to all producers or users.
One element that makes it risky and more difficult to characterize the EU system is the reality that, after more than 20 years of diligent work by the guru and hero of European packaging law, the accomplished Luigi Rossi, with some limited exceptions (i.e., regenerated cellulose and ceramics), the only directives that have issued have focused on plastics. The keystone document is 90/128/EEC, the so-called Monomers Directive, as amended four times, which includes annexes legalizing the use of certain plastics packaging monomers and additives. Soon to come is the long-awaited Fifth Amendment to the Monomers Directive, which will clear a number of additional plastics adjuvants. The basic Monomers Directive was published in 1990, i.e., 18 years after the Commission drew its initial program of action for food contact materials (1972), 14 years after the initial Framework Directive 76/893/EEC was adopted(1976), and two years after adoption of the current Framework Directive 88/109/EEC (1988). The Fourth Amendment, really a kind of grandfather clause for substances not requiring Special Migration Limits (SMLs), was adopted in 1996 (i.e., six years after the Monomers Directive); and since then Dr. Rossi has been working on the Fifth Amendment to this directive. We hope it will see daylight in 1998. These are important directives, no doubt.However, while they have been in the making, many of the national governments have stopped updating their own laws or giving rulings on new substances, noting that they are deferring to and counting for action on the EU. Yet even the Fifth Amendment will be significantly incomplete and somewhat out of date when it issues because, among other things, it will not include a number of important substances that are the subject of pending dossiers awaiting review.
The fact is that this system is not working and is possibly even less efficient in a modern, fast-moving marketplace than is the U.S. system. Worse, it is highly controversial because it has brought into play and left in doubt issues such as the following:(1) what to do about catalysts and other reactions control agents in light of the urgent need to protect legitimate and dearly prized trade secrets while trying to establish all-inclusive positive lists to prescribe very precisely and comprehensively what may be used to make a package or component; (2) how to permit the use of substances that may not even contact food because there is a "functional barrier" between the substance and the food; and (3) how to make the SMLs meaningful and enforceable in the absence of generally accepted methods of analysis. These are but examples. We are puzzled, too, by the notion that it makes sense to have a list of monomers as the means for declaring all polymers made from these monomers safe--is this a truly sound scientific way to pass on all polymers and copolymers made from the listed monomers?
There are more, very important questions that are collateral to these but that could have tremendous practical consequences.What will Europe do to try to cut down on its regulatory workload? Will there ultimately be some acceptance of the fact that exposure to a substance has as much to do with safety as toxicology, so that the use of exposure data based on consumption factors will be sanctioned?9 Will some concept of Threshold of Regulation find its place in the European game plan?Can some system be devised to permit interim or provisional clearance of substances while the world awaits the preparation of new directives which, the record shows, take years to be drafted,adopted, and finally implemented in member states' legislation?
What the current procedures and policies in Europe and the United States have in common is the fact that both systems are extremely complex, virtually impossible to fathom in all of their details and unintended consequences, and, worst of all, are not responsive to the needs of those who are competing in the fast pace of today's world marketplace, nor to the public's desire to be assured that their food supply, including packaging, is as safe as it can be. And this set of failings is so profound and so defeating because, in my opinion, all of the responsible authorities to date have been trying to hammer square blocks into round holes. What they have proven, and what is finally being recognized, is that packaging comes in so many shapes and sizes,is made of so many varying substances used for as many varying purposes, and is so unsusceptible to broad rulemaking, that it makes no sense to use the broad-brush treatments that the current rulemaking procedures contemplate. What should always have been done, and what should be done now, is to give food contact materials case-by-case treatment in a way that allows the 95 percent of situations that require little review because they present no significant risk to be handled very summarily, while providing sufficient screening to permit more comprehensive consideration of the 5 percent or less that might warrant intense scrutiny. In short, we should have a system that allows the wild iris to be seen and dealt with without treating the great mass of applications as if they present real risks--when we all know this is not the case.
I come before you now at a time when the subject of food contact substance regulation in the United States has finally commanded enough attention to bring about a landmark change in the governing statute. The impossible has happened, and true,constructive reform is on the way. On November 21, 1997, the Food and Drug Administration Modernization Act of 1997 was signed by the President and became law.10 As a result, after new rules are adopted within the next 16 months, the present,tortuous petition-regulation requirements in the United States will move over to make way for a sensible premarket notification system. Under that system, any interested producer or user of a food contact substance will file a notification with the Food and Drug Administration that will become effective automatically (and permit immediate legal marketing) at the end of 120 days unless FDA advises that more time will be required to review the proposal because it raises substantial safety questions. Under this plan, FDA will get all of the information it gets now about a new substance and will have every chance to look it over.However, it will no longer be required to issue regulations to clear the material and will only need to hold up an effective date if it has serious safety questions. In other words, it will now have a way to deal with the wild irises; but, more importantly and more typically, it will not have to hold up clearances for the no-significant-risk cases by treating them in the same way as the few problem situations that arise so rarely.
Not without humility, I suggest to you that this is one time the American example might be profitably studied by the European Union and the national governments in the Union. I realize that in the EU there are 15 independent nations with their own authorities, not to mention the other nations of Europe that look to the EU for regulatory guidance, that there is no European FDA,and that national authorities could differ over which cases are no-significant-risk cases and which are not. Nonetheless, premarket notification is not a completely new idea in Europe. It has been effectively employed in circumstances presenting much more potential risk than is the case with food contact substances. For example, we are aware that Europe has a notification system--ordained by the Seventh Amendment to the Dangerous Substances Directive--whereby producers and users of"new chemical substances" (where the potential risk from improper use of substances is not insignificant) must obtain individual clearances for their products in one member state. Itwould certainly seem that this system might serve as a starting template for a food contact substances notification system. Afterall, there is no central European house for clearing chemicals;and, in this field, the case-by-case ruling of one European government is given open full faith and credit by the other nations. So, why would this not be possible for clearing food contact substances?11
I have no doubt that a procedural technique can be found if it is Europe's wish to do so. Nor will any of the good work done to date be lost. In the United States, the present Food Additive Regulations will remain in effect even while the new premarket notification plan is being implemented and thereafter. The same could be done in Europe so that the existing directives will remain in effect and simply be supplemented in the future by a notification or other time-conscious clearance program. This also would not be "new"; to continue our reference to the EU regulation on chemicals, the chemicals notification system was instituted after the grandfathering of the chemicals that were on the European market in 1981, the so-called EINECS (or European Inventory of Existing Chemical Substances).
What must be recognized and acknowledged to bring this about is that the current systems do not work because they seek to develop broad rules in situations where it is much simpler and more sensible to rule narrowly by analysis of all the relevant facts in a given case and granting explicit permission to do what a specific applicant has shown can be done quite safely. This same permission can be given to others who can demonstrate that theirproduct is equally safe. If the notification-clearance time is 120 days or less, as is contemplated by the new U.S. law, there need be no long-term adverse competitive impact.
I think the stage has been set for a new era of rationality and practicality in this field. The world is now so small and the marketplace so global that what is done here is of tremendous interest to business in the United States and everywhere else. I urge you to consider again what can be done to facilitate trade and the use of innovative food contact materials so that they can be deemed acceptable worldwide within a time frame that is consistent with marketing in the world class economy of today.
1 Prepared for presentation at the ICI/PIRA InternationalConference to be held in London on December 16, 1997.
2 Determining what is and is not exempt from the basic requirement that a Food Additive Petition must be filed and a Food Additive Regulation promulgated before a substance can be used in a package or in processing equipment is an important and difficult jurisdictional exercise. It has occasioned a good bit of legal interpretation over the years because of the vagaries of FDA administration of the law it is charged to implement and enforce. This is a subject that is beyond the scope of this paper, but it has been dealt with in depth in other papers by the author. See J. Heckman, "Fathoming Food Packaging Regulations," 42 Food Drug and Cosmetic Law Journal 38 (January 1987); J. Heckman, "Food, Drug and Cosmetic Packaging Regulations" in The Wiley Encyclopedia of Packaging Technology at 351-359 (Bakker, ed., 1986).
3 These are the sections that contain the great body of indirect food additive prescriptions. There are other Parts of the nine volumes of the CFR -"Foods and Drugs" that relate to such important collateral subjects as the interpretation of the term "indirect additive" (21 CFR 170.3 et. seq.),"prior sanctioned" substances ( 21 CFR 181) and substances that are generally recognized as safe (GRAS) (21 CFR 182-184).
4 In the case of basic polymers, for one example, most of these regulations do not specify what catalysts or other reaction control agents are used to make them. Thus, 21 CFR 177.1520 has specifications for the polyolefins, but FDA has wisely refrained from limiting coverage to polymers made with specific catalysts.On the other hand, some of the regulations covering, for example,acrylics (21 CFR 177.1010), melamine formaldehyde (21 CFR 1460),and polyurethanes (21 CFR 1680) list permissible catalysts, which could lead interested persons to believe that only these catalysts may be used to make the particular polymer. The fact is that the petitioners that sought the inclusion of catalysts in the indicated regulations did so out of ignorance or a desire to protect a competitive position and FDA, in writing the final regulations for these substances, simply went along with what the petitioners requested. For an example of duplication and essentially complete and confusing overlap, compare 21 CFR177.1640 and 21 CFR 177.1810; both of these regulations govern the use of polystyrene, the basic residual monomer limitation of 0.5 weight percent being the basic specification applicable to both at the time the regulations were promulgated. The only reason there are two regulations is because sometime in the late 1960s, one manufacturer of block polymers believed a new regulation was required for what was then a new way to make polystyrene. These rules have been amended from time to time over the years so they now differ somewhat in their coverage and particulars. This has simply added to the confusion and further duplication of effort without providing any dividends as far as clarity or public health protection are concerned.
5 J. Heckman, "The Packaging Industries and the Food Additives Amendment of 1958--It's Time for a Change in the Law," presented at American Chemical Society Symposium onSafety Evaluation of Coatings and Plastics for Food Packaging(September 14, 1966).
6 FDA, Product Review Performance Report (July 1997).
7 H. Rep. 436, "The FDA Food Additive Review Process:Backlog and Failure to Observe Statutory Deadline," 104th Cong., 1st Sess. (December 21, 1995); Hearings before the Subcommittee on Human Resources and Intergovernmental Regulations of the United States House of Representatives Committee on Government Reform and Oversight Concerning the Need for Modifying the Food Additive Regulatory Process (June 1995).
8 A. Rulis, "Food Safety Reform: Pros and Cons and the Problems," and S. Varner, "Improving the Petition Review Process," presented at The Society of the Plastics Industry, Food, Drug, and Cosmetic Packaging Materials Committee Meeting (June 1996).
9 Cf. J. Heckman, "De Minimis and Harmonization of International Regulations," presented at the ICI/PIRAInternational Symposium in Geneva (May 10, 1994); J. Heckman,"U.S. and European Regulation of Food Packaging: Finding Common Ground to Reach a Common Goal," presented at the ICI6th Annual International Migration Symposium in Amsterdam (May 19, 1992); L. Borodinsky, "The Scientific Case for Case-by-Case," presented at The Society of the Plastics Industry's Food, Drug, and Cosmetic Packaging Materials Committee meeting (June 10-11, 1997).
10 Pub. L. No. 105-115; 11 Stat. 2296 (1997).
11 J. Montfort, Keller and Heckman, "The Article 30 Solution: An Alternative to Market Food Contact Materials in the European Union," 51 Food, Drug, and Cosmetic Law Journal 161 (1996).